CODE OF FEDERAL REGULATIONS
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The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. The Code is divided into 50 titles which represent broad areas subject to Federal regulation. Each title is divided into chapters which usually bear the name of the issuing agency. Each chapter is further subdivided into parts covering specific regulatory areas.
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Title 9—
For this volume, Cheryl E. Sirofchuck was Chief Editor. The Code of Federal Regulations publication program is under the direction of Michael L. White, assisted by Ann Worley.
(This book contains parts 1 to 199)
Other regulations issued by the Department of Agriculture appear in title 7, title 36, chapter II, and title 41, chapter 4.
7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.7.
For the purposes of this subchapter, unless the context otherwise requires, the following terms shall have the meanings assigned to them in this section. The singular form shall also signify the plural and the masculine form shall also signify the feminine. Words undefined in the following paragraphs shall have the meaning attributed to them in general usage as reflected by definitions in a standard dictionary.
(1) Between a place in a State and any place outside of such State, including any foreign country, or between points within the same State but through any place outside thereof, or within any territory, possession, or the District of Columbia; or
(2) Which affects the commerce described in this part.
(1) It must be capable of controlling the temperature within the building or structure within the limits set forth for that species of animal, of maintaining humidity levels of 30 to 70 percent and of rapidly eliminating odors from within the building; and
(2) It must be an enclosure created by the continuous connection of a roof, floor, and walls (a shed or barn set on top of the ground does not have a continuous connection between the walls and the ground unless a foundation and floor are provided); and
(3) It must have at least one door for entry and exit that can be opened and closed (any windows or openings which provide natural light must be covered with a transparent material such as glass or hard plastic).
(1) Establishments or persons who deal in dogs used for hunting, security, or breeding purposes;
(2) Establishments or persons exhibiting, selling, or offering to exhibit or sell any wild or exotic or other nonpet species of warmblooded animals (except birds), such as skunks, raccoons, nonhuman primates, squirrels, ocelots, foxes, coyotes, etc.;
(3) Any establishment or person selling warmblooded animals (except birds, and laboratory rats and mice) for research or exhibition purposes; and
(4) Any establishment wholesaling any animals (except birds, rats and mice).
(5) Any establishment exhibiting pet animals in a room that is separate from or adjacent to the retail pet store, or in an outside area, or anywhere off the retail pet store premises.
At 64 FR 15920, Apr. 2, 1999, the definitions of
7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.7.
(a)(1) Any person operating or intending to operate as a dealer, exhibitor, or operator of an auction sale, except persons who are exempted from the licensing requirements under paragraph (a)(3) of this section, must have a valid license. A person must be 18 years of age or older to obtain a license. A person seeking a license shall apply on a form which will be furnished by the AC Regional Director in the State in which that person operates or intends to operate. The applicant shall provide the information requested on the application form, including a valid mailing address through which the licensee or applicant can be reached at all times, and a valid premises address where animals, animal facilities, equipment, and records may be inspected for compliance. The applicant shall file the completed application form with the AC Regional Director.
(2) If an applicant for a license or license renewal operates in more than one State, he or she shall apply in the State in which he or she has his or her principal place of business. All premises, facilities, or sites where such person operates or keeps animals shall be indicated on the application form or on a separate sheet attached to it. The completed application form, along with the application fee indicated in paragraph (c) of this section, and the annual license fee indicated in table 1 or 2 of § 2.6 shall be filed with the AC Regional Director.
(3) The following persons are exempt from the licensing requirements under section 2 or section 3 of the Act:
(i) Retail pet stores which sell nondangerous, pet-type animals, such as dogs, cats, birds, rabbits, hamsters, guinea pigs, gophers, domestic ferrets, chinchilla, rats, and mice, for pets, at retail only:
(ii) Any person who sells or negotiates the sale or purchase of any animal except wild or exotic animals, dogs, or cats, and who derives no more than $500 gross income from the sale of such animals to a research facility, an exhibitor, a dealer, or a pet store during any calendar year and is not otherwise required to obtain a license;
(iii) Any person who maintains a total of three (3) or fewer breeding female dogs, cats, and/or small exotic or wild mammals, such as hedgehogs, degus, spiny mice, prairie dogs, flying squirrels, and jerboas, and who sells only the offspring of these dogs, cats, or small exotic or wild mammals, which were born and raised on his or her premises, for pets or exhibition, and is not otherwise required to obtain a license. This exemption does not extend to any person residing in a household that collectively maintains a total of more than three breeding female dogs, cats, and/or small exotic or wild mammals, regardless of ownership, nor to any person maintaining breeding female dogs, cats, and/or small exotic or wild mammals on premises on which more than three breeding female dogs, cats, and/or small exotic or wild mammals are maintained, nor to any person acting in concert with others where they collectively maintain a total of more than three breeding female dogs, cats, and/or small exotic or wild mammals regardless of ownership;
(iv) Any person who sells fewer than 25 dogs and/or cats per year, which were born and raised on his or her premises, for research, teaching, or testing purposes or to any research facility and is not otherwise required to obtain a license. This exemption does not extend to any person residing in a household that collectively sells 25 or more dogs and/or cats, regardless of ownership, nor to any person acting in concert with others where they collectively sell 25 or more dogs and/or cats, regardless of ownership. The sale of any dog or cat not born and raised on the premises for research purposes requires a license;
(v) Any person who arranges for transportation or transports animals solely for the purpose of breeding, exhibiting in purebred shows, boarding (not in association with commercial transportation), grooming, or medical treatment, and is not otherwise required to obtain a license;
(vi) Any person who buys, sells, transports, or negotiates the sale, purchase, or transportation of any animals used only for the purposes of food or fiber (including fur);
(vii) Any person who breeds and raises domestic pet animals for direct retail sales to another person for the buyer's own use and who buys no animals for resale and who sells no animals to a research facility, an exhibitor, a dealer, or a pet store (e.g., a purebred dog or cat fancier) and is not otherwise required to obtain a license;
(viii) Any person who buys animals solely for his or her own use or enjoyment and does not sell or exhibit animals, or is not otherwise required to obtain a license;
(b) No person shall have more than one license.
(c) A license will be issued to any applicant, except as provided in §§ 2.10 and 2.11, when:
(1) The applicant has met the requirements of this section and §§ 2.2 and 2.3; and
(2) The applicant has paid the application fee of $10 and the annual license fee indicated in § 2.6 to the appropriate Animal Care regional office for an initial license, and, in the case of a license renewal, the annual license fee has been received by the appropriate Animal Care regional office on or before the expiration date of the license.
(d)(1) A licensee who wishes a renewal must submit to the appropriate Animal Care regional office a completed application form and the annual license fee indicated in § 2.6 by certified check, cashier's check, personal check, money order, or credit card. The application form and the annual license fee must be received by the appropriate Animal Care regional office on or before the expiration date of the license. An applicant whose check is returned by the bank will be charged a fee of $20 for each returned check. A returned check will be deemed nonpayment of fee and will result in the denial of the license. If an applicant's check is returned, subsequent fees must be paid by certified check, cashier's check, or money order.
(2) A license fee indicated in § 2.6 must also be paid if an applicant is applying for a changed class of license. The applicant may pay the fee by certified check, cashier's check, personal check, money order, or credit card. An applicant whose check is returned by a bank will be charged a fee of $20 for each returned check. If an applicant's check is returned, subsequent fees must be paid by certified check, cashier's check, or money order.
(e) The failure of any person to comply with any provision of the Act, or any of the provisions of the regulations or standards in this subchapter, shall constitute grounds for denial of a license; or for its suspension or revocation by the Secretary, as provided in the Act.
(a)
(b)
(a) Each applicant must demonstrate that his or her premises and any animals, facilities, vehicles, equipment, or other premises used or intended for use
(b) Each applicant for an initial license must be inspected by APHIS and demonstrate compliance with the regulations and standards, as required in paragraph (a) of this section, before APHIS will issue a license. If the first inspection reveals that the applicant's animals, premises, facilities, vehicles, equipment, other premises, or records do not meet the requirements of this subchapter, APHIS will advise the applicant of existing deficiencies and the corrective measures that must be completed to come into compliance with the regulations and standards. An applicant who fails the first inspection will have two additional chances to demonstrate his or her compliance with the regulations and standards through a second inspection by APHIS. The applicant must request the second inspection, and if applicable, the third inspection, within 90 days following the first inspection. If the applicant fails inspection or fails to request reinspections within the 90-day period, he or she will forfeit the application fee and cannot reapply for a license for a period of 6 months from the date of the failed third inspection or the expiration of the time to request a third inspection. Issuance of a license will be denied until the applicant demonstrates upon inspection that the animals, premises, facilities, vehicles, equipment, other premises, and records are in compliance with all regulations and standards in this subchapter.
A licensee or applicant for an initial license shall not interfere with, threaten, abuse (including verbally abuse), or harass any APHIS official in the course of carrying out his or her duties.
(a) A license issued under this part shall be valid and effective unless:
(1) The license has been revoked or suspended pursuant to section 19 of the Act.
(2) The license is voluntarily terminated upon request of the licensee, in writing, to the AC Regional Director.
(3) The license has expired or been terminated under this part.
(4) The annual license fee has not been paid to the appropriate Animal Care regional office as required. There will not be a refund of the annual license fee if a license is terminated prior to its expiration date.
(b) Any person who is licensed must file an application for a license renewal and an annual report form (APHIS Form 7003), as required by § 2.7 of this part, and pay the required annual license fee. The required annual license fee must be received in the appropriate Animal Care regional office on or before the expiration date of the license or the license will expire and automatically terminate. Failure to comply with the annual reporting requirements or pay the required annual license fee on or before the expiration date of the license will result in automatic termination of the license.
(c) Any person who seeks the reinstatement of a license that has been automatically terminated must follow the procedure applicable to new applicants for a license set forth in § 2.1.
(d) Licenses are issued to specific persons for specific premises and do not transfer upon change of ownership, nor are they valid at a different location.
(e) A license which is invalid under this part shall be surrendered to the AC Regional Director. If the license cannot be found, the licensee shall provide a written statement so stating to the AC Regional Director.
(a) For an initial license, the applicant must submit a $10 application fee in addition to the initial license fee prescribed in this section. Licensees applying for license renewal or changed class of license must submit only the license fee prescribed in this section. The license fee for an initial license, license renewal, or changed class of license is determined from table 1 or 2 in paragraph (c) of this section. Paragraph (b) of this section indicates the method used to calculate the license fee. All initial license and changed class of license fees must be submitted to the appropriate Animal Care regional office, and, in the case of license renewals, all fees must be received by the appropriate Animal Care regional office on or before the expiration date of the license.
(b)(1) Class “A” license. The annual license renewal fee for a Class “A” dealer shall be based on 50 percent of the total gross amount, expressed in dollars, derived from the sale of animals to research facilities, dealers, exhibitors, retail pet stores, and persons for use as pets, directly or through an auction sale, by the dealer or applicant during his or her preceding business year (calendar or fiscal) in the case of a person who operated during such a year. If animals are leased, the lessor shall pay a fee based on 50 percent of any compensation received from the leased animals and the lessee shall pay a fee based upon the net compensation received from the leased animals, as indicated for dealers in Table 1 in paragraph (c) of this section.
(2) Class “B” license. The annual license renewal fee for a Class “B” dealer shall be established by calculating the total amount received from the sale of animals to research facilities, dealers, exhibitors, retail pet stores, and persons for use as pets, directly or through an auction sale, during the preceding business year (calendar or fiscal) less the amount paid for the animals by the dealer or applicant. This net difference, exclusive of other costs, shall be the figure used to determine the license fee of a Class “B” dealer. If animals are leased, the lessor and lessee shall each pay a fee based on the net compensation received from the leased animals calculated from Table 1 in paragraph (c) of this section.
(3) The annual license renewal fee for a broker or operator of an auction sale shall be that of a class “B” dealer and shall be based on the total gross amount, expressed in dollars, derived from commissions or fees charged for the sale of animals, or for negotiating the sale of animals, by brokers or by the operator of an auction sale, to research facilities, dealers, exhibitors, retail pet stores, and persons for use as pets, during the preceding business year (calendar or fiscal).
(4) In the case of a new applicant for a license as a dealer, broker or operator of an auction sale who did not operate during a preceding business year, the annual license fee will be based on the anticipated yearly dollar amount of business, as provided in paragraphs (b)(1), (2), and (3) of this section, derived from the sale of animals to research facilities, dealers, exhibitors, retail pet stores, and persons for use as pets, directly or through an auction sale.
(5) The amount of the annual fee to be paid upon application for a class “C” license as an exhibitor under this section shall be based on the number of animals which the exhibitor owned, held, or exhibited at the time the application is signed and dated or during the previous year, whichever is greater, and will be the amount listed in Table 2 in paragraph (c) of this section. Animals which are leased shall be included in the number of animals being held by both the lessor and the lessee when calculating the annual fee. An exhibitor shall pay his or her annual license fee on or before the expiration date of the license and the fee shall be based on the number of animals which the exhibitor is holding or has held during the year (both owned and leased).
(c) The license fee shall be computed in accordance with the following tables:
(d) If a person meets the licensing requirements for more than one class of license, he shall be required to obtain a license and pay the fee for the type business which is predominant for his operation, as determined by the Secretary.
(e) In any situation in which a licensee shall have demonstrated in writing to the satisfaction of the Secretary that he or she has good reason to believe that the dollar amount of his or her business for the forthcoming business year will be less than the previous business year, then his or her estimated dollar amount of business shall be used for computing the license fee for the forthcoming business year:
(a) Each year, within 30 days prior to the expiration date of his or her license, a licensee shall file with the AC Regional Director an application for license renewal and annual report upon a form which the AC Regional Director will furnish to him or her upon request.
(b) A person licensed as a dealer shall set forth in his or her license renewal application and annual report the dollar amount of business, from the sale of animals, upon which the license fee is based, directly or through an auction sale, to research facilities, dealers, exhibitors, retail pet stores, and persons for use as pets, by the licensee during the preceding business year (calendar or fiscal), and any other information as may be required thereon.
(c) A licensed dealer who operates as a broker or an operator of an auction sale shall set forth in his or her license renewal application and annual report the total gross amount, expressed in dollars, derived from commissions or fees charged for the sale of animals by the licensee to research facilities, dealers, exhibitors, retail pet stores, and persons for use as pets, during the preceding business year (calendar or fiscal), and any other information as may be required thereon.
(d) A person licensed as an exhibitor shall set forth in his or her license renewal application and annual report the number of animals owned, held, or exhibited by him or her, including those which are leased, during the previous year or at the time he signs and dates the report, whichever is greater.
A licensee shall promptly notify the AC Regional Director by certified mail of any change in the name, address, management, or substantial control or ownership of his business or operation, or of any additional sites, within 10 days of any change.
Any person who has been or is an officer, agent, or employee of a licensee whose license has been suspended or revoked and who was responsible for or participated in the violation upon which the order of suspension or revocation was based will not be licensed within the period during which the order of suspension or revocation is in effect.
(a) Any person whose license has been suspended for any reason shall not be licensed in his or her own name or in any other manner within the period during which the order of suspension is in effect. No partnership, firm, corporation, or other legal entity in which any such person has a substantial interest, financial or otherwise, will be licensed during that period. Any person whose license has been suspended for any reason may apply to the AC Regional Director, in writing, for reinstatement of his or her license. No license will be renewed during the period that it is suspended. Renewal of the license may be initiated during the suspension in accordance with §§ 2.2(b) and 2.12.
(b) Any person whose license has been revoked shall not be licensed in his or her own name or in any other manner; nor will any partnership, firm, corporation, or other legal entity in which any such person has a substantial interest, financial or otherwise, be licensed.
(c) Any person whose license has been suspended or revoked shall not buy, sell, transport, exhibit, or deliver for transportation, any animal during the period of suspension or revocation.
(a) A license will not be issued to any applicant who:
(1) Has not complied with the requirements of §§ 2.1, 2.2, 2.3, and 2.4 and has not paid the fees indicated in § 2.6;
(2) Is not in compliance with any of the regulations or standards in this subchapter;
(3) Has had a license revoked or whose license is suspended, as set forth in § 2.10;
(4) Has pled
(5) Is or would be operating in violation or circumvention of any Federal, State, or local laws; or
(6) Has made any false or fraudulent statements or provided any false or fraudulent records to the Department or other government agencies, or has pled
(b) An applicant whose license application has been denied may request a hearing in accordance with the applicable rules of practice for the purpose of showing why the application for license should not be denied. The license denial shall remain in effect until the final legal decision has been rendered. Should the license denial be upheld, the applicant may again apply for a license 1 year from the date of the final order denying the application, unless the order provides otherwise.
(c) No partnership, firm, corporation, or other legal entity in which a person whose license application has been denied has a substantial interest, financial or otherwise, will be licensed within 1 year of the license denial.
(d) No license will be issued under circumstances that the Administrator determines would circumvent any order suspending, revoking, terminating, or denying a license under the Act.
A license may be terminated during the license renewal process or at any other time for any reason that an initial license application may be denied pursuant to § 2.11 after a hearing in accordance with the applicable rules of practice.
(a) Each carrier and intermediate handler, and each exhibitor not required to be licensed under section 3 of the Act and the regulations of this subchapter, shall register with the Secretary by completing and filing a properly executed form which will be furnished, upon request, by the AC Regional Director. The registration form shall be filed with the AC Regional Director for the State in which the registrant has his or her principal place of business, and shall be updated every 3 years by the completion and filing of a new registration form which will be provided by the AC Regional Director.
(b) A subsidiary of a business corporation, rather than the parent corporation, will be registered as an exhibitor unless the subsidiary is under such direct control of the parent corporation that the Secretary determines that it is necessary that the parent corporation be registered to effectuate the purposes of the Act.
(c) No registrant or person required to be registered shall interfere with, threaten, abuse (including verbally abuse), or harass any APHIS official who is in the course of carrying out his or her duties.
APHIS will supply a copy of the regulations and standards in this subchapter with each registration form. The registrant shall acknowledge receipt of and shall agree to comply with the regulations and standards by signing a form provided for this purpose by APHIS, and by filing it with the AC Regional Director.
(a) A registrant shall notify the AC Regional Director by certified mail of any change in the name, address, or ownership, or other change in operations affecting its status as an exhibitor, carrier, or intermediate handler, within 10 days after making such change.
(b)(1) A registrant which has not used, handled, or transported animals for a period of at least 2 years may be placed in an inactive status by making a written request to the AC Regional Director a registrant shall notify the AC Regional Director in writing at least 10 days before using, handling, or transporting animals again after being in an inactive status.
(2) A registrant which goes out of business or which ceases to function as a carrier, intermediate handler, or exhibitor, or which changes its method of operation so that it no longer uses, handles, or transports animals, and which does not plan to use, handle, or transport animals again at any time in the future, may have its registration canceled by making a written request to the AC Regional Director. The former registrant is responsible for reregistering and demonstrating its compliance with the Act and regulations should it start using, handling, or transporting animals at any time after its registration is canceled.
(a)
(2) In any situation in which a school or department of a university or college demonstrates to the Secretary that it is a separate legal entity and its operations and administration are independent of those of the university or college, the school or department will be registered rather than the university or college.
(3) A subsidiary of a business corporation, rather than the parent corporation, will be registered as a research facility unless the subsidiary is under such direct control of the parent corporation that the Secretary determines that it is necessary that the parent corporation be registered to effectuate the purposes of the Act.
(b)
(c)
(2) A research facility which has not used, handled, or transported animals for a period of at least 2 years may be placed in an inactive status by making a written request to the AC Regional Director. A research facility shall file an annual report of its status (active or inactive). A research facility shall notify the AC Regional Director in writing at least 10 days before using, handling, or transporting animals again after being in an inactive status.
(3) A research facility which goes out of business or which ceases to function as a research facility, or which changes its method of operation so that it no longer uses, handles, or transports animals, and which does not plan to use, handle, or transport animals at any time in the future, may have its registration canceled by making a written request to the AC Regional Director. The research facility is responsible for reregistering and demonstrating its compliance with the Act and regulations should it start using, handling, or transporting animals at any time after its registration is canceled.
(d) No research facility shall interfere with, threaten, abuse (including verbally abuse), or harass any APHIS official who is in the course of carrying out his or her duties.
(a) The Chief Executive Officer of the research facility shall appoint an Institutional Animal Care and Use Committee (IACUC), qualified through the experience and expertise of its members to assess the research facility's animal program, facilities, and procedures. Except as specifically authorized by law or these regulations, nothing in this part shall be deemed to permit the Committee or IACUC to prescribe methods or set standards for the design, performance, or conduct of actual research or experimentation by a research facility.
(b)
(2) The Committee shall be composed of a Chairman and at least two additional members;
(3) Of the members of the Committee:
(i) At least one shall be a Doctor of Veterinary Medicine, with training or experience in laboratory animal science and medicine, who has direct or
(ii) At least one shall not be affiliated in any way with the facility other than as a member of the Committee, and shall not be a member of the immediate family of a person who is affiliated with the facility. The Secretary intends that such person will provide representation for general community interests in the proper care and treatment of animals;
(4) If the Committee consists of more than three members, not more than three members shall be from the same administrative unit of the facility.
(c)
(1) Review, at least once every six months, the research facility's program for humane care and use of animals, using title 9, chapter I, subchapter A—Animal Welfare, as a basis for evaluation;
(2) Inspect, at least once every six months, all of the research facility's animal facilities, including animal study areas, using title 9, chapter I, subchapter A-Animal Welfare, as a basis for evaluation;
(3) Prepare reports of its evaluations conducted as required by paragraphs (c)(1) and (2) of this section, and submit the reports to the Institutional Official of the research facility;
(4) Review, and, if warranted, investigate concerns involving the care and use of animals at the research facility resulting from public complaints received and from reports of noncompliance received from laboratory or research facility personnel or employees;
(5) Make recommendations to the Institutional Official regarding any aspect of the research facility's animal program, facilities, or personnel training;
(6) Review and approve, require modifications in (to secure approval), or withhold approval of those components of proposed activities related to the care and use of animals, as specified in paragraph (d) of this section;
(7) Review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the care and use of animals in ongoing activities; and
(8) Be authorized to suspend an activity involving animals in accordance with the specifications set forth in paragraph (d)(6) of this section.
(d) IACUC review of activities involving animals. (1) In order to approve proposed activities or proposed significant changes in ongoing activities, the IACUC shall conduct a review of those components of the activities related to the care and use of animals and determine that the proposed activities are in accordance with this subchapter unless acceptable justification for a departure is presented in writing;
(i) Procedures involving animals will avoid or minimize discomfort, distress, and pain to the animals;
(ii) The principal investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animals, and has provided a written narrative description of the methods and sources,
(iii) The principal investigator has provided written assurance that the activities do not unnecessarily duplicate previous experiments;
(iv) Procedures that may cause more than momentary or slight pain or distress to the animals will:
(A) Be performed with appropriate sedatives, analgesics or anesthetics, unless withholding such agents is justified for scientific reasons, in writing, by the principal investigator and will continue for only the necessary period of time;
(B) Involve, in their planning, consultation with the attending veterinarian or his or her designee;
(C) Not include the use of paralytics without anesthesia;
(v) Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly euthanized at the end of the procedure or, if appropriate, during the procedure;
(vi) The animals' living conditions will be appropriate for their species in accordance with part 3 of this subchapter, and contribute to their health and comfort. The housing, feeding, and nonmedical care of the animals will be directed by the attending veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied;
(vii) Medical care for animals will be available and provided as necessary by a qualified veterinarian;
(viii) Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures;
(ix) Activities that involve surgery include appropriate provision for pre-operative and post-operative care of the animals in accordance with established veterinary medical and nursing practices. All survival surgery will be performed using aseptic procedures, including surgical gloves, masks, sterile instruments, and aseptic techniques. Major operative procedures on non-rodents will be conducted only in facilities intended for that purpose which shall be operated and maintained under aseptic conditions. Non-major operative procedures and all surgery on rodents do not require a dedicated facility, but must be performed using aseptic procedures. Operative procedures conducted at field sites need not be performed in dedicated facilities, but must be performed using aseptic procedures;
(x) No animal will be used in more than one major operative procedure from which it is allowed to recover, unless:
(A) Justified for scientific reasons by the principal investigator, in writing;
(B) Required as routine veterinary procedure or to protect the health or well-being of the animal as determined by the attending veterinarian; or
(C) In other special circumstances as determined by the Administrator on an individual basis. Written requests and supporting data should be sent to the Animal and Plant Health Inspection Service, Animal Care, 4700 River Road, Unit 84, Riverdale, Maryland 20737-1234;
(xi) Methods of euthanasia used must be in accordance with the definition of
(2) Prior to IACUC review, each member of the Committee shall be provided with a list of proposed activities to be reviewed. Written descriptions of all proposed activities that involve the care and use of animals shall be available to all IACUC members, and any member of the IACUC may obtain, upon request, full Committee review of those activities. If full Committee review is not requested, at least one member of the IACUC, designated by the chairman and qualified to conduct the review, shall review those activities, and shall have the authority to approve, require modifications in (to secure approval), or request full Committee review of any of those activities. If full Committee review is requested for a proposed activity, approval of that activity may be granted only after review, at a convened meeting of a quorum of the IACUC, and with the approval vote of a majority of the quorum present. No member may participate in the IACUC review or approval of an activity in which that member has a conflicting interest (e.g., is personally involved in the activity), except to provide information requested by the IACUC, nor may a member who has a conflicting interest contribute to the constitution of a quorum;
(3) The IACUC may invite consultants to assist in the review of complex issues arising out of its review of proposed activities. Consultants may not approve or withhold approval of an activity, and may not vote with the IACUC unless they are also members of the IACUC;
(4) The IACUC shall notify principal investigators and the research facility in writing of its decision to approve or withhold approval of those activities related to the care and use of animals, or of modifications required to secure IACUC approval. If the IACUC decides to withhold approval of an activity, it shall include in its written notification a statement of the reasons for its decision and give the principal investigator an opportunity to respond in person or in writing. The IACUC may reconsider its decision, with documentation in Committee minutes, in light of the information provided by the principal investigator;
(5) The IACUC shall conduct continuing reviews of activities covered by this subchapter at appropriate intervals as determined by the IACUC, but not less than annually;
(6) The IACUC may suspend an activity that it previously approved if it determines that the activity is not being conducted in accordance with the description of that activity provided by the principal investigator and approved by the Committee. The IACUC may suspend an activity only after review of the matter at a convened meeting of a quorum of the IACUC and with the suspension vote of a majority of the quorum present;
(7) If the IACUC suspends an activity involving animals, the Institutional Official, in consultation with the IACUC, shall review the reasons for suspension, take appropriate corrective action, and report that action with a full explanation to APHIS and any Federal agency funding that activity; and
(8) Proposed activities and proposed significant changes in ongoing activities that have been approved by the IACUC may be subject to further appropriate review and approval by officials of the research facility. However, those officials may not approve an activity involving the care and use of animals if it has not been approved by the IACUC.
(e) A proposal to conduct an activity involving animals, or to make a significant change in an ongoing activity involving animals, must contain the following:
(1) Identification of the species and the approximate number of animals to be used;
(2) A rationale for involving animals, and for the appropriateness of the species and numbers of animals to be used;
(3) A complete description of the proposed use of the animals;
(4) A description of procedures designed to assure that discomfort and pain to animals will be limited to that which is unavoidable for the conduct of scientifically valuable research, including provision for the use of analgesic, anesthetic, and tranquilizing drugs
(5) A description of any euthanasia method to be used.
(a) It shall be the responsibility of the research facility to ensure that all scientists, research technicians, animal technicians, and other personnel involved in animal care, treatment, and use are qualified to perform their duties. This responsibility shall be fulfilled in part through the provision of training and instruction to those personnel.
(b) Training and instruction shall be made available, and the qualifications of personnel reviewed, with sufficient frequency to fulfill the research facility's responsibilities under this section and § 2.31.
(c) Training and instruction of personnel must include guidance in at least the following areas:
(1) Humane methods of animal maintenance and experimentation, including:
(i) The basic needs of each species of animal;
(ii) Proper handling and care for the various species of animals used by the facility;
(iii) Proper pre-procedural and post-procedural care of animals; and
(iv) Aseptic surgical methods and procedures;
(2) The concept, availability, and use of research or testing methods that limit the use of animals or minimize animal distress;
(3) Proper use of anesthetics, analgesics, and tranquilizers for any species of animals used by the facility;
(4) Methods whereby deficiencies in animal care and treatment are reported, including deficiencies in animal care and treatment reported by any employee of the facility. No facility employee, Committee member, or laboratory personnel shall be discriminated against or be subject to any reprisal for reporting violations of any regulation or standards under the Act;
(5) Utilization of services (e.g., National Agricultural Library, National Library of Medicine) available to provide information:
(i) On appropriate methods of animal care and use;
(ii) On alternatives to the use of live animals in research;
(iii) That could prevent unintended and unnecessary duplication of research involving animals; and
(iv) Regarding the intent and requirements of the Act.
(a) Each research facility shall have an attending veterinarian who shall provide adequate veterinary care to its animals in compliance with this section:
(1) Each research facility shall employ an attending veterinarian under formal arrangements. In the case of a part-time attending veterinarian or consultant arrangements, the formal arrangements shall include a written program of veterinary care and regularly scheduled visits to the research facility;
(2) Each research facility shall assure that the attending veterinarian has appropriate authority to ensure the provision of adequate veterinary care and to oversee the adequacy of other aspects of animal care and use; and
(3) The attending veterinarian shall be a voting member of the IACUC;
(b) Each research facility shall establish and maintain programs of adequate veterinary care that include:
(1) The availability of appropriate facilities, personnel, equipment, and services to comply with the provisions of this subchapter;
(2) The use of appropriate methods to prevent, control, diagnose, and treat diseases and injuries, and the availability of emergency, weekend, and holiday care;
(3) Daily observation of all animals to assess their health and well-being;
(4) Guidance to principal investigators and other personnel involved in the care and use of animals regarding handling, immobilization, anesthesia, analgesia, tranquilization, and euthanasia; and
(5) Adequate pre-procedural and post-procedural care in accordance with current established veterinary medical and nursing procedures.
(a) The research facility shall maintain the following IACUC records:
(1) Minutes of IACUC meetings, including records of attendance, activities of the Committee, and Committee deliberations;
(2) Records of proposed activities involving animals and proposed significant changes in activities involving animals, and whether IACUC approval was given or withheld; and
(3) Records of semiannual IACUC reports and recommendations (including minority views), prepared in accordance with the requirements of § 2.31(c)(3) of this subpart, and forwarded to the Institutional Official.
(b) Every research facility shall make, keep, and maintain records or forms which fully and correctly disclose the following information concerning each live dog or cat purchased or otherwise acquired, owned, held, or otherwise in their possession or under their control, transported, euthanized, sold, or otherwise disposed of by the research facility. The records shall include any offspring born of any animal while in the research facility's possession or under its control:
(1) The name and address of the person from whom a dog or cat was purchased or otherwise acquired, whether or not the person is required to be licensed or registered under the Act;
(2) The USDA license or registration number of the person if he or she is licensed or registered under the Act;
(3) The vehicle license number and State, and the driver's license number (or photographic identification card for nondrivers issued by a State) and State of the person, if he or she is not licensed or registered under the Act;
(4) The date of acquisition of each dog or cat;
(5) The official USDA tag number or tattoo assigned to each dog or cat under § 2.38(g) of this subpart;
(6) A description of each dog or cat which shall include:
(i) The species and breed or type of animal;
(ii) The sex;
(iii) The date of birth or approximate age; and
(iv) The color and any distinctive markings;
(7) Any identification number or mark assigned to each dog or cat by the research facility;
(8) If dogs or cats are acquired from any person not licensed or registered under the Act and not a pound or shelter, the research facility must obtain a certification that the animals were born and raised on the person's premises and that the person has sold fewer than 25 dogs and/or cats that year.
(c) In addition to the information required to be kept and maintained by every research facility concerning each live dog or cat under paragraph (a) of this section, every research facility transporting, selling, or otherwise disposing of any live dog or cat to another person, shall make and maintain records or forms which fully and correctly disclose the following information:
(1) The name and address of the person to whom a live dog or cat is transported, sold, or otherwise disposed of;
(2) The date of transportation, sale, euthanasia, or other disposition of the animal; and
(3) The method of transportation, including the name of the initial carrier or intermediate handler, or if a privately owned vehicle is used to transport the dog or cat, the name of the owner of the privately owned vehicle.
(d)(1) The USDA Interstate and International Certificate of Health Examination for Small Animals (APHIS Form 7001) and Record of Aquisition and Dogs and Cats on Hand (APHIS Form 7005) are forms which may be used by research facilities to keep and maintain the information required by paragraph (b) of this section.
(2) The USDA Interstate and International Certificate of Health Examination for Small Animals (APHIS Form 7001) and Record of Disposition of Dogs and Cats (APHIS Form 7006) are forms which may be used by research facilities to keep and maintain the information required by paragraph (c) of this section.
(e) One copy of the record containing the information required by paragraphs (b) and (c) of this section shall accompany each shipment of any live dog or cat sold or otherwise disposed of by a research facility;
(f) All records and reports shall be maintained for at least three years. Records that relate directly to proposed activities and proposed significant changes in ongoing activities reviewed and approved by the IACUC shall be maintained for the duration of the activity and for an additional three years after completion of the activity. All records shall be available for inspection and copying by authorized APHIS or funding Federal agency representatives at reasonable times. APHIS inspectors will maintain the confidentiality of the information and will not remove the materials from the research facilities' premises unless there has been an alleged violation, they are needed to investigate a possible violation, or for other enforcement purposes. Release of any such materials, including reports, summaries, and photographs that contain trade secrets or commercial or financial information that is privileged or confidential will be governed by applicable sections of the Freedom of Information Act. Whenever the Administrator notifies a research facility in writing that specified records shall be retained pending completion of an investigation or proceeding under the Act, the research facility shall hold those records until their disposition is authorized in writing by the Administrator.
(a) The reporting facility shall be that segment of the research facility, or that department, agency, or instrumentality of the United States, that uses or intends to use live animals in research, tests, experiments, or for teaching. Each reporting facility shall submit an annual report to the AC Regional Director for the State where the facility is located on or before December 1 of each calendar year. The report shall be signed and certified by the CEO or Institutional Official, and shall cover the previous Federal fiscal year.
(b) The annual report shall:
(1) Assure that professionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of anesthetic, analgesic, and tranquilizing drugs, prior to, during, and following actual research, teaching, testing, surgery, or experimentation were followed by the research facility;
(2) Assure that each principal investigator has considered alternatives to painful procedures;
(3) Assure that the facility is adhering to the standards and regulations under the Act, and that it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and approved by the IACUC. A summary of all such exceptions must be attached to the facility's annual report. In addition to identifying the IACUC-approved exceptions, this summary must include a brief explanation of the exceptions, as well as the species and number of animals affected;
(4) State the location of all facilities where animals were housed or used in actual research, testing, teaching, or experimentation, or held for these purposes;
(5) State the common names and the numbers of animals upon which teaching, research, experiments, or tests were conducted involving no pain, distress, or use of pain-relieving drugs. Routine procedures (e.g., injections, tattooing, blood sampling) should be reported with this group;
(6) State the common names and the numbers of animals upon which experiments, teaching, research, surgery, or tests were conducted involving accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs were used;
(7) State the common names and the numbers of animals upon which teaching, experiments, research, surgery, or tests were conducted involving accompanying pain or distress to the animals and for which the use of appropriate anesthetic, analgesic, or tranquilizing drugs would have adversely affected the procedures, results, or interpretation of the teaching, research, experiments, surgery, or tests. An explanation of the procedures producing pain or distress in these animals and the reasons such drugs were not used shall be attached to the annual report;
(8) State the common names and the numbers of animals being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery but not yet used for such purposes.
Each Federal research facility shall establish an Institutional Animal Care and Use Committee which shall have the same composition, duties, and responsibilities required of nonfederal research facilities by § 2.31 with the following exceptions:
(a) The Committee shall report deficiencies to the head of the Federal agency conducting the research rather than to APHIS; and
(b) The head of the Federal agency conducting the research shall be responsible for all corrective action to be taken at the facility and for the granting of all exceptions to inspection protocol.
(a)
(b)
(i) To enter its place of business;
(ii) To examine records required to be kept by the Act and the regulations in this part;
(iii) To make copies of the records;
(iv) To inspect the facilities, property, and animals, as the APHIS officials consider necessary to enforce the provisions of the Act, the regulations, and the standards in this subchapter; and
(v) To document, by the taking of photographs and other means, conditions and areas of noncompliance.
(2) The use of a room, table or other facilities necessary for the proper examination of the records and for inspection of the property or animals shall be extended to APHIS officials by the research facility.
(c)
(d)
(1) The police or other law officer shall furnish to the research facility a written description of the missing animal and the name and address of its owner before making a search;
(2) The police or other law officer shall abide by all security measures required by the research facility to prevent the spread of disease, including the use of sterile clothing, footwear, and masks where required, or to prevent the escape of an animal.
(e)
(2) In the event that the APHIS official is unable to locate or notify the research facility as required in this section, the APHIS official shall contact a local police or other law officer to accompany him or her to the premises and shall provide for adequate care when necessary to alleviate the animal's suffering. If, in the opinion of the Administrator, the condition of the animal(s) cannot be corrected by this temporary care, the APHIS official shall confiscate the animal(s).
(3) Confiscated animals may be placed, by sale or donation, with other registrants or licensees that comply with the standards and regulations and can provide proper care, or they may be euthanized. The research facility from which the animals were confiscated shall bear all costs incurred in performing the placement or euthanasia activities authorized by this section.
(f)
(2)(i) Physical abuse shall not be used to train, work, or otherwise handle animals.
(ii) Deprivation of food or water shall not be used to train, work, or otherwise handle animals;
(g)
(i) By the official tag or tattoo which was affixed to the animal at the time it was acquired by the research facility, as required by this section; or
(ii) By a tag, tattoo, or collar, applied to the live dog or cat by the research facility and which individually identifies the dog or cat by number.
(2) All official tag or tattoo numbers shall be correctly listed in the records of purchase, acquisition, disposal, or sale which shall be maintained in accordance with § 2.35.
(3) Unweaned puppies or kittens need not be individually identified while they are maintained as a litter with their dam in the same primary enclosure, provided the dam has been individually identified.
(4) The official tag shall be made of a durable alloy such as brass, bronze, or steel, or of a durable plastic. Aluminum of a sufficient thickness to assure the tag is durable and legible may
(5) Each tag shall have the following information embossed or stamped on so that it is easily readable:
(i) The letters “USDA”;
(ii) Numbers identifying the State and dealer, exhibitor, or research facility (e.g., 39-AB); and
(iii) Numbers identifying the animal (e.g., 82488).
(6) Official tags shall be serially numbered and shall be applied to dogs or cats in the manner set forth in this section in as close to consecutive numerical order as possible. No tag number shall be used to identify more than one animal or shall be reused within a 5-year period.
(7) Research facilities may obtain, at their own expense, official tags from commercial tag manufacturers.
(8) Each research facility shall be held accountable for all official tags acquired. In the event an official tag is lost from a dog or cat while in the possession of a research facility, the facility shall make a diligent effort to locate and reapply the tag to the proper animal. If the lost tag is not located, the research facility shall affix another official tag to the animal in the manner prescribed in this section and record the tag number on the official records.
(9) When a dog or cat wearing or identified by an official tag arrives at a research facility, the facility may continue to use that tag to identify the dog or cat or the tag may be replaced as indicated in paragraph (g)(1) of this section. All tags removed by a research facility shall be retained and disposed of as indicated in this section.
(10) Where a dog or cat to which is affixed or which is identified by an official tag is euthanized, or dies from other causes, the research facility shall remove and retain the tag for the required period, as set forth in paragraph (g)(11) of this section.
(11) All official tags removed and retained by a research facility shall be held until called for by an APHIS official or for a period of 1 year.
(12) When official tags are removed from animals for disposal, the tags must be disposed of so as to preclude their reuse for animal identification. No animal identification number shall be used within any 5-year period following its previous use.
(h)
(i) The licensed veterinarian inspected the dog, cat, or nonhuman primate on a specified date which shall not be more than 10 days prior to the delivery of the dog, cat, or nonhuman primate for transportation; and
(ii) When so inspected, the dog, cat, or nonhuman primate appeared to the licensed veterinarian to be free of any infectious disease or physical abnormality which would endanger the animal(s) or other animals or endanger public health.
(2) The Secretary may provide exceptions to the health certification requirement on an individual basis for animals shipped to a research facility for purposes of research, testing, or experimentation when the research facility requires animals not eligible for certification. Requests should be addressed to the Animal and Plant Health Inspection Service, Animal Care, 4700 River Road, Unit 84, Riverdale, Maryland 20737-1234.
(3) The U.S. Interstate and International Certificate of Health Examination for Small Animals (APHIS Form 7001) may be used for health certification by a licensed veterinarian as required by this section.
(i)
(1) The other person agrees, in writing, to comply with the regulations in this part and the standards in part 3 of this subchapter, and to allow inspection of the premises by an APHIS official during business hours;
(2) The animals remain under the total control and responsibility of the research facility; and
(3) The Institutional Official agrees, in writing, that the other person or premises is a recognized animal site under its research facility registration. APHIS Form 7009 shall be used for approval.
(j)
(k)
(2) No person shall obtain live dogs or cats by use of false pretenses, misrepresentation, or deception.
(3) No person shall acquire, buy, sell, exhibit, use for research, transport, or offer for transportation, any stolen animal.
(4) Each research facility shall comply with the regulations set forth in § 2.133 of subpart I of this part.
(a) Each dealer or exhibitor shall have an attending veterinarian who shall provide adequate veterinary care to its animals in compliance with this section.
(1) Each dealer and exhibitor shall employ an attending veterinarian under formal arrangements. In the case of a part-time attending veterinarian or consultant arrangements, the formal arrangements shall include a written program of veterinary care and regularly scheduled visits to the premises of the dealer or exhibitor; and
(2) Each dealer and exhibitor shall assure that the attending veterinarian has appropriate authority to ensure the provision of adequate veterinary care and to oversee the adequacy of other aspects of animal care and use.
(b) Each dealer or exhibitor shall establish and maintain programs of adequate veterinary care that include:
(1) The availability of appropriate facilities, personnel, equipment, and services to comply with the provisions of this subchapter;
(2) The use of appropriate methods to prevent, control, diagnose, and treat diseases and injuries, and the availability of emergency, weekend, and holiday care;
(3) Daily observation of all animals to assess their health and well-being;
(4) Adequate guidance to personnel involved in the care and use of animals regarding handling, immobilization, anesthesia, analgesia, tranquilization, and euthanasia; and
(5) Adequate pre-procedural and post-procedural care in accordance with established veterinary medical and nursing procedures.
(a) A class “A” dealer (breeder) shall identify all live dogs and cats on the premises as follows:
(1) All live dogs and cats held on the premises, purchased, or otherwise acquired, sold or otherwise disposed of, or removed from the premises for delivery to a research facility or exhibitor or to another dealer, or for sale, through an auction sale or to any person for use as a pet, shall be identified by an official tag of the type described in § 2.51 affixed to the animal's neck by means of a collar made of material generally considered acceptable to pet owners as a means of identifying their pet dogs or cats
(2) Live puppies or kittens, less than 16 weeks of age, shall be identified by:
(i) An official tag as described in § 2.51;
(ii) A distinctive and legible tattoo marking approved by the Administrator; or
(iii) A plastic-type collar acceptable to the Administrator which has legibly placed thereon the information required for an official tag pursuant to § 2.51.
(b) A class “B” dealer shall identify all live dogs and cats under his or her control or on his or her premises as follows:
(1) When live dogs or cats are held, purchased, or otherwise acquired, they shall be immediately identified:
(i) By affixing to the animal's neck an official tag as set forth in § 2.51 by means of a collar made of material generally acceptable to pet owners as a means of identifying their pet dogs or cats
(ii) By a distinctive and legible tattoo marking approved by the Administrator.
(2) If any live dog or cat is already identified by an official tag or tattoo which has been applied by another dealer or exhibitor, the dealer or exhibitor who purchases or otherwise acquires the animal may continue identifying the dog or cat by the previous identification number, or may replace the previous tag with his own official tag or approved tattoo. In either case, the class B dealer or class C exhibitor shall correctly list all old and new official tag numbers or tattoos in his or her records of purchase which shall be maintained in accordance with §§ 2.75 and 2.77. Any new official tag or tattoo number shall be used on all records of any subsequent sales by the dealer or exhibitor, of any dog or cat.
(3) Live puppies or kittens less than 16 weeks of age, shall be identified by:
(i) An official tag as described in § 2.51;
(ii) A distinctive and legible tattoo marking approved by the Administrator; or
(iii) A plastic-type collar acceptable to the Administrator which has legibly placed thereon the information required for an official tag pursuant to § 2.51.
(4) When any dealer has made a reasonable effort to affix an official tag to a cat, as set forth in paragraphs (a) and (b) of this section, and has been unable to do so, or when the cat exhibits serious distress from the attachment of a collar and tag, the dealer shall attach the collar and tag to the door of the
(c) A class “C” exhibitor shall identify all live dogs and cats under his or her control or on his or her premises, whether held, purchased, or otherwise acquired:
(1) As set forth in paragraph (b)(1) or (b)(3) of this section, or
(2) By identifying each dog or cat with:
(i) An official USDA sequentially numbered tag that is kept on the door of the animal's cage or run;
(ii) A record book containing each animal's tag number, a written description of each animal, the data required by § 2.75(a), and a clear photograph of each animal; and
(iii) A duplicate tag that accompanies each dog or cat whenever it leaves the compound or premises.
(d) Unweaned puppies or kittens need not be individually identified as required by paragraphs (a) and (b) of this section while they are maintained as a litter with their dam in the same primary enclosure, provided the dam has been individually identified.
(e)(1) All animals, except dogs and cats, delivered for transportation, transported, purchased, sold, or otherwise acquired or disposed of by any dealer or exhibitor shall be identified by the dealer or exhibitor at the time of delivery for transportation, purchase, sale, acquisition or disposal, as provided for in this paragraph and in records maintained as required in §§ 2.75 and 2.77.
(2) When one or more animals, other than dogs or cats, are confined in a primary enclosure, the animal(s) shall be identified by:
(i) A label attached to the primary enclosure which shall bear a description of the animals in the primary enclosure, including:
(A) The number of animals;
(B) The species of the animals;
(C) Any distinctive physical features of the animals; and
(D) Any identifying marks, tattoos, or tags attached to the animals;
(ii) Marking the primary enclosure with a painted or stenciled number which shall be recorded in the records of the dealer or exhibitor together with:
(A) A description of the animal(s);
(B) The species of the animal(s); and
(C) Any distinctive physical features of the animal(s); or
(iii) A tag or tattoo applied to each animal in the primary enclosure by the dealer or exhibitor which individually identifies each animal by description or number.
(3) When any animal, other than a dog or cat, is not confined in a primary enclosure, it shall be identified on a record, as required by § 2.75, which shall accompany the animal at the time it is delivered for transportation, transported, purchased, or sold, and shall be kept and maintained by the dealer or exhibitor as part of his or her records.
(a) The official tag shall be made of a durable alloy such as brass, bronze, or steel, or of a durable plastic. Aluminum of a sufficient thickness to assure the tag is durable and legible may also be used. The tag shall be one of the following shapes:
(1) Circular in shape and not less than 1
(2) Oblong and flat in shape, not less than 2 inches by
(b) Each tag shall have the following information embossed or stamped on so that it is easily readable:
(1) The letters “USDA”;
(2) Numbers identifying the State and dealer, exhibitor, or research facility (e.g., 39-AB); and
(3) Numbers identifying the animal (e.g., 82488).
(c) Official tags shall be serially numbered. No individual dealer or exhibitor shall use any identification tag number more than once within a 5-year period.
Dealers or exhibitors may obtain, at their own expense, official tags from
Official tags obtained by a dealer, exhibitor, or research facility, shall be applied to dogs or cats in the manner set forth in § 2.50 and in as close to consecutive numerical order as possible. No tag number shall be used to identify more than one animal. No number shall be repeated within a 5-year period.
Each dealer or exhibitor shall be held accountable for all official tags acquired. In the event an official tag is lost from a dog or cat while in the possession of a dealer or exhibitor, the dealer or exhibitor shall make a diligent effort to locate and reapply the tag to the proper animal. If the lost tag is not located, the dealer or exhibitor shall affix another official tag to the animal in the manner prescribed in § 2.50, and record the tag number on the official records.
(a) Where a dog or cat to which is affixed or which is identified by an official tag is euthanized, or dies from other causes, the dealer or exhibitor shall remove and retain the tag for the required period, as set forth in paragraph (b) of this section.
(b) All official tags removed and retained by a dealer or exhibitor shall be held until called for by an APHIS official or for a period of 1 year.
(c) When official tags are removed from animals for disposal, the tags must be disposed of so as to preclude their reuse for animal identification. No animal identification number shall be used within any 5-year period following its previous use.
No person shall buy, sell, exhibit, use for research, transport, or offer for transportation, any stolen animal.
(a)(1) Each dealer, other than operators of auction sales and brokers to whom animals are consigned, and each exhibitor shall make, keep, and maintain records or forms which fully and correctly disclose the following information concerning each dog or cat purchased or otherwise acquired, owned, held, or otherwise in his or her possession or under his or her control, or which is transported, euthanized, sold, or otherwise disposed of by that dealer or exhibitor. The records shall include any offspring born of any animal while in his or her possession or under his or her control.
(i) The name and address of the person from whom a dog or cat was purchased or otherwise acquired whether or not the person is required to be licensed or registered under the Act;
(ii) The USDA license or registration number of the person if he or she is licensed or registered under the Act;
(iii) The vehicle license number and State, and the driver's license number (or photographic identification card for nondrivers issued by a State) and State of the person, if he or she is not licensed or registered under the Act;
(iv) The name and address of the person to whom a dog or cat was sold or given and that person's license or registration number if he or she is licensed or registered under the Act;
(v) The date a dog or cat was acquired or disposed of, including by euthanasia;
(vi) The official USDA tag number or tattoo assigned to a dog or cat under §§ 2.50 and 2.54;
(vii) A description of each dog or cat which shall include:
(A) The species and breed or type;
(B) The sex;
(C) The date of birth or approximate age; and
(D) The color and any distinctive markings;
(viii) The method of transportation including the name of the initial carrier or intermediate handler or, if a privately owned vehicle is used to transport a dog or cat, the name of the owner of the privately owned vehicle;
(ix) The date and method of disposition of a dog or cat, e.g., sale, death, euthanasia, or donation.
(2) Each dealer and exhibitor shall use Record of Aquisition and Dogs and Cats on Hand (APHIS Form 7005) and Record of Disposition of Dogs and Cats (APHIS Form 7006) to make, keep, and maintain the information required by paragraph (a)(1) of this section:
(i) The request for a variance must consist of a written statement describing why APHIS Form 7005 and APHIS Form 7006 are unsuitable for the dealer or exhibitor to make, keep, and maintain the information required by paragraph (a)(1) of this section, and a description of the computerized recordkeeping system the person would use in lieu of APHIS Form 7005 and APHIS Form 7006 to make, keep, and maintain the information required by paragraph (a)(1) of this section. APHIS will advise the person as to the disposition of his or her request for a variance from the requirement to use APHIS Form 7005 and APHIS Form 7006.
(ii) A dealer or exhibitor whose request for a variance has been denied may request a hearing in accordance with the applicable rules of practice for the purpose of showing why the request for a variance should not be denied. The denial of the variance shall remain in effect until the final legal decision has been rendered.
(3) The USDA Interstate and International Certificate of Health Examination for Small Animals (APHIS Form 7001) may be used by dealers and exhibitors to make, keep, and maintain the information required by § 2.79.
(4) One copy of the record containing the information required by paragraph (a)(1) of this section shall accompany each shipment of any dog or cat purchased or otherwise acquired by a dealer or exhibitor. One copy of the record containing the information required by paragraph (a)(1) of this section shall accompany each shipment of any dog or cat sold or otherwise disposed of by a dealer or exhibitor:
(b)(1) Every dealer other than operators of auction sales and brokers to whom animals are consigned, and exhibitor shall make, keep, and maintain records or forms which fully and correctly disclose the following information concerning animals other than dogs and cats, purchased or otherwise acquired, owned, held, leased, or otherwise in his or her possession or under his or her control, or which is transported, sold, euthanized, or otherwise disposed of by that dealer or exhibitor. The records shall include any offspring born of any animal while in his or her possession or under his or her control.
(i) The name and address of the person from whom the animals were purchased or otherwise acquired;
(ii) The USDA license or registration number of the person if he or she is licensed or registered under the Act;
(iii) The vehicle license number and State, and the driver's license number (or photographic identification card for nondrivers issued by a State) and State of the person, if he or she is not licensed or registered under the Act;
(iv) The name and address of the person to whom an animal was sold or given;
(v) The date of purchase, acquisition, sale, or disposal of the animal(s);
(vi) The species of the animal(s); and
(vii) The number of animals in the shipment.
(2) Record of Animals on Hand (other than dogs and cats) (APHIS Form 7019) and Record of Acquisition, Disposition, or Transport of Animals (other than dogs and cats) (APHIS Form 7020) are forms which may be used by dealers and exhibitors to keep and maintain the information required by paragraph (b)(1) of this section concerning animals other than dogs and cats except as provided in § 2.79.
(3) One copy of the record containing the information required by paragraph (b)(1) of this section shall accompany each shipment of any animal(s) other than a dog or cat purchased or otherwise acquired by a dealer or exhibitor. One copy of the record containing the information required by paragraph (b)(1) of this section shall accompany each shipment of any animal other than a dog or cat sold or otherwise disposed of by a dealer or exhibitor;
(a) Every operator of an auction sale or broker shall make, keep, and maintain records or forms which fully and correctly disclose the following information concerning each animal consigned for auction or sold, whether or not a fee or commission is charged:
(1) The name and address of the person who owned or consigned the animal(s) for sale;
(2) The name and address of the buyer or consignee who received the animal;
(3) The USDA license or registration number of the person(s) selling, consigning, buying, or receiving the animals if he or she is licensed or registered under the Act;
(4) The vehicle license number and State, and the driver's license number (or photographic identification card for nondrivers issued by a State) and State of the person, if he or she is not licensed or registered under the Act;
(5) The date of the consignment;
(6) The official USDA tag number or tattoo assigned to the animal under §§ 2.50 and 2.54;
(7) A description of the animal which shall include:
(i) The species and breed or type of animal;
(ii) The sex of the animal; and
(iii) The date of birth or approximate age; and
(iv) The color and any distinctive markings;
(8) The auction sales number or records number assigned to the animal.
(b) One copy of the record containing the information required by paragraph (a) of this section shall be given to the consignor of each animal, one copy of the record shall be given to the purchaser of each animal:
(a) In connection with all live animals accepted for shipment on a C.O.D. basis or other arrangement or practice under which the cost of an animal or the transportation of an animal is to be paid and collected upon delivery of the animal to the consignee, the accepting carrier or intermediate handler, if any, shall keep and maintain a copy of the consignor's written guarantee for the payment of transportation charged for any animal not claimed as provided in § 2.80, including,
(b) In connection with all live dogs, cats, or nonhuman primates delivered for transportation, in commerce, to any carrier or intermediate handler, by any dealer, research facility, exhibitor, operator of an auction sale, broker, or department, agency or instrumentality of the United States or of any state or local government, the accepting carrier or intermediate handler shall keep and maintain a copy of the health certification completed as required by § 2.79, tendered with each live dog, cat, or nonhuman primate.
(a) No dealer, exhibitor, operator of an auction sale, broker, or department, agency, or instrumentality of the United States or of any State or local government shall deliver to any intermediate handler or carrier for transportation, in commerce, or shall transport in commerce any dog, cat, or nonhuman primate unless the dog, cat, or nonhuman primate is accompanied by a health certificate executed and issued by a licensed veterinarian. The health certificate shall state that:
(1) The licensed veterinarian inspected the dog, cat, or nonhuman primate on a specified date which shall not be more than 10 days prior to the delivery of the dog, cat, or nonhuman primate for transportation; and
(2) when so inspected, the dog, cat, or nonhuman primate appeared to the licensed veterinarian to be free of any infectious disease or physical abnormality which would endanger the animal(s) or other animals or endanger public health.
(b) The Secretary may provide exceptions to the health certification requirement on an individual basis for animals shipped to a research facility for purposes of research, testing, or experimentation when the research facility requires animals not eligible for certification. Requests should be addressed to the Animal and Plant Health Inspection Service, Animal Care, 4700 River Road, Unit 84, Riverdale, Maryland 20737-1234.
(c) No intermediate handler or carrier to whom any live dog, cat, or nonhuman primate is delivered for transportation by any dealer, research facility, exhibitor, broker, operator of an auction sale, or department, agency, or instrumentality of the United States or any State or local government shall receive a live dog, cat, or nonhuman primate for transportation, in commerce, unless and until it is accompanied by a health certificate issued by a licensed veterinarian in accordance with paragraph (a) of this section, or an exemption issued by the Secretary in accordance with paragraph (b) of this section.
(d) The U.S. Interstate and International Certificate of Health Examination for Small Animals (APHIS Form 7001) may be used for health certification by a licensed veterinarian as required by this section.
(a) No carrier or intermediate handler shall accept any animal for transportation, in commerce, upon any C.O.D. or other basis where any money is to be paid and collected upon delivery of the animal to the consignee, unless the consignor guarantees in writing the payment of all transportation, including any return transportation, if the shipment is unclaimed or the consignee cannot be notified in accordance with paragraphs (b) and (c) of this section, including reimbursing the carrier or intermediate handler for all out-of-pocket expenses incurred for the care, feeding, and storage or housing of the animal.
(b) Any carrier or intermediate handler receiving an animal at a destination on a C.O.D. or other basis any
(c) It is the responsibility of any carrier or intermediate handler to hold, feed, and care for any animal accepted for transportation, in commerce, under a C.O.D. or other arrangement where any money is to be paid and collected upon delivery of the animal until the consignee accepts shipment at destination or until returned to the consignor or his or her designee should the consignee fail to accept delivery of the animal or if the consignee could not be notified as prescribed in paragraph (b) of this section.
(d) Nothing in this section shall be construed as prohibiting any carrier or intermediate handler from requiring any guarantee in addition to that required in paragraph (a) of this section for the payment of the cost of any transportation or out-of-pocket or other incidental expenses incurred in the transportation of any animal.
(a) No dealer, exhibitor, broker, operator of an auction sale, carrier, or intermediate handler shall, for a period of 1 year, destroy or dispose of, without the consent in writing of the Administrator, any books, records, documents, or other papers required to be kept and maintained under this part.
(b) Unless otherwise specified, the records required to be kept and maintained under this part shall be held for 1 year after an animal is euthanized or disposed of and for any period in excess of one year as necessary to comply with any applicable Federal, State, or local law. Whenever the Administrator notifies a dealer, exhibitor, broker, operator of an auction sale, carrier, or intermediate handler in writing that specified records shall be retained pending completion of an investigation or proceeding under the Act, the dealer, exhibitor, broker, operator of an auction sale, carrier, or intermediate handler shall hold those records until their disposition is authorized by the Administrator.
(a) Each dealer, exhibitor, operator of an auction sale, and intermediate handler shall comply in all respects with the regulations set forth in part 2 and the standards set forth in part 3 of this subchapter for the humane handling, care, treatment, housing, and transportation of animals.
(b) Each carrier shall comply in all respects with the regulations in part 2 and the standards in part 3 of this subchapter setting forth the conditions and requirements for the humane transportation of animals in commerce and their handling, care, and treatment in connection therewith.
(a) Any live dog or cat acquired by a dealer
(1) That any live dog or cat acquired by a dealer or exhibitor from any private or contract animal pound or shelter shall be held by that dealer or exhibitor under his or her supervision and control for a period of not less than 10 full days, not including the day of acquisition, after acquiring the animal, excluding time in transit;
(2) Live dogs or cats which have completed a 5-day holding period with another dealer or exhibitor, or a 10-day holding period with another dealer or exhibitor if obtained from a private or contract shelter or pound, may be sold or otherwise disposed of by subsequent dealers or exhibitors after a minimum holding period of 24 hours by each subsequent dealer or exhibitor excluding time in transit;
(3) Any dog or cat suffering from disease, emaciation, or injury may be destroyed by euthanasia prior to the completion of the holding period required by this section; and
(4) Any live dog or cat, 120 days of age or less, that was obtained from the person that bred and raised such dog or cat, may be exempted from the 5-day holding requirement and may be disposed of by dealers or exhibitors after a minimum holding period of 24 hours, excluding time in transit. Each subsequent dealer or exhibitor must also hold each such dog or cat for a 24-hour period excluding time in transit.
(b) During the period in which any dog or cat is being held as required by this section, the dog or cat shall be unloaded from any means of conveyance in which it was received, for food, water, and rest, and shall be handled, cared for, and treated in accordance with the standards set forth in part 3, subpart A, of this subchapter and § 2.131.
(a) If any dealer or exhibitor obtains the prior approval of the AC Regional Director, he may arrange to have another person hold animals for the required period provided for in paragraph (a) of § 2.101:
(1) The other person agrees in writing to comply with the regulations in part 2 and the standards in part 3 of this subchapter and to allow inspection of his premises by an APHIS official during business hours; and
(2) The animals remain under the total control and responsibility of the dealer or exhibitor.
(3) Approval will not be given for a dealer or exhibitor holding a license as set forth in § 2.1 to have animals held for purposes of this section by another licensed dealer or exhibitor. APHIS Form 7009 shall be used for approval.
(b) If any intermediate handler obtains prior approval of the AC Regional Director, it may arrange to have another person hold animals:
(1) The other person agrees in writing to comply with the regulations in part 2 and the standards in part 3 of this subchapter and to allow inspection of the premises by an APHIS official during business hours; and
(2) The animals remain under the total control and responsibility of the research facility or intermediate handler.
Each dealer, exhibitor, operator of an auction sale, intermediate handler, and carrier shall furnish to any APHIS official any information concerning the business of the dealer, exhibitor, operator of an auction sale, intermediate handler or carrier which the APHIS official may request in connection with the enforcement of the provisions of
(a) Each dealer, exhibitor, intermediate handler, or carrier, shall, during business hours, allow APHIS officials:
(1) To enter its place of business;
(2) To examine records required to be kept by the Act and the regulations in this part;
(3) To make copies of the records;
(4) To inspect and photograph the facilities, property and animals, as the APHIS officials consider necessary to enforce the provisions of the Act, the regulations and the standards in this subchapter; and
(5) To document, by the taking of photographs and other means, conditions and areas of noncompliance.
(b) The use of a room, table, or other facilities necessary for the proper examination of the records and inspection of the property or animals must be extended to APHIS officials by the dealer, exhibitor, intermediate handler or carrier, and a responsible adult shall be made available to accompany APHIS officials during the inspection process.
APHIS will publish lists of persons licensed or registered in accordance with the provisions of this part in the
Each dealer, exhibitor, intermediate handler and carrier shall allow, upon request and during business hours, police or officers of other law enforcement agencies with general law enforcement authority (not those agencies whose duties are limited to enforcement of local animal regulations) to enter his or her place of business to inspect animals and records for the purpose of seeking animals that are missing, under the following conditions:
(a) The police or other law officer shall furnish to the dealer, exhibitor, intermediate handler or carrier a written description of the missing animal and the name and address of its owner before making a search.
(b) The police or other law officer shall abide by all security measures required by the dealer, exhibitor, intermediate handler or carrier to prevent the spread of disease, including the use of sterile clothing, footwear, and masks where required, or to prevent the escape of an animal.
(a) If an animal being held by a dealer, exhibitor, intermediate handler, or by a carrier is found by an APHIS official to be suffering as a result of the failure of the dealer, exhibitor, intermediate handler, or carrier to comply with any provision of the regulations or the standards set forth in this subchapter, the APHIS official shall make a reasonable effort to notify the dealer, exhibitor, intermediate handler, or carrier of the condition of the animal(s) and request that the condition be corrected and that adequate care be given to alleviate the animal's suffering or distress, or that the animal(s) be destroyed by euthanasia. In the event that the dealer, exhibitor, intermediate handler, or carrier refuses to comply with this request, the APHIS official may confiscate the animal(s) for care, treatment, or disposal as indicated in paragraph (b) of this section, if, in the opinion of the Administrator, the circumstances indicate the animal's health is in danger.
(b) In the event that the APHIS official is unable to locate or notify the dealer, exhibitor, intermediate handler, or carrier as required in this section, the APHIS official shall contact a local police or other law officer to accompany him to the premises and shall
(c) Confiscated animals may be:
(1) Placed, by sale or donation, with other licensees or registrants that comply with the standards and regulations and can provide proper care; or
(2) Placed with persons or facilities that can offer a level of care equal to or exceeding the standards and regulations, as determined by APHIS, even if the persons or facilities are not licensed by or registered with APHIS; or
(3) Euthanized.
(d) The dealer, exhibitor, intermediate handler, or carrier from whom the animals were confiscated must bear all costs incurred in performing the placement or euthanasia activities authorized by this section.
No dog or cat shall be delivered by any person to any carrier or intermediate handler for transportation, in commerce, or shall be transported in commerce by any person, except to a registered research facility, unless such dog or cat is at least eight (8) weeks of age and has been weaned.
(a) All licensees who maintain wild or exotic animals must demonstrate adequate experience and knowledge of the species they maintain.
(b)(1) Handling of all animals shall be done as expeditiously and carefully as possible in a manner that does not cause trauma, overheating, excessive cooling, behavioral stress, physical harm, or unnecessary discomfort.
(2)(i) Physical abuse shall not be used to train, work, or otherwise handle animals.
(ii) Deprivation of food or water shall not be used to train, work, or otherwise handle animals;
(c)(1) During public exhibition, any animal must be handled so there is minimal risk of harm to the animal and to the public, with sufficient distance and/or barriers between the animal and the general viewing public so as to assure the safety of animals and the public.
(2) Performing animals shall be allowed a rest period between performances at least equal to the time for one performance.
(3) Young or immature animals shall not be exposed to rough or excessive public handling or exhibited for periods of time which would be detrimental to their health or well-being.
(4) Drugs, such as tranquilizers, shall not be used to facilitate, allow, or provide for public handling of the animals.
(d)(1) Animals shall be exhibited only for periods of time and under conditions consistent with their good health and well-being.
(2) A responsible, knowledgeable, and readily identifiable employee or attendant must be present at all times during periods of public contact.
(3) During public exhibition, dangerous animals such as lions, tigers, wolves, bears, or elephants must be under the direct control and supervision of a knowledgeable and experienced animal handler.
(4) If public feeding of animals is allowed, the food must be provided by the animal facility and shall be appropriate to the type of animal and its nutritional needs and diet.
(e) When climatic conditions present a threat to an animal's health or well-being, appropriate measures must be taken to alleviate the impact of those conditions. An animal may never be subjected to any combination of temperature, humidity, and time that is detrimental to the animal's health or well-being, taking into consideration such factors as the animal's age, species, breed, overall health status, and acclimation.
(a) A class “B” dealer may obtain live random source dogs and cats only from:
(1) Other dealers who are licensed under the Act and in accordance with the regulations in part 2;
(2) State, county, or city owned and operated animal pounds or shelters; and
(3) A legal entity organized and operated under the laws of the State in which it is located as an animal pound or shelter, such as a humane shelter or contract pound.
(b) No person shall obtain live dogs, cats, or other animals by use of false pretenses, misrepresentation, or deception.
(c) Any dealer, exhibitor, research facility, carrier, or intermediate handler who also operates a private or contract animal pound or shelter shall comply with the following:
(1) The animal pound or shelter shall be located on premises that are physically separated from the licensed or registered facility. The animal housing facility of the pound or shelter shall not be adjacent to the licensed or registered facility.
(2) Accurate and complete records shall be separately maintained by the licensee or registrant and by the pound or shelter. The records shall be in accordance with §§ 2.75 and 2.76, unless the animals are lost or stray. If the animals are lost or stray, the pound or shelter records shall provide:
(i) An accurate description of the animal;
(ii) How, where, from whom, and when the dog or cat was obtained;
(iii) How long the dog or cat was held by the pound or shelter before being transferred to the dealer; and
(iv) The date the dog or cat was transferred to the dealer.
(3) Any dealer who obtains or acquires a live dog or cat from a private or contract pound or shelter, including a pound or shelter he or she operates, shall hold the dog or cat for a period of at least 10 full days, not including the day of acquisition, excluding time in transit, after acquiring the animal, and otherwise in accordance with § 2.101.
(d) No dealer or exhibitor shall knowingly obtain any dog, cat, or other animal from any person who is required to be licensed but who does not hold a current, valid, and unsuspended license. No dealer or exhibitor shall knowingly obtain any dog or cat from any person who is not licensed, other than a pound or shelter, without obtaining a certification that the animals were born and raised on that person's premises and, if the animals are for research purposes, that the person has sold fewer than 25 dogs and/or cats that year, or, if the animals are for use as pets, that the person does not maintain more than three breeding female dogs and/or cats.
(a) Each of the entities listed in paragraphs (a)(1) through (a)(3) of this section that acquire any live dog or cat shall, before selling or providing the live dog or cat to a dealer, hold and care for the dog or cat for a period of not less than 5 full days after acquiring the animal, not including the date of acquisition and excluding time in transit. This holding period shall include at least one Saturday. The provisions of this paragraph apply to:
(1) Each pound or shelter owned and operated by a State, county, or city;
(2) Each private pound or shelter established for the purpose of caring for animals, such as a humane society, or other organization that is under contract with a State, county, or city, that operates as a pound or shelter, and that releases animals on a voluntary basis; and
(3) Each research facility licensed by USDA as a dealer.
(b) A dealer shall not sell, provide, or make available to any person a live random source dog or cat unless the dealer provides the recipient of the dog or cat with certification that contains the following information:
(1) The name, address, USDA license number, and signature of the dealer;
(2) The name, address, USDA license or registration number, if such number
(3) A description of each dog or cat being sold, provided, or made available that shall include:
(i) The species and breed or type (for mixed breeds, estimate the two dominant breeds or types);
(ii) The sex;
(iii) The date of birth or, if unknown, then the approximate age;
(iv) The color and any distinctive markings; and
(v) The Official USDA-approved identification number of the animal. However, if the certification is attached to a certificate provided by a prior dealer which contains the required description, then only the official identification numbers are required;
(4) The name and address of the person, pound, or shelter from which the dog or cat was acquired by the dealer, and an assurance that the person, pound, or shelter was notified that the cat or dog might be used for research or educational purposes;
(5) The date the dealer acquired the dog or cat from the person, pound, or shelter referred to in paragraph (b)(4) of this section; and
(6) If the dealer acquired the dog or cat from a pound or shelter, a signed statement by the pound or shelter that it met the requirements of paragraph (a) of this section. This statement must at least describe the animals by their official USDA identification numbers. It may be incorporated within the certification if the dealer makes the certification at the time that the animals are acquired from the pound or shelter or it may be made separately and attached to the certification later. If made separately, it must include the same information describing each animal as is required in the certification. A photocopy of the statement will be regarded as a duplicate original.
(c) The original certification required under paragraph (b) of this section shall accompany the shipment of a live dog or cat to be sold, provided, or otherwise made available by the dealer.
(d) A dealer who acquires a live dog or cat from another dealer must obtain from that dealer the certification required by paragraph (b) of this section and must attach that certification (including any previously attached certification) to the certification which he or she provides pursuant to paragraph (b) of this section (a photocopy of the original certification will be deemed a duplicate original if the dealer does not dispose of all of the dogs or cats in a single transaction).
(e) A dealer who completes, provides, or receives a certification required under paragraph (b) of this section shall keep, maintain, and make available for APHIS inspection a copy of the certification for at least 1 year following disposition.
(f) A research facility which acquires any live random source dog or cat from a dealer must obtain the certification required under paragraph (b) of this section and shall keep, maintain, and make available for APHIS inspection the original for at least 3 years following disposition.
(g) In instances where a research facility transfers ownership of a live random source dog or cat acquired from a dealer to another research facility, a copy of the certification required by paragraph (b) of this section must accompany the dog or cat transferred. The research facility to which the dog or cat is transferred shall keep, maintain, and make available for APHIS inspection the copy of the certification for at least 3 years following disposition.
7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.7.
(a)
(b)
(c)
(i) Be free of excessive rust that prevents the required cleaning and sanitization, or that affects the structural strength of the surface; and
(ii) Be free of jagged edges or sharp points that might injure the animals.
(2)
(3)
(d)
(e)
(f)
(g)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(e)
(i) Indoor floor areas in contact with the animals;
(ii) Outdoor floor areas in contact with the animals, when the floor areas are not exposed to the direct sun, or are made of a hard material such as wire, wood, metal, or concrete; and
(iii) All walls, boxes, houses, dens, and other surfaces in contact with the animals.
(2) Outside floor areas in contact with the animals and exposed to the direct sun may consist of compacted earth, absorbent bedding, sand, gravel, or grass.
(a)
(i) Dogs or cats that are not acclimated to the temperatures prevalent in the area or region where they are maintained;
(ii) Breeds of dogs or cats that cannot tolerate the prevalent temperatures of the area without stress or discomfort (such as short-haired breeds in cold climates); and
(iii) Sick, infirm, aged or young dogs or cats.
(2) When their acclimation status is unknown, dogs and cats must not be kept in outdoor facilities when the ambient temperature is less than 50 °F (10 °C).
(b)
(1) Provide the dogs and cats with adequate protection and shelter from the cold and heat;
(2) Provide the dogs and cats with protection from the direct rays of the sun and the direct effect of wind, rain, or snow;
(3) Be provided with a wind break and rain break at the entrance; and
(4) Contain clean, dry, bedding material if the ambient temperature is below 50 °F (10 °C). Additional clean, dry bedding is required when the temperature is 35 °F (1.7 °C) or lower.
(c)
(a)
(b)
(c)
Primary enclosures for dogs and cats must meet the following minimum requirements:
(a)
(2) Primary enclosures must be constructed and maintained so that they:
(i) Have no sharp points or edges that could injure the dogs and cats;
(ii) Protect the dogs and cats from injury;
(iii) Contain the dogs and cats securely;
(iv) Keep other animals from entering the enclosure;
(v) Enable the dogs and cats to remain dry and clean;
(vi) Provide shelter and protection from extreme temperatures and weather conditions that may be uncomfortable or hazardous to all the dogs and cats;
(vii) Provide sufficient shade to shelter all the dogs and cats housed in the primary enclosure at one time;
(viii) Provide all the dogs and cats with easy and convenient access to clean food and water;
(ix) Enable all surfaces in contact with the dogs and cats to be readily cleaned and sanitized in accordance with § 3.11(b) of this subpart, or be replaceable when worn or soiled;
(x) Have floors that are constructed in a manner that protects the dogs' and cats' feet and legs from injury, and that, if of mesh or slatted construction, do not allow the dogs' and cats' feet to pass through any openings in the floor;
(xi) Provide sufficient space to allow each dog and cat to turn about freely, to stand, sit, and lie in a comfortable, normal position, and to walk in a normal manner; and
(xii) Primary enclosures constructed on or after February 20, 1998 and floors replaced on or after that date, must
(b)
(i) Prior to February 15, 1994 each cat housed in any primary enclosure shall be provided a minimum of 2
(ii) On and after February 15, 1994:
(A) Each primary enclosure housing cats must be at least 24 in. high (60.96 cm);
(B) Cats up to and including 8.8 lbs (4 kg) must be provided with at least 3.0 ft
(C) Cats over 8.8 lbs (4 kg) must be provided with at least 4.0 ft
(iii) Each queen with nursing kittens must be provided with an additional amount of floor space, based on her breed and behavioral characteristics, and in accordance with generally accepted husbandry practices. If the additional amount of floor space for each nursing kitten is equivalent to less than 5 percent of the minimum requirement for the queen, such housing must be approved by the attending veterinarian in the case of a research facility, and, in the case of dealers and exhibitors, such housing must be approved by the Administrator; and
(iv) The minimum floor space required by this section is exclusive of any food or water pans. The litter pan may be considered part of the floor space if properly cleaned and sanitized.
(2)
(3)
(4)
(5)
(c)
(ii) Each bitch with nursing puppies must be provided with an additional amount of floor space, based on her breed and behavioral characteristics, and in accordance with generally accepted husbandry practices as determined by the attending veterinarian. If the additional amount of floor space for each nursing puppy is less than 5 percent of the minimum requirement for the bitch, such housing must be approved by the attending veterinarian in the case of a research facility, and, in the case of dealers and exhibitors, such housing must be approved by the Administrator.
(iii) The interior height of a primary enclosure must be at least 6 inches higher than the head of the tallest dog in the enclosure when it is in a normal standing position:
(2)
(3)
(4)
(d) Innovative primary enclosures not precisely meeting the floor area and height requirements provided in paragraphs (b)(1) and (c)(1) of this section, but that provide the dogs or cats with a sufficient volume of space and the opportunity to express species-typical behavior, may be used at research facilities when approved by the Committee, and by dealers and exhibitors when approved by the Administrator.
Dogs and cats that are housed in the same primary enclosure must be compatible, with the following restrictions:
(a) Females in heat (estrus) may not be housed in the same primary enclosure with males, except for breeding purposes;
(b) Any dog or cat exhibiting a vicious or overly aggressive disposition must be housed separately;
(c) Puppies or kittens 4 months of age or less may not be housed in the same primary enclosure with adult dogs or cats other than their dams or foster dams, except when permanently maintained in breeding colonies;
(d) Dogs or cats may not be housed in the same primary enclosure with any other species of animals, unless they are compatible; and
(e) Dogs and cats that have or are suspected of having a contagious disease must be isolated from healthy animals in the colony, as directed by the attending veterinarian. When an entire group or room of dogs and cats is known to have or believed to be exposed to an infectious agent, the group may be kept intact during the process of diagnosis, treatment, and control.
Dealers, exhibitors, and research facilities must develop, document, and follow an appropriate plan to provide
(a)
(b)
(1) Housing in compatible groups is not in accordance with a research proposal and the proposal has been approved by the research facility Committee;
(2) In the opinion of the attending veterinarian, such housing would adversely affect the health or well-being of the dog(s); or
(3) Any dog exhibits aggressive or vicious behavior.
(c)
(2) Dealers, exhibitors, and research facilities, in developing their plan, should consider providing positive physical contact with humans that encourages exercise through play or other similar activities. If a dog is housed, held, or maintained at a facility without sensory contact with another dog, it must be provided with positive physical contact with humans at least daily.
(3) The opportunity for exercise may be provided in a number of ways, such as:
(i) Group housing in cages, pens or runs that provide at least 100 percent of the required space for each dog if maintained separately under the minimum floor space requirements of § 3.6(c)(1) of this subpart;
(ii) Maintaining individually housed dogs in cages, pens, or runs that provide at least twice the minimum floor space required by § 3.6(c)(1) of this subpart;
(iii) Providing access to a run or open area at the frequency and duration prescribed by the attending veterinarian; or
(iv) Other similar activities.
(4) Forced exercise methods or devices such as swimming, treadmills, or carousel-type devices are unacceptable for meeting the exercise requirements of this section.
(d)
(2) A research facility may be exempted from the requirements of this section if the principal investigator determines for scientific reasons set forth in the research proposal that it is inappropriate for certain dogs to exercise. Such exemption must be documented in the Committee-approved proposal and must be reviewed at appropriate intervals as determined by the Committee, but not less than annually.
(3) Records of any exemptions must be maintained and made available to
(a) Dogs and cats must be fed at least once each day, except as otherwise might be required to provide adequate veterinary care. The food must be uncontaminated, wholesome, palatable, and of sufficient quantity and nutritive value to maintain the normal condition and weight of the animal. The diet must be appropriate for the individual animal's age and condition.
(b) Food receptacles must be used for dogs and cats, must be readily accessible to all dogs and cats, and must be located so as to minimize contamination by excreta and pests, and be protected from rain and snow. Feeding pans must either be made of a durable material that can be easily cleaned and sanitized or be disposable. If the food receptacles are not disposable, they must be kept clean and must be sanitized in accordance with § 3.11(b) of this subpart. Sanitization is achieved by using one of the methods described in § 3.11(b)(3) of this subpart. If the food receptacles are disposable, they must be discarded after one use. Self-feeders may be used for the feeding of dry food. If self-feeders are used, they must be kept clean and must be sanitized in accordance with § 3.11(b) of this subpart. Measures must be taken to ensure that there is no molding, deterioration, and caking of feed.
If potable water is not continually available to the dogs and cats, it must be offered to the dogs and cats as often as necessary to ensure their health and well-being, but not less than twice daily for at least 1 hour each time, unless restricted by the attending veterinarian. Water receptacles must be kept clean and sanitized in accordance with § 3.11(b) of this subpart, and before being used to water a different dog or cat or social grouping of dogs or cats.
(a)
(b)
(2) Used primary enclosures and food and water receptacles for dogs and cats must be sanitized at least once every 2 weeks using one of the methods prescribed in paragraph (b)(3) of this section, and more often if necessary to prevent an accumulation of dirt, debris, food waste, excreta, and other disease hazards.
(3) Hard surfaces of primary enclosures and food and water receptacles must be sanitized using one of the following methods:
(i) Live steam under pressure;
(ii) Washing with hot water (at least 180 °F (82.2 °C)) and soap or detergent, as with a mechanical cage washer; or
(iii) Washing all soiled surfaces with appropriate detergent solutions and disinfectants, or by using a combination detergent/disinfectant product that accomplishes the same purpose, with a thorough cleaning of the surfaces to remove organic material, so as
(4) Pens, runs, and outdoor housing areas using material that cannot be sanitized using the methods provided in paragraph (b)(3) of this section, such as gravel, sand, grass, earth, or absorbent bedding, must be sanitized by removing the contaminated material as necessary to prevent odors, diseases, pests, insects, and vermin infestation.
(c)
(d)
Each person subject to the Animal Welfare regulations (9 CFR parts 1, 2, and 3) maintaining dogs and cats must have enough employees to carry out the level of husbandry practices and care required in this subpart. The employees who provide for husbandry and care, or handle animals, must be supervised by an individual who has the knowledge, background, and experience in proper husbandry and care of dogs and cats to supervise others. The employer must be certain that the supervisor and other employees can perform to these standards.
(a) Carriers and intermediate handlers must not accept a dog or cat for transport in commerce more than 4 hours before the scheduled departure time of the primary conveyance on which the animal is to be transported. However, a carrier or intermediate handler may agree with anyone consigning a dog or cat to extend this time by up to 2 hours.
(b) Carriers and intermediate handlers must not accept a dog or cat for transport in commerce unless they are provided with the name, address, and telephone number of the consignee.
(c) Carriers and intermediate handlers must not accept a dog or cat for transport in commerce unless the consignor certifies in writing to the carrier or intermediate handler that the dog or cat was offered food and water during the 4 hours before delivery to the carrier or intermediate handler. The certification must be securely attached to the outside of the primary enclosure in a manner that makes it easily noticed and read. Instructions for no food or water are not acceptable unless directed by the attending veterinarian. Instructions must be in compliance with § 3.16 of this subpart. The certification must include the following information for each dog and cat:
(1) The consignor's name and address;
(2) The tag number or tattoo assigned to each dog or cat under §§ 2.38 and 2.50 of this chapter;
(3) The time and date the animal was last fed and watered and the specific instructions for the next feeding(s) and watering(s) for a 24-hour period; and
(4) The consignor's signature and the date and time the certification was signed.
(d) Carriers and intermediate handlers must not accept a dog or cat for transport in commerce in a primary enclosure unless the primary enclosure meets the requirements of § 3.14 of this subpart. A carrier or intermediate handler must not accept a dog or cat for transport if the primary enclosure is obviously defective or damaged and
(e) Carriers and intermediate handlers must not accept a dog or cat for transport in commerce unless their animal holding area meets the minimum temperature requirements provided in §§ 3.18 and 3.19 of this subpart, or unless the consignor provides them with a certificate signed by a veterinarian and dated no more than 10 days before delivery of the animal to the carrier or intermediate handler for transport in commerce, certifying that the animal is acclimated to temperatures lower than those required in §§ 3.18 and 3.19 of this subpart. Even if the carrier or intermediate handler receives this certification, the temperatures the dog or cat is exposed to while in a terminal facility must not be lower than 45 °F (2.2 °C) for more than 4 consecutive hours when dogs or cats are present, as set forth in § 3.18, nor lower than 45 °F (2.2 °C) for more than 45 minutes, as set forth in § 3.19, when moving dogs or cats to or from terminal facilities or primary conveyances. A copy of the certification must accompany the dog or cat to its destination and must include the following information:
(1) The consignor's name and address;
(2) The tag number or tattoo assigned to each dog or cat under §§ 2.38 and 2.50 of this chapter;
(3) A statement by a veterinarian, dated no more than 10 days before delivery, that to the best of his or her knowledge, each of the dogs or cats contained in the primary enclosure is acclimated to air temperatures lower than 50 °F (10 °C); but not lower than a minimum temperature, specified on a certificate, that the attending veterinarian has determined is based on generally accepted temperature standards for the age, condition, and breed of the dog or cat; and
(4) The signature of the veterinarian and the date the certification was signed.
(f) When a primary enclosure containing a dog or cat has arrived at the animal holding area at a terminal facility after transport, the carrier or intermediate handler must attempt to notify the consignee upon arrival and at least once in every 6-hour period thereafter. The time, date, and method of all attempted notifications and the actual notification of the consignee, and the name of the person who notifies or attempts to notify the consignee must be written either on the carrier's or intermediate handler's copy of the shipping document or on the copy that accompanies the primary enclosure. If the consignee cannot be notified within 24 hours after the dog or cat has arrived at the terminal facility, the carrier or intermediate handler must return the animal to the consignor or to whomever the consignor designates. If the consignee is notified of the arrival and does not accept delivery of the dog or cat within 48 hours after arrival of the dog or cat, the carrier or intermediate handler must return the animal to the consignor or to whomever the consignor designates. The carrier or intermediate handler must continue to provide proper care, feeding, and housing to the dog or cat, and maintain the dog or cat in accordance with generally accepted professional and husbandry practices until the consignee accepts delivery of the dog or cat or until it is returned to the consignor or to whomever the consignor designates. The carrier or intermediate handler must obligate the consignor to reimburse the carrier or intermediate handler for the cost of return transportation and care.
Any person subject to the Animal Welfare regulations (9 CFR parts 1, 2, and 3) must not transport or deliver for transport in commerce a dog or cat unless the following requirements are met:
(a)
(1) The primary enclosure is strong enough to contain the dogs and cats securely and comfortably and to withstand the normal rigors of transportation;
(2) The interior of the primary enclosure has no sharp points or edges and no protrusions that could injure the animal contained in it;
(3) The dog or cat is at all times securely contained within the enclosure and cannot put any part of its body outside the enclosure in a way that could result in injury to itself, to handlers, or to persons or animals nearby;
(4) The dog or cat can be easily and quickly removed from the enclosure in an emergency;
(5) Unless the enclosure is permanently affixed to the conveyance, adequate devices such as handles or handholds are provided on its exterior, and enable the enclosure to be lifted without tilting it, and ensure that anyone handling the enclosure will not come into physical contact with the animal contained inside;
(6) Unless the enclosure is permanently affixed to the conveyance, it is clearly marked on top and on one or more sides with the words “Live Animals,” in letters at least 1 inch (2.5 cm.) high, and with arrows or other markings to indicate the correct upright position of the primary enclosure;
(7) Any material, treatment, paint, preservative, or other chemical used in or on the enclosure is nontoxic to the animal and not harmful to the health or well-being of the animal;
(8) Proper ventilation is provided to the animal in accordance with paragraph (c) of this section; and
(9) The primary enclosure has a solid, leak-proof bottom or a removable, leak-proof collection tray under a slatted or mesh floor that prevents seepage of waste products, such as excreta and body fluids, outside of the enclosure. If a slatted or mesh floor is used in the enclosure, it must be designed and constructed so that the animal cannot put any part of its body between the slats or through the holes in the mesh. Unless the dogs and cats are on raised slatted floors or raised floors made of mesh, the primary enclosure must contain enough previously unused litter to absorb and cover excreta. The litter must be of a suitably absorbent material that is safe and nontoxic to the dogs and cats.
(b)
(c)
(i) Ventilation openings located on two opposing walls of the primary enclosure and the openings must be at least 16 percent of the surface area of each such wall, and the total combined surface area of the ventilation openings must be at least 14 percent of the total combined surface area of all the walls of the primary enclosure; or
(ii) Ventilation openings on three walls of the primary enclosure, and the openings on each of the two opposing walls must be at least 8 percent of the total surface area of the two walls, and the ventilation openings on the third wall of the primary enclosure must be at least 50 percent of the total surface area of that wall, and the total combined surface area of the ventilation openings must be at least 14 percent of the total combined surface area of all the walls of the primary enclosure; or
(iii) Ventilation openings located on all four walls of the primary enclosure and the ventilation openings on each of the four walls must be at least 8 percent of the total surface area of each such wall, and the total combined surface area of the openings must be at least 14 percent of total combined surface area of all the walls of the primary enclosure; and
(iv) At least one-third of the ventilation area must be located on the upper half of the primary enclosure.
(2) Unless the primary enclosure is permanently affixed to the conveyance, projecting rims or similar devices must be located on the exterior of each enclosure wall having a ventilation opening, in order to prevent obstruction of the openings. The projecting rims or similar devices must be large enough to provide a minimum air circulation space of 0.75 in. (1.9 cm) between the primary enclosure and anything the enclosure is placed against.
(3) If a primary enclosure is permanently affixed to the primary conveyance so that there is only a front ventilation opening for the enclosure, the primary enclosure must be affixed to the primary conveyance in such a way that the front ventilation opening cannot be blocked, and the front ventilation opening must open directly to an unobstructed aisle or passageway inside the conveyance. The ventilation opening must be at least 90 percent of the total area of the front wall of the enclosure, and must be covered with bars, wire mesh, or smooth expanded metal having air spaces.
(d)
(2) Puppies or kittens 4 months of age or less may not be transported in the same primary enclosure with adult dogs or cats other than their dams.
(3) Dogs or cats that are overly aggressive or exhibit a vicious disposition must be transported individually in a primary enclosure.
(4) Any female dog or cat in heat (estrus) may not be transported in the same primary enclosure with any male dog or cat.
(e)
(2) Primary enclosures used to transport dogs and cats must be positioned in the primary conveyance so as to provide protection from the elements.
(f)
(2) No more than one live puppy, 8 weeks to 6 months of age, and weighing over 20 lbs (9 kg), may be transported in a primary enclosure when shipped via air carrier.
(3) No more than two live puppies or kittens, 8 weeks to 6 months of age, that are of comparable size, and weighing 20 lbs (9 kg) or less each, may be transported in the same primary enclosure when shipped via air carrier.
(4) Weaned live puppies or kittens less than 8 weeks of age and of comparable size, or puppies or kittens that are less than 8 weeks of age that are littermates and are accompanied by their dam, may be transported in the same primary enclosure when shipped to research facilities, including Federal research facilities.
(g)
(2) Weaned live puppies or kittens less than 8 weeks of age and of comparable size, or puppies or kittens that are less than 8 weeks of age that are littermates and are accompanied by their dam, may be transported in the same primary enclosure when shipped to research facilities, including Federal research facilities, and only if all other requirements in this section are met.
(h)
(a) The animal cargo space of primary conveyances used to transport dogs and cats must be designed, constructed, and maintained in a manner that at all times protects the health and well-being of the animals transported in them, ensures their safety and comfort, and prevents the entry of engine exhaust from the primary conveyance during transportation.
(b) The animal cargo space must have a supply of air that is sufficient for the normal breathing of all the animals being transported in it.
(c) Each primary enclosure containing dogs or cats must be positioned in the animal cargo space in a manner that provides protection from the elements and that allows each dog or cat enough air for normal breathing.
(d) During air transportation, dogs and cats must be held in cargo areas that are heated or cooled as necessary to maintain an ambient temperature and humidity that ensures the health and well-being of the dogs or cats. The cargo areas must be pressurized when the primary conveyance used for air transportation is not on the ground, unless flying under 8,000 ft. Dogs and cats must have adequate air for breathing at all times when being transported.
(e) During surface transportation, auxiliary ventilation, such as fans, blowers or air conditioning, must be used in any animal cargo space containing live dogs or cats when the ambient temperature within the animal cargo space reaches 85 °F (29.5 °C). Moreover, the ambient temperature may not exceed 85 °F (29.5 °C) for a period of more than 4 hours; nor fall below 45 °F (7.2 °C) for a period of more than 4 hours. The preceding requirements are in addition to, not in place of, all other requirements pertaining to climatic conditions in parts 2 and 3 of this chapter.
(f) Primary enclosures must be positioned in the primary conveyance in a manner that allows the dogs and cats to be quickly and easily removed from the primary conveyance in an emergency.
(g) The interior of the animal cargo space must be kept clean.
(h) Live dogs and cats may not be transported with any material, substance (e.g., dry ice) or device in a manner that may reasonably be expected to harm the dogs and cats or cause inhumane conditions.
(a) Each dog and cat that is 16 weeks of age or more must be offered food at least once every 24 hours. Puppies and kittens less than 16 weeks of age must be offered food at least once every 12 hours. Each dog and cat must be offered potable water at least once every 12 hours. These time periods apply to dealers, exhibitors, research facilities. including Federal research facilities, who transport dogs and cats in their own primary conveyance, starting from the time the dog or cat was last offered food and potable water before transportation was begun. These time periods apply to carriers and intermediate handlers starting from the date and time stated on the certificate provided under § 3.13(c) of this subpart. Each dog and cat must be offered food and potable water within 4 hours before being transported in commerce. Consignors who are subject to the Animal Welfare regulations (9 CFR parts 1, 2, and 3) must certify that each dog and cat was offered food and potable water within the 4 hours preceding delivery of the dog or cat to a carrier or intermediate handler for transportation in commerce, and must certify the date and time the food and potable water was offered, in accordance with § 3.13(c) of this subpart.
(b) Any dealer, research facility, including a Federal research facility, or exhibitor offering any dog or cat to a carrier or intermediate handler for transportation in commerce must securely attach to the outside of the primary enclosure used for transporting the dog or cat, written instructions for the in-transit food and water requirements for a 24-hour period for the dogs and cats contained in the enclosure. The instructions must be attached in a manner that makes them easily noticed and read.
(c) Food and water receptacles must be securely attached inside the primary enclosure and placed so that the receptacles can be filled from outside the enclosure without opening the door. Food and water containers must be designed, constructed, and installed so that a dog or cat cannot leave the primary enclosure through the food or water opening.
(a)
(b)
(c) If a dog or cat is obviously ill, injured, or in physical distress, it must not be transported in commerce, except to receive veterinary care for the condition.
(d) Except during the cleaning of primary enclosures, as required in § 3.14(b) of this subpart, during transportation in commerce a dog or cat must not be removed from its primary enclosure, unless it is placed in another primary enclosure or facility that meets the requirements of § 3.6 or § 3.14 of this subpart.
(e) The transportation regulations contained in this subpart must be complied with until a consignee takes physical delivery of the dog or cat if the animal is consigned for transportation, or until the animal is returned to the consignor.
(a)
(b)
(c)
(d)
(e)
(1)
(2)
(f)
(a) Any person subject to the Animal Welfare regulations (9 CFR parts 1, 2, and 3) who moves (including loading and unloading) dogs or cats within, to, or from the animal holding area of a terminal facility or a primary conveyance must do so as quickly and efficiently as possible and must provide the following during movement of the dog or cat:
(1) Shelter from sunlight and extreme heat. Sufficient shade must be provided to protect the dog or cat from the direct rays of the sun. The dog or cat must not be exposed to an ambient air temperature above 85 °F (29.5 °C) for a period of more than 45 minutes while being moved to or from a primary conveyance or a terminal facility. The temperature must be measured in the manner provided in § 3.18(d) of this subpart. The preceding requirements are in addition to, not in place of, all other requirements pertaining to climatic conditions in parts 2 and 3 of this chapter.
(2)
(3)
(b) Any person handling a primary enclosure containing a dog or cat must use care and must avoid causing physical harm or distress to the dog or cat.
(1) A primary enclosure containing a live dog or cat must not be placed on unattended conveyor belts, or on elevated conveyor belts, such as baggage
(2) A primary enclosure containing a dog or cat must not be tossed, dropped, or needlessly tilted, and must not be stacked in a manner that may reasonably be expected to result in its falling. It must be handled and positioned in the manner that written instructions and arrows on the outside of the primary enclosure indicate.
(c) This section applies to movement of a dog or cat from primary conveyance to primary conveyance, within a primary conveyance or terminal facility, and to or from a terminal facility or a primary conveyance.
(a)
(b)
(c)
(d)
(e)
(a)
(b)
(c)
(d)
(a) Hamsters shall not be housed in outdoor facilities.
(b) Guinea pigs shall not be housed in outdoor facilities unless such facilities are located in an appropriate climate and prior approval for such outdoor housing is obtained from the Deputy Administrator.
All primary enclosures for guinea pigs and hamsters shall conform to the following requirements:
(a)
(2) Primary enclosures shall be constructed and maintained so that the guinea pigs or hamsters contained therein have convenient access to clean food and water as required in this subpart.
(3) Primary enclosures having a solid floor shall be provided with clean bedding material.
(4) Primary enclosures equipped with mesh or wire floors shall be so constructed as to allow feces to pass through the spaces of the mesh or wire:
(b)
(2)
(i) The interior height of any primary enclosure used to confine guinea pigs shall be at least 6
(ii) Each guinea pig housed in a primary enclosure shall be provided a minimum amount of floor space in accordance with the following table:
(3)
(i) The interior height of any primary enclosure used to confine hamsters shall be at least 5
(ii) A nursing female hamster, together with her litter, shall be housed in a primary enclosure which contains no other hamsters and which provides at least 121 square inches of floor space:
(iii) The minimum amount of floor space per individual hamster and the maximum number of hamsters allowed in a single primary enclosure, except as provided for nursing females in paragraph (b)(3)(ii) of this section, shall be in accordance with the following table:
(c)
(ii) The interior height of any primary enclosure used to confine guinea pigs shall be at least 7 inches (17.78 cm).
(iii) Each guinea pig shall be provided a minimum amount of floor space in any primary enclosure as follows:
(2)
(ii) The interior height of any primary enclosure used to confine hamsters shall be at least 6 inches (15.24 cm).
(iii) Except as provided in paragraph (c)(2)(iv) of this section, each hamster shall be provided a minimum amount of floor space in any primary enclosure as follows:
(iv) A nursing female hamster, together with her litter, shall be housed in a primary enclosure that contains no other hamsters and that provides at least 121 square inches of floor space:
(3) Innovative primary enclosures that do not precisely meet the space requirements of paragraph (c)(1) or (c)(2) of this section, but that do provide guinea pigs or hamsters with a sufficient volume of space and the opportunity to express species-typical behavior, may be used at research facilities when approved by the Institutional Animal Care and Use Committee, and by dealers and exhibitors when approved by the Administrator.
(a) Guinea pigs and hamsters shall be fed each day except as otherwise might be required to provide adequate veterinary care. The food shall be free from contamination, wholesome, palatable and of sufficient quantity and nutritive value to meet the normal daily requirements for the condition and size of the guinea pig or hamster.
(b) Food comprising the basic diet shall be at least equivalent in quality and content to pelleted rations produced commercially and commonly available from feed suppliers.
(c) The basic diet of guinea pigs and hamsters may be supplemented with good quality fruits or vegetables consistent with their individual dietary requirements.
(d) Food receptacles, if used, shall be accessible to all guinea pigs or hamsters in a primary enclosure and shall be located so as to minimize contamination by excreta. All food receptacles shall be kept clean and shall be sanitized at least once every 2 weeks. If self-feeders are used for the feeding of pelleted feed, measures must be taken to prevent molding, deterioration or caking of the feed. Hamsters may be fed pelleted feed on the floor of a primary enclosure.
(e) Fruit or vegetable food supplements may be placed upon the bedding within the primary enclosure:
Unless food supplements consumed by guinea pigs or hamsters supply them with their normal water requirements, potable water shall be provided daily except as might otherwise be required to provide adequate veterinary care. Open containers used for dispensing water to guinea pigs or hamsters shall be so placed in or attached
(a)
(2) In the event a primary enclosure becomes soiled or wet to a degree that might be harmful or uncomfortable to the animals therein due to leakage of the watering system, discharges from dead or dying animals, spoiled perishable foods, or moisture condensation, the guinea pigs or hamsters shall be transferred to clean primary enclosures.
(3) Prior to the introduction of guinea pigs or hamsters into empty primary enclosures previously occupied, such enclosures shall be sanitized in the manner provided in paragraph (a)(4) of this section.
(4) Primary enclosures for guinea pigs or hamsters shall be sanitized by washing them with hot water (180 °F.) and soap or detergent as in a mechanical cage washer, or by washing all soiled surfaces with a detergent solution followed by a safe and effective disinfectant, or by cleaning all soiled surfaces with live steam.
(b)
(c)
A sufficient number of employees shall be utilized to maintain the prescribed level of husbandry practices set forth in this subpart. Such practices shall be under the supervision of an animal caretaker who has a background in animal husbandry or care.
Animals housed in the same primary enclosure shall be maintained in compatible groups, with the following additional restrictions:
(a) Except where harem breeding is practiced, preweanling guinea pigs shall not be housed in the same primary enclosure with adults other than their parents.
(b) Guinea pigs shall not be housed in the same primary enclosure with hamsters, nor shall guinea pigs or hamsters be housed in the same primary enclosure with any other species of animals.
(c) Guinea pigs or hamsters under quarantine or treatment for a communicable disease shall be separated from other guinea pigs or hamsters and other susceptible species of animals in such a manner as to minimize dissemination of such disease.
Sections 3.35 through 3.41 issued under secs. 3, 5, 6, 10, 11, 14, 16, 17, 21; 80 Stat. 353; 84 Stat. 1561, 1562, 1563, 1564; 90 Stat. 418, 419, 420, 423; (7 U.S.C. 2133, 2135, 2136, 2140, 2141, 2144, 2146, 2147, 2151); 37 FR 28464, 28477, 38 FR 19141.
(a) Carriers and intermediate handlers shall not accept any live guinea pig or hamster presented by any dealer, research facility, exhibitor, operator of an auction sale, or other person, or any department, agency, or instrumentality of the United States or any State or local govenment for shipment, in commerce, more than 4 hours prior to the scheduled departure of the primary conveyance on which it is to be transported:
(b) Any carrier or intermediate handler shall only accept for transportation or transport, in commerce any live guinea pig or hamster in a primary enclosure which conforms to the requirements set forth in § 3.36 of the standards:
(1) Name and address of the consignor;
(2) The number of guinea pigs or hamsters in the primary enclosure(s);
(3) A certifying statement (e.g., “I hereby certify that the __ (number) primary enclosure(s) which are used to transport the animal(s) in this shipment complies (comply) with USDA standards for primary enclosures (9 CFR part 3).”); and
(4) The signature of the consignor, and date.
(c) Carriers or intermediate handlers whose facilities fail to meet the minimum temperature allowed by the standards may accept for transportation or transport, in commerce, any live hamster consigned by any department, agency, or instrumentality of the United States or of any State or local government, or by any person (including any licensee or registrant under the Act, as well as any private individual) if the consignor furnishes to the carrier or intermediate handler a certificate executed by a veterinarian accredited by this Department pursuant to part 160 of this title on a specified date which shall not be more than 10 days prior to delivery of such hamster for transportation in commerce, stating that such live hamster is acclimated to air temperatures lower than those prescribed in §§ 3.40 and 3.41. A copy of such certificate shall accompany the shipment to destination. The certificate shall include the following information:
(1) Name and address of the consignor;
(2) The number of hamsters in the shipment;
(3) A certifying statement (e.g., “I hereby certify that the animal(s) in this shipment is (are), to the best of my knowledge, acclimated to air temperatures lower than 7.2 °C. (45 °F.).”); and
(4) The signature of the USDA accredited veterinarian, assigned accreditation number, and date.
(d) Carriers and intermediate handlers shall attempt to notify the consignee at least once in every 6 hour period following the arrival of any live guinea pig or hamster at the animal holding area of the terminal cargo facility. The time, date, and method of each attempted notification and the final notification to the consignee and the name of the person notifying the consignee shall be recorded on the copy of the shipping document retained by the carrier or intermediate handler and on a copy of the shipping document accompanying the animal shipment.
No person subject to the Animal Welfare regulations shall offer for transportation, or transport, in commerce any live guinea pig or hamster in a primary enclosure that does not conform to the following requirements:
(a) Primary enclosures, such as compartments, transport cages, cartons, or
(b) Live guinea pigs or hamsters tranported in the same primary enclosure shall be of the same species and maintained in compatible groups.
(c) Primary enclosures used to transport live guinea pigs or hamsters shall be large enough to ensure that each animal contained therein has sufficient space to turn about freely and to make normal postural adjustments.
(d) Not more than 15 live guinea pigs shall be transported in the same primary enclosure. No more than 50 live hamsters shall be transported in the same primary enclosure.
(e) In addition to the other provisions of this section, the following requirements shall also apply to primary enclosures used to transport live guinea pigs or hamsters:
(1)
(ii) Each live guinea pig transported in a primary enclosure shall be provided a minimum amount of floor space in accordance with the following table:
(2)
(ii) Each live hamster transported in a primary enclosure shall be provided a minimum amount of floor space in accordance with the following table:
(f) Primary enclosures used to transport live guinea pigs or hamsters as provided in this section shall have solid bottoms to prevent leakage in shipment and shall be cleaned and sanitized in a manner prescribed in § 3.31 of the standards, if previously used. Such primary enclosures shall contain clean litter of a suitable absorbent material, which is safe and nontoxic to the guinea pigs or hamsters, in sufficient quantity to absorb and cover excreta, unless the guinea pigs or hamsters are on wire or other nonsolid floors.
(g) Primary enclosures used to transport live guinea pigs or hamsters, except where such primary enclosures are permanently affixed in the animal cargo space of the primary conveyance, shall be clearly marked on top and on one or more sides with the words “Live Animals” in letters not less than 2.5 centimeters (1 inch) in height, and with arrows or other markings, to indicate the correct upright position of the container.
(h) Documents accompanying the shipment shall be attached in an easily accessible manner to the outside of a primary enclosure which is part of such shipment.
(i) When a primary enclosure is permanently affixed within the animal cargo space of the primary conveyance so that the front opening is the only source of ventilation for such primary enclosure, the front opening shall open directly to the outside or to an unobstructed aisle or passageway within the primary conveyance. Such front ventilation opening shall be at least 90 percent of the total surface area of the front wall of the primary enclosure and covered with bars, wire mesh or smooth expanded metal.
(a) The animal cargo space of primary conveyances used in transporting live guinea pigs and hamsters shall be designed and constructed to protect the health, and ensure the safety and comfort of the live guinea pigs and hamsters at all times.
(b) The animal cargo space shall be constructed and maintained in a manner to prevent the ingress of engine exhaust fumes and gases from the primary conveyance during transportation in commerce.
(c) No live guinea pig or hamster shall be placed in an animal cargo space that does not have a supply of air sufficient for normal breathing for each live animal contained therein, and the primary enclosures shall be positioned in the animal cargo space in such a manner that each live guinea pig or hamster has access to sufficient air for normal breathing.
(d) Primary enclosures shall be positioned in the primary conveyance in such a manner that in an emergency the live guinea pigs or hamsters can be removed from the primary conveyance as soon as possible.
(e) The interior of the animal cargo space shall be kept clean.
(f) Live guinea pigs and hamsters shall not be transported with any material, substance (e.g., dry ice) or device which may reasonably be expected to be injurious to the health and well-being of the guinea pigs and hamsters unless proper precaution is taken to prevent such injury.
(g) The animal cargo space of primary conveyances used to transport guinea pigs or hamsters shall be mechanically sound and provide fresh air by means of windows, doors, vents, or air conditioning so as to minimize
(a) If live guinea pigs or hamsters are to be transported for a period of more than 6 hours, the animals shall have access to food and water or a type of food, which provides the requirements for food and water in quantity and quality sufficient to satisfy their food and water needs, during transit.
(b) Any dealer, research facility, exhibitor or operator of an auction sale offering any live guinea pig or hamster to any carrier or intermediate handler for transportation, in commerce, shall provide an adequate supply of food or type of food, which provides the requirements for food and water, within the primary enclosure to meet the requirements of this section.
(c) No carrier or intermediate handler shall accept for transportation, in commerce, any live guinea pig or hamster without an adequate supply of food or type of food, which provides the requirements for food and water, within the primary enclosure to meet the requirements of this section.
(a) During surface transportation, it shall be the responsibility of the driver or other employee to visually observe the live guinea pigs or hamsters as frequently as circumstances may dictate, but not less than once every 4 hours, to assure that they are receiving sufficient air for normal breathing, their ambient temperatures are within the prescribed limits, all other applicable standards are being complied with and to determine whether any of the live guinea pigs or hamsters are in obvious physical distress and to provide any needed veterinary care as soon as possible. When transported by air, live guinea pigs and hamsters shall be visually observed by the carrier as frequently as circumstances may dictate, but not less than once every 4 hours, if the animal cargo space is accessible during flight. If the animal cargo space is not accessible during flight, the carrier shall visually observe the live guinea pigs or hamsters whenever loaded and unloaded and whenever the animal cargo space is otherwise accessible to assure that they are receiving sufficient air for normal breathing, their ambient temperatures are within the prescribed limits, all other applicable standards are being complied with and to determine whether any such live guinea pigs or hamsters are in obvious physical distress. The carrier shall provide any needed veterinary care as soon as possible. No guinea pig or hamster in obvious physical distress shall be transported in commerce.
(b) During the course of transportation, in commerce, live guinea pigs or hamsters shall not be removed from their primary enclosures unless placed in other primary enclosures or facilities conforming to the requirements provided in this subpart.
No person subject to the Animal Welfare regulations shall commingle shipments of live guinea pigs or hamsters with inanimate cargo. All animal holding areas of a terminal facility where shipments of live guinea pigs or hamsters are maintained shall be cleaned and sanitized as prescribed in § 3.31 of the standards often enough to prevent an accumulation of debris or excreta, to minimize vermin infestation, and to prevent a disease hazard. An effective program for the control of insects, ectoparasites, and avian and mammalian pests shall be established and maintained for all animal holding areas. Any animal holding area containing live guinea pigs or hamsters shall be provided with fresh air by
(a) Any person who is subject to the Animal Welfare regulations and who moves live guinea pigs or hamsters from an animal holding area of a terminal facility to a primary conveyance or vice versa shall do so as quickly and efficiently as possible. Any person subject to the Animal Welfare Act and holding any live guinea pig or hamster in an animal holding area of a terminal facility or transporting any live guinea pig or hamster to or from a terminal facility shall provide the following:
(1)
(2)
(3)
(b) Care shall be exercised to avoid handling of the primary enclosure in such a manner that may cause physical or emotional trauma to the live guinea pig or hamster contained therein.
(c) Primary enclosures used to transport any live guinea pig or hamster shall not be tossed, dropped, or needlessly tilted and shall not be stacked in a manner which may reasonably be expected to result in their falling.
(a)
(b)
(c)
(d)
(e)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(e)
All primary enclosures for rabbits shall conform to the following requirements:
(a)
(2) Primary enclosures shall be constructed and maintained so as to enable the rabbits to remain dry and clean.
(3) Primary enclosures shall be constructed and maintained so that the rabbits contained therein have convenient access to clean food and water as required in this subpart.
(4) The floors of the primary enclosures shall be constructed so as to protect the rabbits' feet and legs from injury. Litter shall be provided in all primary enclosures having solid floors.
(5) A suitable nest box containing clean nesting material shall be provided in each primary enclosure housing a female with a litter less than one month of age.
(b)
(c)
(2) Each rabbit housed in a primary enclosure shall be provided a minimum amount of floor space, exclusive of the space taken up by food and water receptacles, in accordance with the following table:
(3) Innovative primary enclosures that do not precisely meet the space requirements of paragraph (c)(2) of this section, but that do provide rabbits with a sufficient volume of space and the opportunity to express species-typical behavior, may be used at research facilities when approved by the Institutional Animal Care and Use Committee, and by dealers and exhibitors when approved by the Administrator.
(a) Rabbits shall be fed at least once each day except as otherwise might be required to provide adequate veterinary care. The food shall be free from contamination, wholesome, palatable and of sufficient quantity and nutritive value to meet the normal daily requirements for the condition and size of the rabbit.
(b) Food receptacles shall be accessible to all rabbits in a primary enclosure and shall be located so as to minimize contamination by excreta. All food receptacles shall be kept clean and sanitized at least once every 2 weeks. If self feeders are used for the feeding of dry feed, measures must be taken to prevent molding, deterioration or caking of the feed.
Sufficient potable water shall be provided daily except as might otherwise be required to provide adequate veterinary care. All watering receptacles shall be sanitized when dirty:
(a)
(2) In primary enclosures equipped with solid floors, soiled litter shall be removed and replaced with clean litter at least once each week.
(3) If primary enclosures are equipped with wire or mesh floors, the troughs or pans under such enclosures shall be cleaned at least once each week. If worm bins are used under such enclosures they shall be maintained in a sanitary condition.
(b)
(2) Prior to the introduction of rabbits into empty primary enclosures previously occupied, such enclosures shall be sanitized in the manner provided in paragraph (b)(3) of this section.
(3) Primary enclosures for rabbits shall be sanitized by washing them with hot water (180 °F.) and soap or detergent as in a mechanical cage washer, or by washing all soiled surfaces with a detergent solution followed by a safe and effective disinfectant, or by cleaning all soiled surfaces with live steam or flame.
(c)
(d)
A sufficient number of employees shall be utilized to maintain the prescribed level of husbandry practices set forth in this subpart. Such practices shall be under the supervision of an animal caretaker who has a background in animal husbandry or care.
Animals housed in the same primary enclosure shall be maintained in compatible groups, with the following additional restrictions:
(a) Rabbits shall not be housed in the same primary enclosure with any other species of animals unless required for scientific reasons.
(b) Rabbits under quarantine or treatment for a communicable disease shall be separated from other rabbits and other susceptible species of animals in such a manner as to minimize dissemination of such disease.
Sections 3.60 through 3.66 issued under secs. 3, 5, 6, 10, 11, 14, 16, 17, 21; 80 Stat. 353; 84 Stat. 1561, 1562, 1563, 1564; 90 Stat. 418, 420, 423 (7 U.S.C. 2133, 2135, 2136, 2140, 2141, 2144, 2146, 2147, 2151); 37 FR 28464, 28477, 38 FR 19141.
(a) Carriers and intermediate handlers shall not accept any live rabbit presented by any dealer, research facility, exhibitor, operator of an auction sale, or other person, or any department, agency, or instrumentality of the United States or any State or local government for shipment, in commerce, more than 4 hours prior to the scheduled departure of the primary conveyance on which it is to be transported:
(b) Any carrier or intermediate handler shall only accept for transportation or transport, in commerce, any live rabbit in a primary enclosure which conforms to the requirements set forth in § 3.61 of the standards:
(1) Name and address of the consignor;
(2) The number of rabbits in the primary enclosure(s);
(3) A certifying statement (e.g., “I hereby certify that the __ (number) primary enclosure(s) which are used to transport the animal(s) in this shipment complies (comply) with USDA standards for primary enclosures (9 CFR part 3).”); and
(4) The signature of the consignor, and date.
(c) Carriers or intermediate handlers whose facilities fail to meet the minimum temperature allowed by the standards may accept for transportation or transport, in commerce, any live rabbit consigned by any department, agency, or instrumentality of the United States or of any State or local government, or by any person (including any licensee or registrant under the Act, as well as any private individual) if the consignor furnishes to the carrier or intermediate handler a certificate executed by a veterinarian accredited by this Department pursuant to part 160 of this title on a specified date which shall not be more than 10 days prior to delivery of such rabbit for transportation in commerce, stating that such live rabbit is acclimated to air temperatures lower than those prescribed in §§ 3.65 and 3.66. A copy of such certificate shall accompany the shipment to destination. The certificate shall include at least the following information:
(1) Name and address of the consignor;
(2) The number of rabbits in the shipment;
(3) A certifying statement (e.g., “I hereby certify that the animal(s) in this shipment is (are), to the best of my knowledge, acclimated to air temperatures lower than 7.2 °C. (45 °F.).)”; and
(4) The signature of the USDA accredited veterinarian, assigned accreditation number, and date.
(d) Carriers and intermediate handlers shall attempt to notify the consignee at least once in every 6 hour period following the arrival of any live rabbit at the animal holding area of the terminal cargo facility. The time, date, and method of each attempted notification and the final notification to the consignee and the name of the person notifying the consignee shall be recorded on the copy of the shipping document retained by the carrier or intermediate handler and on a copy of the shipping document accompanying the animal shipment.
No person subject to the Animal Welfare regulations shall offer for transportation or transport in commerce any live rabbit in a primary enclosure that does not conform to the following requirements:
(a) Primary enclosures, such as compartments, transport cages, cartons, or crates, used to transport live rabbits shall be constructed in such a manner that:
(1) The stuctural strength of the enclosure shall be sufficient to contain the live rabbits and to withstand the normal rigors of transportation;
(2) The interior of the enclosure shall be free from any protrusions that could be injurious to the live rabbits contained therein;
(3) The openings of such enclosures are easily accessible at all times for emergency removal of the live rabbits;
(4) Except as provided in paragraph (h) of this section, there are ventilation openings located on two opposite
(5) Except as provided in paragraph (h) of this section, projecting rims or other devices shall be on the exterior of the outside walls with any ventilation openings to prevent obstruction of the ventilation openings and to provide a minimum air circulation space 1.9 centimeters (.75 inch) between the primary enclosure and any adjacent cargo or conveyance wall; and
(6) Except as provided in paragraph (h) of this section, adequate handholds or other devices for lifting shall be provided on the exterior of the primary enclosure to enable the primary enclosure to be lifted without tilting and to ensure that the person handling the primary enclosure will not be in contact with the rabbit.
(b) Live rabbits transported in the same primary enclosure shall be maintained in compatible groups and shall not be transported in the same primary enclosure with other specie of animals.
(c) Primary enclosures used to transport live rabbits shall be large enough to ensure that each rabbit contained therein has sufficient space to turn about freely and to make normal postural adjustments.
(d) Not more than 15 live rabbits shall be transported in the same primary enclosure.
(e) Primary enclosures used to transport live rabbits as provided in this section shall have solid bottoms to prevent leakage in shipment and shall be cleaned and sanitized in a manner prescribed in § 3.56 of the standards, if previously used. Such primary enclosures shall contain clean litter of a suitable absorbent material which is safe and nontoxic to the rabbits, in sufficient quantity to absorb and cover excreta, unless the rabbits are on wire or other nonsolid floors.
(f) Primary enclosures used to transport live rabbits, except where such primary enclosures are permanently affixed in the animal cargo space of the primary conveyance, shall be clearly marked on top and on one or more sides with the works “Live Animal” in letters not less than 2.5 centimeters (1 inch) in height, and with arrows or other markings, to indicate the correct upright position of the container.
(g) Documents accompanying the shipment shall be attached in an easily accessible manner to the outside of a primary enclosure which is part of such shipment.
(h) When a primary enclosure is permanently affixed within the animal cargo space of the primary conveyance so that the front opening is the only source of ventilation for such primary enclosure, the front opening shall open directly to the outside or to an unobstructed aisle or passageway within the primary conveyance. Such front ventilation opening shall be at least 90 percent of the total surface area of the front wall of the primary enclosure and covered with bars, wire mesh or smooth expanded metal.
(a) The animal cargo space of primary conveyances used in transporting live rabbits shall be designed and constructed to protect the health, and ensure the safety and comfort of the rabbits contained therein at all times.
(b) The animal cargo space shall be constructed and maintained in a manner to prevent the ingress of engine exhaust fumes and gases from the primary conveyance during transportation in commerce.
(c) No live rabbit shall be placed in an animal cargo space that does not
(d) Primary enclosures shall be positioned in the primary conveyance in such a manner that in an emergency the live rabbits can be removed from the primary conveyance as soon as possible.
(e) The interior of the animal cargo space shall be kept clean.
(f) Live rabbits shall not be transported with any material, substance (e.g., dry ice) or device which may reasonably be expected to be injurious to the health and well-being of the rabbits unless proper precaution is taken to prevent such injury.
(g) The animal cargo space of primary conveyances used to transport rabbits shall be mechanically sound and provide fresh air by means of windows, doors, vents, or air conditioning so as to minimize drafts, odors, and moisture condensation. Auxiliary ventilation, such as fans, blowers, or air conditioners, shall be used in any cargo space containing live rabbits when the ambient temperature in the animal cargo space is 75 °F (23.9 °C) or higher. The ambient temperature within the animal cargo space shall not exceed 85 °F (29.5 °C) or fall below 45 °F (7.2 °C), except that the ambient temperature in the cargo space may be below 45 °F (7.2 °C) if the rabbits are accompanied by a certificate of acclimation to lower temperatures, as provided in § 3.60(c) of this part.
(a) If live rabbits are to be transported for a period of more than 6 hours, they shall have access to food and water or a type of food, which provides the requirements for food and water in quantity and quality sufficient to satisfy their food and water needs, during transit.
(b) Any dealer, research facility, exhibitor or operator of an auction sale offering any live rabbit to any carrier or intermediate handler for transportation, in commerce, shall provide an adequate supply of food or type of food, which provides the requirements for food and water, within the primary enclosure to meet the requirements of this section.
(c) No carrier or intermediate handler shall accept for transportation, in commerce, any live rabbit without an adequate supply of food or type of food, which provides the requirements for food and water, within the primary enclosure to meet the requirements of this section.
(a) During surface transportation, it shall be the responsibility of the driver or other employee to visually observe the live rabbits as frequently as circumstances may dictate, but not less than once every 4 hours, to assure that they are receiving sufficient air for normal breathing, their ambient temperatures are within the prescribed limits, all other applicable standards are being complied with and to determine whether any of the live rabbits are in obvious physical disress and to provide any needed veterinary care as soon as possible. When transported by air, live rabbits shall be visually observed by the carrier as frequently as circumstances may dictate, but not less than once every 4 hours, if the cargo space is accessible during flight. If the animal cargo space is not accessible during flight, the carrier shall visually observe the live rabbits whenever loaded and unloaded and whenever the animal cargo space is otherwise accessible to assure that they are receiving sufficient air for normal breathing, their ambient temperatures are within the prescribed limits, all other applicable standards are being complied with and to determine whether any such live rabbits are in obvious physical distress. The carrier shall provide any needed veterinary care as soon as possible. No rabbit in obvious physical distress shall be transported in commerce.
(b) During the course of transportation, in commerce, live rabbits shall not be removed from their primary enclosures unless placed in other primary enclosures or facilities conforming to the requirements provided in this subpart.
No person subject to the Animal Welfare regulations shall commingle shipments of live rabbits with inanimate cargo. All animal holding areas of a terminal facility where shipments of rabbits are maintained shall be cleaned and sanitized as prescribed in § 3.56 of the standards often enough to prevent an accumulation of debris or excreta, to minimize vermin infestation, and to prevent a disease hazard. An effective program for the control of insects, ectoparasites, and avian and mammalian pests shall be established and maintained for all animal holding areas. Any animal holding area containing live rabbits shall be provided with fresh air by means of windows, doors, vents, or air conditioning and may be ventilated or air circulated by means of fans, blowers, or an air conditioning system so as to minimize drafts, odors, and moisture condensation. Auxiliary ventilation, such as exhaust fans and vents or fans or blowers or air conditioning shall be used for any animal holding area containing live rabbits when the air temperature within such animal holding area is 23.9 °C. (75 °F.) or higher. The air temperature around any live rabbit in any animal holding area shall not be allowed to fall below 7.2 °C. (45 °F.) nor be allowed to exceed 29.5 °C. (85 °F.) at any time. To ascertain compliance with the provisions of this paragraph, the air temperature around any live rabbit shall be measured and read outside the primary enclosure which contains such rabbit at a distance not to exceed .91 meters (3 feet) from any one of the external walls of the primary enclosure and on a level parallel to the bottom of such primary enclosure at a point which approximates half the distance between the top and bottom of such primary enclosure.
(a) Any person who is subject to the Animal Welfare regulations and who moves live rabbits from an animal holding area of a terminal facility to a primary conveyance or vice versa shall do so as quickly and efficiently as possible. Any person subject to the Animal Welfare regulations and holding any live rabbit in an animal holding area of a terminal facility or transporting any live rabbit to or from a terminal facility shall provide the following:
(1)
(2)
(3)
(b) Care shall be exercised to avoid handling of the primary enclosure in such a manner that may cause physical or emotional trauma to the live rabbit contained therein.
(c) Primary enclosures used to transport any live rabbit shall not be tossed, dropped, or needlessly tilted and shall not be stacked in a manner which may reasonably be expected to result in their falling.
(a)
These minimum standards apply only to live nonhuman primates, unless stated otherwise.
(b)
(c)
(i) Be free of excessive rust that prevents the required cleaning and sanitization, or that affects the structural strength of the surface; and
(ii) Be free of jagged edges or sharp points that might injure the animals.
(2)
(3)
(d)
(e)
(f)
(g)
(a)
(b)
(c)
(a)
(b)
(c)
(d)
(e)
(f)
(1) The outside walls of the primary enclosure are made of a sturdy, durable material such as concrete, wood, plastic, metal, or glass, and are high enough and constructed in a manner that restricts contact with or entry by humans and animals that are outside the sheltered housing facility; or
(2) The housing facility is surrounded by a natural barrier that restricts the nonhuman primates to the housing facility and protects them from contact with unauthorized humans and animals that are outside the sheltered housing facility, and the Administrator gives written permission
(g)
(a)
(b)
(c)
(d)
(1) The outside walls of the primary enclosure are made of a sturdy, durable material such as concrete, wood, plastic, metal, or glass, and are high enough and constructed in a manner that restricts contact with or entry by humans and animals that are outside the housing facility; or
(2) The housing facility is surrounded by a natural barrier that restricts the nonhuman primates to the housing facility and protects them from contact with unauthorized humans and animals that are outside the housing facility, and the Administrator gives written permission.
(e)
(a)
(b)
(c)
(d)
Primary enclosures for nonhuman primates must meet the following minimum requirements:
(a)
(2) Primary enclosures must be constructed and maintained so that they:
(i) Have no sharp points or edges that could injure the nonhuman primates;
(ii) Protect the nonhuman primates from injury;
(iii) Contain the nonhuman primates securely and prevent accidental opening of the enclosure, including opening by the animal;
(iv) Keep other unwanted animals from entering the enclosure or having physical contact with the nonhuman primates;
(v) Enable the nonhuman primates to remain dry and clean;
(vi) Provide shelter and protection from extreme temperatures and weather conditions that may be uncomfortable or hazardous to the species of nonhuman primate contained;
(vii) Provide sufficient shade to shelter all the nonhuman primates housed in the primary enclosure at one time;
(viii) Provide the nonhuman primates with easy and convenient access to clean food and water;
(ix) Enable all surfaces in contact with nonhuman primates to be readily cleaned and sanitized in accordance with § 3.84(b)(3) of this subpart, or replaced when worn or soiled;
(x) Have floors that are constructed in a manner that protects the nonhuman primates from injuring themselves; and
(xi) Provide sufficient space for the nonhuman primates to make normal postural adjustments with freedom of movement.
(b)
(1) Prior to February 15, 1994:
(i) Primary enclosures must be constructed and maintained so as to provide sufficient space to allow each nonhuman primate to make normal postural adjustments with adequate freedom of movement; and
(ii) Each nonhuman primate housed in a primary enclosure must be provided with a minimum floor space equal to an area at least three times the area occupied by the primate when standing on four feet.
(2) On and after February 15, 1994:
(i) The minimum space that must be provided to
Group 1—marmosets, tamarins, and infants (less than 6 months of age) of various species.
Group 2—capuchins, squirrel monkeys and similar size species, and juveniles (6 months to 3 years of age) of various species.
Group 3—macaques and African species.
Group 4—male macaques and large African species.
Group 5—baboons and nonbrachiating species larger than 33.0 lbs. (15 kg.).
Group 6—great apes over 55.0 lbs. (25 kg.), except as provided in paragraph (b)(2)(ii) of this section, and brachiating species.
(ii) Dealers. exhibitors, and research facilities, including Federal research facilities, must provide great apes weighing over 110 lbs. (50 kg) an additional volume of space in excess of that required for Group 6 animals as set forth in paragraph (b)(2)(i) of this section, to allow for normal postural adjustments.
(iii) In the case of research facilities, any exemption from these standards must be required by a research proposal or in the judgment of the attending veterinarian and must be approved by the Committee. In the case of dealers and exhibitors, any exemption from these standards must be required in the judgment of the attending veterinarian and approved by the Administrator.
(iv) When more than one nonhuman primate is housed in a primary enclosure, the minimum space requirement for the enclosure is the sum of the minimum floor area space required for each individual nonhuman primate in the table in paragraph (b)(2)(i) of this section, and the minimum height requirement for the largest nonhuman primate housed in the enclosure. Provided however, that mothers with infants less than 6 months of age may be maintained together in primary enclosures that meet the floor area space and height requirements of the mother.
(c) Innovative primary enclosures not precisely meeting the floor area and height requirements provided in paragraphs (b)(1) and (b)(2) of this section, but that do provide nonhuman primates with a sufficient volume of space and the opportunity to express species-typical behavior, may be used at research facilities when approved by the Committee, and by dealers and exhibitors when approved by the Administrator.
Dealers, exhibitors, and research facilities must develop, document, and follow an appropriate plan for environment enhancement adequate to promote the psychological well-being of nonhuman primates. The plan must be in accordance with the currently accepted professional standards as cited in appropriate professional journals or reference guides, and as directed by the attending veterinarian. This plan must be made available to APHIS upon request, and, in the case of research facilities, to officials of any pertinent funding agency. The plan, at a minimum, must address each of the following:
(a)
(1) If a nonhuman primate exhibits vicious or overly aggressive behavior, or is debilitated as a result of age or
(2) Nonhuman primates that have or are suspected of having a contagious disease must be isolated from healthy animals in the colony as directed by the attending veterinarian. When an entire group or room of nonhuman primates is known to have or believed to be exposed to an infectious agent, the group may be kept intact during the process of diagnosis, treatment, and control.
(3) Nonhuman primates may not be housed with other species of primates or animals unless they are compatible, do not prevent access to food, water, or shelter by individual animals. and are not known to be hazardous to the health and well-being of each other. Compatibility of nonhuman primates must be determined in accordance with generally accepted professional practices and actual observations, as directed by the attending veterinarian, to ensure that the nonhuman primates are in fact compatible. Individually housed nonhuman primates must be able to see and hear nonhuman primates of their own or compatible species unless the attending veterinarian determines that it would endanger their health, safety, or well-being.
(b)
(c)
(1) Infants and young juveniles;
(2) Those that show signs of being in psychological distress through behavior or appearance;
(3) Those used in research for which the Committee-approved protocol requires restricted activity;
(4) Individually housed nonhuman primates that are unable to see and hear nonhuman primates of their own or compatible species; and
(5) Great apes weighing over 110 lbs. (50 kg). Dealers, exhibitors, and research facilities must include in the environment enhancement plan special provisions for great apes weighing over 110 lbs. (50 kg), including additional opportunities to express species-typical behavior.
(d)
(e)
(2) For a research facility, the Committee may exempt an individual nonhuman primate from participation in some or all of the otherwise required environment enhancement plans for scientific reasons set forth in the research proposal. The basis of the exemption shall be documented in the approved proposal and must be reviewed
(3) Records of any exemptions must be maintained by the dealer, exhibitor, or research facility and must be made available to USDA officials or officials of any pertinent funding Federal agency upon request.
(a) The diet for nonhuman primates must be appropriate for the species, size, age, and condition of the animal, and for the conditions in which the nonhuman primate is maintained, according to generally accepted professional and husbandry practices and nutritional standards. The food must be clean, wholesome, and palatable to the animals. It must be of sufficient quantity and have sufficient nutritive value to maintain a healthful condition and weight range of the animal and to meet its normal daily nutritional requirements.
(b) Nonhuman primates must be fed at least once each day except as otherwise might be required to provide adequate veterinary care. Infant and juvenile nonhuman primates must be fed as often as necessary in accordance with generally accepted professional and husbandry practices and nutritional standards, based upon the animals' age and condition.
(c) Food and food receptacles, if used, must be readily accessible to all the nonhuman primates being fed. If members of dominant nonhuman primate or other species are fed together with other nonhuman primates, multiple feeding sites must be provided. The animals must be observed to determine that all receive a sufficient quantity of food.
(d) Food and food receptacles, if used, must be located so as to minimize any risk of contamination by excreta and pests. Food receptacles must be kept clean and must be sanitized in accordance with the procedures listed in § 3.84(b)(3) of this subpart at least once every 2 weeks. Used food receptacles must be sanitized before they can be used to provide food to a different nonhuman primate or social grouping of nonhuman primates. Measures must be taken to ensure there is no molding, deterioration, contamination, or caking or wetting of food placed in self-feeders.
Potable water must be provided in sufficient quantity to every nonhuman primate housed at the facility. If potable water is not continually available to the nonhuman primates, it must be offered to them as often as necessary to ensure their health and well-being, but no less than twice daily for at least l hour each time, unless otherwise required by the attending veterinarian, or as required by the research proposal approved by the Committee at research facilities. Water receptacles must be kept clean and sanitized in accordance with methods provided in § 3.84(b)(3) of this subpart at least once every 2 weeks or as often as necessary to keep them clean and free from contamination. Used water receptacles must be sanitized before they can be used to provide water to a different nonhuman primate or social grouping of nonhuman primates.
(a)
(b)
(2) Indoor primary enclosures must be sanitized at least once every 2 weeks and as often as necessary to prevent an excessive accumulation of dirt, debris, waste, food waste, excreta, or disease hazard, using one of the methods prescribed in paragraph (b)(3) of this section. However, if the species of nonhuman primates housed in the primary enclosure engages in scent marking, the primary enclosure must be sanitized at regular intervals determined in accordance with generally accepted professional and husbandry practices.
(3) Hard surfaces of primary enclosures and food and water receptacles must be sanitized using one of the following methods:
(i) Live steam under pressure;
(ii) Washing with hot water (at least 180 °F (82.2 °C)) and soap or detergent, such as in a mechanical cage washer;
(iii) Washing all soiled surfaces with appropriate detergent solutions or disinfectants, or by using a combination detergent/disinfectant product that accomplishes the same purpose, with a thorough cleaning of the surfaces to remove organic material, so as to remove all organic material and mineral buildup, and to provide sanitization followed by a clean water rinse.
(4) Primary enclosures containing material that cannot be sanitized using the methods provided in paragraph (b)(3) of this section, such as sand, gravel, dirt, absorbent bedding, grass, or planted areas, must be sanitized by removing the contaminated material as necessary to prevent odors, diseases, pests, insects, and vermin infestation.
(c)
(d)
Every person subject to the Animal Welfare regulations (9 CFR parts 1, 2, and 3) maintaining nonhuman primates must have enough employees to carry out the level of husbandry practices and care required in this subpart. The employees who provide husbandry practices and care, or handle nonhuman primates, must be trained and supervised by an individual who has the knowledge, background, and experience in proper husbandry and care of nonhuman primates to supervise others. The employer must be certain that the supervisor can perform to these standards.
(a) Carriers and intermediate handlers must not accept a nonhuman primate for transport in commerce more than 4 hours before the scheduled departure time of the primary conveyance on which the animal is to be transported. However, a carrier or intermediate handler may agree with anyone consigning a nonhuman primate to extend this time by up to 2 hours.
(b) Carriers and intermediate handlers must not accept a nonhuman primate for transport in commerce unless they are provided with the name, address, telephone number, and telex number, if applicable, of the consignee.
(c) Carriers and intermediate handlers must not accept a nonhuman primate for transport in commerce unless the consignor certifies in writing to the carrier or intermediate handler that the nonhuman primate was offered food and water during the 4 hours before delivery to the carrier or intermediate handler. The certification must be securely attached to the outside of the primary enclosure in a manner that makes it easily noticed and read. Instructions for no food or water are not acceptable unless directed by the attending veterinarian. Instructions must be in compliance with § 3.89 of this subpart. The certification must include the following information for each nonhuman primate:
(1) The consignor's name and address;
(2) The species of nonhuman primate;
(3) The time and date the animal was last fed and watered and the specific instructions for the next feeding(s) and watering(s) for a 24-hour period; and
(4) The consignor's signature and the date and time the certification was signed.
(d) Carriers and intermediate handlers must not accept a nonhuman primate for transport in commerce unless the primary enclosure meets the requirements of § 3.87 of this subpart. A carrier or intermediate handler must not accept a nonhuman primate for transport if the primary enclosure is obviously defective or damaged and cannot reasonably be expected to safely and comfortably contain the nonhuman primate without suffering or injury.
(e) Carriers and intermediate handlers must not accept a nonhuman primate for transport in commerce unless their animal holding area facilities meet the minimum temperature requirements provided in §§ 3.91 and 3.92 of this subpart, or unless the consignor provides them with a certificate signed by a veterinarian and dated no more than 10 days before delivery of the animal to the carrier or intermediate handler for transport in commerce, certifying that the animal is acclimated to temperatures lower than those that are required in §§ 3.91 and 3.92 of this subpart. Even if the carrier or intermediate handler receives this certification, the temperatures the nonhuman primate is exposed to while in the carrier's or intermediate handler's custody must not be lower than the minimum temperature specified by the veterinarian in accordance with paragraph (e)(4) of this section, and must be reasonably within the generally and professionally accepted temperature range for the nonhuman primate, as determined by the veterinarian, considering its age, condition, and species. A copy of the certification must accompany the nonhuman primate to its destination and must include the following information for each primary enclosure:
(1) The consignor's name and address;
(2) The number of nonhuman primates contained in the primary enclosure;
(3) The species of nonhuman primate contained in the primary enclosure;
(4) A statement by a veterinarian that to the best of his or her knowledge, each of the nonhuman primates contained in the primary enclosure is acclimated to air temperatures lower than 50 °F (10 °C), but not lower than a minimum temperature specified on the certificate based on the generally and professionally accepted temperature range for the nonhuman primate, considering its age, condition, and species; and
(5) The veterinarian's signature and the date the certification was signed.
(f) When a primary enclosure containing a nonhuman primate has arrived at the animal holding area of a terminal facility after transport, the carrier or intermediate handler must attempt to notify the consignee upon arrival and at least once in every 6-hour period after arrival. The time, date, and method of all attempted notifications and the actual notification of the consignee, and the name of the person who notifies or attempts to notify the consignee must be written either on the carrier's or intermediate handler's copy of the shipping document or
Any person subject to the Animal Welfare regulations (9 CFR parts 1, 2, and 3) must not transport or deliver for transport in commerce a nonhuman primate unless it is contained in a primary enclosure, such as a compartment, transport cage, carton, or crate, and the following requirements are met:
(a)
(1) The primary enclosure is strong enough to contain the nonhuman primate securely and comfortably and to withstand the normal rigors of transportation;
(2) The interior of the enclosure has no sharp points or edges and no protrusions that could injure the animal contained in it;
(3) The nonhuman primate is at all times securely contained within the enclosure and cannot put any part of its body outside the enclosure in a way that could result in injury to the animal, or to persons or animals nearby;
(4) The nonhuman primate can be easily and quickly removed from the enclosure in an emergency;
(5) The doors or other closures that provide access into the enclosure are secured with animal-proof devices that prevent accidental opening of the enclosure, including opening by the nonhuman primate;
(6) Unless the enclosure is permanently affixed to the conveyance, adequate devices such as handles or handholds are provided on its exterior, and enable the enclosure to be lifted without tilting it, and ensure that anyone handling the enclosure will not come into physical contact with the animal contained inside;
(7) Any material, treatment, paint, preservative, or other chemical used in or on the enclosure is nontoxic to the animal and not harmful to the health or well-being of the animal;
(8) Proper ventilation is provided to the nonhuman primate in accordance with paragraph (c) of this section;
(9) Ventilation openings are covered with bars, wire mesh, or smooth expanded metal having air spaces; and
(10) The primary enclosure has a solid, leak-proof bottom, or a removable, leak-proof collection tray under a slatted or wire mesh floor that prevents seepage of waste products, such as excreta and body fluids, outside of the enclosure. If a slatted or wire mesh floor is used in the enclosure, it must be designed and constructed so that the animal cannot put any part of its body between the slats or through the holes in the mesh. It must contain enough previously unused litter to absorb and cover excreta. The litter must be of a suitably absorbent material that is safe and nontoxic to the nonhuman primate and is appropriate for the species transported in the primary enclosure.
(b)
(c)
(i) If ventilation openings are located on two opposite walls of the primary enclosure, the openings on each wall must be at least 16 percent of the total surface area of each such wall and be located above the midline of the enclosure; or
(ii) If ventilation openings are located on all four walls of the primary enclosure, the openings on every wall must be at least 8 percent of the total surface area of each such wall and be located above the midline of the enclosure.
(2) Unless the primary enclosure is permanently affixed to the conveyance, projecting rims or similar devices must be located on the exterior of each enclosure wall having a ventilation opening, in order to prevent obstruction of the openings. The projecting rims or similar devices must be large enough to provide a minimum air circulation space of 0.75 inches (1.9 centimeters) between the primary enclosure and anything the enclosure is placed against.
(3) If a primary enclosure is permanently affixed to the primary conveyance so that there is only a front ventilation opening for the enclosure, the primary enclosure must be affixed to the primary conveyance in such a way that the front ventilation opening cannot be blocked, and the front ventilation opening must open directly to an unobstructed aisle or passageway inside of the conveyance. The ventilation opening must be at least 90 percent of the total area of the front wall of the enclosure, and must be covered with bars, wire mesh, or smooth expanded metal having air spaces.
(d)
(i) A mother and her nursing infant may be transported together;
(ii) An established male-female pair or family group may be transported together, except that a female in estrus must not be transported with a male nonhuman primate;
(iii) A compatible pair of juveniles of the same species that have not reached puberty may be transported together.
(2) Nonhuman primates of different species must not be transported in adjacent or connecting primary enclosures.
(e)
(f)
(g)
(a) The animal cargo space of primary conveyances used to transport nonhuman primates must be designed, constructed, and maintained in a manner that at all times protects the health and well-being of the animals transported in it, ensures their safety and comfort, and prevents the entry of engine exhaust from the primary conveyance during transportation.
(b) The animal cargo space must have a supply of air that is sufficient for the normal breathing of all the animals being transported in it.
(c) Each primary enclosure containing nonhuman primates must be positioned in the animal cargo space in a manner that provides protection from the elements and that allows each nonhuman primate enough air for normal breathing.
(d) During air transportation, the ambient temperature inside a primary conveyance used to transport nonhuman primates must be maintained at a level that ensures the health and well-being of the species housed, in accordance with generally accepted professional and husbandry practices, at all times a nonhuman primate is present.
(e) During surface transportation, the ambient temperature inside a primary conveyance used to transport nonhuman primates must be maintained between 45 °F (7.2 °C) and 85 °F (30 °C) at all times a nonhuman primate is present.
(f) A primary enclosure containing a nonhuman primate must be placed far enough away from animals that are predators or natural enemies of nonhuman primates, whether the other animals are in primary enclosures or not, so that the nonhuman primate cannot touch or see the other animals.
(g) Primary enclosures must be positioned in the primary conveyance in a manner that allows the nonhuman primates to be quickly and easily removed from the primary conveyance in an emergency.
(h) The interior of the animal cargo space must be kept clean
(i) Nonhuman primates must not be transported with any material, substance (e.g., dry ice), or device in a manner that may reasonably be expected to harm the nonhuman primates or cause inhumane conditions.
(a) Each nonhuman primate that is 1 year of age or more must be offered food
(b) Any dealer, exhibitor, or research facility, including a Federal research facility, offering a nonhuman primate to a carrier or intermediate handler for transportation in commerce must securely attach to the outside of the primary enclosure used for transporting
(c) Food and water receptacles must be securely attached inside the primary enclosure and placed so that the receptacles can be filled from outside of the enclosure without opening the door. Food and water receptacles must be designed, constructed, and installed so that a nonhuman primate cannot leave the primary enclosure through the food or water opening.
(a)
(b)
(c) If a nonhuman primate is obviously ill, injured, or in physical distress, it must not be transported in commerce, except to receive veterinary care for the condition.
(d) During transportation in commerce, a nonhuman primate must not be removed from its primary enclosure unless it is placed in another primary enclosure or a facility that meets the requirements of § 3.80 or § 3.87 of this subpart. Only persons who are experienced and authorized by the shipper, or authorized by the consignor or the consignee upon delivery, if the animal is consigned for transportation, may remove nonhuman primates from their primary enclosure during transportation in commerce, unless required for the health or well-being of the animal.
(e) The transportation regulations contained in this subpart must be complied with until a consignee takes physical delivery of the animal if the animal is consigned for transportation, or until the animal is returned to the consignor.
(a)
(b)
(c)
(d)
(e)
(1)
(2)
(f)
(a) Any person subject to the Animal Welfare regulations (9 CFR parts 1, 2, and 3) who moves (including loading and unloading) nonhuman primates within, to, or from the animal holding area of a terminal facility or a primary conveyance must do so as quickly and efficiently as possible, and must provide the following during movement of the nonhuman primate:
(1)
(2)
(3)
(b) Any person handling a primary enclosure containing a nonhuman primate must use care and must avoid causing physical harm or distress to the nonhuman primate.
(1) A primary enclosure containing a nonhuman primate must not be placed on unattended conveyor belts or on elevated conveyor belts, such as baggage
(2) A primary enclosure containing a nonhuman primate must not be tossed, dropped, or needlessly tilted, and must not be stacked in a manner that may reasonably be expected to result in its falling. It must be handled and positioned in the manner that written instructions and arrows on the outside of the primary enclosure indicate.
(c) This section applies to movement of a nonhuman primate from primary conveyance to primary conveyance, within a primary conveyance or terminal facility, and to or from a terminal facility or a primary conveyance.
(a) All persons subject to the Animal Welfare Act who maintain or otherwise handle marine mammals in captivity must comply with the provisions of this subpart, except that they may apply for and be granted a variance,
(b) An application for a variance must be made to the Deputy Administrator in writing. The request must include:
(1) The species and number of animals involved,
(2) A statement from the attending veterinarian concerning the age and health status of the animals involved, and concerning whether the granting of a variance would be detrimental to the marine mammals involved,
(3) Each provision of the regulations that is not met,
(4) The time period requested for a variance,
(5) The specific reasons why a variance is requested, and
(6) The estimated cost of coming into compliance, if construction is involved.
(c) After receipt of an application for a variance, the Deputy Administrator may require the submission in writing of a report by two experts recommended by the American Association of Zoological Parks and Aquariums and approved by the Deputy Administrator concerning potential adverse impacts on the animals involved or on other matters relating to the effects of the requested variance on the health and well-being of such marine mammals. Such a report will be required only in those cases when the Deputy Administrator determines that such expertise is necessary to determine whether the granting of a variance would cause a situation detrimental to the health and well-being of the marine mammals involved. The cost of such report is to be paid by the applicant.
(d) Variances granted for facilities because of ill or infirm marine mammals that cannot be moved without placing their well-being in jeopardy, or for facilities within 0.3048 meters (1 foot) of compliance with any space requirement may be granted for up to the life of the marine mammals involved. Otherwise, variances shall be granted for a period not exceeding July 30, 1986,
(e) The Deputy Administrator shall deny any application for a variance if he determines that it is not justified under the circumstances or that allowing it will be detrimental to the health and well-being of the marine mammals involved.
(f) Any facility housing marine mammals that does not meet all of the space requirements as of July 30, 1984, must meet all of the requirements by September 28, 1984, or may operate without meeting such requirements until action is taken on an application for a variance if the application is submitted to the Deputy Administrator on or before September 28, 1984.
(g) A research facility may be granted a variance from specified requirements of this subpart when such variance is necessary for research purposes and is fully explained in the experimental design. Any time limitation stated in this section shall not be applicable in such case.
(a)
(2) All marine mammals must be provided with protection from abuse and harassment by the viewing public by the use of a sufficient number of uniformed or readily identifiable employees or attendants to supervise the viewing public, or by physical barriers, such as fences, walls, glass partitions, or distance, or any combination of these.
(3) All surfaces in a primary enclosure must be constructed of durable, nontoxic materials that facilitate cleaning, and disinfection as appropriate, sufficient to maintain water quality parameters as designated in § 3.106. All surfaces must be maintained in good repair as part of a regular, ongoing maintenance program. All facilities must implement a written protocol on cleaning so that surfaces do not constitute a health hazard to animals.
(4) Facilities that utilize natural water areas, such as tidal basins, bays, or estuaries (subject to natural tidewater action), for housing marine mammals are exempt from the drainage requirements of paragraph (c)(1) of this section.
(b)
(c)
(2) Drainage must be provided for primary enclosures and areas immediately surrounding pools. All drain covers and strainers must be securely fastened in order to minimize the potential risk of animal entrapment. Drains must be located so as to rapidly eliminate excess water (except in pools). Drainage effluent must be disposed of in a manner that complies with all applicable Federal, State, and local pollution control laws.
(d)
(e)
(f)
(g)
(a)
(b)
(c)
(a)
(1) The water surface of pools in outdoor primary enclosures housing polar bears and ice or cold water dwelling species of pinnipeds shall be kept sufficiently free of solid ice to allow for entry and exit of the animals.
(2) The water surface of pools in outdoor primary enclosures housing cetaceans and sea otters shall be kept free of ice.
(3) No sirenian or warm water dwelling species of pinnipeds or cetaceans shall be housed in outdoor pools where water temperature cannot be maintained within the temperature range to meet their needs.
(b)
(c)
(1) Where the outside walls of the primary enclosure are made of sturdy, durable material, which may include certain types of concrete, wood, plastic, metal, or glass, and are high enough and constructed in a manner that restricts entry by animals and unauthorized persons and the Administrator gives written approval; or
(2) Where the outdoor housing facility is protected by an effective natural barrier that restricts the marine mammals to the facility and restricts entry by animals and unauthorized persons and the Administrator gives written approval; or
(3) Where appropriate alternative security measures are employed and the Administrator gives written approval; or
(4) For traveling facilities where appropriate alternative security measures are employed.
(a)
(b)
(1)(i)
(ii) The MHD of a pool for Group II cetaceans shall be 7.32 meters (24.0 feet) or four times the average adult length of the longest species of cetacean to be housed therein (as measured in a parallel or horizontal line from the tip of its upper jaw, or from the most anterior portion of the head in bulbous headed animals, to the notch in the tail fluke), whichever is greater; except that such MHD measurement may be reduced from the greater number by up to 20 percent if the amount of the reduction is added to the MHD at the 90-degree angle and if the minimum volume and surface area requirements are met based on an MHD of 7.32 meters (24.0 feet) or four times the average adult length of the longest species of Group II cetacean housed therein, whichever is greater.
(iii) In a pool housing a mixture of Group I and Group II cetaceans, the MHD shall be the largest required for any cetacean housed therein.
(iv) Once the required MHD has been satisfied, the pool size may be required to be adjusted to increase the surface area and volume when cetaceans are added. Examples of MHD and volume requirements for Group I cetaceans are shown in Table I, and for Group II cetaceans in Table II.
(2)
(3)
(i) The minimum volume of water required for up to two Group I cetaceans is based upon the following formula:
(ii) The minimum volume of water required for up to four Group II cetaceans is based upon the following formula:
(iii) When a mixture of both Group I and Group II cetaceans are housed together, the MHD must be satisfied as stated in § 3.104(b)(1), and the minimum depth must be satisfied as stated in § 3.104(b)(2). Based on these figures, the resulting volume must then be calculated
(4)(i)
(ii) When a mixture of Group I and Group II cetaceans are to be housed in a pool, the required MHD, depth, and volume must be met. Then the required surface area must be determined for each animal in the pool. The sum of these surface areas must then be compared to the surface area which is obtained by a computation based on the required MHD of the pool.
SA = π × (MHD / 2)
(iii) Surface area requirements are given in Table IV.
(c)
(1) The required MHD of a primary enclosure pool for sirenians shall be two times the average adult length of the longest species of sirenian to be housed therein. Calculations shall be based on the average adult length of such sirenians as measured in a horizontal line from the tip of the muzzle to the notch in the tail fluke of dugongs and from the tip of the muzzle to the most distal point in the rounded tail of the manatee.
(2) The minimum depth requirements for primary enclosure pools for all sirenians shall be one-half the average adult length of the longest species to be housed therein, or 1.52 meters (5.0 feet), whichever is greater. Those parts of the primary enclosure pool which do not meet the minimum depth requirements cannot be included when calculating space requirements for sirenians.
(3) A pool which satisfies the required MHD and depth shall be adequate for one or two sirenians. Volume and surface area requirements for additional animals shall be calculated using the same formula as for Group I cetaceans, except that the figure for depth requirement for sirenians shall be one-half the average adult length or 1.52 meters (5.0 feet), whichever is greater.
(d)
(2) The minimum size of the dry resting or social activity area of the primary enclosure for pinnipeds (exclusive of the pool of water) shall be based on the average adult length of each pinniped contained therein, as measured in a horizontal or extended position in a straight line from the tip of its nose to the tip of its tail. The minimum size of the dry resting or social activity area shall be computed using the following methods:
(i)
(ii)
(iii)
(3)(i) The minimum surface area of a pool of water for pinnipeds shall be at least equal to the dry resting or social activity area required.
(ii) The MHD of the pool shall be at least one and one-half (1.5) times the average adult length of the largest species of pinniped to be housed in the enclosure; except that such MHD measurement may be reduced by up to 20
(iii) The pool of water shall be at least 0.91 meters (3.0 feet) deep or one-half the average adult length of the longest species of pinniped contained therein, whichever is greater. Parts of the pool that do not meet the minimum depth requirement cannot be used in the calculation of the dry resting and social activity area, or as part of the MHD or required surface area of the pool.
(e)
(f)
(2) The minimum volume of water required for a primary enclosure pool for sea otters shall be based on the sea otter's average adult length. The minimum volume of water required in the pool shall be computed using the following method: Multiply the square of the sea otter's average adult length by 3.14 and then multiply the total by 0.91 meters (3.0 feet). This volume is satisfactory for one or two otters. To calculate the additional volume of water for each additional sea otter above two in a primary enclosure, multiply one-half of the square of the sea otter's average adult length by 3.14, then multiply by 0.91 meters (3.0 feet). (See Table V).
(3) The minimum dry resting area required for one or two sea otters shall be based on the sea otter's average adult length. The minimum dry resting area for one or two sea otters shall be computed using the following method: Square the average adult length of the sea otter and multiply the total by 3.14. When the enclosure is to contain more than two sea otters, the dry resting area for each additional animal shall be computed by multiplying one-half of the sea otter's average adult length by 3.14. Using 1.25 meters or 4.1 feet (the average adult length of a sea otter), the calculations for additional space will result in the following figures:
(a) The food for marine mammals must be wholesome, palatable, and free from contamination and must be of sufficient quantity and nutritive value to maintain marine mammals in a state of good health. The diet must be prepared with consideration for factors such as age, species, condition, and size of the marine mammal being fed. Marine mammals must be offered food at least once a day, except as directed by the attending veterinarian.
(b) Food receptacles, if used, must be located so as to be accessible to all marine mammals in the same primary enclosure and must be placed so as to minimize contamination of the food they contain. Such food receptacles must be cleaned and sanitized after each use.
(c) Food, when given to each marine mammal individually, must be given by an employee or attendant responsible to management who has the necessary knowledge to assure that each marine mammal receives an adequate quantity of food to maintain it in good health. Such employee or attendant is required to have the ability to recognize deviations from a normal state of good health in each marine mammal so that the food intake can be adjusted accordingly. Inappetence exceeding 24 hours must be reported immediately to the attending veterinarian. Public feeding may be permitted only in the presence and under the supervision of a sufficient number of knowledgeable, uniformed employees or attendants. Such employees or attendants must assure that the marine mammals are receiving the proper amount and type of food. Only food supplied by the facility where the marine mammals are kept may be fed to the marine mammals by the public. Marine mammal feeding records noting the estimated individual daily consumption must be maintained at the facility for a period of 1 year and must be made available for APHIS inspection. For marine mammals that are individually fed and not subject to public feeding, the feeding records should reflect an accurate account of food intake; for animals fed, in part, by the public, and for large, group-fed colonies of marine mammals where individual rations are not practical or feasible to maintain, the daily food consumption should be estimated as precisely as possible.
(d) Food preparation and handling must be conducted so as to assure the wholesomeness and nutritive value of the food. Frozen fish or other frozen food must be stored in freezers that are maintained at a maximum temperature of −18 °C (0 °F). The length of time food is stored and the method of storage, the thawing of frozen food, and the maintenance of thawed food must be conducted in a manner that will minimize contamination and that will assure that the food retains nutritive value and wholesome quality until the time of feeding. When food is thawed in standing or running water, cold water must be used. All foods must be fed to the marine mammals within 24 hours following the removal of such foods from the freezers for thawing, or if the food has been thawed under refrigeration, it must be fed to the marine mammals within 24 hours of thawing.
(a)
(b)
(2) When the water is chemically treated, the chemicals shall be added so as not to cause harm or discomfort to the marine mammals.
(3) Water samples shall be taken and tested at least weekly for coliform count and at least daily for pH and any chemical additives (e.g. chlorine and copper) that are added to the water to maintain water quality standards. Facilities using natural seawater shall be exempt from pH and chemical testing unless chemicals are added to maintain water quality. However, they are required to test for coliforms. Records must be kept documenting the time when all such samples were taken and the results of the sampling. Records of all such test results shall be maintained by management for a 1-year period and must be made available for inspection purposes on request.
(c)
(d)
(a)
(2) Particulate animal and food waste, trash, or debris that enters the primary enclosure pools of water must be removed at least daily, or as often as necessary, to maintain the required water quality and to minimize health and disease hazards to the marine mammals.
(3) The wall and bottom surfaces of the primary enclosure pools of water must be cleaned as often as necessary to maintain proper water quality. Natural organisms (such as algae, coelenterates, or molluscs, for example) that do not degrade water quality as defined in § 3.106, prevent proper maintenance, or pose a health or disease hazard to the animals are not considered contaminants.
(b)
(c)
(d)
(a) A sufficient number of adequately trained employees or attendants, responsible to management and working in concert with the attending veterinarian, must be utilized to maintain the prescribed level of husbandry practices set forth in this subpart. Such practices must be conducted under the supervision of a marine mammal caretaker who has demonstrable experience in marine mammal husbandry and care.
(b) The facility will provide and document participation in and successful completion of a facility training course for such employees. This training course will include, but is not limited to, species appropriate husbandry techniques, animal handling techniques, and information on proper reporting protocols, such as recordkeeping and notification of veterinary staff for medical concerns.
(c) Any training of marine mammals must be done by or under the direct supervision of experienced trainers.
(d) Trainers and handlers must meet professionally recognized standards for experience and training.
Marine mammals, whenever known to be primarily social in the wild, must be housed in their primary enclosure with at least one compatible animal of the same or biologically related species, except when the attending veterinarian, in consultation with the husbandry/training staff, determines that such housing is not in the best interest of the marine mammal's health or well-being. However, marine mammals that are not compatible must not be housed in the same enclosure. Marine mammals must not be housed near other animals that cause them unreasonable stress or discomfort or interfere with their good health. Animals housed separately must have a written plan, approved by the attending veterinarian, developed in consultation with the husbandry/training staff, that includes the justification for the length of time the animal will be kept separated or isolated, information on the type and frequency of enrichment and interaction, if appropriate, and provisions for periodic review of the plan by the attending veterinarian. Marine mammals that are separated for nonmedical purposes must be held in facilities that meet minimum space requirements as outlined in § 3.104.
(a) Newly acquired marine mammals must be isolated from resident marine mammals. Animals with a known medical history must be isolated unless or until the newly acquired animals can be reasonably determined to be in good health by the attending veterinarian. Animals without a known medical history must be isolated until it is determined that the newly acquired animals are determined to be in good health by the attending veterinarian. Any communicable disease condition in a newly acquired marine mammal must be remedied before it is placed with resident marine mammals, unless, in the judgment of the attending veterinarian, the potential benefits of a resident animal as a companion to the newly acquired animal outweigh the risks to the resident animal.
(b) Holding facilities must be in place and available to meet the needs for isolation, separation, medical treatment, and medical training of marine mammals. Marine mammals that are isolated or separated for nonmedical purposes must be held in facilities that meet minimum space requirements as outlined in § 3.104. Holding facilities used only for medical treatment and medical training need not meet the minimum space requirements as outlined in § 3.104. Holding of a marine mammal in a medical treatment or medical training enclosure that does not meet minimum space requirements for periods longer than 2 weeks must be noted in the animal's medical record and the attending veterinarian must provide a justification in the animal's medical record. If holding in such enclosures for medical treatment and/or medical training is to last longer than
(c) Any holding facility used for medical purposes that has contained a marine mammal with an infectious or contagious disease must be cleaned and/or sanitized in a manner prescribed by the attending veterinarian. No healthy animals may be introduced into this holding facility prior to such cleaning and/or sanitizing procedures. Any marine mammal exposed to a contagious animal must be evaluated by the attending veterinarian and monitored and/or isolated for an appropriate period of time as determined by the attending veterinarian.
(d) Individual animal medical records must be kept and made available for APHIS inspection. These medical records must include at least the following information:
(1) Animal identification/name, a physical description, including any identifying markings, scars, etc., age, and sex; and
(2) Physical examination information, including but not limited to length, weight, physical examination results by body system, identification of all medical and physical problems with proposed plan of action, all diagnostic test results, and documentation of treatment.
(e) A copy of the individual animal medical record must accompany any marine mammal upon its transfer to another facility, including contract or satellite facilities.
(f) All marine mammals must be visually examined by the attending veterinarian at least semiannually and must be physically examined under the supervision of and when determined to be necessary by the attending veterinarian. All cetaceans and sirenians must be physically examined by the attending veterinarian at least annually, unless APHIS grants an exception from this requirement based on considerations related to the health and safety of the cetacean or sirenian. These examinations must include, but are not limited to, a hands-on physical examination, hematology and blood chemistry, and other diagnostic tests as determined by the attending veterinarian.
(g)(1) A complete necropsy, including histopathology samples, microbiological cultures, and other testing as appropriate, must be conducted by or under the supervision of the attending veterinarian on all marine mammals that die in captivity. A preliminary necropsy report must be prepared by the veterinarian listing all pathologic lesions observed. The final necropsy report must include all gross and histopathological findings, the results of all laboratory tests performed, and a pathological diagnosis.
(2) Necropsy records will be maintained at the marine mammal's home facility and at the facility at which it died, if different, for a period of 3 years and must be presented to APHIS inspectors when requested.
Swim-with-the-dolphin programs shall comply with the requirements in this section, as well as with all other applicable requirements of the regulations pertaining to marine mammals.
(a)
(1) The horizontal dimension for each area must be at least three times the average adult body length of the species of cetacean used in the program;
(2) The minimum surface area required for each area is calculated as follows:
(i)
(ii)
(iii)
(3) The average depth for sea pens, lagoons, and similar natural enclosures at low tide shall be at least 9 feet. The average depth for any manmade enclosure or other structure not subject to tidal action shall be at least 9 feet. A portion of each area may be excluded when calculating the average depth, but the excluded portion may not be used in calculating whether the interactive, buffer, and sanctuary area meet the requirements of paragraphs (a)(1), (a)(2), and (a)(4) of this section.
(4) The minimum volume required for each animal is calculated as follows:
(b)
(c)
(1) Licensee or manager—at least one full-time staff member with at least 6 years experience in a professional or managerial position dealing with captive cetaceans;
(2) Head trainer/behaviorist—at least one full-time staff member with at least 6 years experience in training cetaceans for SWTD behaviors in the past 10 years, or an equivalent amount of experience involving in-water training of cetaceans, who serves as the head trainer for the SWTD program;
(3) Trainer/supervising attendant—at least one full-time staff member with at least 3 years training and/or handling experience involving human/cetacean interaction programs;
(4) Attendant—an adequate number of staff members who are adequately trained in the care, behavior, and training of the program animals. Attendants shall be designated by the trainer, in consultation with the head trainer/behaviorist and licensee/manager, to conduct and monitor interactive sessions in accordance with § 3.111(e); and
(5) Attending veterinarian—at least one staff or consultant veterinarian who has at least the equivalent of 2 years full-time experience (4,160 or more hours) with cetacean medicine within the past 10 years, and who is licensed to practice veterinary medicine.
(d)
(e)
(2) All cetaceans used in an interactive session shall be adequately trained and conditioned in human interaction so that they respond in the session to the attendants with appropriate behavior for safe interaction. The head trainer/behaviorist, trainer/supervising attendant, or attendant shall, at all times, control the nature
(3) All cetaceans used in interactive sessions shall be in good health, including, but not limited to, not being infectious. Cetaceans undergoing veterinary treatment may be used in interactive sessions only with the approval of the attending veterinarian.
(4) The ratio of human participants to cetaceans shall not exceed 3:1. The ratio of human participants to attendants or other authorized SWTD personnel (
(5) Prior to participating in an SWTD interactive session, members of the public shall be provided with oral and written rules and instructions for the session, to include the telephone and FAX numbers for APHIS, Animal Care, for reporting injuries or complaints. Members of the public shall agree, in writing, to abide by the rules and instructions before being allowed to participate in the session. Any participant who fails to follow the rules or instructions shall be removed from the session by the facility.
(6) All interactive sessions shall have at least two attendants or other authorized SWTD personnel (
(7) All SWTD programs shall limit interaction between cetaceans and humans so that the interaction does not harm the cetaceans, does not remove the element of choice from the cetaceans by actions such as, but not limited to, recalling the animal from the sanctuary area, and does not elicit unsatisfactory, undesirable, or unsafe behaviors from the cetaceans. All SWTD programs shall prohibit grasping or holding of the cetacean's body, unless under the direct and explicit instruction of an attendant eliciting a specific cetacean behavior, and shall prevent the chasing or other harassment of the cetaceans.
(8) In cases where cetaceans used in an interactive session exhibit unsatisfactory, undesirable, or unsafe behaviors, including, but not limited to, charging, biting, mouthing, or sexual contact with humans, such cetaceans shall either be removed from the interactive area or the session shall be terminated. Written criteria shall be developed by each SWTD program, and shall be submitted to and approved by APHIS
(f)
(i) Identification of each cetacean in the program, by means of name and/or number, sex, age, and any other means the Administrator determines to be necessary to adequately identify the cetacean;
(ii) A description of the educational content and agenda of planned interactive sessions, and the anticipated average and maximum frequency and duration of encounters per cetacean per day;
(iii) The content and method of pre-encounter orientation, rules, and instructions, including restrictions on types of physical contact with the cetaceans;
(iv) A description of the SWTD facility, including the primary enclosure and other SWTD animal housing or holding enclosures at the facility;
(v) A description of the training, including actual or expected number of hours each cetacean has undergone or will undergo prior to participation in the program;
(vi) The resume of the licensee and/or manager, the head trainer/behaviorist, the trainer/supervising attendant, any other attendants, and the attending veterinarian;
(vii) The current behavior patterns and health of each cetacean, to be assessed and submitted by the attending veterinarian;
(viii) For facilities that employ a part-time attending veterinarian or consultant arrangements, a written program of veterinary care (APHIS form 7002), including protocols and schedules of professional visits; and
(ix) A detailed description of the monitoring program to be used to detect and identify changes in the behavior and health of the cetaceans.
(2) All SWTD programs shall comply in all respects with the regulations and standards set forth in parts 2 and 3 of this subchapter.
(3) Individual animal veterinary records, including all examinations, laboratory reports, treatments, and necropsy reports shall be kept at the SWTD site for at least 3 years and shall be made available to an APHIS official upon request during inspection.
(4) The following records shall be kept at the SWTD site for at least 3 years and shall be made available to an APHIS official upon request during inspection:
(i) Individual cetacean feeding records; and
(ii) Individual cetacean behavioral records.
(5) The following reports shall be kept at the SWTD site for at least 3 years and shall be made available to an APHIS official upon request during inspection:
(i) Statistical summaries of the number of minutes per day that each animal participated in an interactive session;
(ii) A statistical summary of the number of human participants per month in the SWTD program; and
(6) A description of any changes made in the SWTD program, which shall be submitted to APHIS
(7) All incidents resulting in injury to either cetaceans or humans participating in an interactive session, which shall be reported to APHIS within 24 hours of the incident.
(g)
(2) The attending veterinarian shall observe an interactive swim session at the SWTD site at least once each month.
(3) The attending veterinarian shall conduct a complete physical examination of each cetacean at least once every 6 months. The examination shall include a profile of the cetacean, including the cetacean's identification (name and/or number, sex, and age), weight,
Females: Natural log of body mass = −8.44 + 1.34(natural log of girth) + 1.28(natural log of standard length).
Males: Natural log of body mass= −10.3 + 1.62(natural log of girth) + 1.38(natural log of standard length).
(4) The attending veterinarian, during the monthly site visit, shall record the nutritional and reproductive status of each cetacean (
(5) The attending veterinarian shall examine water quality records and provide a written assessment, to remain at the SWTD site for at least 3 years, of the overall water quality during the preceding month. Such records shall be made available to an APHIS official upon request during inspection.
(6) In the event that a cetacean dies, complete necropsy results, including all appropriate histopathology, shall be recorded in the cetacean's individual file and shall be made available to APHIS officials during facility inspections, or as requested by APHIS. The necropsy shall be performed within 48 hours of the cetacean's death, by a veterinarian experienced in marine mammal necropsies. If the necropsy is not to be performed within 3 hours of the discovery of the cetacean's death, the cetacean shall be refrigerated until necropsy. Written results of the necropsy shall be available in the cetacean's individual file within 7 days after death for gross pathology and within 45 days after death for histopathology.
At 64 FR 15920, Apr. 2, 1999, § 3.111 was suspended, effective Apr. 2, 1999.
(a) Carriers and intermediate handlers shall not accept any marine mammal that is presented by any dealer, research facility, exhibitor, operator of an auction sale, or other person, or any department, agency, or instrumentality of the United States or any State or local government for shipment, in commerce, more than 4 hours prior to the scheduled departure of the primary conveyance on which it is to be transported, and that is not accompanied by a health certificate signed by the attending veterinarian stating that the animal was examined within the prior 10 days and found to be in acceptable health for transport:
(b) Any carrier or intermediate handler shall only accept for transportation or transport, in commerce, any marine mammal in a primary transport enclosure that conforms to the requirements in § 3.113 of this subpart:
(1) Name and address of the consignor;
(2) The number, age, and sex of animals in the primary transport enclosure(s);
(3) A certifying statement (e.g., “I hereby certify that the—(number) primary transport enclosure(s) that are used to transport the animal(s) in this shipment complies (comply) with USDA standards for primary transport enclosures (9 CFR part 3).”); and
(4) The signature of the consignor, and date.
(c) Carriers or intermediate handlers whose facilities fail to maintain a temperature within the range of 7.2 °C (45 °F) to 23.9 °C (75 °F) allowed by § 3.117 of this subpart may accept for transportation or transport, in commerce, any marine mammal consigned by any department, agency, or instrumentality of the United States or of any State or local government, or by any person (including any licensee or registrant under the Act, as well as any private individual) if the consignor furnishes to the carrier or intermediate handler a certificate executed by the attending veterinarian on a specified date that is not more than 10 days prior to delivery of the animal for transportation in commerce, stating that the marine mammal is acclimated to a specific air temperature range lower or higher than those prescribed in §§ 3.117 and 3.118. A copy of the certificate must accompany the shipment to destination. The certificate must include at least the following information:
(1) Name and address of the consignor;
(2) The number, age, and sex of animals in the shipment;
(3) A certifying statement (e.g., “I hereby certify that the animal(s) in this shipment is (are), to the best of my knowledge, acclimated to an air temperature range of ____”); and
(4) The signature of the attending veterinarian and the date.
(d) Carriers and intermediate handlers must attempt to notify the consignee (receiving party) at least once in every 6-hour period following the arrival of any marine mammals at the animal holding area of the terminal cargo facility. The time, date, and method of each attempted notification and the final notification to the consignee and the name of the person notifying the consignee must be recorded on the copy of the shipping document retained by the carrier or intermediate handler and on a copy of the shipping document accompanying the animal shipment.
No dealer, research facility, exhibitor, or operator of an auction sale shall offer for transportation or transport, in commerce, any marine mammal in a primary enclosure that does not conform to the following requirements:
(a) Primary enclosures that are used to transport marine mammals other than cetaceans and sirenians must:
(1) Be constructed from materials of sufficient structural strength to contain the marine mammals;
(2) Be constructed from material that is durable, nontoxic, and cannot be chewed and/or swallowed;
(3) Be able to withstand the normal rigors of transportation;
(4) Have interiors that are free from any protrusions or hazardous openings that could be injurious to the marine mammals contained within;
(5) Be constructed so that no parts of the contained marine mammals are exposed to the outside of the enclosures in any way that may cause injury to the animals or to persons who are nearby or who handle the enclosures;
(6) Have openings that provide access into the enclosures and are secured with locking devices of a type that cannot be accidentally opened;
(7) Have such openings located in a manner that makes them easily accessible at all times for emergency removal and potential treatment of any live marine mammal contained within;
(8) Have air inlets at heights that will provide cross ventilation at all levels (particularly when the marine mammals are in a prone position), are
(9) Have projecting rims or other devices placed on any ends and sides of the enclosures that have ventilation openings so that there is a minimum air circulation space of 7.6 centimeters (3.0 inches) between the enclosures and any adjacent cargo or conveyance wall;
(10) Be constructed so as to provide sufficient air circulation space to maintain the temperature limits set forth in this subpart; and
(11) Be equipped with adequate handholds or other devices on the exterior of the enclosures to enable them to be lifted without unnecessary tilting and to ensure that the persons handling the enclosures will not come in contact with any marine mammal contained inside.
(b) Straps, slings, harnesses, or other devices used for body support or restraint, when transporting marine mammals such as cetaceans and sirenians must:
(1) Be designed so as not to prevent access to the marine mammals by attendants for the purpose of administering in-transit care;
(2) Be equipped with special padding to prevent trauma or injury at critical weight pressure points on the body of the marine mammals; and
(3) Be capable of keeping the animals from thrashing about and causing injury to themselves or their attendants, and yet be adequately designed so as not to cause injury to the animals.
(c) Primary enclosures used to transport marine mammals must be large enough to assure that:
(1) In the case of pinnipeds, polar bears, and sea otters, each animal has sufficient space to turn about freely in a stance whereby all four feet or flippers are on the floor and the animal can sit in an upright position and lie in a natural position;
(2) In the case of cetaceans and sirenians, each animal has sufficient space for support of its body in slings, harnesses, or other supporting devices, if used (as prescribed in paragraph (b) of this section), without causing injury to such cetaceans or sirenians due to contact with the primary transport enclosure:
(d) Marine mammals transported in the same primary enclosure must be of the same species and maintained in compatible groups. Marine mammals that have not reached puberty may not be transported in the same primary enclosure with adult marine mammals other than their dams. Socially dependent animals (e.g., sibling, dam, and other members of a family group) must be allowed visual and olfactory contact whenever reasonable. Female marine mammals may not be transported in the same primary enclosure with any mature male marine mammals.
(e) Primary enclosures used to transport marine mammals as provided in this section must have solid bottoms to prevent leakage in shipment and must be cleaned and sanitized in a manner prescribed in § 3.107 of this subpart, if previously used. Within the primary enclosures used to transport marine mammals, the animals will be maintained on sturdy, rigid, solid floors with adequate drainage.
(f) Primary enclosures used to transport marine mammals, except where such primary enclosures are permanently affixed in the animal cargo space of the primary conveyance, must be clearly marked on top (when present) and on at least one side, or on all sides whenever possible, with the words “Live Animal” or “Wild Animal” in letters not less than 2.5 centimeters (1 inch) in height, and with arrows or other markings to indicate the correct upright position of the container.
(g) Documents accompanying the shipment must be attached in an easily accessible manner to the outside of a primary enclosure that is part of such shipment or be in the possession of the shipping attendant.
(h) When a primary transport enclosure is permanently affixed within the animal cargo space of the primary conveyance so that the front opening is the only source of ventilation for such primary enclosure, the front opening
(a) The animal cargo space of primary conveyances used in transporting live marine mammals must be constructed in a manner that will protect the health and assure the safety and comfort of the marine mammals contained within at all times. All primary conveyances used must be sufficiently temperature-controlled to provide an appropriate environmental temperature for the species involved and to provide for the safety and comfort of the marine mammal, or other appropriate safeguards (such as, but not limited to, cooling the animal with cold water, adding ice to water-filled enclosures, and use of fans) must be employed to maintain the animal at an appropriate temperature.
(b) The animal cargo space must be constructed and maintained in a manner that will prevent the ingress of engine exhaust fumes and gases in excess of that ordinarily contained in the passenger compartments.
(c) Marine mammals must only be placed in animal cargo spaces that have a supply of air sufficient for each live animal contained within. Primary transport enclosures must be positioned in the animal cargo spaces of primary conveyances in such a manner that each marine mammal contained within will have access to sufficient air.
(d) Primary transport enclosures must be positioned in primary conveyances in such a manner that, in an emergency, the live marine mammals can be removed from the conveyances as soon as possible.
(e) The interiors of animal cargo spaces in primary conveyances must be kept clean.
(f) Live marine mammals must not knowingly be transported with any material, substance, or device that may be injurious to the health and well-being of the marine mammals unless proper precaution is taken to prevent such injury.
(g) Adequate lighting must be available for marine mammal attendants to properly inspect the animals at any time. If such lighting is not provided by the carrier, provisions must be made by the shipper to supply such lighting.
(a) Those marine mammals that require drinking water must be offered potable water within 4 hours of being placed in the primary transport enclosure for transport in commerce. Marine mammals must be provided water as often as necessary and appropriate for the species involved to prevent dehydration, which would jeopardize the good health and well-being of the animals.
(b) Marine mammals being transported in commerce must be offered food as often as necessary and appropriate for the species involved or as determined by the attending veterinarian.
(a) A licensed veterinarian, employee, and/or attendant of the shipper or receiver of any marine mammal being transported, in commerce, knowledgeable and experienced in the area of marine mammal care and transport, must accompany all marine mammals during periods of transportation to provide for their good health and well-being, to observe such marine mammals to determine whether they need veterinary care, and to obtain any needed veterinary care as soon as possible. Any transport of greater than 2 hours duration requires a transport plan approved by the attending veterinarian that will include the specification of the necessity of the presence of a veterinarian during the transport. If the attending veterinarian does not accompany the animal, communication
(b) The following marine mammals may be transported in commerce only when the transport of such marine mammals has been determined to be appropriate by the attending veterinarian:
(1) A pregnant animal in the last half of pregnancy;
(2) A dependent unweaned young animal;
(3) A nursing mother with young; or
(4) An animal with a medical condition requiring veterinary care, that would be compromised by transport. The attending veterinarian must note on the accompanying health certificate the existence of any of the above conditions. The attending veterinarian must also determine whether a veterinarian should accompany such marine mammals during transport.
(c) Carriers must inform the crew as to the presence of the marine mammals on board the craft, inform the individual accompanying the marine mammals of any unexpected delays as soon as they become known, and accommodate, except as precluded by safety considerations, requests by the shipper or his agent to provide access to the animals or take other necessary actions for the welfare of the animals if a delay occurs.
(d) A sufficient number of employees or attendants of the shipper or receiver of cetaceans or sirenians being transported, in commerce, must provide for such cetaceans and sirenians during periods of transport by:
(1) Keeping the skin moist or preventing the drying of the skin by such methods as intermittent spraying of water or application of a nontoxic emollient;
(2) Assuring that the pectoral flippers are allowed freedom of movement at all times;
(3) Making adjustments in the position of the marine mammals when necessary to prevent necrosis of the skin at weight pressure points;
(4) Keeping the animal cooled and/or warmed sufficiently to prevent overheating, hypothermia, or temperature related stress; and
(5) Calming the marine mammals to avoid struggling, thrashing, and other unnecessary activity that may cause overheating or physical trauma.
(e) A sufficient number of employees or attendants of the shipper or receiver of pinnipeds or polar bears being transported, in commerce, must provide for such pinnipeds and polar bears during periods of transport by:
(1) Keeping the animal cooled and/or warmed sufficiently to prevent overheating, hypothermia, or temperature related stress; and
(2) Calming the marine mammals to avoid struggling, thrashing, and other unnecessary activity that may cause overheating or physical trauma.
(f) Sea otters must be transported in primary enclosures that contain false floors through which water and waste freely pass to keep the interior of the transport unit free from waste materials. Moisture must be provided by water sprayers or ice during transport.
(g) Marine mammals may be removed from their primary transport enclosures only by the attendants or other persons capable of handling such mammals safely.
Carriers and intermediate handlers must not commingle marine mammal shipments with inanimate cargo. All animal holding areas of a terminal facility of any carrier or intermediate handler where marine mammal shipments are maintained must be cleaned and sanitized in a manner prescribed in § 3.107 of this subpart to minimize health and disease hazards. An effective program for the control of insects, ectoparasites, and avian and mammalian pests must be established and maintained for all animal holding areas. Any animal holding area containing marine mammals must be ventilated with fresh air or air circulated by means of fans, blowers, or an air conditioning system so as to minimize drafts, odors, and moisture condensation. Auxiliary ventilation, such as exhaust fans and vents or fans or blowers or air conditioning must be used for any animal holding area containing marine mammals when the air temperature within such animal holding
(a) Carriers and intermediate handlers moving marine mammals from the animal holding area of the terminal facility to the primary conveyance or from the primary conveyance to the animal holding area of the terminal facility must provide the following:
(1)
(2)
(3)
(b) Care must be exercised to avoid handling of the primary transport enclosure in a manner that may cause physical harm or distress to the marine mammal contained within.
(c) Enclosures used to transport any marine mammal must not be tossed, dropped, or needlessly tilted and must not be stacked unless properly secured.
(a)
(b)
(c)
(d)
(e)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(1) Where the outside walls of the primary enclosure are made of sturdy, durable material, which may include certain types of concrete, wood, plastic, metal, or glass, and are high enough and constructed in a manner that restricts entry by animals and unauthorized persons and the Administrator gives written approval; or
(2) Where the outdoor housing facility is protected by an effective natural barrier that restricts the animals to the facility and restricts entry by animals and unauthorized persons and the Administrator gives written approval; or
(3) Where appropriate alternative security measures are employed and the Administrator gives written approval; or
(4) For traveling facilities where appropriate alternative security measures are employed; or
(5) Where the outdoor housing facility houses only farm animals, such as, but not limited to, cows, sheep, goats, pigs, horses (for regulated purposes), or donkeys, and the facility has in place effective and customary containment and security measures.
Enclosures shall be constructed and maintained so as to provide sufficient space to allow each animal to make normal postural and social adjustments with adequate freedom of movement. Inadequate space may be indicated by evidence of malnutrition, poor condition, debility, stress, or abnormal behavior patterns.
(a) The food shall be wholesome, palatable, and free from contamination and of sufficient quantity and nutritive value to maintain all animals in good health. The diet shall be prepared with consideration for the age, species, condition, size, and type of the animal. Animals shall be fed at least once a day except as dictated by hibernation, veterinary treatment, normal fasts, or other professionally accepted practices.
(b) Food, and food receptacles, if used, shall be sufficient in quantity and located so as to be accessible to all animals in the enclosure and shall be placed so as to minimize contamination. Food receptacles shall be kept clean and sanitary at all times. If self-feeders are used, adequate measures shall be taken to prevent molding, contamination, and deterioration or caking of food.
If potable water is not accessible to the animals at all times, it must be provided as often as necessary for the health and comfort of the animal. Frequency of watering shall consider age, species, condition, size, and type of the animal. All water receptacles shall be kept clean and sanitary.
(a)
(b)
(c)
(d)
A sufficient number of adequately trained employees shall be utilized to maintain the professionally acceptable level of husbandry practices set forth in this subpart. Such practices shall be under a supervisor who has a background in animal care.
Animals housed in the same primary enclosure must be compatible. Animals shall not be housed near animals that interfere with their health or cause them discomfort.
(a) Carriers and intermediate handlers shall not accept any live animals presented by any dealer, research facility, exhibitor, operator of an auction sale, or other person, or any department, agency, or instrumentality of the United States or any State or local government for shipment, in commerce, more than 4 hours prior to the scheduled departure of the primary conveyance on which it is to be transported:
(b) Any carrier or intermediate handler shall only accept for transportation or transport, in commerce, any live animal in a primary enclosure which conforms to the requirements set forth in § 3.137 of the standards:
(1) Name and address of the consignor;
(2) The number of animals in the primary enclosure(s);
(3) A certifying statement (e.g., “I hereby certify that the __ (number) primary enclosure(s) which are used to transport the animal(s) in this shipment complies (comply) with USDA standards for primary enclosures (9 CFR part 3).”); and
(4) The signature of the consignor, and date.
(c) Carriers or intermediate handlers whose facilities fail to meet the minimum temperature allowed by the standards may accept for transportation or transport, in commerce, any live animal consigned by any department, agency, or instrumentality of the United States or of any State or local government, or by any person (including any licensee or registrant under the Act, as well as any private individual) if the consignor furnishes to the carrier or intermediate handler
(1) Name and address of the consignor;
(2) The number of animals in the shipment;
(3) A certifying statement (e.g., “I hereby certify that the animal(s) in this shipment is (are), to the best of my knowledge, acclimated to air temperatures lower than 7.2 °C. (45 °F.)”); and
(4) The signature of the USDA accredited veterinarian, assigned accrediation number, and date.
(d) Carriers and intermediate handlers shall attempt to notify the consignee at least once in every 6 hour period following the arrival of any live animals at the animal holding area of the terminal cargo facility. The time, date, and method of each attempted notification and the final notification to the consignee and the name of the person notifying the consignee shall be recorded on the copy of the shipping document retained by the carrier or intermediate handler and on a copy of the shipping document accompanying the animal shipment.
No dealer, research facility, exhibitor, or operator of an auction sale shall offer for transportation or transport, in commerce, any live animal in a primary enclosure which does not conform to the following requirements:
(a) Primary enclosures, such as compartments, transport cages, cartons, or crates, used to transport live animals shall be constructed in such a manner that (1) the structural strength of the enclosure shall be sufficient to contain the live animals and to withstand the normal rigors of transportation; (2) the interior of the enclosure shall be free from any protrusions that could be injurious to the live animals contained therein; (3) the opernings of such enclosures are easily accessible at all times for emergency removal of the live animals; (4) except as provided in paragraph (g) of this section, there are ventilation openings located on two opposite walls of the primary enclosure and the ventilation openings on each such wall shall be at least 16 percent of the total surface area of each such wall, or there are ventilation openings located on all four walls of the primary enclosure and the ventilation openings on each such wall shall be at least 8 percent of the total surface area of each such wall:
(b) Live animals transported in the same primary enclosure shall be of the same species and maintained in compatible groups. Live animals that have not reached puberty shall not be transported in the same primary enclosure with adult animals other than their dams. Socially dependent animals (e.g., sibling, dam, and other members of a family group) must be allowed visual
(c) Primary enclosures used to transport live animals shall be large enough to ensure that each animal contained therein has sufficient space to turn about freely and to make normal postural adjustments:
(d) Primary enclosures used to transport live animals as provided in this section shall have solid bottoms to prevent leakage in shipment and still be cleaned and sanitized in a manner prescribed in § 3.131 of the standards, if previously used. Such primary enclosures shall contain clean litter of a suitable absorbant material, which is safe and nontoxic to the live animals contained therein, in sufficient quantity to absorb and cover excreta, unless the animals are on wire or other nonsolid floors.
(e) Primary enclosures used to transport live animals, except where such primary enclosures are permanently affixed in the animal cargo space of the primary conveyance, shall be clearly marked on top and on one or more sides with the words “Live Animal” or “Wild Animal”, whichever is appropriate, in letters not less than 2.5 centimeters (1 inch) in height, and with arrows or other markings to indicate the correct upright position of the container.
(f) Documents accompanying the shipment shall be attached in an easily accessible manner to the outside of a primary enclosure which is part of such shipment.
(g) When a primary enclosure is permanently affixed within the animal cargo space of the primary conveyance so that the front opening is the only source of ventilation for such primary enclosure, the front opening shall open directly to the outside or to an unobstructed aisle or passageway within the primary conveyance. Such front ventilation opening shall be at least 90 percent of the total surface area of the front wall of the primary enclosure and covered with bars, wire mesh or smooth expanded metal.
(a) The animal cargo space of primary conveyances used in transporting live animals shall be designed and constructed to protect the health, and ensure the safety and comfort of the live animals contained therein at all times.
(b) The animal cargo space shall be constructed and maintained in a manner to prevent the ingress of engine exhaust fumes and gases from the primary conveyance during transportation in commerce.
(c) No live animal shall be placed in an animal cargo space that does not have a supply of air sufficient for normal breathing for each live animal contained therein, and the primary enclosures shall be positioned in the animal cargo space in such a manner that each live animal has access to sufficient air for normal breathing.
(d) Primary enclosures shall be positioned in the primary conveyance in such a manner that in an emergency the live animals can be removed from the primary conveyance as soon as possible.
(e) The interior of the animal cargo space shall be kept clean.
(f) Live animals shall not be transported with any material, substance (e.g., dry ice) or device which may reasonably be expected to be injurious to the health and well-being of the animals unless proper precaution is taken to prevent such injury.
(a) All live animals shall be offered potable water within 4 hours prior to being transported in commerce. Dealers, exhibitors, research facilities and operators of auction sales shall provide potable water to all live animals transported in their own primary conveyance at least every 12 hours after such transportation is initiated, and carriers and intermediate handlers shall
(b) Each live animal shall be fed at least once in each 24 hour period, except as directed by hibernation, veterinary treatment, normal fasts, or other professionally accepted practices. Those live animals which, by common accepted practice, require feeding more frequently shall be so fed.
(c) A sufficient quantity of food and water shall accompany the live animal to provide food and water for such animals for a period of at least 24 hours, except as directed by hibernation, veterinary treatment, normal fasts, and other professionally accepted practices.
(d) Any dealer, research facility, exhibitor or operator of an auction sale offering any live animal to any carrier or intermediate handler for transportation in commerce shall affix to the outside of the primary enclosure used for transporting such live animal, written instructions concerning the food and water requirements of such animal while being so transported.
(e) No carrier or intermediate handler shall accept any live animals for transportation in commerce unless written instructions concerning the food and water requirements of such animal while being so transported is affixed to the outside of its primary enclosure.
(a) During surface transportation, it shall be the responsibility of the driver or other employee to visually observe the live animals as frequently as circumstances may dictate, but not less than once every 4 hours, to assure that they are receiving sufficient air for normal breathing, their ambient temperatures are within the prescribed limits, all other applicable standards are being complied with and to determine whether any of the live animals are in obvious physical distress and to provide any needed veterinary care as soon as possible. When transported by air, live animals shall be visually observed by the carrier as frequently as circumstances may dictate, but not less than once every 4 hours, if the animal cargo space is accessible during flight. If the animal cargo space is not accessible during flight, the carrier shall visually observe the live animals whenever loaded and unloaded and whenever the animal cargo space is otherwise accessible to assure that they are receiving sufficient air for normal breathing, their ambient temperatures are within the prescribed limits, all other applicable standards are being complied with and to determine whether any such live animals are in obvious physical distress. The carrier shall provide any needed veterinary care as soon as possible. No animal in obvious physical distress shall be transported in commerce.
(b) Wild or otherwise dangerous animals shall not be taken from their primary enclosure except under extreme emergency conditions:
Carriers and intermediate handlers shall not commingle live animal shipments with inanimate cargo. All animal holding areas of a terminal facility of any carrier or intermediate handler wherein live animal shipments are maintained shall be cleaned and sanitized in a manner prescribed in § 3.141 of the standards often enough to prevent an accumulation of debris or excreta, to minimize vermin infestation and to prevent a disease hazard. An effective program for the control of insects, ectoparasites, and avian and mammalian pests shall be established and maintained for all animal holding areas. Any animal holding area containing live animals shall be provided
(a) Carriers and intermediate handlers shall move live animals from the animal holding area of the terminal facility to the primary conveyance and from the primary conveyance to the animal holding area of the terminal facility as expeditiously as possible. Carriers and intermediate handlers holding any live animal in an animal holding area of a terminal facility or in transporting any live animal from the animal holding area of the terminal facility to the primary conveyance and from the primary conveyance to the animal holding area of the terminal facility, including loading and unloading procedures, shall provide the following:
(1)
(2)
(3)
(b) Care shall be exercised to avoid handling of the primary enclosure in such a manner that may cause physical or emotional trauma to the live animal contained therein.
(c) Primary enclosures used to transport any live animal shall not be tossed, dropped, or needlessly tilted and shall not be stacked in a manner which may reasonably be expected to result in their falling.
7 U.S.C. 2149 and 2151; 7 CFR 2.22, 2.80, and 371.7.
The Uniform Rules of Practice for the Department of Agriculture promulgated in subpart H of part 1, subtitle A, title 7, Code of Federal Regulations, are the Rules of Practice applicable to adjudicatory, administrative proceedings under section 19 of the Animal Welfare Act (7 U.S.C. 2149). In addition, the Supplemental Rules of Practice set forth in subpart B of this part shall be applicable to such proceedings.
(a) In any situation where the Administrator has reason to believe that any person licensed under the Act has violated or is violating any provision of the Act, or the regulations or standards issued thereunder, and he deems it warranted under the circumstances, the Administrator may suspend such person's license temporarily, for a period not to exceed 21 days, effective, except as provided in § 4.10(b), upon written notification given to such person of the suspension of his license pursuant to § 1.147(b) of the Uniform Rules of Practice (7 CFR 1.147(b)).
(b) In any case of actual or threatened physical harm to animals in violation of the Act, or the regulations or standards issued thereunder, by a person licensed under the Act, the Administrator may suspend such person's license temporarily, for a period not to exceed 21 days, effective upon oral or written notification, whichever is earlier. In the event of oral notification, a written confirmation thereof shall be given to such person pursuant to § 1.147(b) of the Uniform Rules of Practice (7 CFR 1.147(b)) as promptly as circumstances permit.
(c) The temporary suspension of a license shall be in addition to any sanction which may be imposed against said person by the Secretary pursuant to the Act after notice and opportunity for hearing.
(a) At any time prior to the issuance of a complaint seeking a civil penalty under the Act, the Administrator, in his discretion, may enter into a stipulation with any person in which:
(1) The Administrator gives notice of an apparent violation of the Act, or the regulations or standards issued thereunder, by such person and affords such person an opportunity for a hearing regarding the matter as provided by the Act;
(2) Such person expressly waives hearing and agrees to pay a specified penalty within a designated time; and
(3) The Administrator agrees to accept the specified penalty in settlement of the particular matter involved if it is paid within the designated time.
(b) If the specified penalty is not paid within the time designated in such a stipulation, the amount of the stipulated penalty shall not be relevant in any respect to the penalty which may be assessed after issuance of a complaint.
15 U.S.C. 1823-1825 and 1828; 7 CFR 2.22, 2.80, and 371.7.
For the purpose of this part, unless the context otherwise requires, the following terms shall have the meanings assigned to them in this section. The singular form shall also impart the plural and the masculine form shall also impart the feminine. Words of art undefined in the following paragraphs shall have the meaning attributed to them by trade usage or general usage as reflected by definition in a standard dictionary, such as “Webster's.”
(1) An irritating or blistering agent has been applied, internally or externally by a person to any limb of a horse,
(2) Any burn, cut, or laceration has been inflicted by a person on any limb of a horse,
(3) Any tack, nail, screw, or chemical agent has been injected by a person into or used by a person on any limb of a horse, or
(4) Any other substance or device has been used by a person on any limb of a horse or a person has engaged in a practice involving a horse, and, as a result of such application, infliction, injection, use, or practice, such horse suffers, or can reasonably be expected to suffer, physical pain or distress, inflammation, or lameness when walking, trotting, or otherwise moving, except that such term does not include such an application, infliction, injection, use, or practice in connection with the therapeutic treatment of a horse by or under the supervision of a person licensed to practice veterinary medicine in the State in which such treatment was given.
(a)
(b)
(1) All beads, bangles, rollers, and similar devices, with the exception of rollers made of lignum vitae (hardwood), aluminum, or stainless steel, with individual rollers of uniform size, weight and configuration, provided each such device may not weigh more than 6 ounces, including the weight of the fastener.
(2) Chains weighing more than 6 ounces each, including the weight of the fastener.
(3) Chains with links that are not of uniform size, weight and configuration; and, chains that have twisted links or double links.
(4) Chains that have drop links on any horse that is being ridden, worked on a lead, or otherwise worked out or moved about.
(5) More than one action device on any one limb of a horse.
(6) Chains or lignum vitae, stainless steel, or aluminum rollers which are not smooth and free of protrusions, projections, rust, corrosion, or rough or sharp edges.
(7)(i) Boots, collars, or any other devices, with protrusions or swellings, or rigid, rough, or sharp edges, seams or any other abrasive or abusive surface that may contact a horse's leg; and
(ii) Boots, collars, or any other devices that weigh more than 6 ounces, except for soft rubber or soft leather bell boots and quarter boots that are used as protective devices.
(8) Pads or other devices on yearling horses (horses up to 2 years old) that elevate or change the angle of such horses' hooves in excess of 1 inch at the heel.
(9) Any weight on yearling horses, except a keg or similar conventional horseshoe, and any horseshoe on yearling horses that weighs more than 16 ounces.
(10) Artificial extension of the toe length, whether accomplsihed with pads, acrylics or any other material or combinations thereof, that exceeds 50 percent of the natural hoof length, as measured from the coronet band, at the center of the front pastern along the front of the hoof wall, to the distal portion of the hoof wall at the tip of the toe. The artificial extension shall be measured from the distal portion of the hoof wall at the tip of the toe at a 90 degree angle to the proximal (foot/hoof) surface of the shoe.
(11) Toe length that does not exceed the height of the heel by 1 inch or more. The length of the toe shall be measured from the coronet band, at the center of the front pastern along the front of the hoof wall to the ground. The heel shall be measured from the coronet band, at the most lateral portion of the rear pastern, at a 90 degree angle to the ground, not including normal caulks at the rear of a horseshoe that do not exceed
(12) Pads that are not made of leather, plastic, or a similar pliant material.
(13) Any object or material inserted between the pad and the hoof other than acceptable hoof packing, which includes pine tar, oakum, live rubber, sponge rubber, silicone, commercial hoof packing or other substances used to maintain adequate frog pressure or sole consistency.
(14) Single or double rocker-bars on the bottom surface of horseshoes which extend more than 1
(15) Metal hoof bands, such as used to anchor or strengthen pads and shoes, placed less than
(16) Metal hoof bands that can be easily and quickly loosened or tightened by hand, by means such as, but not limited to, a wing-nut or similar fastener.
(17) Any action device or any other device that strikes the coronet band of the foot of a horse except for soft rubber or soft leather bell boots that are used as protective devices.
(18) Shoeing a horse, or trimming a horse's hoof in a manner that will cause such horse to suffer, or can reasonably be expected to cause such horse to suffer pain or distress, inflammation, or lameness when walking, trotting, or otherwise moving.
(19) Lead or other weights attached to the outside of the hoof wall, the outside surface of the horseshoe, or any portion of the pad except the bottom surface within the horseshoe. Pads may not be hollowed out for the purpose of inserting or affixing weights, and weights may not extend below the bearing surface of the shoe. Hollow shoes or artificial extensions filled with mercury or similar substances are prohibited.
(c)
(1) The horse show, horse exhibition, or horse sale or auction management agrees to furnish all such lubricants and to maintain control over them when used at the horse show, horse exhibition, or horse sale or auction.
(2) Any such lubricants shall be applied only after the horse has been inspected by management or by a DQP and shall only be applied under the supervision of the horse show, horse exhibition, or horse sale, or auction management.
(3) Horse show, horse exhibition, or horse sale or auction management makes such lubricants available to Department personnel for inspection and sampling as they deem necessary.
(d)
(e)
The scar rule applies to all horses born on or after October 1, 1975. Horses subject to this rule that do not meet the following scar rule criteria shall be considered to be “sore” and are subject to all prohibitions of section 5 of the Act. The scar rule criteria are as follows:
(a) The anterior and anterior-lateral surfaces of the fore pasterns (extensor surface) must be free of bilateral granulomas,
(b) The posterior surfaces of the pasterns (flexor surface), including the sulcus or “pocket” may show bilateral areas of uniformly thickened epithelial tissue if such areas are free of proliferating granuloma tissue, irritation, moisture, edema, or other evidence of inflammation.
For the purpose of effective enforcement of the Act:
(a) Each horse owner, exhibitor, trainer, or other person having custody of, or responsibility for, any horse at any horse show, horse exhibition, or horse sale or auction, shall allow any APHIS representative to reasonably inspect such horse at all reasonable times and places the APHIS representative may designate. Such inspections may be required of any horse which is stabled, loaded on a trailer, being prepared for show, exhibition, or sale or auction, being exercised or otherwise on the grounds of, or present at, any horse show, horse exhibition, or horse sale or auction, whether or not such horse has or has not been shown, exhibited, or sold or auctioned, or has or has not been entered for the purpose of being shown or exhibited or offered for sale or auction at any such horse show, horse exhibition, or horse sale or auction. APHIS representatives will not generally or routinely delay or interrupt actual individual classes or performances at horse shows, horse exhibitions, or horse sales or auctions for the purpose of examining horses, but they may do so in extraordinary situations, such as but not limited to, lack of proper facilities for inspection, refusal of management to cooperate with Department inspection efforts, reason to believe that failure to immediately perform inspection may result in the loss, removal, or masking of any evidence of a violation of the Act or the regulations, or a request by management that such inspections be performed by an APHIS representative.
(b) When any APHIS representative notifies the owner, exhibitor, trainer, or other person having custody of or responsibility for a horse at any horse show, horse exhibition, or horse sale or auction that APHIS desires to inspect such horse, it shall not be moved from the horse show, horse exhibition, or horse sale or auction until such inspection has been completed and the horse has been released by an APHIS representative.
(c) For the purpose of examination, testing, or taking of evidence, APHIS representatives may detain for a period not to exceed 24 hours any horse, at any horse show, horse exhibition, or horse sale or auction, which is sore or which an APHIS veterinarian has probable cause to believe is sore. Such detained horse may be marked for identification and any such identifying markings shall not be removed by any person other than an APHIS representative.
(d) Detained horses shall be kept under the supervision of an APHIS representative or secured under an official USDA seal or seals in a horse stall,
(1) The life or well-being of the detained horse is immediately endangered by fire, flood, windstorm, or other dire circumstances that are beyond human control.
(2) The detained horse is in need of such immediate veterinary attention that its life may be in peril before an APHIS representative can be located.
(3) The horse has been detained for a maximum 24-hour detention period, and an APHIS representative is not available to release the horse.
(e) The owner, exhibitor, trainer, or other person having custody of or responsibility for any horse detained by APHIS for further examination, testing, or the taking of evidence shall be allowed to feed, water, and provide other normal custodial and maintenance care, such as walking, grooming, etc., for such detained horse:
(1) Such feeding, watering, and other normal custodial and maintenance care of the detained horse is rendered under the direct supervision of an APHIS representative.
(2) Any non-emergency veterinary care of the detained horse requiring the use, application, or injection of any drugs or other medication for therapeutic or other purposes is rendered by a Doctor of Veterinary Medicine in the presence of an APHIS representative and, the identity and dosage of the drug or other medication used, applied, or injected and its purpose is furnished in writing to the APHIS representative prior to such use, application, or injection by the Doctor of Veterinary Medicine attending the horse. The use, application, or injection of such drug or other medication must be approved by the APHIS Show Veterinarian or his appointed representative.
(f) It shall be the policy of APHIS to inform the owner, trainer, exhibitor, or other person having immediate custody of or responsibility for any horse allegedly found to be in violation of the Act or the regulations of such alleged violation or violations before the horse is released by an APHIS representative.
(g) The owner, trainer, exhibitor, or other person having immediate custody of or responsibility for any horse or horses that an APHIS representative determines shall be detained for examination, testing, or taking of evidence pursuant to paragraph (e) of this section shall be informed after such determination is made and shall allow said horse to be immediately put under the supervisory custody of APHIS or secured under official USDA seal as provided in paragraph (d) of this section until the completion of such examination, testing, or gathering of evidence, or until the 24-hour detention period expires.
(h) The owner, trainer, exhibitor, or other person having custody of or responsibility for any horse allegedly found to be in violation of the Act or regulations, and who has been notified of such alleged violation by an APHIS representative as stated in paragraph (f) of this section, may request reexamination and testing of said horse within a 24-hour period:
(1) Such request is made to the APHIS Show Veterinarian immediately after the horse has been examined by APHIS representatives and before such horse has been removed from the APHIS inspection facilities; and
(2) The APHIS Show Veterinarian determines that sufficient cause for reexamination and testing exists; and
(3) The horse is maintained under APHIS supervisory custody as prescribed in paragraph (d) of this section until such reexamination and testing has been completed.
(i) The owner, exhibitor, trainer, or other person having custody of, or responsibility for any horse being inspected shall render such assistance as the APHIS representative may request for purposes of such inspection.
(ii) [Reserved]
Requirements regarding access to premises for inspection of horses and records are as follows:
(a)
(2) The management of any horse show, horse exhibition, or horse sale or auction shall, without fee, charge, assessment, or other compensation, provide APHIS representatives with an adequate, safe, and accessible area for the visual inspection and observation of horses while such horses are competitively or otherwise performing at any horse show or horse exhibition, or while such horses are being sold or auctioned or offered for sale or auction at any horse sale or horse auction.
(b)
(2) Each owner, trainer, exhibitor, or other person having custody of or responsibility for, any horse at any horse show, horse exhibition, or horse sale or auction shall promptly present his horse for inspection upon notification, orally or in writing, by any APHIS representative or Designated Qualified Person appointed by management, that said horse has been selected for examination for the purpose of determining whether such horse is in compliance with the Act and regulations.
The management of every horse show, horse exhibition, or horse sale or auction, containing Tennessee Walking Horses or racking horses, shall provide, without fee, sufficient space and facilities for APHIS representatives to carry out their duties under the Act and regulations at every horse show, horse exhibition, or horse sale or auction, containing Tennessee Walking Horses or racking horses, whether or not management has received prior notification or otherwise knows that such show may be inspected by APHIS. The management of every horse show, horse exhibition, horse sale or auction which does not contain Tennessee Walking Horses or racking horses shall provide, without fee, such sufficient space and facilities when requested to do so by APHIS representatives. With respect to such space and facilities, it shall be the responsibility of management to provide at least the following:
(a) Sufficient space in a convenient location to the horse show, horse exhibition, or horse sale or auction arena, acceptable to the APHIS Show Veterinarian, in which horses may be physically, thermographically, or otherwise inspected.
(b) Protection from the elements of nature, such as rain, snow, sleet, hail, windstorm, etc., if required by the APHIS Show Veterinarian.
(c) A means to control crowds or onlookers in order that APHIS personnel may carry out their duties without interference and with a reasonable measure of safety, if requested by the APHIS Show Veterinarian.
(d) An accessible, reliable, and convenient 110-volt electrical power source, if electrical service is available at the show, exhibition, or sale or auction site and is requested by the APHIS Show Veterinarian.
(e) An appropriate area adjacent to the inspection area for designated
(a)
(1) Doctors of Veterinary Medicine who are accredited in any State by the United States Department of Agriculture under part 161 of chapter I, title 9 of the Code of Federal Regulations, and who are:
(i) Members of the American Association of Equine Practitioners, or
(ii) Large animal practitioners with substantial equine experience, or
(iii) Knowledgeable in the area of equine lameness as related to soring and soring practices (such as Doctors of Veterinary Medicine with a small animal practice who own, train, judge, or show horses, or Doctors of Veterinary Medicine who teach equine related subjects in an accredited college or school of veterinary medicine). Accredited Doctors of Veterinary Medicine who meet these criteria may be licensed as DQP's by a horse industry organization or association whose DQP program has been certified by the Department under this part without undergoing the formal training requirements set forth in this section.
(2) Farriers, horse trainers, and other knowledgeable horsemen whose past experience and training would qualify them for positions as horse industry organization or association stewards or judges (or their equivalent) and who have been formally trained and licensed as DQP's by a horse industry organization or association whose DQP program has been certified by the Department in accordance with this section.
(b)
(1) The criteria to be used in selecting DQP candidates and the minimum qualifications and knowledge regarding horses each candidate must have in order to be admitted to the program.
(2) A copy of the formal training program, classroom and practical, required to be completed by each DQP candidate before being licensed by such horse industry organization or association, including the minimum number of hours, classroom and practical, and the subject matter of the training program. Such training program must meet the following minimum standards in order to be certified by the Department under the Act.
(i) Two hours of classroom instruction on the anatomy and physiology of the limbs of a horse. The instructor teaching the course must be specified, and a resume of said instructor's background, experience, and qualifications to teach such course shall be provided to the Administrator.
(ii) Two hours of classroom instruction on the Horse Protection Act and regulations and their interpretation. Instructors for this course must be furnished or recommended by the Department. Requests for instructors to be
(iii) Four hours of classroom instruction on the history of soring, the physical examination procedures necessary to detect soring, the detection and diagnosis of soring, and related subjects. The instructor teaching the course must be specified and a summary of said instructor's background, experience, and qualifications to teach such course must be provided to the Administrator.
(iv) Four hours of practical instruction in clinics and seminars utilizing live horses with actual application of the knowledge gained in the classroom subjects covered in paragraphs (b)(2)(i), (ii), and (iii) of this section. Methods and procedures required to perform a thorough and uniform examination of a horse shall be included. The names of the instructors and a resume of their background, academic and practical experience, and qualifications to present such instruction shall be provided to the Administrator.
(v) One hour of classroom instruction regarding the DQP standards of conduct promulgated by the licensing organization or association pursuant to paragraph (d)(7) of this section.
(vi) One hour of classroom instruction on recordkeeping and reporting requirements and procedures.
(3) A sample of a written examination which must be passed by DQP candidates for successful completion of the program along with sample answers and the scoring thereof, and proposed passing and failing standards.
(4) The criteria to be used to determine the qualifications and performance abilities of DQP candidates selected for the training program and the criteria used to indicate successful completion of the training program, in addition to the written examination required in paragraph (b)(3) of this section.
(5) The criteria and schedule for a continuing education program and the criteria and methods of monitoring and appraising performance for continued licensing of DQP's by such organization or association. A continuing education program for DQP's shall consist of not less than 4 hours of instruction per year.
(6) Procedures for monitoring horses in the unloading, preparation, warmup, and barn areas, or other such areas. Such monitoring may include any horse that is stabled, loaded on a trailer, being prepared for show, exhibition, sale, or auction, or exercised, or that is otherwise on the grounds of, or present at, any horse show, horse exhibition, or horse sale or auction.
(7) The methods to be used to insure uniform interpretation and enforcement of the Horse Protection Act and regulations by DQP's and uniform procedures for inspecting horses for compliance with the Act and regulations;
(8) Standards of conduct for DQP's promulgated by the organization or association in accordance with paragraph (d)(7) of this section; and
(9) A formal request for Department certification of the DQP program.
(c)
(1) Issue each DQP licensed by such horse industry organization or association a numbered identification card bearing the name and personal signature of the DQP, a picture of the DQP, and the name and address, including
(2) Submit a list to the Administrator
(3) Notify the Department of any additions or deletions of names of licensed DQP's from the licensed DQP list submitted to the Department or of any change in the address of any licensed DQP or any warnings and license revocations issued to any DQP licensed by such horse industry organization or association within 10 days of such change;
(4) Not license any person as a DQP if such person has been convicted of any violation of the Act or regulations occurring after July 13, 1976, or paid any fine or civil penalty in settlement of any proceeding regarding a violation of the Act or regulations occurring after July 13, 1976, for a period of at least 2 years following the first such violation, and for a period of at least 5 years following the second such violation and any subsequent violation;
(5) Not license any person as a DQP until such person has attended and worked two recognized or affiliated horse shows, horse exhibitions, horse sales, or horse auctions as an apprentice DQP and has demonstrated the ability, qualifications, knowledge and integrity required to satisfactorily execute the duties and responsibilities of a DQP;
(6) Not license any person as a DQP if such person has been disqualified by the Secretary from making detection, diagnosis, or inspection for the purpose of enforcing the Act, or if such person's DQP license is canceled by another horse industry organization or association.
(d)
(i) The name and address, including street address or post office box and zip code, of the show and the show manager.
(ii) The name and address, including street address or post office box and zip code, of the horse owner.
(iii) The name and address, including street address or post office box and zip code, of the horse trainer.
(iv) The name and address, including street address or post office box and zip code, of the horse exhibitor.
(v) The exhibitors number and class number, or the sale or auction tag number of said horse.
(vi) The date and time of the inspection.
(vii) A detailed description of all of the DQP's findings and the nature of the alleged violation, or other reason for disqualifying or excusing the horse, including said DQP's statement regarding the evidence or facts upon which the decision to disqualify or excuse said horse was based.
(viii) The name, age, sex, color, and markings of the horse; and
(ix) The name or names of the show manager or other management representative notified by the DQP that such horse should be excused or disqualified and whether or not such manager or management representative excused or disqualified such horse.
(2) The DQP shall inform the custodian of each horse allegedly found in
(3) Each horse industry organization or association having a Department certified DQP program shall submit a report to the Department containing the following information, from records required in paragraph (d)(1) of this section and other available sources, to the Department on a monthly basis:
(i) The identity of all horse shows, horse exhibitions, horse sales, or horse auctions that have retained the services of DQP's licensed by said organization or association during the month covered by the report. Information concerning the identity of such horse shows, horse exhibitions, horse sales, or horse auctions shall include:
(A) The name and location of the show, exhibition, sale, or auction.
(B) The name and address of the manager.
(C) The date or dates of the show, exhibition, sale, or auction.
(ii) The identity of all horses at each horse show, horse exhibition, horse sale, or horse auction that the licensed DQP recommended be disqualified or excused for any reason. The information concerning the identity of such horses shall include:
(A) The registered name of each horse.
(B) The name and address of the owner, trainer, exhibitor, or other person having custody of or responsibility for the care of each such horse disqualified or excused.
(4) Each horse industry organization or association having a Department certified DQP program shall provide, by certified mail if personal service is not possible, to the trainer and owner of each horse allegedly found in violation of the Act or its regulations or otherwise disqualified or excused for any reason, the following information;
(i) The name and date of the show, exhibition, sale, or auction.
(ii) The name of the horse and the reason why said horse was excused, disqualified, or alleged to be in violation of the Act or its regulations.
(5) Each horse industry organization or association having a Department certified DQP program shall provide each of its licensed DQP's with a current list of all persons that have been disqualified by order of the Secretary from showing or exhibiting any horse, or judging or managing any horse show, horse exhibition, horse sale, or horse auction. The Department will make such list available, on a current basis, to organizations and associations maintaining a certified DQP program.
(6) Each horse industry organization or association having a Department certified DQP program shall develop and provide a continuing education program for licensed DQP's which provides not less than 4 hours of instruction per year to each licensed DQP.
(7) Each horse industry organization or association having a Department certified DQP program shall promulgate standards of conduct for its DQP's, and shall provide administrative procedures within the organization or association for initiating, maintaining, and enforcing such standards. The procedures shall include the causes for and methods to be utilized for canceling the license of any DQP who fails to properly and adequately carry out his duties. Minimum standards of conduct for DQP's shall include the following;
(i) A DQP shall not exhibit any horse at any horse show or horse exhibition, or sell, auction, or pruchase any horse sold at a horse sale or horse auction at which he or she has been appointed to inspect horses;
(ii) A DQP shall not inspect horses at any horse show, horse exhibition, horse sale or horse auction in which a horse or horses owned by a member of the DQP's immediate family or the DQP's employer are competing or are being offered for sale;
(iii) A DQP shall follow the uniform inspection procedures of his certified organization or association when inspecting horses; and
(iv) The DQP shall immediately inform management of each case regarding any horse which, in his opinion, is in violation of the Act or regulations.
(e)
(1) Does not hold a valid, current DQP license issued by a horse industry organization or association having a DQP program certified by the Department.
(2) Has had his DQP license canceled by the licensing organization or association.
(3) Is disqualified by the Secretary from performing diagnosis, detection, and inspection under the Act, after notice and opportunity for a hearing,
(f)
(2) Each horse industry organization or association having a Department certified DQP program shall cancel the license of any DQP licensed under its program who has been convicted of any violation of the Act or regulations or of any DQP who has paid a fine or civil penalty in settlement of any alleged violation of the Act or regulations if such alleged violation occurred after July 13, 1976.
(g)
(a) The management of any horse show, horse exhibition, or horse sale or auction which does not appoint and retain a DQP shall be responsible for identifying all horses that are sore or otherwise in violation of the Act or regulations, and shall disqualify or disallow any horses which are sore or otherwise in violation of the Act or regulations from participating or competing in any horse show, horse exhibition, horse sale, or horse auction. Horses entered for sale or auction at a horse sale or horse auction must be identified as sore or otherwise in violation of the Act or regulations prior to the sale or auction and prohibited from entering the sale or auction ring. Sore horses or horses otherwise in violation of the Act or regulations that have been entered in a horse show or horse exhibition for the purpose of show or exhibition must be identified and excused prior to the show or exhibition. Any horses found to be sore or otherwise in violation of the Act or regulations during actual participation in the show or exhibition, must be removed from further participation prior to the tyeing of the class or the completion of the exhibition. All horses tyed first in each Tennessee Walking Horse or racking horse class or event at any horse show or horse exhibition shall be inspected after being shown or exhibited to determine if such horses are sore or otherwise in violation of the Act or regulations.
(b)(1) The management of any horse show, horse exhibition, horse sale or auction which designates and appoints a Designated Qualified Person (or persons) to inspect horses shall accord said DQP access to all records and areas of the grounds of such show, exhibition, sale, or auction and the same right to inspect horses and records as is accorded to any APHIS representative. Further, management shall not take any action which would interfere with or influence said DQP in carrying out his duties or making decisions concerning whether or not any horse is sore or otherwise in violation of the Act or regulations. In the event management is dissatisfied with the performance of a particular DQP, including disagreement with decisions concerning violations, management shall not dismiss or otherwise interfere with said DQP during the DQP's appointed tour of duty.
(2) The DQP shall physically inspect: (i) All Tennessee Walking Horses and racking horses entered for sale or auction, (ii) all Tennessee Walking Horses and racking horses entered in any animated gait class (whether under saddle, horse to cart, or otherwise), (iii) all Tennessee Walking Horses and racking horses entered for exhibition before
(3) The DQP shall immediately report, to the management of any horse show, horse exhibition, or horse sale or auction, any horse which, in his opinion, is sore or otherwise in violation of the Act or regulations. Such report shall be made, whenever possible, before the show class or exhibitioin involving said horse has begun or before said horse is offered for sale or auction.
(c) The management of any horse show, exhibition, sale, or auction that designates and appoints a DQP to inspect horses shall appoint and designate at least two DQP's when more than 150 horses are entered.
(a)(1) During the preshow inspection, the DQP shall direct the custodian of the horse to walk and turn the horse in a manner that allows the DQP to determine whether the horse exhibits signs of soreness. The DQP shall determine whether the horse moves in a free and easy manner and is free of any signs of soreness.
(2) The DQP shall digitally palpate the front limbs of the horse from knee to hoof, with particular emphasis on the pasterns and fetlocks. The DQP shall examine the posterior surface of the pastern by picking up the foot and examining the posterior (flexor) surface. The DQP shall apply digital pressure to the pocket (sulcus), including the bulbs of the heel, and continue the palpation to the medial and lateral surfaces of the pastern, being careful to observe for responses to pain in the horse. While continuing to hold onto the pastern, the DQP shall extend the foot and leg of the horse to examine the front (extensor) surfaces, including the coronary band. The DQP may examine the rear limbs of all horses inspected after showing, and may examine the rear limbs of any horse examined preshow or on the showgrounds when he deems it necessary, except that the DQP shall examine the rear limbs of all horses exhibiting lesions on, or unusual movement of, the rear legs. While carrying out the procedures set forth in this paragraph, the DQP shall also inspect the horse to determine whether the provisions of § 11.3 of this part are being complied with, and particularly whether there is any evidence of inflammation, edema, or proliferating granuloma tissue.
(3) The DQP shall observe and inspect all horses for compliance with the provisions set forth in § 11.2(a) through § 11.2(c) of this part. All action devices, pads, and other equipment shall be observed and/or examined to assure that they are in compliance with the regulations. All such equipment on horses examined postshow, and on horses examined preshow that are not clearly in compliance, shall be weighed and/or measured.
(4) The DQP shall instruct the custodian of the horse to control it by holding the reins approximately 18 inches from the bit shank. The DQP shall not be required to examine a horse if it is presented in a manner that might cause the horse not to react to a DQP's examination, or if whips, cigarette smoke, or other actions or paraphernalia are used to distract a horse during examination. All such incidents
(b) The DQP shall inspect horses no more than three classes ahead of the time the inspected horses are to be shown, except that, in shows with fewer than 150 horses, the DQP shall inspect horses no more than 2 classes ahead of the time the inspected horses are to be shown. Inspected horses shall be held in a designated area that is under observation by the DQP or APHIS representative. Horses shall not be permitted to leave the designated area before showing. Only the horse, the rider, the groom, the trainer, the DQP(s) and APHIS representatives shall be allowed in the designated area.
(c) The DQP may carry out additional inspection procedures as he deems necessary to determine whether the horse is sore.
(d) The certified DQP organization shall assess appropriate penalties for violations, as set forth in the rule book of the certified program under which the DQP is licensed, or as set forth by the Department, and shall report all violations, in accordance with § 11.20(b)(3) of this part.
(a) The management of any horse show, horse exhibition, or horse sale or auction, that contains Tennessee Walking Horses or racking horses, shall maintain for a period of at least 90 days following the closing date of said show, exhibition, or sale or auction, all pertinent records containing:
(1) The dates and place of the horse show, horse exhibition, horse sale, or horse auction.
(2) The name and address (including street address or post office box number and ZIP code) of the sponsoring organization.
(3) The name and address of the horse show, exhibition, horse sale or horse auction management.
(4) The name and address (including street address or post office box number and ZIP code) of the DQP, if any, employed to conduct inspections under § 11.20; and, the name of the horse industry organization or association certifying the DQP.
(5) The name and address (including street address or post office box number, and ZIP code) of each show judge.
(6) A copy of each class or sale sheet containing the names of horses, the names and addresses (including street address, post office box and ZIP code) of horse owners, the exhibitor number and class number, or sale number assigned to each horse, the show class or sale lot number, and the name and address (including street address, post office box, and ZIP code) of the person paying the entry fee and entering the horse in a horse show, horse exhibition, or horse sale or auction.
(7) A copy of the official horse show, horse exhibition, horse sale, or horse auction program, if any such program has been prepared.
(8) The identification of each horse, including the name of the horse, the name and address (including street address, post office box, and ZIP code) of the owner, the trainer, the rider or other exhibitor, and the location (including street address, post office box, and ZIP code) of the home barn or other facility where the horse is stabled.
(b) The management of any horse show, horse exhibition, or horse sale or auction containing Tennessee Walking Horses or racking horses shall designate a person to maintain the records required in this section.
(c) The management of any horse show, horse exhibition, or horse sale or auction containing Tennessee Walking Horses or racking horses shall furnish to any APHIS representative, upon request, the name and address (including street address, or post office box, and ZIP code) of the person designated by the sponsoring organization or manager to maintain the records required by this section.
(d) The Administrator may, in specific cases, require that a horse show,
(a) The management of any horse show, horse exhibition, or horse sale or auction shall permit any APHIS representative, upon request, to examine and make copies of any and all records pertaining to any horse, either required in any part of the regulations, or otherwise maintained, during ordinary business hours or such other times as may be mutually agreed upon. A room, table, or other facilities necessary for proper examination of such records shall be made available to the APHIS representative.
(b) Horse industry organizations or associations who train, maintain, and license DQP's under a certified DQP program shall permit any APHIS representative, upon request, to examine and copy any and all records relating to the DQP program which are required by any part of the regulations. Such requests shall be made during ordinary business hours or such other times as mutually agreed upon. A room, table or other facilities necessary for proper examination shall be made available upon the request of the APHIS representative.
(a) Within 5 days following the conclusion of any horse show, horse exhibition, or horse sale or auction, containing Tennessee Walking Horses or racking horses, the managements of such show, exhibition, sale or auction shall submit to the Regional Director
(b) Within 5 days following the conclusion of any horse show, horse exhibition, or horse sale or auction which does not contain Tennessee Walking Horses or racking horses, the management of such show, exhibition, sale or auction shall inform the Regional Director for the State in which the show, exhibition, sale or auction was held, of any case where a horse was excused or disqualified by management or its representatives from being shown, exhibited, sold or auctioned because it was found to be sore.
(a) Each person who ships, transports, or otherwise moves, or delivers or receives for movement, any horse with reason to believe such horse may be shown, exhibited, sold or auctioned at any horse show, horse exhibition, or horse sale or auction, shall allow and assist in the inspection of such horse at any such show, exhibition, sale, or auction to determine compliance with the Act as provided in § 11.4 of the regulations and shall furnish to any APHIS representatives upon his request the following information:
(1) Name and address (including street address, post office box, and ZIP code) of the horse owner and of the shipper, if different from the owner or trainer.
(2) Name and address (including street address, post office box, and ZIP code) of the horse trainer.
(3) Name and address (including street address, post office box, and ZIP code) of the carrier transporting the horse, and of the driver of the means of conveyance used.
(4) Origin of the shipment and date thereof, and,
(5) Destination of shipment.
(b) [Reserved]
Each horse industry organization or association which sponsors, or which sanctions any horse show, horse exhibition, or horse sale or auction, shall furnish the Department
15 U.S.C. 1825 and 1828; 7 CFR 2.22, 2.80, and 371.7.
The Uniform Rules of Practice for the Department of Agriculture promulgated in subpart H of part 1, subtitle A, title 7, Code of Federal Regulations, are the Rules of Practice applicable to adjudicatory, administrative proceedings under section 6(a) of the Horse Protection Act of 1970 (15 U.S.C. 1825(a)) and sections 6 (b) and (c) of the Horse Protection Act (15 U.S.C. 1825 (b) and (c)). In addition, the Supplemental Rules of Practice set forth in subpart B of this part shall be applicable to such proceedings.
(a) At any time prior to the issuance of a complaint seeking a civil penalty under the Act, the Administrator, in his discretion, may enter into a stipulation with any person in which:
(1) The Administration gives notice of an apparent violation of the Act or the regulations issued thereunder by such person and affords such person an opportunity for a hearing regarding the matter as provided by the Act;
(2) Such person expressly waives hearing and agrees to a specified order including an agreement to pay a specified civil penalty within a designated time; and
(3) The Administrator agrees to accept the specified order including a civil penalty in settlement of the particular matter involved if it is paid within the designated time.
(b) If the specified penalty is not paid within the time designated in such a stipulation, the amount of the stipulated penalty shall not be relevant in any respect to the penalty which may
7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
The Uniform Rules of Practice for the Department of Agriculture promulgated in subpart H of part 1, subtitle A, title 7, Code of Federal Regulations, are the Rules of Practice applicable to adjudicatory, administrative proceedings under the following statutory provisions:
(a) At any time prior to the issuance of a complaint seeking a civil penalty under any of the Acts listed in § 49.1, the Administrator, in his discretion, may enter into a stipulation with any person in which:
(1) The Administrator or the Administrator's delegate gives notice of an apparent violation of the applicable Act, or the regulations issued thereunder, by such person and affords such person an opportunity for a hearing regarding the matter as provided by such Act;
(2) Such person expressly waives hearing and agrees to pay a specified penalty within a designated time; and
(3) The Administrator agrees to accept the penalty in settlement of the particular matter involved if the penalty is paid within the designated time.
(b) If the penalty is not paid within the time designated in such a stipulation, the amount of the stipulated penalty shall not be relevant in any respect to the penalty which may be assessed after issuance of a complaint.
7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
For the purposes of this part, the following terms mean:
(a) The provisions of this subpart apply to all payments made by the Department for the destruction of animals because of tuberculosis, except as specifically provided in subpart B of this part.
(b) The Administrator cooperates with the proper State authorities in the eradication of tuberculosis and pays Federal indemnities for the destruction of cattle, bison, captive cervids, or swine affected with or exposed to tuberculosis.
(a) The Administrator is authorized to agree on the part of the Department to pay indemnity to owners of the following animals:
(1) Cattle, bison, or captive cervids destroyed because the animals are infected with or exposed to tuberculosis;
(2) Cattle, bison, or captive cervids that have been classified as suspect for tuberculosis, except that the payment of indemnity for the destruction of suspect cattle, bison, and captive cervids will be withheld until the tuberculosis status of the suspect animal has been determined and, if the cattle, bison, or captive cervid is found to be infected with tuberculosis, until all cattle, bison, and captive cervids 12 months of age or older in the claimant's herd have been tested for tuberculosis under APHIS or State supervision; and
(3) Other livestock destroyed because they are classified as exposed to tuberculosis by the designated tuberculosis epidemiologist by reason of an association with an affected herd of cattle, bison, or captive cervids.
(b) In each case, the joint State-Federal indemnity paid, together with the amount for net salvage the owner receives, may not exceed the appraised value of the animal, as determined in accordance with § 50.9. Additionally, the Department will in no case pay more than $3,000 for an animal that is destroyed.
(a) Cattle, bison, and captive cervids are classified as infected with tuberculosis on the basis of an intradermal tuberculin test applied by a Federal, State, or an accredited veterinarian or by other diagnostic procedure approved in advance by the Administrator.
(b) Cattle, bison, and captive cervids are classified as exposed to tuberculosis when such cattle, bison, and captive cervids (1) are part of a known infected herd, or (2) are found to have moved from an infected herd before the time infection was disclosed in such herd and after the time such herd had apparently become infected, or (3) are found to have been exposed by virtue of nursing a reactor dam:
(c) Cattle and bison are classified as suspects for tuberculosis based on a positive response to an official tuberculin test, in accordance with the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” (incorporated into the regulations by reference in part 77). Captive cervids are classified as suspects for tuberculosis in the same manner as cattle and bison.
(d) The designated tuberculosis epidemiologist will determine whether livestock other than cattle, bison, or captive cervids are classified as exposed to tuberculosis by reason of association with an affected herd of cattle, bison, or captive cervids.
When any cattle, bison, or captive cervid in a herd is classified by an APHIS or State representative or accredited veterinarian as a reactor to a test for tuberculosis, a complete test record shall be made for such herd, including the reactor tag number of each reacting animal and the registration name and number of each reacting registered animal. VS Form 6-22 or an equivalent State form shall be used for the record of any herd having any reactor to a tuberculin test. A copy of the applicable test record shall be given to the owner of any such herd, and one copy of each such record shall be furnished to the appropriate State veterinarian's office.
(a) Livestock to be destroyed because of tuberculosis must be identified as follows:
(1) Livestock classified as reactors for tuberculosis must be identified within 15 days after being classified as reactors, except that the veterinarian in charge may extend the time limit for identification to 30 days when he or
(2) Livestock other than reactors for tuberculosis that are to be destroyed because of tuberculosis must be identified prior to movement from the premises of origin to the place of destruction.
(b)
(c)
(d)
(a)
(b)
The Department may pay, when approved in advance in writing by the Veterinarian in Charge, one half the expenses of transporting infected, exposed, or suspect livestock to slaughter or to the point where disposal will take place, and one half the expenses of destroying, burying, incinerating, rendering, or otherwise disposing of infected, exposed, or suspect livestock;
(a) Livestock to be destroyed because of tuberculosis under § 50.3 must be appraised within 15 days after being classified as infected with tuberculosis, except that the veterinarian in charge may extend the time limit for appraisal to 30 days when he or she receives a request for such an extension before the end of the expiration date of the original 15-day period allowed and circumstances beyond the control of the owner warrant such an extension, and the Administrator may extend the time limit for appraisal beyond 30 days upon request in specific cases when circumstances beyond the control of the owner warrant such an extension.
(b) Animals for which indemnity is to be paid under this part must be appraised at their fair market value by an appraiser selected by APHIS. APHIS may decline to accept any appraisal that appears to it to be unreasonable or out of proportion to the value of like animals of a like quality. Should the appraisal made by the appraiser selected by APHIS be deemed inadequate by the owner of the animals, the owner will have 15 days from the receipt of the appraisal to submit to the Administrator a request for a review of the appraisal, along with the reasons why the animals should be appraised at a higher value. The decision by the Administrator regarding the value of the animals is final.
(c) When livestock to be destroyed because of tuberculosis are appraised, due consideration will be given to their breeding value as well as to their dairy or meat value. Livestock presented for payment as registered must be accompanied by their registration papers. If the registration papers are temporarily not available, or if the livestock are less than 3 years old and unregistered, the veterinarian in charge may grant a reasonable time for the presentation of their registration papers.
Appraisals of livestock made in accordance with § 50.9 shall be recorded on forms furnished by APHIS. The appraisal form shall be signed by the appraiser and by the owner certifying his acceptance of the appraisal. The “date of appraisal” shall be the date that the owner signs the appraisal form. The original of the appraisal form and as many copies thereof as may be required for APHIS, the State, and the owner of the animals shall be sent to the appropriate Veterinarian in Charge.
A report of the salvage derived from the sale of each animal on which a claim for indemnity may be made under the provisions of § 50.3 shall be made on a salvage form acceptable to APHIS which shall be signed by the purchaser or his agent or by the selling agent handling the animals. If the livestock are sold by the pound, the salvage form shall show the weight, price per pound, gross receipts, expenses if any, and net proceeds. If the livestock are not sold on a per pound basis, the net purchase price of each animal must
Claims for Federal indemnity for livestock destroyed because of tuberculosis shall be presented on indemnity claim forms furnished by APHIS on which the owner of the animals covered thereby shall certify that the animals are or are not, subject to any mortgage as defined in this Part. If the owner states there is a mortgage, the APHIS indemnity claim form shall be signed by the owner and by each person holding a mortgage on the animals consenting to the payment of any indemnity allowed to the person specified thereon. Payment will be made only if the APHIS indemnity claim form has been approved by a proper State official and if payment of the claim has been recommended by the appropriate Veterinarian in Charge or an official designated by him. On claims for indemnity made under the provisions of § 50.3, the Veterinarian in Charge or official designated by him shall record on the APHIS indemnity claim form the amount of Federal and State indemnity payments that appear to be due to the owner of the animals. The owner of the animals shall be furnished a copy of the APHIS indemnity claim form. The Veterinarian in Charge or official designated by him shall then forward the APHIS indemnity claim form to the appropriate official for further action on the claim. No charges for holding the livestock on the farm pending slaughter or for trucking by the owner shall be so deducted or otherwise paid by the Department.
All premises, including all structures, holding facilities, conveyances, or materials which are determined by the appropriate Veterinarian in Charge to constitute a health hazard to humans or animals because of tuberculosis shall be properly cleaned and disinfected, in accordance with procedures approved by the Department, within 15 days after the removal of tuberculosis infected or exposed livestock except that the Veterinarian in Charge, for reasons satisfactory to him, may extend the time limit for disinfection to 30 days when request for such extension is received by him prior to the expiration date of the original 15-day period allowed.
Claims for compensation for livestock destroyed because of tuberculosis will not be allowed in any of the following cases:
(a) The claimant has failed to comply with any of the requirements of this part:
(b) All cattle, bison, and captive cervids 12 months of age or over in the claimant's herd have not been tested for tuberculosis under APHIS or State supervision:
(c) There is substantial evidence that the owner of the animals or the agent of the owner has in any way been responsible for any attempt to obtain indemnity funds for the animals unlawfully or improperly.
(d) At the time the cattle, bison, or captive cervids in the claimant's herd were tested for tuberculosis, the cattle, bison, captive cervids, or other livestock in the herd belonged to or were on the premises of any person to whom they had been sold, shipped, or delivered for slaughter unless or until all of the cattle, bison, captive cervids, and other livestock remaining on the premises or in the herd from which the tested cattle, bison, or captive cervids originated are tested or otherwise examined for tuberculosis in a manner satisfactory to the Administrator or his or her designated representative.
(e) If the cattle, bison, or captive cervids were added to a herd while the herd was quarantined for tuberculosis, unless an approved herd plan was in effect at the time the claim was filed. As part of the approved herd plan, cattle, bison, or captive cervids added to a herd quarantined for tuberculosis must:
(1) Be from an accredited herd, as defined in § 77.1 of this chapter; or
(2)(i) Be from a herd that tested negative to an official tuberculin test, as defined in § 77.1 of this chapter, during the 60 days before the cattle, bison, or captive cervids were added to the claimant's herd; and
(ii) Have been found negative to an official tuberculin test, as defined in § 77.1 of this chapter, during the 60 days before the cattle, bison, or captive cervids were added to the claimant's herd.
(f) For exposed cattle, bison, or captive cervids destroyed during herd depopulation, if a designated tuberculosis epidemiologist has determined that other livestock in the herd have been exposed to tuberculosis by reason of association with tuberculous livestock, and those other livestock determined to have been exposed to tuberculosis have not been destroyed.
(g) For livestock other than cattle, bison, and captive cervids that are destroyed because of association with herds of affected cattle, bison, or captive cervids:
(1) If the livestock did not reside among the herd for a period of 4 months or more;
(2) If the livestock have not received a postmortem examination for tuberculosis; or
(3) If the livestock were added to a herd that was under quarantine for tuberculosis at the time the livestock were added to the herd, unless an approved herd plan was in effect at that time.
(a)
(b) To be eligible for payment, each of the owners of dairy cattle and other property within the area described in paragraph (a) of this section must sign and adhere to an agreement with APHIS to do the following:
(1) Cease all dairy cattle operations within the described area and dispose of all sexually intact cattle on the dairy operation premises no later than 3 years after all eligible owners have signed their respective agreements;
(2) Conduct no dairy farming or other dairy activity, including the rearing of breeding cattle, but not including the grazing or feeding of steers and spayed heifers intended for terminal market, within the area described in paragraph (a) of this section until the described area and the adjoining area of Mexico have been declared free of bovine tuberculosis, as determined epidemiologically by APHIS, but in any event for a period of not less than 20 years after all eligible owners have signed their respective agreements.
(3) Allow a covenant to be placed on their properties where dairy operations have been conducted that will prevent the establishment of any breeding cattle operations (not including the grazing or feeding of steers and spayed heifers intended for terminal market) on the premises until the described area and the adjoining area of Mexico have been declared free of bovine tuberculosis, as determined epidemiologically by APHIS, but in any event for a period of not less than 20 years after all eligible owners have signed their respective agreements.
(4) Maintain responsibility for all cattle on the premises used in the dairy operation until those animals are removed from the premises;
(5) Make all arrangements for the removal of sexually intact cattle from the premises;
(6) Notify APHIS officials of the intended removal of all sexually intact cattle from the premises and provide APHIS officials with the opportunity to monitor and evaluate the removal operations; and
(7) Such other terms, provisions, and conditions as agreed by each owner and APHIS.
(c)
(1) For milking cows, an amount not to exceed $2,922 per animal; and
(2) For heifers, an amount not to exceed $834 per animal.
(d) Any dairy cattle added to a premises after the date an owner has signed the agreement required under paragraph (b) of this section will not be included in the rate calculation in paragraph (c) of this section and must be disposed of within 3 years after all eligible owners have signed their respective agreements.
(e)
(1) For expenses in relocating equipment of a reverse osmosis plant in El Paso County, TX, an amount equal to the costs of relocating the plant's equipment, not to exceed $675,000.
(2) In conjunction with the permanent closure of a fluid milk processing plant in El Paso County, TX, an amount not to exceed $950,000, with payment to be made in the same manner and at the same times, on a pro rata basis, as payments are made to such owners for their dairy cattle and other property.
(a) All dairy cattle disposed of under this subpart must travel from the premises of origin to their final destination with an approved metal eartag, supplied by APHIS or the State
(b) Dairy cattle disposed of under this subpart must be shipped under permit either:
(1) Directly to slaughter at a Federal or State inspected slaughtering establishment; or
(2) Under permit directly to a livestock market and, under the supervision of an APHIS representative or State representative, through a livestock market pen that is dedicated to and marked exclusively for use for animals moved to slaughter, and then directly to slaughter at a Federal or State inspected slaughtering establishment.
A report of the salvage derived from the sale of each animal for which a claim for payment is made under this subpart must be made on a salvage form acceptable to APHIS that must be signed by the purchaser or by the selling agent handling the animals. If the cattle are sold by the pound, the salvage form must show the weight, price per pound, gross receipts, expenses if any, and net proceeds. If the cattle are not sold on a per-pound basis, the net purchase price of each animal must be stated on the salvage form and an explanation showing how the amount was arrived at must be submitted. In the event the animals are not disposed of through regular slaughterers or through selling agents, the owner must furnish, in lieu of the salvage form, an affidavit showing the amount of salvage obtained by him or her and must certify that such amount is all he or she has received or will receive as salvage for the animals. The original of the salvage form or the affidavit of the owner must be furnished to the veterinarian in charge within 3 months of destruction of the animals, if such document is not already in his or her possession. Disposal of cattle by burial, incineration, or other means must be supervised by an APHIS or State representative, who will prepare and transmit to the veterinarian in charge a report identifying the animals and showing their disposition, or be documented by an affidavit of the owner that identifies the animals and describes their disposition. The owner must provide a copy of the affidavit to the veterinarian in charge within 3 months of destruction of the animals. The salvage form, disposal certificate, or affidavit will be for information purposes only and will have no effect on the amount of any payment due.
Claims for payment, other than for reimbursement of relocation expenses of the reverse osmosis dairy plant, must be presented on payment claim forms furnished by APHIS.
(a) The Department will make payment, other than for reimbursement of relocation expenses of the equipment of the reverse osmosis plant, at 90-day intervals. The first payment will be made no earlier than 30 days after all owners eligible for payment have signed their agreements required under § 50.17(b). The Department will determine the amount to be paid to each owner in each payment by multiplying the total agreement amount for that owner by a fraction that is arrived at by dividing the initial census number of dairy cattle for the respective owner into the number of dairy cattle that have been removed from the owner's herd during that payment period. From this amount, 10 percent will be withheld until all animals in the herd have been disposed of and the requirements of this subpart have been met. The payments to other property owners will be determined by multiplying the total agreement amount for that other property times the same ratio as for the herd related to that other property, minus 10 percent. The Department will make payment for reimbursement of relocation expenses of the reverse osmosis plant within 30 days after the relocation of the plant is completed and the owner of the plant has submitted to APHIS all documentation of the costs of the relocation.
(b) The Department will not make final payments until the premises used for dairy operations have been without sexually intact cattle for at least 30 days and until APHIS has inspected the premises and has found them to be free of manure, except for non-solid areas such as lagoons, and free of all feedstuffs that are not in barns, containers or feeders.
The Department will not allow claims for payment if the claimant has failed to comply with any of the requirements of this subpart, or there is substantial evidence, as determined by the Administrator, that the claimant has been responsible for any attempt to obtain payment funds for such cattle or other dairy property unlawfully or improperly.
7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
For the purposes of this part, the following terms shall be construed, respectively, to mean:
For
The Administrator has been delegated the authority to cooperate with the proper State authorities in the eradication of brucellosis and to pay indemnities for the destruction of brucellosis-reactor animals or brucellosis-exposed animals.
(a)
(1)
(i) Cattle and bison identified as reactors as a result of a complete herd test and any sexually intact exposed female calves;
(ii) Cattle and bison in a herd that has been approved for depopulation; and
(iii) Brucellosis-exposed cattle and brucellosis-exposed bison that were previously sold or traded from any herd that was, subsequent to the sale or trade, found to be affected with brucellosis. Epidemiological information such as test results, herd history, and related evidence will be used to establish a probable date when the herd was first affected with brucellosis. Animals sold after that date will be considered to be exposed; those sold before that date will not.
(2)
(i)
(ii)
(A)
(B)
(b)
(2)
(3)
The claimant shall be responsible for providing information to an APHIS representative, State representative, or accredited veterinarian so that a complete test record may be made by such person on an APHIS approved form for each herd known to be affected, including the reactor tag number of each brucellosis reactor animal and the registration name and number of each brucellosis reactor registered animal. A copy of the applicable test record shall be given to the owner of any such herd, and one copy of each such record shall be furnished to the appropriate State veterinarian's office by such person who completes the test record.
(a) The claimant shall be responsible for insuring that any animal for which indemnity is claimed shall be identified in accordance with the provisions of this section within 15 days after having been classified as a reactor or for any other animal subject to this part within 15 days after having been condemned. The veterinarian in charge may extend the time limit to 30 days when a request for such extension is received by him prior to the expiration date of the original 15 day period allowed, and when he determines that the extension will not adversely affect the brucellosis eradication program; and except further, that the Administrator shall upon request in specific cases, extend the time limit beyond the 30-day period when unusual or unforeseen circumstances occur which prevent or hinder the identification of the animals within the 30-day period, such as, but not limited to, floods, storms, or other Acts of God which are beyond the control of the owner, or when identification is delayed due to requirements of another Federal Agency.
(b) Except as provided in paragraph (b)(4) of this section, cattle and bison to be destroyed because of brucellosis shall be individually identified prior to moving interstate by attaching to the left ear a metal tag bearing a serial number and the inscription “U.S. Reactor,” or a similar State reactor tag, and must be:
(1) “B” branded (as defined in § 78.1); or
(2) Accompanied directly to slaughter by an APHIS or State representative; or
(3) Moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official
(4) Reactor and exposed cattle and bison in herds scheduled for herd depopulation may be moved interstate without eartagging or branding if they are identified by USDA approved backtags and either accompanied directly to slaughter by an APHIS or State representative or moved directly to slaughter in vehicles closed with official seals. Such official seals must be applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative.
(c) Swine shall be individually identified by tagging with a metal tag bearing a serial number and inscription “U.S. Reactor” or a similar State reactor tag or other identification approved by the Administrator, upon request in specific cases, attached to the left ear of each animal.
(a)
(b)
(c)
(d)
(a) Claims for indemnity for animals destroyed because of brucellosis shall be presented on indemnity claim forms furnished by APHIS on which the owner of the animals covered thereby shall certify that the animals are or are not subject to any mortgage as defined in this part. If the owner states there is a mortgage, the APHIS indemnity claim form shall be signed by the owner and by each person holding a mortgage on the animals, consenting to the payment of any indemnity allowed to the person specified thereon. Payment will be made only if the claimant has submitted a complete indemnity claim form to, and such claim has been approved by the Veterinarian in Charge or by an APHIS representative designated by him. On claims for indemnity made under the provisions of § 51.3, the Veterinarian in Charge or an APHIS representative designated by him shall record on the APHIS indemnity claim form the amount of Federal and State indemnity payments that appear to be due to the owner of the animals. The owner of the animals shall be furnished a copy of the completed APHIS indemnity claim form. The Veterinarian in Charge or an APHIS representative designated by him shall then forward the completed APHIS indemnity claim form to the Administrator for further action on the claim. No charges for holding the animals on the farm pending slaughter or for trucking by the owner shall be so deducted or otherwise paid by the United States Department of Agriculture.
(b) Claims for indemnity for registered cattle shall be accompanied by the cattle's registration papers issued in the name of the owner. If the registration papers are unavailable or if the cattle are less than 1 year old and are not registered at the time the claim for indemnity is submitted, the Veterinarian in Charge may grant a 60-day extension or the Administrator may grant an extension longer than 60 days for the presentation of registration papers.
All premises, including all structures, holding facilities, conveyances, and materials, contaminated because of occupation or use by brucellosis reactor or exposed animals shall be properly cleaned and disinfected with a disinfectant permitted by APHIS in accordance with recommendations of the APHIS or State representative within 15 days from the date reactors were removed from the premises, except that the appropriate Veterinarian in Charge may extend the time limit for disinfection to 30 days when request for such extension is received by him prior to the expiration date of the original 15-day period allowed, and when he determines that such extension will not adversely affect the Brucellosis Eradication Program; and except further, that the Administrator may, upon request in specific cases, extend the time limit beyond the 30-day period when unusual and unforeseen circumstances occur, such as but not limited to floods, storms, or other Acts of God, which are beyond the control of the owner, preventing or hindering the disinfection of premises, conveyances, and materials. Certain premises may be exempted from such cleaning and disinfecting requirements by approval of the appropriate Veterinarian in Charge on written recommendations by the APHIS or State representative or when a written report by the APHIS or State representative determines that there are no buildings, holding facilities, conveyances, or other materials on the
Claims for compensation for animals destroyed because of brucellosis shall not be allowed if any of the following circumstances exist:
(a) If the claimant has failed to comply with any of the requirements of this part.
(b) If the existence of brucellosis in the animal was determined based on the results of an official test, as defined in § 78.1 of this chapter, and specific instructions for the administration of the official test had not previously been issued to the individual performing the test by APHIS and the State animal health official.
(c) If all cattle, bison, and swine eligible for testing in the claimant's herd have not been tested for brucellosis under APHIS or State supervision.
(d) If the animals are:
(1) Barrows or gilts maintained for feeding purposes; or
(2) Spayed heifers or steers, unless the steers are work oxen, or unless the spayed heifers or steers are unweaned animals in a herd approved for depopulation in accordance with § 51.3 of this part.
(e) If the animals are classified as reactors and are unofficial vaccinates, unless there is either a record of a negative official test made not less than 30 days following the date of unofficial vaccination or unless other APHIS approved tests show the unofficial vaccinates are affected with virulent Brucella.
(f) If there is substantial evidence that the owner or his agent has in any way been responsible for any unlawful or improper attempt to obtain indemnity funds for such animal.
(g) If, at the time of test or condemnation, the animals belonged to or were upon the premises of any person to whom they had been sold for slaughter; shipped for slaugher, or delivered for slaughter.
(h) If any known brucellosis reactor animal remains in the herd, unless, in the opinion of the Veterinarian in Charge, a reasonable search has been made for the brucellosis reactor animal and the brucellosis reactor animal could not be found and removed.
(i) If the animals are brucellosis reactor animals which are slaughtered other than as part of a herd depopulation, and which are from a herd: (1) That was already classified as a “herd known to be affected” at the time the animals were identified as brucellosis reactor animals and (2) for which an approved action plan or approved individual herd plan (as defined in § 78.1 of this chapter) was not in effect at the time the claim was filed.
No claim for indemnity for animals destroyed because of brucellosis shall hereafter be paid under the regulations contained in part 53 of this chapter, but all such claims shall be presented and paid pursuant to and in compliance with regulations contained in this part.
(2) Any horse that has been determined by a designated brucellosis epidemiologist to be affected with brucellosis, based on epidemiological information or culture results, or positive results for brucellosis in accordance with one of the following tests:
(3) Any cattle, bison, or swine classified as a brucellosis reactor as provided in the definition of official test in § 78.1 of this chapter.
The Administrator has been delegated the authority to cooperate with the proper State authorities in the eradication of brucellosis and to pay indemnities for the destruction of brucellosis-reactor animals or brucellosis-exposed animals.
(a) The Administrator may authorize the payment of Federal indemnity by the U.S. Department of Agriculture to any owner whose goats, sheep, or horses are destroyed after having been approved for destruction by APHIS.
(b) The amount of Federal indemnity will be determined in accordance with the regulations in this part that were in effect on the date infected animals were found, or the date that the whole-herd/flock depopulation or destruction of individual animals was approved.
(c) Prior to payment of indemnity, proof of destruction must be furnished to the Veterinarian in Charge.
Owners of animals destroyed because of brucellosis are eligible to receive Federal indemnity for their animals if the animals are:
(a) Sheep and goats in an affected herd or flock;
(b) Sheep and goats that were obtained from a herd or flock that was subsequently found to be an affected herd or flock. Epidemiological information such as test results, herd/flock history, and related evidence will be used to establish a probable date when the herd or flock was first affected with
(c) Individual horses that have been found to be brucellosis reactor animals.
Owners of the types of animals listed in § 51.22 of this subpart are eligible to receive Federal indemnity for their animals. All animals must be individually appraised to determine their fair market value. The indemnity amount will be the appraised value minus the salvage value of the animal, up to a maximum of $20,000 per animal in the case of horses. An independent appraiser selected by the Administrator will conduct appraisals. APHIS will pay the cost of appraisals.
The Veterinarian in Charge will accept any of the following documents as proof of destruction:
(a) A postmortem report;
(b) A meat inspection certification of slaughter;
(c) A written statement by a State representative, APHIS representative, or accredited veterinarian attesting to the destruction of the animals;
(d) A written, sworn statement by the owner or caretaker of the animal attesting to the destruction of the animals;
(e) A permit (VS Form 1-27) consigning the animal from a farm or livestock market directly to a slaughter establishment; or
(f) In unique situations where none of the documents listed above are available, other similarly reliable forms of proof of destruction.
An APHIS representative, State representative, or accredited veterinarian will compile, on an APHIS-approved form, a complete test record for each animal. The claimant must provide any information necessary to complete the form. The test record must include the type of test and the test results for each animal. It must also include the individual identification of each tested animal. Any unique, individually numbered identification is acceptable. The animal's owner and the appropriate State veterinarian's office will each receive a copy of the test record.
The claimant must ensure that any goats, sheep, and horses for which indemnity is claimed are marked with unique, individually numbered identification showing they are to be destroyed. This must be done within 15 days after the animals are condemned. The Veterinarian in Charge may extend the time limit to 30 days when the Veterinarian in Charge receives a request for extension prior to the expiration date of the original 15-day period, and when the Veterinarian in Charge determines that the extension will not adversely affect the brucellosis eradication program. However, the Administrator may extend the time limit beyond 30 days when unusual or unforeseen circumstances occur that prevent or hinder the identification of the animal within 30 days, such as, but not limited to, floods, storms, or other Acts of God, which are beyond the control of the owner, or when identification is delayed due to requirements of another Federal agency.
Goats, sheep, and horses to be destroyed because of brucellosis must be accompanied by a permit and either:
(a) Accompanied directly to slaughter by an APHIS or State representative; or
(b) Moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official
(a) The claimant must ensure that goats, sheep, and horses infected with or exposed to
(1) Sold under permit to a recognized slaughtering establishment;
(2) Moved to an approved stockyard for sale to a recognized slaughtering establishment; or
(3) Destroyed and buried, incinerated, or rendered in accordance with applicable State law.
(b) The claimant must ensure that goats and sheep destroyed because of
(c) Indemnity will be paid under this part only if the animals are destroyed within 15 days after the date they are marked with identification showing they are to be destroyed. However, the Veterinarian in Charge may extend the time limit to 30 days if:
(1) The animals' owner asks the Veterinarian in Charge for an extension before the initial 15-day period expires, or the animals were sold for slaughter before the original 15-day period expires; and
(2) The Veterinarian in Charge determines that extending the time limit will not adversely affect the Brucellosis Eradication Program.
(d) The Administrator may extend the time limit beyond 30 days when unusual and unforeseen circumstances occur that prevent or hinder the destruction of the animals within 30 days, such as, but not limited to, floods, storms, or other Acts of God, which are beyond the control of the owner, or when destruction is delayed due to requirements of another Federal agency.
(a) Claims for indemnity for goats, sheep, and horses destroyed because of brucellosis must be made using an indemnity claim form furnished by APHIS. On the form, the owner of the animals must certify whether the animals are subject to a mortgage. If the owner states there is a mortgage, the claim form must be signed by the owner and by each mortgage holder, consenting to the payment of any indemnity allowed to the owner. Payment will be made only if the claimant has submitted a complete indemnity claim form to the Veterinarian in Charge and the claim has been approved by the Veterinarian in Charge or by an APHIS representative designated by him or her. The Veterinarian in Charge or an APHIS representative designated by the Veterinarian in Charge will record on the APHIS indemnity claim form the amount of Federal and State indemnity payments that appear to be due to the owner of the animals. The owner of the animals will receive a copy of the completed APHIS indemnity claim form. The owner is responsible for paying all fees for holding the animals on the farm pending disposal and for all trucking fees.
(b) Claims for indemnity for registered sheep and registered goats must be accompanied by the animal's registration papers, issued in the name of the owner. If the registration papers are unavailable or if the animal is less than 1 year old and not registered at the time the claim for indemnity is submitted, the Veterinarian in Charge may grant a 60-day extension or the Administrator may grant an extension longer than 60 days for the presentation of registration papers. Any animal that is not registered but is eligible for registration at the time the claim is submitted will be considered unregistered unless the animal has been in the flock for less than 12 months.
All premises, including all structures, holding facilities, conveyances, and materials contaminated because they have been used by animals destroyed because of brucellosis, must be properly cleaned and disinfected in accordance with recommendations of the
Claims for indemnity for goats, sheep, and horses destroyed because of brucellosis will not be allowed if any of the following circumstances exist:
(a) The claimant has failed to comply with any of the requirements of this part;
(b) The claim is based on a brucellosis test, and the person who administered the test was not properly trained, authorized, or certified at the time of the test;
(c) Testing of goats, sheep, and horses in the herd or flock for brucellosis was not done under APHIS or State supervision, or by an accredited veterinarian;
(d) There is substantial evidence that the claim is an unlawful or improper attempt to obtain indemnity; or
(e) If, at the time of test or condemnation, the animals belonged to or were upon the premises of any person to whom they had been sold for slaughter, shipped for slaughter, or delivered for slaughter.
APHIS has indemnity programs for several other livestock diseases. However, if a claim is paid for indemnity for animals destroyed because of brucellosis, no other claims for indemnity will be paid for the same animals.
7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
(a) Except as provided in paragraph (b) of this section, the Administrator is authorized to agree on the part of the Department to pay indemnity to the owner of herds of swine destroyed because the herds are known to be infected with pseudorabies, or individual breeding sows destroyed because they are known to be infected with pseudorabies. The amount of indemnity paid, together with the amount for net salvage the owner receives when the animals are slaughtered, shall not exceed the fair market value of the swine. Such swine must be sent directly to slaughter under permit in a conveyance closed with an official seal applied and removed by either an APHIS employee, a State representative, an accredited veterinarian, or an individual authorized for this purpose by an APHIS employee. The swine must be sent to a recognized slaughtering establishment.
(b) If swine from herds that are destroyed because the herds are known to be infected with pseudorabies are not accepted at a recognized slaughtering establishment, or the owner and an APHIS employee or State representative agree they will not be accepted by a recognized slaughtering establishment, the Administrator is authorized to pay 100 percent of the expenses of the purchase, destruction, and disposition of such swine.
(a) Herds of swine and individual breeding sows to be destroyed because they are known to be infected with pseudorabies will be appraised by an APHIS employee and a representative of the State jointly, a representative of the State alone, or, if the State authorities approve, by an APHIS employee alone.
(b) The appraisal of swine will be based on the fair market value as determined by the meat or breeding value of the animals. Animals may be appraised in groups, provided that where appraisal is by the head, each animal in the group is the same value per head, and where appraisal is by the pound, each animal in the group is the same value per pound.
(c) Appraisals of swine must be reported on forms furnished by APHIS and signed by the owner of the swine. Reports of appraisals must show the number of swine and the value per head or the weight and value by pound.
(a) When swine have been destroyed under § 52.2(a), any claim for indemnity must be presented, along with the report of net salvage proceeds required under § 52.5, to the veterinarian in charge on a form furnished by APHIS.
(b) When swine have been destroyed under § 52.2(b), any claim for indemnity must be presented, through the inspector in charge, to APHIS on a form furnished by APHIS.
(c) For all claims for indemnity, the owner of the swine must certify on the claim form that the swine covered are, or are not, subject to any mortgage as defined in this part. If the owner states there is a mortgage, the owner and each person holding a mortgage on the swine must sign, consenting to the payment of indemnity to the person specified on the form.
A report of the amount for net salvage derived from the sale of each animal for which a claim for indemnity is made under § 52.2(a) must be made on a salvage form that shows the gross receipts, expenses if any, and net proceeds. The original or a copy of the salvage form must be furnished by the owner to the veterinarian in charge.
(a) The Department will not allow claims arising out of the destruction of swine unless the swine have been appraised as prescribed in this part and the owners have signed a written agreement to the appraisals.
(b) The Department will not allow claims arising out of the destruction of swine that have been moved or handled by the owner or a representative of the owner in violation of a law or regulation administered by the Secretary regarding animal disease, or in violation of a law or regulation for which the Secretary has entered into a cooperative agreement.
All premises, including barns, stockyards and pens, and all cars and other conveyances, and the materials on any premises or conveyances used to house or transport swine for which indemnity is paid under this part must be cleaned and disinfected under the supervision of an APHIS employee after removal of the swine from the known infected herd. Premises may be restocked with swine 30 days following an approved cleaning and disinfection, unless an official pseudorabies epidemiologist determines that a shorter or longer period of time is adequate or necessary to protect new animals against infection. The owner to whom the indemnity is paid will be responsible for expenses incurred in connection with the cleaning
7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
For non-applicability of part 53 with respect to certain claims for indemnity, see § 51.10 of this chapter.
(2) Any H5 or H7 virus that does not meet the criteria in paragraph (1) of this definition, but has an amino acid sequence at the hemagglutinin cleavage site that is compatible with highly pathogenic avian influenza viruses; or
(3) Any influenza virus that is not an H5 or H7 subtype and that kills one to five chickens and grows in cell culture in the absence of trypsin.
(a) The Administrator is hereby authorized to invite the proper State authorities to cooperate with the Department in the control and eradication of any disease within the meaning of § 53.1.
(b) Upon agreement of the authorities of the State to enforce quarantine restrictions and orders and directives properly issued in the control and eradication of such a disease, the Administrator is hereby authorized to agree, on the part of the Department, to cooperate with the State in the control and eradication of the disease, and, except as provided in § 53.11, to pay 50 percent (and in the case of exotic Newcastle disease or highly pathogenic avian influenza, up to 100 percent, and in the case of infectious salmon anemia, up to 60 percent) of the expenses of purchase, destruction and disposition of animals and materials required to be destroyed because of being contaminated by or exposed to such disease:
(a) Animals affected by or exposed to disease, and materials required to be destroyed because of being contaminated by or exposed to disease shall be appraised by an APHIS employee and a representative of the State jointly, or, if the State authorities approve, by an APHIS employee alone.
(b) The appraisal of animals shall be based on the fair market value and shall be determined by the meat, egg production, dairy or breeding value of such animals. Animals may be appraised in groups providing they are the same species and type and providing that where appraisal is by the head each animal in the group is the same value per head or where appraisal is by the pound each animal in the group is the same value per pound.
(c) Appraisals of animals shall be reported on forms furnished by APHIS. Reports of appraisals shall show the number of animals of each species and the value per head or the weight and value by pound.
(d) Appraisals of materials shall be reported on forms furnished by APHIS. Reports of appraisals of materials shall, when practicable, show the number, size or quantity, unit price, and
(a) Except as provided in paragraph (b) of this section, animals infected with or exposed to disease shall be killed promptly after appraisal and disposed of by burial or burning, unless otherwise specifically provided by the Administrator, at his or her discretion. In the case of animals depopulated due to spring viremia of carp or infectious salmon anemia, salvageable fish may be sold for rendering, processing, or any other purpose approved by the Administrator. The proceeds gained from the sale of the fish will be subtracted from any payment from APHIS for which the producer or owner is eligible under § 53.2(b) or § 53.11.
(b) [Reserved]
(c) The killing of animals and the burial, burning, or other disposal of carcasses of animals pursuant to the regulations in this part shall be supervised by an APHIS employee who shall prepare and transmit to the Administrator a report identifying the animals and showing the disposition thereof.
(a) In order to prevent the spread of disease, materials contaminated by or exposed to disease shall be disinfected:
(b) The disinfection or destruction of materials under this section shall be under the supervision of an APHIS employee who shall prepare and transmit to the Administrator a certificate identifying all materials which are destroyed, showing the disposition thereof.
Animals of species not susceptible to the disease for which a quarantine has been established, but which have been exposed to the disease, shall be disinfected when necessary by such methods as the Administrator shall prescribe from time to time.
All premises, including barns, corrals, stockyards and pens, and all cars, vessels, aircraft, and other conveyances, and the materials thereon, shall be cleaned and disinfected under supervision of an APHIS employee whenever necessary for the control and eradication of disease. Expenses incurred in connection with such cleaning and disinfection shall be shared according to the agreement reached under § 53.2 with the State in which the work is done. In the case of low pathogenic avian influenza related to the 2002 disease situations in Virginia and Texas associated with the H5 or H7 virus, premises may not be restocked with poultry until at least 7 days following such cleaning and disinfection, unless the Administrator determines that a shorter or longer period of time is adequate or necessary to protect new poultry against infection.
(a) Claims for the following must be presented to APHIS, through the inspector in charge, on a form approved by the Administrator:
(1) Compensation for the value of animals;
(2) The cost of burial, burning, or other disposition of animals;
(3) The value of material destroyed; and
(4) The expenses of destruction.
(b) [Reserved]
When animals or materials have been destroyed pursuant to the requirements contained in this part, any claim for indemnity shall be presented on forms furnished by APHIS on which the owner of the animals or materials shall certify that the animals or materials covered thereby, are, or are not, subject to any mortgage as defined in this part. If the owner states there is a mortgage, forms furnished by APHIS shall be signed by the owner and by each person holding a mortgage on the animals or materials, consenting to the payment of any indemnity allowed to the person specified thereon.
(a) The Department will not allow claims arising under the terms of this part if the payee has not complied with all quarantine requirements.
(b) Expenses for the care and feeding of animals held for destruction will not be paid by the Department, unless the payment of such expense is specifically authorized or approved by the Administrator.
(c) The Department will not allow claims arising out of the destruction of animals or materials unless they shall have been appraised as prescribed in this part and the owners thereof shall have executed a written agreement to the appraisals.
(d) The Department will not allow claims arising out of the destruction of animals or materials which have been moved or handled by the owner thereof or its officer, employee, or agent, acting within the scope of his or its office, employment or agency, in violation of a law or regulation administered by the Secretary for the prevention of the introduction into or the dissemination within the United States of any communicable disease of livestock or poultry for which the animal or material was destroyed, or in violation of a law or regulation for the enforcement of which the Secretary enters or has entered into a cooperative agreement for the control and eradication of such disease.
(e) The Department will not allow claims arising out of the destruction of fish due to infectious salmon anemia (ISA) unless the claimants have agreed in writing to participate fully in the cooperative ISA control program administered by APHIS and the State of Maine. Participants in the ISA control program must:
(1) Establish and maintain a veterinary client-patient relationship with an APHIS accredited veterinarian and inform the ISA Program Veterinarian in writing of the name of their accredited veterinarian at the time the participant enrolls in the ISA program and within 15 days of any change in accredited veterinarians.
(2) Cooperate with and assist in periodic on-site disease surveillance, testing, and reporting activities for ISA, which will be conducted by their APHIS accredited veterinarian or a State or Federal official as directed by the ISA Program Veterinarian.
(3) Develop and implement biosecurity protocols for use at all participant-leased finfish sites and participant-operated vessels engaged in aquaculture operations throughout Maine. A copy of these protocols shall be submitted to the ISA Program Veterinarian at the time the participant enrolls in the ISA program and within 15 days of any change in the protocols.
(4) Develop, with the involvement of the participant's accredited veterinarian and the fish site health manager, a site-specific ISA action plan for the control and management of ISA. A copy of the action plan shall be submitted to APHIS for review at the time the participant enrolls in the ISA program and within 15 days of any change in the action plan.
(5) Participate in the State of Maine's integrated pest management (IPM) program for the control of sea lice on salmonids. A copy of the management plan developed by the participant for the State IPM program shall be submitted to APHIS for review at
(6) Submit to the ISA Program Veterinarian at the time the participant enrolls in the ISA program a complete and current fish inventory information for each participant-leased finfish site with site and cage identifiers. Fish inventory information must include the numbers, age, date of saltwater transfer, vaccination status, and previous therapeutant history for all fish in each participant-leased finfish site.
(7) Maintain, and make available to the ISA Program Veterinarian upon request, mortality data for each participant-leased finfish site and pen in production.
(8) Cooperate with and assist APHIS in the completion of biosecurity audits at all participant-leased finfish sites and participant-operated vessels involved in salmonid aquaculture.
(f) The Department will not allow claims arising out of the destruction of fish due to spring viremia of carp (SVC) unless the claimants have done the following:
(1) Depopulated all SVC-infected and SVC-exposed fish on their property under the supervision of USDA or State officials;
(2) Thoroughly cleaned and disinfected all affected sites and all affected equipment under the supervision of USDA or State officials;
(3) If an affected site is to be restocked after cleaning and disinfection, the claimant must have done the following:
(i) Restocked with fish certified free of SVC by an APHIS-approved laboratory or in accordance with the diagnostic procedures described in the Office of International des Epizooties Manual of Diagnostic Tests For Aquatic Animals;
(ii) Demonstrated that their water sources are from first-use spring water, spring water without fish, well water, ozone or ultraviolet treated surface water, or bore-hole water and are free of wild carp and any other SVC-susceptible species; and
(iii) Prevented the migration of wild carp and any other wild SVC-susceptible species into their farming establishment.
7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
(2) In the case of exposed or high-risk animals that are not known to be infected, either euthanized or disposed of by slaughter; or
(3) Moved to a quarantined research facility if the movement has been approved by the Administrator.
(2) Any animal born in a flock after a scrapie-positive animal was born into that flock or lambed in that flock, if born before that flock completes the requirements of a flock plan; or
(3) Any animal that was commingled with a scrapie-positive female animal during or up to 30 days after she lambed, kidded, or aborted, or while a visible vaginal discharge was present, or that was commingled with any other scrapie-positive female animal for 24 hours or more, including during activities such as shows and sales or while in marketing channels; or
(4) Any animal in a noncompliant flock.
(1) The flocks are enrolled as separate flocks in the SFCP; or
(2) A State or APHIS representative determines, based upon examination of flock records, that:
(i) There is no interchange of animals between the flocks;
(ii) The flocks never commingle and are kept at least 30 feet apart at all times or are separated by a solid wall through, over, or under which fluids cannot pass and through which contact cannot occur;
(iii) The flocks have separate flock records and identification;
(iv) The flocks have separate lambing facilities, including buildings and pastures, and a pasture or building used for lambing by one flock is not used by the other flock at any time; and
(v) The flocks do not share equipment without cleaning and disinfection in accordance with § 54.7(e). Additional guidance on acceptable means of cleaning and disinfection is also available in the Scrapie Flock Certification Program standards and the Scrapie Eradication Uniform Methods and Rules.
(1) The progeny of a scrapie-positive dam; or
(2) Born in the same flock during the same lambing season as progeny of a scrapie-positive dam, unless the progeny of the scrapie-positive dam are from separate contemporary lambing groups; or
(3) Born in the same flock during the same lambing season that a scrapie-positive animal was born, or during any subsequent lambing season, if born before that flock completes the requirements of a flock plan; or
(4) An exposed female sheep that has not tested QR, HR, or RR at codon 171 using an official genotype test.
(2) Any exposed flock whose owner fails to make animals available for testing within 60 days of notification, or as mutually agreed, or whose owner fails to submit required postmortem samples;
(3) Any flock whose owner has misrepresented, or who employs a person who has misrepresented, the scrapie status of an animal or any other information on a certificate, permit, owner statement, or other official document within the last 5 years; or
(4) Any flock whose owner or manager has moved, or who employs a person who has moved, an animal in violation of this chapter within the last 5 years.
(1) Histopathological examination of central nervous system (CNS) tissues from the animal for characteristic microscopic lesions of scrapie;
(2) The use of proteinase-resistant protein analysis methods including but not limited to immunohistochemistry and/or western blotting on CNS and/or peripheral tissue samples from a live or a dead animal for which a given method has been approved by the Administrator for use on that tissue;
(3) Bioassay;
(4) Scrapie associated fibrils (SAF) detected by electron microscopy; or
(5) Any other test method approved by the Administrator in accordance with § 54.10.
(1) A sheep or goat that exhibits any of the following possible signs of scrapie and that has been determined to be suspicious for scrapie by an accredited veterinarian or a State or APHIS representative: Weight loss despite retention of appetite; behavioral abnormalities; pruritus (itching); wool pulling; biting at legs or side; lip smacking; motor abnormalities such as incoordination, high stepping gait of forelimbs, bunny hop movement of rear legs, or swaying of back end; increased sensitivity to noise and sudden movement; tremor, “star gazing,” head pressing, recumbency, or other signs of neurological disease or chronic wasting.
(2) A sheep or goat that has tested positive for scrapie or for the proteinase resistant protein associated with scrapie on a live-animal screening test or any other test, unless the animal is designated a scrapie-positive animal.
(3) A sheep or goat that has tested inconclusive or suggestive on an official test for scrapie.
APHIS will execute cooperative agreements and/or memoranda of understanding with the animal health agency of any State in order to cooperatively administer the Scrapie Eradication Program and the Scrapie Flock Certification Program within that State. These agreements will describe the respective roles of APHIS and State personnel in implementing the Scrapie Eradication Program and the Scrapie Flock Certification Program. Each agreement may specify the financial, material, and personnel resources to be committed to these programs and other scrapie control measures by APHIS and the State; assign specific activities related to the control of scrapie within a State to APHIS or State personnel; establish schedules for APHIS representatives or State representatives to visit flocks; establish procedures for maintaining and sharing program records specified in this part, and specify other responsibilities of State representatives and APHIS representatives in support of the Scrapie Eradication Program and the Scrapie Flock Certification Program.
(a) Indemnity may be paid for an animal only after the owner of the animal has applied for indemnification and been approved in accordance with § 54.4. Indemnity may be paid only for the following:
(1) Destruction of high-risk animals;
(2) Destruction of animals based on an epidemiologic investigation, when the Administrator determines that the destruction of these animals will contribute to the eradication of scrapie;
(3) Destruction of live scrapie-positive animals;
(4) Destruction of animals that test positive on a live-animal screening test; and
(5) Destruction of suspect animals that are destroyed at the request of an APHIS representative.
(b) No indemnity will be paid for an animal if the owner of the animal fails to provide APHIS, within 30 days of request, animal registration certificates, sale and movement records, or other records requested in accordance with § 54.5. No indemnity will be paid until the premises, including all structures, holding facilities, conveyances, and materials contaminated because of occupation or use by the depopulated animals, have been properly cleaned and disinfected in accordance with § 54.7(e). Additional guidance on acceptable means of cleaning and disinfection is also available in the Scrapie Flock Certification Program standards and the Scrapie Eradication Uniform Methods and Rules. Premises or portions of premises may be exempted from the cleaning and disinfecting requirements if a designated scrapie epidemiologist determines, based on epidemiologic investigation, that cleaning and disinfection of such buildings, holding facilities, conveyances, or other materials on the premises will not significantly reduce the risk of the spread of scrapie, either because effective disinfection is not possible or because the normal operations on the premises prevent transmission of scrapie. No indemnity will be paid to an owner if the owner assembled or increased his flock for the purpose of collecting or increasing indemnity.
(a) Normally, an application for indemnification will be initiated by a State or APHIS representative who is working with the owner of a flock that has already been determined to be an infected flock or source flock, or that
(1) Name, address, and social security number of the flock owner;
(2) Number and breed(s) of animals in the flock, including a current inventory;
(3) Location of flock premises;
(4) Reasons the owner believes animals in his or her flock may be eligible for indemnification, including any diagnosis of scrapie made for animals in the flock; any signs of scrapie observed in the flock by the owner; and any movement of animals into the flock from flocks infected with or exposed to scrapie;
(5) A copy of the registration papers issued in the name of the owner for any registered animals in the flock (registration papers are not required for the payment of indemnity for animals that are not registered). If the registration papers are unavailable, the owner may choose to accept a lesser indemnity in accordance with § 54.6(b)(2) or the area veterinarian in charge may grant a 60-day extension or the Administrator may grant an extension longer than 60 days for the presentation of registration papers; and
(6) Signed release letters addressed to any sheep or goat registry associations that maintain records of the owner's sheep or goats requesting the associations to release to APHIS all records maintained by the association on sheep or goats currently or formerly owned by the applicant.
(b) APHIS will evaluate each application to determine whether the owner's flock contains animals eligible for indemnity in accordance with § 54.3.
Before any indemnity is paid to an owner, the owner must sign a written agreement with APHIS, certifying the following:
(a) The owner will make available for review upon request by a State or APHIS representative all bills of sale, pedigree registration certificates, and other records regarding movement of animals into and from the flock;
(b) If the owner maintains any flock after the payment of indemnity or acquires a new flock that is housed on the same premises within 5 years after the last high-risk or scrapie-positive animal is removed, the owner will maintain the flock in accordance with a post-exposure management and monitoring plan for 5 years;
(c) If the animal for which indemnity is paid is subject to any mortgage, the owner consents to the payment of the indemnity, up to the value of the mortgage, to the person(s) holding the mortgage;
(d) That the animal may be removed to a U.S. Department of Agriculture facility or a quarantined research facility, slaughtered, or euthanized and necropsied and tissues removed for diagnostic or other purposes.
(a) Indemnity paid for sheep in accordance with § 54.3 will be set based on the following price reports published by the Agricultural Marketing Service (AMS). If pricing information is unavailable from these markets during a given week or month or if the numbers of animals sold are too low to give an accurate market value, the preceding week or month's value will be used. The AMS reports from the most recent week or month prior to the date APHIS offers to pay an owner indemnity shall be used to calculate the indemnity for that owner's sheep:
(1) The weekly weighted average Choice/Prime slaughter lamb price per pound at Greeley, CO;
(2) The weekly weighted average Utility slaughter ewe price per pound at San Angelo, TX;
(3) The monthly weighted average commercial western ewe lamb replacement price per head;
(4) The monthly weighted average commercial western yearling ewe replacement price per head;
(5) The monthly weighted average commercial western running age ewe price per head.
(6) The monthly weighted average commercial western aged ewe price per head.
(b) For animals under 1 year of age, the basic indemnity shall equal the price per pound from paragraph (a)(1) of this section times the greater of 50 lbs or the actual weight of the animal; except that, for ewe lambs under 1 year of age, the indemnity shall equal the per-head price from paragraph (a)(3) of this section if that price is higher. For sexually intact sheep 8 years of age or older and castrated animals 1 year of age or older, the basic indemnity shall equal the price per pound from paragraph (a)(2) of this section times 150, based on an average weight of 150 lbs. For sexually intact sheep at least 1 year of age and under 2 years of age, the indemnity shall equal the greater of the price per head from paragraph (a)(4) of this section, or the price per pound from paragraph (a)(2) of this section times 150, based on an average weight of 150 lbs. For sexually intact sheep at least 2 years of age and under 6 years of age, the basic indemnity shall equal the greater of the price per head from paragraph (a)(5) of this section or the price per pound from paragraph (a)(2) of this section times 150, based on an average weight of 150 lbs. For sexually intact sheep at least 6 years of age and under 8 years of age, the basic indemnity will equal the greater of the price per head from paragraph (a)(6) of this section or the price per pound from paragraph (a)(2) of this section times 150, based on an average weight of 150 lbs. A premium shall be added to the basic indemnity for each registered animal, equal to $100 for each registered animal under 1 year of age, $200 for each registered animal at least 1 year of age and under 4 years of age, and $100 for each registered animal at least 4 years of age and under 8 years of age. An additional premium of $50 will be added to the basic indemnity for each flock sire. The owner must provide adequate records to qualify for these premiums. When the animals to be indemnified are goats, or are sheep that fall outside the classes covered previously in this paragraph, the Administrator may take into consideration the producer's purchase records and sales records for the preceding 12 to 24 months in determining the indemnity amount, but the indemnity shall not exceed the maximum indemnity calculated for registered sheep in accordance with this section.
(1) If records and identification are inadequate to determine the actual age of animals, an APHIS or State representative will count all sexually intact animals that are apparently under 1 year of age, and those that are apparently at least 1 and under 2 years of age, based on examination of their teeth, and the indemnity for these animals will be calculated. The total number of these animals will be subtracted from the total number of sexually intact animals in the group to be indemnified, and indemnity for the remainder will be calculated based on the assumption that the remainder of the flock is 80 percent aged 2 to 6 years and 20 percent aged 6 to 8 years.
(2) Any animal that is not registered at the time indemnity is first offered, but is eligible to be registered, will receive the registered animal premium reduced by $50.
(c) For animals destroyed by slaughter, the owner will retain the salvage value (the amount paid by a slaughter plant for the animal) of the animals in lieu of receiving the base indemnity. If the salvage value, less transport costs, is less than the base indemnity, APHIS will pay the owner the difference. APHIS will also indemnify the owner in the amount of any registered animal or flock sire premiums for which the animal qualifies.
(d) If the owner disagrees with the average weight estimate, he may have the sheep weighed at a public scale at his own expense, provided that the sheep may not come in contact with other sheep or goats during movement to the public scales, and will be paid based on the actual weight times the AMS weekly average price.
(e) Indemnity will be paid to an owner only for animals actually in a flock at the time indemnity is first offered. Animals removed from the flock as part of a post-exposure management and monitoring plan will be paid indemnity based on the AMS average prices at the time an APHIS representative designates the animals for removal.
(a) Scrapie-positive and suspect animals for which indemnification is sought must be destroyed on the premises where they are held, pastured, or penned at the time indemnity is approved or moved to an approved research facility, unless the APHIS representative involved approves in advance of destruction moving the animals to another location for destruction. Animals that are not scrapie-positive or suspect animals for which indemnification is sought may be:
(1) Slaughtered when moved in accordance with part 79 of this chapter and with the prior written approval of the APHIS representative involved;
(2) Destroyed on the premises where they are held, pastured, or penned at the time indemnity is approved;
(3) Moved to an approved research facility; or
(4) Moved to another location for destruction if an APHIS representative approves the movement in advance.
(b) The carcasses of animals destroyed in accordance with this section are authorized by the Administrator to be buried, incinerated, or disposed of by other methods in accordance with local, State, and Federal laws. The carcasses of scrapie-positive and suspect animals may not be processed for human or animal food.
(c) The destruction of animals and disposition of their carcasses in accordance with this part must be monitored by an APHIS representative who will prepare and transmit to the Administrator a report identifying the animals and showing their disposition.
(d) APHIS may pay the reasonable costs of disposal for scrapie-positive and suspect animals that are indemnified. To obtain reimbursement for disposal costs, animal owners must obtain written approval of the disposal costs from APHIS, prior to disposal. The Administrator may also authorize payment of up to half the reasonable disposal costs for animals that are eligible to be destroyed by slaughter under this section but for which slaughter is not a practical or cost efficient means of disposal;
(e)
(1)
(2)
(i) Incinerate items by high-temperature incineration methods;
(ii) Autoclave instruments, small tools, and other items at 136 °C for 1 hour;
(iii) To clean dry surfaces, apply a 2-percent chlorine bleach solution at room temperature (at least 18.3 °C for 1 hour, or apply a 1-molar solution of sodium hydroxide (approximately 5 oz. of sodium hydroxide dissolved in l gallon water) at room temperature for at least 1 hour. Note: A 2-molar solution is more effective than a 1-molar solution and should be used when circumstances permit.
(a) The owner of the flock or his or her agent must identify all animals 1 year of age or over within the flock. All animals less than 1 year of age must be identified when a change of ownership occurs, with the exception of those animals under 1 year of age moving within slaughter channels that must be identified in accordance with §§ 79.2 and 79.3 of this chapter. The form of identification must be an electronic implant, flank tattoo, ear tattoo, or tamper-resistant ear tag approved for this use by APHIS. In the case of goats, the form of identification may alternatively be a tail fold tattoo. The official identification must provide a unique identification number that is applied by the owner of the flock or his or her agent and must be linked to that flock in the National Scrapie Database.
(b) Upon request by a State or APHIS representative, the owner of the flock or his or her agent must have an accredited veterinarian collect tissues from animals for scrapie diagnostic purposes and submit them to a laboratory designated by a State or APHIS representative.
(c) Upon request by a State or APHIS representative, the owner of the flock or his or her agent must make animals in the flock and the records required to be kept as a part of these plans available for inspection.
(d) The owner of the flock or his or her agent must meet requirements found necessary by a State or APHIS representative to monitor for scrapie and to prevent the recurrence of scrapie in the flock and to prevent the spread of scrapie from the flock. These other requirements may include, but are not limited to: Utilization of a live-animal screening test; restrictions on the animals that may be moved from the flock; segregated lambing; cleaning and disinfection of lambing facilities; and/or education of the owner of the flock and personnel working with the flock in techniques to recognize clinical signs of scrapie and to control the spread of scrapie.
(e) The owner of the flock or his or her agent must immediately report the following animals to a State representative, APHIS representative, or an accredited veterinarian, and not remove them from a flock without written permission of a State or APHIS representative:
(1) Any sheep or goat exhibiting weight loss despite retention of appetite; behavioral abnormalities; pruritus (itching); wool pulling; biting at legs or side; lip smacking; motor abnormalities such as incoordination, high stepping gait of forelimbs, bunny hop movement of rear legs, swaying of back end; increased sensitivity to noise and sudden movement; tremor, “star gazing,” head pressing, recumbency, or other signs of neurological disease or chronic wasting illness; and
(2) Any sheep or goat in the flock that has tested positive for scrapie or for the proteinase resistant protein associated with scrapie on a live-animal screening test or any other test.
(f)
(2) The premises of a flock under a flock plan must be cleaned and disinfected in accordance with § 54.7(e). Additional guidance on acceptable means of cleaning and disinfection is also available in the Scrapie Flock Certification Program standards and the Scrapie Eradication Uniform Methods and Rules. Premises or portions of premises may be exempted from the cleaning and disinfecting requirements if a designated scrapie epidemiologist
(3) The owner of the flock, or his or her agent, must request breed associations and registries, livestock markets, and packers to disclose records to APHIS representatives or State representatives, to be used to identify source flocks and trace exposed animals, including high-risk animals; and
(4) The flock owner must agree to conduct post-exposure management and monitoring.
(g)
(1) Any identifying marks or tags present on the animal, including the animal's individual official identification number from its electronic implant, flank tattoo, ear tattoo, tamper resistant ear tag, or, in the case of goats, tail fold tattoo, and any secondary form of identification the owner of the flock may choose to maintain;
(2) Sex, year of birth, breed, and when possible to determine, the following: sire, dam, and offspring of the animal;
(3) Date of acquisition and previous flock, if the animal was not born in the flock; and
(4) Disposition of the animal, including the date and cause of death, if known, or date of removal from the flock and name and address of the person to whom the animal was transferred.
(h)
(1) That a State or APHIS representative inspect the flock and flock records at least once every 12 months;
(2) The testing of animals at a level that will result in 99 percent confidence of detecting a 1 percent prevalence in the flock (for flock plans only);
(3) The official identification of all animals upon leaving the premises of the flock for purposes other than slaughter and of all animals over 18 months of age (as evidenced by the eruption of the second incisor) in slaughter channels; and
(4) Recordkeeping including:
(i) For acquired animals, the date of acquisition, name and address of the person from whom the animal was acquired, any identifying marks or tags present on the animal including the animal's individual official identification number from its electronic implant, flank tattoo, ear tattoo, tamper resistant ear tag, or, in the case of goats, tail fold tattoo, and any secondary form of identification the owner of the flock may choose to maintain.
(ii) For animals leaving the premises of the flock, the disposition of the animal, including, for those animals that are required to be identified, any identifying marks or tags present on the animal, including the animal's individual official identification number from its electronic implant, flank tattoo, ear tattoo, tamper resistant ear tag, or, in the case of goats, a tail fold tattoo, and any secondary form of identification the owner of the flock may choose to maintain, the date and cause of death, if known, or date of removal from the flock and name and address of the person to whom the animal was transferred.
(iii) Maintenance of these records for 5 years.
(5) Requirements equivalent to those contained in paragraphs (b), (c), (d), and (e) of this section.
(i)
The Administrator may waive the following requirements of this part for participants in a scrapie control pilot project by recording the requirements waived in the scrapie control pilot project plan:
(a) The determination that an animal is a high-risk animal, if the scrapie control pilot project plan contains testing or other procedures that indicate that an animal, despite meeting the definition of high-risk animal, is unlikely to spread scrapie; and
(b) The requirement that high-risk animals must be removed from a flock if the scrapie control pilot project plan contains alternative procedures to prevent the further spread of scrapie without removing high-risk animals from the flock.
(a) The Administrator may approve new tests for the diagnosis of scrapie conducted on live or dead animals for use in the Scrapie Eradication Program. The Administrator will base the approval or disapproval of a test on the evaluation by APHIS and, when appropriate, outside scientists, of:
(1) A standardized test protocol that must include a description of the test, a description of the reagents, materials, and equipment used for the test, the test methodology, and any control or quality assurance procedures;
(2) Data to support reproducibility, that is, the ability to reproduce the same result repeatedly on a given sample;
(3) Data to support suitability, that is, data to show that similar results can be produced when the test is run at other laboratories;
(4) Data to support the sensitivity and specificity of the test; and
(5) Any other data requested by the Administrator to determine the suitability of the test for program use.
(b) To be approved, a scrapie test must be able to be replicated at the National Veterinary Services Laboratories, or another reliable, timely, and cost effective method of check testing must be available to APHIS.
(c) A test or combination of tests may be approved for the identification of suspect animals, for the identification of scrapie-positive animals, or for other purposes such as flock certification. For a test to be approved for the identification of scrapie-positive animals, the test must have a specificity comparable to the specificity of the currently approved tests. For a test to be approved as a live animal screening test for the identification of suspect animals, the test must be usually reliable but need not be definitive for diagnosing scrapie.
(d) Specific guidelines for use of approved scrapie tests within the Scrapie Eradication Program or Scrapie Flock Certification Program will be added to this part as tests are approved and will also be contained in the Scrapie Eradication UM&R and the Scrapie Flock Certification Program standards based on the characteristics of the test, including specificity, sensitivity, and predictive value.
(e) If an owner elects to have an unofficial test conducted on an animal for scrapie, or for the proteinase resistant protein associated with scrapie, and that animal tests positive to such a test, the animal will be designated a suspect animal, unless:
(1) The test was run as part of a bona fide research protocol designed to evaluate an unapproved test in which the owner is not informed of the test result; or
(2) The test protocol includes appropriate measures to prevent the spread of scrapie.
(a) State, Federal, and university laboratories, or in the case of genotype tests, private laboratories will be approved by the Administrator when he or she determines that the laboratory:
(1) Employs personnel assigned to supervise the testing who are qualified to conduct the test based on education, training, and experience and who have been trained by the National Veterinary Services Laboratories (NVSL) or who have completed equivalent training approved by NVSL;
(2) Has adequate facilities and equipment to conduct the test;
(3) Follows standard test protocols;
(4) Meets check test proficiency requirements;
(5) Meets recordkeeping requirements;
(6) Will retain records, slides, blocks, and other specimens from all cases for at least 1 year and from positive cases for 5 years;
(7) Will allow APHIS to inspect the laboratory without notice during normal business hours; and
(8) Will report all test results to State and Federal animal health officials within agreed timeframes. An inspection may include, but is not limited to, review and copying of records, examination of slides, observation of the test being conducted, and interviewing of personnel.
(b) A laboratory may request approval to conduct one or more types of scrapie test or genotype test on one or more types of tissue. To be approved, a laboratory must meet the requirements in paragraph (a) of this section for each type of test and for each type of tissue for which they request approval.
(c) The Administrator may withdraw approval of any laboratory for failure to meet any of the conditions required by paragraph (a) of this section. The Administrator shall give written notice of the proposed withdrawal to the director of the laboratory and shall give the director an opportunity to respond. If there are conflicts as to any material fact concerning the reason for withdrawal, a hearing will be held to resolve the conflicts.
The Scrapie Flock Certification Program is a cooperative effort between APHIS; members of the sheep and goat industry, including owners of flocks, slaughtering and rendering establishments, and breed associations and registries; accredited veterinarians; and State governments. APHIS coordinates with State scrapie certification boards and State animal health agencies to encourage flock owners to certify their flocks as free of scrapie by being in continuous compliance with the Scrapie Flock Certification Program standards.
Any owner of a sheep or goat flock may apply to enter the Scrapie Flock Certification Program by sending a written request to a State scrapie certification board or to the area veterinarian in charge. A notice containing a current list of flocks participating in the Scrapie Flock Certification Program, and the certification status of each flock, may be obtained from the APHIS web site at URL
An area veterinarian in charge, after consulting with a State representative and industry representatives, may appoint a State scrapie certification board for the purpose of coordinating activities for the Scrapie Flock Certification Program, including making decisions to admit flocks to the Scrapie Flock Certification Program and to change flock status in accordance with the Scrapie Flock Certification Program standards. These boards are not appointed for the purpose of providing APHIS with consensus advice or policy recommendations. No more than one State scrapie certification board may be formed in each State. Each State scrapie certification board shall include as members the area veterinarian
21 U.S.C. 111-113, 114, 114a, 114a-1, 120, 121, 125, and 134b; 7 CFR 2.22, 2.80, and 371.4.
At 71 FR 41701, July 21, 2006, the authority citation for part 55 was revised, effective Oct. 19, 2006. At 71 FR 52983, Sept. 8, 2006, the effective date was delayed until further notice. For the convenience of the user, the revised text is set forth as follows:
7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
(1) Under common ownership or supervision and are grouped on one or more parts of any single premises (lot, farm, or ranch) or
(2) All animals under common ownership or supervision on two or more premises which are geographically separated but on which animals have been interchanged or had direct or indirect contact with one another.
At 71 FR 41701, July 21, 2006, § 55.1 was amended by removing the definition of
(1) National Uniform Eartagging System.
(2) Animal identification number (AIN).
(3) Premises-based number system. The premises-based number system combines an official premises identification number (PIN), as defined in this section, with a producer's livestock production numbering system to provide a unique identification number. The PIN and the production number must both appear on the official tag.
(4) Any other numbering system approved by the Administrator for the identification of animals in commerce.
(1) The State's two-letter postal abbreviation followed by the premises' assigned number; or
(2) A seven-character alphanumeric code, with the right-most character being a check digit. The check digit number is based upon the ISO 7064 Mod 36/37 check digit algorithm.
The Administrator is authorized to pay for the purchase and destruction of CWD positive animals, CWD exposed animals, and CWD suspect animals. Subject to available funding, the amount of the Federal payment for any such animals will be 95 percent of the appraised value established in accordance with § 55.3 of this part, but the Federal payment shall not exceed $3,000 per animal. If a non-Federal source makes a payment for an animal for which a Federal indemnity is paid, and the non-Federal payment exceeds 5 percent of the appraised value established in accordance with § 55.3 of this part, the amount of the Federal payment for any such animals will be reduced by the amount by which the non-Federal payment exceeds 5 percent of the appraised value. The Administrator is also authorized to reimburse State governments or State animal health agencies for payments they make for the purchase and destruction, on or after October 1, 2001, of CWD positive animals, CWD exposed animals, and CWD suspect animals, and for State expenditures for associated carcass disposal and cleaning and disinfection costs resulting from such purchase and destruction, in accordance with cooperative agreements signed by the Administrator and the duly authorized agent of the State.
(a) CWD positive herds, or individual CWD suspect animals or exposed animals removed by APHIS from a herd for testing, will be appraised by an APHIS official appraiser and a State official appraiser jointly, or, if APHIS and State authorities agree, by either a State official appraiser or an APHIS official appraiser alone.
(b) The appraisal of cervids will be the fair market value as determined by the meat or breeding value of the animals. Animals may be appraised in groups, provided that where appraisal is by the head, each animal in the group is the same value per head, and where appraisal is by the pound, each animal in the group is the same value per pound.
(c) Appraisals of cervids must be reported on forms furnished by APHIS and signed by the appraisers, and signed by the owner of the cervids to indicate agreement with the appraisal amount. Reports of appraisals must show the number of cervids and the value per head or the weight and value by pound.
(d) In accordance with instructions from an APHIS employee, cervids for which indemnification is sought must be:
(1) Destroyed on the premises where they are held, pastured, or penned at the time indemnity is approved;
(2) Moved to another location for destruction under conditions specified by the APHIS employee; or
(3) Moved to an approved research facility under conditions specified by the APHIS employee.
(e) The carcasses of any cervids destroyed in accordance with this part are authorized by the Administrator to be incinerated, destroyed in an alkaline hydrolysis tissue digestor, or disposed of by any other method authorized by an APHIS employee and in accordance with local, State, and Federal laws. APHIS will pay the reasonable costs of destruction and carcass disposal for animals that are indemnified. To obtain reimbursement for disposal costs, animal owners must obtain written approval of the disposal costs from APHIS, prior to disposal. Except in cases where APHIS or a State directly arranges for disposal, the owner of the animals must present an APHIS employee with a written contract or estimate of disposal costs. Prior to receiving reimbursement, the owner must also present an APHIS employee with a copy of either a receipt for expenses paid by the owner or a bill for services rendered to the owner. Any bill for services rendered presented by the owner must not be greater than the normal fee for similar services provided by commercial entities. The carcasses of cervids destroyed in accordance with this section may not be sold to be processed for human or animal food, including dietary supplements.
After cervids are destroyed in accordance with this part, all premises, including barns, stockyards and pens, all cars and other conveyances, and all other materials on any premises or conveyances used to house or transport such cervids must be cleaned and disinfected under the supervision of an APHIS employee or a State representative, using methods specified by the APHIS employee or a State representative. Premises may not be restocked with cervids until after the date specified in the herd plan required by § 55.7(b) of this part. The owner to whom the indemnity is paid will be responsible for expenses incurred in connection with the cleaning and disinfection, except that APHIS or a State will pay for cleaning and disinfection of the conveyances used to transport the cervids to the location of disposal. However, APHIS may also decide to pay the cost of cleaning and disinfecting premises when the procedures needed to conduct effective cleaning and disinfection are unusually extensive and require methods that are not normally available on a premises. For example, normal procedures would include washing surfaces with high-pressure hoses and disinfectants and burying or burning contaminated materials. Unusually extensive procedures would include disposing of contaminated materials by digestive disposal or high-temperature incineration.
Claims for indemnity for the value of animals destroyed must be documented on a form furnished by APHIS and presented to an APHIS employee or a State representative authorized to accept the claims.
When cervids have been destroyed under this part, any claim for indemnity must be presented on forms furnished by APHIS. The owner of the cervids must certify on the forms that the cervids covered are, or are not, subject to any mortgage as defined in this part. If the owner states there is a mortgage, the owner and each person holding a mortgage on the cervids must sign, consenting to the payment of indemnity to the person specified on the form.
(a) The Department will not allow claims arising out of the destruction of cervids unless the cervids have been appraised as prescribed in this part and the owners have signed the appraisal form indicating agreement with the appraisal amount as required by § 55.3(c) of this part.
(b) The Department will not allow claims arising out of the destruction of cervids unless the owners have signed a written agreement with APHIS in which they agree that if they maintain cervids in the future on the premises used for cervids for which indemnity is paid, they will maintain the cervids in accordance with a herd plan and will not introduce cervids onto the premises until after the date specified in that herd plan. Persons who violate this written agreement may be subject to civil and criminal penalties.
(c) The Department will not allow claims arising out of the destruction of cervids that have been moved or handled by the owner or a representative of the owner in violation of a law or regulation administered by the Secretary regarding animal disease, or in violation of a law or regulation for which the Secretary has entered into a cooperative agreement.
(a) An official CWD test is:
(1) Histopathological examination of central nervous system (CNS) tissues from the animal for characteristic microscopic lesions of CWD, using test protocols provided by the National Veterinary Services Laboratories (NVSL);
(2) The use of proteinase-resistant protein analysis methods including but not limited to immunohistochemistry and/or western blotting on CNS and/or peripheral tissue samples from a live or a dead animal, using test protocols provided by NVSL; or
(3) Any other test method approved by the Administrator in accordance with this section.
(b) The Administrator may approve new tests for the diagnosis of CWD conducted on live or dead animals, and will base the approval or disapproval of a test on the evaluation by APHIS and, when appropriate, outside scientists, of:
(1) A standardized test protocol that must include a description of the test, a description of the reagents, materials, and equipment used for the test, the test methodology, and any control or quality assurance procedures;
(2) Data to support reproducibility, that is, the ability to reproduce the same result repeatedly on a given sample;
(3) Data to support suitability, that is, data to show that similar results can be produced when the test is run at other laboratories;
(4) Data to support the sensitivity and specificity of the test; and
(5) Any other data requested by the Administrator to determine the suitability of the test for program use.
(c) Specific protocols for official CWD tests are available upon request to NVSL.
(d) State, Federal, and university laboratories will be approved by the Administrator to conduct official CWD
(1) Employs personnel assigned to supervise the testing who are qualified to conduct the test based on education, training, and experience and who have been trained by NVSL or who have completed equivalent training approved by NVSL;
(2) Has adequate facilities and equipment to conduct the test;
(3) Follows standard test protocols;
(4) Meets check test proficiency requirements;
(5) Meets recordkeeping requirements;
(6) Will retain records, slides, blocks, and other specimens from all cases for at least 1 year and from positive cases for 5 years;
(7) Will allow APHIS to inspect
(8) Will report all test results to State and Federal animal health officials within agreed timeframes.
(e) The Administrator may withdraw approval of any laboratory for failure to meet any of the conditions required by paragraph (d) of this section. The Administrator shall give written notice of the proposed withdrawal to the director of the laboratory and shall give the director an opportunity to respond. If there are conflicts as to any material fact concerning the reason for withdrawal, a hearing will be held to resolve the conflicts. The hearing will be conducted in accordance with rules of practice that will be adopted by the Administrator for the proceeding.
At 71 FR 41702, July 21, 2006, subpart B was added to part 55, effective Oct. 19, 2006. At 71 FR 52983, Sept. 8, 2006, the effective date was delayed until further notice.
The CWD Herd Certification Program is a cooperative effort between APHIS, State animal health and wildlife agencies, and deer, elk, and moose owners. APHIS coordinates with these State agencies to encourage deer, elk, and moose owners to certify their herds as low risk for CWD by being in continuous compliance with the CWD Herd Certification Program standards.
(a)
(1)
(i) For herds already participating in State CWD programs, the enrollment
(ii) For herds that enroll directly in the Federal CWD Herd Certification Program, which is allowed only when there is no Approved State CWD Herd Certification Program in their State, the enrollment date will be the earlier of:
(A) The date APHIS approves enrollment; or
(B) If APHIS determines that the herd owner has maintained the herd in a manner that substantially meets the conditions specified in § 55.23(b) for herd owners, the first day that the herd participated in such a program. However, in such cases the enrollment date may not be set at a date more than 2 years prior to the date that APHIS approved enrollment of the herd. This type of constructed enrollment date will be unavailable for herds that apply to enroll after October 19, 2007, and herds that apply to enroll after that date will have an enrollment date of the date APHIS approves the herd participation.
(iii) For new herds that were formed from and contain only animals from herds enrolled in the CWD Herd Certification Program, the enrollment date will be the latest enrollment date for any source herd for the animals.
(2) [Reserved]
(b)
(a)
(1) Has the authority, based on State law or regulation, to restrict the intrastate movement of all CWD-positive, CWD-suspect, and CWD-exposed animals.
(2) Has the authority, based on State law or regulation, to require the prompt reporting of any animal suspected of having CWD and test results for any animals tested for CWD to State or Federal animal health authorities.
(3) Has, in cooperation with APHIS personnel, drafted and signed a memorandum of understanding with APHIS that delineates the respective roles of the State and APHIS in CWD Herd Certification Program implementation.
(4) Has placed all known CWD-positive, CWD-exposed, and CWD-suspect animals and herds under movement restrictions, with movement of animals from them only for destruction or under permit.
(5) Has effectively implemented policies to:
(i) Promptly investigate all animals reported as CWD-suspect animals;
(ii) Designate herds as CWD-positive, CWD-exposed, or CWD-suspect and
(iii) Remove herd movement restrictions only after completion of a herd plan agreed upon by the State representative, APHIS, and the owner;
(iv) Conduct an epidemiologic investigation of CWD-positive, CWD-exposed, and CWD-suspect herds that includes the designation of suspect and exposed animals and that identifies animals to be traced;
(v) Conduct tracebacks of CWD-positive animals and traceouts of CWD-exposed animals and report any out-of-State traces to the appropriate State promptly after receipt of notification of a CWD-positive animal; and
(vi) Conduct tracebacks based on slaughter or other sampling promptly after receipt of notification of a CWD-positive animal at slaughter.
(6) Effectively monitors and enforces State quarantines and State reporting laws and regulations for CWD.
(7) Has designated at least one State animal health official, or has worked with APHIS to designate an APHIS official, to coordinate CWD Herd Certification Program activities in the State.
(8) Has programs to educate those engaged in the interstate movement of deer, elk, and moose regarding the identification and recordkeeping requirements of this part.
(9) Requires, based on State law or regulation, and effectively enforces identification of all animals in herds participating in the CWD Herd Certification Program;
(10) Maintains in the CWD National Database administered by APHIS, or in a State database approved by the Administrator as compatible with the CWD National Database, the State's:
(i) Premises information and assigned premises numbers;
(ii) Individual animal information on all deer, elk, and moose in herds participating in the CWD Herd Certification Program in the State;
(iii) Individual animal information on all out-of-State deer, elk, and moose to be traced; and
(iv) Accurate herd status data.
(11) Requires that tissues from all CWD-exposed or CWD-suspect animals that die or are depopulated or otherwise killed be submitted to a laboratory authorized by the Administrator to conduct official CWD tests and requires appropriate disposal of the carcasses of CWD-positive, CWD-exposed, and CWD-suspect animals.
(b)
(1) Each animal in the herd must be identified using means of animal identification specified in § 55.25 of this subpart. All animals in an enrolled herd must be identified before reaching 12 months of age. In addition, all animals of any age in an enrolled herd must be identified before being moved from the herd premises. In addition, all animals in an enrolled herd must be identified before the inventory required under paragraph (b)(4) of this section, and animals found to be in violation of this requirement during the inventory must be identified during or after the inventory on a schedule specified by the APHIS employee or State representative conducting the inventory;
(2) The herd premises must have perimeter fencing adequate to prevent ingress or egress of cervids. This fencing must also comply with any applicable State regulations;
(3) The owner must immediately report to an APHIS employee or State representative all animals that escape or disappear, and all deaths (including animals killed on premises maintained for hunting and animals sent to slaughter) of deer, elk, and moose in the herd aged 12 months or older;
(4) The owner must maintain herd records that include a complete inventory of animals that states the age and sex of each animal, the date of acquisition and source of each animal that was not born into the herd, the date of disposal and destination of any animal removed from the herd, and all individual identification numbers (from tags, tattoos, electronic implants, etc.) associated with each animal. Upon request, the owner must allow an APHIS employee or State representative access to the premises and herd to conduct an annual physical herd inventory with verification reconciling animals and identifications with the records maintained by the owner. The owner must present the entire herd for inspection under conditions where the APHIS employee or State representative can safely read all identification on the animals. The owner will be responsible for assembling, handling and restraining the animals and for all costs incurred to present the animals for inspection;
(5) If an owner wishes to maintain separate herds, he or she must maintain separate herd inventories, records, working facilities, water sources, equipment, and land use. There must be a buffer zone of at least 30 feet between the perimeter fencing around separate herds, and no commingling of animals may occur. Movement of animals between herds must be recorded as if they were separately owned herds;
(6) New animals may be introduced into the herd only from other herds enrolled in the CWD Herd Certification Program. If animals are received from an enrolled herd with a lower program status, the receiving herd will revert to that lower program status. If animals are obtained from a herd not participating in the program, then the receiving herd will be required to start over in the program.
(a)
(b)
(2) If a herd is designated a CWD-suspect herd, a trace back herd, or a trace forward herd, it will immediately be placed in Suspended status pending an epidemiologic investigation by APHIS or a State animal health agency. If the epidemiologic investigation determines that the herd was not commingled with a CWD-positive animal, the herd will be reinstated to its former program status, and the time spent in Suspended status will count toward its promotion to the next herd status level.
(i) If the epidemiologic investigation determines that the herd was commingled with a CWD-positive animal, the herd will lose its program status and will be designated a CWD-exposed herd.
(ii) If the epidemiological investigation is unable to make a determination regarding the exposure of the herd, because the necessary animal or animals are no longer available for testing (i.e. a trace animal from a known positive herd died and was not tested) or for other reasons, the herd status will continue as Suspended unless and until a herd plan is developed for the herd. If a herd plan is developed and implemented, the herd will be reinstated to its former program status, and the time spent in Suspended status will count toward its promotion to the next herd status level;
(3) If an APHIS or State representative determines that animals from a herd enrolled in the program have commingled with animals from a herd with a lower program status, the herd with the higher program status will be reduced to the status of the herd with which its animals commingled.
(c)
(1) Herd owners may appeal cancellation of enrollment or loss or suspension of herd status by writing to the Administrator within 10 days after being informed of the reasons for the proposed action. The appeal must include all of the facts and reasons upon which the herd owner relies to show that the reasons for the proposed action are incorrect or do not support the action. The Administrator will grant or deny the appeal in writing as promptly as circumstances permit, stating the reason for his or her decision. If there is a conflict as to any material fact, a hearing will be held to resolve the conflict. Rules of practice concerning the hearing will be adopted by the Administrator. However, cancellation of enrollment or loss or suspension of herd status shall become effective pending final determination in the proceeding if the Administrator determines that such action is necessary to prevent the possible spread of CWD. Such action shall become effective upon oral or written notification, whichever is earlier, to the herd owner. In the event of oral notification, written confirmation shall be given as promptly as circumstances allow. This cancellation of enrollment or loss or suspension of herd status shall continue in effect pending the completion of the proceeding, and any judicial review thereof, unless otherwise ordered by the Administrator.
(2) [Reserved]
(d)
Each animal required to be identified by this subpart must have at least two forms of animal identification attached to the animal. The means of animal identification must be approved for this use by APHIS, and must be an electronic implant, flank tattoo, ear tattoo, tamper-resistant ear tag, or other device approved by APHIS. One of the animal identifications must be official animal identification as defined in this part, with a nationally unique animal identification number that is linked to that animal in the CWD National Database. The second animal identification must be unique for the individual animal within the herd and also must be linked to that animal and herd in the CWD National Database.
7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
(1) H5/H7 LPAI virus has been isolated and identified as such from poultry; or
(2) Viral antigen or viral RNA specific to the H5 or H7 subtype of AI virus has been detected in poultry; or
(3) Antibodies to the H5 or H7 subtype of the AI virus that are not a consequence of vaccination have been detected in poultry. If vaccine is used, methods should be used to distinguish vaccinated birds from birds that are both vaccinated and infected. In the case of isolated serological positive results, H5/H7 LPAI infection may be ruled out on the basis of a thorough epidemiological investigation that does not demonstrate further evidence of H5/H7 LPAI infection.
(a) The Administrator has been delegated the authority to cooperate with Cooperating State Agencies in the eradication of H5/H7 LPAI. This cooperation may include, but is not necessarily limited to, the following activities:
(1) Payment to Cooperating State Agencies for surveillance and monitoring associated with poultry that
(2) Transfer of vaccine for H5/H7 LPAI to Cooperating State Agencies if provided for in the initial State response and containment plan developed by the Official State Agency and approved by APHIS under § 56.10; and
(3) Payment for vaccine administration by Cooperating State Agencies, if provided for in the initial State response and containment plan developed by the Official State Agency and approved by APHIS under § 56.10
(b)(1) Any payment made to a State or an Official State Agency for the activities listed in paragraphs (a)(1) and (a)(3) of this section must be made through a cooperative agreement between the Cooperating State Agency and APHIS. The payment for which the Cooperating State Agency is eligible will be determined in the cooperative agreement.
(i) For any Cooperating State Agency that participates in the National Poultry Improvement Plan diagnostic surveillance program for H5/H7 LPAI, as described in § 146.14 of this chapter, and has an initial State response and containment plan for H5/H7 LPAI that is approved by APHIS, as described in § 56.10 of this part, the cooperative agreement will provide that the Cooperating State Agency is eligible for payment of 100 percent of the costs of surveillance and monitoring and 100 percent of the costs of vaccine administration, as determined in the cooperative agreement.
(ii) For any Cooperating State Agency that does not meet the criteria in paragraph (b)(1)(i) of this section, the cooperative agreement will provide that the Cooperating State Agency is eligible for payment of 25 percent of the costs of surveillance and monitoring and 25 percent of the costs of vaccine administration, as determined in the cooperative agreement.
(2) Transfer of vaccine under paragraph (a)(2) of this section must be accomplished through a cooperative agreement between the Cooperating State Agency and APHIS.
(c) States will be responsible for making the determination to request Federal assistance under this part in the event of an outbreak of H5/H7 LPAI.
(a)
(1) Destruction and disposal of poultry that were infected with or exposed to H5/H7 LPAI;
(2) Destruction of any eggs destroyed during testing of poultry for H5/H7 LPAI during an outbreak of H5/H7 LPAI; and
(3) Cleaning and disinfection of premises, conveyances, and materials that came into contact with poultry that were infected with or exposed to H5/H7 LPAI; or, in the case of materials, if the cost of cleaning and disinfection would exceed the value of the materials or cleaning and disinfection would be impracticable for any reason, the destruction and disposal of the materials.
(b)
(1) The poultry are egg-type breeding chickens from a flock that participates in any Plan program in part 145 of this chapter but that does not participate in the U.S. Avian Influenza Clean program of the Plan in § 145.23(h) of this chapter; or
(2) The poultry are meat-type breeding chickens from a flock that participates in any Plan program in part 145 of this chapter but that does not participate in the U.S. Avian Influenza
(3) The poultry are breeding turkeys from a flock that participates in any Plan program in part 145 of this chapter but that does not participate in the U.S. H5/H7 Avian Influenza Clean program of the Plan in § 145.43(g) of this chapter; or
(4) The poultry are commercial table-egg layers from a premises that has 75,000 or more birds and that does not participate in the U.S. H5/H7 Avian Influenza Monitored program of the Plan in § 146.23(a) of this chapter; or
(5) The poultry are commercial meat-type chickens that are associated with a slaughter plant that slaughters 200,000 or more meat-type chickens per operating week and that does not participate in the U.S. H5/H7 Avian Influenza Monitored program of the Plan in § 146.33(a) of this chapter; or
(6) The poultry are commercial meat-type turkeys that are associated with a slaughter plant that slaughters 2 million or more meat-type turkeys in a 12-month period and that does not participate in the U.S. H5/H7 Avian Influenza Monitored program of the Plan in § 146.43(a) of this chapter; or
(7) The poultry are associated with a flock or slaughter plant that participates in the Plan, but they are located in a State that does not participate in the National Poultry Improvement Plan diagnostic surveillance program for H5/H7 LPAI, as described in § 146.14 of this chapter, or that does not have an initial State response and containment plan for H5/H7 LPAI that is approved by APHIS, unless such poultry participate in the Plan with another State that does participate in the National Poultry Improvement Plan diagnostic surveillance program for H5/H7 LPAI, as described in § 146.14 of this chapter, and has an initial State response and containment plan for H5/H7 LPAI that is approved by APHIS.
(c)
(a)
(2) Indemnity for disposal of poultry infected with or exposed to H5/H7 LPAI will be based on receipts or other documentation maintained by the claimant verifying expenditures for disposal activities authorized by this part. Any disposal of poultry infected with or exposed to H5/H7 LPAI for which compensation is requested must be performed under a compliance agreement between the claimant, the Cooperating State Agency, and APHIS. APHIS will review claims for compensation for disposal to ensure that all expenditures relate directly to activities described in § 56.5 and in the initial State response and containment plan described in § 56.10. If disposal is performed by the Cooperating State Agency, APHIS will indemnify the Cooperating State Agency for disposal under a cooperative agreement.
(3) The destruction and disposal of the indemnified poultry must be conducted in accordance with the initial State response and containment plan for H5/H7 LPAI, as described in § 56.10.
(b)
(c)
(2) In the case of materials, if the cost of cleaning and disinfection would exceed the value of the materials or cleaning and disinfection would be impracticable for any reason, indemnity for the destruction of the materials will be based on the fair market value of those materials, as determined by an appraisal. Materials will be appraised by an APHIS official appraiser and a State official appraiser jointly, or, if APHIS and State authorities agree, by either an APHIS official appraiser or a State official appraiser alone. Indemnity for disposal of the materials will be based on receipts or other documentation maintained by the claimant verifying expenditures for disposal activities authorized by this part. Any disposal of materials for which indemnity is requested must be performed under a compliance agreement between the claimant, the Cooperating State Agency, and APHIS. APHIS will review claims for compensation for disposal to ensure that all expenditures relate directly to activities described in § 56.5 and in the initial State response and containment plan described in § 56.10.
(a)
(1) The species, size, and number of the poultry to be destroyed;
(2) The environment in which the poultry are maintained;
(3) The risk to human health or safety of the method used;
(4) Whether the method requires specialized equipment or training;
(5) The risk that the method poses of spreading the H5/H7 LPAI virus;
(6) Any hazard the method could pose to the environment;
(7) The degree of bird control and restraint required to administer the destruction method; and
(8) The speed with which destruction must be conducted.
(b)
(c)
(i) Poultry infected with or exposed to H5/H7 LPAI must not be transported to a market for controlled marketing until 21 days after the acute phase of the infection has concluded, as determined by the Cooperating State Agency in accordance with the initial State response and containment plan described in § 56.10; and
(ii) Within 7 days prior to slaughter, each flock to be moved for controlled marketing must be tested for H5/H7 LPAI using a test approved by the Cooperating State Agency and found to be free of the virus.
(2) Poultry moved for controlled marketing will not be eligible for indemnity under § 56.3.
(d)
(1)
(i) Secure and remove all feathers that might blow around outside the house in which the infected or exposed poultry were held by raking them together and burning the pile;
(ii) Apply insecticides and rodenticides immediately after the removal of the birds, before the house cools;
(iii) Close the house in which the poultry were held, maintaining just enough ventilation to remove moisture. Leave the house undisturbed for a minimum of 21 days and for as long as possible thereafter, in order to allow as much H5/H7 LPAI virus as possible to die a natural death.
(iv) Heat the house to 100 °F for the 72 hours prior to cleaning and disinfection.
(2)
(i)
(ii)
(iii)
(vi)
(3)
(4)
Claims for the following must be documented on a form furnished by APHIS and presented to an APHIS employee or the State representative authorized to accept the claims:
(a) Compensation for the value of poultry to be destroyed due to infection with or exposure to H5/H7 LPAI;
(b) Compensation for the value of eggs to be destroyed during testing for H5/H7 LPAI; and
(c) Compensation for the cost of cleaning and disinfection of premises, conveyances, and materials that came into contact with poultry infected with or exposed to H5/H7 LPAI, or, in the
When poultry or eggs have been destroyed under this part, any claim for indemnity must be presented on forms furnished by APHIS. The owner of the poultry or eggs must certify on the forms that the poultry or eggs covered are, or are not, subject to any mortgage as defined in this part. If the owner states there is a mortgage, the owner and each person holding a mortgage on the poultry or eggs must sign the APHIS-furnished form, consenting to the payment of indemnity to the person specified on the form.
(a) When poultry or eggs have been destroyed pursuant to this part, the Administrator may pay claims to any party with which the owner of the poultry or eggs has entered into a contract for the growing or care of the poultry or eggs. The indemnity the Administrator may pay to such a party or parties shall be determined as follows:
(1) Divide the value of the contract the owner of the poultry or eggs entered into with another party for the growing and care of the poultry or eggs in dollars by the duration of the contract as it was signed prior to the H5/H7 LPAI outbreak in days;
(2) Multiply this figure by the time in days between the date the other party began to provide services relating to the destroyed poultry or eggs under the contract and the date the birds were destroyed due to H5/H7 LPAI.
(b)(1) If indemnity for the destroyed poultry or eggs is being provided for 100 percent of eligible costs under § 56.3(b), the Administrator may pay contractors eligible for compensation under this section 100 percent of the indemnity determined in paragraph (a) of this section.
(2) If indemnity for the destroyed poultry or eggs is being provided for 25 percent of eligible costs under § 56.3(b), the Administrator may pay contractors eligible for compensation under this section 25 percent of the indemnity determined in paragraph (a) of this section.
(c) If indemnity is paid to a contractor under this section, the owner of the poultry or eggs will be eligible to receive the difference between the indemnity paid to the growers and the total amount of indemnity that may be paid for the poultry or eggs.
(d) In the event that determination of indemnity to a party with which the owner of destroyed poultry or eggs has entered into a contract for the growing or care of the poultry or eggs using the method described in paragraph (a) of this section is determined to be impractical or inappropriate, APHIS may use any other method that the Administrator deems appropriate to make that determination.
(a) The Department will not allow claims arising out of the destruction of poultry unless the poultry have been appraised as prescribed in this part and the owners have signed the appraisal form indicating agreement with the appraisal amount as required by § 56.4(a)(1).
(b) The Department will not allow claims arising out of the destruction of poultry unless the owners have signed a written agreement with APHIS in which they agree that if they maintain poultry in the future on the premises used for poultry for which indemnity is paid, they will maintain the poultry in accordance with a plan set forth by the Cooperating State Agency and will not introduce poultry onto the premises until after the date specified by the Cooperating State Agency. Persons who do not maintain their poultry and premises in accordance with this written agreement will not be eligible to receive indemnity under this part.
(c) The Department will not allow claims arising out of the destruction of poultry unless the poultry have been moved or handled by the owner in accordance with an agreement for the control and eradication of H5/H7 LPAI and in accordance with part 56, for any progeny of any poultry unless the poultry have been moved or handled by the
(a) In order for poultry owners within a State to be eligible for indemnity for 100 percent of eligible costs under § 56.3(b), the State in which the poultry participate in the Plan must have in place an initial State response and containment plan that has been approved by APHIS. The initial State response and containment plan must be developed by the Official State Agency and administered by the Cooperating State Agency of the relevant State. This plan must include:
(1) Provisions for a standing emergency disease management committee, regular meetings, and exercises, including coordination with any tribal governments that may be affected;
(2) A minimum biosecurity plan followed by all poultry producers;
(3) Provisions for adequate diagnostic resources;
(4) Detailed, specific procedures for initial handling and investigation of suspected cases of H5/H7 LPAI;
(5) Detailed, specific procedures for reporting test results to APHIS. These procedures must be developed after appropriate consultation with poultry producers in the State and must provide for the reporting only of confirmed cases of H5/H7 LPAI in accordance with § 146.13 of this chapter;
(6) Detailed, strict quarantine measures for presumptive and confirmed index cases;
(7) Provisions for developing flock plans for infected and exposed flocks;
(8) Detailed plans for disposal of infected flocks, including preexisting agreements with regulatory agencies and detailed plans for carcass disposal, disposal sites, and resources for conducting disposal, and detailed plans for disposal of materials that come into contact with poultry infected with or exposed to H5/H7 LPAI;
(9) Detailed plans for cleaning and disinfection of premises, repopulation, and monitoring after repopulation;
(10) Provisions for appropriate control/monitoring zones, contact surveys, and movement restrictions;
(11) Provisions for monitoring activities in control zones;
(12) If vaccination is considered as an option, a written plan for use in place with proper controls and provisions for APHIS approval of any use of vaccine;
(13) Plans for H5/H7 LPAI-negative flocks that provide for quarantine, testing, and controlled marketing; and
(14) Public awareness and education programs regarding avian influenza.
(b) If a State is designated a U.S. Avian Influenza Monitored State, Layers under § 146.24(a) of this chapter or a U.S. Avian Influenza Monitored State, Turkeys under § 146.44(a) of this chapter, it will lose that status during any outbreak of H5/H7 LPAI and for 90 days after the destruction and disposal of all infected or exposed birds and cleaning and disinfection of all affected premises are completed.
7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
The Uniform Rules of Practice for the Department of Agriculture promulgated in subpart H of part 1, subtitle A, title 7, Code of Federal Regulations, are the Rules of Practice applicable to adjudicatory, administrative proceedings under the following statutory provisions:
(a) At any time prior to the issuance of a complaint seeking a civil penalty under any of the Acts listed in § 70.1, the Administrator, in his discretion, may enter into a stipulation with any person in which:
(1) The Administrator or the Administrator's delegate gives notice of an apparent violation of the Act, or the regulations issued thereunder, by such person and affords such person an opportunity for a hearing regarding the matter as provided by the Act;
(2) Such person expressly waives hearing and agrees to pay a specified penalty within a designated time; and
(3) The Administrator agrees to accept the penalty in settlement of the particular matter involved if the penalty is paid within the designated time.
(b) If the penalty is not paid within the time designated in such a stipulation, the amount of the stipulated penalty shall not be relevant in any respect to the penalty which may be assessed after issuance of a complaint.
7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
As used in this part, the following terms shall have the meanings set forth in this section.
(1) National Uniform Eartagging System.
(2) Animal identification number (AIN).
(3) Premises-based number system. The premises-based number system combines an official premises identification number (PIN), as defined in this section, with a producer's livestock production numbering system to provide a unique identification number. The PIN and the production number must both appear on the official tag.
(4) Any other numbering system approved by the Administrator for the identification of animals in commerce.
(1) The State's two-letter postal abbreviation followed by the premises' assigned number; or
(2) A seven-character alphanumeric code, with the right-most character being a check digit. The check digit number is based upon the ISO 7064 Mod 36/37 check digit algorithm.
The plan must identify all premises that are part of the swine production system and that receive or send swine in interstate commerce and must provide for health monitoring of all swine within the system. Such health monitoring must include inspections by the swine production system accredited veterinarian(s). Inspections of all identified premises that contain swine that are or will be in the process of moving interstate within the swine production system and of all swine on those premises must be conducted by the accredited veterinarian(s) at intervals of no greater than 30 days. Inspections of all identified receiving premises that contain only swine that have completed their interstate movement within a single swine production system and of all swine on those premises must be conducted in accordance with State regulations. The plan must also describe the recordkeeping system of the swine production system. The plan will not be valid unless it is signed by an official of each swine production system identified in the plan, the swine production system accredited veterinarian(s), an APHIS representative, and the State animal health official from each State in which the swine production system has premises. In the plan, the swine production system
When the Secretary of Agriculture shall determine the fact that poultry or other animals in any State, Territory, or the District of Columbia are affected with any contagious, infectious, or communicable disease of livestock or poultry for which, in his opinion, a quarantine should be established or that other basis for a quarantine exists, notice will be given of that fact, and a rule will be issued accordingly, placing in quarantine such State, Territory, or the District of Columbia, or specified portion thereof. This rule will either absolutely forbid the interstate movement of the quarantined animals from the quarantined area or will indicate the regulations under which interstate movements may be made.
(a) Animals or poultry affected with any of the following diseases, which are endemic to the United States: Equine piroplasmosis, bovine piroplasmosis or splenetic fever, scabies in cattle, pseudorabies, acute swine erysipelas, tuberculosis, Johne's disease, brucellosis, scrapie, bluetongue, anthrax, chlamydiosis, and Newcastle disease, or any other communicable disease which is endemic to the United States, or which are cattle fever tick infested, shall not be moved interstate.
(b) Animals or poultry affected with any of the following diseases, not known to exist in the United States: foot-and-mouth disease, rinderpest, African swine fever, classical swine fever, Teschen disease, contagious bovine pleuropneumonia, European fowl pest, dourine, contagious equine metritis, vesicular exanthema, screwworms and glanders, scabies in sheep or any other communicable foreign disease not known to exist in the United States, shall not be moved interstate.
(c) Notwithstanding the provisions of paragraphs (a) and (b) of this section:
(1) Domestic animals that have reacted to an official test for brucellosis, are not affected with any other disease referred to in this section, and are not tick infested may be moved interstate in accordance with part 78 of this chapter.
(2) Domestic animals that are positive to an official Johne's disease test, are not affected with any other disease referred to in this section, and are not
(3) Cattle which have reacted to the tuberculin test, which are not affected with any other disease referred to in this section and are not tick infested, may be moved interstate in accordance with the provisions of § 77.17 of this subchapter.
(4) Swine infected with or exposed to pseudorabies may be moved interstate in accordance with part 85 of this chapter.
(d) Notwithstanding the provisions of paragraphs (a) and (b) of this section, livestock which is found to be diseased may be moved interstate in accordance with paragraphs (d)(1) through (6) of this section:
(1) Livestock affected with one or more of the following diseases may be moved interstate for immediate slaughter to a slaughtering establishment where State or Federal meat inspection is maintained; Actinomycosis, actinobacillosis, anaplasmosis, atrophic rhinitis, contagious ecthyma, foot rot, infectious keratitis, ram epididymitis, ringworm, swine influenza, arthritis (simple lesions only), and shipping fever.
(2) Cattle with slight unopened cases of actinomycosis or actinobacillosis (or both) may be moved interstate to a feed lot in the State of destination:
(3) Sheep affected with or exposed to contagious ecthyma may be moved interstate to a feed lot located in a State the laws, rules, or regulations of which require that such sheep be segregated or quarantined under a permit from an official of such State:
(4) Livestock affected with one or more of the following diseases may be moved interstate for any purpose to a State the laws, rules, or regulations of which require that such livestock be segregated or quarantined under a permit from the appropriate livestock sanitary official of such State: actinomycosis, actinobacillosis, contagious ecthyma, foot rot, and shipping fever:
(5) Livestock affected with infectious keratitis or ringworm (or both) may be moved interstate for any purpose if treated under the supervision of an APHIS or State representative or an accredited veterinarian prior to movement:
(6) Fish affected with spring viremia of carp may be moved interstate only if they are being moved directly to a facility to be processed into food for human consumption.
(7)
(e) Notwithstanding the provisions of paragraphs (a) and (b) of this section, the Administrator in specific cases and under such conditions as he may prescribe to prevent the dissemination of disease may provide for the interstate
(f) Before offering cattle or other livestock or poultry for interstate transportation, transporting them interstate, or introducing them into any stockyards or upon routes of traffic for interstate transportation, all persons, companies, or corporations are required to exercise reasonable diligence to ascertain whether such animals or poultry are affected with any contagious, infectious, or communicable disease, or have been exposed to the contagion or infection of any such disease by contact with other animals or poultry so diseased or by location in pens, cars, or other vehicles, or upon premises that have contained animals or poultry so diseased.
For
(a) Yards, pens, chutes, alleys, and other facilities and premises which are used in connection with the interstate movement of livestock or poultry shall be maintained by the person in possession of the facilities and premises in a clean and sanitary condition, in accordance with good animal husbandry practices, and shall be subject to inspection by an APHIS or State representative. When an APHIS or State representative determines that such facilities or premises are not in such clean and sanitary condition and gives written notice of his determination to such person, the facilities and premises shall be cleaned and disinfected in accordance with §§ 71.7 and 71.10 through 71.12 by such person under the supervision of an APHIS or State representative or an accredited veterinarian before such premises are again used for livestock or poultry.
(b) Yards, pens, chutes, alleys, and other facilities and premises which have contained interstate shipments of cattle, sheep, swine, poultry, or other animals affected with, or carrying the infection of, any contagious, infectious, or communicable disease of livestock or poultry other than slight unopened cases of actinomycosis or actinobacillosis (or both), bovine foot rot, atrophic rhinitis, ram epididymitis, ringworm, infectious keratitis, and arthritis (simple lesions only), shall be cleaned and disinfected under the supervision of an APHIS or State representative or an accredited veterinarian in accordance with §§ 71.7 and 71.10 through 71.12 before such premises are again used for animals, and any poultry or other animals unloaded into such yards or premises before they have been so cleaned and disinfected shall thereafter be classed as “exposed” within the meaning of the regulations in this subchapter and shall not be moved interstate except in compliance with the provisions of such regulations applicable to “exposed” animals.
No person who receives notice from an APHIS representative that a railroad car, truck, boat, aircraft or other means of conveyance owned or operated by such person is not in a clean and sanitary condition in accordance with good animal husbandry practices, shall thereafter use such means of conveyance in connection with the interstate movement of livestock or poultry, or move said means of conveyance interstate, until it has been cleaned and disinfected under the supervision of an APHIS or State representative or
(a) Railroad cars, trucks, boats, aircraft, and other means of conveyance which have been used in the interstate transportation of cattle, sheep, swine, poultry, or other animals affected with, or carrying the infection of, any contagious, infectious, or communicable disease of livestock or poultry, other than slight unopened cases of actinomycosis or actinobacillosis (or both), atrophic rhinitis, bovine foot rot, brucellosis, ram epididymitis, ringworm, infectious keratitis, and arthritis (simple lesions only), shall be cleaned and disinfected under APHIS supervision in accordance with §§ 71.7 and 71.10 through 71.12 at the point where the animals are unloaded and the final carrier shall be responsible for such cleaning and disinfecting:
(b) No railroad car, truck, boat, aircraft or other means of conveyance from which poultry or other animals affected with an infectious, contagious or communicable disease of livestock or poultry, other than those specified in § 71.4(b), have been unloaded shall thereafter be used in connection with the interstate movement of animals, including poultry, or be moved interstate until it has been cleaned and disinfected by the final carrier under the supervision of an APHIS or State representative or an accredited veterinarian in accordance with §§ 71.7 and 71.10 through 71.12.
(c) If APHIS supervision or other supervision as required by paragraph (a) or (b) of this section or proper cleaning and disinfecting facilities are not available at the point where the animals are unloaded, upon permission first received from the Animal and Plant Health Inspection Service, the means of conveyance may be forwarded empty to a point at which such supervision and facilities are available, and there be cleaned and disinfected under supervision in accordance with §§ 71.7 and 71.10 through 71.12.
(a) Railroad cars, trucks, aircraft, or other means of conveyance, except boats, required by the regulations in this subchapter to be cleaned and disinfected shall be treated in the following manner: Remove all litter and manure from all portions of the conveyance, including any external ledges and framework; clean the exterior and interior of the conveyance; and saturate the entire interior surface, including the inner surface of the doors of the conveyance, with a permitted disinfectant specified in §§ 71.10 through 71.12.
(b) Boats required by the regulations in this subchapter to be cleaned and disinfected shall be treated in the following manner: Remove all litter and manure from the decks and stalls, and all other parts of the boat occupied or traversed by any poultry or other animals and from the portable chutes or other appliances or fixtures used in loading and unloading the animals, and saturate with a permitted disinfectant the entire surface of the deck, stalls, or other parts of the boat occupied or traversed by any animals or with which they may come in contact or which have contained litter or manure.
(c) Yards, pens, chutes, alleys, cages, and other equipment required by the regulations in this subchapter to be disinfected shall be treated in the following manner: Empty all troughs, racks, or other feeding or watering appliances; remove all litter and manure from the floors, posts, or other parts; and saturate the entire surface of the fencing, troughs, chutes, floors, walls,
(a) Disinfectants permitted for use on cars, boats, and other vehicles, premises, and cages and other equipment are as follows:
(1) “Cresylic disinfectant” in the proportion of at least 4 fluid ounces to 1 gallon of water.
(2) Liquefied phenol (U.S.P. strength 87 percent phenol) in the proportion of at least 6 fluid ounces to 1 gallon of water.
(3) Chlorinated lime (U.S.P. strength, 30 percent available chlorine) in the proportion of 1 pound to 3 gallons of water.
(4) Sodium hydroxide (Lye) prepared in a fresh solution in the proportion of not less than 1 pound avoirdupois of sodium hydroxide of not less than 95 percent purity to 6 gallons of water, or one 13
(5) Disinfectants which are registered under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135
(b) The use of “cresylic disinfectant” is permitted subject to the following conditions:
(1) The manufacturer thereof shall have obtained specific permission from APHIS for the use of his products in official disinfection. To obtain such permission manufacturers shall first submit a sample of at least 8 ounces for examination, together with a statement of the formula employed and a guaranty that the product will be maintained of a quality uniform with the sample submitted.
(2) To prevent confusion, the product of each manufacturer and distributor shall bear a distinctive trade name or brand, together with the name of the manufacturer or distributor.
(3) The product shall at all times conform to specifications for composition and performance issued by the Administrator.
The following specifications will be employed for determining the suitability of cresylic disinfectant for use under the provisions of § 71.10(b)(3):
(a) The product shall remain a uniform liquid when held at 0 °C. (32 °F.) for 3 hours (chill test).
(b) The product shall dissolve completely in 30 parts of distilled water at 25 °C. (77 °F.) within 2 minutes (solution-rate test), producing a solution entirely free from globules and not more than faintly opalescent (solubility-degree test).
(c) The product shall contain not more than 25 percent of inert ingredients (water and glycerin), not more excess alkali than the equivalent of 0.5 percent of sodium hydroxide, and not less than 21 percent of soap exclusive of water, glycerin, and excess alkali.
(d) The product shall contain not less than 50 percent and not more than 53 percent of total phenols. It shall contain less than 5 percent of benzophenol (C
(e) The methods of determining compliance with the specifications in paragraphs (a) to (d) of this section will be those described in United States Department of Agriculture Bulletin 1308, Chemical and Physical Methods for the Control of Saponified Cresol Solutions, so far as they are applicable.
(f) Any suitable glyceride, fat acid, or resin acid may be used in preparing the
(a) A permitted brand of sodium orthophenylphenate in a proportion of at least one pound to 12 gallons of water is permitted in tuberculosis eradication work for disinfecting infected premises following the removal of cattle that reacted to the tuberculin test.
(b) It is absolutely necessary that the solution be applied at a temperature of 60 °F. or over. Whenever the temperature of the building to be disinfected is below 60 °F., as indicated by a wall thermometer, the solution shall be heated to 120 °F. and higher in very cold weather, to insure effective disinfection.
All persons and corporations having control of the interstate transportation of livestock or poultry shall, when directed by an APHIS inspector so to do, stop the same in transit for inspection, and if any of such poultry or other animals are found upon such inspection to be infected with any contagious, infectious, or communicable disease or to have been exposed to such infection, the person or corporation having control of the transportation of such poultry or other animals shall, upon receipt of an order from an APHIS representative so to do, cease the carriage, transportation, or moving of such poultry or other animals unless such carriage, transportation, or moving can be accomplished in accordance with the regulations in this subchapter governing the interstate movement of poultry or other animals infected with or which have been exposed to the infection of such disease, and in all cases after the discovery of such infection or exposure thereto such poultry or other animals shall be handled in accordance with such regulations.
When, in order to prevent the spread of any contagious, infectious, or communicable disease, it becomes necessary to slaughter any diseased or exposed animals, including poultry, and the purchase of such animals, including poultry, by the United States is authorized by law and an appropriation is available therefor, the value of the animals, including poultry shall be ascertained and compensation made therefor in accordance with the orders or regulations of the Secretary of Agriculture.
No livestock or poultry shall be shipped, trailed, driven, or hauled in private conveyance from the quarantined area in any State, Territory, or the District of Columbia to the free area in the same State, Territory, or the District of Columbia and subsequently delivered to a transportation company for shipment or moved to any other State, Territory, or the District of Columbia without complying with all Federal and State regulations pertaining to such movements.
(a)
(b)
(1) In the case of such movement by a common carrier issuing waybills or other form or forms of billing covering the movement, the said certificate, statement, test chart, or other writing shall be delivered to such carrier at the time the poultry or other animal or poultry or other animals are delivered for shipment, and shall become the property of the carrier, and be by such carrier attached to the billing covering the transportation of such poultry or other animal or poultry or other animals, and accompany such billing to destination, and be filed with such billing for future reference.
(2) In case of such movement otherwise than by common carrier issuing waybills or other form or forms of billing, the said certificate, statement, test chart, or other writing shall accompany the poultry or other animal or poultry or other animals to destination and be delivered to the consignees, or, in case the consignor and consignee is the same person, to the first purchaser purchasing during or after such movement in interstate commerce, or to the person to whom the poultry or other animal or poultry or other animals are delivered.
No dead poultry or other animals shall be offered or accepted for transportation or transported in the same car with live poultry or other animals from the original point of shipment in any State or Territory or the District of Columbia to or through any other State, Territory, or the District of Columbia.
(a) No cattle 2 years of age or over, except steers and spayed heifers and cattle of any age which are being moved interstate during the course of normal ranching operations without change of ownership to another premises owned, leased, or rented by the same individual as provided in §§ 78.9(a)(3)(ii), 78.9(b)(3)(iv), and 78.9(c)(3)(iv) of this chapter, shall be moved in interstate commerce other than in accordance with the requirements of this section. Any movement in interstate commerce of any cattle shall also comply with the other applicable provisions in this part and other parts of this subchapter.
(1) When permitted under such other provisions, cattle subject to this section:
(i) May be moved in interstate commerce from any point to any destination, if such cattle, when moved in interstate commerce, are identified by a Department-approved backtag
(ii) May be moved in interstate commerce only from a farm, ranch, or feedlot to a recognized slaughtering establishment as defined in § 78.1 of this chapter; or to a stockyard posted under the provisions of the Packers and Stockyards Act, 1921, as amended (7 U.S.C. 181
(iii) May be moved in interstate commerce for any purpose other than slaughter if such cattle, when moved in interstate commerce, are identified by Animal and Plant Health Inspection Service-approved eartags in lieu of backtags, and, except as provided in paragraph (a)(5) of this section, are accompanied when moved interstate by an owner's statement or other document
(2) The owner's or shipper's statement or other document
(3) Each person who ships, transports, or otherwise causes the cattle to be moved in interstate commerce is responsible for the identification of the cattle as required by this section.
(4) No person shall remove or tamper with or cause the removal of or tampering with a backtag, eartag, brand, or other identification device required to be on cattle pursuant to this section while such cattle are being moved in interstate commerce, except at the time of slaughter, or as may be authorized by the Administrator, upon request in specific cases and under such conditions as the Administrator, may impose to ensure continuing identification.
(5) Cattle that would otherwise be required to be accompanied by an owner-shipper statement or other document
(b) In lieu of the backtags, eartags, and brands referred to in this section, any other official identification device or method that is approved by the Administrator may also be used.
(a)(1) Except as provided in paragraphs (c) and (g) of this section, no swine may be sold, transported, received for transportation, or offered for sale or transportation, in interstate commerce, unless each swine is identified at whichever of the following comes first:
(i) The point of first commingling of the swine in interstate commerce with swine from any other source;
(ii) Upon unloading of the swine in interstate commerce at any livestock market;
(iii) Upon transfer of ownership of the swine in interstate commerce; or
(iv) Upon arrival of the swine in interstate commerce at their final destination.
(2) The identification shall be by means of identification approved by the Administrator and listed in paragraph (b) of this section. All swine shall remain so identified while they are in interstate commerce.
(3) Each person who buys or sells, for his or her own account or as the agent of the buyer or seller, transports, receives for transportation, offers for sale or transportation, or otherwise handles swine in interstate commerce, is responsible for the identification of the swine as provided by this section.
(b) Means of swine identification approved by the Administrator are:
(1) Official eartags, when used on any swine;
(2) United States Department of Agriculture backtags, when used on swine moving to slaughter;
(3) Official swine tattoos, when used on swine moving to slaughter, when the use of the official swine tattoo has been requested by a user or the State animal health official, and the Administrator authorizes its use in writing based on a determination that the tattoo will be retained and visible on the carcass of the swine after slaughter, so as to provide identification of the swine;
(4) Tattoos of at least 4-characters when used on swine moving to slaughter, except sows and boars as provided in § 78.33 of this chapter;
(5) Ear notching when used on any swine, if the ear notching has been recorded in the book of record of a purebred registry association;
(6) Tattoos on the ear or inner flank of any swine, if the tattoos have been recorded in the book of record of a swine registry association;
(7) For slaughter swine and feeder swine, an eartag or tattoo bearing the premises identification number assigned by the State animal health official to the premises on which the swine originated; and
(8) Any other official identification device or method that is approved by the Administrator.
(c) Swine that are kept as a group are not required to be individually identified when in interstate commerce if:
(1) They were born on the same premises;
(2) They were raised on the same premises where they were born;
(3) They are moved in a group directly to a slaughtering establishment from the place where they were raised;
(4) They are not mixed with swine from any other premises, between the time they are born and the time they arrive at the slaughtering establishment; and
(5) They are slaughtered one after another, as a group, and not mixed with other swine at slaughter; or approved identification is applied to the swine after entry into the slaughtering establishment.
(d) Serial numbers of United States Department of Agriculture backtags and official swine tattoos will be assigned to each person who applies to the State animal health official or the Area Veterinarian in Charge for the State in which that person maintains his/her or its place of business. Serial numbers of official eartags will be assigned to each accredited veterinarian or State or Federal representative who requests official eartags from the State animal health official or the Area Veterinarian in Charge, whoever is responsible for issuing official eartags in that State. Persons assigned serial numbers of United States Department of Agriculture backtags, official swine tattoos, and official eartags must:
(1) Record the following information on a document:
(i) All serial numbers applied to the swine;
(ii) Any other serial numbers and approved identification appearing on the swine that are needed to identify the swine to its previous owner and location;
(iii) The street address, including the city and state, or the township, county, and state, of the premises where the approved means of identification were applied; and
(iv) The telephone number, if available, of the person who owns or possesses the swine.
(2) Maintain these records at the person's place of business for 2 years; and
(3) Make these records available for inspection and copying during ordinary business hours (8 a.m. to 5:30 p.m., Monday through Friday) upon request by any authorized employee of the United States Department of Agriculture, upon that employee's request and presentation of his or her official credentials.
(e)(1) Each person who buys or sells, for his or her own account or as the agent of the buyer or seller, transports, receives for transportation, offers for sale or transportation, or otherwise handles swine in interstate commerce, must keep records relating to the transfer of ownership, shipment, or handling of the swine, such as yarding receipts, sale tickets, invoices, and waybills upon which is recorded:
(i) All serial numbers and other approved means of identification appearing on the swine that are necessary to identify it to the person from whom it was purchased or otherwise obtained; and
(ii) The street address, including city and state, or the township, county, and state, and the telephone number, if available, of the person from whom the swine were purchased or otherwise obtained.
(2) Each person required to keep records under this paragraph must maintain the records at his/her or its place of business for at least 2 years after the person has sold or otherwise disposed of the swine to another person, and for such further period as the Administrator may require by written notice to the person, for purposes of any investigation or action involving the swine identified in the records. The person shall make the records available for inspection and copying during ordinary business hours (8 a.m. to 5:30 p.m., Monday through Friday) by any authorized employee of the United States Department of Agriculture, upon that employee's request and presentation of his or her official credentials.
(f) No person may remove or tamper with any approved means of identification required to be on swine pursuant to this section while it is in interstate commerce, except at the time of slaughter as provided in 9 CFR 309.16(e).
(g)
(1) The swine may be moved interstate only to another premises identified in a valid swine production health plan for that swine production system.
(2) The swine production system must operate under a valid swine production health plan, in which both the sending and receiving States have agreed to allow the movement.
(3) The swine must have been found free from signs of any communicable disease during the most recent inspection of the premises by the swine production system accredited veterinarian(s) within 30 days prior to movement.
(4) Prior to the movement of any swine, the producer(s) moving swine must deliver the required interstate swine movement report to the following individuals identified in the swine production health plan:
(i) The swine production system accredited veterinarian for the premises from which the swine are to be moved, and
(ii) The State animal health officials for the sending and receiving States, and any other State employees designated by the State animal health officials.
(5) The receiving premises must not commingle swine received from different premises in a manner that prevents identification of the premises that sent the swine or groups of swine. This may be achieved by use of permanent premises or individual identification marks on animals, by keeping groups of animals received from one premises physically separate from animals received from other premises, or by any other effective means.
(6) Each premises must maintain, for 3 years after their date of creation,
(7) Each premises must allow APHIS representatives and State animal health officials access to the premises upon request to inspect animals and review records.
(8) Once a month, each swine production system must send APHIS a written summary based on the interstate swine movement report data that shows how many animals were moved in the past month, the premises from which they were moved, and the premises to which they were moved.
(h)
(1) A State animal health official may cancel his or her State's participation in a swine production health plan by giving written notice to all swine producers, APHIS representatives, accredited veterinarians, and other State animal health officials listed in the plan. Withdrawal shall be effective upon the date specified by the State animal health official in the notice, but for shipments in transit, withdrawal shall become effective 7 days after the date of such notice. Upon withdrawal of a State, the swine production health plan may continue to operate among the other States and parties signatory to the plan.
(2) A swine production system may withdraw one or more of its premises from participation in the plan upon giving written notice to the Administrator, the accredited veterinarian(s), all swine producers listed in the plan, and State animal health officials listed in the plan. Withdrawal shall be effective upon the date specified by the swine production system in the written notice, but for shipments in transit, withdrawal shall become effective 7 days after the date of such notice.
(3) The Administrator may cancel a swine production health plan by giving written notice to all swine producers, accredited veterinarians, and State animal health officials listed in the plan. The Administrator shall cancel a swine production health plan after determining that swine movements within the swine production system have occurred that were not in compliance with the swine production health plan or with other requirements of this chapter. Before a swine health production plan is canceled, an APHIS representative will inform a representative of the swine production system of the reasons for the proposed cancellation. The swine production system may appeal the proposed cancellation in writing to the Administrator within 10 days after being informed of the reasons for the proposed cancellation. The appeal must include all of the facts and reasons upon which the swine production system relies to show that the reasons for the proposed cancellation are incorrect or do not support the cancellation. The Administrator will grant or deny the appeal in writing as promptly as circumstances permit, stating the reason for his or her decision. If there is a conflict as to any material fact, a hearing will be held to resolve the conflict. Rules of practice concerning the hearing will be adopted by the Administrator. However, cancellation of the disputed swine production health plan shall become effective pending final determination in the proceeding if the Administrator determines that such action is necessary to protect the public's health, interest, or safety. Such cancellation shall become effective upon oral or written notification, whichever is earlier, to the swine production system representative. In the event of oral notification, written confirmation shall be given as promptly as circumstances allow. This cancellation shall continue in effect pending the completion of the proceeding, and any judicial review thereof, unless
(a) To qualify for approval by the Administrator as an approved livestock facility
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(1) The State animal health official and the area veterinarian in charge shall be provided with a schedule of the facility's sale days, which shall indicate the types of animals that will be handled at the facility on each sale day, and shall be apprised of any changes to that schedule prior to the implementation of the changes.
(2) An accredited veterinarian, State representative, or APHIS representative shall be on the facility premises on all sale days to perform duties in accordance with State and Federal regulations.
(3) State representatives and APHIS representatives shall be granted access to the facility during normal business hours to evaluate whether the facility and its operations are in compliance with the applicable provisions of this agreement and 9 CFR parts 71, 75, 78, and 85.
(4) An APHIS representative, State representative, or accredited veterinarian shall be immediately notified of the presence at the facility of any livestock that are known to be infected, exposed, or suspect, or that show signs of possibly being infected, with any infectious, contagious, or communicable disease.
(5) Any reactor, suspect, or exposed livestock shall be held in quarantined pens apart from all other livestock at the facility.
(6) No reactor, suspect, or exposed livestock, nor any livestock that show signs of being infected with any infectious, contagious, or communicable disease, may be sold at the facility, except as authorized by an APHIS representative, State representative, or accredited veterinarian.
(7) Documents such as weight tickets, sales slips, and records of origin, identification, and destination that relate to livestock that are in, or that have been in, the facility shall be maintained by the facility for a period of 2 years. APHIS representatives and State representatives shall be permitted to review and copy those documents during normal business hours.
(8) All livestock must be officially identified in accordance with the applicable regulations in 9 CFR parts 71, 75, 78, and 85 at the time of, or prior to, entry into the facility.
(9) The facility, including all yards, docks, pens, alleys, sale rings, chutes, scales, means of conveyance, and their associated equipment, shall be maintained in a clean and sanitary condition. The operator of the facility shall be responsible for the cleaning and disinfection of the facility in accordance with 9 CFR part 71 and for maintaining an adequate supply of disinfectant and serviceable equipment for cleaning and disinfection.
(10) All facilities and equipment shall be maintained in a state of good repair. The facility shall contain well-constructed and well-lighted livestock handling chutes, pens, alleys, and sales rings for the inspection, identification, vaccination, testing, and branding of livestock.
(11) Quarantined pens shall be clearly labeled with paint or placarded with the word “Quarantined” or the name of the disease of concern, and shall be cleaned and disinfected in accordance with 9 CFR part 71 before being used to pen livestock that are not reactor, suspect, or exposed animals.
(12) Quarantined pens shall have adequate drainage, and the floors and those parts of the walls of the quarantined pens with which reactor, or suspect, or exposed livestock, their excrement, or discharges may have contact shall be constructed of materials that are substantially impervious to moisture and able to withstand continued cleaning and disinfection.
(13) Electrical outlets shall be provided at the chute area for branding purposes.
(14) Cattle and bison:
(i) Cattle and bison shall be received, handled, and released by the facility only in accordance with 9 CFR parts 71 and 78.
(ii) All brucellosis reactor, brucellosis suspect, and brucellosis exposed cattle or bison arriving at the facility shall be placed in quarantined pens and consigned from the facility only in accordance with 9 CFR part 78.
(iii) Any cattle or bison classified as brucellosis reactors at the facility shall be identified in accordance with 9 CFR part 78, placed in quarantined pens, and consigned from the facility only to a recognized slaughtering establishment or an approved intermediate handling facility in accordance with 9 CFR part 78.
(iv) Any cattle or bison classified as brucellosis exposed at the facility shall be identified in accordance with 9 CFR part 78, placed in quarantined pens, and consigned from the facility only to a recognized slaughtering establishment, approved intermediate handling facility, quarantined feedlot, or farm of origin in accordance with 9 CFR part 78.
(v) The identity of cattle from Class Free States or areas and Class A States or areas shall be maintained.
(vi) The identity of cattle from Class B States or areas shall be maintained, and test-eligible cattle from Class B States or areas shall not be placed in pens with cattle from any other area until they have fulfilled the requirements of 9 CFR part 78 for release from the facility.
(vii) The identity of cattle from Class C States or areas shall be maintained, and test-eligible cattle from Class C States or areas shall not be placed in pens with cattle from any other area until they have fulfilled the requirements of 9 CFR part 78 for release from the facility.
(viii) The identity of cattle from quarantined areas shall be maintained, and test-eligible cattle from quarantined areas shall not be placed in pens with cattle from any other area until they have fulfilled the requirements of 9 CFR part 78 for release from the facility.
(ix) Test-eligible cattle that are penned with test-eligible cattle from a lower class State or area, in violation of this agreement, shall have the status of the State or area of lower class for any subsequent movement.
(x) Laboratory space shall be furnished and maintained for conducting diagnostic tests. All test reagents, testing equipment, and documents relating to the State-Federal cooperative eradication programs on the facility's premises shall be secured to prevent misuse and theft. Adequate heat, cooling, electricity, water piped to a properly drained sink, and sanitation shall be provided for properly conducting diagnostic tests.
(15) Swine:
(i) Swine shall be received, handled, and released by the livestock facility only in accordance with 9 CFR parts 71, 78, and 85.
(ii) Pens, alleys, and sales rings for holding, inspecting, and otherwise handling swine shall be imperviously surfaced.
(iii) Slaughter swine may be handled only on days when no feeder swine or breeder swine are present at the facility, unless the facility has provisions to keep slaughter swine physically separated from feeder swine and breeder swine or unless those areas of the facility used by slaughter swine have been cleaned and disinfected before being used by feeder swine or breeder swine.
(iv) No feeder swine or breeder swine may remain in the livestock facility for more than 72 hours, and no slaughter swine may remain in the livestock market for more than 120 hours.
(v) Feeder swine shall be kept separate and apart from other swine while in the livestock facility.
(vi) No release shall be issued for the removal of slaughter swine from the livestock facility unless the slaughter swine are consigned for immediate slaughter or to another slaughter market and the consignee is identified on the release document.
(16) Horses:
(i) Horses shall be received, handled, and released by the livestock facility only in accordance with 9 CFR parts 71 and 75.
(ii) Any horses classified as EIA reactors and accepted by the facility for sale shall be placed in quarantined pens at least 200 yards from all non-EIA-reactor horses.
(iii) Any horses classified as EIA reactors and accepted by the facility for sale shall be consigned from the facility only to a slaughtering establishment or to the home farm of the reactor in accordance with 9 CFR part 75.
(iv) Fly Control Program: The livestock facility shall have in effect a fly control program utilizing at least one of the following: Baits, fly strips, electric bug killers (“Fly Zappers,” “Fly Snappers,” or similar equipment), or the application of a pesticide effective against flies, applied according to the schedule and dosage recommended by the manufacturer for fly control.
(17) Request for approval:
I hereby request approval for this facility to operate as an approved livestock facility for the classes of livestock indicated in paragraphs (14) through (16) of this agreement. I acknowledge that I have received a copy of 9 CFR parts 71, 75, 78 and 85, and acknowledge that I have been informed and understand that failure to abide by the provisions of this agreement and the applicable provisions of 9 CFR parts 71, 75, 78, and 85 constitutes a basis for the withdrawal of this approval. [
(18) Pre-approval inspection of livestock facility conducted by [
(19) Recommend approval:
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(20) Approval granted:
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(b)
(1) In the case of a denial, the operator of the facility will be informed of the reasons for the denial and may appeal the decision in writing to the Administrator within 10 days after receiving notification of the denial. The appeal must include all of the facts and reasons upon which the person relies to show that the livestock facility was wrongfully denied approval to receive livestock moved interstate under this subchapter. The Administrator will grant or deny the appeal in writing as promptly as circumstances permit, stating the reason for his or her decision. If there is a conflict as to any material fact, a hearing will be held to resolve the conflict. Rules of practice concerning the hearing will be adopted by the Administrator.
(2) In the case of withdrawal, before such action is taken, the operator of the facility will be informed of the reasons for the proposed withdrawal. The operator of the facility may appeal the proposed withdrawal in writing to the Administrator within 10 days after being informed of the reasons for the proposed withdrawal. The appeal must include all of the facts and reasons upon which the person relies to show that the reasons for the proposed withdrawal are incorrect or do not support the withdrawal of the approval of the livestock facility to receive livestock moved interstate under this subchapter. The Administrator will grant or deny the appeal in writing as promptly as circumstances permit, stating the reason for his or her decision. If there is a conflict as to any material fact, a hearing will be held to resolve the conflict. Rules of practice concerning the hearing will be adopted by the Administrator. However, withdrawal shall become effective pending final determination in the proceeding when the Administrator determines that such action is necessary to protect the public health, interest, or safety. Such withdrawal shall be effective upon oral or written notification, whichever is earlier, to the operator of the facility. In the event of oral notification, written confirmation shall be given as promptly as circumstances allow. This withdrawal shall continue
(3) Approval for a livestock facility to handle livestock under this subchapter will be automatically withdrawn by the Administrator when:
(i) The operator of the facility notifies the Administrator, in writing, that the facility no longer handles livestock moved interstate under this subchapter; or
(ii) The person who signed the agreement executed in accordance with paragraph (a) of this section is no longer responsible for the day-to-day operations of the facility.
(a) Any person moving livestock or poultry interstate for slaughter or rendering may only move the animals to a slaughtering establishment or a rendering establishment that has been listed by the Administrator
(1) The establishment provides space and equipment in accordance with paragraph (b) of this section
(2) The establishment allows APHIS, FSIS, or APHIS contractors to take blood and tissue samples from all livestock or poultry at the facility without cost to the United States, and specifically allows these personnel access to the processing line to collect samples; and
(3) The establishment allows APHIS, FSIS, or APHIS contractors to record the identification of individual animals and retain any external or internal identification devices.
(b) The establishment must provide office and sample collection space, including necessary furnishings, light, heat, and janitor service, rent free, for the use by APHIS, FSIS, or APHIS contractors collecting samples for blood and tissue testing under this section. The Administrator will inform each establishment of the exact amount and type of space required, taking into account whether APHIS will be conducting complete tests at the facility, or only collecting samples and sending them elsewhere for testing. At the discretion of the Administrator, small plants need not furnish facilities as prescribed in this section if adequate facilities exist in a nearby convenient location. In granting or denying listing of an establishment, the Administrator will consider whether the space at the facility:
(1) Is conveniently located, properly ventilated, and provided with lockers suitable for the protection and storage of supplies;
(2) Has sufficient light to be adequate for proper conduct of sample collection and processing;
(3) Includes racks, receptacles, or other suitable devices for retaining
(4) Includes tables, benches, and other equipment on which sample collection and processing are to be performed, of such design, material, and construction as to enable sample collection and processing in a safe, ready, efficient, and clean manner;
(5) Has adequate arrangements, including liquid soap and cleansers, for cleansing and disinfecting hands, dissection tools, floors, and other articles and places that may be contaminated by diseased carcasses or otherwise; and
(6) Has adequate facilities, including denaturing materials, for the proper disposal in accordance with this chapter of tissue, blood, and other waste generated during test sample collection.
(c) The Administrator will give the operator of the establishment actual notice that APHIS, FSIS, or an APHIS contractor will be taking blood and/or tissue samples at the establishment. The Administrator may give the operator of the establishment notice in any form or by any means that the Administrator reasonably believes will reach the operator of the establishment prior to the start of sample collection.
(1) The notice will include the anticipated date and time sample collection will begin. The notice will also include the anticipated ending date and time.
(2) The Administrator will give the operator of the establishment as much advance notice as possible. However, the actual amount of notice will depend on the specific situation.
(d)
(1) In the case of a denial, the operator of the establishment will be informed of the reasons for the denial and may appeal the decision in writing to the Administrator within 10 days after receiving notification of the denial. The appeal must include all of the facts and reasons upon which the person relies to show that the establishment was wrongfully denied listing. The Administrator will grant or deny the appeal in writing as promptly as circumstances permit, stating the reason for his or her decision. If there is a conflict as to any material fact, a hearing will be held to resolve the conflict. Rules of practice concerning the hearing will be adopted by the Administrator.
(2) In the case of withdrawal, before such action is taken, the operator of the establishment will be informed of the reasons for the proposed withdrawal. The operator of the establishment may appeal the proposed withdrawal in writing to the Administrator within 10 days after being informed of the reasons for the proposed withdrawal. The appeal must include all of the facts and reasons upon which the person relies to show that the reasons for the proposed withdrawal are incorrect or do not support the withdrawal of the listing. The Administrator will grant or deny the appeal in writing as promptly as circumstances permit, stating the reason for his or her decision. If there is a conflict as to any material fact, a hearing will be held to resolve the conflict. Rules of practice concerning the hearing will be adopted by the Administrator. However, withdrawal shall become effective pending final determination in the proceeding when the Administrator determines that such action is necessary to protect the public health, interest, or safety. Such withdrawal shall be effective upon oral or written notification, whichever is earlier, to the operator of the establishment. In the event of oral notification, written confirmation shall be given as promptly as circumstances allow. This withdrawal shall continue in effect pending the completion of the proceeding, and any judicial review thereof, unless otherwise ordered by the Administrator.
Official identification devices are intended to provide permanent identification of livestock and to ensure the
7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
No animals infested with ticks [Boophilus annulatus (Margaropus annulatus), Boophilus microplus, or Rhipicephalus evertsi evertsi] or exposed to tick infestation shall be shipped, trailed, driven, or otherwise moved interstate for any purpose, except as provided in this part.
Notice is hereby given that the contagious, infectious, and communicable disease known as splenetic or tick fever exists in cattle in portions of the State of Texas and the Virgin Islands of the United States. Notice is also hereby given that ticks which are vectors of said disease exist in the Northern Mariana Islands, the Commonwealth of Puerto Rico, and the Island
The entire Territories of the Virgin Islands of the United States and the Island of Guam, the Northern Mariana Islands, and the Commonwealth of Puerto Rico are quarantined.
The area quarantined in Texas is the quarantined area described in the regulations of the Texas Animal Health Commission (TAHC) contained in §§ 41.14 through 41.22 of title 4, part II, of the Texas Administrative Code (4 TAC 41.14 through 41.22), effective June 23, 2002, which is incorporated by reference. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of 4 TAC 41.14 through 41.22 may be obtained from the TAHC at 2105 Kramer Lane, Austin, TX 78758, and from area offices of the TAHC, which are listed in local Texas telephone directories. The TAHC also maintains a copy of its regulations on its Internet homepage at
Cattle in quarantined areas where tick eradication is not being conducted
Cattle in areas where tick eradication is being conducted in cooperation with State authorities,
Cattle located in areas where tick eradication is being conducted in co- operation with the State authorities, and which are on premises shown by the official records of tick eradication to be free from ticks, may, upon inspection and certification by an APHIS inspector, be shipped or transported interstate for any purpose without dipping upon compliance with the requirements set forth under §§ 72.9, 72.10, 72.12.
All interstate movements of inspected and certified and dipped and certified cattle shall be accompanied to final destination by a certificate of an APHIS inspector (which certificate shall show that the cattle so being moved have been dipped as required by § 72.6 or by § 72.7 and are free of ticks, or have been inspected as required by § 72.8 and are free of ticks); all such certificates shall be handled, delivered, kept, and preserved in accordance with the provisions of § 72.16; and all such cattle shall be handled through noninfectious pens, alleys, and chutes, and when shipped shall be loaded into clean and disinfected cars or trucks, and shall not be unloaded in the quarantined area except at such points reserved for noninfested cattle as may from time to time be authorized by APHIS.
All such interstate movements of inspected or dipped and certified cattle are subject to such restrictions, which are not inconsistent with the regulations in this subchapter, as may be imposed at destination by the officials of the State, Territory, or the District of Columbia.
Cattle of the quarantined area shall be considered infested and shall not be placed in noninfectious pens or premises until after the final inspection or dipping.
The cattle shall not be exposed to tick infestation after treatment and/or inspection.
(a)
(b)
(1) Approved proprietary brands of a Dioxathion (Delnav
(2) Approved proprietary brands of coumaphos (Co-Ral
(3) Approved proprietary brands of organophosphorous insecticides (Prolate
(4) Approved proprietary brands of organophosphorous insecticides (Ciodrin
(c)
(d)
When the cattle are to be dipped under APHIS supervision the owner of the cattle, offered for shipment, or his agent duly authorized thereto, shall first execute and deliver to an APHIS inspector an application for inspection and supervised dipping wherein he shall agree to waive all claims against the United States for any loss or damage to said cattle occasioned by or resulting from dipping or other treatment under this part, or resulting from any subsequent treatment prior to their interstate shipment, or resulting from the fact that they are later found to be still tick infested, and also for all subsequent loss or damage to any other cattle in the possession or control of such owner which may come into contact with the cattle so dipped or treated.
When deemed advisable and upon recommendation by the proper livestock sanitary authorities, designated dipping stations may be approved by the Administrator, APHIS as points at which cattle of the quarantined area of the State in which said station is located may be inspected, dipped, and certified for interstate movement. The facilities furnished shall include proper dipping equipment, noninfectious pens constructed in accordance with § 72.17 and a roofed or covered section of pens of sufficient size to protect all dipped animals from exposure to rain or hot sun. All alleys, chutes, and pens shall be paved or properly floored.
(a)
(1) The outside fences enclosing such pens, and the fences on either side of the alleys, chutes, and platforms leading thereto, shall be tight board fences not less than 6 feet high on the inside.
(2) If such pens, alleys, chutes, and platforms are adjacent to pens, alleys, chutes, and platforms used by cattle of the quarantined area, there shall be between them a space not less than 10 feet wide, which shall be inaccessible to livestock. This space shall be limited on each side by the 6-foot fence required by paragraph (a)(1) of this section. The remaining space around such yards shall be limited as in paragraph (a)(3) of this section.
(3) If such pens, alleys, chutes, and platforms are isolated from other pens, alleys, chutes, or platforms, there shall be built and maintained outside thereof on all sides to which cattle of the vicinity might otherwise approach a cattle-proof fence not less than 5 feet high and not less than 15 feet from the 6-foot fence required by paragraph (a)(1) of this section.
(4) The only means of egress from such pens shall be by way of the alleys, chutes, and platforms inclosed by 6-foot fences as required by paragraph (a)(1) of this section, to cars for reforwarding; and under no circumstances shall there exist any connection between such pens and other adjacent premises.
(5) Such noninfectious premises shall be so located, or such drainage facilities shall be provided therefor, that water from the surrounding area will not flow on to or through them.
(6) Such pens shall be marked by a conspicuous sign bearing the words “Noninfectious Pens” in letters not less than 10 inches in height.
(b)
(a)
(b)
(c)
Pine straw, grass, or similar litter collected from tick-infested pastures, ranges, or premises may disseminate the contagion of splenetic, southern, or Texas fever; therefore pine straw, grass, or similar litter originating in the quarantined area shall not be transported or moved interstate therefrom or used as packing material or car bedding for commodities or livestock to be transported or moved from the quarantined area of any State, Territory, or the District of Columbia, to or through the free area of any other State, Territory, or the District of Columbia, unless such material is first disinfected in accordance with the provisions of § 72.24.
The exhibition of noninfected cattle at fairs or exhibitions in the quarantined area and their reshipment to the free area without dipping may, by written order of the Administrator, APHIS be permitted:
Animals other than cattle which are infested with ticks [Boophilus annulatus (Margaropus annulatus), Boophilus microplus, or Rhipicephalus evertsi evertsi] or exposed to tick infestation shall not be moved interstate unless they are treated, handled, and moved in accordance with the requirements specified in §§ 72.9 through 72.15 and § 72.18 of this part governing the interstate movement of cattle.
Cars and other vehicles, and yards, pens, chutes, or other premises or facilities, which have contained interstate shipments of animals infested with or exposed to ticks, shall be cleaned and treated within 72 hours of use and prior to further use in the required concentration with a permitted dip listed in § 72.13 under supervision of a State or Federal inspector or an accredited veterinarian.
Cars or others vehicles which have carried cattle exposed to or infested with ticks within the quarantined area of any State shall be cleaned and treated in the required concentration with a permitted dip listed in § 72.13 before being moved interstate under supervision of a State or Federal inspector or an accredited veterinarian.
The litter and manure removed from cars, boats, or other vehicles and from pens, chutes, alleys, or other premises or inclosures which have contained interstate shipments of tick-infested animals, shall be destroyed or treated by the transportation or yard company, or other owner thereof, under APHIS supervision, by saturating it in the required concentration with a permitted dip listed in § 72.13, or shall be otherwise disposed of under prior permission received from the Administrator, APHIS.
Dipping is accomplished by thoroughly wetting the entire skin by either immersion in a chemical solution in a dip vat, or by spraying with a
7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
(a)
(b)
(c)
Under the Animal Health Protection Act (7 U.S.C. 8301
For purposes of this part the following terms shall have the meaning set forth in this section.
(a)
(1) They shall not be diverted en route.
(2) The means of conveyance shall be placarded and the billing shall be marked “Treated Scabby Cattle,” in accordance with § 73.6.
(b)
(c)
(d)
Cattle affected with scabies may be shipped interstate for any purpose if dipped twice in a permitted dip, 10 to 14 days apart, under the supervision of an APHIS inspector or State inspector, and so certified by such inspector, or such cattle may be so shipped if dipped once in a permitted dip under APHIS supervision or State supervision at the point of origin, provided arrangements have been made for the second dipping, under APHIS supervision, en route or at destination within 10 to 14 days after the first dipping. If shipped in the latter manner the means of conveyance containing the cattle shall be placarded and the billing shall be marked “Treated Scabby Cattle,” in accordance with § 73.6.
Cattle not visibly diseased with scabies, but which are known to be part of a diseased herd or to have come in contact with diseased cattle or infectious means of conveyance or premises, may be shipped interstate for any purpose if dipped at the point of origin, under the
Cattle of any herd in any quarantined area, which herd is not diseased with scabies, may be shipped, transported, or otherwise moved interstate for any purpose upon inspection by an APHIS or State inspector within 10 days prior to the date of shipment and when accompanied by a certificate from such inspector showing the cattle to be free from such disease or exposure thereto. When it is determined by the Administrator that all cattle of all herds in any quarantined area have been inspected for scabies by an APHIS or State inspector, that all the infected or exposed herds have been identified, and that all the infected herds have been dipped twice, and all the exposed herds have been dipped in a permitted dip as prescribed in § 73.10, under supervision of an APHIS or APHIS-approved inspector, cattle of herds in such area which are not diseased with or exposed to scabies may be moved interstate in accordance with this section, without further APHIS inspection or certification, directly to a slaughtering plant where Federal Meat Inspection is maintained:
When cattle are shipped as “Treated Scabby Cattle,” or “Cattle Exposed to Scabies,” the transportation companies shall securely affix to and maintain upon both sides of each means of conveyance carrying such cattle a durable, conspicuous placard, not less than 5
No person, firm, or corporation shall deliver for transportation, transport, drive on foot, or otherwise move interstate from the free area of any State, Territory, or the District of Columbia any cattle which have been moved from the quarantined area of the same State, Territory, or the District of Columbia into such free area:
(a)
(b)
When the cattle are to be dipped under APHIS supervision or control, the owner of the cattle offered for shipment, or his agent duly authorized thereto, shall first execute and deliver to an APHIS inspector an application for inspection and supervised dipping wherein he shall agree to waive all claims against the United States for any loss or damage to said cattle occasioned by or resulting from dipping or
(a) The dips at present permitted by the Department for the treatment, as required in this part, of cattle affected with or exposed to scabies, are as follows:
(1) Lime-sulphur dip, other than proprietary brands thereof, made in the proportion of 12 pounds of unslaked lime (or 16 pounds of commercial hydrated lime, not airslaked lime) and 24 pounds of flowers of sulphur or sulphur flour to 100 gallons of water; or a specifically permitted proprietary brand of lime-sulphur dip.
(2) Dips made from specifically permitted proprietary brand emulsions of toxaphene and maintained throughout the dipping operation at a concentration between 0.50 and 0.60 percent toxaphene. Animals treated by such dips should not be slaughtered for food purposes until the expiration of such period as may be required under the Federal Meat Inspection Act (21 U.S.C., Supp. III, 601
(3) Approved proprietary brands of coumaphos (Co-Ral
(4) Approved proprietary brands of organophosphorous insecticides (Prolate
(b) The dipping bath for lime-sulphur dip must be used at a temperature of 95 ° to 105 °F., and must be maintained through the dipping operation at a concentration of not less than 2 percent of “sulphide sulphur”, as indicated by the field test for lime-sulphur dipping baths approved by the APHIS.
(c) Proprietary brands of lime-sulphur or toxaphene dips may be used in official dipping only after specific permission therefor has been granted by the Administrator. Before a dip will be specifically approved as a permitted dip for the eradication of scabies in cattle, the APHIS
Means of conveyance, yards, pens, sheds, chutes, or other premises or facilities which have contained cattle of a consignment in which scabies is found shall be treated within 72 hours of use and prior to further use in the
(a)
(1) Such cattle are kept physically separated for 14 days following treatment from all cattle not part of the group treated together with ivermectin (regardless of whether the cattle are moved interstate before the end of the 14-day period); and
(2) If such cattle are moved interstate before the end of the 14th day following treatment, at the time of interstate movement they are accompanied by a certificate issued and signed by an APHIS inspector or State inspector identifying the group of cattle treated with ivermectin and stating the date on which the cattle were treated with ivermectin; and
(3) If such cattle are moved interstate before the end of the 14th day following treatment, at the time of interstate movement the means of conveyance carrying them is placarded and the billing marked in accordance with § 73.6.
Cattle from nonquarantined areas which are not affected with scabies or which just prior to movement were not affected with or exposed to scabies may be moved interstate without restrictions under this part. Accordingly, cattle from nonquarantined areas which had been treated with ivermectin more than 14 days before movement interstate may be moved interstate without restriction under this part unless following treatment they become affected with scabies or just prior to movement become affected with or exposed to scabies.
(b) Cattle may be moved interstate from a quarantined area after being treated with ivermectin under the supervision of an APHIS inspector or State inspector in accordance with the directions on the label of the drug if the following conditions are met:
(1) Such cattle are moved interstate within 21 days following treatment with ivermectin; and
(2) Such cattle are kept physically separated for 14 days following treatment from all cattle not part of the group treated together with ivermectin (regardless of whether the cattle are moved interstate before the end of the 14 day period); and, if such cattle are moved within the 15- to 21-day period following treatment, they remain kept physically separated from all cattle not a part of the group treated together with ivermectin until after they are moved interstate; and
(3) Such cattle are accompanied at the time of interstate movement by a certificate issued and signed by an APHIS inspector or State inspector identifying the group of cattle treated with ivermectin and stating the date on which the cattle were treated with ivermectin; and
(4) If such cattle are moved interstate before the end of the 14 day period following treatment, at the time of interstate movement the means of conveyance carrying them is placarded and the billing marked in accordance with § 73.6.
7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
The interstate movement of leopard tortoise (
7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
(a)
(b)
(1) The reactor is moved interstate for immediate slaughter, either to a Federally inspected slaughtering establishment operating under the provisions of the Federal Meat Inspection Act (21 U.S.C. 601
(2) The reactor is moved interstate to a diagnostic or research facility after the individual issuing the certificate has consulted with the State animal health official in the State of destination and has determined that the reactor to be moved interstate will be maintained in isolation sufficient to prevent the transmission of equine infectious anemia to other horses, asses, ponies, mules, or zebras, and will remain quarantined under State authority at the diagnostic or research facility until natural death, slaughter, or until disposed of by euthanasia; or
(3) The reactor is moved interstate to its home farm after the individual issuing the certificate has consulted with the State animal health official in the State of destination and has determined that the reactor to be moved interstate will be maintained in isolation sufficient to prevent the transmission of equine infectious anemia to other horses, asses, ponies, mules, or zebras, and will remain quarantined under State authority on the reactor's home farm until natural death, slaughter, or until disposed of by euthanasia; and
(4) The reactor is moved interstate through no more than one approved stockyard for sale for immediate slaughter, and is moved within five days of its arrival at the approved stockyard directly to:
(i) Slaughter at a federally inspected slaughtering establishment operating under the provisions of the Federal Meat Inspection Act (21 U.S.C. 601
(ii) Slaughter at a state-inspected slaughtering establishment that has inspection by a state representative at the time of slaughter, or,
(iii) The home farm of the reactor in accordance with paragraph (b)(3) of this section.
(c)
(i) Has technical personnel assigned to conduct the official test who have received training prescribed by the National Veterinary Services Laboratories;
(ii) Uses United States Department of Agriculture licensed antigen;
(iii) Follows standard test protocol prescribed by the National Veterinary Services Laboratories;
(iv) Meets check test proficiency requirements prescribed by the National Veterinary Services Laboratories; and
(v) Reports all official test results to the State animal health official and the Veterinarian in Charge.
(2) The Administrator will approve diagnostic or research facilities to which reactors may be moved interstate under paragraph (b)(2) of this section, after a determination by the Administrator that the facility has facilities and employs procedures which are adequate to prevent the transmission of equine infectious anemia from reactors to other equine animals.
(d)
(1) In the case of a denial, the operator of the laboratory or facility will be informed of the reasons for denial and may appeal the decision in writing to the Administrator within 10 days
(2) In the case of withdrawal, before such action is taken, the operator of the laboratory or facility will be informed of the reasons for the proposed withdrawal. The operator of the laboratory or facility may appeal the proposed withdrawal in writing to the Administrator within 10 days after being informed of the reasons for the proposed withdrawal. The appeal must include all of the facts and reasons upon which the person relies to show that the reasons for the proposed withdrawal are incorrect or do not support the withdrawal of the approval of the laboratory or facility to conduct the official test or receive reactors moved interstate. The Administrator will grant or deny the appeal in writing as promptly as circumstances permit, stating the reason for his or her decision. If there is a conflict as to any material fact, a hearing will be held to resolve the conflict. Rules of practice concerning the hearing will be adopted by the Administrator. However, the withdrawal shall become effective pending final determination in the proceeding when the Administrator determines that such action is necessary to protect the public health, interest, or safety. Such withdrawal shall be effective upon oral or written notification, whichever is earlier, to the operator of the laboratory or facility. In the event of oral notification, written confirmation shall be given as promptly as circumstances allow. The withdrawal shall continue in effect pending the completion of the proceeding, and any judicial review thereof, unless otherwise ordered by the Administrator.
(3) Approval for a laboratory to conduct the official test will be automatically withdrawn by the Administrator when the operator of the approved laboratory notifies the National Veterinary Services Laboratories in Ames, Iowa, in writing, that the laboratory no longer conducts the official test.
(4) Approval for a diagnostic or research facility to receive reactors moved interstate will be automatically withdrawn by the Administrator when the operator of the approved diagnostic or research facility notifies the Administrator, in writing, that the diagnostic or research facility no longer receives reactors moved interstate.
7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
(a) The procedures specified in the Uniform Methods and Rules—Bovine Tuberculosis Eradication (January 22, 1999, edition) must be followed for the interstate movement of certain animals regulated under this part.
(b)
(1) Are available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
(2) Are available for inspection at the APHIS reading room, room 1141, USDA South Building, 14th Street and Independence Avenue, SW., Washington, DC; or
(3) May be obtained from the National Animal Health Programs, Veterinary Services, APHIS, 4700 River Road Unit 43, Riverdale, MD 20737-1231.
As used in this part, the following terms shall have the meanings set forth in this section except as otherwise specified.
(1) National Uniform Eartagging System.
(2) Animal identification number (AIN).
(3) Premises-based number system. The premises-based number system combines an official premises identification number (PIN), as defined in this section, with a producer's livestock production numbering system to provide a unique identification number. The PIN and the production number must both appear on the official tag.
(4) Any other numbering system approved by the Administrator for the identification of animals in commerce.
(1) The State's two-letter postal abbreviation followed by the premises' assigned number; or
(2) A seven-character alphanumeric code, with the right-most character being a check digit. The check digit number is based upon the ISO 7064 Mod 36/37 check digit algorithm.
(2) A name assigned by a State or Federal animal health authority to the premises on which the animals originated that, in the judgment of that State or Federal animal health authority, is a geographically distinct location from other livestock production units; or
(3) A brand registered with an official brand registry.
The Administrator shall classify each State for tuberculosis in accordance with this part. A zone comprising less than an entire State will be given a particular classification upon request of the State only if the Administrator determines that:
(a) The State meets the requirements of this part for establishment of zones;
(b) The State has adopted and is enforcing regulations that impose restrictions on the intrastate movement of cattle, bison, and captive cervids that are substantially the same as those in place under this part for the interstate movement of cattle, bison, and captive cervids; and
(c) The designation of part of a State as a zone will otherwise be adequate to prevent the interstate spread of tuberculosis.
(a) A State animal health official may request at any time that the Administrator designate part of a State as having a different tuberculosis classification under this part than the rest of the State. The requested zones must be delineated by the State animal health authorities, subject to approval by the Administrator. The request from the State must demonstrate that the State complies with the following requirements:
(1) The State must have the legal and financial resources to implement and enforce a tuberculosis eradication program and must have in place an infrastructure, laws, and regulations that require and ensure that State and Federal animal health authorities are notified of tuberculosis cases in domestic livestock or outbreaks in wildlife;
(2) The State in which the intended zones are located must maintain, in each intended zone, clinical and epidemiologic surveillance of animal species at risk of tuberculosis at a rate that allows detection of tuberculosis in the overall population of livestock at a 2 percent prevalence rate with 95 percent confidence. The designated tuberculosis epidemiologist must review reports of all testing for each zone within the State within 30 days of the testing; and
(3) The State must enter into a memorandum of understanding with APHIS in which the State agrees to adhere to any conditions for zone recognition particular to that request.
(b) Retention of APHIS recognition of a zone is subject to annual review by the Administrator. To retain recognition of a zone, a State must continue to comply with the requirements of paragraphs (a)(1), (a)(2), and (a)(3) of this section, as well as the requirements for maintaining or improving the tuberculosis risk classification of each zone in the State, and must retain for at least 2 years all certificates required under this part for the movement of cattle, bison, and captive cervids.
As used in subpart B, the following terms shall have the meanings set forth in this section except as otherwise specified.
All references in this subpart to the tuberculosis status of States and zones pertain to such status for cattle and bison only.
(a) The following are accredited-free States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, the Virgin Islands of the United States, Washington, West Virginia, Wisconsin, and Wyoming.
(b) The following are accredited-free zones:
(1) A zone in Michigan known as the Upper Peninsula that comprises Alger, Baraga, Chippewa, Delta, Dickinson, Gogebic, Houghton, Iron, Keweenaw, Luce, Mackinac, Marquette, Menominee, Ontonagon, and Schoolcraft Counties.
(2) All of the State of New Mexico except for the zone that comprises those portions of Curry and Roosevelt Counties, NM, described in § 77.9(b)(2).
(c) If an affected herd is detected in a State or zone classified as accredited-free, and the herd is depopulated and an epidemiologic investigation is completed within 90 days of the detection of the affected herd with no evidence of the spread of tuberculosis, the State or zone may retain its accredited-free status. If two or more affected herds are detected in an accredited-free State or zone within a 48-month period, the State or zone will be removed from the
(d) If any livestock other than cattle or bison are included in a newly assembled herd on a premises where a tuberculous herd has been depopulated, the State or zone must apply the herd test requirements contained in the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” (January 22, 1999, edition), which is incorporated by reference at § 77.1, to those other livestock in the same manner as to cattle and bison. Failure to do so will result in reclassification of the State or zone as modified accredited advanced.
(e) If tuberculosis is diagnosed within an accredited-free State or zone in an animal not specifically regulated by this part and a risk assessment conducted by APHIS determines that the outbreak poses a tuberculosis risk to livestock within the State or zone, the State or zone must implement a tuberculosis management plan, approved jointly by the State animal health official and the Administrator, within 6 months of the diagnosis. The management plan must include provisions for immediate investigation of tuberculosis in animals held for exhibition and in livestock and wildlife; the prevention of the spread of the disease to other animals held for exhibition and to livestock and wildlife; increased surveillance for tuberculosis in animals held for exhibition and wildlife; eradication of tuberculosis from individual herds; a timeline for tuberculosis eradication; and performance standards by which to measure yearly progress toward eradication. If a State or zone does not implement such a plan within the required 6 months, the State or zone will lose its accredited-free status and will be reclassified as modified accredited advanced.
(f) Accredited-free State or zone status must be renewed annually. To qualify for renewal of accredited-free State or zone status, a State must submit an annual report to APHIS certifying that the State or zone within the State complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication.” The report must be submitted to APHIS each year between October 1 and November 30.
Cattle or bison that originate in an accredited-free State or zone may be moved interstate without restriction.
(a) The following are modified accredited advanced States: Minnesota.
(b) The following are modified accredited advanced zones:
(1) All of the State of Michigan except for the zones that comprise those counties or portions of counties in Michigan described in § 77.7(b)(1) and § 77.11(b).
(2) The zone in New Mexico that comprises those portions of Curry and Roosevelt Counties, NM, described as follows:
(i)
(B) In T. 1 N., R. 35 E., of the NMPM: S
(ii)
(B) In T. 1 S., R. 35 E., of the NMPM: Secs. 2 through 10; secs. 15 through 22; SW
(C) In T. 2 S., R. 34 E., of the NMPM: Secs. 1 and 2; secs. 11 through 13; N
(D) In T. 2 S., R. 35 E., of the NMPM: Secs. 2 through 11; secs. 14 through 21; N
(c) If any livestock other than cattle or bison are included in a newly assembled herd on a premises where a tuberculous herd has been depopulated, the State or zone must apply the herd test requirements contained in the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” (January 22, 1999), which is incorporated by reference at § 77.1, for such newly assembled herds to those other livestock in the same manner as to cattle and bison. Failure to do so will result in the removal of the State or zone from the list of modified accredited advanced States or zones and its being reclassified as modified accredited.
(d) If tuberculosis is diagnosed within a modified accredited advanced State or zone in an animal not specifically regulated by this part and a risk assessment conducted by APHIS determines that the outbreak poses a tuberculosis risk to livestock within the State or zone, the State or zone must implement a tuberculosis management plan, approved jointly by the State animal health official and the Administrator, within 6 months of the diagnosis. The management plan must include provisions for immediate investigation of tuberculosis in animals held for exhibition and in livestock and wildlife; the prevention of the spread of the disease to other animals held for exhibition and to livestock and wildlife; increased surveillance for tuberculosis in animals held for exhibition and wildlife; eradication of tuberculosis from individual herds; a timeline for tuberculosis eradication; and performance standards by which to measure yearly progress toward eradication. If a State or zone does not implement such a plan within the required 6 months, the State or zone will be reclassified as modified accredited.
(e) Modified accredited advanced State or zone status must be renewed annually. To qualify for renewal of a modified accredited advanced State or zone status, a State must submit an annual report to APHIS certifying that the State or zone complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication.” The report must be submitted to APHIS each year between October 1 and November 30.
(f) To qualify for accredited-free status, a modified accredited advanced State or zone must demonstrate to the Administrator that it complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication,” has zero percent prevalence of affected cattle and bison herds, and has had no findings of tuberculosis in any cattle or bison in the State or zone for the previous 5 years.
Cattle or bison that originate in a modified accredited advanced State or zone, and that are not known to be infected with or exposed to tuberculosis, may be moved interstate only under one of the following conditions:
(a) The cattle or bison are moved directly to slaughter at an approved slaughtering establishment.
(b) The cattle or bison are sexually intact heifers moved to an approved feedlot, or are steers or spayed heifers; and are either officially identified or identified by premises of origin identification.
(c) The cattle or bison are from an accredited herd and are accompanied by a certificate stating that the accredited herd completed the testing
(d) The cattle or bison are sexually intact animals; are not from an accredited herd; are officially identified; and are accompanied by a certificate stating that they were negative to an official tuberculin test conducted within 60 days prior to the date of movement.
(a) The following are modified accredited States: None.
(b) The following are modified accredited zones: A zone in Michigan that comprises Alcona, Alpena, Antrim, Charlevoix, Cheboygan, Crawford, Emmet, Montmorency, Oscoda, Otsego, and Presque Isle Counties and those portions of Iosco and Ogemaw Counties that are north of the southernmost boundary of the Huron National Forest and the Au Sable State Forest.
(c) If any livestock other than cattle or bison are included in a newly assembled herd on a premises where a tuberculous herd has been depopulated, the State or zone must apply the herd test requirements contained in the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” (January 22, 1999, edition), which is incorporated by reference at § 77.1, for such newly assembled herds to those other livestock in the same manner as to cattle and bison. Failure to do so will result in the removal of the State or zone from the list of modified accredited States or zones and its being reclassified as accreditation preparatory.
(d) If tuberculosis is diagnosed within a modified accredited State or zone in an animal not specifically regulated by this part and a risk assessment conducted by APHIS determines that the outbreak poses a tuberculosis risk to livestock within the State or zone, the State or zone must implement a tuberculosis management plan, approved jointly by the State animal health official and the Administrator, within 6 months of the diagnosis. The management plan must include provisions for immediate investigation of tuberculosis in animals held for exhibition and in livestock and wildlife; the prevention of the spread of the disease to other animals held for exhibition and to livestock and wildlife; increased surveillance for tuberculosis in animals held for exhibition and wildlife; eradication of tuberculosis from individual herds; a timeline for tuberculosis eradication; and performance standards by which to measure yearly progress toward eradication. If a State or zone does not implement such a plan within the required 6 months, the State or zone will be reclassified as accreditation preparatory.
(e) Modified accredited State or zone status must be renewed annually. To qualify for renewal of a modified accredited State or zone status, a State must submit an annual report to APHIS certifying that the State or zone complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication.” The report must be submitted to APHIS each year between October 1 and November 30.
(f) To qualify for modified accredited advanced status, a modified accredited State or zone must demonstrate to the Administrator that it complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” and that tuberculosis has been prevalent in less than 0.01 percent of the total number of herds of cattle and bison in the State or zone for the most recent 2 years.
Cattle or bison that originate in a modified accredited State or zone, and that are not known to be infected with or exposed to tuberculosis, may be moved interstate only under one of the following conditions:
(a) The cattle or bison are moved directly to slaughter at an approved slaughtering establishment.
(b) The cattle or bison are sexually intact heifers moved to an approved feedlot, or are steers or spayed heifers; are either officially identified or identified by premises of origin identification; and are accompanied by a certificate stating that they were classified negative to an official tuberculin test conducted within 60 days prior to the date of movement.
(c) The cattle or bison are from an accredited herd and are accompanied by a certificate stating that the accredited herd completed the testing necessary for accredited status with negative results within 1 year prior to the date of movement.
(d) The cattle or bison are sexually intact animals; are not from an accredited herd; are officially identified; and are accompanied by a certificate stating that the herd from which they originated was negative to a whole herd test conducted within 1 year prior to the date of movement and that the individual animals to be moved were negative to an additional official tuberculin test conducted within 60 days prior to the date of movement, except that the additional test is not required if the animals are moved interstate within 60 days following the whole herd test.
(a) The following are accreditation preparatory States: None.
(b) The following are accreditation preparatory zones: None.
(c) If any livestock other than cattle or bison are included in a newly assembled herd on a premises where a tuberculous herd has been depopulated, the State or zone must apply the herd test requirements contained in the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” (January 22, 1999 edition), which is incorporated by reference at § 77.1, for such newly assembled herds to those other livestock in the same manner as to cattle and bison. Failure to do so will result in the removal of the State or zone from the list of accreditation preparatory States or zones and its being reclassified as nonaccredited.
(d) If tuberculosis is diagnosed within an accreditation preparatory State or zone in an animal not specifically regulated by this part and a risk assessment conducted by APHIS determines that the outbreak poses a tuberculosis risk to livestock within the State or zone, the State or zone must implement a tuberculosis management plan, approved jointly by the State animal health official and the Administrator, within 6 months of the diagnosis. The management plan must include provisions for immediate investigation of tuberculosis in animals held for exhibition and in livestock and wildlife; the prevention of the spread of the disease to other animals held for exhibition and to livestock and wildlife; increased surveillance for tuberculosis in animals held for exhibition and wildlife; eradication of tuberculosis from individual herds; a timeline for tuberculosis eradication; and performance standards by which to measure yearly progress toward eradication. If a State or zone does not implement such a plan within the required 6 months, the State or zone will be reclassified as nonaccredited.
(e) Accreditation preparatory State or zone status must be renewed annually. To qualify for renewal of accreditation preparatory State or zone status, a State must submit an annual report to APHIS certifying that the State or zone complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication.” The report must be submitted to APHIS each year between October 1 and November 30.
(f) To qualify for modified accredited status, an accreditation preparatory
Cattle or bison that originate in an accreditation preparatory State or zone, and that are not known to be infected with or exposed to tuberculosis, may be moved interstate only under one of the following conditions:
(a) The cattle or bison are moved directly to slaughter at an approved slaughtering establishment.
(b) The cattle or bison are sexually intact heifers moved to an approved feedlot, or are steers or spayed heifers; are officially identified or identified by a premises of origin identification; and are accompanied by a certificate stating that the herd from which they originated was negative to a whole herd test conducted within 1 year prior to the date of movement and that the individual animals to be moved were negative to an additional official tuberculin test conducted within 60 days prior to the date of movement, except that the additional test is not required if the animals are moved interstate within 6 months following the whole herd test.
(c) The cattle or bison are from an accredited herd; are officially identified; and are accompanied by a certificate stating that the accredited herd completed the testing necessary for accredited status with negative results within 1 year prior to the date of movement and that the animals to be moved were negative to an official tuberculin test conducted within 60 days prior to the date of movement.
(d) The cattle or bison are sexually intact animals; are not from an accredited herd; are officially identified; and are accompanied by a certificate stating that the herd from which they originated was negative to a whole herd test conducted within 1 year prior to the date of movement and that the individual animals to be moved were negative to two additional official tuberculin tests conducted at least 60 days apart and no more than 6 months apart, with the second test conducted within 60 days prior to the date of movement, except that the second additional test is not required if the animals are moved interstate within 60 days following the whole herd test.
(a) The following are nonaccredited States: None.
(b) The following are nonaccredited zones: None.
(c) To qualify for accreditation preparatory status, a nonaccredited State or zone must demonstrate to the Administrator that it complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” and that tuberculosis is prevalent in less than 0.5 percent of the total number of herds of cattle and bison in the State or zone.
Cattle or bison that originate in a nonaccredited State or zone, and that are not known to be infected with or exposed to tuberculosis, may be moved interstate only if the cattle or bison are accompanied by VS Form 1-27 and are moved interstate for slaughter in an officially sealed means of conveyance directly to an approved slaughtering establishment.
(a)
(1) Reactor cattle and bison must be individually identified by attaching to the left ear an approved metal eartag bearing a serial number and the inscription “U.S. Reactor,” or a similar State reactor tag, and must be:
(i) Branded with the letter “T,” at least 5 by 5 centimeters (2 by 2 inches) in size, high on the left hip near the tailhead; or
(ii) Permanently identified with the letters “TB” tattooed legibly in the left ear and sprayed with yellow paint on the left ear and either accompanied directly to slaughter by an APHIS or State representative or moved directly to slaughter in vehicles closed with official seals. Such official seals must be applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative.
(2) The reactor cattle or bison must be accompanied by a permit; and
(3) The reactor cattle or bison may not be moved interstate in a means of conveyance containing any animals susceptible to tuberculosis unless all of the animals are being moved directly to slaughter; and
(4) Any person who moves reactor cattle or bison interstate under this paragraph must plainly write or stamp upon the face of the transportation document the words “Tuberculin Reactor” and the following statement: “This conveyance must be cleaned and disinfected in accordance with 9 CFR 77.17(a)(5).”; and
(5) Each means of conveyance in which reactor cattle or bison have been transported interstate under this paragraph must be cleaned and disinfected by the carrier, in accordance with the provisions of §§ 71.6, 71.7, and 71.10 of this subchapter, under the supervision of an APHIS representative or State representative or an accredited veterinarian or other person designated by the Administrator. If, at the point where the cattle or bison are unloaded, such supervision or proper cleaning and disinfecting facilities are not available, and permission is obtained from an APHIS representative or State representative, the empty means of conveyance may be moved to a location where such supervision and facilities are available for cleaning and disinfecting. Permission will be granted if such movement does not present a risk of disseminating tuberculosis.
(b)
(1) Exposed cattle and bison must be individually identified by attaching to either ear an approved metal eartag bearing a serial number and must be:
(i) Branded with the letter “S,” at least 5 by 5 centimeters (2 by 2 inches) in size, high on the left hip near the tailhead; or
(ii) Accompanied directly to slaughter by an APHIS or State representative; or
(iii) Moved directly to slaughter in vehicles closed with official seals. Such official seals must be applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative.
(2) The exposed cattle and bison must be moved in accordance with paragraphs (a)(2), (a)(3), and (a)(5) of this section.
(c)
The Administrator may, with the concurrence of the State animal health official of the State of destination, upon request in specific cases, allow the interstate movement of cattle or bison not otherwise provided for in this part that have not been classified as reactor cattle or bison and are not otherwise known to be affected with tuberculosis, under such conditions as the Administrator may prescribe in each specific case to prevent the spread of tuberculosis. The Administrator shall promptly notify the appropriate State animal health official of the State of destination of any such action.
All conveyances and associated equipment, premises, and structures that are used for receiving, holding, shipping, loading, unloading, and delivering cattle or bison in connection with their interstate movement and that are determined by cooperating State and Federal animal health officials to be contaminated because of occupation or use by tuberculous or reactor livestock must be cleaned and disinfected under the supervision of the cooperating State or Federal animal health officials. Such cleaning and disinfecting must be done in accordance with procedures approved by the cooperating State or Federal animal health officials. Cleaning and disinfection must be completed before the premises, conveyances, or materials may again be used to convey, hold, or in any way come in contact with any livestock.
As used in subpart C, the following terms shall have the meanings set forth in this section except as otherwise specified.
(1) The single cervical tuberculin (SCT) test.
(2) The comparative cervical tuberculin test (CCT) test.
All references in this subpart to the tuberculosis status of States and zones pertain to such status for captive cervids.
(a) The following are accredited-free States: None.
(b) The following are accredited-free zones: None.
(c) If an affected herd is detected in a State or zone classified as accredited-free, and the herd is depopulated and a complete epidemiologic investigation is completed within 120 days of the detection of the affected herd with no evidence of the spread of tuberculosis, the State or zone may retain its accredited-free status. If two or more affected herds are detected in an accredited-free State or zone within a 48-month period, the State or zone will be removed from the list of accredited-free States or zones and will be reclassified as modified accredited advanced.
(d) If any livestock other than captive cervids are included in a newly assembled herd on a premises where a tuberculous herd has been depopulated, the State or zone must apply the herd test requirements contained in the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” (January 22, 1999 edition), which is incorporated by reference at § 77.1, to those other livestock in the same manner as to captive cervids. Failure to do so will result in reclassification of the State or zone as modified accredited advanced.
(e) If tuberculosis is diagnosed within an accredited-free State or zone in an animal not specifically regulated by this part and a risk assessment conducted by APHIS determines that the outbreak poses a tuberculosis risk to livestock within the State or zone, the State or zone must implement a tuberculosis management plan, approved jointly by the State animal health official and the Administrator, within 6 months of the diagnosis. The management plan must include provisions for immediate investigation of tuberculosis in animals held for exhibition and in livestock and wildlife; the prevention of the spread of the disease to other animals held for exhibition and to livestock and wildlife; increased surveillance for tuberculosis in animals held for exhibition and wildlife; eradication of tuberculosis from individual
(f) Accredited-free State or zone status must be renewed annually. To qualify for renewal of accredited-free State or zone status, a State must submit an annual report to APHIS certifying that the State or zone within the State complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication.” The report must be submitted to APHIS each year between October 1 and November 30.
Notwithstanding any other provisions of this part, captive cervids that originate in an accredited-free State or zone may be moved interstate without restriction.
(a) The following are modified accredited advanced States: None.
(b) The following are modified accredited advanced zones: None.
(c) If any livestock other than captive cervids are included in a newly assembled herd on a premises where a tuberculous herd has been depopulated, the State or zone must apply the herd test requirements contained in the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” (January 22, 1999 edition), which is incorporated by reference at § 77.1, for such newly assembled herds to those other livestock in the same manner as to captive cervids. Failure to do so will result in the removal of the State or zone from the list of modified accredited advanced States or zones and its being reclassified as modified accredited.
(d) If tuberculosis is diagnosed within a modified accredited advanced State or zone in an animal not specifically regulated by this part and a risk assessment conducted by APHIS determines that the outbreak poses a tuberculosis risk to livestock within the State or zone, the State or zone must implement a tuberculosis management plan, approved jointly by the State animal health official and the Administrator, within 6 months of the diagnosis. The management plan must include provisions for immediate investigation of tuberculosis in animals held for exhibition and in livestock and wildlife; the prevention of the spread of the disease to other animals held for exhibition and to livestock and wildlife; increased surveillance for tuberculosis in animals held for exhibition and wildlife; eradication of tuberculosis from individual herds; a timeline for tuberculosis eradication; and performance standards by which to measure yearly progress toward eradication. If a State or zone does not implement such a plan within the required 6 months, the State or zone will be reclassified as modified accredited.
(e) Modified accredited advanced State or zone status must be renewed annually. To qualify for renewal of a modified accredited advanced State or zone status, a State must submit an annual report to APHIS certifying that the State or zone complies with all the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” regarding modified accredited advanced States. The report must be submitted to APHIS each year between October 1 and November 30.
(f) To qualify for accredited-free status, a modified accredited advanced State or zone must demonstrate to the Administrator that it complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication,” has zero percent prevalence of affected captive cervid herds, and has had no findings of tuberculosis in any captive cervids in the State or zone for the previous 5 years.
Captive cervids that originate in a modified accredited advanced State or zone, and that are not known to be infected with or exposed to tuberculosis, may be moved interstate only under one of the following conditions:
(a) The captive cervids are moved directly to slaughter at an approved slaughtering establishment.
(b) The captive cervids are from an accredited herd, qualified herd, or monitored herd; are officially identified; and are accompanied by a certificate stating that the herd completed the requirements for accredited herd, qualified herd, or monitored herd status within 24 months prior to the date of movement.
(c) The captive cervids are officially identified and are accompanied by a certificate stating that they were negative to an official tuberculin test conducted within 90 days prior to the date of movement.
(a) States listed in paragraph (b) of this section must submit to APHIS
(b) The following are modified accredited States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, the Virgin Islands of the United States, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.
(c) The following are modified accredited zones: None.
(d) If any livestock other than captive cervids are included in a newly assembled herd on a premises where a tuberculous herd has been depopulated, the State or zone must apply the herd test requirements contained in the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” (January 22, 1999, edition), which is incorporated by reference at § 77.1, for such newly assembled herds to those other livestock in the same manner as to captive cervids. Failure to do so will result in the removal of the State or zone from the list of modified accredited States or zones and its being reclassified as accreditation preparatory.
(e) If tuberculosis is diagnosed within a modified accredited State or zone in an animal not specifically regulated by this part and a risk assessment conducted by APHIS determines that the outbreak poses a tuberculosis risk to livestock within the State or zone, the State or zone must implement a tuberculosis management plan, approved jointly by the State animal health official and the Administrator, within 6 months of the diagnosis. The management plan must include provisions for immediate investigation of tuberculosis in animals held for exhibition and in livestock and wildlife; the prevention of the spread of the disease to other animals held for exhibition and to livestock and wildlife; increased surveillance for tuberculosis in animals
(f) Modified accredited State or zone status must be renewed annually. To qualify for renewal of a modified accredited State or zone status, a State must submit an annual report to APHIS certifying that the State or zone complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication.” The report must be submitted to APHIS each year between October 1 and November 30.
(g) To qualify for modified accredited advanced status, a modified accredited State or zone must demonstrate to the Administrator that it complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” and that tuberculosis has been prevalent in less than 0.01 percent of the total number of captive cervids in the State or zone for the most recent 2 years.
Except for captive cervids from a qualified herd or monitored herd, as provided in §§ 77.36 and 77.37, respectively, captive cervids that originate in a modified accredited State or zone, and that are not known to be infected with or exposed to tuberculosis, may be moved interstate only under one of the following conditions:
(a) The captive cervids are moved directly to slaughter at an approved slaughtering establishment.
(b) The captive cervids are from an accredited herd and are accompanied by a certificate stating that the accredited herd completed the testing necessary for accredited status with negative results within 24 months prior to the date of movement.
(c) The captive cervids are sexually intact animals; are not from an accredited herd; are officially identified; and are accompanied by a certificate stating that the herd from which they originated was negative to a whole herd test conducted within 1 year prior to the date of movement and that the individual animals to be moved were negative to an additional official tuberculin test conducted within 90 days prior to the date of movement, except that the additional test is not required if the animals are moved interstate within 6 months following the whole herd test.
(a) The following are accreditation preparatory States: None.
(b) The following are accreditation preparatory zones: None.
(c) If any livestock other than captive cervids are included in a newly assembled herd on a premises where a tuberculous herd has been depopulated, the State or zone must apply the herd test requirements contained in the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” (January 22, 1999, edition), which is incorporated by reference at § 77.1, for such newly assembled herds to those other livestock in the same manner as to captive cervids. Failure to do so will result in the removal of the State or zone from the list of accreditation preparatory States or zones and its being reclassified as nonaccredited.
(d) If tuberculosis is diagnosed within an accreditation preparatory State or zone in an animal not specifically regulated by this part and a risk assessment conducted by APHIS determines that the outbreak poses a tuberculosis risk to livestock within the State or zone, the State or zone must implement a tuberculosis management plan, approved jointly by the State animal
(e) Accreditation preparatory State or zone status must be renewed annually. To qualify for renewal of accreditation preparatory State or zone status, a State must submit an annual report to APHIS certifying that the State or zone complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication.” The report must be submitted to APHIS each year between October 1 and November 30.
(f) To qualify for modified accredited status, an accreditation preparatory State or zone must demonstrate to the Administrator that it complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” and that tuberculosis has been prevalent in less than 0.1 percent of the total number of herds of captive cervids in the State or zone for the most recent year.
Except for captive cervids from a qualified herd or monitored herd, as provided in §§ 77.36 and 77.37, respectively, captive cervids that originate in an accreditation preparatory State or zone, and that are not known to be infected with or exposed to tuberculosis, may be moved interstate only under one of the following conditions:
(a) The captive cervids are moved directly to slaughter at an approved slaughtering establishment.
(b) The captive cervids are from an accredited herd; are officially identified; and are accompanied by a certificate stating that the accredited herd completed the testing necessary for accredited status with negative results within 24 months prior to the date of movement and that the individual animals to be moved were negative to an official tuberculin test conducted within 90 days prior to the date of movement.
(c) The captive cervids are sexually intact animals; are not from an accredited herd; are officially identified; and are accompanied by a certificate stating that the herd from which they originated was negative to a whole herd test conducted within 1 year prior to the date of movement and that the individual animals to be moved were negative to two additional official tuberculin tests conducted at least 90 days apart and no more than 6 months apart, with the second test conducted within 90 days prior to the date of movement, except that the second additional test is not required if the animals are moved interstate within 6 months following the whole herd test.
(a) The following are nonaccredited States: None.
(b) The following are nonaccredited zones: None.
(c) To qualify for accreditation preparatory status, a nonaccredited State or zone must demonstrate to the Administrator that it complies with the provisions of the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” and that tuberculosis is prevalent in less than 0.5 percent of the total number of herds of captive cervids in the State or zone.
Captive cervids that originate in a nonaccredited State or zone and that are not known to be infected with or exposed to tuberculosis may not be moved interstate only if they are accompanied by VS Form 1-27 and are moved interstate in an officially sealed means of conveyance directly to slaughter at an approved slaughtering establishment.
(a) Except for movement from accredited-free States and zones in accordance with § 77.23, movement from accredited herds in accordance with § 77.35, and movement to slaughter in accordance with §§ 77.25(a), 77.27(a), 77.29(a), and 77.31(d), no captive cervid may be moved interstate unless it has been tested using an official tuberculosis test, and it is moved in compliance with this part.
(b) No captive cervid with a response to any official tuberculosis test is eligible for interstate movement unless the captive cervid subsequently tests negative to a supplemental official tuberculosis test or is moved interstate directly to slaughter or necropsy in accordance with § 7.40.
(c) Except for captive cervids moving interstate under permit directly to slaughter or necropsy under § 77.40, each captive cervid or shipment of captive cervids to be moved interstate must be accompanied by a certificate issued within 30 days of the movement by a State or Federal animal health official or an accredited veterinarian.
(d) Captive cervids in zoological parks that have been accredited by the American Zoo and Aquarium Association (AZA) are exempt from the regulations in this part when the captive cervids are moved directly interstate between AZA member facilities. Any captive cervids moved interstate that are not moved directly from an AZA member facility to another AZA member facility must be moved in accordance with the regulations in this subpart.
(a)
(1) A designated accredited veterinarian may conduct the SCT test, except as provided in § 77.34(a)(2) and § 77.39(e) and (f).
(2) [Reserved]
(b)
(2) [Reserved]
(c)
(d)
(2) [Reserved]
(e)
(2) Interpretation of a CCT test will be in accordance with the classification requirements described in § 77.34(b).
(3) [Reserved]
(f)
(a)
(2) The SCT test is the primary test to be used in affected herds and in herds that have received captive cervids from an affected herd. When used with affected herds or in herds that have received captive cervids from an affected herd, the SCT test may only be administered by a veterinarian employed by the State in which the test is administered or employed by USDA. In affected herds or herds that have received captive cervids from an affected herd, each captive cervid that responds to the SCT test must be classified as a reactor, unless the DTE determines that the captive cervid should be classified as a suspect because of possible exposure to a tuberculous animal.
(b)
(2) A captive cervid tested with the CCT test must be classified as negative if it has a response to the bovine PPD tuberculin that is less than 1 mm.
(3) Unless the testing veterinarian determines that the captive cervid should be classified as a reactor because of possible exposure to a tuberculous animal, a captive cervid tested with the CCT test must be classified as a suspect if:
(i) It has a response to the bovine PPD tuberculin that is greater than 2 mm and that is equal to the response to the avian PPD tuberculin; or
(ii) It has a response to the bovine PPD tuberculin that is equal to or greater than 1mm and equal to or less than 2mm and that is equal to or greater than the response to the avian PPD tuberculin.
(4) A captive cervid tested with the CCT test must be classified as a reactor if:
(i) It has a response to the bovine PPD tuberculin that is greater than 2 mm and that is at least 0.5 mm greater than the response to the avian PPD tuberculin; or
(ii) It has been classified as a suspect on two successive CCT tests.
(iii) Any exceptions to reactor classification under the conditions in paragraph (b)(4)(i) and (b)(4)(ii) of this section must be justified by the testing veterinarian in writing and have the concurrence of the DTE.
(a)
(1) All captive cervids in the herd eligible for testing in accordance with § 77.33(f) must have tested negative to at least two consecutive official tuberculosis tests, conducted at 9-15 month intervals. However, captive cervids under 1 year of age that are not natural additions to the herd do not have to be tested if they were born in and originate from an accredited herd.
(2) The owner of the herd must have a document issued by cooperating State or Federal animal health officials stating that the herd has met the requirements in paragraph (a)(1) of this section and is classified as an accredited herd.
(b)
(c)
(1) The captive cervid to be added must be moved directly from an accredited herd;
(2) The captive cervid to be added must be moved directly from a qualified or monitored herd and must have tested negative to an official tuberculosis test conducted within 90 days prior to movement to the premises of the accredited herd. Any captive cervid moved from a qualified or monitored herd must also be isolated from all members of the accredited herd until it tests negative to an official tuberculosis test conducted at least 90 days following the date of arrival at the premises of the accredited herd. If a group of captive cervids is being moved together, the entire group must be isolated from all other livestock during the testing period, but captive cervids in the group need not be isolated from each other during that period. Such herd additions will not receive status as members of the accredited herd for purposes of interstate movement until they have tested negative to an official tuberculosis test and have been released from isolation; or
(3) If the captive cervid to be added is not being moved directly from a classified herd, the captive cervid must be isolated from all other members of the herd of origin and must test negative to two official tuberculosis tests. The isolation must begin at the time of the first official tuberculosis test. The tests must be conducted at least 90 days apart, and the second test must be conducted within 90 days prior to movement to the premises of the accredited herd. The captive cervid must also be isolated from all members of the accredited herd until it tests negative to an official tuberculosis test conducted at least 90 days following the date of arrival at the premises of the accredited herd. If a group of captive cervids is being moved together, the entire group must be isolated from all other animals during the testing period, but captive cervids in the group need not be isolated from each other during that period. Such herd additions will not receive status as members of the accredited herd for purposes of interstate movement until they have tested negative to an official tuberculosis test and have been released from isolation.
(4) A captive cervid to be added must not have been exposed during the 90 days prior to its movement to either:
(i) A captive cervid from a herd with a lower classification status than its own; or
(ii) Any tuberculous livestock.
(d)
(a)
(1) All captive cervids in the herd eligible for testing in accordance with § 77.33(f) must have tested negative to one official tuberculosis test that was administered to the herd within a 7-month period. However, captive cervids under 1 year of age that are not natural additions do not have to be tested if they were born in and originate from an accredited, qualified, or monitored herd.
(2) The owner of the herd must have a document issued by cooperating State and Federal animal health officials stating that the herd has met the requirement in paragraph (a)(1) of this section and is classified as a qualified herd.
(b)
(1) The captive cervid is not known to be infected with or exposed to tuberculosis; and
(2) The captive cervid is accompanied by a certificate, as provided in § 77.32(c), that includes a statement that the captive cervid is from a qualified herd. Except as provided in paragraphs (b)(3) and (b)(4) of this section, the certificate must also state that the captive cervid has tested negative to an official tuberculosis test conducted within 90 days prior to the date of movement. If a group of captive cervids from a qualified herd is being moved interstate together to the same destination, all captive cervids in the group may be moved under one certificate.
(3) Captive cervids under 1 year of age that are natural additions to the qualified herd or that were born in and originate from a classified herd may move without testing, provided that the certificate accompanying them states that the captive cervids are natural additions to the qualified herd or were born in and originated from a classified herd and have not been exposed to captive cervids from an unclassified herd.
(4) Captive cervids being moved interstate for the purpose of exhibition only may be moved without testing, provided they are returned to the premises of origin no more than 90 days after leaving the premises, have no contact with other livestock during movement and exhibition, and are accompanied by a certificate that includes a statement that the captive cervid is from a qualified herd and will otherwise meet the requirements of this paragraph.
(c)
(1) The captive cervid to be added must be moved directly from an accredited herd;
(2) The captive cervid to be added must be moved directly from a qualified or monitored herd and must have tested negative to an official tuberculosis test conducted within 90 days
(3) If the captive cervid to be added is not being moved directly from a classified herd, the captive cervid must be isolated from all other animals in its herd of origin and must test negative to two official tuberculosis tests prior to movement. The isolation must begin at the time of the first official tuberculosis test. The tests must be conducted at least 90 days apart, and the second test must be conducted within 90 days prior to movement to the premises of the qualified herd. The captive cervid must then be kept in isolation from all animals until it tests negative to an official tuberculosis test conducted at least 90 days following the date of arrival at the premises of the qualified herd. If a group of captive cervids is being moved together, the entire group must be isolated from all other livestock during the testing period, but captive cervids in the group need not be isolated from each other during that period. Such herd additions will not receive status as members of the qualified herd for purposes of interstate movement until they have tested negative to an official tuberculosis test and been released from isolation.
(4) A captive cervid to be added must not have been exposed during the 90 days prior to its movement to either:
(i) A captive cervid from a herd with a lower classification status than its own; or
(ii) Any tuberculous livestock.
(d)
(a)
(1) Identification records must be maintained by the person, firm, or corporation responsible for the management of the herd for as long as status as a monitored herd is desired. Such records must be maintained on all captive cervids in the herd that are slaughtered, inspected, and found negative for tuberculosis at an approved slaughtering establishment or necropsied at an approved diagnostic laboratory. Identification records may also include captive cervids from the herd that tested negative for tuberculosis in accordance with requirements for interstate movement. No less than one-half of the captive cervids on which records are kept must be slaughter inspected; and
(2) A sufficient number of captive cervids in the herd must be slaughter inspected or tested for interstate movement to ensure that tuberculosis infection at a prevalence level of 2 percent or more will be detected with a confidence level of 95 percent.
(b)
(1) The captive cervid is not known to be infected with or exposed to tuberculosis; and
(2) The captive cervid is accompanied by a certificate, as provided in § 77.32(c), that includes a statement that the captive cervid is from a monitored herd. Except as provided in paragraph (b)(3) of this section, the certificate must also state that the captive cervid has tested negative to an official tuberculosis test conducted within 90 days prior to the date of movement. If a group of captive cervids from a monitored herd is being moved interstate together to the same destination, all captive cervids in the group may be moved under one certificate.
(3) Captive cervids under 1 year of age that are natural additions to the monitored herd or that were born in and originate from a classified herd may move without testing, provided that the certificate accompanying them states that the captive cervids are natural additions to the monitored herd or were born in and originated from a classified herd and have not been exposed to captive cervids from an unclassified herd.
(c)
(1) The captive cervid to be added must be moved directly from an accredited herd;
(2) The captive cervid to be added must be moved directly from a qualified or monitored herd and must have tested negative to an official tuberculosis test conducted within 90 days prior to movement to the premises of the monitored herd; or
(3) If the captive cervid to be added is not being moved directly from a classified herd, the captive cervid must be isolated from all other animals and must test negative to two official tuberculosis tests. The isolation must begin at the time of the first official tuberculosis test. The tests must be conducted at least 90 days apart, and the second test must be conducted within 90 days prior to movement to the premises of the monitored herd. The captive cervid must then be kept in isolation from all animals until it tests negative to an official tuberculosis test conducted at least 90 days following the date it arrives at the premises of the monitored herd. If a group of captive cervids is being moved together, the entire group must be isolated from all other animals during the testing period, but captive cervids in the group need not be isolated from each other during that period. Such herd additions will not receive status as members of the monitored herd for purposes of interstate movement until they have tested negative to an official tuberculosis test and been released from isolation.
(4) A captive cervid to be added must not have been exposed during the 90 days prior to its movement to either:
(i) A captive cervid from a herd with a lower classification status than its own; or
(ii) Any tuberculous livestock.
(d)
The Administrator may, with the concurrence of the cooperating State animal health officials of the State of destination, and upon request in specific cases, permit the movement of captive cervids not otherwise provided for in this part which have not been classified as reactors and are not otherwise known to be affected with tuberculosis, under such conditions as the Administrator may prescribe in each specific case to prevent the spread of tuberculosis. The Administrator shall promptly notify the appropriate cooperating State animal health officials of the State of destination of any such action.
(a)
(A) The first CCT test must be administered within the first 10 days following the SCT test or, if not, must be administered at least 90 days after the SCT test. If the CCT test is administered within 10 days of the SCT test, the injection must be on the side of the neck opposite the injection for the SCT test.
(B) [Reserved]
(ii) A captive cervid classified as a suspect on the first CCT test must be quarantined until the following has occurred:
(A) A suspect on the first CCT test is tested with a second CCT test at least 90 days after the first CCT test and is found negative for tuberculosis.
(B) [Reseerved]
(2)
(b)
(1)
(2)
(i) If, upon slaughter inspection or necropsy, any reactors exhibit lesions compatible with or suggestive of tuberculosis, found by histopathology, without the isolation of
(ii) If
(iii) If upon slaughter inspection or necropsy all reactors exhibit no gross lesions (NGL) of tuberculosis and no evidence of tuberculosis infection is found by histopathology and culture of
(A) The remainder of the herd is given a whole herd test and is found negative for tuberculosis.
(B) The remainder of the herd is given a whole herd test, and all reactors to the whole herd test exhibit no gross lesions (NGL) of tuberculosis upon slaughter inspection or necropsy and no evidence of tuberculosis infection is found by histopathology or culture of
(iv) If no evidence of tuberculosis is found in any reactor upon slaughter inspection or necropsy, but it is not possible to conduct a whole herd test on the remainder of the herd, the herd will be evaluated, based on criteria such as the testing history of the herd and the State history of tuberculosis infection, by the DTE to determine whether the herd may be released from quarantine.
(c)
(d)
(e)
(1) If bovine tuberculosis is confirmed in any of the exposed captive cervids by bacterial isolation of
(2) If any of the exposed captive cervids are found to exhibit lesions compatible with or suggestive of tuberculosis, found by histopathology, without the isolation of
(3) If all the exposed captive cervids test negative for tuberculosis, the receiving herd will be released from quarantine if it is given a whole herd test and is found negative for tuberculosis and will return to the herd classification in effect before the herd was quarantined. In addition, the receiving herd must be retested with the SCT test 1 year after release from quarantine in
(f)
(1) If the herd is identified as the source of captive cervids having lesions of tuberculosis and
(2) If the herd is identified as the source of captive cervids that exhibit lesions compatible with or suggestive of tuberculosis, found by histopathology, without the isolation of
(3) If the herd is not identified as the source herd, the herd will be released from quarantine if the herd is given a whole herd test and is found negative for tuberculosis. The herd will then return to the herd classification status in effect before the herd was quarantined.
(g)
(2) A herd newly assembled on premises where a tuberculous herd has been depopulated must be given two consecutive annual whole herd tests. The first test must be administered at least 6 months after the assembly of the new herd. If the whole herd tests are not conducted within the indicated timeframe, the herd will be quarantined. If the herd tests negative to the two whole herd tests, there are no further requirements. If any captive cervid in the herd responds on one of the whole herd tests, the herd will be subject to the provisions of paragraph (a) or (b) of this section. If the premises has been vacant for more than 1 year preceding the assembly of the new herd on the premises, these requirements may be waived if the risk of tuberculosis transmission to the newly assembled herd is deemed negligible by cooperating State and Federal animal health officials.
(a)
(2) If, upon necropsy, a captive cervid is found without evidence of
(3) Reactors, suspects, and exposed captive cervids may be slaughtered only at an approved slaughtering establishment, as defined in § 77.20.
(b)
(i) The classification of the captive cervid (reactor, suspect, or exposed);
(ii) The reactor eartag number or, for suspects and exposed captive cervids, the official eartag or other approved identification number;
(iii) The owner's name and address;
(iv) The origin and destination of the captive cervids;
(v) The number of captive cervids covered by the permit; and
(vi) The purpose of the movement.
(2)
(i) Branded with the letter “T” high on the left hip near the tailhead and at least 5 by 5 centimeters (2 by 2 inches) in size; or
(ii) Permanently identified by the letters “TB” tattooed legibly in the left ear, sprayed on the left ear with yellow paint, and either accompanied directly to necropsy or slaughter by an APHIS or State representative or moved directly to necropsy or slaughter in a vehicle closed with official seals. Such official seals must be applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative.
(3)
(i) Branded with the letter “S” high on the left hip near the tailhead and at least 5 by 5 centimeters (2 by 2 inches) in size; or
(ii) Either accompanied directly to necropsy or slaughter by an APHIS or State representative or moved directly to necropsy or slaughter in a vehicle closed with official seals. Such official seals must be applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative.
All conveyances and associated equipment, premises, and structures that are used for receiving, holding, shipping, loading, unloading, and delivering captive cervids in connection with their interstate movement and that are determined by cooperating State and Federal animal health officials to be contaminated because of occupation or use by tuberculous or reactor livestock must be cleaned and disinfected under the supervision of the cooperating State or Federal animal health officials. Such cleaning and disinfecting must be done in accordance with the procedures approved by the cooperating State or Federal animal health officials. Cleaning and disinfection must be completed before the premises, conveyances, or materials may again be used to convey, hold, or in any way come in contact with any livestock.
7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
The following terms are defined in this section:
(a) The certificate must show the official eartag number, individual animal register breed association registration tattoo, individual animal registered breed association registration brand, individual animal registered breed association registration number, or similar individual identification of each animal to be moved; the number of animals covered by the certificate; the purpose for which the animals are to be moved; the points of origin and destination; the consignor; and the consignee. Ownership brands may be used in place of individual animal identification on certificates for cattle moved interstate when no official test for brucellosis is required under this part, provided the ownership brands are registered with the official brand recording agency. Except as provided in paragraphs (b) and (c) of this definition, all of the information required by this paragraph must be typed or written on the certificate.
(b) As an alternative to typing or writing individual animal identification on a certificate, another document may be used to provide this information, but only under the following conditions:
(1) The document must be a state form or APHIS form that requires individual identification of animals;
(2) A legible copy of the document must be stapled to the original and each copy of the certificate;
(3) Each copy of the document must identify each animal to be moved with the certificate, but any information pertaining to other animals, and any unused space on the document for recording animal identification, must be crossed out in ink; and
(4) The following information must be written in ink in the identification column on the original and each copy of the certificate and must be circled or boxed, also in ink, so that no additional information can be added:
(i) The name of the document; and
(ii) Either the serial number on the document or, if the document is not imprinted with a serial number, both the name of the person who prepared the document and the date the document was signed.
(c) As an alternative to typing or writing ownership brands on a certificate, an official brand inspection certificate may be used to provide this information, but only under the following conditions:
(1) A legible copy of the official brand inspection certificate must be stabled to the original and each copy of the certificate;
(2) Each copy of the official brand inspection certificate must show the ownership brand of each animal to be moved with the certificate, but any other ownership brands, and any unused space for recording ownership brands, must be crossed out in ink;
(3) The following information must be written in ink in the identification column on the original and each copy of the certificate and must be circled or boxed, also in ink, so that no additional information can be added:
(i) The name of the attached document; and
(ii) Either the serial number on the official brand inspection certificate or, if the official brand inspection certificate is not imprinted with a serial number, both the name of the person who prepared the official brand inspection certificate and the date it was signed.
(a)
(1) In the case of dairy cattle, by conducting a minimum of four consecutive negative brucellosis ring tests at not less than 90-day intervals, followed by a negative herd blood test within 90 days after the last negative brucellosis ring test; or
(2) By conducting at least two consecutive negative herd blood tests not less than 10 months nor more than 14 months apart.
(b)
(a)
(2)
(ii)
(B)
(
(
(
(
(
(3)
(b)
(2)
(3) All herds known to be affected shall have approved individual herd plans in effect within 15 days after notification by a State representative or APHIS representative of a brucellosis reactor in the herd. Each State shall ensure that such approved individual herd plans are effectively complied with, as determined by the Administrator.
(a)
(2)
(ii)
(B)
(
(
(
(
(
(3)
(b)
(2)
(3) All herds known to be affected shall have approved individual herd plans in effect within 45 days after notification by a State representative or APHIS representative of a brucellosis reactor in the herd. Each State shall ensure that such approved individual herd plans are effectively complied with, as determined by the Administrator.
(a)
(2)
(ii)
(B)
(
(
(
(
(
(3)
(b)
(2)
(3) All herds known to be affected shall have approved individual herd plans in effect within 45 days after notification by a State representative or APHIS representative of a brucellosis reactor in the herd. Each State shall ensure that such approved individual herd plans are effectively complied with, as determined by the Administrator.
(c)
(2) A State or area must make continued progress over a 2-year period in reducing the prevalence of brucellosis as determined by epidemiologic evaluation or it will be placed under Federal quarantine.
(a)
(2)
(ii)
(B)
(
(
(
(
(
(3)
(b)
(2)
(3) All herds known to be affected shall have approved individual herd plans in effect within 15 days after notification by a State representative or APHIS representative of a brucellosis reactor in the herd. Each State shall ensure that such approved individual herd plans are effectively complied with, as determined by the Administrator.
(4)
(A) The affected herd must be immediately quarantined, tested for brucellosis, and depopulated; and
(B) An epidemiological investigation must be performed and the investigation must confirm that brucellosis has not spread from the affected herd. All herds on premises adjacent to the affected herd (adjacent herds), all herds from which animals may have been brought into the affected herd (source herds), and all herds that may have had contact with or accepted animals from the affected herd (contact herds) must be epidemiologically investigated, and each of those herds must be placed under an approved individual herd plan. If the investigating epidemiologist determines that a herd blood test
(ii) After the close of the 60-day period following the date an animal in the herd is determined to be infected, APHIS will conduct a review to confirm that the requirements of paragraph (b)(4)(i) have been satisfied and that the State is in compliance with all other applicable provisions.
(b) Premises where cattle or bison remain for not less than 4 months immediately before movement from the premises but which are not used to assemble cattle or bison from any other premises for 4 months before such movement.
(b) All animals under common ownership or supervision on two or more premises which are geographically separated but on which animals from the different premises have been interchanged or had contact with each other.
(1) 6 months of age or over and not official vaccinates, except steers and spayed heifers;
(2) Official calfhood vaccinates of any age which are parturient or postparturient;
(3) Official calfhood vaccinates of beef breeds or bison with the first pair of permanent incisors fully erupted (2 years of age or over); and
(4) Official calfhood vaccinates of dairy breeds with partial eruption of the first pair of permanent incisors (20 months of age or over).
(b) [Reserved]
(b)(1) Permanently identified by a “V” hot brand high on the hip near the tailhead at least 5 by 5 centimeters (2 by 2 inches) in size, or by an official AV (adult vaccination) tattoo in the right ear preceded by the quarter of the year and followed by the last digit of the year; and
(2) Identified with an official eartag or individual animal registered breed association registration brand or individual animal registered breed association tattoo.
(b) Permanently identified by a tattoo and by an official vaccination
(a) National Uniform Eartagging System.
(b) Animal identification number (AIN).
(c) Premises-based number system. The premises-based number system combines an official premises identification number (PIN), as defined in § 71.1 of this chapter, with a producer's livestock production numbering system to provide a unique identification number. The PIN and the production number must both appear on the official tag.
(d) Any other numbering system approved by the Administrator for the identification of animals in commerce.
(A) When conditions and time are such that no other test is available; or
(B) When the owner or the owner's agent requests it because of time or situation constraints; or
(C) In specifically approved stockyards when the State animal health official either:
(
(
(D) To test market cattle identification (MCI) program test samples. Cattle and bison which test positive to the BAPA test or RST under the MCI program must be retested using the standard card test or the standard plate or tube agglutination test.
(ii) Results of the standard card test also may be used to supplement the results of other official tests conducted in the cooperative State-Federal laboratory to give the designated epidemiologist additional information when classifying cattle and bison.
(iii)
(2)
(3)
(i) Cattle and bison which are not official vaccinates:
(A) Fifty percent fixation (2 plus) in a dilution of 1:20 or higher—brucellosis reactor;
(B) Fifty percent fixation (2 plus) in a dilution of 1:10 but less than 50 percent fixation (2 plus) in a dilution of 1:20—brucellosis suspect;
(C) Less than 50 percent fixation (2 plus) in a dilution of 1:10—brucellosis negative;
(ii) Official vaccinates vaccinated with a
(A) Twenty-five percent fixation (1 plus) in a dilution of 1:40 or higher—brucellosis reactor;
(B) Fifty percent fixation (2 plus) in a dilution of 1:10 but less than 25 percent
(C) Less than 50 percent fixation (2 plus) in a dilution of 1:10—brucellosis negative.
(iii) Official vaccinates vaccinated with an approved brucella vaccine other than a
(A) Fifty percent fixation (2 plus) in a dilution of 1:20 or higher—brucellosis reactor;
(B) Fifty percent fixation (2 plus) in a dilution of 1:10 but less than 50 percent fixation (2 plus) in a dilution of 1:20—brucellosis suspect;
(C) Less than 50 percent fixation (2 plus) in a dilution of 1:10—brucellosis negative.
(4)
(i) Cattle and bison which are not official vaccinates:
(A) Fixation in a dilution of 1:10 or higher—brucellosis reactor;
(B) Fixation in a dilution of 1:5 but no fixation in a dilution of 1:10—brucellosis suspect;
(C) No fixation in a dilution of 1:5 or lower—brucellosis negative;
(ii) Official vaccinates vaccinated with a
(A) Fixation in a dilution of 1:20 or higher—brucellosis reactor;
(B) Fixation in a dilution of 1:10 but no fixation in a dilution of 1:20—brucellosis suspect;
(C) Fixation in a dilution of 1:5 or less but no fixation in a dilution of 1:10—brucellosis negative.
(iii) Official vaccinates vaccinated with an approved brucella vaccine other than a
(A) Fixation in a dilution of 1:10 or higher—brucellosis reactor;
(B) Fixation in a dilution of 1:5 but no fixation in a dilution of 1:10—brucellosis suspect;
(C) No fixation in a dilution of 1:5 or lower—brucellosis negative.
(5)
(i) Cattle and bison which are not official vaccinates:
(A) Complete agglutination at a titer of 1:25 or higher—brucellosis reactor;
(B) Less than complete agglutination at a titer of 1:25—brucellosis negative;
(ii) Official adult vaccinates more than 5 months after vaccination with a
(A) Incomplete agglutination at a titer of 1:100 or higher—brucellosis reactor;
(B) Complete agglutination at a titer of 1:25 or higher when the manual or technicon automated complement-fixation test is not conducted—brucellosis reactor;
(C) Complete agglutination at a titer of 1:50 or less when the manual complement-fixation test or the technicon automated complement-fixation test is conducted and results in a classification of brucellosis suspect or brucellosis negative—brucellosis suspect;
(D) Less than complete agglutination at a titer of 1:25—brucellosis negative;
(iii) Official adult vaccinates less than 5 months after vaccination with a
(iv) Official vaccinates vaccinated with an approved brucella vaccine other than a
(A) Complete agglutination at a titer of 1:25 or higher—brucellosis reactor;
(B) Less than complete agglutination at a titer of 1:25—brucellosis negative.
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(13)
(14) The evaluation of test results for all cattle and bison shall be the responsibility of a designated epidemiologist in each State. The designated epidemiologist shall consider the animal and herd history and other epidemiologic factors when determining the brucellosis classification of cattle and bison. Deviations from the brucellosis classification criteria as provided in this definition of official test are acceptable when made by the designated epidemiologist.
(i) The designated epidemiologist may consider the results of CITE
(b)
(2)
(i) If all of the following apply: (A) The swine are part of a herd not known to be affected; (B) No swine tested, individually or as part of a group, has a complete agglutination reaction at a dilution of 1:100 or higher; and (C) the swine are tested as part of a herd blood test or are part of a validated brucellosis-free herd, then the swine are classified according to the following agglutination reactions:
(ii) If any of the following apply: (A) The swine are part of a herd known to be affected; (B) Any swine tested, individually or as part of a group, has a complete agglutination reaction at a dilution of 1:100 or higher or; (C) The swine are not part of a validated brucellosis-free herd and are not being tested as part of a herd blood test, then the swine are classified according to the following agglutination reactions:
(3)
(4)
(5)
(6) The evaluation of test results for all swine shall be the responsibility of a designated epidemiologist in each State. The designated epidemiologist shall consider the animal and herd history and other epidemiologic factors when determining the brucellosis classification of swine. Deviations from the brucellosis classification criteria as provided in this definition of official test are acceptable when made by the designated epidemiologist.
(1) They were born and maintained in the herd since birth; or
(2) They have been in the herd for at least 120 days.
(b) Animals will have the status of the State or area from which they are moved if:
(1) They were born and maintained in the State or area since birth; or
(2) They were previously moved from a State or area of equal or higher class to the State or area; or
(3) They were previously moved from a State or area of lower class to the
(c) Cattle penned in a specifically approved stockyard with cattle from a lower class State or area, in violation of the requirements set forth in § 71.20 of this chapter, shall have the status of the State or area of lower class for any subsequent movement.
(2) Any certified brucellosis-free herd in a quarantined area which is negative to a herd blood test 120 days before or after designation of the area as a quarantined area.
(b)
(a) All cattle and bison, except steers and spayed heifers, leaving the quarantined feedlot must (1) Be accompanied by a permit and move directly to a recognized slaughtering establishment; or (2) Be “S” branded and accompanied by an “S” brand permit and move directly to an approved intermediate handling facility and then directly to another quarantined feedlot or a recognized slaughtering establishment; or (3) Be accompanied by a permit issued by the State animal health official and move directly to another quarantined feedlot; or (4) After being “S” branded at the quarantined feedlot, be accompanied by an “S” brand permit and move directly to a specifically approved stockyard approved to receive brucellosis exposed cattle and bison and then directly to a recognized slaughtering establishment or another quarantined feedlot; or (5) After being “S” branded at the quarantined feedlot, be accompanied by an “S” brand permit and move directly to a specifically approved stockyard approved to receive brucellosis exposed cattle and bison and then directly to an approved intermediate handling facility and then directly to another quarantined feedlot or a recognized slaughtering establishment. However, finished fed cattle moving directly to a recognized slaughtering establishment are exempt from the permit/”S” brand permit requirement.
(b) The State animal health official and the Veterinarian in Charge shall establish procedures for accounting for all cattle and bison entering or leaving quarantined feedlots.
(a) Cattle and bison which are not official vaccinates and which have lost their first pair of temporary incisors (18 months of age or over), except steers and spayed heifers;
(b) Official calfhood vaccinates 18 months of age or over which are parturient or postparturient;
(c) Official calfhood vaccinates of beef breeds or bison with the first pair of permanent incisors fully erupted (2 years of age or over); and
(d) Official calfhood vaccinates of dairy breeds with partial eruption of the first pair of permanent incisors (20 months of age or over).
(b) A swine herd in a State that has not been validated as brucellosis-free, provided the herd meets the conditions for validation, as follows:
(1)
(2)
(a) Any herd found to have swine brucellosis during the 2-year qualification period preceding the application has been depopulated. More than one finding of a swine brucellosis-infected herd during the qualification period disqualifies the State from validation as brucellosis-free; and
(b) During the 2-year qualification period, the State has completed surveillance, annually, as follows:
(1)
(2)
(3)
(c) To maintain validation, a State must annually survey at least 5 percent of its breeding swine, and demonstrate traceback to herd of origin of at least 80 percent of all MST reactors. A State must demonstrate its continuing ability to meet the criteria set forth in paragraph (c) of this definition within 36-40 months of receiving validated brucellosis-free State status to retain that status.
For
(a) Any certificate, permit, or “S” brand permit required by this part for the interstate movement of animals shall be delivered to the person moving the animals by the shipper or shipper's agent at the time the animals are delivered for movement and shall accompany the animals to their destination and be delivered to the consignee or the person receiving the animals.
(b) The APHIS representative, State representative, or accredited veterinarian issuing a certificate or permit required for the interstate movement of animals under this part, except for permits for entry and “S” brand permits, shall forward a copy thereof as follows:
(1) A copy of each certificate shall be forwarded to the State animal health official of the State of destination, or to the State animal health official of the State of origin for forwarding to the State of destination; or
(2) A copy of each permit shall be forwarded to the State animal health official of the State of destination.
Cattle and bison moving interstate, except cattle and bison moved directly to a recognized slaughtering establishment, approved intermediate handling facility, or quarantined feedlot, shall be moved only in a means of conveyance which has been cleaned in accordance with §§ 71.5, 71.7, 71.10, and 71.11 of this chapter and, if unloaded in the course of such movement, shall be handled only in pens cleaned in accordance with the provisions of §§ 71.4, 71.7, 71.10, and 71.11 of this chapter.
Cattle may not be moved interstate except in compliance with this subpart.
Steers and spayed heifers may be moved interstate without restriction under this subpart.
(a)
(1) Directly to a recognized slaughtering establishment;
(2) Directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment; or
(3) From a farm of origin directly to a specifically approved stockyard approved to receive brucellosis reactors and then
(i) Directly to a recognized slaughtering establishment; or
(ii) Directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment.
(b)
(1) “B” branded (as defined in § 78.1); or
(2) Accompanied directly to slaughter by an APHIS or State representative; or
(3) Moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying permit.
(c)
(d)
(e)
Brucellosis exposed cattle may be moved interstate only as follows:
(a)
(i) Directly to a recognized slaughtering establishment without further restriction under this part; or
(ii) Directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment if accompanied by a permit or “S” brand permit.
(2) Brucellosis exposed cattle may be moved interstate directly to a recognized slaughtering establishment if such cattle are:
(i) Individually identified by an official eartag or a United States Department of Agriculture backtag;
(ii) Accompanied by a permit or “S” brand permit; and
(iii)(A) “S” branded before leaving the premises from which they are to be moved interstate; or
(B) “B” branded when a claim for indemnity is made under part 51 of this chapter; or
(C) Official adult vaccinates; or
(D) Accompanied directly to slaughter by an APHIS or State representative; or
(E) Moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative.
(3) Brucellosis exposed cattle may be moved interstate directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment if such cattle are:
(i) Individually identified by an official eartag or a United States Department of Agriculture backtag;
(ii) Accompanied by a permit or “S” brand permit; and
(iii)(A) “S” branded before leaving the premises from which they are to be moved interstate; or
(B) “B” branded when a claim for indemnity is made under part 51 of this chapter; or
(C) Official adult vaccinates; or
(D) Moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying permit or “S” brand permit.
(4) Brucellosis exposed cattle moving to slaughter from a farm of origin may be moved directly to a specifically approved stockyard approved to receive brucellosis exposed cattle and then directly to a recognized slaughtering establishment if such cattle are:
(i) Individually identified by an official eartag or United States Department of Agriculture backtag;
(ii) Accompanied by a permit or “S” brand permit; and
(iii)(A) “S” branded before leaving the premises from which they are to be moved interstate; or
(B) “B” branded when a claim for indemnity is made under part 51 of this chapter; or
(C) Official adult vaccinates; or
(D) Moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative.
(5) Brucellosis exposed cattle moving to slaughter from a farm of origin may be moved directly to a specifically approved stockyard approved to receive brucellosis exposed cattle and then directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment if such cattle are:
(i) Individually identified by an official eartag or United States Department of Agriculture backtag;
(ii) Accompanied by a permit or “S” brand permit; and
(iii)(A) “S” branded before leaving the premises from which they are to be moved interstate; or
(B) “B” branded when a claim for indemnity is made under part 51 of this chapter; or
(C) Official adult vaccinates; or
(D) Moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying permit or “S” brand permit.
(b)
(1) Individually identified by an official eartag or a United States Department of Agriculture backtag;
(2) Accompanied by a permit or “S” brand permit; and
(3)(i) “S” branded before leaving the premises from which they are to be moved interstate; or
(ii) Official adult vaccinates; or
(iii) Moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying permit or “S” brand permit.
(c)
(1) Such brucellosis exposed cattle from herds known to be affected other than female cattle which originate in Class B States or areas or Class C States or areas may be moved interstate if the cattle are:
(i) Under 6 months of age and weaned from brucellosis reactors or brucellosis exposed cows not less than 30 days immediately preceding interstate movement; or
(ii) Under 6 months of age and nursing brucellosis exposed cows in a herd subjected to a herd blood test within 10 days prior to interstate movement; or
(iii) Official vaccinates under 1 year of age from a herd following an approved individual herd plan.
(2) Cattle moved interstate from a farm of origin directly to a specifically approved stockyard in accordance with § 78.9(b)(3)(iii), 78.9(c)(3)(iii), or 78.9(d)(3) of this part and subsequently determined to be brucellosis exposed may be moved interstate directly back to the farm of origin under the following conditions:
(i) Prior to interstate movement, State representatives of the State in which the cattle are located and the State of destination advise APHIS that such movement would not be contrary to the laws and regulations of their respective States;
(ii) Prior to interstate movement, the State representative of the State of destination agrees to quarantine the cattle on arrival and to require that all test-eligible cattle on the farm of origin be subjected to an official test; and
(iii) The cattle are accompanied to the farm of origin by a permit.
Male cattle which are not test eligible and are from herds not known to be affected may be moved interstate without further restriction. Female cattle which are not test eligible and are from herds not known to be affected may be moved interstate only in accordance with § 78.10 of this part and this section. Test-eligible cattle which are not brucellosis exposed and are from herds not known to be affected may be moved interstate only in accordance with § 78.10 and as follows:
(a)
(1)
(ii) Such cattle may be moved interstate from a farm of origin directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment if accompanied by a permit.
(iii) Such cattle may be moved interstate from other than a farm of origin directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment
(2)
(3)
(i) Such cattle are moved interstate from a farm of origin directly to a specifically approved stockyard; or
(ii) Such cattle are moved interstate from a farm of origin or returned interstate to a farm of origin in the course of normal ranching operations, without change of ownership, directly to or from another premises owned, leased, or rented by the same individual; or
(iii) Such cattle are moved interstate accompanied by a certificate which states, in addition to the items specified in § 78.1, that the cattle originated in a Class Free State or area.
(b)
(1)
(ii) Such cattle may be moved interstate from a farm of origin directly to an approved intermediate handling facility without restriction under this subpart.
(iii) Such cattle from other than a farm of origin or nonquarantined feedlot may be moved interstate directly to a recognized slaughtering establishment or directly to a specifically approved stockyard and then directly to a recognized slaughtering establishment if identity to the Class A State or area is maintained by means of identification tag numbers appearing on sale records showing the consignor or by penning cattle from the farm or State or area apart from other animals.
(iv) Such cattle from other than a farm of origin may be moved interstate accompanied by a permit.
(A) Directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment; or
(B) Directly to a specifically approved stockyard and then directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment.
(2)
(ii) Such cattle from other than a farm of origin may be moved interstate directly to a quarantined feedlot or directly to a specifically approved stockyard and then directly to a quarantined feedlot if identity to the Class A State or area is maintained by means of identification tag numbers appearing on sale records showing the consignor or by penning cattle from one farm or State or area apart from other animals.
(3)
(i) Such cattle originate in a certified brucellosis-free herd and are accompanied interstate by a certificate which states, in addition to the items specified in § 78.1, that the cattle originated in a certified brucellosis-free herd; or
(ii) Such cattle are negative to an official test within 30 days prior to such interstate movement and are accompanied interstate by a certificate which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(iii) Such cattle are moved interstate from a farm of origin directly to a specifically approved stockyard and are subjected to an official test upon arrival at the specifically approved stockyard prior to losing their identity with the farm of origin; or
(iv) Such cattle are moved interstate from a farm of origin or returned interstate to a farm of origin in the course of normal ranching operations, without change of ownership, directly to or from another premises owned, leased, or rented by the same individual.
(c)
(1)
(ii) Such cattle may be moved interstate from a farm of origin directly to an approved intermediate handling facility without restriction under this subpart.
(iii) Such cattle may be moved interstate from a nonquarantined feedlot directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment if they are accompanied by a permit or “S” brand permit.
(iv) Such cattle may be moved interstate from a farm of origin or a nonquarantined feedlot directly to a specifically approved stockyard and then to a recognized slaughtering establishment if:
(A) They are negative to an official test conducted at the specifically approved stockyard and are accompanied to slaughter by a certificate or “S” brand permit which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(B) They originate from a certified brucellosis-free herd and identity to the certified brucellosis-free herd is maintained; or
(C) They are “S” branded at the specifically approved stockyard, accompanied by an “S” brand permit, and moved directly to a recognized slaughtering establishment; or
(D) They are moved from the specifically approved stockyard accompanied by an “S” brand permit and in vehicles closed with official seals applied and removed by an APHIS representative, a State representative, an accredited veterinarian, or an individual authorized for this purpose by an APHIS representative.
(v) Such cattle may be moved interstate from a farm of origin or a nonquarantined feedlot directly to a specifically approved stockyard and then to an approved intermediate handling facility and then directly to a recognized slaughtering establishment if:
(A) They are negative to an official test conducted at the specifically approved stockyard and are accompanied by an “S” brand permit which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(B) They originate from a certified brucellosis-free herd, identity to the certified brucellosis-free herd is maintained, and they are accompanied by an “S” brand permit; or
(C) They are “S” branded at the specifically approved stockyard, accompanied by an “S” brand permit, and moved directly to an approved intermediate handling facility; or
(D) They are accompanied by an “S” brand permit and moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying “S” brand permit.
(vi) Such cattle from other than a farm of origin or a nonquarantined feedlot may be moved interstate to a recognized slaughtering establishment only if:
(A) They are negative to an official test within 30 days prior to such interstate movement and are accompanied by a certificate or “S” brand permit which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(B) They originate from a certified brucellosis-free herd and identity to the certified brucellosis-free herd is maintained; or
(C) They are “S” branded, accompanied by an “S” brand permit, and moved directly to a recognized slaughtering establishment; or
(D) They are accompanied by an “S” brand permit and moved in vehicles closed with official seals applied and removed by an APHIS representative, a State representative, an accredited veterinarian, or by an individual authorized for this purpose by an APHIS representative.
(vii) Such cattle from other than a farm of origin or a nonquarantined feedlot may be moved interstate to an approved intermediate handling facility and then directly to a recognized slaughtering establishment only if:
(A) They are negative to an official test within 30 days prior to such interstate movement and are accompanied by a permit or “S” brand permit which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(B) They originate from a certified brucellosis-free herd, identity to the certified brucellosis-free herd is maintained, and they are accompanied by an “S” brand permit; or
(C) They are “S” branded, accompanied by an “S” brand permit, and moved directly to an approved intermediate handling facility; or
(D) They are accompanied by an “S” brand permit and moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying “S” brand permit.
(2)
(A) A quarantined feedlot if such cattle are “S” branded upon arrival at the quarantined feedlot; or
(B) A specifically approved stockyard and then directly to a quarantined feedlot or directly to an approved intermediate handling facility and then directly to a quarantined feedlot, if the cattle are “S” branded upon arrival at the specifically approved stockyard and are accompanied to the quarantined feedlot by an “S” brand permit; or
(C) An approved intermediate handling facility and then directly to a quarantined feedlot, if the cattle are “S” branded upon arrival at the approved intermediate handling facility and are accompanied to the quarantined feedlot by an “S” brand permit; or
(D) A quarantined feedlot, a specifically approved stockyard and then directly to a quarantined feedlot, or an approved intermediate handling facility and then directly to a quarantined feedlot if the cattle are accompanied by an “S” brand permit and moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying “S” brand permit.
(ii) Such cattle from other than a farm of origin may be moved interstate to a quarantined feedlot if:
(A) They are negative to an official test within 30 days prior to such movement and are accompanied by a certificate which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(B) They are “S” branded, accompanied by an “S” brand permit, and moved directly to a quarantined feedlot; or
(C) They are accompanied by an “S” brand permit and moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying “S” brand permit.
(3)
(i) Such cattle originate in a certified brucellosis-free herd and are accompanied interstate by a certificate which states, in addition to the items specified in § 78.1, that the cattle originated in a certified brucellosis-free herd; or
(ii) Such cattle are negative to an official test within 30 days prior to interstate movement, have been issued a permit for entry, and are accompanied interstate by a certificate which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(iii) Such cattle are moved interstate from a farm of origin directly to a specifically approved stockyard and are subjected to an official test upon arrival at the specifically approved stockyard prior to losing their identity with the farm of origin; or
(iv) Such cattle are moved interstate from a farm of origin or returned interstate to a farm of origin in the course of normal ranching operations, without change of ownership, directly to or from another premises owned, leased or rented by the same individual, and (A) The cattle being moved originate from a herd in which (
(v) The State animal health officials of the State of origin and State of destination may waive the requirements of paragraph (c)(3)(iv) of this section in writing.
(d)
(1)
(ii) Such cattle may be moved interstate from a farm of origin directly to an approved intermediate handling facility without restriction under this subpart.
(iii) Such cattle may be moved interstate from a nonquarantined feedlot directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment if they are accompanied by a permit or “S” brand permit.
(iv) Such cattle may be moved interstate from a farm of origin or a nonquarantined feedlot directly to a specifically approved stockyard and then to a recognized slaughtering establishment if:
(A) They are negative to an official test conducted at the specifically approved stockyard and are accompanied by a certificate or “S” brand permit which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(B) They originate from a certified brucellosis-free herd and identity to
(C) They are “S” branded at the specifically approved stockyard, accompanied by an “S” brand permit, and moved directly to a recognized slaughtering establishment; or
(D) They are moved from the specifically approved stockyard accompanied by an “S” brand permit and in vehicles closed with official seals applied and removed by an APHIS representative, a State representative, an accredited veterinarian, or an individual authorized for this purpose by an APHIS representative.
(v) Such cattle may be moved interstate from a farm of origin or a nonquarantined feedlot directly to a specifically approved stockyard and then to an approved intermediate handling facility and then directly to a recognized slaughtering establishment if:
(A) They are negative to an official test conducted at the specifically approved stockyard and are accompanied by an “S” brand permit which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(B) They originate from a certified brucellosis-free herd, identity to the certified brucellosis-free herd is maintained, and they are accompanied by an “S” brand permit; or
(C) They are “S” branded at the specifically approved stockyard, accompanied by an “S” brand permit, and moved directly to an approved intermediate handling facility; or
(D) They are accompanied by an “S” brand permit and moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying “S” brand permit.
(vi) Such cattle from other than a farm of origin or a nonquarantined feedlot may be moved interstate to a recognized slaughtering establishment only if:
(A) They are negative to an official test within 30 days prior to such interstate movement and are accompanied by a certificate or “S” brand permit which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(B) They originate from a certified brucellosis-free herd and identity to the certified brucellosis-free herd is maintained; or
(C) They are “S” branded, accompanied by an “S” brand permit, and moved directly to a recognized slaughtering establishment; or
(D) They are accompanied by an “S” brand permit and moved in vehicles closed with official seals applied and removed by an APHIS representative, a State representative, an accredited veterinarian, or by an individual authorized for this purpose by the APHIS representative.
(vii) Such cattle from other than a farm of origin or a nonquarantined feedlot may be moved interstate to an approved intermediate handling facility and then directly to a recognized slaughtering establishment only if:
(A) They are negative to an official test within 30 days prior to such interstate movement and are accompanied by a permit or “S” brand permit which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(B) They originate from a certified brucellosis-free herd, identity to the certified brucellosis-free herd is maintained, and they are accompanied by an “S” brand permit; or
(C) They are “S” branded, accompanied by an “S” brand permit, and moved directly to an approved intermediate handling facility; or
(D) They are accompanied by an “S” brand permit and moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying “S” brand permit.
(2)
(A) A quarantined feedlot if such cattle are “S” branded upon arrival at the quarantined feedlot; or
(B) A specifically approved stockyard and then directly to a quarantined feedlot, or directly to an approved intermediate handling facility and then directly to a quarantined feedlot, if the cattle are “S” branded upon arrival at the specifically approved stockyard and are accompanied to the quarantined feedlot by an “S” brand permit; or
(C) An approved intermediate handling facility and then directly to a quarantined feedlot, if the cattle are “S” branded upon arrival at the approved intermediate handling facility and are accompanied to the quarantined feedlot by an “S” brand permit; or
(D) A quarantined feedlot, a specifically approved stockyard and then directly to a quarantined feedlot, or an approved intermediate handling facility and then directly to a quarantined feedlot if the cattle are accompanied by an “S” brand permit and moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying “S” brand permit.
(ii) Such cattle from other than a farm of origin may be moved interstate to a quarantined feedlot if:
(A) They are negative to an official test within 30 days prior to such movement and are accompanied by a certificate which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(B) They are “S” branded, accompanied by an “S” brand permit, and moved directly to a quarantined feedlot; or
(C) They are accompanied by an “S” brand permit and moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying “S” brand permit.
(3)
(a) Female dairy cattle born after January 1, 1984, which are 4 months of age or over must be official vaccinates to move interstate into or out of a Class B State or area
(b) Female cattle born after January 1, 1984, which are 4 months of age or over must be official vaccinates to move into a Class C State or area
(c) Female cattle born after January 1, 1984, which are 4 months of age or over must be official vaccinates to move interstate out of a Class C State or area
Cattle, except brucellosis reactors and brucellosis exposed cattle, which are moved interstate to a specifically approved stockyard but fail to comply with the requirements of this part for release from the specifically approved stockyard may be moved from the specifically approved stockyard only as follows:
(a) With the concurrence of the State animal health officials of the State of origin and State of destination, directly back to the farm of origin accompanied by a permit; or
(b) Directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment or directly to an approved intermediate handling facility and then directly to a quarantined feedlot and then directly to a recognized slaughtering establishment if such cattle are “S” branded and accompanied by an “S” brand permit; or
(c) Directly to a recognized slaughtering establishment if such cattle are
(1) “S” branded and accompanied by an “S” brand permit; or
(2) Accompanied by an “S” brand permit and moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, an accredited veterinarian, or an individual authorized for this purpose by an APHIS representative.
(d) Directly to a quarantined feedlot if such cattle are “S” branded and accompanied by an “S” brand permit.
Not withstanding any provisions in the regulations to the contrary, cattle may be moved interstate from a quarantined area only in accordance with § 78.10 and this section.
(a)
(b)
(c)
(d)
(1)
(ii) Cattle from qualified herds in a quarantined area may be moved interstate from a farm of origin directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment or directly to an approved intermediate handling facility and then directly to a quarantined feedlot and then directly to a recognized slaughtering establishment if they are negative to an official test within 30 days prior to such interstate movement and are accompanied by an “S” brand permit which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(iii) Cattle from qualified herds in a quarantined area may be moved interstate from a farm of origin directly to a specifically approved stockyard and then directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment or directly to an approved intermediate handling facility and then directly to a quarantined feedlot and then directly to a recognized slaughtering establishment if they are negative to an official test within 30 days prior to such interstate movement and are accompanied by a permit or “S” brand permit which states, in addition to the items specified in § 78.1, the test dates and results of the official tests; or
(iv) Cattle from qualified herds in a quarantined area may be moved interstate in accordance with § 78.8(a).
(2)
(ii) Cattle from qualified herds in a quarantined area may be moved in accordance with § 78.8(b).
(3)
(i) The cattle, except official vaccinates less than 1 year of age and cattle less than 6 months of age, are negative to an official test within 30 days prior to such interstate movement; and
(ii) The cattle are accompanied interstate by a certificate which states, in addition to the items specified in § 78.1, the test dates and results of the official tests when such tests are required.
(e)
The Administrator may, upon request in specific cases, permit the interstate movement of cattle not otherwise provided for in this subpart, under such conditions as the Administrator may prescribe in each case to prevent the spread of brucellosis. The
(a) A rodeo bull that is test-eligible and that is from a herd not known to be affected may be moved interstate if:
(1) The bull is classified as brucellosis negative based upon an official test conducted less than 365 days before the date of interstate movement:
(2) The bull is identified with an official eartag or any other official identification device or method approved by the Administrator;
(3) There is no change of ownership since the date of the last official test;
(4) A certificate accompanies each interstate movement of the bull; and
(5) A permit for entry is issued for each interstate movement of the bull.
(b) A bull that would qualify as a rodeo bull, but that is used for breeding purposes during the 365 days following the date of being tested, may be moved interstate only if the bull meets the requirements for cattle in this subpart.
Bison may not be moved interstate except in compliance with this subpart.
Bison steers and spayed heifers may be moved interstate without restriction under this subpart.
(a)
(1) Directly to a recognized slaughtering establishment;
(2) Directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment; or
(3) From a farm of origin directly to a specifically approved stockyard approved to receive brucellosis reactors and then
(i) Directly to a recognized slaughtering establishment; or
(ii) Directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment.
(b)
(1) “B” branded (as defined in § 78.1); or
(2) Accompanied directly to slaughter by an APHIS or State representative; or
(3) Moved in vehicles closed with official seals applied and removed by an APHIS representative, State representative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official seal numbers must be recorded on the accompanying permit.
(c)
(d)
(e)
Brucellosis exposed bison may be moved interstate only as follows:
(a)
(1) Directly to a recognized slaughtering establishment or directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment; or
(2) From a farm of origin directly to a specifically approved stockyard approved to receive brucellosis exposed bison and then
(i) Directly to a recognized slaughtering establishment; or
(ii) Directly to an approved intermediate handling facility and then directly to a recognized slaughtering establishment.
(b)
(c)
(1) Are under 6 months of age and were weaned from brucellosis reactor or brucellosis exposed bison not less than 30 days immediately preceding interstate movement; or
(2) Are under 6 months of age and nursing brucellosis exposed bison in a herd subjected to a herd blood test within 10 days prior to interstate movement; or
(3) Are official vaccinates under 1 year of age from a herd following an approved individual herd plan.
Bison from herds not known to be affected may be moved interstate only as follows:
(a)
(b)
(c)
(d)
(1) Such bison under 6 months of age may be moved interstate when accompanied by a certificate.
(2) Such bison which are official vaccinates under 2 years of age and are not parturient or postparturient may be moved interstate when accompanied by a certificate.
(3) Such bison may be moved interstate if they are negative to an official test within 30 days prior to such movement and are accompanied by a certificate which states, in addition to the items specified in § 78.1, the dates and results of the official tests.
(4) Such bison may be moved interstate if they originate in a certified brucellosis-free herd and are accompanied by a certificate which states, in addition to the items specified in § 78.1,
The Administrator may, upon request in specific cases, permit the interstate movement of bison not otherwise provided for in this subpart, under such conditions as the Administrator may prescribe in each case to prevent the spread of brucellosis. The Administrator shall promptly notify the State animal health officials of the States involved of any such action.
(a) Brucellosis reactor swine, brucellosis exposed swine, feral swine, sows, and boars may not be moved interstate or in interstate commerce except in compliance with this subpart.
(b) Each person who causes the movement of swine in interstate commerce is responsible for the identification of the swine as required by this subpart. No such person shall remove or tamper with or cause the removal of or tampering with an identification tattoo or approved swine identification tag required in this subpart except at the time of slaughter, or as may be authorized by the Administrator upon request in specific cases and under such conditions as the Administrator may impose to ensure continuing identification.
(c)(1) Feral swine may be moved interstate directly to slaughter if they do not come into physical contact with any domestic swine or other livestock.
(2) Feral swine from monitored-negative populations may be moved interstate other than directly to slaughter if accompanied by a permit issued by the APHIS representative or the State animal health official in the State of origin.
(3) Feral swine found negative to an official test within the 30 days prior to the interstate movement may be moved interstate other than directly to slaughter if accompanied by a permit issued by the APHIS representative or the State animal health official in the State of origin.
(a)
(1) Directly to a recognized slaughtering establishment; or
(2) Directly to a stockyard posted under the Packers and Stockyards Act, as amended (7 U.S.C. 181
(b)
(c)
(d)
(e)
(a) Brucellosis exposed swine may be moved interstate only if accompanied by a permit and only for immediate slaughter as follows:
(1) Directly to a recognized slaughtering establishment; or
(2) Directly to a stockyard posted under the Packers and Stockyards Act, as amended (7 U.S.C. 181
(b) Brucellosis exposed swine from a herd known to be affected with brucellosis may be moved interstate from the herd known to be affected only if such swine are individually identified by attaching to the left ear a metal tag bearing a serial number and the inscription, “U.S. Reactor,” or a metal tag bearing a serial number designated by the State animal health official for identifying brucellosis reactors.
(a) Sows and boars may be moved in interstate commerce for slaughter or for sale for slaughter if they are identified in accordance with § 71.19 of this chapter either:
(1) Before being moved in interstate commerce and before being mixed with swine from any other source; or
(2) After being moved in interstate commerce but before being mixed with swine from any other source only if they have been moved directly from their herd of origin to:
(i) A recognized slaughtering establishment; or
(ii) A stockyard, market agency, or dealer operating under the Packers and Stockyards Act, as amended (7 U.S.C. 181
(b) Sows and boars may be moved in interstate commerce for breeding only if they are identified in accordance with § 71.19 of this chapter before being moved in interstate commerce and before being mixed with swine from any other source, and the sows and boars either:
(1) Are from a validated brucellosis-free herd or a validated brucellosis-free State and are accompanied by a certificate that states, in addition to the items specified in § 78.1, that the swine originated in a validated brucellosis-free herd or a validated brucellosis-free State; or
(2) Have tested negative to an official test conducted within 30 days prior to interstate movement and are accompanied by a certificate that states, in addition to the items specified in § 78.1, the dates and results of the official tests.
(c) Sows and boars may be moved in interstate commerce for purposes other than slaughter or breeding without restriction under this subpart if they are identified in accordance with § 71.19 of this chapter.
The Administrator may, upon request in specific cases, permit the movement in interstate commerce of swine not otherwise provided for in this subpart under such conditions as the Administrator may prescribe in each case to prevent the spread of brucellosis. The Administrator shall promptly notify the State animal health officials of the States involved of any such action.
The Administrator may amend §§ 78.41 and 78.42 to reclassify States and areas as Class Free, Class A, Class B, Class C, or quarantined when the Administrator determines that the States or areas meet the appropriate
(a)
(b)
(c)
For
None.
Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Vermont, Virgin Islands, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
For
7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
(i) Meets the requirements of § 79.6; or
(ii) Effectively enforces a State designed plan that the Administrator determines is at least as effective in controlling scrapie as the requirements of § 79.6.
(2) The Administrator has determined the following States to be Consistent States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.
(2) Any animal born in a flock after a scrapie-positive animal was born into that flock or lambed in that flock, if born before that flock completes the requirements of a flock plan; or
(3) Any animal that was commingled with a scrapie-positive female animal during or up to 30 days after she lambed, kidded, or aborted, or while a visible vaginal discharge was present, or that was commingled with any other scrapie-positive female animal for 24 hours or more, including during activities such as shows and sales or while in marketing channels; or
(4) Any animal in a noncompliant flock.
(1) The flocks are enrolled as separate flocks in the SFCP; or
(2) A State or APHIS representative determines, based upon examination of flock records, that:
(i) There is no interchange of animals between the flocks;
(ii) The flocks never commingle and are kept at least 30 feet apart at all times or are separated by a solid wall through, over, or under which fluids cannot pass and through which contact cannot occur;
(iii) The flocks have separate flock records and identification;
(iv) The flocks have separate lambing facilities, including buildings and pastures, and a pasture or building used for lambing by one flock is not used by the other flock at any time; and
(v) The flocks do not share equipment without cleaning and disinfection in accordance with § 54.7(e) of this chapter. Additional guidance on acceptable means of cleaning and disinfection is also available in the Scrapie Flock Certification Program standards and the Scrapie Eradication Uniform Methods and Rules.
(1) The progeny of a scrapie-positive dam; or
(2) Born in the same flock during the same lambing season as progeny of a scrapie-positive dam, unless the progeny of the scrapie-positive dam are from separate contemporary lambing groups; or
(3) Born in the same flock during the same lambing season that a scrapie-positive animal was born, or during any subsequent lambing season, if born before that flock completes the requirements of a flock plan; or
(4) An exposed female sheep that has not tested QR, HR, or RR at codon 171 using an official genotype test.
(1) A State in which scrapie has not been identified in a goat during the previous 10 years;
(2) A State in which scrapie has been identified in a goat during the previous 10 years, but the scrapie-positive goat was not born in the State and resided in the State for less than 54 months and did not kid while in the State; or,
(3) A State in which scrapie has been identified in a goat during the previous 10 years, and the scrapie-positive goat was commingled with sheep, but flock records allowed a complete epidemiologic investigation to be completed and all resulting infected, source, and exposed goat herds have completed flock plans and are in compliance with post-exposure monitoring plans.
(2) Any exposed flock whose owner fails to make animals available for testing within 60 days of notification, or as mutually agreed, or whose owner fails to submit required postmortem samples;
(3) Any flock whose owner has misrepresented, or who employs a person who has misrepresented, the scrapie status of an animal or any other information on a certificate, permit, owner statement, or other official document within the last 5 years; or
(4) Any flock whose owner or manager has moved, or who employs a person who has moved, an animal in violation of this chapter within the last 5 years.
(1) National Uniform Eartagging System.
(2) Animal identification number (AIN).
(3) Premises-based number system. The premises-based number system combines an official premises identification number (PIN), as defined in this section, with a producer's livestock production numbering system to
(4) Any other numbering system approved by the Administrator for the identification of animals in commerce.
(1) The State's two-letter postal abbreviation followed by the premises' assigned number; or
(2) A seven-character alphanumeric code, with the right-most character being a check digit. The check digit number is based upon the ISO 7064 Mod 36/37 check digit algorithm.
(1) Histopathological examination of central nervous system (CNS) tissues from the animal for characteristic microscopic lesions of scrapie;
(2) The use of proteinase-resistant protein analysis methods including but not limited to immunohistochemistry and/or western blotting on CNS and/or peripheral tissue samples from a live or a dead animal for which a given method has been approved by the Administrator for use on that tissue;
(3) Bioassay;
(4) Scrapie associated fibrils (SAF) detected by electron microscopy; or
(5) Any other test method approved by the Administrator in accordance with § 54.10 of this chapter.
(1) A sheep or goat that exhibits any of the following possible signs of scrapie and that has been determined to be suspicious for scrapie by an accredited veterinarian or a State or APHIS representative: Weight loss despite retention of appetite; behavioral abnormalities; pruritus (itching); wool pulling; biting at legs or side; lip smacking; motor abnormalities such as incoordination, high stepping gait of forelimbs, bunny hop movement of rear legs, or swaying of back end; increased sensitivity to noise and sudden movement; tremor, “star gazing,” head pressing, recumbency, or other signs of neurological disease or chronic wasting.
(2) A sheep or goat that has tested positive for scrapie or for the proteinase resistant protein associated with scrapie on a live-animal screening
(3) A sheep or goat that has tested inconclusive or suggestive on an official test for scrapie.
(2) A pasture when approved by and maintained under the supervision of the State and in which only nonpregnant animals are permitted, where there is no direct fence-to-fence contact with another flock, and from which animals are moved only to another terminal feedlot or directly to slaughter.
(3) Records of all animals entering and leaving a terminal feedlot must be maintained for 1 year after the animal leaves the feedlot and must include the person from whom the animals were acquired and the slaughtering facility in which they were slaughtered. Records must be made available for inspection by an APHIS or State representative upon request.
(a) No sheep or goat that is required to be individually identified or premises identified by § 79.3 may be sold, transported, received for transportation, or offered for sale or transportation in interstate commerce unless each sheep or goat is identified in accordance with this section.
(1) The sheep or goat must be identified to its flock of origin and, for an animal born after January 1, 2002, to its flock of birth, by the owner of the flock or his or her agent; at whichever of the following points in commerce comes first,
(i) The point of first commingling of the sheep or goats in interstate commerce with sheep or goats from any other flock of origin;
(ii) Upon unloading of the sheep or goats in interstate commerce at any livestock market, except a market described in paragraph (a)(1)(iii) of this section;
(iii) Upon leaving a livestock market that has been approved in accordance with this chapter to handle sheep and goats in interstate commerce and that has agreed to act as an agent for the owner to apply official identification to the animals. In such cases the animals must be:
(A) Moved to the market and maintained until officially identified in distinguishable groups identifiable to their flocks of origin and when required their flock of birth by means of partitions or other such maintenance; and,
(B) Accompanied by an owner statement that contains the information needed to officially identify the animals to their flock of origin and, when required, their flock of birth;
(iv) Upon transfer of ownership of the sheep or goats in interstate commerce;
(v) In the case of animals shipped directly to slaughter at a slaughter plant that has agreed to act as an agent for the owner to apply official identification to the animals, upon arrival of the sheep or goats in interstate commerce
(A) Moved to the slaughter plant and maintained until officially identified in distinguishable groups identifiable to their flocks of origin and when required their flock of birth by means of partitions or other such maintenance; and,
(B) Accompanied by an owner statement that contains the information needed to officially identify the animals to their flock of origin and, when required, their flock of birth. If the slaughter plant has agreed to allow APHIS to conduct slaughter sampling, animals need not be identified if they arrive at the plant on days that an APHIS designated sampler is not available at the plant to collect samples; or
(vi) Prior to moving a sheep or goat across a State line, unless the animals are moving to an approved livestock market in accordance with paragraph (a)(1)(iii) of this section or to an approved slaughter plant in accordance with paragraph (a)(1)(v) of this section.
(2) The sheep or goats must be identified by one of the following means of identification, and must remain so identified until they reach their final destination:
(i) Electronic implants for animals required to be identified by the SFCP, when used in a flock participating in the SFCP and when accompanied by a certificate or owner statement that includes the electronic implant numbers and the name of the chip manufacturer;
(ii) Official eartags, including tags approved for use in the SFCP or APHIS-approved premises identification number eartags when combined with a unique animal identification number;
(iii) United States Department of Agriculture backtags or official premises identification backtags that include a unique animal identification number, when used on sheep or goats moving directly to slaughter and when applied within 3 inches of the poll on the dorsal surface of the head or neck;
(iv) Legible official registry tattoos that have been recorded in the book of record of a sheep or goat registry association when the animal is accompanied by either a registration certificate or a certificate of veterinary inspection. These tattoos may also be used as premises identification if they contain a unique premises prefix that has been linked in the National Scrapie Database with the assigned premises identification number of the flock of origin;
(v) Premises identification eartags or tattoos, if the premises identification method includes a unique animal number or is combined with a flock eartag that has a unique animal number and the animal is accompanied by an owner statement;
(vi) Premises identification when premises identification is allowed by § 79.3 and the animal is accompanied by an owner statement; or
(vii) Any other official identification method or device approved by the Administrator.
(3) The owner of the flock of origin is responsible for the identification of animals required to be identified by this section. No person who buys or sells, for his or her own account or as the agent of the buyer or seller, transports, receives for transportation, offers for sale or transportation, or otherwise handles sheep or goats in interstate commerce shall receive or otherwise handle any animal in interstate commerce that has not been identified as required by this section. If an animal loses its identification to its flock of origin while in interstate commerce it is the responsibility of the person who has control or possession of the animal to identify the animal prior to commingling it with any other animals. This shall be done by applying individual animal identification to the animal as required in paragraph (a)(2) of this section and recording the means of identification and the corresponding animal identification number. If the flock of origin cannot be determined, all possible flocks of origin shall be listed on the record.
(b) Serial numbers for use in official identification will be assigned to each person who applies to the State animal health official or the area veterinarian in charge for the State in which that person maintains his or her place of business. Serial numbers of official eartags will be assigned to each accredited veterinarian or State or APHIS
(1) If the person assigned the numbers is a flock owner, so that the assigned numbers are directly linked to the flock of origin in the national scrapie database, record the following information on a document:
(i) The premises identification number or serial numbers;
(ii) The number of animals so identified;
(iii) The date the animals were identified;
(iv) For animals born after January 1, 2002, that were not born in the flock of origin and that are not identified to the previous flock of origin, the individual identification number applied and the name, street address, including the city and State, or the township, county, and State, and the telephone number, if the telephone number is available, of the flock of birth if known.
(2) If the person assigned the numbers is a veterinarian, extension agent, auction market operator, dealer, or any person other than the owner of the flock of origin, record the following information on a document:
(i) All serial numbers applied to a sheep or goat;
(ii) Any other serial numbers and approved identification appearing on the sheep or goat;
(iii) The street address, including the city and State, or the township, county, and State, of the premises where the approved means of identification was applied;
(iv) The date the identification was applied;
(v) The name, street address, including the city and State, or the township, county, and State, and the telephone number if the telephone number is available, of the owner of the flock of origin and, if different, the person who owns or possesses the sheep or goat, and
(vi) For animals born after January 1, 2002, that were not born in the flock of origin and that are not identified to the previous flock of origin, the individual identification number applied and the name, street address, including the city and State, or the township, county, and State, and the telephone number if the telephone number is available, of the flock of birth if known.
(vii) The serial numbers, the manufacturer, and the type and color of all official tags received. Usually maintaining the tag invoice will meet this requirement.
(3) Maintain these records for 5 years; and
(4) Make these records available for inspection and copying during ordinary business hours (8 a.m. to 5:30 p.m., Monday through Friday) upon request by any authorized employee of the United States Department of Agriculture or the State, and presentation of his or her official credentials.
(5) Any person who fails to comply with these requirements shall not be assigned serial numbers of United States Department of Agriculture backtags, official sheep and goat tattoos, official eartags, or premises identification numbers. If a person who is
(c) No person shall apply a premises identification number or a brand or earnotch pattern to an animal that did not originate on the premises to which the number was assigned by a State or APHIS representative or to which the brand or earnotch pattern has been assigned by an official brand registry. This includes individual identification such as USDA tags and backtags that have been assigned to a premises for use as premises identification and registration tattoos that contain prefixes that have been assigned to a premises for use as premises identification. This does not preclude the owner of a flock from using a premises identification number tag assigned to that flock on an animal owned by him that resides in that flock but that was born or previously resided on a different premises as long as the records required in paragraph (b)(1)(iv) of this section are maintained.
(d) Each person who buys or sells, for his or her own account or as the agent of the buyer or seller, transports, receives for transportation, offers for sale or transportation, or otherwise handles sheep or goats in interstate commerce must ensure that the animals are identified as required in this part and must keep records relating to the transfer of ownership, shipment, or handling of the sheep or goats, such as yarding receipts, sale tickets, invoices, and waybills.
(1) If official individual animal identification is required, the records must include the number of sheep and/or goats; the breed or cross if known; the name, street address, including city and State, or the township, county, and State, and the telephone number if the telephone number is available, of the owner of the flock of origin and, if different, the person from whom the sheep or goats were purchased or otherwise obtained; and a copy of any documents required to accompany the animal including any certificate, owner statement, letter, or permit; and
(i) For animals not in slaughter channels the records must include all serial numbers and other approved means of identification appearing on the sheep or goat. This requirement may usually be met by maintaining a copy of the certificate that accompanied the animals. The premises number may be recorded instead of the individual numbers in the case of animals identified with premises identification if:
(A) The premises identification meets the requirements of paragraph (a)(2)(v) of this section for individual animal identification; or
(B) The animals are allowed to move interstate with only premises identification in accordance with § 79.3.
(ii) For animals in slaughter channels that are identified with individual animal identification traceable to the flock of origin or that are identified to the flock of origin with official premises identification that meets the requirements for individual animal identification, no additional records are required;
(iii) For animals in slaughter channels that are identified with individual animal identification traceable to a previous flock but not to the flock of origin, or that are identified with official premises identification that meets the requirements for individual animal identification that is traceable to a previous flock but not to the flock of origin, the records must include all serial numbers and other approved means of identification appearing on the sheep or goat;
(iv) For animals that are not required to be identified until they reach their final destination, the records must include the final destination.
(2) If official premises identification is required or allowed, the records must include:
(i) The premises identification number(s) and the number of animals identified with each premises number;
(ii) Copies of any required documents such as the brand inspection certificate, an owner's statement, an accredited veterinarian's statement, or a health certificate;
(iii) The name, street address, including city and State, or the township, county, and State, and the telephone number if the telephone number is available, of the owner of the flock of origin and, if different, the person from whom the sheep or goats were purchased or otherwise obtained.
(3) Each person required to keep records under this paragraph must maintain the records for at least 5 years after the person has sold or otherwise disposed of the sheep or goat to another person, and for such further period as the Administrator may require by written notice to the person, for purposes of any investigation or action involving the sheep or goat identified in the records. The person must make the records available for inspection and copying during ordinary business hours (8 a.m. to 5:30 p.m., Monday through Friday) by any authorized employee of the United States Department of Agriculture or the State, upon that employee's request and presentation of his or her official credentials.
(e) No person may remove or tamper with any means of identification required to be on sheep or goats pursuant to this section while the animals are in interstate commerce, and, at the time of slaughter, animal identification must be maintained throughout postmortem inspection in accordance with regulations of the Food Safety and Inspection Service, U.S. Department of Agriculture, in chapter III of this title.
(f)
(2) Written requests for approval of official premises identification tags for sheep and goats should be sent to the Animal and Plant Health Inspection Service, Veterinary Services, National Animal Health Programs Staff, Attention: National Scrapie Program Coordinator, 4700 River Road Unit 43, Riverdale, MD 20737-1235. The request must include:
(i) Data supporting the durability of the tag and durability and legibility of the identification numbers and high retention rates of the tags in animals, preferably sheep and/or goats. Preference will be given to tags with high legibility and retention rates in sheep and goats that minimize injury to the ear.
(ii) A signed statement agreeing to:
(A) Send official eartags only to a State or APHIS representative, to a flock owner at the address to which the premises number or tag sequence was assigned by a State or APHIS representative, or as directed by APHIS;
(B) Provide a monthly report by State of all tags produced, including the tag sequences produced and the person's and address to which the tags were shipped; and
(C) When required by APHIS, enter the sequences of tags shipped into the National Scrapie Database through a web page interface or other means specified by APHIS.
(iii) Twenty-five sample tags. Additional tags must be submitted if requested by APHIS.
(3) Approval to produce official premises and/or individual identification tags will be valid for 1 year and must be renewed annually. The Administrator may also grant approval to produce tags for periods of less than 1 year in cases where all of the submissions required by this section have not been received or evaluated but there is substantial evidence that the tags meet the requirements of this section. The Administrator may decline to renew a company's approval if the tags
(g)
The following prohibitions and movement conditions apply to the interstate movement of sheep and goats, and no sheep or goat may move interstate except in compliance with them.
(a)
(1) A State or APHIS veterinarian will designate an animal to be a suspect animal after determining that the animal meets the criteria of the relevant definition in § 79.1.
(2) A designated scrapie epidemiologist will designate a flock to be a source, infected, or exposed flock after reviewing sale, movement, and breeding records that indicate the flock meets the criteria of the relevant definition in § 79.1.
(i) A designated scrapie epidemiologist may conduct testing of animals if he or she determines such testing is needed to properly designate a flock to be a source, infected, or exposed flock. The designated scrapie epidemiologist will select animals for testing in a manner that will provide a 95 percent confidence of detecting scrapie at a prevalence of 1 percent or, when flock records are adequate and all exposed animals that lambed in the flock are available for testing, may limit the testing to all exposed and suspect animals. Flocks meeting the definition of infected or source flocks that are designated as exposed flocks must complete a post exposure monitoring and management plan. Testing may include live-animal testing using a live-animal official test, an official genotype test, the culling and postmortem examination and testing of genetically susceptible animals in the flock that cannot be evaluated by a live animal test, and postmortem examination and testing of animals found dead or cull animals at slaughter.
(ii) If an owner does not make his or her animals available for testing within 60 days of notification or as mutually agreed or fails to submit required postmortem samples, the flock will be designated a source, infected, or exposed flock, whichever definition applies. Any flock that is pending designation must comply with the movement restrictions for infected flocks.
(3) A designated scrapie epidemiologist will designate a flock to be a noncompliant flock after determining that the flock meets the definition of a noncompliant flock in § 79.1.
(b)
(2) A State or APHIS veterinarian may remove the suspect animal designation from an animal that had clinical signs of scrapie and that did not test positive for scrapie or for the proteinase resistant protein associated with scrapie upon determination that it is alive and no longer exhibits such signs, or that the signs are not caused by scrapie.
(3) A designated scrapie epidemiologist may remove the suspect animal designation from an animal that has tested positive for scrapie or for the proteinase resistant protein associated with scrapie on an unofficial test based on knowledge of the test used or based on an epidemiologic investigation which may include additional testing of the suspect animal and or animals that have been commingled with the suspect animal.
(4) A designated scrapie epidemiologist may remove the suspect animal designation from an animal that tested positive on a live-animal screening test based on an epidemiologic investigation which includes additional official testing of the suspect animal and when appropriate, animals that have been commingled with the suspect animal.
(5) A designated scrapie epidemiologist may remove the exposed flock designation after completing an epidemiologic investigation or upon completion of a post-exposure management and monitoring plan. As part of the epidemiologic investigation the designated scrapie epidemiologist may conduct testing of animals if he or she determines such testing is needed to properly redesignate the flock. The designated scrapie epidemiologist will
(6) Based on an epidemiologic investigation and testing, a designated scrapie epidemiologist may redesignate an infected flock or source flock as an exposed flock. The designated scrapie epidemiologist may only use this option when the epidemiologic investigation reveals that the scrapie exposure was minor or could not be confirmed due to inadequate records. The designated scrapie epidemiologist will select animals for testing in a manner that will provide a 95 percent confidence of detecting scrapie at a prevalence of 1 percent or, when flock records are adequate and all exposed animals that lambed in the flock are available for testing, may limit the testing to all exposed and suspect animals. Testing may include live-animal testing using a live-animal official test, an official genotype test, the culling and postmortem examination and testing of genetically susceptible animals in the flock that cannot be evaluated by a live animal test, and postmortem examination and testing of animals found dead or cull animals at slaughter. Infected or source flocks that are redesignated as exposed flocks must complete a post exposure monitoring and management plan. If an owner does not make his or her animals available for testing within 60 days of notification or as mutually agreed or fails to submit required postmortem samples, the flock designation will remain unchanged.
(7) A designated scrapie epidemiologist may remove the noncompliant flock designation after reviewing any required testing of the flock and determining that the flock has complied with the required testing or no longer meets the definition of a noncompliant flock.
(8) A designated scrapie epidemiologist may redesignate an exposed animal, exposed flock, or infected flock by removing that designation after completing an epidemiologic investigation and determining that the exposure was limited to a scrapie-positive male animal that was not born in the flock (the owner must have adequate records and animal identification to show that the scrapie-positive male animal was purchased).
(c)
(1) A description of the interstate movement restrictions and identification requirements;
(2) Reporting requirements;
(3) Sample submission requirements for suspect and high-risk animals contained in this part;
(4) Options for controlling the spread of scrapie from, and eradicating scrapie in, an infected flock or source flock or to reduce the risk of the occurrence of scrapie in a flock that contains a high-risk or an exposed animal; and
(5) In the case of flocks that are pending designation the notification shall include the testing options available to them and the designation their flock will receive if they decline to test.
(a) Certificates are required as specified by § 79.3 for certain interstate movements of animals. A certificate must show the official ear tag number, individual animal registered breed association registration tattoo, individual animal registered breed association registration brand, individual animal registered breed association registration number, and any other official individual identification of each animal to be moved;
(b)
(1) The document must be a State form or APHIS form that requires individual identification of animals;
(2) A legible copy of the document must be stapled to the original and each copy of the certificate;
(3) Each copy of the document must identify each animal to be moved with the certificate, but any information pertaining to other animals, and any unused space on the document for recording animal identification, must be crossed out in ink; and
(4) The following information must be typed or written in ink in the identification column on the original and each copy of the certificate and must be circled or boxed, also in ink, so that no additional information can be added:
(i) The name of the document; and
(ii) Either the serial number on the document or, if the document is not imprinted with a serial number, both the name of the person who prepared the document and the date the document was signed.
(c)
(1) A legible copy of the official brand inspection certificate must be stapled to the original and each copy of the certificate;
(2) Each copy of the official brand inspection certificate must show the ownership brand of each animal to be moved with the certificate, but any other ownership brands, and any unused space for recording ownership brands, must be crossed out in ink; and
(3) The following information must be typed or written in ink in the official identification column on the original and each copy of the certificate and must be circled or boxed, also in ink, so that no additional information can be added:
(i) The name of the attached document; and
(ii) Either the serial number on the official brand inspection certificate or, if the official brand inspection certificate is not imprinted with a serial number, both the name of the person who prepared the official brand inspection certificate and the date it was signed.
(a) In reviewing a State for Consistent State status, the Administrator will evaluate the State statutes, regulations, and directives pertaining to animal health activities; reports and publications of the State animal health agency; and a written statement from the State animal health agency describing State scrapie control activities and certifying that these activities meet the requirements of this section. In determining whether a State is a Consistent State, the Administrator will determine whether the State:
(1) Has the authority, based on State law or regulation, to restrict the movement of all scrapie-infected and source flocks.
(2) Has the authority, based on State law or regulation, to require the reporting of any animal suspected of having scrapie and test results for any animals tested for scrapie to State or Federal animal health authorities.
(3) Has, in cooperation with APHIS personnel, drafted and signed a memorandum of understanding between APHIS and the State that delineates the respective roles of each in the National Scrapie Program implementation.
(4) Has placed all known scrapie-infected and source flocks under movement restrictions, with movement of animals only to slaughter, to feedlots under permit and movement restrictions that ensure later movement to slaughter, for destruction, or for research. Scrapie-positive and suspect animals may be moved only for transport to an approved research facility or for purposes of destruction.
(5) Has effectively implemented policies to:
(i) Investigate all animals reported as scrapie suspect animals within 7 days of notification;
(ii) Designate a flock's status, within 15 days of notification that the flock contains a scrapie-positive animal, based on an investigation by State or Federal animal health authorities and in accordance with this part;
(iii) Restrict the movement, in accordance with paragraph (a)(4) of this section, of newly designated scrapie-infected and source flocks within 7 days after they are designated in accordance with § 79.4;
(iv) Relieve infected and source flock movement restrictions only after completion of a flock plan created in accordance with § 54.14 of this chapter or a flock plan created in accordance with an approved scrapie control pilot project, or as permitted by the conditions of such a flock plan, and after agreement by the owner to comply with a 5-year post-exposure management and monitoring plan;
(v) Conduct an epidemiologic investigation of source and infected flocks that includes the designation of high-risk and exposed animals and that identifies animals to be traced;
(vi) Conduct tracebacks of scrapie-positive animals and traceouts of high-risk and exposed animals and report any out-of-State traces to the appropriate State within 45 days of receipt of notification of a scrapie-positive animal; and
(vii) Conduct tracebacks based on slaughter sampling within 15 days of receipt of notification of a scrapie-positive animal at slaughter.
(6) Effectively monitors and enforces quarantines.
(7) Effectively enforces State reporting laws and regulations for scrapie.
(8) Has designated at least one APHIS or State animal health official to coordinate scrapie program activities in the State and to serve as the designated scrapie epidemiologist in the State.
(9) Has educated those engaged in the interstate movement of sheep and goats regarding the identification and recordkeeping requirements of this part.
(10) Has provided APHIS with a plan and timeline for complying with the
(i) Requires, based on State law or regulation, and effectively enforces official identification upon change of ownership of all animals of any age not in slaughter channels and any sheep over 18 months of age as evidenced by eruption of the second incisor such that the animal may be traced to its flock of birth; provided that:
(A) A State may exempt commercial goats in intrastate commerce that have not been in contact with sheep from this identification requirement if there has been in that State no case of scrapie in a commercial goat in the past 10 years that originated in that State and cannot be attributed to exposure to infected sheep, and there are no exposed commercial goat herds in that State; and
(B) A State may exempt commercial whitefaced sheep or commercial hair sheep under 18 months of age in intrastate commerce from this identification requirement if there has been in that State no case of scrapie in the exempted class that originated from that State, and there are no exposed commercial whitefaced or hair sheep flocks in that State that have been exposed by a female animal.
(C) States that exempt these types of commercial animals must put in place the regulations necessary to require identification of these animals within 90 days of these conditions no longer existing.
(ii) Maintains in the National Scrapie Database administered by APHIS, or in a State database approved by the Administrator as compatible with the National Scrapie Database, the State's:
(A) Premises information and assigned premises numbers and individual identification number sequences assigned for use as premises identification;
(B) Individual animal information on all scrapie-positive, suspect, high-risk, and exposed animals in the State;
(C) Individual animal information on all out-of-State animals to be traced; and
(D) Accurate flock status data.
(iii) Requires official individual identification of any live scrapie-positive, suspect, or high-risk animal of any age and of any sexually intact exposed animal of more than 1 year of age or any sexually intact exposed animal of less than 1 year of age upon change of ownership (except for exposed animals moving in slaughter channels at less than 1 year of age), whether or not the animal resides in a source or infected flock.
(iv) Effectively enforces movement restrictions on all scrapie-positive, suspect, and high-risk animals throughout their lives unless they are moved in accordance with § 79.3.
(v) Requires that tissues from all scrapie-positive or suspect animals and female high-risk animals that have lambed (when they have died or have been destroyed) be submitted to a laboratory authorized by the Administrator to conduct scrapie tests and requires complete destruction of the carcasses of scrapie-positive and suspect animals.
(vi) Prohibits any animal from being removed from slaughter channels unless it is identified to the flock of birth, is not from an Inconsistent State, and is not scrapie-exposed or from an infected or source flock.
(b) If the Administrator determines that statutory changes are needed to bring a State into full compliance, the Administrator may grant up to a 2-year extension to allow a State to acquire additional authorities before removing a State's Consistent Status. The decision to grant an extension will be based on the State's ability to prevent the movement of scrapie-infected animals out of the State and on the progress being made in making the needed statutory changes.
(a) The Administrator may waive the following requirements of this part for participants in a scrapie control pilot
(1) The determination that an animal is a high-risk animal, if the scrapie control pilot project plan contains testing or other procedures that indicate that an animal, despite meeting the definition of high-risk animal, is unlikely to spread scrapie; and
(2) The requirement that high-risk animals must be removed from a flock, if the scrapie control pilot project plan contains alternative procedures to prevent the further spread of scrapie without removing high-risk animals from the flock.
(b) [Reserved]
7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
The following definitions apply to this part:
(1) National Uniform Eartagging System.
(2) Animal identification number (AIN).
(3) Premises-based number system. The premises-based number system combines an official premises identification number (PIN), as defined in this section, with a producer's livestock production numbering system to provide a unique identification number. The PIN and the production number must both appear on the official tag.
(4) Any other numbering system approved by the Administrator for the identification of animals in commerce.
(1) The State's two-letter postal abbreviation followed by the premises' assigned number; or
(2) A seven-character alphanumeric code, with the right-most character being a check digit. The check digit number is based upon the ISO 7064 Mod 36/37 check digit algorithm.
Domestic animals that are positive to an official Johne's disease test may not be moved interstate except in compliance with this part.
(a)
(1) The animals are moved directly to a recognized slaughtering establishment or to an approved livestock facility for sale to a recognized slaughtering establishment;
(2) An owner-shipper statement that identifies the animals as positive to an official Johne's disease test accompanies the animals during the movement and is delivered to the consignee;
(3) Each animal bears an official eartag; and
(4) The animals are moved to the destination in one continuous movement without unloading.
(b)
(c)
Animals that are positive to an official Johne's disease test may not be moved interstate in a railroad car, boat, truck, or other vehicle containing healthy animals susceptible to Johne's disease unless all of the animals are for immediate slaughter, or unless the positive animals are kept separate from the other animals by a partition that is securely affixed to the sides of the vehicle and prevents the transfer of fecal matter from the animals positive to an official Johne's disease test to the healthy animals in the vehicle.
7 U.S.C., 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
At 71 FR 41705, July 21, 2006, part 81 was added, effective Oct. 19, 2006. At 71 FR 52983, Sept. 8, 2006, the effective date was delayed until further notice.
(1) National Uniform Eartagging System.
(2) Animal identification number (AIN).
(3) Premises-based number system. The premises-based number system combines an official premises identification number (PIN), as defined in this section, with a producer's livestock production numbering system to provide a unique identification number. The PIN and the production number must both appear on the official tag.
(4) Any other numbering system approved by the Administrator for the identification of animals in commerce.
(1) The State's two-letter postal abbreviation followed by the premises' assigned number; or
(2) A seven-character alphanumeric code, with the right-most character being a check digit. The check digit number is based upon the ISO 7064 Mod 36/37 check digit algorithm.
Each animal required to be identified by this subpart must have at least two forms of animal identification attached to the animal. The means of animal identification must be approved for this use by APHIS, and must be an electronic implant, flank tattoo, ear tattoo, tamper-resistant ear tag, or other device approved by APHIS. One of the animal identifications must be an official animal identification as defined in this part, with a nationally unique animal identification number that is linked to that animal in the CWD National Database. The second animal identification must be unique for the individual animal within the herd and also must be linked to that animal and herd in the CWD National Database.
No farmed or captive deer, elk, or moose may be moved interstate unless it meets the requirements of this section.
(a)
(1) Enrolled in the CWD Herd Certification Program and:
(i) If the movement occurs between October 19, 2006 and January 19, 2009, the herd has achieved at least Second Year status in accordance with § 55.24 of this chapter;
(ii) If the movement occurs between January 19, 2009 and January 19, 2010, the herd has achieved at least Third Year status in accordance with § 55.24 of this chapter;
(iii) If the movement occurs between January 19, 2010 and January 19, 2011, the herd has achieved at least Fourth Year status in accordance with § 55.24 of this chapter;
(iv) If the movement occurs between January 19, 2011 and January 19, 2012, the herd has achieved at least Fifth Year status in accordance with § 55.24 of this chapter;
(v) If the movement occurs after January 19, 2012, the herd has achieved
(2) The farmed or captive deer, elk, or moose is accompanied by a certificate issued in accordance with § 81.4 of this part that identifies its herd of origin and its herd's CWD Herd Certification Program status, and states that it is not a CWD-positive, CWD-exposed, or CWD-suspect animal.
(b)
(c)
(d)
(1) To apply for a research animal permit, contact an APHIS employee or State representative and provide the following information:
(i) The name and address of the person to whom the special permit is issued, the address at which the research cervids to be moved interstate are being held, and the name and address of the person receiving the cervids to be moved interstate;
(ii) The number and type of cervids to be moved interstate;
(iii) The reason for the interstate movement;
(iv) Any safeguards in place to prevent transmission of CWD during movement or at the receiving location; and
(v) The date on which movement will occur.
(2) A copy of the research animal permit must accompany the cervids moved, and copies must be submitted so that a copy is received by the State animal health official and the veterinarian in charge for the State of destination at least 72 hours prior to the arrival of the cervids at the destination listed on the research animal permit.
(e)
(a)
(b)
(1) The document must be a State form or APHIS form that requires individual identification of animals;
(2) A legible copy of the document must be stapled to the original and each copy of the certificate;
(3) Each copy of the document must identify each animal to be moved with the certificate, but any information pertaining to other animals, and any unused space on the document for recording animal identification, must be crossed out in ink; and
(4) The following information must be typed or written in ink in the identification column on the original and each copy of the certificate and must be circled or boxed, also in ink, so that no additional information can be added:
(i) The name of the document; and
(ii) Either the serial number on the document or, if the document is not imprinted with a serial number, both the name of the person who issued the document and the date the document was issued.
7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
As used in connection with this subpart, the following terms shall have the meaning set forth in this section.
(a) The determination that birds or poultry are infected with END must be made by either a Federal veterinarian or a State veterinarian.
(b) The determination that birds or poultry are exposed to END must be made by either a Federal veterinarian or a State veterinarian. They will base that determination on an evaluation of all related circumstances, including: the proximity of the birds or poultry to birds or poultry infected with END, to excrement from birds or poultry infected with END, and to other material touched by birds or poultry infected with END; the number of birds or poultry infected with END to which the birds or poultry were exposed; the species involved; the virulence of the END to which the birds or poultry were exposed; and the length of time the birds or poultry were in contact with birds or poultry infected with END, and to material touched by birds or poultry infected with END. Birds or poultry determined to be exposed to END will continue to be treated as exposed unless they are subsequently determined to be infected with END or until either a Federal veterinarian or a State veterinarian finds them to be free of END based on one or more of the factors listed in paragraph (a) of this section.
(a) Any area where birds or poultry infected with END are located will be designated as a quarantined area. A quarantined area is any geographical area, which may be a premises or all or part of a State, deemed by epidemiological evaluation to be sufficient to contain all birds or poultry known to be infected with or exposed to END. Less than an entire State will be designated as a quarantined area only if the State enforces restrictions on intrastate movements from the quarantined area that are at least as stringent as this subpart.
(b) Any area designated as a quarantined area because of END will remain designated as a quarantined area until all of the requirements of § 82.14 have been met.
(c) The following areas are quarantined because of END: There are no areas in the United States quarantined because of END.
(a)
(1) Dead birds and dead poultry, including any parts of the birds or poultry, that are infected with END, or are from a flock of birds or poultry infected with END;
(2) Litter used by or manure generated by birds or poultry, or a flock of birds or poultry, infected with END;
(3) Any eggs from birds or poultry, or a flock of birds or poultry, infected with END;
(4) Hatching eggs from flocks of birds or poultry exposed to END; and
(5) Live birds or live poultry from flocks infected with or exposed to END.
(b)
(1) Live birds or live poultry not known to be infected with or exposed to END;
(2) Dressed carcasses of birds and poultry, and other dead birds and dead poultry, including any parts of the birds or poultry, that are not known to be infected with END;
(3) Litter used by or manure generated by birds or poultry not known to be infected with END;
(4) Eggs, other than hatching eggs, from birds or poultry from flocks not known to be infected with END;
(5) Hatching eggs from birds or poultry not known to be infected with or exposed to END; and
(6) Cages, coops, containers, troughs, vehicles, or other equipment used for birds, poultry, eggs, manure, or litter.
(c)
(a)
(1) The birds are accompanied by a permit obtained in accordance with § 82.11;
(2) Epidemiological evidence, as described in § 82.2(a), indicates that the birds are not infected with any communicable disease;
(3) The birds show no clinical signs of sickness (such as diarrhea, nasal discharge, ocular discharge, ruffled feathers, or lack of appetite) during the 90 days before interstate movement;
(4) The birds have been maintained apart from other birds and poultry in the quarantined area during the 90 days before interstate movement;
(5) The birds have been under the ownership and control of the individual to whom the permit is issued for the 90 days before interstate movement;
(6) The birds are moved interstate by the individual to whom the permit is issued;
(7) The birds are caged while being moved interstate;
(8) The individual to whom the permit is issued maintains ownership and control of the birds and maintains them apart from other birds and poultry from the time they arrive at the place to which the individual is taking them until a Federal representative or State representative
(9) The individual to whom the permit is issued allows Federal representatives and State representatives to examine the birds at any time until they are declared free of END by either a Federal veterinarian or a State veterinarian;
(10) Within 24 hours of a bird's dying or showing clinical signs of sickness (such as diarrhea, nasal discharge, ocular discharge, ruffled feathers, or lack of appetite), the individual to whom the permit is issued notifies the veterinarian in charge or the State animal health official
(11) The individual to whom the permit is issued submits copies of the permit so that a copy is received by the State animal health official and the veterinarian in charge for the State of destination within 72 hours of the arrival of the birds at the destination listed on the permit.
(b)
(1) The birds and poultry are accompanied by a permit obtained in accordance with § 82.11;
(2) The birds or poultry are covered in such a way as to prevent feathers and other debris from blowing or falling off the means of conveyance;
(3) The birds or poultry are moved in a means of conveyance either under official seal or are accompanied by a Federal representative;
(4) Except for emergencies, the birds or poultry are not unloaded until their arrival at the destination listed on the permit required by paragraph (b)(1) of this section;
(5) If poultry, the poultry are moved interstate to a recognized slaughtering establishment
(6) If birds other than poultry, the birds are moved to a site approved by the Administrator; and
(7) The permit required by paragraph (b)(1) of this section is presented upon arrival at the recognized slaughtering establishment or approved site to a State representative or Federal representative. Copies of the permit must also be submitted so that a copy is received by the State animal health official and the veterinarian in charge for the State of destination within 72 hours of arrival at the recognized slaughtering establishment.
(a) Except as provided in paragraph (b) of this section for dressed carcasses, dead birds and dead poultry, including any parts of the birds and poultry, that are not known to be infected with END may be moved interstate from a quarantined area only if:
(1) The dead birds and dead poultry are accompanied by a permit obtained in accordance with § 82.11;
(2) The dead birds and dead poultry are covered in such a way as to prevent feathers and other debris from blowing or falling off the means of conveyance;
(3) The dead birds and dead poultry are moved in a means of conveyance either under official seal or accompanied by a Federal representative;
(4) The dead birds and dead poultry are not unloaded until their arrival at the destination listed on the permit required by paragraph (a)(1) of this section;
(5) The dead birds and dead poultry are moved, without stopping, to the destination listed on the permit required by paragraph (a)(1) of this section, except for normal traffic conditions, such as traffic lights and stop signs;
(6) The dead birds and dead poultry are disposed of, within 24 hours after being loaded for interstate movement, by burial or composting in accordance with the procedures set forth in § 82.14(c)(1) and (c)(2), or by rendering, incineration, or other means approved by the Administrator as being adequate to prevent the dissemination of END; and
(7) Copies of the permit accompanying the dead birds and dead poultry interstate are submitted so that a copy is received by the State animal health official and the veterinarian in charge for the State of destination within 72 hours of the arrival of the dead birds and dead poultry at the destination listed on the permit required by paragraph (a)(1) of this section.
(b) Dressed carcasses from birds and poultry that are not known to be infected with END may be moved interstate from a quarantined area only if:
(1) The dressed carcasses are from birds or poultry that were slaughtered in a recognized slaughtering establishment;
(2) The dressed carcasses are accompanied by a permit obtained in accordance with § 82.11;
(3) The dressed carcasses are moved in a means of conveyance either under official seal or accompanied by a Federal representative;
(4) The dressed carcasses are not unloaded until their arrival at the destination listed on the permit required by paragraph (b)(2) of this section;
(5) The dressed carcasses are moved, without stopping, to the destination
(6) Copies of the permit accompanying the dressed carcasses interstate are submitted so that a copy is received by the State animal health official and the veterinarian in charge for the State of destination within 72 hours of the arrival of the dressed carcasses at the destination listed on the permit required by paragraph (b)(2) of this section.
Manure generated by and litter used by birds or poultry not known to be infected with END may be moved interstate from a quarantined area only if:
(a) The manure and litter is accompanied by a permit obtained in accordance with § 82.11;
(b) The manure and litter has been heated throughout, in the quarantined area, to a temperature of not less than 175 °F (79.4 °C), and then placed either in a previously unused container or in a container that has been cleaned and disinfected, since last being used, in accordance with part 71 of this chapter;
(c) The declaration or affidavit required by § 82.11(b) lists the location of the poultry or birds that generated the manure or used the litter, and the name and address of the owner of the poultry or birds that generated the manure or used the litter; and
(d) Copies of the permit accompanying the manure and litter interstate are submitted so that a copy is received by the State animal health official and the veterinarian in charge for the State of destination within 72 hours of the arrival of the manure and litter at the destination listed on the permit.
(a) Eggs, other than hatching eggs, from birds or poultry from flocks not known to be infected with END may be moved interstate from a quarantined area only if:
(1) The eggs are accompanied by a permit obtained in accordance with § 82.11;
(2) The eggs have been cleaned and sanitized in accordance with 7 CFR part 59;
(3) The eggs are packed either in previously unused flats or cases or in used plastic flats or cases that were cleaned and disinfected, since last being used, in accordance with part 71 of this chapter;
(4) The eggs are moved to a facility where they are examined to ensure they have been cleaned and sanitized in accordance with paragraph (a)(2) of this section; and
(5) Copies of the permit accompanying the eggs interstate are submitted so that a copy is received by both the State animal health official and the veterinarian in charge for the State of destination within 72 hours of the arrival of the eggs at the facility.
(b) Any flats or cases intended for reuse after being used to move eggs interstate to a facility under this section must be cleaned and disinfected in accordance with part 71 of this chapter before being moved to a premises where birds or poultry are kept.
Hatching eggs from birds or poultry not known to be infected with or exposed to END may be moved interstate from a quarantined area only if:
(a) The hatching eggs are accompanied by a permit obtained in accordance with § 82.11;
(b) Copies of the permit accompanying the hatching eggs are submitted so that a copy is received by both the State animal health official and the veterinarian in charge for the State of destination within 72 hours of the arrival of the hatching eggs at the premises described in paragraph (c) of this section; and
(c) The hatching eggs are held in the State of destination at a premises designated jointly by the veterinarian in charge and the State animal health official from the time of arrival until hatch and the birds and poultry hatched from the eggs are held at the designated premises for not less than 30
(a) This section does not apply to cages, coops, or other containers or equipment used by or to move pet birds moved interstate in accordance with § 82.5(a).
(b) Vehicles, cages, coops, containers, troughs, and other equipment that have held or that have otherwise been used in a quarantined area in the handling of birds or poultry or their eggs, or for manure generated by or litter used by the birds or poultry, may be moved interstate from a quarantined area only in accordance with the following conditions:
(1) They are made of hard plastic or metal, and the other conditions of this section are met; or
(2) They are made of a disposable material, such as cardboard, fiber, or waxed cardboard, are previously unused, and are disposed of by incineration without being reused after being moved interstate.
(c) Before moving interstate any vehicles, cages, coops, containers, troughs, or other equipment described in paragraph (b)(1) of this section, and after using these items to move birds, poultry, eggs, manure, or litter interstate from a quarantined area, the vehicles, cages, coops, containers, troughs, and other equipment must be cleaned and disinfected in accordance with paragraphs (c)(1) through (c)(5) of this section:
(1) Clean and disinfect the vehicles, cages, coops, containers, troughs, and other equipment at the place where the birds, poultry, eggs, manure, and litter are unloaded or where the equipment is used, no more than 2 hours after the birds, poultry, eggs, manure, and litter are unloaded or the equipment is used;
(2) Clean the items in accordance with part 71 of this chapter;
(3) Have a Federal representative or State representative
(4) Disinfect the items in the presence of a Federal representative or State representative; and
(5) Disinfect the items in accordance with part 71 of this chapter and by using a disinfectant as specified in part 71 of this chapter.
(d) If the place where the cleaning and disinfection would otherwise be required has no facilities for cleaning and disinfecting, the items may be moved to a place where facilities are available for cleaning and disinfecting, provided a Federal representative or State representative has determined that such movement will not cause a risk of the spread of END.
(e) Vehicles, cages, coops, containers, troughs, and other equipment that are moved interstate under this section must be accompanied by a permit obtained in accordance with § 82.11, and copies of the permit accompanying the vehicles, cages, coops, containers, troughs, and other equipment interstate must be submitted so that a copy is received by the State animal health official and the veterinarian in charge
(a) Application for the permits required by this subpart to move interstate from a quarantined area birds, eggs, poultry, or other items requiring a permit under this part must be in writing. The application must be submitted to a Federal representative or State representative and must include the following:
(1) The applicant's name and mailing address;
(2) The name and mailing address of the person who will receive the birds, eggs, poultry, or other items;
(3) The addresses of both the origin and destination of the birds, eggs, poultry, or other items;
(4) The number and types of birds, poultry, eggs, and other items intended for interstate movement; and
(5) The reason for the interstate movement.
(b) In addition to the information required by paragraph (a) of this section, to obtain permits to move birds, poultry, eggs, manure, litter, cages, coops, containers, troughs, vehicles or other equipment interstate from a quarantined area, an applicant for a permit must submit to a Federal representative or State representative a declaration or affidavit listing the requirements of § 82.5 for live birds or live poultry, § 82.6 for dead birds and dead poultry, § 82.7 for litter or manure, § 82.8 for eggs other than hatching eggs, § 82.9 for hatching eggs, or § 82.10 for cages, coops, containers, troughs, vehicles, and other equipment, and stating that the applicant will move the items interstate only if all of the listed requirements are met.
(a) A special permit is required for the interstate movement of birds, poultry, or other items whose movement is restricted under this subpart, from a quarantined area in a manner or to a destination other than is specifically prescribed by this subpart, under special conditions determined by the Administrator to be necessary to prevent the dissemination of END. A special permit is required for the disposal of dead birds or dead poultry that are infected with END, or dead birds or dead poultry from flocks infected with END, or manure generated by or eggs from birds or poultry infected with END, in a manner other than is specifically prescribed in this subpart, and for cleaning and disinfection carried out in a manner other than is specifically prescribed in this subpart, under special conditions determined by the Administrator to be necessary to prevent the dissemination of END. To apply for a special permit, contact the veterinarian in charge
(b) The special permit will list the name and address of the person to whom the special permit is issued, and the special conditions under which the interstate movement, disposal, or cleaning and disinfection may be carried out.
(1) For an interstate movement, the special permit will also include the following:
(i) The name and mailing address of the person who will receive the birds, poultry, or other items;
(ii) The addresses of both the origin and destination of the birds, poultry, or other items;
(iii) The number and type of birds, poultry, or other items to be moved interstate; and
(iv) The reason for the interstate movement.
(2) For destruction or cleaning and disinfection, the special permit will also include the following:
(i) The address of the place where the dead birds, dead poultry, manure, or eggs are located; and
(ii) The number and type of birds, poultry, or other items involved.
(c) For an interstate movement, a copy of the special permit must accompany the items moved, and copies must be submitted so that a copy is received by the State animal health official and the veterinarian in charge for the State of destination within 72 hours of the arrival of the birds, poultry, or other items at the destination listed on the special permit.
(a)
(b)
(c)
An area will be removed from quarantine only when all of the following requirements have been met:
(a) All birds and poultry exposed to END in the quarantined area have been found to be free of END;
(b) All birds and poultry infected with END in the quarantined area have been euthanized;
(c) All birds and poultry, including any parts of the birds and poultry, euthanized in accordance with paragraph (b) of this section, and all birds and poultry in the quarantined area, including any parts of the birds and poultry, that died from any cause other than slaughter, have been buried, reduced to ashes by incineration, rendered, or reduced to dust by composting:
(1) If the birds and poultry are buried, all birds and poultry infected with END must be buried in the quarantined area. The birds and poultry must be buried in a location that meets all United States Environmental Protection Agency, State, and local requirements for landfills. They must be buried at least 6 feet deep and be covered at the time of burial with soil; and
(2) If the birds and poultry are composted, all birds and poultry infected with END must be composted in the quarantined area. The birds and poultry must be composted according to the following instructions:
(i) Place a 1-foot layer of litter and manure in a free-standing composter bin, unless the compost pile will be covered in accordance with paragraph (c)(2)(ii) of this section. Add a 6-inch layer of straw, peanut hulls, or wood chips. Add a layer of dead birds or dead poultry, leaving 6 inches between the carcasses and the bin walls. Add water sparingly and cover with 6 inches of a dry mixture of litter and manure. Repeat the layering process two more times and cap with a double layer of dry manure cake. After the bin is capped off and covered, monitor the temperature in the compost pile daily,
(ii) Composting of birds and poultry may be accomplished outside of covered bins by following the layering and temperature requirements set forth in paragraph (c)(2)(i) of this section, then covering the compost pile with tarpaulins or 6-mm polyethylene sheets anchored with tires or straw bales. The mixture must be kept moist. The final product may not be spread or otherwise utilized until at least 30 days following completion of the second heating cycle.
(iii) Composting of birds and poultry must be carried out at least 50 yards from any building or pen where poultry and birds are housed and be inaccessible to birds and poultry. Composted material may not be commingled with, or otherwise be brought into contact with, non-composted manure cake;
(d) All eggs produced by birds or poultry infected with or exposed to END in the quarantined area have been buried, reduced to ashes by incineration, or rendered. If the eggs are buried, the eggs must be buried in the quarantined area in a location that meets all United States Environmental Protection Agency requirements and all State and local requirements for landfills. The eggs must be buried at least 6 feet deep and be covered at the time of burial with soil;
(e) All manure generated by or litter used by birds or poultry infected with or exposed to END in the quarantined area has been reduced to ashes by incineration, or has been buried, composted, or spread on a field and turned under, as follows:
(1)
(2)
(3)
(f) All vehicles with which the birds or poultry infected with or exposed to END or their excrement or litter have had physical contact have been cleaned and disinfected in accordance with part 71 of this chapter. The vehicles have been inspected after cleaning, and before disinfection, by a Federal representative or State representative, and then have been disinfected in the presence of a Federal representative or State representative with a disinfectant listed in part 71 of this chapter;
(g) All cages, coops, containers, troughs, and other equipment used for birds or poultry infected with or exposed to END, or their excrement or litter have been reduced to ashes by incineration, or have been cleaned and disinfected in accordance with part 71 of this chapter. The items must be inspected after cleaning, and before disinfection, by a Federal representative or State representative, and then must be disinfected in the presence of a Federal representative or State representative, with a disinfectant listed in part 71 of this chapter; and
(h) The premises where birds or poultry infected with or exposed to END were located have been cleaned and disinfected in accordance with part 71 of this chapter. The premises have been inspected after cleaning, and before disinfection, by a Federal representative or State representative, and then have been disinfected in the presence of a Federal representative or State representative with a disinfectant listed in part 71 of this chapter.
Birds and poultry that have been destroyed because of a quarantine for END may not be replaced by birds or poultry moved interstate into the quarantined area until the Administrator decides that END has been eradicated and that replacement birds or poultry will not become infected with END.
When, in accordance with sec. 10407 of the Animal Health Protection Act (7 U.S.C. 8306), the Secretary of Agriculture determines that an extraordinary emergency exists because of END, the regulations in this subpart regarding interstate movement shall be applicable to intrastate movement within any State or portion of a State subject to the Secretary's declaration of extraordinary emergency until such time as the Secretary terminates that declaration.
As used in connection with this subpart, the following terms shall have the meaning set forth in this section.
The following items may not be moved interstate:
(a) Live poultry infected with chlamydiosis;
(b) Dead poultry that were infected with chlamydiosis when they died, and parts of dead poultry that were infected with chlamydiosis when they died; and
(c) Offal from poultry infected with chlamydiosis.
(a) Before moving vehicles, cages, coops, containers, troughs, and other equipment interstate that have held or have otherwise been used in the handling of poultry infected with chlamydiosis, and after using these items to move poultry infected with chlamydiosis interstate, the vehicles, cages, coops, containers, troughs, and other equipment must be cleaned and disinfected in accordance with paragraphs (a)(1) through (a)(5) of this section:
(1) Clean and disinfect the vehicles, cages, coops, containers, troughs, and other equipment at the place where the poultry are unloaded or where the equipment is used, no more than 2 hours after the poultry infected with chlamydiosis are unloaded or the equipment is used;
(2) Clean the items in accordance with part 71 of this chapter;
(3) Have a Federal representative, State representative,
(4) Disinfect the items in the presence of a Federal representative, State representative, or an accredited veterinarian; and
(5) Disinfect the items in accordance with part 71 of this chapter and by using a disinfectant as specified in part 71 of this chapter.
(b) If the place where the cleaning and disinfection would otherwise be required has no facilities for cleaning and disinfecting, the items may be moved to a place where facilities are available for cleaning and disinfecting, provided a Federal representative or State representative has determined that such movement will not cause a risk of the spread of chlamydiosis.
(c) Vehicles, cages, coops, containers, troughs, and other equipment moved interstate under this section must be accompanied by a permit obtained in accordance with § 82.23, and copies of the permit accompanying the vehicles, cages, coops, containers, troughs, and other equipment interstate must be submitted so that a copy is received by both the State animal health official and the veterinarian in charge
Premises that contained poultry that were infected with chlamydiosis must be cleaned and disinfected in accordance with this section before any poultry are moved interstate onto the premises.
(a) The premises must be cleaned in accordance with part 71 of this chapter;
(b) After being cleaned, the premises must be inspected by a Federal representative, State representative, or an accredited veterinarian; and
(c) After being inspected, the premises must be disinfected in the presence of a Federal representative, State representative, or an accredited veterinarian, in accordance with part 71 of this chapter, using a disinfectant listed in part 71 of this chapter.
(a) Application for the permit required by this subpart to move vehicles, cages, coops, containers, troughs, or other equipment interstate must be in writing, and must be submitted to a Federal representative or State representative. The application must include the following:
(1) The applicant's name and mailing address;
(2) The name and mailing address of the person who will receive the items;
(3) The addresses of both the origin and destination of the items;
(4) The number and types of items intended for interstate movement; and
(5) The reason for the interstate movement.
(b)
(a) A special permit is required for the interstate movement of items whose movement interstate is restricted under this subpart in a manner or to a destination other than is specifically prescribed by this subpart. A special permit is required for the disinfection of vehicles, premises, cages, coops, containers, troughs, and other equipment by a method other than is specifically prescribed by this subpart. To apply for a special permit, contact the veterinarian in charge for the State in which the items are located. The Administrator may, at his or her discretion, issue special permits if he or she determines the activity authorized will not increase the risk of spreading chlamydiosis interstate.
(b) The special permit will list the name and address of the person to whom the special permit is issued, and the special conditions under which the interstate movement, or cleaning and disinfection, may be carried out.
(1) For an interstate movement, the special permit will also include the following:
(i) The name and mailing address of the person who will receive the items;
(ii) The addresses of both the origin and destination of the items;
(iii) The number and type of items to be moved interstate; and
(iv) The reason for the interstate movement.
(2) For cleaning and disinfection, the special permit will also include the following:
(i) The address of the place where the items are located; and
(ii) The number and type of items involved.
(c) For an interstate movement, a copy of the special permit must accompany the items moved, and copies must be submitted so that a copy is received by both the State animal health official and the veterinarian in charge for the State of destination within 72 hours of the arrival of the items at the destination listed on the special permit.
(a)
(b)
(c)
7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
For purposes of this part, the following terms mean:
(a) A herd of livestock, other than swine, shall no longer be classified as a known infected herd after 10 days since the last clinical case of pseudorabies in the herd.
(b) A herd of swine which has been released from pseudorabies quarantine in accordance with the following provisions shall no longer be classified as a known infected herd if:
(1) All swine positive to an official pseudorabies test have been removed from the premises; all swine which remain in the herd, except swine nursing from their mothers, are subjected to an official pseudorabies serologic test and found negative 30 days or more after removal of swine positive to an official pseudorabies test; and no livestock on the permises have shown clinical signs of pseudorabies after removal of the postive swine; or
(2) All swine have been depopulated for 30 days and the herd premises have been cleaned and disinfected in accordance with § 85.13; or
(3) In a herd of swine in which swine are positive to an official pseudorabies serologic test but no swine are postive at titers greater than 1:8, all titered swine are subjected to another official pseudorabies serologic test and found negative; and all other swine in the herd which an epidemiologist, approved by the State animal health official and the Veterinarian in Charge, requires to be subjected to an official pseudorabies serologic test are tested and found negative.
(4) In a herd of swine containing official gene-altered pseudorabies vaccinates:
(i) All vaccinates have been vaccinated with the same official gene-altered pseudorabies vaccine; and
(ii) All swine positive to an approved differential pseudorabies test have been gone from the herd for at least 60 days; and
(iii) No livestock on the same premises as the herd have shown clinical signs of pseudorabies since removal of the positive swine; and
(iv) The herd has been tested for pseudorabies and found negative in accordance with one of the following two provisions:
(A) All swine in the herd, except suckling swine, are tested with an approved differential pseudorabies test. If all tested swine are found negative, no further testing is required. If any swine test positive, they may be retested with an approved differential pseudorabies test within 30 days of the first test if they are isolated from the remainder of the herd until the retest shows them to be negative.
(B) All swine in the herd over 6 months of age and a random sample of 30 or more swine in each segregated group of swine in the herd between 2 and 6 months of age are tested with an approved differential pseudorabies test. Not less than 30 days nor more than 60 days after this first test, another random sample of 30 or more swine in each segregated group of swine in the herd between 2 and 6 months of age is tested with an approved differential pseudorabies test. If all swine are negative on these tests, no further testing is required. If any swine test positive on either of these tests, the positive swine may be retested with an approved differential test within 30 days of the initial test if they are isolated from the remainder of the herd until the retest shows them to be negative.
(b) If on the qualifying official pseudorabies serologic test or any subsequent official pseudorabies test, any swine so tested are positive, pseudorabies controlled vaccinated herd status is attained or regained by: removing all positive swine; cleaning and disinfecting the herd premises in accordance with § 85.13; subjecting all swine in the herd, except swine nursing from their mothers, to an official pseudorabies serologic test 30 days or more after removal of the positive swine and finding all swine so tested negative; and, after an interval of 30 to 60 days after the first such negative official pseudorabies serologic herd test, subjecting all swine in the herd over 6 months of age to another official pseudorabies serologic test and finding all swine so tested negative.
(c)(1) Pseudorabies controlled vaccinated herd status is maintained by: subjecting 25 percent of all the offspring to an official pseudorabies serologic test when they are between 16 and 20 weeks of age and finding all swine so tested negative, or by leaving 10 percent of the swine over 6 months of age in the herd unvaccinated and subjecting all such unvaccinated swine to an official pseudorabies serologic test every 80-105 days and finding all swine so tested negative.
(2) Any swine in the herd over 6 months of age may be vaccinated for pseudorabies within 15 days after being subjected to an official pseudorabies serologic test and found negative;
(3) All swine intended to be added to a pseudorabies controlled vaccinated herd shall be isolated until the swine have been found negative to an official pseudorabies serologic test conducted
(4) Swine which have not been vaccinated for pseudorabies and which are to be tested to maintain pseudorabies controlled vaccinated herd status shall be maintained in the herd so that the pseudorabies vaccinates can physically touch nonvaccinates or so that the pseudorabies vaccinates are within 10 feet of nonvaccinates while sharing a direct common ventilation system with such nonvaccinates.
(1) All swine in the herd over 6 months of age must be tested with an official pseudorabies serologic test. For a minimum of 30 days before the test, the herd must not have been a known infected herd. During the 90 days before the test, at least 90 percent of the swine in the herd either must have been on the premises and a part of the herd, or must have entered the herd directly from a qualified pseudorabies negative herd. If any of the tested swine are found positive on this or any other official pseudorabies test prior to vaccination with the official gene-altered pseudorabies vaccine, the requirements in paragraph (a)(2) must be met.
(2) All swine that are positive on an official pseudorabies test must be removed from the herd, or must be isolated until another official pseudorabies test conducted within 30 days of the first test shows them to be negative. If the results of the second test are negative, no additional testing is required before the herd may be vaccinated in accordance with paragraph (a)(3). If the results of the second test are positive, all swine that tested positive must be removed from the herd. Not less than 30 days after any positive swine are removed from the herd, all remaining swine in the herd, except suckling swine, must be tested with an official pseudorabies serologic test and found negative. Not less than 30 days after this negative test, the herd must be tested again in accordance with paragraph (a)(1).
(3) Not more than 30 days after test results show the herd to be negative for pseudorabies in accordance with paragraph (a)(1), all swine in the herd over 6 months of age must be vaccinated with an official gene-altered pseudorabies vaccine. Only one official gene-altered pseudorabies vaccine may be used in the herd.
(b) Any herd designated as a qualified pseudorabies negative herd may achieve new status as a qualified negative gene-altered vaccinated herd if all swine in the herd over 6 months of age are vaccinated with an official gene-altered pseudorabies vaccine. Only one official gene-altered pseudorabies vaccine may be used in the herd.
(c) Any herd in which no swine are known to be infected with or exposed to pseudorabies, and in which the only swine vaccinated for pseudorabies are official gene-altered pseudorabies vaccinates, may achieve status as a qualified negative gene-altered vaccinated herd under the following conditions:
(1) Only one official gene-altered pseudorabies vaccine may be used in the herd.
(2) All swine in the herd over 6 months of age must be tested with an approved differential pseudorabies test. For a minimum of 60 days before the test, the herd must not have been a known infected herd. During the 90 days before the test, at least 90 percent of the swine in the herd either must have been on the premises and a part of the herd or must have entered the herd directly from a qualified pseudorabies negative herd or a qualified negative
(3) All swine positive on an approved differential pseudorabies test must be removed from the herd, or must be isolated until another approved differential pseudorabies test conducted within 30 days of the first test shows them to be negative. If the results of the second test are negative, no additional testing is required before the herd may be vaccinated in accordance with paragraph (c)(4). If the results of the second test are positive, all swine that tested positive must be removed from the herd. No less than 30 days after any negative swine are removed from the herd, all remaining swine in the herd, except suckling swine, must be tested with an approved differential pseudorabies test and found negative. No less than 30 days after this negative test, the herd must be tested again in accordance with paragraph (c)(2).
(4) No more than 30 days after test results show the herd to be negative for pseudorabies in accordance with paragraph (c)(2), all swine in the herd over 6 months of age that are not already official gene-altered pseudorabies vaccinates must be vaccinated with an official gene-altered pseudorabies vaccine. Only one official gene-altered pseudorabies vaccine may be used in the herd.
(d) Qualified negative gene-altered vaccinated herd status is maintained under the following conditions:
(1) All swine over 6 months of age in the herd must be official gene-altered pseudorabies vaccinates, and only one official gene-altered pseudorabies vaccine may be used in the herd.
(2) All swine over 6 months of age in the herd must be tested at least once a year with an approved differential pseudorabies test and found negative; except that, if any swine are positive, the herd may maintain its status if the positive swine are isolated from the rest of the herd until they are found negative to a second approved differential pseudorabies test conducted within 30 days of the first. The requirement for annual testing of all swine in the herd over 6 months of age may be met by testing 25 percent of the swine over 6 months of age every 80-105 days, or by testing 10 percent of the swine over 6 months of age each month. No swine may be tested twice in 1 year to comply with the 25 percent requirement, or twice in 10 months to comply with the 10 percent requirement.
(3) Swine may be added to a qualified negative gene-altered vaccinated herd only under one of the following conditions:
(i) The swine are moved to the qualified negative gene-altered vaccinated herd from another qualified negative gene-altered vaccinated herd, or from a qualified pseudorabies negative herd, without having any contact en route with swine other than those from a qualified negative gene-altered vaccinated herd or a qualified pseudorabies negative herd.
(ii) The swine are moved to the qualified negative gene-altered vaccinated herd from a qualified pseudorabies negative herd, have contact en route with swine other than those from a qualified negative gene-altered vaccinated herd or a qualified pseudorabies negative herd, and, before being added, are isolated until they are found negative to an official pseudorabies serologic test conducted 30 days or more after the swine are isolated.
(iii) The swine are moved to the qualified negative gene-altered vaccinated herd from another qualified negative gene-altered vaccinated herd, have contact en route with swine other than those from a qualified negative gene-altered vaccinated herd or a qualified pseudorabies negative herd, and, before being added, are isolated until they are found negative to an approved differential pseudorabies test conducted 30 days or more after the swine are isolated.
(iv) The swine are removed to the qualified negative gene-altered vaccinated herd from a herd other than a qualified negative gene-altered vaccinated herd or a qualified pseudorabies negative herd, and, before being added, are isolated until they are found negative to two official pseudorabies serologic tests, one conducted at the time the swine are isolated, and the second conducted 30 days or more after the swine are isolated.
(b)(1) If on a qualifying official pseudorabies serologic test or any subsequent official pseudorabies test, any swine so tested are positive, qualified pseudorabies negative herd status is attained or regained by: Removing all positive swine and cleaning and disinfecting the herd premises in accordance with § 85.13; subjecting all swine in the herd, except swine nursing from their mothers, to an official pseudorabies serologic test 30 days or more after removal of the positive swine and finding all swine so tested negative; and, after an interval of 30 to 60 days after the first such negative official pseudorabies serologic herd test, subjecting all swine in the herd over 6 months of age to another official pseudorabies serologic test and finding all swine so tested negative; or
(2) If on any qualifying official pseudorabies serologic test or any subsequent official pseudorabies serologic test, any swine so tested are positive, but no swine are positive at titers greater than 1:8, qualified pseudorabies negative herd status is attained or regained by: Subjecting all titered swine and all other swine required to be tested by an epidemiologist, approved by the State animal health official and the Veterinarian in Charge, to an official pseudorabies serologic test and finding all such swine negative.
(c) Qualified pseudorabies negative herd status is maintained by subjecting all swine over 6 months of age in the herd to an official pseudorabies serologic test at least once each year (this must be accomplished by testing 25 percent of swine over 6 months of age every 80-105 days and finding all swine so tested negative, or by testing 10 percent of the swine over 6 months of age each month and finding all swine so tested negative; no swine shall be tested twice in 1 year to comply with the 25 percent requirement or twice in 10 months to comply with the 10 percent requirement). All swine intended to be added to a qualified pseudorabies negative herd shall be isolated until the swine have been found negative to two official pseudorabies serologic tests, one conducted 30 days or more after the swine have been placed in isolation, the second test being conducted 30 days or more after the first test; except (1) swine intended to be added to a qualified pseudorabies negative herd directly from another qualified pseudorabies negative herd may be added without isolation or testing; (2) swine intended to be added to a qualified pseudorabies negative herd from another qualified pseudorabies negative herd, but with interim contact with swine other than those from a single qualified pseudorabies negative herd, shall be isolated until the swine have been found negative to an official pseudorabies serologic test, conducted 30 days or more after the swine have been placed in isolation; (3) swine returned to the herd after contact with swine other than those from a single qualified pseudorabies negative herd shall be isolated until the swine have been found negative to an official pseudorabies serologic test conducted 30 days or more after the swine have been placed in isolation.
Notice is hereby given that there is reason to believe that the contagion of pseudorabies may exist in each State
Livestock shall not be moved interstate except in compliance with the regulations in this part.
(a) Livestock showing clinical evidence of pseudorabies shall not be moved interstate.
(b) Livestock that have been exposed to an animal showing clinical evidence of pseudorabies shall not be moved interstate within 10 days of such exposure.
(c) Except as provided in paragraphs (a) and (b) of this section, livestock other than swine may be moved interstate without restriction under this part.
(d) Except as provided in paragraphs (a) and (b) of this section, swine, swine semen, and swine embryos shall be moved interstate only in compliance with the regulations in this part.
Infected swine or exposed swine, other than swine described in § 85.4 (a) or (b), shall only be moved interstate in accordance with the following provisions:
(a)
(1) The swine are moved directly to a recognized slaughtering establishment or directly through one or more slaughter markets and then directly to a recognized slaughtering establishment;
(2) The swine are accompanied by a permit or owner-shipper statement and such permit or owner-shipper statement is delivered to the con-signee;
(3) The permit, in addition to the information in § 85.1, or the owner-shipper statement, in addition to the information in § 85.1, lists the identification of the swine as required by § 71.19 of this chapter;
(4) The swine are moved to destination in one continuous movement without unloading enroute.
(b)
(1) The swine are negative to an official pseudorabies serologic test 21 days or more after last being exposed to any livestock showing clinical evidence of pseudorabies;
(2) The swine are officially vaccinated for pseudorabies within 15 days after the negative test;
(3) The swine are moved interstate within 30 days after the negative test;
(4) The swine are accompanied by a permit and such permit is delivered to the consignee; and
(5) The permit, in addition to the information described in § 85.1, states: (i) The present pseudorabies quarantine status of the farm of origin; (ii) the identification of the swine as required by § 71.19 of this chapter; (iii) the date of the official pseudorabies serologic test and the name of the laboratory where the test was conducted; (iv) the date of the official vaccination for pseudorabies; and (v) that approval for the interstate movement has been issued by the State animal health official of the State of destination prior to the interstate movement of the swine.
Pseudorabies vaccinate swine, except swine from qualified negative gene-altered vaccinated herds, not known to be infected with or exposed to pseudorabies shall only be moved interstate in accordance with the following provisions:
(a)
(1) The swine are moved directly to a recognized slaughtering establishment or directly through one or more slaughter markets and then directly to a recognized slaughtering establishment;
(2) The swine are accompanied by a permit or owner-shipper statement and such permit or owner-shipper statement is delivered to the consignee; and
(3) The swine are moved to destination in one continuous movement without unloading enroute.
(b)
(1) The swine are accompanied by a permit and such permit is delivered to the consignee; and
(2) The permit in addition to information described in § 85.1 states: (i) The pseudorabies status of the herd; (ii) the identification of the swine required by § 71.19 of this chapter; (iii) the date of the vaccination for pseudorabies; and (iv) that approval for the interstate movement has been issued by the State animal health official of the State of destination prior to the interstate movement of the swine.
(c)
(1) The swine are accompanied by a certificate and such certificate is delivered to the consignee; and
(2) The certificate, in addition to the information described in § 85.1, states:
(i) The identification required by § 71.19 of this chapter;
(ii) That each animal to be moved was vaccinated for pseudorabies with a gpI-deleted gene-altered pseudorabies vaccine;
(iii) That each animal to be moved was subjected to a gpI enzyme-linked immunosorbent assay (ELISA) or a gpI Particle Concentration Fluorescence Immunoassay (PCFIA) approved differential pseudorabies test no more than 30 days prior to the interstate movement and was found negative;
(iv) The date of the gpI ELISA or the gpI PCFIA approved differential pseudorabies test; and
(v) The name of the laboratory that conducted the gpI ELISA or the gpI PCFIA approved differential pseudorabies test.
Swine not vaccinated for/pseudorabies and not known to be infected with or exposed to pseudorabies shall only be moved interstate in accordance with the following provisions:
(a)
(b)
(1) The swine are moved from a qualified pseudorabies negative herd directly to a feedlot, quarantined feedlot, quarantined herd, or approved livestock market; or
(2) The swine are moved directly to a feedlot, quarantined feedlot, quarantined herd, or to an approved livestock market for subsequent movement to a feedlot or quarantined feedlot, quarantined herd in accordance with paragraph (c) of this section; or
(3) The swine are moved from a State which requires the State animal health official of that State to be immediately notified of any suspected or confirmed case of pseudorabies in that State and which requires that exposed or infected livestock be quarantined, such quarantine to be released only after having met quarantine release standards no less restrictive than those in the definition of known infected herd in § 85.1, and
(i) Unless the swine are moving interstate in a swine production system in compliance with § 71.19(g) of this chapter, the swine are accompanied by an owner-shipper statement and are moved from a farm of origin directly to an approved livestock market; and
(A) The owner-shipper statement is delivered to the consignee, and
(B) The swine are identified at the approved livestock market to the farm of origin by the identification required by § 71.19 of this chapter.
(ii) Unless the swine are moving interstate in a swine production system in compliance with § 71.19(g) of this chapter, the swine are accompanied by a certificate and such certificate is delivered to the consignee; the certificate, in addition to the information in § 85.1, states the identification of the farm of origin of each swine being moved by a means of identification required by § 71.19 of this chapter, and approval for the interstate movement has been issued by the State animal health official of the State of destination prior to the interstate movement of the swine, and
(A) The swine are moved directly to a feedlot, quarantined feedlot, quarantined herd or approved livestock market from a farm of origin; or
(B) The swine are moved directly to a feedlot, quarantined feedlot, quarantined herd or approved livestock market from an approved livestock market which received the swine directly from a farm of origin, or
(C) The swine are moved directly to a feedlot, quarantined feedlot, or quarantined herd from an approved livestock market, which received the swine from another approved livestock market, which received the swine directly from a farm of origin.
(c)
(1) Unless the swine are moving interstate in a swine production system in compliance with § 71.19(g) of this chapter, the swine are accompanied by a certificate and such certificate is delivered to the consignee; and
(2) The certificate, in addition to the information described in § 85.1, states: (i) The identification required by § 71.19 of this chapter; and (ii) that each animal to be moved: (A) Was subjected to an official pseudorabies serologic test within 30 days prior to the interstate movement and was found negative, the test date and the name of the laboratory conducting the test; or (B) is part of a currently recognized qualified pseudorabies negative herd and the date of the last qualifying test; or, (C) is part of a pseudorabies controlled vaccinated herd and is one of the off-spring that was subjected to the official pseudorabies serologic test to achieve or maintain the status of the
Swine from a qualified negative gene-altered vaccinated herd, and not known to be infected with or exposed to pseudorabies, may be moved interestate only in accordance with the following provisions:
(a) Without further restriction under this part if:
(1) The swine are moved directly to a recognized slaughtering establishment, or directly through one or more slaughter markets and then directly to a recognized slaughtering establishment; or
(2) The swine are moved directly to a feedlot, quarantined feedlot, or approved livestock market; or
(3) The swine are moved from an approved livestock market to a feedlot, quarantined feedlot, or other approved livestock market; or
(4) The swine are moved interstate in a swine production system in compliance with § 71.19(g) of this chapter.
(b) For all interstate movements other than those set forth in paragraph (a) of this section, the swine must be accompanied by a certificate, and the certificate must be delivered to the consignee. In addition to the information required by § 85.1 of this part, the certificate must state: (1) That the swine are from a qualified negative gene-altered vaccinated herd; (2) The date of the herd's last qualifying test; (3) The identification for the swine to be moved interstate, in accordance with § 71.19 of this chapter; and (4) If the swine to be moved are official gene-altered pseudorabies vaccinates, the official gene-altered pseudorabies vaccine used in the herd.
The Administrator may, upon request in specific cases, permit the interstate movement of livestock not otherwise provided for in this part under such conditions as he may prescribe to prevent the spread of pseudorabies. The Animal and Plant Health Inspection Service intends that such authority be used only in situations and under circumstances presenting problems that could not have been reasonably anticipated in advance and in unique situations. The Animal and Plant Health Inspection Service does not intend that such authority be used repeatedly to cover the same problem, but that the regulation be amended to conform with needed changes as they come to light.
Swine semen and swine embryos moved interstate for insemination of swine or implantation into swine shall be accompanied by a document issued by an accredited veterinarian stating that the donor swine are not known to be infected with or exposed to pseudorabies, were negative to an official pseudorabies serologic test within 30 days prior to the collection of the semen or embryos or were members of a qualified pseudorabies negative herd, and had not been exposed to pseudorabies within 30 days prior to the collection of the semen or embryos.
(a) Each permit, certificate or owner-shipper statement required under this part to accompany swine interstate shall be delivered with the swine to the consignee by the person delivering the swine.
(b) A copy of each permit or certificate required under this part to accompany swine interstate shall be mailed or delivered to the State animal health official of the State of destination by the person issuing the document within 3 days of the interstate movement of the swine covered by said document.
All means of conveyance used in connection with the interstate movement of pseudorabies infected or exposed livestock shall be cleaned and disinfected in accordance with § 71.7 of this chapter using one of the disinfectants registered under the Federal Insecticide, Fungicide and Rodenticide Act, as amended (7 U.S.C. 135
Livestock markets and other facilities used in connection with the interstate movement of pseudorabies infected or exposed livestock shall be cleaned and disinfected in compliance with § 71.7 of this chapter using one of the disinfectants registered under the Federal Insecticide, Fungicide and Rodenticide Act, as amended (7 U.S.C. 135
7 U.S.C. 1901, 7 CFR 2.22, 2.80, 371.4.
The following definitions apply to this part:
(a) State governments may enact and enforce regulations that are consistent with or that are more stringent than the regulations in this part.
(b) To determine whether an individual or other entity found to transport equines to a slaughtering facility is subject to the regulations in this part, a USDA representative may request from any individual or other entity who transported the equines information regarding the business of that individual or other entity. When such information is requested, the individual or other entity who transported the equines must provide the information within 30 days and in a format as may be specified by the USDA representative.
(a) The animal cargo space of conveyances used for the commercial transportation of equines to slaughtering facilities must:
(1) Be designed, constructed, and maintained in a manner that at all times protects the health and well-being of the equines being transported (e.g., provides adequate ventilation, contains no sharp protrusions, etc.);
(2) Include means of completely segregating each stallion and each aggressive equine on the conveyance so that no stallion or aggressive equine can come into contact with any of the other equines on the conveyance;
(3) Have sufficient interior height to allow each equine on the conveyance to stand with its head extended to the fullest normal postural height; and
(4) Be equipped with doors and ramps of sufficient size and location to provide for safe loading and unloading.
(b) Equines in commercial transportation to slaughtering facilities must not be transported in any conveyance that has the animal cargo space divided into two or more stacked levels, except that conveyances lacking the capability to convert from two or more stacked levels to one level may be used until December 7, 2006. Conveyances with collapsible floors (also known as “floating decks”) must be configured to transport equines on one level only.
(a) Prior to the commercial transportation of equines to a slaughtering facility, the owner/shipper must:
(1) For a period of not less than 6 consecutive hours immediately prior to the equines being loaded on the conveyance, provide each equine appropriate food (
(2) Apply a USDA backtag
(3) Complete and sign an owner-shipper certificate for each equine being transported. The owner-shipper certificate for each equine must accompany the equine throughout transit to the slaughtering facility and must include the following information, which must be typed or legibly completed in ink:
(i) The owner/shipper's name, address, and telephone number;
(ii) The receiver's (destination) name, address, and telephone number;
(iii) The name of the auction/market, if applicable;
(iv) A description of the conveyance, including the license plate number;
(v) A description of the equine's physical characteristics, including such information as sex, breed, coloring, distinguishing markings, permanent brands, tattoos, and electronic devices that could be used to identify the equine;
(vi) The number of the USDA backtag applied to the equine in accordance with paragraph (a)(2) of this section;
(vii) A statement of fitness to travel at the time of loading, which will indicate that the equine is able to bear weight on all four limbs, able to walk unassisted, not blind in both eyes, older than 6 months of age, and not likely to give birth during the trip;
(viii) A description of any preexisting injuries or other unusual condition of the equine, such as a wound or blindness in one eye, that may cause the equine to have special handling needs;
(ix) The date, time, and place the equine was loaded on the conveyance; and
(x) A statement that the equine was provided access to food, water, and rest prior to transport in accordance with paragraph (a)(1) of this section; and
(4) Load the equines on the conveyance so that:
(i) Each equine has enough floor space to ensure that no equine is crowded in a way likely to cause injury or discomfort; and
(ii) Each stallion and any aggressive equines are completely segregated so that no stallion or aggressive equine can come into contact with any other equine on the conveyance.
(b) During transit to the slaughtering facility, the owner/shipper must:
(1) Drive in a manner to avoid causing injury to the equines;
(2) Observe the equines as frequently as circumstances allow, but not less than once every 6 hours, to check the physical condition of the equines and ensure that all requirements of this part are being followed. The owner/shipper must obtain veterinary assistance as soon as possible from an equine veterinarian for any equines in obvious physical distress. Equines that become nonambulatory en route must be euthanized by an equine veterinarian. If an equine dies en route, the owner/shipper must contact the nearest APHIS office as soon as possible and allow an APHIS veterinarian to examine the equine. If an APHIS veterinarian is not available, the owner/shipper must contact an equine veterinarian;
(3) Offload from the conveyance any equine that has been on the conveyance for 28 consecutive hours and provide the equine appropriate food, potable water, and the opportunity to rest for at least 6 consecutive hours; and
(4) If offloading is required en route to the slaughtering facility, the owner/shipper must prepare another owner-shipper certificate as required by paragraph (a)(2) of this section and record the date, time, and location where the offloading occurred. In this situation, both owner-shipper certificates would need to accompany the equine to the slaughtering facility.
(c) Handling of all equines in commercial transportation to a slaughtering facility shall be done as expeditiously and carefully as possible in a manner that does not cause unnecessary discomfort, stress, physical harm, or trauma. Electric prods may not be used on equines in commercial transportation to a slaughtering facility for any purpose, including loading or offloading on the conveyance, except when human safety is threatened.
(d) At any point during the commercial transportation of equines to a slaughtering facility, a USDA representative may examine the equines, inspect the conveyance, or review the owner-shipper certificates required by paragraph (a)(3) of this section.
(e) At any time during the commercial transportation of equines to a slaughtering facility, a USDA representative may direct the owner/shipper to take appropriate actions to alleviate the suffering of any equine. If deemed necessary by the USDA representative, such actions could include securing the services of an equine veterinarian to treat an equine, including performing euthanasia if necessary.
(f) The individual or other entity who signs the owner-shipper certificate must maintain a copy of the owner-shipper certificate for 1 year following the date of signature.
(a) Upon arrival at a slaughtering facility, the owner/shipper must:
(1) Ensure that each equine has access to appropriate food and potable water after being offloaded;
(2) Present the owner-shipper certificates to a USDA representative;
(3) Allow a USDA representative access to the equines for the purpose of examination; and
(4) Allow a USDA representative access to the animal cargo area of the conveyance for the purpose of inspection.
(b) If the owner/shipper arrives during normal business hours, the owner/shipper must not leave the premises of a slaughtering facility until the equines have been examined by a USDA representative. However, if the owner/shipper arrives outside of normal business hours, the owner/shipper may leave the premises but must return to the premises of the slaughtering facility to meet the USDA representative upon his or her arrival.
(c) Any owner/shipper transporting equines to slaughtering facilities outside of the United States must present the owner-shipper certificates to USDA representatives at the border.
(a) The Secretary is authorized to assess civil penalties of up to $5,000 per violation of any of the regulations in this part.
(b) Each equine transported in violation of the regulations of this part will be considered a separate violation.
49 U.S.C. 80502; 7 CFR 2.22, 2.80, and 371.4.
(a) Under normal conditions, the amount of feed designated in the following schedule will be considered as sustaining rations for livestock in transit when fed at the intervals required by the Twenty-Eight Hour Law:
(b) When the owner of a consignment of livestock desires that they be fed larger amounts of feed than those designated in paragraph (a) of this section for the particular kind and quantity of livestock, or the carrier believes that they should be fed larger amounts, the amounts to be fed should be agreed upon, if practicable, by the owner and the carrier at the time the animals are offered for shipment.
(c) When emergency conditions arise, such as severe changes in the weather,
(d) When the movement of livestock is delayed en route so that the period of their confinement in the cars materially exceeds that specified by the Twenty-Eight Hour Law, the livestock should receive additional feed in proportion to such excess time.
When livestock are held at a feeding station 12 hours after the last previous feed has been substantially consumed, they should again be fed the ration prescribed by § 89.1(a) for that station:
(a) Livestock should be unloaded into pens of the character described in § 89.5(a) for feeding, watering, and resting, unless there is ample room in the car for all of the animals to lie down at the same time.
(b) If livestock are watered in the car, adequate facilities should be provided and ample water furnished to insure all the animals an opportunity to drink their fill. In the case of hogs, water should be available for not less than 1 hour.
(c) Livestock unloaded for feed and water and returned to the car for rest should be allowed to remain in the pens not less than 2 hours.
(d) Livestock unloaded for water and returned to the car for feed and rest should be allowed to remain in the pens not less than 1 hour.
(e) When livestock are fed in the car, the feed should be evenly distributed throughout the car.
Livestock should be furnished an ample supply of potable water. Water treated with chemicals for industrial or boiler use, or taken from streams or ponds containing sewage, mud, or other objectionable matter should not be used. Troughs and other receptacles should be clean. In cold weather, the water should be free from ice.
(a) Stock pens and other enclosures for feeding, watering, and resting livestock in transit should have (1) sufficient space for all of the livestock to lie down at the same time, (2) properly designed facilities for feeding and watering the livestock, (3) reasonably well-drained, clean, and safe floors of concrete, cinders, gravel, hard-packed earth, or other suitable material, and (4) suitable protection from weather reasonably to be expected in the region in which the pens are located.
(b) Care should be taken to protect livestock unloaded en route at a point having marked difference in temperature from that at the point from which they were shipped.
7 U.S.C. 8301-8317; 19 U.S.C. 1644a(c); 21 U.S.C. 136, 136a, and 618; 46 U.S.C. 3901 and 3902; 7 CFR 2.22, 2.80, and 371.4.
Whenever in the regulations in this part the following terms are used, they shall be construed as follows:
No animals covered by the regulations in this part shall be exported to a foreign country except in compliance with the provisions in this part.
(a) All animals intended for exportation to a foreign country, except by land to Mexico or Canada, must be accompanied from the State of origin of the export movement to the port of embarkation by an origin health certificate. All animals intended for exportation by land to Mexico or Canada must be accompanied from the State of origin of the export movement to the border of the United States by an origin health certificate. The origin health certificate must certify that the animals were inspected within the 30 days prior to the date of export, except as follows: When the Administrator allows sampling or testing to be done more than 30 days prior to the date of export, in accordance with paragraph (c) of this section, then the animals also may be inspected within that same time period, and the origin health certificate will remain valid for that time period. The origin health certificate must certify that the animals were found upon inspection to be healthy and free from evidence of communicable disease and exposure to communicable disease. The origin health certificate must be endorsed by an authorized APHIS veterinarian in the State of origin and must include any test results added by the authorized APHIS veterinarian pursuant to § 161.3(k) of this chapter (any added test results must be initialed by the authorized veterinarian). The origin health certificate must individually identify the animals in the shipment as to species, breed, sex, and age and, if applicable, must also show registration name and number, tattoo markings, or other natural or acquired markings. The origin health certificate must include all test results, certifications, or other statements required by the country of destination.
(b)
(c)
(d)
(e)
The Administrator may, upon request in specific cases, permit the exportation of livestock not otherwise provided for in this part under such conditions as he may prescribe in each specific case to prevent the spread of livestock diseases and to insure the humane treatment of the animals while in transit.
In order to be eligible for export, cattle shall be tested with results as specified in this section, and the origin health certificate shall specify the type of tests conducted, the dates of the tests, and the results of the tests.
(a)
(1)
(i) Cattle exported directly to slaughter in a country that the Administrator has determined has an acceptable tuberculosis surveillance system at slaughter plants and that agrees to share any findings of tuberculosis in U.S. origin cattle with APHIS;
(ii) Cattle exported directly to slaughter from a State designated as an Accredited-Free State in § 77.7 of this chapter;
(iii) Cattle exported to a country that does not require cattle from the United States to be tested for tuberculosis as described in this part; or
(iv) Cattle exported from a State designated as an Accredited-free State in
(2) The Administrator has determined that the following countries have an acceptable tuberculosis surveillance system at slaughter plants: Canada and Mexico.
(b)
(1)
(i) Official vaccinates of dairy breeds under 20 months of age;
(ii) Official vaccinates of beef breeds under 24 months of age;
(iii) Steers and spayed heifers;
(iv) Cattle exported directly to slaughter in a country that the Administrator has determined has an acceptable brucellosis surveillance system at slaughter plants and that agrees to share any findings of brucellosis in U.S. origin cattle with APHIS;
(v) Cattle exported directly to slaughter from a State designated as a Class Free State in 9 CFR 78.41;
(vi) Cattle exported to a country that does not require cattle from the United States to be tested for brucellosis as described in this part; or
(vii) Cattle exported from a State designated as a Class Free State in § 78.41 of this chapter to a country that does not require cattle from Class Free States to be tested for brucellosis as described in this part.
(2) The Administrator has determined that the following country has an acceptable brucellosis surveillance system at slaughter plants: Canada.
(c)
(a) In order to be eligible for export, goats shall be tested with results as specified in this section, and the origin health certificate for such animals shall specify the type of test conducted, the date of the tests, and the results of the tests.
(1)
(2)
(3) No goat shall be exported if it is a scrapie-positive animal or an exposed animal, as defined in 9 CFR parts 54 and 79, or if it has ever been in an infected flock, source flock, or trace flock, as defined in 9 CFR parts 54 and 79; or if it is the progeny, parent, or sibling of any scrapie-positive animal.
(4) Goats exported for immediate slaughter need not comply with the requirements of paragraphs (a)(1), (2), (3), and (5) of this section.
(5) All goats intended for export shall be identified by eartags or tattoos approved by the Administrator, except that goats for export to Canada or
To be eligible for export, a captive cervid must be accompanied by an origin health certificate stating that the captive cervid has tested negative to an official single cervical tuberculin test for tuberculosis, as described in part 77, subpart B, of this chapter, within 90 days prior to export. The origin health certificate must specify the date the test was conducted and the test results.
(a) No sheep shall be exported if it is a scrapie-positive animal or an exposed animal, as defined in 9 CFR parts 54 and 79, or if it has ever been in an infected flock, source flock, or trace flock, as defined in 9 CFR parts 54 and 79; or if it is the progeny, parent, or sibling of any scrapie-positive animal.
(1) Sheep exported for immediate slaughter need not comply with the requirements of paragraph (a)(2) of this section.
(2) All sheep intended for export shall be identified by eartags or tattoos approved by the Administrator.
(a) No swine shall be exported if they were fed garbage at any time. The swine shall be accompanied by a certification from the owner stating that they were not fed garbage, and that any additions to the herd made within the 30 days immediately preceding the export shipment, have been maintained isolated from the swine to be exported. All breeding swine shall be tested for and show negative test results to brucellosis by a test prescribed in “Standard Agglutination Test Procedures for the Diagnosis of Brucellosis” or “Supplemental Test Procedures for the Diagnosis of Brucellosis”. The test results shall be classified negative in accordance with the provisions prescribed in the Recommended Brucellosis Eradication Uniform Methods and Rules, chapter 2, part II, G, 1, 2, and 3.
(b) [Reserved]
(a) The following ports which have export inspection facilities which satisfy the requirements of paragraph (c) of this section are hereby designated as ports of embarkation. All animals, except animals being exported by land to Mexico or Canada, shall be exported through said ports or through ports designated in special cases under paragraph (b) of this section:
(1)
(i) Los Angeles—airport and ocean port.
(A) Jet Pets, Inc., 9014 Pershing Drive, Plaza del Rey, CA 90291, (213) 823-8901.
(B) Valley Livestock, 14380 South Euclid Avenue, Chino, CA 91710, (909) 597-1756.
(ii) San Francisco—airport and ocean port.
(A) Cow Palace, P.O. Box 34206, San Francisco, CA 94134, (415) 469-6000.
(B) Petair, 145 Bel Air Road, P.O. Box 2431, South San Francisco, CA 94080, (415) 877-0200.
(2)
(i) Miami—airport and ocean port.
(A) USDA Import-Export Center, 6300 NW. 36th Street, P.O. Box 523054, Miami, FL 33152, (305) 526-2828.
(ii) Tampa—ocean port.
(A) Tampa Port Authority, 2703 E. 7th Avenue, Tampa, FL 33605, (813) 248-1924.
(3)
(i) Atlanta Hartsfield International Airport.
(A) Atlanta Equine Complex, 1270 Woolman Place, Atlanta, GA 30354, (404) 767-1700.
(B) Tumbleweed Farm (horses only), 1677 Buckner Road, Mableton, GA 30059, (770) 948-3556.
(C) Southern Cross Ranch (horses only), 1670 Bethany Church Road, Madison, GA 30650, (706) 342-8027.
(4)
(i) Honolulu—airport and ocean port.
(A) Hawaii State Quarantine Station, 99-762 Moanalua Road, Aiea, Hawaii 96701, (808) 487-5351.
(5)
(i) Chicago—airport only.
(A) C&R Midwest Quarantine Facilities, Ltd., Box 470, Route 31, Dundee, IL 60118, (312) 426-5009.
(B) Knief Quarantine Facility, 11 N 470 Chapman Road, Box 305, Burlington, Illinois 60109, (312) 683-3873.
(6)
(i) Greater Cincinnati Airport, Covington; and Standiford Field Airport, Louisville—airport only.
(A) Newton Paddocks (horses only), Barn No. 8, Newton Pike, Lexington, KY 40511, (606) 253-3456.
(7)
(i) New Iberia—airport only.
(A) Acadiana Regional Airport, Star R-3, Box 390-H (ARA), New Iberia, LA 70560, (318) 365-7204.
(8)
(i) Boston—airport only.
(A) Logan International Airport (miniature swine only), East Boston, Massachusetts 02128, (617) 565-4649.
(9)
(i) Minneapolis/St. Paul—airport only.
(A) American Livestock Export Company, 25789 Northfield Blvd., Hampton, MN 55031, (612) 831-3873.
(B) Cannon Export Center, 2870 Rochester Blvd., Cannon Falls, MN 55009, (507) 263-3064.
(10)
(i) Kansas City—airport only.
(A) KCI Multipurpose Export Facility, 12600 NW Prairie View Road, Kansas City, MO 64195, (314) 751-4338 (mailing address: P.O. Box 20462, Kansas City, MO 64195-0462).
(11)
(i) Elizabeth—ocean port.
(A) Tolleshunt Horse Farm (horses only), 10 Island Road, Box 469, Whitehouse, NJ 08888-0469, (908) 534-7738.
(B) The U.S. Equestrian Team's headquarters (horses only), Pottersville Road, Gladstone, NJ 07934, (908) 234-1251.
(ii) Newark International Airport.
(A) Tolleshunt Horse Farm (horses only), 10 Island Road, Box 469, Whitehouse, NJ 08888-0469, (908) 534-7738.
(B) The U.S. Equestrian Team's headquarters (horses only), Pottersville Road, Gladstone, NJ 07934, (908) 234-1251.
(iii) Salem—ocean port.
(A) Mannington Meadows Farm (horses only), 60 Oechsle Road, Woodstown, NJ 08098, (609) 769-2009.
(12)
(i) New York—airport and ocean port.
(A) Tolleshunt Horse Farm (horses only), 10 Island Road, Box 469, Whitehouse, NJ 08888-0469, (908) 534-7738.
(B) The U.S. Equestrian Team's headquarters (horses only), Pottersville Road, Gladstone, NJ 07934, (908) 234-1251.
(C) Vetport, Inc., Bldg. 189, J.F. Kennedy International Airport (Cargo Area), Jamaica, NY 11430, (212) 656-6042.
(13)
(i) Dayton International Airport.
(A) Instone Air Services, Inc., (equines only), 1 Emory Plaza, Dayton International Airport, Vandalia, OH 45377, (970) 382-0002.
(B) [Reserved]
(ii) Wilmington—airport only.
(A) Airborne Express Animal Export Facility, 145 Hunter Drive, Wilmington, OH 96701, (513) 382-5591.
(B) [Reserved]
(14)
(i) Harrisburg—airport only.
(A) Penn. Holstein Farm Export Inspection Facility, R.D. #1, Middletown, PA 17057, (717) 944-1374.
(15)
(i) San Juan—airport.
(A) El Commandante Race Track (Horses Only), P.O. Box 1304, Rio Piedras, PR 00929, (809) 724-6060.
(16)
(i) Brownsville—airport, ocean port, and border port.
(A) Texas Department of Agriculture, Livestock Inspection Facility, International Airport, Brownsville, TX 78520, (512) 546-5135.
(ii) Dallas/Fort Worth International Airport.
(A) DFW Quarantine (horses only), 1010 A Chinn Chapel Road, Lewisville, TX 75067, (214) 317-6861.
(B) [Reserved]
(iii) Del Rio—border port.
(A) Texas Department of Agriculture, Livestock Export Facility, Box 1046, Del Rio, TX 78840, (512) 775-1518.
(iv) Eagle Pass—border port.
(A) Texas Department of Agriculture, Livestock Export Facility, Box 1164, Eagle Pass, TX 78852, (512) 773-2359.
(v) El Paso—border port.
(A) Texas Department of Agriculture, Livestock Export Facility, 10800 Socorro Drive, El Paso, TX 79927, (915) 543-7419.
(vi) Houston—airport and ocean port.
(A) Texas Department of Agriculture, Livestock Export Facility, Box 60107, AMF, Houston, TX 77205, (713) 443-2447.
(vii) Laredo—airport and border port.
(A) El Primero Equine Export Facility (horses only), Route 7, Box 305, Laredo, TX 78041, (512) 723-5436.
(B) Texas Department of Agriculture, Livestock Export Facility, Route 1, Box 67-P, Laredo, TX 78040, (512) 722-6308.
(17)
(i) Richmond—airport and ocean port.
(A) American Marketing Services, Inc., 1301 Hermitage Road, Richmond, VA 23220, (804) 359-4433.
(18)
(i) Moses Lake—airport only.
(A) Port of Moses Lake, Grant County Airport, Terminal Bldg., Moses Lake, WA 98837, (509) 762-5363.
(ii) Seattle—airport and ocean port.
(A) Stevedoring Service of America, 3415 11th Avenue SW., Seattle, WA 98134, (800) 422-3505.
(iii) Olympia—ocean port.
(A) Port of Olympia Animal Export Facility, 915 Washington Street NE., Olympia, Washington 98507-0827, (206) 586-6150.
(iv) Tacoma—airport and ocean port.
(A) Pacific Rim Livestock Quarantine, 17835 Highway 507 SE., Yelm, WA 98507, (206) 458-1762.
(b) In special cases, other ports may be designated as ports of embarkation by the Administrator, with the concurrence of the Director of Customs, when the exporter can show to the satisfaction of the Administrator that the animals to be exported would suffer undue hardship if they are required to be moved to a port of embarkation listed in § 91.14(a). Such ports shall be designated only if the inspection facilities are approved as meeting the requirements of paragraph (c) of this section.
(c)
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(d)
For
(a) All animals offered for exportation to any foreign country, except by land to Mexico or Canada, shall be inspected within 24 hours of embarkation by an APHIS veterinarian at an export inspection facility at a port designated in § 91.14(a), or at a port or inspection facility designated by the Administrator in a special case under § 91.14(b).
(b) Such animals shall be held for a period of not less than 5 hours at the port of embarkation or export inspection facility during which time the animals shall be given a careful visual health inspection. Sorting, grouping, identification, or other handling of the animals by the exporter may be before or after this period of time. If individual clinical inspection of an animal is deemed necessary by an APHIS veterinarian for the purpose of determining its health status, such inspection may be made during this period of time or thereafter.
(c)
If, upon inspection by an APHIS veterinarian at the export inspection facility, the animals offered for export are found to be sound, healthy, and free from evidence of communicable disease or exposure thereto, an export certificate, VS Form 17-37, shall be issued by said APHIS veterinarian and shall contain a statement to that effect.
(a) The owner or operator of an ocean vessel carrying animals from the United States to a foreign country shall provide, for such animals, feed and water, space, ventilation, fittings, and other facilities aboard the carrier as set forth in this part. For animals embarked for a voyage which will be of more than 36 hours duration, there shall be provided to the satisfaction of
(b) Owners masters, or operators of such vessels shall not accept for transportation any animal that in the judgment of the APHIS veterinarian is in an unfit condition to withstand the rigors of such transportation. Further, no animal intended for export shall be placed aboard any ocean vessel, unless in the opinion of the inspector the loading arrangements, fittings, ventilation systems, and the arrangements provided by the vessel for their use reasonably assure arrival of a viable animal in the country of destination. Halters, ropes, or other suitable equipment provided for the handling and tying of horses shall be found to be satisfactory by the APHIS veterinarian to assure humane treatment of the animals.
All fittings, utensils and equipment, unless new, to be used in the loading, stowing, or other handling of animals aboard surface vessels under the provisions of this part, shall first be cleaned and disinfected under the supervision of an inspector before being used for, or in connection with, the transportation of animals from any United States port. Such disinfection of halters, ropes, and similar equipment used in handling and tying of animals shall be by immersion in an approved disinfectant. When the surface vessel has last been used to carry livestock to or from a foot-and-mouth disease infected country, the approved disinfectant shall be a freshly prepared solution of:
(a) Sodium carbonate (4 percent) in the proportion of 1 pound to 3 gallons of water.
(b) 4 percent sodium carbonate plus 0.1 percent sodium silicate.
(c) Sodium hydroxide (Lye) prepared in a fresh solution in the proportion of not less than 1 pound avoirdupois of sodium hydroxide of not less than 95 percent purity to 6 gallons of water, or one 13
It shall be the responsibility of the owners or the masters of an ocean vessel intended for use in exporting livestock to present the vessel to an inspector at a United States port of embarkation or at the descretion of the Administrator, upon request of the exporter, transporting company, or their agent, at a foreign port, for an inspection to determine if the fittings aboard the vessel are in compliance with the provisions of this part. A notarized statement from an engineering concern shall be required to certify to the rate of air exchange in each compartment. Such notarized statement shall be required upon first use of such vessel:
A variety of construction materials such as wood, metal plate, or pipe may be used for stalls, crates, or pens aboard ocean vessels. Pipe fittings have the advantage of smooth surfaces, easy maintenance, long range economy and spaces between pipe rails to allow for feeding, watering, cleaning and better ventilation. Material used for stalls, crates, or pens shall be properly formed, closely fitted, and rigidly secured in place. Special care shall be taken to design and finish all edges, welds, and hardware that are accessible to animals. A combination of wood and steel pipe or other steel profile construction may be accepted if the construction complies with the regulations in this part. Where the sides of pens are adjacent to the ship's sides which have steel casing, frames, stays or similar fittings, the carrier shall cover these profiles with wooden battens of at least 2 inch thick lumber or plywood of similar strength to prevent animals from injury.
Each underdeck compartment on which animals are being transported aboard an ocean vessel shall be equipped with a system of mechanical ventilation that will furnish a complete change of air in each compartment every 2 minutes when deck height
No animals shall be stowed along the alleyways leading to the engine or boiler rooms unless the sides of said engine or boiler rooms are covered by a tongue and groove tight sheathing producing a 3-inch-wide air space except that on ships powered with internal combustion engines this sheathing may not be required at the discretion of the inspector.
(a) Ramps connecting one deck of a ship to another shall have a clear width of 3 feet and a clear height of not less than 6 feet 6 inches. The incline of the ramps shall not exceed 1:2 (26
(b) Alleyways running fore and aft on the ocean vessel that are used for feeding, watering, and loading animals, including horses in box stalls, shall have a minimum width of 3 feet. However, for a distance not to exceed 8 feet at the end of alleyways in the bow and the stern of ship, and where obstructions of less than 3 feet in length occur, the width may be reduced to a minimum of 24 inches. A sufficient number of athwartship alleyways at least 24 inches in width shall be provided to afford ready access to scuppers and to ends of alleyways running fore and aft. However, on exposed decks where scuppers and the end of fore and aft alleyways are readily accessible athwartship alleyways are not required and if the alleyways are to be used for feeding
It shall be the responsibility of the captain of the ocean vessel to carry at least three men on board the vessel who are experienced in the handling of the kind/kinds of livestock to be carried, and a sufficient number of attendants, satisfactory to the inspector or the APHIS veterinarian at the port embarkation to insure proper care of the animals:
(a)
(b)
(c)
(d)
(e)
(f)(1) Except as provided in paragraph (c) of this section, space in pens on ocean vessels for cattle weighing 1000 pounds or more shall be no less than 8 feet in width and 6 feet 3 inches from roof or beams overhead to flooring underfoot, except that when floors are raised over pipes and similar obstructions, a height of not less than 6 feet may be permitted at the discretion of the inspector. Pens for cattle weighing less than 1,100 pounds may not exceed 226 square feet. Pens for cattle weighing 1,100 pounds or more may not exceed 610 square feet. When any such pen includes stanchions, sounding tubes, ventilators, and other obstructions, 20 percent more space for each animal shall be required.
(2) Single stalls in ocean vessels for cattle weighing 1000 pounds or more shall be not less than 8 feet in length by 3 feet in width.
(3) Calves and yearlings may be stowed in pens or stalls at the discretion of the inspector or the APHIS veterinarian at the port of embarkation.
(g)
(a) Pens aboard an ocean vessel shall have a 3 inch concrete pavement, proportioned and mixed to give 2000 psi. compressive strength in 28 days. The pavement shall have a broom or rough finish. Steel angle bars may be used for footlocks if they are mounted into the flooring in such a way that, at the same time, the bars serve as gutterways. The angle bars shall not be less than 2 inches by 2 inches and
(b)(1)
(2)
(3)
(c)(1)
(2)
All stalls and pens aboard an ocean vessel shall be equipped with proper
(a)
(b)
(a)(1) Pipes used for stanchions and rails for pens aboard an ocean vessel shall be made of zinc coated, galvanized, extra strong, medium carbon steel. Steel pipes or other steel profiles shall consist of not less than 4 pipes or profiles, the upper one to have 3 inch diameter and the others a diameter of not less than 2
(2) Threaded pipe connections shall not be used. All parts shall be cut from factory fabricated, seamless pipe.
(3) Bolt and pin holes shall not be drilled to more than
(4) Pipe shall not be deformed or weakened by welding such items as reinforcing rods or hinges thereto. Welding shall be used for such attachment to be exposed in the finished work. Pins, plates, and parts other than pipe shall be made of galvanized steel. All areas where galvanizing of the steel has eroded or has been damaged shall be finished with a rust preventative.
(5) Pipe rails shall be placed in proper alignment with tops of all gates at the same height.
(b) All gates of animal pens aboard an ocean vessel shall have smooth finished surfaces and the pivot-pins shall have a minimum diameter of
(c) Animals may be carried on upper decks of an ocean vessel in space abutting the outside rails or bulwarks only if such rails or bulwarks are 3 feet or more in height from the deck and are of sufficient strength to hold the necessary fittings securely or if the space available is sufficient to permit securing the required fittings to provide the necessary strength. When animals are carried on upper decks, bulkheads shall be erected at all unprotected ends of stalls.
(d)(1)
(2)
(e) For all animals, two beams of 2″×6″ lumber shall be bolted on each side of the stanchions using
(f) All pens for carrying animals on exposed decks aboard an ocean vessel shall be roofed with not less than 1 inch thick, watertight lumber extending from outside planking to at least 2 feet beyond the line of breast boards:
(g) All pens for carrying animals on exposed decks shall be provided with outside planking of not less than 1
(h)(1)
(2)
(3)
(i)(1)
(2)
(j)(1)
(2)
(a) Animals may be placed on hatches on exposed decks on an ocean vessel if the pens or stalls are securely lashed down.
(b) Animals may be placed on hatches on underdecks on an ocean vessel provided the height requirements of § 91.25 (e) and (f) are met and sufficient space shall be left clear on such hatches for passageway across ship.
(c) On all hatches on which animals are carried and under which hay and feed or animals are stowed, sufficient space shall be left clear for the proper removal and handling of such hay and feed and animal carcasses. Such hatches shall be watertight.
If previously used fittings aboard an ocean vessel are employed, any portion thereof found by the inspector to be worn, decayed, unsound, or otherwise defective shall be replaced.
Prior to loading of animals, the stowage area of aircraft to be used to export animals under the provisions of this part shall, under the supervision of an inspector, be cleaned and then disinfected using a freshly prepared solution of 4 percent sodium carbonate plus 0.1 percent sodium silicate. In addition, all loading ramps, fittings, and equipment to be used in loading the animals on the aircraft shall be cleaned and disinfected using an approved disinfectant listed in § 71.10 of this chapter. The time at which the cleaning and disinfection is performed must be approved by the inspector, who will give approval only if he or she determines that the cleaning and disinfection will be effective up to the projected time of loading of animals. If the animals are not loaded by the projected time, the inspector shall determine whether further cleaning and disinfection are necessary. The cleaning must remove all garbage, soil, manure, plant materials, insects, paper, and other debris from the stowage area. The disinfectant solution must be applied with a device that creates an aerosol or mist that covers 100 percent of the surfaces in the stowage area, except for any loaded cargo and deck surface under it that, in the opinion of the inspector, do not contain materials that may contain animal disease pathogens such as garbage, soil, manure, plant materials, insects, waste paper, or debris. After cleaning and disinfection is performed, the inspector shall sign and deliver to the captain of the aircraft or other responsible official of the airline involved, a document stating that the aircraft has been properly cleaned and disinfected, and stating further the date, the carrier, the flight number, and the name of the airport and the city and state in which it is located. If an aircraft is cleaned and disinfected
7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
(1) A national entity (country);
(2) Part of a national entity ( zone, county, department, municipality, parish, Province, State, etc.);
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
(a) The representative of the national government(s) of any country or countries who has the authority to request such a change may request at any time that all or part of the country or countries be recognized as a region, be included within an adjacent previously recognized region, or be made part of a region larger than an individual country. Requests for recognition of a region must be sent to the Administrator, in accordance with paragraph (c) of this section.
(b) Each request for approval to export a particular type of animal or animal product to the United States from a foreign region must be made to the Administrator, in accordance with paragraph (c) of this section, and must include, in English, the following information about the region:
(1) The authority, organization, and infrastructure of the veterinary services organization in the region.
(2) Disease status—
(3) The status of adjacent regions with respect to the agent.
(4) The extent of an active disease control program, if any, if the agent is known to exist in the region.
(5) The vaccination status of the region. When was the last vaccination? What is the extent of vaccination if it is currently used, and what vaccine is being used?
(6) The degree to which the region is separated from adjacent regions of higher risk through physical or other barriers.
(7) The extent to which movement of animals and animal products is controlled from regions of higher risk, and the level of biosecurity regarding such movements.
(8) Livestock demographics and marketing practices in the region.
(9) The type and extent of disease surveillance in the region—e.g., is it passive and/or active; what is the quantity and quality of sampling and testing?
(10) Diagnostic laboratory capabilities.
(11) Policies and infrastructure for animal disease control in the region—
(c) Requests for recognition of a region or for approval to export animals or animal products to the United States from a region, including the information required by this section, must be sent to the Administrator, c/o National Center for Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231. (Where possible, include a copy of the request and accompanying information on a 3.5-inch floppy disk in ASCII or a word processing format.)
(d) The information submitted in accordance with paragraph (b) of this section will be made available to the public prior to initiation by APHIS of any rulemaking action on the request.
(e) If, after review of the information submitted, APHIS believes the requested importation can be safely allowed, APHIS will publish a proposed rule in the
(f) APHIS will provide a period of time during which the public may comment on the proposal. During the comment period, the public will have access to the information upon which APHIS based its analysis of the risk of such importation, as well as to its methodology in conducting the analysis. Once APHIS has reviewed all comments received, it will make a final decision on what conditions will be necessary to allow the importation in question, and will publish the conditions for import in the
(g) If a region is granted animal health status under the provisions of this section, that region may be required to submit additional information pertaining to animal health status or allow APHIS to conduct additional information collection activities in order for that region to maintain its animal health status.
Whenever the European Commission (EC) establishes a quarantine for a disease in the European Union in a region the Animal and Plant Health Inspection Service recognizes as one in which the disease is not known to exist and the EC imposes prohibitions or other restrictions on the movement of animals or animal products from the quarantined area in the European Union, such animals and animal products are prohibited importation into the United States.
This section applies to regions that are designated in this subchapter D as free of a specific animal disease and then experience an outbreak of that disease.
(a)
(b)
(2) Prior to taking any action to relieve or finalize prohibitions or restrictions imposed by the interim rule, APHIS will make information regarding its reassessment of the region's disease status available to the public for comment. APHIS will announce the
(c)
(1) Publish a final rule that reinstates the disease-free status of the region, or a portion of the region, covered by the interim rule;
(2) Publish an affirmation of the interim rule that imposed prohibitions or restrictions on the imports of animals and animal products from that region; or
(3) Publish another document in the
7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
Wherever in this subpart the following terms are used, unless the context otherwise requires, they shall be construed, respectively, to mean:
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.);
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
(a) No product or bird subject to the provisions of this part shall be brought into the United States except in accordance with the regulations in this part and part 94 of this subchapter;
(b)(1) Birds from Canada may be imported in accordance with this section or, except for ratites in accordance with the provisions applicable to importation of poultry from Canada as specified in §§ 93.205, 93.214, and 93.216 of this part.
(2) Ratites and hatching eggs of ratites may be imported into the United States only in accordance with the provisions in this part that apply to commercial and zoological birds, and, where specified, with the provisions that apply to ratites or hatching eggs of ratites.
(3) Except for ratites imported as zoological birds, and ratites and ratite hatching eggs imported from Canada in accordance with § 93.107, ratites and hatching eggs of ratites may not be imported into the United States unless the following conditions are met:
(i) The ratites or hatching eggs are produced by a pen-raised flock, and, in the case of ratites, maintained in a pen-raised flock;
(ii) Each ratite produced in the flock is identified with an identification number by means of a microchip implanted at 1-day of age in the pipping muscle of ostriches and in the upper neck of other ratites, each ratite added from outside the flock is identified in
(iii) On the date it is produced, each hatching egg produced in the flock is marked in indelible ink with the date of the production, and with identification, assigned by the national government of the region of export, of the premises and region from which the ratites or hatching eggs are intended for exportation;
(iv) The owner or manager of the premises from which the ratites or hatching eggs are intended for importation into the United States maintains on a daily basis a register listing the following:
(A) Number of live ratites hatched in the flock or added to the flock, and number of live ratites removed from the flock, and the microchip number for each of these ratites;
(B) Number of eggs produced in the flock and date of production, and number of eggs removed from the flock and date of production; and
(C) Number of eggs in incubator/hatcher and date of production;
(v) The owner or manager of the premises submits a copy of the registers to the National Veterinary Service of the region of export on a quarterly basis. The region of export in turn submits a copy of the registers to the Administrator upon his or her request;
(vi) The region from which the ratites or hatching eggs are exported to the United States maintains a registry of premises that wish to export ratites or hatching eggs of ratites to the United States, that lists each ratite according to the microchip number required under paragraph (b)(3)(iv) of this section, and also maintains a count of hatching eggs of ratites produced on or added to the premises;
(vii) Before a premises is added to the registry, either a veterinary officer of the national government of the region of export, or an employee of that government responsible for the protection of fish and wildlife, visits the premises and determines that all ratites and hatching eggs of ratites are identified as required under paragraphs (b)(3)(ii) and (b)(3)(iii) of this section.
(viii) The region from which the ratites or hatching eggs of ratites are exported to the United States requires each premises from which ratites or hatching eggs of ratites are exported to the United States to receive approval from the National Veterinary Service of that region before ratites are added to the premises from outside the premises, and also prohibits the addition of ratites to a flock during production seasons;
(ix) The region from which ratites or hatching eggs of ratites are exported to the United States establishes a maximum number of hatching eggs of ratites that may be produced on each premises over a set production season. The ceiling for each premises is calculated jointly by a full-time salaried veterinary officer of the national government of the region of export and the APHIS representative who conducts the site visit required under § 93.103(a)(2)(iv), and is adjusted jointly by an APHIS representative and a full-time salaried veterinary officer of the national government of the region of export according to changes in the number of laying hens in the flock;
(x) The region of export conducts random inspections of each premises intending to export ratites or hatching eggs of ratites to the United States, at least twice during each production season, to ensure that all ratites and hatching eggs of ratites on the premises are identified as required under paragraphs (b)(3)(ii) and (b)(3)(iii) of this section. These inspections must be conducted by either a veterinary officer of the national government of the region of export or an employee of that government responsible for the protection of fish and wildlife. If any ratites or hatching eggs are not identified as required, the region of export must not
(xi) The region of export requires each premises on which ratites or hatching eggs of ratites intended for export to the United States are kept to submit to the National Veterinary Service of that region a copy of the certificate required under § 93.104(a);
(xii) The person intending to import ratites into the United States provides the APHIS veterinary inspector at the intended port of entry with a reader capable of reading the microchip implanted in each of the ratites.
(4) Ratites and hatching eggs of ratites may not be imported into the United States in any container that holds hay, straw, grasses, wood chips, sawdust, or other materials likely to harbor ectoparasites. Ratites and hatching eggs of ratites that are imported into the United States in containers holding such materials will be refused entry.
(c)(1) Pet birds offered for entry from Canada and which are not known to be affected with or exposed to any communicable disease of poultry, which are caged (prior to release from the port of entry) and which are personal pets, may be imported by the owner thereof at any port of entry designated in §§ 93.103 or 93.203:
(2)(i) Except for pet birds that have been in any region where highly pathogenic avian influenza subtype H5N1 exists, which are subject to the provisions of paragraph (c)(3) of this section, pet birds of United States origin that have not been outside the country for more than 60 days may be offered for entry under the provisions of paragraph (c)(1) of this section if:
(A) The pet birds are accompanied by an import permit issued by APHIS:
(B) The birds are also accompanied by a United States veterinary health certificate issued prior to the departure of the birds from the United States and the certificate shows the number from the leg band, tattoo, or microchip affixed to the birds prior to departure; and
(C) During port of entry veterinary inspection it is determined that the number from the leg band, tattoo, or microchip on the bird is the same as the one listed on the health certificate.
(ii) Except for pet birds that have been in any region where highly pathogenic avian influenza subtype H5N1 exists, which are subject to the provisions of paragraph (c)(3) of this section, pet birds of United States origin that have been outside the country for more than 60 days may be imported by their owner if:
(A) The pet birds are accompanied by an import permit issued by APHIS:
(B) The pet birds are found upon port of entry veterinary inspection to be free of poultry diseases; and
(C) The pet birds are accompanied by a United States veterinary health certificate issued prior to the departure of the birds from the United States and the certificate shows the number from the leg band, tattoo, or microchip affixed to the birds prior to departure; and
(D) During port of entry veterinary inspection it is determined that the number from the leg band, tattoo, or microchip on the bird is the same as the one listed on the health certificate; and
(E) The owner importing the pet birds signs and furnishes to the Administrator the following:
(
(
(
(
(3) Any pet birds of United States origin that have been in any region listed in § 94.6(d) of this subchapter as a region where highly pathogenic avian influenza subtype H5N1 exists, regardless of the length of time such birds have been outside of the United States, may only be imported through the port of Los Angeles, CA, Miami, FL, or New York, NY, and only under the following conditions:
(i) The birds meet the requirements of paragraphs (c)(2)(ii)(A) through (D) of this section; and
(ii) The birds are quarantined for a minimum of 30 days, and for such longer period as may be required by the Administrator in any specific case, at a USDA quarantine facility in accordance with § 93.106.
(4) Pet birds which are not known to be affected with or exposed to communicable diseases of poultry may be offered for entry at one of the ports of entry designated in § 93.102(a) under the following conditions:
(i) The pet birds shall be accompanied by a veterinary health certificate issued by a national government veterinary officer of the region of export stating that he or she personally inspected the birds listed on the health certificate and found them to be free of evidence of Newcastle disease, chlamydiosis, and other communicable diseases of poultry, and that the birds were being exported in compliance with the laws and regulations of the region of export, or if exported from Mexico, shall be accompanied either by such a certificate or by a certificate issued by a veterinarian accredited by the National Government of Mexico and endorsed by a full-time salaried veterinary officer of the National Government of Mexico, thereby representing that the veterinarian issuing the certificate was authorized to do so. Certificates in a foreign language must be translated into English at the expense of the importer.
(ii) An advanced reservation fee as required by § 93.103(a)(3) and a request for space which has been confirmed in writing, at a USDA-operated quarantine facility shall be made with the port veterinarian
(iii) During the isolation period, the birds shall be subjected to such tests and procedures as required by the Administrator to determine whether the birds are free from communicable diseases of poultry.
(iv) Following the isolation period, if the birds are found to be free of communicable disease of poultry, the port veterinarian shall issue an agriculture release for entry through U.S. Customs. If the birds are found during port of entry inspection or during quarantine to be infected with or exposed to a communicable disease of poultry, such birds shall be refused entry and handled in accordance with § 93.106(a) of this part.
(v) The owner of the birds is responsible for all costs which result from these procedures and shall reimburse APHIS for governmental expenses in accordance with § 93.210 (b) and (c) of this part.
(d) The provisions in this subpart relating to birds shall not apply to healthy birds, except ratites, not known to be infected with or exposed, within the 90 days preceding the date of export from the region of origin, to communicable diseases of poultry, if an import permit
(1)(i) They are maintained under continuous confinement in transit through the United States aboard an aircraft, ocean vessel, or other means of conveyance; or
(ii) Except for birds in transit through Anchorage, Alaska, under § 93.103(c) of this part, which are not allowed to be unloaded, they are unloaded, in the course of such transit, into a bird holding facility which is provided by the carrier or its agent and has been approved
(2) The carrier or its agent executes and furnishes to the collector of Customs at the first port of arrival a declaration stating that the poultry or birds will be retained aboard such means of conveyance or in an approved holding facility during transhipment as required by this paragraph.
(3) Provisions for the approval of facilities required in this paragraph are:
(i) They must be sufficiently isolated to prevent direct or indirect contact with all other animals and birds while in the United States.
(ii) They must be so constructed that they provide adequate protection against environmental conditions and can be adequately cleaned, washed and disinfected.
(iii) They must provide for disposal of animal and bird carcasses, manure, bedding, waste and any related shipping materials in a manner that will prevent dissemination of disease.
(iv) They must have provisions for adequate sources of feed and water and for attendants for the care and feeding of birds in the facility.
(v) They must comply with additional requirements as may be imposed by the Administrator if deemed applicable for a particular shipment.
(vi) They must also comply with all applicable local, State and Federal requirements for environmental quality and with the provisions of the Animal Welfare Regulations in chapter I of this title, as applicable.
(e) Commercial birds, zoological birds, research birds, or pet birds may be imported into the United States if they meet the requirements of §§ 93.102(a), 93.103, 93.104, 93.105(a), and 93.106(a) which specifically apply to such birds and the requirements of all other sections in this part that are applicable to poultry generally.
(f)
(i) The birds are found upon port of entry veterinary inspection to be free of avian diseases; and
(ii) The birds are accompanied by a United States veterinary health certificate issued prior to the departure of the birds from the United States and the certificate shows the number from the leg band, tattoo, or microchip affixed to the birds prior to departure; and
(iii) During port of entry veterinary inspection it is determined that the number from the leg band, tattoo, or microchip on the birds is the same as the one listed on the health certificate.
(2) Except for performing or theatrical birds that have been in any region where highly pathogenic avian influenza subtype H5N1 exists, which are subject to the provisions of paragraph (f)(3) of this section, performing or theatrical poultry of United States origin that have been outside the United States in a region other than Canada or Mexico may be imported if:
(i) The birds meet the requirements of paragraphs (f)(1)(i) through (iii) of this section; and
(ii) The birds are accompanied by an import permit issued by APHIS; and
(iii) The owner importing the birds signs and furnishes to the Administrator the following:
(A) A notarized declaration under oath or affirmation (or a statement signed by the owner and witnessed by a Department inspector) stating that the birds have not been in contact with other birds while out of the region (for example, association with other avian species at exhibitions or at aviaries); and
(B) An agreement on VS Form 17-8, obtainable from a Federal inspector at the port of entry, stating:
(
(
(3) Any performing or theatrical birds of United States origin that have been in any region listed in § 94.6(d) of this subchapter as a region where highly pathogenic avian influenza subtype H5N1 exists may only be imported through the port of Los Angeles, CA, Miami, FL, or New York, NY, and only under the following conditions:
(i) The birds meet the requirements of paragraphs (f)(1)(i) through (iii) of this section; and
(ii) The birds are accompanied by an import permit issued by APHIS; and
(iii) The birds are quarantined for a minimum of 30 days, and for such longer period as may be required by the Administrator in any specific case, at a quarantine facility maintained by APHIS in accordance with paragraphs (c)(3)(ii) through (c)(3)(iv) of this section.
(g) Any smuggled bird shall:
(1) Be refused entry into the United States and be removed from the United States,
(2) Be quarantined in a USDA-operated quarantine facility pending negative results to two consecutive tests for exotic Newcastle disease (END)
(3) Tissue samples from any smuggled bird which has died prior to release from quarantine shall be submitted for END isolation. Smuggled birds shall also be subject to such other tests and procedures to determine whether the birds are free from communicable diseases of poultry other than END when the port veterinarian determine that the bird in question has shown physical symptoms of being affected with or exposed to communicable diseases of poultry. A lot of smuggled birds placed into the quarantine facility shall be handled on an “all-in, all-out” basis:
(4) If the laboratory tests for END are negative and as determined by the port veterinarian the birds are free of clinical evidence of diseases of poultry at the end of the quarantine period, the port veterinarian shall issue an agricultural release for entry of the birds through the United States Customs Service at the termination of the quarantine period. Providing that the sale of the smuggled birds is not contrary to any Federal law or regulation, expenses incurred by the Department for the handling of the smuggled birds under this paragraph shall be reimbursed from funds derived from the sale or disposition of the smuggled birds after their release from quarantine. Any smuggled bird which by law may not be sold, or so disposed, shall be quarantined in accordance with such
(a)
(b)
(c) Notwithstanding any other provisions of this section, all commercial birds, zoological birds, or research birds shall be imported only at a port of entry specified in § 93.105.
(d)
(a)
(1) For pet birds, commercial birds, research birds, zoological birds, and performing or theatrical birds, intended for importation into the United States, except as otherwise provided in §§ 93.101(b) and (c), 93.103(c), and 93.107(b), the importer shall first apply for and obtain an import permit. The importer (permit applicant) shall submit a completed VS form 17-128 for ratites or hatching eggs of ratites; or, for other birds, a completed VS form 17-20; or shall submit a document that states that it is an application for a permit to import ratites, hatching eggs of ratites, or birds other than ratites or hatching eggs of ratites. The application
(i) The name, address, and telephone number of the importer;
(ii) The status of the importer, such as individual, partnership, or corporation (if incorporated, include State where incorporated and date of incorporation);
(iii) Name and address of the quarantine facility;
(iv) Date of intended quarantine;
(v) The purpose of the importation;
(vi) The region of origin;
(vii) The name and address of the exporter;
(viii) The port of embarkation in the foreign region;
(ix) The mode of transportation, route of travel, and port of entry in the United States;
(x) The name and location of the quarantine facility in the United States to which delivery will be made from the port of entry, in accordance with § 93.106(c)(5);
(xi) A drawing of the floor plan for the facility showing the location of the bird holding area; equipment storage areas; office areas; clothes storage and change areas; feed storage areas; necropsy areas (showing entry and refrigeration); washing areas for equipment; shower areas; ventilation arrangements; and entries and exits; and, for a facility for hatching eggs of ratites in which the hatching eggs of one lot may be quarantined at the same time as the hatched chicks from a previously quarantined lot, the incubation/hatcher and bird (chick) holding areas; and
(xii) Date and certification, by signature of the importer (permit applicant), after the following language:
(xiii) In addition, the application for a permit to import ratites or hatching eggs of ratites, except for ratites and hatching eggs of ratites imported from Canada in accordance with § 93.107, shall specify the number of ratites or hatching eggs intended for importation, the size of the flock of origin, and the location of the premises where the flock of origin is kept; and shall state that, from the date of application through the date of export, APHIS representatives shall be granted access to the premises where the flock of origin is kept. (For ratites intended for importation as zoological birds, the flock of origin shall be the ratites intended for importation.)
(2)(i) An import permit will be issued only after an APHIS representative has inspected the quarantine facility identified on the permit application, and has determined that it meets the standards set forth in § 93.106(c) of this part.
(ii) An application for a permit to import pet birds, commercial birds, research birds, zoological birds, and performing or theatrical birds, may be denied or withdrawn because of: Communicable disease conditions in the area or region of origin, or in a region where the shipment has been or will be held or through which the shipment has been or will be transported; deficiencies in the regulatory programs for the control or eradication of animal diseases and the unavailability of veterinary services in the above mentioned countries; the importer's failure to provide satisfactory evidence concerning the origin, history, and health status of the animals; the lack of satisfactory information necessary to determine that the importation will not be likely to transmit any communicable disease to livestock or poultry of the United States; the lack of APHIS personnel; any outstanding debts to APHIS the permit applicant has not paid when due; or any other circumstances which the Administrator believes require such denial or withdrawal to prevent the dissemination of any communicable disease of livestock or poultry into the United States, such as if:
(A) Any requirement of this subpart is not complied with;
(B) The importer (permit applicant) or any person responsibly connected with the importer's business, any person responsibly connected with the privately owned bird quarantine facility through which the importation is intended, or, in the case of the importation of ratites or ratite hatching eggs, the operator of the flock of origin or a person responsibly connected with the owner of the flock of origin, has been convicted of any crime under any law regarding the import or export of goods, regarding the quarantine of any animal or bird, or the illegal movement of goods within a region, or involving fraud, bribery, extortion, or of any other crime involving lack of the integrity needed for the conduct of operations affecting the importation of birds;
(C) The importer (permit applicant) or any person responsibly connected
(D) For any violation of the regulations in this subpart.
(iii) In addition, a permit to import ratites or hatching eggs of ratites, except for ratites or hatching eggs of ratites imported from Canada in accordance with § 93.107, will be denied or withdrawn unless APHIS representatives are granted access to the premises where the flock of origin is kept (or, in the case of zoological birds, to the premises where the birds are kept), from the date of the application for the permit through the date of export.
(iv) Except for ratites intended for importation as zoological birds and ratites and hatching eggs of ratites imported from Canada in accordance with § 93.107, a permit to import ratites or hatching eggs of ratites will be denied or withdrawn unless an APHIS representative has visited the premises where the flock of origin is kept within the 12-month period before the intended importation and has determined that the flock is pen-raised and contains sufficient breeding pairs to produce the number of ratites or hatching eggs intended for importation.
(v) A permit to import ratites or hatching eggs of ratites will be denied or withdrawn if an inspection of the premises of the flock or origin, carried out by the national government of the region of export under § 93.101(b)(3), indicates that the ratites and hatching eggs are not identified and marked as required under § 93.101(b)(3).
(vi) For the purposes of this section, a person shall be deemed to be responsibly connected with an importer's business, a privately owned bird quarantine facility, or an owner of a flock of origin, if such person has an ownership, mortgage, or lease interest in the physical plant of the importer's business, the privately owned bird quarantine facility, or the farm of the flock of origin, or if such person is a partner, officer, director, holder or owner of 10 per centum or more of the voting stock of the importer's business, the privately owned bird quarantine facility, or the farm of the flock of origin, or is an employee of the importer's business, the privately owned bird quarantine facility, or the owner of the flock of origin.
(vii) A permit may be denied or withdrawn at any time by the Administrator, for any of the reasons provided in paragraphs (a)(2)(ii), (iii), (iv), or (v) of this section. Before such action is taken, the importer will be informed of the reasons for the proposed action and, upon request in case of a dispute of material facts, shall be afforded an opportunity for a hearing with respect to the merits or validity of such action, in accordance with rules of practice which shall be adopted for the proceeding. However, withdrawal of a permit shall become effective pending final determination in the proceeding, when the Administrator determines that such action is necessary to protect the public health, interest, or safety. Such withdrawal shall be effective upon oral or written notification, whichever is earlier, to the importer. In the event of oral notification, written confirmation shall be given to the importer as promptly as circumstances permit. This withdrawal shall continue in effect pending the completion of the proceeding and any judicial review thereof, unless otherwise ordered by the Administrator.
(viii) If APHIS receives more than one application for a permit to import birds through a specified port of entry at approximately the same time, such that APHIS personnel could provide services to only one importer (permit applicant) who requests them, APHIS
(3)(i) The importer or importer's agent shall pay or ensure payment of a reservation fee for each lot of birds to be quarantined in a facility maintained by USDA. For birds the reservation fee shall be 100 percent of the cost of providing care, feed, and handling during quarantine, as estimated by the quarantine facility's veterinarian in charge.
(ii) At the time the importer or the importer's agent requests a reservation of quarantine space, the importer or importer's agent shall pay the reservation fee by check or U.S. money order or ensure payment of the reservation fee by an irrevocable letter of credit from a commercial bank (the effective date on such letter of credit shall run to 30 days after the date the birds are scheduled to be released from quarantine); except that anyone who issues a check to the Department for a reservation fee which is returned because of insufficient funds shall be denied any further request for reservation of a quarantine space until the outstanding amount is paid.
(iii) Any reservation fee paid by check or U.S. money order shall be applied against the expenses incurred for services received by the importer or importer's agent in connection with the quarantine for which the reservation was made. Any part of the reservation fee which remains unused after being applied against the expenses incurred for services received by the importer or the importer's agent in connection with the quarantine for which the reservation was made, shall be returned to the individual who paid the reservation fee. If the reservation fee is ensured by a letter of credit, the Department will draw against the letter of credit unless payment for services received by the importer or importer's agent in connection with the quarantine is otherwise made at least 3 days prior to the expiration date of the letter of credit.
(iv) Any reservation fee shall be forfeited if the importer or the importer's agent fails to present for entry, within 24 hours following the designated time of arrival, the lot of birds for which the reservation was made:
(A) Written notice of cancellation from the importer or the importer's agent is received by the office of the veterinarian in charge of the quarantine facility
(B) The Administrator determines that services, other than provided by carriers, necessary for the importation of the poultry or birds within the requested period are unavailable because of unforeseen circumstances as determined by the Administrator, (such as the closing of an airport due to inclement weather or the unavailability of the reserved space due to the extension of another quarantine.)
(v) If the reservation fee was ensured by a letter of credit and the fee is to be forfeited under paragraph (a)(3)(iv) of this section, the Department will draw against the letter of credit unless the reservation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.
(vi) When a reservation is cancelled in accordance with paragraph (a)(3)(iv)(A) of this section and the provisions of paragraph (a)(3)(iv)(B) of this section do not apply, a $40.00 cancellation fee shall be charged. If a reservation fee was paid, the cancellation fee shall be deducted from any reservation fee returned to the importer or the importer's agent. If the reservation fee was ensured by a letter of credit, the Department will draw the amount of the cancellation fee against the letter of credit unless the cancellation fee is
(4)
(ii) Quarantine space for ratites will be offered in the order that permit applications are or have been received, beginning with those permit applications received on August 12, 1991. Reservations for quarantine space at the Miami Animal Import Center will be limited to a maximum of 100 ratites per permit application. There will be a single waiting list for quarantine space at the Miami Animal Import Center and the New York Animal Import Center. Importers who prefer one of these two facilities over the other may remain on the waiting list until space opens up at the facility of their choice.
(b)
(c) Notwithstanding any other provisions in this part, importers are not required to obtain an import permit and provide the shipper with an original import permit for each individual shipment of birds other than ratites transiting the port of Anchorage, Alaska, if the following conditions are met:
(1) The importer applies for and obtains an import permit for multiple shipments of birds transiting the port of Anchorage, Alaska, in accordance with the provisions of this section and related requirements concerning application for the permit. However, the following information is not required on the application:
(i) The species, breed, and number of birds to be imported;
(ii) The region of origin;
(iii) The name and address of the exporter;
(iv) The port of embarkation in the foreign region;
(v) The mode of transportation and the route of travel;
(vi) The proposed date of arrival of the birds; and
(vii) The name and address of the person to whom the birds or poultry will be delivered.
(2) The importer completes a copy of the import permit obtained under paragraph (c)(1) of this section for each separate shipment of birds intended to transit the port of Anchorage, Alaska, by inserting the following information on a copy of the permit:
(i) The species, breed, and number of birds to be imported;
(ii) The region of origin;
(iii) The name and address of the exporter;
(iv) The port of embarkation in the foreign region;
(v) The mode of transportation and the route of travel;
(vi) The proposed date of arrival of the birds; and
(vii) The name and address of the person to whom the birds will be delivered.
(3) The importer, not less than 2 weeks prior to the anticipated date of arrival of each separate intransit shipment of birds at the port of Anchorage,
(4) A copy of the completed import permit accompanies each separate intransit shipment of birds or poultry to the port of Anchorage, Alaska;
(5) Import permits issued for multiple shipments of birds transiting the port of Anchorage, Alaska, will be valid only during the calendar year in which they are issued.
(a)
(b)
(1) That all birds covered by the certificate have been inspected by the veterinarian issuing the certificate;
(2) That no evidence of Newcastle disease, chlamydiosis, or other communicable disease of poultry was found among the birds;
(3) That insofar as has been possible to determine, the birds were not exposed to Newcastle disease, chlamydiosis, or other communicable disease of poultry during the 90 days immediately preceding their exportation;
(4) That the birds have not been vaccinated with Newcastle disease vaccine;
(5) That Newcastle disease did not occur anywhere on the premises from which the birds were to be exported or on adjacent premises during the 90 days immediately preceding the exportation of the birds;
(6) That neither the premises from which the birds were to be exported nor any adjacent premises were located in any area under quarantine for poultry diseases at any time during the 90 days immediately preceding the exportation of the birds; and
(7) That the birds were placed into previously unused containers at the premises from which the birds were to be exported.
(c)
(1) That, except as provided in paragraph (c)(13) of this section, all ratites covered by the certificate, and their flock of origin, have been inspected by the veterinarian issuing the certificate;
(2) That, except when the certificate is for zoological birds or ratites imported from Canada in accordance with § 93.107, the flock of origin is pen- raised and the ratites covered by the certificate were produced and maintained in that flock;
(3) That no evidence of Newcastle disease, chlamydiosis, or other communicable disease of poultry was found in the flock of origin;
(4) That insofar as has been possible to determine, the flock of origin was not exposed to Newcastle disease, chlamydiosis, or other communicable disease of pountry during the 90 days immediately preceding the exportation;
(5) That none of the ratites intended for shipment to the United States have been vaccinated with Newcastle disease vaccine;
(6) That Newcastle disease did not occur anywhere on the premises where the flock of origin was kept or on adjacent premises during the 90 days immediately preceding the exportation;
(7) That neither the premises where the flock of origin was kept nor any adjacent premises was located in any
(8) That, except as provided in § 93.107 for ratites imported from Canada for immediate slaughter, the ratites were treated at least 3 days but not more than 14 days before being loaded for shipment to the United States with a pesticide of a type and concentration sufficient to kill ectoparasites on the ratites;
(9) That the pesticide was applied to all body surfaces of the ratites under the supervision of the veterinarian issuing the certificate;
(10) That the ratites, after being treated for ectoparasites, did not have physical contact with, or share a pen or bedding materials with, any ratite not in the same shipment to the United States; and
(11) That the ratites were placed in previously unused containers for shipment to the United States at the premises where the flock of origin was kept.
(12) The number of ratites contained in the shipment;
(13) That the number of ratites and hatching eggs of ratites exported from the flock of origin has not exceeded the ceiling required to be established under § 93.101(b)(3)(ix);
(14) That all the ratites and hatching eggs of ratites in the flock from which the ratites come were identified in accordance with § 93.101(b)(3);
(15) Except for ratites imported from Canada in accordance with § 93.107, the number of ratite laying hens in the flock from which the ratites come;
(16) For ratites required to be treated prior to shipment with a pesticide for ectoparasites, the certificate must also state the name, concentration, and date of administration of the pesticide used to treat the ratites;
(17) When ratites intended for importation are zoological birds, only the ratites to be imported must be inspected, and the provisions in paragraphs (c)(3), (c)(4), (c)(5), (c)(6), (c)(7), and (c)(11) that apply to the flock of origin shall apply only to the ratites intended for importation.
(d)
(1) That the flock of origin of the hatching eggs has been inspected by the veterinarian issuing the certificate;
(2) That, except when the certificate is for hatching eggs of ratites imported from Canada in accordance with § 93.107, the flock of origin is pen- raised, and the hatching eggs covered by the certificate were produced by that flock;
(3) That no evidence of Newcastle disease, chlamydiosis, or other communicable disease of poultry was found in the flock of origin;
(4) That insofar as has been possible to determine, the flock of origin was not exposed to Newcastle disease, chlamydiosis, or other communicable disease of poultry during the 90 days immediately preceding the exportation of the hatching eggs;
(5) That Newcastle disease did not occur anywhere on the premises where the flock of origin was kept or on adjacent premises during the 90 days immediately preceding the exportation of the hatching eggs;
(6) That neither the premises where the flock of origin was kept nor any adjacent premises were located in any area under quarantine for poultry diseases at any time during the 90 days immediately preceding the exportation of the hatching eggs; and
(7) That the hatching eggs were placed into previously unused containers for shipment to the United States at the premises where the flock of origin was kept.
(8) The number of hatching eggs contained in the shipment;
(9) That the number of ratites and hatching eggs of ratites exported from the flock of origin has not exceeded the ceiling required to be established under § 93.101(b)(3)(ix);
(10) That all the ratites and hatching eggs of ratites in the flock from which the hatching eggs come were identified in accordance with § 93.101(b)(3);
(11) Except for hatching eggs of ratites imported from Canada in accordance with § 93.107, the number of
(a) All commercial birds, zoological birds, and research birds, including hatching eggs of ratites, but excluding other ratites, imported into the United States, must be inspected by the port veterinarian at the Customs port of entry, which may be any international airport, or any land-border port within 20 miles of an international airport, serviced by Customs, as well as, for Canadian-origin hatching eggs of ratites, ports listed in § 93.107 (c). However, hatching eggs of ratites may be shipped, in bond, from the port of first arrival to the Customs port of entry at which they will be quarantined, for inspection, at that port.
(b) All pet birds imported from any part of the world, except pet birds from Canada and pet birds meeting the provisions of § 93.101(c)(2), shall be subjected to inspection at the Customs port of entry by a veterinary inspector of APHIS and such birds shall be permitted entry only at the ports listed in § 93.102(a). Pet birds of Canadian origin and those birds meeting the provisions of § 93.101(c)(2) shall be subject to veterinary inspection at any of the ports of entry listed in § 93.102 and 93.203.
(c) Ratites, other than hatching eggs of ratites, imported from any part of the world must be inspected at the Customs port of entry by a veterinary inspector of APHIS and, except as provided in § 93.107(b) for ratites imported from Canada, shall be permitted entry only at one of the following ports of entry:
(1) Ostriches:
(i) Up to 36 inches in height (as measured from the top of the head to the base of the feet) or 30 pounds in weight: New York, NY; Stewart Airport, Newburgh, NY; and Miami, FL.
(ii) Exceeding 36 inches in height or 30 pounds in weight: New York, NY, and Stewart Airport, Newburgh, NY.
(2) Ratites other than ostriches: New York, NY; Stewart Airport, Newburgh, NY; and Miami, FL.
(a)
(b)
(2) Each lot of hatching eggs of ratites imported from any part of the world except as provided in § 93.107, shall be quarantined upon arrival, incubated for the full incubation period (approximately 42 days), and held in quarantine for a minimum of 30 days following the hatch of the last chick in the lot, and for such longer period as may be required by the Administrator to determine the ratites' freedom from communicable diseases. Quarantine shall be conducted at a facility that meets the requirements of paragraph (c) of this section, and in the manner prescribed by paragraph (c) of this section.
(3) During the quarantine period, the ratites, including chicks hatched in quarantine, shall be tested for viral diseases of poultry, including Newcastle disease. If any of the ratites exhibit evidence of other communicable diseases, they will be subjected to such additional tests as may be required by the Administrator to determine their freedom from communicable diseases. Ratites other than those imported as hatching eggs also shall be treated for ectoparasites
(4) If the ratites, including chicks hatched during quarantine, are determined to be free of communicable diseases, the port veterinarian shall issue an agricultural release for entry through U.S. Customs. If the port veterinarian finds evidence of communicable disease, or exposure to communicable disease, during port of entry inspection or quarantine of the ratites, the ratites shall be refused entry, or shall be held in quarantine until they are determined to be free of communicable disease, or shall be otherwise disposed of as directed by the Administrator.
(c)
(1)
(2)
(i)
(A) Within the immediate metropolitan area of the port of entry to prevent the imported birds, while in transit to the quarantine facility, from introducing or disseminating disease to domestic poultry or livestock.
(B) At least one-half mile from any concentration of avian species, such as, but not limited to, poultry processing plants, poultry or bird farms, pigeon lofts, or other bird quarantine facilities. Factors such as prevailing winds, the efficiency of the air filtration system of the quarantine facility, possible exposure to poultry or birds moving in local traffic, etc., shall be taken into consideration.
(ii)
(A) Be constructed only with material that can withstand continued cleaning and disinfection. All solid walls, floors, and ceilings must be constructed of impervious material. All openings to the outside must be double-screened, with an interior screen of metal or nylon mesh that is impervious to biting insects such as gnats or mosquitos, and an exterior metal screen that is rodent-proof and is made of wire, such as rabbit wire, hardware cloth, or smooth welded wire, with mesh size no larger than 1 inch×1.5 inches (2.54 cm×3.81 cm). The interior and exterior screens must be separated by at least 3 inches (7.62 cm);
(B) Have a bird holding area of sufficient size to prevent overcrowding of the birds in quarantine. (All access into this holding area shall be from within the building and each entryway into such area shall be equipped with self-closing, double doors:
(C) Have a ventilation capacity sufficient to control moisture and odor at levels that are not injurious to the health of the birds in quarantine;
(D) Have a vermin-proof feed storage area;
(E) Have office space for recordkeeping;
(F) Have a separate necropsy room which shall have refrigerated storage space for carcasses retained for laboratory examination and facilities adequate for specimen preparation and carcass disposal;
(G) Have a separate area for washing facility equipment;
(H) Have a shower at the entrance into the area comprised of the bird holding and necropsy rooms and a clothes storage and change area at each end of the shower area;
(I) Have a storage area for equipment necessary for quarantine operations;
(J) Have equipment necessary to maintain the facility in clean and sanitary condition, including insect and pest control equipment;
(K) Have a receptacle for soiled and contaminated clothing in the clothes change area located nearest the entrance to the bird holding area;
(L) All construction must be completed before any permit application is submitted in accordance with § 93.103.
(M) An APHIS representative shall inspect the facility to determine whether the facility complies with the standards set forth in this section before any permit is issued in accordance with § 93.103. Inspections shall take place at least once each year.
(N) In addition, a facility for hatching eggs of ratites, in which the hatching eggs of one lot may be quarantined at the same time as the hatched chicks from the previously quarantined lot, shall:
(
(
(
(O) The bird (chick) holding area in any facility for hatching eggs of ratites shall be of a size large enough to accommodate 75 percent of the incubator capacity, with a minimum of 10 square feet per egg.
(P) If a facility for hatching eggs of ratites has a sun room, the sun room shall be connected to the chick holding area by a wall with a lockable door. This wall; the other walls, if any; and the flooring, must be impervious to water and able to withstand continued cleaning and disinfection. All walls of the sun room must be at least 8 feet high.
(
(
(
(iii)
(A) A supply of water adequate to meet all watering and cleaning needs.
(B) Disposal of wastes by incineration or a public sewer system which meets all applicable environmental quality control standards;
(C) Control of surface drainage onto or from the facility to prevent any disease agent from entering or escaping;
(D) Protective clothing and footwear adequate to insure that workers at the facility have clean clothing and footwear at the start of each workday and at any time such articles become soiled or contaminated;
(E) Power cleaning and disinfecting equipment with adequate capacity to disinfect the facility and equipment;
(F) Sufficient stocks of a disinfectant authorized in § 71.10(a)(5) of this chapter;
(G) A security system which prevents contact of birds in quarantine with persons not authorized entry to the facility and with other birds and animals. Such a system shall include a daily log to record the entry and exit of all persons entering the facility and controls at all doorways and other openings to the facility to prevent escape or accidental entry of birds.
(3)
(i)
(A) All personnel granted access to the bird holding area or the incubator/hatcher area shall:
(
(
(
(
(B) The importer shall handle soiled clothing worn within the quarantine unit in a manner approved by the port veterinarian as adequate to preclude transmission of a poultry disease agent from the facility.
(ii)
(A) Each lot of birds to be quarantined shall be placed in the facility on an “all-in, all-out” basis. No birds shall be taken out of the lot while it is in quarantine except for diagnostic purposes and if additional birds are added to a lot, the total quarantine period for that lot shall be extended so that all birds will have completed at least 30 consecutive days of quarantine before release for entry into the commerce of the United States. The quarantine period may be extended as provided in paragraph (a) of this section.
(
(
(B) The birds may be vaccinated during quarantine only with a vaccine that has been approved by the Administrator, and is administered by a licensed veterinarian under the direct supervision of a veterinarian employed by the Animal and Plant Health Inspection Service. The Administrator will approve a vaccine if:
(
(
(C) Birds of the psittacine family shall receive a balanced, medicated feed ration treatment containing not less than 1% CTC with not more than 0.7% calcium for the entire quarantine period as a precautionary measure against chlamydiosis (psittacosis).
(D) The importer shall immediately collect all birds which die in quarantine and hold them under refrigeration, within the facility, shall account for all birds in the shipment, and shall not dispose of any carcass or parts thereof unless authorized to do so by a Veterinary Medical Officer of APHIS of the Department. Birds that die enroute to the United States or while in quarantine shall be made available at the port of entry for necropsy by a Department poultry disease diagnostician who may submit specimens from such birds for laboratory examination.
(E) During the period of quarantine, the birds shall be subjected to such tests and procedures as are required in specific cases by the port veterinarian, to determine whether the birds are free from communicable diseases of poultry and it shall be the responsibility of the importer to identify individually each psittacine bird within 7 days of the entry of the bird into the quarantine facility with a serially numbered legband which has been coded to the quarantine facility or by other suitable means of identification. Any identification device must be approved by the Administrator, upon written request to him, before it shall be used to identify birds under this section. Such means of identification shall be supplied by the importer, and the importer shall insure that each bird is so identified at the time the bird is released from the facility. If frank or clinical Newcastle disease occurs among any birds in quarantine, all birds in the facility shall be destroyed or refused entry and the entire facility shall be thoroughly
(F) The quarantine facility from which a lot of birds has been released shall be thoroughly cleaned and disinfected with a disinfectant authorized in § 71.10(a)(5) of this chapter, under supervision of an inspector before a new lot is placed in the facility.
(iii)
(4) Additional requirements as to location, security, physical plant and facilities, sanitation, and other items may be imposed by the Administrator, in each specific case in order to assure that the quarantine of the birds in such facility will be adequate to enable determination of their health status, prevent spread of disease among birds in quarantine, and prevent escape of poultry disease agents from the facility.
(5) Cooperative and Trust Fund Agreement for services required by importer at a privately owned bird quarantine facility.
(i) When the Administrator determines that a privately owned bird quarantine facility meets the requirements set forth in paragraph (c) of this section, the Department and the importer shall execute a Cooperative and Trust Fund Agreement, as specified in paragraph (c)(5)(iii) of this section. In conjunction with the Cooperative and Trust Fund Agreement, the importer shall deposit with the Administrator a money order or cashier's check in an amount determined by the Administrator to cover all costs incurred by the Department in providing services in accordance with the provisions of the Cooperative and Trust Fund Agreement. Any unobligated funds will, upon request, be returned to the importer, after the birds' release from quarantine.
(ii) The Administrator may provide services required by the importer at a privately owned quarantine facility for the importation of birds on a first come, first served basis, if adequate APHIS personnel are available to provide those services, upon determining that the importer has executed a Cooperative and Trust Fund Agreement, and has deposited funds in an amount determined by the Administrator to be sufficient to cover all costs incurred by the Department in providing services in accordance with that agreement, as specified in paragraph (c)(5)(iii) of this section.
(iii) Cooperative and Trust Fund Agreement.
This agreement is made and entered into by and between _____ (name of importer), hereinafter referred to as the Importer, and the U.S. Department of Agriculture, Animal and Plant Health Inspection Service, hereinafter referred to as the Service, with respect to ______ (quarantine facility and address of facility). Whereas, the Service is authorized pursuant to the Animal Health Protection Act (7 U.S.C. 8301
Whereas, the Importer is interested in the importation of certain birds from regions presently under restrictions for such importation; and
Whereas, the Importer is equipped with a bird quarantine facility that meets the requirements of paragraph (c) of this section; and
Whereas, the Importer has requested the Service to conduct inspections, perform laboratory procedures, complete examinations, and supervise the isolation, quarantine, and care and handling of birds to insure that they meet the Department's quarantine requirements before release into the United States; and
Whereas, it is the intention of the parties hereto that such cooperation shall be for their mutual benefit and the benefit of the people of the United States;
Now therefore, for and in consideration of the promises and mutual covenants herein contained, the parties hereto do hereby mutually agree with each other as follows:
(A) The Importer Agrees:
(1) To operate the quarantine facility in accordance with all Federal Laws and regulations.
(2) To provide a current list of designated personnel employed by the Importer who will be used to handle and care for birds during the quarantine period. The list will include the legal names, current residential addresses, and social security numbers of the designated personnel. The list will be furnished to the port veterinarian at the time an application for an import permit to import birds into the quarantine facility is submitted to the Service. The list will be updated for any changes in or additions to the designated personnel in advance of such personnel working in the quarantine facility.
(3) To furnish to the Service a signed statement from each of the designated personnel employed by the Importer which provides that such personnel agree that for a period of 3 days from their most recent contact with birds in the quarantine facility, such personnel will refrain from having contact with other birds and poultry. This restriction ceases to apply on the date the birds are released from quarantine.
(4) To not permit any designated personnel which the Service determines to be unfit to be employed at a quarantine facility upon written notice from the Service. Such determination shall be based upon such employee's committing or aiding and abetting in the commission of any violation of title 9, Code of Federal Regulations, part 93. The Importer further agrees to suspend any designated employee from working at a quarantine facility when the Service has reason to believe that such employee has violated any provision of title 9, Code of Federal Regulations, part 93, and the Administrator has determined that the actions of such employee constitute a severe threat to introduce or disseminate a communicable disease of poultry into the United States. Such action shall be made upon receipt of notice from the Service requiring such action by the Importer.
(5) To allow the unannounced entry into the quarantine facility of Service personnel or other persons authorized by the Service for the purpose of inspecting birds in quarantine, the operations at the quarantine facility and to ascertain compliance with the Standards for quarantine facilities and handling procedures for importation of birds contained in title 9, Code of Federal Regulations, § 93.106(c).
(6) To provide permanent restrooms in both the clean and the quarantine areas of the quarantine facility.
(7) To provide a T.V. monitoring system or a window or windows sufficient to provide a full view of the quarantine area excluding the clothes changing area.
(8) To install a communication system between the clean and quarantine areas of the quarantine facility. Such communication system shall not interfere with the maintenance of the biological security of the quarantine area.
(9) To secure all windows and any openings in the quarantine facility in a manner satisfactory to the Department which will insure the biological security of the quarantine facility and prevent the unauthorized removal of birds.
(10) To install tamperproof hasps and to install hinges on doors from which the pins cannot be removed.
(11) To install a hood with a viewing window over the necropsy table.
(12) To bag waste material in leakproof bags. Such material shall be handled in a manner that spoilage is kept to a minimum and control of pests is maintained. Such material shall be disposed of by incineration or by public sewer or other method authorized by the Administrator to prevent the spread of disease. The disposition of such material shall only be under the direction and supervision of the Service.
(13) To feed chlortetracycline to psittacine birds, upon their arrival in the facility as prescribed in § 93.106(c)(3)(ii)(C).
(14) To install an electronic security system which is coordinated through or with the local police so that monitoring of the quarantine facility is maintained whenever Service personnel are not at the facility or, in lieu of such electronic monitoring system to arrange for continuous guarding of the facility with personnel from a bonded, security company.
(15) To not have non-Service personnel in the quarantine area when birds are in the quarantine facility unless Service personnel are present.
(16) To have seals of the Service placed on all entrances and exits of the facility when determined necessary by the Service and to take all necessary steps to ensure that such seals are only broken in the presence of Service personnel.
(17) To decide what the disposition of a lot of birds will be within 48 hours following official notification that such a lot is infected with or exposed to exotic Newcastle disease. Final disposition of the infected or exposed lot is to be accomplished within 4 working days following official notification. Disposition of the birds will be under the supervision of the Service.
(18) To furnish a telephone number or numbers to the Service at which the Importer can be reached on a daily basis or furnish the same for an agent or representative that can act and make decisions on the Importer's behalf.
(19) To deposit with the Service, upon execution of this agreement, a money order or cashier's check, in an amount determined by the Administrator to be sufficient to defray all costs incurred by the Service in providing services required. If such costs exceed the deposited amount, the importer will pay for additional costs incurred, based on official accounting records, within 14 days of receipt of the bill showing the balance due.
(20) To provide for the maintenance and operation of the quarantine facility in accordance with standards for quarantine facilities and handling procedures for importation of birds contained in title 9, Code of Federal Regulations, § 93.106(c).
(B) The Service agrees:
(1) To furnish the services of technical and/or professional personnel needed to conduct inspections, perform laboratory procedures, complete examinations, and supervise the isolation, quarantine, and care and handling of birds being imported to ensure that they meet the Department's quarantine requirements before release into the United States.
(2) To issue permits 3 working days following receipt of the permit application, depending upon the availability of personnel to provide the services required for quarantine and the results of an APHIS representative's inspection of the quarantine facility.
(3) To provide the Importer within 30 days following receipt of a written request from the Importer, with an accounting of funds expended in providing services under paragraph (B)(1) of this agreement. Any unobligated balance upon termination or expiration of this agreement shall be returned to the Importer.
(4) To inform the Importer when a diagnosis of END has been made in any facility.
(5) To promptly inform the Embassy or Consulate of the foreign region to which lots of birds, refused entry into the United States due to a diagnosis of END, are to be shipped.
(6) To notify in writing the Importer of any designated employee which the Service believes should be suspended from work at the quarantine facility and the basis for such action. Similar notice shall be afforded to the designated employee. Subsequent to such suspension, the designated employee shall have the right to request an immediate review of such action by the Administrator, including presenting his or her views to the Administrator in an informal conference. If the Administrator makes a final determination that grounds existed to suspend such employee, he or she shall notify the Importer and the suspended employee of his or her decision and such employee shall be discharged by the Importer.
(7) Prior to any final determination being made by the Service concerning the discharge of any designated personnel employed by the Importer, the Service will inform, in writing, the Importer and the designated personnel of the basis for such action. If such person contests such action he or she shall be permitted to present his or her views to the Administrator, provided such request is made within 30 days of the receipt of the aforementioned written notice. If a final determination is made by the Administrator that such personnel should be discharged, he or she shall notify such personnel and the Importer of such determination.
(C) It is mutually understood and agreed:
(1) That a maximum capacity will be established for each quarantine lot. This will be based upon the capacity of the quarantine facility to handle the birds. The number of birds on the permits will not exceed this capacity.
(2) If the seals referred to in paragraph (c)(5)(iii)(A)(
(3) During the performance of this cooperative work, the Importer agrees to be bound
(4) No member of or delegate to Congress or resident commissioner, shall be admitted to any share or part of this agreement or to any benefit to arise therefrom; but this provision shall not be construed to extend to this agreement if made with a corporation of its general benefit.
(5) This agreement shall become effective upon date of final signature and shall continue until the permitted lot of birds is released from quarantine. This agreement may be amended by agreement of the parties in writing. It may be terminated by either party upon 30 days written notice to the other party.
(d)
(1) The appropriate GS hourly rate (including appropriate premium pay in accordance with 5 U.S.C. 5541-5549) of the employee who actually performs the service, including his or her travel time and his or her travel expenses:
(2) All applicable user fees, as listed in part 130 of this chapter; and
(3) A surcharge for overhead based on the most current historical data available showing the percentage of APHIS funds expended for administrative support.
(e) Requirements of other Federal laws and regulations, such as the Department's Animal Welfare Regulations in subchapter A of this chapter shall also apply as applicable to the quarantine facilities.
(a)
(b)
(1) Without being quarantined upon arrival in the United States; and
(2) At any of the following ports of entry: Anchorage, AK; Fairbanks, AK; Los Angeles, CA; San Diego, CA; Denver, CO; Miami, FL; Tampa, FL; Atlanta, GA; Eastport, ID; Chicago, IL; New Orleans, LA; Boston, MA; Baltimore, MD; Houlton, ME; Jackman, ME; Detroit, MI; Port Huron, MI; Sault Ste. Marie, MI; Minneapolis, MN; Raymond, MT; Sweetgrass, MT; Buffalo, NY; Champlain, NY; New York, NY; Stewart Airport, Newburgh, NY; Dunseith, ND; Pembina, ND; Portal, ND; Portland, OR; San Juan, PR; Houston, TX; Highgate Springs, VT; Seattle, WA; and Sumas, WA; and
(3) If offered for entry at a Canadian land border port listed in § 93.203(b), without an import permit; and
(4) If consigned directly to slaughter from the port of entry, without being treated for ectoparasites within 3 to 14 days before shipment to the United States, as otherwise required by § 93.104(c)(8); and
(5) If in compliance with all of the applicable regulations of the U.S. Fish and Wildlife Service contained in Title 50, subchapter B, of the Code of Federal Regulations.
(c)
(1) Without being quarantined upon arrival in the United States; and
(2) At any of the ports of entry listed in paragraph (b)(2) of this section or authorized by § 93.105(a); and
(3) If offered for entry at a Canadian land border port listed in § 93.203(b), without an import permit; and
(4) If in compliance with all of the applicable regulations of the U.S. Fish and Wildlife Service contained in Title 50, subchapter B, of the Code of Federal Regulations.
Wherever in this subpart the following terms are used, unless the context otherwise requires, they shall be construed, respectively, to mean:
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
(a) No poultry or product subject to the provisions of this part shall be brought into the United States except in accordance with the regulations in this part and part 94 of this subchapter;
(b) The provisions in this part 93 relating to poultry shall not apply to healthy poultry not known to be infected with or exposed, within the 90 days preceding the date of export from the region of origin, to communicable diseases of poultry, if an import permit
(1)(i) They are maintained under continuous confinement in transit through the United States aboard an aircraft, ocean vessel, or other means of conveyance; or
(ii) Except for poultry in transit through Anchorage, Alaska, under § 93.204(c) of this part, which are not allowed to be unloaded, they are unloaded, in the course of such transit, into an animal or bird holding facility which is provided by the carrier or its agent and has been approved
(2) The carrier or its agent executes and furnishes to the collector of Customs at the first port of arrival a declaration stating that the poultry will be retained aboard such means of conveyance or in an approved holding facility during transshipment as required by this paragraph.
(3) Provisions for the approval of facilities required in this paragraph are:
(i) They must be sufficiently isolated to prevent direct or indirect contact with all other animals and birds while in the United States.
(ii) They must be so constructed that they provide adequate protection against environmental conditions and
(iii) They must provide for disposal of animal and bird carcasses, manure, bedding, waste and any related shipping materials in a manner that will prevent dissemination of disease.
(iv) They must have provisions for adequate sources of feed and water and for attendants for the care and feeding of poultry in the facility.
(v) They must comply with additional requirements as may be imposed by the Administrator if deemed applicable for a particular shipment.
(vi) They must also comply with all applicable local, State and Federal requirements for environmental quality and with the provisions of the Animal Welfare Regulations in chapter I of this title, as applicable.
(c)
(i) The poultry are found upon port of entry veterinary inspection to be free of poultry diseases; and
(ii) The poultry are accompanied by a United States veterinary health certificate issued prior to the departure of the poultry from the United States and the certificate shows the number from the leg band, tattoo, or microchip affixed to the poultry prior to departure; and
(iii) During port of entry veterinary inspection it is determined that the number from the leg band, tattoo, or microchip on the poultry is the same as the one listed on the health certificate.
(2) Except for performing or theatrical poultry that have been in any region where highly pathogenic avian influenza subtype H5N1 exists, which are subject to the provisions of paragraph (c)(3) of this section, performing or theatrical poultry of United States origin that have been outside the United States in a region other than Canada or Mexico may be imported if:
(i) The poultry meet the requirements of paragraphs (c)(1)(i) through (iii) of this section; and
(ii) The poultry are accompanied by an import permit issued by APHIS; and
(iii) The owner importing the poultry signs and furnishes to the Administrator the following:
(A) A notarized declaration under oath or affirmation (or a statement signed by the owner and witnessed by a Department inspector) stating that the poultry have not been in contact with poultry or other birds while out of the region (for example, association with other avian species at exhibitions or at aviaries); and
(B) An agreement on VS Form 17-8, obtainable from a Federal inspector at the port of entry, stating:
(
(
(3) Any performing or theatrical poultry of United States origin that have been in any region listed in § 94.6(d) of this subchapter as a region where highly pathogenic avian influenza subtype H5N1 exists may only be imported through the port of Los Angeles, CA, Miami, FL, or New York, NY, and only under the following conditions:
(i) The poultry meet the requirements of paragraphs (c)(1)(i) through (iii) of this section; and
(ii) The poultry are accompanied by an import permit issued by APHIS; and
(iii) The poultry are quarantined for a minimum of 30 days, and for such longer period as may be required by the Administrator in any specific case, at a quarantine facility maintained by APHIS in accordance with §§ 93.209 and 93.210.
(d) The provisions in this part relating to poultry shall not be applicable to performing or theatrical poultry.
(a)
(b)
(c)
(d) For purposes of this section, the term “shipping container” means any container of a type specially adapted for use in transporting any article on the means of conveyance involved.
(a)
(b)
(c)
(d)
(e)
(a)
(2) An application for permit to import poultry may also be denied because of: Communicable disease conditions in the area or region of origin, or in a region where the shipment has been or will be held or through which the shipment has been or will be transported; deficiencies in the regulatory programs for the control or eradication of animal diseases and the unavailability of veterinary services in the above mentioned regions; the importer's failure to provide satisfactory evidence concerning the origin, history, and health status of the poultry; the lack of satisfactory information necessary to determine that the importation will not be likely to transmit any communicable disease to livestock or poultry of the United States; or any other circumstances which the Administrator believes require such denial to prevent the dissemination of any communicable disease of livestock or poultry into the United States.
(3)(i) The importer or importer's agent shall pay or ensure payment of a reservation fee for each lot of poultry to be quarantined in a facility maintained by USDA. For poultry, the reservation fee shall be 100 percent of the
(ii) At the time the importer or the importer's agent requests a reservation of quarantine space, the importer or importer's agent shall pay the reservation fee by check or U.S. money order or ensure payment of the reservation fee by an irrevocable letter of credit from a commercial bank (the effective date on such letter of credit shall run to 30 days after the date the poultry are scheduled to be released from quarantine); except that anyone who issues a check to the Department for a reservation fee which is returned because of insufficient funds shall be denied any further request for reservation of a quarantine space until the outstanding amount is paid.
(iii) Any reservation fee paid by check or U.S. money order shall be applied against the expenses incurred for services received by the importer or importer's agent in connection with the quarantine for which the reservation was made. Any part of the reservation fee which remains unused after being applied against the expenses incurred for services received by the importer or the importer's agent in connection with the quarantine for which the reservation was made, shall be returned to the individual who paid the reservation fee. If the reservation fee is ensured by a letter of credit, the Department will draw against the letter of credit unless payment for services received by the importer or importer's agent in connection with the quarantine is otherwise made at least 3 days prior to the expiration date of the letter of credit.
(iv) Any reservation fee shall be forfeited if the importer or the importer's agent fails to present for entry, within 24 hours following the designated time of arrival, the lot of poultry for which the reservation was made:
(A) Written notice of cancellation from the importer or the importer's agent is received by the office of the veterinarian in charge of the quarantine facility
(B) The Administrator determines that services, other than provided by carriers, necessary for the importation of the poultry within the requested period are unavailable because of unforeseen circumstances as determined by the Administrator, (such as the closing of an airport due to inclement weather or the unavailability of the reserved space due to the extension of another quarantine).
(v) If the reservation fee was ensured by a letter of credit and the fee is to be forfeited under paragraph (a)(3)(iv) of this section, the Department will draw against the letter of credit unless the reservation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.
(vi) When a reservation is cancelled in accordance with paragraph (a)(3)(iv)(A) of this section and the provisions of paragraph (a)(3)(iv)(B) of this section do not apply, a $40.00 cancellation fee shall be charged. If a reservation fee was paid, the cancellation fee shall be deducted from any reservation fee returned to the importer or the importer's agent. If the reservation fee was ensured by a letter of credit, the Department will draw the amount of the cancellation fee against the letter of credit unless the cancellation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.
(b)
(c) Notwithstanding any other provisions in this part, importers are not required to obtain an import permit and provide the shipper with an original import permit for each individual shipment of poultry or pigeons transiting the port of Anchorage, Alaska, if the following conditions are met:
(1) The importer applies for and obtains an import permit for multiple shipments of poultry or pigeons transiting the port of Anchorage, Alaska, in accordance with the provisions of this section and related requirements concerning application for the permit. However, the following information is not required on the application:
(i) The species, breed, and number of poultry or pigeons to be imported;
(ii) The individual poultry identification;
(iii) The region of origin;
(iv) The name and address of the exporter;
(v) The port of embarkation in the foreign region;
(vi) The mode of transportation and the route of travel;
(vii) The proposed date of arrival of the poultry or pigeons; and
(viii) The name and address of the person to whom the poultry or pigeons will be delivered.
(2) The importer completes a copy of the import permit obtained under paragraph (c)(1) of this section for each separate shipment of poultry or pigeons intended to transit the port of Anchorage, Alaska, by inserting the following information on a copy of the permit:
(i) The species, breed, and number of poultry or pigeons to be imported;
(ii) The region of origin;
(iii) The name and address of the exporter;
(iv) The port of embarkation in the foreign region;
(v) The mode of transportation and the route of travel;
(vi) The proposed date of arrival of the poultry or pigeons; and
(vii) The name and address of the person to whom the poultry or pigeons will be delivered.
(3) The importer, not less than 2 weeks prior to the anticipated date of arrival of each separate intransit shipment of poultry or pigeons at the port of Anchorage, Alaska, provides the port veterinarian with a copy of the completed import permit;
(4) A copy of the completed import permit accompanies each separate intransit shipment of poultry or pigeons to the port of Anchorage, Alaska;
(5) Import permits issued for multiple shipments of poultry or pigeons transiting the port of Anchorage, Alaska, will be valid only during the calendar year in which they are issued.
All poultry, except eggs for hatching, offered for importation from any region of the world shall be accompanied by a certificate of a salaried veterinary officer of the national government of the region of origin, or if exported from Mexico, shall be accompanied either by such a certificate or by a certificate issued by a veterinarian accredited by the National Government of Mexico and endorsed by a full-time salaried veterinary officer of the National Government of Mexico, thereby representing that the veterinarian issuing the certificate was authorized to do so, stating that such poultry and their flock or flocks of origin were inspected on the premises of origin immediately before the date of movement from such region and that they were then found to be free of evidence of communicable diseases of poultry, and that, as far as it has been possible to determine, they were not exposed to any such disease common to poultry during the 90 days immediately preceding the date of such movement and that these premises are not located in any area under quarantine during the preceding 90 days. Certificates for such poultry shall also state that the poultry have been kept in the region from which they are offered for importation for at least 90 days immediately preceding the date of movement therefrom or since hatched and that, as far as it has been possible to determine, no case of European fowl pest (fowl plague) or Newcastle disease occurred on the premises where such poultry were kept, or on adjoining premises, during that 90-day period. All eggs for hatching offered for importation from any part of the world, shall be accompanied by a certificate of a salaried veterinary officer of the national government of the region of origin, or if exported from Mexico, shall be accompanied either by such a certificate or by a certificate issued by a veterinarian accredited by the National Government of Mexico and endorsed by a full-time salaried veterinary officer of the National Government of Mexico, thereby representing that the veterinarian issuing the certificate was authorized to do so, stating that the flock or flocks of origin were found upon inspection to be free from evidence of communicable diseases of poultry, that no Newcastle disease has occurred on the premises of origin or on adjoining premises during the 90 days immediately preceding the date of movement of the eggs from such region, and that as far as it has been possible to determine such flock or flocks were not exposed to such disease during the preceding 90 days.
(a) The certificates, declarations, and affidavits required by the regulations in this part shall be presented by the importer or his or her agent to the collector of customs at the port of entry, upon arrival of poultry at such port, for the use of the veterinary inspector at the port of entry.
(b) For all poultry offered for importation, the importer or his or her agent shall first present two copies of a declaration which shall list the port of entry, the name and address of the importer, the name and address of the broker, the origin of the poultry, the number, breed, species, and purpose of the importation, the name of the person to whom the poultry will be delivered, and the location of the place to which such delivery will be made.
Inspection shall be made at the port of entry of all poultry imported from any part of the world except as provided in §§ 93.215 and 93.220. All poultry found to be free from communicable disease and not to have been exposed thereto within 90 days prior to their exportation to the United States shall be admitted subject to the other provisions in this part; all other poultry shall be refused entry. Poultry refused entry, unless exported within a time fixed in each case by the Administrator, and in accordance with other provisions he or she may require in each case for their handling shall be disposed of as the Administrator may direct. Such portions of the transporting vessel, and of its cargo, which have been exposed to any such poultry
No litter or manure, fodder or other aliment, nor any equipment such as boxes, buckets, ropes, chains, blankets, or other things used for or about poultry governed by the regulations this part, shall be landed from any conveyance except under such restrictions as the inspector in charge at the port of entry shall direct.
(a) Poultry, other than eggs for hatching, imported, except as provided in § 93.216 of this part, shall be quarantined for not less than 30 days, counting from the date of arrival at the port of entry. During their quarantine, such poultry shall be subject to any inspections, disinfections, and tests as may be required by the Administrator, to determine their freedom from communicable diseases of poultry, and their freedom from exposure to such diseases.
(b) Poultry eggs for hatching imported, except from regions designated in § 94.6(a)(2) of this chapter as free of exotic Newcastle disease, shall be quarantined from time of arrival at the port of entry until hatched and the poultry from such eggs shall remain quarantined for not less than 30 days following hatch. During their quarantine, such eggs for hatching and poultry from such eggs shall be subject to any inspections, disinfections, and tests as may be required by the Administrator, to determine their freedom from communicable diseases of poultry.
(a)
(b)
(c) Amounts collected from the importer, or his or her agent, for service rendered shall be deposited so as to be available for defraying the expenses involved in this service.
Visitors shall not be admitted to the quarantine enclosure during any time that poultry are in quarantine except that an importer (or his or her accredited agent or veterinarian) may be admitted to the yards and buildings containing his or her quarantined poultry at such intervals as may be deemed necessary, and under such conditions and restrictions as may be imposed, by the inspector in charge of the quarantine station. On the last day of the quarantine period, owners, officers or registry societies, and others having official business or whose services may be necessary in the removal of the poultry may be admitted upon written permission from the said inspector. No exhibition or sale shall be allowed within the quarantine grounds.
No manure shall be removed from the quarantine premises until the release of the poultry producing same.
If any contagious disease appears among poultry during the quarantine period special precautions shall be taken to prevent spread of the infection to other poultry in the quarantine station or to those outside the grounds. The affected poultry shall be disposed
(a)
(b) For all poultry offered for importation from Canada, the importer or his or her agent shall present two copies of a declaration as provided in § 93.206.
(a)
(2)
(b)
Poultry imported from Canada is not required to meet the requirements of § 93.209 but shall meet all other requirements of this part applicable to poultry or to animals generally.
(a) For
(b) For all poultry offered for importation from regions of Central America or of the West Indies, the importer or his or her agent shall present two copies of a declaration as provided in § 93.206.
(c) All poultry offered for importation from regions of Central America and the West Indies shall also meet the additional requirements in §§ 93.205, 93.207, 93.209, and 93.210 to qualify for entry. All poultry which fail to meet these requirements shall be rejected entry and shall be disposed of as directed by the Administrator in accordance with applicable laws.
(a) For poultry
(b) For poultry intended for importation into the United States from Mexico, the importer or his or her agent shall deliver to the veterinary inspector at the port of entry an application, in writing, for inspection, so that the veterinary inspector and customs representatives may make mutually satisfactory arrangements for the orderly inspection of the poultry.
For all poultry offered for importation from Mexico, the importer or his or her agent shall present two copies of a declaration as provided in § 93.206.
(a) All poultry offered for entry from Mexico, including such poultry intended for movement through the United States in bond for immediate return to Mexico, shall be inspected at the port of entry, and all such poultry found to be free from communicable disease and fever tick infestation and not to have been exposed thereto, shall be admitted into the United States subject to the other applicable provisions of this part. Poultry found to be affected with or to have been exposed to a communicable disease, or infested with fever ticks, shall be refused entry. Poultry refused entry, unless exported within a time fixed in each case by the Administrator, shall be disposed of as said Administrator may direct.
(b) Poultry covered by paragraph (a) of this section shall be imported through ports designated in § 93.203.
Wherever in this subpart the following terms are used, unless the context otherwise requires, they shall be construed, respectively, to mean:
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
(a) No horse or product subject to the provisions of this part shall be brought into the United States except in accordance with the regulations in this part and part 94 of this subchapter;
(b) The provisions in this part 93 relating to horses shall not apply to healthy horses in transit through the United States if they are not known to be infected with or exposed, within 60 days preceding the date of export from the region of origin, to communicable diseases of horses if an import permit
(1)(i) They are maintained under continuous confinement in transit through the United States aboard an aircraft, ocean vessel, or other means of conveyance; or
(ii) They are unloaded, in the course of such transit, into a horse holding facility which is provided by the carrier or its agent and has been approved
(2) The carrier or its agent executes and furnishes to the collector of Customs at the first port of arrival a declaration stating that the horses will be retained aboard such means of conveyance or in an approved holding facility during transshipment as required by this paragraph.
(3) Provisions for the approval of facilities required in this paragraph are:
(i) They must be sufficiently isolated to prevent direct or indirect contact with all other animals and birds while in the United States.
(ii) They must be so constructed that they provide adequate protection against environmental conditions and can be adequately cleaned, washed and disinfected.
(iii) They must provide for disposal of horse carcasses, manure, bedding, waste and any related shipping materials in a manner that will prevent dissemination of disease.
(iv) They must have provisions for adequate sources of feed and water and for attendants for the care and feeding of horses in the facility.
(v) They must comply with additional requirements as may be imposed by the Administrator if deemed applicable for a particular shipment.
(vi) They must also comply with all applicable local, State and Federal requirements for environmental quality and with the provisions of the Animal Welfare Regulations in chapter I of this title, as applicable.
(c)
Montenegro and Serbia have asserted the formation of a joint independent State entitled “The Federal Republic of Yugoslavia,” but this entity has not been formally recognized by the United States.
(2)
(i) Wild (non-domesticated) species of equidae if captured in the wild or imported from a zoo or other facility where it would be unlikely that the animal would come in contact with domesticated horses used for breeding;
(ii) Geldings;
(iii) Weanlings or yearlings whose age is certified on the import health certificate required under § 93.314(a);
(iv) Horses imported in accordance with conditions prescribed by the Administrator as provided in § 93.301(a);
(v) Spanish Pure Breed horses imported for permanent entry from Spain or thoroughbred horses imported for permanent entry from France, Germany, Ireland, or the United Kingdom if the horses meet the requirements of paragraph (d) of this section;
(vi) Stallions or mares over 731 days of age imported for permanent entry if the horses meet the requirements of paragraph (e) of this section;
(vii) Horses over 731 days of age imported into the United States for no more than 90 days to compete in specified events if the horses meet the requirements of paragraph (f) of this section; and
(viii) Horses temporarily exported from the United States or from another region not known to be affected with CEM to a region listed in paragraph (c)(1) of this section within the 12 months immediately preceding their being offered for entry into the United States if the horses meet the requirements of paragraph (g) of this section.
(d)
(i) Each horse is accompanied at the time of importation by an import permit in accordance with § 93.304;
(ii) Each horse is accompanied at the time of importation by an import health certificate issued in accordance with § 93.314(a). In addition to the information required by § 93.314(a), the veterinarian signing and issuing the certificate must certify that:
(A) He or she has examined the daily records of the horse's activities maintained by the trainer and certified to be current, true, and factual by the veterinarian in charge of the training or racing stable;
(B) He or she has examined the records of the horse's activities maintained by a breed association specifically approved by the Department
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(C) He or she has compared the records maintained by the approved breed association with the records kept by the trainer and has found the information in those two sets of records to be consistent and current;
(D) For Spanish Pure Breed horses and thoroughbred horses over 731 days of age, cultures negative for CEM were obtained from sets of specimens collected on 3 separate occasions within a 7-day period from the mucosal surfaces of the clitoral fossa and the clitoral sinuses of any female horses and from the surfaces of the prepuce, the urethral sinus, and the fossa glandis, including the diverticulum of the fossa glandis, of any male horses. For both female and male horses, the sets of specimens must be collected on days 1, 4, and 7 of the 7-day period, and the last of these sets of specimens must be collected within 30 days of exportation. All specimens required by this paragraph must be collected by a licensed veterinarian who either is, or is acting in the presence of, the veterinarian signing the certificate; and
(E) All specimens required by paragraph (d)(1)(ii)(D) of this section were received within 48 hours of collection by a laboratory approved to culture for CEM by the national veterinary service of the region of export and were accompanied by a statement indicating the date and time of their collection.
(2) If any specimen collected in accordance with paragraph (d)(1)(ii)(D) of this section is found to be positive for CEM, the horse must be treated for CEM in a manner approved by the national veterinary service of the region of export. After the treatment is completed, at least 21 days must pass before the horse will be eligible to be tested again in accordance with paragraph (d)(1)(ii)(D) of this section. All treatments performed, and the dates of the treatments, must be recorded on the health certificate.
(3) Spanish Pure Breed horses and thoroughbred horses imported under paragraph (d)(1) of this section may be released upon completion of the Federal quarantine required under § 93.308. Spanish Pure Breed horses and thoroughbred horses found positive for CEM that have been treated and retested as provided in paragraph (d)(2) of this section shall, upon completion of the Federal quarantine required under § 93.308, be consigned to an approved State listed in paragraph (h)(6) or (h)(7)
(e)
(i) Each horse is accompanied at the time of importation by an import permit issued in accordance with § 93.304. The import permit must indicate that, after completion of the Federal quarantine required in § 93.308, the stallion or mare will be consigned to a State that the Administrator has approved to receive such horses in accordance with paragraph (h) of this section;
(ii) The horses are accompanied at the time of importation by an import health certificate issued in accordance with § 93.314(a);
(iii) A set of specimens must be collected from each horse within 30 days prior to the date of export by a licensed veterinarian who either is, or is acting in the presence of, the veterinarian signing the certificate. For stallions, the specimens must be collected from the prepuce, urethral sinus, and fossa glandis, including the diverticulum of the fossa glandis; for mares, the specimens must be collected from the mucosal surfaces of the clitoral fossa and the clitoral sinuses. All of the specimens collected must be cultured for CEM with negative results in a laboratory approved to culture for CEM by the national veterinary service of the region of origin;
(iv) The horses described on the certificate must not have been used for natural breeding, for the collection of semen for artificial insemination in the case of stallions, or for artificial insemination in the case of mares, from the time the specimens were collected through the date of export;
(v) All specimens required by paragraph (e)(1)(iii) of this section must be received within 48 hours of collection by a laboratory approved to culture for CEM by the national veterinary service of the region of export and must be accompanied by a statement indicating the date and time of their collection; and
(vi) If any specimen collected in accordance with paragraph (e)(1)(iii) of this section is found to be positive for CEM, the stallion or mare must be treated for CEM in a manner approved by the national veterinary service of the region of export. After the treatment is completed, at least 21 days must pass before the horse will be eligible to be tested again in accordance with paragraph (e)(1)(ii) of this section. All treatments performed, and the dates of the treatments, must be recorded on the health certificate.
(2)
(ii) Once in the approved State, the stallions or mares shall be quarantined under State or Federal supervision until the stallions have met the testing and treatment requirements of paragraph (e)(3) of this section and the mares have met the testing and treatment requirements of paragraph (e)(5) of this section.
(iii) All tests and cultures required by paragraphs (e)(3) through (e)(5) of this section shall be conducted at the National Veterinary Services Laboratories, Ames, IA, or at a laboratory approved by the Administrator in accordance with paragraph (i) of this section to conduct CEM cultures and tests.
(iv) To be eligible for CEM culture or testing, all specimens collected in accordance with paragraphs (e)(3) through (e)(5) of this section must be received by the National Veterinary Services Laboratories or the approved laboratory within 48 hours of collection and must be accompanied by a statement indicating the date and time of their collection.
(3)
(A) The stallion must be treated for 5 consecutive days by thoroughly cleaning and washing (scrubbing) its prepuce, penis, including the fossa glandis, and urethral sinus while the stallion is in full erection with a solution of not less than 2 percent surgical scrub chlorhexidine and then thoroughly coating (packing) the stallion's prepuce, penis, including the fossa glandis, and urethral sinus with an ointment effective against the CEM organism.
(B) Each mare to which the stallion has been test bred shall be cultured for CEM from sets of specimens that are collected from the mucosal surfaces of the clitoral fossa and clitoral sinuses on the third, sixth, and ninth days after the breeding, with negative results. A complement fixation test for CEM must be done with negative results on the fifteenth day after the breeding.
(ii) If any culture or test required by this paragraph is positive for CEM, the stallion shall be treated as described in paragraph (e)(3)(i)(A) of this section and retested by being test bred to two mares no less than 21 days after the last day of treatment.
(iii) A stallion may be released from State quarantine only if all cultures and tests of specimens from the mares used for test breeding are negative for CEM and all cultures performed on specimens taken from the stallion are negative for CEM.
(4)
(ii) The test mares must be qualified prior to breeding as apparently free from CEM and may not be used for breeding from the time specimens are taken to qualify the mares as free from CEM. To qualify, each mare shall be tested with negative results by a complement fixation test for CEM, and specimens taken from each mare shall be cultured negative for CEM. For culture, sets of specimens shall be collected on the first, fourth, and seventh days of a 7-day period from the mucosal surfaces of the clitoral fossa and clitoral sinuses.
(iii) A test mare that has been used to test stallions for CEM may be released from quarantine only if:
(A) The test mare is found negative for CEM on all cultures and tests required under paragraph (e)(3)(ii) of this section; or
(B) The test mare is subjected to an ovariectomy by an accredited veterinarian under the direct supervision of a State or Federal veterinarian; or
(C) The test mare is treated and handled in accordance with paragraph (e)(5) of this section; or
(D) The test mare is moved directly to slaughter without unloading en route, is euthanized, or dies.
(5)
(ii) After the three sets of specimens required by paragraph (e)(5)(i) of this section have been collected, an accredited veterinarian shall manually remove organic debris from the sinuses of each mare and then flush the sinuses with a cerumalytic agent.
(iii) For 5 consecutive days after the sinuses have been cleaned, an accredited veterinarian shall aseptically clean and wash (scrub) the external genitalia and vaginal vestibule, including the clitoral fossa, with a solution of not less than 2 percent chlorhexidine in a detergent base and then fill the clitoral fossa and sinuses, and coat the external genitalia and vaginal vestibule with an antibiotic ointment effective against the CEM organism.
(iv) A mare may be released from State quarantine only if all cultures performed on specimens taken from the mare are negative for CEM.
(v) If any culture required by this paragraph is positive for CEM, the mare shall be treated as described in paragraphs (e)(5)(ii) and (e)(5)(iii) of this section. No less than 21 days after the last day of treatment, the mare shall be tested again in accordance with paragraph (e)(5)(i) of this section. If all specimens are negative for CEM, the mare may be released from quarantine.
(f)
(1) The horse may remain in the United States for not more than 90 days following the horse's arrival in the United States, except as provided in paragraph (f)(6) of this section and, while in the United States, the horse must be moved according to the itinerary and methods of transport specified in the import permit provided for in § 93.304 of this part;
(2) While the horse is in the United States, the following conditions must be met:
(i) Except when in transit, the horse must be kept on a premises that has been approved, orally or in writing, by an APHIS representative. If the approval is oral, it will be confirmed in writing by the Administrator as soon as circumstances permit. To receive approval, the premises:
(A) Must not be a breeding premises; and
(B) Must be or contain a building in which the horse can be kept in a stall that is separated from other stalls containing horses, either by an empty stall, by an open area across which horses cannot touch each other, or by a solid wall that is at least 8 feet (2.4 m) high.
(ii) While at the premises at which the horse competes, the horse must be monitored by an accredited veterinarian or APHIS representative to ensure that the provisions of paragraphs (f)(2)(i), (f)(2)(iv), and (f)(2)(v) of this section are met. If the monitoring is performed by an accredited veterinarian, the Veterinarian in Charge will ensure that the accredited veterinarian is familiar with the requirements of this section and spot checks will be conducted by an APHIS representative to ensure that the requirements of this section are being met. If an APHIS representative finds that requirements are not being met, the Administrator may require that all remaining monitoring for the event be conducted by APHIS representatives to ensure compliance.
(iii) While in transit, the horse must be moved in either an aircraft or a sealed van or trailer. If the horse is moved in a sealed van or trailer, the seal may be broken only by an APHIS representative at the horse's destination, except in situations where the horse's life is in danger.
(iv) Except when actually competing or being exercised, the horse must be kept in a stall that is separated from other stalls containing horses, either
(v) The horse may not be used for breeding purposes (including artificial insemination), may not have any other sexual contact with other horses, and may not undergo any genital examinations.
(vi) After the horse is transported anywhere in the United States, any vehicle in which the horse was transported must be cleaned and disinfected in the presence of an APHIS representative, according to the procedures specified in §§ 71.7 through 71.12 of this chapter, before any other horse is transported in the vehicle.
(vii) The cleaning and disinfection specified in paragraph (f)(2)(vi) of this section must be completed before the vehicle is moved from the place where the horse is unloaded. In those cases where the facilities or equipment for cleaning and disinfection are inadequate at the place where the horse is unloaded, the Administrator may allow the vehicle to be moved to another location for cleaning and disinfection when the move will not pose a disease risk to other horses in the United States.
(viii) The owner or importer of the horse must comply with any other provisions of this part applicable to him or her.
(3) If the owner or importer wishes to change the horse's itinerary or the methods by which the horse is transported from that which he or she specified in the application for the import permit, the owner or importer must make the request for change in writing to the Administrator. Requests should be sent to the Administrator, c/o Import-Export Animals Staff, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231. The change in itinerary or method of transport may not be made without the written approval of the Administrator, who may grant the request for change when he or she determines that granting the request will not endanger other horses in the United States and that sufficient APHIS personnel are available to provide the services required by the owner or importer. If more than one application for an import permit is received, APHIS personnel will be assigned in the order that the applications that otherwise meet the requirements of this section are received.
(4) The Administrator may cancel, orally or in writing, the import permit provided for under § 93.304 of this part whenever the Administrator finds that the owner or importer of the horse has not complied with the provisions of paragraphs (f)(1) through (f)(3) of this section or any conditions imposed under those provisions. If the cancellation is oral, the Administrator will confirm the cancellation and the reasons for the cancellation in writing as soon as circumstances permit. Any person whose import permit is canceled may appeal the decision in writing to the Administrator within 10 days after receiving oral or written notification of the cancellation, whichever is earlier. If the appeal is sent by mail, it must be postmarked within 10 days after the owner or importer receives oral or written notification of the cancellation, whichever is earlier. The appeal must include all of the facts and reasons upon which the person relies to show that the import permit was wrongfully canceled. The Administrator will grant or deny the appeal in writing as promptly as circumstances permit, stating the reason for his or her decision. If there is a conflict as to any material fact, a hearing will be held to resolve the conflict. Rules of practice concerning the hearing will be adopted by the Administrator.
(5) Except in those cases where an appeal is in process, any person whose import permit is canceled must move the horse identified in the import permit out of the United States within 10 days after receiving oral or written notification of cancellation, whichever is earlier. The horse is not permitted to enter competition from the date the owner or importer receives the notice of cancellation until the horse is moved out of the United States or until resolution of an appeal in favor of the owner or importer. Except when being exercised, the horse must be kept, at the expense of the owner or importer, in a stall on the premises where the horse is located when the notice of cancellation is received, or, if the horse is
(6) Stallions or mares over 731 days of age that are imported for no more than 90 days in accordance with paragraphs (f)(1) through (f)(3) of this section may be eligible to remain in the United States if the following is completed:
(i) Following completion of the itinerary specified in the import permit provided for in § 93.304 of this part, the horse's owner or importer applies for and receives a new import permit that specifies that the stallion or mare will be moved to an approved State listed in paragraph (h)(6) or (h)(7) of this section; and
(ii) The stallion or mare is transported in a sealed vehicle that has been cleaned and disinfected to an approved facility in an approved State where it is quarantined under State or Federal supervision until the stallion or mare has met the testing and treatment requirements of paragraph (e)(3) or (e)(5) of this section.
(7) All costs and charges associated with the supervision and maintenance of a horse imported under paragraphs (f)(1) through (f)(3) of this section will be borne by the horse's owner or importer. The costs associated with the supervision and maintenance of the horse by an APHIS representative at his or her usual places of duty will be reimbursed by the horse's owner or importer through user fees payable under part 130 of this chapter.
(8) In the event that an APHIS representative must be temporarily detailed from his or her usual place of duty in connection with the supervision and maintenance of a horse imported under paragraphs (f)(1) through (f)(3) of this section, the owner or importer of the horse must execute a trust fund agreement with APHIS to reimburse all expenses (including travel costs, salary, per diem or subsistence, administrative expenses, and incidental expenses) incurred by the Department in connection with the temporary detail. Under the trust fund agreement, the horse's owner or importer must deposit with APHIS an amount equal to the estimated cost, as determined by APHIS, for the APHIS representative to inspect the premises at which the horse will compete, to conduct the monitoring required by paragraph (f)(2)(ii) of this section, and to supervise the cleaning and disinfection required by paragraph (f)(2)(vi) of this section. The estimated costs will be based on the following factors:
(i) Number of hours needed for an APHIS representative to conduct the required inspection and monitoring;
(ii) For services provided during regular business hours (8 a.m. to 4:30 p.m., Monday through Saturday, except holidays), the average salary, per hour, for an APHIS representative;
(iii) For services provided outside regular business hours, the applicable rate for overtime, night differential, or Sunday or holiday pay, based on the average salary, per hour, for an APHIS representative;
(iv) Number of miles from the premises at which the horse competes to the APHIS office or facility that is monitoring the activities;
(v) Government rate per mile for automobile travel or, if appropriate, cost of other means of transportation between the premises at which the horse competes and the APHIS office or facility;
(vi) Number of trips between the premises at which the horse competes and the APHIS office or facility that APHIS representatives are required to make in order to conduct the required inspection and monitoring;
(vii) Number of days the APHIS representative conducting the inspection and monitoring must be in “travel status;”
(viii) Applicable government per diem rate; and
(ix) Cost of related administrative support services.
(9) If a trust fund agreement with APHIS has been executed by the owner or importer of a horse in accordance with paragraph (f)(8) of this section and APHIS determines, during the horse's stay in the United States, that the amount deposited will be insufficient to cover the services APHIS is scheduled to provide during the remainder of the horse's stay, APHIS will issue to the horse's owner or importer a bill to restore the deposited amount to a level sufficient to cover the estimated cost to APHIS for the remainder of the horse's stay in the United States. The horse's owner or importer must pay the amount billed within 14 days after receiving the bill. If the bill is not paid within 14 days after its receipt, APHIS will cease to perform the services provided for in paragraph (f)(2) of this section until the bill is paid. The Administrator will inform the owner or importer of the cessation of services orally or in writing. If the notice of cessation is oral, the Administrator will confirm, in writing, the notice of cessation and the reason for the cessation of services as soon as circumstances permit. In such a case, the horse must be kept, at the expense of the owner or importer and until the bill is paid, in a stall either on the premises at which the horse is located when the notice of cessation of services is received, or, if the horse is in transit when the notice of cessation of services is received, on the premises at which it is next scheduled to compete according to the import permit. The stall in which the horse is kept must be separated from other stalls containing horses either by an empty stall, an open area across which horses cannot touch each other, or a solid wall that is at least 8 feet (2.4 m) high. In cases where the owners of the above specified premises do not permit the horse to be kept on those premises, or when the Administrator determines that keeping the horse on the above specified premises will pose a disease risk to other horses in the United States, the horse must be kept, at the expense of the owner or importer, on an alternative premises approved by the Administrator. Until the bill is paid, the horse is not permitted to enter competition. Any amount deposited in excess of the costs to APHIS to provide the required services will be refunded to the horse's owner or importer.
(g)
(1) The horse must be accompanied by a certificate that meets the requirements of § 93.314(a) of this part issued by each CEM-affected region that the horse has visited during the term of its temporary exportation, and each certificate must contain the following additional declarations:
(i) That the horse was held separate and apart from all other horses except for the time it was actually participating in an event or was being exercised by its trainer;
(ii) That the premises on which the horse was held were not used for any equine breeding purpose;
(iii) That the horse was not bred to or bred by any animal, nor did it have any other sexual contact or genital examination while in such region; and
(iv) That all transport while in such region was carried out in cleaned and disinfected vehicles in which no other horses were transported since such cleaning and disinfection;
(2) The horse is accompanied by an import permit issued in accordance with § 93.304 of this part at the time of exportation;
(3) If the horse was temporarily exported from the United States and is being returned to the United States, the horse must be accompanied by a
(4) The horse must be examined by an inspector at the U.S. port of entry and found by the inspector to be the identical horse covered by the documents required by paragraphs (a) through (c) of this section and found by the inspector to be free of communicable disease and exposure thereto; and
(5) The horse must be quarantined and tested at the U.S. port of entry as provided in § 93.308 of this part prior to release.
(h)
(1) The State must enter into a written agreement with the Administrator, whereby the State agrees to enforce its laws and regulations to control CEM and to abide by the conditions of approval established by the regulations in this part.
(2) The State must agree to quarantine all stallions and mares over 731 days of age imported under the provisions of paragraph (e) of this section until the stallions have been treated in accordance with paragraph (e)(3) of this section and the mares have been treated in accordance with paragraph (e)(5) of this section.
(3) The State must agree to quarantine all mares used to test stallions for CEM until the mares have been released from quarantine in accordance with paragraph (e)(4) of this section.
(4) The State must have laws or regulations requiring that stallions over 731 days of age imported under paragraph (e) of this section be treated in the manner specified in paragraph (e)(3) of this section, and that mares over 731 days of age imported under paragraph (e) of this section be treated in the manner specified in paragraph (e)(5) of this section.
(5) Approval of any State to receive stallions or mares imported from regions affected with CEM may be suspended by the Administrator upon his or her determination that any requirements of this section are not being met. After such action is taken, the animal health authorities of the approved State will be informed of the reasons for the action and afforded an opportunity to present their views thereon before such suspension is finalized; however, such suspension of approval shall continue in effect unless otherwise ordered by the Administrator. In those instances where there is a conflict as to the facts, a hearing shall be held to resolve such conflict.
(6) The following States have been approved to receive stallions over 731 days of age imported under paragraph (e) of this section:
(7) The following States have been approved to receive mares over 731 days of age imported under paragraph (e) of this section:
(i)
(i) Has technical personnel assigned to conduct the CEM culturing and testing who possess the following minimum qualifications:
(A) A bachelor's degree in microbiology;
(B) A minimum of 2 years experience working in a bacteriology laboratory; and
(C) Experience working with the CEM organism, including knowledge of the specific media requirements, atmospheric requirements, and procedures for the isolation and identification of the CEM organism.
(ii) Follows standard test protocols that will reliably and consistently provide for the isolation and identification of the CEM organism;
(iii) Reports all official test results to the State animal health official and the Veterinarian in Charge.
(2) To retain approval, the laboratory must meet the requirements prescribed in paragraph (i)(1) of this section, and shall test with the CEM organism each lot of media it prepares to ensure that the media will support growth of the laboratory's reference culture. Media that will not support growth of the reference culture must be discarded.
(3) The Administrator may deny or withdraw approval of any laboratory to conduct CEM culturing or testing upon a determination that the laboratory does not meet the criteria for approval or maintenance of approval under paragraphs (i)(1) and (i)(2) of this section.
(i) In the case of a denial of approval, the operator of the laboratory will be informed of the reasons for denial and, upon request, will be afforded an opportunity for a hearing with respect to the merits or validity of the denial in accordance with rules of practice that will be adopted for the hearing.
(ii) In the case of a withdrawal of approval, before such action is taken, the operator of the laboratory will be informed of the reasons for the proposed withdrawal and, upon request, will be afforded an opportunity for a hearing with respect to the merits or validity of the proposed withdrawal in accordance with rules of practice that will be adopted for the hearing. However, the withdrawal will become effective pending a final determination in the hearing when the Administrator determines that such action is necessary to protect the public health, interest, or safety. The withdrawal will be effective upon oral or written notification, whichever is earlier, to the operator of the laboratory. In the event of oral notification, written confirmation will be given as promptly as circumstances allow. The withdrawal will continue in effect pending completion of the hearing and any judicial review of the hearing, unless otherwise ordered by the Administrator.
(iii) Approval for a laboratory to conduct CEM culturing or testing will be automatically withdrawn by the Administrator when the operator of the approved laboratory notifies the National Veterinary Services Laboratories, Ames, IA 50010, in writing, that the laboratory no longer conducts CEM culturing and testing.
(j)
(1) A veterinarian must treat horses with ivermectin 3 to 5 days prior to the date of export to the United States according to the recommended dose prescribed on the product's label.
(2) Horses must be examined for screwworm by a full-time salaried veterinary official of the exporting country within 24 hours prior to shipment to the United States. The official must fully examine the horses, including their external genitalia. If horses are found to be infested with screwworm, they must be treated until free from infestation.
(3) At the time horses are loaded onto a means of conveyance for export, a veterinarian must treat any visible wounds on the animals with a solution of coumaphos dust at a concentration of 5 percent active ingredient.
(4) Horses must be accompanied to the United States by a certificate signed by a full-time salaried veterinary official of the exporting country. The certificate must state that the horses, including their external genitalia, have been thoroughly examined and found free of screwworm and that the horses have been treated in accordance with paragraphs (j)(1) and (j)(3) of this section.
(5) Horses must be quarantined upon arrival in the United States at an APHIS animal import center for at least 7 days.
(6) Horses must be examined for screwworm by a veterinarian within 24 hours after arrival at an APHIS animal import center in the United States. The examining veterinarian must examine horses, including their external genitalia, to determine whether the horse is infested with screwworm.
(7) Horses must be held at the animal import center for a minimum of 7 days. On day 7, prior to the horses' release, the horses must be examined by a veterinarian at the expense of the owner or broker. For this examination, male horses must be tranquilized or sedated so that the external genitalia of the horses can be thoroughly examined. If screwworm is found during this examination, the horses must be held in quarantine and treated until free of infestation.
For
(a)
(b)
(c)
(d) For purposes of this section, the term “shipping container” means any container of a type specially adapted for use in transporting any article on the means of conveyance involved.
(a)
(b)
(2) International Falls, Minnesota, is designated as a port of entry for horses from Canada.
(c)
(d)
(e)
(f)
(a)
(ii) Horses intended for importation under § 93.301(f) of this part must meet the permit requirements of paragraph (a)(1)(i) of this section. Additionally, for horses intended for importation under § 93.301(f) of this part, the horse's owner or importer must include the following information with the application for permit that is required by paragraph (a)(1)(i) of this section:
(A) That the application is being made for a horse that will remain in the United States for no more than 90 days;
(B) The names, dates, and locations of the events in which the horse will compete while in the United States;
(C) The names and locations of the premises on which the horse will be kept while in the United States, and the dates the horse will be kept on each premises; and
(D) The methods and routes by which the horse will be transported while in the United States.
(iii) Approval of an application for a permit to import a horse under § 93.301(f) of this part is contingent upon a determination by the Administrator that sufficient APHIS personnel are available to provide the services required. If more than one application for an import permit is received, APHIS personnel will be assigned in the order that applications that otherwise meet the requirements of this section are received.
(2) An application for permit to import horses from regions listed in § 93.301(c)(1) of the regulations, horses intended for quarantine at a quarantine facility provided by the importer, may also be denied because of: Communicable disease conditions in the area or region of origin, or in a region where the shipment has been or will be held or through which the shipment has been or will be transported; deficiencies in the regulatory programs for the control or eradication of animal diseases and the unavailability of veterinary services in the above mentioned regions; the importer's failure to provide satisfactory evidence concerning the origin, history, and health
(3)(i) The importer or importer's agent shall pay or ensure payment of a reservation fee for each lot of horses to be quarantined in a facility maintained by USDA. For horses, the reservation fee shall be 100 percent of the cost of providing care, feed, and handling during quarantine, as estimated by the quarantine facility's veterinarian in charge.
(ii) At the time the importer or the importer's agent requests a reservation of quarantine space, the importer or importer's agent shall pay the reservation fee by check or U.S. money order or ensure payment of the reservation fee by an irrevocable letter of credit from a commercial bank (the effective date on such letter of credit shall run to 30 days after the date the horses are scheduled to be released from quarantine); except that anyone who issues a check to the Department for a reservation fee which is returned because of insufficient funds shall be denied any further request for reservation of a quarantine space until the outstanding amount is paid.
(iii) Any reservation fee paid by check or U.S. money order shall be applied against the expenses incurred for services received by the importer or importer's agent in connection with the quarantine for which the reservation was made. Any part of the reservation fee which remains unused after being applied against the expenses incurred for services received by the importer or the importer's agent in connection with the quarantine for which the reservation was made, shall be returned to the individual who paid the reservation fee. If the reservation fee is ensured by a letter of credit, the Department will draw against the letter of credit unless payment for services received by the importer or importer's agent in connection with the quarantine is otherwise made at least 3 days prior to the expiration date of the letter of credit.
(iv) Any reservation fee shall be forfeited if the importer or the importer's agent fails to present for entry, within 24 hours following the designated time of arrival, the horse for which the reservation was made:
(v) If the reservation fee was ensured by a letter of credit and the fee is to be forfeited under paragraph (a)(3)(iv) of this section, the Department will draw against the letter of credit unless the reservation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.
(vi) If a reservation is canceled, the importer or the importer's agent will be charged a fee according to the following schedule:
(vii) If the reservation fee was ensured by a letter of credit, the Department will draw the amount of the cancellation fee against the letter of credit unless the cancellation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.
(b)
(2) Horses and horse test specimens for which a permit is required under paragraph (a) of this section will be received at the port of entry specified on the permit within the time prescribed in the permit, which shall not exceed 14 days from the first day that the permit is effective.
(3) Horses and horse test specimens for which a permit is required under paragraph (a) of this section will not be eligible for entry if:
(i) A permit has not been issued for the importation of the horse or horse test specimen;
(ii) If the horse or horse test specimen is unaccompanied by the permit issued for its importation;
(iii) If the horse or horse test specimen is shipped from any port other than the one designated in the permit;
(iv) If the horse or horse test specimen arrives in the United States at any port other than the one designated in the permit;
(v) If the horse or horse test specimen offered for entry differs from that described in the permit; or
(vi) If the horse or horse test specimen is not handled as outlined in the application for the permit and as specified in the permit issued.
(a) The certificates, declarations, and affidavits required by the regulations in this part shall be presented by the importer or his or her agent to the collector of customs at the port of entry, upon arrival of horses at such port, for the use of the veterinary inspector at the port of entry.
(b) For all horses offered for importation, the importer or his or her agent shall first present two copies of a declaration which shall list the port of entry, the name and address of the importer, the name and address of the broker, the origin of the horses, the number, breed, species, and purpose of the importation, the name of the person to whom the horses will be delivered, and the location of the place to which such delivery will be made.
Inspection shall be made at the port of entry of all horses imported from any part of the world except as provided in §§ 93.318 and 93.323. All horses found to be free from communicable disease and not to have been exposed thereto within 60 days prior to their exportation to the United States shall be admitted subject to the other provisions in this part; all other horses shall be refused entry. Horses refused entry, unless exported within a time fixed in each case by the Administrator of Veterinary Service, and in accordance with other provisions he or she may require in each case for their handling shall be disposed of as the Administrator may direct. Such portions of the transporting vessel, and of its cargo, which have been exposed to any such horses or their emanations shall be disinfected in such manner as may be considered necessary by the inspector in charge at the port of entry, to prevent the introduction or spread of livestock or poultry disease, before the cargo is allowed to land.
No litter or manure, fodder or other aliment, nor any equipment such as boxes, buckets, ropes, chains, blankets, or other things used for or about horses governed by the regulations this part, shall be landed from any conveyance except under such restrictions as the inspector in charge at the port of entry shall direct.
(a) Except as provided in this section and in § 93.324, horses intended for importation into the United States from any part of the world shall be shipped directly to a port designated in §§ 93.303 and 92.324 and be quarantined at said port until negative results to port of entry tests are obtained and the horses are certified by the port veterinarian to be free from clinical evidence of disease.
(1) Except as provided in §§ 93.317 and 93.324, and except with respect to horses from Argentina, Bermuda, and the British Virgin Islands, horses intended for importation from the Western Hemisphere shall be quarantined at a port designated in § 93.303 for not less than 7 days to be evaluated for signs of Venezuelan equine encephalomyelitis.
(2) Horses intended for importation from regions APHIS considers to be affected with African horse sickness may enter the United States only at the port of New York, and must be quarantined at the New York Animal Import Center in Newburgh, New York, for at least 60 days. This restriction also applies to horses that have stopped in or transited a region considered affected with African horse sickness. APHIS considers the following regions to be affected with African horse sickness: Oman, Saudi Arabia, the Yemen Arab Republic, and all the regions on the continent of Africa except Morocco.
(3) To qualify for release from quarantine, all horses, except horses from Iceland, must test negative to official tests for dourine, glanders, equine piroplasmosis, and equine infectious anemia.
(4) Any quarantine period required for a horse shall be counted using the first day after arrival of the horse at the quarantine facility as the first day of quarantine and may be extended for such additional period as the Administrator may require to determine its freedom from disease. Any horse which is positive to any of the port of entry tests named in this paragraph or any other test required by the Administrator, or which is found by the port veterinarian to exhibit evidence of communicable disease during quarantine shall be refused entry into the United States and removed by the importer to a country other than the United States within 10 days of the date that the importer is notified by APHIS that such horse has been refused entry into the United States. Upon request, the Administrator may grant additional time for the removal of a horse from the United States in any case in which he or she determines that delay is unavoidable due to unforseen circumstances and the additional time for removal of the horse will not present a threat of the spread of communicable disease to other animals in the United States. At the option of the importer, such horse may be disposed of in accordance with such conditions as the Administrator believes necessary to prevent the dissemination of communicable disease into the United States. The importer shall be responsible for all costs of such removal or disposal.
(b)
(c)
(1)
(2)
(ii)
(B) Doors, windows, and other openings of the facility shall be provided with double screens which will prevent insects from entering the facility.
(3)
(ii) All feed and bedding used for horses in approved quarantine facilities shall originate from an area not under quarantine because of cattle fever ticks (see §§ 72.3 and 72.5 of subchapter C of this title) and shall be stored within the facility.
(iii) Upon the death or destruction of any horse, the importer shall arrange for the disposal of the horse's carcass by incineration. Disposal of all other waste removed from the facility during the time the horses are in quarantine or from horses which are refused entry into the United States shall be either by incineration or in a public sewer system which meets all applicable environmental quality control standards. Following completion of the quarantine period and the release of the horses into the United States all waste may be removed from the quarantine facility without further restriction.
(iv) The facility shall be maintained and operated in accordance with any additional requirements the Administrator deems appropriate to prevent the dissemination of any communicable disease.
(v) The facility shall comply with all applicable local, State and Federal requirements for environmental quality.
(4)
(B) The importer shall provide attendants for the care and feeding of horses while in the quarantine facility.
(C) Persons working in the quarantine facility shall not come in contact with any horses outside the quarantine facility during the quarantine period for any horses in such quarantine facility.
(ii)
For
(a)
(b)
(c) Amounts collected from the importer, or his or her agent, for service rendered shall be deposited so as to be available for defraying the expenses involved in this service.
Visitors shall not be admitted to the quarantine enclosure during any time that horses are in quarantine except that an importer (or his or her accredited agent or veterinarian) may be admitted to the yards and buildings containing his or her quarantined horses at such intervals as may be deemed necessary, and under such conditions and restrictions as may be imposed, by the inspector in charge of the quarantine station. On the last day of the quarantine period, owners, officers or registry societies, and others having official business or whose services may be necessary in the removal of the horses may be admitted upon written permission from the said inspector. No exhibition or sale shall be allowed within the quarantine grounds.
Milk or cream from horses quarantined under the provisions of this part shall not be used by any person other than those in charge of such horses, nor be fed to any animals other than those within the same enclosure, without permission of the inspector in charge of the quarantine station and subject to such restrictions as he or she may consider necessary to each instance. No milk or cream shall be removed from the quarantine premises except in compliance with all State and local regulations.
No manure shall be removed from the quarantine premises until the release of the horses producing same.
If any contagious disease appears among horses during the quarantine period special precautions shall be taken to prevent spread of the infection to other animals in the quarantine station or to those outside the grounds. The affected horses shall be disposed of as the Administrator may direct, depending upon the nature of the disease.
(a) Horses offered for importation from any part of the world shall be accompanied by a certificate of a salaried veterinary officer of the national government of the region of origin, or if exported from Mexico, shall be accompanied either by such a certificate or by a certificate issued by a veterinarian accredited by the National Government of Mexico and endorsed by a full-time salaried veterinary officer of the National Government of Mexico, thereby representing that the veterinarian issuing the certificate was authorized to do so, showing that:
(1) The horses described in the certificate have been in said region during the 60 days preceding exportation;
(2) That each horse has been inspected on the premises of origin and found free of evidence of communicable disease and, insofar as can be determined, exposure thereto during the 60 days preceding exportation;
(3) That each horse has not been vaccinated with a live or attenuated or inactivated vaccine during the 14 days preceding exportation:
(4) That, insofar as can be determined, no case of African horse sickness, dourine, glanders, surra, epizootic lymphangitis, ulcerative lymphangitis, equine piroplasmosis, Venezuelan equine encephalomyelitis, vesicular stomatitis, or equine infectious anemia has occurred on the premises of origin or on adjoining premises during the 60 days preceding exportation; and
(5) That, except as provided in § 93.301(g):
(i) The horses have not been in any region listed in § 93.301(c)(1) as affected with CEM during the 12 months immediately prior to their importation into the United States;
(ii) The horses have not been on any premises at any time during which time such premises were found by an official of the veterinary services of the national government of the region where such premises are located, to be affected with CEM;
(iii) The horses have not been bred by or bred to any horses from an affected premises; and
(iv) The horses have had no other contact with horses that have been found to be affected with CEM or with horses that were imported from regions affected with CEM.
(b) If a horse is presented for importation from a region where it has been for less than 60 days, the horse must be accompanied by a certificate that meets the requirements of paragraph (a) of this section that has been issued by a salaried veterinary officer of the national government of each region in which the horse has been during the 60 days immediately preceding its shipment to the United States. The dates during which the horse was in each region during the 60 days immediately preceding its exportation to the United States shall be included as a part of the certification.
(c) Following the port-of-entry inspection required by § 93.306 of this part, and before a horse offered for importation from any part of the world is released from the port of entry, an inspector may require the horse and its accompanying equipment to be disinfected as a precautionary measure against the introduction of foot-and-mouth disease or any other disease dangerous to the livestock of the United States.
For all horses offered for importation from Canada, the importer or his or her agent shall present two copies of a declaration as provided in § 93.305.
Horses imported from Canada for immediate slaughter shall be consigned from the port of entry directly to a recognized slaughtering establishment and there be slaughtered within two weeks from the date of entry. Such horses shall be inspected at the port of entry and otherwise handled in accordance with § 93.306. As used in this section, “directly” means without unloading en route if moved in a means of
(a) Except as provided in paragraph (c) of this section, horses from Canada shall be inspected as provided in § 93.306; shall be accompanied by a certificate as required by § 93.314 which shall include evidence of a negative test for equine infectious anemia for which blood samples were drawn during the 180 days preceding exportation to the United States and which test was conducted in a laboratory approved by the Canada Department of Agriculture or the United States Department of Agriculture;
(b) Horses of United States origin that are imported into Canada under an export health certificate valid for a period of 30 days from the date of issue may re-enter the United States an unlimited number of times during the 30-day period, without USDA veterinary port inspection, at any Custom land border port of entry designated for animals from Canada, if accompanied by the original export health certificate under which they were permitted entry into Canada.
(c) Horses for immediate slaughter may be imported from Canada without the certification prescribed in paragraph (a) of this section, but shall be subject to the other applicable provisions of this part, and shall be accompanied by a certificate issued or endorsed by a salaried veterinarian of the Canadian Government stating that:
(1) The horses were inspected on the premises where assembled for shipment to the United States within the 30 days immediately prior to the date of export and were found free of evidence of communicable disease, and
(2) As far as can be determined, they have not been exposed to any such disease during the 60 days immediately preceding their exportation.
(a)
(2)
(b)
For all horses offered for importation from regions of Central America or of the West Indies, the importer or his or her agent shall present two copies of a declaration as provided in § 93.305.
Horses from Central America and the West Indies shall be inspected as provided in § 93.306; shall be accompanied by a certificate and otherwise handled as provided in § 93.314; and shall be quarantined and tested as provided in § 93.308(a), (b) and (c):
For horses intended for importation into the United States from Mexico, the importer or his or her agent shall deliver to the veterinary inspector at the port of entry an application, in writing, for inspection, so that the veterinary inspector and customs representatives may make mutually satisfactory arrangements for the orderly inspection of the horses. The veterinary inspector at the port of entry will provide the importer or his or her agent with a written statement assigning a date when the horses may be presented for import inspection.
For all horses offered for importation from Mexico, the importer or his or her agent shall present two copies of a declaration as provided in § 93.305.
(a) All horses offered for entry from Mexico, including such horses intended for movement through the United States in bond for immediate return to Mexico, shall be inspected at a facility described in § 93.324, and all such horses found to be free from communicable disease and fever tick infestation, and not to have been exposed thereto, shall be admitted into the United States subject to the other applicable provisions of this part. Horses found to be affected with or to have been exposed to a communicable disease, or infested with fever ticks, shall be refused entry. Horses refused entry, unless exported within a time fixed in each case by the Administrator, shall be disposed of as said Administrator may direct.
(b) Horses covered by paragraph (a) of this section shall be imported through facilities described in § 93.324, which are equipped with facilities necessary for proper chute inspection, dipping, and testing, as provided in this part.
Horses intended for importation from Mexico shall be quarantined until they qualify for release from such quarantine, either at an APHIS facility designated in § 93.303 (a) or at a facility in Mexico. In order to qualify for such release, all horses while so detained shall test negative to an official test for dourine, glanders, equine piroplasmosis, equine infectious anemia,
Horses offered for entry from Mexico shall be inspected as provided in §§ 93.306 and 93.323; shall be accompanied by a certificate and otherwise handled as provided in § 93.314; and shall be quarantined and tested as provided in § 93.324:
Horses may be imported from Mexico, subject to the applicable provisions of §§ 93.321, 93.322, and 93.323 for immediate slaughter if accompanied by a certificate of a salaried veterinarian of the Mexican Government, or by a certificate issued by a veterinarian accredited by the Mexican Goverment and endorsed by a salaried veterinarian of the Mexican Government, thereby representing that the veterinarian issuing the certificate was authorized to do so, stating that he or she has inspected such horses on the premises of origin and found them free of evidence of communicable disease, and that, so far as it has been possible to determine, they have not been exposed to any such disease common to animals of their kind during the preceding 60 days, and if the horses are shipped by
Wherever in this subpart the following terms are used, unless the context otherwise requires, they shall be construed, respectively, to mean:
(1) Originated from a tuberculosis-free herd; or
(2) Originated from an accredited herd or originated from a herd of origin that tested negative to a whole herd test, and the individual cattle to be added to the herd also tested negative to any additional individual tests for tuberculosis required by the Administrator.
(1) Is owned, operated, and financed by a person other than the Federal Government;
(2) Is subject to the strict oversight of APHIS representatives;
(3) Is constructed, operated, and maintained in accordance with the requirements for medium security facilities in § 93.412(d); and
(4) Provides the necessary level of quarantine services for the holding of ruminants in an indoor, vector-proof environment prior to the animals' entry into the United States. Quarantine services would have to include testing or observation for any OIE listed diseases and other livestock diseases exotic to the United States, as well as any other diseases, as necessary, to be determined by the Administrator.
(1) Is owned, operated, and financed by a person other than the Federal Government;
(2) Is subject to the strict oversight of APHIS representatives;
(3) Is constructed, operated, and maintained in accordance with the requirements for minimum security facilities in § 93.412(d);
(4) Is used for the quarantine of ruminants that pose no significant
(5) Provides the necessary level of quarantine services for the outdoor holding of ruminants, prior to the animals' entry into the United States. Quarantine services would have to include testing or observation for any OIE listed diseases and other livestock diseases exotic to the United States, as well as any other diseases, as necessary, to be determined by the Administrator.
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.);
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
(2) A sheep or goat that exhibits any of the following signs and that has been determined to be suspicious for a transmissible spongiform encephalopathy by a veterinarian: Weight loss despite retention of appetite; behavior abnormalities; pruritus (itching); wool pulling; biting at legs or side; lip smacking; motor abnormalities such as incoordination, high stepping gait of forelimbs, bunny hop movement of rear legs, or swaying of back end; increased sensitivity to noise and sudden movement; tremor, “star gazing,” head pressing, recumbency, or other signs of neurological disease or chronic wasting.
(1) Were born in and originated from a tuberculosis-free herd; or
(2) Were born in and originated from an accredited herd or originated from a herd of origin that has tested negative to a whole herd test, and the individual cattle have tested negative to any additional individual tests for tuberculosis required by the Administrator.
(a) No ruminant or product subject to the provisions of this part shall be brought into the United States except in accordance with the regulations in this part and part 94 of this subchapter;
(b) Except for ruminants prohibited entry , the provisions in this part relating to ruminants shall not apply to healthy ruminants in transit through the United States if they are not known to be infected with or exposed, within 60 days preceding the date of export from the region of origin, to communicable diseases of such ruminants, if an import permit
(1)(i) They are maintained under continuous confinement in transit through the United States aboard an aircraft, ocean vessel, or other means of conveyance; or
(ii) They are unloaded, in the course of such transit, into a ruminant holding facility which is provided by the carrier or its agent and has been approved
(2) The carrier or its agent executes and furnishes to the collector of Customs at the first port of arrival a declaration stating that the ruminants will be retained aboard such means of conveyance or in an approved holding facility during transshipment as required by this paragraph.
(3) Provisions for the approval of facilities required in this paragraph are:
(i) They must be sufficiently isolated to prevent direct or indirect contact with all other animals and birds while in the United States.
(ii) They must be so constructed that they provide adequate protection against environmental conditions and can be adequately cleaned, washed and disinfected.
(iii) They must provide for disposal of ruminant carcasses, manure, bedding, waste and any related shipping materials in a manner that will prevent dissemination of disease.
(iv) They must have provisions for adequate sources of feed and water and for attendants for the care and feeding of ruminants in the facility.
(v) They must comply with additional requirements as may be imposed by the Administrator if deemed applicable for a particular shipment.
(vi) They must also comply with all applicable local, State and Federal requirements for environmental quality and with the provisions of the Animal Welfare Regulations in chapter I of this title, as applicable.
(c)
(a)
(b)
(c)
(d) For purposes of this section, the term “shipping container” means any container of a type specially adapted for use in transporting any article on the means of conveyance involved.Q06
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(a)
(2) An application for permit to import will be denied for domestic ruminants from any region designated in § 94.1 of this chapter as a region where rinderpest or foot-and-mouth disease exists.
(3) An application for permit to import ruminants may also be denied because of: Communicable disease conditions in the area or region of origin, or in a region where the shipment has been or will be held or through which the shipment has been or will be transported; deficiencies in the regulatory programs for the control or eradication of animal diseases and the unavailability of veterinary services in the above mentioned regions; the importer's failure to provide satisfactory evidence concerning the origin, history, and health status of the ruminants; the lack of satisfactory information necessary to determine that the importation will not be likely to transmit any communicable disease to livestock or poultry of the United States; or any other circumstances which the Administrator believes require such denial to prevent the dissemination of any communicable disease of livestock or poultry into the United States.
(4)(i) The importer or importer's agent shall pay or ensure payment of a reservation fee for each lot of ruminants to be quarantined in a facility maintained by USDA. For ruminants, the reservation fee shall be 100 percent of the cost of providing care, feed, and handling during quarantine, as estimated by the quarantine facility's veterinarian in charge.
(ii) At the time the importer or the importer's agent requests a reservation of quarantine space, the importer or importer's agent shall pay the reservation fee by check or U.S. money order or ensure payment of the reservation fee by an irrevocable letter of credit from a commercial bank (the effective
(iii) Any reservation fee paid by check or U.S. money order shall be applied against the expenses incurred for services received by the importer or importer's agent in connection with the quarantine for which the reservation was made. Any part of the reservation fee which remains unused after being applied against the expenses incurred for services received by the importer or the importer's agent in connection with the quarantine for which the reservation was made, shall be returned to the individual who paid the reservation fee. If the reservation fee is ensured by a letter of credit, the Department will draw against the letter of credit unless payment for services received by the importer or importer's agent in connection with the quarantine is otherwise made at least 3 days prior to the expiration date of the letter of credit.
(iv) Any reservation fee shall be forfeited if the importer or the importer's agent fails to present for entry, within 24 hours following the designated time of arrival, the lot of ruminants for which the reservation was made:
(A) Written notice of cancellation from the importer or the importer's agent is received by the office of the veterinarian in charge of the quarantine facility
(B) The Administrator determines that services, other than provided by carriers, necessary for the importation of the ruminants within the requested period are unavailable because of unforeseen circumstances as determined by the Administrator, (such as the closing of an airport due to inclement weather or the unavailability of the reserved space due to the extension of another quarantine).
(v) If the reservation fee was ensured by a letter of credit and the fee is to be forfeited under paragraph (a)(4)(iv) of this section, the Department will draw against the letter of credit unless the reservation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.
(vi) When a reservation is cancelled in accordance with paragraph (a)(4)(iv)(A) of this section and the provisions of paragraph (a)(4)(iv)(B) of this section do not apply, a $40.00 cancellation fee shall be charged. If a reservation fee was paid, the cancellation fee shall be deducted from any reservation fee returned to the importer or the importer's agent. If the reservation fee was ensured by a letter of credit, the Department will draw the amount of the cancellation fee against the letter of credit unless the cancellation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.
(b)
(c)
(1) Permits for the importation of wild ruminants will be issued only for importations through the Port of New York, and only if the animals are imported for exhibition in a PEQ Zoo. A PEQ Zoo is a zoological park or other place maintained for the exhibition of live animals for recreational or educational purposes that:
(i) Has been approved by the Administrator in accordance with paragraph (c)(2) of this section to receive and maintain imported wild ruminants; and
(ii) Has entered into the agreement with APHIS set forth in paragraph (c)(4) of this section for the maintenance and handling of imported wild ruminants.
(2) Approval of a PEQ Zoo shall be on the basis of an inspection, by an authorized representative of the Department, of the physical facilities of the establishment and its methods of operation. Standards for acceptable physical facilities shall include satisfactory pens, cages, or enclosures in which the imported ruminants can be maintained so as not to be in contact with the general public and free from contact with domestic livestock; natural or established drainage from the PEQ Zoo which will avoid contamination of land areas where domestic livestock are kept or with which domestic livestock may otherwise come in contact; provision for the disposition of manure, other wastes, and dead ruminants within the PEQ Zoo; and other reasonable facilities considered necessary to prevent the dissemination of diseases from the PEQ Zoo. The operator of the PEQ Zoo shall have available the services of a full-time or part-time veterinarian, or a veterinarian on a retainer basis, who shall make periodic examinations of all animals maintained at the PEQ Zoo for evidence of disease; who shall make a post-mortem examination of each animal that dies; and who shall make a prompt report of suspected cases of contagious or communicable diseases to an APHIS representative or the State agency responsible for livestock disease control programs.
(3) Manure and other animal wastes must be disposed of within the PEQ Zoo park for a minimum of one year following the date an imported wild ruminant enters the zoo. If an APHIS veterinarian determines that an imported ruminant shows no signs of any communicable disease or exposure to any such disease during this 1-year period, its manure and other wastes need not be disposed of within the zoo after the 1-year period. If, however, an APHIS veterinarian determines that an imported ruminant does show signs of any communicable disease during this 1-year period, an APHIS veterinarian will investigate the disease and determine whether the ruminant's manure and other wastes may safely be disposed of outside the zoo after the 1-year period has ended.
(4) Prior to the issuance of an import permit under this section, the operator of the approved PEQ Zoo to which the imported ruminants are to be consigned, and the importer of the ruminants, if such operator and importer are different parties, shall execute an agreement covering each ruminant or group of ruminants for which the import permit is requested. The
____, operator(s) of the zoological park known as __________ (Name) located at __________ (City and state), and __________ (Importer) hereby request a permit for the importation of ____ (Number and kinds of animals) for exhibition purposes at the said zoological park, said animals originating in a region where foot-and-mouth disease or rinderpest exists and being subject to restrictions under regulations contained in part 93, title 9, Code of Federal Regulations.
In making this request, it is understood and agreed that:
1. The animals for which an import permit is requested will be held in isolation at a port of embarkation in the region of origin, approved by the Administrator as a port having facilities which are adequate for maintaining wild animals in isolation from all other animals and having veterinary supervision by officials of the region of origin of the animals. Such animals will be held in such isolation for not less than 60 days under the supervision of the veterinary service of that region to determine whether the animals show any clinical evidence of foot-and-mouth disease, rinderpest, or other communicable disease that is exotic to the United States or for which APHIS has an eradication or control program in 9 CFR chapter I, and to assure that the animals will not have been exposed to such a disease within the 60 days next before their exportation from that region.
2. Shipment will be made direct from such port of embarkation to the port of New York as the sole port of entry in the United States. If shipment is made by ocean vessel the animals will not be unloaded in any foreign port en route. If shipment is made by air, the animals will not be unloaded at any port or other place of landing, except at a port approved by the Administrator as a port not located in a region where rinderpest or foot-and-mouth disease exists or as a port in such a region having facilities and inspection adequate for maintaining wild animals in isolation from all other animals.
3. No ruminants or swine will be aboard the transporting vehicle, vessel or aircraft, except those for which an import permit has been issued.
4. The animals will be quarantined for not less than 30 days in the Department's Animal Import Center in Newburgh, New York.
5. Upon release from quarantine the animals will be delivered to the zoological park named in this agreement to become the property of the park and they will not be sold, exchanged or removed from the premises without the prior consent of APHIS. If moved to another zoological park in the United States, the receiving zoological park must be approved by the Administrator in accordance with paragraph 6 of this agreement.
6. The Administrator will approve the movement of an imported animal subject to this agreement if the Administrator determines that the animal has spent at least one year in quarantine in a PEQ Zoo following importation without showing clinical evidence of foot-and-foot mouth disease, rinderpest, or other communicable disease that is exotic to the United States or for which APHIS has an eradication or control program in 9 CFR chapter I, and determines that the receiving zoological park is accredited by the American Zoo and Aquarium Association (AZA), or the receiving zoological park has facilities and procedures in place related to preventing the spread of communicable animal diseases (including but not limited to procedures for animal identification, record keeping, and veterinary care) that are equivalent to those required for AZA accreditation. The Administrator will approve the movement of a carcass, body part, or biological specimen derived from an imported animal subject to this agreement if the Administrator determines that the animal has spent at least one year in quarantine in a PEQ Zoo following importation without showing clinical evidence of foot-and-foot mouth disease, rinderpest, or other communicable disease that is exotic to the United States or for which APHIS has an eradication or control program in 9 CFR chapter I, and determines that the carcass, body part, or biological specimen will be moved only for scientific research or museum display purposes.
Subscribed and sworn to before me this __ day of __, __.
Subscribed and sworn to before me this __ day of __,__
(a) All ruminants intended for importation from any part of the world, except as provided in §§ 93.423(c) and 93.428(d), shall be accompanied by a certificate issued by a full-time salaried veterinary officer of the national government of the region of origin, or issued by a veterinarian designated or accredited by the national government of the region of origin and endorsed by a full-time salaried veterinary officer of the national government of the region of origin, representing that the veterinarian issuing the certificate was authorized to do so. The certificate shall state:
(1) That the ruminants have been kept in that region during the last 60 days immediately preceding the date of shipment to the United States, and that during this time the region has been entirely free from foot-and-mouth disease, rinderpest, contagious pleuropneumonia, and surra;
(2) That the ruminants are not in quarantine in the region of origin; and
(3) If the ruminants are from Angola, Argentina, Bahrain, Bangladesh, Benin, Bolivia, Botswana, Brazil, Brunei, Burkina Faso, Burundi, Cambodia, Cameroon, Central African Republic, China, Columbia, Congo, Dominican Republic, Ecuador, Equatorial Guinea, French Guiana, Gabon, Gambia, Ghana, Guinea, Guinea-Bissau, Guyana, Haiti, India, Indonesia, Iraq, Isla de Pascua (Easter Island, part of Chile), Ivory Coast, Jamaica, Kenya, Kuwait, Laos, Lesotho, Liberia, Macau, Malawi, Malaysia, Mali, Mauritania, Mozambique, Myanmar, Namibia, Nigeria, Oman, Pacific Islands (Palau), Panama, Papua New Guinea, Paracel Islands, Paraguay, Peru, Philippines, Qatar, Rwanda, Saudi Arabia, Senegal, Sierra Leone, Singapore, South Africa, Spratly Islands, Sri Lanka, Surinam, Swaziland, Taiwan, Tanzania, Thailand, Togo, Trinidad and Tobago, Uganda, United Arab Emirates, Uruguay, Venezuela, Vietnam, Zaire, Zambia, Zimbabwe, or any other region of the world where screwworm is considered to exist, the ruminants may be imported into the United States only if they meet the following requirements and all other applicable requirements of this part:
(i) A veterinarian must treat the ruminants with ivermectin 3 to 5 days prior to the date of export to the United States according to the recommended dose prescribed on the product's label.
(ii) The ruminants must be fully examined for screwworm by a full-time salaried veterinary official of the exporting country within 24 hours prior to shipment to the United States. If ruminants are found to be infested with screwworm, they must be treated until free from infestation.
(iii) At the time ruminants are loaded onto a means of conveyance for export, a veterinarian must treat any visible wounds on the animals with a solution of coumaphos dust at a concentration of 5 percent active ingredient.
(iv) The ruminants must be accompanied to the United States by a certificate signed by a full-time salaried veterinary official of the exporting country. The certificate must state that the ruminants have been thoroughly examined and found free of screwworm and that the ruminants have been treated in accordance with paragraphs (a)(3)(i) and (a)(3)(iii) of this section.
(4) If the ruminants are bovines, sheep, or goats from regions listed as BSE minimal-risk regions in § 94.18(a)(3) of this subchapter, the certificate must also include the name
(b)
(i) That none of the goats in the herd from which the goats will be imported is the progeny of a sire or dam that has been affected with scrapie or that has produced offspring that have been affected with scrapie;
(ii) That none of the female goats in the herd from which the goats will be imported has been impregnated, during the 5 years immediately preceding shipment of the goats to the United States, with germ plasm from a herd known to be infected with scrapie;
(iii) That the veterinarian issuing the certificate has inspected the goats in the herd from which the animals will be imported and found the herd to be free of any evidence of infectious or contagious disease; and
(iv) That as far as it is possible for the veterinarian who inspects the animals to determine, none of the goats in the herd from which the animals will be imported has been exposed to any infectious or contagious disease during the 60 days immediately preceding shipment to the United States.
(2) In addition, the certificate accompanying goats intended for importation from any part of the world except Australia and New Zealand must state:
(i) That the goats have not been in any herd nor had contact with sheep or goats that have been in any flock or herd where scrapie has been diagnosed or suspected during the 5 years immediately prior to shipment; and
(ii) That the goats have not had any contact with sheep during the 5 years immediately prior to shipment;
(c)
(i) That none of the sheep in the flock from which the sheep will be imported is the progeny of a sire or dam that has been affected with scrapie or that has produced offspring that have been affected with scrapie;
(ii) That none of the female sheep in the flock from which the sheep will be imported has been impregnated, during the 5 years immediately preceding shipment of the sheep to the United States, with germ plasm from a flock known to be infected with scrapie;
(iii) That the veterinarian issuing the certificate has inspected the sheep in the flock from which the animals will be imported and found the flock to be free of any evidence of infectious or contagious disease; and
(iv) That as far as it is possible for the veterinarian who inspects the animals to determine, none of the sheep in the flock from which the animals will be imported has been exposed to any infectious or contagious disease during the 60 days immediately preceding shipment to the United States.
(2) In addition, except for sheep imported from Canada for immediate slaughter, the certificate accompanying sheep intended for importation
(3) In addition, the certificate accompanying sheep intended for importation from Australia and New Zealand must state that none of the female sheep in the flock from which the sheep will be imported has been impregnated, during the 5 years immediately preceding shipment of the sheep to the United States, with germ plasm from a region other than Australia, New Zealand, or the United States, or from a flock of unknown scrapie status;
(d) If ruminants are unaccompanied by the certificate as required by paragraphs (a), (b), and (c) of this section, or if such ruminants are found upon inspection at the port of entry to be affected with a communicable disease or to have been exposed thereto, they shall be refused entry and shall be handled or quarantined, or otherwise disposed of as the Administrator may direct.
(a)
(1)
(2)
(ii) For sexually intact cattle that are from an accredited herd, the herd was certified as an accredited herd for tuberculosis within 1 year prior to the date of exportation to the United States; or
(iii) For sexually intact cattle that are not from an accredited herd, the cattle originated from a herd of origin that tested negative to a whole herd test for tuberculosis within 1 year prior to the date of exportation to the United States, and the animals each tested negative to one additional official tuberculin test conducted no more than 6 months and no less than 60 days prior to the date of exportation to the United States, and any individual cattle that had been added to the herd tested negative to any individual tests for tuberculosis required by the Administrator, except that the additional
(b)
(c)
(d)
(a) The certificates, declarations, and affidavits required by the regulations in this part shall be presented by the importer or his or her agent to the collector of customs at the port of entry, upon arrival of ruminants at such port, for the use of the veterinary inspector at the port of entry.
(b) For all ruminants offered for importation, the importer or his or her agent shall first present two copies of a declaration which shall list the port of entry, the name and address of the importer, the name and address of the broker, the origin of the ruminants, the number, breed, species, and purpose of the importation, the name of the person to whom the ruminants will be delivered, and the location of the place to which such delivery will be made.
Inspection shall be made at the port of entry of all ruminants imported from any part of the world except as provided in §§ 93.421 and 93.426. All ruminants found to be free from communicable disease and not to have been exposed thereto within 60 days prior to their exportation to the United States shall be admitted subject to the other provisions in this part; all other ruminants except as provided in §§ 93.423(c) and 93.427(a) shall be refused entry. Ruminants refused entry, unless exported within a time fixed in each case by the Administrator, and in accordance with other provisions he or she may require in each case for their handling shall be disposed of as the Administrator may direct in accordance with the Animal Health Protection Act (7 U.S.C. 8301
No litter or manure, fodder or other aliment, nor any equipment such as boxes, buckets, ropes, chains, blankets, or other things used for or about ruminants governed by the regulations in this part, shall be landed from any conveyance except under such restrictions as the inspector in charge at the port of entry shall direct.
Platforms and chutes used for handling imported ruminants shall be cleaned and disinfected under APHIS supervision after being so used. The said ruminants shall not be unnecessarily moved over any highways nor allowed to come in contact with other animals, but shall be transferred from the conveyance to the quarantine grounds in boats, cars, or vehicles approved by the inspector in charge at the port of entry. Such cars, boats, or vehicles shall be cleaned and disinfected under APHIS supervision immediately after such use, by the carrier moving the same. The railway cars so used shall be either cars reserved for this exclusive use or box cars not otherwise employed in the transportation of animals or their fresh products. When movement of the aforesaid ruminants upon or across a public highway is unavoidable, it shall be under such careful supervision and restrictions as the inspector in charge at the port of entry and the local authorities may direct.
(a) Except for cattle from Central America and the West Indies, and except for ruminants from Canada and Mexico, all ruminants imported into the United States shall be quarantined for not less than 30 days counting from the date of arrival at the port of entry.
(b) Wild ruminants shall be subject, during their quarantine, to such inspections, disinfection, blood tests, or other tests as may be required by the Administrator to determine their freedom from disease.
(a)
(b)
(c) APHIS collection of payments from the importer, or his or her agent, or the operator, for service rendered shall be deposited so as to be available for defraying the expenses involved in this service.
(d)
(A) If APHIS determines that an application is complete and merits further consideration, the person applying for facility approval must agree to pay the costs of all APHIS services associated with APHIS' evaluation of the application and facility. APHIS charges for evaluation services at hourly rates are listed in § 130.30 of this chapter. If the facility is approved by APHIS, the operator must enter into a compliance agreement in accordance with paragraph (d)(2) of this section.
(B) Requests for approval must be submitted at least 120 days prior to the date of application for local building
(ii)
(A) APHIS must find, based on an environmental assessment, and based on any required Federal, State, and local environmental permits or evaluations secured by the operator and copies of which are provided to APHIS, that the operation of the facility will not have significant environmental effects;
(B) The facility must meet all the requirements of paragraph (d) of this section;
(C) The facility must meet any additional requirements that may be imposed by the Administrator in each specific case, as specified in the compliance agreement required under paragraph (d)(2) of this section, to ensure that the quarantine of ruminants in the facility will be adequate to enable determination of their health status, as well as to prevent the transmission of livestock diseases into, within, and from the facility; and
(D) The Administrator must determine whether sufficient personnel, including one or more APHIS veterinarians and other professional, technical, and support personnel, are available to serve as APHIS representatives at the facility and provide continuous oversight and other technical services to ensure the biological security of the facility, if approved. APHIS will assign personnel to facilities requesting approval in the order that the facilities meet all of the criteria for approval. The Administrator has sole discretion on the number of APHIS personnel to be assigned to the facility.
(iii)
(iv)
(A) Before facility approval is denied or withdrawn, APHIS will inform the operator of the proposed or existing facility and include the reasons for the proposed action. If there is a conflict as to any material fact, APHIS will afford the operator, upon request, the opportunity for a hearing with respect to the merits or validity of such action in accordance with rules of practice that APHIS adopts for the proceeding.
(B) Withdrawal of approval of an existing facility will become effective pending final determination in the proceeding when the Administrator determines that such action is necessary to protect the public health, interest, or safety. Such withdrawal will be effective upon oral or written notification, whichever is earlier, to the operator of the facility. In the event of oral notification, APHIS will give written confirmation to the operator of the facility as promptly as circumstances allow. This withdrawal will continue in effect pending the completion of the proceeding and any judicial review, unless otherwise ordered by the Administrator. In addition to withdrawal of approval for the reasons provided in paragraph (d)(1)(iv)(C) of this section, the Administrator will also automatically withdraw approval when the operator of any approved facility notifies the area veterinarian in charge for the State in which the facility is located, in writing, that the facility is no longer in operation.
(C) The Administrator may deny or withdraw the approval of a privately owned medium or minimum security quarantine facility if:
(
(
(
(
(
(
(D) For the purposes of paragraph (d)(1)(iv) of this section, a person is deemed to be responsibly connected with the business of the facility if such person has an ownership, mortgage, or lease interest in the facility, or if such person is a partner, officer, director, holder, or owner of 10 percent or more of its voting stock, or an employee in a managerial or executive capacity.
(2)
(A) The facility must meet all applicable requirements of paragraph (d) of this section;
(B) The facility's quarantine operations are subject to the strict oversight of APHIS representatives;
(C) The operator agrees to be responsible for the cost of building the facility; all costs associated with its maintenance and operation; all costs associated with the hiring of personnel to attend to the ruminants, as well as to maintain and operate the facility; all costs associated with the care of quarantined ruminants, such as feed, bedding, medicines, inspections, testing, laboratory procedures, and necropsy examinations; all costs associated with the death or destruction and disposition of quarantined ruminants; and all APHIS charges for the services of APHIS representatives in accordance with this section and part 130 of this chapter;
(D) The operator obtained, prior to execution of this agreement, a financial instrument (insurance or surety bond) approved by APHIS that financially guarantees the operator's ability to cover all costs and other financial liabilities and obligations of the facility, including a worst case scenario in which all quarantined ruminants must be destroyed and disposed of because of an animal health emergency, as determined by the Administrator.
(E) The operator will deposit with the Administrator, prior to commencing quarantine operations, a certified check or U.S. money order to cover the estimated costs, as determined by the Administrator, of professional, technical, and support services to be provided by APHIS at the facility over the duration of the quarantine. If actual costs incurred by APHIS over the quarantine period exceed the deposited amount, the operator will pay for any additional costs incurred by APHIS, based on official accounting records. Payment for all services received in connection with each lot of ruminants in quarantine shall be made prior to release of the ruminants. The operator must pay for any other costs incurred by APHIS with respect to the quarantine following the release of the ruminants, based on official records, within 14 days of receipt of the bill showing the balance due. APHIS will return to the operator any unobligated funds deposited with APHIS, after the release of the lot of ruminants from the facility and termination or expiration of the compliance agreement, or, if requested, credit to the operator's account such funds to be applied towards payment of APHIS services at a future date.
(ii) Prior to the entry of each subsequent lot of ruminants into the medium or minimum security facility, a
(3)
(i)
(B) In the case of a medium security facility, the facility must be located at least one-half mile from any premises holding livestock. In the case of a minimum security facility, the Administrator will establish the required minimum distance between the facility and other premises holding livestock on a case-by-case basis.
(C) If the medium or minimum security facility is to be located more than 1 mile from a designated port, the operator must make arrangements for the imported ruminants to be held in a temporary inspection facility to allow for the inspection of the imported ruminants by a Federal or State veterinarian prior to the animals' movement to the medium or minimum security facility.
(
(
(
(
(
(
(ii)
(A)
(B)
(C)
(D)
(E)
(F)
(iii)
(A)
(B)
(C)
(D)
(E)
(F)
(G)
(H)
(I)
(J)
(K)
(L)
(M)
(N)
(iv)
(A) Equipment and supplies necessary to maintain the facility in a clean and sanitary condition, including pest control equipment and supplies and cleaning and disinfecting equipment with adequate capacity to disinfect the facility and equipment.
(B) Separately maintained sanitation and pest control equipment and supplies for each lot-holding area if the facility will hold more than one lot of ruminants at a time (applicable to medium security facilities only).
(C) A supply of potable water adequate to meet all watering and cleaning needs, with water faucets for hoses located throughout the facility. An emergency supply of water for ruminants in quarantine also must be maintained.
(D) A stock of disinfectant authorized in § 71.10(a)(5) of this chapter or otherwise approved by the Administrator that is sufficient to disinfect the entire facility.
(E) The capability to dispose of wastes, including manure, urine, and used bedding, by means of burial, incineration, or public sewer. Other waste material must be handled in such a manner that minimizes spoilage and the attraction of pests and must be disposed of by incineration, public sewer, or other preapproved manner that prevents the spread of disease. Disposal of wastes must be carried out under the direct oversight of APHIS representatives.
(F) The capability to dispose of ruminant carcasses in a manner approved by the Administrator and under conditions that prevent the spread of disease from the carcasses.
(G) For incineration to be carried out at the facility, incineration equipment that is detached from other facility structures and is capable of burning wastes or carcasses as required. The incineration site must include an area sufficient for solid waste holding. Incineration may also take place at a local site away from the facility premises. All incineration activities must be carried out under the direct oversight of an APHIS representative.
(H) The capability to control surface drainage and effluent into, within, and from the facility in a manner that prevents the spread of disease into, within, and from the facility. If the facility is approved to handle more than one lot of ruminants at the same time, there must be separate drainage systems for each lot-holding area in order to prevent cross contamination.
(v)
(
(
(
(
(
(B) A privately owned medium security facility also must provide the following security measures:
(
(
(4)
(i)
(B) If, for any reason, the operator fails to properly care for, feed, or handle the quarantined ruminants as required in paragraph (d) of this section, or in accordance with animal health and husbandry standards provided elsewhere in this chapter, or fails to maintain and operate the facility as provided in paragraph (d) of this section, APHIS representatives are authorized to furnish such neglected services at the operator's expense, as authorized in paragraph (a) of this section.
(ii)
(B) The operator must provide APHIS with an updated list of all personnel who have access to the facility. The list must include the names, current residential addresses, and identification numbers of each person, and must be updated with any changes or additions in advance of such person having access to the quarantine facility.
(C) The operator must provide APHIS with signed statements from all personnel having access to the facility in which the person agrees to comply with paragraph (d) of this section and applicable provisions of this part, all terms of the compliance agreement, and any related instructions from APHIS representatives pertaining to quarantine operations, including contact with animals both inside and outside the facility.
(iii)
(B) All visitors, except veterinary practitioners who enter the facility to provide emergency care, must sign an affidavit before entering the quarantine area, if determined necessary by the overseeing APHIS representative, declaring that they will not have contact with any susceptible animals outside the facility for at least 5 days after contact with the ruminants in quarantine, or for a period of time determined by the overseeing APHIS representative as necessary to prevent the transmission of communicable livestock diseases of ruminants.
(iv)
(
(
(
(
(B) All equipment (including tractors) must be cleaned and disinfected prior to being used in the quarantine area of the facility with a disinfectant that is authorized in § 71.10(a)(5) of this chapter or that is otherwise approved by the Administrator. The equipment must remain dedicated to the facility for the entire quarantine period. Any equipment used with quarantined
(C) Any vehicle, before entering or leaving the quarantine area of the facility, must be immediately cleaned and disinfected under the oversight of an APHIS representative with a disinfectant that is authorized in § 71.10(a)(5) of this chapter or that is otherwise approved by the Administrator.
(D) If the facility has a single loading dock, the loading dock must be immediately cleaned and disinfected after each use under the oversight of an APHIS representative with a disinfectant that is authorized in § 71.10(a)(5) of this chapter or that is otherwise approved by the Administrator.
(E) That area of the facility in which a lot of ruminants had been held or had access must be thoroughly cleaned and disinfected under the oversight of an APHIS representative upon release of the ruminants, with a disinfectant that is authorized in § 71.10(a)(5) of this chapter or that is otherwise approved by the Administrator, before a new lot of ruminants is placed in that area of the facility.
(F) For medium security facilities only, the following additional sanitary practices also must be followed:
(
(
(
(
(
(
(
(v)
(B) The facility must provide sufficient feed and bedding for the ruminants in quarantine, and it must be free of vermin and not spoiled. Feed and bedding must originate from a region that has been approved by APHIS as a source for feed and bedding.
(C) Breeding of ruminants or collection of germ plasm from ruminants is prohibited during the quarantine period unless necessary for a required import testing procedure.
(D) Ruminants in quarantine will be subjected to such tests and procedures as directed by an APHIS representative to determine whether the ruminants are free of communicable livestock diseases. While in quarantine, ruminants may be vaccinated only with vaccines that have been approved by the APHIS
(E) Any death or suspected illness of ruminants in quarantine must be reported immediately to the overseeing APHIS representative. The affected ruminants must be disposed of as the Administrator may direct or, depending on the nature of the disease, must be cared for as directed by APHIS to prevent the spread of disease.
(F) Quarantined ruminants requiring specialized medical attention or additional postmortem testing may be transported off the quarantine site, if authorized by APHIS. A second quarantine site must be established to house the ruminants at the facility of destination (e.g., veterinary college hospital). In such cases, APHIS may extend the quarantine period until the results of any outstanding tests or postmortems are received.
(G) Should the Administrator determine that an animal health emergency exists at the facility, arrangements for the final disposition of the infected or exposed lot of ruminants must be accomplished within 4 workdays following disease confirmation. Subsequent disposition of the ruminants must occur under the direct oversight of APHIS representatives.
(vi)
(B) The operator must retain the daily log, along with any logs kept by APHIS and deposited with the operator, for at least 2 years following the date of release of the ruminants from quarantine and must make such logs available to APHIS representatives upon request.
(5)
(6)
(7)
Visitors are not permitted in the quarantine enclosures during any time that ruminants are in quarantine unless the APHIS representative or inspector in charge specifically grants access under such conditions and restrictions as may be imposed by the APHIS representative or inspector in charge. An importer (or his or her accredited agent or veterinarian) may be admitted to the yards and buildings containing his or her quarantined ruminants at such intervals as may be deemed necessary, and under such conditions and restrictions as may be imposed, by the APHIS representative or the inspector in charge of the quarantine facility or station. On the last day of the quarantine period, owners,
Milk or cream from ruminants quarantined under the provisions of this part shall not be used by any person other than those in charge of such ruminants, nor be fed to any animals other than those within the same enclosure, without permission of the APHIS representative or inspector in charge of the quarantine station and subject to such restrictions as he or she may consider necessary to each instance. No milk or cream shall be removed from the quarantine premises except in compliance with all State and local regulations.
No manure shall be removed from the quarantine premises until the release of the ruminants producing same.
If any contagious disease appears among ruminants during the quarantine period special precautions shall be taken to prevent spread of the infection to other animals in the quarantine station or to those outside the grounds. The affected ruminants shall be disposed of as the Administrator may direct, depending upon the nature of the disease.
(a) For ruminants intended for importation from Canada, the importer shall first apply for and obtain from APHIS an import permit as provided in § 93.404:
(1) A wether;
(2) A sheep or goat imported for immediate slaughter; or
(3) A ruminant other than a sheep or goat and that ruminant:
(i) Was born in Canada or the United States, and has been in no region other than Canada or the United States, or
(ii) Has been legally imported into Canada from some other region and unconditionally released in Canada so as to be eligible to move freely within that region without restriction of any kind and has been in Canada after such release for 60 days or longer.
(b) For all ruminants offered for importation from Canada, the importer or his or her agent shall present two copies of a declaration as provided in § 93.407.
(a)
(b)
(2) Except for cattle prohibited from importation under paragraph (b)(1) of this section, cattle from Canada may be imported into the United States if:
(i) The cattle are imported for immediate slaughter in accordance with § 93.420; or
(ii) The cattle are imported for movement to a feedlot and then to slaughter and the certificate accompanying the cattle shows, in addition to the information required under § 93.405, the breed of the animal, and:
(A) That the cattle are from a tuberculosis-free herd; or
(B) The date and place the cattle were last tested for tuberculosis; that the cattle were found negative for tuberculosis on such test; and that such test was performed within 60 days preceding the arrival of the cattle at the port of entry; or
(C) That the cattle are at least five days but not more than four weeks of age and, therefore, exempt from the tuberculosis testing requirement; or
(D) For a calf imported with its dam, the date and place the calf's dam was last tested for tuberculosis; that the dam was found negative for tuberculosis on such test; that such test was performed within 60 days preceding the arrival of the calf and dam at the port of entry; and that the calf was born after such test was performed.
(c)
(2) Except for cattle prohibited from importation into the United States under paragraph (c)(1) of this section, cattle 6 months of age or older from Canada may be imported into the United States if the following conditions are met:
(i) The cattle are imported for immediate slaughter in accordance with § 93.420;
(ii) The cattle are steers; or
(iii) The cattle are imported for movement to a feedlot and then to slaughter and the certificate accompanying the cattle shows, in addition to the information required under § 93.405, the breed of the animal, and:
(A) That the cattle are from a brucellosis certified-free herd, province, or territory; or
(B) The date and place the cattle were last tested for brucellosis; that the cattle were found negative for brucellosis on such test; and that such test was performed within 30 days preceding the arrival of the cattle at the port of entry; or
(C) That the female cattle under 18 months of age were vaccinated against brucellosis in accordance with Canadian regulations; the date of such vaccination; the dosage of vaccine used; and the age of each animal on the date of vaccination.
(a) Sheep and goats intended for importation from Canada must be accompanied by a certificate issued in accordance with § 93.405.
(b) If the sheep or goats are unaccompanied by the certificate required by paragraph (a) of this section, or if they are found upon inspection at the port of entry to be affected with or exposed to a communicable disease, they shall be refused entry and shall be handled or quarantined, or otherwise disposed of, as the Administrator may direct.
(c) Any sheep or goats imported from Canada must not be pregnant, must be less than 12 months of age when imported into the United States and when slaughtered, must be from a flock or herd subject to a ruminant feed ban equivalent to the requirements established by the U.S. Food and Drug Administration at 21 CFR 589.2000, and must be individually identified by an official Canadian Food Inspection Agency eartag, applied before the animal's arrival at the port of entry into the United States, that is determined by the Administrator to meet standards equivalent to those for official eartags in the United States as defined in § 71.1 of this chapter and to be traceable to the premises of origin of the animal. No person may alter, deface, remove, or otherwise tamper with the individual identification while the animal is in the United States or moving into or through the United States, except that the identification may be removed at the time of slaughter. The animals must be accompanied by the
(d)
(1) The animals have not tested positive for and are not suspect for a transmissible spongiform encephalopathy;
(2) The animals have not resided in a flock or herd that has been diagnosed with BSE; and
(3) The animals' movement is not restricted within Canada as a result of exposure to a transmissible spongiform encephalopathy.
(e)
(1) The sheep and goats must be permanently and humanely identified before arrival at the port of entry with a distinct and legible “C” mark, properly applied with a freeze brand, hot iron, or other method, and easily visible on the live animal and on the carcass before skinning. The mark must be not less than 1 inch or more than 1
(2) The animals may be moved from the port of entry only to a feedlot designated in accordance with paragraph (e)(7) of this section and must be accompanied from the port of entry to the designated feedlot by APHIS Form VS 17-130 or other movement documentation deemed acceptable by the Administrator, which must identify the physical location of the feedlot, the individual responsible for the movement of the animals, and the individual identification of each animal, which includes the eartag required under paragraph (c) of this section and any other identification present on the animal, including registration number, if any;
(3) The seals of the national government of Canada must be broken only at the port of entry by the APHIS port veterinarian or at the designated feedlot by an authorized USDA representative. If the seals are broken by the APHIS port veterinarian at the port of entry, the means of conveyance must be resealed with seals of the U.S. Government before being moved to the designated feedlot;
(4) The animals must remain at the designated feedlot until transported to a recognized slaughtering establishment. The animals must be moved directly to the recognized slaughtering establishment in a means of conveyance sealed with seals of the U.S. Government by an accredited veterinarian, a State representative, or an APHIS representative. The seals must be broken at the recognized slaughtering establishment only by an authorized USDA representative;
(5) The animals must be accompanied to the recognized slaughtering establishment by APHIS Form VS 1-27 or other documentation deemed acceptable by the Administrator, which must identify the physical location of the recognized slaughtering establishment, the individual responsible for the movement of the animals, and the individual identification of each animal, which includes the eartag required under paragraph (c) of this section and any other identification present on the animal, including registration number, if any;
(6) The animals must be less than 12 months of age when slaughtered;
(7) To be approved to receive sheep or goats imported for feeding, a feedlot must have signed a written agreement with the Administrator stating that the feedlot:
(i) Will not remove eartags from animals unless medically necessary, in which case another eartag or other form of official identification, as defined in § 79.1 of this chapter, will be applied and cross referenced in the records;
(ii) Will monitor all incoming imported feeder animals to ensure that they have the required “C” brand;
(iii) Will maintain records of the acquisition and disposition of all imported sheep and goats entering the feedlot, including the Canadian Food Inspection Agency tag number and all other identifying information, the age of each animal, the date each animal was acquired and the date each animal was shipped to slaughter, and the name and location of the plant where each animal was slaughtered. For Canadian animals that die in the feedlot, the feedlot will remove its eartag and place it in a file along with a record of the disposition of the carcass;
(iv) Will maintain copies of the APHIS Forms VS 17-130 and VS 1-27 or other movement documentation deemed acceptable by the Administrator that have been issued for incoming animals and for animals moved to slaughter and that list the official identification of each animal;
(v) Will allow State and Federal animal health officials access to inspect its premises and animals and to review inventory records and other required files upon request;
(vi) Will keep required records for at least 5 years;
(vii) Will designate either the entire feedlot or pens within the feedlot as terminal for sheep and goats to be moved only directly to slaughter at less than 12 months of age, and
(viii) Agrees that if inventory cannot be reconciled or if animals are not moved to slaughter as required the approval of the feedlot will be immediately withdrawn.
The requirements for the importation of sheep and goats from Canada for immediate slaughter are contained in § 93.419. The requirements for the importation of bovines from Canada for immediate slaughter are contained in § 93.436. All other ruminants imported from Canada for immediate slaughter, in addition to meeting all other applicable requirements of this part, must be imported only through a port of entry listed in § 93.403(b) or as provided for in § 93.403(f) to a recognized slaughtering establishment for slaughter, in conveyances that must be sealed with seals of the U.S. Government at the port of entry. The seals may be broken
(a)
(2)
(b)
(a)
(b) For all ruminants offered for importation from countries of Central America or of the West Indies, the importer or his or her agent shall present two copies of a declaration as provided in § 93.407.
(a) Ruminants intended for importation from Central America and the West Indies, except as provided in paragraph (c) of this section, must be accompanied by a certificate issued in accordance with § 93.405(a) stating that the animals have been in that region at least 60 days immediately preceding the date of shipment to the United States; that he or she has inspected the ruminants on the premises of origin and found them free from evidence of any communicable disease; and that, as far as it has been possible to determine, the ruminants have not been exposed to any communicable disease during the preceding 60 days. If no such veterinary officer is available in the region of origin, ruminants, other than sheep and goats, may be accompanied by an affidavit of the owner or importer stating that such ruminants have been in the region from which they were directly shipped to the United States for a period of at least 60 days immediately preceding the date of shipment therefrom, and that during such period no communicable disease has existed among them or among animals of their kind with which they have come in contact. Ruminants for which such affidavit is presented, unless imported for immediate slaughter, shall be quarantined at the port of entry at least seven days and during that time shall be subjected to such dipping, blood tests or other tests, as may be required by the Administrator to determine their freedom from communicable diseases. If imported for immediate slaughter, such animals shall be handled as provided in § 93.420.
(b) The certificate accompanying sheep and goats intended for importation from Central America and the West Indies must, in addition to the statements required by paragraph (a) of this section, meet all of the requirements of § 93.405.
(c) Cattle, which have been infested with or exposed to fever ticks, may be imported from the British Virgin Islands into the United States Virgin Islands, for immediate slaughter, only, if they are free from fever ticks at the time of such importation; if they are entered through one of the ports designated in § 93.403(d) and are consigned to a recognized slaughtering establishment with facilities approved by the Administrator for holding the animals in isolation until slaughtered, which shall be within 14 days after the date of entry into the United States Virgin Islands; and if they are accompanied by a certificate of a responsible official of the government of the British Virgin Islands certifying that the cattle originated in and are being shipped directly from the British Virgin Islands, that they are free of fever ticks, and that, as far as it has been possible to determine, such cattle are free from evidence of communicable disease and have not been exposed to any such disease common to animals of their kind, other than splenetic, southern, or tick fever, during the 60 days preceding their movement to the United States Virgin Islands.
(d) If ruminants are unaccompanied by the certificate or affidavit as required by paragraphs (a), (b), or (c) of this section, or if they are found upon inspection at the port of entry to be affected with a communicable disease or to have been exposed thereto, they shall be refused entry, except as provided in paragraph (c) of this section.
(a) For
(1) A wether; or
(2) A sheep or goat imported for immediate slaughter.
(b) For ruminants intended for importation into the United States from Mexico, the importer or his or her agent shall deliver to the veterinary inspector at the port of entry an application, in writing, for inspection, so that the veterinary inspector and customs representatives may make mutually satisfactory arrangements for the orderly inspection of the animals. For all cattle, except those entering pursuant to the third proviso in § 93.427(d), and except for steers, an official record of negative brucellosis test conducted on the herd of origin as required in § 93.427(d) shall be presented to the veterinary inspector at the port of entry when application is made for inspection. The veterinary inspector at the port of entry will provide the importer or his or her agent with a written statement assigning a date when the animals may be presented for import inspection.
For all ruminants offered for importation from Mexico, the importer or his or her agent shall present two copies of a declaration as provided in § 93.407.
(a) All ruminants offered for entry from Mexico, including such ruminants intended for movement through the United States in bond for immediate return to Mexico, shall be inspected at the port of entry, and all such ruminants found to be free from communicable disease and fever tick infestation, and not to have been exposed thereto, shall be admitted into the United States subject to the other applicable provisions of this part. Ruminants found to be affected with or to have been exposed to a communicable disease, or infested with fever ticks, shall be refused entry except as provided in § 93.427(b)(2). Ruminants refused entry shall be handled or quarantined or otherwise disposed of as the Administrator may direct.
(b) Ruminants covered by paragraph (a) of this section shall be imported through ports, designated in § 93.403, which are equipped with facilities necessary for proper chute inspection, dipping, and testing, as provided in this part.
(a) Cattle and other ruminants imported from Mexico, except animals being transported in bond for immediate return to Mexico or animals imported for immediate slaughter, may be detained at the port of entry, and there subjected to such disinfection, blood tests, other tests, and dipping as required in this part to determine their freedom from any communicable disease or infection of such disease. The importer shall be responsible for the care, feed, and handling of the animals during the period of detention.
(b)
(2) Cattle that have been exposed to splenetic, southern, or tick fever, or that have been infested with or exposed to fever ticks, may be imported from Mexico for admission into the State of Texas, except into areas quarantined because of said disease or tick infestation as specified in § 72.5 of this chapter, either at one of the land border ports in Texas listed in § 93.403(c) of this part, or at the port of Santa Teresa, NM, provided that the following conditions are strictly observed and complied with:
(i) The cattle shall be accompanied by a certificate issued in accordance with § 93.405(a), and showing that the veterinarian issuing the certificate has inspected the cattle and found them free from fever ticks and any evidence of communicable disease, and that, as far as it has been possible to determine, they have not been exposed to any such disease, except splenetic, southern, or tick fever, during the 60 days immediately preceding their movement to the port of entry.
(ii) The cattle shall be shown by a certificate issued in accordance with § 93.405(a) to have been dipped in a tickicidal dip within 7 to 12 days before being offered for entry.
(iii) The importer, or his or her duly authorized agent, shall first execute and deliver to an inspector at the port of entry an application for inspection and supervised dipping wherein he or she shall agree to waive all claims against the United States for any loss or damage to the cattle occasioned by or resulting from dipping, or resulting from the fact that they are later found to be still tick infested; and also for all subsequent loss or damage to any other cattle in the possession or control of such importer which may come into contact with the cattle so dipped.
(iv) The cattle when offered for entry shall receive a chute inspection by an inspector. If found free from ticks they shall be given one dipping in one of the permitted dips listed in § 72.13(b) of this chapter under the supervision of an inspector 7 to 14 days after the dipping required by paragraph (b)(2)(ii) of this section. The selection of the permitted dip to be used will be made by the port veterinarian in each case. If found to be infested with fever ticks, the entire lot of cattle shall be rejected and will not be again inspected for entry until 10 to 14 days after they have again been dipped in the manner provided by paragraph (b)(2)(ii) of this section.
(v) The conditions at the port of entry shall be such that the subsequent movement of the cattle can be made without exposure to fever ticks.
(c)
(2) Cattle from a herd or herds in which one or more reactors to the tuberculin test have been disclosed shall not be eligible for importation until the herd to which the animals in the lot belong achieve accredited herd status as defined in § 93.400, and provided that the animals offered for entry have met the other applicable requirements of this section.
(3) All sexually intact cattle accompanied by the certificate required by § 93.405(a) will be detained at the port of entry under the supervision of the port veterinarian until tested for tuberculosis with negative results: Provided, That if any reactor is disclosed in any lot when so tested at the port of entry, the entire lot will be refused entry and the entire lot or any portion of it will not be eligible for importation until the herd to which the animals in the lot belong achieve accredited herd status as defined in § 93.400, and provided that the animals offered for entry have met the other applicable requirements of this section.
(4) The importation of Holstein steers, Holstein spayed heifers, Holstein cross steers, and Holstein cross spayed heifers from Mexico is prohibited.
(d)
(1) Are accompanied by a certificate issued in accordance with § 93.405(a) stating:
(i) That such cattle originated in a herd in which all cattle (except calves under 6 months of age and steers) were tested for brucellosis not less than 30 days nor more than 90 days prior to the date of certification and were found to be negative;
(ii) The date and place such herd was tested; and
(iii) That the cattle in the herd have been isolated from all other cattle from the time the herd was tested negative for brucellosis to the date of the offer of the cattle for entry into the United States; and
(2) Except for calves under 6 months of age, are subjected to an additional test for brucellosis at the port of entry and found negative to such test:
(a) Sheep and goats intended for importation from Mexico shall be accompanied by a certificate issued in accordance with § 93.405 and stating, if such sheep and goats are shipped by rail or truck, that such animals were loaded into cleaned and disinfected cars or trucks for transportation direct to the port of entry. Notwithstanding such certificate, such sheep and goats shall be detained as provided in § 93.427(a) and shall be dipped at least once in a permitted scabies dip under supervision of an inspector.
(b) The certificate accompanying goats offered for importation from Mexico shall, in addition to the statements required by paragraph (a) of this section, state that such goats have been tested for tuberculosis and brucellosis with negative results within 30 days preceding their being offered for entry, and give the date and method of testing, the name of the consignor and of the consignee, and a description of the animals including breed, ages, markings, and tattoo and eartag numbers. Notwithstanding such certification, such goats shall be detained or quarantined as provided in § 93.427 and retested for brucellosis.
(c) If sheep or goats are unaccompanied by the certificate as required by paragraphs (a) and (b) of this section, or if they are found upon inspection or retesting, as provided for in this part, to be affected with a communicable disease or to have been exposed thereto, they shall be refused entry and shall be handled or quarantined, or otherwise disposed of as the Administrator may direct.
(d) Certificates will not be required for wild ruminants, other than sheep and goats, originating in and shipped direct from Mexico, but such animals are subject to inspection at the port of entry as provided in § 93.426.
Ruminants, other than sheep and goats, may be imported from Mexico, subject to the applicable provisions of §§ 93.424, 93.425, 93.426, and 93.427(b)(2) for immediate slaughter if accompanied by a certificate issued in accordance with § 93.405(a) and stating that the veterinarian who issued the certificate has inspected the animals in the herd from which the ruminants will be imported and found them free of evidence of communicable disease, and that, so far as it has been possible to determine, they have not been exposed to any such disease common to animals of their kind during the preceding 60 days, and if the ruminants are shipped by rail or truck, the certificate shall further specify that the ruminants were loaded into cleaned and disinfected cars or trucks for transportation directly to the port of entry. Such ruminants shall be moved from the port of entry in conveyances sealed with seals of the United States Government. Sheep and goats from any part of Mexico may be imported only in compliance with other applicable sections in this part.
(a) All cattle to be imported from the Republic of Ireland shall be accompanied by a certificate issued or endorsed by a salaried veterinarian of the Republic of Ireland showing that the cattle originated from a herd which is officially certified by the Republic of Ireland as a brucellosis qualified for export herd and that the cattle meet the requirements in § 93.432(c).
(b) A brucellosis qualified for export herd is a herd in which all of the cattle have been maintained as a herd unit for at least two years prior to importation and all of the test eligible cattle in the herd (
(1) Such herd unit may include cattle which were born and raised within such herd unit during the two year period, or cattle which were moved directly to the herd from another herd unit of like status; or
(2) Such herd unit may include other cattle (except brucellosis reactors, suspects and animals listed in § 93.432(c)(1)) if:
(i) Such other cattle have been tested for brucellosis and found negative within 30 days prior to entry into the herd unit and all eligible cattle in the herd unit have been tested for brucellosis and found negative not less than 90 days following the date when the last of the other cattle had been added to the herd unit; or
(ii) All eligible cattle in the herd unit have been tested negative for brucellosis no less than 180 days nor more than 12 months (365 days) following the date when the last of the other cattle had been added to the herd unit.
(c) The certificate accompanying cattle offered for importation from the Republic of Ireland shall show that the cattle are from a brucellosis qualified for export herd and that they meet the following requirements:
(1) The cattle to be exported were not born to or nursed by brucellosis reactors and they were not born in a herd at the time the herd was under quarantine due to brucella infection.
(2) The cattle were placed in an isolation facility approved by a full-time, salaried, Government of Ireland veterinary official, on separate premises a minimum of 500 yards from other livestock not destined for export to the United States for at least 60 days prior to export.
(3) The cattle were negative to the following tests conducted not less than 60 nor more than 120 days from the date of export and a second set of tests conducted within 30 days of the date of export;
(i) Plate or Tube agglutination test conducted in dilutions to detect reactions at 30, 60, 120, and 240 International Units per milliliter (IU/ml);
(ii) Brucellosis card test (Rose Bengal test);
(iii) Complement Fixation (CF) test conducted in dilutions to detect prozone reactions, when present.
(4) Cattle are eligible for entry only if classified as negative at 30 IU to the Plate or Tube agglutination test, negative to the brucellosis card test and negative to the CF test as performed and interpreted by standard methods at the Republic of Ireland Brucellosis Diagnostic Laboratory. Any animal exhibiting a prozone serological reaction is ineligible for export to the United States.
(5) Cattle showing a serological titer more than 60 IU to the Plate or Tube agglutination test, or a reaction to the Brucellosis card test (Rose Bengal) or CF test that would be interpreted to be an infected animal (reactor) under the Republic of Ireland brucellosis control program. Animals from that herd of origin and all other cattle having the opportunity for contact with the reactor animal shall not be eligible for export to the United States. Brucellosis bacteriologically positive animals, if known, regardless of serologic reactions, are not eligible for importation nor are any animals in contact with such animals.
(6) The cattle were moved directly to the port of export from the isolation facility without contact with any other cattle which are not qualified for export to the United States.
(d) The certificate accompanying the cattle offered for importation must also show the dates and places of testing, names of the consignor and consignee, and descriptions of the cattle, including breed, ages, markings, and tattoo and eartag numbers.
(a) Except as provided in paragraph (b) of this section, all sheep and goats imported into the United States must be placed in a flock or herd in the United States that participates in the Voluntary Scrapie Flock Certification Program (see 9 CFR part 54, subpart B) and:
(1) The flock or herd qualifies as a “Certified” flock or herd; or
(2) The flock or herd owner has agreed, in writing, to maintain the flock or herd in compliance with all requirements of the Voluntary Scrapie Flock Certification Program until the flock or herd qualifies as a “Certified” flock or herd.
(b) The following sheep and goats are not subject to paragraph (a) of this section:
(1) Goats intended for importation from Australia, Canada, or New Zealand;
(2) Goats intended for importation from any region other than Australia, Canada, or New Zealand, provided that such goats have not had any contact with sheep during the 5 years immediately prior to shipment, in accordance with § 93.405(b)(2)(ii);
(3) Sheep intended for importation from Australia, Canada, or New Zealand, provided that none of the female sheep in the flock from which the sheep will be imported has been impregnated, during the 5 years immediately preceding shipment of the sheep to the United States, with germ plasm from a region other than Australia, Canada, New Zealand, or the United States, in accordance with § 93.405(c)(3);
(4) Wethers;
(5) Sheep or goats imported for immediate slaughter; and
(6) Wild sheep or goats imported for exhibition purposes to an approved zoological park in accordance with § 93.404(c).
(c) Sheep or goats may be imported under paragraph (a) of this section only if the importer provides the Voluntary Scrapie Flock Certification Program identification number of the receiving flock or herd as part of the application for an import permit.
(d) Sheep and goats may be imported under paragraph (a)(1) of this section only if they come from a flock or herd in the region of origin that participates in a program determined by the Administrator to be equivalent to the Voluntary Scrapie Flock Certification Program, and the flock or herd has been determined by the Administrator to be at a level equivalent to “Certified” in the Voluntary Scrapie Flock Certification Program.
(e) Sheep and goats may be imported under paragraph (a)(2) of this section only if they are placed in a Certifiable Class C flock or herd participating in the Voluntary Scrapie Flock Certification Program;
(f) Sheep and goats imported under paragraph (a)(2) of this section must be monitored for scrapie disease until the flock or herd qualifies as a “Certified” flock or herd.
(g) Except for imported sheep and goats placed in Certifiable Class C flocks or herds, the certificate accompanying sheep or goats imported under paragraph (a) of this section must contain the following statement: “The animals identified on this certificate have
(1) The Administrator will determine, based upon information supplied by the importer, whether the flock or herd from which the animals are to be imported participates in a program in the country of origin that is equivalent to the Voluntary Scrapie Flock Certification Program, and if so, at what level the source flock or herd should be classified.
(2) In order for the Administrator to make a determination, the importer must supply the following information with the application for an import permit no less than 1 month prior to the anticipated date of importation:
(i) The name, title, and address of a knowledgeable official in the veterinary services of the region of origin;
(ii) The details of scrapie control programs in the region of origin, including information on disease surveillance and border control activities and the length of time such activities have been in effect;
(iii) Any available information concerning additions, within the 5 years immediately preceding shipment to the United States, to the flock or herd from which the sheep and goats will be imported;
(iv) Any available data concerning disease incidence, within the 5 years immediately preceding shipment to the United States, in the flock or herd from which the sheep or goats are to be imported, including, but not limited to, the results of diagnostic tests, especially histopathology tests, conducted on any animals in the flock or herd;
(v) Information concerning the health, within the 5 years immediately preceding shipment to the United States, of other ruminants, flocks, and herds with which the imported sheep and goats, and with which animals in the sheep or goats' flock or herd might have had physical contact, and a description of the type and frequency of such physical contact; and
(vi) Any other information requested by the Administrator in specific cases as needed to make a determination.
The importation of ruminants from regions listed in § 94.18(a)(3) of this subchapter is prohibited, unless the conditions of this section and any other applicable conditions of this part are met. Once the ruminants are imported, if they do not meet the conditions of this section, they must be disposed of as the Administrator may direct.
(a)
(1) The bovines must have been born on or after a date determined by APHIS to be the date of effective enforcement of a ruminant-to-ruminant feed ban in the region of export. For bovines imported from Canada, that date is March 1, 1999.
(2) Each bovine must be individually identified by an official eartag of the country of origin, applied before the animal's arrival at the port of entry into the United States, that is determined by the Administrator to meet standards equivalent to those for official eartags in this chapter and to be traceable to the premises of origin of the animal. No person may alter, deface, remove, or otherwise tamper with the official identification while the animal is in the United States or moving into or through the United States, except that the identification may be removed at the time of slaughter;
(3) The bovines must be accompanied by a certificate issued in accordance with § 93.405 that states, in addition to the statements required by § 93.405, that the conditions of paragraphs (a)(1) and (a)(2) of this section have been met;
(4) The bovines must be imported only through a port of entry listed in
(5) The bovines must be moved directly from the port of entry to a recognized slaughtering establishment. Bovines imported from Canada must be moved to the slaughtering establishment in conveyances that are sealed with seals of the U.S. Government at the port of entry. The seals may be broken only at the recognized slaughtering establishment by an authorized USDA representative; and
(6) The bovines must be accompanied from the port of entry to the recognized slaughtering establishment by APHIS Form VS 17-33.
(b)
(1) The bovines must have been born on or after a date determined by APHIS to be the date of effective enforcement of a ruminant-to-ruminant feed ban in the region of export. For bovines imported from Canada, that date is March 1, 1999.
(2) The bovines must be permanently and humanely identified before arrival at the port of entry with a distinct and legible mark identifying the exporting country. Acceptable means of permanent identification include the following:
(i) A mark properly applied with a freeze brand, hot iron, or other method, and easily visible on the live animal and on the carcass before skinning. Such a mark must be not less than 2 inches nor more than 3 inches high, and must be applied to each animal's right hip, high on the tail-head (over the junction of the sacral and first cocygeal vertebrae). Bovines exported from Canada so marked must be marked with “CN”;
(ii) A tattoo with letters identifying the exporting country must be applied to the inside of one ear of the animal. For bovines exported from Canada, the tattoo must read “CAN”;
(iii) Other means of permanent identification upon request if deemed adequate by the Administrator to humanely identify the animal in a distinct and legible way as having been imported from the BSE minimal-risk exporting region.
(3) Each bovine must be individually identified by an official eartag of the country of origin, applied before the animal's arrival at the port of entry into the United States, that is determined by the Administrator to meet standards equivalent to those for official eartags in § 71.1 of this chapter and to be traceable to the premises of origin of the animal. No person may alter, deface, remove, or otherwise tamper with the official identification while the animal is in the United States or moving into or through the United States, except that the identification may be removed at the time of slaughter;
(4) The bovines must be accompanied by a certificate issued in accordance with § 93.405 that states, in addition to the statements required by § 93.405, that the conditions of paragraphs (a)(1) and (a)(2) of this section have been met; and
(5) The bovines must be imported only through a port of entry listed in § 93.403(b) or as provided for in § 93.403(f).
(c)
(d)
(e)
(f)
Wherever in this subpart the following terms are used, unless the context otherwise requires, they shall be construed, respectively, to mean:
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.);
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
(a) No swine or product subject to the provisions of this part shall be brought into the United States except in accordance with the regulations in this part and part 94 of this subchapter;
(b) Except for swine prohibited entry, the provisions in this part 93 relating to swine shall not apply to healthy swine in transit through the United States if they are not known to be infected with or exposed, within 60 days preceding the date of export from the region of origin, to communicable diseases of such swine, if an import permit
(1)(i) They are maintained under continuous confinement in transit through the United States aboard an aircraft, ocean vessel, or other means of conveyance; or
(ii) They are unloaded, in the course of such transit, into a swine holding facility which is provided by the carrier or its agent and has been approved
(2) The carrier or its agent executes and furnishes to the collector of Customs at the first port of arrival a declaration stating that the swine will be retained aboard such means of conveyance or in an approved holding facility during transshipment as required by this paragraph.
(3) Provisions for the approval of facilities required in this paragraph are:
(i) They must be sufficiently isolated to prevent direct or indirect contact with all other animals and birds while in the United States.
(ii) They must be so constructed that they provide adequate protection against environmental conditions and can be adequately cleaned, washed and disinfected.
(iii) They must provide for disposal of swine carcasses, manure, bedding, waste and any related shipping materials in a manner that will prevent dissemination of disease.
(iv) They must have provisions for adequate sources of feed and water and for attendants for the care and feeding of swine in the facility.
(v) They must comply with additional requirements as may be imposed by the Administrator if deemed applicable for a particular shipment.
(vi) They must also comply with all applicable local, State and Federal requirements for environmental quality and with the provisions of the Animal Welfare Regulations in chapter I of this title, as applicable.
(c)
(a)
(b)
(c)
(d) For purposes of this section, the term “shipping container” means any container of a type specially adapted for use in transporting any article on the means of conveyance involved.
(a)
(b)
(c)
(d)
(e)
(f)
(a)
(2) An application for permit to import will be denied for domestic swine from any region designated in § 94.1 of this chapter as a region where rinderpest or foot-and-mouth disease exists.
(3) An application for permit to import swine may also be denied because of: Communicable disease conditions in the area or region of origin, or in a region where the shipment has been or will be held or through which the shipment has been or will be transported; deficiencies in the regulatory programs for the control or eradication of animal diseases and the unavailability of veterinary services in the above mentioned regions; the importer's failure to provide satisfactory evidence concerning the origin, history, and health status of the swine; the lack of satisfactory information necessary to determine that the importation will not be likely to transmit any communicable disease to livestock or poultry of the United States; or any other circumstances which the Administrator believes require such denial to prevent the dissemination of any communicable disease of livestock or poultry into the United States.
(4)(i) The importer or importer's agent shall pay or ensure payment of a reservation fee for each lot of swine to be quarantined in a facility maintained by USDA. For swine the reservation fee shall be 100 percent of the cost of providing care, feed, and handling during quarantine, as estimated by the quarantine facility's veterinarian in charge.
(ii) At the time the importer or the importer's agent requests a reservation of quarantine space, the importer or importer's agent shall pay the reservation fee by check or U.S. money order or ensure payment of the reservation fee by an irrevocable letter of credit from a commercial bank (the effective date on such letter of credit shall run to 30 days after the date the swine are scheduled to be released from quarantine); except that anyone who issues a check to the Department for a reservation fee which is returned because of insufficient funds shall be denied any further request for reservation of a quarantine space until the outstanding amount is paid.
(iii) Any reservation fee paid by check or U.S. money order shall be applied against the expenses incurred for services received by the importer or importer's agent in connection with the quarantine for which the reservation was made. Any part of the reservation fee which remains unused after being applied against the expenses incurred for services received by the importer or the importer's agent in connection with the quarantine for which the reservation was made, shall be returned to the individual who paid the reservation fee. If the reservation fee is ensured by a letter of credit, the Department will draw against the letter of credit unless payment for services received by the importer or importer's agent in connection with the quarantine is otherwise made at least 3 days prior to the expiration date of the letter of credit.
(iv) Any reservation fee shall be forfeited if the importer or the importer's agent fails to present for entry, within 24 hours following the designated time of arrival the lot of swine for which the reservation was made:
(A) Written notice of cancellation from the importer or the importer's agent is received by the office of the veterinarian in charge of the quarantine facility
(B) The Administrator determines that services, other than provided by carriers, necessary for the importation
(v) If the reservation fee was ensured by a letter of credit and the fee is to be forfeited under paragraph (a)(4)(iv) of this section, the Department will draw against the letter of credit unless the reservation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.
(vi) When a reservation is cancelled in accordance with paragraph (a)(4)(iv)(A) of this section and the provisions of paragraph (a)(4)(iv)(B) of this section do not apply, a $40.00 cancellation fee shall be charged. If a reservation fee was paid, the cancellation fee shall be deducted from any reservation fee returned to the importer or the importer's agent. If the reservation fee was ensured by a letter of credit, the Department will draw the amount of the cancellation fee against the letter of credit unless the cancellation fee is otherwise paid at least 3 days prior to the expiration date of the letter of credit.
(b)
(c)
(1) Permits for the importation of wild swine will be issued only for importations through the Port of New York, and only if the animals are imported for exhibition in a PEQ Zoo. A PEQ Zoo is a zoological park or other place maintained for the exhibition of live animals for recreational or educational purposes that:
(i) Has been approved by the Administrator in accordance with paragraph (c)(2) of this section to receive and maintain imported wild swine; and
(ii) Has entered into the agreement with APHIS set forth in paragraph (c)(4) of this section for the maintenance and handling of imported wild swine.
(2) Approval of a PEQ Zoo shall be on the basis of an inspection, by an authorized representative of the Department, of the physical facilities of the establishment and its methods of operation. Standards for acceptable physical facilities shall include satisfactory pens, cages, or enclosures in which the imported swine can be maintained so as not to be in contact with the general public and free from contact with domestic livestock; natural or established drainage from the PEQ Zoo which will avoid contamination of land areas where domestic livestock are kept or with which domestic livestock may otherwise come in contact; provision for the disposition of manure, other wastes, and dead swine within
(3) Manure and other animal wastes must be disposed of within the PEQ Zoo park for a minimum of one year following the date an imported wild swine enters the zoo. If an APHIS veterinarian determines that an imported swine shows no signs of any communicable disease during this 1-year period, its manure and other wastes need not be disposed of within the zoo after the 1-year period. If, however, an APHIS veterinarian determines that the swine does show signs of any communicable disease during this 1-year period, an APHIS veterinarian will investigate the disease and determine whether the swine's manure and other wastes may safely be disposed of outside the zoo after the 1-year period has ended.
(4) Prior to the issuance of an import permit under this section, the operator of the approved PEQ Zoo to which the imported swine are to be consigned, and the importer of the swine, if such operator and importer are different parties, shall execute an agreement covering each swine or group of swine for which the import permit is requested. The agreement shall be in the following form:
____, operator(s) of the zoological park known as ______ (Name) located at _______ (City and state), and ______ (Importer) hereby request a permit for the importation of ____ (Number and kinds of animals) for exhibition purposes at the said zoological park, said animals originating in a region where foot-and-mouth disease or rinderpest exists and being subject to restrictions under regulations contained in part 93, title 9, Code of Federal Regulations.
In making this request, it is understood and agreed that:
1. The animals for which an import permit is requested will be held in isolation at a port of embarkation in the region of origin, approved by the Administrator as a port having facilities which are adequate for maintaining wild animals in isolation from all other animals and having veterinary supervision by officials of the region of origin of the animals. Such animals will be held in such isolation for not less than 60 days under the supervision of the veterinary service of that region to determine whether the animals show any clinical evidence of foot-and-mouth disease, rinderpest, or other communicable disease that is exotic to the United States or for which APHIS has an eradication or control program in 9 CFR chapter I, and to assure that the animals will not have been exposed to such a disease within the 60 days next before their exportation from that region.
2. Shipment will be made direct from such port of embarkation to the port of New York as the sole port of entry in this region. If shipment is made by ocean vessel, the animals will not be unloaded in any foreign port en route. If shipment is made by air, the animals will not be unloaded at any port or other place of landing, except at a port approved by the Administrator as a port not located in a region where rinderpest or foot-and-mouth disease exists or as a port in such a region having facilities and inspection adequate for maintaining wild animals in isolation from all other animals.
3. No ruminants or swine will be aboard the transporting vehicle, vessel or aircraft, except those for which an import permit has been issued.
4. The animals will be quarantined for not less than 30 days in the Department's Animal Import Center in Newburgh, New York.
5. Upon release from quarantine the animals will be delivered to the zoological park named in this agreement to become the property of the park and they will not be sold, exchanged or removed from the premises without the prior consent of APHIS. If moved to another zoological park in the United States, the receiving zoological park must be approved by the Administrator in accordance with paragraph 6 of this agreement.
6. The Administrator will approve the movement of an imported animal subject to this agreement if the Administrator determines that the animal has spent at least one year in quarantine in a PEQ Zoo following importation without showing clinical evidence of foot-and-mouth disease, rinderpest, or other communicable disease that is exotic
Subscribed and sworn to before me this __ day of __, __
Subscribed and sworn to before me this __ day of __,__
(a) All swine offered for importation from any part of the world except as provided in § 93.517 shall be accompanied by a certificate of a salaried veterinary officer of the national government of the region of origin, or if exported from Mexico, shall be accompanied either by such a certificate or by a certificate issued by a veterinarian accredited by the National Government of Mexico and endorsed by a full-time salaried veterinary officer of the National Government of Mexico, thereby representing that the veterinarian issuing the certificate was authorized to do so, stating that such swine have been kept in said region at least 60 days immediately preceding the date of movement therefrom and that said region during such period has been entirely free from foot-and-mouth disease, rinderpest, contagious pleuropneumonia, and surra:
(b) Swine from Angola, Argentina, Bahrain, Bangladesh, Benin, Bolivia, Botswana, Brazil, Brunei, Burkina Faso, Burundi, Cambodia, Cameroon, Central African Republic, China, Columbia, Congo, Dominican Republic, Ecuador, Equatorial Guinea, French Guiana, Gabon, Gambia, Ghana, Guinea, Guinea-Bissau, Guyana, Haiti, India, Indonesia, Iraq, Isla de Pascua (Easter Island, part of Chile), Ivory Coast, Jamaica, Kenya, Kuwait, Laos, Lesotho, Liberia, Macau, Malawi, Malaysia, Mali, Mauritania, Mozambique, Myanmar, Namibia, Nigeria, Oman, Pacific Islands (Palau), Panama, Papua New Guinea, Paracel Islands, Paraguay, Peru, Philippines, Qatar, Rwanda, Saudi Arabia, Senegal, Sierra Leone, Singapore, South Africa, Spratly Islands, Sri Lanka, Surinam,
(1) A veterinarian must treat the swine with ivermectin 3 to 5 days prior to the date of export to the United States according to the recommended dose prescribed on the product's label.
(2) The swine must be fully examined for screwworm by a full-time salaried veterinary official of the exporting country within 24 hours prior to shipment to the United States. If swine are found to be infested with screwworm, they must be treated until free from infestation.
(3) At the time swine are loaded onto a means of conveyance for export, a veterinarian must treat any visible wounds on the animals with a solution of coumaphos dust at a concentration of 5 percent active ingredient.
(4) The swine must be accompanied to the United States by a certificate signed by a full-time salaried veterinary official of the exporting country. The certificate must state that the swine have been thoroughly examined and found free of screwworm and that the swine have been treated in accordance with paragraphs (b)(1) and (b)(3) of this section.
(c) If swine are unaccompanied by the certificate as required by paragraph (a) of this section, or if such swine are found upon inspection at the port of entry to be affected with a communicable disease or to have been exposed thereto, they shall be refused entry and shall be handled or quarantined, or otherwise disposed of as the Administrator may direct.
(a) The certificates, declarations, and affidavits required by the regulations in this part shall be presented by the importer or his or her agent to the collector of customs at the port of entry, upon arrival of swine at such port, for the use of the veterinary inspector at the port of entry.
(b) For all swine offered for importation, the importer or his or her agent shall first present two copies of a declaration which shall list the port of entry, the name and address of the importer, the name and address of the broker, the origin of the swine, the number, breed, species, and purpose of the importation, the name of the person to whom the swine will be delivered, and the location of the place to which such delivery will be made.
Inspection shall be made at the port of entry of all swine imported from any part of the world except as provided in § 93.519. All swine found to be free from communicable disease and not to have been exposed thereto within 60 days prior to their exportation to the United States shall be admitted subject to the other provisions in this part; all other swine shall be refused entry. Swine refused entry, unless exported within a time fixed in each case by the Administrator, and in accordance with other provisions he or she may require in each case for their handling shall be disposed of as the Administrator may direct. Such portions of the transporting vessel, and of its cargo, which have been exposed to any such swine or their emanations shall be disinfected in such manner as may be considered necessary by the inspector in charge at the port of entry, to prevent the introduction or spread of livestock or poultry disease, before the cargo is allowed to land.
No litter or manure, fodder or other aliment, nor any equipment such as boxes, buckets, ropes, chains, blankets,
Platforms and chutes used for handling imported swine shall be cleaned and disinfected under APHIS supervision after being so used. The said swine shall not be unnecessarily moved over any highways nor allowed to come in contact with other swine, but shall be transferred from the conveyance to the quarantine grounds in boats, cars, or vehicles approved by the inspector in charge at the port of entry. Such cars, boats, or vehicles shall be cleaned and disinfected under APHIS supervision immediately after such use, by the carrier moving the same. The railway cars so used shall be either cars reserved for this exclusive use or box cars not otherwise employed in the transportation of swine or their fresh products. When movement of the aforesaid swine upon or across a public highway is unavoidable, it shall be under such careful supervision and restrictions as the inspector in charge at the port of entry and the local authorities may direct.
Swine shall be quarantined for not less than 15 days, counting from the date of arrival at the port of entry. During their quarantine, wild swine shall be subject to such inspections, disinfection, blood tests, or other tests as may be required by the Administrator, to determine their freedom from disease and the infection of disease.
(a)
(b)
(c) Amounts collected from the importer, or his or her agent, for service rendered shall be deposited so as to be available for defraying the expenses involved in this service.
Visitors shall not be admitted to the quarantine enclosure during any time that swine are in quarantine except that an importer (or his or her accredited agent or veterinarian) may be admitted to the yards and buildings containing his or her quarantined swine at such intervals as may be deemed necessary, and under such conditions and restrictions as may be imposed, by the inspector in charge of the quarantine station. On the last day of the quarantine period, owners, officers or registry societies, and others having official business or whose services may be necessary in the removal of the swine may be admitted upon written permission from the said inspector. No exhibition or sale shall be allowed within the quarantine grounds.
Milk or cream from swine quarantined under the provisions of this part shall not be used by any person other than those in charge of such swine, nor be fed to any animals other than those within the same enclosure, without permission of the inspector in charge of the quarantine station and subject to such restrictions as he or she may consider necessary to each instance. No milk or cream shall be removed from the quarantine premises except in compliance with all State and local regulations.
No manure shall be removed from the quarantine premises until the release of the swine producing same.
If any contagious disease appears among swine during the quarantine period special precautions shall be taken to prevent spread of the infection to other animals in the quarantine station or to those outside the grounds. The affected swine shall be disposed of as the Administrator may direct, depending upon the nature of the disease.
(a)
(1) Was born in Canada or the United States, and has been in no region other than Canada or the United States, or
(2) Has been legally imported into Canada from some other region and unconditionally released in Canada so as to be eligible to move freely within that region without restriction of any kind and has been in Canada after such release for 60 days or longer.
(b) For all swine offered for importation from Canada, the importer or his or her agent shall present two copies of a declaration as provided in § 93.506.
(a)
(b)
Swine imported from Canada for immediate slaughter shall be consigned from the port of entry directly to a recognized slaughtering establishment and there be slaughtered within two weeks from the date of entry. As used in this section, “directly” means without unloading en route if moved in a means of conveyance, or without stopping if moved in any other manner.
(a)
(2)
(b)
For all swine offered for importation from countries of Central America or of the West Indies, the importer or his or her agent shall present two copies of a declaration as provided in § 93.506.
For all swine offered for importation from Mexico, the importer or his or her agent shall present two copies of a declaration as provided in § 93.506.
(a)
(1) Dogs must be accompanied by a certificate signed by a full-time salaried veterinary official of the region of origin stating that the dog has been inspected for screwworm within 5 days preceding its shipment to the United States.
(2) The certificate must state that the dog is either free from screwworm or was found to be infested with screwworm and was held in quarantine and treated until free from screwworm prior to leaving the region of origin.
(b)
Wherever in this subpart the following terms are used, unless the context otherwise requires, they shall be construed, respectively, to mean:
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
(a) No person may import a hedgehog or tenrec into the United States from any region designated in § 94.1 of this chapter as a region where foot-and-mouth disease exists.
(b) No person may import a brushtail possum or hedgehog into the United States from New Zealand.
(c) No person may import leopard tortoise (
Hedgehogs and tenrecs not specifically prohibited from being imported under § 93.701 may be imported into the United States only in accordance with the regulations in this subpart.
(a) Any person importing a hedgehog or tenrec into the United States may import it, except as provided in paragraph (b) of this section, only through the following ports:
(1)
(2)
(3)
(b) The Secretary of the Treasury has approved the designation, as inspection stations, of the ports specified in paragraph (a) of this section. In special cases, the Administrator may designate other ports as inspection stations in accordance with this section, with the concurrence of the Secretary of the Treasury.
(a)
(b)
(c)
(1) The name and address of the shipper in the region of origin of the hedgehog or tenrec intended for importation into the United States.
(2) The name, address, and telephone number of the importer.
(3) The port of embarkation.
(4) The region from which the hedgehog or tenrec will be shipped to the United States.
(5) The mode of transportation.
(6) The number, breed, species, and descriptions of the hedgehogs or tenrecs to be imported.
(7) The purpose of the importation.
(8) The route of travel, including all carrier stops en route.
(9) The proposed shipping and arrival dates.
(10) The port of first arrival in the United States.
(11) The name, mailing address, and telephone number of the person to whom the hedgehog or tenrec will be delivered in the United States.
(12) The location of the place where delivery will be made in the United States.
(13) Any remarks regarding the shipment.
(d)
(a) No person may import a hedgehog or tenrec into the United States unless it is accompanied by a health certificate either issued by a full-time salaried veterinary officer of the national government of the exporting region or issued by a veterinarian authorized or accredited by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of that region. The health certificate must contain the names and street addresses of the consignor and consignee and must state:
(1) That the hedgehog or tenrec originated in a region that has been recognized as free of foot-and-mouth disease by the USDA;
(2) That the hedgehog or tenrec has never been in a region where foot-and-mouth disease exists;
(3) That the hedgehog or tenrec has not been commingled with any other hedgehog or tenrec that originated in or has ever been in a region where foot-and-mouth disease exists;
(4) That the hedgehog or tenrec was inspected by the individual issuing the health certificate and was found free of any ectoparasites not more than 72 hours before being loaded on the means of conveyance which transported the animal to the United States;
(5) That all body surfaces of the hedgehog or tenrec were treated for ectoparasites under the supervision of the veterinarian issuing the health certificate at least 3 days but not more than 14 days before being loaded on the means of conveyance that transported the animal to the United States;
(6) That the pesticide and the concentration used would kill the types of ectoparasites that may infest the animal to be imported;
(7) That the hedgehog or tenrec, after being treated for ectoparasites in accordance with paragraphs (a)(5) and (a)(6) of this section, had physical contact only with, or shared a pen or bedding materials only with, treated hedgehogs or tenrecs in the same shipment to the United States; and
(8) The name and concentration of the pesticide used to treat the hedgehog or tenrec.
(b) [Reserved]
Upon the arrival of a hedgehog or tenrec at the port of first arrival in the United States, the importer or his or her agent must present the import permits and health certificates required by this subpart to the collector of customs for the use of the inspector at that port.
(a) A hedgehog or tenrec from any part of the world must be inspected by an APHIS inspector at the port of first arrival. Subject to the other provisions in this subpart, a shipment of hedgehogs or tenrecs may enter the United
(b) If any hedgehog or tenrec in a shipment is found to be infested with ectoparasites or demonstrates any clinical signs of communicable diseases, then the entire shipment will be refused entry. The importer will be given the following options:
(1) Remove the shipment from the United States; or
(2) Release the shipment to the U.S. Department of Agriculture. The Administrator will destroy or otherwise dispose of the shipment as necessary to prevent the possible introduction into the United States of communicable animal diseases.
The following terms, when used in this part, shall be construed as defined. Those terms used in the singular form in this part shall be construed as the plural form and vice versa, as the case may demand.
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
Elephants, hippopotami, rhinoceroses, or tapirs shall not be imported or entered into the United States unless in accordance with this part.
(a) An elephant, hippopotamus, rhinoceros, or tapir shall not be imported into the United States unless accompanied by an import permit issued by APHIS and unless imported into the United States within 30 days after the proposed date of arrival stated in the import permit. The port veterinarian must be notified of the date of arrival at least 72 hours before the animal arrives in the United States.
(b) An application for an import permit must be submitted to the Animal and Plant Health Inspection Service, Veterinary Services, National Center for Import-Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231. pplication forms for import permits may be obtained from this staff.
(c) The completed application shall include the following information:
(1) The name and address of the person intending to export an elephant, hippopotamus, rhinoceros, or tapir to the United States;
(2) The name and address of the person intending to import an elephant, hippopotamus, rhinoceros, or tapir into the United States;
(3) The species, breed, and number of elephants, hippopotami, rhinoceroses, or tapirs to be imported;
(4) The purpose of the importation;
(5) The port of embarkation;
(6) The name and concentration of the pesticide intended to be used to treat the elephant, hippopotamus, rhinoceros, or tapir for ectoparasites prior to the animal being transported to the United States;
(7) The mode of transportation;
(8) The route of travel;
(9) The port of entry in the United States and, if applicable, the address of the facility to be provided by the importer for inspection, treatment, and incineration pursuant to § 93.6 of this part;
(10) The proposed date of arrival in the United States; and
(11) The name and address of the person to whom the elephant, hippopotamus, rhinoceros, or tapir will be delivered in the United States.
(d) After receipt and review of the application by APHIS, an import permit indicating the applicable conditions under this part for importation into the United States shall be issued for the importation of the elephant, hippopotamus, rhinoceros, or tapir described in the application if such animal appears to be eligible to be imported. Even though an import permit has been issued for the importation of an elephant, hippopotamus, rhinoceros, or tapir, the animal may be imported only if all applicable requirements of this part are met.
(a) An elephant, hippopotamus, rhinoceros, or tapir shall not be imported into the United States unless accompanied by a health certificate either signed by a salaried veterinarian of the national veterinary services of the region where the inspection and treatment required by this section occurred or signed by a veterinarian authorized by the national veterinary services of such region and endorsed by a salaried veterinarian of the national veterinary services of such region (the endorsement representing that the veterinarian signing the health certificate was authorized to do so), certifying:
(1) That the elephant, hippopotamus, rhinoceros, or tapir was inspected by the individual signing the health certificate and found free of any ectoparasites not more than 72 hours before being loaded on the means of conveyance which transported the animal to the United States; and
(2) That the elephant, hippopotamus, rhinoceros, or tapir was treated for ectoparasites at least 3 days but not more than 14 days before being loaded on the means of conveyance which transported the animal to the United States. The animal shall have been treated, under the supervision of the individual signing the health certificate, by being thoroughly wetted with a pesticide applied with either a sprayer with a hand-held nozzle, a spray-dip machine, or a dip vat; and
(3) That the elephant, hippopotamus, rhinoceros, or tapir, after being treated for ectoparasites in accordance with paragraph (a)(2) of this section, did not have physical contact with or share a
(4) The name and concentration of the pesticide used to treat the animal (such pesticide and the concentration used must be adequate to kill the types of ectoparasites likely to infest the animal to be imported; a list of recommended pesticides and concentrations may be obtained from the Animal and Plant Health Inspection Service, Veterinary Services, National Center for Import-Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231; and
(5) The name and address of the consignor and consignee.
Upon arrival of an elephant, hippopotamus, rhinoceros, or tapir at a port of entry, the importer or the importer's agent shall notify APHIS of the arrival by giving an inspector a completed VS Form 17-29, “Declaration of Importation for Animals, Animal Semen, Birds, Poultry, and Eggs for Hatching.” (This form is available from the Animal and Plant Health Inspection Service, Veterinary Services, National Center for Import-Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231.) It must state:
(a) The port of entry;
(b) The date of arrival;
(c) The import permit number;
(d) The name of the carrier and identification of the means of conveyance;
(e) The name and address of the importer;
(f) The name and address of the broker;
(g) The region from which the elephant, hippopotamus, rhinoceros, or tapir was shipped;
(h) The number, species, and purpose of importation of the elephant, hippopotamus, rhinoceros, or tapir; and
(i) The name and address of the person to whom the elephant, hippopotamus, rhinoceros, or tapir will be delivered.
(a) An elephant, hippopotamus, rhinoceros, or tapir shall be imported into the United States only:
(1) At Los Angeles, California; Miami, Florida; and Newburgh, New York; or
(2) On a case-by-case basis, at another port of entry if:
(i) The animals will be inspected and treated at a facility provided by the importer;
(ii) The Administrator has determined that the importer's facility is adequate for inspection, treatment, and incineration required under this section;
(iii) The Administrator has determined that an inspector is available to perform at the importer's facility the services that are required under this section; and
(iv) The Administrator has determined that an inspector is available to perform at the port of entry the services that are required under this section if the animals will be inspected and treated at a facility provided by the importer.
(b) An elephant, hippopotamus, rhinoceros, or tapir shall be entered into the United States only under the following conditions:
(1) Any documents accompanying the animal shall be subject to inspection by an inspector at the port of entry;
(2) If the animal is to be moved from the port of entry to a facility provided by the importer:
(i) At the port of entry the animal shall be subject to as much inspection by an inspector as is feasible and shall be sprayed or dipped, as feasible, under the supervision of an inspector and
(ii) At the port of entry, as much hay, straw, feed, bedding, and other material as can feasibly be removed from the shipping crate or vehicle containing the animal shall be removed, sealed in plastic bags, and incinerated by the importer under the supervision of an inspector;
(iii) At the port of entry, the shipping crate or the vehicle containing the animal shall be sealed by an inspector with an official seal of the United States Department of Agriculture:
(iv) If the animal is moved from the port of entry in a shipping crate, plastic must be fastened around the shipping crate so that all animal waste, hay, straw, feed, bedding, and other material accompanying the animal are retained inside the crate, but not so as to interefere with ventilation, feeding, and watering of the animal;
(v) After the arrival of the animal at the facility provided by the importer, the seal shall be broken by an inspector;
(3) The animal shall be inspected by an inspector within 24 hours of being unloaded at the port of entry or at a facility provided by the importer, and shall be treated under the supervision of an inspector, as follows:
(i) The animal shall be removed from its shipping crate or cargo hold, placed on a concrete or other nonporous surface, and physically inspected for ectoparasites by an inspector. If inspection and treatment are not performed upon unloading, the animal must be isolated from all other animals, except those in the same shipment, and kept in a facility with a nonporous floor and where any ectoparasites that may drop off the animal can be contained and destroyed, until the animal has been inspected and treated;
(ii) If the inspector finds no ectoparasites, the animal shall be sprayed or dipped one time in accordance with label instructions with a permitted dip listed in § 72.13(b) of this chapter; or
(iii) If the inspector finds ectoparasites, the animal shall be sprayed or dipped in accordance with label instructions with a permitted dip listed in § 72.13(b) of this chapter for as many times as necessary until the inspector finds no ectoparasites; and thereafter the animal shall be sprayed or dipped one additional time in accordance with label instructions with a permitted dip listed in § 72.13(b) of this chapter;
(4) All hay, straw, feed, bedding, and other material that has been placed with the animal at any time prior to the final treatment referred to in paragraph (b)(3) of this section, and any plastic sheet used to wrap any shipping crate, shall be sealed in plastic bags and incinerated under the supervision of an inspector;
(5) Any shipping crate shall be, under the supervision of an inspector, either cleaned and disinfected using a disinfectant listed in § 71.10 of this chapter or incinerated; and if the shipping crate is cleaned and disinfected, it shall then be treated under the supervision of an inspector with a permitted dip listed in § 72.13(b) of this chapter;
(6) Any means of conveyance used to transport an animal not in a shipping crate shall be, under the supervision of an inspector, cleaned and disinfected using a disinfectant listed in § 71.10 of this chapter and then treated with a permitted dip listed in § 72.13(b) of this chapter.
Any elephant, hippopotamus, rhinoceros, or tapir refused entry into the United States for noncompliance with the requirements of this part shall be removed from the United States within a time period specified by the Administrator or shall be considered abandoned by the importer, and pending removal or abandonment, the animal shall be subject to such safeguards as the inspector determines necessary to prevent the possible introduction of ectoparasites into the United States. If such animal is not removed from the United States within such time period or is abandoned, it may be seized, destroyed, or otherwise disposed of as the Administrator determines necessary to
(a) Elephants, hippopotami, rhinoceroses, and tapirs are exempt from the regulations in this part under the following circumstances:
(1) They are imported from Canada and are accompanied by a document signed by a salaried veterinarian of the Canadian Government that states:
(i) They were not imported into Canada during the year preceding their importation into the United States; and
(ii) They did not, during the year preceding their importation into the United States, have physical contact with or share a pen or bedding materials with any elephant, hippopotamus, rhinoceros, or tapir imported into Canada during that year; or
(2) They were exported into Canada from the United States and then imported back into the United States accompanied by a United States health certificate.
(b) Notwithstanding other provisions in this part, the Administrator may in specific cases allow the importation and entry of elephants, hippopotami, rhinoceroses, or tapirs into the United States other than as provided for in this part under such conditions as the Administrator may prescribe to prevent the introduction of ectoparasites into the United States.
Wherever in this subpart the following terms are used, unless the context otherwise requires, they shall be construed, respectively, to mean:
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.);
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
(a) No live fish, fertilized eggs, or gametes of SVC-susceptible species may be imported into the United States except in accordance with this subpart,
(b) Other provisions of this subpart relating to the importation of live fish, fertilized eggs, and gametes shall not apply to shipments of SVC-susceptible species of live fish, fertilized eggs, or gametes in transit through the United States if an import permit has been obtained under § 93.903 and all conditions of the permit are observed; and if the live fish, fertilized eggs, and gametes are handled as follows:
(1) They are maintained under continuous confinement while in transit through the United States aboard an aircraft, ocean vessel, or other means of conveyance; or
(2) They are unloaded, in the course of such transit, into a holding facility
(3) They are moved in accordance with any additional conditions prescribed in the permit and determined by the Administrator to be necessary to ensure that the live fish, fertilized eggs, or gametes through the United States do not introduce SVC into the United States.
(4) For a holding facility to be approved by the Administrator:
(i) The holding facility must be sufficiently isolated to prevent direct or indirect contact of the live fish, fertilized eggs, or gametes it contains with any other SVC-susceptible species in the United States;
(ii) The holding facility must be constructed to provide adequate protection against environmental conditions and so that it can be adequately cleaned, washed and disinfected;
(iii) Provision must be made for disposal of fish carcasses, shipping water, waste and any associated shipping materials in a manner that will prevent dissemination of disease;
(iv) Provision must be made for adequate sources of feed and water and for attendants for the care and feeding of
(v) The holding facility must comply with all applicable local, State and Federal requirements for environmental quality.
(vi) The holding facility must comply with any additional requirements that may be imposed by the Administrator for a particular shipment if necessary to prevent the dissemination of disease.
(a) The following ports are designated as ports of entry for live fish, fertilized eggs, and gametes of SVC-susceptible species imported under this subpart:
(1)
(2)
(3)
(b)
(a) Live fish, fertilized eggs, or gametes of SVC-susceptible species imported into the United States must be accompanied by an import permit issued by APHIS and must be imported within 30 days after the proposed date of arrival stated in the import permit.
(b) An application for an import permit must be submitted for each shipment of live fish, fertilized eggs, or gametes of SVC-susceptible species to the Animal and Plant Health Inspection Service, Veterinary Services, National Center for Import and Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231. Application forms for import permits may be obtained from this address.
(c) A completed application shall include the following information:
(1) The name and address of the person intending to export live fish, fertilized eggs, or gametes of SVC-susceptible species to the United States;
(2) The proposed date of shipment to the United States;
(3) The name and address of the person intending to import live fish, fertilized eggs, or gametes of SVC-susceptible species into the United States;
(4) The species and number of live fish, fertilized eggs, or gametes of SVC-susceptible species to be imported into the United States;
(5) The purpose of the importation;
(6) The port of embarkation;
(7) The mode of transportation;
(8) The route of travel, including all carrier stops en route;
(9) The port of entry in the United States;
(10) The proposed date of arrival in the United States; and
(11) The name and address of the person to whom the live fish, fertilized eggs, or gametes of SVC-susceptible species will be delivered in the United States.
(d) If APHIS determines that the live fish, fertilized eggs, or gametes are eligible for importation, APHIS will issue an import permit indicating the applicable conditions for importation. An import permit does not guarantee that any live fish, fertilized eggs, or gametes will be allowed entry into the United States; the fish, fertilized eggs, or gametes will be allowed to enter the United States only if they meet all applicable requirements of the permit and regulations.
(a)
(1) The live fish, fertilized eggs, or gametes were inspected by the veterinarian or certifying official who issued the certificate within 72 hours prior to shipment, and were found to be free of any clinical signs of disease consistent with SVC; and
(2) The live fish, fertilized eggs, or gametes covered by the health certificate meet the requirements of this section.
(b)
(1) The live fish, fertilized eggs, or gametes must originate in a region or establishment which conducts a surveillance program for SVC under the supervision of the competent authority.
(2) The region or establishment must demonstrate freedom from SVC through a minimum of 2-years' continuous health history, supported by laboratory testing by a pathogen detection facility approved for SVC viral assays by the competent authority.
(3) SVC-susceptible fish populations in the region or establishment must be tested at least twice annually, with at least 3 months between the tests and at times or under environmental conditions that would facilitate the detection of SVCV if it were present. Sampling procedures must utilize an assumed pathogen prevalence of 2 percent, with a corresponding confidence level of 95 percent. Samples must be collected and submitted by a certifying official or veterinarian recognized by the competent authority. The standard screening method for SVC must include isolation of SVCV in cell culture, using either the epithelioma papulosum cyprini (EPC) or fathead minnow (FHM) cell lines. However, the Administrator may authorize other assays for SVCV detection in lieu of virus isolation through cell culture, if the Administrator determines that such assays provide equivalent assurance of the SVC status of an exporting region or establishment. All viral testing results must be negative.
(c)
(1) Cleaning and disinfection of shipping containers must take place under the supervision of the veterinarian or certifying official who issues the health certificate.
(2) Cleaning and disinfection must be sufficient to neutralize any SVC virus to which shipping containers may have been exposed. Acceptable disinfection procedures include individual or combination treatments with: Solutions having a pH of 12 or higher or 3 or lower with a contact time of at least 10 minutes; heat at or above 56 °C for at least 15 minutes; chlorine solutions having a concentration of at least 500 ppm with a contact time of at least 10 minutes; iodine solutions having a concentration of at least 100 ppm with a contact time of at least 10 minutes; ultraviolet exposure (254 nm; min exposure of 10,000 microwatt seconds/cm
(3) Cleaning and disinfection protocols must be referenced in the health certificate or in a separate cleaning and disinfection certificate accompanying the shipment to the U.S. port of entry.
(a) For all live fish, fertilized eggs, and gametes offered for importation under this subpart, the importer or his or her agent must submit the following documents to the collector of customs for use by the port veterinarian:
(1) All permits, certificates, or other documentation required by this subpart; and
(2) Two copies of a declaration that lists the port of entry, the name and address of the importer, the name and address of the broker, the origin of the live fish, fertilized eggs, or gametes, the number, species, and the purpose of the importation, the name of the person to whom the fish will be delivered, and the location of the place to which such delivery will be made.
(b) [Reserved]
(a) All live fish, fertilized eggs, and gametes of SVC-susceptible species imported from any part of the world must be presented for inspection at a port of entry designated under § 93.902. The APHIS port veterinarian must be notified at least 72 hours in advance of the arrival in the United States of a shipment of live fish, fertilized eggs, or gametes of SVC-susceptible species. Any shipment of live SVC-susceptible fish species that the port veterinarian determines to exhibit clinical signs consistent with SVCV infection or disease, or any shipments of live fish, fertilized eggs, and gametes of SVC-susceptible species that otherwise do not meet the requirements of this subpart, shall be refused entry.
(b) Shipments refused entry, unless exported within a time fixed in each case by the Administrator, and in accordance with other provisions he or she may require in each case for their handling, shall be disposed of as the Administrator may direct.
7 U.S.C. 450, 7701-7772, 7781-7786, and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
As used in this part, the following terms shall have the meanings set forth in this section.
(1) Maintains, and, in the case of regions where BSE was detected, had in place prior to the detection of BSE in an indigenous ruminant, risk mitigation measures adequate to prevent widespread exposure and/or establishment of the disease. Such measures include the following:
(i) Restrictions on the importation of animals sufficient to minimize the possibility of infected ruminants being imported into the region, and on the importation of animal products and animal feed containing ruminant protein sufficient to minimize the possibility of ruminants in the region being exposed to BSE;
(ii) Surveillance for BSE at levels that meet or exceed recommendations of the World Organization for Animal Health (Office International des Epizooties) for surveillance for BSE; and
(iii) A ruminant-to-ruminant feed ban that is in place and is effectively enforced.
(2) In regions where BSE was detected, conducted an epidemiological investigation following detection of BSE sufficient to confirm the adequacy of measures to prevent the further introduction or spread of BSE, and continues to take such measures.
(3) In regions where BSE was detected, took additional risk mitigation measures, as necessary, following the BSE outbreak based on risk analysis of the outbreak, and continues to take such measures.
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
(2) A sheep or goat that exhibits any of the following signs and that has been determined to be suspicious for a transmissible spongiform encephalopathy by a veterinarian: Weight loss despite retention of appetite; behavior abnormalities; pruritus (itching); wool pulling; biting at legs or side; lip smacking; motor abnormalities such as incoordination, high stepping gait of forelimbs, bunny hop movement of rear legs, or swaying of back end; increased sensitivity to noise and sudden movement; tremor, “star gazing,” head pressing, recumbency, or other signs of neurological disease or chronic wasting.
(a) Notice is hereby given that, in accordance with the Animal Health Protection Act (7 U.S.C. 8301
(1) Rinderpest or foot-and-mouth disease exists in all regions of the world,
(2) The following regions are declared to be free of both rinderpest and foot-and-mouth disease: Australia, Austria, The Bahamas, Barbados, Belgium, Bermuda, British Honduras (Belize), Canada, Channel Islands, Chile, Costa Rica, Czech Republic, Denmark, Dominican Republic, El Salvador, Estonia, Fiji, Finland, France, Germany, Greece, Greenland, Guatemala, Haiti, Honduras, Hungary, Iceland, Ireland, Italy, Jamaica, Japan, Latvia, Lithuania, Luxembourg, Mexico, Namibia (excluding the region north of the Veterinary Cordon Fence), The Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Panama, Papua New Guinea, Poland, Portugal, Spain, Territory of St. Pierre and Miquelon, Sweden, Switzerland, Trinidad and Tobago, Trust Territory of the Pacific Islands, and the United Kingdom.
(3) The following regions are declared to be free of rinderpest: Namibia, the Republic of South Africa, and Uruguay.
(b) The importation of any ruminant or swine or any fresh (chilled or frozen) meat of any ruminant or swine
(1) Except as provided in part 93 of this chapter for wild ruminants and wild swine;
(2) Except as provided in paragraph (d) of this section for fresh (chilled or frozen) meat of ruminants or swine that is otherwise eligible for importation under this part but that enters a port or otherwise transits a region where rinderpest or foot-and-mouth disease exists; and
(3) Except as provided in § 94.4 of this part for cooked or cured meat from regions where rinderpest or foot-and-mouth disease exists.
(4) Except as provided in § 94.22 for fresh (chilled or frozen) beef from Uruguay.
(c) The importation of any used farm equipment that originates in any region where rinderpest or foot-and-mouth disease exists, as designated in paragraph (a) of this section, is prohibited, unless the equipment is accompanied by an original certificate signed by an authorized official of the national animal health service of the exporting region that states that the equipment, after its last use and prior to export, was steam-cleaned free of all exposed dirt and other particulate matter. Such farm equipment is subject to APHIS inspection at the port of arrival. If it is found during such inspection to contain any exposed dirt or other particulate matter, it will be denied entry into the United States, unless, in the judgment of the APHIS inspector, the amount of exposed soil is minimal enough to allow cleaning at the port of arrival, and there are adequate facilities and personnel at the port to conduct such cleaning without risk of disease contamination.
(d) Except as otherwise provided in this part, fresh (chilled or frozen) meat of ruminants or swine raised and slaughtered in a region free of foot-and-mouth disease and rinderpest, as designated in paragraph (a)(2) of this section, and fresh (chilled or frozen) beef exported from Uruguay in accordance with § 94.22, which during shipment to the United States enters a port or otherwise transits a region where rinderpest or foot-and-mouth disease exists may be imported provided that all of the following conditions are met:
(1) The meat is accompanied by the foreign meat inspection certificate required by § 327.4 of this title and, upon arrival of the meat in the United States, the foreign meat inspection certificate is presented to an authorized inspector at the port of arrival;
(2) The meat is placed in the transporting carrier in a hold, compartment, or, if the meat is containerized, in a container that which was sealed in the region of origin by an official of such region with serially numbered seals approved by APHIS, so as to prevent contact of the meat with any other cargo,
(3) If any foreign official breaks a seal applied in the region of origin in order to inspect the meat, he or she then reseals the hold, compartment, or container with a new serially numbered seal; and, if any member of a ship's crew breaks a seal, the serial number of the seal, the location of the seal, and the reason for breaking the seal are recorded in the ship's log.
(4) The serial numbers of the seals used to seal the hold, compartment, or container are recorded on the foreign meat inspection certificate which accompanies the meat;
(5) Upon arrival of the carrier in the United States port of arrival, the seals are found by an APHIS representative to be intact, and the representative finds that there is no evidence indicating that any seal has been tampered with;
(6) The meat is found by an authorized inspector to be as represented on the foreign meat inspection certificate.
For
(a) The importation of fresh (chilled or frozen) products (other than meat and milk and milk products) derived from ruminants or swine, originating in, shipped from, or transiting any region designated in § 94.1(a) as a region infected with rinderpest or foot-and-mouth disease is prohibited, except as provided in § 94.3 and parts 95 and 96 of this chapter.
(b) The importation of milk and milk products of ruminants and swine originating in, shipped from, or transiting any region designated in § 94.1(a) as a region infected with rinderpest or foot-and-mouth disease is prohibited, except as provided in § 94.16.
The importation of fresh (chilled or frozen) organs, glands, extracts, or secretions derived from ruminants or swine, originating in any region where rinderpest or foot-and-mouth disease exists, as designated in § 94.1, except for pharmaceutical or biological purposes under conditions prescribed by the Administrator in each instance, is prohibited.
(a) The importation of cured meats derived from ruminants or swine, originating in any region where rinderpest or foot-and-mouth disease exists, as designated in § 94.1, is prohibited unless the following conditions have been fulfilled:
(1) All bones shall have been completely removed in the region of origin.
(2) The meat shall have been held in an unfrozen, fresh condition for at
(3)(i) The meat shall have been thoroughly cured and fully dried in such manner that it may be stored and handled without refrigeration, as in the case of salami and other summer sausages, tasajo, xarque, or jerked beef, bouillon cubes, dried beef, and Westphalia, Italian and similar type hams. The term “fully dried” as used in this paragraph means dried to the extent that the water-protein ratio in the wettest portion of the product does not exceed 2.25 to 1.
(ii) Laboratory analysis of samples to determine the water-protein ratios will not be made in the case of all shipments of cured and dried meats. However, in any case in which the inspector is uncertain whether the meat complies with the requirements of paragraph (a)(3)(i) of this section, he will send a sample of the meat representative of the wettest portion to the Meat Inspection Division for analysis of the water-protein ratio. Pending such analysis the meat shall not be released or removed from the port of arrival.
(4) The cured meat shall be accompanied by a certificate issued by an official of the national government of the region of origin who is authorized to issue the foreign meat inspection certificate required by § 327.4 of this title, stating that such meat has been prepared in accordance with paragraphs (a)(1), (a)(2) and (a)(3)(i) of this section. Upon arrival of the cured meat in the United States, the certificate must be presented to an authorized inspector at the port of arrival.
(b) The importation of cooked meats from ruminants or swine originating in any region where rinderpest or foot-and-mouth disease exists, as designated in § 94.1, is prohibited, except as provided in this section.
(1) The cooked meat must be boneless and must be thoroughly cooked.
(2) The cooked meat must have been prepared in an establishment that is eligible to have its products imported into the United States under the Federal Meat Inspection Act (21 U.S.C. 601
(3) Canned product (canned meat), as defined in § 318.300(d) of this chapter, is exempt from the requirements in this section.
(4)
(5)
(i)
(ii)
(iii)
(6)
(i) For meat that is cooked and is intended for further processing, up to two tubes from each batch per cooker must be randomly selected by the official of the National Government of the region of origin who is authorized to issue the meat inspection certificate required by § 327.4 of this title. If a TID is not used, a cylindrical or square piece of at least 3.8 cm (1.5 in) in each dimension must be cut from the cold spot of each tube. The cylindrical or square piece will be the indicator piece for the pink juice test. The indicator piece or piece containing the TID must be sealed in plastic or other material approved by the U.S. Food and Drug Administration, and be accompanied by a certificate issued by the official who selected the tube. The certificate must provide the date the tube was cooked and the cooker and batch number, and the date the tube was selected for sampling. Each batch per cooker must have at least one but no more than two indicator pieces or pieces containing TID's. All indicator pieces and pieces containing TID's must be individually sealed, properly labeled, and enclosed together in one sealed box that accompanies the shipment. Any indicator pieces or pieces containing TID's that are not used to accompany a shipment to the United States must be destroyed following loading of the batch into a container; and
(ii) After removing the indicator piece or piece containing a TID, all remaining meat from the same batch may be cut into smaller cubes and sealed in plastic or other material approved by the U.S. Food and Drug Administration. After being processed into smaller cubes once, the meat may not be further processed before shipment to the United States. The cubes of meat and the indicator piece or piece containing a TID must be accompanied to the United States by a certificate as provided in paragraph (b)(8) of this section.
(7) Any TID used in accordance with § 94.4 (b)(4) or (b)(5) must remain in the meat, as originally inserted, and must accompany the cooked meat whose temperature it has gauged when that meat is shipped to the United States.
(8)
(ii) For cooked meat that is further processed in accordance with paragraph (b)(6) of this section, the certificate must include the following statement, in addition to the certification required under paragraph (b)(8)(i) of this section: “No more than two tubes were randomly selected per batch per cooker for cutting an indicator piece or obtaining a piece containing a TID. The indicator piece or piece containing a TID represents a shipment of (describe form of processed product—e.g., diced cubes of a particular size). A piece containing a TID or a piece 3.8
(9) The meat is inspected by an FSIS inspector at a port of arrival in a defrost facility approved by the Administrator
(i) Request for approval of any defrost facility must be made to the Administrator. The Administrator will approve a defrost facility only under the following conditions:
(A) The defrost facility has equipment and procedures that permit FSIS inspectors to determine whether meat is thoroughly cooked;
(B) The defrost facility is located at a port of arrival; and
(C) The defrost facility is approved by the Food Safety and Inspection Service, United States Department of Agriculture.
(ii) The Administrator may deny approval of any defrost facility if the Administrator determines that the defrost facility does not meet the conditions for approval. If approval is denied, the operator of the defrost facility will be informed of the reasons for denial and be given an opportunity to respond. The operator will be afforded an opportunity for a hearing with respect to any disputed issues of fact. The hearing will be conducted in accordance with rules of practice that will be adopted for the proceeding.
(iii) The Administrator may withdraw approval of any defrost facility as follows: (A) When the operator of the defrost facility notifies the Administrator in writing that the defrost facility no longer performs the required services; or (B) when the Administrator determines that the defrost facility does not meet the conditions for approval. Before the Administrator withdraws approval from any defrost facility, the operator of the defrost facility will be informed of the reasons for the proposed withdrawal and given an opportunity to respond. The operator will be afforded a hearing with respect to any disputed issues of fact. The hearing will be conducted in accordance with rules of practice that will be adopted for the proceeding. If approval of a defrost facility is withdrawn, the Administrator will remove its name from the list of approved defrost facilities.
(c)
(i) That the meat processing establishment has furnished APHIS with a description of the process used to inactivate rinderpest or FMD virus that may be present in meat intended for export to the United States, and with blueprints of the facilities where this meat is cooked and packaged;
(ii) That an APHIS representative has inspected the establishment and found that it meets the standards set forth in paragraph (c)(2) of this section;
(iii) That the operator of the establishment has signed a cooperative service agreement with APHIS, stating: (A) That all cooked meat processed for importation into the United States will be processed in accordance with the requirements of this part; (B) that a full-time, salaried meat inspection official of the National Government of the exporting region will supervise the processing (including certification of the cold spot) and examination of the product, and certify that it has been processed in accordance with this section; and (C) that APHIS personnel or other persons authorized by the Administrator may enter the establishment, unannounced, to inspect the establishment and its records; and
(iv) That the operator of the establishment has entered into a trust fund
(2)
(i) The facilities used for processing cooked meat in the meat processing establishment are separate from the facilities used for processing raw meat (precooking, boning, preparation, and curing), with only the through-the-wall cooking system through which the meat product is delivered at the end of the cooking cycle connecting them; and there is at all times a positive air flow from the cooked to the raw product side;
(ii) The cooking equipment has the capacity to cook all meat pieces in accordance with § 94.4(b)(4) or (b)(5);
(iii) Workers who process cooked meat are at all times kept separate from workers who process raw meat, and have, for their exclusive use: A separate entrance, dining area, toilets, lavatories with cold and hot water, soap, disinfectants, paper towels, clothes hampers and waste baskets for disposal, and changing rooms stocked with the clean clothing and rubber boots into which all persons must change upon entering the establishment. Workers and all other persons entering the establishment must wash their hands and change into the clean clothing and boots provided in the changing rooms before entering the cooking facilities, and must leave this clothing for laundering and disinfecting before exiting from the establishment, regardless of the amount of time spent inside or away from the establishment;
(iv) Original records identifying the slaughtering facility from which the meat was obtained and the date the meat entered the meat processing establishment, and original certification (including temperature recording charts and graphs), must be kept for all cooked meat by the full-time salaried meat inspection official of the National Government of the exporting region assigned to the establishment, and must be retained for 2 years.
(a)
(2)
(b)
(c)
(i) Not all garbage generated onboard a means of conveyance is regulated for the purposes of this section. Garbage regulated for the purposes of this section is defined as “regulated garbage” in paragraphs (c)(2) and (c)(3) of this section.
(ii) Garbage that is commingled with regulated garbage is also regulated garbage.
(2)
(i)
(A) The aircraft had previously been cleared of all garbage and of all meats and meat products, whatever the country of origin, except meats that are shelf-stable; all fresh and condensed milk and cream from countries designated in § 94.1 as those in which foot-and-mouth disease exists; all fresh fruits and vegetables; and all eggs; and the items previously cleared from the aircraft as prescribed by this paragraph have been disposed of according to the procedures for disposing of regulated garbage, as specified in paragraphs (c)(4)(ii) and (c)(4)(iii) of this section.
(B) After the garbage and stores referred to in paragraph (c)(2)(i)(A) of this section were removed, the aircraft has not been in a non-Canadian foreign port.
(ii)
(A) The means of conveyance is accompanied by a certificate from an inspector stating the following:
(
(
(B) Since being cleaned and disinfected, the means of conveyance has not been in a non-Canadian foreign port.
(3)
(i)
(A) The aircraft had been previously cleared of all garbage and all fresh fruits and vegetables, and the items previously cleared from the aircraft as prescribed by this paragraph have been disposed of according to the procedures for disposing of regulated garbage, as specified in paragraphs (c)(4)(ii) and (c)(4)(iii) of this section.
(B) After the garbage and stores referred to in paragraph (c)(3)(i)(A) of this section were removed, the aircraft has not moved to the continental United States from any territory or possession or from Hawaii, to any territory or possession from any other territory or possession or from Hawaii, or to Hawaii from any territory or possession.
(ii)
(A) The means of conveyance is accompanied by a certificate from an inspector stating that the means of conveyance had been cleared of all garbage and all fresh fruits and vegetables, and the items previously cleared from the means of conveyance as prescribed by this paragraph have been disposed of according to the procedures for disposing of regulated garbage, as specified in paragraphs (c)(4)(ii) and (c)(4)(iii) of this section.
(B) After being cleared of the garbage and stores referred to in paragraph (c)(3)(ii)(A) of this section, the means of conveyance has not moved to the continental United States from any territory or possession or from Hawaii; to any territory or possession from any other territory or possession or from Hawaii; or to Hawaii from any territory or possession.
(4)
(ii) Regulated garbage is subject to general surveillance for compliance with this section by inspectors and to disposal measures authorized by the Plant Protection Act and the Animal Health Protection Act to prevent the introduction and dissemination of pests and diseases of plants and livestock.
(iii) All regulated garbage must be contained in tight, covered, leak-proof receptacles during storage on board a means of conveyance while in the territorial waters, or while otherwise within the territory of the United States. All such receptacles shall be contained inside the guard rail if on a watercraft. Such regulated garbage shall not be unloaded from such means of conveyance in the United States unless such regulated garbage is removed in tight, covered, leak-proof receptacles under the direction of an inspector to an approved facility for incineration, sterilization, or grinding into an approved sewage system, under direct supervision by such an inspector, or such regulated garbage is removed for other handling in such manner and under such supervision as may, upon request in specific cases, be approved by the Administrator as adequate to prevent the introduction and dissemination of plant pests and animal diseases and sufficient to ensure compliance with applicable laws for environmental protection.
(A) Application for approval of a facility or sewage system may be made in writing by the authorized representative of any carrier or by the official having jurisdiction over the port or place of arrival of the means of conveyance to the Administrator, Animal and Plant Health Inspection Service, U.S. Department of Agriculture, Washington, DC 20250. The application must be endorsed by the operator of the facility or sewage system.
(B) Approval will be granted if the Administrator determines that the requirements set forth in this section are met. Approval may be denied or withdrawn at any time, if the Administrator determines that such requirements are not met, after notice of the proposed denial or withdrawal of the approval and the reasons therefor, and an opportunity to demonstrate or achieve compliance with such requirements, has been afforded to the operator of the facility or sewage system and to the applicant for approval. However, approval may also be withdrawn without such prior procedure in any case in which the public health, interest, or safety requires immediate action, and in such case, the operator of the facility or sewage system and the applicant for approval shall promptly thereafter be given notice of the withdrawal and the reasons therefore and an opportunity to show cause why the approval should be reinstated.
(iv) The Plant Protection and Quarantine Programs and Veterinary Services, Animal, and Plant Health Inspection Service, will cooperate with other Federal, State, and local agencies responsible for enforcing other statutes and regulations governing disposal of the regulated garbage to the end that such disposal shall be adequate to prevent the dissemination of plant pests and livestock or poultry diseases and comply with applicable laws for environmental protection. The inspectors, in maintaining surveillance over regulated garbage movements and disposal, shall coordinate their activities with the activities of representatives of the U.S. Environmental Protection Agency and other Federal, State, and local agencies also having jurisdiction over such regulated garbage.
(d)
(i) Industrial process wastes, mining wastes, sewage sludge, incinerator ash, or other wastes from Hawaii that the Administrator determines do not pose risks of introducing animal or plant pests or diseases into the continental United States are not regulated under this section.
(ii) The interstate movement from Hawaii to the continental United States of agricultural wastes and yard waste (other than incidental amounts (less than 3 percent) that may be present in municipal solid waste despite reasonable efforts to maintain source separation) is prohibited.
(iii) Garbage generated onboard any means of conveyance during interstate movement from Hawaii is regulated under paragraph (c) of this section.
(2)
(i) The garbage must be processed, packaged, safeguarded, and disposed of using a methodology that the Administrator has determined is adequate to prevent the introduction and dissemination of plant pests into noninfested areas of the United States.
(ii) The garbage must be moved under a compliance agreement in accordance with paragraph (e) of this section. APHIS will only enter into a compliance agreement when the Administrator is satisfied that the Agency has first satisfied all its obligations under the National Environmental Policy Act and all applicable Federal and State statutes to fully assess the impacts associated with the movement of garbage under the compliance agreement.
(iii) All such garbage moved interstate from Hawaii to any of the continental United States must be moved in compliance with all applicable laws for environmental protection.
(e)
(2) A person who enters into a compliance agreement, and employees or agents of that person, must comply with the following conditions and any supplemental conditions which are listed in the compliance agreement, as deemed by the Administrator to be necessary to prevent the introduction and dissemination into or within the United States of plant pests and livestock or poultry diseases:
(i) Comply with all applicable provisions of this section;
(ii) Allow inspectors access to all records maintained by the person regarding handling or disposal of garbage, and to all areas where handling or disposal of garbage occurs;
(iii)(A) If the garbage is regulated under paragraph (c) of this section, remove garbage from a means of conveyance only in tight, covered, leak-proof receptacles;
(B) If the garbage is regulated under paragraph (d) of this section, transport garbage interstate in sealed, leak-proof
(iv) Move the garbage only to a facility approved by the Administrator; and
(v) At the approved facility, dispose of the garbage in a manner approved by the Administrator and described in the compliance agreement.
(3) Approval for a compliance agreement may be denied at any time if the Administrator determines that the applicant has not met or is unable to meet the requirements set forth in this section. Prior to denying any application for a compliance agreement, APHIS will provide notice to the applicant thereof, and will provide the applicant with an opportunity to demonstrate or achieve compliance with requirements.
(4) Any compliance agreement may be canceled, either orally or in writing, by an inspector whenever the inspector finds that the person who has entered into the compliance agreement has failed to comply with this section. If the cancellation is oral, the cancellation and the reasons for the cancellation will be confirmed in writing as promptly as circumstances allow. Any person whose compliance agreement has been canceled may appeal the decision, in writing, within 10 days after receiving written notification of the cancellation. The appeal must state all of the facts and reasons upon which the person relies to show that the compliance agreement was wrongfully canceled. As promptly as circumstances allow, the Administrator will grant or deny the appeal, in writing, stating the reasons for the decision. A hearing will be held to resolve any conflict as to any material fact. Rules of practice concerning a hearing will be adopted by the Administrator. This administrative remedy must be exhausted before a person can file suit in court challenging the cancellation of a compliance agreement.
(5) Where a compliance agreement is denied or canceled, the person who entered into or applied for the compliance agreement may be prohibited, at the discretion of the Administrator, from handling or disposing of regulated garbage.
(a)
(2) The following regions are considered to be free of Exotic Newcastle disease (END): Argentina, Australia, Canada, Chile, Costa Rica, Denmark, Fiji, Finland, France, Great Britain (England, Scotland, Wales, and the Isle of Man), Greece, Iceland, Luxembourg, Mexico (States of Campeche, Quintana Roo, and Yucatan), New Zealand, Republic of Ireland, Spain, Sweden, and Switzerland.
(b)
(1) Carcasses of game birds may be imported if eviscerated, with heads and feet removed. Viscera, heads, and feet removed from game birds are ineligible for entry into the United States.
(2) Carcasses, or parts or products of carcasses, of poultry, game birds, and other birds may be imported for consignment to any museum, educational institution or other establishment which has provided the Administrator
(3) Carcasses, or parts or products of carcasses, of poultry, game birds, and other birds, may be imported if packed in hermetically sealed containers and if cooked by a commercial method after such packing to produce articles which are shelf stable without refrigeration.
(4) Carcasses, or parts or products of carcasses, of poultry, game birds, and other birds may be imported if thoroughly cooked, and if, upon inspection by a representative of the United States Department of Agriculture at the port of arrival, the carcasses or parts or products thereof have a thoroughly cooked appearance throughout.
(5) Poultry carcasses or parts or products of poultry carcasses that originated in a region considered to be free of END and are processed (cut, packaged, and/or cooked) in a region where END is considered to exist may be imported under the following conditions:
(i)
(B) the poultry carcasses or parts or products of poultry carcasses may be removed from containers at the processing establishment in the region where END is considered to exist only after an official of that region's national government has determined that the seals are intact and free of any evidence of tampering. The official must attest to this fact by signing the certificate accompanying the shipment.
(ii)
(A) May not receive or handle any live poultry.
(B) Must keep any records required by this section on file at the facility for a period of at least 2 years after export of processed products to the United States, and must make those records available to USDA inspectors during inspections.
(C) May process poultry carcasses or parts or products of poultry carcasses that originate in both END-free regions and regions where END is considered to exist, provided that:
(
(
(
(
(iii)
(iv)
(6) Carcasses or parts or products of carcasses, of poultry, game birds, and other birds that do not otherwise qualify for importation under paragraphs (b)(1) through (b)(5) of this section may be imported only if the importer applies to, and is granted a permit by, the Administrator, authorizing such importation. Permission will be given only when the Administrator determines that such importation will not constitute a risk of introduction or dissemination of END into the United States. Application for a permit may be made in accordance with paragraph (f) of this section.
(c)
(1)
(i) The eggs are imported in cases marked with the identity of the flock of origin and sealed with the seal of the national government of the region of origin.
(ii) The certificate accompanying the eggs is presented to an authorized inspector when the eggs reach the port of arrival in the United States.
(iii) The certificate identifies the flock of origin and shows the region of origin, the port of embarkation, the port of arrival, the name and address of the exporter and importer, the total number of eggs, and cases of eggs, shipped with the certificate, and the date the certificate was signed.
(iv) The certificate states that the eggs qualify for importation in accordance with this section.
(v) No more than 90 days before the certificate was signed, a salaried veterinary officer of the national government of the region of origin inspected the flock of origin and found no evidence of communicable diseases of poultry.
(vi) The eggs were washed, to remove foreign material from the surface of the shells, and sanitized on the premises of origin with a hypochlorite solution of from 100 ppm to 200 ppm available chlorine.
(vii) The eggs were packed on the premises of origin in previously unused cases.
(viii) Before leaving the premises of origin, the cases in which the eggs were packed were sealed with a seal of the national government of the region of origin by the salaried veterinarian who signed the certificate.
(ix) And, if the eggs were laid in any region where END is considered to exist (see paragraph (a) of this section):
(A) No END occurred on the premises of origin or on adjoining premises during the 90 days before the certificate was signed.
(B) There is no evidence that the flock of origin was exposed to END during the 90 days before the certificate was signed.
(C) The eggs are from a flock of origin found free of END in one of the following ways:
(
(
(2)
(3)
(4)
(d) Highly pathogenic avian influenza (HPAI) subtype H5N1 is considered to exist in the following regions: Cambodia, China, Indonesia, Japan,
(e)
(f) To apply for a permit, contact the Animal and Plant Health Inspection Service, Veterinary Services, National Center for Import-Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231.
For
(a) Ruminants and swine, and fresh (chilled or frozen) meats, prohibited importation under §§ 94.1, 94.8, 94.9, 94.10, 94.12, 94.14, or 94.18, which come into the United States by ocean vessel and are offered for entry and refused admission into this country, shall be destroyed or otherwise disposed of as the Administrator may direct, unless they are exported by the consignee within 48 hours, and meanwhile are retained under such isolation and other safeguards as the Administrator may require to prevent the introduction or dissemination of livestock diseases into the United States.
(b) Ruminants and swine, and fresh (chilled or frozen) meats, prohibited importation under §§ 94.1, 94.8, 94.9, 94.10, 94.12, 94.14, or 94.18, which come into the United States aboard an airplane or railroad car and are offered for entry and refused admission into this country, shall be destroyed or otherwise disposed of as the Administrator may direct, unless they are exported by the consignee within 24 hours, and meanwhile are retained under such isolation and other safeguards as the Administrator may require to prevent the introduction or dissemination of livestock diseases into the United States.
(c) Ruminants and swine, and fresh (chilled or frozen) meats, prohibited importation under §§ 94.1, 94.8, 94.9, 94.10, 94.12, 94.14, or 94.18, which come into the United States by any means other than ocean vessel, airplane, or railroad car and are offered for entry and refused admission into this country, shall be destroyed or otherwise disposed of as the Administrator may direct, unless they are exported by the consignee within 8 hours, and meanwhile are retained under such isolation and other safeguards as the Administrator may require to prevent the introduction or dissemination of livestock diseases into the United States.
(d) Ruminants and swine, and fresh (chilled or frozen) meats, prohibited importation under §§ 94.1, 94.8, 94.9, 94.10, 94.12, 94.14, or 94.18, which come into the United States by any means but are not offered for entry into this country, and other animals, meats, and other articles prohibited importation under other sections of this part, which come into the United States by any means, whether they are offered for entry into this country or not, shall be immediately destroyed or otherwise disposed of as the Administrator may direct at any time.
African swine fever exists or the Administrator has reason to believe that
(a) No pork or pork products may be imported into the United States from any region listed in this section unless:
(1) Such pork or pork product has been fully cooked by a commercial method in a container hermetically sealed promptly after filling but before such cooking, so that such cooking and sealing produced a fully-sterilized product which is shelf-stable without refrigeration; or
(2) Such pork or pork product is not otherwise prohibited importation under this part and is consigned directly from the port of arrival in the United States to a meat processing establishment operating under Federal meat inspection, approved by the Administrator, for further processing of such pork or pork product by heat.
(3) Such pork or pork product:
(i) Was processed in a single establishment that meets the requirements in paragraph (a)(4).
(ii) Was heated by other than a flash-heating method to an internal temperature of at least 69 °C. (156 °F.) throughout after the bones had been removed.
(iii) Is accompanied to the United States by an original certificate stating that all of the requirements of this section have been met. The certificate must be written in English. The certificate must be issued by an official of the national government of the region in which the processing establishment is located. The official must be authorized to issue the foreign meat inspection certificate required by part 327 of chapter III of this title. Upon arrival of the pork or pork products in the United States, the certificate must be presented to an authorized inspector at the port of arrival.
(4) The processing establishment
(i) All areas, utensils, and equipment likely to contact the pork or pork products to be processed, including skinning, deboning, cutting, and packing areas, and related utensils and equipment, must be cleaned and disinfected after processing pork or pork products not eligible for export to the United States and before processing any pork or pork products eligible for export to the United States.
(ii) Pork or pork products eligible for export to the United States may not be handled, cut, or otherwise processed at the same time as any pork or pork products not eligible for export to the United States.
(iii) Pork or pork products eligible for export to the United States must be packed in clean new packaging that is clearly distinguishable from that containing any pork or pork products not eligible for export to the United States.
(b) Pork or pork products consigned from the port of arrival to an approved establishment under the provisions of paragraph (a)(2) of this section shall be moved from the port of arrival to the approved establishment under Customs seals or seals of the Administrator, and shall be otherwise handled as the Administrator, may direct in order to guard against the introduction and dissemination of the contagion of African swine fever. Seals applied under this section shall not be broken except by persons authorized to do so by the Administrator.
(c) Pork or pork products imported into the United States from a region listed in this section which do not meet the requirements specified in this section shall be seized, quarantined, and disposed of as the Administrator, may direct in order to guard against the introduction and dissemination of the contagion of the disease.
For
(a) Classical swine fever is known to exist in all regions of the world except Australia; Canada; Chile; Fiji; Iceland; the Mexican States of Baja California, Baja California Sur, Campeche, Chihuahua, Nayarit, Quintana Roo, Sinaloa, Sonora, and Yucatan; New Zealand; Norway; and Trust Territory of the Pacific Islands.
(b) The APHIS-defined EU CSF region is a single region of low-risk for CSF.
(c) Except as provided in § 94.24 for the APHIS-defined EU CSF region, no fresh pork or pork product may be imported into the United States from any region where classical swine fever is known to exist unless it complies with the following requirements:
(1) Such pork or pork product has been treated in accordance with one of the following procedures:
(i) Such pork and pork product has been fully cooked by a commercial method in a container hermetically sealed promptly after filling but before such cooking, so that such cooking and sealing produced a fully sterilized product which is shelf-stable without refrigeration;
(ii) Such pork or pork product is in compliance with the following requirements:
(A) All bones were completely removed prior to cooking; and
(B) Such pork or pork product was heated by other than a flash-heating method to an internal temperature of 69 °C. (156 °F.) throughout; or
(iii) Such pork or pork product is in compliance with the following requirements:
(A) All bones have been completely removed in the region of origin, and
(B) The meat has been held in an unfrozen, fresh condition for at least 3 days immediately following the slaughter of the animals from which it was derived, and
(C) The meat has been thoroughly cured and fully dried for a period of not less than 90 days so that the product is shelf stable without refrigeration:
(
(
(2) Articles under paragraph (c)(1)(ii) or (iii) of this section were prepared in an inspected establishment that is eligible to have its products imported into the United States under the Federal Meat Inspection Act and § 327.2 of this title; and,
(3) In addition to the foreign meat inspection certificate required by § 327.4 of this title, pork and pork products prepared under paragraph (c)(1)(ii) or (iii) of this section shall be accompanied by a certificate that states that the provisions of paragraph (c)(1)(ii) or (iii) of this section have been met. This certificate shall be issued by an official of the national government of the region of origin who is authorized to issue the foreign meat inspection certificate required by § 327.4 of this title.
(4) Small amounts of pork or pork product, subject to the restrictions in this section, may in specific cases be imported for purposes of examination, testing, or analysis if the importer applies for and receives written approval for such importation from the Administrator. Approval will be granted only when the Administrator determines that the articles have been processed by heat in a manner so that such importation will not endanger the livestock of the United States.
(d) Thoroughly cured and fully dried pork and pork products from regions where both classical swine fever and swine vesicular disease are known or considered to exist need not comply with paragraph (c)(1)(iii) of this section if they are in compliance with the provisions of § 94.12(b)(1)((iii) of this part.
For
(a) Classical swine fever is known to exist in all regions of the world, except Australia; Canada; Chile; Fiji; Iceland; the Mexican States of Baja California, Baja California Sur, Campeche, Chihuahua, Nayarit, Quintana Roo, Sinaloa, Sonora, and Yucatan; New Zealand; Norway; and Trust Territory of the Pacific Islands.
(b) The APHIS-defined EU CSF region is a single region of low-risk for CSF.
(c) Except as provided in § 94.24 for the APHIS-defined EU CSF region, no swine that are moved from or transit any region where classical swine fever is known to exist may be imported into the United States, except for wild swine imported into the United States in accordance with paragraph (d) of this section.
(d) Wild swine may be allowed importation into the United States by the Administrator upon request in specific cases under § 93.501 or § 93.504(c) of this chapter.
(a) Austria, The Bahamas, Belgium, Channel Islands, Chile, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland,
(b) All meat or other animal product from such regions, whether in personal-use amounts or commercial lots (except that which has been fully cooked by a commercial method in a container hermetically sealed promptly after filling but before such cooking and sealing produced a fully sterilized product which is shelf-stable without refrigeration) shall have been prepared only in an inspected establishment that is eligible to have its products imported into the United States under the Federal Meat Inspection Act (21 U.S.C. 601
(c)
(1) The slaughtering establishment is not permitted to receive animals that originated in, or have ever been in, or that have been aboard a means of conveyance at the time such means of conveyance called at or landed at a port in, a region listed in § 94.1(a) as a region infected with rinderpest or foot-and-mouth disease;
(2) The slaughtering establishment is not permitted to receive meat or other animal products derived from ruminants or swine which originated in such a rinderpest or foot-and-mouth disease infected region, or meat or other animal products from a rinderpest and foot-and-mouth disease free region transported through a rinderpest or foot-and-mouth disease infected region except in containers sealed with serially numbered seals of the National Government of the noninfected region of origin;
(3) The meat or other animal product covered by the certificate was derived from animals born and raised in a region listed in § 94.1(a)(2) as free of rinderpest and foot-and-mouth disease and the meat or other animal product has never been in any region in which rinderpest or foot-and-mouth disease existed;
(4) The meat or other animal product has been processed, stored, and transported to the means of conveyance that will bring the article to the United States in a manner to preclude its being commingled or otherwise in contact with meat or other animal products that do not comply with the conditions contained in this certificate.
For
(a) Swine vesicular disease is considered to exist in all regions of the world except Australia, Austria, the Bahamas, Belgium, Bulgaria, Canada, Central American countries, Chile, the Czech Republic, Denmark, Dominican Republic, Fiji, Finland, France, Germany, Greece, Greenland, Haiti, Hungary, Iceland, Latvia, Lithuania, Luxembourg, Mexico, the Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Republic of Ireland, Romania, Spain, Sweden, Switzerland, Trust Territories of the Pacific, the United Kingdom (England, Scotland, Wales, the Isle of Man, and Northern Ireland), Yugoslavia, and the Regions in Italy of Friuli, Liguria, Marche, and Valle d'Aosta.
(b) No pork or pork product may be imported into the United States from any region where swine vesicular disease is known to exist unless it complies with the following requirements and it is not otherwise prohibited importation into the United States under this part:
(1) Such pork or pork product has been treated in accordance with one of the following procedures:
(i) Such pork or pork product has been fully cooked by a commercial method in a container hermetically sealed promptly after filling, but before such cooking, so that such cooking and sealing produced a fully sterilized product which is shelf-stable without refrigeration.
(ii) Such pork or pork product is in compliance with the following requirements:
(A) All bones were completely removed prior to cooking; and
(B) Such pork or pork product received heat treatment in a commercially accepted manner used for perishable canned pork products so that it reached an internal temperature of 69 °C. (156 °F.) throughout.
(iii) Such pork or pork product if cured and dried is in compliance with the following requirements:
(A) All bones have been completely removed in the region of origin, and
(B) Such pork or pork products shall be consigned directly from the port of entry in the United States to a meat processing establishment operating under Federal meat inspection and approved by the Administrator,
(iv) Such pork or pork product, if it originated in a swine vesicular disease free region, has been cured and dried and is in compliance with the following requirements:
(A) All bones have been completely removed, either in the region of origin or in the region where the pork or pork products are processed; and
(B)(
(
(
(
(
(v) Such pork or pork product is in compliance with the following requirements:
(A) All bones were completely removed prior to cooking; and
(B) Such pork or pork product received continual heat treatment in an oven for a minimum of 10 hours so that it reached an internal temperature of 65 °C. (149 °F.) throughout. The oven temperature started at a minimum of 62 °C. (143.6 °F.) and reached at least 85 °C. (185 °F.).
(2) Articles under paragraph (b)(1)(ii), (iii) or (iv) of this section were prepared in an inspected establishment that is eligible to have its products imported into the United States under the Federal Meat Inspection Act and the regulations in § 327.2 in chapter III of this title.
(3) In addition to the foreign meat inspection certificate required in § 327.4 of this title, pork or pork products prepared under paragraph (b)(1)(ii), (iii) or (iv) of this section shall be accompanied by certification that paragraph (b)(1)(ii), (b)(1)(iii)(A), or (b)(1)(iv)(B)(2) of this section has been met. The certification shall be issued by an official of the national government of the region of origin who is authorized to issue the foreign meat inspection certificate required by § 327.4 of this title.
(4) Small amounts of pork or pork product subject to the restrictions of this section, may in specific cases be imported for purposes of examination, testing, or analysis, if the importer applies for and receives written approval for such importation from the Administrator, authorizing such importation. Approval will be granted only when the Administrator determines that the articles have been processed by heat in a manner so that such importation will not endanger the livestock of the United States.
(c)
(2) The operator of the pork-filled pasta processing facility must have signed a cooperative service agreement with APHIS prior to receipt of the pork intended to be used in pork-filled pasta products, stating that all such pork will be processed only in accordance with § 94.12 or § 94.17. Pursuant to the cooperative service agreement, the establishment must allow the unannounced entry into the establishment of APHIS representatives, or other persons authorized by the Administrator, for the purpose of inspecting the facilities, operations, and records of the establishment. The establishment must be current in paying all costs for such inspections (it is anticipated that such inspections will occur up to four times per year). These costs include travel, salary, subsistence, administrative overhead, and other incidental expenses (including an excess baggage provision up to 150 pounds). In accordance with the terms of the cooperative service agreement, the operator of the processing establishment must deposit with the Administrator an amount equal to the approximate costs for APHIS to inspect the establishment one time, including travel, salary, subsistence, administrative overhead and other incidental expenses (including an excess baggage provision up to 150 pounds), and, as funds from that amount are obligated, bills for costs incurred based on official accounting records will be issued to restore the deposit to its original level. Amounts to restore the deposit to its original level must be paid within 14 days of receipt of such bills.
(3) At the pasta processing establishment, pork intended to be used for pork-filled pasta products for export to the United States must be stored apart from any meat or meat products not eligible for export to the United States, either in a separate storage room or facility or in a separate area of the same storage room. Any storage room area reserved for pork or pork products eligible for export to the United States must be separated by at least 1 meter from any storage room area where meat or meat products ineligible for export to the United States are stored and must be marked by signs and by having its borders outlined on the floor.
(4) Prior to handling pork used for pork-filled pasta products intended for export to the United States, workers at the processing facility who handle pork or pork products in the facility must shower and put on a full set of clean clothes, or wait 24 hours after handling pork or pork products that are not eligible for importation into the United States.
(5) All equipment and machinery that will come in contact with the pork or other ingredients of pork-filled pasta products intended for export to the United States must be cleaned and disinfected before each use.
(6) Processing lines working with pork-filled pasta products for export to the United States must be totally dedicated to the production of such products for the time needed to complete a given lot. When any processing line in a facility is working with pork-filled pasta products intended for export to the United States, no other processing lines in the same facility may work on products using meat that is not eligible for export to the United States.
(7) Processing facilities that are completely dedicated to producing only pork-filled pasta products for export to the United States and do not receive, handle, or process any animal product not intended for export to the United States are exempt from the requirements of paragraphs (c)(3) through (c)(6) of this section.
(8) During processing, the pork-filled pasta must be steam-heated to a minimum internal temperature of 90 °C, then dried, cooled, and packed to make the product shelf stable without refrigeration.
(9) The processing facility must maintain under lock and key, for a minimum of 2 years, an original record of each lot of pork or pork products used for pork-filled pasta products for export to the United States. Each record must include the following:
(i) The date that the cooked or dry-cured pork product was received in the processing facility;
(ii) The number of packages, the number of hams or cooked pork products per package, and the weight of each package;
(iii) A lot number or other identification marks;
(iv) The health certificate that accompanied the cooked or dry-cured pork product from the slaughter/processing facility to the meat-filled pasta product processing facility; and
(v) The date that the pork or pork product used in the pasta started dry curing (if the product used is a dry-cured ham) or the date that the product was cooked (if the product used is a cooked pork product).
(10) The pork-filled pasta must be accompanied by a certificate issued by an official of the National Government of the region in which the pasta product is processed who is authorized to issue the foreign meat inspection certificate required under § 327.4 of this title, stating that the pork-filled pasta product has been processed in accordance with the requirements of this section.
Upon arrival of the pork-filled pasta in the United States, the certificate must be presented to an inspector at the port of arrival.
For
Austria, the Bahamas, Belgium, Bulgaria, Chile, the Czech Republic, Denmark, France, Germany, Hungary, Latvia, Lithuania, Luxembourg, the Netherlands, Poland, Portugal, Republic of Ireland, Spain, Switzerland, the United Kingdom (England, Scotland, Wales, the Isle of Man, and Northern Ireland), Yugoslavia, and the Regions in Italy of Friuli, Liguria, Marche, and Valle d'Aosta are declared free of swine vesicular disease in § 94.12(a) of this part. These regions either supplement their national pork supply by the importation of fresh (chilled or frozen) meat of animals from regions where swine vesicular disease is considered to exist, have a common border with such regions, or have trade practices that are less restrictive than are acceptable to the United States. Thus, the pork or pork products produced in such regions may be commingled with fresh (chilled or frozen) meat of animals from a region where swine vesicular disease is considered to exist, resulting in an undue risk of swine vesicular disease introduction into the United States. Therefore, pork or pork products and ship's stores, airplane meals, and baggage containing such pork, other than those articles regulated under part 95 or part 96 of this chapter, produced in such regions shall not be brought into the United States unless the following requirements are met in addition to other applicable requirements of part 327 of this title:
(a) All such pork or pork products, except those treated in accordance with § 94.12(b)(1)(i) of this part, shall have been prepared only in inspected establishments that are eligible to have their products imported into the United States under the Federal Meat Inspection Act (21 U.S.C. 601
(b) Unless such pork or pork products are treated according to one of the procedures described in § 94.12(b) of this part, the pork or pork products must be accompanied by an additional certificate issued by a full-time salaried veterinary official of the agency in the national government responsible for the health of the animals within that region. Upon arrival of the pork or pork products in the United States, the certificate must be presented to an authorized inspector at the port of arrival. The certificate shall state the name and official establishment number of the establishment where the swine involved were slaughtered and
(1) The slaughtering establishment is not permitted to receive animals that originated in, or have ever been in a region listed in § 94.12(a) as a region in which swine vesicular disease is considered to exist;
(2) The slaughtering establishment is not permitted to receive pork derived from swine which originated in such a region or pork from swine from a swine vesicular disease free region which has been transported through a region where swine vesicular disease is considered to exist except pork which was transported in containers sealed with serially numbered seals of the National Government of a region of origin listed in § 94.12 as a region considered free of the disease.
(3) The pork has been processed, stored, and transported to the means of conveyance that will bring the article to the United States in a manner that precludes its being commingled or otherwise coming in contact with pork or pork products that have not been handled in accordance with the requirements of this section.
For
(a) Swine vesicular disease is known to exist in all regions of the world except those listed in § 94.12(a) of this part. No swine which are moved from or transit any region in which swine vesicular disease is known to exist may be imported into the United States except wild swine imported in accordance with paragraph (b) of this section.
(b) Wild swine may be allowed importation into the United States by the Administrator upon request in specific cases under § 93.501 or § 93.504(c) of this chapter.
(a) Any animal product or material which would be eligible for entry into the United States, as specified in the regulations in this part, may transit through the United States for immediate export if the following conditions are met:
(1) Notification of the transiting of such animal product or material must be made by the importer to the Plant Protection and Quarantine Officer at the United States port of arrival prior to such transiting, and
(2) The animal product or material transited shall be contained in a sealed, leakproof carrier or container which shall remain sealed while aboard the transporting carrier or other means of conveyance, or if the container or carrier in which such animal product or material is transported is offloaded in the United States for reshipment, it shall remain sealed at all times.
(b) Pork and pork products from Baja California, Baja California Sur, Campeche, Chihuahua, Coahuila, Nuevo Leon, Quintana Roo, Sinaloa, Sonora, and Yucatan, Mexico, that are not eligible for entry into the United States in accordance with this part may transit the United States via land border ports for immediate export if the following conditions are met:
(1) The person desiring to move the pork and pork products through the United States obtains a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors (VS Form 16-6). (An application for the permit may be obtained from the Animal and Plant Health Inspection Service, Veterinary Services, National Center for Import-Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231.)
(2) The pork or pork products are packaged at a Tipo Inspección Federal
(3) The person moving the pork and pork products through the United States notifies, in writing, the Plant Protection and Quarantine Officer at the United States port of arrival prior to such transiting. The notification must include the following information regarding the pork and pork products:
(i) Permit number;
(ii) Times and dates of arrival in the United States;
(iii) Time schedule and route to be followed through the United States; and
(iv) Serial numbers of the seals on the containers.
(4) The pork and pork products transit the United States under Customs bond and are exported from the United States within the time limit specified on the permit. Any pork or pork products that have not been exported within the time limit specified on the permit or that have not been transited in accordance with the permit or applicable requirements of this part will be destroyed or otherwise disposed of as the Administrator may direct pursuant to the Animal Health Protection Act (7 U.S.C. 8301
(c) Poultry carcasses, parts, or products (except eggs and egg products) from Baja California, Baja California Sur, Campeche, Chihuahua, Nuevo Leon, Quintana Roo, Sinaloa, Sonora, Tamaulipas, or Yucatan, Mexico, that are not eligible for entry into the United States in accordance with the regulations in this part may transit the United States via land ports for immediate export if the following conditions are met:
(1) The person desiring to move the poultry carcasses, parts, or products through the United States obtains a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors (VS Form 16-6). An application for the permit may be obtained from the Animal and Plant Health Inspection Service, Veterinary Services, National Center for Import-Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231.
(2) The poultry carcasses, parts, or products are packaged at a Tipo Inspeccioón Federal plant in Baja California, Baja California Sur, Campeche, Chihuahua, Nuevo Leon, Quintana Roo, Sinaloa, Sonora, Tamaulipas, or Yucatan, Mexico, in leakproof containers with serially numbered seals of the Government of Mexico, and the containers remain sealed during the entire time they are in transit across Mexico and the United States.
(3) The person moving the poultry carcasses, parts, or products through the United States notifies, in writing, the Plant Protection and Quarantine Officer at the U.S. port of arrival prior to such transiting. The notification must include the following information regarding the poultry to transit the United States:
(i) Permit number;
(ii) Times and dates of arrival in the United States;
(iii) Time schedule and route to be followed through the United States; and
(iv) Serial numbers of the seals on the containers.
(4) The poultry carcasses, parts, or products transit the United States under U.S. Customs bond and are exported from the United States within the time limit specified on the permit. Any poultry carcasses, parts, or products that have not been exported within the time limit specified on the permit or that have not transited in accordance with the permit or applicable requirements of this part will be destroyed or otherwise disposed of as the Administrator may direct pursuant to the Animal Health Protection Act (7 U.S.C. 8301
(d) Meat and other products of ruminants or swine from regions listed in § 94.11(a) and pork and pork products from regions listed in § 94.13 that do not meet the requirements of § 94.11(b) or § 94.13(a) may transit through the United States for immediate export, provided the provisions of paragraph
(e) Any meat or other animal products not otherwise eligible for entry into the United States, as provided in this part and part 95 of this chapter, may transit the United States for immediate export if the following conditions are met:
(1) Notification of the transiting of such meat or other animal product is made by the importer to the Plant Protection and Quarantine officer at the United States port of arrival prior to such transiting;
(2) The meat or other animal product is contained in a sealed, leakproof carrier or container, which remains sealed while aboard the transporting carrier or other means of conveyance, or, if the container or carrier in which the meat or other animal product is transported is offloaded in the United States for reshipment, it remains sealed at all times;
(3) Such transit is limited to the maritime or airport port of arrival only, with no overland movement outside the airport terminal area or dock area of the maritime port; and
(4) The meat or other animal product is not held or stored for more than 72 hours at the maritime or airport port of arrival.
(a) The following milk products are exempt from the provisions of this part:
(1) Cheese, but not including cheese with liquid and not including cheese containing any item that is regulated by other sections of this part, unless such item is independently eligible for importation into the United States under this part;
(2) Butter; and
(3) Butteroil.
(b) Milk and milk products originating in, or shipped from, any region designated in § 94.1(a) as a region infected with rinderpest or foot-and-mouth disease may be imported into the United States if they meet the requirements of paragraphs (b)(1), (2), or (3) of this section:
(1) They are in a concentrated liquid form and have been processed by heat by a commercial method in a container hermetically sealed promptly after filling but before such heating, so as to be shelf stable without refrigeration.
(2) They are dry milk or dry milk products, including dry whole milk, nonfat dry milk, dried whey, dried buttermilk, and formulations which contain any such dry milk products, and are consigned directly to an approved establishment
(3) Milk and milk products not exempted under paragraph (a) and not of classes included within the provisions of paragraphs (b)(1) or (2) of this section may be imported if the importer first applies to and receives written permission from the Administrator, authorizing such importation. Permission will be granted only when the Administrator determines that such action will not endanger the health of the livestock of the United States. Products subject to this provision include but are not limited to condensed milk, long-life milks such as sterilized milk, casein and caseinates, lactose, and lactalbumin.
(4) Small amounts of milk and milk products subject to the restrictions of this part may in specific cases be imported for purposes of examination, testing, or analysis, if the importer applies to and receives written approval for such importation from the Administrator. Approval will be granted only when the Administrator determines that such action will not endanger the health of the livestock of the United States.
(c) Milk and milk products originating in and shipped from regions listed in § 94.1(a)(2) as free of rinderpest and foot-and-mouth disease but which have entered a port or otherwise transited any region designated in § 94.1(a)(1) as a region infected with rinderpest or foot-and-mouth disease shall not be imported into the United States unless:
(1) The product was transported under serially numbered official seals applied at the point of origin of the shipment by an authorized representative of the region of such origin; except that, if any seal applied at the point of origin was broken by any foreign official to inspect the shipment, an authorized representative of that region applied a new serially numbered official seal to the hold, compartment, or container in which the milk or milk products were transported; and if any member of a ship's crew broke a seal, the serial number of the seal, the location of the seal, and the reason for breaking the seal were recorded in the ship's log.
(2) The numbers of such seals are listed on, or are on a list attached to, the bill of lading or similar document accompanying the shipment.
(3) Upon arrival of the carrier at the United States port, an inspector of the Animal and Plant Health Inspection Service determines that the seals are intact and that their numbers are in agreement with the numbers appearing on the accompanying document;
(d) Except for milk and milk products imported from Canada, and except as provided in this paragraph, milk or milk products imported from a region listed in § 94.1(a)(2) as free of rinderpest and foot-and-mouth disease must be accompanied by a certificate endorsed by a full-time, salaried veterinarian employed by the region of export. The certificate must state that the milk was produced and processed in a region listed in § 94.1(a)(2), or that the milk product was processed in a region listed in § 94.1(a)(2) from milk produced in a region listed in § 94.1(a)(2). The certificate must name the region in which the milk was produced and the region in which the milk or milk product was processed. Further, the certificate must state that, except for movement under seal as described in § 94.16(c), the milk or milk product has never been in any region in which rinderpest or foot-and-mouth disease exists. Milk or milk products from a region listed in § 94.1(a)(2) that were processed in whole or in part from milk or milk products from a region not listed in § 94.1(a)(2) may be imported into the United States in accordance with § 94.16(b)(3).
Notwithstanding any other provisions in this part, dry-cured ham, pork shoulder, or pork loin, whether whole or sliced and packaged, shall not be prohibited from being imported into the United States if it meets the following conditions:
(a) Except for Italian-type hams, Serrano hams, Iberian hams, Iberian pork shoulders, and Iberian pork loins that have been processed in accordance with paragraph (i) of this section, the dry-cured ham, pork shoulder, or pork loin came from a swine that was never out of the region in which the dry-cured ham, pork shoulder, or pork loin was processed;
(b) The ham, pork shoulder, or pork loin came from a region determined by the Administrator, to have and to enforce laws requiring the immediate reporting to the national veterinary services in that region any premises found to have any animal infected with foot-and-mouth disease, rinderpest, African Swine fever, classical swine fever, or swine vesicular disease;
(c) The ham, pork shoulder, or pork loin came from a swine that was not on any premises where foot-and-mouth disease, rinderpest, African swine fever, classical swine fever, or swine vesicular disease exists or had existed within 60 days prior to slaughter;
(d) The whole ham, pork shoulder, or pork loin was accompanied from the slaughtering facility to the processing establishment by a numbered certificate issued by a person authorized by the government of the region of origin stating that the provisions of paragraphs (a) and (c) of this section have been met;
(e) The ham, pork shoulder, or pork loin was processed whole as set forth in paragraph (i) of this section in only one processing establishment;
(f) The ham, pork shoulder, or pork loin was processed whole in a processing establishment that prior to the processing of any hams, pork shoulders, or pork loins in accordance with this section, was inspected by a veterinarian of APHIS and determined by the Administrator, to be capable of meeting the provisions of this section for processing hams, pork shoulders, or
(g) The ham, pork shoulder, or pork loin was processed whole in a processing establishment for which the operator of the establishment has signed an agreement with APHIS prior to receipt of the hams, pork shoulders, or pork loins for processing, stating that all hams, pork shoulders, or pork loins processed for importation into the United States will be processed only in accordance with the provisions of this part;
(h) Workers who handle fresh pork in the processing establishment where the dry-cured ham, pork shoulder, or pork loin was processed whole are required to shower and put on a full set of clean clothes, or to wait 24 hours after handling fresh pork, before handling hams, pork shoulders, or pork loins that have progressed in the aging/curing process as follows:
(1) In the case of Italian-type hams processed in accordance with paragraph (i)(1) of this section, those that have progressed beyond the final wash stage;
(2) In the case of Serrano hams or Iberian hams or pork shoulders processed in accordance with paragraphs (i)(2), (i)(3), or (i)(4) of this section, those that have progressed beyond salting; and
(3) In the case of Iberian pork loins processed in accordance with paragraph (i)(5) of this section, those that have progressed beyond being placed in a casing.
(i) The dry-cured ham, pork shoulder, or pork loin was processed whole in accordance with this paragraph. Except for pork fat treated to at least 76 °C (168.8 °F), which may have been placed over the meat during curing, the dry-cured pork product must have had no contact with any other meat or animal product during processing.
(1)
(2)
(i) If the ham is received frozen, it was thawed in a chamber with relative humidity between 70 and 80 percent, with room temperature maintained at 12 °C to 13 °C (53.6 °F to 55.4 °F) for the first 24 hours, then at 13 °C to 14 °C (55.4 °F to 57.2 °F) until the internal temperature of the ham reached 3 °C to 4 °C (37.4 °F to 39.2 °F), at which point the blood vessels at the end of the femur were massaged to remove any remaining blood.
(ii) The ham was covered in salt and placed in a chamber maintained at a temperature from 0 °C to 4 °C (32 °F to 39.2 °F), with relative humidity between 75 and 95 percent, for a period no less than 0.65 days per kg and no more
(iii) The ham was rinsed with water and/or brushed to remove any remaining surface salt.
(iv) The ham was placed in a chamber maintained at a temperature of 0 °C to 6 °C (32 °F to 42.8 °F), with a relative humidity of 70 to 95 percent, for no less than 40 and no more than 60 days;
(v) The ham was placed for curing in a chamber with a relative humidity of 60 to 80 percent and a temperature gradually raised in 3 phases, as follows:
(A) A temperature of 6 °C to 16 °C (42.8 °F to 60.8 °F), maintained for a minimum of 45 days;
(B) A temperature of 16 °C to 24 °C (60.8 °F to 75.2 °F), maintained for a minimum of 35 days;
(C) A temperature of 24 °C to 34 °C (75.2 °F to 93.2 °F), maintained for a minimum of 30 days;
(vi) Finally, with the relative humidity unchanged at 60 to 80 percent, the temperature was lowered to 12 °C to 20 °C (53.6 °F to 68 °F) and maintained at that level for a minimum of 35 days, until at least 190 days after the start of the curing process;
(3)
(i) If the ham is received frozen, it was thawed in a chamber with relative humidity between 70 and 80 percent, with room temperature maintained at 5.5 °C to 6.5 °C (41.9 °F to 43.7 °F) for the first 24 hours, then at 9.5 °C to 10.5 °C (49.1 °F to 50.9 °F) until the internal temperature of the ham reached 3 °C to 4 °C (37.4 °F to 39.2 °F), at which point the blood vessels at the end of the femur were massaged to remove any remaining blood.
(ii) The ham was covered in salt and placed in a chamber maintained at a temperature from 0 °C to 4 °C (32 °F to 39.2 °F), with relative humidity between 75 and 95 percent, and kept in the chamber for a period no less than 0.65 days per kg and no more than 2 days per kg of the weight of the ham;
(iii) The ham was rinsed with water and/or brushed to remove any remaining surface salt.
(iv) The ham was placed in a chamber maintained at a temperature of 0 °C to 6 °C (32 °F to 42.8 °F), with relative humidity of 70 to 95 percent, for no less than 40 and no more than 60 days.
(v) The ham was placed for curing in a chamber with a temperature of 6 °C to 16 °C (42.8 °F to 60.8 °F) and relative humidity of 60 to 80 percent for a minimum of 90 days.
(vi) The temperature was raised to 16 °C to 26 °C (60.8 °F to 78.8 °F) and the relative humidity reduced to 55 to 85 percent, for a minimum of 90 days.
(vii) Finally, with the relative humidity raised to 60 to 90 percent, the temperature was lowered to 12 °C to 22 °C (53.6 °F to 71.6 °F) and maintained at that level for a minimum of 115 days, until at least 365 days after the start of the curing process;
(4)
(i) If the pork shoulder is received frozen, it was thawed at a room temperature of 12 °C to 13 °C (53.6 °F to 55.4 °F), with the relative humidity between 75 and 85 percent, for approximately 24 hours, until the internal temperature reached 3 °C to 4 °C (37.4 °F to 39.2 °F), at which point the blood vessels in the scapular region were massaged to remove any remaining blood.
(ii) The pork shoulder was covered in salt and placed in a chamber maintained at a temperature of 0 °C to 4 °C (32 °F to 39.2 °F) with the relative humidity between 75 and 95 percent, for a period of no less than 0.65 days per kg and no more than 2 days per kg of the weight of the pork shoulder.
(iii) The pork shoulder was rinsed with water and/or brushed to remove any remaining surface salt.
(iv) The pork shoulder was placed in a chamber maintained at a temperature of 0 °C to 6 °C (32 °F to 42.8 °F) and a relative humidity of 70 to 95 percent
(v) The pork shoulder was placed for curing in a chamber at a temperature of 6 °C to 16 °C (42.8 °F to 60.8 °F) and a relative humidity of 60 to 80 percent for a minimum of 90 days.
(vi) The temperature was raised to 16 °C to 26 °C (60.8 °F to 78.8 °F) and the relative humidity was changed to 55 to 85 percent, and those levels were maintained for a minimum of 90 days.
(vii) Finally, the temperature was reduced to 12 °C to 22 °C (53.6 °F to 71.6 °F) and the relative humidity was raised to 60 to 90 percent for a minimum of 45 days, until at least 240 days after the start of the curing process.
(5)
(i) If the pork loin is received frozen, it was thawed at a room temperature maintained at 11 °C to 12 °C (51.8 °F to 53.6 °F), with the relative humidity between 70 and 80 per cent for the first 24 hours, then between 75 and 85 percent, until the loin's internal temperature reached 3 °C to 4 °C (37.4 °F to 39.2 °F), at which point the external fat, aponeurosis, and tendons were cleaned from the loin.
(ii) The pork loin was covered in a pickle preparation (25-30 grams of salt for each kilogram of pork loin) and placed in a chamber where it was maintained at a relative humidity of 75 to 95 percent and a temperature of 3 °C to 4 °C (37.4 °F to 39.2 °F) for 72 hours.
(iii) The pork loin was removed from the pickle preparation (25-30 grams of salt for each kilogram of pork loin), externally cleaned (brushed or rinsed), placed in an artificial casing, and fastened shut with a metal clip.
(iv) The pork loin was placed for curing in a chamber with a relative humidity of 60 to 90 percent and a temperature gradually raised in 3 phases, as follows:
(A) A temperature of 2 °C to 6 °C (35.6 °F to 42.8 °F), maintained for a minimum of 20 days;
(B) A temperature of 6 °C to 15 °C (42.8 °F to 59.0 °F), maintained for a minimum of 20 days;
(C) A temperature of 15 °C to 25 °C (59.0 °F to 77.0 °F), maintained for a minimum of 40 days;
(v) Finally, with the relative humidity unchanged at 60 to 80 percent and the temperature lowered to 0 °C to 5 °C (32.0 °F to 41.0 °F), the pork loin was vacuum-packed and maintained under those conditions for a minimum of 15 days, until at least 130 days after the start of the curing process.
(j)(1) The whole ham, if it is Italian-type ham processed in accordance with paragraph (i)(1) of this section, bears a hot iron brand or an ink seal (with the identifying number of the slaughtering establishment) which was placed thereon at the slaughtering establishment under the direct supervision of a person authorized to supervise such activity by the veterinary services of the national government of the region of origin, bears a button seal (approved by the Administrator, as being tamper-proof) on the hock that states the month and year the ham entered the processing establishment and a hot iron brand (with the identifying number of the processing establishment and the date salting began) which were placed thereon at the processing establishment immediately prior to salting, under the supervision of a person authorized to supervise such activity by the veterinary services of the national government of the region of origin;
(2) The whole dry-cured ham, if it is processed in accordance with paragraphs (i)(2) or (i)(3) of this section, or the whole dry-cured pork shoulder, if it is processed in accordance with paragraph (i)(4) of this section, bears an ink seal (with the identifying number of the slaughtering establishment) which was placed thereon at the slaughtering establishment under the direct supervision of a person authorized to supervise such activity by the veterinary services of the national government of the region of origin, and an ink seal (with the identifying number of the processing establishment and the date the salting began) which was placed thereon at the processing establishment, immediately prior to salting, under the supervision of a person authorized to supervise such activity by the veterinary services of the national government of the region of origin; or
(3) The whole dry-cured pork loin, if it is processed in accordance with paragraph (i)(5) of this section, is packaged
(k) The whole dry-cured ham, pork shoulder, or pork loin came from an establishment where a person authorized by the veterinary services of the national government of the region of origin to conduct activities under this paragraph, maintained original records (which shall be kept for a minimum of two years) identifying the dry-cured ham, pork shoulder, or pork loin by the date it entered the processing establishment, by the slaughtering facility from which it came, and by the number of the certificate which accompanied the dry-cured ham, pork shoulder, or pork loin from the slaughtering facility to the processing establishment, and where such original records are maintained under lock and key by such person, with access to such original records restricted to officials of the government of the region of origin, officials of the United States Government, and such person maintaining the records;
(l) The whole dry-cured ham, pork shoulder, or pork loin came from a processing establishment which allows the unannounced entry into the establishment of APHIS personnel, or other persons authorized by the Administrator, for the purpose of inspecting the establishment and records of the establishment;
(m) The dry-cured ham, pork shoulder, or pork loin was processed in accordance with one of the following criteria: (1) The ham, if it is an Italian-type ham processed in accordance with paragraph (i)(1) of this section, was processed in a region which has been determined by the Administrator, to be free of rinderpest, and which has through its veterinary services submitted to the Administrator, a written statement stating that it conducts a program to authorize persons to supervise activities specified under this section;
(2) The Serrano ham, processed in accordance with paragraph (i)(2) of this section, and came from any breed of large, white swine, including but not limited to Landrace, Pietrain, Duroc, Jersey, Hampshire, and Yorkshire breeds, and crosses of such breeds;
(3) The Iberian ham, processed in accordance with paragraph (i)(3) of this section, and came from a swine of the Iberico breed of pigs;
(4) The Iberian pork shoulder, processed in accordance with paragraph (i)(4) of this section, and came from a swine of the Iberico breed of pigs;
(5) The Iberian pork loin, if processed in accordance with paragraph (i)(5) of this section, and came from a swine of the Iberico breed of pigs.
(n) The whole dry-cured ham, pork shoulder, or pork loin came from a processing establishment that has entered into a cooperative service agreement executed by the operator of the establishment or a representative of the establishment and APHIS, and that pursuant to the cooperative service agreement is current in paying all costs for a veterinarian of APHIS to inspect the establishment (it is anticipated that such inspections will occur up to four times per year), including travel, salary, subsistence, administrative overhead, and other incidental expenses (including an excess baggage provision up to 150 pounds). In accordance with the terms of the cooperative service agreement, the operator of the processing establishment shall deposit with the Administrator, an amount equal to the approximate costs for a veterinarian to inspect the establishment one time, including travel, salary, subsistence, administrative overhead and other incidental expenses (including an excess baggage provision up to 150 pounds), and as funds from that amount are obligated, bills for costs incurred based on official accounting records will be issued to restore the deposit to its original level. Amounts to
(o) The dry-cured ham, pork shoulder, or pork loin is accompanied at the time of importation into the United States by a certificate issued by a person authorized to issue such certificates by the veterinary services of the national government of the region of origin, stating:
(1) That all the provisions of this section have been complied with, including paragraphs (i) and (m) of this section;
(2) The paragraph of this section under which the dry-cured ham, pork shoulder, or pork loin was processed; and stating further that, if the product covered by the certificate:
(i) Is an Italian-type ham processed under paragraph (i)(1) of this section, it was processed for a minimum of 400 days;
(ii) Is a Serrano ham processed under paragraph (i)(2) of this section, it was:
(A) Processed for a minimum of 190 days in a region free of swine vesicular disease, in a facility authorized by the veterinary services of the national government of that region to process only meat from regions free of swine vesicular disease; or,
(B) Processed for a minimum of 560 days in any region, in a facility that may also process meat from regions where swine vesicular disease exists;
(iii) Is an Iberian ham processed under paragraph (i)(3) of this section, it was:
(A) Processed for a minimum of 365 days in a region free of swine vesicular disease, in a facility authorized by the veterinary services of the national government of that region to process only meat from regions free of swine vesicular disease; or,
(B) Processed for a minimum of 560 days in any region, in a facility that may also process meat from regions where swine vesicular disease exists;
(iv) Is a dry-cured pork shoulder, it was processed in accordance with paragraph (i)(4) of this section for a minimum of 240 days; or
(v) Is a dry-cured pork loin, it was processed in accordance with paragraph (i)(5) of this section for a minimum of 130 days.
(p) Whole hams, pork shoulders, and pork loins that have been dry-cured in accordance with paragraph (i) of this section may be transported to a facility in the same region for slicing and packaging in accordance with this paragraph.
(1)
(ii) The slicing/packaging facility must be either in a separate, physically detached building, or in a separate room in the facility where the whole ham, pork shoulder, or pork loin was dry-cured in accordance with paragraph (i) of this section. If the slicing/packaging facility is in a separate room, the room must have no direct access to areas in the facility where pork is cured and dried and it must be capable of being closed off from the rest of the facility so unauthorized individuals cannot enter.
(iii) The slicing/packaging facility, including all equipment used to handle pork and pork products, such as containers, work surfaces, slicing machines, and packaging equipment, must be cleaned and disinfected after sliced and packaged pork products that are not eligible for export to the United States leave the facility, and before whole dry-cured hams, pork shoulders, or pork intended for importation into the United States enter the facility for slicing and packaging. Cleaning and disinfecting must be adequate to ensure that disease agents of concern are killed or inactivated and that pork products intended for importation into the United States are not contaminated.
(iv) The slicing/packaging facility must maintain under lock and key for a minimum of 2 years, original records on each lot of whole dry-cured hams, pork shoulders, and pork loins entering the facility for slicing and packaging under this section, including:
(A) The approval number of the facility where the whole ham, shoulder, or loin was dry-cured in accordance with paragraph (i) of this section;
(B) The date the whole ham, shoulder, or loin started dry-curing;
(C) The date the whole ham, shoulder, or loin completed dry-curing;
(D) The date the whole ham, shoulder, or loin was sliced and packaged; and
(E) A copy of all certifications required under paragraph (p) of this section.
(v) Access to records required to be maintained under paragraph (p) of this section must be restricted to officials of the national government of the region of origin, representatives of the United States Government, and persons maintaining the records.
(vi) The operator of the slicing/packaging facility must have signed a cooperative service agreement with APHIS prior to receipt of the whole dry-cured hams, pork shoulders, or pork loins for slicing and packaging, stating that all hams, pork shoulders, or pork loins sliced and packaged at the facility for importation into the United States will be sliced and packaged only in accordance with this section.
(vii) The operator of the slicing/packaging facility must be current, in accordance with the terms of the cooperative service agreement signed with APHIS, in paying all costs for an APHIS representative to inspect the establishment, including travel, salary, subsistence, administrative overhead, and other incidental expenses.
(viii) The slicing/packaging facility must allow the unannounced entry into the establishment of APHIS representatives, or other persons authorized by the Administrator, for the purpose of inspecting the establishment and records of the establishment.
(ix) Workers at the slicing/packaging facility who handle pork or pork products in the facility must shower and put on a full set of clean clothes, or wait 24 hours after handling pork or pork products that are not eligible for importation into the United States, before handling dry-cured hams, pork shoulders, or pork loins in the slicing/packaging facility that are intended for importation into the United States.
(x) Pork products intended for importation into the United States may not be in the slicing/packaging facility at the same time as pork products not intended for exportation to the United States.
(2)
(ii) Either a full-time salaried veterinarian employed by the national government of the region of origin, or, if the national government of the region of origin recognizes a local consortium as responsible for product quality, a representative of that local consortium, must certify in English that he or she personally supervised the entire process of slicing and packaging each lot of dry-cured hams, pork shoulders, and pork loins at the slicing/packaging facility; that each lot of dry-cured hams, pork shoulders, and pork loins was sliced and packaged in accordance with the requirements of this paragraph; and that the sliced and packaged pork ham, shoulder, or loin is the same dry-cured ham, pork shoulder, or pork loin certified under paragraph (p)(2)(i).
(iii) The sliced and packaged dry-cured pork ham, pork shoulder, or pork loin must be labeled with the date that processing of the meat under paragraph (i) of this section began, and with the date the meat was sliced and packaged.
(a)(1) Bovine spongiform encephalopathy exists in the following regions: Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Greece, the Republic of Ireland, Israel, Italy, Japan, Liechtenstein, Luxembourg, Oman, The Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, Switzerland, and the United Kingdom.
(2) The following regions, because of import requirements less restrictive than those that would be acceptable for import into the United States and/or because of inadequate surveillance, present an undue risk of introducing bovine spongiform encephalopathy into the United States: Albania, Andorra, Bosnia-Herzegovina, Bulgaria, Croatia, the Federal Republic of Yugoslavia, Hungary, the Former Yugoslav Republic of Macedonia, Monaco, Norway, Romania, San Marino, and Sweden.
(3) The following are minimal-risk regions with regard to bovine spongiform encephalopathy: Canada.
(4) A region may request at any time that the Administrator consider its removal from a list in paragraphs (a)(1) or (a)(2) of this section, or its addition to or removal from the list in paragraph (a)(3) of this section, by following the procedures in part 92 of this subchapter.
(b) Except as provided in paragraph (d) of this section or in §§ 94.19 or 94.27, the importation of meat, meat products, and edible products other than meat (except for gelatin as provided in paragraph (c) of this section, milk, and milk products) from ruminants that have been in any of the regions listed in paragraph (a) of this section is prohibited.
(c)
(1) The gelatin must be imported for use in human food, human pharmaceutical products, photography, or some other use that will not result in the gelatin coming in contact with ruminants in the United States.
(2) The person importing the gelatin must obtain a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors by filing a permit application on VS form 16-3.
(3) The permit application must state the intended use of the gelatin and the name and address of the consignee in the United States.
(d)
(1) The person moving the articles must obtain a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors by filing a permit application on VS form 16-3.
(2) The articles must be sealed in leakproof containers bearing serial numbers during transit. Each container must remain sealed during the entire time that it is in the United States.
(3) The person moving the articles must notify, in writing, the inspector at both the place in the United States where the articles will arrive and the port of export before such transit. The notification must include the:
(i) United States Veterinary Permit for Importation and Transportation of
(ii) Times and dates of arrival in the United States;
(iii) Times and dates of exportation from the United States;
(iv) Mode of transportation; and
(v) Serial numbers of the sealed containers.
(4) The articles must transit the United States in Customs bond.
(5) The commodities must be eligible to enter the United States in accordance with § 94.19 and must be accompanied by the certification required by that section. Additionally, the following conditions must be met:
(i) The shipment must be exported from the United States within 7 days of its entry;
(ii) The commodities may not be transloaded while in the United States, except for direct transloading under the supervision of an authorized inspector, who must break the seals of the national government of the region of origin on the means of conveyance that carried the commodities into the United States and seal the means of conveyance that will carry the commodities out of the United States with seals of the U.S. Government;
(iii) A copy of the import permit required under paragraph (d)(1) of this section must be presented to the inspector at the port of arrival and the port of export in the United States.
For
Except as provided in § 94.18 and this section, the importation of meat, meat products, and edible products other than meat (excluding gelatin that meets the conditions of § 94.18(c), milk, and milk products), from bovines, sheep, or goats that have been in any of the regions listed in § 94.18(a)(3) is prohibited. The commodities listed in paragraphs (a) through (f) of this section may be imported from a region listed in § 94.18(a)(3) if the conditions of this section are met; if (except for commodities described in paragraph (e) of this section) the commodities are accompanied by an original certificate of such compliance issued by a full-time salaried veterinary officer of the national government of the region of origin, or issued by a veterinarian designated or accredited by the national government of the region of origin and endorsed by a full-time salaried veterinary officer of the national government of the region of origin, representing that the veterinarian issuing the certificate was authorized to do so; and if all other applicable requirements of this part are met.
(a)
(1) The meat, meat byproduct, or meat food product is derived from bovines for which an air-injected stunning process was not used at slaughter; and
(2) The SRMs of the bovines were removed at slaughter.
(b)
(1) The bovines are subject to a ruminant feed ban equivalent to the requirements established by the U.S. Food and Drug Administration at 21 CFR 589.2000; and
(2) The SRMs of the bovines were removed at slaughter.
(c)
(1) The animals were slaughtered at a facility that either slaughters only sheep and/or goats or other ovines and caprines less than 12 months of age or complies with a segregation process approved by the national veterinary authority of the region of origin and the Administrator as adequate to prevent contamination or commingling of the meat with products not eligible for importation into the United States;
(2) The animals did not test positive for and were not suspect for a transmissible spongiform encephalopathy;
(3) The animals have not resided in a flock or herd that has been diagnosed with BSE; and
(4) The animals' movement is not restricted within Canada as a result of exposure to a transmissible spongiform encephalopathy.
(d)
(1) The animals were slaughtered at a facility that either slaughters only sheep and/or goats or other ovines and caprines less than 12 months of age or complies with a segregation process approved by the national veterinary authority of the region of origin and the Administrator as adequate to prevent contamination or commingling of the meat with products not eligible for importation into the United States;
(2) The animals did not test positive for and were not suspect for a transmissible spongiform encephalopathy;
(3) The animals have not resided in a flock or herd that has been diagnosed with BSE; and
(4) The animals' movement is not restricted within Canada as a result of exposure to a transmissible spongiform encephalopathy.
(e)
(1) The meat or dressed carcass is derived from an animal that has been legally harvested in the wild, as verified by proof such as a hunting license, tag, or the equivalent that the hunter must show to the United States Customs and Border Protection official; and
(2) The animal from which the meat is derived was harvested within a jurisdiction specified by the Administrator for which the game and wildlife service of the jurisdiction has informed the Administrator either that the jurisdiction conducts no type of game feeding program, or has complied with, and continues to comply with, a ruminant feed ban equivalent to the requirements established by the U.S. Food and Drug Administration at 21 CFR 589.2000.
(f)
(g)
Gelatin derived from horses or swine, or from ruminants that have not been in any region listed in § 94.18(a) of this part, must be accompanied at the time of importation into the United States by an official certificate issued by a veterinarian employed by the national government of the region of origin. The official certificate must state the species of animal from which the gelatin is derived and, if the gelatin is derived from ruminants, certify that the gelatin is not derived from ruminants that have been in any region listed in § 94.18(a).
Notwithstanding any other provisions of this part, fresh (chilled or frozen) beef from Uruguay may be exported to the United States under the following conditions:
(a) The meat is beef from bovines that have been born, raised, and slaughtered in Uruguay.
(b) Foot-and-mouth disease has not been diagnosed in Uruguay within the previous 12 months.
(c) The beef came from bovines that originated from premises where foot-and-mouth disease has not been present during the lifetime of any bovines slaughtered for the export of beef to the United States.
(d) The beef came from bovines that were moved directly from the premises of origin to the slaughtering establishment without any contact with other animals.
(e) The beef came from bovines that received ante-mortem and post-mortem veterinary inspections, paying particular attention to the head and feet, at the slaughtering establishment, with no evidence found of vesicular disease.
(f) The beef consists only of bovine parts that are, by standard practice, part of the animal's carcass that is placed in a chiller for maturation after slaughter. Bovine parts that may not be imported include all parts of bovine heads, feet, hump, hooves, and internal organs.
(g) All bone and visually identifiable blood clots and lymphoid tissue have been removed from the beef.
(h) The beef has not been in contact with meat from regions other than those listed in § 94.1(a)(2).
(i) The beef came from bovine carcasses that were allowed to maturate at 40 to 50° F (4 to 10° C) for a minimum of 36 hours after slaughter and that reached a pH of 5.8 or less in the loin muscle at the end of the maturation period. Measurements for pH must be taken at the middle of both
(j) An authorized veterinary official of the Government of Uruguay certifies on the foreign meat inspection certificate that the above conditions have been met.
(k) The establishment in which the bovines are slaughtered allows periodic on-site evaluation and subsequent inspection of its facilities, records, and operations by an APHIS representative.
Notwithstanding any other provisions of this part, poultry meat and other poultry products from the States of Sinaloa and Sonora, Mexico, may be imported into the United States under the following conditions:
(a) The poultry meat or other poultry products are derived from poultry born and raised in Sinaloa or Sonora and slaughtered in Sinaloa or Sonora at a federally inspected slaughter plant under the direct supervision of a full-
(b) If processed, the poultry meat or other poultry products were processed in either Sinaloa or Sonora, Mexico, in a federally inspected processing plant that is under the direct supervision of a full-time salaried veterinarian of the Government of Mexico.
(c) The poultry meat or other poultry products have not been in contact with poultry from any State in Mexico other than Sinaloa or Sonora or with poultry from any other region not listed in § 94.6 as a region where exotic Newcastle disease is not known to exist.
(d) The foreign meat inspection certificate accompanying the poultry meat or other poultry products (required by 9 CFR 381.197) includes statements certifying that the requirements in paragraphs (a), (b), and (c) of this section have been met and, if applicable, listing the numbers of the seals required by paragraph (e)(1) of this section.
(e) The shipment of poultry meat or other poultry products has not been in any State in Mexico other than Sinaloa or Sonora or in any other region not listed in § 94.6 as a region where exotic Newcastle disease is not known to exist, unless:
(1) The poultry meat or other poultry products arrive at the U.S. port of entry in shipping containers bearing intact, serially numbered seals that were applied at the federally inspected slaughter plant by a full-time salaried veterinarian of the Government of Mexico, and the seal numbers correspond with the seal numbers listed on the foreign meat inspection certificate; or
(2) The poultry meat or other poultry products arrive at the U.S. port of entry in shipping containers bearing seals that have different numbers than the seal numbers on the foreign meat inspection certificate, but, upon inspection of the hold, compartment, or container and all accompanying documentation, an APHIS representative is satisfied that the poultry containers were opened and resealed en route by an appropriate official of the Government of Mexico and the poultry meat or other poultry products were not contaminated or exposed to contamination during movement from Sinaloa or Sonora to the United States.
(a)
(1) The pork or pork products must not have been derived from swine that were in any of the following regions or zones, unless the swine were slaughtered after the periods described:
(i) Any region when the region was classified in §§ 94.9(a) and 94.10(a) as one in which classical swine fever is known to exist, except for the APHIS-defined EU CSF region;
(ii) A restricted zone in the APHIS-defined EU CSF region established because of detection of classical swine fever in domestic swine, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority of the Member State or until 6 months following depopulation of the swine on affected premises in the restricted zone and the cleaning and disinfection of the last affected premises in the zone, whichever is later; or
(iii) A restricted zone in the APHIS-defined EU CSF region established because of the detection of classical swine fever in wild boar, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority of the Member State.
(2) The pork and pork products must not have been commingled with pork or pork products derived from other swine that were in any of the regions or zones described in paragraphs (a)(1)(i) through (a)(1)(iii) of this section, unless the other swine were slaughtered after the periods described.
(3) The swine from which the pork or pork products were derived must not have transited any region or zone described in paragraphs (a)(1)(i) through (a)(1)(iii) of this section, unless the swine were moved directly through the region or zone in a sealed means of conveyance with the seal determined to be intact upon arrival at the point of destination, or unless the swine were slaughtered after the periods described.
(4) No equipment or materials used in transporting the swine from which the pork or pork products were derived from the farm of origin to the slaughtering establishment may have been used previously for transporting swine that do not meet the requirements of this section, unless the equipment and materials have first been cleaned and disinfected.
(5) The pork and pork products must be accompanied by a certificate issued by an official of the competent veterinary authority of the APHIS-defined EU CSF region Member State who is authorized to issue the foreign meat inspection certificate required by § 327.4 of this title, stating that the applicable provisions of paragraphs (a)(1) through (a)(4) of this section have been met.
(b)
(1) The swine must be breeding swine.
(2) The swine must not have been in any of the following regions or zones, unless the swine are exported to the United States after the periods described:
(i) Any region when the region was classified in §§ 94.9(a) and 94.10(a) as one in which classical swine fever is known to exist, except for the APHIS-defined EU CSF region;
(ii) A restricted zone in the APHIS-defined EU CSF region established because of the detection of classical swine fever in domestic swine, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority of the Member State or until 6 months following depopulation of the swine on affected premises in the restricted zone and the cleaning and disinfection of the last affected premises in the zone, whichever is later; or
(iii) A restricted zone in the APHIS-defined EU CSF region established because of the detection of classical swine fever in wild boar, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority of the Member State.
(3) The swine must not have been commingled with other swine that have at any time been in any of the regions or zones described in paragraphs (b)(2)(i) through (b)(2)(iii) of this section, unless the swine are exported after the periods described.
(4) The swine must not have transited any region or zone described in paragraphs (b)(2)(i) through (b)(2)(iii) of this section, unless the swine were moved directly through the region or zone in a sealed means of conveyance with the seal determined to be intact upon arrival at the point of destination, or unless the swine are exported after the periods described;
(5) No equipment or materials used in transporting the swine may have been used previously for transporting swine that do not meet the requirements of this section, unless the equipment and materials have first been cleaned and disinfected.
(6) The swine must be accompanied by a certificate issued by a salaried veterinary officer of the competent veterinary authority of the APHIS-defined EU CSF region Member State, stating that the conditions of paragraphs (b)(1) through (b)(5) of this section have been met.
(c) The certificates required by paragraphs (a)(5) and (b)(6) of this section must be presented by the importer to an authorized inspector at the port of arrival, upon arrival of the swine, pork, or pork products at the port.
The regions listed in paragraph (a) of this section are recognized as free of classical swine fever (CSF) in §§ 94.9(a) and 94.10(a) but either supplement their pork supplies with fresh (chilled or frozen) pork imported from regions considered to be affected by CSF, or supplement their pork supplies with pork from CSF-affected regions that is not processed in accordance with the requirements of this part, or share a common land border with CSF-affected regions, or import live swine from CSF-affected regions under conditions less restrictive than would be acceptable for importation into the United States. Thus, there exists a possibility that live swine, pork, or pork products from the CSF-free regions listed in paragraph (a) of this section may be commingled with live swine, pork, or pork products from CSF-affected regions, resulting in a risk of CSF introduction into the United States. Therefore, live swine, pork, or pork products and shipstores, airplane meals, and baggage containing pork or pork products, other than those articles regulated under parts 95 or 96 of this chapter, may not be imported into the United States from a region listed in paragraph (a) of this section unless the requirements in this section, in addition to other applicable requirements of part 93 of this chapter and part 327 of this title, are met.
(a) Regions subject to the requirements of this section: Chile and the Mexican States of Baja California, Baja California Sur, Campeche, Chihuahua, Nayarit, Quintana Roo, Sinaloa, Sonora, and Yucatan.
(b)
(1) The swine have not lived in a region designated in §§ 94.9 and 94.10 as affected with CSF;
(2) The swine have never been commingled with swine that have been in a region that is designated in §§ 94.9 and 94.10 as affected with CSF;
(3) The swine have not transited a region designated in §§ 94.9 and 94.10 as affected with CSF unless moved directly through the region to their destination in a sealed means of conveyance with the seal intact upon arrival at the point of destination; and
(4) The conveyances or materials used in transporting the swine, if previously used for transporting swine, have been cleaned and disinfected in accordance with the requirements of § 93.502 of this chapter.
(c)
(1) The pork or pork products were derived from swine that were born and raised in a region designated in §§ 94.9 and 94.10 as free of CSF and were slaughtered in such a region at a federally inspected slaughter plant that is
(2) The pork or pork products were derived from swine that have not lived in a region designated in §§ 94.9 and 94.10 as affected with CSF;
(3) The pork or pork products have never been commingled with pork or pork products that have been in a region that is designated in §§ 94.9 and 94.10 as affected with CSF;
(4) The pork or pork products have not transited through a region designated in §§ 94.9 and 94.10 as affected with CSF unless moved directly through the region to their destination in a sealed means of conveyance with the seal intact upon arrival at the point of destination; and
(5) If processed, the pork or pork products were processed in a region designated in §§ 94.9 and 94.10 as free of CSF in a federally inspected processing plant that is under the direct supervision of a full-time salaried veterinary official of the national government of that region.
Argentina and the Mexican States of Campeche, Quintana Roo, and Yucatan, which are declared in § 94.6(a)(2) to be free of exotic Newcastle disease (END), supplement their meat supply by the importation of fresh (chilled or frozen) poultry meat from regions designated in § 94.6(a) as regions where END is considered to exist, have a common land border with regions where END is considered to exist, or import live poultry from regions where END is considered to exist under conditions less restrictive than would be acceptable for importation into the United States. Thus, even though the Department has declared such regions to be free of END, live poultry originating in such free regions may be commingled with live poultry originating in an END-affected region and the meat and other animal products produced in such free regions may be commingled with the fresh (chilled or frozen) meat of animals from an END-affected region, resulting in an undue risk of introducing END into the United States. Therefore, live poultry, poultry meat and other poultry products, and ship stores, airplane meals, and baggage containing such meat or animal products originating in the free regions listed in this section may not be imported into the United States unless the following requirements, in addition to all other applicable requirements of part 93 of this chapter and of chapter III of this title, are met:
(a)
(b)
(1) The poultry have not been in contact with poultry or poultry products from any region where END is considered to exist;
(2) The poultry have not lived in a region where END is considered to exist; and
(3) The poultry have not transited through a region where END is considered to exist unless moved directly through the region in a sealed means of conveyance with the seal intact upon arrival at the point of destination.
(c)
(1) The poultry meat or other poultry products are derived from poultry that meet all requirements of this section and that have been slaughtered in a region designated in § 94.6 as free of END at a federally inspected slaughter plant that is under the direct supervision of a full-time salaried veterinarian of the national Government of the exporting region and that is approved to export poultry meat and other poultry products to the United States in accordance with § 381.196 of this title;
(2) The poultry meat or other poultry products have not been in contact with poultry meat or other poultry products from any region where END is considered to exist;
(3) The poultry meat or other poultry products have not transited through a region where END is considered to exist unless moved directly through the region in a sealed means of conveyance with the seal intact upon arrival at the point of destination; and
(4) If processed, the poultry meat or other poultry products were processed in a region designated in § 94.6 as free of END in a federally inspected processing plant that is under the direct supervision of a full-time salaried veterinarian of the national Government of the exporting region.
Notwithstanding any other provisions of this part, whole cuts of boneless beef derived from cattle that were born, raised, and slaughtered in Japan may be imported into the United States under the following conditions:
(a) The beef is prepared in an establishment that is eligible to have its products imported into the United States under the Federal Meat Inspection Act (21 U.S.C. 601
(b) The beef is derived from cattle that were not subjected to a pithing process at slaughter.
(c) An authorized veterinary official of the Government of Japan certifies on an original certificate that the above conditions have been met.
7 U.S.C. 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
Whenever in the regulations in this part the following words, names, or terms are used they shall be construed, respectively, to mean:
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
(2) A sheep or goat that exhibits any of the following signs and that has been determined to be suspicious for a transmissible spongiform encephalopathy by a veterinarian: Weight loss despite retention of appetite; behavior abnormalities; pruritus (itching); wool pulling; biting at legs or side; lip smacking; motor abnormalities such as incoordination, high stepping gait of forelimbs, bunny hop movement of rear legs, or swaying of back end; increased sensitivity to noise and sudden movement; tremor, “star gazing,” head pressing, recumbency, or other signs of neurological disease or chronic wasting.
No products or materials specified in the regulations in this part shall be imported unless there be shown upon the commercial invoice, or in some other manner satisfactory to the Deputy Administrator, Veterinary Services, the name of the region of origin of such product or material:
The importation of any animal byproduct taken or removed from an animal affected with anthrax, foot-and-mouth disease, or rinderpest is prohibited.
(a) Except as provided in paragraphs (c) through (i) of this section, the importation of the following is prohibited:
(1) Any of the materials listed in paragraphs (a)(1)(i) through (a)(1)(iv) of this section that have been derived from animals that have been in any region listed in § 94.18(a) of this chapter:
(i) Processed animal protein, tankage, offal, and tallow other than tallow
(ii) Glands, unprocessed fat tissue, and blood and blood products derived from ruminants;
(iii) Processed fats and oils, and derivatives of processed animal protein, tankage, and offal, regardless of the animal species from which the material was derived; and
(iv) Derivatives of glands and blood and blood products derived from ruminants.
(2) Any of the materials listed in paragraphs (a)(2)(i) through (a)(2)(iv) of this section that have been stored, rendered, or otherwise processed in a region listed in § 94.18(a) of this chapter, or that have otherwise been associated with a facility in a region listed in § 94.18(a) of this chapter or with any material listed in paragraph (a)(1) through (a)(3) of this section:
(i) Processed animal protein, tankage, offal, and tallow other than tallow derivatives, unless, in the opinion of the Administrator, the tallow cannot be used in feed, regardless of the animal species from which the material was derived;
(ii) Glands and unprocessed fat tissue derived from ruminants;
(iii) Processed fats and oils, and derivatives of processed animal protein, tankage, and offal, regardless of the animal species from which the material was derived; and
(iv) Derivatives of glands from ruminants.
(3) Products containing any of the items prohibited importation under paragraphs (a)(1) and (a)(2) of this section.
(b) Except as provided in paragraphs (d), (e), and (i) of this section, the importation of serum from ruminants that have been in any region listed in § 94.18(a) of this chapter is prohibited, except that serum from ruminants may be imported for scientific, educational, or research purposes if the Administrator determines that the importation can be made under conditions that will prevent the introduction of bovine spongiform encephalopathy into the United States. Serum from ruminants imported in accordance with this paragraph must be accompanied by a permit issued by APHIS in accordance with § 104.4 of this chapter, and must be moved and handled as specified on the permit.
(c) Materials that are otherwise prohibited importation into the United States under paragraph (a) of this section may be imported into the United States if the following conditions are met prior to importation:
(1) The material is derived from a nonruminant species, or from a ruminant species if the ruminants have never been in any region listed in § 94.18(a) of this chapter.
(2) All steps of processing and storing the material are carried out in a foreign facility that has not been used for the processing and storage of materials derived from ruminants that have been in any region listed in § 94.18(a) of this chapter.
(3) The facility demonstrates to APHIS that the materials intended for exportation to the United States were transported to and from the facility in a manner that would prevent cross-contamination by or commingling with prohibited materials.
(4) Except for facilities in regions listed in § 94.18(a)(3) of this subchapter, if the facility processes or handles any material derived from mammals, the facility has entered into a cooperative service agreement executed by the operator of the facility and APHIS. In accordance with the cooperative service agreement, the facility must be current in paying all costs for a veterinarian of APHIS to inspect the facility (it is anticipated that such inspections will occur approximately once per year), including travel, salary, subsistence, administrative overhead, and other incidental expenses (including excess baggage provisions up to 150 pounds). In addition, the facility must have on deposit with APHIS an unobligated amount equal to the cost for APHIS personnel to conduct one inspection. As funds from that amount are obligated, a bill for costs incurred based on official accounting records will be issued to restore the deposit to the original level, revised as necessary to allow for inflation or other changes in estimated costs. To be current, bills
(5) The facility allows periodic APHIS inspection of its facilities, records, and operations.
(6) Each shipment to the United States is accompanied by an original certificate signed by a full-time, salaried veterinarian of the government agency responsible for animal health in the region of origin certifying that the conditions of paragraph (c)(1) through (c)(3) of this section have been met, except that, for shipments of animal feed from a region listed in § 94.18(a)(3) of this subchapter, the certificate may be signed by a person authorized to issue such certificates by the veterinary services of the national government of the region of origin.
(7) The person importing the shipment has applied for and obtained from APHIS a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors by filing a permit application on VS form 16-3. (VS Form 16-3 may be obtained from APHIS, Veterinary Services, National Center for Import-Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or electronically at
(d) Except as provided in paragraph (e) of this section, the importation of serum albumin, serocolostrum, amniotic liquids or extracts, and placental liquids derived from ruminants that have been in any region listed in § 94.18(a) of this chapter, and collagen and collagen products that meet any of the conditions listed in paragraphs (a)(1) through (a)(3) of this section, is prohibited unless the following conditions have been met:
(1) The article is imported for use as an ingredient in cosmetics;
(2) The person importing the article has obtained a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors by filing a permit application on VS form 16-3 (VS Form 16-3 may be obtained from APHIS, Veterinary Services, National Center for Import-Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or electronically at
(3) The permit application states the intended use of the article and the name and address of the consignee in the United States.
(e) Bovine blood and blood products that are otherwise prohibited importation under paragraph (a)(1) or (d) of this section may be imported into the United States if they meet the following conditions:
(1) For blood collected at slaughter and for products derived from blood collected at slaughter:
(i) The blood was collected in a closed system in which the blood was conveyed directly from the animal in a closed conduit to a closed receptacle, or was collected otherwise in a hygienic manner that prevents contamination of the blood with SRMs.
(ii) The slaughtered animal passed ante-mortem inspection and was not subjected to a pithing process or to a stunning process with a device injecting compressed air or gas into the cranial cavity;
(2) For fetal bovine serum:
(i) The blood from which the fetal bovine serum was derived was collected in a closed system in which the blood was conveyed directly from the animal in a closed conduit to a closed receptacle, or was collected otherwise in a hygienic manner that prevents contamination of the blood with SRMs;
(ii) The dam of the fetal calf passed ante-mortem inspection and was not subjected to a pithing process or to a stunning process with a device injecting compressed air or gas into the cranial cavity;
(iii) The uterus was removed from the dam's abdominal cavity intact and taken to a separate area sufficiently removed from the slaughtering area of the facility to ensure that the fetal blood was not contaminated with SRMs when collected.
(3) For blood collected from live donor bovines and for products derived from blood collected from live donor bovines:
(i) The blood was collected in a closed system in which the blood was
(ii) The donor animal was free of clinical signs of disease.
(4) Each shipment to the United States is accompanied by an original certificate signed by a full-time salaried veterinary officer of the national government of the region of origin, or issued by a veterinarian designated by or accredited by the national government of the region of origin, representing that the veterinarian issuing the certificate was authorized to do so. The certificate must state that the requirements of paragraph (e)(1), (e)(2), or (e)(3) of this section, as applicable, have been met.
(f) Insulin otherwise prohibited from importation into the United States under paragraph (a) of this section is not prohibited from importation under that paragraph if the insulin is for the personal medical use of the person importing it and if the person importing the shipment has applied for and obtained from APHIS a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors by filing a permit application on VS form 16-3. (VS Form 16-3 may be obtained from APHIS, Veterinary Services, National Center for Import-Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or electronically at
Insulin that is not prohibited from importation under this paragraph may be prohibited from importation under other Federal laws, including the Federal Food, Drug, and Cosmetic Act, 21 U.S.C, 321
(g) Tallow otherwise prohibited importation under paragraph (a)(1) of this section may be imported into the United States if it meets the following conditions:
(1) The tallow is derived from bovines that have not been in a region listed in § 94.18(a)(1) or (a)(2) of this subchapter;
(2) The tallow is composed of less than 0.15 percent insoluble impurities;
(3) After processing, the tallow was not exposed to or commingled with any other animal origin material; and
(4) Each shipment to the United States is accompanied by an original certificate signed by a full-time salaried veterinary officer of the national government of the region of origin, or issued by a veterinarian designated by or accredited by the national government of the region of origin and endorsed by a full-time salaried veterinary officer of the national government of the region of origin, representing that the veterinarian issuing the certificate was authorized to do so. The certificate must state that the requirements of paragraphs (f)(1) through (f)(3) of this section have been met; and
(5) The shipment, if arriving at a U.S. land border port, arrives at a port listed in § 94.19(g) of this subchapter.
(h) Offal that is otherwise prohibited importation under paragraph (a)(1) of this section may be imported if the offal is derived from cervids or the offal is derived from bovines, ovines, or caprines from a region listed in § 94.18(a)(3) of this subchapter that have not been in a region listed in § 94.18(a)(1) or (a)(2) of this subchapter, and the following conditions are met:
(1) If the offal is derived from bovines, the offal:
(i) Contains no SRMs and is derived from bovines from which the SRMs were removed;
(ii) Is derived from bovines for which an air-injected stunning process was not used at slaughter; and
(iii) Is derived from bovines that are subject to a ruminant feed ban equivalent to the requirements established by the U.S. Food and Drug Administration at 21 CFR 589.2000;
(2) If the offal is derived from ovines or caprines, the offal:
(i) Is derived from ovines or caprines that were less than 12 months of age when slaughtered and that are from a flock or herd subject to a ruminant feed ban equivalent to the requirements established by the U.S. Food and Drug Administration at 21 CFR 589.2000;
(ii) Is not derived from ovines or caprines that have tested positive for or are suspect for a transmissible spongiform encephalopathy;
(iii) Is not derived from animals that have resided in a flock or herd that has been diagnosed with BSE; and
(iv) Is derived from ovines or caprines whose movement was not restricted in the BSE minimal-risk region as a result of exposure to a transmissible spongiform encephalopathy.
(3) Each shipment to the United States is accompanied by an original certificate signed by a full-time salaried veterinary officer of the national government of the region of origin, or issued by a veterinarian designated by or accredited by the national government of the region of origin and endorsed by a full-time salaried veterinary officer of the national government of the region of origin, representing that the veterinarian issuing the certificate was authorized to do so. The certificate must state that the requirements of paragraph (g)(1) or (g)(2) of this section have been met; and
(4) The shipment, if arriving at a U.S. land border port, arrives at a port listed in § 94.19(g) of this subchapter.
(i)
(1) The person moving the articles has obtained from APHIS a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors by filing a permit application on VS form 16-3. (VS Form 16-3 may be obtained from APHIS, Veterinary Services, National Center for Import-Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or electronically at
(2) The articles are sealed in leakproof containers bearing serial numbers during transit. Each container remains sealed during the entire time that it is in the United States.
(3) The person moving the articles notifies, in writing, the inspector at both the place in the United States where the articles will arrive and the port of export before such transit. The notification includes the following:
(i) United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors permit number;
(ii) Times and dates of arrival in the United States;
(iii) Times and dates of exportation from the United States;
(iv) Mode of transportation; and
(v) Serial numbers of the sealed containers.
(4) The articles are eligible to enter the United States in accordance with this section and are accompanied by the certification required by this section. Additionally, the following conditions must be met:
(i) The shipment is exported from the United States within 7 days of its entry;
(ii) The commodities are not transloaded while in the United States, except for direct transloading under the supervision of an inspector, who must break the seals of the national government of the region of origin on the means of conveyance that carried the commodities into the United States and seal the means of conveyance that will carry the commodities out of the United States with seals of the U.S. Government;
(iii) A copy of the import permit required under paragraph (i)(1) of this section is presented to the inspector at the port of arrival and the port of export in the United States.
Untanned hides and/or skins of cattle, buffalo, sheep, goats, other ruminants, and swine which do not meet the conditions of requirements specified in any one of paragraphs (a) to (e) of this section shall not be imported except subject to handling and treatment in accordance with § 95.6 after arrival at the port of entry:
(a) Hides or skins originating in and shipped directly from a region not declared by the Secretary of Agriculture to be infected with foot-and-mouth disease or rinderpest may be imported without further restriction.
(b) Hides or skins may be imported without other restriction if found upon inspection by an inspector, or by certificate of the shipper or importer satisfactory to said inspector, to be hard dried hides or skins.
(c) Abattoir hides or skins taken from animals slaughtered under national government inspection in a region
(d) Hides or skins may be imported without other restriction if shown upon inspection by an inspector, or by certificate of the shipper or importer satisfactory to said inspector, to have been pickled in a solution of salt containing mineral acid and packed in barrels, casks, or tight cases while still wet with such solution.
(e) Hides or skins may be imported without other restriction if shown upon inspection by an inspector, or by certificate of the shipper or importer satisfactory to said inspector, to have been treated with lime in such manner and for such period as to have become dehaired and to have reached the stage of preparation for immediate manufacture into products ordinarily made from rawhide.
Hides or skins offered for importation which do not meet the conditions or requirements of § 95.5 shall be handled and treated in the following manner after arrival at the port of entry:
(a) They shall be consigned from the coast or border port of arrival to an approved establishment and shall be subject to disinfection by such method or methods as the Deputy Administrator, Veterinary Services may prescribe unless the said establishment discharges drainage into an approved sewerage system or has an approved chlorinating equipment adequate for the proper disinfection of effluents:
(b) They shall be moved from the coast or border port of arrival or, in case of I. T. or in-bound shipments, from the interior port to the approved establishment in cars or trucks or in vessel compartments with no other materials contained therein, sealed with seals of the Department, which shall not be broken except by inspectors or other persons authorized by the Deputy Administrator, Veterinary Services so to do, or without sealing as aforesaid and with other freight when packed in tight cases or casks acceptable to the inspector in charge at the port of entry.
(c) They shall be handled at the approved establishment under the direction of an inspector in a manner approved by the Deputy Administrator, Veterinary Services to guard against the dissemination of foot-and-mouth disease and rinderpest. They shall not be removed therefrom except upon special permission of the Deputy Administrator, Veterinary Services and upon compliance with all the conditions and requirements of this section relative to the movement of the said hides and skins from the port of arrival to the said establishment.
Wool, hair, or bristles derived from ruminants and/or swine which do not meet the conditions or requirements specified in any one of paragraphs (a) to (d) of this section shall not be imported except subject to handling and treatment in accordance with § 95.8 after their arrival at the port of entry:
(a) Such wool, hair, or bristles may be imported without other restriction if originating in and shipped directly from a region not declared by the Secretary of Agriculture to be infected with foot-and-mouth disease or rinderpest.
(b) Wool or hair clipped from live animals or pulled wool or hair may be imported without other restriction if the said wool or hair is reasonably free from animal manure in the form of dung locks or otherwise.
(c) Wool, hair, or bristles taken from sheep, goats, cattle, or swine, when such animals have been slaughtered under national government inspection in a region
(d) Wool, hair, or bristles which have been scoured, thoroughly washed, or dyed may be imported without other restriction.
Wool, hair, or bristles offered for importation which do not meet the conditions or requirements of § 95.7 shall be handled and treated in the following manner after arrival at the port of entry:
(a) Such wool, hair, or bristles shall be consigned from the coast or border port of arrival to an approved establishment:
(b) Such wool, hair, or bristles shall be moved from the coast or border port of arrival or, in the case of I. T. or in-bond shipments, from the interior port to the establishment in cars or trucks or in vessel compartments with no other materials contained therein, sealed with seals of the Department,
(c) Such wool, hair, or bristles shall be handled at the establishment under the direction of an inspector in a manner approved by the Deputy Administrator, Veterinary Services to guard against the dissemination of foot-and-mouth disease and rinderpest. Such products shall not be removed therefrom except upon special permission of the Deputy Administrator, Veterinary Services and upon compliance with all the conditions and requirements of this section relative to the movement of the said wool, hair, or bristles from the port of arrival to the said establishment.
Glue stock which does not meet the conditions or requirements specified in any one of paragraphs (a) to (c) of this section shall not be imported except subject to handling and treatment in accordance with § 95.10 after arrival at the port of entry:
(a) Glue stock originating in and shipped directly from a region not declared by the Secretary of Agriculture to be infected with foot-and-mouth disease or rinderpest may be imported without other restriction.
(b) Glue stock may be imported without other restriction if found upon inspection by an inspector, or by certificate of the shipper or importer satisfactory to said inspector, to have been properly treated by acidulation or by soaking in milk of lime or a lime paste; or to have been dried so as to render each piece of the hardness of a sun-dried hide.
(c) Glue stock taken from cattle, sheep, goats, or swine slaughtered under national government inspection in a region
Glue stock offered for importation which does not meet the conditions or requirements of § 95.9 shall be handled and treated in the following manner after arrival at the port of entry:
(a) It shall be consigned from the coast or border port of arrival to an approved establishment and shall be subject to disinfection by such method or methods as the Deputy Administrator, Veterinary Services may prescribe unless the said establishment discharges drainage into an approved sewerage system or has an approved chlorinating equipment adequate for the proper disinfection of effluents:
(b) It shall be moved from the coast or border port of arrival or, in case of I. T. or in-bond shipments, from the interior port to the establishment in cars or trucks or in vessel compartments with no other materials contained therein, sealed with seals of the Department, which shall not be broken except by inspectors or other persons authorized by the Deputy Administrator, Veterinary Services so to do, or without sealing as aforesaid and with other freight when packed in tight cases or casks acceptable to an inspector at port of entry.
(c) It shall be handled at the establishment under the direction of an inspector in a manner approved by the Deputy Administrator, Veterinary Services to guard against the dissemination of foot-and-mouth disease and rinderpest. It shall not be removed therefrom except upon special permission of the Deputy Administrator, Veterinary Services and upon compliance with all the conditions and requirements of this section relative to the movement of the said glue stock from the port of arrival to the said establishment.
(a) Clean, dry bones, horns, and hoofs, that are free from undried pieces of hide, flesh, and sinew and are offered for entry as trophies or for consignment to museums may be imported without other restrictions.
(b) Clean, dry hoofs disinfected in the region of origin may be imported without other restrictions if the following conditions are met:
(1) The hoofs have been disinfected using one of the following methods:
(i) Dry heat at 180°F (82.2°C) for 30 minutes;
(ii) Soaking in boiling water for 20 minutes;
(iii) Soaking in a 0.1 percent chlorine bleach solution for 2 hours;
(iv) Soaking in a 5 percent acetic acid solution for 2 hours; or
(v) Soaking in a 5 percent hydrogen peroxide solution for 2 hours.
(2) The hoofs are accompanied by a certificate issued by the national government of the region of origin and signed by an official veterinary inspector of that region stating that the hoofs have been disinfected and describing the manner in which the disinfection was accomplished.
Bones, horns, and hoofs offered for importation which do not meet the conditions or requirements of § 95.11 shall be handled and treated in the following manner after arrival at the port of entry:
(a) They shall be consigned from the coast or border port of arrival to an approved establishment having facilities for their disinfection or their conversion into products customarily made from bones, horns, or hoofs:
(b) They shall be moved from the coast or border port of arrival or, in case of I. T. or in-bond shipments, from the interior port to the establishment in cars or trucks with no other materials contained therein, sealed with seals of the Department, which shall not be broken except by inspectors or other persons authorized by the Deputy Administrator, Veterinary Services so to do, or without sealing as aforesaid and with other freight when packed in tight cases or casks acceptable to an inspector at the port of entry.
(c) They shall be handled at the establishment under the direction of an inspector in a manner to guard against the dissemination of anthrax, foot-and-mouth disease, and rinderpest, and the bags, burlap, or other containers thereof, before leaving the establishment,
Steamed or degelatinized or special steamed bone meal, which, in the normal process of manufacture, has been prepared by heating bone under a minimum of 20 pounds steam pressure for at least one hour at a temperature of not less than 250 °Fahrenheit (121 °Centigrade), may be imported without further restrictions for use as fertilizer or as feed for domestic animals if such products are free from pieces of bone, hide, flesh, and sinew and contain no more than traces of hair and wool. Bone meal for use as fertilizer or as feed for domestic animals which does not meet these requirements will not be eligible for entry.
Dried blood or blood meal, lungs or other organs, tankage, meat meal, wool waste, wool manure, and similar products, for use as fertilizer or as feed for domestic animals, shall not be imported except subject to handling and treatment in accordance with paragraphs (a), (b), and (c) of § 95.16, unless:
(a) Such products originated in and were shipped directly from a region not declared by the Secretary of Agriculture to be infected with foot-and-mouth disease or rinderpest; or
(b) The inspector at the port of entry finds that such products have been fully processed by tanking under live steam or by dry rendering.
Blood meal, blood albumin, bone meal, intestines, or other animal materials intended for use in the industrial arts shall not be imported except subject to handling and treatment in accordance with § 95.16, unless such products originated in and were shipped directly from a region not declared by the Secretary of Agriculture to be infected with foot-and-mouth disease or rinderpest.
Blood meal, blood albumin, bone meal, intestines, or other animal materials intended for use in the industrial arts, which do not meet the conditions or requirements of § 95.15 shall be handled and treated in the following manner after arrival at the port of entry.
(a) They shall be consigned from the coast or border port of arrival to an approved establishment:
(b) They shall be moved from the coast or border port of arrival or, in the case of I. T. or in-bond shipments, from the interior port to the establishment in cars or trucks or in vessel
(c) They shall be handled at the establishment under the direction of an inspector in a manner to guard against the dissemination of foot-and-mouth disease and rinderpest. They shall not be removed therefrom except upon special permission of the Deputy Administrator, Veterinary Services and upon compliance with all the conditions and requirements of this section relative to the movement of the said products from the port of arrival to the said establishment.
Glands, organs, ox gall or bile, bone marrow, and various like materials derived from domestic ruminants or swine, intended for use in the manufacture of pharmaceutical products shall not be imported except subject to handling and treatment in accordance with § 95.18, unless such glands, organs, or materials originated in and were shipped directly from a region not declared by the Secretary of Agriculture to be infected with foot-and-mouth disease or rinderpest.
Glands, organs, ox gall or bile, bone marrow, and various like materials derived from domestic ruminants or swine, which do not meet the requirements of § 95.17 may be imported for pharmaceutical purposes if in tight containers and consigned to an approved establishment:
Stomachs or portions of the stomachs of ruminants or swine, other than those imported for food purposes under the meat-inspection regulations of the Department, shall not be imported without permission from the Deputy Administrator, Veterinary Services. Importations permitted shall be subject to such restrictions as the Deputy Administrator, Veterinary Services may deem necessary in each instance.
Manure of horses, cattle, sheep, other ruminants, and swine shall not be imported except upon permission from the Deputy Administrator, Veterinary Services. Importations permitted shall be subject to such restrictions as he may deem necessary in each instance:
Except as provided in § 95.28, hay or straw shall not be imported except subject to handling and treatment in accordance with § 95.22 after arrival at the port of entry, unless such hay or straw originated in and was shipped directly from a region not declared by the Secretary of Agriculture to be infected with foot-and-mouth disease or rinderpest.
Except as provided in § 95.28, hay or straw which does not meet the conditions or requirements of § 95.21 shall be handled and treated in the following manner upon arrival at the port of entry:
(a) Hay or straw packing materials shall be burned or disinfected at the expense of the importer or consignee in the manner and at the time directed by the Deputy Administrator, Veterinary Services.
(b) Hay or straw for use as feeding material, bedding, or similar purposes shall be stored and held in quarantine for a period of not less than 90 days in an approved warehouse at the port of entry and shall be otherwise handled as directed by the Deputy Administrator, Veterinary Services.
Cloth or burlap which has been used to cover fresh or frozen meats originating in any region designated in § 94.1 of this subchapter as a region in which rinderpest or foot-and-mouth disease exists, shall not be imported except under the following conditions:
(a) The cloth or burlap shall be consigned from the coast or border port of arrival to an establishment specifically approved for the purpose by the Deputy Administrator, Veterinary Services.
(b) The cloth or burlap shall be immediately moved from the coast or border port of arrival, or in case of I. T. or in-bond shipments from the interior port, to the establishment, in railroad cars or trucks, or in vessel compartments, with no other material contained therein, sealed with seals of the Department, which shall not be broken except by inspectors or other persons authorized by the Deputy Administrator, Veterinary Services:
(c) The material shall be disinfected and otherwise handled at the establishment under the direction of an inspector in a manner approved by the Deputy Administrator, Veterinary Services to guard against the dissemination of foot-and-mouth disease and rinderpest, and the material shall not be removed therefrom, except upon special permission of the Deputy Administrator, Veterinary Services, until all of the conditions and requirements of this section have been complied with.
Hides, skins, and other materials required by the regulations in this part to be disinfected shall be subjected to disinfection by methods found satisfactory and approved from time to time by the Deputy Administrator, Veterinary Services.
(a) Transportation companies or other operators of cars, trucks or other vehicles carrying import products or materials moving under restriction, other than those in tight cases or casks, shall affix to and maintain on
(b) If it is necessary to unload enroute any of the materials or products transported in a placarded car, truck or other vehicle as provided in this section, the car, truck or other vehicle from which the transfer is made and any part of the premises in or upon which the product or material may have been placed in the course of unloading or reloading shall be cleaned and disinfected by the carrier, in accordance with the provisions of § 95.26, and the said carrier shall immediately report the matter, by telegraph, to the Deputy Administrator, Veterinary Services, Washington, DC 20251. Such report shall include the following information: Nature of emergency; place where product or material was unloaded; original points of shipment and destination; number and materials of the original car or truck; and number and initials of the car, truck or other vehicle into which the product or material is reloaded in case the original car or truck is not used.
Railroad cars, trucks, boats, aircraft and other means of conveyance, equipment or containers, yards, and premises which have been used in the transportation, handling, or storing of restricted import products or materials, other than those contained in leak proof cases or casks, shall be cleaned and disinfected with a disinfectant approved for use in this part under the supervision of the division at the time and in the manner provided in this section. Except as provided in paragraph (a) of this section, such railroad cars, trucks, boats, aircraft and other means of conveyance, equipment or containers, shall not be moved in interstate or foreign commerce until they have been so treated.
(a)
(b)
(2) Boats required by this part to be cleaned and disinfected shall be treated in the following manner: Collect all litter and other refuse from the decks, compartments, and all other parts of the boat used for the transportation of the products or materials covered by this part, and from the portable chutes or other appliances, fixtures or areas used in loading and unloading same, and destroy the litter and other refuse by burning or by other approved methods, and saturate the entire surface of the said decks, compartments, and other parts of the boat with a permitted disinfectant approved for use in this part.
(3) Buildings, sheds, and premises required by this part to be disinfected shall be treated in the following manner: Collect all litter and other refuse therefrom and destroy the same by burning or other approved methods, and saturate the entire surface of the fencing, chutes, floors, walls, and other parts with a permitted disinfectant approved for use in this part.
(c)
(1) Sodium carbonate (4 percent) in the proportion of 1 pound to 3 gallons of water.
(2) Sodium carbonate (4 percent) plus sodium silicate (0.1 percent) in the proportion of 1 pound of sodium carbonate plus sodium silicate to 3 gallons of water.
(3) Sodium hydroxide (Lye) prepared in a fresh solution in the proportion of not less than 1 pound avoirdupois of sodium hydroxide of not less than 95 percent purity to 6 gallons of water, or one 13
(d)
The regulations in this part shall be applicable to all the products and materials specified in this part which are offered for entry into the United States from any place under the jurisdiction of the United States to which the animal-quarantine laws of this country do not apply.
Hay or straw, grass, or similar material from tick-infested pastures, ranges, or premises may disseminate the contagion of splenetic, Southern or Texas fever when imported for animal feed or bedding; therefore, such hay or straw, grass, or similar materials shall not be imported unless such material is first disinfected with a disinfectant specified in § 95.26(d).
(a) In addition to meeting any other certification or permit requirements of this chapter, the following articles may be imported into the United States from any region not listed in § 94.18(a) only if they are accompanied by a certificate, as described in paragraph (b) of this section:
(1) Processed animal protein, tankage, offal, and tallow other than tallow derivatives, unless, in the opinion of the Administrator, the tallow cannot be used in feed, regardless of the animal species from which the material is derived;
(2) Glands and unprocessed fat tissue derived from ruminants;
(3) Processed fats and oils, and derivatives of processed animal protein, tankage, and offal, regardless of the animal species from which the material is derived;
(4) Derivatives of glands from ruminants; and
(5) Any product containing any of the materials listed in paragraphs (a)(1) through (a)(4) of this section.
(b) The certificate required by paragraph (a) of this section must be an original official certificate, signed by a full-time, salaried veterinarian of the agency responsible for animal health in the exporting region, that states the following:
(1) The animal species from which the material was derived;
(2) The region in which any facility where the material was processed is located;
(3) That the material was derived only from animals that have never been in any region listed in § 94.18(a) of this chapter, with the regions listed in § 94.18(a) specifically named;
(4) That the material did not originate in, and was never stored in, rendered or processed in, or otherwise associated with a facility in a region listed in § 94.18(a); and
(5) The material was never associated with any of the materials listed in paragraph (a) of this section that have been in a region listed in § 94.18(a).
(c) The certification required by paragraph (a) of this section must clearly correspond to the shipment by means of an invoice number, shipping marks, lot number, or other method of identification.
(a) Products or byproducts, including feathers, birds' nests, and bird trophies, of poultry, game birds, or other birds may be imported from a region listed in § 94.6(d) of this subchapter as a region where HPAI subtype H5N1 exists only if the Administrator has determined that the importation can be made under conditions that will prevent the introduction of HPAI subtype H5N1 into the United States. The articles must be accompanied by a permit obtained from APHIS prior to the importation in accordance with paragraph (b) of this section, and they must be moved and handled as specified on the permit to prevent the introduction of HPAI subtype H5N1 into the United States.
(b) To apply for a permit, contact the Animal and Plant Health Inspection Service, Veterinary Services, National Center for Import and Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231.
7 U.S.C. 8301-8317; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.4.
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
(a)
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(b)
(1) Casings that are derived from sheep that were slaughtered in a region listed in § 94.18(a)(3) of this subchapter at less than 12 months of age and that
(2) Casings that are derived from bovines that were slaughtered in a region listed in § 94.18(a)(3) of this subchapter may be imported, provided, if the casings are derived from the small intestine, the casings are derived from that part of the small intestine that is eligible for use as human food in accordance with the requirements established by the Food Safety and Inspection Service at 9 CFR 310.22 and the Food and Drug Administration at 21 CFR 189.5.
(3) Casings imported in accordance with either paragraph (b)(1) or (b)(2) of this section must be accompanied by a certificate that:
(i) States that the casings meet the conditions of this section;
(ii) Is written in English;
(iii) Is signed by an individual eligible to issue the certificate required under § 96.3; and
(iv) Is presented to an authorized inspector at the port of entry.
(a) No animal casings shall be imported into the United States from any foreign region unless they are accompanied by a certificate signed by either (1) a veterinarian salaried by the national government of the region in which the animals were slaughtered and the casings were collected, and who is authorized by the national government to conduct casings inspections and issue certificates, and who has inspected the casings before issuing the certificate and determined that the casings meet the criteria described in the Foreign Official Certificate for Animal Casings; or (2) a non-government veterinarian authorized to issue the certificate by the national government of the region in which the animals were slaughtered and the casings were collected, who has inspected the casings before issuing the certificate and determined that the casings meet the criteria described in the Foreign Official Certificate for Animal Casings. A certificate issued by a non-government veterinarian is valid only if the certificate is endorsed by a veterinarian salaried by the national government of the region in which the animals were slaughtered and the casings were collected.
(b) All signatures on the certificate shall be original.
(c) The certificate shall bear the insignia of the national government of the region in which the animals were slaughtered and the casings were collected, and shall be in the following form:
I hereby certify that the animal casings herein described were derived from healthy animals (cattle, sheep, swine, or goats), which received, ante mortem and post mortem veterinary inspections at the time of slaughter, are clean and sound, and were prepared and handled only in a sanitary manner and were not subjected to contagion prior to exportation.
(d) In addition to meeting the requirements of this section, the certificate accompanying sheep casings from a region listed in § 94.18(a)(3) of this subchapter must state that the casings meet the requirements of § 96.2(b)(1), and the certificate accompanying bovine casings from a region listed in
Animal casings which are unaccompanied by the required certificate, those shipped in sheepskins or other skins as containers, and those found upon inspection to be unclean or unsound when offered for importation into the United States shall be kept in customs custody until exported or destroyed, or until disinfected and denaturated as prescribed by the Administrator, Animal and Plant Health Inspection Service (APHIS) in §§ 96.5 through 96.16.
(a) Animal casings are not classed as meat product, therefore the certificate required for foreign meat product is not acceptable for animal casings offered for importation.
(b) Casings offered for importation into the United States shall remain in customs custody at the port until released by an APHIS inspector for admission into the United States or otherwise disposed of as required by this part.
(c) The provision that under certain conditions casings which have been offered for importation shall be exported, shall be construed to mean the removal of the casings from the United States or its possessions.
(1) The provision that under certain conditions casings be destroyed shall be construed to mean the treatment or handling of the casings in a manner to take away completely the usefulness of them as by tanking or incineration.
(2) The provision that under certain conditions casings shall be disinfected and denatured shall be construed to mean such treatment and handling as will be prescribed by the Administrator, Animal and Plant Health Inspection Service (APHIS) to free them from pathogenic substances or organisms, or to render such substances and organisms inert; and that the nature of the casings be changed to make them unfit for eating without destroying other useful properties. For instance, each casing may be split throughout its length and after disinfection, as above indicated, be released for industrial use.
(d) Dried intestines offered for importation into the United States for use as gut strings or similar purpose are not regarded as animal casings within the meaning of this part. Such dried intestines are classed with tendons, sinews, and similar articles and are subject to the provisions of part 95.
(a) Properly certified foreign animal casings arriving in the United States at a seaboard or border port where an APHIS inspector is stationed shall be released for entry by the inspector at the seaboard or border port.
(b) Properly certified foreign animal casings arriving in the United States at a seaboard or border port where no APHIS inspector is stationed, which are destined to a point in the United States where an APHIS inspector is stationed, shall be shipped in United States Customs custody to destination for release.
(c) Properly certified foreign animal casing arriving in the United States at a seaboard or border port where no APHIS inspector is stationed, which are destined to a point in the United States where no APHIS inspector is stationed, shall be transported in United States Customs custody to the nearest point where an APHIS inspector is stationed for release at that point.
(d) Properly certified foreign animal casings forming a part of a foreign meat consignment routed through a border port to an interior point in the United States shall be transported to destination as though the entire consignment consisted of meat. In such cases the APHIS inspector who inspects the meat at destination shall supervise the release of the casings.
Dried animal bladders, dried weasands, and all other dried animal casings offered for importation into the United States as food containers unaccompanied by foreign certification which have been retained in the dry state continuously for not less than 90 days from the date of shipment shown on the consular invoice, may be released for entry as food containers without disinfection.
Uncertified foreign animal casings arriving at a seaboard port may be imported into the United States for use as food containers after they have been disinfected under the direct supervision of an APHIS inspector at the seaboard port.
Foreign animal casings offered for importation into the United States which are admitted upon disinfection shall be handled as follows:
(a) The containers of such casings shall be sealed on the steamship pier or other place of first arrival. Four seals shall be affixed to both ends of each tierce, barrel, and similar container in the space where the ends of the container enter the staves, by means of red sealing wax imprinted with the No. 3 Veterinary Services brass brand from which “
(b) Uncertified animal casings sealed as above indicated shall be transferred from the steamship pier or other place of first arrival to the premises of the importer or other designated place, where they shall be disinfected by the importer under the supervision of an APHIS inspector before they are offered for sale. The object of this ruling is to place full responsibility for disinfection of casings on the original importer and to prevent the sale of casings subject to disinfection by the purchaser.
(a) Foreign animal casings imported into the United States without certification may be forwarded in customs custody to a USDA-approved facility for disinfection under APHIS supervision and release by the United States Customs authorities, provided that, before being transported over land in the United States, each and every container of such casings shall be disinfected by the application of a solution of sodium hydroxide prepared as follows:
(1) Sodium hydroxide (Lye) prepared in a fresh solution in the proportion of not less than 1 pound avoirdupois of sodium hydroxide of not less than 95 percent purity to 6 gallons of water, or one 13
(2) This solution shall be thoroughly applied to all exterior surfaces of the containers and be allowed to remain for at least thirty minutes to accomplish disinfection. The containers should then be washed with water to
(b) When uncertified foreign casings are removed from the original shipping containers these containers shall be destroyed by burning or promptly and thoroughly disinfected both inside and out with the solution and in the manner above prescribed. If these containers are to be re-used it is important that they be thoroughly washed both inside and out with water after disinfection has been completed, and in order to insure against the injurious effect of caustic soda remaining in the wood it is advisable to allow the containers to stand for not less than six hours filled with water.
(c) The salt removed from all original shipping containers of uncertified foreign animal casings shall be immediately dissolved in water and heated to boiling, or disposed of as provided in paragraph (c)(1) or (2) of this section as follows:
(1) Dissolve the salt in the proportion of 90 pounds of salt to 100 gallons of water. Add 2
(2) Dissolve the salt in the proportion of 90 pounds of salt to 100 gallons of water. Add 20 pounds of 95 percent to 98 percent sodium hydroxide (commercial “76 percent caustic soda”) and stir until solution is complete; and allow it to stand for at least 30 minutes. (This solution may be utilized in the disinfection of casing containers as prescribed in paragraphs (a)(2) and (b) of this section.
(3) It is best to employ flaked caustic soda and not the variety which is very finely powdered. The fine powder is irritating and injurious to workers if it becomes suspended in the air. Containers of caustic soda should be kept tightly closed as the product deteriorates from contact with the air.
Uncertified foreign animal casings shall be disinfected only at a plant whose sanitation and disinfecting equipment have been approved by an APHIS inspector.
Foreign animal casings offered for importation without certification shall be disinfected as prescribed in § 96.13 within a period of 30 days after arrival in the United States, subject to the ability of Division inspectors to cover their respective districts. Otherwise such casings shall be exported or destroyed.
Foreign animal casings offered for importation into the United States without certification may be disinfected, as prescribed in this section, under the supervision of an APHIS inspector for use as food containers, as an alternative for foreign certification.
(a) Disinfect the casings in a solution made as follows: Dissolve 90 pounds common salt in 100 gallons water and mix. Add 2
(b) Containers of the disinfectant solution may be either of wood or of metal, but the interior surfaces must be protected by means of an acid resistant coating.
(c) Not more than 175 pounds casings shall be treated with each 100 gallons of the solution. After the treatment of
(d) Shake as much of the adherent salt as possible from the casings and weigh them. Bundles must be separated but individual hanks need not be untied. Place the casings in the disinfecting solution a few hanks at a time with vigorous agitation to insure the fullest possible contact of the solution with them. Then keep the casings completely submerged in the solution for not less than three-fourths of an hour.
(e) Remove the casings from the solution, rinse them with water, and place them in a solution containing 8
Foreign animal casings offered for importation into the United States upon disinfection, may either be disinfected with hydrochloric acid as at present or if preferred may be submerged in a saturated brine solution at a temperature not less than 127 °F. for at least 15 minutes. The time held as well as the temperature of such brine solution must be recorded on a one-hour dial of a recording thermometer and filed in the local APHIS office for official inspection at any time. In order that this required temperature may be more readily maintained, such casings must first be submerged in a brine solution at approximately 127 °F. for about five minutes immediately before the 15-minute recorded submersion period begins. This may be done either in the testing vat or a preliminary vat. By following this procedure the temperature will not vary unduly and thus cause unsatisfactory results. After removing the casings from the testing vat, it will be found advantageous to submerge them in another vat containing cold brine solution or cold water in order to remove the extra heat from the casings as promptly as possible, but of course this is optional with the importer. In order to obtain the most satisfactory results, the hanks, rings, and similar units must be separated as much as possible without untying, but “dolls” will not be permitted to be disinfected by this heating method. In order to keep the temperature of the brine in the testing vat of a uniform degree, it is necessary to agitate the solution occasionally by moving the casings. The tip of the recording thermometer should be located at a point which would be approximately at the bottom of the volume of casings being disinfected.
7 U.S.C. 8301-8317; 49 U.S.C. 80503; 7 CFR 2.22, 2.80, and 371.4.
(a) Any person, firm, or corporation having ownership, custody, or control
(1) For any services performed on a Sunday or holiday, or at any time after 5 p.m. or before 8 a.m. on a weekday, in connection with the arrival in or departure from the United States of a private aircraft or private vessel, the total amount payable shall not exceed $25 for all inspection services performed by the Customs Service, Immigration and Naturalization Service, Public Health Service, and the Department of Agriculture;
(2) Owners and operators of aircraft will be provided service without reimbursement during regularly established hours of service on a Sunday or holiday; and
(3) The overtime rate to be charged owners or operators of aircraft at airports of entry or other places of inspection as a consequence of the operation of the aircraft, for work performed outside of the regularly established hours of service is listed in the following table:
(b) A minimum charge of 2 hours shall be made for any Sunday or holiday or unscheduled overtime duty performed by an employee on a day when no work was scheduled for him or her, or which is performed by an employee on his or her regular workday beginning either at least 1 hour before his or her scheduled tour of duty or which is not in direct continuation of the employee's regular tour of duty. In addition, each such period of Sunday or holiday or unscheduled overtime work to which the 2-hour minimum charge applies may include a commuted traveltime period (CTT) the amount of which shall be prescribed in administrative instructions to be issued by the Administrator, Animal and Plant Health Inspection Service for the areas in which the Sunday or holiday or overtime work is performed and such
(c) As used in this section—
(1) The term
(2) The term
(d)(1) Any principal, or any person, firm, partnership, corporation, or other legal entity acting as an agent or broker by requesting Sunday, holiday, or overtime services of an Animal and Plant Health Inspection Service inspector on behalf of any other person, firm, partnership, corporation, or other legal entity (principal), and who has not previously requested such service from an Animal and Plant Health Inspection Service inspector, must pay the inspector before service is provided.
(2) Since the payment must be collected before service can be provided, the Animal and Plant Health Inspection Service inspector will estimate the amount to be paid. Any difference between the inspector's estimate and the actual amount owed to the Animal and Plant Health Inspection Service will be resolved as soon as reasonably possible following the delivery of service, with the Animal and Plant Health Inspection Service either returning the difference to the agent, broker, or principal, or billing the agent, broker, or principal for the difference.
(3) The prepayment must be in some guaranteed form, such as money order, certified check, or cash. Prepayment in guaranteed form will continue until
(4) For security reasons, cash payments will be accepted only from 7 a.m. to 5 p.m., and only at a location designated by the Animal and Plant Health Inspection Service inspector.
(e)(1) Any principal, or any person, firm, partnership, corporation, or other legal entity requesting Sunday, holiday, or overtime services of an Animal and Plant Health Inspection Service inspector, and who has a debt to the Animal and Plant Health Inspection Service more than 60 days delinquent, must pay the inspector before service is provided.
(2) Since the payment must be collected before service can be provided, the Animal and Plant Health Inspection Service inspector will estimate the amount to be paid. Any difference between the inspector's estimate and the actual amount owed to the Animal and Plant Health Inspection Service will be resolved as soon as reasonably possible following the delivery of service, with the Animal and Plant Health Inspection Service either returning the difference to the agent, broker, or principal, or billing the agent, broker, or principal for the difference.
(3) The prepayment must be in some guaranteed form, such as money order, certified check, or cash. Prepayment in guaranteed form will continue until the debtor pays the delinquent debt.
(4) For security reasons, cash payments will be accepted only from 7 a.m. to 5 p.m., and only at a location designated by the Animal and Plant Health Inspection Service inspector.
(f) Reimbursable Sunday, holiday, or overtime services will be denied to any principal, or any person, firm, partnership, corporation, or other legal entity who has a debt to the Animal and Plant Health Inspection Service more than 90 days delinquent. Services will be denied until the delinquent debt is paid.
Each period of overtime and holiday duty as prescribed in § 97.1 shall in addition include a commuted traveltime period for the respective ports, stations, and areas in which employees are located. The prescribed computed traveltime periods are as follows:
For
7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
An embryo shall not be imported or entered into the United States unless in accordance with the provisions of this part.
The following terms, when used in this subpart, shall be construed as defined. Those terms used in the singular form in this subpart shall be construed as the plural form and vice versa, as the case may demand.
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
Except as provided in subpart B of this part, an animal embryo shall not be imported into the United States unless it is from a region listed in § 94.1(a)(2) of this chapter as being free of rinderpest and foot-and-mouth disease, and:
(a) The embryo is exported to the United States from the region in which it was conceived;
(b) The embryo was conceived as a result of artificial insemination with semen collected from a donor sire at an approved artificial insemination center, or the embryo as conceived as a result of natural breeding by a donor sire at an approved embryo transfer unit;
(c) If artificially inseminated, the donor dam conceived the embryo after being inseminated in an approved embryo transfer unit with semen collected at an approved artificial insemination center;
(d) At the time of collection of the semen used to conceive the embryo or at the time of natural breeding, the donor sire met all requirements the donor sire would have to meet under part 93 of this chapter for a health certificate required as a condition of importation into the United States;
(e) At the time of collection of the embryo from the donor dam, the donor dam met all requirements the donor dam would have to meet under part 92 of this chapter for a health certificate required as a condition of importation into the United States;
(f) There is no basis for denying an import permit for the donor sire or donor dam under § 93.304(a)(2) for horses, § 93.404(a)(2) or (3) for ruminants, and § 93.504(a)(2) or (3) for swine of this chapter;
(g) The embryo is collected and maintained under conditions determined by the Administrator to be adequate to protect against contamination of the embryo with infectious animal disease organisms; and
(h) The embryo was determined, based on microscopic examination, to have an intact zona pellucida at the time the embryo was placed into its immediate container (straw or ampule) for shipping.
(i) The embryo is contained in a shipping container which at the time of offer for entry is sealed with an official seal which was affixed to the shipping container by a full-time salaried veterinarian of the national animal health service of the region of origin or by a veterinarian authorized to do so by the national animal health service of the region of origin.
(a) Except as provided in subpart B of this part, an animal embryo shall not be imported into the United States unless accompanied by an import permit issued by APHIS and unless imported into the United States within 14 days after the proposed date of arrival stated in the import permit.
(b) An application for an import permit must be submitted to the Animal and Plant Health Inspection Service, Veterinary Services, National Center for Import-Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231. An application form for an import permit may be obtained from this staff.
(c) The completed application shall include the following information:
(1) The name and address of the person intending to export an embryo from the region of origin,
(2) The name and address of the person intending to import an embryo,
(3) The species, breed, and number of embryos to be imported,
(4) The purpose of the importation,
(5) The region in which the embryo is conceived,
(6) The port of embarkation,
(7) The mode of transportation,
(8) The route of travel,
(9) The port of entry in the United States,
(10) The proposed date of arrival in the United States,
(11) The name and address of the person to whom the embryo will be delivered in the United States, and
(12) The measures to be taken to ensure that the embryo is collected and maintained under conditions adequate to protect against contamination of the embryo with infectious animal disease organisms.
(d) After receipt and review of the application by APHIS, an import permit indicating the applicable conditions under this subpart for importation into the United States shall be issued for the importation of embryos described
(a) Except as provided in subpart B of this part, an animal embryo shall not be imported into the United States unless it is accompanied by a certificate issued by a full-time salaried veterinary officer of the national government of the region of origin, or issued by a veterinarian designated or accredited by the national government of the region of origin and endorsed by a full-time salaried veterinary officer of the national government of the region of origin, representing that the veterinarian issuing the certificate was authorized to do so. The certificate shall state:
(1) The dates, places, types, and results of all examinations and tests performed on the donor sire and donor dam as a condition for importation of the embryo, and the names and addresses of persons or laboratories conducting the examinations or tests, and a statement that any other requirements established by § 98.3 have been complied with,
(2) The name and address of the consignor and consignee,
(3) The name and address of the approved artificial insemination center where the semen for the embryo was collected, if applicable,
(4) The name and address of the approved embryo transfer unit where the donor dam was inseminated or bred and the embryo was collected, and
(5) The measures taken to ensure that the embryo was collected and maintained under conditions adequate to protect against contamination of the embryo with infectious animal disease organisms.
(b) The certificate accompanying sheep or goat embryos intended for importation from any part of the world shall, in addition to the statements required by paragraph (a) of this section, state that:
(1) The embryos' sire and dam have not been in any flock or herd nor had contact with sheep or goats which have been in any flock or herd where scrapie has been diagnosed or suspected during the 5 years prior to the date of collection of the embryos;
(2) The embryos' sire and dam showed no evidence of scrapie at the time the embryos were collected;
(3) Scrapie has not been suspected nor confirmed in any progeny of the embryos' donor dam; and
(4) The parents of the embryos' sire and dam are not, nor were not, affected with scrapie.
An embryo shall not be imported into the United States unless at a port of entry listed in § 93.303 for horses, § 93.403 for ruminants, or § 93.503 for swine of this chapter.
Upon arrival of an embryo at a port of entry, the importer or the importer's agent shall notify APHIS of the arrival by giving an inspector a document stating:
(a) The port of entry,
(b) The date of arrival,
(c) Import permit number,
(d) Carrier, and identification of the means of conveyance,
(e) The name and address of the importer,
(f) The name and address of the broker,
(g) The region of origin of the embryo,
(h) The number, species, and purpose of importation of the embryo, and
(i) The name and address of the person to whom the embryo will be delivered.
Any embryo offered for entry into the United States in accordance with this subpart and documents accompanying the embryo shall be subject to inspection by an inspector at the time the embryo is offered for entry in order to determine whether the embryo is eligible for entry. The import permit and the health certificate shall be given to the inspector.
Any embryo refused entry into the United States for noncompliance with the requirements of this subpart shall be removed from the United States within a time period specified by the Administrator or abandoned by the importer for destruction, and pending such action shall be subject to such safeguards as the inspector determines necessary to prevent the possible introduction into the United States of infectious animal diseases. If such embryo is not removed from the United States within such time period, or abandoned for destruction, it may be seized, destroyed, or otherwise disposed of as the inspector determines necessary to prevent the possible introduction into the United States of infectious animal diseases.
Notwithstanding other provisions in this part, the Administrator may in specific cases allow the importation and entry into the United States of embryos other than as provided for in this part under such conditions as the Administrator may prescribe to prevent the introduction into the United States of infectious animal diseases.
(a) Except for embryos from sheep in Australia, Canada, or New Zealand, embryos from sheep may only be imported into the United States if they comply with all applicable provisions of this subpart and one of the following conditions:
(1) The embryos are transferred to females in a flock in the United States that participates in the Voluntary Scrapie Flock Certification Program (see 9 CFR part 54, subpart B) and qualifies as a “Certified” flock; or
(2) The embryos are transferred to females in a flock in the United States that participates in the Voluntary Scrapie Flock Certification Program (see 9 CFR part 54, subpart B) and the flock owner has agreed, in writing, to maintain the flock, and all first generation progeny resulting from embryos imported in accordance with this section, in compliance with all requirements of the Voluntary Scrapie Flock Certification Program until the flock, including all first generation progeny resulting from embryos imported in accordance with this section, qualifies as a “Certified” flock.
(b) Sheep embryos may be imported under paragraph (a) of this section only if the importer provides the Voluntary Scrapie Flock Certification Program identification number of the receiving flock as part of the application for an import permit.
(c) Sheep embryos may be imported under paragraph (a)(1) of this section only if they are the progeny of a dam and sire that are part of flocks in the region of origin that participate in a program determined by the Administrator to be equivalent to the Voluntary Scrapie Flock Certification Program, and the flocks have been determined by the Administrator to be at a level equivalent to “Certified” in the Voluntary Scrapie Flock Certification Program.
(d) Sheep embryos may be imported under paragraph (a)(2) of this section only if they are transferred to animals in a Certifiable Class C flock participating in the Voluntary Scrapie Flock Certification Program;
(e) The flock to which the sheep embryos are transferred pursuant to paragraph (a)(2) of this section must be monitored for scrapie disease until the flock, and all first generation progeny resulting from the embryos imported in accordance with this section, qualifies as a “Certified” flock.
(f) Except for sheep embryos being placed in Certifiable Class C flocks, the certificate accompanying sheep embryos imported under paragraph (a) of this section must contain the following statement: “The embryos identified on this certificate are the progeny of a dam and sire that have been monitored by a salaried veterinary officer of [
(1) The Administrator will determine, based upon information supplied by the importer, whether the flock of the embryos' dam and sire participates in a program in the region of origin that is equivalent to the Voluntary Scrapie Flock Certification Program, and if so, at what level the source flock would be classified.
(2) In order for the Administrator to make a determination, the importer must supply the following information with the application for an import permit, no less than 1 month prior to the anticipated date of importation:
(i) The name, title, and address of a knowledgeable official in the veterinary services of the region of origin;
(ii) The details of scrapie control programs in the region of origin, including information on disease surveillance and border control activities and the length of time such activities have been in effect;
(iii) Any available information concerning additions, within the 5 years immediately preceding collection of the embryos, to the flock of the embryos' sire and dam;
(iv) Any available data concerning disease incidence, within the 5 years immediately preceding collection of the embryos, in the flock of the embryos' sire and dam, including, but not limited to, the results of diagnostic tests, especially histopathology tests, conducted on any animals in the flock;
(v) Information concerning the health, within the 5 years immediately preceding collection of the embryos, of other ruminants, flocks, and herds with which the embryos' sire and dam and the flock of the embryos' sire and dam might have had physical contact, and a description of the type and frequency of the physical contact; and
(vi) Any other information requested by the Administrator in specific cases as needed to make a determination.
(g) All first generation progeny resulting from embryos imported under this section are subject to the requirements of 9 CFR part 54 and all other applicable regulations.
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.);
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
(a) Ruminant and swine embryos may not be imported from regions where rinderpest or foot-and-mouth disease exists except in accordance with this subpart.
(b) Ruminant and swine embryos may not be imported into the United States from any region other than the region in which they were conceived and collected.
(a) Ruminant and swine embryos and all test samples required by this subpart may be imported into the United States from regions where foot-and-mouth disease or rinderpest exists only if accompanied by import permits issued by the Animal and Plant Health Inspection Service (APHIS).
(b) An application for the import permits must be submitted to the Animal and Plant Health Inspection Service, Veterinary Services, National Center for Import-Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231. Application forms also may be obtained at this same address. The application for a permit to import embryos will also serve as the application for a permit to import test samples for those embryos; separate applications are not required. The application must include the following information:
(1) The name and address of the exporter;
(2) The name and address of the importer;
(3) The name and address of the place where the donor dam will be bred and where the embryo(s) will be collected;
(4) The species, breed, and number of embryos to be imported;
(5) The purpose of the importation;
(6) The port of embarkation;
(7) The mode of transportation;
(8) The route of travel;
(9) The port of entry in the United States;
(10) The proposed date of arrival in the United States; and
(11) The name and address of the person to whom the embryos will be delivered in the United States.
(a) Ruminant and swine embryos shall not be imported into the United States unless they are accompanied by a certificate issued by a full-time salaried veterinary officer of the national government of the region of origin, or issued by a veterinarian designated or accredited by the national government of the region of origin and endorsed by a full-time salaried veterinary officer of the national government of the region of origin, representing that the veterinarian issuing the certificate was authorized to do so.
(b) The health certificate must state:
(1) The name and address of the place where the embryos were collected;
(2) The name and address of the vetrinarian who collected the embryos;
(3) The date of embryo collection;
(4) The identification and breed of the donor dam and donor sire;
(5) The number of ampules or straws covered by the health certificate and the identification number or code on each ampule or straw;
(6) The dates, types, and results of all examinations and tests performed on the donor dam and donor sire as a condition for importing the embryos;
(7) The dates and results of all tests performed on unfertilized eggs, nontransferrable embryos, and embryo collection and wash fluids;
(8) The names and addresses of the consignor and consignee;
(9) That the embryos are being imported into the United States in accordance with subpart B of 9 CFR part 98.
(c) If any of the information required by paragraph (b) of this section is provided in code, deciphering information must be attached to the health certificate.
(d) The health certificate accompanying sheep or goat embryos intended for importation from any part of the world shall, in addition to the statements required by paragraph (b) of this section, state that:
(1) The embryos' sire and dam have not been in any flock or herd nor had contact with sheep or goats which have been in any flock or herd where scrapie has been diagnosed or suspected during the 5 years prior to the date of collection of the embryos;
(2) The embryos' sire and dam showed no evidence of scrapie at the time the embryos were collected;
(3) Scrapie has not been suspected nor confirmed in any progeny of the embryos' donor dam; and
(4) The parents of the embryos' sire and dam are not, nor were not, affected with scrapie.
(e) There must be a separate health certificate for each collection of embryos.
Ruminant and swine embryos may be imported from a region where rinderpest or foot-and-mouth disease exists only if all of the following conditions are met:
(a) The donor dam is determined to be free of communicable diseases based on tests, and examinations, and other requirements, as follows:
(1) During the year before embryo collection, no case of the following diseases occurred in the embryo collection unit or in any herd in which the donor dam was present:
(i) Ruminant: Bovine spongiform encephalopathy, contagious bovine
(ii) Swine: African swine fever, foot-and-mouth disease, classical swine fever, pseudorabies, rinderpest, swine vesicular disease, or vesicular stomatitis.
(2) During the year before embryo collection, no case of the following diseases occurred within 5 kilometers of the embryo collection unit or in any herd in which the donor dam was present:
(i) Ruminant: Bovine spongiform encephalopathy, contagious bovine pleuropneumonia, foot-and-mouth disease, Rift Valley fever, rinderpest, or vesicular stomatitis; or
(ii) Swine: African swine fever, foot-and-mouth disease, classical swine fever, pseudorabies, rinderpest, swine vesicular disease, or vesicular stomatitis.
(3) During the 60 days before embryo collection, the donor dam did not receive a vaccination for either rinderpest or foot-and-mouth disease.
(4) During the 60 days before the donor dam was required to be in the embryo collection unit, in accordance with § 98.17(a) of this subpart, the donor dam remained in the same herd, and no ruminants or swine were added to that herd.
(5)(i) On the day of embryo collection, and again not less than 30 days nor more than 120 days afterward, one sample of at least 10 ml of serum was collected from the donor dam, frozen, and sent to the Foreign Animal Disease Diagnostic Laboratory for testing.
(ii) The donor dam was determined to be free of foot-and-mouth disease based upon tests of the pair of serum samples. In addition, if any of the following diseases exist in the region of origin, the donor dam was determined to be free of these diseases based upon additional tests of the serum samples:
(A) Ruminant: Contagious bovine pleuropneumonia, Rift Valley fever, rinderpest, or vesicular stomatitis; or
(B) Swine: African swine fever, classical swine fever, pseudorabies, rinderpest, swine vesicular disease, or vesicular stomatitis.
(iii) If the donor dam was in any herd during the year before embryo collection that was not certified free of brucellosis by the national government of the region of origin, the donor dam was determined to be free of brucellosis based on tests of the serum samples.
(iv) The only official test results will be those provided by the Foreign Animal Disease Diagnostic Laboratory.
(6) If the donor dam was in any herd during the year before embryo collection that was not certified free of tuberculosis by the national government of the region of origin, the donor dam was determined to be free of tuberculosis by an official veterinarian based on an intradermal tuberculin test. The test must have been administered to the donor dam by an official veterinarian not less than 30 days nor more than 120 days after embryo collection, and not less than 60 days after any previously administered intradermal test for tuberculosis.
(7)(i) Not less than 30 days nor more than 120 days after embryo collection, the donor dam was examined by an official veterinarian and found free of clinical evidence of the following diseases:
(A) Ruminant: Bovine spongiform encephalopathy, brucellosis, contagious bovine pleuropneumonia, foot-and-mouth disease, Rift Valley fever, rinderpest, tuberculosis, and vesicular stomatitis; or
(B) Swine: African swine fever, brucellosis, foot-and-mouth disease, classical swine fever, pseudorabies, rinderpest, swine vesicular disease, tuberculosis, and vesicular stomatitis.
(ii) All signs of any other communicable disease must be listed on the health certificate that accompanies the embryos to the United States.
(8)(i) Between the time the embryos were collected and all examinations and tests required by this subpart were completed, no animals in the embryo collection unit with the donor dam, or in the donor dam's herd of origin, exhibited any clinical evidence of:
(A) Ruminant: Bovine spongiform encephalopathy, brucellosis, contagious bovine pleuropneumonia, foot-and-mouth disease, Rift Valley fever, rinderpest, tuberculosis, and vesicular stomatitis; or
(B) Swine: African swine fever, brucellosis, foot-and-mouth disease, classical swine fever, pseudorabies, rinderpest, swine vesicular disease, tuberculosis, and vesicular stomatitis.
(ii) All signs of any other communicable disease must be listed on the health certificate that accompanies the embryos to the United States.
(b) The donor dam or donor sire is determined to be free of communicable diseases based on other testing or certifications if required by the Administrator. The Administrator may require additional testing or certifications if he or she determines that they are necessary to determine either the donor dam's or the donor sire's freedom from communicable diseases. Circumstances that may result in additional testing or certifications include, but are not limited to:
(1) The existence of communicable diseases of livestock, other than those diseases specifically listed, in the region of origin;
(2) A high prevalence or an increase in the incidence of a communicable disease in the region of origin;
(3) The use of natural breeding, rather than artificial insemination to conceive the embryos;
(4) The use of fresh, rather than frozen semen, for artificial insemination; and
(5) The use of semen collected at a site other than an artificial insemination center approved by the national government of the region of origin.
(c) Embryos produced by any donor dam or sire that dies before being examined and tested as required under this subpart will not be eligible for importation into the United States.
Ruminant and swine embryos may be imported into the United States from a region where rinderpest or foot-and-mouth disease exists only if they were conceived, collected, processed, and stored prior to importation at an embryo collection unit. The embryo collection unit may be located on the premises where the donor dam's herd of origin is kept, or at any other location, provided that the embryo collection unit has been inspected and approved by an APHIS veterinarian and that the following requirements are met:
(a)
(b)
(c)
(d)
(e)
(a)
(2) The donor dam must remain at the embryo collection unit until the embryos for importation into the United States have been collected.
(3) After collection of embryos, the donor dam must either remain at the embryo collection unit or be returned to the herd of origin and remain there until all examinations and tests required by this subpart have been completed.
(4) During the time the donor dam is in the embryo collection unit, in accordance with paragraphs (a)(1) through (a)(3) of this section, no animals may be in the embryo collection unit with the donor dam unless:
(i) They meet the requirements of § 98.15 of this subpart that are applicable to the donor dam at that time;
(ii) They are part of the donor dam's herd of origin; or
(iii) They are serving as donor sires for the production of embryos to be imported into the United States.
(b)
(2) Officials from the Animal and Plant Health Inspection Service must be given access to all areas of the embryo collection unit and the donor dam's herd of origin during the time the donor dam is housed there, in accordance with paragraphs (a)(1) through (a)(3) of this section.
(c)
(d)
(2) All equipment that comes in contact with a donor dam's secretions or excretions must be sterile and may not be used with any other donor dam until it has been resterilized.
(3) Containers used for storing embryos or for shipping embryos to the United States must be examined and found free of any organic matter and then disinfected before the ampules or straws are placed inside.
(4) The floor, ceiling, and walls of any room or outdoor area used for embryo collection, and the restraining device(s) used for this procedure, must be cleaned with soap and water and disinfected before the room or area is used to collect embryos intended for importation to the United States, and at least daily while in use for this purpose.
(5) The room and work surface used for processing embryos must be kept free of insects, rodents, trash, manure, and other animal matter and must be cleaned with soap and water and disinfected before the room is used for embryos intended for importation to the United States, and the work surface must be cleaned and disinfected at least daily while in use for this purpose.
(6) The area of the embryo collection unit used to store embryos intended for importation to the United States must be kept free of insects, rodents, trash, manure, and other animal matter and must be cleaned with soap and water and disinfected before being used to store the embryos.
(7) The room used for cleaning and disinfecting or sterilizing equipment
(e)
(2) The liquid nitrogen used to freeze embryos may not have been used previously for any other products of animal origin.
(f)
(2) Embryos from donors that do not meet the requirements of § 98.15 of this subpart that are applicable at the time of embryo collection may not be in the processing room at the same time as embryos intended for importation into the United States.
(3) Each embryo must be washed at least 10 times. Each wash must be accomplished by transferring the embryo into an aliquot of fresh medium that is 100 times the volume of the embryo plus any fluid transferred from the previous wash. No more than 10 embryos from the same flush may be washed together. A sterile micropipette must be used for each transfer, and the embryos must be well agitated throughout the entire volume of the wash before the next transfer. Embryos from different donors may not be washed together.
(4) After the last wash, each embryo must be microscopically examined over its entire surface at not less than 50× magnification. An embryo may not be imported into the United States unless its zona pellucida is found to be intact and free from any adherent material.
(5) After washing and examination of the zona pellucida, embryos must be individually packaged in sterile ampules or straws and frozen in liquid nitrogen. The donor dam's and sire's identifications and breed, the date of embryo collection, the name and address of the place where the embryos were collected, and an identification number for the straw or ampule must be recorded with indelible markings on each ampule or straw. If any of this information is provided in code, deciphering information must be attached to the health certificate for the embryos.
(6) The Administrator may require additional measures to be taken in processing embryos after collection (for example, adding trypsin to the washes) if he or she determines that such measures are necessary to ensure the embryos freedom from infectious agents that may cause communicable diseases. Circumstances that may result in such additional measures being required include, but are not limited to:
(i) The existence of communicable diseases of livestock, other than those diseases specifically listed, in the region of origin; and
(ii) A high prevalence or an increase in the incidence of a communicable disease in the region of origin.
(g)
(2) All samples collected in accordance with paragraph (g)(1) of this section must be tested and found negative for viral contamination. The wash fluids also must be found negative for bacterial contamination. The only official results for these tests will be those provided by the Foreign Animal Disease Diagnostic Laboratory.
(h)
(2) Containers in which embryos will be imported into the United States must be sealed by an official veterinarian with the official seal of the region of origin or, if the official veterinarian is an employee of the Animal and Plant Health Inspection Service, with an official seal of the United States Department of Agriculture. The seal number must be recorded on the health certificate that accompanies the embryos to the United States.
(a)
(b)
(c)
(d)
(a) Upon arrival at the port of entry, the importer or the importer's agent must present an inspector at the port with the original health certificate and the original import permit for the embryos.
(b) The shipping container and all straws or ampules containing embryos must be made available to an inspector at the port of entry for inspection, and may not be removed from the port of entry until an inspector determines that the embryos are eligible for entry in accordance with this subpart and releases them.
If any embryos are determined to be ineligible for importation into the United States upon arrival at the port of entry, the importer must remove the embryos from the United States within 30 days, or the embryos will be destroyed.
Except for embryos from sheep in Australia, Canada, or New Zealand, embryos from sheep may only be imported into the United States if they comply with all applicable provisions of this subpart and with § 98.10a.
Whenever in this subpart of the following terms are used, unless the context otherwise requires, they shall be construed, respectively, to mean:
(1) A national entity (country);
(2) Part of a national entity (zone, county, department, municipality, parish, Province, State, etc.)
(3) Parts of several national entities combined into an area; or
(4) A group of national entities (countries) combined into a single area.
(a) No product subject to the provisions of this subpart shall be brought into the United States except in accordance with the regulations in this subpart and part 94 of this subchapter; nor shall any such product be handled or moved after physical entry into the United States before final release from quarantine or any other form of governmental detention except in compliance with such regulations;
(b) Animal semen may not be imported into the United States from any region other than the region in which it was collected.
(a)
(b)
(c)
(d) For purposes of this section, the term “shipping container” means any container of a type specially adapted for use in transporting any article on the means of conveyance involved.
(a)
(b)
(c)
(d)
(e)
(a)
(2) An application for permit to import will be denied for semen from ruminants or swine from any region where it has been declared, under section 306 of the Act of June 17, 1930, that foot-and-mouth disease or rinderpest has been determined to exist, except as provided in paragraph (c) of this section.
(3) An application for permit to import poultry semen or animal semen may also be denied because of: Communicable disease conditions in the area or region of origin, or in a region through which the shipment has been or will be transported; deficiencies in the regulatory programs for the control or eradication of animal diseases and the unavailability of veterinary services in the above mentioned regions; the importer's failure to provide satisfactory evidence concerning the origin, history, and health status of the animals or animal semen; the lack of satisfactory information necessary to determine that the importation will not be likely to transmit any communicable disease to livestock or poultry of the United States; or any other circumstances which the Administrator believes require such denial to prevent the dissemination of any communicable disease of livestock or poultry into the United States.
(b)
(c)
(1) The importer has applied for and obtained an import permit for the semen in accordance with the provisions of this section and related requirements concerning application therefor, which permit is in effect at the time of importation, and has deposited with the Department prior to the issuance of the permit sufficient funds so as to be available for defraying estimated expenses to be incurred in connection with the proposed semen importation and following the issuance of the permit has deposited such other amounts as may be required from time to time to defray unanticipated costs or increased expenses. Such an import permit may be denied for the reasons specified in paragraph (a)(3) of this section. Furthermore, an import permit will be revoked unless the following conditions have been complied with:
(i) The donor animal shall have been inspected on the farm of origin or on another premises (the inspection may be on another premises only if a veterinarian of the Department has traced the donor animal back to its farm of origin) by a veterinarian of the United States Department of Agriculture who, in cooperation with the veterinary service of the region of origin of the donor animal, shall have determined, insofar as possible, that the donor animal was never infected with rinderpest or foot-and-mouth disease; that the donor animal was never on a farm or other premise where rinderpest or foot-and-mouth disease then existed; that the donor animal has not been on a premise that had an animal that was susceptible to the virus of rinderpest or foot-and-mouth disease and that was exposed to either disease during the 12 months immediately prior to the date of inspection of the donor animal; that the donor animal, if a ruminant, has never been vaccinated against rinderpest; that the donor animal, if a swine, has never been vaccinated against rinderpest or foot-and-mouth disease; and that the donor animal was free from evidence of other communicable disease;
(ii) The donor animal shall have been permanently identified in a manner satisfactory to a veterinarian of this Department; a blood sample and an oesophageal-pharyngeal tissue sample (O-P sample) from such a donor ruminant and a blood sample from such a donor swine for tests as specified in paragraph (c)(1)(iv) of this section or other tests shall have been collected by a veterinarian of the United States Department of Agriculture and transported by air to the New York Port Veterinarian for delivery to the Foreign Animal Disease Diagnostic Laboratory, Greenport, New York, in containers approved by a veterinarian of this Department, sealed in the region of origin by a veterinarian of this Department; and pending the results of the tests, the donor animal shall have been kept in isolation on the farm of origin or other acceptable location under the supervision of a veterinarian of this Department, and during such
(iii) The blood samples from the donor animal shall have been negative to the tests specified in paragraph (c)(1)(iv) of this section made at the Foreign Animal Disease Diagnostic Laboratory, Greenport, New York, and to any other test for rinderpest, foot-and-mouth disease or other communicable disease prescribed by the Administrator.
(iv) In the case of a ruminant, each blood sample collected pursuant to paragraph (c)(1)(ii) or (vi) of this section shall have been tested for foot-and-mouth disease using the virus infection associated (VIA) test and each O-P sample collected pursuant to paragraph (c)(1)(ii) or (iv) of this section shall have been tested for foot-and-mouth disease using the virus isolation test. In the case of a swine, each blood sample collected pursuant to paragraph (c)(1)(ii) or (vi) of this section shall have been tested for foot-and-mouth disease using the virus infection associated (VIA) test and the virus neutralization test.”
(v) Following isolation, preliminary veterinary inspection, and testing while the donor animal was on the farm of origin or other acceptable location, the donor animal shall have been transported, under such conditions as the Department veterinarian prescribed to prevent exposure of the animal to the virus of rinderpest or foot-and-mouth disease, to an isolation facility properly equipped for the necessary care and maintenance of the donor animal and for the proper collection and handling of semen, approved by a veterinarian of this Department and under the direct supervision of such veterinarian;
(vi) The semen of the donor animal shall have been collected at the approved isolation facility under the direct supervision of a veterinarian of this Department (any number of collections may be made); such veterinarian shall take a 0.5 ml sample of semen from each semen collection; and all handling procedures, such as examination, dilution, refrigeration, and preparation of the semen for shipment, shall have been under the direct supervision of a veterinarian of this Department. In the case of a ruminant, a blood sample and an O-P sample shall have been taken from the donor animal by a veterinarian of the Department within 7 days after the final semen collection, and between 21 to 28 days after the taking of these samples another blood sample shall have been taken from the donor animal by a veterinarian of the Department. In the case of a swine, a blood sample shall have been taken from the donor animal by a veterinarian of the Department within 7 days after the final semen collection, and between 21 to 28 days after the taking of the sample, another blood sample shall have been taken from the donor animal by a veterinarian of the Department.
(2) The semen collected at the approved isolation facility shall have been at all times, except during air transportation to New York, in the custody of a veterinarian of this Department.
(3) The semen for which an import permit has been issued shall have been transported by air to the port of New York in liquid nitrogen containers approved by a veterinarian of this Department; sealed in the region of origin by a veterinarian of this Department; and accompanied by a statement by such veterinarian showing the identification of the donor animal and the dates the semen was collected, along with a certificate regarding the health status of the donor animal as of the date of shipment of the semen to the port of New York. All semen received at the port of New York shall be held under quarantine in liquid nitrogen storage at such port in the custody of APHIS until released or otherwise disposed of as provided in this section.
(4) The donor animal shall have been retained at the approved isolation facility in the region where the semen
(5) The semen sample from each collection shall have consisted of unprocessed semen without any added substances, and shall have been tested at the Foreign Animal Disease Diagnostic Laboratory, Greenport, New York. Such tests shall have been performed by injecting the semen samples into test animals which are susceptible to rinderpest or foot-and-mouth disease. The semen collected at the approved isolation facility, other than the semen samples, may be held in the region of origin or at the port of New York, at the option of the importer, until all of the testing required to be conducted under this section is completed.
(6) If it is determined that the requirements set forth in this paragraph have been complied with and there are no indications that the donor animal or the semen from the donor animal harbors the virus of rinderpest or foot-and-mouth disease or any other communicable disease and if the donor animal, blood samples from the donor animal, O-P samples (if applicable) from the donor animal, and semen samples from the donor animal are negative to all other tests required, the semen shall be released for shipment to the consignee listed by the importer; otherwise the semen shall be destroyed or disposed of as the Administrator, may direct.
(7)
(i) The donor boars must pass a 60-day isolation/collection period in a facility jointly approved by the OVO of the PRC and the USDA as adequate to prevent exposure of the donor boars to infectious diseases. Any other swine at the isolation facility, such as teaser animals, must also meet the requirements of this paragraph. No animals may be added to the group after the start of the 60-day isolation/collection period. The Department will permit collection of semen to be initiated at the beginning of the isolation/collection period. The facility shall be cleaned and disinfected with a 4 percent sodium carbonate solution used in accordance with applicable label instructions in the presence of OVO quarantine personnel prior to the start of the isolation. During the isolation/collection period, personnel handling the animals shall not have contact with other domestic farm livestock (this term does not include pets such as dogs and cats). Raw animal food wastes (garbage) shall not be fed to the donor boars while in isolation. At the start of the isolation/collection period, and again after 14 days of isolation, all animals offered for collection of semen must be given an intramuscular injection of dihydrostreptomycin at a rate of 25 mg/kg dosage as a precautionary treatment for leptospirosis. Feed and bedding used during the isolation/collection period shall not originate from areas infected with epizootic diseases and must meet veterinary hygienic requirements established by the OVO of the PRC concerning freedom of the feed and bedding from contamination that could transmit diseases. During the isolation/collection period the swine at the collection center shall not have direct contact with, or exposure to, any other animals not included in the group at the isolation facility. Exposure consists of contact with yards, pens, or other facilities or vehicles that have been in contact with animals and have not been cleaned and disinfected.
(ii) Donor boars shall be selected from premises which are solely swine breeding operations. These premises must be located at the center of an area with a 16 km radius that was free of foot-and-mouth disease (FMD), swine vesicular disease (SVD), and classical swine fever for three years prior to semen collection. Donor boars shall not have been vaccinated against
(iii) During the 60-day isolation/collection period, the boars offered for collection of semen shall be subjected to the following tests,
(A) Foot-and-mouth disease:
(
(
(B) Brucellosis: Standard tube test (STT) at less than 30 IU/ml, and card test (antigen and protocol to be supplied by USDA).
(C) Swine vesicular disease: Virus neutralization test at 1:40 dilution (serums to be tested at FADDL).
(D) Classical swine fever: Fluorescent antibody neutralization (FAN) test at 1:16 dilution.
(E) Japanese B encephalitis: Hemagglutination inhibition (HI) test, negative according to PRC standards.
(F) Pseudorabies: Virus neutralization at 1:4 dilution.
(G) Tuberculosis: Intradermal test using bovine PPD tuberculin (Positive animals will be necropsied. If there are lesions of TB in the test positive pigs, the whole group will be ineligible as semen donors. If no lesions are found, the rest of the pigs will be eligible as semen donors with respect to tuberculosis.
(iv) The semen will not be eligible for release in the United States until all tests in paragraph (c)(7)(iii) of this section have been completed with negative results.
(v) Each semen straw or ampule for export must be identified with the name or identification number of the donor boar and with the date of collection. A USDA veterinarian shall certify that he or she has supervised the collection and processing of the semen and its storage until the time it is shipped to the United States. Each shipment will be accompanied by a USDA veterinarian unless the semen is shipped directly to the port of New York, with no stops en route. Shipment to the United States will be in accordance with the terms of a USDA import permit. Semen imported in accordance with this section shall be released by USDA to the importer only after all requirements of this section have been met.
(d)
(1) All first generation (F1) progeny resulting from imported semen will be identified with a permanent official identification consistent with the provisions of § 79.2 of this chapter; and
(2) Records of any sale of F1 progeny, including the name and address of the buyer, will be kept for a period of 5 years. APHIS may view and copy these records during normal business hours.
(a) The certificates, declarations, and affidavits required by the regulations in this subpart shall be presented by the importer or his or her agent to the collector of customs at the port of entry, upon arrival of animal semen at such port, for the use of the veterinary inspector at the port of entry.
(b) For all animal semen offered for importation, the importer or his or her agent shall first present two copies of a declaration which shall list the port of entry, the name and address of the importer, the name and address of the broker, the origin of the animal semen, the number, breed, species, and purpose of the importation, the name of the person to whom the animal semen will be delivered, and the location of the place to which such delivery will be made.
(c) All animal semen intended for importation into the United States shall be accompanied by a health certificate issued by a full-time salaried veterinary officer of the national government of the region of origin, or issued by a veterinarian designated or accredited by the national government of the region of origin and endorsed by a full-time salaried veterinary officer of the national government of the region of origin, representing that the veterinarian issuing the certificate was authorized to do so.
(d) The health certificate must state:
(1) The name and address of the place where the semen was collected;
(2) The name and address of the veterinarian who supervised the collection of the semen;
(3) The date of semen collection;
(4) The identification and breed of the donor animal;
(5) The number of ampules or straws covered by the health certificate and the identification number or code on each ampule or straw;
(6) The dates, types, and results of all examinations and tests performed on the donor animal as a condition for importing the semen;
(7) The seal number on the shipping container;
(8) The names and addresses of the consignor and consignee; and
(9) That the semen is being imported into the United States in accordance with subpart C of 9 CFR part 98.
(e) The certificate accompanying sheep or goat semen intended for importation from any part of the world shall, in addition to the statements required by paragraph (d) of this section, state that:
(1) The donor animals:
(i) Are permanently identified, to enable traceback to their establishment of origin; and
(ii) Have been kept since birth in establishments in which no case of scrapie had been confirmed during their residency; and
(iii) Neither showed clinical signs of scrapie at the time of semen collection nor developed scrapie between the time of semen collection and the export of semen to the United States; and
(iv) The dam of the semen donor is not, nor was not, affected with scrapie.
(2) In the region where the semen originates:
(i) Scrapie is a compulsorily notifiable disease; and
(ii) An effective surveillance and monitoring system for scrapie is in place; and
(iii) Affected sheep and goats are slaughtered and completely destroyed; and
(iv) The feeding of sheep and goats with meat-and-bone meal or greaves derived from ruminants has been
(3) Semen originating in regions other than Australia and New Zealand is to be transferred to females in a flock that is listed in the Scrapie National Database as part of the Scrapie Program in the United States. Imported semen may be further distributed to any other listed flock with written notification to the APHIS Veterinary Services area office.
(f) All shipping containers carrying animal semen for importation into the United States must be sealed with an official seal of the national veterinary service of the region of origin. The health certificate must show the seal number on the shipping container. The semen must remain in the sealed container until arrival in the United States and, at the U.S. port of entry, an inspector determines that either:
(1) The seal numbers on the health certificate and shipping container match; or
(2) The seal numbers on the health certificate and shipping container do not match, but an APHIS representative at the port of entry is satisfied that the shipping container contains the semen described on the health certificate, import permit, declaration, and any other accompanying documents.
(a)
(b)
In addition to meeting all other applicable provisions of this part, swine semen imported from the APHIS-defined EU CSF region must meet the following conditions, except as noted in paragraph (h) of this section with regard to swine semen imported from Denmark, Finland, the Republic of Ireland, Sweden, or the United Kingdom:
(a) The semen must come from a semen collection center approved for export by the competent veterinary authority of the APHIS-defined EU CSF region Member State.
(b) The semen must not have been collected from a donor boar that was in any of the following regions or zones, unless the semen was collected after the periods described:
(1) Any region when the region was classified in §§ 94.9(a) and 94.10(a) of this chapter as one in which classical swine fever is known to exist, except for the APHIS-defined EU CSF region;
(2) A restricted zone in the APHIS-defined EU CSF region established because of the detection of classical swine fever in domestic swine, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority of the Member State or until 6 months following depopulation of the swine on affected premises in the restricted zone and the cleaning and disinfection of the last affected premises in the zone, whichever is later; or
(3) A restricted zone in the APHIS-defined EU CSF region established because of the detection of classical swine fever in wild boar, from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority of the Member State.
(c) The semen must not have been collected from a donor boar that was commingled with swine that at any time were in any of the regions or zones described in paragraphs (b)(1) through (b)(3) of this section, unless the semen was collected after the periods described.
(d) The semen must not have been collected from a donor boar that transited any region or zone described in paragraphs (b)(1) through (b)(3) of this section during the periods described, unless the donor boar was moved directly through the region or zone in a sealed means of conveyance with the seal determined to be intact upon arrival at the point of destination, or unless the semen was collected after the periods described;
(e) The donor boar must be held in isolation for at least 30 days prior to entering the semen collection center.
(f) No more than 30 days prior to being held in isolation as required by paragraph (e) of this section, the donor boar must be tested with negative results with a classical swine fever test approved by the World Organization for Animal Health.
(g) No equipment or materials used in transporting the donor boar from the farm of origin to the semen collection center may have been used previously for transporting swine that do not meet the requirements of this section, unless such equipment or materials have first been cleaned and disinfected.
(h) Except for semen collected from swine in Denmark, Finland, the Republic of Ireland, Sweden, or the United Kingdom, before the semen is exported to the United States, the donor boar must be held at the semen collection center and observed by the center veterinarian for at least 40 days following collection of the semen, and, along with all other swine at the semen collection center, exhibit no clinical signs of classical swine fever.
(i) The semen must be accompanied by a certificate issued by a salaried veterinary officer of the competent veterinary authority of the APHIS-defined EU CSF region Member State, stating that the provisions of paragraphs (a) through (h) of this section have been met.
7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
The Uniform Rules of Practice for the Department of Agriculture promulgated in subpart H of part 1, subtitle A, title 7, Code of Federal Regulations, are the Rules of Practice applicable to adjudicatory, administrative proceedings under the following statutory provisions:
(a) At any time prior to the issuance of a complaint seeking a civil penalty under any of the Acts listed in § 99.1, the Administrator, in his discretion, may enter into a stipulation with any person in which:
(1) The Administrator or the Administrator's delegate gives notice of an apparent violation of the applicable Act, or the regulations issued thereunder, by such person and affords such person an opportunity for a hearing regarding the matter as provided by such Act;
(2) Such person expressly waives hearing and agrees to pay a specified penalty within a designated time; and
(3) The Administrator agrees to accept the penalty in settlement of the particular matter involved if the penalty is paid within the designated time.
(b) If the penalty is not paid within the time designated in such a stipulation, the amount of the stipulated penalty shall not be relevant in any respect to the penalty which may be assessed after issuance of a complaint.
21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
When used in parts 101 through 117 of this subchapter, the meaning of the words and phrases listed shall be as defined in this part.
The following administrative words and phrases shall mean:
(1) A product's intended use shall be determined through an objective standard and not a subjective one, and would be dependent on factors such as representations, claims (either oral or written), packaging, labeling, or appearance.
(2) The term
(i) Substances, at any stage of production, shipment, distribution, or sale, which are intended for use in the treatment of animals and which are similar in function to biological products in that they act, or are intended to act, through the stimulation, supplementation, enhancement, or modulation of the immune system or immune response; or
(ii) Substances, at any stage of production, shipment, distribution, or sale, which are intended for use in the treatment of animals through the detection or measurement of antigens, antibodies, nucleic acids, or immunity; or
(iii) Substances, at any stage of production, shipment, distribution, or sale, which resemble or are represented as biological products intended for use in the treatment of animals through appearance, packaging, labeling, claims (either oral or written), representations, or through any other means.
(3) The term
When used in conjunction with or in reference to a biological product, the following terms shall mean:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(n)
(o)
(1) A suspension of organisms, representing a whole culture or a concentrate thereof, with the toxic growth products from the culture which has been inactivated without appreciable loss of antigenicity as measured by suitable tests, the inactivation of organisms and toxins being demonstrated by acceptable tests written into the filed Outline of Production:
(2) A combination product in which one or more toxoids or bacterin-toxoids is combined with one or more bacterins or one or more bacterin-toxoids.
(p)
Terms pertaining to identification and packaging of biological products shall mean:
(a)
(1) Upon or attached to a final container of a biological product;
(2) Appearing upon any immediate carton or box used to package such final container; and
(3) Appearing on any accompanying enclosures (leaflets, inserts, or circulars) on which required information or directions as to the use of the biological product shall be found.
(b)
(c)
(d)
(e)
(f)
(g)
(h)
Terms used when evaluating biological products shall mean:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(n)
(o)
(1) A completed serial of vaccine or bacterin prepared in accordance with a filed Outline of Production;
(2) A purified preparation of a protective immunogen or antigen; or
(3) A nonadjuvanted harvested culture of microorganisms.
(p)
(1) Master References; or
(2) Serials of product that have been prepared and qualified, in a manner acceptable to Animal and Plant Health Inspection Service for use as reference preparations.
(q)
(2) Qualifying serials used to requalify or extend the dating period of a Master Reference shall be determined to be immunogenic in accordance with methods deemed appropriate by the Animal and Plant Health Inspection Service as provided in paragraph (a)(1) of this section, and, in addition, shall be within their permitted dating period and have been prepared in accordance with the production method described in the currently filed Outline of Production.
(r)
When used in conjunction with or in reference to cell cultures, which may be referred to as tissue cultures, the following terms shall mean:
(a)
(b)
(c)
(d)
When used in conjunction with or in reference to seed organisms, the following shall mean:
(a)
(b)
(c)
21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
Each establishment qualified to prepare biological products under the Virus-Serum-Toxin Act shall hold an unexpired and unrevoked U.S. Veterinary Biologics Establishment License issued by the Administrator and a U.S. Veterinary Biological Product License for each product prepared in such establishment unless the product is subject to the provisions of 9 CFR parts 103 or 106 of this subchapter.
(a) Every person who prepares biological products subject to the Virus-Serum-Toxin Act shall hold an unexpired, unsuspended, and unrevoked U.S. Veterinary Biologics Establishment License and at least one unexpired, unsuspended, and unrevoked U.S. Veterinary Biological Product License issued by the Administrator to prepare a biological product.
(b) An applicant who applies for an establishment license must also apply for at least one product license. An establishment license will not be issued without a license authorizing the production of a biological product in the establishment.
(a)
(2) When a person conducts more than one establishment, a separate application shall be made for each establishment.
(3) Whenever subsidiaries are to operate in an establishment for which license application is made, the applicant shall apply for permission for such subsidiaries to operate in the establishment and furnish therewith a complete statement regarding the relationship between the applicant and the subsidiaries.
(4) Facilities documents, prepared as prescribed in part 108 of this subchapter, shall accompany the application for license unless previously filed with Animal and Plant Health Inspection Service.
(5) Each application for a U.S. Veterinary Biologics Establishment License shall be accompanied by an application for one or more U.S. Veterinary Biological Product Licenses and the supporting documents required by paragraph (b)(2) of this section.
(6) A new application shall be made when a change of ownership, operation, or location of an establishment occurs; or prior to the expiration of a U.S. Veterinary Biologics Establishment License issued for an interim period of time.
(b)
(2) Each application for a U.S. Veterinary Biological Product License shall be supported by:
(i) At least four copies of an Outline of Production prepared in accordance with §§ 114.8 and 114.9 of this subchapter; and
(ii) At least three copies of test reports and research data sufficient to establish purity, safety, potency, and efficacy of the product; and
(iii) Legends prepared as prescribed in § 108.5 of this subchapter designating which facilities are to be used in the preparation of each fraction; and
(iv) Labels in finished form or sketches prepared as prescribed in § 112.5 of this subchapter, together with information regarding all claims to be made on labels and in advertising matter to be used in connection with or related to the biological product.
(a) Before a U.S. Veterinary Biologics Establishment License will be issued by the Administrator for any establishment, an inspection shall be made to determine whether the condition, equipment, facilities, and the like, of the establishment, and the methods used to prepare biological products are in conformity with the requirements in the regulations.
(b) A license shall not be issued unless:
(1) In the opinion of the Administrator, the condition of the establishment, including its facilities, and the methods of preparation of biological products are such as reasonably to assure that the products shall accomplish the purpose for which they are intended; and
(2) The Administrator is satisfied on the basis of information before him that:
(i) The establishment shall be operated in compliance with the Act and applicable regulations and be under the supervision of person(s) competent in the preparation of biological products; and
(ii) The applicant, or the person having the responsibility for producing biological products in the establishment, or both, is qualified by education and experience, and has demonstrated fitness to produce such products in compliance with the Act and regulations issued pursuant thereto;
(3) Written assurance is filed with Animal and Plant Health Inspection Service that the biological products which are licensed to be prepared therein shall not be so advertised as to mislead or deceive the purchasers and that the packages or containers in which the same are to be marketed shall not bear any statement, design, or device which is false or misleading in any particular.
(c) U.S. Veterinary Biologics Establishment Licenses shall be numbered.
(d) Two or more licenses may bear the same number when they are issued for establishments under the same ownership or control, provided a serial letter is added to one or more to identify each license and the product produced thereunder.
(e) When a U.S. Veterinary Biologics Establishment License is issued for an establishment, it shall not apply to more than one person at the same location, except that subsidiaries of the licensee, when named in the license, may operate thereunder at the establishment named. The licensee with its subsidiaries will be held responsible for all operations conducted in the licensed establishment.
(f) When a licensee no longer holds at least one unexpired, unsuspended, or unrevoked product license authorizing the preparation of a biological product, or is in the process of obtaining a product license, the establishment license shall no longer be valid and shall be returned to the Administrator. In the case where an establishment license expires or is suspended or revoked, any product license authorizing preparation of a product at such establishment shall be invalid indefinitely or for as long as the suspension is in effect.
(g) Any license issued under this part to establishments in which biological products are prepared shall be issued on condition that the licensee permit the inspection of such establishments, products, product preparation, and all relevant records as provided in part 115 of this subchapter. Failure to permit inspection may result in the license being suspended or revoked.
(h) The provisions of paragraph (b) of this section shall also be applicable to, and be considered by, the Administrator in connection with each application for an additional product license.
(a) Authorization to produce each biological product shall be specified on a U.S. Veterinary Biological Product License, issued by the Administrator, and supplementary to the U.S. Veterinary Biologics Establishment License named therein.
(b) The following shall appear on the U.S. Veterinary Biological Product License:
(1) The U.S. Veterinary Biologics Establishment License Number for the establishment from which the product is released for marketing.
(2) The true name of the product.
(3) The product code number for the product.
(4) The date of issuance.
(5) Any restrictions designated by the Administrator under paragraph (e) of this section.
(6) When necessary to comply with § 102.6 of this part, a termination date and a brief description of requirements to be met for reissuance.
(c) The following provisions shall apply to all licensed biological products:
(1) Licensed biological products shall be prepared as required by the regulations and in accordance with a filed Outline of Production as prescribed in §§ 114.8 and 114.9 of this subchapter. No change shall be made in the preparation of a biological product without prior approval of the Administrator.
(2) In addition to restrictions imposed by the Administrator pursuant to paragraph (e) of this section, biological products may be subject to restrictions which are imposed by any State or other jurisdiction pertaining to the distribution and use of such products, based on local disease conditions.
(3) When requested by the Administrator, a licensee shall submit a list of licensed biological products prepared in the licensed establishment.
(d) Where the Administrator determines that the protection of domestic animals or the public health, interest, or safety, or both, necessitates restrictions on the use of a product, the product shall be subject to such additional restrictions as are prescribed on the license. Such restrictions may include, but are not limited to, limits on distribution of the product or provisions that the biological product is restricted to use by veterinarians, or under the supervision of veterinarians, or both.
(e) Any person may request that the distribution and use of a veterinary biological product be restricted if the restriction pertains to the protection of domestic animals or the public health, interest, or safety, or both. All requests must be sent, in writing, to the Director, Center for Veterinary Biologics, Licensing and Policy Development, 510 South 17th Street, Suite 104, Ames, IA 50010-8197. Requests must specify the restriction(s) being requested and must explain why the restrictions are needed. Copies of any supporting documents, such as scientific literature, published or unpublished articles, or data from tests, should be attached to the request. When a decision is reached regarding the request, the person submitting the request will be sent written notification of such decision.
In order to meet an emergency condition, limited market, local situation, or other special circumstance, including production solely for intrastate use under a State-operated program, the Administrator may, in response to an application submitted as specified in § 102.3(b) of this part, issue a conditional U.S. Veterinary Biological Product License to an establishment under an expedited procedure which assures purity and safety, and a reasonable expectation of efficacy. Preparation of products under a conditional license shall be in compliance with all applicable regulations and standards and may be restricted as follows:
(a) The preparation may be limited to a predetermined time period which shall be established at the time of issuance and specified on the license. Prior to termination of the license, the licensee may request reissuance. Such requests shall be substantiated with data and information obtained since the license was issued. After considering all data and information available, the Administrator shall either reissue the U.S. Veterinary Biological Product License or allow it to terminate.
(b) Distribution may be limited to the extent necessary to assure that the product will meet the basic criteria for issuance of the conditional license.
(c) Labeling for the product may be required to contain information on the conditional status of the license.
21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
Except as otherwise provided in this section, experimental biological products which are neither composed of nor prepared with organisms or antigens used in biologicals already licensed, shall not be prepared in the production facilities of a licensed establishment. Upon application therefor, the Administrator may authorize the preparation of experimental products on the premises of a licensed establishment if he determines that such preparation will not result in contamination of the licensed products. Each request for permission to prepare an experimental biological product on licensed premises shall indicate the nature of the unlicensed product, designate facilities to be used, and specify precautions which will be taken to prevent contamination of licensed products. Such requests shall be submitted to the Administrator. Research facilities that are entirely separate and apart from facilities used for the preparation of licensed biological products will not be considered a part of the licensed premises for purposes of this section.
Safeguards as herein provided shall be established by the research investigator or research sponsor to control disposition of all animals administered experimental biological products or live organisms.
(a) Surviving test animals (including challenged control animals) shall not be removed from the premises on which the tests are conducted for at least 14 days after administration of an experimental biological product or live organisms:
(b) All animals administered experimental biological products which are to be slaughtered at establishments subject to the Federal Meat Inspection Act, as amended and extended (21 U.S.C. 601
(c) Except as otherwise provided in this paragraph, the research investigator or research sponsor shall maintain adequate records relative to the disposition of each animal administered experimental biological products. These records shall be maintained for a minimum period of two years from the date that an experimental product was administered to such animal, and shall show the name and address of the owner; number, species, class and location of the animals; and if sold, the name and address of the consignee, buyer, commission, firm or abattoir:
Except as provided in this section, no person shall ship or deliver for shipment in or from the United States, the District of Columbia, or any Territory
(a) One copy of a permit or letter of permission from the proper State or foreign animal health authorities of each State or foreign country involved.
(b) Two copies of a tentative list of the names of the proposed recipients and quantity of experimental product that is to be shipped to each individual. In the event of subsequent changes, additional information shall be furnished when such facts are known;
(c) Two copies of a description of the product, recommendations for use, and results of preliminary research work;
(d) Three copies of labels or label sketches which show the name or identification of the product and bear a statement, “Notice! For Experimental Use Only—Not For Sale,” or equivalent. The U.S. Veterinary License legend shall not appear on such labels; and
(e) Two copies of a proposed general plan covering the methods and procedures for evaluating the product and for maintaining records of the quantities of experimental product prepared, shipped and used. At the conclusion of field studies, results shall be obtained, summarized, and submitted to the Animal and Plant Health Inspection Service.
(f) Data acceptable to the Administrator demonstrating that use of the experimental biological product in meat animals is not likely to result in the presence of any unwholesome condition in the edible parts of animals subsequently presented for slaughter.
(g) A statement from the research investigator or research sponsor agreeing to furnish, upon the Administrator's request, additional information concerning each group of meat animals involved prior to movement of these animals from the premises where the test is to be conducted. Such information shall include the owner's name and address; number, species, class and location of animals involved; date shipment is anticipated; along with name and address of consignee, buyer, commission firm or abattoir.
(h) Any information the Administrator may require in order to assess the product's impact on the environment.
21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
Unless otherwise authorized or directed by the Administrator, each permit to import a biological product into the United States shall be issued in accordance with the regulations in this part.
(a) No biological product shall be brought into the United States unless a permit has been issued for such product. A separate U.S. Veterinary Biological Product Permit shall be required for each shipment of biological product to be imported:
(b) Each person importing biological products shall hold an unexpired, unsuspended, and unrevoked permit issued by Animal and Plant Health Inspection Service. Such person shall reside within the United States, or operate a business establishment within the United States, or both.
(a) Animal and Plant Health Inspection Service is authorized to issue three types of permits for importing biological products. They shall be:
(1) U.S. Veterinary Biological Product Permit for Research and Evaluation;
(2) U.S. Veterinary Biological Product Permit for Distribution and Sale; or
(3) U.S. Veterinary Biological Product Permit for Transit Shipment Only.
(b) A permit shall not be issued for a biological product from countries known to have exotic diseases, including but not limited to foot-and-mouth disease, rinderpest, fowl pest (fowl plague), swine vesicular disease, Newcastle disease, and African swine fever, if in the opinion of the Administrator, such products may endanger the livestock or poultry of this country.
(c) A permit shall not be issued until an inspector has determined the condition of the equipment and facilities of the producer, of the applicant, or of both if such a determination is considered necessary by the Administrator.
(d) A permit shall not be issued for a biological product prepared in the United States, exported, and presented for reentry except as provided in § 104.4(d).
(a) Each person desiring to import a biological product shall make written application to Animal and Plant Health Inspection Service for a permit. Blank forms of application shall be furnished upon request.
(b) The application shall specify the type of permit required, the port of entry at which the product shall be cleared through Customs, the estimated quantity involved, and the anticipated date on which the importation shall be made.
(a) An application for a U.S. Veterinary Biological Product Permit to import a biological product for research and evaluation shall be accompanied by a brief description of such product, methods of propagating antigens including composition of medium, species of animals or cell cultures involved, degree of inactivation or attenuation, recommendations for use, and the proposed plan of evaluation. The applicant shall also provide any information the Administrator may require in order to assess the product's impact on the environment.
(b)(1) A permit to import a biological product for research and evaluation shall not be issued unless the scientific capabilities of the investigator are determined to be adequate to safeguard domestic animals and protect public health, interest, or safety from any deleterious effects which might result from use of such product. Special restrictions or tests may be specified as part of the permit when they are deemed necessary or advisable by the Administrator.
(2) No person shall ship a product imported under this section for research and evaluation anywhere in or from the United States unless authorized by the Administrator in accordance with the provisions of § 103.3 of this subchapter.
(c) A biological product shall not be imported for Research and Evaluation which is not packaged and labeled in accordance with § 112.9 of this subchapter.
(d) When a licensed product has been exported from the United States, a permit may be issued to the producer for a small quantity of such product for in
An application for a U.S. Veterinary Biological Product Permit to import a biological product for Distribution and Sale shall be accompanied by supporting material necessary to satisfy the requirements provided in this section.
(a) A permit shall not be issued unless the conditions under which the biological product is to be prepared or the methods to be used are such as to reasonably insure that the product is pure, safe, potent, and efficacious.
(1) Three copies of blueprints of the producing foreign establishment shall be submitted with the application unless satisfactory plans are on file with Animal and Plant Health Inspection Service from a previous application. The production facilities to be used for each product prepared at the establishment shall be designated.
(2) The manufacturer shall submit written authorization for properly accredited inspectors to inspect without previous notification, and at such times as may be demanded by the aforesaid inspectors, all parts of the establishment in which biological products shall be prepared, all processes of preparation, and all records relative to such preparation.
(3) The manufacturer shall furnish written assurance that a biological product to be imported for Distribution and Sale shall be prepared under the supervision of a person competent by education and experience to handle all matters pertaining to the preparation of such product and that each biological product shall be prepared in accordance with the regulations applicable to the product or in a manner acceptable to the Administrator so as to carry out the purposes of the Act.
(4) The methods to be used in the preparation of each biological product shall be written into an approved Outline of Production prepared in accordance with the applicable provisions of part 114 of this subchapter. Four copies of such Outlines of Production shall be submitted to Animal and Plant Health Inspection Service and be approved before the permit is issued.
(5) Data shall be furnished by the applicant which establishes that the product involved complies with the provisions of the Act and the regulations issued pursuant thereto. When deemed necessary to obtain required information, Animal and Plant Health Inspection Service may require that the product be tested under field conditions within or outside the United States as the occasion demands.
(b) The permittee shall furnish the following:
(1) Adequate facilities for storing all imported biological products. An inspection of such facilities shall be made by inspectors before a permit is issued and additional inspections shall be made at any time subsequent to the importation of the biological products if deemed necessary by the Administrator;
(2) Information regarding all claims to be made on labels and advertising matter used in connection with or related to the biological product to be imported;
(3) Mounted copies of final container labels, carton labels, and enclosures to be used with the imported product as provided in part 112 of this subchapter; and
(4) Samples of each serial from each shipment of biological products imported or offered for importation. Such samples shall be collected, examined, and tested in a manner specified by the Administrator. The biological products being sampled shall not be further distributed by the permittee until released by Animal and Plant Health Inspection Service.
An application for a permit for Transit Shipment Only shall be required when a biological product is being shipped from one foreign country to another foreign country by way of the United States. The shipment shall move under a permit subject to the following restrictions:
(a) The shipment shall be confined to the carrier at all times when such shipment is to transit the United States on the same carrier on which it arrived. If the shipment is to be transferred to a carrier other than the one on which it shall arrive into the United States, a schedule of arrival and departure of each shipment shall be furnished by the permittee to Animal and Plant Health Inspection Service prior to arrival in the United States.
(b) The permittee shall be responsible to Animal and Plant Health Inspection Service for handling, storing, and forwarding of the biological product. Animal and Plant Health Inspection Service shall be notified of all shipments received and forwarded by the permittee and an accurate accounting shall be made.
(a) A permit shall be numbered and dated.
(b) The purpose for which the product is imported shall be specified on the permit as for Research and Evaluation, Distribution and Sale, or Transit Shipment Only.
(c) A permit shall not be used after the date specified.
(a) Biological products which are presented for importation without a permit having been issued shall be returned to the country of origin at the expense of the importer or in lieu thereof, destroyed by Department personnel.
(b) Biological products for Distribution and Sale presented for importation under a permit and found to be worthless, contaminated, dangerous, or harmful shall, within a period of 30 days after such finding, be returned to the country of origin at the expense of the importer or in lieu thereof, destroyed by Department personnel:
21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
(a) An establishment license, product license, or permit issued under the Virus-Serum-Toxin Act may be formally suspended or revoked after opportunity for hearing has been accorded the licensee or permittee as provided in part 123 of this subchapter if the Secretary is satisfied that the license or permit is being used to facilitate or effect the preparation, sale, barter, exchange, shipment, or importation contrary to said Act of any worthless, contaminated, dangerous, or harmful biological product. Such use may be found to exist if:
(1) The construction of the establishment in which the biological product is prepared is defective, or the establishment is not conducted as required by the regulations in parts 101 through 118 of this subchapter;
(2) The methods of preparation of the product are faulty, or the product contains impurities or lacks potency;
(3) The product is so labeled or advertised as to mislead or deceive the purchaser in any particular;
(4) The licensee, permittee, or the foreign manufacturer has failed to maintain and make available for inspection records in connection with the development and preparation of product, has failed to provide complete and accurate information when requested, or has failed to provide complete and accurate information in the Outline of Production or in reports and records;
(5) The licensee or permittee has violated or failed to comply with any provision of the Virus-Serum-Toxin Act or the regulations in this subchapter;
(6) The license or permit is otherwise used to facilitate or effect the preparation, sale, barter, exchange, shipment, or importation, contrary to the Virus-Serum-Toxin Act, of any worthless, contaminated, dangerous, or harmful biological product.
(b) In case of willfulness or where the public health, interest, or safety so required the Secretary may, without hearing, informally suspend such establishment license, product license, or permit upon the grounds set forth in paragraph (a) of this section pending determination of formal proceedings under part 123 of this subchapter for suspension or revocation of the license or permit.
If an infraction of a requirement of a product license is brought to the attention of the licensee by written notification thereof by Animal and Plant Health Inspection Service, a subsequent violation of similar nature occurring with the same licensed biological product within 6 months of the said written notification shall be primafacie evidence of willful violation and the license for the product shall be subject to suspension or revocation under the provisions of § 105.1(b).
(a) If at any time it appears that the preparation, sale, barter, exchange, shipment, or importation, as provided in the Virus-Serum-Toxin Act, of any biological product by any person holding a license or permit may be dangerous in the treatment of domestic animals, the Secretary may without hearing notify the licensee or permittee, and pending determination of formal proceedings instituted under part 123 of this subchapter for suspension or revocation of the license or permit insofar as it authorizes the manufacture or importation of the particular product, no person so notified shall thereafter so prepare, sell, barter, exchange, ship, deliver for shipment, or import such product.
(b) If a serial of biological product is found to be unsatisfactory according to applicable Standard Requirements, the Administrator may notify the licensee to stop distribution and sale of the serial.
(c) When notified to stop distribution and sale of a serial or subserial of a veterinary biological product under the provisions of paragraph (a) or (b) of this section, veterinary biologics licensees or permittees shall:
(1) Stop the preparation, distribution, sale, barter, exchange, shipment, or importation of the affected serial(s) or subserial(s) of any veterinary biological product pending further instructions from APHIS.
(2) Immediately, but no later than 2 days, send stop distribution and sale notifications to any wholesalers, jobbers, dealers, foreign consignees, or other persons known to have any such veterinary biological product in their possession, which instruct them to stop the preparation, distribution, sale, barter, exchange, shipment, or importation of any such veterinary biological product. All notifications shall be documented in writing by the licensee or permittee.
(3) Account for the remaining quantity of each serial(s) or subserial(s) of any such veterinary biological product at each location in the distribution channel known to the manufacturer (licensee) or importer (permittee).
(4) When required by the Administrator, submit complete and accurate reports of all notifications concerning stop distribution and sale actions to
(a) If a biological product has not been prepared by a licensee, or imported by a permittee for a period of 5 years or more, the Administrator may require the licensee to show intent to resume production, or the permittee to show intent to resume importation, within 6 months of notification. If the licensee does not resume preparation, or the permittee does not resume importation, within 6 months of notification, or within a mutually agreeable period, the product license, or permit, may be terminated by the Administrator.
(b) When a license or permit is terminated, the licensee or permittee shall continue to be subject to the applicable records provisions of § 116.8.
21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
The Administrator may exempt any biological product from one or more of the requirements of this subchapter if he determines that such product will be used by the Department or under the supervision or control of the Department in the prevention, control or eradication of animal diseases in connection with (a) an official USDA program; or (b) an emergency animal disease situation, or (c) a USDA experimental use of the product.
21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
Products prepared as provided in paragraphs (a) and (b) of this section and establishments in which such products are prepared, shall be exempt from preparation pursuant to unsuspended and unrevoked establishment and product licenses. Persons exempt from licensure under this part shipping products which contain live organisms shall provide any information the Administrator may require prior to shipment, or at any other time deemed necessary, in order to assess the products' safety and effect on the environment. The shipment or delivery for shipment anywhere in or from the United States of any exempted product which is worthless, contaminated, dangerous, or harmful is prohibited, and any person shipping such product, or delivering such product for shipment, shall be subject to sanctions under the Act.
(a)(1) Products prepared by a veterinary practitioner (veterinarian) solely for administration to animals in the course of a State licensed professional practice of veterinary medicine by such veterinarian under a veterinarian-client-patient relationship and establishments in which such products are prepared shall be exempt from licensing under the Act and regulations. Such a relationship is considered to exist when:
(i) The veterinarian has assumed the responsibility for making medical judgments regarding the health of the animal(s) and the need for medical treatment, and the client (owner or other caretaker) has agreed to follow the instructions of the veterinarian; and when
(ii) There is sufficient knowledge of the animal(s) by the veterinarian to
(iii) The practicing veterinarian is readily available for followup in case of adverse reactions or failure of the regimen.
(2) Veterinarians preparing products subject to the exemption for products under this section shall maintain and make available for inspection by Animal and Plant Health Inspection Service representatives or other Federal employees designated by the Secretary such records as are necessary to establish that a valid veterinarian-client-patient relationship exists and that there is a valid basis for the exemption under this section.
(b) Products prepared by a person solely for administration to animals owned by that person shall be exempt from the requirement that preparation be pursuant to an unsuspended and unrevoked license.
(a) The Administrator shall exempt from the requirement of preparation pursuant to an unsuspended and unrevoked USDA establishment and product license, any biological product prepared solely for distribution within the State of production pursuant to a license granted by such State under a program determined by the Administrator to be consistent with the intent of the Act to prohibit the preparation, sale, barter, exchange, or shipment of worthless, contaminated, dangerous, or harmful biological products.
(b) A request for exemption under this section must be made by the appropriate State authority and shall include information demonstrating that:
(1) The State has the authority to license viruses, serums, toxins, and analogous products and establishments that produce such products; and
(2) The State has the authority to review the purity, safety, potency, and efficacy of such products prior to release to the market; and
(3) The State has the authority to review product test results to assure compliance with applicable standards of purity, safety, and potency prior to release to the market; and
(4) The State has the authority to deal effectively with violations of State law regulating viruses, serums, toxins, and analogous products; and
(5) The State effectively exercises the authority specified in paragraphs (b)(1) through (4) of this section consistent with the intent of the Act prohibiting the preparation, sale, barter, exchange, or shipment of worthless, contaminated, dangerous, or harmful viruses, serums, toxins, or analogous products.
(c) Each product to be exempted and each establishment preparing such product shall be identified by the State and the State shall give written notification to the Administrator of each such product and establishment. The State shall also give written notice to the Administrator of each new license issued and of each license terminated.
(d) In order to determine whether a State exercises its authority with respect to biological products and establishments and whether its laws and regulations are being achieved, the Administrator, in cooperation with proper State authorities, may conduct an on-site evaluation of the State's program which may include inspection of establishments and/or products to be included under the exemptions in this section.
21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
Unless otherwise authorized by the Administrator, all buildings, appurtenances, and equipment used in the preparation of biological products shall be in compliance with the regulations in this part. Each land area on which such buildings and appurtenances are located shall be identified by an address which shall appear on the establishment license.
Each applicant for an establishment license shall prepare a plot plan showing all buildings for each particular land area, blueprints for each building used in the preparation of biological products and legends containing a brief description of all activities in each room or area.
Plot plans shall show all of the buildings on a particular land area, whether or not they are all used for the preparation and initial shipping of biological products:
(a) Reduce the entire premises to any standard scale on one sheet of paper which meets any of the American standard trimmed sizes. Indicate the scale used.
(b) Clearly mark the boundaries of the licensed premises and indicate what marking denotes the boundaries. Such boundaries shall coincide with some readily apparent perimeter line. Identify all fences, walls, or streets.
(c) Show buildings as reduced dimensional drawings in the proper scale distance relationship with each other.
(d) Number, letter, or otherwise identify all buildings so that they may be correlated with the respective blueprints and legends.
(e) Describe on the plot plan the use of immediate adjacent properties such as, residential area, pasture, box factory, or the like.
(f) Show compass points.
(g) Show date of preparation.
(h) Apply signature of responsible official of the firm.
(a) Blueprints, drawn to any suitable scale, on regular blueprint paper or a good grade of white paper of any one of the American standard trimmed sizes shall be acceptable:
(b) Use a single sheet of paper for each floor of all buildings in which biological products are prepared. Illustrate in detail the areas in each building utilized for such preparation.
(c) If only a portion of a floor is used in the preparation of a biological product, the blueprint shall illustrate the entire floor in essentially the same detail throughout. All functions or activities performed in the remainder of the floor shall be indicated.
(d) Identify the floors if the drawing is not for all floors in a multiple-story building and identify activities on each floor.
(e) Identify all rooms by letters or numbers.
(f) Show the location of important stationary equipment by a suitable code which will be further identified on legends.
(g) Explain on the blueprint or on the legend, by a statement or listing, which rooms are equipped with water outlets, drains, and lighting. Show the location of doors and windows.
(h) Show compass points.
(i) Show building number.
(j) Show date of preparation.
(k) Apply signature of responsible official of firm.
A brief description of the activities performed in each room or area shall be prepared as provided in this section and shall be referred to as a legend. Legends shall be provided for each plot plan and each blueprint or drawing. All pages of the legends shall be numbered, identified with corresponding plot plan or blueprint, and submitted in booklet form either stapled together or clipped into a suitable folder.
(a) Plot plan legends shall show the following:
(1) Number of each building and the functions performed in each:
(2) A practical and nontechnical description of construction materials used throughout those buildings used entirely or partially for production and handling of biological products.
(b) Blueprint legends shall show the following:
(1) A listing of all rooms by identifying letters or numbers and the fractions prepared in each. Exceptions may be listed for general purpose areas or rooms. Functions performed in each area and room shall be described, whether the licensed or unlicensed products. In rooms where products are exposed to the surroundings, a description of decontamination procedures and other precautions against cross contamination shall be included.
(2) A listing of the coded stationary equipment.
(3) A general listing of other essential biological equipment such as mills, centrifuges, mixing tanks, bottling and sealing equipment, and the like, which are not regarded as stationary but are maintained in certain rooms.
Preliminary drawings may be submitted to Animal and Plant Health Inspection Service for comment prior to construction of new facilities or when remodeling is anticipated, old facilities are to be torn down, or other changes affecting the workflow are to be made. The licensee shall:
(a) Prepare revised plot plans, blueprints, or legends and submit to Animal and Plant Health Inspection Service for review and filing when changes have been completed. Also prepare a statement to accompany each revision to identify, by date of the superseded item, what is being superseded.
(b) Prepare a drawing of the revised rooms, unit, or section to the same scale as the blueprint on file which shall be stamped and applied to the existing blueprint. If changes are numerous, prepare a new blueprint.
(c) Drawings of new buildings may be added to existing plot plans. Indicate the distance from surrounding buildings and boundary lines.
(d) Any change prescribed in this section shall necessitate a change in one or more pages of the respective legends. The revised pages shall carry the same numbers as superseded pages.
Three copies of all plot plans, blueprints, and legends, including revisions, shall be submitted to Animal and Plant Health Inspection Service for review and filing. When the reviewer takes exception to a submitted item, such item shall be returned with appropriate comments for correction and resubmission. Acceptable submissions shall be stamped as filed and the date noted. One stamped copy shall be returned and two copies retained for Animal and Plant Health Inspection Service files.
(a) The floors, walls, ceilings, partitions, posts, doors, and all other parts of all structures, rooms, or facilities used for the preparation of biological products or ingredients of biological products at licensed establishments shall be of such material, construction, and finish as may be readily and thoroughly cleaned.
(b) All rooms used in connection with the preparation of biological products shall be so constructed and arranged as to prevent cross-contamination of such biological products. Halls or walkways shall be provided for the movement of personnel or materials to each biological products preparation area without going through another such area.
(c) Rooms or compartments separate from the remainder of the establishment shall be provided at licensed establishments for preparing, handling, and storing virulent or dangerous microorganisms and products.
(d) All rooms and compartments at licensed establishments shall have an adequate air handling system to supply proper ventilation sufficient to insure sanitary and hygienic conditions for the protection of the products and personnel.
(e) The supply of hot and cold water at licensed establishments shall be ample and clean. Adequate facilities shall be provided for the distribution of water in each establishment and for the washing of all containers, machinery, instruments, other equipment, and animals used in the preparation of a biological product.
(f) There shall be an efficient drainage and plumbing system for each licensed establishment and premises thereof, and all drains and gutters shall be properly installed with approved traps and vents.
Each licensed establishment shall have dressing rooms, toilet facilities, and lavatory accommodations, including hot and cold running water, soap, towels, and the like. They shall be in sufficient number, ample in size, conveniently located, properly ventilated, and meeting all requirements as to sanitary construction and equipment.
(a) These rooms and facilities shall be separate from rooms or compartments in which biological products are prepared, handled, or stored.
(b) These rooms and facilities shall be so located in the establishment as to be readily accessible to all persons without having to enter or pass through biological products preparation areas.
(a) The outer premises of licensed establishments, embracing docks, driveways, approaches, yards, pens, chutes, and alleys shall be drained properly and kept in a clean and orderly condition. No nuisance shall be allowed in any licensed establishment or on its premises.
(b) Stables or other premises for animals used in the production or testing of biological products at licensed establishments shall be properly ventilated and lighted, appropriately drained and guttered, and kept in sanitary condition.
(c) Every practical precaution shall be taken to keep licensed establishments free of flies, rats, mice, and other vermin. The accumulation, on the premises of an establishment, of any material in which flies or other vermin may breed is forbidden. Suitable arrangements, in keeping with the local health practices, shall be made for the disposal of all refuse.
A certification from the appropriate water pollution control agency, that the establishment is in compliance with applicable water quality control standards, pursuant to section 401 of the Federal Water Pollution Control Act, as amended (86 Stat. 877; 33 U.S.C. 1341), shall be filed with Animal and Plant Health Inspection Service for each licensed establishment.
21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
(a) All containers, instruments, and other apparatus and equipment, before being used in preparing, handling, or
(b) Instruments which are found to be damaged by exposure to the degree of heat prescribed in this section, after having been thoroughly cleaned, may be sterilized by boiling for not less than 15 minutes.
Steam and dry-heat sterilizers used in connection with the processing of biological products at licensed establishments shall be equipped with automatic temperature recording gauges:
All pasteurizing equipment shall meet the requirements in paragraphs (a), (b), and (c) of this section and be acceptable to Animal and Plant Health Inspection Service.
(a) Metal serum containers shall be used in licensed establishments. During the heating process, each container shall be surrounded by a separate water jacket or equivalent so that the entire container, including its lid, is heated to the required temperature. Each serum container shall be equipped with a motor-driven agitator and a separate automatic recording thermometer.
(b) Each water bath shall have an automatic temperature control to limit the temperature of the water to a maximum of 62 °C., an automatic recording thermometer, an indicating thermometer set in a fixed position, and circulating mechanism adequate to insure equal temperatures throughout the bath. The heating unit for the bath shall be separated from the serum container and the water jacket.
(c) Accurate thermometers at licensed establishments shall be used at frequent intervals to check temperatures of the serum as registered by recording thermometers.
21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
(a) Unless otherwise authorized or directed by the Administrator, each biological product prepared at a licensed establishment, or imported, shall be packaged and labeled as prescribed in this part before it is removed from the licensed establishment or presented for importation:
(b) No person shall apply or affix to or include with, or cause to be applied or affixed to or included with, any carton or final container of a biological product, any label, stamp, mark or statement that is false or misleading in any particular, is not in compliance with the regulations, or is not approved by APHIS.
(c) No person shall alter, mark or remove any approved labeling affixed to or included with any biological product prior to selling or otherwise distributing such product. In addition, no person shall mark any carton, other container, or final container of a biological product so as to falsify the labeling, make it misleading, or cause it to be illegible.
(d) Labels that are stamped, printed or glued directly on cartons, other containers, or final containers shall be legible throughout the dating period. Biological products bearing labels, which have been altered, mutilated, destroyed, obliterated or removed, shall be withheld from the market.
(a) Unless otherwise provided, final container labels, carton labels, and enclosures (inserts, circulars, or leaflets) shall include the information specified in this section.
(1) The principal part of the true name of the biological product which name shall be identical with that shown in the product license under which such product is prepared, or the permit under which it is imported, shall be prominently lettered and placed giving equal emphasis to each word composing it. Descriptive terms used in the true name on the product license or permit shall also appear. Abbreviations of the descriptive terms may be used on the final container label if complete descriptive terms appear on a carton label and enclosures;
(2) If the biological product is prepared in the United States, the name and address of the producer (licensee or subsidiary) or if the biological product is prepared in a foreign country, the name and address of the permittee and of the foreign producer.
(3) The license or permit number assigned by the Department which shall be shown only in one of the following forms respectively: “U.S. Veterinary License No. ___,” or “U.S. Vet. License No. ___,” or “U.S. Vet Lic. No. ___,” or “U.S. Veterinary Permit No. ___,” or “U.S. Permit No. ___.”
(4) Storage temperature recommendation for the biological product stated as not over 45 °F. or stated as not over 7 °C. or stated as not over 45 °F. or 7 °C.
(5) Full instructions for the proper use of the product, including vaccination schedules, warnings, cautions, and the like:
(6) In the case of a multiple-dose final container, a warning to use entire contents when first opened:
(7) If the biological product contains viable or dangerous organisms or viruses, a warning to “Burn this container and all unused contents,” except that in the case of a small one-dose container, the statement “Burn this container” or “Burn this vial” may be used.
(8) In the case of a biological product recommended for use in domestic animals, the edible portion of which may be used for food purposes, a withholding statement of not less than 21 days to read: “Do not vaccinate within (insert number) days before slaughter” or “Do not vaccinate food-producing animals within (insert number) days before slaughter”:
(9) The following information shall appear on the final container label and carton label, if any, but need not appear on the enclosure:
(i) A permitted expiration date;
(ii) The number of doses where applicable;
(iii) The recoverable quantity of the content of each final container stated in cubic centimeters (cc.) or milliliters (ml.) or units.
(iv) A serial number by which the product can be identified with the manufacturer's records of preparation:
(10) In the case of a product which contains an antibiotic added during the production process, the statement “Contains ___ as a preservative,” or an equivalent statement indicating the antibiotic added shall appear on cartons and enclosures if used:
(11) The number of final containers of biological product and the number of doses in each final container shall be stated on each carton label for all cartons containing more than one final container of biological product. The number of final containers of diluent, if any, and the quantity in each shall also be stated on each carton label.
(b) Labels may also include any other statement which is not false or misleading and may include factual statements regarding variable response of different animals when vaccinated as directed but may not include disclaimers of merchantability, fitness for the purpose offered, or responsibility for the product.
(c) Labels of biological products prepared at licensed establishments or imported shall not include any statement, design, or device, which overshadows the true name of the product as licensed or which is false or misleading in any particular or which may otherwise deceive the purchaser.
(d) Carton labels and enclosures shall be subject to paragraph (d)(1), (d)(2), and (d)(3) of this section.
(1) The statement, “Restricted to use by or under the direction of a veterinarian” or “Restricted to use by a veterinarian,” shall be used on all carton labels and enclosures when such restriction is prescribed on the product license.
(2) If the licensee states on the carton labels and enclosures of a product that its sales are restricted to veterinarians, then the entire production of that particular product in the licensed establishment shall be so restricted by the licensee.
(3) The statement “For veterinary use only” or an equivalent statement may appear on the carton labels and enclosures for a product if such statement is being used to indicate that the product is recommended specifically for animals, and not for humans.
(e) When label requirements of a foreign country conflict with the requirements as prescribed in this part, special labels may be approved for use on biological products to be exported to such country. When laws, regulations, or other requirements of foreign countries require exporters of biological products prepared in a licensed establishment to furnish official certification that such products have been prepared in accordance with the Virus-Serum-Toxin Act and regulations issued pursuant thereto, such certification may be made by Animal and Plant Health Inspection Service upon request of the licensee.
(f) If a carton label or an enclosure is required to complete the labeling for a multiple-dose final container of liquid biological product, only one final container shall be packaged in each carton:
Each final container of diluent, other than a liquid biological product, packaged with desiccated biological products shall bear a label that includes the following:
(a) The name—Sterile Diluent.
(b) True name of the biological product with which the diluent is packaged, except that when the firm packages all desiccated biological products with the same diluent, or two or more types of diluent are used, and the licensees' methods of identification and storage insure that all products are packaged with the correct type of diluent, labels affixed to the containers of diluent are exempt from this provision.
(c) The recoverable quantity of contents in cubic centimeters (cc) or milliliters (ml).
(d) A serial number by which the diluent can be identified with the manufacturer's records of preparation;
(e) Name and address of the licensee or the permittee;
(f) In the case of a diluent with which a desiccated biological product is to come in contact while the diluent is in its original container; and,
(1) Is in a multiple-dose container, a positive warning that all of the biological product shall be used at the time the container is first opened; and/or
(2) The biological product is composed of viable or dangerous organisms or viruses, the notice, “Burn this container and all unused contents,” except that, in the case of a small one-dose container, the statement “Burn this container” or “Burn this vial” may be used.
(g) The establishment license number or the permit number, as the case may be, in one of the forms provided in § 112.2(a)(3).
Labels used by subsidiaries, divisions, distributors, and permittees shall be affixed by the licensee in a licensed establishment where the product is produced. Such labels shall comply with requirements for their review, approval, and filing as provided in the regulations.
(a)
(b)
(c)
(d)
Labels used with biological products prepared at licensed establishments or imported for general distribution and sale must be submitted to the Animal and Plant Health Inspection Service for review for compliance with the regulations and approval in writing prior to use, except as provided in paragraph (c) of this section and under the master label system provided in paragraph (d) of this section.
(a) Transmittal forms, furnished by Animal and Plant Health Inspection Service upon request, shall be used with each submission of sketches (including proofs) and labels. Separate forms shall be used for each biological product but only one copy of the form shall be used for all sketches and labels submitted at the same time for the same biological product.
(b) Sketches may be submitted for comment to Animal and Plant Health Inspection Service by the licensee or permittee before preparing the finished label. Such sketches shall be returned to the licensee or permittee with comments, if any. Failure of the reviewer to take exception to a sketch shall not constitute approval of a finished label subsequently prepared.
(c)(1) Labels must be submitted to the Animal and Plant Health Inspection Service for review and written approval. Only labels which are approved as provided in § 112.5(d) may be used. When changes are made in approved labels, the new labels shall be subject to review and approval before use:
(2) Minor label changes that may be made under the provision for products with approved labels or master labels are:
(i) Changes in the physical dimensions of the label provided that such change does not affect the legibility of the label;
(ii) Change in the color of label print, provided that such change does not affect the legibility of the label;
(iii) The addition or deletion of a Trade Mark (TM) or Registered (R) symbol;
(iv) The correction of typographical errors;
(v) Adding or changing label control numbers of bar codes; and
(vi) Revising or updating logos.
(d) Labels and sketches submitted shall be prepared in the number and manner prescribed in this paragraph.
(1) Copies required:
(i) For label sketches, submit two copies of each sketch of a final container label, carton label, and enclosure. Sketches must be legible, and must include all information specified in § 112.2. One copy of each sketch will be returned with applicable comments, and one copy will be held on file by APHIS for no more than one year after processing, until replaced by a finished label:
(ii) For master label sketches, submit for each product two copies of each sketch of an enclosure, label for the smallest size final container, and carton label;
(iii) For finished labels, submit three copies of each finished final container label, carton label, and enclosure:
(iv) For finished master labels, submit for each product three copies each of the enclosure and the labels for the smallest size final container and carton. Labels for larger sizes of containers or cartons of the same product that are identical, except for physical dimensions, need not be submitted. Such labels become eligible for use, concurrent with the approval of the appropriate finished master label:
(2) Mounting:
(i) Each label or sketch shall be securely fastened to a separate sheet of heavy bond paper (8
(ii) Two-or three-part cartons, including “sleeves,” shall be considered as one label. All parts shall be submitted together.
(iii)(A) When two final containers are packaged together in a combination package, the labels for each shall be mounted on the same sheet of paper and shall be treated as one label. For diagnostic test kits, the labels for use on the individual reagent containers to be included in the kit shall be mounted together on a single sheet of paper, if possible; if necessary, a second sheet of paper may be used. The carton label and enclosure shall be mounted on separate individual sheets.
(B) If either final container label is also used alone or in another combination package, sets of separate labels for each biological product with which it is used shall be submitted for review.
(iv) When the same final container label is applied by different methods such as paper or screen printing, one of each shall be mounted on the same sheet of paper as one submission.
(3) To appear on the top of each page:
(i)(A) Name and product code number of the biological product as it appears on the product license or permit.
(B) Extra copies of enclosures to be used with another product shall bear the name and code number of the product affected.
(ii)(A) Designation of the specimen as a label or master label: sketch, final container label, carton label, or enclosure.
(B) If two final container labels or multiple parts are on one sheet, each shall be named, and the label or part being revised shall be designated.
(iii) Size of package (dose, ml., cc., or units) for which the labels or enclosures are to be used.
(4) To appear on the bottom of each page: The reason for and information relevant to the submission shall be stated in the lower left hand corner as:
(i) Master label dose sizes approved for code ______.
(ii) Replacement for label, master label, and/or sketch No. ______.
(iii) Reference to label or master label No. ______.
(iv) Addition to label No. ______.
(v) License Application Pending ______.
(vi) Foreign Language copy of Label No. ______.
(e) Special requirements for foreign language labels:
(1) If true, a statement that the label is a direct translation from a corresponding approved domestic label.
(2) If the foreign language label is not a direct translation of an approved domestic label, an English version shall be submitted with an explanation for the difference in texts.
(3) Foreign language portion of a bilingual label shall be a true translation of the English portion. Reference to additional information on the enclosure shall not be made unless that enclosure is also bilingual.
(f) When a request is received from Animal and Plant Health Inspection Service, the licensee or permittee shall submit a list of all approved labels currently being used. Each label listed shall be identified as to:
(1) Name and product code number as it appears on the product license or permit for the product; and
(2) Where applicable, the size of the package (doses, ml., cc., or units) on which the label shall be used; and
(3) Label number and date assigned; and
(4) Name of licensee or subsidiary appearing on the label as the producer.
(g) At the time of an inspection, or when requested by APHIS, licensees or permittees shall make all labels and master labels, including labels approved for use but exempted from filing under the master label system, available for review by authorized inspectors. Such labels shall be identical to the approved label or master label except for physical dimensions, reference to recoverable volume or doses and/or certain minor differences permitted in accordance with § 112.5(c).
(a) Each multiple-dose final container of a biological product which requires a diluent for administration shall be packaged in an individual carton with a container of the proper volume of diluent for that dose as specified in the filed Outline of Production. Each multiple-dose final container of a product which does not require a diluent for administration need not be packaged in an individual carton unless the final container labeling does not contain all information required by the regulations. Such information must be included in or on a carton. Exceptions are provided in paragraphs (c) and (d) of this section and § 112.8.
(b) Single-dose final containers of a product need not be packaged one per carton. For single-dose products which require a diluent for administration, the number of containers of the proper amount of diluent specified in the filed Outline of Production for the number of doses contained in the carton shall be included in each carton.
(c) Poultry products for mass administration (including but not limited to administration through drinking water and spray) and products used in automatic vaccinating systems (including but not limited to pneumatic beak injectors and automated needle injectors) may be packaged in multiple-dose final containers as specified in the filed Outline of Production. Poultry products for manual administration to individual birds shall not exceed 1,000 doses in each final container. Diluent need not be packaged with the final container(s) of the product, but the licensee shall provide the required number of containers of diluent as specified in the filed Outline of Production. The following requirements apply to cartons containing more than one final container of poultry product:
(1) They shall be sealed prior to leaving the licensed establishment.
(2) The contents may not be repackaged.
(3) The contents of such cartons may not be sold in fractional units.
(4) The following statement must appear in a prominent place on the carton label: “Federal regulations prohibit the repackaging or sale of the contents of this carton in fractional units. Do not accept if seal is broken.”
(d) Diluent for the following products need not be packaged with the final container(s) of the product, but the licensee shall provide the consumer with the required number of containers of the proper amount of diluent as specified in the filed Outline of Production:
(1) Marek's Disease Vaccine.
(2) Poultry vaccines administered to individual birds using automatic vaccinating equipment.
(e) Final containers of biological product prepared at a licensed establishment, or imported, in cartons or other containers shall not be removed
(f) Labels which are affixed to or included with a biological product shall not be removed or altered in any manner.
The label requirements in this section are additional to those prescribed elsewhere in this part.
(a) In the case of biological products containing live Newcastle Disease virus, a caution statement indicating that Newcastle Disease can cause inflammation of the eyelids of humans, and a warning to the user to avoid infecting his eyes shall be included on the enclosure.
(b) In the case of a biological product containing infectious bronchitis virus, all labels shall show the infectious bronchitis virus type or types used in the product. Abbreviation is permitted.
(c) In the case of a biological product containing inactivated rabies virus, carton labels, enclosures, and all but very small final container labels shall include a warning against freezing and the recommendations provided in this paragraph.
(1) That vaccine be administered to animals at 3 months of age or older, with a repeat dose 1 year later.
(2) Subsequent revaccination as determined from the results of duration of immunity studies conducted as prescribed in § 113.209, paragraph (b) or (c), or both.
(d) In the case of a biological product containing modified live rabies virus, the carton labels, enclosures, and all but very small final container labels shall include the recommendations provided in this paragraph.
(1) For low egg-passage (below the 180th egg-passage level) the statement “For Use in Dogs Only! Not For Use in Any Other Animal!”
(2) For other vaccines containing modified live rabies virus, the statement “For Use In (designate animal(s)) Only! Not For Use In Any Other Animal!”
(3) Intramuscular injection at one site in the thigh shall be recommended.
(4) The statement “In event of accidental exposure to the vaccine virus, the possible hazard to human health should be considered and State Public Health Officials should be consulted for specific recommendations” shall be prominently placed on all carton labels and on enclosures, if used.
(5) That vaccine be administered to animals at 3 months of age or older, with a repeat dose 1 year later.
(6) Subsequent revaccination as determined from the results of duration of immunity studies conducted as prescribed in § 113.312, paragraph (b) or (c), or both.
(e) In the case of bovine rhinotracheitis vaccine containing modified live virus, all labeling except small final container labels shall bear the following statement: “Do not use in pregnant cows or in calves nursing pregnant cows.”:
(f) Unless otherwise authorized in a filed Outline of Production, labels for inactivated bacterial products shall contain an unqualified recommendation for a repeat dose to accomplish primary immunization to be given at an appropriate time interval:
(1)
(2)
(3)
(g) In the case of a liquid product authorized in a filed Outline of Production to be used as a diluent in a combination package, the carton labels and enclosures used for serials which are either not tested for bactericidal or viricidal activity or have been found unsatisfactory by such test shall contain the statement: “CAUTION: DO NOT USE AS DILUENT FOR LIVE VACCINES.”
(h) In the case of wart vaccine, recommendations shall be limited to use in cattle. Indications for use shall be for prophylactic use only, as an aid in the control of viral papillomas (warts). All labels shall include a dosage recommendation of at least 10 ml to be given subcutaneously and the dose repeated in 3 to 5 weeks.
(i) Unless otherwise authorized in an Outline of Production filed subsequent to the effective date of these amendments, all but very small final container labels for Feline Panleukopenia Vaccines shall contain the following recommendations for use:
(1)
(2)
(j) In the case of normal serum, antiserum, or antiserum derivatives, the type of preservative used shall be indicated on all labels.
(k) Unless acceptable data has been filed with Animal and Plant Health Inspection Service, to show that development of corneal opacity is not associated with the product, carton labels and enclosures used with biological products containing modified live canine hepatitis virus or modified live canine adenovirus Type 2 shall bear the following statement: “Occasionally, transient corneal opacity may occur following the administration of this product.”
(l) All labels for autogenous biologics shall bear the following statement: “Potency and efficacy of autogenous biologics have not been established. This product is prepared for use only by or under the direction of a veterinarian or approved specialist.”
(m) In the case of biological products containing Marek's disease virus, all labels shall specify the Marek's disease virus serotype(s) used in the product.
For
The applicable regulations for packaging and labeling a biological product produced in the United States shall apply to such biological product if exported from the United States except as otherwise provided in this section. Only labels approved as provided in § 112.5 shall be used.
(a) Biological products which have been packaged and labeled for export or which have been exported, shall be subject to the applicable provisions in this paragraph.
(1) After leaving the licensed establishment, a biological product shall not be bottled, repackaged, relabeled, or otherwise altered in any way while in the United States; and
(2) An exported biological product shall not be returned to the United States:
(3) An exported biological product which is bottled, rebottled, or altered in any way in a foreign country shall not bear a label which indicates by establishment license number that it has been prepared in the United States.
(b) Desiccated and frozen liquid products, packaged and labeled as for domestic use, may be exported without the diluent required for rehydration or dilution, as the case may be, if the labeling includes adequate instructions for preparing the product for use and the words “For Export Only”.
(c) Final containers of products, labeled or unlabeled, may be exported in sealed shipping boxes, adequately identified as to contents with an approved label, and plainly marked “For Export Only”:
(d) Completed inactivated liquid products, antiserums, and antitoxins, may be exported in large multiple-dose containers identified with an approved label that contains the words “For Export Only” prominently displayed.
(e) Concentrated inactivated liquid product, completed except for dilution to the proper strength for use, may be exported in large multiple-dose containers identified with an approved label that contains the words “For Export Only” prominently displayed.
A biological product imported for research and evaluation under a permit issued in accordance with § 104.4, with the exception of products imported under § 104.4(d), shall be labeled as provided in this section.
(a) The label shall identify the product and the name and address of the manufacturer and shall provide instructions for proper use of the product, including all warnings and cautions needed by the permittee to safely use the product.
(b) Labels on each product to be further distributed in accordance with § 103.3 shall bear the statement “Notice! For Experimental Use Only—Not for Sale!”
(c) The labeling shall contain any other information deemed necessary by the Administrator and specified on the permit.
A biological product, which requires special packaging and/or labeling not provided for in this part, shall be packaged and/or labeled in accordance with requirements written into the approved outline for such product.
21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
The regulations in this part apply to each serial or subserial of a licensed biological product manufactured in a licensed establishment and to each serial or subserial of a biological product in each shipment imported for distribution and sale.
To better ensure consistent and reproducible test results when Standard Requirement tests prescribed in the regulations are conducted, National Veterinary Services Laboratories, U.S. Department of Agriculture, may provide testing aids, when available, to licensees, permittees, and applicants for licenses and permits. Such aids shall be as follows:
(a) Supplemental Assay Method (SAM) is a technical bulletin containing detailed instructions for conducting a test. Such instructions shall be in accordance with the procedures currently being followed at National Veterinary Services Laboratories and as improved, proven procedures are developed, shall be revised and reissued prior to application.
(b) Standard Reference Preparation is a serum, virus, bacterial culture, or antigen to be used in test systems for direct comparison with serials of biological products under test.
(c) Standard Test Reagent is a serum, antitoxin, fluorescent antibody conjugate, toxin, virus, bacterial cultural, or antigen to be used in test systems but not for direct comparison with serials of biological products under test.
(d) Seed cultures are small quantities of standard organisms to be propagated by the recipient to establish a supply for use.
(e) Test Code Number is a number assigned by Animal and Plant Health Inspection Service to each test procedure specified in the Standard Requirements and in each filed Outline of Production where such test is conducted to support a request for release of a serial or subserial.
Each licensee and permittee shall furnish representative samples of each serial or subserial of a biological product manufactured in the United States or imported into the United States as prescribed in this section. Additional samples may be purchased in the open market by a Animal and Plant Health Inspection Service representative.
(a) Either an employee of the Department of Agriculture, of the licensee, or of the permittee, as designated by the Administrator shall select prerelease samples of biological product in the number prescribed in paragraph (b) of this section. Each sample shall be marked for identification by the person making the selection after which they shall be packaged by the licensee or permittee, as the case may be, and forwarded to National Veterinary Services Laboratories; except that an employee of the Department may forward or deliver the samples to National Veterinary Services Laboratories if such action deemed advisable by the Administrator.
(1) Selection shall be made as follows:
(i) Nonviable liquid biological products—either bulk or final container samples of completed product shall be
(ii) Viable liquid biological products; samples shall be in final containers and shall be randomly selected at the end of the filling operation. Bulk containers of completed product may be sampled when authorized by the Administrator.
(iii) Desiccated biological products; samples shall be in final containers and shall be randomly selected if desiccated in the final container. Biological products desiccated in bulk shall be sampled at the end of the filling operation.
(iv) Representative samples of each serial or subserial in each shipment of imported biological products shall be selected.
(2) Comparable samples shall be used by Animal and Plant Health Inspection Service, the licensee, and the permittee for similar tests.
(3) When bulk samples of completed product in liquid form are to be tested as prescribed in paragraph (a)(1) of this section, the number of such samples from each serial and the minimum quantity of product to be provided in each sample shall be stated in the filed Outline of Production.
(b) Unless otherwise prescribed by the Administrator, the number of final container samples to be selected from each serial and subserial shall be:
(1)
(i) Six multiple-dose samples of Brucella Abortus Vaccine;
(ii) Twelve samples of all other live bacterial vaccines;
(iii) Two samples of Coccidiosis Vaccine;
(iv) Eighteen samples of Rabies Vaccine, Modified Live Virus;
(v) Sixteen samples of all other vaccines consisting of live microorganisms;
(vi) Thirty single-dose or 14 multiple-dose samples of Equine Encephalomyelitis Vaccine, Killed Virus;
(vii) Twenty-two single-dose or 14 multiple-dose samples of Rabies Vaccine, Killed Virus;
(viii) Sixteen single-dose or 12 multiple-dose samples of all other vaccines consisting of killed microorganisms.
(2)
(i) Twelve samples of single-fraction products;
(ii) Thirteen samples of two-fraction products;
(iii) Fourteen samples of products consisting of 3 or more fractions.
(3)
(4)
(i) Fourteen single-dose or 12 multiple dose samples of Tetanus Antitoxin;
(ii) Twelve samples of all other antitoxins.
(5)
(i) Eighteen single-dose or 12 multiple dose samples of all toxoids.
(6)
(7)
(8)
(9)
(c) Prelicensing and Outline of Production changes: Samples needed to support a license application or a change in the Outline of Production for a licensed product shall be submitted only upon request from the animal and Plant Health Inspection Service. Except for miscellaneous products specified in paragraph (b)(9) of this section, the number of such samples shall be at least one and one-half times the number prescribed for such product in paragraph (b) of this section. Samples of Master Seeds and Master Cell Stocks with a minimum individual volume of 1 ml shall be submitted as follows:
(1) Ten samples of Bacterial Master Seeds.
(2) Thirteen samples of viral Master Seeds or nonviral Master Seeds requiring cell culture propagation. For Master Seeds isolated or passed in a cell line different from the species of intended use, an additional 2 samples are required for each additional species. For Master Seeds grown in cell culture and intended for use in more than one species, an additional 2 samples are required for each additional species.
(3) Thirty-six samples of at least 1 ml each or six samples of at least 1 ml each, one sample of at least 20 ml, and one sample of at least 10 ml of Master Cell Stocks. In the case of Master Cell Stocks which are persistently infected with a virus, an additional four samples of at least 1 ml each are required. If these persistently infected cell stocks are intended for use in more than one species, an additional two samples of at least 1 ml each are required for each additional species.
(4) Four samples of the Master Cell Stock + n (highest passage) cells.
(d) Sterile diluent: A sample of Sterile Diluent shall accompany each sample of product, other than Marek's Disease Vaccine, if such diluent is required to rehydrate or dilute the product before use. The volume of diluent shall be an appropriate amount to rehydrate or dilute the product. Samples of Sterile Diluent prepared for use with Marek's Disease Vaccine shall be submitted upon request from the Animal and Plant Health Inspection Service.
(e) Reserve samples shall be selected from each serial and subserial of biological product. Such samples shall be selected at random from final containers of completed product by an employee of the Department, of the licensee, or of the permittee, as designated by the administrator. Each sample shall:
(1) Consist of 5 single-dose packages, 2 multiple-dose packages, or 2 diagnostic test kits, except that, in the case of diagnostic test kits in which final packaging consists of multiple microtiter test plates or strips, a sample may consist of a specified number of test plates or strips along with all other test reagents as prescribed in a filed Outline of Production;
(2) Be adequate in quantity for appropriate examination and testing;
(3) Be truly representative and in final containers;
(4) Be held in a special compartment set aside by the licensee or permittee for holding these samples under refrigeration at the storage temperature recommended on the labels for 6 months after the expiration date stated on the labels. The samples that are stored in this manner shall be delivered to the
(a) The test methods and procedures contained in all applicable Standard Requirements shall be complied with unless otherwise exempted by the Administrator and provided that such exemption is noted in the filed Outline of Production for the product.
(b) Test methods and procedures by which the biological products shall be evaluated shall be designated in the Outline of Production for such products.
(a) No biological product shall be released prior to the completion of tests prescribed in a filed Outline of Production or Standard Requirements for the product to establish the product to be pure, safe, potent, and efficacious.
(b) Tests of biological products shall be observed by a competent employee of the manufacturer during all critical periods. A critical period shall be the time when certain specified reactions must occur in required tests to properly evaluate the results.
(c) Records of all tests shall be kept in accordance with part 116 of this chapter. Results of all required tests prescribed in the filed Outline of Production or the Standard Requirements for the product shall be submitted to Animal and Plant Health Inspection Service. Blank forms shall be furnished upon request to Animal and Plant Health Inspection Service.
(d) When the initial or any subsequent test is declared a “No test,” the reasons shall be reported in the test records, the results shall not be considered as final, and the test may be repeated.
(e) When new test methods are developed and approved by Animal and Plant Health Inspection Service, biological products tested thereafter shall be evaluated by such methods, and if not found to be satisfactory when so tested shall not be released.
A biological product shall with reasonable certainty yield the results intended when used as recommended or suggested in its labeling or proposed labeling prior to the expiration date.
(a) The Administrator is authorized to cause a biological product, manufactured in the United States or imported into the United States, to be examined and tested for purity, safety, potency, or efficacy; in which case, the licensee or permittee shall withhold such product from the market until a determination has been made.
(b) The final results of each test conducted by the licensee and Animal and Plant Health Inspection Service shall be considered in evaluating a biological product. A serial or subserial which has been found unsatisfactory by a required test prescribed in a filed Outline of Production or Standard Requirement is not in compliance with the regulations and shall not be released for market.
(a) When a biological product contains more than one immunogenic fraction, the completed product shall be evaluated by tests applicable to each fraction.
(b) When similar potency tests are required for more than one fraction of a combination biological product, different animals must be used to evaluate each fraction except when written Standard Requirements or outlines of production make provisions and set
(c) When the same safety test is required for more than one fraction, requirements are fulfilled by satisfactory results from one test of the completed product.
(d) When an inactivated fraction(s) is used as a diluent for a live virus fraction(s), the inactivated fraction(s) may be tested separately and the live virus fraction(s) may be tested separately:
(e) Virus titrations for a multivirus product shall be conducted by methods which will quantitate each virus.
(a) Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seed for production as specified in the Standard Requirements or in the filed Outline of Production. The Administrator may exempt a product from a required animal potency test for release when an evaluation can, with reasonable certainty, be made by:
(1) Subjecting the master seed to the applicable requirements prescribed in §§ 113.64, 113.100, 113.200, and 113.300;
(2) Testing the Master Seed for immunogenicity in a manner acceptable to the Animal and Plant Health Inspection Service (APHIS);
(3) Establishing satisfactory potency for the product in accordance with the following provisions:
(i) Potency for live products may be determined by log
(ii) Potency for inactivated products may be determined using tests for relative antigen content by comparing the antigen content of the test serial to a reference preparation using a parallel line immunoassay or equivalent method which measures linearity, specificity, and reproducibility in a manner acceptable to APHIS.
(b) In the case of live products, each serial and subserial of desiccated product derived from an approved Master Seed and bulk or final container samples of each serial of completed liquid product derived from an approved Master Seed shall be evaluated by a test procedure acceptable to APHIS. On the basis of the results of the test, as compared with the required minimum potency, each serial and subserial shall either be released to the firm for marketing or withheld from the market. The evaluation of such products shall be made in accordance with the following criteria:
(1) If the initial test shows the count or titer to equal or exceed the required minimum, the serial or subserial is satisfactory without additional testing.
(2) If the initial test shows the count or titer to be lower than the required minimum, the serial or subserial may be retested, using double the number of samples. The average counts or titers obtained in the retests shall be determined. If the average is less than the required minimum, the serial or subserial is unsatisfactory without further consideration.
(3) If the average is equal to or greater than the required minimum, the following shall apply to live virus vaccines:
(i) If the difference between the average titer obtained in the retests and the titer obtained in the initial test is 10
(ii) If the difference between the average titer obtained in the retests and the titer obtained in the initial test is less than 10
(4) If the average is equal to or greater than the required minimum, the following shall apply to bacterial vaccines:
(i) If the average count obtained in the retests is at least three times the count obtained in the initial test, the initial count may be considered a result of test system error and the serial
(ii) If the average count obtained in the retests is less than three times the count obtained in the initial test, a new average shall be determined using the counts obtained in all tests. If the new average count is below the required minimum, the serial or subserial is unsatisfactory.
(5)
(c) In the case of inactivated products, bulk or final container samples of completed product from each serial derived from an approved Master Seed, shall be evaluated for relative antigen content (potency) as compared with an unexpired reference by a parallel line immunoassay or other procedure acceptable to APHIS.
(1) A test that results in no valid lines is considered a “no test” and may be repeated.
(2) An initial test (test 1) that results in valid lines that are not parallel is considered a valid equivocal test. Release of the serial may not be based on such test since the result cannot be termed “satisfactory” or “unsatisfactory.”
(3) If the initial test (test 1) shows that potency equals or exceeds the required minimum potency, the serial is satisfactory without additional testing.
(4) If the initial test (test 1) is an equivocal test due to lack of parallelism, the serial may be retested up to three times (tests 2, 3, and 4) with disposition to be as specified in paragraphs (c)(4)(i) and (ii) of this section;
(i) If: The first retest (test 2) following an initial equivocal test; the second retest (test 3) following two consecutive equivocal tests (tests 1 and 2); or the third retest (test 4) following three consecutive equivocal tests (tests 1, 2, and 3) shows that the potency equals or exceeds the required minimum potency, the serial is satisfactory.
(ii) If the first retest (test 2) following an initial equivocal test shows that potency is less than the required minimum potency, disposition of the serial will be based on the outcome of retests 2 and 3 (tests 3 and 4) as follows: if either retest (test 3 or 4) shows that potency is less than the required minimum potency, the serial is unsatisfactory. If either retest 2 or retest 3 (tests 3 or 4) is an equivocal test, or in the event that each retest (tests 2, 3, and 4) following an initial equivocal test is also an equivocal test, the accumulated test results shall be considered indicative of a lack of potency and release of the serial withheld. In which case, the licensee may submit data confirming the continued validity of the test system to APHIS for review and approval. If the data are acceptable to
(5) If the initial test (test 1) shows that potency is less than the required minimum potency, the serial may be retested a minimum of two times (tests 2 and 3) but not more than three times (tests 2, 3, and 4) with disposition as specified in paragraphs (c)(5) (i) and (ii) of this section;
(i) If two consecutive retests (tests 2 and 3) show that potency of the serial equals or exceeds the required minimum potency, the serial is satisfactory. If one of the two retests (test 2 or 3) shows that the potency is less than the required minimum potency, the serial is unsatisfactory.
(ii) If one of the retests (tests 2 or 3) shows that the potency equals or exceeds the required minimum potency and the other retest (test 2 or 3) is an equivocal test, a third retest (test 4) may be performed. If the third retest (test 4) shows that the potency of the serial equals or exceeds the required minimum potency, the serial is deemed satisfactory. If both retests (tests 2 and 3) or if the third retest (test 4) is an equivocal test, the accumulated test results shall be considered indicative of a lack of potency and release of the serial withheld, in which case the licensee may submit data confirming the continued validity of the test system to APHIS for review and approval. If the data are acceptable to APHIS, the potency test may be repeated by the firm, subject to the provisions specified in paragraphs (c)(4) (i) and (ii) and (c)(5) (i) and (ii) of this section, and confirmatory testing by APHIS.
(d)
(2) All determinations of relative antigen content using parallel line immunoassays or equivalent methods shall be conducted with an unexpired reference. The lot of reference used to determine antigenic content shall have an initial dating period equal to the dating of the product or as supported by data acceptable to APHIS, except that frozen references may have an initial dating of up to 5 years,
(e) Final container samples of completed product derived from Master Seed found immunogenic in accordance with paragraph (a) of this section and found satisfactory in accordance with paragraphs (b) and (c) of this section may also be subjected to an animal potency test by Animal and Plant Health
(1) A one stage test using 20 vaccinates and 5 controls or a two stage test using 10 vaccinates and 5 controls for each stage shall be used. The criteria used for judging the specific response in the controls and vaccinates shall be in accordance with the test protocol used in the Master Seed immunogenicity test.
(2) If at least 80 percent of the controls do not show specific responses to challenge, the test is inconclusive and may be repeated. If a vaccinate shows the specific responses to challenge expected in the controls, the vaccinate shall be listed as a failure.
(3) The results of the testing shall be evaluated according to the following table:
(4) When a serial has been found unsatisfactory for potency by the test provided in paragraphs (e)(1), (2), and (3) of this section, the serial shall be withheld from the market and the following actions taken:
(i) The Administrator shall require that at least two additional serials prepared with the same Master Seed be subjected to similar animal potency tests by Animal and Plant Health Inspection Service or the licensee or both.
(ii) If another serial is found unsatisfactory for potency, the product shall be removed from the market while a reevaluation of the product is made and the problem is resolved.
At 72 FR 72564, Dec. 21, 2007, § 113.8 was amended in the heading of paragraph (d) by removing the words “
A potency test written into the filed Outline of Production for a product shall be considered confidential information by Animal and Plant Health Inspection Service until at least two additional product licenses are issued for the product or unless use of the test is authorized by the licensee, in which case, such potency test may be published as part of the Standard Requirement for the product.
(a) Until a potency test is published as part of the Standard Requirement for the product, reference to such a test shall be made in the filed Outline of Production and the test shall be conducted.
(b) When a potency test has been published as part of the Standard Requirement, such test shall be conducted unless the product is specifically exempted as provided in § 113.4.
When a product is prepared in a licensed establishment for export in large multiple-dose containers as provided in § 112.8(d) or (e) of this subchapter or for further manufacturing purposes as provided in § 114.3(d) of this subchapter, samples of the bulk material shall be subjected to all required tests prescribed in the filed Outline of Production or Standard Requirements for the product. Samples of concentrated liquid product shall be diluted to a volume equal to the contents of the sample times the concentration factor prior to initiating potency tests.
(a) Ingredients for which standards are prescribed in the United States Pharmacopeia, or elsewhere in this part, shall conform to such standards. In lieu of preparing the media from the individual ingredients, they may be made from dehydrated mixtures which,
(b) The licensee shall test each quantity of medium prepared at one time from individual ingredients and the first quantity prepared from each lot of commercial dehydrated medium for growth-promoting qualities. If any portion of a lot of commercial dehydrated medium is held for 90 days or longer after being so tested, it shall be retested before use. Two or more strains of micro-organisms that are exacting in their nutritive requirements shall be used. More than one dilution shall be used to demonstrate the adequacy of the medium to support the growth of a minimum number of micro-organisms.
(c) The sterility of the medium shall be confirmed by incubating an adequate number of test vessels and examining each for growth. Additional control may be used by incubation of representative uninoculated test vessels for the required incubation period during each test.
(d) A determination shall be made by the licensee for each biological product of the ratio of inoculum to medium which shall result in sufficient dilution of such product to prevent bacteriostatic and fungistatic activity. The determination may be made by tests on a representative biological product for each group of comparable products containing identical preservatives at equal or lower concentrations. Inhibitors or neutralizers of preservatives, approved by the Administrator, may be considered in determining the proper ratio.
Each serial and subserial of biological product except live vaccines shall be tested as prescribed in this section unless otherwise specified by the Administrator. When cell lines, primary cells, or ingredients of animal origin used in the preparation of a biological product are required to be free of viable bacteria and fungi, they shall also be tested as prescribed in this section.
(a) The media to be used shall be as follows:
(1) Fluid Thioglycollate Medium with 0.5 percent beef extract shall be used to test for bacteria in biological products containing clostridial toxoids, bacterins, and bacterin-toxoids.
(2) Fluid Thioglycollate Medium with or without 0.5 percent beef extract shall be used to test for bacteria in biological products other than clostridial toxoids, bacterins, and bacterin-toxoids.
(3) Soybean-Casein Digest Medium shall be used to test biological products for fungi; provided, that Fluid Thioglycollate Medium without beef extract shall be substituted when testing biological products containing mercurial preservatives.
(b) Test procedure:
(1) Ten test vessels shall be used for each of two media selected in accordance with paragraph (a)(1), (a)(2), or (a)(3) of this section. Each test vessel shall contain sufficient medium to negate the bacteriostatic or fungistatic activity in the inoculum as determined in § 113.25(d).
(2) Inoculum:
(i) When completed product is tested, 10 final container samples from each serial and each subserial shall be tested. One ml from each sample shall be inoculated into a corresponding individual test vessel of culture medium:
(ii) When cell lines, primary cells, or ingredients of animal origin are tested, at least a 20 ml test sample from each lot shall be tested. One ml shall be inoculated into each test vessel of medium.
(3) Incubation shall be for an observation period of 14 days at 30 °to 35 °C. to test for bacteria and 14 days at 20 °to 25 °C. to test for fungi.
(4) If the inoculum renders the medium turbid so that the absence of growth cannot be determined by visual
(c) Examine the contents of all test vessels for macroscopic microbial growth during the incubation period. When demonstrated by adequate controls to be invalid, the test may be repeated. For each set of test vessels representing a serial or subserial in a valid test, the following rules shall apply:
(1) If no growth is found in any test vessel, the serial or subserial meets the requirements of the test.
(2) If growth is found in any test vessel, one retest to rule out faulty technique may be conducted using 20 unopened final container samples.
(3) If growth is found in any test vessel of the final test, the serial, subserial, or ingredients to be used in the preparation of a biological product, as the case may be, is unsatisfactory.
Unless otherwise specified by the Administrator or elsewhere exempted in this part, each serial and subserial of live vaccine and each lot of Master Seed Virus and Master Seed Bacteria shall be tested for extraneous viable bacteria and fungi as prescribed in this section. A Master Seed found unsatisfactory shall not be used in vaccine production and a serial found unsatisfactory shall not be released.
(a)
(1) Soybean Casein Digest Medium shall be used.
(2) Ten final container samples from each serial and subserial shall be tested.
(3) Immediately prior to starting the test, frozen liquid vaccine shall be thawed, and desiccated vaccine shall be rehydrated as recommended on the label with accompanying diluent or with sterile purified water.
(4) To test for bacteria, place 0.2 ml of vaccine from each final container into a corresponding individual vessel containing at least 120 ml of Soybean Casein Digest Medium. Additional medium shall be used if the determination required in § 113.25(d) indicates the need for a greater dilution of the product. Incubation shall be at 30 °to 35 °C for 14 days.
(5) To test for fungi, place 0.2 ml of vaccine from each final container sample into a corresponding individual vessel containing at least 40 ml of Soybean Casein Digest Medium. Additional medium shall be used if the determination required in § 113.25(d) indicates the need for a greater dilution of the product. Incubation shall be at 20 °to 25 °C for 14 days.
(6) Examine the contents of all test vessels macroscopically for microbial growth at the end of the incubation period. If growth in a vessel cannot be reliably determined by visual examination, judgment shall be confirmed by subcultures, microscopic examination, or both.
(7) For each set of test vessels representing a serial or subserial tested according to these procedures, the following rules shall apply:
(i) If growth is found in 2 or 3 test vessels of the initial test, 1 retest to rule out faulty technique may be conducted using 20 unopened final container samples.
(ii) If no growth is found in 9 or 10 of the test vessels in the initial test, or 19 or 20 vessels in the retest, the serial or subserial meets the requirements of the test.
(iii) If growth is found in four or more test vessels in the initial test, or two or more in a retest, the serial or subserial is unsatisfactory.
(b)
(1) Soybean Casein Digest Medium and Fluid Thioglycollate Medium shall be used.
(2) Ten final container samples from each serial and subserial shall be tested.
(3) Immediately prior to starting the test, frozen liquid vaccine shall be thawed, and desiccated vaccine shall be rehydrated as recommended on the label with accompanying diluent or with sterile purified water. Product recommended for mass vaccination shall be rehydrated at the rate of 30 ml sterile purified water per 1,000 doses.
(4) To test for extraneous bacteria, place 0.2 ml of vaccine from each final container into a corresponding individual vessel containing at least 40 ml of Fluid Thioglycollate Medium. Additional medium shall be used if the determination required in § 113.25(d) indicates the need for a greater dilution of the product. Incubation shall be at 30 °to 35 °C for 14 days.
(5) To test for extraneous fungi, place 0.2 ml of vaccine from each final container into a corresponding individual vessel containing at least 40 ml of Soybean Casein Digest Medium. Additional medium shall be used if the determination required in § 113.25(d) indicates the need for a greater dilution of the product. Incubation shall be at 20 °to 25 °C for 14 days.
(6) Examine the contents of all test vessels macroscopically for atypical microbial growth at the end of the incubation period. If growth of extraneous microorganisms cannot be reliably determined by visual examination, judgment shall be confirmed by subculturing, microscopic examination, or both.
(7) For each set of test vessels representing a serial or subserial tested according to these procedures, the following rules shall apply:
(i) If extraneous growth is found in 2 or 3 test vessels of the initial test, 1 retest to rule out faulty technique may be conducted using 20 unopened final container samples.
(ii) If no extraneous growth is found in 9 or 10 test vessels in the initial test, or 19 or 20 vessels in the retest, the serial or subserial meets the requirements of the test.
(iii) If extraneous growth is found in 4 or more test vessels in the initial test, or 2 or more in a retest, the serial or subserial is unsatisfactory.
(c)
(1) To test for bacteria, place 0.2 ml of the sample of Master Seed Virus into 10 individual vessels each containing at least 120 ml of Soybean Casein Digest Medium. Incubation shall be at 30 °to 35 °C for 14 days.
(2) To test for fungi, place 0.2 ml of the sample of Master Seed Virus into 10 individual vessels each containing at least 40 ml of Soybean Casein Digest Medium. Incubation shall be at 20 °to 25 °C for 14 days.
(3) Examine the contents of all test vessels macroscopically for microbial growth at the end of the incubation period. If growth in a vessel cannot be reliably determined by visual examination, judgment shall be confirmed by subcultures, microscopic examination, or both.
(4) For each set of test vessels representing a lot of Master Seed Virus tested according to these procedures, the following rules shall apply:
(i) If growth is found in any test vessel of the initial test, one retest to rule out faulty technique may be conducted using a new sample of Master Seed Virus.
(ii) If growth is found in any test vessel of the final test, the lot of Master Seed Virus is unsatisfactory.
(d)
(1) To test for extraneous bacteria, place 0.2 ml of the sample of Master Seed Bacteria into 10 individual vessels each containing at least 40 ml of Fluid
(2) To test for extraneous fungi, place 0.2 ml of the sample of Master Seed Bacteria into 10 individual vessels each containing at least 40 ml of Soybean Casein Digest Medium. Incubation shall be at 20 °to 25 °C for 14 days.
(3) Examine the contents of all test vessels macroscopically for atypical microbial growth at the end of the incubation period. If growth of extraneous microorganisms cannot be reliably determined by visual examination, judgment shall be confirmed by subcultures, microscopic examination, or both.
(4) For each set of test vessels representing a lot of Master Seed Bacteria tested according to these procedures, the following rules shall apply:
(i) If extraneous growth is found in any test vessel of the initial test, one retest to rule out faulty technique may be conducted using a new sample of Master Seed Bacteria.
(ii) If extraneous growth is found in any test vessel of the final test, the lot of Master Seed Bacteria is unsatisfactory.
(e) Live viral vaccines of chicken embryo origin recommended for administration other than by parenteral injection, which were not tested or have not been found free of bacteria and fungi by the procedures prescribed in paragraph (a) of this section, may be tested according to the procedures prescribed in this paragraph.
(1) Brain Heart Infusion Agar shall be used with 500 Kinetic (Kersey) units of penicillinase per ml of medium added just prior to pouring the plates.
(2) Ten final containers from each serial and each subserial shall be tested.
(3) Immediately prior to starting the test, frozen liquid vaccine shall be thawed, and lyophilized vaccine shall be rehydrated to the quantity recommended on the label using the accompanying sterile diluent or sterile purified water. Product recommended for mass vaccination shall be rehydrated at the rate of 30 ml sterile purified water per 1,000 doses.
(4) From each container sample, each of 2 plates shall be inoculated with vaccine equal to 10 doses if the vaccine is recommended for poultry or 1 dose if the vaccine is recommended for other animals. Twenty ml of medium shall be added to each plate. One plate shall be incubated at 30 °to 35 °for 7 days and the other plate shall be incubated at 20 °to 25 °C for 14 days.
(5) Colony counts shall be made for each plate at the end of the incubation period. An average colony count for the 10 samples representing the serial or subserial shall be made for each incubation condition.
(6) For each set of test vessels representing a serial or subserial tested according to these procedures, the following rules shall apply:
(i) If the average count at either incubation condition exceeds 1 colony per dose for vaccines recommended for poultry, or 10 colonies per dose for vaccines recommended for other animals in the initial test, 1 retest to rule out faulty technique may be conducted using 20 unopened final containers.
(ii) If the average count at either incubation condition of the final test for a serial or subserial exceeds 1 colony per dose for vaccines recommended for poultry, or 10 colonies per dose for vaccines recommended for other animals, the serial or subserial is unsatisfactory.
The heart infusion test, using heart infusion broth and heart infusion agar, provided in this section shall be conducted when a test for mycoplasma contamination is prescribed in an applicable Standard Requirement or in the filed Outline of Production for the product.
(a) Media additives provided in this paragraph shall be prepared as follows:
(1) DPN-Cysteine Solution:
(i) Use Nicotinamide adenine dinucleotide (oxidized) and L-Cysteine hydrochloride.
(ii) Prepare 1 gram/100 milliliters (ml) purified water (1 percent solution) of each. Mix the solutions together; the cysteine reduces the DPN. Filter sterilize, dispense in appropriate amounts and store frozen at −20 degrees centigrade.
(2) Inactivated horse serum—horse serum which has been inactivated at 56 °C for 30 minutes.
(b) Heart infusion broth shall be prepared as provided in this paragraph.
(1) Dissolve in 970 ml of purified water, 25 grams of heart infusion broth, 10 grams of proteose peptone No. 3, and either 5 grams of yeast autolysate or 5 ml of fresh yeast extract.
(2) Add the following:
(3) Adjust pH to 7.9 with NaOH, filter sterilize, and dispense 100 ml aliquots into 125 ml flasks and store until needed.
(4) Add 2 ml of DPN-Cysteine solution to each 100 ml of broth on day of use.
(c) Heart Infusion Agar shall be prepared as provided in this paragraph.
(1) Dissolve in 900 ml of purified water by boiling the following:
(2) Cool the medium and adjust pH to 7.9 with NaOH.
(3) Autoclave the medium.
(4) Cool the medium 30 minutes in a 56 °C waterbath.
(5) Dissolve 5 grams of yeast autolysate in 100 ml of distilled water, filter sterilize, and add to the medium.
(6) Add to the medium:
(d) The test procedure provided in this paragraph shall be followed when conducting the mycoplasma detection test.
(1) Preparation of inoculum. Immediately prior to starting the test, frozen liquid vaccine shall be thawed, and lyophilized vaccine shall be rehydrated to the volume recommended on the label with mycoplasma medium. In the case of a lyophilized biological product, e.g., 1,000 dose vial of poultry vaccine to be administered via the drinking water, the vaccine shall be rehydrated to 30 ml with mycoplasma medium. In the case of a cell line or a sample of primary cells, the inoculum shall consist of the resuspended cells. Control tests shall be established as provided in paragraph (d)(4) of this section.
(2) Inoculation of plate. Plate 0.1 ml of inoculum on an agar plate and make a short, continuous streak across the plate with a pipet. Tilt the plate to allow the inoculum to flow over the surface.
(3) Inoculation of flask of medium. Transfer 1 ml of the inoculum into a flask containing 100 ml mycoplasma medium and mix thoroughly. Incubate the flask at 33 to 37 °C for 14 days during which time, one of four agar plates shall be streaked with 0.1 ml of material from the incubating flask of inoculated medium on the 3d day, one on the 7th day, one on the 10th day, and one on the 14th day post-inoculation.
(4) Control tests shall be conducted simultaneously with the detection test using techniques provided in paragraphs (d)(2) and (3) of this section, except the inoculum for the positive control test shall be selected mycoplasma cultures and the negative control test shall be uninoculated medium from the same lot used in the detection test.
(5) All plates shall be incubated in a high humidity, 4-6 percent CO
(e) Interpretation of test results.
(1) If growth appears on at least one of the plates in the positive control test and does not appear on any of the plates in the negative control test, the test is valid.
(2) If mycoplasma colonies are found on any of the plates inoculated with material being tested, the results are positive for mycoplasma contamination.
Methods provided in this section must be used when a determination of
(a) Final container samples of completed product shall be tested. The weight loss of the sample due to drying in a vacuum oven shall be determined. All procedures should be performed in an environment with a relative humidity less than 45 percent. The equipment necessary to perform the test is as follows:
(1) Cylindrical weighing bottles with airtight glass stoppers.
(2) Vacuum oven equipped with validated thermometer and thermostat. A suitable air-drying device should be attached to the inlet valve.
(3) Balance, accurate to 0.1 mg (rated precision ±0.01mg).
(4) Desiccator jar equipped with phosphorous pentoxide, silica gel, or equivalent.
(5) Desiccated vaccine in original sealed vial. Sample and control should be kept at room temperature in their original airtight containers until use.
(b) Test procedure:
(1) Thoroughly cleaned and labeled sample-weighing bottles with stoppers should be allowed to dry at 60 ±3 °C under vacuum at less than 2.5 kPa.
(i) Transfer hot bottles and stoppers into the desiccator and allow to cool to room temperature.
(ii) After bottles have cooled, insert stoppers and weigh and record the weights of the bottles as “A.”
(iii) Return weighing bottles to the desiccator.
(2) Remove the sample container seal.
(i) Using a spatula, break up the sample plug and transfer the required amount of sample to the previously tared weighing bottle.
(ii) Insert the stopper and weigh and record the weights of the weighing bottles as “B.”
(3) Place the weighing bottle with the stopper at an angle in the vacuum oven. Set the vacuum to < 2.5 kPa and the temperature to 60 ±3 °C.
(4) After a minimum of 3 hours of drying time, turn off the vacuum pump and allow dry air to bleed into the oven until the pressure inside the oven is equalized with the prevailing atmospheric pressure.
(5) While the bottle is still warm, replace the stopper in its normal position and transfer the weighing bottle to the desiccator.
(i) Allow a minimum of 2 hours for the weighing bottle to cool to room temperature or for its weight to reach equilibrium.
(ii) Weigh, and record the weight as “C.”
(6) Calculate the percentage of moisture in the original sample as follows:
(7) The results are considered satisfactory if the percentage of residual moisture is less than or equal to the manufacturer's specification.
The test for detection of Salmonella contamination provided in this section shall be conducted when such a test is prescribed in an applicable Standard Requirement or in the filed Outline of Production for the product.
(a) Samples shall be collected from the bulk suspension before bacteriostatic or bactericidal agents have been added. When tissue culture products are to be tested, 1 ml of tissue extract used as the source of cells or 1 ml of the minced tissue per se shall be tested.
(b) Five ml of the liquid vaccine suspension shall be used to inoculate each 100 ml of liquid broth medium (tryptose and either selenite F or tetrathionate). The inoculated media shall be incubated 18-24 hours at 35-37 °C.
(c) Transfers shall be made to either MacConkey agar or Salmonella-Shigella agar, incubated for 18-24 hours and examined.
(d) If no growth typical of Salmonella is noted, the plates shall be incubated an additional 18-24 hours and again examined.
(e) If suspicious colonies are observed, further subculture on suitable media shall be made for positive identification. If Salmonella is found, the bulk suspension is unsatisfactory.
The complement-fixation test for detection of avian lymphoid leukosis provided in this section shall be conducted on all biological products containing virus which has been propagated in substrates of chicken origin:
(a) Propagation of contaminating lymphoid leukosis viruses, if present, shall be done in chick embryo cell cultures.
(1) Each vaccine virus, cytopathic to chick embryo fibroblast cells, shall be effectively neutralized, inactivated, or separated so that minimal amounts of lymphoid leukosis virus can be propagated on cell culture during the 21-day growth period. If a vaccine virus cannot be effectively neutralized, inactivated, or separated, a sample of another vaccine prepared the same week from material harvested from each source flock (or other sampling procedure acceptable to Animal and Plant Health Inspection Service) used for the preparation of the questionable vaccine virus that cannot be neutralized, inactivated, or separated shall be tested each week during the preparation of such questionable vaccine.
(2) When cell cultures are tested, 5 ml of the final cell suspension as prepared for seeding of production cell cultures shall be used as inoculum. When vaccines are tested, the equivalent of 200 doses of Newcastle disease vaccine or 500 doses of other vaccines for use in poultry, or one dose of vaccine for use in other animals shall be used as inoculum. Control cultures shall be prepared from the same cell suspension as the cultures for testing the vaccine.
(3) Uninoculated chick embryo fibroblast cell cultures shall act as negative controls. One set of chick fibroblast cultures inoculated with subgroup A virus and another set inoculated with subgroup B virus shall act as positive controls, A and B respectively.
(4) The cell cultures shall be propagated at 35-37 °C for at least 21 days. They shall be passed when necessary to maintain viability and samples harvested from each passage shall be tested for group specific antigen.
(b) The microtiter complement-fixation test shall be performed using either the 50 percent or the 100 percent hemolytic end point technique to determine complement unitage. Five 50 percent hemolytic units or two 100 percent hemolytic units of complement shall be used for each test.
(1) All test materials, including positive and negative controls, shall be stored at −60 °C or colder until used in the test. Before use, each sample shall be thawed and frozen three times to disrupt intact cells and release the group specific antigen.
(2) The antiserum used in the microtiter complement-fixation test shall be a standard reagent supplied or approved by the Animal and Plant Health Inspection Service. Four units of antiserum shall be used for each test.
(3) Presence of complement-fixing activity in the harvested samples (from passages) at the 1:4 or higher dilution, in the absence of anticomplementary activity, shall be considered a positive test unless the activity can definitely be established to be caused by something other than lymphoid leukosis virus, subgroups A and/or B. Activity at the 1:2 dilution shall be considered suspicious and the sample further subcultured to determine presence or absence of the group specific antigen.
(4) Biological products or primary cells which are found contaminated with lymphoid leukosis viruses are unsatisfactory. Source flocks from which contaminated material was obtained are also unsatisfactory.
The test for detection of Brucella contamination provided in this section shall be conducted when such a test is prescribed in an applicable Standard Requirement or in a filed Outline of Production for the product.
(a) One ml of the minced tissue used as the source of cells or 1 ml of the extract of the tissue prior to the addition of antibiotics, diluent and stabilizer, shall be inoculated onto each of three tryptose agar plates and incubated in a 10 percent CO
(b) If colonies are identified as Brucella, the biological product is unsatisfactory.
(c) If colonies suspicious of Brucella are observed but cannot be identified as a Brucella species, either
(1) The biological product shall be regarded as unsatisfactory and destroyed; or
(2) Further subculture or other procedures shall be carried out until a positive identification can be made.
One of the mouse safety tests provided in this section shall be conducted when such test is prescribed in a Standard Requirement or in the filed Outline of Production for a biological product recommended for animals other than poultry:
(a) Final container samples of completed product from live virus vaccines shall be tested for safety using young adult mice in accordance with the test provided in this paragraph.
(1) Vaccine, prepared for use as recommended on the label, shall be tested. Eight mice shall be inoculated intracerebrally with 0.03 ml and eight mice shall be inoculated intraperitoneally with 0.5 ml. Both groups shall be observed for 7 days.
(2) If unfavorable reactions attributable to the product occur in two or more mice in either group during the observation period, the serial or subserial is unsatisfactory. If unfavorable reactions which are not attributable to the product occur in two or more mice in either group, the test shall be declared inconclusive and may be repeated:
(b) Bulk or final container samples of completed product from liquid products, such as but not limited to antiserums and bacterins, shall be tested for safety in accordance with the test provided in this paragraph.
(1) Unless otherwise prescribed in the Standard Requirement or approved in a filed Outline of Production for the product, a 0.5 ml dose shall be injected intraperitoneally or subcutaneously into eight mice and the animals observed for 7 days.
(2) If unfavorable reactions attributable to the product occur in any of the mice during the observation period, the serial or subserial is unsatisfactory. If unfavorable reactions which are not attributable to the product occur, the test shall be declared inconclusive and may be repeated:
At 72 FR 72564, Dec. 21, 2007, § 113.33 was amended by revising paragraphs (a)(1) and (a)(2), effective Jan. 22, 2008. For the convenience of the user, the revised text is set forth as follows:
(a) * * *
(1) Vaccine prepared for use as recommended on the label shall be tested by inoculating eight mice intraperitoneally or subcutaneously with 0.5 mL (the inoculation volume may be divided among more than one injection site), and the animals observed for 7 days.
(2) If unfavorable reactions attributable to the product occur in any of the mice during
The test for detection of hemagglutinating viruses provided in this section shall be conducted when such a test is prescribed in an applicable Standard Requirement or in the filed Outline of Production for the product.
(a) Final container samples of completed product rehydrated as recommended on the label shall be used as inoculum:
(b) Each of ten 9- to 10-day-old embryonating eggs from Newcastle disease susceptible flocks shall be inoculated into the allantoic cavity with 0.2 ml of the undiluted inoculum.
(1) Test five uninoculated embryos of the same age and from the same flock as those used for the test as negative controls.
(2) Test an allantoic fluid sample of Newcastle disease virus as a positive control.
(c) Three to five days post-inoculation, a sample of allantoic fluid from each egg shall be tested separately by a rapid plate test for hemagglutinating activity using a 0.5 percent suspension of fresh chicken red blood cells.
(d) If the results are inconclusive, one or two blind passages shall be made using fluids from each of the original test eggs. Fluids from dead and live embryos may be pooled separately for inoculum in these passages.
(e) If hemagglutinating activity attributable to the product is observed, the serial is unsatisfactory.
The test for detection of viricidal activity provided in this section shall be conducted when such a test is prescribed in an applicable standard requirement or in the filed Outline of Production for each inactivated liquid biological product used as diluent for a desiccated live virus vaccine in a combination package.
(a) Bulk or final container samples of completed product from each serial shall be tested.
(b) The product shall be tested with each virus fraction for which it is to be used as a diluent. If the vaccine to be rehydrated contains more than one virus fraction, the test shall be conducted with each fraction after neutralization of the other fraction(s), and/or dilution of the vaccine beyond the titer range of the other fraction(s), or the test shall be conducted using representative single-fraction desiccated vaccines which are prepared by the licensee and which are licensed.
(c) Test procedure: (1) Rehydrate at least two vials of the vaccine with the liquid product under test according to label recommendations and pool the contents.
(2) Rehydrate at least two vials of the vaccine with the same volume of sterile purified water and pool the contents.
(3) Neutralize to remove other fractions, if necessary.
(4) Hold the two pools of vaccine at room temperature (20 °to 25 °C) for 2 hours. The holding period shall begin when rehydration is completed.
(5) Titrate the virus(es) in each pool of vaccine as provided in the filed Outline of Production or an applicable standard requirement.
(6) Compare respective titers.
(d) If the titer of the vaccine virus(es) rehydrated with the product under test is more than 0.7 log
(e) If the product is unsatisfactory in the first test, one retest to rule out faulty techniques may be conducted using four vials of the vaccine for each pool and the acceptability of the product judged by the results of the second test.
(f) Liquid products found to be unsatisfactory for use as diluent by this test are not prohibited from release as separate licensed products if labeled as prescribed in § 112.7(g).
The test for detection of extraneous pathogens provided in this section shall be conducted when such a test is prescribed in an applicable Standard Requirement or in the filed Outline of Production for the product.
(a) The biological product to be tested shall be prepared for use as recommended on the label, or in the case of desiccated vaccine to be used in poultry, rehydrated with sterile distilled water at the rate of 30 ml per 1,000 doses.
(b) At least 25 healthy susceptible young chickens, properly identified and obtained from the same source and hatch, shall be immunized at least 14 days prior to being put on test. The immunizing agent shall be the same as the product to be tested but from a serial previously tested and found satisfactory.
(c) At least 20 of the previously immunized birds shall be inoculated with 10 label doses of the vaccine being tested by each of the following routes: Subcutaneous, intratracheal, eye-drop, and comb scarification (1 cm
(d) At least five birds shall be isolated as control birds.
(e) All birds shall be observed for 21 days for signs of septicemic diseases, respiratory diseases, or other pathologic conditions.
(f) If the controls remain healthy and unfavorable reactions attributable to the product occur in the vaccinates, the serial or subserial tested is unsatisfactory. If the controls do not remain healthy or if unfavorable reactions not attributable to the product occur in the vaccinates, or both, the test shall be declared inconclusive and may be repeated:
The test for detection of extraneous pathogens provided in this section shall be conducted when such a test is prescribed in an applicable Standard Requirement or in the filed Outline of Production for the product.
(a) The biological product to be tested shall be prepared for use as recommended on the label, or in the case of desiccated vaccine to be used in poultry, rehydrated with sterile distilled water at the rate of 30 ml per 1,000 doses.
(b) One volume of the prepared vaccine shall be mixed with up to nine volumes of sterile heat-inactivated specific antiserum to neutralize the vaccine virus in the product. Each lot of antiserum shall be demonstrated by virus neutralization tests not to inhibit other viruses known to be possible contaminants.
(c) After neutralization, 0.2 ml of the vaccine-serum mixture shall be inoculated into each of at least 20 fully susceptible chicken embryos.
(1) Twenty embryos, 9 to 11 days old, shall be inoculated on the chorio-allantoic membrane (CAM) with 0.1 ml, and in the allantoic sac with 0.1 ml.
(2) Eggs shall be candled daily for 7 days. Deaths occurring during the first 24 hours shall be disregarded but at least 18 viable embryos shall survive 24 hours post-inoculation for a valid test. Examine all embryos and CAM's from embryos which die after the first day. When necessary, embryo subcultures shall be made to determine the cause of a death. The test shall be concluded on the seventh day post-inoculation and the surviving embryos (including CAM's) examined.
(d) If death and/or abnormality attributable to the inoculum occur, the serial is unsatisfactory:
The guinea pig safety test provided in this section shall be conducted when prescribed in a Standard Requirement or approved Outline of Production for a biological product. When desiccated products are tested, final container samples of completed product prepared for administration in the manner recommended on the label shall be used. When liquid products are tested, either bulk or final container samples of completed product shall be used.
(a) Unless otherwise specified in the Standard Requirement or approved Outline of Production for the product, a 2 ml dose shall be injected either intramuscularly or subcutaneously into each of two guinea pigs and the animals observed for 7 days.
(b) If unfavorable reactions attributable to the product occur in either of the guinea pigs during the observation period, the serial or subserial is unsatisfactory. If unfavorable reactions which are not attributable to the product occur, the test shall be declared inconclusive and may be repeated:
The safety tests provided in this section shall be conducted when prescribed in a standard requirement or in the filed Outline of Production for a biological product recommended for use in cats.
(a) The cat safety test provided in this paragraph shall be used when the Master Seed Virus is tested for safety.
(1) The test animals shall be determined to be susceptible to the virus under test as follows:
(i) Throat swabs shall be collected from each cat and individually tested on susceptible cell cultures for the presence of the virus. Blood samples shall also be drawn and individual serum samples tested for antibody to the virus.
(ii) The cats shall be considered susceptible if swabs are negative for virus isolation and the serums are free of virus antibody at the 1:2 final dilution in a 50 percent plaque reduction test or other serum-neutralization test of equal sensitivity.
(iii) When determining susceptibility to a virus which does not lend itself to the methods in paragraphs (a)(1)(i) and (ii) of this section, a method acceptable to Animal and Plant Health Inspection Service shall be used.
(2) Each of at least 10 susceptible cats shall be administered a sample of the Master Seed Virus equivalent to the amount of virus to be used in one cat dose of the vaccine, by the method to be recommended on the label, and the cats observed each day for 14 days.
(3) If unfavorable reactions attributable to the virus occur in any of the cats during the observation period, the Master Seed Virus is unsatisfactory. If unfavorable reactions occur which are not attributable to the Master Seed Virus, the test shall be declared inconclusive and repeated:
(b) The cat safety test provided in this paragraph shall be used when a serial of vaccine is tested for safety before release.
(1) Each of two healthy cats shall be administered 10 cat doses by the method recommended on the label and the cats observed each day for 14 days.
(2) If unfavorable reactions attributable to the biological product occur during the observation period, the serial is unsatisfactory. If unfavorable reactions occur which are not attributable to the product, the test shall be declared inconclusive and repeated:
The safety tests provided in this section shall be conducted when prescribed in a Standard Requirement or
(a) The dog safety test provided in this paragraph shall be used when the Master Seed Virus is tested for safety.
(1) The test animals shall be determined to be susceptible to the virus under test by a method acceptable to the Animal and Plant Health Inspection Service.
(2) Each of at least 10 susceptible dogs shall be administered a sample of the Master Seed Virus equivalent to the amount of virus to be used in one dog dose of the vaccine, by the method recommended on the label, and the dog shall be observed each day for 14 days.
(3) If unfavorable reactions attributable to the virus occur in any of the dogs during the observation period, the Master Seed Virus is unsatisfactory. If unfavorable reactions occur which are not attributable to the Master Seed Virus, the test shall be declared inconclusive and may be repeated:
(b) The dog safety test provided in this paragraph shall be used when a serial of vaccine is tested for safety before release.
(1) Each of two healthy dogs shall be administered 10 dog doses by the method recommended on the label and the dogs shall be observed each day for 14 days.
(2) If unfavorable reactions attributable to the biological product occur during the observation period, the serial is unsatisfactory. If unfavorable reactions occur which are not attributable to the biological product, the test shall be declared inconclusive and may be repeated:
The calf safety test provided in this section shall be conducted when prescribed in a Standard Requirement or in the filed Outline of Production for a product.
(a)
(b)
The test for detection of lymphocytic choriomeningitis (LCM) virus provided in this section shall be conducted when such a test is prescribed in an applicable Standard Requirement or in a filed Outline of Production. Vaccine virus may be neutralized with specific antiserum when necessary.
(a) Each of at least 10 mice obtained from a source free of LCM shall be injected in the footpad of a hindfoot with 0.02 ml of the material being tested and observed each day for 21 days.
(b) If any of the mice show swelling in the injected footpad or if more than one becomes systemically abnormal, the material being tested is unsatisfactory.
The test for chlamydial agents provided in this section shall be conducted when such a test is prescribed in an applicable standard requirement or in a filed Outline of Production.
(a) The yolk sac of 6-day-old chicken embryos shall be injected. Three groups of 10 embryos shall be used sequentially.
(1) The inoculum for each embryo in the first group shall consist of 0.5 ml of a mixture of equal parts of the seed virus with phosphate buffered saline that may contain Streptomycin,
(2) On the 10th day postinoculation, the yolk sac of viable embryos shall be harvested, pooled, homogenized as a 20 percent suspension in phosphate buffered saline antibiotic diluent, and 0.5 ml of the mixture injected into the second group of chicken embryos. This process shall be repeated for the injection of the third group of embryos using the yolk sacs of viable embryos from the second group.
(3) For each of the three passages, embryo deaths occurring within 48 hours of injection shall be disregarded, except that if more than three such deaths occur at any passage, that passage shall be repeated.
(b) If one or more embryo deaths occur at any passage after 48 hours postinjection, the yolk sacs from each of the dead embryos shall be subcultured into 10 additional embryos. If one or more embryo deaths again occur due to chlamydial agents, the Master Seed Virus is unsatisfactory for use to produce vaccine.
The swine safety test provided in this section shall be conducted when prescribed in a Standard Requirement or in the filed Outline of Production for a product.
(a)
(2) Administer vaccine in the manner recommended on the label.
(3) Observe swine each day for 21 days.
(b)
The sheep safety test provided in this section shall be conducted when prescribed in a Standard Requirement or in the filed Outline of Production for a product.
(a)
(2) Administer vaccine in the manner recommended on the label.
(3) Observe sheep each day for 21 days.
(b)
The tests for detection of cytopathogenic and/or hemadsorbing agents provided in this section shall be conducted when prescribed in an applicable Standard Requirement or in the filed Outline of Production for a product.
(a)
(1) Stain each monolayer with a suitable cytological stain.
(2) Examine the entire area of each stained monolayer for evidence of inclusion bodies, abnormal number of giant cells, or other cytopathology indicative of cell abnormalities attributable to an extraneous agent.
(b)
(1) Wash the monolayer with several changes of phosphate buffered saline.
(2) Add an appropriate volume of a 0.2 percent red blood cell suspension to uniformly cover the surface of the monolayer of cultured cells. Suspensions of washed guinea pig and chicken red blood cells shall be used. These suspensions may be mixed before addition to the monolayer or they may be added separately to individual monolayers.
(3) Incubate the monolayer at 4° C for 30 minutes, wash with phosphate buffered saline, and examine for hemadsorption.
(4) If no hemadsorption is apparent, repeat step (b)(2) of this section and incubate the monolayers at 20-25 °C for 30 minutes, wash with phosphate buffered saline, and examine again for hemadsorption. If desired, separate monolayers may be used for each incubation temperature.
(c) If specific cytopathology or hemadsorption attributable to an extraneous agent is found, the material under test is unsatisfactory and shall not be used to prepare biological products. If an extraneous agent is suspected because of cytopathology or hemadsorption and cannot be eliminated as a possibility by additional testing, the material under test is unsatisfactory.
The test for detection of extraneous viruses by the fluorescent antibody technique provided in this section shall be conducted when prescribed in an applicable Standard Requirement or in a filed Outline of Production for a product.
(a) Monolayer cultures of cells (monolayers), at least 7 days after the last subculturing, shall be processed and stained with the appropriate antiviral fluorochrome-conjugated antibody as specified in paragraph (b) of this section.
(1) Three groups of one or more monolayers shall be required for each specific virus prescribed in paragraph (b) of this section.
(i) At the time of the last subculturing, one group of test monolayers shall be inoculated with approximately 100-300 FAID
(ii) One group of monolayers shall be the “material under test.”
(iii) One group of monolayers, that are of the same type of cells as the test monolayers and that have been tested as prescribed in §§ 113.51 or 113.52 (whichever is applicable), shall be prepared as negative controls.
(2) Each group of monolayers shall have a total area of at least 6 cm
(3) Positive control monolayers may be fixed (processed so as to arrest growth and assure attachment of the monolayer to the surface of the vessel in which they are grown) before 7 days after subculturing if fluorescence is enhanced by doing so,
(b) The antiviral fluorochrome-conjugated antibodies to be used shall depend on the type of cells required to be tested for extraneous viruses as specified in an applicable Standard Requirement or in a filed Outline of Production. Antiviral fluorochrome-conjugated antibodies specific for the extraneous viruses shall be applied to each respective type of cell in accordance with the following list. Under certain circumstances, additional tests may need to be conducted, as determined by the Administrator. When a specific antiviral fluorochrome-conjugated antibody is used in testing for the listed extraneous viruses specified in more than one cell type, it need only be applied to the most susceptible cell type.
(1) All cells shall be tested for:
(i) Bovine virus diarrhea virus;
(ii) Reovirus; and
(iii) Rabies virus.
(2) Bovine, caprine, and ovine cells shall, in addition, be tested for:
(i) Bluetongue virus;
(ii) Bovine adenoviruses;
(iii) Bovine parvovirus; and
(iv) Bovine respiratory syncytial virus.
(3) Canine cells shall, in addition, be tested for:
(i) Canine coronavirus;
(ii) Canine distemper virus; and
(iii) Canine parvovirus.
(4) Equine cells shall, in addition, be tested for:
(i) Equine herpesvirus; and
(ii) Equine viral arteritis virus.
(5) Feline cells shall, in addition, be tested for:
(i) Feline infectious peritonitis virus; and
(ii) Feline panleukopenia virus.
(6) Porcine cells shall, in addition, be tested for:
(i) Porcine adenovirus;
(ii) Porcine parvovirus;
(iii) transmissible gastroenteritis virus; and
(iv) Porcine hemagglutinating encephalitis virus.
(7) Firms that do not have rabies virus on premises either for research or production purposes are exempt from having to produce positive rabies virus control monolayers. Fixed positive rabies virus control monolayers will be provided by the National Veterinary Services Laboratories.
(c) After staining, each group of monolayers shall be examined for the presence of specific fluorescence attributable to the presence of extraneous viruses.
(1) If the material under test shows any evidence of specific viral fluorescence, it is unsatisfactory and may not be used;
(2) If the fluorescence of the monolayers inoculated with the specific virus as positive controls is equivocal, or if the negative monolayers show equivocal fluorescence indicating possible viral contamination, or both, the test shall be declared inconclusive, and may be repeated;
All ingredients used in a licensed biological product shall meet accepted standards of purity and quality; shall be sufficiently nontoxic so that the amount present in the recommended dose of the product shall not be toxic to the recipient; and in the combinations used shall not denature the specific substances in the product below the minimum acceptable potency within the dating period when stored at the recommended temperature.
Primary cells used to prepare biological products shall be derived from normal tissue of healthy animals. When prescribed in an applicable Standard Requirement or in the filed Outline of Production, each batch of primary cells used to prepare a biological product shall be tested as prescribed in this section. A batch of primary cells found unsatisfactory by any prescribed test shall not be used. A serial of biological product shall not be released if produced from primary cells that are found unsatisfactory by any prescribed test.
(a) Final container samples of completed product or samples of the final pool of harvested material or samples of each subculture of cells used to prepare the biological product shall be shown free of mycoplasma as prescribed in § 113.28. The sample for testing shall consist of at least 75 cm
(b) Final container samples of completed product or samples of the final pool of harvested material or samples of each subculture of cells used to prepare the biological product shall be
(c) A monolayer at least 75 cm
(1) The test monolayer shall be maintained using the medium (with additives) and under conditions similar to those used to prepare biological products.
(i) Monolayers of avian origin shall be maintained for at least 14 days and shall be subcultured at least once during the maintenance period. All but the last subculture shall result in a new monolayer of at least 75 cm
(ii) Monolayers not of avian origin shall be maintained for at least 28 days and shall be subcultured at least twice during the maintenance period. All but the last subculture shall result in a new monolayer of at least 75 cm
(2) Monolayers shall be examined regularly throughout the required maintenance period for evidence of the presence of cytopathogenic agents. If evidence of a cytopathogenic agent is found, the batch of primary cells is unsatisfactory.
(3) At the conclusion of the required maintenance period, monolayers shall be tested for:
(i) Cytopathogenic and/or hemadsorbing agents as prescribed in § 113.46;
(ii) Extraneous viruses by the fluorescent antibody technique as prescribed in § 113.47.
When prescribed in an applicable Standard Requirement or in a filed Outline of Production each cell line used to prepare a biological product shall be tested as prescribed in this section. A cell line found unsatisfactory by any prescribed test shall not be used. A serial of biological product shall not be released if produced from a cell line that is found unsatisfactory by any prescribed test.
(a)
(2) A Master Cell Stock (MCS) shall be established at a specified passage level for each cell line. The passage level and identity of the MCS and the highest passage level (MCS + n) intended for use in the preparation of a biological product shall be specified in the Outline of Production for the product.
(3) Sufficient 1.0 ml or larger aliquots of MCS and MCS + n shall be prepared, kept in a frozen state, and made available to Animal and Plant Health Inspection Service (APHIS) upon request for performing the tests prescribed in this section.
(4) Each lot of cells shall be monitored for the characteristics determined to be normal for the cell line, such as, but not limited to, microscopic appearance, growth rate, acid production, or other observable features.
(b) The MCS shall be shown to be of the same species of origin as that reported in paragraph (a)(1) of this section by the following method:
(1) At least four monolayers with a total area of at least 6 cm
(2) The monolayers shall be removed from their media, processed, stained, and examined.
(i) At least two monolayers shall be stained with an antispecies fluorchrome-conjugated antibody unrelated to the species of origin of the MCS.
(ii) At least two monolayers shall be stained with an antispecies fluorochrome-conjugated antibody specific to the species of origin of the MCS.
(iii) All monolayers shall be examined for evidence of specific fluorescence.
(3) If specific fluorescence is not found in the monolayers stained with
(4) If nonspecific fluorescence is found in the monolayers stained with conjugate from an unrelated species of origin or other results make the test results equivocal, the procedure shall be repeated until either specific fluorescence is found only in the monolayers stained with conjugate specific to the species of origin of the MCS and not in the control monolayers or specific fluorescence cannot be identified and the MCS is declared unsatisfactory.
(5) Alternate tests to determine the species of origin of the MCS may be used if approved by APHIS.
(c) The MCS and either each subculture of cells used to prepare a biological product or the final pool of harvested material (with or without the stabilizer) or final container samples of completed product for each serial of such product shall be shown to be free of mycoplasma as prescribed in § 113.28. The sample for testing shall consist of at least 75 cm
(d) The MCS and either each subculture used to prepare a biological product or the final pool of harvested material for each serial of such product or final container samples of completed product for each serial of such product shall be tested for bacteria and fungi as prescribed in § 113.26 or § 113.27 (whichever is applicable). If bacteria or fungi are found in the MCS, the MCS shall not be used. If bacteria or fungi are found in a subculture, the subculture shall not be used.
(e) A monolayer at least 75 cm
(1) The test monolayer shall be maintained for at least 21 days using the medium (with additives) intended for growth and maintenance and under conditions similar to those used to prepare biological products.
(2) Cells shall be subcultured at least two times during the maintenance period. All but the last subculture shall result in at least one new monolayer of at least 75 cm
(3) Monolayers shall be examined regularly throughout the 21-day maintenance period for evidence of the presence of cytopathogenic agents. If evidence of a cytopathogenic agent is found, the MCS is unsatisfactory.
(4) At the conclusion of the 21-day maintenance period, monolayers shall be tested for:
(i) Cytopathogenic and/or hemadsorbing agents as prescribed in § 113.46; and
(ii) Extraneous agents by the fluorescent antibody technique as prescribed in § 113.47.
(f) At the conclusion of the 21-day maintenance period provided in paragraph (e) of this section, at least one monolayer of at least 75 cm
(1) Alternately freeze and thaw the monolayer(s) three times. Centrifuge the disrupted cells at no greater than 2,000×g for no more than 15 minutes to remove cellular debris. Divide the supernatant into equal aliquots and dispense 1.0 ml onto each of at least one monolayer (at least 75 cm
(i) Vero (African green monkey kidney) cell line;
(ii) Embryonic cells, neonatal cells, or a cell line of the same species of origin as the MCS if different than provided in paragraph (f)(1)(i) of this section;
(iii) Embryonic cells, neonatal cells, or a cell line of the species for which the vaccine is recommended if different than provided in paragraph (f)(1)(ii) of this section; and
(iv) Embryonic cells, neonatal cells, or a cell line of bovine origin if not specified in paragraphs (f)(1)(ii), and (iii) of this section.
(2) The monolayers of cells specified in paragraphs (f)(1)(i), (ii), (iii), and (iv) of this section shall be maintained for at least 14 days after inoculation with the aliquot of disrupted MCS. Monolayers shall be subcultured at least once during the maintenance period. All but the last subculture shall result in a new monolayer of at least 75
(3) Monolayers shall be examined regularly throughout the 14-day maintenance period for evidence of the presence of cytopathogenic agents. If evidence of a cytopathogenic agent is found, the MCS is unsatisfactory.
(4) At the conclusion of the 14-day maintenance period, monolayers shall be tested for:
(i) Cytopathogenic and/or hemadsorbing agents as prescribed in § 113.46; and
(ii) Extraneous viruses by the fluorescent antibody technique as prescribed in § 113.47.
(g) The karyology of cells lines used in the production of biologics shall be examined as follows. A minimum of 50 mitotic cells shall be examined at both the MCS and MCS+n. The modal number in the MCS+n shall not exceed plus or minus 15 percent of the modal number of the MCS. Any marker chromosomes present in the MCS shall persist at the MCS+n. If the modal number exceeds the limits and/or the marker chromosomes do not persist (through the MCS+n passage level), the cell line shall not be used for vaccine production.
(h) If direct or indirect evidence exists that a cell line which is intended for use in the preparation of a vaccine may induce malignancies in the species for which the product is intended, that cell line shall be tested for tumorigenicity/oncogenicity by a method acceptable to APHIS.
Each lot of ingredient of animal origin which is not subjected to heat sterilization or other sterilization methods acceptable to Animal and Plant Health Inspection Service (APHIS), such as, but not limited to serum and albumin, used to prepare a biological product shall be tested as prescribed in this section by the licensee or a laboratory acceptable to VS. Results of all tests shall be recorded by the testing laboratory and made a part of the licensee's records. A lot of ingredient found unsatisfactory by any prescribed test shall not be used to prepare a biological product. A serial of biological product shall not be released if produced using an ingredient that is found unsatisfactory by any prescribed test.
(a) Samples of each lot of ingredient of animal origin which is not subjected to heat sterilization, used to prepare a biological product shall be shown free of mycoplasma by the method prescribed in § 113.28.
(b) Samples of each lot of ingredient or animal origin which is not subjected to heat sterilization of other sterilization methods acceptable to APHIS used to prepare a biological product shall be shown free of bacteria and fungi as prescribed in § 113.26.
(c) Samples of each lot of ingredient of animal origin, except porcine trypsin, which is not subjected to heat sterilization or other viricidal procedure acceptable to APHIS used in the preparation of biological products shall be tested as prescribed in this paragraph;
(1) Monolayers at least 75 cm
(2) At least 3.75 ml or 15 percent of the ingredient shall be used in the growth medium for the preparation of at least 75 cm
(3) The test monolayers shall be maintained for at least 21 days.
(4) Cells shall be subcultured at least two times during the maintenance period. All but the last subculture shall result in at least one new monolayer of at least 75 cm
(5) Monolayers shall be examined regularly throughout the 21-day maintenance period for evidence of cytopathogenic agents. If evidence of a cytopathogenic agent is found, the ingredient is unsatisfactory.
(6) At the conclusion of the 21-day maintenance period, monolayers shall be tested for:
(i) Cytopathogenic and/or hemadsorbing agents as prescribed in § 113.46; and
(ii) Extraneous viruses by the fluorescent antibody technique as prescribed in § 113.47.
(d) Each lot of porcine trypsin which has not been treated to inactivate porcine parvovirus (PPV) in a manner acceptable to VS shall be tested for PPV as prescribed in this paragraph.
(1) Not less than 5.0 grams of trypsin shall be dissolved in a volume of suitable diluent sufficient to fill a centrifuge angle head. After centrifuging for 1 hour at 80,000×g, the pellet material shall be reconstituted in distilled water and inoculated into a flask containing 75 cm
(2) The test and control monolayers shall be maintained for at least 14 days and subcultured at least once during the maintenance period.
(3) At the end of the 14-day maintenance period, and 4 to 7 days after the last subculturing, monolayers shall be tested for the presence of porcine parvovirus by the fluorescent antibody technique as prescribed in § 113.47(c).
(e) A sample of serum from each donor horse used to produce a lot of equine serum used in the preparation of biological products recommended for use in horses shall be tested at a laboratory approved by Animal and Plant Health Inspection Service using the Coggins test for equine infectious anemia antibodies. If antibodies to equine infectious anemia are found, the lot of serum is unsatisfactory.
Sterile Diluent shall be supplied in a final container by the licensee when such diluent is required for rehydration or dilution of the vaccine.
(a) Sterile Diluent may be distilled or deionized water or it may be a special liquid solution formulated in accordance with an acceptable outline on file with Animal and Plant Health Inspection Service.
(b) Each quantity prepared at one time in a single container and bottled into final containers shall be designated as a serial. Each serial shall be given a number which shall be used in records, test reports, and on the final container label.
(c) Final container samples from each serial shall be tested for bacteria and fungi in accordance with the test provided in § 113.26. Any serial found to be unsatisfactory shall not be released.
Unless otherwise prescribed in a Standard Requirement or in a filed Outline of Production, each Master Seed Virus (MSV) shall be tested as prescribed in this section. A MSV found unsatisfactory by any prescribed test shall not be used. A serial of biological product shall not be released if produced from a MSV that is found unsatisfactory by any prescribed test.
(a) At least a 1.0 ml aliquot per cell culture of MSV shall be dispensed onto monolayers (at least 75 cm
(1) Vero (African green monkey kidney) cell line;
(2) Embryonic cells, neonatal cells, or a cell line of the species for which the vaccine is recommended; and
(3) Embryonic cells, neonatal cells, or a cell line of the species of cells in which the MSV is presently being propagated if different than prescribed in paragraphs (a)(1) and (a)(2) of this section. Cell lines used shall have been found satisfactory when tested as prescribed in § 113.52 and primary cells used shall have been found satisfactory when tested as prescribed in § 113.51. If the MSV is cytopathic for or causes hemadsorption in the cells in which it
(b) At least one monolayer of each cell type used in the test shall be maintained as an uninoculated control.
(c) Each monolayer shall be maintained at least 14 days.
(d) Cells shall be subcultured at least once during the maintenance period. All but the last subculture shall result in at least one new monolayer at least 75 cm
(e) Monolayers shall be examined regularly throughout the 14-day maintenance period for evidence of cytopathogenic agents. If evidence of a cytopathogenic agent is found, the MSV is unsatisfactory.
(f) At the conclusion of the 14-day maintenance period, monolayers shall be tested for:
(1) Cytopathogenic and/or hemadsorbing agents as prescribed in § 113.46;
(2) Extraneous agents by the fluorescent antibody technique as prescribed in § 113.47.
When prescribed in an applicable Standard Requirement or in the filed Outline of Production, a live bacterial vaccine shall meet the requirements in this section.
(a)
(b)
(i) The bacteria or agents in the vaccine are inherently lethal for mice.
(ii) The vaccine is recommended for poultry.
(2) Samples of completed product from each serial or first subserial of live bacterial vaccine shall be tested for safety in one of the species for which the product is recommended as follows:
(i) Live bacterial vaccine recommended for use in dogs shall be tested as provided in § 113.40, except that dogs shall be injected with the equivalent of two doses of vaccine administered as recommended on the label.
(ii) Live bacterial vaccine recommended for use in cattle shall be tested as provided in § 113.41, except that calves shall be injected with the equivalent of two doses of vaccine administered as recommended on the label.
(iii) Live bacterial vaccine recommended for use in sheep shall be tested as provided in § 113.45.
(iv) Live bacterial vaccine recommended for use in swine shall be tested as provided in § 113.44.
(c)
(1)
(2)
(3)
(4)
(d)
(e)
(1)
(2)
(3) Final container samples of completed product from each serial and subserial must be tested for moisture content in accordance with the test provided in § 113.29.
Brucella Abortus Vaccine shall be prepared as a desiccated live culture bacterial vaccine from smooth colonial forms of the
(a)
(1) Macroscopic and microscopic examination shall be made on bulk samples from production containers. If organisms not typical of
(2) Two final container vials of completed product shall be tested by inoculating one tube of Dextrose Andrades broth with gas tube and one tube of thioglycollate broth from each vial. The inoculated media shall be incubated at 35 to 37 ° C for 96 hours. If growth not typical of
(3) Bacterial dissociation test. Final container samples of completed product from each serial and subserial shall be tested for bacterial dissociation. Smooth colonies are the desired form. Rough colonies are undesirable terminal dissociation forms. Intermediate and intermediate-to-rough are also undesirable.
(i) The sample container shall be rehydrated and streaked on one potato agar plate in such a manner as to produce confluent colonies. Artificial reflected light shall be used so that the rays pass through the plate at a 45 °angle.
(ii) If the vaccine contains more than 5 percent rough colonies or more than 15 percent total undesirable colonies, the serial or subserial is unsatisfactory. If organisms or growth not characteristic of
(b)
(1) Two final container vials of completed product shall be tested for the number of viable organisms per dose of rehydrated vaccine. A bacterial count per vial shall be made on tryptose agar plates from suitable dilutions using 1 percent peptone as a diluent. The inoculated media shall be incubated at 35 to 37 ° C for 96 hours.
(2) If the average count of the two final container samples of freshly prepared vaccine contains less than 3.0 or more than 10.0 billion organisms per
(3) If the average count on the initial test is less than the minimum or greater than the maximum required in paragraph (b)(2) of this section, the serial or subserial may be retested one time using four additional final container vials. The average count of the retest is determined. If the average count of the four vials retested is less than the required minimum or greater than the required maximum, the serial or subserial is unsatisfactory. If the average count of the four vials retested is within the required limits described in paragraph (b)(2) of this section, the following shall apply:
(i) If the average count obtained in the initial test is less than one-third or more than three times the average count obtained on the retest, the average count of the initial test shall be considered the result of test system error and the serial or subserial is satisfactory.
(ii) If the average count obtained in the initial test is one-third or more than the average retest count or three times or less than the average retest count, a new average count shall be determined from the counts of all six vials. If the new average is less than the minimum or greater than the maximum required in paragraph (b)(2) of this section, the serial or subserial is unsatisfactory.
(4) If tested at any time within the expiration period, each dose of rehydrated vaccine must contain at least 3.0 billion viable organisms per dose.
(c)
(1) Two final container samples shall be tested for the number of viable organisms per milliliter of rehydrated vaccine. One bacterial count per vial shall be made on tryptose agar plates from suitable dilutions using 1 percent peptone as a diluent. The inoculated media shall be incubated at 35 to 37 ° C for 96 hours.
(2) If the average count of the two final container samples of freshly prepared vaccine does not contain at least 10 billion viable organisms per milliliter, the serial or subserial is unsatisfactory.
(3) If the initial bacterial count is less than 10 billion organisms per milliliter, the serial or subserial may be retested one time using four samples. If the average count of the four vials retested is less than the required minimum, the serial or subserial is unsatisfactory.
(4) If tested at any time within the expiration period, each milliliter of rehydrated vaccine does not contain at least 5 billion viable organisms per milliliter, the serial or subserial is unsatisfactory.
Anthrax Spore Vaccine—Nonencapsulated shall be a live spore suspension prepared from nonencapsulated variants of
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.64 and the requirements in this section.
(b) Each lot of Master Seed shall be tested for immunogenicity as follows:
(1) Forty-two susceptible guinea pigs from the same source each weighing 400 to 500 grams, shall be used as test animals (30 vaccinates and 12 controls).
(2) An arithmetic mean spore count of vaccine produced from the highest passage of the Master Seed shall be established before the immunogenicity test is conducted. The guinea pigs used as vaccinates shall be injected as recommended on the label with a predetermined number of vaccine spores. To confirm the dosage, five replicate spore counts shall be conducted on a sample of the vaccine dilution used.
(3) Fourteen to fifteen days postvaccination the vaccinates and controls shall each be challenged with not less than 4,500 guinea pig LD
(4) If at least 10 of the 12 controls do not die from
(5) If at least 27 of 30 of the vaccinates do not survive the 10-day postchallenge observation period, the Master Seed is unsatisfactory.
(6) The Master Seed shall be retested for immunogenicity in 3 years unless use of the lot previously tested is discontinued. The vaccinates and controls must meet the criteria prescribed in paragraphs (b)(4) and (b)(5) of this section.
(7) An Outline of Production change shall be made before authority for use of a new lot of Master Seed shall be granted by Animal and Plant Health Inspection Service.
(c)
(1)
(2)
At 72 FR 72564, Dec. 21, 2007, § 113.66 was amended by removing paragraph (b)(6) and redesignating paragraph (b)(7) as paragraph (b)(6), effective Jan. 22, 2008.
Erysipelothrix Rhusiopathiae Vaccine shall be prepared as a desiccated live culture of an avirulent or modified strain of
(a) The Master Seed shall meet the applicable requirements prescribed in § 113.64 and the requirements in this section.
(b) Each lot of Master Seed used for vaccine production shall be tested for immunogenicity. The selected bacterial count from the lot of Master Seed shall be established as follows:
(1) Thirty
(2) An arithmetic mean count of the colony forming units from vaccine produced from the highest passage of the Master Seed shall be established before the immunogenicity test is conducted. The 20 swine to be used as vaccinates shall be injected as recommended on the label with a predetermined quantity of vaccine bacteria. The 10 control swine shall be held separately from the vaccinates. To confirm the dosage calculation, an arithmetic mean count shall be established by conducting five replicate titrations on a sample of the bacterial vaccine dilution used. Only plates containing between 30 and 300 colonies shall be considered in a valid test.
(3) The vaccinates and controls shall be examined and their average body temperature determined prior to challenge. Fourteen to twenty-one days postvaccination, the vaccinates and controls shall be challenged with a virulent
(4) A satisfactory challenge shall be evidenced in the controls by a high
(5) If at least 80 percent of the controls do not show characteristic signs during the observation period including, but not limited to a body temperature of 105.6 ° F or higher on at least 2 consecutive days, the test shall be considered inconclusive:
(6) To demonstrate immunity after challenge, the vaccinates shall remain free of clinical signs and the body temperature shall not exceed 104.6 ° F on 2 or more consecutive days. If at least 90 percent of the vaccinates do not remain free from clinical signs and high body temperature throughout the observation period, the Master Seed is unsatisfactory.
(7) The Master Seed shall be retested for immunogenicity in 3 years. Only five vaccinates and five controls need to be used in the retest:
(8) An Outline of Production change shall be made before authority for use of a new Master Seed shall be granted by Animal and Plant Health Inspection Service.
(c)
(1)
(2)
At 72 FR 72564, Dec. 21, 2007, § 113.67 was amended by removing paragraph (b)(7) and redesignating paragraph (b)(8) as paragraph (b)(7), effective Jan. 22, 2008.
Pasteurella Haemolytica Vaccine, Bovine, shall be prepared as a desiccated live culture bacterial vaccine of an avirulent or modified strain of
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.64 and the requirements in this section.
(b) Each lot of Master Seed used for vaccine production shall be tested for immunogenicity. The immunogenicity of a selected bacterial count from the lot of Master Seed shall be established as follows:
(1) Fifteen
(2) An arithmetic mean count of the colony forming units from vaccine produced from the highest passage of the Master Seed shall be established before the immunogenicity test is conducted. The 10 calves to be used as vaccinates
(3) The vaccinates and controls shall be examined and their average body temperature determined prior to challenge. Fourteen to twenty-one days post vaccination, the vaccinates and controls shall each be challenged by the respiratory route with a (virulent) pneumonia producing
(4) A satisfactory challenge shall be evidenced in the controls by progression of clinical signs consistent with respiratory system infection following challenge, including but not limited to lacrimation, mucoid nasal exudates, expiratory dyspnea, tachypnea, pulmonary rales, and cough possibly terminating in death; moribundity, depression with anorexia, diarrhea with substantial weight loss; or any combination of these symptoms.
(5) Lung lesion response to challenge will be assessed in all calves. Lung lesions will be assessed at necropsy in calves that succumb to challenge. Surviving calves will be euthanized on day 4 to 7 following challenge and lung lesions assessed at necropsy. Lung lesion scores will be used in the assessment of the response to challenge exposure. If a significant difference in lung lesion scores cannot be demonstrated between vaccinates and controls using a scoring system approved by the Animal and Plant Health Inspection Service, the Master Seed is unsatisfactory.
(6) The Master Seed shall be retested for immunogenicity in 3 years unless use of the lot previously tested is discontinued. Only five vaccinates and five controls need to be used in the retest:
(7) An Outline of Production change must be made before authority for use of a new lot of Master Seed is granted by the Animal and Plant Health Inspection Service.
(c)
(1)
(2)
At 72 FR 72564, Dec. 21, 2007, § 113.68 was amended by removing paragraph (b)(6) and redesignating paragraph (b)(7) as paragraph (b)(6), effective Jan. 22, 2008.
Pasteurella Multocida Vaccine, Bovine, shall be prepared as a desiccated live culture bacterial vaccine of an avirulent or modified strain of
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.64 and the requirements in this section.
(b) Each lot of Master Seed used for vaccine production shall be tested for immunogenicity. The immunogenicity of a selected bacterial count from the lot of Master Seed shall be established as follows:
(1) Fifteen
(2) An arithmetic mean count of the colony forming units from vaccine produced from the highest passage of the Master Seed shall be established before the immunogenicity test is conducted. The 10 calves to be used as vaccinates shall be injected as recommended on the label with a predetermined quantity of vaccine bacteria. The five control calves shall be held separately from the vaccinates. To confirm the dosage calculation, arithmetic mean count shall be established by conducting five replicate titrations on a sample of the bacterial vaccine used. Only plates containing between 30 and 300 colonies shall be considered a valid test.
(3) The vaccinates and controls shall be examined and their average body temperature determined prior to challenge. Fourteen to twenty-one days post vaccination, the vaccinates and controls shall each be challenged by the respiratory route with a (virulent) pneumonia producing
(4) A satisfactory challenge shall be evidenced in the controls by progression of clinical signs consistent with respiratory system infection following challenge, including but not limited to acute illness with higher body temperature and respiration rate, lacrimation, mucoid nasal exudate, expiratory dyspnea, tachypnea, pulmonary rales, and cough, possibly terminating in death; moribundity, depression with anorexia; diarrhea with substantial weight loss; or any combination of these symptoms.
(5) Lung lesion response to challenge will be assessed in all calves. Lung lesions will be assessed at necropsy in calves that succumb to challenge. Surviving calves will be euthanized on day 4 to 10 following challenge and lung lesions assessed at necropsy. Lung lesion scores will be used in the assessment of the response to challenge exposure. If a significant difference in lung lesion scores cannot be demonstrated between vaccinates and controls using a scoring system approved by the Animal and Plant Health Inspection Service, the Master Seed is unsatisfactory.
(6) The Master Seed shall be retested for immunogenicity in 3 years unless use of the lot previously tested is discontinued. Only five vaccinates and five controls need to be used in the retest:
(7) An Outline of Production change must be made before authority for use of a new lot of Master Seed is granted by the Animal and Plant Health Inspection Service.
(c)
(1)
(2)
At 72 FR 72564, Dec. 21, 2007, § 113.69 was amended by removing paragraph (b)(6) and redesignating paragraph (b)(7) as paragraph (b)(6), effective Jan. 22, 2008.
Pasteurella Multocida Vaccine, Avian Isolate, shall be prepared as a desiccated live culture of an avirulent or modified strain of
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.64 and the requirements in this section.
(b) Each lot of Master Seed used for vaccine production shall be tested for immunogenicity in each species and for each serotype for which the Master Seed is claimed to give protection.
(1) Thirty
(2) An arithmetic mean count of colony forming units from vaccine produced from the highest passage of Master Seed shall be established before the immunogenicity test is conducted. The 20 birds to be used as vaccinates shall be inoculated, as recommended on the label with a predetermined quantity of vaccine bacteria. The 10 control birds shall be held separately from the vaccinates. To confirm the dosage calculation, an arithmetic mean count shall be established by conducting five replicate titrations on a sample of the bacterial vaccine used. Only plates containing between 30 and 300 colonies shall be considered in a valid test.
(3) Not less than 14 days after vaccination, each of 20 vaccinates and each of 10 unvaccinated controls shall be challenged intramuscularly or by other methods acceptable to the Animal and Plant Health Inspection Service with a virulent
(4) Eight or more of the unvaccinated controls must die for the test to be valid. If at least 16 of 20 of the vaccinates do not survive the 14-day postchallenge period, the Master Seed is unsatisfactory at the selected bacterial count.
(5) The Master Seed shall be retested for immunogenicity in 3 years and shall meet the criteria prescribed in paragraph (b)(4) of this section.
(c)
(1)
(i) Ten birds of a species for which the vaccine is recommended shall be given the equivalent of 10 doses each of the vaccine and observed for 10 days. If the vaccine is recommended for more than one species, only one species needs to be tested.
(ii) If unfavorable reactions attributable to the vaccine occur during the observation period in two or more of the test birds, the serial is unsatisfactory.
(iii) If unfavorable reactions occur which are not attributable to the test vaccine, the test is inconclusive and may be repeated. If the results of the next test are not satisfactory, or if the test is not repeated, the serial shall be considered unsatisfactory.
(2)
At 72 FR 72564, Dec. 21, 2007, § 113.70 was amended by removing paragraph (b)(5), effective Jan. 22, 2008.
Chlamydia Psittaci Vaccine (Feline Pneumonitis), Live Chlamydia, shall be prepared from chlamydia-bearing cell culture fluids or embryonated chicken eggs. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.
(a) The Master Seed shall meet the applicable requirements prescribed in § 113.300 and the requirements in this section. Master Seed propagated in chicken embryos shall be tested for pathogens by the chicken embryo test prescribed in § 113.37. If found unsatisfactory by any prescribed test, the Master Seed shall not be used.
(b) Each lot of Master Seed used for vaccine production shall be tested for immunogenicity. The immunogenicity of a selected dose from the lot of Master Seed shall be established as follows:
(1) Thirty feline pneumonitis susceptible cats shall be used as test animals (20 vaccinates and 10 controls). Blood samples shall be drawn and individual serum samples tested. The cats shall be considered suitable for use if all serums are negative for pneumonitis antibody in a complement fixation test or other test of equal sensitivity.
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed shall be established before the immunogenicity test is conducted. The 20 cats used as vaccinates shall be administered a predetermined quantity of vaccine by the method to be recommended on the label and the remaining 10 cats shall be held as controls. To confirm the dosage calculations, five replicate titrations shall be conducted on a sample of the vaccine dilution used. If two doses are used, five replicate confirming titrations shall be conducted on each dose.
(3) Fourteen or more days after the final dose of vaccine, the vaccinates and controls shall each be challenged intranasally with a minimum of 10,000 yolk sac LD50 of virulent feline pneumonitis furnished or approved by the Animal and Plant Health Inspection Service and observed each day for 28 days postchallenge. The rectal temperature of each animal shall be taken and the presence or absence of clinical signs noted and recorded each day.
(i) If less than 8 of 10 controls show clinical signs of feline pneumonitis infection other than fever, the test is inconclusive and may be repeated.
(ii) If a significant difference in clinical signs other than fever or chlamydia shedding cannot be demonstrated between vaccinates and controls using a scoring system approved by the Animal and Plant Health Inspection Service, the Master Seed is unsatisfactory.
(4) The Master Seed shall be retested for immunogenicity in 3 years unless use of the lot previously tested is discontinued. Either 10 vaccinates and 6 controls or 5 vaccinates and 3 controls shall be used in the retest.
(i) If less than five of six or three of three of the controls in the retest show clinical signs of feline pneumonitis infection other than fever, the test is inconclusive and may be repeated.
(ii) A significant difference in clinical signs shall be demonstrated between vaccinates and controls in a valid test as prescribed in paragraph (c)(3)(ii) of this section.
(5) An Outline of Production change must be made before authority for use of a new lot of Master Seed is granted by the Animal and Plant Health Inspection Service.
(c)
(1) The test for pathogens prescribed in § 113.37 shall be conducted on each serial or one subserial of avian origin vaccine.
(2)
At 72 FR 72564, Dec. 21, 2007, § 113.71 was amended by removing paragraph (b)(4) and redesignating paragraph (b)(5) as paragraph (b)(4), effective Jan. 22, 2008.
Unless otherwise prescribed in an applicable Standard Requirement or in the filed Outline of Production, an inactivated bacterial product shall meet the applicable requirements in this section.
(a)
(2) Each lot of Master Seed Bacteria shall be tested for the presence of extraneous viable bacteria and fungi in accordance with the test provided in § 113.27(d).
(b)
(1) The product contains material which is inherently lethal for mice. In such instances, the guinea pig safety test provided in § 113.38 shall be conducted in place of the mouse safety test.
(2) The product is recommended for poultry. In such instances, the product shall be safety tested in poultry as defined in the specific Standard Requirement or Outline of Production for the product.
(3) The product is recommended for fish, other aquatic species, or reptiles. In such instances, the product shall be safety tested in fish, other aquatic species, or reptiles as required by specific Standard Requirement or Outline of Production for the product.
(c)
(1) Cultural characteristics,
(2) Staining reaction,
(3) Biochemical reactivity,
(4) Fluorescent antibody tests,
(5) Serologic tests,
(6) Toxin typing,
(7) Somatic or flagellar antigen characterization, and
(8) Restriction endonuclease analysis.
(d)
(e) Only serials tested for viricidal activity in accordance with the test provided in § 113.35 and found satisfactory by such test shall be packaged as
(f) If formaldehyde is used as the inactivating agent, and the serial has not been found satisfactory by the viricidal activity test, bulk or final container samples of completed product from each serial must be tested for residual free formaldehyde content using the ferric chloride test.
(1) The residual free formaldehyde content of biological products containing clostridial antigens must not exceed 1.85 grams per liter (g/L).
(2) The residual free formaldehyde content of bacterins, bacterin-toxoids, and toxoids, other than those containing clostridial antigens, must not exceed 0.74 grams per liter (g/L).
Leptospira Pomona Bacterin shall be produced from a culture of
(a)
(b)
(c)
(1)
(2)
(3)
(4)
(5) If three or four vaccinates die in the first stage, the second stage shall be conducted in a manner identical to the first stage.
(6) If the second stage is used, each serial shall be evaluated according to the second part of the table. On the basis of cumulative results, each serial shall either pass or fail.
Leptospira Icterohaemorrhagiae Bacterin shall be produced from a culture of
(a)
(b)
(c)
(1)
(2)
(3)
(4)
(5) If three or four vaccinates die in the first stage, the second stage shall be used. The second stage shall be conducted in a manner identical to the first stage.
(6) If the second stage is used, each serial shall be evaluated according to the second part of the table. On the basis of cumulative results, each serial shall either pass or fail.
Leptospira Canicola Bacterin shall be produced from a culture of
(a)
(b)
(c)
(1)
(2)
(3)
(4)
(5) If three or four vaccinates die in the first stage, the second stage shall be used. The second stage shall be conducted in a manner identical to the first stage.
(6) If the second stage is used, each serial shall be evaluated according to the second part of the table. On the basis of cumulative results, each serial shall either pass or fail.
Leptospira Grippotyphosa Bacterin shall be produced from a culture of
(a)
(b)
(c)
(1)
(2)
(3)
(4)
(5) If three or four vaccinates die in the first stage, the second stage shall be conducted in a manner identical to the first stage.
(6) If the second stage is used, each serial shall be evaluated according to the second part of the table. On the basis of cumulative results, each serial shall either pass or fail.
Leptospira Hardjo Bacterin shall be produced from a culture of
(a)
(b)
(c)
Clostridium Chauvoei Bacterin shall be produced from a culture of
(a)
(b)
(c)
(1) Each of at least 8 but not more than 10 guinea pigs, each weighing 300 to 500 grams, shall be injected subcutaneously with a guinea pig dose. A second guinea pig dose shall be injected 21 to 23 days after the first dose. Each guinea pig dose shall be one-fifth of the dose recommended on the label for a calf.
(2)
(3) For a valid test, at least 80 percent of the controls shall die within the 3 day post-challenge observation period. If this requirement is met, the results of the potency test shall be evaluated according to the following table:
Clostridium Haemolyticum Bacterin shall be produced from a culture of
(a)
(b)
(c)
(1) Each of at least 8 but not more than 10 guinea pigs, each weighing 300 to 500 grams, shall be injected subcutaneously with a guinea pig dose. A second guinea pig dose shall be injected 21 to 23 days after the first dose. Each guinea pig dose shall be one-fifth of the dose recommended on the label for a calf.
(2)
(3) For a valid test, at least 80 percent of the controls shall die within the 3 day post-challenge observation period. If this requirement is met, the results of the potency test shall be evaluated according to the following table:
Clostridium Novyi Bacterin-Toxoid shall be produced from a culture of
(a)
(b)
(c)
(1) When used in this test, the following words and terms shall mean:
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(2) Each of at least eight rabbits of a strain acceptable to the Animal and Plant Health Inspection Service, each weighing 4-8 pounds, shall be injected subcutaneously with not more than half of the recommended cattle dose.
(3) Fourteen to seventeen days after the second dose, all surviving rabbits shall be bled, and the serum tested for antitoxin content.
(i) At least seven rabbits are required to make an acceptable serum pool.
(ii) Equal quantities of serum from each rabbit shall be combined and tested as a single pooled serum.
(iii) If less than seven rabbits are available, the test is invalid and shall be repeated:
(4) The antitoxin content of the rabbit serums shall be determined by the serum neutralization test as follows:
(i) Make a dilution of Standard Antitoxin to contain 0.1 International Unit of antitoxin per ml.
(ii) Make a dilution of Standard Toxin in which 0.1 Lo dose is contained in a volume of 1 ml or less. Make a second dilution of Standard Toxin in which 0.1 L+ dose is contained in a volume of 1 ml or less.
(iii) Combine 0.1 International Unit of Standard Antitoxin with 0.1 Lo dose of diluted Standard Toxin and combine 0.1 International Unit of Standard Antitoxin with 0.1 L+ dose of diluted Standard Toxin. Each mixture is adjusted to a final volume of 2.0 ml with diluent.
(iv) Combine 0.1 Lo dose of diluted Standard Toxin with a 0.2 ml volume of undiluted serum. The mixture is adjusted to a final volume of 2.0 ml with diluent.
(v) Neutralize all toxin-antitoxin mixtures at room temperature for 1 hour and hold in ice water until injections of mice can be made.
(vi) Five Swiss white mice, each weighing 16-20 grams, shall be used for each toxin-antitoxin mixture. A dose of 0.2 ml shall be injected intravenously into each mouse. Conclude the test 72 hours post injection and record all deaths.
(5) Test Interpretation shall be as follows:
(i) If any mice inoculated with the mixture of 0.1 International Unit of Standard Antitoxin and 0.1 Lo doses of Standard Toxin die, the results of the serum neutralization test are inconclusive and shall be repeated:
(ii) If less than 80 percent of the mice inoculated with the mixture of 0.1 International Unit of Standard Antitoxin and 0.1 L+ doses of Standard Toxin die, the results of the serum neutralization test are inconclusive and shall be repeated:
(iii) If any mice inoculated with the mixture of 0.2 ml undiluted serum with 0.1 Lo dose of Standard Toxin die, the serum is considered to contain less than 0.50 International Units per ml.
(iv) If the single pooled serum from seven or more rabbits contains less than 0.5 International Unit per ml, the serial is unsatisfactory.
Clostridium Sordellii Bacterin-Toxoid shall be produced from a culture of
(a)
(b)
(c)
(1) When used in this test, the following words and terms shall mean:
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(2) Each of at least eight rabbits of a strain acceptable to the Animal and Plant Health Inspection Service, each weighing 4-8 pounds, shall be injected subcutaneously with not more than half of the recommended cattle dose:
(3) Fourteen to seventeen days after the second dose, all surviving rabbits shall be bled, and the serum tested for antitoxin content.
(i) At least seven rabbits are required to make an acceptable serum pool.
(ii) Equal quantities of serum from each rabbit shall be combined and tested as a single pooled serum.
(iii) If less than seven rabbits are available, the test is invalid and shall be repeated:
(4) The antitoxin content of the rabbit serums shall be determined by the serum neutralization test as follows:
(i) Make a dilution of Standard Antitoxin to contain 1.0 international unit of antitoxin per ml.
(ii) Make a dilution of Standard Toxin in which 1.0 Lo dose is contained in a volume of 1 ml or less. Make a second dilution of Standard Toxin in which 1.0 L+ dose is contained in a volume of 1 ml or less.
(iii) Combine 1.0 International Unit Standard Antitoxin with 1.0 Lo dose of diluted Standard Toxin and combine 1.0 International Unit of Standard Antitoxin with 1.0 L+ dose of diluted Standard Toxin. Each mixture is adjusted to a final volume of 2.0 ml with diluent.
(iv) Combine 1.0 Lo dose of diluted Standard Toxin with a 1.0 ml volume of undiluted serum. This mixture is adjusted to a final volume of 2.0 ml with diluent.
(v) Neutralize all toxin-antitoxin mixtures at room temperature for 1 hour and hold in ice water until injections of mice can be made.
(vi) Five Swiss white mice, each weighing 16-20 grams, shall be used for each toxin-antitoxin mixture. A dose of 0.2 ml shall be injected intravenously into each mouse. Conclude the test 72 hours post injection and record all deaths.
(5) Test Interpretation shall be as follows:
(i) If any mice inoculated with the mixture of 1.0 International Unit of Standard Antitoxin and 1.0 Lo doses of Standard Toxin die, the results of the serum neutralization test are inconclusive and shall be repeated:
(ii) If less than 80 percent of the mice inoculated with the mixture of 1.0 International Unit of Standard Antitoxin and 1.0 L+ doses of Standard Toxin die, the results of the serum neutralization test are inconclusive and shall be repeated:
(iii) If any mice inoculated with the mixture of 1.0 ml undiluted serum with 1.0 Lo dose of Standard Toxin die, the serum is considered to contain less than 1.0 International Units per ml.
(iv) If the single pooled serum from seven or more rabbits contains less than 1.0 International Unit per ml, the serial is unsatisfactory.
Clostridium Botulinum Type C Bacterin-Toxoid shall be produced from a culture of
(a)
(b)
(c)
(1) Each of the vaccinates shall be injected subcutaneously with the dose recommended on the label for mink. Twenty-one to twenty-eight days post-injection, the vaccinates and the controls shall be challenged intraperitoneally with botulinum Type C toxin which has been titrated in mice to provide for a 10
(2) The vaccinates and controls shall be observed for 7 days post-challenge and signs of botulism and deaths noted. For a valid test, the controls shall die of botulism. If the test is valid and 80 percent of the vaccinates do not remain free of botulism, the serial is unsatisfactory.
Clostridium Perfringens Type C Toxoid and Clostridium Perfringens Type C Bacterin-Toxoid shall be produced from a culture of
(a)
(b)
(c)
(1) When used in this test, the following words and terms shall mean:
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(2) Each of at least eight rabbits of a strain acceptable to APHIS, each weighing 4-8 pounds, shall be injected subcutaneously with not more than half of the largest recommended dose for any species indicated on the product label. A second equivalent dose shall be given not less than 20 days nor more than 23 days after the first does.
(3) Fourteen to seventeen days after the second dose, all surviving rabbits shall be bled and the serum tested for antitoxin content.
(i) At least seven rabbits are required to make an acceptable serum pool.
(ii) Equal quantities of serum from each rabbit shall be combined and tested as a single pooled serum.
(iii) If less than seven rabbits are available, the test is invalid and shall be repeated:
(4) The antitoxin content of the rabbit serums shall be determined as follows:
(i) Make a dilution of Standard Antitoxin to contain 10 International Units of antitoxin per ml.
(ii) Make one dilution of Standard Toxin to contain 10 L
(iii) Combine 10 International Units of Standard Antitoxin with 10 L
(iv) Combine 1 ml of undiluted serum with 10 L
(v) Neutralize all toxin-antitoxin mixtures at room temperature for 1 hour and hold in ice water until injections of mice can be made.
(vi) Five Swiss white mice, each weighing 16-20 grams, shall be used for each toxin-antitoxin mixture. A dose of 0.2 ml shall be injected intravenously into each mouse. Conclude the test 24 hours post-injection and record all deaths.
(5) Test Interpretation shall be as follows:
(i) If any mice inoculated with the mixture of 10 International Units of Standard Antitoxin and 10 L
(ii) If less than 80 percent of the mice inoculated with mixture of 10 International Units of Standard Antitoxin and 10 L
(iii) If any mice inoculated with the mixture of serum with 10 L
Clostridium Perfringens Type D Toxoid and Clostridium Perfringens Type D Bacterin-Toxoid shall be produced from a culture of
(a)
(b)
(c)
(1) When used in this test, the following words and terms shall mean:
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(2) Each of at least eight rabbits of a strain acceptable to APHIS, each weighing 4-8 pounds, shall be injected subcutaneously with not more than half of the largest recommended dose for any species indicated on the product label. A second equivalent dose shall be given not less than 20 days nor more than 23 days after the first dose.
(3) Fourteen to seventeen days after the second dose, all surviving rabbits shall be bled, and the serum tested for antitoxin content.
(i) At least seven rabbits are required to make an acceptable serum pool.
(ii) Equal quantities of serum from each rabbit shall be combined and tested as a single pooled serum.
(iii) If less than seven rabbits are available, the test is invalid and shall be repeated:
(4) The antitoxin content of the rabbit serums shall be determined as follows:
(i) Make a dilution of Standard Antitoxin to contain 1 International Unit of antitoxin per ml.
(ii) Make one dilution of Standard Toxin to contain 10 L
(iii) Combine 1 International Unit of Standard Antitoxin with 10 L
(iv) Dilute 1 ml of serum with 1 ml of diluent (1:2) and combine 1 ml of this solution with 10 L
(v) Neutralize all toxin-antitoxin mixtures at room temperature for 1 hour and hold in ice water until injections of mice can be made.
(vi) Five Swiss white mice, each weighing 16-20 grams, shall be used for each toxin-antitoxin mixture. A dose of 0.2 ml shall be injected intravenously into each mouse. Conclude the test 24 hours post-injection and record all deaths.
(5) Test Interpretation shall be as follows:
(i) If any mice inoculated with the mixture of 1 International Unit of Standard Antitoxin and 10 L
(ii) If less than 80 percent of the mice inoculated with mixture of 1 International Unit of Standard Antitoxin and 10 L
(iii) If any mice inoculated with the mixture of serum with 10 L
Autogenous biologics shall be prepared from cultures of microorganisms which have been inactivated and are nontoxic. Such products shall be prepared only for use by or under the direction of a veterinarian under a veterinarian-client-patient relationship,
Each serial of an autogenous biologic shall meet the requirements in this section, and if found unsatisfactory by any prescribed test shall not be used.
(a)
(1) More than one microorganism isolated from the same herd may be used as seed.
(2) Under normal circumstances, microorganisms from one herd must not be used to prepare an autogenous biologic for another herd. The Administrator, however, may authorize preparation of an autogenous biologic for use in herds adjacent to the herd of origin, when adjacent herds are considered to be at risk. To request authorization to prepare a product for use in herds adjacent to the herd of origin, the establishment seeking authorization must submit to the Administrator (in c/o the Director, Center for Veterinary Biologics, Inspection and Compliance, 510 South 17th Street, Suite 104, Ames, IA 50010-8197) the following information. (If any of the data are unavailable, the applicant for authorization should indicate that such data are unavailable and why.)
(i) Name, address, and phone number of the owner of the herd of origin.
(ii) Attending veterinarian's name, address, and phone number.
(iii) Animal species and number in herd of origin.
(iv) Identification of microorganism(s), at least to genus.
(v) Diagnosis or clinical signs of the disease observed.
(vi) Name and address of the person who isolated the microorganism(s) and the date of isolation.
(vii) Number of doses of autogenous biologic requested and vaccination schedule.
(viii) Each adjacent herd owner's name, address, and phone number.
(ix) Number of animals and species in each adjacent herd.
(x) The attending veterinarian's or approved specialist's assessment of the involvement of the adjacent herd(s) with the disease observed.
(3) The Administrator may authorize preparation of an autogenous biologic for use in herds which are not adjacent to the herd of origin, but which he or she considers to be at risk of infection with the same microorganism(s). Except as provided below, the same information which is required for preparation of such product for use in herds adjacent to the herd of origin must be submitted to the Administrator (in c/o the Director, Center for Veterinary
(i) Names and addresses of practitioners in the area in place of the name, address, and phone number of the adjacent herd owner.
(ii) The geographic designations of the area involved.
(iii) A summary of the epidemiology of the disease situation that links the designated geographic areas with the herd of origin.
(4) Under normal circumstances, microorganism(s) used for the production of autogenous biologics may not be older than 15 months from the date of isolation, or 12 months from the date of harvest of the first serial of product produced from the microorganism(s), whichever comes first. The Administrator, however, may authorize production of additional serials from microorganism(s) older than the above stated time periods,
(i) The attending veterinarian's or approved specialist's current assessment of the continued involvement of a herd with the originally isolated microorganism(s), including a summary of the diagnostic work that has been done to support this assessment.
(ii) Evidence of satisfactory protection from the previous use of the autogenous biologic produced from the microorganisms involved.
(iii) Any other information the Administrator may require in order to determine the need to use the microorganism to make additional serials.
(b)
(1) Microorganisms used to prepare autogenous biologics shall not be maintained in the licensed establishment beyond the time authorized for use in production.
(2) The expiration date of the autogenous biologic shall not exceed 18 months from the date of harvest.
(c)
(i) When the number of final containers in a serial or subserial is 50 or less, two final container samples from each serial and subserial shall be tested as prescribed in § 113.26(b):
(ii) Serials which are satisfactory after the third day of observation of purity test cultures and of safety test animals may be released for shipment to the customer and the tests continued throughout the required period; and
(iii) Serials released on the basis of satisfactory results of third day observations shall be immediately recalled if evidence of contamination occurs in test cultures or if any of the test animals used to demonstrate product safety, sicken, or die during the observation period.
(iv) Test summaries must be submitted to the Administrator (in c/o the Director, Center for Veterinary Biologics, Inspection and Compliance, 510 South 17th Street, Suite 104, Ames, IA 50010-8197) on a quarterly basis by the 21st day of January, April, July, and October or more often as required by the Administrator.
(2) Each serial or subserial of autogenous bacterial product other than the first serial or subserial produced from an isolate shall meet the applicable general requirements prescribed in § 113.100 and the special requirements
(i)
(ii)
(iii)
(iv)
(A) Completed product shall be tested for antigenicity or immunogenicity in the species for which the product is recommended or in another animal species whose immunological response has been shown in the scientific literature to correlate with the response of the species for which the product is recommended. Such tests shall be conducted in accordance with a protocol developed by the licensee and approved by the Administrator and the results submitted to the Director, Center for Veterinary Biologics, Licensing and Policy Development, 510 South 17th Street, Suite 104, Ames, IA 50010-8197 for review. Microorganisms not shown to be antigenic (that is, not shown to induce a significant serological response) or immunogenic by such approved tests shall not be used for the preparation of such product.
(B) Bulk or final container samples of completed product from each serial of such autogenous biologics containing fractions for which standard requirement potency test procedures have been established shall be tested for potency in accordance with applicable standard requirement potency tests provided in 9 CFR part 113. If the culture of microorganisms used to produce such fractions is shown to be of a different strain or serotype than the reagent or challenge microorganisms used in the standard requirement potency test, reagents or challenges of the same strain or serotype as the microorganism used for production may be used.
(C) If no standard requirement potency test procedures have been established for a fraction(s) in the autogenous biologic, such fraction(s) of each serial of product shall be tested for potency using a developmental potency test described in the filed outline of production or shall at least be standardized to contain an antigenic mass for such fraction(s) that has been shown to be antigenic or immunogenic in accordance with paragraph (c)(2)(iv)(A) of this section.
Tetanus Toxoid shall be produced from a culture of
(a)
(b)
(c)
(1) Six weeks after injection, all surviving guinea pigs shall be bled and equal portions of serum, but not less than 0.5 ml from each, shall be pooled. For a valid test, the pool shall contain the serum from at least eight animals.
(2) The antitoxin titer of the pooled serum shall be determined in antitoxin units (A.U.) per ml using an enzyme-linked immunosorbent assay method acceptable to the Animal and Plant Health Inspection Service.
(3) If the antitoxin titer of the serum pool is at least 2.0 A.U. per ml, the serial is satisfactory. If the antitoxin titer of the serum pool is less than 2.0 A.U. per ml, the serial may be retested by the following procedure:
(4) For serials in which the serum pool contains less than 2.0 A.U. per ml, the individual serum that constituted the pool may be tested by the enzyme-linked immunosorbent assay. If at least 80 percent of the individual serums have an antitoxin titer of at least 2.0 A.U. per ml, the serial is satisfactory. If less than 80 percent of the individual serums have an antitoxin titer of at least 2.0 A.U. per ml, the serial may be retested in 10 guinea pigs using the procedure described in (c)(1) and (2) above. The antitoxin titer of the pooled serum from the guinea pigs used in the retest shall be averaged with the antitoxin level of the pooled serum from the initial test. If the average of the two pools is at least 2.0 A.U. per ml, the serial is satisfactory. If the average of the two pools is less than 2.0 A.U. per ml, the serial is unsatisfactory and shall not be retested further.
Staphylococcus Aureus Bacterin-Toxoid shall be prepared from toxoided broth cultures of selected toxogenic strains of
(a)
(b)
(c)
(1) Each rabbit shall be given a series of not more than three intramuscular injections at 7 day intervals (1.0 ml, 2.0 ml, 3.0 ml) and observed from 7-14 days following the third injection. At the end of the observation period, a blood sample shall be taken from each rabbit.
(2) The sample of serum from each rabbit, if the five rabbit individual test is conducted or a pooled sample of equal quantities of serum from the rabbits if the eight rabbit pooled serum test is conducted, shall be tested to determine the staphylococcus alpha antitoxin units per ml as provided in paragraphs (c)(3), (4), (5), (6), (7), and (8) of this section.
(3) Inactivate rabbit serum 56 °C for 30 minutes.
(4) Make serial twofold dilutions of the serum samples and conduct the test, using 1 ml of the serial dilutions. Appropriate controls should be included for accurate interpretations.
(5) Add 1 ml of the standardized toxin containing the established “Lh” dose. The “Lh” dose is the amount of toxin which when mixed with one unit of standard antitoxin produces a 50 percent hemolysis of rabbit red blood cells.
(6) Incubate toxin-antitoxin mixture at room temperature for 30 minutes and add 1 ml of a 1.5 percent suspension of washed freshly drawn rabbit red blood cells suspended in normal saline to each tube. Mix and incubate the combined product in a 37 °C water bath for 1 hour. Refrigerate at 5 °C overnight.
(7) Read the hemolysis produced and establish the 50 percent end point. The 50 percent end point of hemolysis should be established by determining the size of the button produced by the unlysed red blood cells.
(8) Determine the units of antitoxin per 1 ml of serum.
(9) If the individual samples from four of the five rabbits in the individual serum test or the pooled samples from the eight rabbits in the pooled serum test do not contain three alpha antitoxin units per ml, the serial is unsatisfactory.
Pasteurella Multocida Bacterin, Avian Isolate, Type 4 shall be prepared from cultures of
(a)
(b)
(c)
(1)
(2)
(3)
(4)
(5) The serial shall pass or fail based on the stage one results of the potency test. However, the second stage may be conducted if seven or eight vaccinates die in stage one, but the serial is unsatisfactory if the second stage is not conducted.
(6) The second stage shall be conducted in a manner identical to the first stage. The serial shall be evaluated according to stage two of the table. On the basis of accumulated results from the data of both stage tests, a serial shall either pass or fail the second stage.
Pasteurella Multocida Bacterin, Avian Isolate, Type 1, shall be prepared from cultures of
(a)
(b)
(c)
(1)
(2)
(3)
(4)
(5) The serial shall pass or fail based on the stage one results of the potency test. However, the second stage may be conducted if seven or eight vaccinates die in stage one, but the serial is unsatisfactory if the second stage is not conducted.
(6) The second stage shall be conducted in a manner identical to the first stage. The serial shall be evaluated according to stage two of the table. On the basis of accumulated results from the data of both stage tests, a serial shall either pass or fail the second stage.
Pasteurella Multocida Bacterin, Avian Isolate, Type 3, shall be prepared from culture of
(a)
(b)
(c)
(1)
(2)
(3)
(4)
(5) The serial shall pass or fail based on the stage one results of the potency test. However, the second stage may be conducted if seven or eight vaccinates die in stage one, but the serial is unsatisfactory if the second stage is not conducted.
(6) The second stage shall be conducted in a manner identical to the first stage. The serial shall be evaluated according to stage two of the table. On the basis of accumulated results from the data of both stage tests, a serial shall either pass or fail the second stage.
Erysipelothrix Rhusiopathiae Bacterin shall be produced from a culture of
(a)
(b)
(c)
(1) The ability of the bacterin being tested (Unknown) to protect mice shall be compared with a Standard Reference Bacterin (Standard) which is either supplied by or acceptable to Animal and Plant Health Inspection Service.
(2) At least three threefold dilutions shall be made with the Standard and the same threefold dilutions shall be made for each Unknown. Dilutions shall be made with physiological saline solution.
(3) For each dilution of the Standard and each dilution of an Unknown, a group of at least 20 mice, each weighing 16 to 22 grams, shall be used. Each mouse in each group shall be injected subcutaneously with one mouse dose of the appropriate dilution.
(4) Each of 20 injected mice from each group shall be challenged subcutaneously 14 to 21 days after being injected. A dose containing at least 100 mouse LD
(5) Test for valid assay: At least two dilutions of the Standard shall protect more than 0 percent and two dilutions shall protect less than 100 percent of the mice injected. The lowest dilution of the Standard shall protect more than 50 percent of the mice. The highest dilution of the Standard shall protect less than 50 percent of the mice.
(6) The relative potency (RP) of the Unknown is determined by comparing the 50 percent endpoint dilution (highest bacterin dilution protecting 50 percent of the mice) of the Unknown with that of the standard by the following formula:
(7) If the RP of the Unknown is less than 0.6, the serial being tested is unsatisfactory.
(8) If the 50 percent endpoint of an Unknown in a valid test cannot be calculated because the lowest dilution does not exceed 50 percent protection, that serial may be retested in a manner identical to the initial test:
(9) If the 50 percent endpoint of an Unknown in a valid test cannot be calculated because the highest dilution exceeds 50 percent protection, the Unknown is satisfactory without additional testing.
(10) If the RP is less than 0.6, the serial may be retested by conducting two independent replicate tests in a manner identical to the initial test. The average of the RP values obtained in the retests shall be determined. If the average RP is less than 0.6, the serial is unsatisfactory without further testing. If the average RP obtained in the retests is equal to or greater than 0.6, the following shall apply:
(i) If the RP obtained in the original test is one-third or less than the average RP obtained in the retests, the initial RP may be considered a result of test system error and the serial is satisfactory for potency.
(ii) If the RP value obtained in the original test is more than one-third the average RP obtained in the retests, a new average shall be determined using the RP values obtained in all tests. If the new average is less than 0.6, the serial is unsatisfactory.
Salmonella Typhimurium Bacterin shall be prepared from a culture of
(a)
(b)
(c)
(1) The ability of the bacterin being tested (Unknown) to protect mice shall be compared with a Standard Reference Bacterin (Standard) which is either supplied by or acceptable to Animal and Plant Health Inspection Service.
(2) At least three tenfold dilutions shall be made with the Standard and the same tenfold dilutions shall be made for each Unknown. The dilutions shall be made in Phosphate Buffered Saline.
(3) For each dilution of the Standard and each dilution of an Unknown, a group of at least 20 mice, each weighing 16-22 grams, shall be used. Each mouse in a group shall be injected intraperitoneally with one mouse dose of the appropriate dilution. Each mouse shall be revaccinated on day 14, using the same schedule.
(4) Each of 20 vaccinated mice per group shall be challenged intraperitoneally 7-10 days after the second vaccination with a 0.25 ml dose containing 100-10,000 mouse LD
(5) Test for valid assay: At least two dilutions of the Standard shall protect more than 0 percent and two dilutions shall protect less than 100 percent of the mice injected. The lowest dilution of the Standard shall protect more than 50 percent of the mice. The highest dilution of the Standard shall protect less than 50 percent of the mice.
(6) The relative potency (RP) of the Unknown is determined by comparing the 50 percent endpoint dilution (highest bacterin dilution protecting 50 percent of the mice) of the Unknown with
(7) If the RP of the Unknown is less than 0.30, the serial being tested is unsatisfactory.
(8) If the 50 percent endpoint of an Unknown cannot be calculated because the lowest dilution does not exceed 50 percent protection, that serial may be retested in a manner identical to the initial test;
(9) If the 50 percent endpoint of an Unknown in a valid test cannot be calculated because the highest dilution exceeds 50 percent protection, the Unknown is satisfactory without additional testing.
(10) If the RP is less than the minimum required in paragraph (c)(7) of this section, the serial may be retested by conducting two independent replicate tests in a manner identical to the initial test. The average of the RP values obtained in the retests shall be determined. If the average RP is less than the required minimum, the serial is unsatisfactory. If the average RP obtained in the retests is equal to or greater than the required minimum, the following shall apply:
(i) If the RP obtained in the original test is one-third or less than the average RP obtained in the retests, the initial RP may be considered a result of test system error and the serial is satisfactory.
(ii) If the RP value obtained in the original test is more than one-third the average RP obtained in the retests, a new average shall be determined using the RP values obtained in all tests. If the new average is less than the minimum required in paragraph (c)(7) of this section, the serial is unsatisfactory.
Pasteurella Multocida Bacterin shall be prepared from a culture of
(a)
(b)
(c)
(1) The ability of the bacterin being tested (Unknown) to protect mice shall be compared with a Standard Reference Bacterin (Standard) which is either supplied by or acceptable to Animal and Plant Health Inspection Service.
(2) At least three fivefold dilutions shall be made with the Standard and the same fivefold dilutions shall be made for each Unknown. The dilutions will be made in Phosphate Buffered Saline.
(3) For each dilution of the Standard and each dilution of each Unknown, a group of at least 20 mice, each weighing 16-22 grams, shall be used. Each mouse in a group shall be injected intraperitoneally with one mouse dose of the appropriate dilution. Each
(4) Each of 20 injected mice per group shall be challenged intraperitoneally 10-12 days after the second vaccination with a 0.2 ml dose containing 100-10,000 mouse LD
(5) Test for valid assay: At least two dilutions of the Standard shall protect more than 0 percent and two dilutions shall protect less than 100 percent of the mice injected. The lowest dilution of the Standard shall protect more than 50 percent of the mice. The highest dilution of the Standard shall protect less than 50 percent of the mice.
(6) The relative potency (RP) of the Unknown is determined by comparing the 50 percent endpoint dilution (highest bacterin dilution protecting 50 percent of the mice) of the Unknown with that of the Standard by the following formula:
(7) If the RP of the Unknown is less than 0.50, the serial being tested is unsatisfactory.
(8) If the 50 percent endpoint of an Unknown cannot be calculated because the lowest dilution does not exceed 50 percent protection, that serial may be retested in a manner identical to the initial test:
(9) If the 50 percent endpoint of an Unknown in a valid test cannot be calculated because the highest dilution exceeds 50 percent protection, the Unknown is satisfactory without additional testing.
(10) If the RP is less than the minimum required in paragraph (c)(7) of this section, the serial may be retested by conducting two independent replicate tests in a manner identical to the initial test. The average of the RP values obtained in the retests shall be determined. If the average RP is less than the required minimum, the serial is unsatisfactory. If the average RP obtained in the retests is equal to or greater than the required minimum, the following shall apply:
(i) If the RP obtained in the original test is one-third or less than the average RP obtained in the retests, the initial RP may be considered a result of test system error and the serial is satisfactory.
(ii) If the RP value obtained in the original test is more than one-third the average RP obtained in the retests, a new average shall be determined using the RP values obtained in all tests. If the new average is less than the minimum required in paragraph (c)(7) of this section, the serial is unsatisfactory.
Salmonella Choleraesuis Bacterin shall be prepared from a culture of
(a)
(b)
(c)
(1) The ability of the bacterin being tested (Unknown) to protect mice shall be compared with a Standard Reference Bacterin (Standard) which is either supplied by or acceptable to Veterinary Services.
(2) At least three fivefold dilutions shall be made with the Standard and the same fivefold dilution shall be made for each Unknown. The dilutions shall be made in Phosphate-Buffered Saline.
(3) For each dilution of the Standard and each dilution of an Unknown, a group of at least 20 mice, each weighing 16 to 22 grams, shall be used. Each mouse in a group shall be injected intraperitoneally with one mouse dose of the appropriate dilution. Each mouse shall be revaccinated on day 14, using the same schedule.
(4) Each of 20 vaccinated mice per group shall be challenged intraperitoneally 7 to 10 days after the second vaccination with a 0.25 ml dose containing 10-1,000 mouse LD
(5) Test for valid assay: At least two dilutions of the Standard shall protect more than 0 percent and two dilutions shall protect less than 100 percent of the mice injected. The lowest dilution of the Standard shall protect more than 50 percent of the mice. The highest dilution of the Standard shall protect less than 50 percent of the mice.
(6) The relative potency (RP) of the Unknown is determined by comparing the 50 percent endpoint dilution (highest bacterin dilution protecting 50 percent of the mice) of the Unknown with that of the Standard by the following formula:
(7) If the RP of the Unknown is less than 0.50, the serial being tested is unsatisfactory.
(8) If the 50 percent endpoint of an Unknown cannot be calculated because the lowest dilution does not exceed 50 percent protection, that serial may be retested in a manner identical to the initial test;
(9) If the 50 percent endpoint of an Unknown in a valid test cannot be calculated because the highest dilution exceeds 50 percent protection, the Unknown is satisfactory without additional testing.
(10) If the RP is less than the minimum required in paragraph (c)(7) of this section, the serial may be retested by conducting two independent replicate tests in a manner identical to the initial test. The average of the RP values obtained in the retests shall be determined. If the average RP is less than the required minimum, the serial is unsatisfactory. If the average RP obtained in the retests is equal to or greater than the required minimum, the following shall apply:
(i) If the RP obtained in the original test is one-third or less than the average RP obtained in the retests, the initial RP may be considered a result of test system error and the serial is satisfactory.
(ii) If the RP value obtained in the original test is more than one-third the average RP obtained in the retests, a new average shall be determined using the RP values obtained in all tests. If the new average is less than the minimum required in paragraph (c)(7) of
Salmonella Dublin Bacterin shall be prepared from a culture of
(a)
(b)
(c)
(1) The ability of the bacterin being tested (Unknown) to protect mice shall be compared with a Standard Reference Bacterin (Standard) which is either supplied by or acceptable to Veterinary Services.
(2) At least three tenfold dilutions shall be made with the Standard and the same tenfold dilutions shall be made for each Unknown. The dilutions shall be made in Phosphate-Buffered Saline.
(3) For each dilution of the Standard and each dilution of an Unknown, a group of at least 20 mice, each weighing 16 to 22 grams, shall be used. Each mouse in a group shall be injected intraperitoneally with one mouse dose of the appropriate dilution. Each mouse shall be revaccinated on day 14, using the same schedule.
(4) Each of 20 vaccinated mice per group shall be challenged intraperitoneally 7 to 10 days after the second vaccination with a 0.25 ml dose containing 1,000-100,000 mouse LD
(5) Test for valid assay: At least two dilutions of the Standard shall protect more than 0 percent and two dilutions shall protect less than 100 percent of the mice injected. The lowest dilution of the Standard shall protect more than 50 percent of the mice. The highest dilution of the Standard shall protect less than 50 percent of the mice.
(6) The relative potency (RP) of the Unknown is determined by comparing the 50 percent endpoint dilution (highest bacterin dilution protecting 50 percent of the mice) of the Unknown with that of the Standard by the following formula:
(7) If the RP of the Unknown is less than 0.30, the serial being tested is unsatisfactory.
(8) If the 50 percent endpoint of an Unknown cannot be calculated because the lowest dilution does not exceed 50 percent protection, that serial may be retested in a manner identical to the initial test;
(9) If the 50 percent endpoint of an Unknown in a valid test cannot be calculated because the highest dilution exceeds 50 percent protection, the Unknown is satisfactory without additional testing.
(10) If the RP is less than the minimum required in paragraph (c)(7) of this section, the serial may be retested by conducting two independent replicate tests in a manner identical to the initial test. The average of the RP
(i) If the RP obtained in the original test is one-third or less than the average RP obtained in the retests, the initial RP may be considered a result of test system error and the serial is satisfactory.
(ii) If the RP value obtained in the original test is more than one-third the average RP obtained in the retests, a new average shall be determined using the RP values obtained in all tests. If the new average is less than the minimum required in paragraph (c)(7) of this section, the serial is unsatisfactory.
When prescribed in an applicable Standard Requirement or in the filed Outline of Production, a killed virus vaccine shall meet the applicable requirements in this section.
(a)
(b)
(c)
(2)
(i)
(ii)
(iii)
(3)
(4)
(d)
(e)
(f)
Canine Distemper Vaccine, Killed Virus, shall be prepared from virus-bearing cell culture fluids. Only Master
(a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.200.
(b) The immunogenicity of vaccine prepared from the Master Seed Virus in accordance with the Outline of Production shall be established. Vaccine used for this test shall be at the highest passage from the Master Seed and prepared at the minimum preinactivation titer specified in the Outline of Production.
(1) Twenty-five canine distemper susceptible dogs (20 vaccinates and 5 controls) shall be used as test animals. Blood samples drawn from each dog shall be individually tested for neutralizing antibody against canine distemper to determine susceptibility. A constant virus-varying serum neutralization test in cell culture using 50 to 300 TCID
(i) The 20 dogs used as vaccinates shall be injected with one dose of vaccine by the method recommended on the label. If a second dose is recommended, the second dose shall be administered at the time specified on the label.
(ii) At least 14 days after the last inoculation, the vaccinates and controls shall each be challenged intracerebrally with canine distemper virus furnished or approved by the Animal and Plant Health Inspection Service and observed each day for 21 days.
(iii) If at least four of the five controls do not die and the survivor, if any, does not show clinical signs of canine distemper, the test is inconclusive and may be repeated.
(iv) If at least 19 of the 20 vaccinated do not survive without showing clinical signs of canine distemper during the observation period, the Master Seed Virus is unsatisfactory.
(c)
(1)
(2)
(i) A constant virus-varying serum neutralization test in tissue culture using 50 to 300 TCID
(ii)
(iii)
(iv)
(v)
(vi)
Canine Hepatitis and Canine Adenovirus Type 2 Vaccine, Killed Virus, shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.200.
(b) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity by one or both of the following methods. Vaccine used for these tests shall be at the highest passage from the Master Seed and prepared at the minimum preinactivation titer specified in the Outline of Production.
(1)
(i) The 20 dogs to be used as vaccinates shall be injected with one dose of vaccine and the remaining five dogs held as controls. If a second dose is recommended, the second dose shall be administered at the time specified on the label.
(ii) Not less than 14 days after the last inoculation, each vaccinate and control shall be challenged intravenously with virulent infectious canine hepatitis virus furnished or approved by the Animal and Plant Health Inspection Service and observed each day for 14 days.
(iii) If at least four of the five controls do not show severe clinical signs of infectious canine hepatitis, the test is inconclusive and may be repeated.
(iv) If at least 19 of the 20 vaccinates do not survive without showing clinical signs of infectious canine hepatitis during the observation period, the Master Seed Virus is unsatisfactory.
(2)
(i) The 20 dogs to be used as vaccinates shall be injected with one dose of vaccine and the remaining 10 dogs held as controls. If a second dose is recommended, the second dose shall be administered at the time specified on the label.
(ii) Not less than 14 days after the last inoculation, the vaccinates and the controls shall be challenged by exposure to a nebulized aerosol of virulent canine adenovirus type 2 furnished or approved by the Animal and Plant Health Inspection Service and observed each day for 14 days postchallenge. The rectal temperature of each animal shall be taken and the presence of respiratory or other clinical signs of canine adenovirus type 2 noted and recorded each day.
(iii) If at least 6 of 10 controls do not show clinical signs of canine adenovirus type 2 infection other than fever, the test is inconclusive and may be repeated.
(iv) If a significant difference in clinical signs in a valid test cannot be demonstrated between vaccinates and controls using a scoring system approved by the Animal and Plant Health Inspection Service, the Master Seed Virus is unsatisfactory.
(c)
(1)
(2)
(i) A constant virus-varying serum neutralization test in tissue culture using 50 to 300 TCID
(ii)
(iii)
(iv)
(v)
(vi)
(3)
(i) A constant virus-varying serum neutralization test in tissue culture using 50 to 300 TCID
(ii)
(iii) Not less than 14 days after the last inoculation, the vaccinates and the controls shall be challenged by exposure to a nebulized aerosol of virulent canine adenovirus type 2 furnished or approved by the Animal and Plant Health Inspection Service and observed each day for 14 days postchallenge. The rectal temperature of each animal shall be taken and the presence of respiratory or other clinical signs of canine adenovirus type 2 noted and recorded each day.
(iv) If at least two of three controls do not show clinical signs of canine adenovirus type 2 other than fever, the test is inconclusive and may be repeated.
(v) If a significant difference in clinical signs cannot be demonstrated between vaccinates and controls using a scoring system approved by the Animal and Plant Health Inspection Service and prescribed in the Outline of Production, the serial is unsatisfactory.
Feline Panleukopenia Vaccine, Killed Virus, shall be prepared from virus-bearing cell culture fluids. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed. The Master Seed shall meet the applicable requirements prescribed in § 113.200. Each serial shall meet the applicable general requirements prescribed in § 113.200 and the special requirements for safety and potency provided in this section.
(a)
(b)
(1) A constant virus-varying serum neutralization test in tissue culture using 100 to 300 TCID
(2)
(3)
(4)
(ii) If at least 3 of the 4 vaccinates in a valid test have not developed titers based upon final serum dilution of at least 1:8, and the remaining vaccinate has not developed a titer of at least 1:4, the serial is unsatisfactory except as provided in paragraphs (b)(5) and (6) of this section.
(5)
(6)
Mink Enteritis Vaccine, Killed Virus, shall be prepared from virus-bearing cell culture fluids or tissues obtained from mink that have developed mink enteritis following inoculation with virulent mink enteritis virus. Each serial shall meet the applicable requirements prescribed in § 113.200 and special requirements prescribed in this section. Any serial found unsatisfactory by a prescribed test shall not be released.
(a)
(b)
(1)
(2)
(3)
Newcastle Disease Vaccine (Killed Virus) shall be prepared from virus-bearing tissues or fluids obtained from embryonated chicken eggs or cell cultures. With the exception of § 113.200(c)(2)(iii), each serial shall meet the applicable general requirements prescribed in § 113.200 and special requirements prescribed in this section. A serial found unsatisfactory by a prescribed test shall not be released.
(a)
(b)
(1) Ten or more chickens shall be vaccinated as recommended on the label
(2) After at least 14 days post-vaccination, the vaccinates and at least 10 unvaccinated chickens that have been kept isolated as controls shall be challenged with a virulent strain of Newcastle disease virus supplied by or approved by Veterinary Services and the vaccinates observed each day for 14 days.
(3) If at least 90 percent of the controls do not show typical signs of Newcastle disease or die, the test is inconclusive and may be repeated. If at least 90 percent of the vaccinates do not remain normal, the serial is unsatisfactory.
Wart Vaccine, Killed Virus, shall be prepared from virus-bearing epidermal tumors (warts) obtained from a bovine. Each serial shall meet the requirements prescribed in this section and any serial found unsatisfactory by a prescribed test shall not be released.
(a)
(b)
(c)
(d)
(1) The vaccine shall be a tissue extract representing at least 10 percent weight to volume suspension of wart tissue; and
(2) The vaccine shall be limited to use in the prevention of warts in cattle. Labeling recommendations shall be in accordance with § 112.7(i).
Encephalomyelitis Vaccine, Eastern, Western, and Venezuelan, Killed Virus, shall be prepared from virus-bearing cell culture fluids. Each serial or subserial shall meet the requirements prescribed in this section and the general requirements prescribed in § 113.200, except those in § 113.200(d). Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(a)
(1) Each of at least ten 6 to 12 hour old chickens shall be injected subcutaneously with 0.5 ml of the product and the chickens observed each day for 10 days.
(2) If unfavorable reactions attributable to the product occur in the chickens during the observation period, the serial is unsatisfactory. If unfavorable reactions not attributable to the product occur, the test is inconclusive and may be repeated:
(b)
(1) For this test, a guinea pig dose shall be one-half the amount recommended on the label for a horse and shall be administered as recommended for a horse. Each of 10 healthy guinea pigs (vaccinates) shall be injected with two guinea pig doses with an interval
(2) Fourteen to 21 days after the second injection, serum samples from each vaccinate and each control shall be tested by a plaque reduction, serum neutralization test using Vero 76 cells.
(3) If the control serum samples show a titer of 1:4 or greater for any fraction, the test is inconclusive for that fraction and may be repeated:
(4) If two or three of the vaccinate serum samples show a titer of less than 1:40 for the Eastern type fraction, less than 1:40 for the Western type fraction, or less than 1:4 for the Venezuelan type fraction, the second stage of the test may be used for the relevant fraction(s):
(5) If the second stage is used and four or more of the vaccinate serum samples show a titer of less than 1:40 for the Eastern type fraction or the Western type fraction, or less than 1:4 for the Venezuelan type fraction, the serial or subserial is unsatisfactory.
(6) The results shall be evaluated according to the following table:
Avian Encephalomyelitis Vaccine (Killed Virus) shall be prepared from virus-bearing tissues or fluids obtained from embryonated chicken eggs. Each serial shall meet the general requirements prescribed in § 113.200 and the requirements prescribed in this section. Any serial found unsatisfactory by a prescribed test shall not be released.
(a)
(2) An inactivation test for viable avian encephalomyelitis (AE) virus shall be conducted on each serial. The test shall be conducted using susceptible chicken embryos:
(i)
(ii)
(b)
(1) At least 28 days post-injection, the vaccinates and the controls shall be challenged intramuscularly with a virulent AE virus and the chickens observed each day for 21 days.
(2) If at least 80 percent of the controls do not show clinical signs of or die from AE infection, the test is inconclusive and may be repeated.
(3) If at least 80 percent of the vaccinates do not remain normal, the serial is unsatisfactory.
Rabies Vaccine (Killed Virus) shall be prepared from virus-bearing cell cultures or nerve tissues obtained from animals that have developed rabies infection following injection with rabies virus. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.200 and the requirements prescribed in this section.
(1) Each lot of Master Seed Virus propagated in tissue or cells of avian origin shall also be tested for extraneous pathogens by procedures prescribed in § 113.37.
(2) Each lot of Master Seed Virus propagated in primary cell cultures of mouse or hamster origin or brain tissues of mouse origin shall be tested for lymphocytic choriomeningitis (LCM) virus by the procedure prescribed in § 113.42. If LCM virus is detected, the Master Seed Virus is unsatisfactory.
(b) The immunogenicity of vaccine prepared with virus at the highest passage from the Master Seed shall be established in each species for which the vaccine is recommended. Tests shall be conducted in accordance with a protocol filed with Animal and Plant Health Inspection Service before initiation of the tests. The vaccine shall be prepared using methods prescribed in the Outline of Production. If Rabies Vaccine is to be in combination with other fractions, the product to be tested shall include all fractions to be tested.
(1) The preinactivation virus titer must be established as soon as possible after harvest by at least five separate virus titrations. A mean relative potency value of the vaccine to be used in the host animal potency test must be established by at least five replicate potency tests conducted in accordance with the standard NIH test for potency in chapter 37 of “Laboratory Techniques in Rabies,” Fourth Edition (1996), edited by F.X. Meslin, M.M. Kaplan, and H. Koprowski, World Health Organization, Geneva, Switzerland (ISBN 92 4 154479 1). The provisions of chapter 37 of “Laboratory Techniques in Rabies,” Fourth Edition (1996), are the minimum standards for achieving compliance with this section and are incorporated by reference. These provisions state that the challenge virus standard to be used as the challenge in the NIH test and the reference vaccine for the test are available from the national control authority. In the United States, that authority is the Animal and Plant Health Inspection Service's Center for Veterinary Biologics Laboratory, located at 1800 Dayton Avenue, P.O. Box 844, Ames, IA 50010; phone (515) 239-8331; fax (515) 239-8673. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the World Health Organization Publications Center USA, 49 Sheridan Avenue, Albany, NY 12210. Copies may be inspected at the Animal and Plant Health Inspection Service, Center for Veterinary
(2) The dose of vaccine to be used in the immunogenicity test shall be no more than the amount which, on the basis of The NIH Test For Potency, has been diluted to the proposed minimum acceptable potency value.
(3) Test animals shall be uniform and have no neutralizing antibodies to rabies as determined by serum-neutralization (SN) tests.
(i) Twenty-five or more animals shall be used as vaccinates. Each shall be administered a dose of vaccine at the proposed minimum potency level and by the method specified in the Outline of Production.
(ii) Ten or more additional animals shall be held as controls.
(iii) On or about 30, 90, 180, 270, and 365 days postvaccination, all test animals shall be bled and individual serum samples tested for neutralizing antibodies to rabies virus.
(iv) All surviving test animals shall be challenged intramuscularly with virulent rabies virus furnished or approved by Animal and Plant Health Inspection Service 1 year after vaccinations, except as provided in (b)(4) of this section. The challenged animals shall be observed each day for 90 days as prescribed in § 113.5(b). The brain of each test animal that dies following challenges shall be examined for rabies by the fluorescent antibody test or other method acceptable to Animal and Plant Health Inspection Service.
(v) Requirements for acceptance in challenge tests shall be death due to rabies in at least 80 percent of the controls while at least 22 of 25 or 26 of 30 or a statistically equivalent number of the vaccinates remain well for a period of 90 days.
(4) An alternative to challenging all surviving test animals in accordance with paragraph (b)(3)(iv) of this section may be used when the test animals are of species other than carnivores. Vaccinates shall be challenged at 1 year postvaccination. These shall include five vaccinates with the lowest SN titers at the 270th-day bleeding, five vaccinates with the lowest SN titers at the 365th-day bleeding, and all vaccinates with SN titers below 1:10 by the mouse SN test or below 1:16 by the rapid-fluorescent-focus-inhibition test at any bleeding. At least five SN-negative controls of each species shall be challenged at the same time as the vaccinates. All SN titers shall be titrated to an endpoint. All of the challenged vaccinates must remain well for a period of 90 days, and at least 80 percent of the controls must die of rabies for a satisfactory test without further challenge. If one or more of the vaccinates die from rabies, all the remaining vaccines, regardless of titer, along with the five controls shall be challenged. The cumulative results from the two challenges shall be evaluated for acceptance as specified in paragraph (b)(3)(v) of this section.
(5) An Outline of Production change shall be made before authority for use a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(c) If more than 1 year duration of immunity is to be claimed, a duration of immunity test for the additional time shall be conducted and interpreted as prescribed in paragraph (b) of this section for the 1 year test. The test animals shall be monitored serologically at least every 180 days. The time of challenge may be adjusted accordingly.
(d) Test requirements for release: Each serial and each subserial shall meet the general requirements prescribed in § 113.200 and special requirements in this paragraph.
(1)
(2)
(i) At the end of the inactivation period, each of 20 12 to 16 gram mice shall be injected intracerebrally with 0.03 ml and two rabbits shall be injected into each cerebral hemisphere with 0.25 ml and observed each day for 21 days. The brains of animals dying between the fourth and 21st day post-injection shall be checked for rabies virus. Material from each brain recovered shall be injected into each of five mice and the mice observed each day for 14 days. The fluorescent antibody test or serum neutralization test shall be used to confirm the presence or absence or live rabies virus. If live rabies virus is confirmed, the serial is unsatisfactory unless reprocessed in accordance with § 114.18.
(ii) A test for safety in three young seronegative animals of the most susceptible species for which the vaccine is recommended shall be conducted. Each shall in injected intramuscularly with one recommended dose of vaccine. If unfavorable reactions attributable to the product occur during a 28 day observation period, the serial is unsatisfactory.
(3)
Feline Calicivirus Vaccine, Killed Virus, shall be prepared from virus-bearing cell culture fluids. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.200.
(b) The Master Seed shall be tested for chlamydial agents as prescribed in § 113.43.
(c) The immunogenicity of vaccine prepared from the Master Seed in accordance with the Outline of Production shall be established by a method acceptable to Animal and Plant Health Inspection Service. Vaccine used for this test shall be at the highest passage from the Master Seed and prepared at the minimum preinactivation titer specified in the Outline of Production.
(d)
(1)
(2)
(i) Eight feline calicivirus susceptible cats (five vaccinates and three controls) shall be used as test animals. Throat and nasal swabs shall be collected from each cat and individually tested on susceptible cell cultures for the presence of feline calicivirus. Blood samples shall be drawn and individual serum samples tested for neutralizing antibody. The cats shall be considered suitable for use if all swabs are negative for virus isolation and all serums are negative for calicivirus antibody at the 1:2 final dilution in a 50 percent plaque reduction test or other test of equal sensitivity.
(ii) The five cats used as vaccinates shall be administered one dose of vaccine by the method recommended on the label. If two doses are recommended, the second dose shall be given after the interval recommended on the label.
(iii) Fourteen or more days after the final dose of vaccine, the vaccinates and controls shall each be challenged intranasally with virulent feline calicivirus furnished or approved by Animal and Plant Health Inspection Service and observed each day for 14 days postchallenge. The rectal temperature of each animal shall be taken and the presence or absence of clinical signs, particularly lesions on the oral mucosa, noted and recorded each day.
(iv) If three of three controls do not show clinical signs of feline calicivirus infection other than fever, the test is inconclusive and may be repeated.
(v) If a significant difference in clinical signs cannot be demonstrated between vaccinates and controls using a scoring system approved by Animal and Plant Health Inspection Service and prescribed in the Outline of Production, the serial is unsatisfactory.
Feline Rhinotracheitis Vaccine, Killed Virus, shall be prepared from virus-bearing cell culture fluids. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.200.
(b) The Master Seed shall be tested for chlamydial agents as prescribed in § 113.43.
(c) The immunogenicity of vaccine prepared from the Master Seed in accordance with the Outline of Production shall be established by a method acceptable to Animal and Plant Health Inspection Service. Vaccine used for this test shall be at the highest passage from the Master Seed and prepared at the minimum preinactivation titer specified in the Outline of Production.
(d)
(1)
(2)
(i) Eight feline rhinotracheitis susceptible cats (five vaccinates and three controls) shall be used as test animals. Throat and nasal swabs shall be collected from each cat and individually tested on susceptible cell cultures for the presence of feline rhinotracheitis virus. Blood samples shall be drawn and individual serum samples tested for neutralizing antibody. The cats shall be considered suitable for use if all swabs are negative for virus isolation and all serums are negative for rhinotracheitis virus antibody at the 1:2 final dilution in a 50 percent plaque reduction test or other test of equal sensitivity.
(ii) The five cats used as vaccinates shall be administered one dose of vaccine by the method recommended on the label. If two doses are recommended, the second dose shall be given after the interval recommended on the label.
(iii) Fourteen or more days after the final dose of vaccine, the vaccinates and controls shall each be challenged intranasally with virulent feline rhinotracheitis virus furnished or approved by Animal and Plant Health Inspection Service and observed each day for 14 days postchallenge. The rectal temperature of each animal shall be taken and the presence or absence of
(iv) If three of three controls do not show clinical signs of feline rhinotracheitis virus infection other than fever, the test is inconclusive and may be repeated.
(v) If a significant difference in clinical signs cannot be demonstrated between vaccinates and controls using a scoring system approved by Animal and Plant Health Inspection Service and prescribed in the Outline of Production, the serial is unsatisfactory.
Bursal Disease Vaccine, Killed Virus, shall be prepared from virus-bearing cell culture fluids or embryonated chicken eggs. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All serials shall be prepared from the first through the fifth passage from the Master Seed.
(a) The Master Seed shall meet the applicable requirements prescribed in § 113.200.
(b) Each lot of Master Seed shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is inconclusive because of a vaccine virus override, the chicken inoculation test prescribed in § 113.36 may be conducted and the virus judged accordingly.
(c) The immunogenicity of vaccine prepared in accordance with the Outline of Production shall be established by a method acceptable to Animal and Plant Health Inspection Service. Vaccine used for this test shall be at the highest passage from the Master Seed and prepared at the minimum preinactivation titer specified in the Outline of Production. The test shall establish that the vaccine, when used as recommended on the label, is capable of inducing an immune response in dams of sufficient magnitude to provide significant protection to offspring.
(d)
(1)
(2)
(i)
(ii)
(iii)
(iv)
(v) If four or five vaccinates show lesions of bursal disease in the first stage, the second stage may be conducted in a manner identical to the first stage. If the second stage is not conducted, the serial is unsatisfactory.
(vi) If the second stage is used, each serial shall be evaluated according to the second part of the table on the basis of cumulative results.
Pseudorabies Vaccine, Killed Virus, shall be prepared from virus-bearing cell culture fluids. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.200.
(b) The immunogenicity of vaccine prepared from the Master Seed in accordance with the Outline of Production shall be established by a method acceptable to Animal and Plant Health Inspection Service. Vaccine used for this test shall be at the highest passage from the Master Seed and at the minimum preinactivation titer provided in the Outline of Production.
(c)
(1)
(2)
(i) Ten pseudorabies susceptible pigs (five vaccinates and five controls) shall be used as test animals. The animals shall be at the minimal age recommended for vaccination. Blood samples shall be drawn and individual serum samples inactivated and tested for neutralizing antibody.
(ii) A constant virus-varying serum neutralization test in cell culture using 50 to 300 TCID
(iii) The five pigs used as vaccinates shall be administered one dose of vaccine as recommended on the label. If two doses are recommended, the second dose shall be given after the interval recommended on the label.
(iv) Fourteen days or more after vaccination, blood samples shall be drawn and individual serum samples inactivated and tested for pseudorabies virus neutralizing antibody by the method used to determine susceptibility.
(v)
(vi)
Parvovirus Vaccine, Killed Virus, recommended for use in dogs, shall be prepared from virus-bearing cell culture fluids. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.200.
(b) The immunogenicity of vaccine prepared in accordance with the Outline of Production shall be established as follows:
(1) Twenty-five parvovirus susceptible dogs (20 vaccinates and 5 controls) shall be used as test animals. Blood samples drawn from each dog shall be individually tested for neutralizing antibody against canine parvovirus to determine susceptibility.
(2) A viral hemagglutination test or another test acceptable to Animal and Plant Health Inspection Service shall be used to measure the antigenic content of vaccine produced at the highest passage from the Master Seed before the immunogenicity test is conducted. The 20 dogs used as vaccinates shall be injected with a predetermined dose of vaccine by the method recommended on the label. To confirm the dosage calculations, five replicate tests shall be conducted on a sample of the vaccine used. If two doses are used, five replicate confirming tests shall be conducted on each dose.
(3) Fourteen days or more after the final dose of vaccine, the vaccinates and the controls shall be challenged with virulent canine parvovirus furnished or approved by Animal and Plant Health Inspection Service and the dogs observed each day for 14 days. Rectal temperature, blood lymphocyte count, and feces for viral detection shall be taken from each dog each day for at least 10 days postchallenge and the presence or absence of clinical signs noted and recorded each day.
(i) The immunogenicity of the vaccine shall be evaluated on the following criteria of infection: temperature ≥103.4 ° F; lymphopenia of ≥50 percent of prechallenge normal; clinical signs such as diarrhea, mucus in feces, or blood in feces; and viral hemagglutinins at a level of ≥1:64 in a 1:5 dilution of feces or a test of equal sensitivity. If at least 80 percent of the controls do not show at least three of the four criteria of infection during the observation period, the test is inconclusive and may be repeated.
(ii) If at least 19 of the 20 vaccinates do not survive the observation period without showing any more than one criterion of infection described in subparagraph (3)(i), of this section, the Master Seed is unsatisfactory.
(4) The Master Seed shall be retested for immunogenicity in 3 years unless use of the lot previously tested is discontinued. Only five susceptible dogs (four vaccinates and one control) need to be used in the retest. Susceptibility shall be determined in the manner provided in paragraph (b)(1) of this section.
(i) Each vaccinate shall be injected with a predetermined quantity of vaccine virus as provided in paragraph (b)(2) of this section.
(ii) Fourteen to 21 days after the last vaccination, a second serum sample
(iii) If the control has not remained seronegative at 1:2, the test is inconclusive and may be repeated.
(iv) If three of the four vaccinates in a valid test do not develop titers based upon final serum dilution of at least 1:16, and the remaining vaccinate does not develop a titer of at least 1:8, the Master Seed is unsatisfactory, except as provided in subparagraph (4)(v) of this section.
(v) If the results of a valid SN test are unsatisfactory, the vaccinates and the control may be challenged as provided in paragraph (b)(3) of this section. If at least three of the four criteria of infection are not shown, the test is inconclusive and may be repeated, except that if any of the vaccinates show more than one criterion of infection, the Master Seed is unsatisfactory.
(5) An Outline of Production change shall be made before authority for use of a new lot of Master Seed shall be granted by Animal and Plant Health Inspection Service.
(c)
(1)
(2)
Bovine Virus Diarrhea Vaccine, Killed Virus, shall be prepared from virus-bearing cell culture fluids. Only Master Seed virus which has been established as pure, safe, and immunogenic shall be used for preparing seed cultures for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.200 and the requirements of this section.
(b) The immunogenicity of vaccine prepared from the Master Seed in accordance with the Outline of Production shall be established by a method acceptable to the Animal and Plant Health Inspection Service. Vaccine used for this test shall be at the highest passage from the Master Seed and at the minimum preinactivation titer provided in the Outline of Production.
(c)
(1)
(2)
(i) Eight bovine virus diarrhea susceptible calves (five vaccinates and three controls) shall be used as test animals. Individual serum samples shall be collected, inactivated, and individually tested for neutralizing antibody.
(ii) A constant virus decreasing serum neutralization test in cell culture using 50-300 TCID50 of virus shall be used. Calves shall be considered susceptible if there is no neutralization at 1:2 final serum dilution. Other tests of equal sensitivity approved by the Animal and Plant Health Inspection Service may be used.
(iii) The five calves used as vaccinates shall be administered one dose of vaccine as recommended on the label. If two doses are recommended, the second dose shall be given according to the interval recommended on the label.
(iv) Fourteen days or more after the last vaccination, blood samples shall be drawn and the individual serum samples inactivated and tested for bovine virus diarrhea virus neutralizing antibody by the same method used to determine susceptibility.
(v)
(vi)
(vii) The prevaccination and postvaccination sera from a satisfactory potency test shall be submitted to the National Veterinary Services Laboratories for confirmatory testing.
Infectious Bovine Rhinotracheitis Vaccine, Killed Virus, shall be prepared from virus-bearing cell culture fluids. Only Master Seed virus which has been established as pure, safe, and immunogenic shall be used for preparing seed cultures for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.200 and the requirements of this section.
(b) The immunogenicity of vaccine prepared in accordance with the Outline of Production shall be established by a method acceptable to the Animal and Plant Health Inspection Service. Vaccine used for this test shall be at the highest passage from the Master Seed and at the minimum preinactivation titer provided in the Outline of Production.
(c)
(1)
(2)
(i) Eight infectious bovine rhinotracheitis susceptible calves (five vaccinates, three controls) shall be used as test animals. Individual serum
(ii) A constant virus decreasing serum neutralization test in cell culture using 50-300 TCID50 of virus shall be used. Calves shall be considered susceptible if there is no neutralization at 1:2 final serum dilution. Other tests of equal sensitivity acceptable to the Animal and Plant Health Inspection Service may be used.
(iii) The five calves used as vaccinates shall be administered one dose of vaccine as recommended on the label. If two doses are recommended, the second dose shall be given according to the interval recommended on the label.
(iv) Fourteen or more days after the last vaccination, blood samples shall be drawn and the individual serum samples inactivated and tested for infectious bovine rhinotracheitis virus neutralizing antibody by the same method used to determine susceptibility.
(v)
(vi)
(vii) The prevaccination and postvaccination sera from a satisfactory potency test shall be submitted to the National Veterinary Services Laboratories for testing by the Animal and Plant Health Inspection Service.
When prescribed in an applicable Standard Requirement or in the filed Outline of Production, a live virus vaccine shall meet the applicable requirements in this section.
(a)
(2)
(3)
(i) Salmonella contamination as prescribed in § 113.30; and
(ii) Lymphoid leukosis virus contamination as prescribed in § 113.31; and
(iii) Hemagglutinating viruses as prescribed in § 113.34.
(4)
(b)
(c)
(1)
(2)
(d)
(e)
(2) Final container samples of completed product from each serial or subserial must be tested for moisture content in accordance with the test prescribed in § 113.29.
Ovine Ecthyma Vaccine shall be prepared from tissue culture fluids or virus-bearing tissues obtained from sheep that have developed ovine ecthyma following inoculation with virulent ovine ecthyma virus. Ovine Ecthyma Vaccine is exempt from the requirements prescribed in §§ 113.27 and 113.300(a), (b), and (c). Each serial shall meet the moisture requirements in § 113.300(e) and the special requirements prescribed in this section. Any serial found unsatisfactory by a prescribed test shall not be released.
(a)
(2) The prechallenge period of the potency test shall constitute a safety test. If unfavorable reactions attributable to the vaccine occur in either of the vaccinates during the observation period, the serial is unsatisfactory.
(b)
(1) Each of two lambs (vaccinates) shall be vaccinated by application of the vaccine to a scarified area on the medial surface of the thigh and observed each day for 14 days.
(2) The immunity of the two vaccinates and one or more unvaccinated lambs (controls) shall be challenged in the same manner as for vaccination, using the opposite thigh.
(3) If typical signs of ovine ecthyma, such as hyperemia, vesicles, and pustules do not develop on the controls during the first 2 weeks following challenge and persist for approximately 30 days, the test is inconclusive and may be repeated.
(4) If the vaccinates do not show a typical immune reaction, the serial is unsatisfactory:
Distemper Vaccine—Mink shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first
(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300 and the requirements prescribed in this section.
(b) The lot of Master Seed Virus shall be tested for extraneous viruses as follows:
(1) To detect virulent canine distemper virus, each of two distemper susceptible mink or ferrets shall be inoculated with 1 ml of the Master Seed Virus and observed each day for 21 days. If undesirable reactions occur in either test animal, the lot of Master Seed Virus is unsatisfactory.
(2) Master Seed Virus propagated in chicken embryos shall be tested for pathogens by the chicken embryo test prescribed in § 113.37 except lesions typical of distemper virus may be disregarded. If found unsatisfactory, the Master Seed Virus shall not be used.
(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows:
(1) At least 25 distemper susceptible mink shall be used as test animals. Blood samples shall be drawn from these animals and individual serum samples tested. The mink shall be considered susceptible if the results are negative at a 1:2 final serum dilution in a varying serum-constant virus neutralization test with less than 500 ID
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. At least 20 mink shall be vaccinated with a predetermined quantity of vaccine virus and at least 5 additional mink shall be held as unvaccinated controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.
(3) At least twenty-one days post-injection, the immunity of each of the vaccinates and the controls shall be challenged with the same size dose of virulent distemper virus and observed each day for 21 days.
(i) If at least 80 percent of the controls do not die or show severe signs of distemper, the test is inconclusive and may be repeated.
(ii) If at least 19 of 20, 27 of 30, or 36 of 40 of the vaccinates do not survive without showing clinical signs of distemper during the observation period, the Master Seed Virus is unsatisfactory.
(4) The Master Seed Virus shall be retested for immunogenicity in 3 years unless use of the lot previously tested is discontinued. Only five vaccinates and five controls need to be used in the retest;
(5) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be authorized by Animal and Plant Health Inspection Service.
(d) Test requirements for release: Each serial and subserial shall meet the general requirements prescribed in § 113.300 and the requirements in this paragraph. Final container samples of completed product shall be tested. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1)
(2)
At 72 FR 72564, Dec. 21, 2007, § 113.302 was amended by removing paragraph (c)(4) and redesignating paragraph (c)(5) as paragraph (c)(4), effective Jan. 22, 2008.
Bluetongue Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing the seeds for vaccine production. All serials of vaccine shall be prepared from the first through the tenth passage from the Master Seed.
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this section.
(b) Each lot of Master Seed shall be tested for transmissibility and reversion to virulence in sheep using a method acceptable to Animal and Plant Health Inspection Service. If reversion to virulence is demonstrated, the Master Seed is unsatisfactory.
(c) Each lot of Master Seed used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed shall be established as follows:
(1) Twenty-five lambs, susceptible to the bluetongue virus serotype contained in the vaccine, shall be used as test animals (20 vaccinates and 5 controls). Blood samples shall be drawn from these animals and individual serums tested. A lamb shall be considered susceptible if there is no neutralization at a 1:2 final serum dilution in a constant virus varying serum neutralization test with 60 to 300 TCID
(2) A geometric mean titer of the vaccine produced from the highest passage from the Master Seed shall be established before the immunogenicity test is conducted. The 20 lambs to be used as vaccinates shall be administered a predetermined quantity of vaccine virus by the method recommended on the label. To confirm the virus dosage administered, five replicate virus titrations shall be conducted on a sample of the vaccine used.
(3) At least once during the period of 14 to 18 days postvaccination, individual serum samples shall be collected from each of the vaccinates and tested for virus neutralizing antibody using the 60 to 300 TCID
(4) Twenty-one to twenty-eight days postvaccination the vaccinates and the controls shall each be challenged with virulent bluetongue virus and observed for 14 days. The rectal temperature of each animal shall be taken and recorded for 17 consecutive days beginning 3 days prechallenge. The presence or absence of lesions or other clinical signs of bluetongue noted and recorded on each of 14 consecutive days postchallenge.
(i) If at least four of the five controls do not show clinical signs of bluetongue and a temperature rise of 3 ° F or higher over the prechallenge mean temperature, the test shall be considered inconclusive and may be repeated.
(ii) If at least 19 of the 20 vaccinates tested as prescribed in paragraph (c)(3) of this section do not have bluetongue neutralizing antibody titers of 1:4 final serum dilution or higher, or if more than one of the vaccinates shows a temperature rise of 3 ° F or higher than its prechallenge mean temperature for 2 or more days, or if more than one of the vaccinates exhibits clinical signs of bluetongue, the Master Seed is unsatisfactory.
(5) An Outline of Production change shall be made before authority for use of a new lot of Master Seed shall be granted by Animal and Plant Health Inspection Service.
(6) The Master Seed Virus shall be retested for immunogenicity in 3 years unless use of the lot previously tested is discontinued. Only five vaccinates
(d)
(1)
(2)
At 72 FR 72564, Dec. 21, 2007, § 113.303 was amended by removing paragraph (c)(6), effective Jan. 22, 2008.
Feline Panleukopenia Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.300 and the requirements prescribed in this section.
(b) The lot of Master Seed Virus shall be tested for other agents as follows:
(1) To detect virulent feline panleukopenia virus or virulent mink enteritis virus, each of two feline panleukopenia susceptible cats, as determined by the criteria prescribed in paragraph (c)(1) of this section, shall be injected subcutaneously with the equivalent of one cat dose each and the cats observed each day for 21 days. If either or both cats show signs of disease or reduced white blood cell counts below 50 percent of the normal level established by an average of three or more counts taken prior to injection, the Master Seed Virus is unsatisfactory.
(2) To detect chlamydial agents, the Master Seed Virus shall be tested as prescribed in § 113.43.
(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows:
(1) Twenty-five feline panleukopenia susceptible cats shall be used as test animals (20 vaccinates and 5 controls). Blood samples drawn from each cat shall be individually tested for neutralizing antibody against feline panleukopenia virus to determine susceptibility.
(i) A constant virus-carrying serum neutralization test in tissue culture using 100 to 300 TCID
(ii) Cats shall be considered susceptible if there is no neutralization at a 1:2 final serum dilution.
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 cats used as vaccinates shall be injected with a predetermined quantity of vaccine virus and the remaining five cats held as uninjected controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.
(3) Fourteen days post-injection, the vaccinates and the controls shall be challenged with virulent feline
(i) If at least 80 percent of the controls do not show clinical signs of feline panleukopenia during the observation period, the test is inconclusive and may be repeated. Clinical signs of feline panleukopenia shall include a pronounced leukopenia wherein the white cell count drops to 4,000 or less per cubic mm, or the white cell count drops to less than 25 percent of the normal level established by an average of three or more counts taken prior to challenge.
(ii) If at least 19 of the 20 vaccinates do not survive the observation period without showing clinical signs of feline panleukopenia as described in paragraph (c)(3)(i) of this section, the Master Seed Virus is unsatisfactory.
(4) The Master Seed Virus shall be retested for immunogenicity in 3 years unless use of the lot previously tested is discontinued. Ten susceptible cats (8 vaccinates and 2 controls) shall be used in the retest. Susceptibility shall be determined in the manner provided in paragraph (c)(1) of this section.
(i) Each vaccinate shall be injected with a predetermined quantity of vaccine virus as provided in paragraph (c)(2) of this section.
(ii) Fourteen to twenty-one days postvaccination, a second serum sample shall be drawn from each cat and tested for neutralizing antibody to feline panleukopenia virus in the same manner used to determine susceptibility.
(iii) If the two controls have not remained seronegative at 1:2, the test is inconclusive and may be repeated.
(iv) If at least 6 of the 8 vaccinates in a valid test do not develop titers based upon final serum dilution of at least 1:8, and the remaining vaccinates do not develop titers of at least 1:4, the Master Seed Virus is unsatisfactory except as provided in paragraph (c)(4)(v) of this section.
(v) If the results of a valid SN test are unsatisfactory, the vaccinates and the controls may be challenged as provided in paragraph (c)(3) of this section. If 100 percent of the controls do not show clinical signs of feline panleukopenia, the test is inconclusive and may be repeated except, that, if any of the vaccinates show such signs, the Master Seed Virus is unsatisfactory.
(5) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(d)
(1)
(i) Each of two healthy cats shall be injected with 10 cat doses by the method recommended on the label and the cats observed each day for 14 days.
(ii) If unfavorable reactions attributable to the biological product occur during the observation period, the serial is unsatisfactory. If unfavorable reactions occur which are not attributable to the product, the test shall be declared inconclusive and repeated:
(2)
At 72 FR 72564, Dec. 21, 2007, § 113.304 was amended by removing
Canine Hepatitis Vaccine and Canine Adenovirus Type 2 Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used in preparing the production seed virus for vaccine production. All serials shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300 except that the dog safety test prescribed in § 113.40(a) shall be conducted by the intravenous route.
(b) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity by one or both of the following methods:
(1)
(i) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 dogs to be used as vaccinates shall be injected with a predetermined quantity of vaccine virus and the remaining five dogs held as uninjected controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.
(ii) Not less than 14 days postinjection, the vaccinates and the controls shall each be challenged intravenously with virulent infectious canine hepatitis virus furnished or approved by the Animal and Plant Health Inspection Service and observed each day for 14 days.
(A) If at least four of the five controls do not show severe clinical signs of canine hepatitis, the test is inconclusive and may be repeated.
(B) If at least 19 of the 20 vaccinates do not survive without showing clinical signs of infectious canine hepatitis during the observation period, the Master Seed Virus is unsatisfactory.
(iii) The Master Seed Virus shall be retested for immunogenicity for canine hepatitis in 3 years unless use of the lot previously tested is discontinued. Ten susceptible dogs (8 vaccinates and 2 controls) shall be used in the retest. Susceptibility shall be determined in the manner provided in paragraph (b)(1) of this section.
(A) Each vaccinate shall be injected with a predetermined quantity of vaccine virus as provided in paragraph (b)(1)(i) of this section.
(B) At least 14 days postvaccination, a second serum sample shall be drawn from each dog and tested for neutralizing antibody to canine adenovirus in the same manner used to determine susceptibility.
(C) If the two controls have not remained seronegative at 1:2, the test is inconclusive and may be repeated.
(D) If at least six of the eight vaccinates in a valid test do not develop titers of at least 1:10 based upon final serum dilution, the Master Seed Virus is unsatisfactory except as provided in paragraph (b)(1)(iii)(E) of this section.
(E) If the results of a valid serum neutralization test are unsatisfactory, the vaccinates and the controls may be challenged as provided in paragraph (b)(1)(ii) of this section. A Master Seed is satisfactory if all vaccinates remain free of clinical signs of canine hepatitis, while both controls develop severe clinical signs of canine hepatitis. If both controls do not show severe clinical signs of canine hepatitis, the test is inconclusive and may be repeated:
(2)
(i) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 dogs to be used as vaccinates shall be injected with a predetermined quantity of vaccine virus and the remaining 10 dogs held as uninjected controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.
(ii) Not less than 14 days postinjection, the vaccinates and the controls shall be challenged by exposure to a nebulized aerosol of virulent canine adenovirus type 2 furnished or approved by the Animal and Plant Health Inspection Service and observed each day for 14 days postchallenge. The rectal temperature of each animal shall be taken and the presence of respiratory or other clinical signs of canine adenovirus type 2 noted and recorded each day.
(A) If at least 6 of 10 controls do not show clinical signs of canine adenovirus type 2 infection other than fever, the test is inconclusive and may be repeated.
(B) If a significant difference in clinical signs in a valid test cannot be demonstrated between vaccinates and controls using a scoring system approved by the Animal and Plant Health Inspection Service, the Master Seed Virus is unsatisfactory.
(iii) The Master Seed Virus shall be retested for immunogenicity in 3 years unless use of the lot previously tested is discontinued. Either 10 vaccinates and 6 controls or 5 vaccinates and 3 controls shall be used in the retest.
(A) If less than 4 of 6 or 2 of 3 of the controls show clinical signs of canine adenovirus type 2 other than fever, the test is inconclusive and may be repeated.
(B) A significant difference in clinical signs shall be demonstrated between vaccinates and controls in a valid test as prescribed in paragraph (b)(2)(ii)(B) of this section.
(iv) An Outline of Production change shall be made before authorization for use of a new lot of Master Seed Virus shall be granted by the Animal and Plant Health Inspection Service.
(c)
(1)
(2) [Reserved]
At 72 FR 72564, Dec. 21, 2007, § 113.305 was amended by removing paragraphs (b)(1)(iii) and (b)(2)(iii) and redesignating paragraph (b)(2)(iv) as paragraph (b)(2)(iii), effective Jan. 22, 2008.
Canine Distemper Vaccine shall be prepared from virus-bearing cell culture fluids or embryonated chicken eggs. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a)
(1) To detect ferret virulent canine distemper virus, each of five canine distemper susceptible ferrets shall be injected with a sample of the Master Seed Virus equivalent to the amount of virus to be used in one dog dose and observed each day for 21 days. If undesirable reactions are observed during the observation period, the lot of Master Seed is unsatisfactory.
(2) Master Seed Virus propagated in tissues or cells of avian origin shall be tested for pathogens by the chicken embryo test prescribed in § 113.37. If found unsatisfactory, the Master Seed Virus shall not be used.
(b) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows:
(1) Twenty-five canine distemper susceptible dogs shall be used as test animals (20 vaccinates and 5 controls). Blood samples shall be drawn from these animals and individual serum samples tested. The dogs shall be considered susceptible if the results are negative at a 1:2 final serum dilution in a varying serum-constant virus neutralization test using 50 to 300 TCID
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 dogs used as vaccinates shall be injected with a predetermined quantity of vaccine virus and the remaining five dogs held as uninjected controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.
(3) At least 14 days post-injection, the vaccinates and the controls shall each be challenged intracerebrally with virulent canine distemper virus furnished or approved by the Animal and Plant Health Inspection Service and observed each day for 21 days.
(i) If at least four of the five controls do not die and the survivor, if any, does not show clinical signs of canine distemper the test is inconclusive and may be repeated.
(ii) If at least 19 of the 20 vaccinates do not survive without showing clinical signs of canine distemper during the observation period, the Master Seed Virus is unsatisfactory.
(4) The Master Seed Virus shall be retested for immunogenicity in 3 years unless use of the lot previously tested is discontinued. Ten susceptible dogs (8 vaccinates and 2 controls) shall be used in the retest. Susceptibility shall be determined in the manner provided in paragraph (b)(1) of this section.
(i) Each vaccinate shall be injected with a predetermined quantity of vaccine virus as provided in paragraph (b)(2) of this section.
(ii) At least 14 days postvaccination, a second serum sample shall be drawn from each dog and tested for neutralizing antibody to canine distemper virus in the same manner used to determine susceptibility.
(iii) If the two controls have not remained seronegative at 1:2, the test is inconclusive and may be repeated.
(iv) If at least 6 of the 8 vaccinates in a valid test do not develop titers of at least 1:50 based upon final serum dilution, the Master Seed Virus is unsatisfactory, except as provided in paragraph (b)(4)(v) of this section.
(v) If the results of a valid serum neutralization test are unsatisfactory, the vaccinates and the controls may be challenged as provided in paragraph (b)(3) of this section. A Master Seed is satisfactory if all vaccinates remain free of clinical signs of canine distemper, while the two controls die with clinical signs of canine distemper. If the two controls do not die with clinical signs of canine distemper, the test is inconclusive and may be repeated:
(5) An Outline of Production change shall be made before authorization for use of a new lot of Master Seed Virus shall be granted by the Animal and Plant Health Inspection Service.
(c)
(1) The test for pathogens prescribed in § 113.37 shall be conducted on each serial or one subserial of avian origin vaccine.
(2)
At 72 FR 72564, Dec. 21, 2007, § 113.306 was amended by removing paragraph (b)(4) and redesignating paragraph (b)(5) as paragraph (b)(4), effective Jan. 22, 2008.
Encephalomyelitis Vaccine, Venezuelan, shall be prepared from virus-bearing cell culture fluids. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.300 except (b), and the requirements prescribed in this section.
(b) Each lot of Master Seed shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed shall be established as follows:
(1) Tests conducted by the Department have established that horses having Venezuelan equine encephalomyelitis antibody titers of 1:20 by the hemagglutination-inhibition (HI) method or 1:40 by the serum neutralization (SN) method were immune to challenge with virulent virus. The immunogenicity test is based on the demonstration of a serological response of at least that magnitude following vaccination of serologically negative horses.
(2) At least 22 horses (20 vaccinates and 2 controls), susceptible to Venezuelan equine encephalomyelitis, shall be used as test animals. Blood samples shall be taken from each horse and the serums individually tested for neutralizing antibody. Horses shall be considered susceptible if there is no neutralization at a 1:2 final serum dilution in a constant virus-varying serum neutralization test using 60 to 300 TCID
(3) A geometric mean titer of the vaccine produced from the highest passage of the Master Seed shall be established using a method acceptable to Veterinary Services before the immunogenicity test is conducted. The 20 horses used as vaccinates shall be injected with a predetermined quantity of vaccine virus by the method to be recommended on the label. To confirm the dosage administered, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.
(4) Twenty-one to twenty-eight days postvaccination, blood samples shall be drawn from all test animals. For a valid test, the controls shall remain seronegative at 1:2 final serum dilution. In a valid test, if at least 19 of 20 vaccinates do not have antibody titers of at least 1:20 in a hemagglutination-inhibition test or at least 1:40 in a serum neutralization test, the Master Seed is unsatisfactory.
(5) The Master Seed shall be retested for immunogenicity in 3 years unless use of the lot is discontinued. Only five vaccinates and two controls need to be used in the retest:
(6) An Outline of Production change shall be made before authority for use of a new lot of Master Seed shall be granted by Animal and Plant Health Inspection Service.
(c)
(1)
(2)
At 72 FR 72564, Dec. 21, 2007, § 113.308 was amended by removing paragraph (b)(5) and redesignating paragraph (b)(6) as paragraph (b)(5), effective Jan. 22, 2008.
Bovine Parainfluenza
(a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.300.
(b) Each lot of Master Seed Virus shall meet the special requirements prescribed in this section.
(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows:
(1) Twenty-five bovine parainfluenza, susceptible calves shall be used as test animals (20 vaccinates and five controls). Blood samples shall be drawn from these animals and individual serums tested. Also, nasal specimens shall be collected for virus isolation attempts. The calves shall be considered susceptible if:
(i) The results are negative at a 1:2 final serum dilution in a varying serum constant virus neutralization test with less than 500 TCID
(ii) Shall be negative to bovine parainfluenza
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 calves to be used as vaccinates shall be injected with a predetermined quantity of vaccine virus and the remaining five calves held as uninjected controls. To confirm the dosage calculation, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.
(3) The vaccinates and controls shall be examined for clinical signs of respiratory disease and the body temperature taken and recorded on each of the first 14 consecutive days post-injection. The vaccinates shall be bled on day 6 ±2 days post-injection.
(4) Three to four weeks post-vaccination, all calves shall be bled for serum antibodies and nasal specimens shall be collected for PI
(5) Each animal shall be examined for clinical signs of respiratory disease and the body temperature recorded on each of the 14 consecutive days of the post-challenge observation period. Each day
(6) Satisfactory Test Criteria:
(i) All virus isolations attempts shall be by culture and at least one subculture in PI
(ii) Two to four weeks post-vaccination, at least 19 of the 20 vaccinates shall have PI
(iii) Satisfactory resistance to challenge by vaccinates shall be determined by a significant difference between virus isolation rates from vaccinates and controls. The virus neutralization titers of post-challenge serums and respiratory symptoms and temperatures from all animals shall be considered in the evaluation of the test validity.
(7) Designated animal alternates for test animals showing anamnestic antibody responses (titers 1:32 or greater) on day 6 serums may be included in the study under the following provisions:
(i) No more than five alternates shall be allowed for the vaccinates and no more than two for the controls.
(ii) Alternates shall be subject to all requirements outlined for the animals for which they are alternates.
(iii) Antibody values from alternate animals may be used only to replace values from up to and including five vaccinates which develop antibody of 1:32 or greater by day 6 ±2 days post-vaccination or up to and including two controls which develop antibody titers of 1:32 or greater by day 6 ±2 days post-challenge.
(8) A sequential test procedure may be used in lieu of the 20 calf requirement. A beta value of .05 and a tolerance level of .78 shall be required.
(9) The Master Seed Virus shall be retested for immunogenicity in 3 years unless use of the lot previously tested is discontinued. Only five vaccinates and five controls need to be used in the retest;
(10) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(d) Test requirements for release: Each serial and subserial shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this paragraph. Final container samples of completed product shall be tested except as prescribed in paragraph (d)(1) of this section. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1)
(2)
(3)
At 72 FR 72564, Dec. 21, 2007, § 113.309 was amended by removing paragraph (c)(9) and redesignating paragraph (c)(10) as paragraph (c)(9), effective Jan. 22, 2008.
Bovine Rhinotracheitis Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the tenth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.300.
(b) Each lot of Master Seed Virus shall meet the special requirements prescribed in this section.
(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows:
(1) Twenty-five infectious bovine rhinotracheitis susceptible calves shall be used as test animals (20 vaccinates and five controls). Blood samples shall be drawn from these animals and individual serums tested. The calves shall be considered susceptible if the results are negative at a 1:2 final serum dilution by the virus plaque reduction method.
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 calves to be used as vaccinates shall be injected with a predetermined quantity of vaccine virus and the remaining five calves held as uninjected controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.
(3) At least once during a period of 14 to 28 days post-vaccination, individual serum samples shall be collected for virus-neutralization tests from each of the vaccinates. The test virus shall be 100 to 500 TCID
(4) The vaccinates and the controls shall each be challenged with virulent infectious bovine rhinotracheitis virus and observed for 14 days. The rectal temperature of each animal shall be taken and the presence or absence of respiratory or other clinical signs of bovine rhinotracheitis noted and recorded on each of the 14 consecutive days.
(5) If at least four of the five controls do not show clinical signs of infectious bovine rhinotracheitis and a marked temperature rise to 104.5 °F. or higher post-challenge, the test shall be considered inconclusive and may be repeated.
(6) If less than 19 of the post-injection serum samples tested as prescribed in paragraph (c)(3) of this section show neutralization in all tubes of the 1:2 final serum dilution, or if more than one of the vaccinates show a temperature of 103.5 °F. or higher for 2 or more days, or if more than one of the vaccinates exhibit respiratory or other clinical signs of infectious bovine rhinotracheitis, or both, the Master Seed Virus is unsatisfactory.
(7) A sequential test procedure may be used in lieu of the 20 calf requirement. A beta value of .05 and a tolerance level of .78 shall be required.
(8) The Master Seed Virus shall be retested for immunogenicity in 3 years unless use of the lot previously tested is discontinued. Only five vaccinates and five controls need to be used in the retest;
(9) An outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(d) Test requirements for release: Each serial and subserial shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this paragraph. Final container samples of completed product shall be tested except as prescribed in paragraph (d)(1) of this section. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1)
(2)
(3)
At 72 FR 72564, Dec. 21, 2007, § 113.310 was amended by removing paragraph (c)(8) and redesignating paragraph (c)(9) as paragraph (c)(8), effective Jan. 22, 2008.
Bovine Virus Diarrhea Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the tenth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.300.
(b) Each lot of Master Seed Virus shall meet the special requirements prescribed in this section.
(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows:
(1) Twenty-five bovine virus diarrhea susceptible calves shall be used as test animals (20 vaccinates and five controls). Blood samples shall be drawn from these animals and individuals serum samples tested. The calves shall be considered susceptible to bovine virus diarrhea virus infection if the results are negative at a 1:2 final serum dilution in a varying serum-constant virus neutralization test with less than 500 TCID
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 calves to be used as vaccinates shall be injected with a predetermined quantity of vaccine virus and the remaining five calves held as uninjected controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.
(3) At least once during a period 14 to 28 days post-vaccination, individual serum samples shall be collected for virus-neutralization tests from each of the vaccinates. The test virus shall be less than 500 TCID
(4) The vaccinates and the controls shall each be challenged with virulent bovine virus diarrhea virus and observed for 14 consecutive days. The white cell count shall be determined daily on each animal from the second through the eighth day post-challenge. If leukopenia does not develop in at least four of the five controls as compared with the vaccinates, the test shall be considered inconclusive and may be repeated.
(5) If less than 19 of the post-injection serum samples, tested as prescribed in paragraph (c)(3) of this section, show neutralization in all tubes of the 1:8 dilution; or if more than one of the vaccinates exhibits respiratory or other clinical signs of bovine virus diarrhea post-challenge; or both, the Master Seed Virus is unsatisfactory.
(6) A sequential test procedure may be used in lieu of the 20 calf requirement. A beta value of .05 and a tolerance level of .78 shall be required.
(7) The Master Seed Virus shall be retested for immunogenicity in 3 years unless use of the lot previously tested is discontinued. Only five vaccinates and five controls need to be used in the retest;
(8) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(d) Test requirements for release: Each serial and subserial shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this paragraph. Final container samples of completed product shall be tested except as prescribed in paragraph (d)(1) of this section. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1)
(2)
(3)
At 72 FR 72564, Dec. 21, 2007, § 113.311 was amended by removing paragraph (c)(7) and redesignating paragraph (c)(8) as paragraph (c)(7), effective Jan. 22, 2008.
Rabies Vaccine shall be prepared from virus-bearing cell cultures or embryonated chicken eggs. Only Master Seed Virus which has been established as pure, safe and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.300.
(1) Each lot of Master Seed Virus shall meet the special requirements prescribed in this section.
(2) Each lot of Master Seed Virus propagated in tissues or cells of avian origin shall be tested for pathogens by procedures prescribed in § 113.37.
(3) Each lot of Master Seed Virus propagated in primary cell cultures of mouse or hamster origin or brain tissues of mouse origin shall be tested for lymphocytic choriomeningitis (LCM) virus by the procedure prescribed in § 113.42. If LCM virus is detected, the Master Seed Virus is unsatisfactory.
(4) The Master Seed Virus shall be studied in each species of carnivore or domesticated wild animal for which the vaccine is specifically recommended to attempt to determine the fate of the vaccine virus. Results shall be considered in evaluating safety of vaccine virus.
(i) Obtain at least 10 unvaccinated animals, negative at 1:2 final serum dilution, of each species in which tests will be conducted. Divide each species into two groups of five animals.
(ii) For each species of animal, inject one group of five animals intramuscularly. Infiltrate a major
(iii) Observe all animals for signs of rabies until scheduled time to sacrifice. If animals show definite symptoms, sacrifice and check regional lymph nodes, brain, salivary glands, and kidney for rabies virus by injection of suckling mice (not more than 7 days of age). Tissues may be held frozen at −70 °C. until suckling mice are available. Inject each mouse in one litter intracerebrally with 0.02 ml of a ground tissue suspension from each organ. Observe mice each day for 21 days. If any mice die, determine if the deaths were due to rabies virus in the brain by a fluorescent antibody test.
(iv) Sacrifice animals that do not show signs of rabies according to the following schedule and check regional lymph nodes, brain, salivary glands, and kidney in suckling mice.
(5) Each lot of Master Seed Virus shall be tested for safety in at least 10 unvaccinated serologically negative animals of each domestic species for which the vaccine is recommended.
(i) Each group of 10 animals shall be divided into 2 groups of 5 animals. For each species, inject one group intramuscularly with 10 doses of high titer virus.
(ii) Infiltrate a major nerve of each of the animals in the other group of 5 with 10 doses of the same high titer virus. For all species except dogs and cats, multiple injections along the cervical spine in the proximity to the nerve trunks emerging from the spinal cord may be used:
(iii) Observe all animals each day for 90 days.
(iv) If any animals show clinical signs of rabies, sacrifice the animal and check appropriate brain tissue for rabies virus by the fluorescent antibody test and by mouse injection.
(v) If rabies is confirmed, the lot of Master Seed Virus is unsatisfactory.
(b) The immunogenicity of vaccine prepared with virus at the highest passage of the Master Seed shall be established in each species for which the vaccine is recommended. Tests shall be conducted in accordance with a protocol filed with Animal and Plant Health Inspection Service before initiation of the tests. The vaccine shall be prepared using methods prescribed in the Outline of Production. If Rabies Vaccine is to be in combination with other fractions, the product tested shall include all fractions to be recommended.
(1) A geometric mean virus titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.
(2) The dose of vaccine to be used in the immunogenicity test shall be no more than the amount of rehydrated vaccine which, on the basis of previous titrations, has been diluted to the proposed minimum acceptable virus titer.
(3) Test animals shall be uniform and have no neutralizing antibodies to rabies as determined by serum-neutralization (SN) tests.
(i) Twenty-five or more animals shall be used as vaccinates. Each shall be injected intramuscularly at one site in the thigh with a dose of vaccine at the proposed minimum virus titer as specified in the filed Outline of Production.
(ii) Ten or more additional animals shall be held as controls.
(iii) On or about days 30, 90, 180, 270, and 365 postvaccination, all animals shall be bled and individual serums tested for neutralizing antibodies to rabies virus.
(iv) All surviving test animals of each species shall be challenged intramuscularly with virulent rabies virus furnished or approved by Animal and Plant Health Inspection Service 1 year after vaccination, except as provided in paragraphs (b)(4), (b)(5), and (b)(6) of this section. The challenged animals shall be observed each day for 90 days as prescribed in § 113.5(b). The brain of each test animal that dies following challenge shall be examined for
(v) Requirements for acceptance in challenge tests shall be death due to rabies in at least 80 percent of controls while at least 22 of 25 or 26 of 30 or a statistically equivalent number of the vaccinates remain well for a period of 90 days.
(4) An alternative to challenging all surviving test animals in accordance with paragraph (b)(3)(iv) of this section may be used when the test animals are of species other than carnivores. Vaccinates shall be challenged at 1 year postvaccination. These shall include five vaccinates with the lowest SN titers at the 270th-day bleeding, five vaccinates with the lowest SN titers at the 365th-day bleeding, and all vaccinates with SN titers below 1:10 by the mouse SN test or below 1:16 by the rapid-fluorescent-focus-inhibition test at any bleeding. At least five SN-negative controls of each species shall be challenged at the same time as the vaccinates. All SN titers shall be iterated to an endpoint. All of the challenged vaccinates must remain well for a period of 90 days, and at least 80 percent of the controls must die of rabies for a satisfactory test without further challenge. If one or more of the vaccinates die from rabies, all the remaining vaccinates, regardless of titer, along with the five controls shall be challenged. The cumulative results from the two challenges shall be evaluated for acceptance as specified in paragraph (b)(3)(v) of this section.
(5) The Master Seed Virus shall be retested for immunogenicity in 3 years and each 5 years thereafter unless use of the lot previously tested is discontinued. Only five vaccinates and five controls need to be used in the retest and the retest may be limited to serological response at 1 year after vaccination of the vaccinates if such response is equal to or greater than that in the original immunogenicity test and all controls remain negative. If the SN response is not satisfactory, the vaccinates and controls may be challenged. To be satisfactory, at least 4 of the 5 controls shall die of rabies and 5 of the 5 vaccinates remain well for a period of 90 days.
(6) The repeat immunogenicity tests may be terminated after 90 day SN tests if at least 10 vaccinates and at least 5 controls of each species are used and the test dose of vaccine contains the minimum acceptable virus titer throughout dating.
(i) If the 10 vaccinates have SN titers equal to or greater than the 90 day SN titers of the vaccinates in the initial immunogenicity test, the Master Seed Virus is satisfactory.
(ii) If the 10 vaccinates do not have acceptable SN titers, each vaccinate and each control shall be challenged at 1 year with virulent rabies street virus and observed for 90 days.
(iii) If at least 80 percent of the controls do not show signs of rabies during the observation period, the test is invalid and shall be repeated.
(iv) If more than 10 percent of the vaccinates show signs of rabies, the Master Seed Virus is unsatisfactory.
(7) An outline of Production change shall be made before authority for use of a new lot of Master Virus shall be granted by Animal and Plant Health Inspection Service.
(c) If more than 1 year duration of immunity is to be claimed, a duration of immunity test for the additional time shall be conducted and interpreted as prescribed in paragraph (b) of this section for the 1 year test. The test animals shall be monitored serologically at least every 180 days. The time of challenge may be adjusted accordingly.
(d) Test requirements for release: Each serial and each subserial shall meet the general requirements prescribed in § 113.300 and special requirements in this paragraph.
(1)
(i) The test for pathogens, prescribed in § 113.37 shall be conducted on each serial or one subserial of avian origin. If necessary, neutralize the rabies virus with specific rabies antiserum.
(ii) A test for safety in three young seronegative animals of the most susceptible species for which the vaccine is recommended shall be conducted. Each shall be injected intramuscularly with 10 recommended doses of vaccine.
(iii) If primary cell cultures of hamster origin or of mouse origin are used vaccine production, they shall be tested for LCM virus as prescribed in § 113.42. The cells shall be disrupted and undiluted cell fluids from each lot shall be tested.
(2)
(3) Young adult mice, each weighing 14 to 16 grams, shall be used as test animals when the virus in vaccine prepared with a low egg passage Flury Strain or high cell passage Street Alabama Dufferin Strain (HCP SAD) of rabies virus is titrated. At least 10 mice for each dilution shall be used.
(i) At least 10 mice shall be used for each dilution. Each shall be injected intracerebrally with 0.03 ml.
(ii) The injected young adult mice shall be observed each day for 14 days except when testing vaccines made with HCP SAD strain of rabies virus, in which case, the mice shall be observed each day for 21 days. Deaths and paralysis occurring subsequent to the fourth day post-injection shall be noted and the LD
(iii) Virus titer requirements for release and at expiration date shall be determined for each vaccine on the basis of data available:
(4) Suckling mice, 6 days of age or younger, shall be used as test animals when virus in vaccine prepared with a high egg passage Flury Strain of rabies virus is titrated.
(i) Six to twelve mice shall be used for each dilution. Each shall be injected intracerebrally with 0.02 ml.
(ii) The injected suckling mice shall be observed each day for 21 days. Deaths and paralysis occurring subsequent to the fourth day post-injection shall be noted and the LD
(iii) Virus titer requirements for release and at expiration date shall be determined for each vaccine on the basis of data available:
At 72 FR 72564, Dec. 21, 2007, § 113.312 was amended by removing paragraphs (b)(5) and (b)(6) and redesignating paragraph (b)(7) as paragraph (b)(5), effective Jan. 22, 2008.
Measles Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.300. Each lot of Master Seed Virus shall meet the special requirements prescribed in this section.
(b) To detect virulent canine distemper virus, each of two canine distemper susceptible ferrets shall be injected with a sample of the Master Seed Virus equivalent to the amount of virus to be used in one dog dose and observed each day for 21 days. If undesirable reactions occur in either ferret, the lot of Master Seed Virus is unsatisfactory.
(c) Each lot of Master Seed Virus used for vaccine production shall be
(1) Twenty-five dogs, less than 12 weeks of age and free of measles antibody, shall be used as test animals (20 vaccinates and five controls). Blood samples shall be drawn from these animals and individual serum samples tested. The dogs shall be considered susceptible if the results are negative at a 1:2 final serum dilution in a varying serum-constant virus neutralization test with less than 500 ID
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. Twenty dogs shall be vaccinated with a predetermined quantity of vaccine virus and the remaining five dogs held as unvaccinated controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.
(3) On the day of challenge, serum samples shall be obtained from each vaccinate and individually tested for antibody against canine distemper virus. For a valid test, each vaccinate shall be negative at a 1:4 final serum dilution in varying serum-constant virus neutralization test using less than 500 ID
(4) At least 21 days postinoculation, the immunity of the vaccinates and controls shall be challenged by exposure to a uniform dose of aerosolized virulent canine distemper virus. All test dogs shall be observed daily for 21 days postchallenge.
(i) If at least 4 of the 5 controls do not die or show signs of distemper, including a temperature of 104.0 °F. or higher and at least 15 percent weight loss, the test is inconclusive and may be repeated.
(ii) If at least 19 of the 20 vaccinates do not survive without showing a temperature of 104.0 °F. or higher and a weight loss exceeding 15 percent after day 8 postchallenge, the Master Seed Virus is unsatisfactory.
(5) When approved in advance by Animal and Plant Health Inspection Service, a sequential test procedure may be used in lieu of the 20 dog requirement. A beta value of 0.05 and a tolerance level of 0.78 shall be required.
(6) The Master Seed Virus shall be retested for immunogenicity in 3 years unless use of the lot previously tested is discontinued. Only five vaccinates and five controls need to be used in the retest;
(7) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(d) Test requirements for release: Each serial and subserial shall meet the general requirements prescribed in § 113.300 and the requirements in this paragraph. Final container samples of completed product shall be tested. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(1)
(2)
At 72 FR 72564, Dec. 21, 2007, § 113.313 was amended by removing paragraph (c)(6) and redesignating paragraph (c)(7) as paragraph (c)(6), effective Jan. 22, 2008.
Feline Calicivirus Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.300.
(b) The Master Seed Virus shall be tested for chlamydial agents as prescribed in § 113.43.
(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows:
(1) Thirty feline calicivirus susceptible cats shall be used as test animals (20 vaccinates and 10 controls). Throat swabs shall be collected from each cat and individually tested on susceptible cell cultures for the presence of feline calicivirus. Blood samples shall be drawn and individual serum samples tested. The cats shall be considered suitable for use if all swabs are negative for virus isolation and if all serums are negative for calicivirus antibody at the 1:2 final dilution in a 50 percent plaque reduction test or other SN test of equal sensitivity.
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 cats used as vaccinates shall be administered a predetermined quantity of vaccine virus by the method to be recommended on the label and the remaining 10 cats shall be held as controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used. If two doses are used, five replicate confirming titrations shall be conducted on each dose.
(3) Twenty-one or more days after the final dose of vaccine, the vaccinates and controls shall each be challenged intranasally with a minimum of 100,000 TCID
(i) If less than 8 of 10 controls show clinical signs of feline calicivirus infection other than fever, the test is inconclusive and may be repeated.
(ii) If a significant difference in clinical signs cannot be demonstrated between vaccinates and controls using a scoring system approved by Animal and Plant Health Inspection Service and prescribed in the Outline of Production, the Master Seed Virus is unsatisfactory.
(4) The Master Seed Virus shall be retested for immunogenicity in 3 years unless use of the lot previously tested is discontinued. Either 10 vaccinates and 6 controls or 5 vaccinates and 3 controls shall be used in the retest.
(i) If less than 5 of 6 or 3 of 3 of the controls in the retest show clinical signs of feline calicivirus infection other than fever, the test is inconclusive and may be repeated.
(ii) A significant difference in clinical signs shall be demonstrated between vaccinates and controls in a valid test as prescribed in paragraph (c)(3)(ii) of this section.
(5) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(d)
(1)
(2)
At 72 FR 72564, Dec. 21, 2007, § 113.314 was amended by removing paragraph (c)(4) and redesignating paragraph (c)(5) as paragraph (c)(4), effective Jan. 22, 2008.
Feline Rhinotracheitis Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.300.
(b) The Master Seed Virus shall be tested for chlamydial agents as prescribed in § 113.43.
(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows:
(1) Thirty feline rhinotracheitis susceptible cats shall be used as test animals (20 vaccinates and 10 controls). Throat swabs shall be collected from each cat and individually tested on susceptible cell cultures for the presence of feline rhinotracheitis virus. Blood samples shall be drawn and individual serum samples tested. The cats shall be considered suitable for use if all swabs are negative for virus isolation and if all serums are negative for feline rhinotracheitis virus antibody at the 1:2 final dilution in a 50 percent plaque reduction test or other SN test of equal sensitivity.
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 cats used as vaccinates shall be administered a predetermined quantity of vaccine virus by the method to be recommended on the label and the remaining 10 cats shall be held as controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used. If two doses are used, five replicate confirming titrations shall be conducted on each dose.
(3) Twenty-one or more days after the final dose of vaccine, the vaccinates and controls shall each be challenged intranasally with a minimum of 100,000 TCID
(i) If less than 8 of 10 controls show clinical signs of feline rhinotracheitis infection other than fever, the test is inconclusive and may be repeated.
(ii) If a significant difference in clinical signs cannot be demonstrated between vaccinates and controls using a scoring system approved by Veterinary Services and prescribed in the Outline of Production, the Master Seed Virus is unsatisfactory.
(4) The Master Seed Virus shall be retested for immunogenicity in 3 years unless use of the lot previously tested is discontinued. Either 10 vaccinates and 6 controls or 5 vaccinates and 3 controls shall be used in the retest.
(i) If less than 5 of 6 or 3 of 3 of the controls in the retest show clinical signs of feline rhinotracheitis infection other than fever, the test is inconclusive and may be repeated.
(ii) A significant difference in clinical signs shall be demonstrated between vaccinates and controls in a valid test as prescribed in paragraph (c)(3)(ii) of this section.
(5) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(d)
(1)
(2)
At 72 FR 72564, Dec. 21, 2007, § 113.315 was amended by removing paragraph (c)(4) and redesignating paragraph (c)(5) as paragraph (c)(4), effective Jan. 22, 2008.
Canine Parainfluenza Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this section.
(b) Each lot of Master Seed shall be tested for immunogenicity. The selected virus dose shall be established as follows:
(1) Twenty-five canine parainfluenza susceptible dogs (20 vaccinates and 5 controls) shall be used as test animals. Nasal swabs shall be collected from each dog on the day the first dose of vaccine is administered and individually tested on susceptible cell cultures for the presence of canine parainfluenza virus. Blood samples shall also be drawn and individual serum samples tested for neutralizing antibody. Dogs shall be considered susceptible if all swabs are negative for virus isolation and if all serums are negative for canine parainfluenza antibody at a 1:2 final dilution in a constant virus-varying serum neutralization test using 50 to 300 TCID
(2) A geometric mean titer of vaccine produced at the highest passage from the Master Seed shall be established before the immunogenicity test is conducted. The 20 dogs used as vaccinates shall be administered a predetermined quantity of vaccine virus. Five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used to confirm the dosage administered. If two doses are used, five replicate confirming titrations shall be conducted on each dose.
(3) Three to 4 weeks after the final dose of vaccine, all dogs shall be bled for serum antibodies and nasal swabs shall be collected for canine parainfluenza virus isolation. On the same day, all vaccinates and controls shall be challenged with canine parainfluenza virus furnished or approved by Animal and Plant Health Inspection Service.
(4) The rectal temperature of each dog shall be taken and the presence of respiratory or other clinical signs of canine parainfluenza virus infection noted and recorded each day for 14 consecutive days postchallenge. Nasal swabs shall be collected from each dog
(i) If five of five controls have not remained seronegative at a final serum dilution of 1:2 during the prechallenge period, the test is inconclusive and may be repeated.
(ii) If more than one vaccinate shows febrile response, respiratory or other clinical signs of canine parainfluenza virus infection; or, if less than 19 of 20 vaccinates show serum neutralization titers of 1:4 or greater; or, if there is not a significant reduction in virus isolation rate in vaccinates when compared with controls, the Master Seed is unsatisfactory.
(5) The Master Seed shall be retested for immunogenicity in 3 years unless use of the lot previously tested is discontinued. Only five vaccinates and five controls need to be used in the retest:
(6) An Outline of Production change shall be made before authority for use of a new lot of Master Seed shall be granted by Animal and Plant Health Inspection Service.
(c)
(1)
(2) [Reserved]
At 72 FR 72564, Dec. 21, 2007, § 113.316 was amended by removing paragraph (b)(5) and redesignating paragraph (b)(6) as paragraph (b)(5), effective Jan. 22, 2008.
Parvovirus Vaccine recommended for use in dogs shall be prepared from virus-bearing cell culture fluids. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this section.
(b) The Master Seed shall be tested for reversion to virulence in dogs using a method acceptable to Animal and Plant Health Inspection Service. If a significant increase in virulence is seen within five backpassages, the Master Seed is unsatisfactory.
(c) Each lot of Master Seed shall be tested for immunogenicity. The selected virus dose shall be established as follows:
(1) Twenty-five canine parvovirus susceptible dogs (20 vaccinates and 5 controls) shall be used as test animals. Blood samples drawn from each dog shall be individually tested for neutralizing antibody against canine parvovirus to determine susceptibility. Dogs shall be considered susceptible if there is no neutralization at a 1:2 final serum dilution in a constant virus-varying serum neutralization test in cell culture using 50 to 300 TCID
(2) A geometric mean titer of the vaccine produced at the highest passage from the Master Seed shall be established before the immunogenicity test is conducted. The 20 dogs used as vaccinates shall be administered a predetermined quantity of vaccine virus by the method recommended on the label. To confirm the dosage calculations, five replicate virus titrations
(3) Fourteen days or more after the final dose of vaccine the vaccinates and the controls shall be challenged with virulent canine parvovirus furnished or approved by Animal and Plant Health Inspection Service and the dogs observed each day for 14 days. Rectal temperature, blood lymphocyte count, and feces for viral detection shall be taken from each dog each day for at least 10 days postchallenge and the presence or absence of clinical signs noted and recorded each day.
(i) The immunogenicity of the Master Seed shall be evaluated on the following criteria of infection: temperature ≥103.4 ° F; lymphopenia of ≥50 percent of prechallenge normal; clinical signs such as diarrhea, mucus in feces, or blood in feces; and viral hemagglutinins at a level of ≥1:64 in a 1:5 dilution of feces or a test of equal sensitivity. If at least 80 percent of the controls do not show at least three of the four criteria of infection during the observation period, the test is inconclusive and may be repeated.
(ii) If at least 19 of the 20 vaccinates do not survive the observation period without showing more than one criterion of infection described in paragraph (c)(3)(i), of this section, the Master Seed is unsatisfactory.
(4) The Master Seed shall be retested for immunogenicity in 3 years unless use of the lot previously tested is discontinued. Five susceptible dogs (four vaccinates and one control) may be used in the retest. Susceptibility shall be determined in the manner provided in paragraph (c)(1) of this section.
(i) Each vaccinate shall be administered a predetermined quantity of vaccine virus as provided in paragraph (c)(2) of this section.
(ii) Fourteen to 21 days after the last vaccination, a second serum sample shall be drawn from each dog and tested for neutralizing antibody to canine parvovirus in the same manner used to determine susceptibility.
(iii) If the control has not remained seronegative at 1:2, the test is inconclusive and may be repeated.
(iv) If three of the four vaccinates in a valid test do not develop titers of at least 1:16 final serum dilution, and the remaining vaccinate does not develop a titer of at least 1:8, the Master Seed is unsatisfactory, except as provided in paragraph (c)(4)(v) of this section.
(v) If the results of a valid SN test are unsatisfactory, the vaccinates and the control may be challenged as provided in paragraph (c)(3) of this section. If at least three of the four criteria of infection are not shown in the control dog, the test is inconclusive and may be repeated, except that if any of the vaccinates show more than one criterion of infection, the Master Seed is unsatisfactory.
(5) An Outline of Production change shall be made before authority for use of a new lot of Master Seed shall be granted by Animal and Plant Health Inspection Service.
(d)
(1)
At 72 FR 72564, Dec. 21, 2007, § 113.317 was amended by removing paragraph (c)(4) and redesignating paragraph (c)(5) as paragraph (c)(4), effective Jan. 22, 2008.
Pseudorabies Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed which has
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.300 and the requirements in this section.
(b) Each lot of Master Seed shall be tested for immunogenicity. The selected virus dose shall be established as follows:
(1) Twenty-five pseudorabies susceptible pigs (20 vaccinates and 5 controls) of the youngest age for which the vaccine is recommended, shall be used as test animals. Blood samples shall be taken from each pig and the serums inactivated and individually tested for neutralizing antibody against pseudorabies virus. Pigs shall be considered susceptible if there is no neutralization at a 1:2 final serum dilution in a constant virus-varying serum neutralization test using 50 to 300 TCID
(2) A geometric mean titer of the vaccine produced at the highest passage from the Master Seed shall be established before the immunogenicity test is conducted. The 20 pigs used as vaccinates shall be administered a predetermined quantity of vaccine virus by the method recommended on the label. To confirm the dosage administered, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.
(3) Fourteen to 28 days postvaccination, the vaccinates and controls shall be challenged with virulent pseudorabies virus furnished or approved by Animal and Plant Health Inspection Service and observed each day for 14 days.
(i) If at least four of the five controls do not develop severe central nervous system signs or die, the test is inconclusive and may be repeated.
(ii) If at least 19 of the 20 vaccinates in a valid test do not remain free of signs of pseudorabies, the Master Seed is unsatisfactory.
(4) The Master Seed shall be retested for immunogenicity in 3 years unless use of the lot is discontinued. Only five vaccinates and five controls need to be used in the retest. Susceptibility and age requirements shall be as provided in paragraph (b)(1) of this section.
(ii) Fourteen to 28 days postvaccination, a blood sample shall be taken from each pig and the serum inactivated and tested for neutralizing antibody to pseudorabies virus by the same method used to determine susceptibility.
(iii) If the five controls have not remained seronegative at 1:2, the test is inconclusive and may be repeated.
(iv) If at least four of the five vaccinates in a valid test have not developed titers of 1:8 final serum dilution or greater and the remaining vaccinate a titer of 1:4 or greater, the Master Seed is unsatisfactory, except as provided in paragraph (b)(4)(v).
(v) If the results of a valid neutralization test are unsatisfactory, the vaccinates and controls may be challenged as provided in paragraph (b)(3) of this section. If at least four of five controls do not develop severe central nervous system signs or die, the test is inconclusive and may be repeated. If all five of the vaccinates in a valid test do not remain free of signs of pseudorabies, the Master Seed is unsatisfactory.
(5) An Outline of Production change shall be made before authority for use of a new lot of Master Seed shall be granted by Animal and Plant Health Inspection Service.
(c)
(2)
At 72 FR 72564, Dec. 21, 2007, § 113.318 was amended by removing paragraph (b)(4) and redesignating paragraph (b)(5) as paragraph (b)(4), effective Jan. 22, 2008.
Avian Encephalomyelitis Vaccine shall be prepared from virus-bearing tissues or fluids from embryonated chicken eggs. Only Master Seed Virus which has been established as pure, safe, and immunogenic in accordance with the requirements in paragraphs (a), (b), and (c) of this section shall be used for preparing the production seed virus for vaccine production. All serials shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300 and the requirements prescribed in this section.
(b) Each lot of Master Seed Virus shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is inconclusive because of a vaccine virus override, the test may be repeated and if the repeat test is inconclusive for the same reason, the chicken inoculation test prescribed in § 113.36 may be conducted and the virus judged accordingly.
(c) Each lot of Master Seed Virus shall be tested for immunogenicity and the selected virus dose to be used shall be established as follows:
(1) Avian encephalomyelitis susceptible chickens, all of the same age (eight weeks or older) and from the same source, shall be used. Twenty or more chickens shall be used as vaccinates for each method of administration recommended on the label. Ten additional chickens of the same age and from the same source shall be held as unvaccinated controls.
(2) A geometric mean titer of the vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. Each vaccinate shall receive a predetermined quantity of vaccine virus. Five replicate virus titrations shall be conducted on an aliquot of the vaccine virus to confirm the amount of virus administered to each chicken used in the test. At least three appropriate (not to exceed tenfold) dilutions shall be used and the test conducted as follows:
(i) For each dilution, inoculate at least 10 embryos, 5 or 6 days old, in the yolk sac with 0.2 ml each. Twenty similar embryos obtained from the same source shall be kept as uninoculated negative controls. Disregard all deaths during the first 48 hours post-inoculation.
(ii) Eggs for each dilution shall be kept in separate containers and allowed to hatch. Sufficient precaution shall be taken to assure that chickens from each dilution remain separated. To be a valid test, at least 75 percent of the uninoculated eggs shall hatch.
(iii) On the third day after normal hatching time, count all unhatched eggs and all dead, paralyzed and ataxic chickens as positive evidence of viral infection.
(iv) A satisfactory titration shall have at least one dilution with between 50 and 100 percent positives and at least one dilution with between 50 and 0 percent positives.
(v) Calculate the EID
(3) At least 21 days post-vaccination, the vaccinates and the controls shall be challenged intracerebrally with a virulent avian encephalomyelitis virus and observed each day for 21 days.
(4) If at least 80 percent of the controls do not show signs of avian encephalomyelitis or die, the test is inconclusive and may be repeated. If at least 19 of 20, or 27 of 30, or 36 of 40 of the vaccinates in each group do not remain free from clinical signs of avian encephalomyelitis during the observation period, the Master Seed Virus is unsatisfactory.
(5) The Master Seed Virus shall be retested for immunogenicity in 3 years unless use of the lot previously tested is discontinued. Only one method of administration recommended on the label need be used in the retest. The vaccinates and the controls shall meet the criteria prescribed in paragraph (c)(4) of this section.
(6) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(d) After a lot of Master Seed Virus has been established as prescribed in paragraphs (a), (b), and (c) of this section, each serial and subserial shall meet the applicable requirements in § 113.300 and the requirements prescribed in this paragraph.
(1) Final container samples from each serial shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is inconclusive because of a vaccine virus override, the chicken inoculation test prescribed in § 113.36 may be conducted and the vaccine judged accordingly.
(2)
(i) At least 25 AE susceptible birds (6 to 10 weeks of age) shall be vaccinated with the equivalent of 10 doses by each of all routes recommended on the label and be observed each day for 21 days.
(ii) If unfavorable reactions attributable to the biological product occur during the observation period, the serial is unsatisfactory. If unfavorable reactions occur which are not attributable to the product, the test shall be declared inconclusive and repeated, except that, if the test is not repeated, the serial shall be unsatisfactory.
(3)
At 72 FR 72564, Dec. 21, 2007, § 113.325 was amended by removing paragraph (c)(5) and redesignating paragraph (c)(6) as paragraph (c)(5), effective Jan. 22, 2008.
Fowl Pox Vaccine and Pigeon Pox Vaccine shall be prepared from virus-bearing cell culture fluids or embryonated chicken eggs. Only Master Seed Virus which has been established as pure, safe, and immunogenic in accordance with the requirements in paragraphs (a), (b), and (c) of this section shall be used for preparing the production seed virus for vaccine production. All serials shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300 except paragraph (c) of this section and shall meet the requirements prescribed in this section.
(b) Each lot of Master Seed Virus shall be tested for pathogens by the chicken inoculation test prescribed in § 113.36.
(c) Each lot of Master Seed Virus shall be tested for immunogenicity and the selected virus dose to be used shall be established as follows:
(1) Fowl pox susceptible birds all of the same age and from the same source, shall be used as test birds. Twenty or more birds shall be used as vaccinates for each method of administration recommended on the label. Ten additional birds of the same age and from the same source as the vaccinates shall be held as unvaccinated controls.
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. Each vaccinate shall receive a predetermined quantity of vaccine virus. Five replicate virus titrations shall be conducted on an aliquot of the vaccine
(i) For each dilution, inoculate at least five embryos, 9 to 11 days old, on the chorioallantoic membrane with at least 0.2 ml each. Disregard all deaths during the first 24 hours post-inoculation. To be a valid test, at least four embryos in each dilution shall remain viable beyond 24 hours.
(ii) Examine the surviving embryos for evidence of infection 5 to 7 days post-inoculation.
(iii) A satisfactory titration shall have at least one dilution with between 50 and 100 percent positives and at least one dilution with between 50 and 0 percent positives.
(iv) Calculate the EID
(3) Fourteen to twenty-one days post-vaccination, all vaccinates and controls shall be challenged by the wing web method and observed each day for 10 days. If the wing web method was used for vaccination, the opposite wing shall be used for challenge. Challenge virus shall be provided or approved by Animal and Plant Health Inspection Service.
(4) If at least 90 percent of the controls do not develop fowl pox during the observation period, the test is inconclusive and may be repeated. If at least 19 of 20, or 27 of 30, or 36 of 40 of the vaccinates in each group do not remain free from clinical signs of fowl pox during the observation period, the Master Seed Virus is unsatisfactory.
(5) The Master Seed Virus shall be retested for immunogenicity in 3 years unless use of the lot previously tested is discontinued. Only one method of administration recommended on the label need be used in the retest. The vaccinates and the controls shall meet the criteria prescribed in paragraph (c)(4) of this section.
(6) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(d) After a lot of Master Seed Virus has been established as prescribed in paragraphs (a), (b), and (c) of this section, each serial and subserial shall meet the requirements in § 113.36, in § 113.300 except paragraph (c), and in this paragraph.
(1)
(i) Each of 25 susceptible birds 5 days of age or younger, properly identified and obtained from the same source and hatch, shall be vaccinated with the equivalent of 10 doses of vaccine by each of all routes recommended on the label and observed each day for 14 days. Severe clinical signs or death shall be counted as failures. Two-stage sequential testing may be conducted if the first test (which then becomes stage one) has three failures.
(ii) The results shall be evaluated according to the following table:
(iii) If unfavorable reactions occur which are not attributable to the product, the test shall be declared inconclusive and may be repeated or, in lieu thereof, the serial declared unsatisfactory.
(iv) Vaccines not recommended for use in birds 10 days of age or younger shall be tested for safety as follows: Each of twenty-five 3- to 5-week-old, fowl-pox susceptible birds shall be vaccinated with the equivalent of 10 doses of vaccine by each of all routes recommended on the label and observed each day for 14 days. If any of the birds show severe clinical signs of disease or death during the observation period due to causes attributable to the product, the serial is unsatisfactory. If unfavorable reactions occur which are not attributable to the product, the test shall be declared inconclusive and may be repeated or, in lieu thereof, the serial declared unsatisfactory.
(2)
At 72 FR 72564, Dec. 21, 2007, § 113.326 was amended by removing paragraph (c)(5) and redesignating paragraph (c)(6) as paragraph (c)(5), effective Jan. 22, 2008.
Bronchitis Vaccine shall be prepared from virus-bearing cell culture fluids or embryonated chicken eggs. Only Master Seed Virus which has been established as pure, safe, and immunogenic in accordance with the requirements in paragraphs (a), (b), and (c) of this section shall be used for preparing the production seed virus for vaccine production. All serials shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300 and the requirements prescribed in this section.
(b) Each lot of Master Seed Virus shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is inconclusive because of a vaccine virus override, the test may be repeated and if the repeat test is inconclusive for the same reason, the chicken inoculation test prescribed in § 113.36 may be conducted and the virus judged accordingly.
(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity and the selected virus dose to be used shall be established as follows:
(1) Bronchitis susceptible chickens, all of the same age and from the same source, shall be used in the virus-recovery test. For each method of administration recommended on the label for each serotype against which protection is claimed, twenty or more chickens shall be used as vaccinates. Ten additional chickens for each serotype against which protection is claimed shall be held as unvaccinated controls.
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity tests are conducted. Each vaccinate shall receive a predetermined quantity of vaccine virus. Five replicate virus titrations shall be conducted on an aliquot of the vaccine virus to confirm the amount of virus administered to each chicken used in such tests. At least three approved (not to exceed tenfold) dilutions shall be used and the test conducted as follows;
(i) For each dilution, inject at least five embryos, 9 to 11 days old, in the allantoic cavity with 0.1 ml each. Deaths occurring during the first 24 hours shall be disregarded, but at least four viable embyros in each dilution shall survive beyond 24 hours of a valid test. After 5 to 8 days incubation, examine the surviving embryos for evidence of infection.
(ii) A satisfactory titration shall have at least one dilution with between 50 and 100 percent positives and at least one dilution with between 50 and 0 percent positives.
(iii) Calculate the EID
(3) Twenty-one to twenty-eight days post-vaccination, all vaccinates and controls shall be challenged by eye-drop with virulent bronchitis virus. A separate set of vaccinates and controls shall be used for each serotype against which protection is claimed. Each challenge virus shall be approved or provided by Animal and Plant Health Inspection Service and shall titer at least 10
(i) Tracheal swabs shall be taken once, 5 days post-challenge, from each
(ii) All embryos surviving the third day post-inoculation shall be used in the evaluation, except that, if a swab is not represented by at least four embryos, the test of that swab is invalid and the results inconclusive. A tracheal swab shall be positive for virus recovery when any of the embryos in a valid test show typical infectious bronchitis virus lesions, such as but not limited to, stunting, curling, kidney urates, clubbed down, or death during the 4 to 7 day post-inoculation period. If less than 20 percent of the embryos which survive the third day post-inoculation die during the 4 to 7 day post-inoculation period and show no gross lesions typical of infectious bronchitis, they may be disregarded.
(iii) If less than 90 percent of the controls are positive for virus recovery, the test is inconclusive and may be repeated.
(iv) If less than 90 percent of the vaccinates are negative for virus recovery, the Master Seed Virus is unsatisfactory.
(4) The Master Seed Virus shall be retested for immunogenicity in 3 years unless use of the lot previously tested is discontinued. Only one method of administration recommended on the label need be used in the retest. The vaccinates and the controls shall meet the criteria prescribed in paragraph (c)(3) of this section.
(5) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(d) After a lot of Master Seed Virus has been established as prescribed in paragraphs (a), (b), and (c) of this section, each serial and subserial shall meet the applicable requirements in § 113.300 and the requirements prescribed in this paragraph, except that, if the vaccine contains more than one virus type, bulk samples taken from each type prior to mixing shall be used in the virus identity tests prescribed in § 113.300(c). The additional requirements in this paragraph shall also be met.
(1) Final container samples from each serial shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is inconclusive because of a vaccine virus override, the chicken inoculation test prescribed in § 113.36 may be conducted and the vaccine judged accordingly.
(2)
(i) Twenty-five susceptible chickens, 5 days of age or younger, properly identified and obtained from the same source and hatch, shall be vaccinated by the eye-drop method with the equivalent of 10 doses of vaccine and observed each day for 21 days post-vaccination. Severe respiratory signs or death shall be counted as failures. Two-stage sequential testing may be conducted if the first test (which then becomes stage one) has three failures.
(ii) The results shall be evaluated according to the following table:
(3)
(i) The Newcastle disease virus fraction of combined Newcastle-Bronchitis Vaccines shall be neutralized prior to titration of the bronchitis virus fraction. Equal parts of heat-inactivated
(ii) Each bronchitis virus type shall be harvested separately and a sample of bulk harvested material shall be collected prior to mixing with the other virus type(s). Each sample shall contain not less than the minimum virus titer stated in the filed Outline of Production.
(iii) To be eligible for release, each serial and each subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10
At 72 FR 72564, Dec. 21, 2007, § 113.327 was amended by removing paragraph (c)(4) and redesignating paragraph (c)(5) as paragraph (c)(4), effective Jan. 22, 2008.
Fowl Laryngotracheitis Vaccine shall be prepared from virus-bearing cell culture fluids or embryonated chicken eggs. Only Master Seed Virus which has been established as pure, safe, and immunogenic in accordance with the requirements in paragraphs (a), (b), and (c) of this section shall be used for preparing the production seed virus for vaccine production. All serials shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300 and the requirements prescribed in this section.
(b) Each lot of Master Seed Virus shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is inconclusive because of vaccine virus override, the test may be repeated and if the repeat test is inconclusive for the same reason, the chicken inoculation test prescribed in § 113.36 may be conducted and the virus judged accordingly. Each lot shall also be tested for safety as follows:
(1) Each of at least ten 3 to 4 week old susceptible chickens obtained from the same source and hatch as those used in the immunogenicity test prescribed in paragraph (c) of this section shall be injected intratracheally with 0.2 ml of the virus as used in the vaccine and the chickens observed each day for 14 days.
(2) If more than 20 percent of the chickens die during the observation period, the virus is unsatisfactory.
(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity and the selected virus dose to be used shall be established as follows:
(1) Fowl laryngotracheitis susceptible chickens all of the same age and from the same source shall be used. Twenty or more chickens shall be used as vaccinates for each method of administration recommended on the label. Ten additional chickens of the same age and from the same source shall be held as unvaccinated controls.
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. Each vaccinate shall receive a predetermined quantity of vaccine virus. Five replicate virus titrations shall be conducted on an aliquot of the vaccine virus to confirm the amount of virus administered to each chicken used in the test. At least three appropriate (not to exceed tenfold) dilutions shall be used for vaccine of chicken embryo origin and the test conducted as follows:
(i) For each dilution, inject at least five embryos, 9 to 11 days old, on the chorioallantoic membrane with 0.2 ml each. Disregard all deaths during the first 24 hours post-injection. To be a valid test, at least four embryos in each dilution shall remain viable beyond 24 hours.
(ii) Examine the surviving embryos for evidence of infection 5 to 8 days post-injection.
(iii) A satisfactory titration shall have at least one dilution with between 50 and 100 percent positives and at least one dilution with between 50 and 0 percent positives.
(iv) Calculate the EID
(3) Tissue culture origin vaccine may be titrated by a tissue culture method approved by Animal and Plant Health Inspection Service and written into the filed Outline of Productions.
(4) Ten to fourteen days post-vaccination, all vaccinates and controls shall be challenged intratracheally or in the orbital sinus with infectious fowl laryngotracheitis virus and observed each day for 10 days. Challenge virus shall be provided or approved by Animal and Plant Health Inspection Service.
(5) If at least 80 percent of the controls do not die or show clinical signs of fowl laryngotracheitis during the observation period, the test is inconclusive and may be repeated. If at least 19 of 20, 27 of 30, or 36 of 40 of the vaccinates in each group do not remain free of clinical signs of fowl laryngotracheitis during the observation period, the Master Seed Virus is unsatisfactory.
(6) The Master Seed Virus shall be retested for immunogenicity in 3 years unless use of the lot previously tested is discontinued. Only one method of administration recommended on the label need be used in the retest. The vaccinates and the controls shall meet the criteria prescribed in paragraphs (c)(4) and (5) of this section.
(7) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(d) After a lot of Master Seed Virus has been established as prescribed in paragraphs (a), (b), and (c) of this section, each serial and subserial shall meet the applicable requirements in § 113.300 and the requirements prescribed in this paragraph.
(1) Final container samples from each serial shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is inconclusive because of a vaccine virus override, the chicken inoculation test prescribed in § 113.36 may be conducted and the vaccine judged accordingly.
(2)
(i) Twenty-five 3 to 4 week old laryngotracheitis susceptible chickens shall be injected intratracheally with 0.2 ml of vaccine rehydrated at the rate of 30 ml for 1,000 doses. Chickens shall be observed each day for 14 days. Deaths shall be counted as failures. Two-stage sequential testing may be conducted if the first test (which then becomes stage one) has five, six, or seven failures.
(ii) The results shall be evaluated according to the following table:
(iii) If unfavorable reactions occur which are not attributable to the product, the test shall be declared inconclusive and repeated or in lieu thereof, the serial declared unsatisfactory.
(3)
At 72 FR 72564, Dec. 21, 2007, § 113.328 was amended by removing paragraph (c)(6) and redesignating paragraph (c)(7) as paragraph (c)(6), effective Jan. 22, 2008.
Newcastle Disease Vaccine shall be prepared from virus-bearing cell culture fluids or embryonated chicken eggs. Only Master Seed Virus which has been established as pure, safe, and immunogenic in accordance with the requirements in paragraphs (a), (b), and (c) of this section shall be used for preparing the production seed virus for vaccine production. All serials shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300, except § 113.34, and the requirements prescribed in this section.
(b) Each lot of Master Seed Virus shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is inconclusive because of a vaccine virus override, the test may be repeated and if the repeat test is inconclusive for the same reason, the chicken inoculation test prescribed in § 113.36 may be conducted and the virus judged accordingly.
(c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity and the selected virus dose to be used shall be established as follows:
(1) Newcastle Disease susceptible chickens, all of the same age and from the same source, shall be used. Twenty or more chickens shall be used as vaccinates for each method of administration recommended on the label. Ten additional chickens of the same age and from the same source shall be held as unvaccinated controls.
(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. Each vaccinate shall receive a predetermined quantity of vaccine virus. Five replicate virus titrations shall be conducted on an aliquot of the vaccine virus to confirm the amount of virus administered to each chicken used in the test. At least three appropriate (not to exceed tenfold) dilutions shall be used and the test conducted as follows:
(i) For each dilution, inject at least five embryos, 9 to 11 days old, in the allantoic cavity with at least 0.1 ml each. Disregard all deaths during the first 24 hours post-injection. To be a valid test, at least four embryos in each dilution shall remain viable beyond 24 hours.
(ii) Examine the surviving embryos for evidence of infection 5 to 7 days post-injection.
(iii) A satisfactory titration shall have at least one dilution with between 50 and 100 percent positives and at least one dilution with between 50 and 0 percent positives.
(iv) Calculate the EID
(3) Twenty to twenty-eight days postvaccination, all vaccinates and controls shall be challenged intramuscularly with at least 10
(4) If at least 90 percent of the controls do not develop clinical signs of Newcastle disease during the observation period, the test is inconclusive and may be repeated. If at least 19 of 20, or 27 of 30, or 36 of 40 of the vaccinates in each group do not remain free from
(5) The Master Seed Virus shall be retested for immunogenicity in 3 years unless use of the lot previously tested is discontinued. Only one method of administration recommended on the label need be used in the retest. The vaccinates and the controls shall meet the criteria prescribed in paragraph (c)(4) of this section.
(6) A strain identity test acceptable to Animal and Plant Health Inspection Service shall be conducted.
(7) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(d) After a lot of Master Seed Virus has been established as prescribed in paragraphs (a), (b), and (c) of this section, each serial and subserial shall meet the applicable requirements in § 113.300, except § 113.34, and the requirements prescribed in this paragraph.
(1) Final container samples from each serial shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is inconclusive because of a vaccine virus override, the chicken inoculation test prescribed in § 113.36 may be conducted and the vaccine judged accordingly.
(2) Safety test: Final container samples of completed product from each serial shall be tested to determine whether the vaccine is safe for use in susceptible young chickens. Vaccines recommended for use in chickens 10 days of age or younger shall be tested in accordance with paragraphs (d)(2)(i), (ii), and (iii) of this section.
(i) Twenty-five susceptible chickens, 5 days of age or younger, properly identified and obtained from the same source and hatch, shall be vaccinated by the eye drop method with the equivalent of 10 doses of vaccine and the chickens observed each day for 21 days. Severe respiratory signs or death shall be counted as failures. Two-stage sequential testing may be conducted if the first test (which then becomes stage one) has 3 failures.
(ii) The results shall be evaluated according to the following table:
(iii) If unfavorable reactions occur which are not attributable to the product, the test shall be declared inconclusive and may be repeated.
(iv) Vaccines not recommended for use in chickens 10 days of age or younger shall be tested for safety as follows:
Each of twenty-five 3 to 5 week old Newcastle disease susceptible chickens shall be vaccinated as recommended on the label with the equivalent of ten doses and observed each day for 21 days. If any of the birds show severe clinical signs of disease or death during the observation period due to causes attributable to the product, the serial is unsatisfactory.
(3)
At 72 FR 72564, Dec. 21, 2007, § 113.329 was amended by removing paragraph (c)(5) and redesignating paragraphs (c)(6) and (c)(7) as paragraphs (c)(5) and (c)(6), effective Jan. 22, 2008.
Marek's disease vaccine shall be prepared from virus-bearing tissue culture cells. Only Master Seed Virus which has been established as pure, safe, and
(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300, and the requirements prescribed in this section. The identity test required in § 113.300(c) shall be conducted in a serotype-specific manner by a method acceptable to APHIS. Each lot of Master Seed Virus shall also be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is inconclusive because of a vaccine virus override, the chicken inoculation test prescribed in § 113.36 may be conducted and the virus judged accordingly.
(b)
(1) Specific pathogen free chickens or embryos, negative for Marek's disease virus antibodies, and from the same source, shall be isolated into the following groups:
(i)
(ii)
(iii)
(iv)
(2) At least 40 chickens in each group shall survive to 5 days of age. All chickens that die shall be necropsied and examined for lesions of Marek's disease and cause of death. The test shall be judged according to the following criteria:
(i) At 50 days of age, the remaining chickens in group 2 shall be killed and examined for gross lesions of Marek's disease. If at least 80 percent of this group do not develop Marek's disease, the test is inconclusive and may be repeated.
(ii) At 120 days of age, the remaining chickens in groups 1, 3, and 4 shall be weighed, killed, and necropsied. If less than 30 of the chickens in group 3 survive the 120 day period, or if any of the chickens in group 3 have gross lesions of Marek's disease at necropsy, the test is declared inconclusive. If less than 30 chickens in groups 1 and 4 survive the 120 day period; or if any of the chickens in groups 1 and 4 have gross lesions of Marek's disease at necropsy; or if the average body weight of the chickens in groups 1 or 4 is significantly (statistically) different from the average in group 3 at the end of the 120 days, the lot of Master Seed Virus is unsatisfactory.
(3) For tests involving
(c)
(1) Specific pathogen free chickens or embryos, negative for Marek's disease antibodies, and from the same source, shall be isolated into the following groups:
(i)
(ii)
(iii)
(iv)
(2) At least 30 chickens in groups 1, 2, and 4, and at least 20 chickens in group 3, shall survive to 5 days of age. All chickens in groups 1, 2, and 4 shall be challenged at 5 days of age in the following manner:
(i) For studies evaluating vaccines which contain only a Serotype 3 virus as the Marek's disease fraction, groups 1 and 2 shall be inoculated with a standard virulent challenge virus provided or approved by APHIS.
(ii) For all other Marek's disease vaccines, groups 1, 2, and 4 shall be inoculated with a very virulent challenge virus provided or approved by APHIS.
(3) All chickens shall be observed until 7 weeks of age, necropsied, and examined for grossly observable lesions consistent with Marek's disease. All chickens dying before the end of the 7 week observation period shall be necropsied and evaluated for gross lesions of Marek's disease. Any chickens not so examined shall be scored as positive for Marek's disease.
(4) For a valid test, at least 80 percent of the chickens in group 2 must develop grossly observable lesions, none of the chickens in group 3 shall develop grossly observable lesions, and (when included) greater than 20 percent of the chickens in group 4 must develop grossly observable lesions.
(5) For a valid test to be considered satisfactory, at least 80 percent of the chickens in group 1 must remain free of grossly observable lesions. The appropriate product claim resulting from a satisfactory test would be to aid in the prevention of Marek's disease, for vaccines containing only a Serotype 3 virus as the Marek's disease fraction, or to aid in the prevention of very virulent Marek's disease, for all other vaccines.
(d)
(1)
(2)
(i) If at least 20 chickens do not survive the observation period, the test is inconclusive.
(ii) If lesions of any disease or cause of death are directly attributable to the vaccine, the serial is unsatisfactory.
(iii) If less than 20 chicks survive the observation period and there are no deaths or lesions attributable to the vaccine, the test may be repeated one time,
(3)
(i) Samples of desiccated vaccine shall be incubated at 37°C for 3 days before preparation for use in the potency test. Samples of desiccated or frozen vaccine shall be reconstituted in diluent according to the label recommendations, and held in an ice bath at 0°C to 4°C for 2 hours prior to use in the potency test.
(ii) For a serial or subserial to be eligible for release, each serotype contained in the vaccine shall have a virus titer per dose which is at least 3 times greater than the number of plaque forming units (pfu) used in the immunogenicity test prescribed in paragraph (c) of this section, but not less than 1000 pfu per dose.
(iii) When tested (without the pretest incubation of desiccated products) at
Bursal Disease Vaccine shall be prepared from virus-bearing cell culture fluids or embryonated chicken eggs. Only Master Seed Virus which has been established as pure, safe, and immunogenic in accordance with the requirements in paragraphs (a), (b), and (c) of this section shall be used for preparing the production seed virus for vaccine production. All serials shall be prepared from the first through the fifth passage from the Master Seed Virus.
(a) The Master Seed Virus shall meet the applicable requirements prescribed in § 113.300 and the requirements prescribed in this section.
(b) Each lot of Master Seed Virus shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is inconclusive because of a vaccine virus override, the chicken inoculation test prescribed in § 113.36 may be conducted and the virus judged accordingly. Each lot of Master Seed Virus used in the preparation of modified live virus vaccines shall also be nonpathogenic to chickens as determined by the following procedures:
(1) Each of twenty-five 1-day-old bursal disease susceptible chickens (vaccinates) shall be injected subcutaneously with 10 times the recommended dose of vaccine virus and observed for 21 days. Fifteen chickens of the same source and hatch shall be kept isolated as controls.
(i) Seventeen days postvaccination, each of five controls shall be administered at least 10
(ii) If the vaccinates do not remain free of clinical signs of bursal disease, the Master Seed Virus is unsatisfactory. If unfavorable reactions which are not attributable to the Master Seed Virus occur in more than two of the vaccinates, the test shall be declared inconclusive and may be repeated.
(iii) Twenty-one days postvaccination, the vaccinates and the controls shall be necropsied and examined for gross lesions of bursal disease. If more than two of the vaccinates have such lesions, the Master Seed Virus is unsatisfactory, except that, if any of the negative controls or less than four of the positive controls have such lesions, the test is inconclusive and may be repeated. For purposes of this test, gross lesions shall include obvious pathological processes and/or obvious reduction in size of the bursa from normal.
(2) Each of thirty-five 3- to 4-week-old bursal disease susceptible chickens (vaccinates) shall be vaccinated with approximately one minimum protective dose of vaccine virus as determined in paragraph (c) of this section. Each of 10 chickens of the same source and hatch shall be administered at least 10
(i) Three or four days postvaccination, 10 of the vaccinates, the 10 positive controls, and 10 of the negative controls shall be necropsied and examined for gross lesions of bursal disease. If any of the vaccinates have such lesions, the Master Seed Virus is unsatisfactory, except that, if any of the negative controls or less than 8 of the positive controls have such lesions, the test is inconclusive and may be repeated. For purposes of this test, gross lesions shall include peri-bursal edema and/or edema and/or macroscopic hemorrhage in the bursal tissue.
(ii) Fourteen days post-vaccination, the remaining vaccinates and negative controls shall be necropsied and examined for obvious bursal atrophy. If any of the vaccinates have such atrophy, the Master Seed Virus is unsatisfactory, except that, if any of the negative controls have such atrophy, the test is inconclusive and may be repeated.
(c) Each lot of Master Seed Virus shall be tested for immunogenicity and
(1) Bursal Disease susceptible chickens, all of the same age (3 weeks or younger) and from the same source, shall be used. Twenty or more chickens shall be used as vaccinates for each method of administration recommended on the label. Ten additional chickens of the same age and from the same source shall be held as unvaccinated controls.
(2) A geometric mean titer of the vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. Each vaccinate shall receive a predetermined quantity of vaccine virus. Five replicate virus titrations shall be conducted on an aliquot of the vaccine virus to confirm the amount of virus administered to each chicken used in the test. At least three appropriate (not to exceed tenfold) dilutions shall be used to conduct the titrations by a method acceptable to Animal and Plant Health Inspection Service.
(3) When the test chickens are 28 to 35 days of age but not less than 14 days postvaccination, each vaccinate and each control shall be challenged by eye-drop with a virulent bursal disease virus provided or approved by Animal and Plant Health Inspection Service.
(i) Three to five days postchallenge, all vaccinates and controls shall be necropsied and examined for gross lesions of bursal disease as described in paragraph (b)(2)(i) of this section.
(ii) If at least 19 of 20, or 27 of 30, or 36 of 40 vaccinates in each group are not free from such lesions, the Master Seed Virus is unsatisfactory, except that, if less than 90 percent of the controls have such lesions, the test is inconclusive and may be repeated.
(4) The Master Seed Virus shall be retested for immunogenicity in 3 years from the original testing unless use of the lot previously tested is discontinued. Only one method of administration recommended on the label need be used in the retest. The vaccinates and the controls shall meet the criteria prescribed in paragraph (c)(3) of this section.
(5) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.
(d) After a lot of Master Seed Virus has been established as prescribed in paragraphs (a), (b), and (c) of this section, each serial and subserial shall meet the applicable requirements in § 113.300 and the requirements prescribed in this paragraph.
(1)
(2)
(A) For vaccines intended for parenteral administration, each of twenty-five 1-day-old bursal disease susceptible chickens shall be vaccinated with the equivalent of 10 doses by subcutaneous injection.
(B) For vaccines intended for drinking water administration, each of twenty-five 4- to 5-week-old bursal disease susceptible chickens shall be vaccinated orally with the equivalent of 10 doses.
(C) Ten chickens of the same source and hatch shall be maintained in isolation as negative controls. The vaccinates and controls shall be observed each day for 21 days.
(ii) If unfavorable reactions which are attributable to the biological product occur during the observation period, the serial is unsatisfactory. If unfavorable reactions occur in more than one of the controls or if unfavorable reactions which are not attributable to the biological product occur in more than two of the vaccinates, the test shall be declared inconclusive and repeated, except that, if the test is not repeated, the serial shall be unsatisfactory.
(3)
At 72 FR 72564, Dec. 21, 2007, § 113.331 was amended by removing paragraph (c)(4) and redesignating paragraph (c)(5) as paragraph (c)(4), effective Jan. 22, 2008.
Tenosynovitis Vaccine shall be prepared from virus-bearing cell culture fluids or embryonated chicken eggs.
Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed.
(a) The Master Seed shall meet the applicable general requirements prescribed in § 113.300, except (a)(3)(ii) and (c), and the special requirements in this section.
(b) Each lot of Master Seed shall be tested for:
(1) Pathogens by the chicken inoculation test prescribed in § 113.36.
(2) Lymphoid leukosis virus contamination as follows:
(i) Each of at least 10 3-week-old or older lymphoid leukosis free chickens from the same source and hatch shall be injected intra-muscularly with an amount of Master Seed equal to 100 label doses of vaccine. At least 15 chickens of the same source and hatch shall be used as controls; 5 or more shall be unvaccinated and serve as negative controls; 5 or more shall be injected with subgroup A lymphoid leukosis virus; and 5 or more with subgroup B lymphoid leukosis virus. Each group of control chickens shall be held isolated from each other and from the vaccinates.
(ii) Twenty-one to 28 days postinoculation, blood samples shall be taken from each chicken and the serum separated using a technique conducive to virus preservation. These serums shall be used as inocula in the complement fixation for avian lymphoid leukosis (COFAL) test prescribed in § 113.31.
(iii) Serums from the vaccinates shall be tested separately, but serums within each control group may be pooled. A valid test shall have positive COFAL reactions from each virus inoculated group and negative reactions from the uninoculated controls. If any of the chickens injected with the Master Seed have positive COFAL test reactions in a valid test, the Master Seed is unsatisfactory.
(3) Identity using the following agar gel immunodiffusion test. The undiluted Master Seed may be used as test antigen or the Master Seed may be inoculated onto the chorioallantoic membrane (CAM) of fully susceptible chicken embryos and the infected CAMs ground and used as antigen. A known tenosynovitis antiserum and a known tenosynovitis antigen shall be used in the test. A precipitin line shall form between the test antigen and the known antiserum in the center well which shows identity with the line formed between the antiserum and the known antigen, or the Master Seed is unsatisfactory.
(4) Safety using the following chicken test:
(i) For vaccines intended for use in chickens less than 14 days of age, Master Seed equal to 10 label doses shall be administered subcutaneously to each of 25 1-day-old tenosynovitis susceptible chickens.
(ii) For vaccines intended for use only in chickens 14 days of age or older, Master Seed equal to 10 label doses shall be administered subcutaneously to each of 25 4-week-old or older tenosynovitis susceptible chickens.
(iii) The vaccinates shall be observed each day for 21 days. If unfavorable reactions occur which are attributable to the vaccine, the Master Seed is unsatisfactory. If unfavorable reactions
(c) Each lot of Master Seed shall be tested for immunogenicity. The selected virus dose shall be established as follows:
(1) Tenosynovitis susceptible chickens, of the same age and from the same source shall be used as test birds. Vaccines intended for use in very young chickens shall be administered to chickens of the youngest age for which the vaccine is recommended. Vaccines intended for use in older chickens shall be administered to 4-week-old or older chickens. Twenty or more vaccinates shall be used for each method of administration recommended on the label. Ten or more chickens shall be held as unvaccinated controls.
(2) A geometric mean titer of the vaccine produced at the highest passage from the Master Seed shall be established using a method acceptable to Animal and Plant Health Inspection Service before the immunogenicity test is conducted. A predetermined quantity of vaccine virus shall be administered to each vaccinate. Five replicate virus titrations shall be conducted on an aliquot of the vaccine virus to confirm the dose.
(3) Twenty-one to 28 days postvaccination, each vaccinate and control shall be challenged by injecting virulent virus furnished or approved by Animal and Plant Health Inspection Service into one foot pad. The vaccinates and controls shall be observed each day for 14 days. If at least 90 percent of the controls do not develop swelling and discoloration in the phalangeal joint area of the injected foot pad typical of infection with tenosynovitis virus, the test is inconclusive and may be repeated. If at least 19 of 20, 27 of 30, or 36 of 40 vaccinates do not remain free from these signs, disregarding transient swelling which subsides within 5 days postchallenge, the Master Seed is unsatisfactory.
(4) The Master Seed shall be retested for immunogenicity in 3 years unless use of the lot is discontinued. Only one method of administration recommended on the label need be used in the retest. The vaccinates and controls shall meet the criteria prescribed in paragraph (c)(3) of this section.
(5) An Outline of Production change shall be made before authority for use of a new lot of Master Seed shall be granted by Animal and Plant Health Inspection Service.
(d)
(1)
(2)
(A) For vaccines intended for use in very young chickens, each of 25 1-day-old tenosynovitis susceptible chickens shall be vaccinated with the equivalent of 10 doses by one method recommended on the label.
(B) For vaccines intended for use in older chickens, each of 25 4-week-old or older tenosynovitis susceptible chickens shall be vaccinated with the equivalent of 10 doses by one method recommended on the label.
(ii) The vaccinates shall be observed each day for 21 days. If unfavorable reactions occur which are attributable to the product, the serial is unsatisfactory. If unfavorable reactions occur in more than two vaccinates which are not attributable to the product, the test is inconclusive and may be repeated. If the test is not repeated, the serial is unsatisfactory.
(3)
(4)
At 72 FR 72564, Dec. 21, 2007, § 113.332 was amended by removing paragraph (c)(4) and redesignating paragraph (c)(5) as paragraph (c)(4), effective Jan. 22, 2008.
Tuberculin, Intradermic, is a filtrate produced from cultures of Pn, C, and Dt strains of
(a)
(1) Final container samples of completed product shall be tested for viable bacteria and fungi as prescribed in § 113.26.
(2) A 20 ml sample shall be centrifuged and the sediment examined microscopically for the presence of acidfast (Ziehl-Nielsen stain) or other microorganisms (Gram stain). A serial which contains microorganisms is unsatisfactory for release.
(b)
(c)
(1) The guinea pigs shall be sensitized with a sterile heat-killed suspension of equal amounts of strains Pn, C, and Dt of
(2) The guinea pigs shall be prepared for sensitivity testing at least 4 hours prior to the injection of tuberculin. The entire abdominal and flank areas shall be clipped, a depilatory agent applied for 5-10 minutes, the area rinsed with warm water, and dried.
(3) Dilutions of 1:100, 1:200, and 1:400 shall be prepared with the Reference Tuberculin and the unknown tuberculin. Three test sites on each side of and equidistant from the abdominal midline shall be chosen on each guinea pig. Using a tuberculin syringe and needle, 0.05 ml of each dilution shall be injected intradermally at one of the test sites which has been randomly selected for the dilution.
(4) The sensitivity of the tuberculins shall be determined 24 hours after injected by measuring the area of erythema. Measurements in millimeters shall be made anterior of the greatest diameter and perpendicular to the first measurement. The square millimeter shall be calculated by multiplying the two measurements.
(5) The total area of response for each tuberculin tested shall be determined by adding the areas of erythema for each dilution of each of the test animals in a group. The sums of the areas
(6) The total tuberculin response area of the serial being tested shall be expressed as a percentage of the total tuberculin response area of the Reference Tuberculin. (The total response area of the serial divided by the total response area of the Reference Tuberculin times 100.)
(7) If the total tuberculin response area of the serial being tested does not fall between 75 percent and 125 percent of the total tuberculin response area of the Reference Tuberculin, the serial is unsatisfactory.
(8) Two unsensitized guinea pigs are given 0.05 ml intradermal injections of 1:4 and 1:10 dilutions of both the serial being tested and the Reference Tuberculin as a control for nonspecific positive reactions. If positive reactions are observed with the Reference Tuberculin, the test is considered a “No Test” and repeated. If positive reactions are observed with the serial being tested only, the serial is unsatisfactory.
(d)
(1)
(2)
(3)
(4)
(5)
Pullorum Antigen shall be produced from a culture of representative strains of
(a)
(b)
(c)
(2) The phenol content for Pullorum Tube Antigen shall be 0.55 ±0.05 percent as determined by direct titration with a standardized bromide-bromate solution.
(d)
(2) A total of at least 12 serums shall be used. This shall include at least three definitely positive, at least three weakly positive, and at least six negative serums. At least three positive chicken serums diluted with negative chicken serum shall be used to further assay comparative sensitivity between test and reference plate antigens. All test antigens shall agree closely with the reference antigen. Tests in which variation of readings between the reference and test antigen would result in a different National Poultry Improvement Plan classification shall be regarded as unsatisfactory. No unsatisfactory tests among the six or more negative serums and not more than one unsatisfactory test among the six or more positive serums shall be permitted. All tests performed shall be included for evaluation of the sensitivity assay. In the event of an unsatisfactory test using positive serums, at least three additional definitely positive and three additional weakly positive serums shall be tested. If not more than one unsatisfactory test is obtained with the additional serums, the antigen shall be acceptable.
(e)
(f)
Mycoplasma antigens shall be prepared from organisms, grown in broth cultures, that are inactivated and standardized. Plate antigens shall be stained with a dye acceptable to Animal and Plant Health Inspection Service (APHIS). Final container samples of completed product from each serial shall be tested for density, preservative content, homogeneity, hydrogen ion concentration, purity, sensitivity, and specificity in accordance with the conditions prescribed for each test. A serial found unsatisfactory by any prescribed test shall not be released.
(a)
(b)
(c)
(2) Stereo-microscopic examination shall be used when necessary to evaluate a granular appearing antigen.
(d)
(e)
(f)
(1) The sensitivity of Mycoplasma Gallisepticum Antigen shall be tested using a set of chicken and a set of turkey serums (the positive serums shall have varying degrees of reactivity from weakly positive to strongly positive).
(2) The sensitivity of Mycoplasma Synoviae Antigen shall be tested using chicken serums.
(3) The sensitivity of Mycoplasma Meleagridis Antigen shall be tested using turkey serums.
(g)
Tuberculin—PPD Bovis, Intradermic is a purified protein derivative produced from cultures of
(a)
(b)
(c)
(1)
(2)
(ii) Sensitize one group of guinea pigs to
(iii) Maintain an unsensitized group as control animals.
(3) Thirty-five days post-injection, the guinea pigs shall be used for tuberculin testing.
(4) The sensitized animals and controls shall be prepared at least 4 hours prior to injection of PPD tuberculin by clipping the hair from the entire abdominal and flank areas, applying a depilatory agent for 5 to 10 minutes, then rinsing with warm water and drying.
(i) Select four sites on each guinea pig for injection of PPD tuberculin. Two sites shall be on each side of the
(ii) Prepare four dilutions of the Reference PPD Tuberculin and each serial of PPD tuberculin being tested so as to contain 0.6, 1.2, 2.4, and 4.8 micrograms of protein per 0.1 ml dose. Each of the four dilutions of the same tuberculin shall be randomly assigned a site on a guinea pig.
(iii) Inject one dose of each dilution at the assigned site using a tuberculin syringe.
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(d)
(1)
(2)
Unless otherwise prescribed in a Standard Requirement or in a filed Outline of Production, all antibody
(a)
(b)
(1)
(2)
(3)
(4)
(c)
(1) No animal shall be used while showing clinical signs of disease. The presence of minor localized injuries or lesions (contusions, lacerations, burns, etc.) without body temperature elevation and without significant pain and distress shall not be construed as clinical evidence of disease.
(2) Before first use and on a regular basis, all animals used in the manufacture of antibody products shall be individually subjected to applicable tests for infectious diseases. Records of all test results shall be maintained. An animal which tests positive for an infectious disease shall not be used in the manufacture of antibody products. Retests shall be conducted as deemed necessary by the Administrator.
(i) Before first use, horses shall be tested as follows for:
(A) Equine infectious anemia (EIA) at a laboratory approved by APHIS.
(B) Piroplasmosis, dourine, and glanders at the National Veterinary Services Laboratories.
(C) Brucellosis at a laboratory approved by APHIS. Horses with standard agglutination titers of 1:50 or less can be used for production. Horses with standard agglutination titers equal to or greater than 1:100 may be tested by the Rivanol or card tests. Reactors to these supplemental tests shall not be
(ii) Horses shall be retested annually for EIA and, if housed or pastured with any other species, shall be retested annually for brucellosis.
(iii) Before first use, cattle shall be tested as follows for:
(A) Tuberculosis by an accredited veterinarian:
(B) Brucellosis at a laboratory approved by APHIS. Cattle with standard agglutination titers of 1:50 or less can be used for production. Cattle with standard agglutination titers equal to or greater than 1:100 may be tested by the Rivanol or card tests. Reactors to these supplemental tests shall not be used for production. Nonreactors to the supplemental tests shall be retested after 30 days. If the supplemental tests are negative and the agglutination titer has not increased, the animal may be used for production; otherwise, the animal is unsatisfactory for this purpose. Cattle at Grade A dairies supplying only lacteal secretions need not be tested individually for brucellosis if a portion of their secretions contribute to the herd milk pool tested as required by the brucellosis ring test. An animal of a herd testing positive by this test shall not be used in production.
(iv) Cattle shall be retested annually for both tuberculosis and brucellosis. Cattle at Grade A dairies supplying only lacteal secretions need only be tested for tuberculosis in accordance with applicable Milk Ordinances or similar laws or regulations. Cattle at Grade A dairies supplying only lacteal secretions need not be tested individually for brucellosis if a portion of their secretions contribute to the herd milk pool tested as required by the brucellosis ring test. An animal of a herd testing positive by this test shall not be used in production.
(v) For other species, appropriate tests and the frequency with which they are applied shall be specified in the filed Outline of Production for the product.
(vi) If a positive result is obtained on any prescribed test, the positive animal(s) shall be removed from the herd and the remaining animals retested. Production shall not be renewed until a negative herd test is obtained not less than 28 days following removal of the positive animal(s).
(vii) Negative animals shall be maintained separate and apart from untested or positive animals of any species. Production animals shall not be used for any other purpose, such as testing, work, or recreation.
(d)
(e)
(1) Blood derivatives of equine origin shall be heated at 58.0-59.0° C for 60 minutes, and blood derivatives of bovine, porcine, or other origin shall be heated at 58.0-59.0° C for 30 minutes. In lieu of heat treatment, blood derivatives of any origin may be treated with at least 2.5 megarads of ionizing radiation, with a maximum radiation dosage specified in the filed Outline of Production for the product.
(2) Lacteal secretions shall be heated as described in paragraph (e)(1) of this
(3) Egg material shall be heated at 58.0-59.0° C for 30 minutes, or treated with at least 2.5 megarads of ionizing radiation, with a maximum radiation dosage specified in the filed Outline of Production for the product.
(4) Blood derivatives, lacteal secretions, and egg material shall not contain preservatives at the time of heat treatment, and immediately after heat treatment shall be cooled to 7° C or lower.
(5) Licensees shall keep detailed records as to each batch treated and each serial of product prepared for marketing. Recording charts shall bear full information concerning the material treated and tests made of the equipment used for treatment.
(f)
(1) Phenol 0.25 to 0.55 percent, or
(2) Cresol 0.10 to 0.30 percent, and/or
(3) Thimerosal 0.01 to 0.03 percent, or
(4) Other preservative(s) specified in the filed Outline of Production for the product.
(g)
(1) For each antigen, a Master Seed shall be established.
(i) Bacterial Master Seeds shall be tested for purity and identity as prescribed for live bacterial vaccines in § 113.64.
(ii) Viral Master Seeds shall be tested for purity and identity as prescribed for live virus vaccines in § 113.300.
(2) The maximum allowable passage level of the hyperimmunizing antigen shall be the passage level of the antigen used to generate product shown to be efficacious and shall not exceed 10 passages from the Master Seed.
(h)
(1) Dried products for parenteral administration and liquid products shall be tested as prescribed in § 113.26.
(2) For dried products for oral administration, 10 final container samples shall be reconstituted with sterile water at the volume recommended on the label and tested for the following contaminants:
(i)
(ii)
(iii)
(iv)
(i)
Tetanus Antitoxin is a specific antibody product containing antibodies directed against the toxin of
(a)
(1) All final containers of Tetanus Antitoxin shall yield not less than the labeled unitage of antitoxin throughout the dating period. The minimum package size permitted for marketing in the United States shall be a 1,500 unit vial.
(2) The expiration date of Tetanus Antitoxin shall be not more than 3 years after the date of a potency test which demonstrates that the recoverable antitoxin from the final container provides at least 20 percent excess over the number of units claimed on the label or not more than 1 year after the date of a potency test which demonstrates that the recoverable antitoxin from the final container provides 10 to 19 percent excess over the number of units claimed on the label.
(b)
(1) One ml of the Standard Antitoxin shall be diluted before use so the final volume contains 0.1 unit per ml. The dilution shall be held at 20° to 25 ° C for 30 minutes prior to combination with a test does of toxin.
(2) The Standard Toxin test dose is that amount which when mixed with 0.1 unit of Standard Antitoxin, incubated at 20° to 25 ° C for 1 hour, and injected subcutaneously into a 340 to 380 gram guinea pig, results in death of that guinea pig within 60 to 120 hours with clinical signs of tetanus. The toxin shall be diluted so the test dose shall be in 2.0 ml.
(3) A mixture of diluted Standard Toxin and diluted Standard Antitoxin shall be made so that 0.1 unit of antitoxin in 1 ml is combined with a test dose of toxin. This Standard Toxin-Antitoxin mixture shall be held at 20° to 25 ° C for 1 hour before injections of guinea pigs are made.
(4) A sample from each serial of antitoxin shall be prepared as was the Standard Toxin-Antitoxin mixture; except the amount of antitoxin shall be based on an estimation of the expected potency. When testing is done on bulk material, the final container fill shall reflect the endpoint value plus 10 percent overage for 1 year dating and 20 percent overage for 3 year dating.
(5) Normal guinea pigs weighing within a range of 340 to 380 grams shall be used. Pregnant guinea pigs must not be used.
(i) Each of two guinea pigs (controls) shall be injected subcutaneously with a 3 ml dose of the Standard Toxin-Antitoxin mixture. Injections shall be made in the same order that toxin is added to the dilutions of antitoxins. These shall be observed parallel with the titration of one or more unknown antitoxins.
(ii) Two guinea pigs shall be used as test animals for each dilution of the unknown antitoxin. A 3.0 ml dose shall be injected subcutaneously into each animal.
(6) Controls shall be observed until they are down and are unable to rise or stand under their own power. At this time they are euthanized and the time of death is recorded in hours. For a satisfactory test, the controls must reach this point with clinical signs of tetanus within 24 hours of each other and within an overall time of 60 to 120 hours. The clinical signs to be observed are increased muscle tonus, curvature of the spine, asymmetry of the body outline when the resting animal is viewed from above, generalized spastic paralysis, particularly of the extensor muscles, inability to rise from a smooth surface when the animal is placed on its side, or any combination of these signs. If the control guinea pigs do not respond in this manner, the entire test shall be repeated.
(7) Potency of an unknown antitoxin is determined by finding the mixture which will protect the test animal the same as the Standard Toxin-Antitoxin mixture. Test animals dying sooner than the controls indicate the unit value selected in that dilution was not
Erysipelothrix Rhusiopathiae Antibody is a specific antibody product containing antibodies directed against one or more somatic antigens of
(a) Each serial shall meet the applicable general requirements provided in § 113.450.
(b)
(1) In the first stage, each of 40 Swiss mice, each weighing 16 to 20 grams, shall be injected subcutaneously with 0.1 ml of product (dried product shall be rehydrated according to label directions). Twenty-four hours postinjection, the injected mice and 10 additional mice designated controls shall be challenged subcutaneously with the same culture of
(2) If less than eight of the 10 controls die from erysipelas within 7 days post-challenge, the test is invalid. All dead mice shall be examined to determine if the cause of death was
(3) The mice injected with product shall be observed for 10 days postchallenge and all deaths recorded. The second stage shall be required when 7-10 of the mice injected with product die in the first stage. The second stage shall be conducted in a manner identical to the first stage.
(4) The results of the test shall be evaluated according to the following table:
Clostridium Perfringens Type C Antitoxin is a specific antibody product containing antibodies directed against the toxin of
(a) Each serial shall meet the applicable general requirements provided in § 113.450.
(b)
(1) When used in this test, the following words and terms shall mean:
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(2) The antitoxin content of the test sample shall be determined as follows:
(i) Make a dilution of Standard Antitoxin to contain 10 International Units of antitoxin per ml.
(ii) Make one dilution of Standard Toxin to contain 10 L
(iii) Dilute 1 ml of the test sample with 49 ml of diluent and combine 1 ml of this dilution with 1 ml of the Standard Toxin diluted to contain 10 L
(iv) Combine 10 International Units of Standard Antitoxin with 10 L
(v) Neutralize all toxin-antitoxin mixtures at room temperature for 1 hour and hold in ice water until injections of mice can be made.
(vi) Five Swiss white mice, each weighing 16-20 grams, shall be used for each toxin-antitoxin mixture. A dose of 0.2 ml shall be injected intravenously into each mouse. Conclude the test 24 hours post-injection and record all deaths.
(3)
(ii) If less than 80 percent of the mice inoculated with the mixture of 10 International Units of Standard Antitoxin and 10 L
(iii) If any mice inoculated with the mixture of Clostridium Perfringens Type C Antitoxin diluted 1:50 and 10 L
Clostridium Perfringens Type D Antitoxin is a specific antibody product containing antibodies directed against the toxin of
(a) Each serial shall meet the applicable general requirements provided in § 113.450.
(b)
(1) When used in this test, the following words and terms shall mean:
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(2) The antitoxin content of the test sample shall be determined as follows:
(i) Make a dilution of Standard Antitoxin to contain 1 International Unit of antitoxin per ml.
(ii) Make one dilution of Standard Toxin to contain 10 L
(iii) Dilute 1 ml of the test sample with 33 ml of diluent and combine 1 ml of this dilution with 1 ml of the Standard Toxin diluted to contain 10 L
(iv) Combine 1 International Unit of Standard Antitoxin with 10 L
(v) Neutralize all toxin-antitoxin mixtures at room temperature for 1 hour, and hold in ice water until injections of mice can be made.
(vi) Five Swiss white mice, each weighing 16-20 grams, shall be used for each toxin-antitoxin mixture. A dose of 0.2 ml shall be injected intravenously into each mouse. Conclude the test 24 hours post-injection and record all deaths.
(3) Test Interpretation. (i) If any mice inoculated with the mixture of 1 International Unit of Standard Antitoxin and 10 L
(ii) If less than 80 percent of the mice inoculated with mixture of 1 International Unit of Standard Antitoxin and 10 L
(iii) If any mice inoculated with the mixture of Clostridium Perfringens Type D Antitoxin diluted 1:34 and 10 L
A product for the treatment of failure of passive transfer (FPT) shall contain a specified minimum quantity of IgG per dose and shall be recommended for use only in neonates of the same species as that of antibody origin. A product for oral administration shall not be recommended for use in animals more than 24 hours of age, while one for parenteral administration shall only be recommended for use in neonatal animals. Each serial shall meet the applicable general requirements provided in § 113.450 and be tested for potency as provided in this section. Any serial found unsatisfactory by a prescribed test shall not be released.
(a)
(1) At least 20 newborn, colostrum-deprived animals of the species for which the product is recommended shall be randomly selected.
(2) Blood samples shall be taken from each animal.
(3) Each animal shall be administered one dose of reference by the recommended route and shall be observed for 24 hours.
(i) Any adverse reactions shall be recorded.
(ii) The dosage of reference administered to each animal shall be in accordance with label directions. Label directions may indicate a single dosage regardless of weight, in which case the animals in the study shall be at or near the maximum weight for neonates of the species.
(4) After 24 hours, blood samples shall be taken from each animal.
(5) Pretreatment and post treatment serum IgG concentrations shall be concurrently determined for each animal using a radial immunodiffusion (RID) method acceptable to APHIS and described in the filed Outline of Production for the product.
(6) Concurrently, using the same method, five IgG measurements shall be made on an IgG Species Standard supplied or approved by APHIS. The IgG Species Standard shall be a preparation that contains IgG specific for the species in question at a concentration acceptable to APHIS.
(7) For an IgG Reference Product to be satisfactory, all animals used to qualify the reference must remain free of unfavorable product-related reactions and at least 90 percent of the paired serum samples must reflect an increase in IgG concentration (posttreatment minus pretreatment concentration) equal to or greater than the IgG concentration of the IgG Species Standard.
(b)
(c)
21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
Unless exempted by regulation or otherwise authorized by the Administrator, all biological products prepared, sold, bartered or exchanged, shipped or delivered for shipment in or from the United States, the District of Columbia, any Territory of the United States, or any place under the jurisdiction of the United States shall be prepared in accordance with the regulations in this part. The licensee or permittee shall
(a) When an establishment license is issued, if biological products which were not prepared in compliance with the regulations are in the establishment, such products shall not be shipped or delivered for shipment or otherwise dealt with as having been prepared under such regulations.
(b) Except as provided in 9 CFR part 103, a biological product shall not be prepared in a licensed establishment unless the person to whom the establishment license is issued holds an unexpired, unsuspended, and unrevoked product license issued by the Administrator to prepare such biological product, or unless the products prepared are subject to the provisions of § 107.2 of this subchapter.
(c) A biological product produced in a USDA-licensed establishment shall be produced under a U.S. Veterinary Biological Product License or a license granted by a State under § 107.2 (referred to as a State biological product license and the products prepared pursuant thereto as State-licensed biological products, including autogenous biologics), but not under both a U.S. Veterinary Biological Product License and a State biological product license. Before a U.S. Veterinary Biological Product License (including a conditional license) is issued, the licensee shall relinquish its State license for that product:
(1) State-licensed biological products (including autogenous biologics) shall only be distributed or shipped intrastate, must not bear a U.S. Veterinary Biologics Establishment License Number, and must not otherwise be represented in any manner as having met the requirements for a U.S. Veterinary Biological Product license. Labeling of State- and USDA-licensed biological products produced in the same establishment must be distinctly different in color and design.
(2) All biological products in USDA-licensed establishments, whether licensed by USDA or by the State, shall be prepared only in locations indicated in legends filed in accordance with 9 CFR part 108. A description of each State-licensed product must be filed with the Animal and Plant Health Inspection Service as part of the blueprint legends and must be sufficient for Animal and Plant Health Inspection Service to determine any risk to the production of other products in the licensed establishment and to determine that adequate procedures are followed to prevent contamination during production.
(3) Records in such establishments must be maintained in accordance with §§ 116.1 and 116.2 of this subchapter and shall include all products licensed by the State or USDA.
(4) Reports prescribed in § 116.5 of this subchapter for USDA-licensed establishments shall be submitted for all veterinary biological products in the establishment.
(5) Under the following conditions, an autogenous biologic may be produced in a USDA-licensed establishment under either a State or U.S. Veterinary Biological Product License:
(i) When a culture of microorganisms, isolated from a herd in a State, is received at a USDA-licensed establishment that is in the same State but that holds both a State and a U.S. Veterinary Biological Products License for autogenous biologics, the isolate shall be designated by the licensee for use in the production of an autogenous biological product under either the State product license, or the U.S. Veterinary Biological Product License:
(ii) The true name of a State-licensed autogenous biologic shall specify the State of licensure: e.g.
(a) Each licensed establishment shall be separate and distinct from any other establishment in which a biological product is prepared.
(b) No biological products authorized to be prepared in a licensed establishment shall be prepared in whole or in part by another licensed establishment except as provided in paragraphs (c) and (d) of this section.
(c) When a partially prepared biological product cannot be completed at a licensed establishment due to failure of essential equipment, the Administrator may authorize the use of similar equipment at another licensed establishment:
(d) Partially prepared products or serials of completed products for further manufacture may be moved from one licensed establishment to another licensed establishment, imported under the provisions of § 104.5, or moved from a licensed establishment for purpose of being exported under conditions prescribed in an Outline of Production filed with Animal and Plant Health Inspection Service. Licensed products or products imported for distribution and sale may be prepared and recommended for final use, for further manufacturing purposes, or both. All serials shall be subject to the requirements for testing and release specified in § 113.5 or § 113.10 and to the requirements for identification specified in § 114.4.
Suitable tags or labels of a distinct design shall be used for identifying all ingredients used in the preparation of biological products, all component parts to be combined to form a biological product, all biological products while in the course of preparation and all completed biological products held in storage at licensed establishments:
Micro-organisms used in the preparation of biological products at licensed establishments shall be free from the causative agents of other diseases or conditions. A complete record of such micro-organisms shall be kept currently correct and a list submitted to Animal and Plant Health Inspection Service upon request of the Administrator.
Each biological product, when in liquid form, shall be mixed thoroughly in a single container. During bottling operations, the product shall be constantly mixed sufficient to maintain physical uniformity of the entire fill. A serial number, with any other markings that may be necessary for ready identification of the serial, shall be applied to identify it with the records of preparation and labeling.
(a) Each licensee shall designate a person(s) to make all official contacts with Animal and Plant Health Inspection Service on matters pertaining to the preparation of biological products under the Virus-Serum-Toxin Act. The licensee shall file three copies of biographical summary with Animal and Plant Health Inspection Service for such designated person and for each
(b) All personnel employed in the preparation of biological products at a licensed establishment shall be competent in good laboratory techniques through education or training, or both, so as to consistently prepare high quality products.
(c) All biological products prepared at licensed establishments shall be prepared and handled with due sanitary precautions. Good sanitary measures shall be practiced at all times by all personnel involved in such preparation and handling of biological products.
(1) The clothing worn by persons while preparing biological products shall be clean. All persons, immediately before entering laboratory rooms of a licensed establishment, shall change their outer clothing or effectively cover the same with gowns or other satisfactory clean garments.
(2) Unsanitary practices such as, but not limited to, eating, smoking, or expectorating on the floors or otherwise creating a nuisance in any room, compartment, or place in which biological products are prepared, handled, or stored at licensed establishments are prohibited.
An Outline of Production shall be on file with Animal and Plant Health Inspection Service for each licensed biological product or for each biological product authorized to be imported into the United States for Distribution and Sale. Preparation of a biological product in a licensed establishment shall be in accordance with the Outline of Production for such product filed with Animal and Plant Health Inspection Service as provided in this section, but subject to changes as may be required under § 114.8(f).
(a) The Outline of Production shall be prepared as prescribed in § 114.9 and submitted to Animal and Plant Health Inspection Service for filing. When objectionable features, if any, are corrected and no further exceptions are taken by Animal and Plant Health Inspection Service to an Outline of Production for a biological product, such Outline of Production shall be approved for filing.
(b) Each page shall be stamped as filed on the date such action was taken in the bottom right hand corner. Although the filed outline may be referred to as an approved outline, approval for filing constitutes no endorsement by Animal and Plant Health Inspection Service of such biological product or the methods and procedures used to prepare such biological product.
(c) The original and two copies shall be retained by Animal and Plant Health Inspection Service and the remaining copies returned.
(d) Each licensee shall review each Outline of Production for accuracy and sufficiency not less frequently than once a year. Revisions necessary to bring an Outline of Production into compliance with the regulations shall be submitted to Animal and Plant Health Inspection Service.
(e) When a list of licensed products to be continued in production at a licensed establishment is requested by the Administrator in accordance with § 102.5(d) of this subchapter, the licensee shall supplement the list with information for each product as follows:
(1) The Outline of Production currently being used shall be identified as to the date when last revised and filed with Animal and Plant Health Inspection Service and the date of the last review made by the licensee.
(2) The Outline of Production to be kept in the active file shall be designated. If more than one has been filed for a product, only the Outline of Production currently being used shall be included.
(f) The Administrator may, upon the basis of information not available to him at the time the current Outline of Production for a biological product was filed, object to the methods or procedures being used in the preparation of such biological product and notify the licensee to modify the filed Outline of Production to eliminate such objections. If the licensee does not comply with the notice, the Administrator
Each Outline of Production shall be prepared in accordance with the applicable directions provided in this section.
(a)
(2) The name of the biological product (or component), the establishment license number, and the date prepared shall appear on a front cover page and each page of the Outline of Production or special outline. The name of the licensee (or foreign manufacturer) shall appear on the front cover page.
(3) The pages shall be numbered in the upper center. At least 1
(4) Amended pages shall be numbered the same as those being superseded. They shall bear the date prepared and refer to the date on the pages being superseded. If one replacement page supersedes more than one page, the new page shall indicate same, but if several replacement pages are added to supersede one page, the page number followed by letters shall be used.
(5) The last page of the original and one copy of either a new or a completely rewritten Outline of Production and each page revised separately shall be signed in the lower left corner by the authorized representative of the licensee (or foreign producer). Stamped or facsimile signatures are not acceptable.
(6) A summary of changes shall appear on an attached page and refer to each page, paragraph, or subparagraph being changed.
(7) Transmittal forms shall be used for the original and subsequent revisions. Blank forms shall be available upon request to Animal and Plant Health Inspection Service.
(b)
(c) Outline of Production for anti-serum, antitoxin, and normal serum shall be written according to the following:
I.
B. Examination, preparation, care, quarantine, tests, and treatment of animals before injections are started.
C. Holding, handling, exercising, and monitoring the condition of animals after injections are started.
II.
1. Micro-organisms.
2. Source and date of accession of each micro-organism.
3. Strains.
4. Proportions of each micro-organism and strain.
B. Identification methods used for each micro-organism and frequency with which these methods are applied.
C. Virulence and purity of cultures or antigen and the determination and maintenance thereof. Range of subcultures or passages to be used in production.
D. Attenuation, if any, before use for production purposes.
E. Character, size, and shape of containers used for growing micro-organisms.
F. Media used for stock, seed, and antigen cultures (composition and reaction of). May refer to a special outline by number.
G. Preparation of the antigen or toxin and toxoid. Complete and full description of each
III.
1. Character and dose of the antigen.
2. Method and frequency of injections.
3. Time required for immunization or hyperimmunization.
4. Preliminary bleedings and tests, if any, to ascertain quality of serum.
5. All other similar matters, including treatments between bleedings.
B. Period of time elapsing between last injection and first bleeding; and between bleedings.
C. Technique of bleeding operations; volume of blood collected at each bleeding; and period of rest.
IV.
B. Composition of the preservative and proportions used. Indicate at which step of production, and the method used in adding the preservative.
C. Agglutination and complement-fixation titers and the methods of their determinations.
D. Disposition of unsatisfactory biological products and infective materials not used in production.
E. Assembly of units to make a serial; volume of the average serial; and the volume of the maximum serial.
V.
A. Purity.
B. Safety.
C. Potency.
D. Other tests.
VI.
A. Form and size of final containers in which the product is to be distributed.
B. Methods and techniques of filling final containers. Volume of fill for each size final container.
C. Collection, storage, and submission of representative samples. Indicate at which steps in the production these samples are taken.
D. Expiration date based on the earliest date of harvest and the date of the last satisfactory potency test.
E. Use, dosage, and route of administration for each animal species for which it is recommended.
F. Include any additional pertinent information.
(d) Outline of Production for
I.
B. Source and date of accession of each micro-organism.
C. Strains.
D. Proportions of each strain.
II.
B. Virulence and purity of cultures and the determination and maintenance thereof. Range of subcultures or passages to be used in production.
C. Composition and reaction of media used for seed and production cultures. Include the source of eggs, tissue, or cell cultures, and the tests to determine that eggs, tissues, and cells are free of contamination.
D. Character, size, and shape of containers used for growing cultures.
E. Storage conditions of seed cultures.
F. Methods of preparing suspensions for seeding or inoculation.
G. Technique of inoculating (1) seed media; (2) production media. Titer or concentration of inoculum, and the volume of medium for each size and type of culture container.
H. Period of time and conditions for incubation and degree of temperature used for each micro-organism or group of micro-organisms.
I. Character and amount of growth; observation as to contamination of growth.
J. Method of attenuation, if any, before used for production purposes.
III.
B. Minimum and maximum period of time elapsing from time of inoculation until harvest.
C. Technique of harvesting micro-organisms or tissues (specify) for production purposes.
D. Specifications for acceptable harvest material.
E. Handling of discarded material not used in production.
F. Include any additional pertinent information.
IV.
A. Method of inactivation, attenuation, or detoxification.
B. Composition of preservative, adjuvant or stabilizer, and proportions used stated in such a manner that the concentration can be calculated; stage and method of addition.
C. Method and degree of concentration.
D. If product is standardized to give concentration of antigen, show procedures and calculations.
E. 1. Assembly of units to make a serial (illustrate by example).
2. Volume of average serial.
3. Volume of maximum serial.
4. Any other pertinent information.
F. Volume of fill for each size vial. Type of vial if unusual.
G. Method and technique of filling and sealing of final containers.
H. Desiccation, including moisture control. Give maximum percent moisture.
I. Amount of antigenic material per dose or doses in final container.
V.
A. Purity.
B. Safety.
C. Potency.
D. Moisture, if desiccated.
E. Any other tests.
VI.
B. Collection, storage, and submission of representative samples. Indicate at which steps in the production these samples are taken.
C. Expiration date based on the earliest date of harvest and the date of the last satisfactory potency test. If applicable, give the date of lyophilization.
D. Use, dosage, and route of administration for each animal species for which the biological product is recommended.
(e) Outlines of Production for allergenic extracts shall be written according to the following:
I.
B. Weight/volume concentration.
II.
1. Method of extraction.
2. Composition of preservative, adjuvant or stabilizer, and proportions used; stage and method of addition.
3. Method and degree of concentration.
4. Standardization of the product.
5. (a) Assembly of units to make a serial.
(b) Volume of average serial.
(c) Maximum serial.
6. Volume of fill for each size vial.
7. Method and technique of filling and sealing of final containers.
8. Amount material per dose or doses in final container.
III.
A. Purity.
B. Safety.
C. Potency.
D. Any other tests.
E. Include any additional pertinent information.
IV.
B. Collection, storage, and submission of representative samples. Indicate at which steps in the production these samples are taken.
C. Expiration date based on the earliest date of harvest and the date of the last satisfactory potency test.
D. Use, dosage, and route of administration for each animal species for which the biological product is recommended.
(f) Outlines of Production for diagnostic test kits based on antigen-antibody reactions, and other diagnostics whose production methods are amenable to description as described herein shall be written according to the following requirements:
Provide a brief description of the kit as follows:
1. Principle of the test (ELISA, latex agglutination, etc.).
2. Antigen or antibody detection test.
3. Sample(s) used for testing (serum, whole blood, tears, etc.).
4. List reagents, references, and equipment included.
5. Identify materials obtained under split manufacturing agreements.
6. General description of test interpretations and their limitations, including followup tests.
A. Production of polyclonal antibody components.
1. If purchased, list suppliers, criteria for acceptability, and describe all tests performed after receipt to determine that specifications have been met.
2. If produced in-house, describe the species, age, weight, conditions, and general health of all animals used in antiserum production.
a. Preinjection considerations:
Describe the examination, preparation, care, quarantine procedures, and treatments administered before immunization(s). Describe all tests used to determine suitability for use. Describe the preparation of any standard negative serum(s) collected prior to immunization.
b. Immunization of animals.
i. Describe the character and dose of the antigen; if adjuvant is used provide details on its preparation. If commercial product is used include its true name as shown on the label, the manufacturer, serial number, and expiration date.
ii. Describe the method and schedule for immunizations.
iii. Describe the method for harvesting and evaluating the immunization product, including tests for acceptability.
iv. Provide number and intervals between harvests, volume obtained, and any other pertinent information.
B. Production of Monoclonal Antibody Components.
1. Hybridoma components:
a. If hybridoma components are purchased, list suppliers and criteria for acceptability; if tests are performed after receipt, describe fully.
b. If hybridomas are prepared inhouse, identify the antigen(s) used, describe the immunization scheme, and the species of animal used.
c. Identify the tissue of origin, and the procedures for harvesting, isolating, and identifying the immune cells.
d. Describe the source, identity, and the product secreted (light or heavy chain) by the parent Myeloma Cell Line.
e. Summarize cloning and recloning procedures, including clone characterization and propagation, if appropriate.
f. If appropriate, describe procedures for establishing and maintaining seed lots.
g. Describe any other pertinent tests or procedures performed on the hybridoma cell line.
2. Antibody production:
a. Describe the production method. If produced in cell culture, animal serum additives must conform to 9 CFR 113.53. If produced in animals, describe fully including husbandry practices and passage procedures.
b. Provide the criteria for acceptable monoclonal antibody, including tests for purity.
c. Describe all tests or other methods used to ensure uniformity between production lots of monoclonal antibody. Include all reaction conditions, equipment used, and reactivity of the component.
d. Describe all characterization procedures and include the expected reactivity of all reference monoclonal antibodies.
A. Identify the microorganism(s) or antigen being used. If previously approved Master Seed virus, bacteria, or antigen derived therefrom is used, provide pertinent information on the testing performed, and details of dates of United States Department of Agriculture confirmatory tests and approval, as appropriate.
B. Describe all propagation steps, including identification of cell cultures, media ingredients, cell culture conditions, and harvest methods. For antigen produced in eggs, give the egg source, age, and route of inoculation. If cell lines are being used, give dates of testing and approval as specified in 9 CFR 113.52.
C. Describe procedures used for extracting and characterizing the antigen.
D. Describe the method used to standardize the antigen.
E. If the antigen is purchased, identify the supplier and describe the criteria for acceptable material, including all tests performed by the producer and/or the recipient to determine acceptability.
A. Describe the positive and negative controls included in the kit. If purchased, list suppliers and criteria for acceptance.
B. Describe the preparation and standardization of the conjugate(s). If purchased, list suppliers and criteria for acceptance.
C. Describe the preparation and standardization of the substrate(s). If purchased, list suppliers and criteria for acceptance.
D. Identify buffers, diluents, and other reagents included in the kit. The preparation of these components may be described in this section or in filed Special Outlines.
Fully describe methods used to standardize antigens, reference standards, positive control serum, negative control serum, and standard reagents from production/purchase to completion of finished product in final containers, including the following:
1. Composition and quantity of preservative in each.
2. Method of filling, plating, or attaching the antigen or antibody component to a solid phase.
3. Minimum and maximum acceptable fill volumes for each final container of reagent included in the kit.
4. The disposition of unsatisfactory material.
Refer to all applicable standard requirements.
A. Purity.
Describe all tests of the kit for purity or specify the exemption as provided in 9 CFR 113.4.
B. Safety.
In vitro products are exempt from safety tests.
C. Potency.
Provide details of tests used to determine the relative reactivity of the kit including minimum requirements for a satisfactory test. Reference standards and control serum used for this purpose should be identified by unique codes or lot numbers.
A. Describe the form and size of final containers of each reagent/component included in the kit.
B. Describe the collection, storage, and submission of representative samples. Refer to 9 CFR 113.3(b)(7).
C. Specify the expiration date. Refer to 9 CFR 114.13.
D. Provide details of recommendations for use, including all limitations, qualifications, and interpretation of results.
E. Submit confidentiality statement identifying specific parts of the outline containing information, the release of which would cause harm to the submitter.
Antibiotics are authorized for use as preservatives for biological products if used within the limitations as to kinds and amounts prescribed in this section.
(a) When an antibiotic or combination of antibiotics, with or without a fungistat is to be used in the preparation of a biological product, the kind(s) and amount(s) of each shall be specified in the outline for such product in such a way that the concentration in the final product may be calculated. Except as may be approved by the Administrator, only those individual antibiotics or combinations of antibiotics listed in paragraphs (b) and (c) of this section shall be used.
(b) Permitted individual antibiotics:
(1) The antibiotic level of a specified individual antibiotic in one ml. of a biological product, when prepared as recommended for use, shall not exceed the amounts listed in this paragraph:
(2) Except as prescribed in paragraph (c) of this section, only one antibiotic shall be used as a preservative in a biological product. The kind and maximum amount per ml. of such antibiotic shall be restricted to:
(c) Permitted combinations:
(1) Penicillin and streptomycin.
(2) Either amphotericin B or nystatin, but not both, may be used with one of the other antibiotics listed in paragraph (b) of this section, or with a combination of penicillin and streptomycin, or with a combination of polymyxin B and neomycin.
(3) The maximum amount of each antibiotic in a combination shall be the amount prescribed for such antibiotic in paragraph (b) of this section.
(d) Antibiotics used in virus seed stock purification are not restricted as to kind or amounts provided carryover into the final product is controlled and specified in outlines of production.
Biological products at licensed establishments shall be protected at all times against improper storage and handling. Completed product shall be kept under refrigeration at 35 °to 45 °F. (2 °to 7 °C.) unless the inherent nature of the product makes storage at a different temperature advisable, in which
Each serial or subserial of biological product prepared in a licensed establishment shall be given an expiration date determined in accordance with the requirements provided in § 114.13 or § 114.14. A licensed biological product shall be considered worthless under the Virus-Serum-Toxin Act subsequent to the expiration date appearing on the label.
Unless otherwise provided for in a Standard Requirement of filed Outline of Production, the expiration date for each product shall be computed from the date of the initiation of the potency test. Prior to licensure, stability of each fraction shall be determined by methods acceptable to Animal and Plant Health Inspection Service. Expiration dates based on this stability data shall be confirmed as follows:
(a)
(b)
(c) Subsequent changes in the dating period for a product may be granted, based on statistically valid data submitted to support a revision of the Outline of Production.
(a) Unless otherwise provided for in a filed Outline of Production for the product, the expiration date shall not be extended:
(1) If all fractions of the product are not evaluated for potency by tests designated in the filed Outline of Production for such product in accordance with § 113.4(b) of this subchapter.
(2) For any serial or portion of any serial which has left licensed premises:
(3) For a serial or portion of a serial if the expiration date has been extended previously, unless otherwise authorized in accordance with § 114.1.
(b) An extension of the expiration date may be granted by Animal and Plant Health Inspection Service if a request from the licensee is substantiated by valid test data which demonstrate the potency of the product meets or exceeds the requirements for release. The new expiration date shall be calculated from the date the latest satisfactory potency test was initiated. The extension of the expiration date shall not exceed the maximum dating allowed in the filed Outline of Production.
(1) Serials are approved for redating under the condition that Animal and Plant Health Inspection Service may require the firm to retest the redated serial for potency during the extended dating period and if found unsatisfactory require it be removed from the market by the licensee.
(2) [Reserved]
All biological products found to be unsatisfactory for marketing, all biological products which have become worthless subsequent to the expiration date, all refuse, other materials deemed unsatisfactory for production purposes, all carcasses (part or whole) of production or test animals, and any undesirable byproducts of manufacture shall be disposed of as may be required by the Administrator.
A serial or subserial of a biological product may be produced jointly by a
The Administrator may authorize the rebottling of a completed product in liquid form subject to the conditions prescribed in this section.
(a) All or part of a serial which has not left the licensed establishment may be aseptically returned to the mixing tank, thoroughly mixed, and rebottled in new final containers.
(b) The rebottled product shall be adequately identified by serial number or subserial number, as the case may be.
(c) Required purity tests for final container samples of the product shall be conducted on new samples selected from the rebottled product (serial or subserials). Rebottled product found to be unsatisfactory by such tests shall not be released.
(d) New test samples from each serial or subserial and copies of test reports of all tests conducted on the rebottled product shall be submitted to Animal and Plant Health Inspection Service.
(e) The licensee shall not release the rebottled product unless notified by Animal and Plant Health Inspection Service that such product is eligible for release. Production records shall show the results of all tests conducted and shall accurately reflect the actions taken.
The Administrator may authorize a licensee to reprocess a serial of completed product subject to the conditions prescribed in this section.
(a) Reprocessing shall not include any method or procedure which would be deleterious to the product.
(b) All appropriate tests for purity, safety, potency, and efficacy for the product shall be conducted on the reprocessed product. A serial found unsatisfactory by a required test shall not be released.
(c) The reprocessed serial shall be identified by a new serial number and the records for the serial shall accurately reflect the action taken.
(d) Test samples of the reprocessed serial and test reports for all tests conducted shall be submitted to Animal and Plant Health Inspection Service. The licensee shall not release the serial until notified by Animal and Plant Health Inspection Service that the serial is eligible for release.
21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
(a) Any inspector shall be permitted to enter any establishment where any biological product is prepared, at any hour during the day or night, and shall be permitted to inspect, without previous notification, the entire premises of the establishment, including all buildings, compartments, and other places, all biological products, and organisms and vectors in the establishment, and all materials and equipment, such as chemicals, instruments, apparatus, and the like, and the methods used in the manufacture of, and all records maintained relative to, biological products produced at such establishment.
(b) Each inspector will have in his or her possession a numbered USDA badge or identification card. Either shall be sufficient identification to entitle him/her to admittance at all regular entrances and to all parts of such establishment and premises and to any place at any time for the purpose of making an inspection pursuant to paragraph (a) of this section.
(a) Any biological product, the container of which bears a United States veterinary license number or a United States veterinary permit number or other mark required by these regulations, may be inspected at any time or place. If, as a result of such inspection, it appears that any such product is worthless, contaminated, dangerous, or harmful, the Secretary shall give notice to stop distribution and sale to the manufacturer (licensee) or importer (permittee) and may proceed against such product pursuant to the provisions of part 118 of this subchapter.
(b) When notified to stop distribution and sale of a serial or subserial of a veterinary biological product by the Secretary, veterinary biologics licensees or permittees shall:
(1) Stop the preparation, distribution, sale, barter, exchange, shipment, or importation of the affected serial(s) or subserial(s) of any such veterinary biological product pending further instructions from APHIS.
(2) Immediately, but no later than 2 days, send stop distribution and sale notifications to any jobbers, wholesalers, dealers, foreign consignees, or other persons known to have any such veterinary biological product in their possession, which instruct them to stop the preparation, distribution, sale, barter, exchange, shipment, or importation of any such veterinary biological product. All notifications shall be documented in writing by the licensee or permittee.
(3) Account for the remaining quantity of each serial(s) or subserial(s) of any such veterinary biological product at each location in the distribution channel known to the manufacturer (licensee) or importer (permittee).
(4) When required by the Administrator, submit complete and accurate reports of all notifications concerning stop distribution and sale actions to the Animal and Plant Health Inspection Service pursuant to § 116.5 of this subchapter.
(c) Unless and until the Secretary shall otherwise direct, no persons so notified shall thereafter sell, barter, or exchange any such product in any place under the jurisdiction of the United States or ship or deliver for shipment any such product in or from any State, Territory, or the District of Columbia. However, failure to receive such notice shall not excuse any person from compliance with the Virus-Serum-Toxin Act.
21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
(a) Each licensee, permittee, and foreign manufacturer of biological products imported into the United States shall maintain, at the licensed or foreign establishment in which the products are prepared, detailed records of information necessary to give a complete accounting of all the activities within each establishment. Such records shall include, but shall not be limited to, the items enumerated in this part.
(1) Records shall be made concurrently with the performance of successive steps in the development and preparation of biological products, including new products under development. Such records shall include the date and where critical, the time that each essential step was taken, the identity and quantity of ingredients added or removed at each step, and any gain or loss of product from the beginning to the end of product preparation.
(2) Records shall be legible and indelible; shall be as detailed as necessary for a clear understanding of each step by one experienced in the preparation of biological products; and shall be verified by initials or signature of the
(3) Records (other than disposition records) required by this part shall be completed by the licensee or the foreign manufacturer, as the case may be, before any portion of a serial of any product shall be marketed in the United States or exported.
(b) In the case of imported products, each permittee shall maintain at the permittee's place of business detailed and accurate records that are relevant to each imported product and that include, but are not limited to, importation documents, sampling records, test summaries, shipping records, and inventory and disposition records as required in § 116.2.
(c) When authorized by the Administrator, the licensee, permittee, or foreign manufacturer may maintain and retain records required under this part at an alternative location. Such authorization shall be confirmed by the filing of an addendum to the plot plan legend. The addendum shall list the location of the records and the condition of their storage and shall permit the inspection of the records by APHIS inspectors, or foreign inspectors acting on behalf of APHIS.
(a) Records shall show the quantity and location of each biological product being prepared, in storage, and in distribution channels.
(b) Detailed disposition records, in a form satisfactory to the Administrator, shall be maintained by each licensee, each distributor, and each permittee showing the sale, shipment, or other disposition made of the biological products handled by such person.
(a) Each licensee and permittee shall maintain a list of all approved labels currently being used. Each label shall be identified as to:
(1) Name and product code number as it appears on the product license or permit for the product;
(2) Where applicable, the size of the package (doses, ml, cc, or units) on which the label shall be used;
(3) Label number and date assigned; and
(4) Name of licensee or subsidiary appearing on the label as the producer.
(b) All labels printed shall be accounted for and an inventory maintained.
Records shall be made by means of automatic recording devices or an equivalent accurate and reliable system. Such records shall be identified with the ingredients, equipment, or biological product subjected to sterilization or pasteurization.
(a) When required by the Administrator, reports containing accurate and complete information concerning biological products, including but not limited to, product development and preparation, and market suspensions and recalls, shall be prepared and submitted to the Animal and Plant Health Inspection Service by the licensee, permittee, or foreign manufacturer (whose products are being imported or offered for importation). Unless otherwise authorized by the Administrator, records necessary to make such reports shall be maintained in each establishment.
(b) If, at any time, there are indications that raise questions regarding the purity, safety, potency, or efficacy of a product, or if it appears that there may be a problem regarding the preparation, testing, or distribution of a product, the licensee, permittee, or foreign manufacturer must immediately notify the Animal and Plant Health Inspection Service concerning the circumstances and the action taken, if any. Notification may be made by mail to Director, Center for Veterinary Biologics, Inspection and Compliance, 510 South 17th Street, Suite 104, Ames, IA 50010-8197; by electronic mail to
Complete records shall be kept for all animals at a licensed establishment. Results of tests performed, antigens or treatment administered, maintenance and production records, disposition records, necropsy records, if any, and all other pertinent records shall be included.
Detailed records of all tests conducted on each serial and each subserial shall be maintained by the licensee. Summaries of such tests shall be prepared from such records and submitted to the Animal and Plant Health Inspection Service using APHIS Form 2008 or an acceptable equivalent form prior to release of the serial or subserial. Blank forms for such summaries shall be available from Animal and Plant Health Inspection Service upon request.
All records (other than disposition records) required by this part shall be completed by the licensee, permittee, or foreign manufacturer before any portion of a serial of any product may be marketed in the United States or exported. All records shall be retained at the licensed or foreign establishment or permittee's place of business for a period of two years after the expiration date of a product, or for such longer period as may be required by the Administrator.
21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
(a) All animals used in licensed establishments in the preparation or testing of biological products shall meet the regulations in this subchapter and special requirements as may be prescribed by the Administrator to prevent the preparation, sale, and distribution of worthless, contaminated, dangerous, or harmful biological products.
(b) Unless otherwise authorized or directed by the Administrator, animals used in the preparation or testing of biological products shall be admitted to and maintained at the licensed establishment and ultimately disposed of in accordance with the regulations in this part, and with the Act of August 24, 1966 (Pub. L. 89-544) as amended by the Animal Welfare Act of 1970 (Pub. L. 91-579) and the regulations in parts 1, 2, and 3 of this chapter. Personnel who supervise the care and welfare of such
Animal facilities shall comply with the requirements provided in part 108 of this chapter.
(a) No animal which shows clinical signs or other evidence of disease shall be admitted to the premises of licensed establishments, except as provided in paragraphs (d) and (e) of this section. The health status of all animals offered for admission shall be determined by or under the direction of a veterinarian prior to admission. If the determination cannot be made prior to admission, the animals shall be kept separate from animals already on the premises and in a quarantine area to be provided by the licensee for this purpose until the animal's health status is determined.
(b) If special test requirements for admittance of the animals are specified in the Outline of Production for the product to be produced, the animals shall remain in the quarantine area until such tests have been performed and the results obtained. Animals which do not meet the requirements shall not be admitted to the production area or allowed to contact production animals.
(c) All animals admitted to the premises of a licensed establishment shall be permanently identified either collectively or individually by the licensee with tags, marks, or other means acceptable to the Administrator.
(d) When an animal which has a disease is to be used to prepare a biological product for control of such disease, the animal shall be admitted directly to the processing facilities in which the product is to be prepared but shall not be permitted contact with other animals on the premises.
(e) The Administrator may authorize the maintenance of diagnostic facilities at the licensed establishment:
(a) All test animals shall be examined for clinical signs of illness, injury, or abnormal behavior prior to the start of a test and throughout the observation period specified in the test protocol.
(b) All animals used for test purposes shall be identified either collectively or individually in a manner conducive to an accurate interpretation of the results of the test.
(c) No test animals shall be given a biological product during the preconditioning period which would affect its eligibility according to the test requirements. No treatment, with a biological product or otherwise, shall be administered to a test animal during a test period which could interfere with a true evaluation of the biological product being tested.
(d) During the course of a test, animals that are injured or show clinical signs of illness or unfavorable reactions that are not due to the test may be removed from the test and treated or humanely destroyed. If sufficient animals do not remain for the test to be evaluated, the test shall be declared inconclusive and may be repeated.
(e) Test animals that show clinical signs of illness that are due to the test may be treated or humanely destroyed if the illness has progressed to a point (defined in the filed Outline of Production) when death is certain to occur without therapeutic intervention. When interpreting the results of the test, the animals that were treated or humanely destroyed because of illness due to the test and the animals that have died from illness due to the test prior to being humanely destroyed shall be combined into a common statistic of mortality due to the test.
Animals which have been infected with or exposed to a dangerous, infectious, contagious, or communicable disease shall be kept effectively segregated at a licensed establishment until such time as they are humanely destroyed or successfully treated and removed as healthy animals.
Production animals or ex-test animals which are no longer useful at the licensed establishment may be removed from the premises of the licensed establishment; provided, such removal is accomplished in a manner as shall preclude the dissemination of disease and in accordance with the following conditions:
(a) Meat-producing animals which received a biological product containing inactivated microorganisms and adjuvants within 21 days shall not be removed; or
(b) Animals which received virulent microorganisms within 30 days shall not be removed; or
(c) Only animals that are in a healthy condition as determined by a veterinarian shall be removed, except as provided in paragraph (d) of this section.
(d) Other animals that are injured or otherwise unhealthy, except when affected with a communicable disease, may be removed for immediate slaughter to an abattoir operated in accordance with the Federal Meat Inspection Act of March 4, 1907, 34 Stat. 1260, as amended by the Wholesome Meat Act of 1967, 81 Stat. 585 (21 U.S.C. sec. 601
(e) All animals on the premises shall be disposed of in accordance with the provisions of the regulations in this part and where specific provision is not made therefor shall be disposed of as required by the Administrator.
21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
Whenever any biological product which is prepared, sold, bartered, exchanged, or shipped in violation of the Act or regulations is found by any authorized representative of the Administrator upon any premises, it may be detained by such representative for a period not to exceed 20 days, pending action under § 118.4, and shall not be moved by any person from the place at which it is located when so detained, until released by such representative.
An authorized representative of the Administrator shall detain any biological product subject to detention under this part by:
(a) Giving oral notification to the owner of the biological product if such owner can be ascertained, and, if not, to the agent representing the owner or to the immediate custodian of the biological product; and
(b) Promptly furnishing the person so notified with a preliminary notice of detention which shall include identity and quantity of the product detained, the location where detained, the reason for the detention, and the name of the authorized representative of the Administrator.
(c) Within 48 hours after the detention of any biological product, an authorized representative of the Administrator shall, if the detention is to continue, give written notification to the owner of the biological product detained by furnishing a written statement which shall include the identity and quantity of the product detained,
Except as provided in paragraphs (a) and (b) of this section, no biological product detained in accordance with the provisions in this part shall be moved by any person from the place at which such product is located when it is detained.
(a) A detained biological product may be moved from the place at which it is located when so detained for the purpose of providing proper storage conditions if such movement has been approved by an authorized representative of the Administrator;
(b) A detained biological product may be moved from the place at which it is detained on written notification by an authorized representative of the Administrator that the detention is terminated;
Any biological product which is prepared, sold, bartered, exchanged, or shipped in violation of the Act or regulations shall be liable to be proceeded against and seized and condemned, at any time, on a libel of information in any United States district court or other proper court within the jurisdiction of which the product is found. If the product is condemned, it shall, after entry of the decree, be disposed of by destruction or sale as the court may direct, and the proceeds, if sold, less the court costs and fees, and storage and other proper expenses, shall be paid into the Treasury of the United States, but the product shall not be sold contrary to the provisions of the Act or the laws of the jurisdiction in which it is sold;
7 U.S.C. 8401; 7 CFR 2.22, 2.80, and 371.4.
(1) Death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism;
(2) Deterioration of food, water, equipment, supplies, or material of any kind; or
(3) Deleterious alteration of the environment.
(1) Any poisonous substance or biological product that may be engineered as a result of biotechnology produced by a living organism; or
(2) Any poisonous isomer or biological product, homolog, or derivative of such a substance.
This part implements the provisions of the Agricultural Bioterrorism Protection Act of 2002 setting forth the requirements for possession, use, and transfer of select agents and toxins. The biological agents and toxins listed in this part have the potential to pose a severe threat to public health and safety, to animal health, or to animal products. Overlap select agents and toxins are subject to regulation by both APHIS and CDC.
(a) Except as provided in paragraphs (d) and (e) of this section, the Administrator has determined that the biological agents and toxins listed in this section have the potential to pose a severe threat to animal health or to animal products.
(b) VS select agents and toxins:
African horse sickness virus;
African swine fever virus;
Akabane virus;
Avian influenza virus (highly pathogenic);
Bluetongue virus (exotic);
Bovine spongiform encephalopathy agent;
Camel pox virus;
Classical swine fever virus;
Foot-and-mouth disease virus;
Goat pox virus;
Japanese encephalitis virus;
Lumpy skin disease virus;
Malignant catarrhal fever virus (Alcelaphine herpesvirus type 1);
Menangle virus;
Newcastle disease virus (velogenic);
Peste des petits ruminants virus;
Rinderpest virus;
Sheep pox virus;
Swine vesicular disease virus;
Vesicular stomatitis virus (exotic).
(c) Genetic elements, recombinant nucleic acids, and recombinant organisms:
(1) Nucleic acids that can produce infectious forms of any of the select agent viruses listed in paragraph (b) of this section.
(2) Recombinant nucleic acids that encode for the functional forms of any toxin listed in paragraph (b) of this section if the nucleic acids:
(i) Can be expressed
(ii) Are in a vector or recombinant host genome and can be expressed
(3) VS select agents and toxins listed in paragraph (b) of this section that have been genetically modified.
(d) VS select agents or toxins that meet any of the following criteria are excluded from the requirements of this part:
(1) Any VS select agent or toxin that is in its naturally occurring environment, provided that the agent or toxin has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source.
(2) Nonviable VS select agents or nonfunctional VS toxins.
(e) An attenuated strain of a VS select agent or toxin may be excluded from the requirements of this part based upon a determination that the attenuated strain does not pose a severe threat to animal health or to animal products.
(1) To apply for an exclusion, an individual or entity must submit a written request and supporting scientific information. A written decision granting or denying the request will be issued. An exclusion will be effective upon notification of the applicant. Exclusions will be published periodically in the notice section of the
(2) If an excluded attenuated strain is subjected to any manipulation that restores or enhances its virulence, the resulting select agent or toxin will be subject to the requirements of this part.
(3) An individual or entity may make a written request to the Administrator for reconsideration of a decision denying an exclusion application. The written request for reconsideration must state the facts and reasoning upon which the individual or entity relies to show the decision was incorrect. The Administrator will grant or deny the request for reconsideration as promptly as circumstances allow and will state, in writing, the reasons for the decision.
(f) Any VS select agent or toxin seized by a Federal law enforcement agency will be excluded from the requirements of this part during the period between seizure of the agent or toxin and the transfer or destruction of such agent or toxin provided that:
(1) As soon as practicable, the Federal law enforcement agency transfers the seized agent or toxin to an entity eligible to receive such agent or toxin or destroys the agent or toxin by a recognized sterilization or inactivation process.
(2) The Federal law enforcement agency safeguards and secures the seized agent or toxin against theft, loss, or release, and reports any theft, loss, or release of such agent or toxin.
(3) The Federal law enforcement agency reports the seizure of the select agent or toxin to APHIS or CDC.
(i) The seizure of any of the following VS select agents and toxins must be reported within 24 hours by telephone, facsimile, or e-mail: African horse sickness virus, African swine fever virus, avian influenza virus (highly pathogenic), bovine spongiform encephalopathy agent, classical swine fever virus, foot-and-mouth disease virus, Newcastle disease virus (velogenic), rinderpest virus, and swine vesicular disease virus. This report must be followed by submission of APHIS/CDC Form 4 within 7 calendar days after seizure of the select agent or toxin.
(ii) For all other VS select agents or toxins, APHIS/CDC Form 4 must be submitted within 7 calendar days after seizure of the agent or toxin.
(iii) A copy of APHIS/CDC Form 4 must be maintained for 3 years.
(4) The Federal law enforcement agency reports the final disposition of the select agent or toxin by submission of APHIS/CDC Form 4. A copy of the completed form must be maintained for 3 years.
(a) Except as provided in paragraphs (d) and (e) of this section, the Administrator has determined that the biological agents and toxins listed in this section have the potential to pose a severe threat to public health and safety, to animal health, or to animal products.
(b) Overlap select agents and toxins:
Botulinum neurotoxins;
Botulinum neurotoxin producing species of
Eastern equine encephalitis virus;
Hendra virus;
Nipah virus;
Rift Valley fever virus;
Shigatoxin;
Staphylococcal enterotoxins;
T-2 toxin;
Venezuelan equine encephalitis virus.
(c) Genetic elements, recombinant nucleic acids, and recombinant organisms:
(1) Nucleic acids that can produce infectious forms of any of the overlap select agent viruses listed in paragraph (b) of this section.
(2) Recombinant nucleic acids that encode for the functional forms of any overlap toxin listed in paragraph (b) of this section if the nucleic acids:
(i) Can be expressed
(ii) Are in a vector or recombinant host genome and can be expressed
(3) Overlap select agents and toxins listed in paragraph (b) of this section that have been genetically modified.
(d) Overlap select agents or toxins that meet any of the following criteria are excluded from the requirements of this part:
(1) Any overlap select agent or toxin that is in its naturally occurring environment, provided that the agent or toxin has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source.
(2) Nonviable overlap select agents or nonfunctional overlap toxins.
(3) Overlap toxins under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor, if the aggregate amount does not, at any time, exceed the following amounts: 0.5 mg of Botulinum neurotoxins, 100 mg of
(e) An attenuated strain of an overlap select agent or toxin may be excluded from the requirements of this part based upon a determination that the attenuated strain does not pose a severe threat to public health and safety, to animal health, or to animal products.
(1) To apply for an exclusion, an individual or entity must submit a written request and supporting scientific information. A written decision granting or denying the request will be issued. An exclusion will be effective upon notification of the applicant. Exclusions will be published periodically in the notice section of the
(2) If an excluded attenuated strain is subjected to any manipulation that restores or enhances its virulence, the resulting overlap select agent or toxin will be subject to the requirements of this part.
(3) An individual or entity may make a written request to the Administrator for reconsideration of a decision denying an exclusion application. The written request for reconsideration must state the facts and reasoning upon which the individual or entity relies to show the decision was incorrect. The Administrator will grant or deny the
(f) Any overlap select agent or toxin seized by a Federal law enforcement agency will be excluded from the requirements of this part during the period between seizure of the agent or toxin and the transfer or destruction of such agent or toxin provided that:
(1) As soon as practicable, the Federal law enforcement agency transfers the seized agent or toxin to an entity eligible to receive such agent or toxin or destroys the agent or toxin by a recognized sterilization or inactivation process.
(2) The Federal law enforcement agency safeguards and secures the seized agent or toxin against theft, loss, or release, and reports any theft, loss, or release of such agent or toxin.
(3) The Federal law enforcement agency reports the seizure of the overlap select agent or toxin to APHIS or CDC.
(i) The seizure of any of the following overlap select agents and toxins must be reported within 24 hours by telephone, facsimile, or e-mail:
(ii) For all other overlap select agents or toxins, APHIS/CDC Form 4 must be submitted within 7 calendar days after seizure of the agent or toxin.
(iii) A copy of APHIS/CDC Form 4 must be maintained for 3 years.
(4) The Federal law enforcement agency reports the final disposition of the overlap select agent or toxin by submission of APHIS/CDC Form 4. A copy of the completed form must be maintained for 3 years.
(a) Diagnostic laboratories and other entities that possess, use, or transfer a VS select agent or toxin that is contained in a specimen presented for diagnosis or verification will be exempt from the requirements of this part for such agent or toxin contained in the specimen, provided that:
(1) Unless directed otherwise by the Administrator, within 7 calendar days after identification, the agent or toxin is transferred in accordance with § 121.16 or destroyed on-site by a recognized sterilization or inactivation process;
(2) The agent or toxin is secured against theft, loss, or release during the period between identification of the agent or toxin and transfer or destruction of such agent or toxin, and any theft, loss, or release of such agent or toxin is reported; and
(3) The identification of the agent or toxin is reported to APHIS or CDC.
(i) The identification of any of the following select agents and toxins must be immediately reported by telephone, facsimile, or e-mail: African horse sickness virus, African swine fever virus, avian influenza virus (highly pathogenic), bovine spongiform encephalopathy agent, classical swine fever virus, foot-and-mouth disease virus, Newcastle disease virus (velogenic), rinderpest virus, and swine vesicular disease virus. This report must be followed by submission of APHIS/CDC Form 4 within 7 calendar days after identification.
(ii) For all other VS select agents or toxins, APHIS/CDC Form 4 must be submitted within 7 calendar days after identification.
(iii) Less stringent reporting may be required during agricultural emergencies or outbreaks, or in endemic areas.
(iv) A copy of APHIS/CDC Form 4 must be maintained for 3 years.
(b) Diagnostic laboratories and other entities that possess, use, or transfer a VS select agent or toxin that is contained in a specimen presented for proficiency testing will be exempt from the requirements of this part for such agent or toxin contained in the specimen, provided that:
(1) Unless directed otherwise by the Administrator, within 90 calendar days of receipt, the agent or toxin is transferred in accordance with § 121.16 or destroyed on-site by a recognized sterilization or inactivation process;
(2) The agent or toxin is secured against theft, loss, or release during the period between identification of the agent or toxin and transfer or destruction of such agent or toxin, and any theft, loss, or release of such agent or toxin is reported; and
(3) The identification of the agent or toxin, and its derivative, is reported to APHIS or CDC. To report the identification of a select agent or toxin, APHIS/CDC Form 4 must be submitted within 90 days of receipt of the agent or toxin. A copy of the completed form must be maintained for 3 years.
(c) Diagnostic reagents and vaccines that are, bear, or contain VS select agents or toxins that are produced at USDA diagnostic facilities will be exempt from the requirements of this part.
(d) Unless the Administrator by order determines that additional regulation is necessary to protect animal health or animal products, products that are, bear, or contain VS select agents or toxins will be exempt from the requirements of this part if the products have been cleared, approved, licensed, or registered pursuant to:
(1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
(2) Section 351 of Public Health Service Act (42 U.S.C. 262);
(3) The Virus-Serum-Toxin Act (21 U.S.C. 151-159); or
(4) The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 131
(e) The Administrator may exempt from the requirements of this part an experimental product that is, bears, or contains a VS select agent or toxin if such product is being used in an investigation authorized by any Federal law and the Administrator determines that additional regulation under this part is not necessary to protect animal health or animal products. To apply for an exemption, an individual or entity must submit APHIS/CDC Form 5. A written decision granting or denying the exemption will be issued. The applicant must notify APHIS when an authorization for an investigation no longer exists. This exemption automatically terminates when such authorization is no longer in effect.
(f) In addition to the exemptions provided in paragraphs (a) through (e) of this section, the Administrator may grant a specific exemption upon a showing of good cause and upon his or her determination that such exemption is consistent with protecting animal health or animal products. An individual or entity may request in writing an exemption from the requirements of this part. If granted, such exemptions are valid for a maximum of 3 years; thereafter, an individual or entity must request a new exemption. If a request for exemption is denied, an individual or entity may request reconsideration in writing to the Administrator. The request for reconsideration must state all of the facts and reasons upon which the individual or entity relies to show that the exemption was wrongfully denied. The Administrator will grant or deny the request for reconsideration as promptly as circumstances allow and will state, in writing, the reasons for the decision.
(a) Clinical or diagnostic laboratories and other entities that possess, use, or transfer an overlap select agent or toxin that is contained in a specimen presented for diagnosis or verification will be exempt from the requirements of this part for such agent or toxin contained in the specimen, provided that:
(1) Unless directed otherwise by the Administrator or the HHS Secretary, within 7 calendar days after identification, the agent or toxin is transferred in accordance with § 121.16 or 42 CFR 73.16 or destroyed on-site by a recognized sterilization or inactivation process;
(2) The agent or toxin is secured against theft, loss, or release during the period between identification of the agent or toxin and transfer or destruction of such agent or toxin, and any theft, loss, or release of such agent or toxin is reported; and
(3) The identification of the agent or toxin is reported to APHIS or CDC.
(i) The identification of any of the following overlap select agents and toxins must be immediately reported by telephone, facsimile, or e-mail:
(ii) For all other overlap select agents or toxins, APHIS/CDC Form 4 must be submitted within 7 calendar days after identification.
(iii) Less stringent reporting may be required during agricultural emergencies or outbreaks, or in endemic areas.
(iv) A copy of APHIS/CDC Form 4 must be maintained for 3 years.
(b) Clinical or diagnostic laboratories and other entities that possess, use, or transfer an overlap select agent or toxin that is contained in a specimen presented for proficiency testing will be exempt from the requirements of this part for such agent or toxin contained in the specimen, provided that:
(1) Unless directed otherwise by the Administrator or the HHS Secretary, within 90 days of receipt, the agent or toxin is transferred in accordance with § 121.16 or 42 CFR 73.16 or destroyed on-site by a recognized sterilization or inactivation process;
(2) The agent or toxin is secured against theft, loss, or release during the period between identification of the agent or toxin and transfer or destruction of such agent or toxin, and any theft, loss, or release of such agent or toxin is reported; and
(3) The identification of the agent or toxin, and its derivative, is reported to APHIS or CDC. To report the identification of an overlap select agent or toxin, APHIS/CDC Form 4 must be submitted within 90 calendar days of receipt of the agent or toxin. A copy of the completed form must be maintained for 3 years.
(c) Unless the Administrator by order determines that additional regulation of a specific product is necessary to protect animal health or animal products, products that are, bear, or contain overlap select agents or toxins will be exempt from the requirements of this part if the products have been cleared, approved, licensed, or registered pursuant to:
(1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
(2) Section 351 of Public Health Service Act (42 U.S.C. 262);
(3) The Virus-Serum-Toxin Act (21 U.S.C. 151-159); or
(4) The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 131
(d) After consultation with the HHS Secretary, the Administrator may exempt from the requirements of this part an investigational product that is, bears, or contains an overlap select agent or toxin if such product is being used in an investigation authorized by any Federal law and the Administrator determines that additional regulation under this part is not necessary to protect animal health or animal products.
(1) To apply for an exemption, an individual or entity must submit APHIS/CDC Form 5.
(2) The Administrator will make a determination regarding an exemption within 14 calendar days after receipt of the application and notification that the investigation has been authorized under a Federal law. A written decision granting or denying the exemption will be issued.
(3) The applicant must notify APHIS or CDC when an authorization for an investigation no longer exists. This exemption automatically terminates when such authorization is no longer in effect.
(e) The Administrator may exempt an individual or entity from the requirements of this part for 30 calendar days if it is necessary to respond to a domestic or foreign agricultural emergency involving an overlap select agent or toxin. The Administrator may extend the exemption once for an additional 30 days. An individual or entity may apply for this exemption by submitting APHIS/CDC Form 5. A written decision granting or denying the exemption will be issued.
(f) Upon request of the Secretary of Health and Human Services, the Administrator may exempt an individual or entity from the requirements of this part for 30 calendar days if the Secretary of Health and Human Services has granted an exemption for a public health emergency involving an overlap
(a) Unless exempted under § 121.5, an individual or entity shall not possess, use, or transfer any VS select agent or toxin without a certificate of registration issued by the Administrator. Unless exempted under § 121.6 or 42 CFR 73.6, an individual or entity shall not possess, use, or transfer any overlap select agent or toxin without a certificate of registration issued by the Administrator and the HHS Secretary.
(b) As a condition of registration, each entity must designate an individual to be its responsible official. While most registrants are likely to be entities, in the event that an individual applies for and is granted a certificate of registration, the individual will be considered the responsible official.
(c)(1) As a condition of registration, the following must be approved by the Administrator or the HHS Secretary based on a security risk assessment by the Attorney General:
(i) The individual or entity;
(ii) The responsible official; and
(iii) Unless otherwise exempted under this section, any individual who owns or controls the entity.
(2) Federal, State, or local governmental agencies, including public accredited academic institutions, are exempt from the security risk assessments for the entity and the individual who owns or controls such entity.
(3) An individual will be deemed to own or control an entity under the following conditions:
(i) For a private institution of higher education, an individual will be deemed to own or control the entity if the individual is in a managerial or executive capacity with regard to the entity's select agents or toxins or with regard to the individuals with access to the select agents or toxins possessed, used, or transferred by the entity.
(ii) For entities other than institutions of higher education, an individual will be deemed to own or control the entity if the individual:
(A) Owns 50 percent or more of the entity, or is a holder or owner of 50 percent or more of its voting stock; or
(B) Is in a managerial or executive capacity with regard to the entity's select agents or toxins or with regard to the individuals with access to the select agents or toxins possessed, used, or transferred by the entity.
(4) An entity will be considered to be an institution of higher education if it is an institution of higher education as defined in section 101(a) of the Higher Education Act of 1965 (20 U.S.C. 1001(a)), or is an organization described in 501(c)(3) of the Internal Revenue Code of 1986, as amended (26 U.S.C. 501(c)(3)).
(5) To obtain a security risk assessment, an individual or entity must submit the information necessary to conduct a security risk assessment to the Attorney General.
(d) To apply for a certificate of registration for only VS select agents or toxins, or for VS and PPQ select agents or toxins, an individual or entity must submit the information requested in the registration application package (APHIS/CDC Form 1) to APHIS. To apply for a certificate of registration for overlap select agents or toxins, overlap select agents or toxins and any combination of PPQ or VS select agents or toxins, or HHS select agents or toxins and any combination of PPQ or VS select agents or toxins, an individual or entity must submit the information requested in the registration application package (APHIS/CDC Form 1) to APHIS or CDC, but not both.
(e) Prior to the issuance of a certificate of registration, the responsible official must promptly provide notification of any changes to the application for registration by submitting the relevant page(s) of the registration application.
(f) The issuance of a certificate of registration may be contingent upon inspection or submission of additional information, such as the security plan, biosafety plan, incident response plan, or any other documents required to be prepared under this part.
(g) A certificate of registration will be valid for one physical location (a
(h) A certificate of registration may be amended to reflect changes in circumstances (e.g., replacement of the responsible official or other personnel changes, changes in ownership or control of the entity, changes in the activities involving any select agents or toxins, or the addition or removal of select agents or toxins).
(1) Prior to any change, the responsible official must apply for an amendment to a certificate of registration by submitting the relevant page(s) of the registration application.
(2) The responsible official will be notified in writing if an application to amend a certificate of registration has been approved. Approval of an amendment may be contingent upon an inspection or submission of additional information, such as the security plan, biosafety plan, incident response plan, or any other documents required to be prepared under this part.
(3) No change may be made without such approval.
(i) An entity must immediately notify APHIS or CDC if it loses the services of its responsible official. In the event that an entity loses the services of its responsible official, an entity may continue to possess or use select agents or toxins only if it appoints as the responsible official another individual who has been approved by the Administrator or the HHS Secretary following a security risk assessment by the Attorney General and who meets the requirements of this part.
(j) A certificate of registration will be terminated upon the written request of the entity if the entity no longer possesses or uses any select agents or toxins and no longer wishes to be registered.
(k) A certificate of registration will be valid for a maximum of 3 years.
(a) An application may be denied or a certificate of registration revoked or suspended if:
(1) The individual or entity, the responsible official, or an individual who owns or controls the entity is within any of the categories described in 18 U.S.C. 175b;
(2) The individual or entity, the responsible official, or an individual who owns or controls the entity is reasonably suspected by any Federal law enforcement or intelligence agency of:
(i) Committing a crime set forth in 18 U.S.C. 2332b(g)(5); or
(ii) Knowing involvement with an organization that engages in domestic or international terrorism (as defined in 18 U.S.C. 2331) or with any other organization that engages in intentional crimes of violence; or
(iii) Being an agent of a foreign power as defined in 50 U.S.C. 1801;
(3) The individual or entity does not meet the requirements of this part;
(4) It is determined that such action is necessary to protect animal health or animal products.
(b) Upon revocation or suspension of a certificate of registration, the individual or entity must:
(1) Immediately stop all use of each select agent or toxin covered by the revocation or suspension order;
(2) Immediately safeguard and secure each select agent or toxin covered by the revocation or suspension order from theft, loss, or release; and
(3) Comply with all disposition instructions issued by the Administrator for each select agent or toxin covered by the revocation or suspension.
(c) Denial of an application for registration and revocation of registration may be appealed under § 121.20. However, any denial of an application for registration or revocation of a certificate of registration will remain in effect until a final agency decision has been rendered.
(a) An individual or entity required to register under this part must designate an individual to be the responsible official. The responsible official must:
(1) Be approved by the Administrator or the HHS Secretary following a security risk assessment by the Attorney General;
(2) Be familiar with the requirements of this part;
(3) Have authority and responsibility to act on behalf of the entity;
(4) Ensure compliance with the requirements of this part; and
(5) Ensure that annual inspections are conducted for each laboratory where select agents or toxins are stored or used in order to determine compliance with the requirements of this part. The results of each inspection must be documented, and any deficiencies identified during an inspection must be corrected.
(b) An entity may designate one or more individuals to be an alternate responsible official, who may act for the responsible official in his/her absence. These individuals must have the authority and control to ensure compliance with the regulations when acting as the responsible official.
(c) The responsible official must report the identification and final disposition of any select agent or toxin contained in a specimen presented for diagnosis or verification.
(1) The identification of any of the following select agents or toxins must be immediately reported by telephone, facsimile, or e-mail: African horse sickness virus, African swine fever virus, avian influenza virus (highly pathogenic),
(2) To report the identification and final disposition of any other select agent or toxin, APHIS/CDC Form 4 must be submitted within 7 calendar days after identification. A copy of the completed form must be maintained for 3 years.
(3) Less stringent reporting may be required during agricultural emergencies or outbreaks, or in endemic areas.
(d) The responsible official must report the identification and final disposition of any select agent or toxin contained in a specimen presented for proficiency testing. To report the identification and final disposition of a select agent or toxin, APHIS/CDC Form 4 must be submitted within 90 calendar days of receipt of the agent or toxin. A copy of the completed form must be maintained for 3 years.
(a) An individual or entity required to register under this part may not provide an individual access to a select agent or toxin, and an individual may not access a select agent or toxin, unless the individual is approved by the Administrator or the HHS Secretary following a security risk assessment by the Attorney General.
(b) An individual will be deemed to have access at any point in time if the individual has possession of a select agent or toxin (e.g., carries, uses, or manipulates) or the ability to gain possession of a select agent or toxin.
(c) Each individual with access to select agents or toxins must have the appropriate education, training, and/or experience to handle or use such agents or toxins.
(d) To apply for access approval, each individual must submit the information necessary to conduct a security risk assessment to the Attorney General.
(e) An individual's security risk assessment may be expedited upon written request by the responsible official and a showing of good cause (e.g., public health or agricultural emergencies, national security, or a short-term visit
(f) An individual's access approval for VS select agents or toxins may be denied, limited, or revoked if:
(1) The individual is within any of the categories described in 18 U.S.C. 175b;
(2) The individual is reasonably suspected by any Federal law enforcement or intelligence agency of committing a crime set forth in 18 U.S.C. 2332b(g)(5); knowing involvement with an organization that engages in domestic or international terrorism (as defined in 18 U.S.C. 2331) or with any other organization that engages in intentional crimes of violence; or being an agent of a foreign power as defined in 50 U.S.C. 1801; or
(3) It is determined that such action is necessary to protect animal health or animal products.
(g) For overlap select agents or toxins, an individual's access approval will be denied or revoked if the individual is within any of the categories described in 18 U.S.C. 175b. An individual's access approval may be denied, limited, or revoked for the reasons set forth in paragraphs (f)(2) through (f)(3) of this section.
(h) An individual may appeal the Administrator's decision to deny, limit, or revoke access approval under § 121.20.
(i) Access approval is valid for a maximum of 5 years.
(j) The responsible official must immediately notify APHIS or CDC when an individual's access to select agents or toxins is terminated by the entity and the reasons therefore.
(a) An individual or entity required to register under this part must develop and implement a written security plan. The security plan must be sufficient to safeguard the select agent or toxin against unauthorized access, theft, loss, or release.
(b) The security plan must be designed according to a site-specific risk assessment and must provide graded protection in accordance with the risk of the select agent or toxin, given its intended use. The security plan must be submitted upon request.
(c) The security plan must:
(1) Describe procedures for physical security, inventory control, and information systems control;
(2) Contain provisions for the control of access to select agents and toxins;
(3) Contain provisions for routine cleaning, maintenance, and repairs;
(4) Establish procedures for removing unauthorized or suspicious persons;
(5) Describe procedures for addressing loss or compromise of keys, passwords, combinations, etc. and protocols for changing access numbers or locks following staff changes;
(6) Contain procedures for reporting unauthorized or suspicious persons or activities, loss or theft of select agents or toxins, release of select agents or toxins, or alteration of inventory records; and
(7) Contain provisions for ensuring that all individuals with access approval from the Administrator or the HHS Secretary understand and comply with the security procedures.
(d) An individual or entity must adhere to the following security requirements or implement measures to achieve an equivalent or greater level of security:
(1) Allow access only to individuals with access approval from the Administrator or the HHS Secretary;
(2) Allow individuals not approved for access by the Administrator or the HHS Secretary to conduct routine cleaning, maintenance, repairs, and other activities not related to select agents or toxins only when continuously escorted by an approved individual;
(3) Provide for the control of select agents and toxins by requiring freezers, refrigerators, cabinets, and other containers where select agents or toxins are stored to be secured against unauthorized access (e.g., card access system, lock boxes);
(4) Inspect all suspicious packages before they are brought into or removed from an area where select agents or toxins are used or stored;
(5) Establish a protocol for intra-entity transfers under the supervision of an individual with access approval from the Administrator or the HHS
(6) Require that individuals with access approval from the Administrator or the HHS Secretary refrain from sharing with any other person their unique means of accessing a select agent or toxin (e.g., keycards or passwords);
(7) Require that individuals with access approval from the Administrator or the HHS Secretary immediately report any of the following to the responsible official:
(i) Any loss or compromise of keys, passwords, combinations, etc.;
(ii) Any suspicious persons or activities;
(iii) Any loss or theft of select agents or toxins;
(iv) Any release of a select agent or toxin; and
(v) Any sign that inventory or use records for select agents or toxins have been altered or otherwise compromised; and
(8) Separate areas where select agents and toxins are stored or used from the public areas of the building.
(e) In developing a security plan, an individual or entity should consider the document entitled, “Laboratory Security and Emergency Response Guidance for Laboratories Working with Select Agents,” in Morbidity and Mortality Weekly Report (December 6, 2002); 51 (No. RR-19):1-6. This document is available on the Internet at
(f) The plan must be reviewed annually and revised as necessary. Drills or exercises must be conducted at least annually to test and evaluate the effectiveness of the plan. The plan must be reviewed and revised, as necessary, after any drill or exercise and after any incident.
(a) An individual or entity required to register under this part must develop and implement a written biosafety plan that is commensurate with the risk of the select agent or toxin, given its intended use.
(b) The biosafety and containment procedures must be sufficient to contain the select agent or toxin (e.g., physical structure and features of the entity, and operational and procedural safeguards).
(c) In developing a biosafety plan, an individual or entity should consider the following:
(1) The CDC/NIH publication, “Biosafety in Microbiological and Biomedical Laboratories.” This document may be obtained from the U.S. Government Printing Office. It is also available on the Internet at
(2) The Occupational Safety and Health Administration (OSHA) regulations in 29 CFR 1910.1200 and 1910.1450.
(3) The “NIH Guidelines for Research Involving Recombinant DNA Molecules.” This document is available on the Internet at
(d) The plan must be reviewed annually and revised as necessary. Drills or exercises must be conducted at least annually to test and evaluate the effectiveness of the plan. The plan must be reviewed and revised, as necessary, after any drill or exercise and after any incident.
(a) An individual or entity may not conduct a restricted experiment with a VS select agent or toxin unless approved by and conducted in accordance with any conditions prescribed by the Administrator. In addition, an individual or entity may not conduct a restricted experiment with an overlap select agent or toxin unless approved by and conducted in accordance with any
(b)
(2) Experiments involving the deliberate formation of recombinant DNA containing genes for the biosynthesis of toxins lethal for vertebrates at an LD
(c) The Administrator may revoke approval to conduct any of the experiments in paragraph (b) of this section, or revoke or suspend a certificate of registration, if the individual or entity fails to comply with the requirements of this part.
(d) To apply for approval to conduct any of the experiments in paragraph (b) of this section, an individual or entity must submit a written request and supporting scientific information. A written decision granting or denying the request will be issued.
(a) An individual or entity required to register under this part must develop and implement a written incident response plan.
(b) The incident response plan must fully describe the entity's response procedures for the theft, loss, or release of a select agent or toxin; inventory discrepancies; security breaches (including information systems); severe weather and other natural disasters; workplace violence; bomb threats and suspicious packages; and emergencies such as fire, gas leak, explosion, power outage, etc. The response procedures must account for hazards associated with the select agent or toxin and appropriate actions to contain such agent or toxin.
(c) The incident response plan must also contain the following information:
(1) The name and contact information (e.g., home and work) for the individual or entity (e.g., responsible official, alternate responsible official(s), biosafety officer, etc.);
(2) The name and contact information for the building owner and/or manager, where applicable;
(3) The name and contact information for tenant offices, where applicable;
(4) The name and contact information for the physical security official for the building, where applicable;
(5) Personnel roles and lines of authority and communication;
(6) Planning and coordination with local emergency responders;
(7) Procedures to be followed by employees performing rescue or medical duties;
(8) Emergency medical treatment and first aid;
(9) A list of personal protective and emergency equipment, and their locations;
(10) Site security and control;
(11) Procedures for emergency evacuation, including type of evacuation, exit route assignments, safe distances, and places of refuge; and
(12) Decontamination procedures.
(d) The plan must be reviewed annually and revised as necessary. Drills or exercises must be conducted at least annually to test and evaluate the effectiveness of the plan. The plan must be reviewed and revised, as necessary, after any drill or exercise and after any incident.
(a) An individual or entity required to register under this part must provide information and training on biosafety and security to each individual with access approval from the Administrator or the HHS Secretary before he/she has such access. In addition, an individual or entity must provide information and training on biosafety and security to each individual not approved for access by the Administrator or the HHS Secretary before he/she works in or visits areas where select
(b) Refresher training must be provided annually.
(c) A record of the training provided to each individual must be maintained. The record must include the name of the individual, the date of training, a description of the training provided, and the means used to verify that the employee understood the training.
(a) Except as provided in paragraphs (c) and (d) of this section, a select agent or toxin may only be transferred to individuals or entities registered to possess, use, or transfer that agent or toxin. A select agent or toxin may only be transferred under the conditions of this section and must be authorized by APHIS or CDC prior to the transfer.
(b) In addition to any permit required under part 122 of this subchapter, a transfer may be authorized if:
(1) The sender:
(i) Has at the time of transfer a certificate of registration that covers the particular select agent or toxin to be transferred and meets all the requirements of this part;
(ii) Meets the exemption requirements for the particular select agent or toxin to be transferred; or
(iii) Is transferring the select agent or toxin from outside of the United States and meets all import requirements.
(2) At the time of transfer, the recipient has a certificate of registration that includes the particular select agent or toxin to be transferred and meets all of the requirements of this part.
(c) A select agent or toxin that is contained in a specimen for proficiency testing may be transferred without prior authorization from APHIS or CDC provided that, at least 7 calendar days prior to the transfer, the sender reports to APHIS or CDC the select agent or toxin to be transferred and the name and address of the recipient.
(d) On a case-by-case basis, the Administrator may authorize a transfer of a select agent or toxin not otherwise eligible for transfer under this part under conditions prescribed by the Administrator.
(e) To obtain authorization for a transfer, APHIS/CDC Form 2 must be submitted.
(f) The recipient must submit a completed APHIS/CDC Form 2 within 2 business days of receipt of a select agent or toxin.
(g) The recipient must immediately notify APHIS or CDC if the select agent or toxin has not been received within 48 hours after the expected delivery time or if the package containing the select agent or toxin has been damaged to the extent that a release of the select agent or toxin may have occurred.
(h) An authorization for a transfer shall be valid only for 30 calendar days after issuance, except that such an authorization becomes immediately null and void if any facts supporting the authorization change (e.g., change in the certificate of registration for the sender or recipient, change in the application for transfer).
(i) The sender must comply with all applicable laws governing packaging and shipping.
(a) An individual or entity required to register under this part must maintain complete records relating to the activities covered by this part. Such records must include:
(1) An accurate, current inventory for each select agent (including viral genetic elements, recombinant nucleic acids, and recombinant organisms) held in long-term storage (placement in a system designed to ensure viability for future use, such as in a freezer or lyophilized materials), including:
(i) The name and characteristics (e.g., strain designation, GenBank Accession number, etc.);
(ii) The quantity acquired from another individual or entity (e.g., containers, vials, tubes, etc.), date of acquisition, and the source;
(iii) Where stored (e.g., building, room, and freezer);
(iv) When moved from storage and by whom and when returned to storage and by whom;
(v) The select agent used and purpose of use;
(vi) Records created under § 121.16 or 42 CFR 73.16 (Transfers);
(vii) For intra-entity transfers (sender and the recipient are covered by the same certificate of registration), the select agent, the quantity transferred, the date of transfer, the sender, and the recipient; and
(viii) Records created under § 121.19 or 42 CFR 73.19 (Notification of theft, loss, or release);
(2) An accurate, current inventory for each toxin held, including:
(i) The name and characteristics;
(ii) The quantity acquired from another individual or entity (e.g., containers, vials, tubes, etc.), date of acquisition, and the source;
(iii) The initial and current quantity amount (e.g., milligrams, milliliters, grams, etc.);
(iv) The toxin used and purpose of use, quantity, date(s) of the use and by whom;
(v) Where stored (e.g., building, room, and freezer);
(vi) When moved from storage and by whom and when returned to storage and by whom, including quantity amount;
(vii) Records created under § 121.16 or 42 CFR 73.16 (Transfers);
(viii) For intra-entity transfers (sender and the recipient are covered by the same certificate of registration), the toxin, the quantity transferred, the date of transfer, the sender, and the recipient;
(ix) Records created under § 121.19 or 42 CFR 73.19 (Notification of theft, loss, or release);
(x) If destroyed, the quantity of toxin destroyed, the date of such action, and by whom.
(3) A current list of all individuals that have been granted access approval by the Administrator or the HHS Secretary;
(4) Information about all entries into areas containing select agents or toxins, including the name of the individual, name of the escort (if applicable), and the date and time of entry;
(5) Accurate, current records created under § 121.9 or 42 CFR 73.9 (Responsible official), § 121.11 or 42 CFR 73.11 (Security), § 121.12 or 42 CFR 73.12 (Biosafety), § 121.14 or 42 CFR 73.14 (Incident response), and § 121.15 or 42 CFR 73.15 (Training); and
(6) A written explanation of any discrepancies.
(b) The individual or entity must implement a system to ensure that all records and databases created under this part are accurate, have controlled access, and that their authenticity may be verified.
(c) All records created under this part must be maintained for 3 years and promptly produced upon request.
(a) Without prior notification, APHIS must be allowed to inspect any site at which activities regulated under this part are conducted and must be allowed to inspect and copy any records relating to the activities covered by this part.
(b) Prior to issuing a certificate of registration to an individual or entity, APHIS may inspect and evaluate the premises and records to ensure compliance with this part.
(a) An individual or entity must immediately notify APHIS or CDC upon discovery of the theft or loss of a select agent or toxin. Thefts or losses must be reported even if the select agent or toxin is subsequently recovered or the responsible parties are identified.
(1) The theft or loss of a select agent or toxin must be reported by telephone, facsimile, or e-mail. The following information must be provided:
(i) The name of the select agent or toxin and any identifying information (e.g., strain or other characterization information);
(ii) An estimate of the quantity stolen or lost;
(iii) An estimate of the time during which the theft or loss occurred;
(iv) The location (building, room) from which the theft or loss occurred; and
(v) The list of Federal, State, or local law enforcement agencies to which the individual or entity reported, or intends to report, the theft or loss.
(2) A completed APHIS/CDC Form 3 must be submitted within 7 calendar days.
(b) An individual or entity must immediately notify APHIS or CDC upon discovery of a release of a select agent or toxin causing occupational exposure or a release of a select agent or toxin outside of the primary barriers of the biocontainment area.
(1) The release of a select agent or toxin must be reported by telephone, facsimile, or e-mail. The following information must be provided:
(i) The name of the select agent or toxin and any identifying information (e.g., strain or other characterization information);
(ii) An estimate of the quantity released;
(iii) The time and duration of the release;
(iv) The environment into which the release occurred (e.g., in building or outside of building, waste system);
(v) The location (building, room) from which the release occurred; and
(vi) The number of individuals potentially exposed at the entity;
(vii) Actions taken to respond to the release; and
(viii) Hazards posed by the release.
(2) A completed APHIS/CDC Form 3 must be submitted within 7 calendar days.
An individual or entity may appeal a denial, revocation, or suspension of registration under this part. An individual may appeal a denial, limitation, or revocation of access approval under this part.
7 U.S.C. 8301-8317; 21 U.S.C. 151-158; 7 CFR 2.22, 2.80, and 371.4.
The following words, when used in the regulations in this part 122, shall be construed, respectively, to mean:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
No organisms or vectors shall be imported into the United States or transported from one State or Territory or the District of Columbia to another State or Territory or the District of Columbia without a permit issued by the Secretary and in compliance with the terms thereof:
The Secretary may issue, at his discretion, a permit as specified in § 122.2 when proper safeguards are set up as provided in § 122.2 to protect the public. Application for such a permit shall be made in advance of shipment, and each permit shall specify the name and address of the consignee, the true name and character of each of the organisms or vectors involved, and the use to which each will be put.
(a) Any permit for the importation or transportation of organisms or vectors issued under this part may be formally suspended or revoked after opportunity for hearing has been accorded the permittee, as provided in part 123 of this subchapter, if the Secretary finds that the permittee has failed to observe the safeguards and instructions prescribed by the Administrator with respect to the particular importation or transportation or that such importation or transportation for any other reason may result in the introduction or dissemination from a foreign country into the United States, or from one State, Territory or the District of Columbia to another, of the contagion of any contagious, infectious or communicable disease of animals (including poultry).
(b) In cases of wilfulness or where the public health, interest or safety so requires, however, the Secretary may without hearing informally suspend such a permit upon the grounds set forth in paragraph (a) of this section, pending determination of formal proceedings under part 123 of this subchapter for suspension or revocation of the permit.
7 U.S.C. 8301-8317; 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
The Uniform Rules of Practice for the Department of Agriculture promulgated in subpart H of part 1, subtitle A, title 7, Code of Federal Regulations, are the Rules of Practice applicable to adjudicatory, administrative proceedings under the Virus-Serum-Toxin Act.
35 U.S.C. 156; 7 CFR 2.22, 2.80, and 371.4.
(a) This parts sets forth procedures and requirements for APHIS review of applications for the extension of the term of certain patents for veterinary biological products pursuant to 35 U.S.C. 156—Extension of patent term. Responsibilities of APHIS include:
(1) Assisting PTO in determining eligibility for patent term restoration;
(2) Determining the length of a product's regulatory review period;
(3) If petitioned, reviewing and ruling on due diligence challenges to APHIS's regulatory review period determinations; and
(4) Conducting hearings to review initial APHIS findings on due diligence challenges.
(b) The regulations in this part are designed to be used in conjunction with regulations issued by PTO concerning patent term extension which may be found at 37 CFR 1.710 through 1.791.
Upon receipt of a copy of an application for extension of the term of a veterinary biologic patent from PTO, APHIS will assist PTO in determining whether a patent related to a biological product is eligible for patent term extension by:
(a)(1) Verifying whether the product was subject to a regulatory review period before its commercial marketing or use;
(2) Determining whether the permission for commercial marketing or use of the product after the regulatory review period was the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred, and, if so, whether it was the first permitted commercial marketing or use of the veterinary biological product for administration to a food-producing animal;
(3) Ascertaining whether the patent term restoration application was submitted within 60 days after the product was approved for marketing or use; and
(4) Providing such other information as may be necessary and relevant to PTO's determination of whether a patent related to a product is eligible for patent term restoration.
(b) APHIS will notify PTO of its findings in writing, send a copy of this notification to the applicant, and make a copy available for public inspection in room 1141, South Building, 14th Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays.
(a) As provided in 37 CFR 1.779 of PTO's regulations, in order to determine a product's regulatory review period, APHIS will review the information in each application to determine the lengths of the following phases of the review period, and will then find their sum:
(1) The number of days in the period beginning on the date authorization to prepare an experimental biological product under the Virus-Serum-Toxin Act became effective and ending on the date an application for a license was initially submitted under the Virus-Serum-Toxin Act; and
(2) The number of days in the period beginning on the date an application for a license was initially submitted for approval under the Virus-Serum-Toxin Act and ending on the date such license was issued.
(b) A license application is “initially submitted” on the date it contains sufficient information to allow APHIS to commence review of the application. A product license is issued on the date of the APHIS letter informing the applicant of the issuance. The issuance of a license releases the product for commercial marketing or use.
(a) Not later than 30 days after the receipt of an application from PTO, APHIS shall determine the regulatory review period. Once the regulatory review period for a product has been determined, APHIS will notify PTO in writing of the determination, send a copy of the determination to the applicant, and make a copy available for public inspection in room 1141, South Building, 14th Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays.
(b) APHIS will also publish a notice of the regulatory review period determination in the
(1) The name of the applicant;
(2) The trade name and true name of the product;
(3) The number of the patent for which an extension of the term is sought;
(4) The approved indications or uses for the product;
(5) The regulatory review period determination, including a statement of the length of each phase of the review period and the dates used in calculating each phase.
(a) Any interested person may request a revision of the regulatory review period determination within the 30 day period beginning on its publication in the
(1) The identity of the product;
(2) The identity of the applicant for patent term restoration;
(3) The docket number of the
(4) The basis for the request for revision, including any documentary evidence.
(b) If APHIS decides to revise its prior determination, APHIS will notify PTO of the decision, and will send a copy of notification to the applicant and the person requesting the revision (if different from the applicant) with a request for comments within 10 days of notification. If no comment on the proposed revision is received, APHIS will publish the revision in the
APHIS will consider its regulatory review period determination to be final upon expiration of the 180-day period for filing a due diligence petition under § 124.30 unless it receives:
(a) New information from PTO records, or APHIS records, that affects the regulatory review period determination;
(b) A request under § 124.22 for revision of the regulatory review period determination;
(c) A due diligence petition filed under § 124.30; or
(d) A request for a hearing filed under § 124.40.
(a) Any interested person may file a petition with APHIS, no later than 180 days after the publication of a regulatory review period determination under § 124.21, alleging that a license applicant did not act with due diligence in seeking APHIS approval of the product during the regulatory review period.
(b) The petition must be filed with APHIS under the docket number of the
(c) The petition must allege that the applicant failed to act with due diligence sometime during the regulatory review period and must set forth sufficient facts to merit an investigation by APHIS of whether the applicant acted with due diligence.
(d) The petition must contain a certification that the petitioner has served a true and complete copy of the petition on interested parties by certified or registered mail (return receipt requested) or by personal delivery.
(a) The applicant may file with APHIS a written response to the petition no later than 20 days after the applicant's receipt of a copy of the petition.
(b) The applicant's response may present additional facts and circumstances to address the assertions in the petition, but shall be limited to the issue of whether the applicant acted with due diligence during the regulatory review period. The applicant's response may include documents that were not in the original patent term extension application.
(c) If the applicant does not respond to the petition, APHIS will decide the matter on the basis of the information submitted in the patent term restoration application, the due diligence petition, and APHIS records.
(a) Within 90 days after APHIS receives a petition filed under § 124.30, the Under Secretary for Marketing and Regulatory Programs shall make a determination under paragraphs (b) or (c) of this section or under § 124.33 whether the applicant acted with due diligence during the regulatory review period. APHIS will publish its determination in the
(b) APHIS may deny a due diligence petition without considering the merits of the petition if:
(1) The petition is not filed in accordance with § 124.30;
(2) The petition does not contain information or allegations upon which APHIS may reasonably determine that the applicant did not act with due diligence during the applicable regulatory review period; or
(3) The petition fails to allege a sufficient total amount of time during which the applicant did not exercise due diligence so that, even if the petition were granted, the petition would not affect the maximum patent term extension which the applicant is entitled to under 35 U.S.C. 156.
(a) In determining the due diligence of an applicant, APHIS will examine the facts and circumstances of the applicant's actions during the regulatory review period to determine whether the applicant exhibited the degree of attention, continuous directed effort, and timeliness as may reasonably be expected from, and are ordinarily exercised by, a person during a regulatory review period. APHIS will take into consideration all relevant factors, such as the amount of time between the approval of an experimental use permit and licensure of the veterinary biological product.
(b) For purposes of this Part, the actions of the marketing applicant shall be imputed to the applicant for patent term restoration. The actions of an agent, attorney, contractor, employee, licensee, or predecessor in interest of the marketing applicant shall be imputed to the applicant for patent term restoration.
(a) Any interested person may request, within 60 days beginning on the date of publication of a due diligence determination by APHIS in accordance with § 124.32, that APHIS conduct an informal hearing on the due diligence determination.
(b) The request for a hearing must:
(1) Be in writing;
(2) Contain the docket number of the
(3) Be delivered to the Director, Center for Veterinary Biologics, Licensing and Policy Development, 510 South 17th Street, Suite 104, Ames, IA 50010-8197.
(4) Contain a full statement of facts upon which the request for hearing is based;
(5) Contain the name, the address, and the principal place of business of the person requesting the hearing; and
(6) Contain a certification that the person requesting the hearing has served a true and complete copy of the request upon the petitioner of the due diligence determination and the applicant for patent term extension by certified or registered mail (return receipt requested) or by personal service.
(c) The request must state whether the requesting party seeks a hearing not later than 30 days after the date APHIS receives the request, or, at the request of the person making the request, not later than 60 days after such date.
No later than ten days before the hearing, APHIS will notify the requesting party, the applicant, the petitioner, and any other interested person of the date, time, and location of the hearing.
(a) The presiding officer shall be appointed by the Administrator of APHIS from officers and employees of the Department who have not participated in any action of the Secretary which is the subject of the hearing and who are not directly responsible to an officer or employee of the Department who has participated in any such action.
(b) Each party to the hearing shall have the right at all times to be advised and accompanied by an attorney.
(c) Before the hearing, each party to the hearing shall be given reasonable notice of the matters to be considered at the hearing, including a comprehensive statement of the basis for the action taken or proposed by the Secretary which is the subject of the hearing and any general summary of the information which will be presented at the hearing in support of such action.
(d) At the hearing the parties to the hearing shall have the right to hear a full and complete statement of the action which is the subject of the hearing together with the information and reasons supporting such action, to conduct reasonable questioning, and to present any oral and written information relevant to such action.
(e) The presiding officer in such hearing shall prepare a written report of the hearing to which shall be attached all written material presented at the hearing. The participants in the hearing shall be given the opportunity to review and correct or supplement the presiding officer's report of the hearing.
(f) The Secretary may require the hearing to be transcribed. A party to the hearing shall have the right to have the hearing transcribed at his expense. Any transcription of a hearing shall be included in the presiding officer's report of the hearing.
(g) The due diligence hearing will be conducted in accordance with rules of practice adopted for the proceeding. APHIS will provide the requesting party, the applicant, and the petitioner with an opportunity to participate as a party in the hearing. The standard of due diligence set forth in § 124.33 will apply at the hearing. The party requesting the due diligence hearing will have the burden of proof at the hearing.
Within 30 days after completion of the due diligence hearing, the Under Secretary for Marketing and Regulatory Programs, taking into consideration the recommendation of the Administrator, will affirm or revise the determination made under § 124.32. APHIS will publish the due diligence redetermination in the
5 U.S.C. 5542; 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 3701, 3716, 3717, 3719, and 3720A; 7 CFR 2.22, 2.80, and 371.4.
As used in this part, the following terms shall have the meaning set forth in this section.
(a)
(b)
(c)
(d)
At 72 FR 70765, Dec. 13, 2007, § 130.2 was amended in paragraph (a) in the first sentence, by adding the words “for any service rendered by an APHIS representative” after the word “fees”, effective Jan. 14, 2008.
(a)(1) An importer may request to exclusively occupy a space at an APHIS animal import center. The user fees for spaces at APHIS animal import centers are listed in the following table. The person for whom the service is provided and the person requesting the service are jointly and severally liable for payment of these user fees in accordance with §§ 130.50 and 130.51.
(2) Any importer who occupies space for more than 30 days must pay 1/30th of the 30-day fee for each additional day or part of a day. The person for whom the service is provided and the person requesting the service are jointly and severally liable for any additional charges.
(3) Unless the importer cancels the reservation for exclusive use of space in time to receive a refund of the reservation fee in accordance with 9 CFR 93.103, 93.204, 93.304, 93.404, or 93.504, as appropriate, the 30-day user fee will be effective as of the first day for which the importer has reserved the space, regardless of whether the user occupies the space on that date or not.
(b) Users must provide APHIS personnel at the Animal Import Center, at the time they make a reservation for quarantine space, with the following information:
(1) Species of animals and birds to be quarantined;
(2) Ages of animals and birds to be quarantined; and
(3) Sizes of animals and birds to be quarantined.
(c)(1) APHIS personnel at the Animal Importer Center will determine, based on the information provided by the importer under paragraph (b) of this section, and on routine husbandry needs, the maximum number of animals and
(2) If the number of animals and birds requested by the importer can be housed in the space requested, as determined by APHIS personnel at the Animal Import Center, but two animal health technicians cannot fulfill the routine husbandry needs of the number of animals or birds proposed by the importer, then the importer must pay for additional services on an hourly basis, or reduce the number of animals or birds to be quarantined to a number which APHIS personnel at the Animal Import Center determine can be handled by two animal health technicians.
(3) If the importer requests additional services, then the user fees for those services will be calculated at the hourly rate user fee listed in § 130.30, for each employee required to perform the service.
(d) The importer must provide feed, or pay for it on an actual cost basis, including cost of delivery to the Animal Import Center.
At 72 FR 70765, Dec. 13, 2007, § 130.3 was amended in paragraph (c)(3) by removing the words “for those services” and adding the words “for any service rendered by an APHIS representative” in their place, effective Jan. 14, 2008.
User fees for processing applications for permits to import certain animals and animal products (using VS forms 16-3 and 17-129) are listed in the table in this section. The person for whom the service is provided and the person requesting the service are jointly and severally liable for payment of these user fees in accordance with §§ 130.50 and 130.51. The table follows:
At 72 FR 70766, Dec. 13, 2007, § 130.4 was amended in the first sentence of the section by adding the words “for any service rendered by an APHIS representative” after the word “fees”, and by adding the sentence “These fees are nonrefundable.” after the second sentence, effective Jan. 14, 2008.
(a) User fees for each animal quarantined in a privately operated permanent or temporary import quarantine facility will be calculated at the hourly user fee rate listed in § 130.30, for each employee required to perform the service. The person for whom the service is
(b) [Reserved]
At 72 FR 70766, Dec. 13, 2007, § 130.5 was amended in paragraph (a), in the first sentence, by adding the words “for any service rendered by an APHIS representative” after the word “fees”, effective Jan. 14, 2008.
(a) User fees for live animals presented for importation into or entry into the United States through a land border port along the United States-Mexico border are listed in the following table. The minimum user fee for this service is listed in § 130.30. The person for whom the service is provided and the person requesting the service are jointly and severally liable for payment of these user fees in accordance with §§ 130.50 and 130.51.
(b) [Reserved]
At 72 FR 70766, Dec. 13, 2007, § 130.6 was amended in paragraph (a), in the first sentence, by adding the words “for any service rendered by an APHIS representative” after the word “fees”, effective Jan. 14, 2008.
(a) User fees for live animals presented for importation into or entry into the United States through a land border port along the United States-Canada border are listed in the following table. The minimum user fee for this service is listed in § 130.30. The person for whom the service is provided and the person requesting the service are jointly and severally liable for payment of these user fees in accordance with §§ 130.50 and 130.51.
(b) [Reserved]
At 72 FR 70766, Dec. 13, 2007, § 130.7 was amended in paragraph (a), first sentence, by adding the words “for any service rendered by an APHIS representative” after the word “fees” and by adding paragraph (b), effective Jan. 14, 2008. For the convenience of the user, the added text is set forth as follows:
(b) If a service must be conducted on a Sunday or holiday or at any other time outside the normal tour of duty of the employee, then reimbursable overtime, as provided for in part 97 of this chapter, must be paid for each service, in addition to the user fee listed in this section.
(a) User fees for other services that are not specifically addressed elsewhere in part 130 are listed in the following table. The person for whom the service is provided and the person requesting the service are jointly and severally liable for payment of these user fees in accordance with §§ 130.50 and 130.51.
(b) [Reserved]
At 72 FR 70766, Dec. 13, 2007, § 130.8 was amended in paragraph (a), in the first sentence by adding the words “for any service rendered by an APHIS representative” after the word “fees”, effective Jan. 14, 2008.
(a) User fees for pet birds of U.S. origin returning to the United States, except pet birds of U.S. origin returning from Canada, are as follows:
(b) User fees for each pet bird quarantined in an animal import center or other APHIS-owned or supervised quarantine facility are listed in the following table. These user fees include standard care, feed, and handling. The person for whom the service is provided and the person requesting the service are jointly and severally liable for payment of these user fees in accordance with §§ 130.50 and 130.51.
(c) Based on the information provided to APHIS personnel, APHIS personnel at the Animal Import Center or other APHIS owned or supervised quarantine facility will determine the appropriate number of birds that should be housed per isolette.
(d) If the importer requests additional services, then the user fees for those services will be calculated at the hourly rate user fee listed in § 130.30, for each employee required to perform the service.
(a) User fees for the inspection of various import and export facilities and establishments are listed in the following table. The person for whom the service is provided and the person requesting the service are jointly and severally liable for payment of these user fees in accordance with §§ 130.50 and 130.51.
(b) [Reserved]
At 72 FR 70766, Dec. 13, 2007, § 130.11 was amended in paragraph (a) by adding the sentence “These user fees do not apply to inspection activities covered in § 130.30(a)(2).” after the last sentence, effective Jan. 14, 2008.
(a) Diagnostic reagents. User fees for diagnostic reagents
(b)
(c)
(a)
(b)
At 72 FR 71746, Dec. 19, 2007, § 130.15 was amended by revising the tables in paragraphs (a) and (b), effective Jan. 18, 2007. For the convenience of the user, the revised text is set forth as follows:
(a) * * *
(b) * * *
(a)
(b)
At 72 FR 71746, Dec. 19, 2007, § 130.16 was amended by revising the tables in paragraphs (a) and (b), effective Jan. 18, 2007. For the convenience of the user, the revised text is set forth as follows:
(a) * * *
(b) * * *
(a) User fees for veterinary diagnostics tests performed at the Pathobiology Laboratory at NVSL (excluding FADDL) or at authorized sites are listed in the following table. The person for whom the service is provided and the person requesting the service are jointly and severally liable for payment of these user fees in accordance with §§ 130.50 and 130.51.
(b) [Reserved]
At 72 FR 71747, Dec. 19, 2007, § 130.17 was amended by revising the table in (a), effective Jan. 18, 2007. For the convenience of the user, the revised text is set forth as follows:
(a) * * *
(a)
(b)
At 72 FR 71748, Dec. 19, 2007, § 130.18 was amended by revising the tables in paragraphs (a) and (b), effective Jan. 18, 2007. For the convenience of the user, the revised text is set forth as follows:
(a) * * *
(b) * * *
(a) User fees for other veterinary diagnostic services or materials available from NVSL (excluding FADDL) are listed in the following table. The person for whom the service is provided and the person requesting the service are jointly and severally liable for payment of these user fees in accordance with §§ 130.50 and 130.51.
(b) [Reserved]
At 72 FR 71749, Dec. 19, 2007, § 130.19 was amended by revising the table in paragraph (a), effective Jan. 18, 2007. For the convenience of the user, the revised text is set forth as follows:
(a) * * *
(a) User fees for the endorsement of export health certificates that do not require the verification of tests or vaccinations are listed in the following table. The user fees apply to each export health certificate
(b)(1) User fees for the endorsement of export health certificates that require the verification of tests or vaccinations are listed in the following table. The user fees apply to each export health certificate
(2) If an export certificate covers more than one animal, but the number of tests required for different animals are not the same, the user fee for the certificate is the fee which would be due if all the animals on the certificate required the same number of tests as the animal which requires the greatest number of tests.
(c) The user fees prescribed in this section will not apply to an export health certificate if the export health certificate is prepared for endorsement completely at the site of the inspection by an APHIS veterinarian in the course of performing inspection or supervision services for the animals listed on the certificate, and an APHIS user fee is payable under § 130.30 of this part for the inspection or supervision services performed by the veterinarian.
(d) If a service must be conducted on a Sunday or holiday or at any other time outside the normal tour of duty of the employee, then reimbursable overtime, as provided for in part 97 of this chapter, must be paid for each service, in addition to the user fee listed in this section.
At 72 FR 70766, Dec. 13, 2007, § 130.20 was amended in paragraph (b)(1) by adding footnote 1 in the table heading and by revising in the table the entry for “Nonslaughter horses to Canada”, effective Jan. 14, 2008. For the convenience of the user, the added and revised text is set forth as follows:
(b)(1) * * *
(a) If inspection services (including inspection, testing, and supervision services) are performed outside the United States, in accordance with this title, and the regulations do not contain a provision for payment of the cost of the service, the person requesting the service must pay a user fee under this section.
(b) Any person who wants APHIS to provide inspection services outside the United States must contact the Animal and Plant Health Inspection Service, Veterinary Services, National Center for Import-Export, 4700 River Road, Unit 38, Riverdale, Maryland 20737-1231, to make an agreement.
(c) All agreements must include the following:
(1) Name, mailing address, and telephone number of either the person requesting the inspection services, or his or her agent;
(2) Explanation of inspection services to be provided, including the regulations in title 9, Code of Federal Regulations which provide for the services;
(3) Date(s) and time(s) the inspection services are to be provided;
(4) Location (including street address) where inspection services are to be provided;
(5) An estimate of the actual cost, as calculated by APHIS, to provide the described inspection services for 6 months;
(6) A statement that APHIS agrees to provide the inspection services;
(7) A statement that the person requesting the inspection services, or, if appropriate, his or her agent, agrees to pay, at the time the agreement is entered into, a user fee equal to the estimated cost of providing the described inspection services for 6 months; and
(8) A statement that the person requesting the inspection services, or, if appropriate, his or her agent, agrees to maintain a user fee payment account equal to the cost of providing the described inspection services for 6 months, as calculated monthly by APHIS.
(d) APHIS will enter into an agreement only if qualified personnel can be made available to provide the inspection services.
(e) An agreement can be terminated by either party on 30 days written notice.
(f) If, at the time an agreement is terminated, any unobligated funds remain in the user fee payment account, APHIS will refund the funds to the person who requested the inspection services, or his or her agent.
(a) User fees for import- or export-related veterinary services listed in paragraphs (a)(1) through (a)(13) of this section, except those services covered by flat rate user fees elsewhere in this part, will be calculated at the hourly rate listed in the following table for each employee required to perform the service. The person for whom the service is provided and the person requesting the service are jointly and severally liable for payment of these user fees in accordance with §§ 130.50 and 130.51.
(1) Providing services to live animals for import or entry at airports, ocean ports, and rail ports.
(2) Conducting inspections, including laboratory and facility inspections, required to obtain permits, either to import animal products, aquaculture products, organisms or vectors, or to maintain compliance with import permits.
(3) Obtaining samples required to be tested, either to obtain import permits or to ensure compliance with import permits.
(4) Providing services for imported birds or ratites that are not subject to quarantine.
(5) Supervising the opening of in-bond shipments.
(6) Providing services for in-bond or in-transit animals to exit the United States.
(7) Inspecting an export isolation facility and the animals in it.
(8) Supervising animal or bird rest periods prior to export.
(9) Supervising loading and unloading of animals or birds for export shipment.
(10) Inspecting means of conveyance used to export animals or birds.
(11) Conducting inspections under part 156 of this chapter.
(12) Inspecting and approving an artificial insemination center or a semen collection center or the animals in it.
(13) Providing other import-or export-related veterinary services for which there is no flat rate user fee specified elsewhere in this part.
(b)
At 72 FR 70766, Dec. 13, 2007, § 130.30 was amended in the introductory text of paragraph (a), by removing the words “through (a)(13)” and adding the words “through (a)(18)” in their place; by revising paragraph (a)(2); in paragraph (a)(4), by adding the words “, such as monitoring birds—including but not limited to pet birds—between flights” after the word “quarantine”; by redesignating paragraph (a)(13) as paragraph (a)(18); and by adding new paragraphs (a)(13), (a)(14), (a)(15), (a)(16), and (a)(17), effective Jan. 14, 2008. For the convenience of the user, the added and revised text is set forth as follows:
(a) * * *
(2) Conducting inspections, including inspections of laboratories and facilities (such as biosecurity level two facilities), required either to obtain import permits for animal products, aquaculture products, or organisms or vectors, or to maintain compliance with import permits. This hourly rate does not apply to inspection activities covered in § 130.11.
(13) Import or entry services for feeder animals including, but not limited to, feeder goats and feeder bison not covered by a flat rate user fee in § 130.7.
(14) Export-related bird banding for identification.
(15) Export-related inspection and approval of pet food facilities, including laboratories that perform pet food testing.
(16) Export-related services provided at animal auctions.
(17) Various export-related facility inspections, including, but not limited to, fertilizer plants that utilize poultry waste, rendering plants, and potential embarkation facilities.
(a)
(1) When veterinary diagnostic services are provided in connection with Federal programs to control or eradicate diseases or pests of livestock or poultry in the United States (program diseases);
(2) When veterinary diagnostic services are provided in support of zoonotic disease surveillance when the Administrator has determined that there is a significant threat to human health; and
(3) When veterinary diagnostic reagents are distributed within the
(b) [Reserved]
(a)
(b)
(2)
(3)
(i)
(ii)
(c)
(2)
(3)
(4)
(5)
(d)
(1) Cash, will be accepted only during normal business hours if payment is made at an APHIS office
(2) All types of checks, including traveler's checks, drawn on a U.S. bank in U.S. dollars and made payable to the U.S. Department of Agriculture or USDA;
(3) Money orders, drawn on a U.S. bank in U.S. dollars and made payable to the U.S. Department of Agriculture or USDA; or
(4) Credit cards (VISA
(a)
(1)
(i) For unbilled fees, the user fee is unpaid 60 days after the date the pertinent regulatory provision indicates payment is due;
(ii) For billed fees, the user fee is unpaid 60 days after date of bill;
(iii) The person for whom the service is provided or the person requesting the service has not paid the late payment penalty or interest on any delinquent APHIS user fee; or
(iv) Payment has been dishonored.
(2)
(3)
(4)
(i) For unbilled fees, the user fee is unpaid 90 days after date the pertinent regulatory provision indicates payment is due;
(ii) For billed fees, the user fee is unpaid 90 days after date of bill;
(iii) The person for whom the service is provided or the person requesting the service has not paid the late payment penalty or interest on any delinquent APHIS user fee; or
(iv) Payment has been dishonored.
(b)
(1)
(2)
(3)
(c)
(d)
(e)
(1)
(2)
(3)
(4)
(f)
(1) After APHIS releases the abandoned animals or birds from quarantine, APHIS may seize them and sell or otherwise dispose of them, as determined by the Administrator, provided that their sale is not contrary to any Federal law or regulation, and may recover all expenses of handling the animals or birds from the proceeds of their sale or disposition.
(2) If animals or birds abandoned in quarantine at an animal import center cannot be released from quarantine, APHIS may seize and dispose of them, as determined by the Administrator, and may recover all expenses of handling the animals or birds from the proceeds of their disposition and from persons liable for user fees under § 130.50(a).
7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
Words used in this part in the singular form shall be deemed to import the plural, and vice versa, as the case may demand. Except where the context otherwise requires, for the purposes of this part the following terms shall be construed, respectively, to mean:
(2)
(2)
(a) The Department cooperates through a Memorandum of Understanding with Official State Agencies in the administration of the Plan.
(b) The administrative procedures and decisions of the Official State Agency are subject to review by the Service. The Official State Agency shall carry out the administration of the Plan within the State according to the applicable provisions of the Plan and the Memorandum of Understanding.
(c) An Official State Agency may accept for participation an affiliated flock located in another State under a mutual understanding and agreement, in writing, between the two Official State Agencies regarding conditions of participation and supervision.
(d) The Official State Agency of any State may, except as limited by § 145.3(d), adopt regulations applicable to the administration of the Plan in such State further defining the provisions of the Plan or establishing higher standards compatible with the Plan.
(e) An authorized laboratory of the National Poultry Improvement Plan will follow the laboratory protocols outlined in part 147 of this chapter when determining the status of a participating flock with respect to an official Plan classification.
(a) Any person producing or dealing in products may participate in the Plan when he has demonstrated, to the satisfaction of the Official State Agency, that his facilities, personnel, and practices are adequate for carrying out the applicable provisions of the Plan, and has signed an agreement with the Official State Agency to comply with the general and the applicable specific provisions of the Plan and any regulations of the Official State Agency under § 145.2. Affiliated flockowners may participate without signing an agreement with the Official State Agency.
(b) Each participant shall comply with the Plan throughout the operating year of the Official State Agency, or until released by such Agency.
(c) A participant in any State shall participate with all of his poultry hatching egg supply flocks and hatchery operations within such State. He shall report to the Official State Agency on VS Form 9-2 (formerly NPIP Form 3B) or through other appropriate means each breeding flock before the birds reach 24 weeks of age or, in the case of ostriches, emus, rheas, cassowaries, before the birds reach 20 months of age. This report will include:
(1) Name and address of flockowner;
(2) Flock location and designation;
(3) Type: Primary or Multiplier;
(4) Breed, variety, strain, or trade name of stock;
(5) Source of males;
(6) Source of females;
(7) Number of birds in the flock; and
(8) Intended classification of flock.
(d) No person shall be compelled by the Official State Agency to qualify products for any of the other classifications described in § 145.10 as a condition of qualification for the U.S. Pullorum-Typhoid Clean classification.
(e) Participation in the Plan shall entitle the participant to use the Plan emblem reproduced below:
(a) Records of purchases and sales and the identity of products handled shall be maintained in a manner satisfactory to the Official State Agency.
(b) Products, records of sales and purchase of products, and material used to advertise products shall be subject to inspection by the Official State Agency at any time.
(c) Advertising must be in accordance with the Plan, and applicable rules and regulations of the Official State Agency and the Federal Trade Commission. A participant advertising products as being of any official classification may include in his advertising reference to associated or franchised hatcheries only when such hatcheries produce the same kind of products of the same classification.
(d) Except as provided by this paragraph, participants in the Plan may not buy or receive products for any purpose from nonparticipants unless they are part of an equivalent program, as determined by the Official State Agency. Participants in the Plan may buy or receive products from flocks that are neither participants nor part of an equivalent program, for use in breeding flocks or for experimental purposes, under the following conditions only:
(1) With the permission of the Official State Agency and the concurrence of the Service; and
(2) By segregation of all birds before introduction into the breeding flock. Upon reaching sexual maturity, the segregated birds must be tested and found negative for pullorum-typhoid. The Official State Agency may require a second test at its discretion.
(e) Each participant shall be assigned a permanent approval number by the Service. This number, prefaced by the numerical code of the State, will be the official approval number of the participant and may be used on each certificate, invoice, shipping label, or other document used by the participant in the sale of his products. Each Official State Agency which requires an approval or permit number for out-of-State participants to ship into its State should honor this number. The approval number shall be withdrawn when the participant no longer qualifies for participation in the Plan.
(a) Poultry equipment, and poultry houses and the land in the immediate vicinity thereof, shall be kept in sanitary condition as recommended in §§ 147.21 and 147.22 (a) and (e) of this chapter. The participating flock, its eggs, and all equipment used in connection with the flock shall be separated from nonparticipating flocks, in a manner acceptable to the Official State Agency.
(b) All flocks shall consist of healthy, normal individuals characteristic of the breed, variety, cross, or other combination which they are stated to represent.
(c) A flock shall be deemed to be a participating flock at any time only if it has qualified for the U.S. Pullorum-Typhoid Clean classification, as prescribed in Subparts B, C, D, E, or F of this part.
(d) Each bird shall be identified with a sealed and numbered band obtained through or approved by the Official State Agency:
(a) Hatcheries must be kept in sanitary condition, acceptable to the Official State Agency. The procedures outlined in §§ 147.22 through 147.25 of this chapter will be considered as a guide in determining compliance with this provision. The minimum requirements with respect to sanitation include the following:
(1) Egg room walls, ceilings, floors, air filters, drains, and humidifiers should be cleaned and disinfected at least two times per week. Cleaning and disinfection procedures should be as outlined in § 147.24 of this chapter.
(2) Incubator room walls, ceilings, floors, doors, fan grills, vents, and ducts should be cleaned and disinfected after each set or transfer. Incubator rooms should not be used for storage. Plenums should be cleaned at least weekly. Egg trays and buggies should be cleaned and disinfected after each transfer. Cleaning and disinfection procedures should be as outlined in § 147.24 of this chapter.
(3) Hatcher walls, ceilings, floors, doors, fans, vents, and ducts should be cleaned and disinfected after each hatch. Hatcher rooms should be cleaned and disinfected after each hatch and should not be used for storage. Plenums should be cleaned after each hatch. Cleaning and disinfection procedures should be as outlined in § 147.24 of this chapter.
(4) Chick/poult processing equipment and rooms should be thoroughly cleaned and disinfected after each hatch. Chick/poult boxes should be cleaned and disinfected before being reused. Vaccination equipment should be cleaned and disinfected after each use. Cleaning and disinfection procedures should be as outlined in § 147.24 of this chapter.
(5) Hatchery residue, such as chick/poult down, eggshells, infertile eggs, and dead germs, should be disposed of promptly and in a manner satisfactory to the Official State Agency.
(6) The entire hatchery should be kept in a neat, orderly condition and cleaned and disinfected after each hatch.
(7) Effective insect and rodent control programs should be implemented.
(b) A hatchery that keeps started poultry must keep such poultry separated from the incubator room in a manner satisfactory to the Official State Agency.
(c) All baby and started poultry offered for sale under Plan terminology should be normal and typical of the breed, variety, cross, or other combination represented.
(d) Eggs incubated should be sound in shell, typical for the breed, variety, strain, or cross thereof and reasonably uniform in shape. Hatching eggs should be trayed and the baby poultry boxed with a view to uniformity of size.
(e) Any nutritive material provided to baby poultry must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10.
(f) If a person is responsibly connected with more than one hatchery, all of such hatcheries must participate in the Plan if any of them participate. A person is deemed to be responsibly connected with a hatchery if he or she is a partner, officer, director, holder, owner of 10 percent or more of the voting stock, or an employee in a managerial or executive capacity.
Dealers in poultry breeding stock, hatching eggs, or baby or started poultry shall comply with all provisions in this part which apply to their operations.
(a) The official classification terms defined in §§ 145.9 and 145.10 and the various designs illustrative of the official classifications reproduced in § 145.10 may be used only by participants and to describe products that have met all the specific requirements of such classifications.
(b) Products produced under the Plan shall lose their identity under Plan terminology when they are purchased for resale by or consigned to nonparticipants.
(c) Participating flocks, their eggs, and the baby and started poultry produced from them may be designated by their strain or trade name. When a breeder's trade name or strain designation is used, the participant shall be able by records to substantiate that the products so designated are from flocks that are composed of either birds hatched from eggs produced under the direct supervision of the breeder of such strain, or stock multiplied by persons designated and so reported by the breeder to each Official State Agency concerned.
Participating hatcheries and dealers shall be designated as “National Plan Hatchery” and “National Plan Dealer”, respectively. All Official State Agencies shall be notified by the Service of additions, withdrawals, and changes in classification.
Participating flocks, products produced from them, and States which have met the respective requirements specified in part 145 subpart B, C, D, E, or F may be designated by the following terms or illustrative designs:
(a) [Reserved]
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l) [Reserved]
(m)
(n)
(o)
(p)
(q)
(r)
(s)
(t)
(a) The Official State Agency may designate qualified persons as Authorized Agents to do the sample collecting provided for in § 145.14 and may designate qualified persons as Authorized Testing Agents to do the sample collecting and blood testing provided for in § 145.14.
(b) The Official State Agency shall employ or authorize qualified persons as State Inspectors to perform the qualification testing of participating flocks, and to perform the official inspections necessary to verify compliance with the requirements of the Plan.
(c) Authorities issued under the provisions of this section shall be subject to cancellation by the official State agency on the grounds of incompetence or failure to comply with the provisions of the Plan or regulations of the official State agency. Such actions shall not be taken until a thorough investigation has been made by the official State agency and the authorized person has been given notice of the proposed action and the basis therefor and an opportunity to present his views.
(a) Each participating hatchery shall be audited at least one time annually or a sufficient number of times each year to satisfy the Official State Agency that the operations of the hatchery are in compliance with the provisions of the Plan.
(b) The records of all flocks maintained primarily for production of hatching eggs shall be examined annually by a State Inspector. Records shall include VS Form 9-2, “Flock Selecting and Testing Report”; VS Form 9-3, “Report of Sales of Hatching Eggs, Chicks, and Poults”; set and hatch records; egg receipts; and egg/chick orders or invoices. Records shall be maintained for 3 years. On-site inspections of flocks and premises will be conducted if the State Inspector determines that a breach of sanitation, blood testing, or other provisions has occurred for Plan programs for which the flocks have or are being qualified.
Participants in the Plan, who after investigation by the Official State Agency or its representative, are notified in writing of their apparent noncompliance with the Plan provisions or regulations of the Official State Agency, shall be afforded a reasonable time, as specified by the Official State Agency, within which to demonstrate or achieve compliance. If compliance is not demonstrated or achieved within the specified time, the Official State Agency may debar the participant from further participation in the Plan for such period, or indefinitely, as the Agency may deem appropriate. The
(a)
Poultry must be more than 4 months of age when blood tested for an official classification:
(a)
(2) [Reserved]
(3) There shall be an interval of at least 21 days between any official blood test and any previous test with pullorum-typhoid antigen.
(4) [Reserved]
(5) The official blood test shall include the testing of a sample of blood from each bird in the flock:
(6) Poultry from flocks undergoing qualification testing for participation in the Plan that have a positive reaction to an official blood test named in paragraph (a)(1) of this section shall be evaluated for pullorum-typhoid as follows:
(i) Serum samples that react on rapid serum test or enzyme-labeled immunosorbent assay test (ELISA), or blood from birds that react on the stained antigen, rapid whole-blood test for all birds except turkeys, shall be tested with either the standard tube agglutination test or the microagglutination test.
(ii) Reactors to the standard tube agglutination test (in dilutions of 1:50 or greater) or the microagglutination test (in dilutions of 1:40 or greater) shall be submitted to an authorized laboratory for bacteriological examination. If there are more than four reactors in a flock, a minimum of four reactors shall be submitted to the authorized laboratory; if the flock has four or fewer reactors, all of the reactors must be submitted. The approved procedure for bacteriological examination is set forth in § 147.11 of this chapter. When reactors are submitted to the authorized laboratory within 10 days of the date of reading an official blood test named in paragraph (a)(6)(i) of this section, and the bacteriological examination fails to demonstrate pullorum-typhoid infection, the Official State Agency shall presume that the flock has no pullorum-typhoid reactors.
(iii) If a flock owner does not wish to submit reactors for bacteriological examination, then the reactors shall be isolated and retested within 30 days using an official blood test named in paragraph (a)(1) of this section. If this retest is positive, additional examination of the reactors and flock will be performed in accordance with paragraph (a)(6)(ii) of this section. During this 30-day period, the flock must be maintained under a security system, specified or approved by the Official State Agency, that will prevent physical contact with other birds and assure that personnel, equipment, and supplies that could be a source of pullorum-typhoid spread are sanitized.
(7) When
(i) The taking of blood samples—performed by or in the presence of a State Inspector—from all birds on premises exposed to birds, equipment, supplies, or personnel from the primary breeding flock during the period when the State Inspector determined that exposure to
(ii) The banding of all birds of these premises—performed or physically supervised by a State Inspector—in order to identify any bird that tests positive; and
(iii) The testing of blood samples at an authorized laboratory using an official blood test named in paragraph (a)(1) of this section.
(8) All domesticated fowl, except waterfowl, on the farm of the participant shall either be properly tested to meet the same standards as the participating flock or these birds and their eggs shall be separated from the participating flock and its eggs.
(9) All tests for pullorum-typhoid in flocks participating in or candidates for participation in the Plan shall be reported to the Official State Agency within 10 days following the completion of such tests. All reactors shall be considered in determining the classification of the flock.
(10) Any drug, for which there is scientific evidence of masking the test reaction or hindering the bacteriological recovery of Salmonella organisms, shall not be fed or administered to poultry within 3 weeks prior to a test or bacteriological examination upon which a Salmonella classification is based.
(11) When suitable evidence, as determined by the Official State Agency or the State Animal Disease Control Official, indicates that baby or started poultry produced by participating hatcheries are infected with organisms for which the parent flock received an official control classification and this evidence indicates that the infection was transmitted from the parent flock, the Official State Agency may, at its discretion, require additional testing of the flock involved. If infection is found in the parent flock, its classification shall be suspended until the flock is requalified under the requirements for the classification. Furthermore, the Official State Agency may require that the hatching eggs from such flocks be removed from the incubator and destroyed prior to hatching. When Salmonella organisms are isolated from a specimen which originated in a participating hatchery, the Official State Agency shall attempt to locate the source of the infection. The results of the investigation and the action taken to eliminate the infection shall be reported by the Official State Agency to the Service.
(b)
A.A. Ansari, R.F. Taylor, T.S. Chang, “Application of Enzyme-Linked Immunosorbent Assay for Detecting Antibody to Mycoplasma gallisepticum Infections in Poultry,”
H.M. Opitz, J.B. Duplessis, and M.J. Cyr, “Indirect Micro-Enzyme-Linked Immunosorbent Assay for the Detection of Antibodies to Mycoplasma synoviae and M. gallisepticum,”
H.B. Ortmayer and R. Yamamoto, “Mycoplasma Meleagridis Antibody Detection by Enzyme-Linked Immunosorbent Assay (ELISA),”
(2) The tests shall be conducted using M. gallisepticum or M. synoviae antigens approved by the Department or the Official State Agency and shall be performed in accordance with the recommendations of the producer of the antigen.
(3) When reactors to the test for which the flock was tested are submitted to a laboratory as prescribed by the Official State Agency, the criteria found in § 147.6 of this chapter shall be used in determining the final status of the flock.
(4) Any drug, for which there is scientific evidence of masking the test reaction or hindering the bacteriological recovery of mycoplasma organisms, shall not be fed or administered to poultry within three weeks prior to a test or bacteriological examination
(c)
(d)
(1) The AGID test must be conducted on all ELISA-positive samples. Positive tests by AGID or ELISA must be further tested by Federal Reference Laboratories. Final judgment may be based upon further sampling or culture results.
(2) The tests must be conducted using antigens or test kits approved by the Department and the Official State Agency and must be performed in accordance with the recommendations of the producer or manufacturer.
For
(a) The procedures for the bacteriological examination of poultry and poultry environments described in part 147 of this subchapter are approved tests for use in the NPIP. In addition, all tests that use veterinary biologics (e.g., antiserum and other products of biological origin) that are licensed or produced by the Service and used as described in part 147 of this subchapter are approved for use in the NPIP.
(b) Diagnostic test kits that are not licensed by the Service (e.g., bacteriological culturing kits) may be approved through the following procedure:
(1) The sensitivity of the kit will be estimated in at least three authorized laboratories selected by the Service by testing known positive samples, as determined by the official NPIP procedures found in part 147 of this subchapter. If certain conditions or interfering substances are known to affect the performance of the kit, appropriate samples will be included so that the magnitude and significance of the effect(s) can be evaluated.
(2) The specificity of the kit will be estimated in at least three authorized laboratories selected by the Service by testing known negative samples, as determined by the official NPIP procedures found in part 147 of this subchapter. If certain conditions or interfering substances are known to affect the performance of the kit, appropriate samples will be included so that the magnitude and significance of the effect(s) can be evaluated.
(3) The kit will be provided to the cooperating laboratories in its final form and include the instructions for use. The cooperating laboratories must perform the assay exactly as stated in the supplied instructions. Each laboratory must test a panel of at least 25 known positive clinical samples supplied by the manufacturer of the test kit. In addition, each laboratory will be asked to test 50 known negative clinical samples obtained from several sources, to provide a representative sampling of the general population. The identity of the samples must be coded so that the cooperating laboratories are blinded to identity and classification. Each sample must be provided in duplicate or triplicate, so that error and repeatability data may be generated.
(4) Cooperating laboratories will submit to the kit manufacturer all raw data regarding the assay response. Each sample tested will be reported as positive or negative and the official NPIP procedure used to classify the sample must be submitted in addition to the assay response value.
(5) The findings of the cooperating laboratories will be evaluated by the NPIP technical committee, and the technical committee will make a recommendation regarding whether to approve the test kit to the General Conference Committee. If the technical committee recommends approval, the final approval will be granted in accordance with the procedures described in §§ 147.46 and 147.47 of this subchapter.
Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean:
Participating flocks of multiplier egg type chickens, and the eggs and chicks produced from them, shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart B.
(a) Started chickens shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a).
(b) Hatching eggs produced by multiplier breeding flocks shall be fumigated (see § 147.25 of this chapter) or otherwise sanitized.
(c) Any nutritive material provided to chicks must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10.
Participating flocks, and the eggs and chicks produced from them, which have met the respective requirements specified in this section may be designated by the following terms and the corresponding designs illustrated in § 145.10:
(a) [Reserved]
(b)
(1) It has been officially blood tested with no reactors.
(2) It is a multiplier breeding flock and meets the following specifications as determined by the Official State Agency and the Service:
(i) The flock is located in a State where all persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated;
(ii) The flock is composed entirely of birds that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision; and
(iii) The flock is located on a premises where either no poultry or a flock not classified as U.S. Pullorum-Typhoid Clean were located the previous year;
(3) It is a multiplier breeding flock that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision, and is located in a State in which it has been determined by the Service that:
(i) All hatcheries within the State are qualified as “National Plan Hatcheries” or have met equivalent requirements for pullorum-typhoid control under official supervision;
(ii) All hatchery supply flocks within the State, are qualified as U.S. Pullorum-Typhoid Clean or have met equivalent requirements for pullorum-typhoid control under official supervision:
(iii) All shipments of products other than U.S. Pullorum-Typhoid Clean, or equivalent, into the State are prohibited;
(iv) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated;
(v) All reports of any disease outbreak involving a disease covered under the Plan are promptly followed by an investigation by the Official State Agency to determine the origin of the infection;
(vi) All flocks found to be infected with pullorum or typhoid are quarantined until marketed or destroyed under the supervision of the Official State Agency, or until subsequently blood tested, following the procedure for reacting flocks as contained in § 145.14(a)(5), and all birds fail to demonstrate pullorum or typhoid infection;
(vii) All poultry, including exhibition, exotic, and game birds, but excluding waterfowl, going to public exhibition shall come from U.S. Pullorum-Typhoid Clean or equivalent flocks, or have had a negative pullorum-typhoid test within 90 days of going to public exhibition;
(viii) Discontinuation of any of the conditions or procedures described in paragraphs (b)(3)(i), (ii), (iii), (iv), (v), (vi), and (vii) of this section, or the occurrence of repeated outbreaks of pullorum or typhoid in poultry breeding flocks within or originating within the State shall be grounds for the Service to revoke its determination that such conditions and procedures have been met or complied with. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity to present its views.
(4) It is a multiplier breeding flock located in a State which has been determined by the Service to be in compliance with the provisions of (b)(3) of this section, and in which pullorum disease or fowl typhoid is not known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months.
(c)
(i) [Reserved]
(ii) It is a multiplier breeding flock which originated as U.S. M. Gallisepticum Clean chicks from primary breeding flocks and from which a sample comprised of a minimum of 150 birds per flock has been tested for
(A) At intervals of not more than 90 days, 75 birds from the flock shall be tested,
(B) At intervals of not more than 30 days, a sample of 25 cull chicks produced from the flock shall be subjected to laboratory procedures acceptable to the Official State Agency and approved by the Service, for the detection and recovery of
(C) At intervals of not more than 30 days, egg yolk testing shall be conducted in accordance with § 147.8 of this chapter.
(2) A participant handling U.S. M. Gallisepticum Clean products shall keep these products separate from other products in a manner satisfactory to the Official State Agency.
(3) U.S. M. Gallisepticum Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected as described in § 147.24(a) of this chapter.
(d)
(1) A flock and the hatching eggs and chicks produced from it which have met the following requirements as determined by the Official State Agency:
(i) The flock originated from a U.S.
(ii) All feed fed to the flock shall meet the following requirements:
(A) Pelletized feed shall contain either no animal protein or only animal protein products produced under the Animal Protein Products Industry (APPI)
(B) Mash feed may contain no animal protein other than an APPI animal protein product supplement manufactured in pellet form and crumbled:
(iii) Feed shall be stored and transported in such a manner as to prevent possible contamination;
(iv) The flock is maintained in compliance with §§ 147.21, 147.24(a), and 147.26 of this chapter. Rodents and other pests should be effectively controlled;
(v) Environmental samples shall be collected from the flock by an Authorized Agent, as described in § 147.12 of this chapter, when the flock is 2 to 4 weeks of age. The samples shall be examined bacteriologically for group D salmonella at an authorized laboratory. Cultures from positive samples shall be serotyped. The authorized agent shall also collect samples every 30 days after the first sample has been collected.
(vi) If a
(A) Administer the vaccine after the pullorum-typhoid testing is done as described in paragraph (d)(1)(vii) of this section.
(B) If an injectable bacterin or live vaccine that does not spread is used, keep a sample of 350 birds unvaccinated and banded for identification until the flock reaches at least 4 months of age. Following negative serological and bacteriological examinations as described in paragraph (d)(1)(vii) of this section, vaccinate the banded, non-vaccinated birds.
(vii) Blood samples from 300 non-vaccinated birds as described in paragraph (d)(1)(vi) of this section shall be tested
(viii) Hatching eggs are collected as quickly as possible and are handled as described in § 147.22 of this chapter and are sanitized or fumigated (see § 147.25 of this chapter).
(ix) Hatching eggs produced by the flock are incubated in a hatchery that is in compliance with the recommendations in §§ 147.23 and 147.24(b) of this chapter, and sanitized either by a procedure approved by the Official State Agency or fumigated (see § 147.25 of this chapter).
(2) A flock shall not be eligible for this classification if
(3) A non-vaccinated flock shall be eligible for this classification if
(4) In order for a hatchery to sell products of this classification, all products handled shall meet the requirements of the classification.
(5) This classification may be revoked by the Official State Agency if the participant fails to follow recommended corrective measures.
(e)
(i) [Reserved]
(ii) It is a multiplier breeding flock which originated as U.S. M. Synoviae Clean chicks from primary breeding flocks and from which a sample comprised of a minimum of 150 birds has been tested for
(A) At intervals of not more than 90 days, 75 birds from the flock shall be tested:
(B) At intervals of not more than 30 days, egg yolk testing shall be conducted in accordance with § 147.8 of this chapter.
(2) A participant handling U.S. M. Synoviae Clean products shall keep these products separate from other products in a manner satisfactory to the Official State Agency.
(3) U.S. M. Synoviae Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected as described in § 147.24(a) of this chapter.
(f)
(2) All other poultry on the premises of the candidate flock must originate
(3) The flock is maintained in compliance with the provisions of § 147.26 of this chapter.
(4) The flock's freedom from
(5) Started poultry shall be delivered to and from the farm premises in crates and vehicles which have been cleaned and disinfected as described in § 147.24(a) of this chapter.
(g)
(2) All other poultry on the premises of the candidate flock must originate from U.S. M. Synoviae Clean sources.
(3) The flock is maintained in compliance with the provisions of § 147.26 of this chapter.
(4) The flocks's freedom from
(5) Started poultry shall be delivered to and from the farm premises in crates and vehicles which have been cleaned and disinfected as described in § 147.24(a) of this chapter.
(h)
(1) [Reserved]
(2) It is a multiplier breeding flock in which a minimum of 30 birds have been tested negative for antibodies to avian influenza when more than 4 months of age. To retain this classification:
(i) A sample of at least 30 birds must be tested negative at intervals of 180 days
(ii) A sample of fewer than 30 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 30 birds is tested within each 180-day period.
For
(a)
(i) The State is in compliance with the provisions contained in § 145.23(b)(3)(i) through (vii), § 145.33(b)(3)(i) through (vii), § 145.43(b)(3)(i) through (vi), § 145.53(b)(3)(i) through (vii), § 145.73(b)(2)(i), and § 145.83(b)(2)(i).
(ii) No pullorum disease or fowl typhoid is known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months:
(2) Discontinuation of any of the conditions described in paragraph (a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatchery supply flocks described in paragraph (a)(1)(ii) of this section, or if an infection spreads from the originating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classification. Such action shall not be
(b) [Reserved]
Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean:
Participating flocks of multiplier meat type chickens, and the eggs and chicks produced from them, shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart C.
(a) Started chickens shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a).
(b) Hatching eggs produced by multiplier breeding flocks shall be fumigated (see § 147.25 of this chapter) or otherwise sanitized.
(c) Any nutritive material provided to chicks must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10.
Participating flocks, and the eggs and chicks produced from them, which have met the respective requirements specified in this section may be designated by the following terms and the corresponding designs illustrated in § 145.10:
(a) [Reserved]
(b)
(1) It has been officially blood tested with no reactors.
(2) It is a multiplier breeding flock and meets the following specifications as determined by the Official State Agency and the Service:
(i) The flock is located in a State where all persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated;
(ii) The flock is composed entirely of birds that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision; and
(iii) The flock is located on a premises where either no poultry or a flock not classified as U.S. Pullorum-Typhoid Clean were located the previous
(3) It is a multiplier breeding flock that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision, and is located in a State in which it has been determined by the Service that:
(i) All hatcheries within the State are qualified as “National Plan Hatcheries” or have met equivalent requirements for pullorum-typhoid control under official supervision;
(ii) All hatchery supply flocks within the State, are qualified as U.S. Pullorum-Typhoid Clean or have met equivalent requirements for pullorum-typhoid control under official supervision:
(iii) All shipments of products other than U.S. Pullorum-Typhoid Clean, or equivalent, into the State are prohibited;
(iv) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated;
(v) All reports of any disease outbreak involving a disease covered under the Plan are promptly followed by an investigation by the Official State Agency to determine the origin of the infection;
(vi) All flocks found to be infected with pullorum or typhoid are quarantined until marketed or destroyed under the supervision of the Official State Agency, or until subsequently blood tested following the procedure for reacting flocks as contained in § 145.14(a)(5), and all birds fail to demonstrate pullorum or typhoid infection;
(vii) All poultry, including exhibition, exotic, and game birds, but excluding waterfowl, going to public exhibition shall come from U.S. Pullorum-Typhoid Clean or equivalent flocks, or have had a negative pullorum-typhoid test within 90 days of going to public exhibition;
(viii) Discontinuation of any of the conditions or procedures described in paragraphs (b)(3)(i), (ii), (iii), (iv), (v), (vi), and (vii) of this section, or the occurrence of repeated outbreaks of pullorum or typhoid in poultry breeding flocks within or originating within the State shall be grounds for the Service to revoke its determination that such conditions and procedures have been met or complied with. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity to present its views.
(4) It is a multiplier breeding flock located in a State which has been determined by the Service to be in compliance with the provisions of paragraph (b)(3) of this section, and in which pullorum disease or fowl typhoid is not known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months.
(c)
(i) [Reserved]
(ii) It is a multiplier breeding flock which originated as U.S. M. Gallisepticum Clean chicks from primary breeding flocks and from which a sample comprised of a minimum of 150 birds per flock has been tested for
(A) At intervals of not more than 90 days, 75 birds from the flock shall be tested,
(B) At intervals of not more than 30 days, a sample of 25 cull chicks produced from the flock shall be subjected to laboratory procedures acceptable to the Official State Agency and approved by the Service, for the detection and recovery of
(C) At intervals of not more than 30 days, egg yolk testing shall be conducted in accordance with § 147.8 of this chapter.
(2) A participant handling U.S. M. Gallisepticum Clean products must keep these products separate from other products through the use of separate hatchers and incubators, separate hatch days, and proper hatchery sanitation and biosecurity (see §§ 147.22, 147.23, and 147.24) in a manner satisfactory to the Official State Agency.
(3) U.S. M. Gallisepticum Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected as described in § 147.24(a) of this chapter.
(4) Before male breeding birds may be added to a participating multiplier breeding flock, a sample of at least 30 birds to be added, with a minimum of 10 birds per pen, shall be tested for
(d)
(1) A flock and the hatching eggs and chicks produced from it which have met the following requirements as determined by the Official State Agency:
(i) The flock shall originate from a source where sanitation and management practices, as outlined in § 145.33(d)(1) of this paragraph, are conducted;
(ii) The flock is maintained in compliance with §§ 147.21, 147.24(a), and 147.26 of this chapter;
(iii) If pelletized feed contains animal protein, the protein products shall be purchased from participants in the Animal Protein Products Industry (APPI)
(iv) If mash feed contains animal protein, the protein products shall be purchased from participants in the Animal Protein Products Industry (APPI)
(v) Feed shall be stored and transported in such a manner as to prevent possible contamination;
(vi) Chicks shall be hatched in a hatchery meeting the requirements of §§ 147.23 and 147.24(b) of this chapter and sanitized or fumigated (see § 147.25 of this chapter);
(vii) An Authorized Agent shall take environmental samples, as described in § 147.12 of this chapter, from each flock at 4 months of age and every 90 days thereafter. An authorized laboratory for
(viii) Owners of flocks found infected with a paratyphoid
(2) The Official State Agency may use the procedures described in § 147.14 of this chapter to monitor the effectiveness of the sanitation practices.
(3) In order for a hatchery to sell products of this classification, all products handled shall meet the requirements of the classification.
(4) This classification may be revoked by the Official State Agency if the participant fails to follow recommended corrective measures.
(e)
(i) [Reserved]
(ii) It is a multiplier breeding flock which originated as U.S. M. Synoviae Clean chicks from primary breeding flocks and from which a sample comprised of a minimum of 150 birds has been tested for
(A) At intervals of not more than 90 days, 75 birds from the flock shall be tested:
(B) At intervals of not more than 30 days, egg yolk testing shall be conducted in accordance with § 147.8 of this chapter.
(2) A participant handling U.S. M. Synoviae Clean products shall keep these products separate from other products in a manner satisfactory to the official State Agency.
(3) U.S. M. Synoviae Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected as described in § 147.24(a) of this chapter.
(4) Before male breeding birds may be added to a participating multiplier breeding flock, a sample of at least 30 birds to be added, with a minimum of 10 birds per pen, shall be tested for
(f)
(2) All other poultry on the premises of the candidate flock must originate from U.S. M. Gallisepticum Clean sources.
(3) The flock is maintained in compliance with the provisions of § 147.26 of this chapter.
(4) The flock's freedom from
(5) Started poultry shall be delivered to and from the farm premises in crates and vehicles which have been
(g)
(2) All other poultry on the premises of the candidate flock must originate from U.S. M. Synoviae Clean sources.
(3) The flock is maintained in compliance with the provisions of § 147.26 of this chapter.
(4) The flock's freedom from
(5) Started poultry shall be delivered to and from the farm premises in crates and vehicles which have been cleaned and disinfected as described in § 147.24(a) of this chapter.
(h)-(i) [Reserved]
(j)
(2) A participant handling U.S. M. Gallisepticum Monitored products shall keep these products separate from other products in a manner satisfactory to the Official State Agency:
(3) U.S. M. Gallisepticum Monitored chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected as described in § 147.24(a) of this chapter.
(k)
(2) A participant handling U.S. M. Synoviae Monitored products shall keep these products separate from other products in a manner satisfactory to the Official State Agency:
(3) U.S. M. Synoviae Monitored chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected as described in § 147.24(a) of this chapter.
(l)
(1) [Reserved]
(2) It is a multiplier breeding flock in which a minimum of 30 birds have been tested negative for antibodies to avian influenza when more than 4 months of age and prior to the onset of egg production. To retain this classification:
(i) A sample of at least 30 birds must be tested negative at intervals of 180 days:
(ii) A sample of fewer than 30 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 30 birds is tested within each 180-day period.
For
(a)
(i) The State is in compliance with the provisions contained in § 145.23(b)(3)(i) through (vii), § 145.33(b)(3)(i) through (vii), § 145.43(b)(3)(i) through (vi), § 145.53(b)(3)(i) through (vii), § 145.73(b)(2)(i), and § 145.83(b)(2)(i).
(ii) No pullorum disease or fowl typhoid is known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months:
(2) Discontinuation of any of the conditions described in paragraph (a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatchery supply flocks described in paragraph (a)(1)(ii) of this section, or if an infection spreads from the originating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classification. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity for a hearing in accordance with rules of practice adopted by the Administrator.
(b)
(i) No
(ii) All meat-type chicken breeding flocks in production are classified as U.S. M. Gallisepticum Clean in accordance with §§ 145.33(c) and 145.83(c) or have met equivalent requirements for
(iii) All hatcheries within the State which handle products from meat-type chicken breeding flocks only handle products which are classified as U.S. M. Gallisepticum Clean or have met equivalent requirements for
(iv) All shipments of products from meat-type chicken breeding flocks other than those classified as U.S. M. Gallisepticum Clean, or equivalent, into the State are prohibited;
(v) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all specimens from chickens from meat-type chicken breeding flocks that have been identified as being infected with
(vi) All reports of
(vii) All chickens from meat-type chicken breeding flocks found to be infected with
(2) Discontinuation of any of the conditions described in paragraph (b)(1) of this section, or if repeated outbreaks of
Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean:
(a) Participating turkey flocks, and the eggs and poults produced from them, shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart D.
(b) Hatching eggs shall be fumigated (see § 147.25 of this chapter) or otherwise sanitized.
(c) Any nutritive material provided to poults must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10.
Participating flocks, and the eggs and poults produced from them, which have met the respective requirements specified in this section may be designated by the following terms and the corresponding designs illustrated in § 145.10:
(a) [Reserved]
(b)
(1) It has been officially blood tested with no reactors.
(2) It is a multiplier breeding flock, or a breeding flock composed of progeny of a primary breeding flock which is intended solely for the production of multiplier breeding flocks, and meets the following specifications as determined by the Official State Agency and the Service:
(i) The flock is located in a State where all persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated;
(ii) The flock is composed entirely of birds that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision; and
(iii) The flock is located on a premises where either no poultry or a flock not classified as U.S. Pullorum-Typhoid Clean were located the previous year;
(3) It is a multiplier breeding flock, or a breeding flock composed of progeny of a primary breeding flock which is intended solely for the production of multiplier breeding flocks, that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision, and is located in a State in which it has been determined by the Service that:
(i) All turkey hatcheries within the State are qualified as “National Plan Hatcheries” or have met equivalent requirements for pullorum-typhoid control under official supervision;
(ii) All turkey hatchery supply flocks within the State are qualified as U.S. Pullorum-Typhoid Clean or have met equivalent requirements for pullorum-typhoid control under official supervision:
(iii) All shipments of products other than U.S. Pullorum-Typhoid Clean, or equivalent, into the State are prohibited;
(iv) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated;
(v) All reports of any disease outbreak involving a disease covered under the Plan are promptly followed by an investigation by the Official State Agency to determine the origin of the infection;
(vi) All flocks found to be infected with pullorum or typhoid are quarantined until marketed or destroyed under the supervision of the Official State Agency, or until subsequently blood tested, following the procedure for reacting flocks as contained in § 145.14(a)(5), and all birds fail to demonstrate pullorum or typhoid infection;
(vii) [Reserved]
(viii) Discontinuation of any of the conditions or procedures described in paragraphs (b)(3)(i), (ii), (iii), (iv), (v), and (vi) of this section, or the occurrence of repeated outbreaks of pullorum or typhoid in turkey breeding flocks within or originating within the State shall be grounds for the Service to revoke its determination that such conditions and procedures have been met or complied with. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity to present its views.
(4) It is a multiplier breeding flock located in a State which has been determined by the Service to be in compliance with the provisions of paragraph (b)(3) of this section and in which pullorum disease or fowl typhoid is not known to exist nor to have existed in turkey hatchery supply flocks within the State during the preceding 24 months.
(5) It is a primary breeding flock located in a State determined to be in compliance with the provisions of paragraph (b)(4), of this section and in which a sample of 300 birds from flocks of more than 300, and each bird in
(c)
(2) A flock qualified as U.S. M. Gallisepticum Clean may retain the classification through its first egg-laying cycle, provided it is maintained in isolation and no evidence of
(3) In order to sell hatching eggs or poults of this classification, all hatching eggs and poults handled by the participant must be of this classification.
(d)
(i) A sample of 100 birds from each flock has been tested for
(2) The official blood tests for
(3) The tests shall be conducted using
(4) When reactors to the official test are found and can be identified, 10 tracheal swabs and/or vaginal or phallus swabs and their corresponding blood samples shall be submitted to a laboratory for serological and cultural examination. If reactors cannot be identified, at least 30 tracheal swabs and/or vaginal or phallus swabs and their corresponding blood samples shall be submitted. In a flock with a low reactor rate (less than 5 reactors) the reactors may be submitted to the laboratory within 10 days for serology, necropsy, and thorough bacteriological examination.
(5) If a mycoplasma is isolated, the organism must be serotyped. If
(e)
(2) When reactors to the official test are found and can be identified, tracheal swabs and their corresponding blood samples from 10 (all if fewer than 10) reacting birds shall be submitted to
(3) Flocks located on premises which, during 3 consecutive years, have contained breeding flocks qualified as U.S. M. Synoviae Clean, as described in paragraph (e)(1) above, may qualify for this classification by a negative blood test of at least 100 birds from flocks of more than 100 and each bird in flocks of 100 or less, when more than 12 weeks of age, and by testing a minimum of 30 samples from male flocks and 60 samples from female flocks at 28-30 weeks of age and at 45 weeks of age.
(f)
(1) Hatchery debris (dead germ hatching eggs, fluff, and meconium collected by sexors), swabs collected from hatch debris in hatcher trays, a sample of all the poults that died within 10 days after hatching up to 10 poults, or a combination of 2 or all 3 of the above, from each hatch or a candidate breeding flock produced by a primary breeder, are examined bacteriologically at an authorized laboratory for
(2) The poults for the candidate breeding flock are placed in a building that has been cleaned and disinfected. An Authorized Agent must collect environmental samples from the building and submit them to an authorized laboratory for a bacteriological examination for the presence of
(3) Feed for turkeys in the candidate and breeding flock should meet the following requirements:
(i) All feed manufactured in pellet form must have a maximum moisture content of 13.5 percent upon delivery to the farm. It should have been preconditioned to the minimum of one of the following parameters before pelleting:
(A) Feed is to reach a minimum temperature of 185 °F for a minimum of 6 minutes of retention in the conditioning chamber. The conditioned mash feed moisture must be a minimum of 16 percent during the conditioning process. This method utilizes time retention to allow permeation to the center core of each feed particle; or
(B) The feed is to be pressurized in order to expedite the transfer of the heat and moisture to the core of each feed particle. The feed should be conditioned to the parameters of a minimum of 16 percent moisture and 200 °F; or
(C) The feed should be submitted to pressurization to the extent that the initial feed temperature rises to 235 °F for 4 seconds; or
(D) The feed should be submitted to an equivalent thermal lethality treatment; or
(E) A Food and Drug Administration (FDA)-approved product for
(ii) Mash feed should be treated with an FDA-approved
(iii) All feed is to be stored and transported in such a manner as to prevent possible contamination with pathogenic bacteria.
(iv) FDA-approved products for
(4) Environmental samples shall be taken by an Authorized Agent, as described in § 147.12 of this chapter, from each flock at 12-20 weeks of age and examined bacteriologically at an authorized laboratory for Salmonella.
(5) Owners of flocks found infected with a paratyphoid Salmonella may
(6) Environmental samples shall be taken by an Authorized Agent, as described in § 147.12 of this chapter, from each flock at 35-50 weeks of age and from each molted flock at midlay, and examined bacteriologically at an authorized laboratory for Salmonella.
(7) Hatchery debris (dead germ hatching eggs, fluff, and meconium collected by sexors), swabs collected from hatch debris in hatcher trays, a sample of all the poults that died within 10 days after hatching up to 10 poults, or a combination of 2 or all 3 of the above, shall be cultured as a means of evaluating the effectiveness of the control procedures.
(g)
(1) It is a primary breeding flock in which a minimum of 30 birds has been tested negative for antibodies to type A avian influenza virus by the agar gel immunodiffusion test specified in § 147.9 of this subchapter. Positive samples shall be further tested by an authorized laboratory using the hemagglutination inhibition test to detect antibodies to the hemagglutinin subtypes H5 and H7 when more than 4 months of age and prior to the onset of egg production. To retain this classification:
(i) A sample of at least 30 birds must be tested negative at intervals of 90 days;
(ii) A sample of fewer than 30 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 30 birds are tested within each 90-day period.
(2) It is a multiplier breeding flock in which a minimum of 30 birds has been tested negative for antibodies to type A avian influenza virus by the agar gel immunodiffusion test specified in § 147.9 of this subchapter. Positive samples shall be further tested by an authorized laboratory using the hemagglutination inhibition test to detect antibodies to the hemagglutinin subtypes H5 and H7 when more than 4 months of age and prior to the onset of egg production. To retain this classification:
(i) A sample of at least 30 birds must be tested negative at intervals of 180 days;
(ii) A sample of fewer than 30 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 30 birds are tested within each 180-day period.
(3) For both primary and multiplier breeding flocks, if a killed influenza vaccine against avian influenza subtypes other than H5 and H7 is used, then the hemagglutinin and the neuraminidase subtypes of the vaccine must be reported to the Official State Agency for laboratory and reporting purposes.
For
(a)
(i) The State is in compliance with the provisions contained in § 145.23(b)(3)(i) through (vii), § 145.33(b)(3)(i) through (vii),
(ii) No pullorum disease or fowl typhoid is known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months:
(2) Discontinuation of any of the conditions described in paragraph (a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatchery supply flocks described in paragraph (a)(1)(ii) of this section, or if an infection spreads from the originating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classification. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity for a hearing in accordance with rules of practice adopted by the Administrator.
(b)
(i) The State is in compliance with the provisions contained in § 145.43(b)(3)(i) through (vi).
(ii) No pullorum disease or fowl typhoid is known to exist nor to have existed in turkey hatchery supply flocks within the State during the preceding 24 months.
(2) Discontinuation of any of the conditions described in paragraph (b)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatchery supply flocks described in paragraph (b)(1)(ii) of this section, or if an infection spreads from the originating premises, Service shall have grounds to revoke its determination that the State is entitled to this classification. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity for a hearing in accordance with rules of practice adopted by the Administrator.
(c)
(i) No
(ii) All turkey breeding flocks in production are classified as U.S. M. Gallisepticum Clean or have met equivalent requirements for
(iii) All turkey hatcheries within the State handle products which are classified as U.S. M. Gallisepticum Clean or have met equivalent requirements for
(iv) All shipments of turkey products other than those classified as U.S. M. Gallisepticum Clean, or equivalent, into the State are prohibited.
(v) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all turkey specimens that have been identified as being infected with
(vi) All reports of
(vii) All turkey flocks found to be infected with
(2) Discontinuation of any of the conditions described in paragraph (c)(1) of this section, or if repeated outbreaks of
(3) If a State retains this status for 2 or more years, individual breeding flocks in the State may qualify for an
(d)
(i) No
(ii) All turkey breeding flocks in production are tested and classified as U.S. M. Synoviae Clean or have met equivalent requirements for
(iii) All turkey hatcheries within the State only handle products that are classified as U.S. M. Synoviae Clean or have met equivalent requirements for
(iv) All shipments of products from turkey breeding flocks other than those classified as U.S. M. Synoviae Clean, or equivalent, into the State are prohibited;
(v) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all turkey specimens that have been identified as being infected with
(vi) All reports of
(vii) All turkey breeding flocks found to be infected with
(2) The Service may revoke the State's classification as a U.S. M. Synoviae Clean State, Turkeys, if any of the conditions described in paragraph (d)(1) of this section are discontinued. The Service shall not revoke the State's classification as a U.S. M. Synoviae Clean State, Turkeys, until it has conducted an investigation and the Official State Agency has been given an opportunity for a hearing in accordance with rules of practice adopted by the Administrator of the Service.
(e)
(i) No
(ii) All turkey breeding flocks in production are tested and classified as U.S. M. Meleagridis Clean or have met equivalent requirements for
(iii) All turkey hatcheries within the State only handle products that are classified as U.S. M. Meleagridis Clean or have met equivalent requirements for
(iv) All shipments of products from turkey breeding flocks other than those classified as U.S. M. Meleagridis Clean, or equivalent, into the State are prohibited;
(v) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all turkey specimens that have been identified as being infected with
(vi) All reports of
(vii) All turkey breeding flocks found to be infected with
(2) The Service may revoke the State's classification as a U.S. M. Meleagridis Clean State, Turkeys, if any of the conditions described in paragraph (d)(1) of this section are discontinued. The Service will not revoke the State's classification as a U.S. M. Meleagridis Clean State, Turkeys, until it has conducted an investigation and the Official State Agency has been given an opportunity for a hearing in
Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean:
Participating flocks of waterfowl, exhibition poultry, and game birds, and the eggs and baby poultry produced from them shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart E.
(a) Started poultry shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a).
(b) Hatching eggs produced by primary breeding flocks shall be fumigated (see § 147.25 of this chapter) or otherwise sanitized.
(c) Subject to the approval of the Service and the Official State Agencies in the importing and exporting States, participating flocks may report poultry sales to importing States by using printouts of computerized monthly shipping and receiving reports in lieu of VS Form 9-3, “Report of Sales of Hatching Eggs, Chicks, and Poults.”
(d) Any nutritive material provided to baby poultry must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10.
Participating flocks, and the eggs and baby poultry produced from them, which have met the respective requirements specified in this section may be designated by the following terms and the corresponding designs illustrated in § 145.10.
(a) [Reserved]
(b)
(1) It has been officially blood tested within the past 12 months with no reactors.
(2) It is a multiplier breeding flock, or a breeding flock composed of progeny of a primary breeding flock which is intended solely for the production of multiplier breeding flocks, and meets the following specifications as determined by the Official State Agency and the Service:
(i) The flock is located in a State where all persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated;
(ii) The flock is composed entirely of birds that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision; and
(iii) The flock is located on a premises where either no poultry or a flock
(3) It is a multiplier breeding flock that originated from U.S. Pullorum-Typhoid Clean breeding flocks or from flocks that met equivalent requirements under official supervision, and is located in a State in which it has been determined by the Service that:
(i) All hatcheries within the State are qualified as “National Plan Hatcheries” or have met equivalent requirements for pullorum-typhoid control under official supervision;
(ii) All hatchery supply flocks within the State, are qualified as U.S. Pullorum-Typhoid Clean or have met equivalent requirements for pullorum-typhoid control under official supervision:
(iii) All shipments of products other than U.S. Pullorum-Typhoid Clean, or equivalent, into the State are prohibited;
(iv) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which S. pullorum or S. gallinarum is isolated;
(v) All reports of any disease outbreak involving a disease covered under the Plan are promptly followed by an investigation by the Official State Agency to determine the origin of the infection;
(vi) All flocks found to be infected with pullorum or typhoid are quarantined until marketed or destroyed under the supervision of the Official State Agency, or until subsequently blood tested, following the procedure for reacting flocks as contained in § 145.14(a)(5), and all birds fail to demonstrate pullorum or typhoid infection;
(vii) All poultry, including exhibition, exotic, and game birds, but excluding waterfowl, going to public exhibition shall come from U.S. Pullorum-Typhoid Clean or equivalent flocks, or have had a negative pullorum-typhoid test within 90 days of going to public exhibition;
(viii) Discontinuation of any of the conditions or procedures described in paragraphs (b)(3)(i), (ii), (iii), (iv), (v), (vi), and (vii) of this section, or the occurrence of repeated outbreaks of pullorum or typhoid in poultry breeding flocks within or originating within the State shall be grounds for the Service to revoke its determination that such conditions and procedures have been met or complied with. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity to present its views.
(4) It is a multiplier breeding flock located in a State which has been determined by the Service to be in compliance with the provisions of paragraph (b)(3) of this section, and in which pullorum disease or fowl typhoid is not known to exist nor to have existed in hatchery supply flocks within the State during the preceding 24 months.
(5) It is a primary breeding flock located in a State determined to be in compliance with the provisions of paragraph (b)(4) of this section, and in
(c)
(i) It is a flock in which all birds or a sample of at least 300 birds has been tested for
(ii) It is a multiplier breeding flock which originated as U.S. M. Gallisepticum Clean baby poultry from primary breeding flocks and a random sample comprised of 50 percent of the birds in the flock, with a maximum of 200 birds and a minimum of 30 birds per flock, has been tested for M. gallisepticum as provided in § 145.14(b) when more than 4 months of age or upon reaching sexual maturity:
(A) At intervals of not more than 90 days, a random sample of serum or egg yolk from at least 2 percent of the birds in the flock, with a minimum of 30 birds per pen, shall be tested; or
(B) At intervals of not more than 30 days, a sample of 25 cull baby poultry produced from the flock shall be subjected to laboratory procedures acceptable to the Official State Agency and approved by the Service, for the detection and recovery of M. gallisepticum.
(2) A participant handling U.S. M. Gallisepticum Clean products shall keep these products separate from other products in a manner satisfactory to the Official State Agency:
(3) U.S. M. Gallisepticum Clean baby poultry shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected as described in § 147.24(a) of this chapter.
(d)
(i) It is a flock in which a minimum of 300 birds has been tested for
(ii) It is a multiplier breeding flock that originated as U.S. M. Synoviae Clean chicks from primary breeding
(A) At intervals of not more than 90 days, a sample of 50 birds shall be tested:
(B) At intervals of not more than 30 days, egg yolk testing shall be conducted in accordance with § 147.8 of this chapter.
(2) A participant handling U.S. M. Synoviae Clean products shall keep those products separate from other products in a manner satisfactory to the Official State Agency:
(3) U.S. M. Synoviae Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected as described in § 147.24(a) of this chapter.
(e)
(1) It is a primary breeding flock in which a minimum of 30 birds has been tested negative for antibodies to the H5 and H7 subtypes of avian influenza by the agar gel immunodiffusion test specified in § 147.9 of this chapter when more than 4 months of age. To retain this classification:
(i) A sample of at least 30 birds must be tested negative at intervals of 90 days; or
(ii) A sample of fewer than 30 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 30 birds are tested within each 90-day period.
(2) It is a multiplier breeding flock in which a minimum of 30 birds has been tested negative for antibodies to the H5 and H7 subtypes of avian influenza by the agar gel immunodiffusion test specified in § 147.9 of this chapter when more than 4 months of age. To retain this classification:
(i) A sample of at least 30 birds must be tested negative at intervals of 180 days; or
(ii) A sample of fewer than 30 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 30 birds are tested within each 180-day period.
(a)
(i) The State is in compliance with the provisions contained in § 145.23(b)(3)(i) through (vii), § 145.33(b)(3)(i) through (vii), § 145.43(b)(3)(i) through (vi), and § 145.53(b)(3)(i) through (vii).
(ii) No pullorum disease or fowl typhoid is known to exist nor to have existed in hatchery supply flocks within
(2) Discontinuation of any of the conditions described in paragraph (a)(1)(i) of this section, or repeated outbreaks of pullorum or typhoid occur in hatchery supply flocks described in paragraph(a)(1)(ii) of this section, or if an infection spreads from the originating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classification. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity for a hearing in accordance with rules of practice adopted by the Administrator.
Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean:
Participating flocks of ostriches, emus, rheas, and cassowaries, and the eggs and chicks produced from them, shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart.
(a) Started poultry shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a).
(b) Hatching eggs produced by primary breeding flocks shall be fumigated or otherwise sanitized (see § 147.22 of this chapter).
(c) Any nutritive material provided to chicks must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10.
Participating flocks, and the eggs and baby poultry produced from them, that have met the respective requirements specified in this section may be designated by the following terms and their corresponding designs illustrated in § 145.10.
(a)
(1) It has been officially blood tested within the past 12 months with no reactors.
(2) It is a breeding flock that meets one of the following criteria:
(i)(A) It is a multiplier or primary breeding flock of fewer than 300 birds in which a sample of 10 percent of the birds in a flock or at least 1 bird from each pen, whichever is more, has been officially tested for pullorum-typhoid within the past 12 months with no reactors; or
(B) It is a multiplier or primary breeding flock of 300 birds or more in which a sample of a minimum of 30 birds has been officially tested for pullorum-typhoid within the past 12 months with no reactors.
(ii) It is a flock that has already been designated U.S. Pullorum-Typhoid
(iii) It is a multiplier breeding flock located in a State that has been deemed to be a U.S. Pullorum-Typhoid Clean State for the past 3 years, and during which time no isolation of pullorum or typhoid has been made that can be traced to a source in that State, that uses a bacteriological examination monitoring program of hatcher debris or eggs or a serological examination monitoring program acceptable to the Official State Agency and approved by the Service in lieu of annual blood testing.
(b) [Reserved]
Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean:
Participating flocks of primary egg-type chickens, and the eggs and chicks produced from them, shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart G.
(a) Started chickens shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a).
(b) Hatching eggs produced by primary breeding flocks shall be fumigated (see § 147.25 of this subchapter) or otherwise sanitized.
(c) Any nutritive material provided to chicks must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10.
Participating flocks, and the eggs and chicks produced from them, which have met the respective requirements specified in this section, may be designated by the following terms and the corresponding designs illustrated in § 145.10:
(a) [Reserved]
(b)
(1) It has been officially blood tested with no reactors.
(2) It is a primary breeding flock that meets the following criteria:
(i) The primary breeding flock is located in a State in which pullorum disease or fowl typhoid is not known to exist nor to have existed in hatchery supply flocks during the preceding 12 months and in which it has been determined by the Service that:
(A) All hatcheries within the State are qualified as “National Plan Hatcheries” or have met equivalent requirements for pullorum-typhoid control under official supervision;
(B) All hatchery supply flocks within the State are qualified as U.S. Pullorum-Typhoid Clean or have met equivalent requirements for pullorum-typhoid control under official supervision:
(C) All shipments of products other than U.S. Pullorum-Typhoid Clean, or equivalent, into the State are prohibited;
(D) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which
(E) All reports of any disease outbreak involving a disease covered under the Plan are promptly followed by an investigation by the Official State Agency to determine the origin of the infection;
(F) All flocks found to be infected with pullorum or typhoid are quarantined until marketed or destroyed under the supervision of the Official State Agency, or until subsequently blood tested following the procedure for reacting flocks as contained in § 145.14(a)(5), and all birds fail to demonstrate pullorum or typhoid infection;
(G) All poultry, including exhibition, exotic, and game birds, but excluding waterfowl, going to public exhibition shall come from U.S. Pullorum-Typhoid Clean or equivalent flocks, or have had a negative pullorum-typhoid test within 90 days of going to public exhibition; and
(H) Discontinuation of any of the conditions or procedures described in paragraphs (b)(2)(i)(A) through (b)(2)(i)(G) of this section, or the occurrence of repeated outbreaks of pullorum or typhoid in poultry breeding flocks within or originating within the State shall be grounds for the Service to revoke its determination that such conditions and procedures have been met or complied with. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity to present its views; and
(ii) In the primary breeding flock, a sample of 300 birds from flocks of more than 300, and each bird in flocks of 300 or less, has been officially tested for pullorum-typhoid with no reactors:
(c)
(i) It is a flock in which all birds or a sample of at least 300 birds has been tested for
(ii) [Reserved]
(2) A participant handling U.S. M. Gallisepticum Clean products shall handle only products of equivalent status.
(3) U.S. M. Gallisepticum Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected as described in § 147.24(a) of this subchapter.
(d)
(1) A flock and the hatching eggs and chicks produced from it which have met the following requirements as determined by the Official State Agency:
(i) The flock originated from a U.S. S. Enteritidis Clean flock, or meconium from the chick boxes and a sample of chicks that died within 7 days after hatching are examined bacteriologically for salmonella at an authorized laboratory. Cultures from positive samples shall be serotyped.
(ii) All feed fed to the flock shall meet the following requirements:
(A) Pelletized feed shall contain either no animal protein or only animal protein products produced under the Animal Protein Products Industry (APPI)
(B) Mash feed may contain no animal protein other than an APPI animal protein product supplement manufactured in pellet form and crumbled:
(iii) Feed shall be stored and transported in such a manner as to prevent possible contamination;
(iv) The flock is maintained in compliance with §§ 147.21, 147.24(a), and 147.26 of this subchapter. Rodents and other pests should be effectively controlled;
(v) Environmental samples shall be collected from the flock by an Authorized Agent, as described in § 147.12 of this subchapter, when the flock is 2 to 4 weeks of age. The samples shall be examined bacteriologically for group D salmonella at an authorized laboratory. Cultures from positive samples shall be serotyped. The Authorized Agent shall also collect samples every 30 days after the first sample has been collected.
(vi) If a
(A) Administer the vaccine after the pullorum-typhoid testing is done as described in paragraph (d)(1)(vii) of this section.
(B) If an injectable bacterin or live vaccine that does not spread is used, keep a sample of 350 birds unvaccinated and banded for identification until the flock reaches at least 4 months of age. Following negative serological and bacteriological examinations as described in paragraph (d)(1)(vii) of this section, vaccinate the banded, non-vaccinated birds.
(vii) Blood samples from 300 non-vaccinated birds as described in paragraph (d)(1)(vi) of this section shall be tested with either pullorum antigen or by a federally licensed
(viii) Hatching eggs are collected as quickly as possible and are handled as described in § 147.22 of this subchapter and are sanitized or fumigated (see § 147.25 of this subchapter).
(ix) Hatching eggs produced by the flock are incubated in a hatchery that is in compliance with the recommendations in §§ 147.23 and 147.24(b) of this subchapter, and sanitized either by a procedure approved by the Official State Agency or fumigated (see § 147.25 of this subchapter).
(2) A flock shall not be eligible for this classification if
(3) A non-vaccinated flock shall be eligible for this classification if SE is isolated from an environmental sample collected from the flock in accordance with paragraph (d)(1)(v) of this section:
(4) In order for a hatchery to sell products of this classification, all products handled shall meet the requirements of the classification.
(5) This classification may be revoked by the Official State Agency if the participant fails to follow recommended corrective measures. The Official State Agency shall not revoke the participant's classification until the participant has been given an opportunity for a hearing in accordance with rules of practice adopted by the Official State Agency.
(e)
(i) It is a flock in which a minimum of 300 birds has been tested for
(ii) [Reserved]
(2) A participant handling U.S. M. Synoviae Clean products shall handle only products of equivalent status.
(3) U.S. M. Synoviae Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected as described in § 147.24(a) of this subchapter.
(f)
(1) It is a primary breeding flock in which a minimum of 30 birds have been tested negative for antibodies to avian influenza when more than 4 months of age. To retain this classification:
(i) A sample of at least 30 birds must be tested negative at intervals of 90 days:
(ii) A sample of fewer than 30 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 30 birds is tested within each 90-day period.
(2) [Reserved]
Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean:
Participating flocks of primary meat-type chickens, and the eggs and chicks produced from them, shall comply with the applicable general provisions of subpart A of this part and the special provisions of this subpart H.
(a) Started chickens shall lose their identity under Plan terminology when not maintained by Plan participants under the conditions prescribed in § 145.5(a).
(b) Hatching eggs produced by primary breeding flocks shall be fumigated (see § 147.25 of this subchapter) or otherwise sanitized.
(c) Any nutritive material provided to chicks must be free of the avian pathogens that are officially represented in the Plan disease classifications listed in § 145.10.
Participating flocks, and the eggs and chicks produced from them, which have met the respective requirements specified in this section, may be designated by the following terms and the corresponding designs illustrated in § 145.10:
(a) [Reserved]
(b)
(1) It has been officially blood tested with no reactors.
(2) It is a primary breeding flock that meets the following criteria:
(i) The primary breeding flock is located in a State in which pullorum disease or fowl typhoid is not known to exist nor to have existed in hatchery supply flocks within the State during the preceding 12 months and in which it has been determined by the Service that:
(A) All hatcheries within the State are qualified as “National Plan Hatcheries” or have met equivalent requirements for pullorum-typhoid control under official supervision;
(B) All hatchery supply flocks within the State are qualified as U.S. Pullorum-Typhoid Clean or have met equivalent requirements for pullorum-typhoid control under official supervision:
(C) All shipments of products other than U.S. Pullorum-Typhoid Clean, or equivalent, into the State are prohibited;
(D) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency within 48 hours the source of all poultry specimens from which
(E) All reports of any disease outbreak involving a disease covered under the Plan are promptly followed by an investigation by the Official State Agency to determine the origin of the infection;
(F) All flocks found to be infected with pullorum or typhoid are quarantined until marketed or destroyed under the supervision of the Official State Agency, or until subsequently blood tested following the procedure for reacting flocks as contained in § 145.14(a)(5) of this subchapter, and all birds fail to demonstrate pullorum or typhoid infection;
(G) All poultry, including exhibition, exotic, and game birds, but excluding waterfowl, going to public exhibition shall come from U.S. Pullorum-Typhoid Clean or equivalent flocks, or have had a negative pullorum-typhoid
(H) Discontinuation of any of the conditions or procedures described in paragraphs (b)(2)(i)(A) through (b)(2)(i)(G) of this section, or the occurrence of repeated outbreaks of pullorum or typhoid in poultry breeding flocks within or originating within the State shall be grounds for the Service to revoke its determination that such conditions and procedures have been met or complied with. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity to present its views; and
(ii) In the primary breeding flock, a sample of 300 birds from flocks of more than 300, and each bird in flocks of 300 or less, has been officially tested for pullorum-typhoid with no reactors:
(c)
(i) It is a flock in which all birds or a sample of at least 300 birds has been tested for
(ii) [Reserved]
(2) A participant handling U.S. M. Gallisepticum Clean products must handle only products of equivalent status.
(3) U.S. M. Gallisepticum Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected as described in § 147.24(a) of this subchapter.
(d)
(i) It is a flock in which all birds or a sample of at least 300 birds has been tested for
(ii) [Reserved]
(2) A participant handling U.S. M. Synoviae Clean products shall handle only products of equivalent status.
(3) U.S. M. Synoviae Clean chicks shall be boxed in clean boxes and delivered in trucks that have been cleaned and disinfected as described in § 147.24(a) of this subchapter.
(e)
(1) A flock and the hatching eggs and chicks produced from it shall be eligible for this classification if they meet the following requirements, as determined by the Official State Agency:
(i) The flock originated from a U.S. S. Enteritidis Clean flock, or one of the following samples has been examined bacteriologically for
(A) A 25-gram sample of meconium from the chicks in the flock collected and cultured as described in § 147.12(a)(5) of this subchapter; or
(B) A sample of chick papers collected and cultured as described in § 147.12(c) of this subchapter; or
(C) A sample of 10 chicks that died within 7 days after hatching.
(ii) All feed fed to the flock meets the following requirements:
(A) Pelletized feed must have a minimum moisture content of 14.5 percent and must have been heated throughout to a minimum temperature of 190 °F, or to a minimum temperature of 165 °F for at least 20 minutes, or to a minimum temperature of 184 °F under 70 lbs. pressure during the manufacturing process;
(B) Mash feed may contain animal protein if the finished feed is treated with a salmonella control product approved by the U.S. Food and Drug Administration.
(C) All feed is stored and transported in such a manner as to prevent possible contamination.
(iii) The flock is maintained in compliance with §§ 147.21, 147.24(a), and 147.26 of this subchapter.
(iv) Environmental samples are collected from the flock by or under the supervision of an Authorized Agent, as described in § 147.12 of this subchapter, when the flock reaches 4 months of age and every 30 days thereafter. The environmental samples shall be examined bacteriologically for group D salmonella at an authorized laboratory, and cultures from group D positive samples shall be serotyped.
(v) Blood samples from 300 birds from the flock are officially tested with pullorum antigen when the flock is at least 4 months of age. All birds with positive or inconclusive reactions, up to a maximum of 25 birds, shall be submitted to an authorized laboratory and examined for the presence of group D salmonella in accordance with §§ 147.10 and 147.11 of this subchapter. Cultures from group D positive samples shall be serotyped.
(vi) Hatching eggs produced by the flock are collected as quickly as possible and are handled as described in § 147.22 of this subchapter.
(vii) Hatching eggs produced by the flock are incubated in a hatchery that is in compliance with the recommendations in §§ 147.23 and 147.24(b) of this subchapter, and the hatchery must have been sanitized either by a procedure approved by the Official State Agency or by fumigation.
(2) If
(3) If SE is isolated from an environmental sample collected from the flock in accordance with paragraph (e)(1)(iv) of this section, 25 randomly selected live birds from the flock and/or 500 cloacal swabs collected in accordance with § 147.12(a)(2) of this subchapter must be bacteriologically examined for SE as described in § 147.11 of this subchapter. If only 1 bird from the 25-bird sample is found positive for SE, the participant may request bacteriological examination of a second 25-bird sample from the flock. If no SE is recovered from any of the specimens in the second sample, the flock will be eligible for the classification and will remain eligible for this classification if the flock is tested in accordance with paragraph (e)(1)(v) of this section each 30 days and no positive samples are found.
(4) In order for a hatchery to sell products of this classification, all products handled by the hatchery must meet the requirements of this paragraph.
(5) This classification may be revoked by the Official State Agency if the participant fails to follow recommended corrective measures. The Official State Agency shall not revoke the participant's classification until the participant has been given an opportunity for a hearing in accordance with rules of practice adopted by the Official State Agency.
(6) A pedigree, experimental, or great-grandparent flock that is removed from the U.S. S. Enteritidis Clean program may be reinstated whenever the following conditions are met:
(i) The owner attests that corrective measures have been implemented, which may include one or more of the following:
(A) Test and slaughter infected birds based on blood tests of every bird in the flock, with either pullorum antigen or by a federally licensed
(B) Perform other corrective actions including, but not limited to, vaccination, medication, cleaning and disinfection of houses, rodent control, and movement of uninfected birds to premises that have been determined to be environmentally negative for
(C) One hundred percent of blood samples from the birds moved to the
(D) Two consecutive environmental drag swabs taken at the clean premises collected as specified in § 147.12(a) of this subchapter 4 weeks apart are negative for
(E) Other corrective measures at the discretion of the Official State Agency.
(ii) Following reinstatement, a flock will remain eligible for this classification if the flock is tested in accordance with paragraph (e)(1)(v) of this section every 30 days and no positive samples are found and the flock meets the requirements set forth in § 145.83(e).
(f)
(1) A flock and the hatching eggs and chicks produced from it that have met the following requirements, as determined by the Official State Agency.
(i) The flock is maintained in compliance with §§ 147.21, 147.24(a), and 147.26 of this subchapter;
(ii) If feed contains animal protein, the protein products must have a minimum moisture content of 14.5 percent and must have been heated throughout to a minimum temperature of 190 °F or above, or to a minimum temperature of 165 °F for at least 20 minutes, or to a minimum temperature of 184 °F under 70 lbs. pressure during the manufacturing process;
(iii) Feed shall be stored and transported in a manner to prevent possible contamination;
(iv) Chicks shall be hatched in a hatchery meeting the requirements of §§ 147.23 and 147.24(b) of this subchapter and sanitized or fumigated (see § 147.25 of this subchapter).
(v) An Authorized Agent shall take environmental samples from the hatchery every 30 days; i.e., meconium or chick papers. An authorized laboratory for
(vi) An Authorized Agent shall take environmental samples as described in § 147.12 of this subchapter from each flock at 4 months of age and every 30 days thereafter. An authorized laboratory for
(vii) Owners of flocks may vaccinate with a paratyphoid vaccine:
(2) The Official State Agency may use the procedures described in § 147.14 of this subchapter to monitor the effectiveness of the egg sanitation practices.
(3) In order for a hatchery to sell products of this classification, all products handled shall meet the requirements of the classification.
(4) This classification may be revoked by the Official State Agency if the participant fails to follow recommended corrective measures.
(g)
(1) It is a primary breeding flock in which a minimum of 30 birds have been tested negative for antibodies to avian influenza when more than 4 months of age and prior to the onset of egg production. To retain this classification:
(i) A sample of at least 30 birds must be tested negative at intervals of 90 days;
(ii) A sample of fewer than 30 birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 30 birds is tested within each 90-day period.
(2) [Reserved]
7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean:
(1) H5/H7 LPAI virus has been isolated and identified as such from poultry; or
(2) Viral antigen or viral RNA specific to the H5 or H7 subtype of AI virus has been detected in poultry; or
(3) Antibodies to the H5 or H7 subtype of the AI virus that are not a consequence of vaccination have been detected in poultry. If vaccine is used, methods should be used to distinguish vaccinated birds from birds that are both vaccinated and infected. In the case of isolated serological positive results, H5/H7 LPAI infection may be ruled out on the basis of a thorough epidemiological investigation that does not demonstrate further evidence of H5/H7 LPAI infection.
(a) The Department cooperates through a Memorandum of Understanding with the Official State Agency in the administration of the Plan.
(b) The administrative procedures and decisions of the Official State Agency are subject to review by the Service. The Official State Agency shall carry out the administration of the Plan within the State according to the applicable provisions of the Plan and the Memorandum of Understanding.
(c)(1) An Official State Agency may accept for participation a commercial table-egg layer flock or a commercial meat-type flock (including an affiliated flock) located in another participating State under a mutual understanding and agreement, in writing, between the two Official State Agencies regarding conditions of participation and supervision.
(2) An Official State Agency may accept for participation a commercial table-egg layer flock or a commercial meat-type flock (including an affiliated flock) located in a State that does not participate in the Plan under a mutual
(d) The Official State Agency of any State may adopt regulations applicable to the administration of the Plan in such State further defining the provisions of the Plan or establishing higher standards, compatible with the Plan.
(e) An authorized laboratory will follow the laboratory protocols outlined in part 147 of this chapter when determining the status of a participating flock with respect to an official Plan classification.
(f) States will be responsible for making the determination to request Federal assistance under part 56 of this chapter in the event of an outbreak of H5/H7 LPAI.
(a) Any table-egg producer and any meat-type chicken or meat-type turkey slaughter plant, including its affiliated flocks, may participate in the Plan when the producer or plant has demonstrated, to the satisfaction of the Official State Agency, that its facilities, personnel, and practices are adequate for carrying out the relevant special provisions of this part and has signed an agreement with the Official State Agency to comply with the relevant special provisions of this part.
(b) Each participant shall comply with the Plan throughout the operating year, or until released by the Official State Agency.
(c) A participating slaughter plant shall participate with all of the meat-type chicken and/or meat-type turkey flocks that are processed at the facility, including affiliated flocks. Affiliated flocks must participate through a written agreement with a participating slaughter plant that is approved by the Official State Agency.
(d) Participation in the Plan shall entitle the participant to use the Plan emblem reproduced as follows:
(e) Participation in the NPIP by commercial table-egg layers will cease after September 26, 2008 unless the majority of the commercial table-egg layer delegates vote to continue the program in accordance with subpart E of part 147 of this chapter at a National Plan Conference.
(a) Records that establish the identity of products handled shall be maintained in a manner satisfactory to the Official State Agency.
(b) Material that is used to advertise products shall be subject to inspection by the Official State Agency at any time.
(c) Advertising must be in accordance with the Plan, and applicable rules and regulations of the Official State Agency and the Federal Trade Commission. A participant advertising products as being of any official classification may include in their advertising reference to associated or franchised slaughter or production facilities only when such facilities produce products of the same classification.
(d) Each participant shall be assigned a permanent approval number by the Service. This number, prefaced by the numerical code of the State, will be the
(a) Participating flocks, and all equipment used in connection with the flocks, shall be separated from non-participating flocks in a manner acceptable to the Official State Agency.
(b) Poultry equipment, and poultry houses and the land in the immediate vicinity thereof, shall be kept in sanitary condition as recommended in § 147.21(c) of this subchapter.
(a) Only meat-type chicken and meat-type turkey slaughter plants that are under continuous inspection by the Food Safety and Inspection Service of the Department or under State inspection that the Food Safety Inspection Service has recognized as equivalent to federal inspection may participate in the Plan.
(b) To participate in the Plan, meat-type chicken and meat-type turkey slaughter plants must follow the relevant special provisions in §§ 146.33(a) and 146.43(a), respectively, for sample collection and flock monitoring, unless they are exempted from the special provisions under §§ 146.32(b) or 146.42(b), respectively.
The official classification terms defined in §§ 146.8 and 146.9 and the various designs illustrative of the official classifications reproduced in § 146.9 may be used only by participants and to describe products that have met all of the specific requirements of such classifications.
Participating slaughter plants shall be designated as “U.S. H5/H7 Avian Influenza Monitored.” All Official State Agencies shall be notified by the Service of additions, withdrawals, and changes in classification.
Participating flocks (including affiliated flocks), products produced from them, and States which have met the respective requirements specified in subparts B, C, or D of this part may be designated by the following terms or illustrative designs:
(a)
(b)
(c)
(a) The Official State Agency may designate qualified persons as Authorized Agents to do the sample collecting provided for in § 146.13 of this part.
(b) The Official State Agency shall employ or authorize qualified persons as State Inspectors to perform the selecting and testing of participating flocks and to perform the official inspections necessary to verify compliance with the requirements of the Plan.
(c) Authorities issued to Authorized Agents or State Inspectors under the provisions of this section shall be subject to cancellation by the Official State Agency on the grounds of incompetence or failure to comply with the provisions of the Plan or regulations of the Official State Agency. Such actions shall not be taken until thorough investigation has been made by the Official State Agency and the authorized person has been given notice of the proposed action and the basis thereof and an opportunity to present his or her views.
(a) Each participating slaughter plant shall be audited at least once annually or a sufficient number of times each year to satisfy the Official State Agency that the participating slaughter plant is in compliance with the provisions of this part.
(b) On-site inspections of any participating flocks and premises will be conducted if a State Inspector determines that a breach of testing has occurred for the Plan programs for which the flocks are certified.
(c) The official H5/H7 LPAI testing records of all participating flocks and slaughter plants shall be examined annually by a State Inspector. Official H5/H7 LPAI testing records shall be maintained for 3 years.
Participants in the Plan who, after investigation by the Official State Agency or its representative, are notified in writing of their apparent noncompliance with the Plan provisions or regulations of the Official State Agency shall be afforded a reasonable time, as specified by the Official State Agency, within which to demonstrate or achieve compliance. If compliance is not demonstrated or achieved within the specified time, the Official State Agency may debar the participant from further participation in the Plan for such period, or indefinitely, as the Official State Agency may deem appropriate. The debarred participant shall be afforded notice of the bases for the debarment and opportunity to present his or her views with respect to the debarment in accordance with procedures adopted by the Official State Agency. The Official State Agency shall thereupon decide whether the debarment order shall continue in effect. Such decision shall be final unless the debarred participant, within 30 days after the issuance of the debarment order, requests the Administrator to determine the eligibility of the debarred participant for participation in the Plan. In such an event, the Administrator shall determine the matter de novo in accordance with the rules of practice in 7 CFR part 50, which are hereby made applicable to proceedings before the Administrator under this section. The definitions in 7 CFR 50.10 and the following definitions shall apply with respect to terms used in such rules of practice:
(a)
(b) [Reserved]
(a)
(1)
(2)
(b)
(1) The AGID test must be conducted on all ELISA-positive samples. Any samples that are found to be positive by AGID must be further tested and subtyped by Federal Reference Laboratories using the hemagglutination inhibition test. Final judgment may be based upon further sampling or culture results.
(2) The tests must be conducted using antigens or test kits approved by the Service. Test kits must be licensed by the Service and approved by the Official State Agency, and tests must be performed in accordance with the recommendations of the producer or manufacturer.
(3) The official determination of a flock as positive for the H5 or H7 subtypes of low pathogenic avian influenza may be made only by the National Veterinary Services Laboratories.
(a) The Official State Agency must develop a diagnostic surveillance program for H5/H7 low pathogenic avian influenza for all poultry in the State. The exact provisions of the program are at the discretion of the States. The Service will use the standards in paragraph (b) of this section in assessing individual State plans for adequacy, including the specific provisions that the State developed. The standards should be used by States in developing those plans.
(b) Avian influenza must be a disease reportable to the responsible State authority (State veterinarian, etc.) by all licensed veterinarians. To accomplish this, all laboratories (private, State, and university laboratories) that perform diagnostic procedures on poultry must examine all submitted cases of unexplained respiratory disease, egg production drops, and mortality for avian influenza by both an approved serological test and an approved antigen detection test. Memoranda of understanding or other means must be used to establish testing and reporting criteria (including criteria that provide
(a) Participating commercial table-egg layer flocks shall comply with the applicable general provisions of subpart A of this part and the special provisions of subpart B of this part.
(b) Commercial table-egg laying premises with fewer than 75,000 birds are exempt from the special provisions of subpart B of this part.
Participating flocks which have met the respective requirements specified in this section may be designated by the following terms and the corresponding designs illustrated in § 146.9 of this part:
(a)
(1) It is a commercial table-egg layer flock in which a minimum of 11 birds or egg samples have been tested negative for antibodies to the H5/H7 subtypes of avian influenza within 30 days prior to disposal;
(2) It is a commercial table-egg layer flock in which a minimum of 11 birds or egg samples have been tested negative for antibodies to the H5/H7 subtypes of avian influenza within a 12-month period; or
(3) It is a commercial table-egg layer flock that has an ongoing active and diagnostic surveillance program for the H5/H7 subtypes of avian influenza in which the number of birds or egg samples tested is equivalent to the number required in paragraph (a)(1) or (a)(2) and that is approved by the Official State Agency and the Service.
(b) [Reserved]
(a)
(i) All commercial table-egg layer flocks in production within the State that are not exempt from the special provisions of this subpart B under § 146.22 are classified as U.S. H5/H7 Avian Influenza Monitored under § 146.23(a) of this part;
(ii) All egg-type chicken breeding flocks in production within the State are classified as U.S. Avian Influenza Clean under § 145.23(h) of this subchapter;
(iii) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency, within 24 hours, the source of all table-egg layer specimens that were deemed positive on an official test for avian influenza, as designated in § 146.13(a) of this chapter;
(iv) All table-egg layer specimens that were deemed positive on an official test for avian influenza, as designated in § 146.13(a) of this chapter, are sent to an authorized laboratory for subtyping; and
(v) All table-egg layer flocks within the State that are found to be infected with the H5/H7 subtypes of avian influenza are quarantined, in accordance with an initial State response and containment plan as described in part 56 of
(2) If there is a discontinuation of any of the conditions described in paragraph (a)(1) of this section, or if repeated outbreaks of the H5/H7 subtypes of avian influenza occur in commercial table-egg layer flocks as described in paragraph (a)(1)(i) of this section, or if an infection spreads from the originating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classification. Such action shall not be taken until a thorough investigation has been made by the Service and the Official State Agency has been given an opportunity for a hearing in accordance with rules of practice adopted by the Administrator.
(b) [Reserved]
(a) Participating meat-type chicken slaughter plants shall comply with applicable general provisions of subpart A of this part and the special provisions of this subpart C.
(b) Meat-type chicken slaughter plants that slaughter fewer than 200,000 meat-type chickens in an operating week are exempt from the special provisions of this subpart C.
Participating meat-type chicken slaughter plants that have met the respective requirements specified in this section may be designated by the following terms and the corresponding designs illustrated in § 146.9 of this part:
(a)
(1) It is a meat-type chicken slaughter plant where a minimum of 11 birds per shift are tested negative for antibodies to the H5/H7 subtypes of avian influenza at slaughter;
(2) It is a meat-type chicken slaughter plant which accepts only meat-type chickens from flocks where a minimum of 11 birds have been tested negative for antibodies to the H5/H7 subtypes of avian influenza no more than 21 days prior to slaughter; or
(3) It is a meat-type chicken slaughter plant that has an ongoing active and diagnostic surveillance program for the H5/H7 subtypes of avian influenza in which the number of birds tested is equivalent to the number required in paragraph (a)(1) or (a)(2) and that is approved by the Official State Agency and the Service.
(b) [Reserved]
(a) Participating meat-type turkey slaughter plants shall comply with applicable general provisions of subpart A of this part and the special provisions of this subpart D.
(b) Meat-type turkey slaughter plants that slaughter fewer than 2 million meat-type turkeys in a 12-month period are exempt from the special provisions of this subpart D.
Participating meat-type turkey slaughter plants which have met the respective requirements specified in this section may be designated by the following terms and the corresponding designs illustrated in § 146.9 of this part:
(a)
(1) It is a meat-type turkey slaughter plant at which a sample of a minimum of 60 birds has tested negative each month for antibodies to type A avian influenza virus. Positive samples shall be further tested by an authorized laboratory using the hemagglutination inhibition test to detect antibodies to the hemagglutinin subtypes H5 and H7. It is recommended that samples be collected from flocks over 10 weeks of age with respiratory signs such as coughing, sneezing, snicking, sinusitis, or rales; depression; or decreases in food or water intake.
(2) It is a meat-type turkey slaughter plant that has an ongoing active and diagnostic surveillance program for the H5/H7 subtypes of avian influenza in which the number of birds tested is equivalent to the number required in paragraph (a)(1) and that is approved by the Official State Agency and the Service.
(b) [Reserved]
(a)
(i) All meat-type turkey slaughter plants within the State that are not exempt from the special provisions of this subpart D under § 146.42 are classified as U.S. H5/H7 Avian Influenza Monitored under § 146.43(a) of this part;
(ii) All turkey breeding flocks in production within the State are classified as U.S. H5/H7 Avian Influenza Clean under § 145.43(g) of this subchapter;
(iii) All persons performing poultry disease diagnostic services within the State are required to report to the Official State Agency, within 24 hours, the source of all meat-type turkey specimens that were deemed positive on an official test for avian influenza, as designated in § 146.13(a) of this chapter;
(iv) All meat-type turkey specimens that were deemed positive on an official test for avian influenza, as designated in § 146.13(a) of this chapter, are sent to an authorized laboratory for subtyping; and
(v) All meat-type turkey flocks within the State that are found to be infected with the H5/H7 subtypes of avian influenza are quarantined, in accordance with an initial State response and containment plan as described in part 56 of this chapter, and under the supervision of the Official State Agency.
(2) If there is a discontinuation of any of the conditions described in paragraph (a)(1) of this section, or if repeated outbreaks of the H5/H7 subtypes of avian influenza occur in meat-type turkey flocks as described in paragraph (a)(1)(i) of this section, or if an infection spreads from the originating premises, the Service shall have grounds to revoke its determination that the State is entitled to this classification. Such action shall not be
7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
(a) The blood samples should be collected and delivered as follows:
(1) The blood samples should be taken by properly qualified and authorized persons only, and in containers provided by the laboratory. The containers should be stout-walled test tubes, preferably
(2) Sufficient blood should be procured by making a small incision in the large median wing vein with a small sharp lancet and allowing the blood to run into the tube, or by the use of a small syringe (with 20 or 21 gage needle) which is properly cleansed between bleedings with physiological saline solution. To facilitate the separation of the serum, the tubes should be placed in a slanted position until the blood has solidified. After the blood has completely clotted, they should be packed and shipped by mail (special delivery), rapid express, or by messenger, to the laboratory. All labeling must be clear and permanent, and may be done with a suitable pencil on etched portions of the tube, or by means of fast-gum labels.
(3) The blood samples must reach the laboratory in a fresh and unhemolyzed condition. Hemolyzed samples should be rejected. It is imperative, therefore, to cool the tubes immediately after slanting and clotting, and unless they reach the laboratory within a few hours, to pack them with ice in special containers, or use some other cooling system which will insure their preservation during transportation. In severe cold seasons, extreme precautions must be exercised to prevent freezing and consequent laking. The samples must be placed in cold (5 °to 10 °C.) storage, immediately upon arrival at the laboratory.
(b) The antigen shall consist of representative strains of S. pullorum which are of known antigenic composition, high agglutinability, but are not sensitive to negative and nonspecific sera. The stock cultures may be maintained satisfactorily by transferring to new sloped agar at least once a month and keeping at 18 °to 25 °C. (average room temperature) in a dark closet or chest, following incubation for from 24 to 36 hours at 37 °C. The antigenic composition and purity of the stock cultures should be checked consistently.
(c) A medium which has been used satisfactorily has the following composition:
(d) Large 1-inch test tubes, Kolle flasks, or Blake bottles should be streaked liberally over the entire agar surface with inoculum from 48-hour slant agar cultures prepared from the stock cultures of the selected strains. The antigen-growing tubes or bottles should be incubated 48 hours at 37 °C., and the surface growth washed off with sufficient phenolized (0.5 percent) saline (0.85 percent) solution to make a heavy suspension. The suspension should be filtered free of clumps through a thin layer of absorbent cotton in a Buchner funnel with the aid of suction. The antigens of the separate strains should be combined in equal volume-density and stored in the refrigerator (5 °to 10 °C.) in tightly stoppered bottles.
(e) Thiosulfate-Glycerin (TG) medium may be used as an alternate medium for the preparation of tube agglutination antigen. The TG medium, formerly used for the preparation of stained, whole-blood antigen, is described in more detail in the article by A. D. MacDonald, Recent Developments in Pullorum Antigen for the Rapid, Whole-Blood Test, Report of the Conference of the National Poultry Improvement Plan, pages 122-127, 1941. This medium provides a tube antigen of excellent specificity and greatly increases the yield of antigen from a given amount of medium. The TG medium has the following composition:
(f) The diluted antigen to be used in the routine testing should be prepared from the stock antigen by dilution of the latter with physiological (0.85 percent) saline solution containing 0.25 percent of phenol to a turbidity corresponding to 0.75-1.00 on the McFarland nephelometer scale. The hydrogen-ion concentration of the diluted antigen should be corrected to pH 8.2 to 8.5 by the addition of dilute sodium hydroxide. New diluted antigen should be prepared each day and kept cold. The diluted antigen may be employed in 2 cc. quantities in 4 by
(g) The maximum serum dilution employed must not exceed 1:50 for chickens, nor 1:25 for turkeys. The available data indicate that 1:25 dilution is the most efficient. In all official reports on the blood test, the serum dilutions shall be indicated. The sera should be introduced into the agglutination tubes in the desired amounts with well-cleaned serological pipettes or special serum-delivery devices which do not permit the mixing of different sera. The antigen and serum should be well mixed before incubation. The serum and antigen mixture must be incubated for at least 20 hours at 37 °C.
(h) The results shall be recorded as:
(a) The procedure for the collection and delivery of blood samples in the rapid serum test is the same as that described in § 147.1(a).
(b) The selection and maintenance of suitable strains of S. pullorum and the composition of a satisfactory medium are described in § 147.1 (b) and (c).
(c) Large 1-inch test tubes, Kolle flasks, or Blake bottles are streaked liberally from 48-hour slant-agar cultures prepared from stock cultures of the selected strains.
(d) The antigen-growing tubes or bottles should be incubated 48 hours at 37 °C., and the surface growth washed off with a very slight amount of 12 percent solution of sodium chloride containing 0.25 to 0.5 percent phenol, filtered through lightly packed sterile absorbent cotton placed in the apex of a sterile funnel.
(e) The washings should be adjusted (using 12 percent sodium chloride containing 0.25 to 0.5 percent phenol) so that the turbidity is 50 times greater than tube 0.75 of McFarland's nephelometer, or to a reading of 7 mm. by the Gates nephelometer.
(f) The individual strain antigens should be tested with negative sera for their insensitivity and with positive sera for high agglutinability in comparison with known satisfactory antigen. The antigens of the separate strains should be combined in equal volume-density and stored in the refrigerator (5 °to 10 °C.) in tightly stoppered bottles.
(g) The tests should be conducted on a suitable, smooth plate. The serum-antigen dilution should be made so that the dilution will not exceed 1:50 when compared to the standard tube agglutination test. When testing turkey blood samples, it is desirable to use a serum-antigen dilution equivalent to the 1:25 in the tube method. The serum should be added to the antigen and mixed thoroughly by use of the tip of the serum pipette. Most strong positive reactions will be plainly evident within 15 to 20 seconds. The final reading should be made at the end of 2 or 3 minutes. Heating the plate at approximately 37 °C. will hasten agglutination. Before reading, the plate should be rotated several times.
(h) The results shall be recorded as described in § 147.1(h).
(a) The description of the preparation of antigen is not herein included because the antigen is a proprietary product produced only under license from the Secretary of Agriculture.
(b) A loop for measuring the correct quantity of blood can usually be obtained from the manufacturer of the antigen. A satisfactory loop may be made from a piece of No. 20 gage nichrome wire, 2
(c) A drop of antigen should be placed on the testing plate. A loopful of blood should be taken up from the wing vein. When submerged in the blood and then carefully withdrawn, the loop becomes properly filled. On looking down edgewise at the filled loop, one observes that the blood appears to bulge. The loopful of blood then should be stirred into the drop of antigen, and the mixture spread to a diameter of about 1 inch. The loop then should be rinsed in clean water and dried by touching it to a piece of clean blotting paper, if necessary. The test plate should be rocked from side to side a few times to mix the antigen and blood thoroughly, and to facilitate agglutination. The antigen should be used according to the directions of the producer.
(d) Various degrees of reaction are observed in this as in other agglutination tests. The greater the agglutinating ability of the blood, the more rapid the clumping and the larger the clumps. A positive reaction consists of a definite clumping of the antigen surrounded by clear spaces. Such reaction is easily distinguished against a white background. A somewhat weaker reaction consists of small but still clearly visible clumps of antigen surrounded by spaces only partially clear. Between this point and a negative or homogeneous smear, there sometimes occurs a very fine granulation barely visible to the naked eye; this should be disregarded in making a diagnosis. The very fine marginal clumping which may occur just before drying up is also regarded as negative. In a nonreactor, the smear remains homogeneous. (Allowance should be made for differences in the sensitiveness of different antigens and different set-ups, and therefore, a certain amount of independent, intelligent judgment must be exercised at all times. Also, the histories of the
Routinely, the microagglutination test is applied as a single-dilution test and only a single 18-24 hour reading is made.
(a) The procedure for the collection and delivery of blood samples in the microagglutination test is the same as that described in § 147.1(a). A method that has proven advantageous is to transfer the serum samples from the blood clot to a microplate as described in “Applied Microbiology,” volume 24, No. 4, October 1972, pages 671-672. The dilutions are then performed according to paragraphs (d) or (e) of this section.
(b) Stained microtest antigen for pullorum-typhoid is supplied as concentrated stock suspension and must be approved by the Department.
(c) Available data indicate that a 1:40 dilution for the microagglutination test is most efficient for the detection of pullorum-typhoid agglutinins in both chickens and turkeys. In all official reports on the blood test, the serum dilutions shall be indicated.
(d) The recommended procedure for the 1:40 dilution in the microagglutination test is as follows:
(1) Add 100 microliters (0.10 cc.) of 0.85 percent physiological saline to each well of the microplate.
(2) Using a microdiluter or a multimicrodiluter handle fitted with twelve 10 microliter microdiluters, transfer 5 microliters (0.005 cc.) of the serum sample from the collected specimen to the corresponding well of the microplate. This is accomplished by touching the surface of the serum sample with the microdiluter and then transferring and mixing with the diluent in the microplate well. The microdiluter is removed, blotted, touched to the surface of the distilled water wash, and again blotted. Other acceptable methods of serum delivery are described in “Applied Microbiology,” volume 21, No. 3, March 1971, pages 394-399.
(3) Dilute the microtest antigens with 0.50 percent phenolized saline and add 100 microliters (0.1 cc.) to each microplate well.
(4) Seal each plate with a plastic sealer or place unsealed in a tight incubation box as described in “Applied Microbiology,” volume 23, No. 5, May 1972, pages 931-937. Incubate at 37°C. for 18-24 hours.
(5) Read the test results as described in paragraph (f) of this section.
(e) The recommended procedure for a microagglutination test titration is as follows:
(1) Add 50 microliters (0.05cc.) of 0.85 percent physiological saline to each well of the microplate.
(2) To the wells representative of the lowest dilution in the titration, add an additional 50 microliters (0.05 cc.) of 0.85 percent physiological saline making a total of 100 microliters in these wells.
(3) Transfer each serum sample as described in § 147.5(d)(2) of this section to the first well containing 100 microliters (0.10cc.) in the titration, which represents the lowest dilution.
(4) Make twofold serial dilutions of each serum by transferring 50 microliters (0.05cc.) of diluted serum from one well to the next using twelve 50 microliter microdiluters fitted in a multimicrodiluter handle. When transfers have been made to all of the wells of the desired series, the 50 microliters
(5) Dilute the desired microtest antigen with 0.50 percent phenolized saline and add 50 microliters (0.05 cc.) to each microplate well.
(6) Seal each plate with a plastic sealer or place the unsealed microplates in a tight incubation box and incubate at 37 °C. for 18-24 hours.
(7) Read the test results as described in paragraph (f) of this section.
(f) Read the test results with the aid of a reading mirror. Results are interpreted as follows:
(1) N, or − (negative) when the microplate well has a large, distinct button of stained cells; or
(2) P, or + (positive) when the microplate well reveals no antigen button; or
(3) S, or ? (suspicious) when the microplate well has a small button. Suspicious reactions may tend to be more positive than negative [±] or vice versa [∓] and can be so noted if desired.
The macroagglutination tests for Mycoplasma antibodies, as described in “Standard Methods for Testing Avian Sera for the Presence of Mycoplasma Gallisepticum Antibodies” published by the Agricultural Research Service, USDA, March 1966, and the microagglutination tests, as reported in the Proceedings, Sixteenth Annual Meeting of the American Association of Veterinary Laboratory Diagnosticians, 1973, shall be the official tests. Procedures for isolation and identification of Mycoplasma may be found in Isolation and Identification of Avian Pathogens, published by the American Association of Avian Pathologists and §§ 147.15 and 147.16.
(a) The status of a flock for Mycoplasma shall be determined according to the following criteria:
(1) If the tube agglutination or the serum plate test is negative, the flock qualifies.
(2) If the tube agglutination or the serum plate test is positive, the hemaglutination inhibition (HI) test and/or the Serum Plate Dilution (SPD) test shall be conducted.
(3) If the tube agglutination or serum plate tests are positive and HI and/or the SPD tests are negative, the flock shall be retested in accordance with paragraph (a)(6) of this section.
(4) If HI titers of 1:40 or SPD titers of 1:5 are found, the flock shall be considered suspicious and shall be retested in accordance with paragraph (a)(6) of this section.
(5) If HI titers of 1:80, positive enzyme-labeled immunosorbent assay (ELISA) titers, or SPD titers of 1:10 or higher are found, the Official State Agency shall presume the flock to be infected. If the indicated titers are found, tracheal swabs from 30 randomly selected birds shall be taken promptly and cultured individually or a PCR-based procedure conducted on these specimens for Mycoplasma, and additional tests conducted in accordance with paragraph (a)(6) of this section before final determination of the flock status is made.
(6) Fourteen days after the previous bleeding date, all birds or a random sample comprised of 75 birds shall be tested by the serum plate or tube agglutination test. Tested birds shall be identified by numbered bands.
(7) If the tube agglutination test or serum plate test is negative for the
(8) If the tube agglutination or serum plate test is positive on the retest, the HI and/or SPD test shall be conducted on the reacting samples.
(9) On the retest, if the tube agglutination or serum plate tests are positive at the same or higher rate and the HI or SPD tests are negative, the flock shall be considered suspicious and shall be retested in accordance with paragraph (a)(6) of this section.
(10) On the retest if HI titers of 1:80 and/or SPD titers of 1:10 or higher are found, the flock shall be considered infected:
(11) If HI titers of 1:80 and/or SPD titers of 1:10 or higher are found on the second retest, the flock shall be considered infected for the Mycoplasma for which it was tested.
(12) If the tube agglutination or serum plate tests are found on the second retest to be positive at the same or higher rate and the HI and/or SPD tests are negative, the flock should be considered infected:
(13) If the in vivo bio-assay, PCR-based procedures, and culture procedures are negative, the Official State Agency may qualify the flock for the classification for which it was tested.
(14) If the in vivo bio-assay, PCR-based procedures, or culture procedures are positive, the flock will be considered infected. However, the following considerations may apply:
(i) In PCR-positive flocks for which there are other negative mycoplasma test results, the flock's mycoplasma status should be confirmed through either seroconversion or culture isolation of the organism, or through both methods, before final determination of the flock's status is made.
(ii) In flocks for which only the bio-assay is positive, additional in vivo bio-assay, PCR-based procedures, or cultural examinations may be conducted by the Official State Agency before final determination of the flock's status is made.
(15) If the in vivo bio-assay, PCR-based procedures, or cultures are positive on retest, the flock shall be considered infected for the mycoplasma for which it was tested.
(b) [Reserved]
The serum plate agglutination test, the tube agglutination test, and the enzyme-linked immunosorbent assay (ELISA) test should be considered basic screening tests for mycoplasma antibodies. The test selected will depend on preference, laboratory facilities, and availability of antigen. These three tests, though quite accurate, determine flock status rather than individual bird status, since occasional reactions are nonspecific. Under normal circumstances, the rate of such nonspecific reactions is low. Nonspecific reactions may occasionally be high,
(a)
(i) Allow antigen and test serums to warm up to room temperature before use.
(ii) Dispense test serums in 0.02 ml amounts with a pipette or standardized loop (rinsed between samples) to 1
(iii) Dispense 0.03 ml of antigen beside the test serum on each square. Hold antigen dispensing bottle vertically.
(iv) Mix the serum and antigen, using a multimixing device if large numbers are to be run at one time.
(v) Rotate the plate for 5 seconds. At the end of the first minute, rotate the plate again for 5 seconds and read 55 seconds later.
(2) A positive reaction is characterized by the formation of definite clumps, usually starting at the periphery of the mixture. Most samples that are highly positive will react well within the 2-minute test period. Reactions thereafter should be considered negative, although partial agglutination at 3 and 5 minutes may warrant further retesting. High-quality antigen contacted with negative serum will usually dry up on the plate without visible clumping. Whenever samples are run, the antigen should be tested against known positive and negative control serums. Standard reference antigens and negative and positive titered sera are available from the National Veterinary Services Laboratories (NVSL), P.O. Box 884, Ames, Iowa 50010.
(3) Since it is difficult to measure uniform amounts of serum with a calibrated loop, this technique should not be used in conducting an official test.
(b)
(i) Rack three tubes and put 0.8 ml of phosphate-buffered saline (PBS) in tube 1 and 0.5 ml of PBS in tubes 2 and 3.
(ii) Pipette 0.2 ml of the test serum into tube 1 and discard the pipette.
(iii) With a pipette, mix the serum and PBS in tube 1 and withdraw 0.5 ml and add to tube 2.
(iv) Repeat the process in step (iii), mixing the contents of tube 2 and transferring 0.5 ml to tube 3.
(v) Conduct the test, as described for the serum plate test in paragraph (a), on the undiluted sample and on samples in tubes 1, 2, and 3 after proper mixing of each dilution.
(vi) To assist in the evaluation of the test, conduct concurrent SPD tests using both positive 1:80 and positive 1:160 HI sera for the mycoplasma being tested. The antigen should be pretested for reactivity with standard serum at the 1:5 and 1:10 dilution.
(vii) Interpretation of the SPD test results should be based on the criteria in § 147.6(a).
(c)
(i) Rack 12×75 mm clean tubes and identify the tubes according to the sample to be tested.
(ii) Add 0.08 ml of the individual test serum to each tube. This will create approximately a 1:12.5 screening dilution of test serum when 1.0 ml of diluted antigen is added. The use of a pipetting device will insure proper mixing of serum and antigen.
(iii) To interpret positive reactions to the 1:12.5 dilution, two additional dilutions may be made by adding 0.04 ml of serum for 1:25 dilution and 0.02 ml of serum for 1:50 dilution, with the addition of 1.0 ml of diluted antigen as indicated in paragraph (c)(1)(ii) of this section.
(iv) Shake racks and incubate test systems for 18-24 hours at 37° C.
(2) Tests are read against a dark background under indirect fluorescent light. Regarded as a positive reaction is a clearing of the supernatant fluid, with visible sediment in the bottom of the tube. Incomplete reactions are suspect. Positive and negative control serums should be incorporated into each day's run of tests. Reactions at 1:25 or greater are considered positive. They should be confirmed by the HI test. Incubation for periods greater than 24 hours may be helpful in evaluating suspicious reactions and need for possible retesting or other diagnostic tests.
(d)
(1)
(ii) Collect the turkey or chicken red blood cells (RBC's) in Alsever's solution which has been prepared as follows:
(iii) From a turkey(s) or chicken(s) known to be free of the mycoplasma being tested, withdraw sufficient blood with a syringe containing Alsever's solution to give a ratio of 1 part blood to 5 parts Alsever's solution (e.g., 8 ml blood in 40 ml of Alsever's solution). Centrifuge the blood suspension at 1,000 rpm for 10 minutes and remove the Alsever's solution or supernatant with a pipette.
(iv) Wash the RBC's two times in 10 or more parts of Alsever's solution, centrifuging after each washing. Centrifugation is at 1,000 rpm for 10 minutes. The supernatant fluid is removed and the RBC deposit resuspended to give a 25 percent suspension of packed RBC's in Alsever's solution. (In testing either chicken or turkey sera, the homologous RBC system must be used;
(v) For the test, 1 ml of the 25 percent RBC's is added to 99 ml of buffered saline to make a 0.25 percent RBC suspension.
(2)
(i) Rack a series of 11 chemically clean 12×75 mm test tubes. Label the tubes 1-11 left to right.
(ii) Put 0.8 ml of PBS in tube 1 and 0.5 ml of PBS in each of tubes 2-11.
(iii) Add 0.2 ml of antigen to tube 1. This will make a 1:5 dilution of antigen. Discard pipette.
(iv) Mix contents of tube 1 thoroughly with a clean pipette, and transfer 0.5 ml to tube 2. This will make a 1:10 dilution of antigen in tube 2. Discard pipette.
(v) Continue making serial twofold dilutions of antigen, changing pipettes after each transfer, through tube 10. This will result in a series of twofold dilutions ranging from 1:5 to 1:2560. Discard 0.5 ml of antigen dilution from tube 10.
(vi) Add 0.5 ,ml of 0.25 percent RBC's to tubes 1-11. Tube 11 will serve as PBS/RBC control.
(vii) Shake the rack and incubate at room temperature until the cells in the PBS/RBC control tube have settled into a compact button at the bottom of the tube.
(viii) If turkey sera is also to be tested for HI titer, repeat steps outlined in paragraphs (d)(2)(i) through (vii) of this section, using 0.25 percent turkey RBC's.
(ix) The end point of the titration is the highest dilution of antigen that produces complete agglutination of the RBC's, as evidenced by the formation of a thin sheet of cells covering the
(x) Specificity of HA antigen should be determined by conducting HI tests with specific chicken sera of variable HI titers. Specific turkey sera of varying HI titers should be used if turkey sera is also to be tested.
(3)
(ii) Four-unit antigen (made by diluting surplus 8-unit antigen 1:2 with PBS).
(iii) PBS at pH 7.0.
(iv) Unknown test serums.
(v) Positive control serum of known titer (should be from the same species as the unknown).
(vi) Negative control serum (should be from the same species as the unknown).
(vii) Solution of 0.25 percent washed RBC's.
(4)
(ii) Put 0.8 ml of PBS in tube 1 of each test row; put 0.5 ml of 8-unit antigen in tube 2 of each test row; put 0.5 ml of 4-unit antigen in each of tubes 3-10 in each test row; and put 0.5 ml of PBS in tube 11.
(iii) Add 0.2 ml of test serum to tube 1. This tube will be the serum control in the test system.
(iv) Mix and make 0.5 ml transfers from tube 1 through tube 10. This will result in serial twofold dilutions of serum starting with 1:5 and ending with 1:2560. Discard 0.5 ml from tube 10.
(v) Rack five tubes in which to set up an antigen control.
(vi) In tube 1, put 1.0 ml of 4-unit antigen; put 0.5 ml of PBS in tubes 2-5.
(vii) Make 0.5 ml serial transfers from tube 1 through tube 5, changing pipettes after each transfer. Discard 0.5 ml from tube 5. This will result in a series of tubes respectively containing 4, 2, 1,
(viii) After 20-30 minutes at room temperature to permit antibody-antigen reaction, add 0.5 ml of 0.25 percent washed RBC's to each tube. Shake racks and incubate as for HA titration.
(ix) In this test system, positive serum should inhibit the HA activity of the antigen, while negative serum should have no effect. Inhibition will be evidenced by the formation of a free-flowing bottom of cells in the botton of the tube. The titer of the serum can be calculated as the reciprocal of the highest dilution of serum that produces complete HI. Controls should read as follows:
(A) Serum control (tube 1). Cells should settle out.
(B) PBS/RBC control (tube 11). Cells should settle out.
(C) Antigen control. HA in tubes 1-3. Cells should settle out in tubes 4-5.
(D) Positive and negative serum control. Positive control should inhibit to its known titer; negative control should have no inhibitory effect.
(x) With this test system and 4 units of antigen, HI titers of 80 or above are considered positive and titers of 40 are strongly suspicious. However, titers of 10 or 20 are usually negative. Sample test results are illustrated in Table 4 in this paragraph.
(xi) If serological results from agglutination tests complemented by the HI test are inconclusive, cultural examination, bio-assay, or retesting of samples after an interval of at least 21 days may be indicated.
(e)
(i)
(B) Phosphate-buffered saline (PBS).
(C) Reagents from NVSL;
(D) Homologous red blood cells (RBC's) suspension 0.5 percent (2 ml of 25 percent RBC's to 98 ml of PBS) obtained from birds free of the mycoplasma to be tested. (See paragraphs (d)(1)(ii) through (v) of this section for preparation of RBC's.)
(ii)
(B) Mark last well in each row for cell controls.
(C) Prepare in small test tube (12×75 mm) a starting dilution of antigen by combining 0.1 ml antigen with 0.9 ml PBS. This is a 1:10 dilution.
(D) Add 0.05 ml PBS to all wells, including cell controls.
(E) Add 0.05 ml antigen (1:10 dilution) with diluters to the first well in both rows, mix thoroughly, transfer diluter to second well of each row and mix, continuing through the 10th well of each row. With mixture in diluter from last well, check diluter on go-no-go card, then place diluter in distilled water. If diluter checks out, antigen dilution will be 1:20, 1:40, 1:80, 1:160, 1:320, 1:640, 1:1280, 1:2560, 1:5120.
(F) Add 0.05 ml of 0.5 percent RBC suspension to all wells using a 0.05 dropper.
(G) Seal plate (if plate is to be held over 2 hours); shake and allow to stand at room temperature until cells in cell control gather in compact button. The titer is the highest dilution in which agglutination is complete. The dilution contains 1 HA unit in 0.05 ml.
(H) Prepare a dilution of antigen which contains 8 HA units in 0.05 ml. Example: if the antigen titer is 1:640, then that dilution contains 1 HA unit per 0.05 ml. Then 640÷8=80, or a dilution of 1:80 containing 8 HA units. Or 640÷4=160, a dilution of 1:160 containing 4 HA units per 0.05 ml.
(iii)
(B) Mark off one row of 8 wells for each test.
(C) Prepare a 1:5 dilution of each sera to be tested in a small test tube (12×75 mm): 0.1 ml serum plus 0.4 ml PBS or 0.05 ml serum plus 0.20 ml PBS.
(D) Add 0.05 ml PBS with the 0.05 ml dropper to the first well in each row.
(E) Add 0.05 ml of 8-unit antigen to well 2 in each row.
(F) Add 0.05 ml of 4-unit antigen to well 3 through 8 for each row.
(G) For each serum to be tested, load 0.05 ml diluter with 1:5 dilution as prepared in paragraph (iii) above and place in first well of row.
(H) Mix well and transfer loaded diluter to well 2. Continue serial twofold dilutions through well number 8.
(I) Well 1 (serum dilution of 1:10) is serum control. Well 2=1:20 dilution; well 3=1:40 dilution; well 4=1:80 dilution; well 5=1:160 dilution; well 6=1:320 dilution; well 7=1:640 dilution; and well 8=1:1280 dilution.
(J)
(
(
(
(
(
(
(
(
(K)
(2)
(i)
(B) Positive and negative control sera.
(C) Phosphate buffered saline (PBS).
(D) Microtiter plates, 96-well, U-bottom.
(E) 12-channel pipettor (Titerek).
(F) 50 μL pipettor (Pipetman P200).
(G) Pipette tips.
(H) 0.5 percent homologous red blood cells (RBC's) in PBS (use RBC's from the same species being tested).
(I) Plate-sealing tape.
(J) Mirrored plate reader.
(ii)
(
(
(
(
(B) Incubate at room temperature (approximately 30 minutes) until the control RBC's give tight buttons. The HA titer is read as the last well to give a complete lawn (hemagglutination).
(C) Dilute stock antigen to 4 HA units for the HI test. The dilution required to give 4 HA units is calculated by dividing the stock antigen HA titer by 8. (Example: 1:320 HA units ÷ 8 = 40, dilute stock antigen 1:40.)
(iii)
(B) Add 40 μL of PBS to the top row of wells (row A) of the plate.
(C) Add 25 μL of PBS to all remaining wells of the plate.
(D) Add 10 μL of each test sera to well A of each column (making a 1:5 sera dilution).
(E) Serially dilute 25 μL from well A through H using a 12-channel pipettor. Discard the final 25 μL. Row A = 1:5...row H = 1:640.
(F) With an Oxford doser, add 25 μL of 4 HA unit antigen to wells B through H. Well A serves as sera control.
(G) Prepare an antigen backtitration by adding 25 μL of PBS to each well of one column. Add 25 μL of diluted antigen to well A and serially dilute 25 μL from wells A to D. This prepares 1:2, 1:4, 1:8, and 1:16 dilutions. (It is recommended that the antigen control backtitration be performed before the diluted antigen is used in the assay. Dilution problems could be detected and corrected before the inappropriately diluted antigen is used in the assay.)
(H) Leave a column of wells blank for an RBC control.
(I) Agitate gently and incubate for 30 minutes at room temperature.
(J) Add 50 μL of 0.5 percent RBC's to all wells. Note: Do not agitate after RBC's have been added (agitation may result in false positive reactions by causing the RBC's to fall, resulting in “false” buttons).
(K) Cover the plate with sealing tape. Incubate at room temperature for 30 minutes or until control RBC's give a tight button.
(L) Read the reaction on a mirrored plate reader.
(iv)
(B) For the assay to be valid:
(
(
(
(
(
(v)
(B)
(C)
(D)
(
(
(
(
(
(
The following testing provisions may be used for retaining the classification U.S. M. Gallisepticum Clean under § 145.23(c)(1)(ii)(C) and § 145.33(c)(1)(ii)(C), for retaining the classification U.S. M. Synoviae Clean under § 145.23(e)(1)(ii)(
(a) Under the supervision of an Authorized Agent or State Inspector, the eggs which are used in egg yolk testing must be selected from the premises where the breeding flock is located, must include a representative sample of 30 eggs collected from a single day's production from the flock, must be identified as to flock of origin and pen, and must be delivered to an authorized laboratory for preparation for diagnostic testing.
(b) The authorized laboratory must identify each egg as to the breeding flock and pen from which it originated, and maintain this identity through each of the following:
(1) Crack the egg on the round end with a blunt instrument.
(2) Place the contents of the egg in an open dish (or a receptacle to expose the yolk) and prick the yolk with a needle.
(3) Using a 1 ml syringe without a needle, aspirate 0.5 ml of egg yolk from the opening in the yolk.
(4) Dispense the yolk material in a tube. Aspirate and dispense 0.5 ml of PBS (phosphate-buffered saline) into the same tube, and place in a rack.
(5) After all the eggs are sampled, place the rack of tubes on a vortex shaker for 30 seconds.
(6) Centrifuge the samples at 2500 RPM (1000×g) for 30 minutes.
(7)(i) For egg yolk samples being tested to retain the U.S. M. Gallisepticum Clean and U.S. M. Synoviae Clean classifications, test the resultant supernatant for
(ii) For egg yolk samples being tested to retain the U.S. H5/H7 Avian Influenza Monitored classification, test the resultant supernatant in accordance with the requirements in § 146.13(b).
For evaluating the test results of any egg yolk test, it should be remembered that a 1:2 dilution of the yolk in saline was made of the original specimen.
(a) The agar gel immunodiffusion (AGID) test should be considered the basic screening test for antibodies to Type A influenza viruses. The AGID test is used to detect circulating antibodies to Type A influenza group-specific antigens, namely the ribonucleoprotein (RNP) and matrix (M) proteins. Therefore, this test will detect antibodies to all influenza A viruses, regardless of subtype. The AGID test can also be used as a group-specific test to identify isolates as Type A influenza viruses. The method used is similar to that described by Beard.
(1)
(ii) Freezer (−20 °C).
(iii) Incubator or airtight container for room temperature (approximately 25 °C) incubations.
(iv) Autoclave.
(v) Hot plate/stirrer and magnetic stir bar (optional).
(vi) Vacuum pump.
(vii) Microscope illuminator or other appropriate light source for viewing results.
(viii) Immunodiffusion template cutter, seven-well pattern (a center well surrounded by six evenly spaced wells). Wells are 5.3 mm in diameter and 2.4 mm apart.
(ix) Top loading balance (capable of measuring 0.1 gm differences).
(x) Pipetting device capable of delivering 50μl portions.
(xi) Common laboratory supplies and glassware—Erlenmeyer flasks, graduated cylinders, pipettes, 100 × 15 mm or 60 × 15 mm petri dishes, flexible vacuum tubing, side-arm flask (500 mL or larger), and a 12- or 14-gauge blunt-ended cannula.
(2)
(ii) Agarose (Type II Medium grade, Sigma Chemical Co. Cat.# A-6877 or equivalent).
(iii) Avian influenza AGID antigen and positive control antiserum approved by the Department and the Official State Agency.
(iv) Strong positive, weak positive, and negative control antisera approved by the Department and the Official State Agency (negative control antisera optional).
(3)
(ii) To mix the agar, either:
(A) Autoclave the mixture for 10 minutes and mix the contents by swirling after removing from the autoclave to ensure a homogeneous mixture of ingredients; or
(B) Dissolve the mixture by bringing to a boil on a hot plate using a magnetic stir bar to mix the contents in the flask while heating. After boiling, allow the agar to cool at room temperature (approximately 25 °C) for 10 to 15 minutes before dispensing into petri plates.
(iii) Agar can be dispensed into small quantities (daily working volumes) and
Do not use agar if microbial contamination or precipitate is observed.
(4)
(B) Allow plates to cool in a relatively dust-free environment with the lids off to permit the escape of water vapor. The lids should be left off for at least 15 minutes, but not longer than 30 minutes, as electrolyte concentration of the agar may change due to evaporation and adversely affect formation of precipitin lines.
Plates should be used within 24 hours after they are poured.
(C) Record the sample identification, reagent lot numbers, test date, and identification of personnel performing and reading the test.
(D) Using the template, cut the agar after it has hardened. Up to seven template patterns can be cut in a 100×15 mm plate and two patterns can be cut in a 60×15 mm plate.
(E) Remove the agar plugs by aspiration with a 12- to 14-gauge cannula connected to a side arm flask with a piece of silicone or rubber tubing that is connected to a vacuum pump with tubing. Adjust the vacuum so that the agar surrounding the wells is not disturbed when removing the plugs.
(F) To prepare the wells, either:
(
(
A pattern can be included with positive, weak positive, and negative reference serum in the test sera wells to aid in the interpretation of results (see figure 3).
(G) Cover each plate after filling all wells and allow the plates to incubate for 24 hours at room temperature (approximately 25 °C) in a closed chamber to prevent evaporation. Humidity should be provided by placing a damp paper towel in the incubation chamber. Note: Temperature changes during migration may lead to artifacts.
(ii)
(B) The type of reaction will vary with the concentration of antibody in the sample being tested. The positive control serum line is the basis for reading the test. If the line is not distinct, the test is not valid and must be repeated. The following types of reactions are observed (see figure 3):
(
(
(
(b) The enzyme-linked immunosorbent assay (ELISA) may be used as a screening test for avian influenza. Use only federally licensed ELISA kits and follow the manufacturer's instructions. All ELISA-positive serum samples must be confirmed with the AGID test conducted in accordance with paragraph (a) of this section.
Birds selected for bacteriological examination from egg-type breeding flocks positive for
(a) Except when visibly pathological tissues are present, direct culture, § 147.11(a)(1) of this subpart, may be omitted; and
(b) Enrichment culture of organ (non-intestinal) tissues using a non- selective broth, § 147.11(a)(2) of this subpart, may be omitted.
(a)
(1) Direct culture (refer to illustration 1). Grossly normal or diseased liver, heart, pericardial sac, spleen, lung, kidney, peritoneum, gallbladder, oviduct, misshapen ova or testes, inflamed or unabsorbed yolk sac, and other visibly pathological tissues where purulent, necrotic, or proliferative lesions are seen (including cysts, abscesses, hypopyon, and inflamed serosal surfaces) should be sampled for direct culture using either flamed wire loops or sterile swabs. Since some strains may not dependably survive and grow in certain selective media, inoculate non-selective plates (such as blood or nutrient agar) and selective plates (such as MacConkey [MAC] and brilliant green novobiocin [BGN] for pullorum-typhoid and MAC, BGN, and xylose-lysine-tergitol 4 [XLT 4] for SE). After inoculating the plates, pool the swabs from the various organs into a tube of non-selective broth (such as nutrient or brain-heart infusion). Refer to illustration 1 for recommended bacteriological recovery and identification procedures.
(2) Selective enrichment culture (refer to illustration 1). Collect and culture organ samples separately from intestinal samples, with intestinal tissues collected last to prevent cross-contamination. Samples from the following organs or sites should be collected for culture in selective enrichment broth:
(i) Heart (apex, pericardial sac, and contents if present);
(ii) Liver (portions exhibiting lesions or, in grossly normal organs, the drained gallbladder and adjacent liver tissues);
(iii) Ovary-Testes (entire inactive ovary or testes, but if ovary is active, include any atypical ova);
(iv) Oviduct (if active, include any debris and dehydrated ova);
(v) Kidneys and spleen; and
(vi) Other visibly pathological sites where purulent, necrotic, or proliferative lesions are seen.
(3) From each bird, aseptically collect 10 to 15 grams of each organ or site listed in paragraph (a)(2) of this section. Mince, grind, or blend and place in a sterile plastic bag. All the organs or sites listed in paragraph (a)(2) of this section from the same bird may be pooled into one bag. Do not pool samples from more than one bird. Add sufficient tetrathionate enrichment broth to give a 1:10 (sample to enrichment) ratio. Follow the procedure outlined in illustration 1 for the isolation and identification of
(4) From each bird, aseptically collect 10 to 15 grams of each of the following parts of the digestive tract: Crop wall, duodenum, jejunum (including remnant of yolk sac), both ceca, cecal tonsils, and rectum-cloaca. Mince, grind, or blend tissues and pool them into a sterile plastic bag. Do not pool tissues from different birds into the same sample. Add sufficient tetrathionate enrichment broth to give a 1:10 (sample to enrichment) ratio. Follow the procedure outlined in illustration 1 for the isolation and identification of
(5) After selective enrichment, inoculate selective plates (such as MAC and BGN for pullorum-typhoid and MAC, BGN, and XLT 4) for SE. Inoculate three to five
(6) If the initial selective enrichment is negative for
(7) Serogroup all isolates identified as salmonellae and serotype all serogroup D1 isolates. Phage-type all SE isolates.
(b) [Reserved]
Information concerning the pen arrangement and number of birds per pen should be obtained from the owner so that the required number of samples per pen and per flock can be determined. A means of identifying each sample by pen of origin should be provided. The vehicle transporting the personnel taking the samples should be left as far as practical from the poultry pens. Sanitary precautions, including personal cleanliness, should be observed during the sampling procedure. The hands should be carefully washed with a sanitizing soap prior to the sampling. Outer clothing, including gloves, should be changed between visits to different premises so that clean clothing is worn upon entering each premises.
The used and clean apparel should be kept separate. Boots or footwear should be cleaned and disinfected between visits to different premises. Disposable caps should be provided and discarded after use on each premises. After collection, the samples should be protected from drying, light, and excessive temperatures and delivered to the laboratory within one day. If delivery is delayed, samples should be refrigerated.
(a)
(1)
(i)
(ii)
(2)
(i)
(ii) [Reserved]
(3)
(i)
(ii)
(iii)
(iv)
(v)
(4)
(i) Instructions for collecting samples from chick box papers:
(A) Collect 1 chick box paper for each 10 boxes of chicks placed in a house and lay the papers on a clean surface.
(B) Clean your hands and put on latex gloves. Do not apply disinfectant to the gloves. Change gloves after collecting samples from 10 chick box papers or any time a glove is torn.
(C) Saturate a sterile 3-by-3 inch gauze pad with double-strength skim milk (see footnote 12 to this section) and rub the pad across the surface of five chick box papers. Rub the pad over at least 75 percent of each paper and use sufficient pressure to rub any dry meconium off the paper. Pouring a small amount of double-strength skim milk (1 to 2 tablespoons) on each paper will make it easier to collect samples.
(D) After collecting samples from 10 chick box papers, place the two gauze pads used to collect the samples (
(E) Promptly refrigerate the Whirl-Pak bags containing the samples and transport them, on ice or otherwise refrigerated, to a laboratory within 48 hours of collection. The samples may be frozen for longer storage if the Plan participant is unable to transport them to a laboratory within 48 hours.
(ii) The Plan participant may send chick box papers directly to a laboratory, where samples may be collected as described in paragraph (a)(4)(i) of this section. To send chick box papers directly to a laboratory:
(A) Collect 1 chick box paper for each 10 boxes of chicks placed in a house and place the chick papers immediately into large plastic bags and seal the bags.
(B) Place the plastic bags containing the chick box papers in a clean box and transport them within 48 hours to a laboratory. The plastic bags do not require refrigeration.
(iii) The laboratory must follow the procedure set forth in paragraph (a)(5)
(5)
(ii) Shake each plastic bag of meconium until a uniform consistency is achieved.
(iii) Transfer a 25 gm sample of meconium to a sterile container. Add 225 mL of a preenrichment broth to each sample (this is a 1:10 dilution), mix gently, and incubate at 37 °C for 18-24 hours.
(iv) Enrich the sample with selective enrichment broth for 24 hours at 42 °C.
(v) Streak the enriched sample onto brilliant green novobiocin (BGN) agar and xylose-lysine-tergitol 4 (XLT4) agar.
(vi) Incubate both plates at 37 °C for 24 hours and process suspect
(b)
(1) Tetrathionate enrichment with delayed secondary enrichment (DSE):
(i) Add tetrathionate enrichment broth to the sample to give a 1:10 (sample to enrichment) ratio. Incubate the sample at 37 or 41.5 °C for 20 to 24 hours as shown in illustration 2.
(ii) After selective enrichment, inoculate selective plates (such as BGN and XLT4). Incubate the plates at 37 °C for 20 to 24 hours. Inoculate three to five
(iii) If the initial selective enrichment is negative for
(iv) Serogroup all isolates identified as
(2) Pre-enrichment followed by selective enrichment. (See illustration 2.)
(3)
(c)
(i)
(ii)
The composite samples above may be pooled to not less than five samples at the laboratory as long as the volume of material collected equals approximately 10 percent of the volume of the broth.
(2)
(i)
(ii) [Reserved]
(3)
(i)
(ii)
(B)
Proper precautions to avoid environmental contamination of the samples during the collection and laboratory process, and proper handling of the samples following collection are essential. Each State Inspector involved in eggshell culture activities must receive instruction in the necessary sanitation procedures, sampling procedures, and sample handling by the authorized laboratory involved. The Official State Agency will maintain a record showing that the required instruction was given to each State Inspector.
(a)
(b)
(1) From the tube containing four swabs and lactose broth or other suitable media, 1 ml. will be transferred to 10 ml. lactose in a fermentation tube.
(2) Incubate at 37 °C for 48 hours. The presence of acid, and gas in the amount of 10 percent or more after 24 and 48
The following monitoring procedures
(a) Monitor effectiveness of sanitation program.
(1) Culture the surface of cased eggs periodically for fecal contaminating organisms as described in § 147.13.
(2) Culture a sample of dead-in-shell eggs periodically from each breeding flock for coliforms. Such eggs should also be cultured for the dependable recovery of
(i) Preenrichment broths supplemented with 35 mg ferrous sulfate per 1,000 ml preenrichment to block iron-binding,
(ii) Tetrathionate selective enrichment broths, competitor-controlling plating media (XLT4, BGN, etc.), delayed secondary enrichment procedures, and colony lift assays detailed in paragraph (a)(5) and illustration 2 of § 147.11.
(a) Turbinates, trachea, air sacs, sinuses, nasal passages, respiratory exudates, synovial fluid, eggs (including yolk, yolk sacs, membranes and allantoic fluid), should be directly sampled with sterile swabs. Aseptic techniques are very important as some organisms may not be suppressed by the antimicrobial agents used in this procedure. Tissue suspensions from large volumes are sometimes desirable from the sites listed above and occasionally from the oviduct and cloaca. Tissues should be ground or blended completely in 10 times their volume of Mycoplasma Broth Medium (MBM). (See paragraph (f) of this section.) Specimens submitted to referral laboratories in order of preference for recovery of the mycoplasma organisms are: (1) live birds, (2) refrigerated fresh tissues, (3) tissue specimens packed with dry ice.
(b) Inoculate 5-10 ml of MBM with a swab, wire loop or 0.1 ml of the tissue suspension. When evidence of growth is observed (lowered pH or turbidity of broth) transfer each broth culture as needed to maintain the original isolates. Incubate tubes at 37 °C for at least 21 days before discarding as negative. When growth is first observed or if no growth occurs by the
(c) Isolates must be serotyped.
(1) Isolates may be shipped in MBM with ice packs if shipment will be in transit less than 2-3 days. Longer shipments require freezing of the MBM with dry ice, or shipping MAM slants at room temperature. Isolates must have indications of growth before shipment is made.
(2) Isolates may be stored in MBM at −20 °C for 2-3 weeks, or they may be stored at −68 °C for several years.
(d) Alternate method of culture: An overlay enrichment culture for fastidious and sensitive mycoplasma, especially for
(1) Pour 2-3 ml of MAM into a test tube and tilt the tube until a slant (approximately 45°) is obtained. Other containers are acceptable.
(2) Overlay the slant with sufficient MBM, so that the media (including inoculum) covers the agar slope.
(3) Inoculate the culture as indicated in paragraph (b) of this section.
(4) Incubate and examine the overlay as indicated in paragraph (b) of this section.
(e) Preparation of media components:
(1) Deionized distilled water suitable for cell culture fluids should be used.
(2) All glassware should be carefully washed with a nonresidue detergent such as Alcojet and rinsed three times in tap water and twice in deionized distilled water.
(3) Thallium acetate in a 10 percent solution is added to an approximate final concentration of 1:4000; however, highly contaminated specimens may require a final concentration of 1:2000.
(4) Mycoplasma Broth Base, dextrose, phenol red, and cysteine hydrochloride are added to deionized distilled water first if autoclave sterilization is used.
(5) Use sterile deionized distilled water to reconstitute penicillin.
(6) Sterile serum should be inactivated by heating at 56 °C for 30 minutes. Swine serum may be used for
(7) Phenol red should be prepared as a 1 percent solution.
(8) NAD (beta nicotinamide adenine dinucleotide or coenzyme I) should be prepared as a 1 percent solution.
(9) Cysteine hydrochloride, prepared as a 1 percent solution, is used to reduce the NAD for
(10) A purified agar product such as Nobel (Special agar) is used in the MAM.
(11) Adjust the pH with NaOH.
(12) Sterilization may be accomplished by two methods:
(i) Filtration sterilization through a 0.20 micron filter is the recommended method. Aseptic techniques must be utilized.
(ii) Autoclave sterilization at 120 °C, 15 pounds pressure (103 kPa), for 15 minutes may be used, if preferred, when following the procedure described in paragraph (e)(4) of this section.
(13) Phenol red, dextrose, and NAD may be omitted when culturing for
(14) When culturing for
(f) Mycoplasma Broth Medium (Frey) is prepared as follows: To 850-880 ml of deionized distilled water;
Add:
(1) Broth may be stored at 4 °C for at least 2 weeks or at −40 °C for longer periods.
(g) Mycoplasma Agar Medium (Frey) is prepared as follows: To 850-880 ml of deionized distilled water;
Add:
(1) Rotate flask gently and pour about 15 ml of media into each petri dish.
(2) Stack petri dishes only 2-3 high in a 37 °C incubator up to 2 hours to remove excess moisture.
(3) Wrap inverted plates in sealed bundles and store at 4 °C for not more than 15 days.
(h) New component or media batches should be monitored to compensate for changes in formulation due to alterations of purity, concentration, preparation, etc. A known series of titrations from a single culture should be made on both new and old media. The media should be compared on the basis of growth, colony size, and numbers of colonies which develop.
This procedure has been shown to be sensitive enough to detect less than 100 mycoplasma organisms under proper conditions.
(a) Obtain chickens or turkeys (test birds) which are at least 3 weeks of age and are free of
(1) Maintain test birds in an area that has been effectively cleaned and disinfected.
(2) The area should be isolated from other birds or animals.
(3) Personnel caring for the test birds should take the necessary precautions (see § 147.26(b)) to prevent the mechanical transfer of infectious avian diseases from other sources.
(b) Test birds to be used for inoculation with contaminated tissues should be serologically negative by the serum plate agglutination test.
(1) Inoculated test birds should be isolated from non-inoculated control birds for the length of any experiment.
(c) Aseptically obtain tracheal, turbinate, and sinus mucosa, lung and sinus exudates, cervical, thoracic, and abdominal airsac tissues (including lesions), and portions of oviduct and synovial fluid from at least four suspect, donor birds. In a sterile device, blend the tissues completely in four times their volume of Mycoplasma Broth Medium (Frey), (see § 147.15(f)). Suspensions may be made from tissue pools. Inoculate test birds within 30 minutes for preparation of suspensions.
(1) Inoculate at least four test birds for each suspension pool via the abdominal air sac and infraorbital sinus, with up to
(2) Test birds should be bled every 7 days for 35 days to identify sero-converters.
(3) At 35 days, test birds should be sacrificed and bacteriologic isolation and identification of mycoplasma attempted (see § 147.15). Note especially the sites of inoculation for typical gross or microscopic mycoplasma lesions.
(d) Donor birds are considered infected when:
(1) Test birds have serum plate antibodies for the mycoplasma for which the donor birds were tested, regardless of HI test results,
(2) Mycoplasma organisms are isolated from the test birds and serotyped positive for the mycoplasma for which the donor birds were tested,
(e) Laboratory findings may be verified by direct cultures of material from sick birds or by inoculating seronegative birds from the suspect flock and comparing serological findings with those from the test birds.
The laboratory procedure described in this section is recommended for the bacteriological examination of cull chicks from egg-type and meat-type chicken flocks and waterfowl, exhibition poultry, and game bird flocks and poults from turkey flocks for salmonella.
(a) For cull chicks, from 25 randomly selected 1- to 5-day-old chicks that have not been placed in a brooding house, prepare 5 organ pools, 5 yolk pools, and 5 intestinal tissue pools as follows. For poults, from a sample of 10 poults that died within 10 days after hatching, prepare organ pools, yolk pools, and intestinal pools as follows:
(1)
(2)
(3)
(b) Transfer each pool to tetrathionate selective enrichment broth (Hajna or Mueller-Kauffmann) at a ratio of 1 part tissue pool to 10 parts broth.
(c) For cull chicks, repeat the steps in paragraphs (a) and (b) of this section for each 5-chick group until all 25 chicks have been examined, producing a total of 15 pools (5 organ, 5 yolk, and 5 intestinal). For poults, repeat the steps in paragraphs (a) and (b) of this section for each two-poult group until all the poults in the sample have been examined.
(d) Culture the tetrathionate pools as outlined for selective enrichment in illustration 2 of § 147.11. Incubate the organ and yolk pools for 24 hours at 37 °C and the intestinal pools at 41.5 °C. Plate as described in illustration 2 of § 147.11 and examine after both 24 and 48 hours of incubation. Confirm suspect colonies as described. Further culture all salmonella-negative tetrathionate broths by delayed secondary enrichment procedures described for environmental, organ, and intestinal samples in illustration 2 of § 147.11. A colony lift assay may also be utilized as a supplement to TSI and LI agar picks of suspect colonies.
To aid in the maintenance of healthy flocks, the following procedures should be practiced:
(a) Baby poultry should be started in a clean brooder house and maintained in constant isolation from older birds and other animals. Personnel that are in contact with older birds and other animals should take precautions, including disinfection of footwear and change of outer clothing, to prevent the introduction of infection through droppings that may adhere to the shoes, clothing, or hands. (See § 147.24(a).)
(b) Range used for growing young stock should not have been used for poultry the preceding year. Where broods of different ages must be kept on the same farm, there should be complete depopulation of brooder houses and other premises following infection of such premises by any contagious disease.
(c) Poultry houses should be screened and proofed against free-flying birds. An active rodent eradication campaign is an essential part of the general sanitation program. The area adjacent to the poultry house should be kept free from accumulated manure, rubbish, and unnecessary equipment. Dogs, cats, sheep, cattle, horses, and swine should never have access to poultry operations. Visitors should not be admitted to poultry areas, and authorized personnel should take the necessary precautions to prevent the introduction of disease.
(d) Poultry houses and equipment should be thoroughly cleaned and disinfected prior to use for a new lot of birds. (See § 147.24(a).) Feed and water containers should be situated where they cannot be contaminated by droppings and should be frequently cleaned and disinfected. Dropping boards or pits should be constructed so birds do not have access to the droppings.
(e) Replacement breeders shall be housed at the proper density consistent with the type of building and locality and which will allow the litter to be maintained in a dry condition. Frequent stirring of the litter may be necessary to reduce excess moisture and prevent surface accumulation of droppings. Slat or wire floors should be constructed so as to permit free passage of droppings and to prevent the birds from coming in contact with the droppings. Nesting areas should be kept clean and, where appropriate, filled with clean nesting material.
(f) When an outbreak of disease occurs in a flock, dead or sick birds should be taken, by private carrier, to a diagnostic laboratory for complete examination. All Salmonella cultures isolated should be typed serologically, and complete records maintained by the laboratory as to types recovered from each flock within an area. Records on isolations and serological types should be made available to Official State Agencies or other animal disease control regulatory agencies in the respective States for followup of foci of infection. Such information is necessary for the development of an effective Salmonella control program.
(g) Introduction of started or mature birds should be avoided to reduce the possible hazard of introducing infectious diseases. If birds are to be introduced, the health status of both the flock and introduced birds should be evaluated.
(h) In rearing broiler or replacement stock, a sound and adequate immunization program should be adopted. Since different geographic areas may require certain specific recommendations, the program recommended by the State experiment station or other State agencies should be followed.
(i) Feed, pelleted by heat process, should be fed to all age groups. Proper feed pelleting procedures can destroy many disease producing organisms contaminating feedstuffs.
Hatching eggs should be collected from the nests at frequent intervals and, to aid in the prevention of contamination with disease-causing organisms, the following practices should be observed:
(a) Cleaned and disinfected containers, such as egg flats, should be used in collecting the nest eggs for hatching. Egg handlers should thoroughly wash their hands with soap and
(b) Dirty eggs should not be used for hatching purposes and should be collected in a separate container from the nest eggs. Slightly soiled nest eggs may be gently dry cleaned by hand.
(c) Hatching eggs should be stored in a designated egg room under conditions that will minimize egg sweating. The egg room walls, ceiling, floor, door, heater, and humidifier should be cleaned and disinfected after every egg pickup. Cleaning and disinfection procedures should be as outlined in § 147.24.
(d) The egg processing area should be cleaned and disinfected daily.
(e) Effective rodent and insect control programs should be implemented.
(f) The egg processing building or area should be designed, located, and constructed of such materials as to assure that proper egg sanitation procedures can be carried out, and that the building itself can be easily, effectively, and routinely sanitized.
(g) All vehicles used for transporting eggs or chicks/poults should be cleaned and disinfected after use. Cleaning and disinfection procedures should be as outlined in § 147.24.
An effective program for the prevention and control of
(a) An effective hatchery sanitation program should be designed and implemented.
(b) The hatchery building should be arranged so that separate rooms are provided for each of the four operations: Egg receiving, incubation and hatching, chick/poult processing, and egg tray and hatching basket washing. Traffic and airflow patterns in the hatchery should be from clean areas to dirty areas (
(c) The hatchery rooms, and tables, racks, and other equipment in them should be thoroughly cleaned and disinfected frequently. All hatchery wastes and offal should be burned or otherwise properly disposed of, and the containers used to remove such materials should be cleaned and sanitized after each use.
(d) The hatching compartments of incubators, including the hatching trays, should be thoroughly cleaned and disinfected after each hatch.
(e) Only clean eggs should be used for hatching purposes.
(f) Only new or cleaned and disinfected egg cases should be used for transportation of hatching eggs. Soiled egg case fillers should be destroyed.
(g) Day-old chicks, poults, or other newly hatched poultry should be distributed in clean, new boxes and new chick papers. All crates and vehicles used for transporting birds should be cleaned and disinfected after each use.
The following procedures are recommended:
(a) In the poultry houses:
(1) Remove all live “escaped” and dead birds from the building. Blow dust from equipment and other exposed surfaces. Empty the residual feed from the feed system and feed pans and remove it from the building. Disassemble feeding equipment and dump and scrape as needed to remove any and all feed cake and residue. Clean up spilled feed around the tank and clean out the tank. Rinse down and wash out the inside of the feed tank to decontaminate the surfaces and allow to dry.
(2) Remove all litter and droppings to an isolated area where there is no opportunity for dissemination of any infectious disease organisms that may be present. Housing where poultry infected with a mycoplasmal disease were kept should remain closed for 7 days before removal of the litter.
(3) Wash down the entire inside surfaces of the building and all the installed equipment such as curtains, ventilation ducts and openings, fans, fan housings and shutters, feeding equipment, watering equipment, etc. Use high pressure and high volume water spray (for example 200 pounds per square inch and 10 gallons per minute or more) to soak into and remove the dirt to decontaminate the building. Scrub the walls, floors, and
(4) Spray with a disinfectant which is registered by the Environmental Protection Agency as germicidal, fungicidal, pseudomonocidal, and tuberculocidal, in accordance with the specifications for use, as shown on the label of such disinfectant.
(b) In the hatchers and hatchery rooms:
(1) Use cleaning agents and sanitizers that are registered by the U.S. Environmental Protection Agency as germicidal, fungicidal, pseudomonocidal, and tuberculocidal. Use manufacturer's recommended dilution. Remove loose organic debris by sweeping, scraping, vacuuming, brushing, or scrubbing, or by hosing surface with high pressure water (for example 200 pounds per square inch and 10 gallons per minute or more). Remove trays and all controls and fans for separate cleaning. Use hot water (minimum water temperature of 140 °F) for cleaning hatching trays and chick separator equipment. Thoroughly wet the ceiling, walls, and floors with a stream of water, then scrub with a hard bristle brush. Use a cleaner/sanitizer that can penetrate protein and fatty deposits. Allow the chemical to cling to treated surfaces at least 10 minutes before rinsing off. Manually scrub any remaining deposits of organic material until they are removed. Rinse until there is no longer any deposit on the walls, particularly near the fan opening, and apply disinfectant. Use a clean and sanitized squeegee to remove excess water, working down from ceilings to walls to floors and being careful not to recontaminate cleaned areas.
(2) Replace the cleaned fans and controls. Replace the trays, preferably still wet from cleaning, and bring the incubator to normal operating temperature.
(3) The hatcher should be fumigated (see § 147.25) or otherwise disinfected prior to the transfer of the eggs.
(4) If the same machine is used for incubating and hatching, the entire machine should be cleaned after each hatch. A vacuum cleaner should be used to remove dust and down from the egg trays; then the entire machine should be vacuumed, mopped, and fumigated (see § 147.25) or otherwise sanitized.
(c) The egg and chick/poult delivery truck drivers and helpers should use the following good biosecurity practices while picking up eggs or delivering chicks/poults:
(1) Spray truck tires thoroughly with disinfectant before leaving the main road and entering the farm driveway.
(2) Put on sturdy, disposable plastic boots or clean rubber boots before getting out of the truck cab. Put on a clean smock or coveralls and a hairnet before entering the poultry house.
(3) After loading eggs or unloading chicks/poults, remove the dirty smock/coveralls and place into plastic garbage bag before loading in the truck. Be sure to keep clean coveralls separate from dirty ones.
(4) Reenter the cab of the truck and remove boots before placing feet onto floorboards. Remove hairnet and leave with disposable boots on farm.
(5) Sanitize hands using appropriate hand sanitizer.
(6) Return to the hatchery or go to the next farm and repeat the process.
Fumigation may be used for sanitizing eggs and hatchery equipment or rooms as a part of a sanitation program. APHIS disclaims any liability in the use of formaldehyde for failure on the part of the user to adhere to the Occupational Safety and Health Administration (OSHA) standards for formaldehyde fumigation, published in the Dec. 4, 1987,
(a) The following procedures are required for participation under the U.S. Sanitation Monitored, U.S. M. Gallisepticum Clean, U.S. M. Synoviae Clean, U.S. S. Enteritidis Monitored, and U.S. S. Enteritidis Clean classifications:
(1) Allow no visitors except under controlled conditions to minimize the introduction of
(2) Maintain breeder flocks on farms free from market birds and other domesticated fowl. Follow proper isolation procedures as approved by the Official State Agency;
(3) Dispose of all dead birds by locally approved methods.
(b) Recommended procedures:
(1) Avoid the introduction of Salmonella, Mycoplasma gallisepticum, or Mycoplasma synoviae infected poultry;
(2) Prevent indirect transmission from outside sources through contaminated equipment, footwear, clothing, vehicles, or other mechanical means;
(3) Provide adequate isolation of breeder flocks to avoid airborne transmission from infected flocks;
(4) Minimize contact of breeder flocks with free-flying birds;
(5) Establish a rodent control program to keep the rodent population and other pests under control;
(6) Tailor vaccination programs to needs of farm and area;
(7) Clean and disinfect equipment after each use;
(8) Provide clean footwear and provide an adequate security program;
(9) Clean and disinfect houses before introducing a new flock;
(10) Use clean, dry litter free of mold;
(11) Keep accurate records of death losses;
(12) Seek services of veterinary diagnostician if unaccountable mortality or signs of disease occur;
(13) Adopt and maintain a clean-egg program.
(14) Use only crates and vehicles that have been cleaned and disinfected in accordance with the provisions of § 147.24(a) to haul live poultry to and from the premises.
(a) The vehicle transporting the insemination crew should be left as far as practical from the turkey pens.
(b) The personnel of the insemination crew should observe personal cleanliness, including the following sanitary procedures:
(1) Outer clothing should be changed between visits to different premises so that clean clothing is worn upon entering each premises. The used apparel should be kept separate until laundered. This also applies to gloves worn while handling turkeys;
(2) Boots or footwear should be cleaned and disinfected between visits to different premises;
(3) Disposable caps should be provided and discarded after use on each premises.
(c) The use of individual straw or similar technique is highly recommended. Insemination equipment which is to be reused should be cleaned and disinfected before reusing. Equipment used for the convenience of the workers should not be moved from premises to premises.
(d) No obviously diseased flock should be inseminated. If evidence of active disease is noted after insemination is begun, operations should be stopped and the hatchery notified.
(e) Care should be taken during the collection of semen to prevent fecal contamination. If fecal material is present, it should be removed before the semen is collected. Likewise, care should be taken not to introduce fecal material into the oviduct of the hen.
(a)
(b)
(2)
(c)
(i) 5 μl 10x PCR buffer, 1 μl dNTP (10 mM), 1 μl of Reverse primer (50 μM), 1 μl of Forward primer (50 μM), 4 μl MgCl
(ii) 18 μl water, 25 μl PCR mix (Promega), 1 μl Reverse primer (50 μM), 1 μl Forward primer (50 μM).
(2) Perform DNA amplification in a Perkin-Elmer 9600 thermocycler or in a Hybaid PCR Express thermocycler.
(d)
Except where the context otherwise requires, for the purposes of this subpart the following terms shall be construed, respectively, to mean:
Changes in this subchapter shall be made in accordance with the procedure described in this subpart:
(a) The General Conference Committee Chairperson and the Vice Chairperson shall be elected by the members of the General Conference Committee. A representative of the Animal and Plant Health Inspection Service will serve as Executive Secretary and will provide the necessary staff support for the General Conference Committee. The General Conference Committee shall consist of one member-at-large who is a participant in the National Poultry Improvement Plan and one member to be elected, as provided in paragraph (b) of this section, from each of the following regions:
(1) North Atlantic: Maine, New Hampshire, Vermont, Massachusetts, Rhode Island, Connecticut, New York, New Jersey, and Pennsylvania.
(2) East North Central: Ohio, Indiana, Illinois, Michigan, and Wisconsin.
(3) West North Central: Minnesota, Iowa, Missouri, North Dakota, South Dakota, Nebraska, and Kansas.
(4) South Atlantic: Delaware, District of Columbia, Maryland, Virginia, West Virginia, North Carolina, South Carolina, Georgia, Florida, and Puerto Rico.
(5) South Central: Kentucky, Tennessee, Alabama, Mississippi, Arkansas, Louisiana, Oklahoma, and Texas.
(6) Western: Montana, Idaho, Wyoming, Colorado, New Mexico, Arizona, Utah, Nevada, Washington, Oregon, California, Alaska, and Hawaii.
(b) The regional committee members and their alternates will be elected by the official delegates of their respective regions, and the member-at-large will be elected by all official delegates. There must be at least two nominees for each position, the voting will be by secret ballot, and the results will be recorded. At least one nominee from each region must be from an underrepresented group (minorities, women, or persons with disabilities). The process for soliciting nominations for regional committee members will include, but
(c) Three regional members shall be elected at each Plan Conference. All members shall serve for a period of 4 years, subject to the continuation of the Committee by the Secretary of Agriculture, and may not succeed themselves:
(d) The duties and functions of the General Conference Committee shall be as follows:
(1) Advise and make recommendations to the Department on the relative importance of maintaining, at all times, adequate departmental funding for the NPIP to enable the Senior Coordinator and staff to fully administer the provisions of the Plan.
(2) Advise and make yearly recommendations to the Department with respect to the NPIP budget well in advance of the start of the budgetary process.
(3) Assist the Department in planning, organizing, and conducting the biennial National Poultry Improvement Plan Conference.
(4) Recommended whether new proposals (
(5) During the interim between Plan Conferences, represent the cooperating States in:
(i) Advising the Department with respect to administrative procedures and interpretations of the Plan provisions as contained in 9 CFR.
(ii) Assisting the Department in evaluating comments received from interested persons concerning proposed amendments to the Plan provisions.
(iii) Recommending to the Secretary of Agriculture any changes in the provisions of the Plan as may be necessitated by unforeseen conditions when postponement until the next Plan Conference would seriously impair the operation of the program. Such recommendations shall remain in effect only until confirmed or rejected by the next Plan Conference, or until rescinded by the committee.
(6) Serve as a forum for the study of problems relating to poultry health and as the need arises, to make specific recommendations to the Secretary of Agriculture concerning ways in which the Department may assist the industry in solving these problems.
(7) Serve as a direct liaison between the NPIP and the United States Animal Health Association.
(8) Advise and make recommendations to the Department regarding NPIP involvement or representation at poultry industry functions and activities as deemed necessary or advisable for the purposes of the NPIP.
(a) Changes in this subchapter may be proposed by any participant, Official State Agency, the Department, or other interested person or industry organization.
(b) Except as provided in § 147.43(d)(2), proposed changes shall be submitted in writing so as to reach the Service not later than 150 days prior to the opening
(c) The name of the proponent shall be indicated on each proposed change when submitted. Each proposal should be accompanied by a brief supporting statement.
(d) The Service will notify all persons on the NPIP mailing lists concerning the dates and general procedure of the conference. Hatchery and dealer participants will be reminded of their privilege to submit proposed changes and to request copies of all the published proposed changes.
(e) The proposed changes, together with the names of the proponents and supporting statements, will be compiled by the Service and issued in processed form. When two or more similar changes are submitted, the Service will endeavor to unify them into one proposal acceptable to each proponent. Copies will be distributed to officials of the Official State Agencies cooperating in the NPIP. Additional copies will be made available for meeting individual requests.
Each cooperating State shall be entitled to one official delegate for each of the programs prescribed in subparts B, C, D, E, and F of part 145 of this chapter and for each of the programs prescribed in subparts B, C, and D of part 146 of this chapter in which it has one or more participants at the time of the Conference. The official delegates shall be elected by a representative group of participating industry members and be certified by the Official State Agency. It is recommended but not required that the official delegates be Plan participants. Each official delegate shall endeavor to obtain, prior to the Conference, the recommendations of industry members of his State with respect to each proposed change.
(a) The following committees shall be established to give preliminary consideration to the proposed changes falling in their respective fields:
(1) Egg-type breeding chickens.
(2) Meat-type breeding chickens.
(3) Breeding turkeys.
(4) Breeding waterfowl, exhibition poultry, and game birds.
(5) Breeding ostriches, emus, rheas, and cassowaries.
(6) Egg-type commercial chickens.
(7) Meat-type commercial chickens.
(8) Meat-type commercial turkeys.
(b) Each official delegate shall be appointed a voting member in one of the committees specified in paragraph (a) of this section.
(c) Since several of the proposals may be interrelated, the committees shall consider them as they may relate to others, and feel free to discuss related proposals with other committees.
(d) The committees shall make recommendations to the conference as a whole concerning each proposal. The committee report shall show any proposed change in wording and the record of the vote on each proposal, and suggest an effective date for each proposal recommended for adoption. The individual committee reports shall be submitted to the chairman of the conference, who will combine them into one report showing, in numerical sequence, the committee recommendations on each proposal.
(e) The committee meetings shall be open to any interested person. Advocates for or against any proposal should feel free to appear before the appropriate committee and present their views.
(a) The chairman of the conference shall be a representative of the Department.
(b) At the time designated for voting on proposed changes by the official delegates, the chairman of the General Conference Committee and the four
(c) Each committee chairman shall present the proposals which his committee approves or recommends for adoption as follows: “Mr. Chairman. The committee for Egg-type chickens recommends the adoption of Proposal No. ___, for the following reasons (stating the reasons): I move the adoption of Proposal No. ___.” A second will then be called for. If the recommendation is seconded, discussion and a formal vote will follow.
(d) Each committee chairman shall present the proposals which his committee does not approve as follows: “Mr. Chairman. The Committee for Egg-type chickens does not approve Proposal No. ___.” The chairman will then ask if any official delegate wishes to move for the adoption of the proposal. If moved and seconded, the proposal is subject to discussion and voted. If there is no motion for approval, or if moved but not seconded, there can be no discussion or vote.
(e) Discussion on any motion must be withheld until the motion has been properly seconded, except that the delegate making the motion is privileged, if he desires, to give reasons for his motion at the time of making it. To gain the floor for a motion or for discussion on a motion, the official delegate in the case of a motion, or anyone in case of discussion on a motion, shall rise, address the chair, give his name and State, and be recognized by the chair before proceeding further. While it is proper to accept motions only from official delegates and to limit voting only to such delegates, it is, however, equally proper to accept discussion from anyone interested. To conserve time, discussion should be pointed and limited to the pertinent features of the motion.
(f) Proposals that have not been submitted in accordance with § 147.44 will be considered by the conference only with the unanimous consent of the General Conference Committee. Any such proposals must be referred to the appropriate committee for consideration before being presented for action by the conference.
(g) Voting will be by States, and each official delegate, as determined by § 147.45, will be allowed one vote on each proposal pertaining to the program prescribed by the subpart which he represents.
(h) A roll call of States for a recorded vote will be used when requested by a delegate or at the discretion of the chairman.
(i) All motions on proposed changes shall be for adoption.
(j) Proposed changes shall be adopted by a majority vote of the official delegates present and voting.
(k) The conference shall be open to any interested person.
Proposals adopted by the official delegates will be recommended to the Department for incorporation into the provisions of the NPIP. The Department reserves the right to approve or disapprove the recommendations of the conference as an integral part of its sponsorship of the National Poultry Improvement Plan.
19 U.S.C. 1202; 7 CFR 2.22, 2.80, and 371.4.
Words used in this part in the singular form shall be deemed to import the plural, and vice versa, as the case may demand. As used in this part, the following words, names, or terms shall have the meanings set forth in this section, unless otherwise clearly indicated by the context.
(a)
The Administrator will issue a certificate of pure breeding for an animal claimed to be entitled to free entry under the act provided the requirements of the regulations in this part are complied with. Such certificate will be presented to the owner, agent, or importer who in turn shall present it to the collector of customs at the port where customs entry is made.
An application for a certificate of pure breeding executed by the owner, agent, or importer of an animal shall be made on ANH Form 17-338 (available from the collector of customs) before the animal will be examined as provided in § 151.7. Such application shall be made to the inspector at the port of entry for all animals:
A pedigree certificate for an animal of a breed listed in § 151.9 issued by the custodian of the appropriate book of record listed in said section and on which there has been entered in accordance with the rules of entry of the registry association, a complete record of transfers of ownership from the breeder to and including the United States importer, or a complete record of transfers of ownership from the breeder to and including the person who owns the animal when it is imported into the United States and the name of the United States importer (for example, a lessee), shall be furnished by the owner, agent, or importer to the inspector at the time of the examination of the animal as provided in § 151.7. The inspector will return the document to the party who submitted it. A verbatim translation of the description relating to color and markings shall appear in English in the pedigree certificate for the animal or in a separate certificate appended to the pedigree certificate.
No pedigree certificate which in the opinion of the Administrator has been substantially altered will be accepted.
The owner, agent, or importer who applies for a certificate of pure breeding for any animal offered for duty-free entry under this part, shall execute on ANH Form 17-338 a statement that the animal so offered for entry is the animal described in the pedigree certificate furnished to the inspector as prescribed in § 151.4. This form shall be presented to the inspector before the animal and pedigree certificate are examined as provided in § 151.7.
(a) For the purpose of determining identity, an examination shall be made by an inspector of each animal for which free entry is claimed under the act. All animals shall be examined at the port of entry:
(b) The owner, agent, or importer shall provide adequate assistance and facilities for restraining and otherwise handling the animal and present it in such manner and under such conditions as in the opinion of the inspector will make a proper examination possible. Otherwise, the examination of the animal will be refused or postponed by the inspector until the owner, agent, or importer meets these requirements.
(c) A pedigree certificate, as required by § 151.4 shall be presented at the time of examination to the inspector making the examination in order that proper identification of the animal may be made. When upon such examination of any animal, the color, markings, or other identifying characteristics do not conform with the description given in the pedigree certificate and the owner, agent, or importer desires to pursue the matter further, the inspector shall issue ANH Form 17-419 to the owner, agent, or importer, and shall forward the pedigree certificate for this animal, together with ANH Form 17-419, to the Washington office of APHIS by certified mail. A determination will be made by such office as to the identity of the animal in question and the eligibility of the animal for certification under § 151.2. The pedigree certificate will be returned to the party who submitted it as soon as such determination is made. Removal of an animal from the port where examination is made prior to presentation of the pedigree certificate or other failure to comply with the requirements of this paragraph shall constitute a waiver of any further claim to certification under the regulations in this part.
To be eligible for certification under the act, an animal must be purebred of a recognized breed and have been registered in good faith in a book of record listed in § 151.9 and must not have been registered on inspection without regard to purity of breeding.
Breeds of animals and books of record listed in paragraphs (a) and (b) are hereby recognized. Recognition of such breeds and books of record will be continued, however, only if the books of record involved are kept by the custodians thereof in a form which is reasonably current and the book otherwise meets the requirements of this part, in the opinion of the Administrator. When a registry association which publishes a book of record that was recognized in printed form ceases to publish the book in such form and in lieu thereof publishes the book in microfilm form, the recognition of such book of record will be continued only if the book meets the requirements of this part. A copy of each printed volume and microfilm record of a book of record published after the book is recognized under this part shall be sent to APHIS immediately following such publication. All books of record sent to the Animal and Plant Health Inspection Service, United States Department of Agriculture, shall be submitted through the Veterinary Services, Operational Support, 4700 River Road, Unit 33, Riverdale, Maryland 20737-1231.
(a)
(b)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
For
Before a breed or a book of record shall be added to those listed in this part, the custodian of the book of record involved shall submit to APHIS a complete copy of the book of record, consisting of any published printed volumes and any microfilm records issued by the registry association up to date of application, together with a copy of all rules and forms in force on said date
(a) If a registry association has not published its book of record in printed form, a record in approved microfilm form which the Administrator finds provides a system for determining the recorded ancestry of the animals identified therein will be acceptable. When a registry association which has published its book of record in printed form ceases such publication and in lieu thereof publishes a microfilm record, the microfilm record shall commence with the first pedigree recorded by the association which is not in the printed volumes and shall otherwise be in approved form.
(b) A microfilm record will be approved under this part only if it is 16 mm. non-perforated safety film exposed at a reduction ratio not to exceed 24 diameters. All information on the original document shall be reproduced onto the microfilm so that it is clearly readable. The microfilm carton shall be indexed to state the numbers of the pedigree certificates on the roll of film it contains.
7 U.S.C. 1622 and 1624; 21 U.S.C. 136a; 7 CFR 2.22, 2.80, and 371.4.
Words used in this part in the singular form shall import the plural, and vice versa, as the case may demand.
For the purposes of this part, unless the context otherwise requires, the following terms shall be construed, respectively, to mean:
At 72 FR 70766, Dec. 13, 2007, § 156.2 was amended by removing the definition of
Laws, regulations or other requirements of foreign countries and specifications of contracts for the purchase and sale of animal products, on occasion require vendors of such products to furnish official certificates concerning the class, quality, quantity, or condition of such products to be imported into such countries or to be delivered under the contracts. The service under this part, shall consist of the inspection of the processing, handling, and storage of the products at any plant at which service is furnished and the certification, on the basis of such requirements of foreign countries or such contract specifications, of the class, quality, quantity, or condition of such of the products as are found to conform to such requirements or specifications as the case may be. Processing procedures will be actually supervised. The operator of the plant shall fully inform the inspector with respect to, and the inspector shall actually observe, the processing procedures, handling, and storage of the products intended for certification. The inspector shall keep such records of the temperatures reached, the duration of time the temperatures are maintained, and the pounds of pressure
Any person who is eligible under a cooperative agreement to receive service under this part may apply therefor to the Administrator, upon an application form which will be furnished by the Administrator upon request. The application form shall require the applicant to state, among other things, the forms of certificates desired.
At 72 FR 70766, Dec. 13, 2007, § 156.4 was amended by removing the words “under a cooperative agreement”, effective Jan. 14, 2008.
Subject to § 156.8, service under this part will be furnished, upon application, within the limits of available Department personnel and facilities, at any plant the operator of which applies for or endorses the application for the service if the Administrator finds that: the forms of certificates desired by the applicant require the certification of class, quality, quantity, or condition; the plant and its methods of processing, handling and storage of the products intended for certification are adequate to warrant the issuance of the desired certificates; service is to be furnished under a cooperative agreement; and the requirements of § 156.7 are met.
At 72 FR 70766, Dec. 13, 2007, § 156.5 was amended by removing the words “service is to be furnished under a cooperative agreement;” and adding the words “the requirements of part 130 of this title are met;” in their place, effective Jan. 14, 2008.
The inspector shall sign and issue certificates in forms approved by the Administrator for animal products, if the inspector finds that the requirements as stated in the certification have been met. The original and one copy of each certificate shall be furnished to the applicant, and one copy of each certificate shall be retained by the Department until disposal is authorized in accordance with law. Additional copies may be furnished the applicant at his request upon payment of the fees prescribed in § 156.7. Copies of the certificates may be furnished without charge to other properly interested Federal agencies or under compulsory process.
Fees and charges, and user fees under 9 CFR part 130, for service (including travel and other expenses incurred in connection with the furnishing of service) under this part shall be paid by the applicant in accordance with the terms of the cooperative agreement under which service is furnished and in accordance with this section which shall be deemed to be incorporated in such agreement. If required by the Administrator, the fees and charges, and user fees under 9 CFR part 130, shall be paid in advance. Since the fees and charges, and user fees under 9 CFR part 130, are for the purpose of reimbursing the Department for all costs incurred in connection with the furnishing of service under this part, the appropriate fees and charges, and user fees under 9 CFR part 130, to cover any such costs shall be paid even though service is withheld pursuant to § 156.8.
At 72 FR 70766, Dec. 13, 2007, § 156.7 was revised, effective Jan. 14, 2008. For the convenience of the user, the revised text is set forth as follows:
User fees under part 130 of this chapter for service (including travel and other expenses incurred in connection with the furnishing of
(a) Service under this part will be refused if the conditions stated in §§ 156.5 and 156.6 are not met.
(b) Service under this part may be withdrawn from, or denied to, any applicant by the Administrator, for such period as the Administrator may prescribe, when the Administrator is satisfied, after opportunity for hearing before a proper official has been accorded the applicant, that the applicant or other operator of the plant where service has been or would be furnished under the application, or the agent or employee of such applicant or operator within the scope of his employment, has persistently failed to give the inspector full and correct information with respect to the processing procedures, handling, and storage of animal products intended for certification or certified; or has given to any employee of the Department false information in connection with service under this part; or has altered or imitated any certificate, mark, or device provided for under this part; or has used any such certificate, mark, or device without authority from the Administrator, or any imitation of any such certificate, mark, or device, on or with respect to any animal products; or has knowingly and without promptly notifying the Administrator retained possession of any such device or imitation thereof or altered or imitation certificate or of any animal products marked with any such device without authority from the Administrator or marked with any imitation of such device; or has given or attempted to give, for any purpose whatsoever, any money, favor, or other thing of value, to any employee of the Department authorized to perform any function under this part; or has interfered with or obstructed, or attempted to interfere with or to obstruct, any employee of the Department in or with respect to the performance of his duties under this part by intimidation, threats, assaults, or any other improper means. The inspector assigned to any plant may suspend service at such plant for any of the reasons set forth in this paragraph, without hearing, and in that event shall report his actions to the Administrator, and the Administrator may continue such suspension or otherwise deny or suspend service at any plant for any of such reasons, without hearing, pending final disposal of the matter under this paragraph.
(c) All final orders in any proceeding to deny or withdraw the service for any of the reasons set forth in paragraph (b) of this section (except orders required for good cause to be held confidential and not cited as precedents) shall be filed with the Hearing Clerk of the Department and be available to public inspection.
7 U.S.C. 8301-8317; 15 U.S.C. 1828; 7 CFR 2.22, 2.80, and 371.4.
For the purposes of this subchapter the following words, phrases, names and terms shall be construed, respectively, to mean:
(1) Someone other than the accredited veterinarian has signed it on behalf of or in the name of the accredited veterinarian, regardless of the authority granted them by the accredited veterinarian; or
(2) If any mechanical device, other than an approved digital signature, has been used to affix the signature.
7 U.S.C. 8301-8317; 15 U.S.C. 1828; 7 CFR 2.22, 2.80, and 371.4.
(a) This subchapter concerns a program administered by APHIS to accredit veterinarians and thereby authorize them to perform, on behalf of APHIS, certain activities specified in this chapter. This program is intended to ensure that an adequate number of qualified veterinarians are available in the United States to perform such activities.
(b) If an accredited veterinarian wishes to perform accredited duties in a State other than the State for which the veterinarian has completed an orientation in accordance with § 161.2(a)(4), the accredited veterinarian shall so inform the Veterinarian-in-Charge of the new State. The Veterinarian-in-Charge of the new State may require the accredited veterinarian to complete, prior to performing any accredited duties in the new State, an orientation in animal health procedures and issues relevant to the new State. The Veterinarian-in-Charge shall review the content of each such orientation and shall approve its use after determining that it includes adequate information about animal health agencies, regulatory requirements, administrative procedures, and animal disease problems in the new State, to prepare an accredited veterinarian from another State to perform accredited duties in the new State. The Veterinarian-in-Charge shall also give the State Animal Health Official of the new State an opportunity to review the contents of the orientation, and invite him or her to participate in developing orientation materials and conducting the orientation.
(c) An accredited veterinarian may not perform accredited duties in a State in which the accredited veterinarian is not licensed or legally able to practice veterinary medicine.
(a)
(1) Completed Forms 1-36A received by a Veterinarian-in-Charge shall be reviewed by the State Animal Health Official for the State in which the veterinarian wishes to perform accredited duties. Within 14 days after receiving an application, a State Animal Health Official shall either endorse the application or send a written statement to the Administrator explaining why it was not endorsed; but if the State Animal Health Official fails to take one of these actions within 14 days, the Veterinarian-in-Charge shall proceed to review the application. The Administrator will review the application and the written statement, if any, and determine whether the applicant meets the requirements for accreditation contained in this part.
(2) The Administrator is hereby authorized to accredit a veterinarian when he or she determines that:
(i) The veterinarian is a graduate with a Doctorate of Veterinary Medicine or an equivalent degree (any degree that qualifies the holder to be licensed by a State to practice veterinary medicine) from a college of veterinary medicine;
(ii) The veterinarian is licensed or legally able to practice veterinary medicine in the State in which the veterinarian wishes to perform accredited duties. APHIS will confirm licensing status of the applicant by contacting the State board of veterinary medical examiners or any similar State organization that maintains records of veterinarians licensed in a State; and,
(iii) The veterinarian has completed an orientation program approved by the Veterinarian-in-Charge for the State in which the veterinarian wishes to practice, and upon completion of the orientation, has signed a written statement listing the date and place of orientation, the subjects covered in the orientation, and any written materials provided to the veterinarian at the orientation. The Veterinarian-in-Charge shall also give the State Animal Health Official an opportunity to review the contents of the orientation, and invite him or her to participate in developing orientation materials and conducting the orientation. The orientation program shall include the following topics:
(A) Federal animal health laws, regulations, and rules;
(B) Interstate movement requirements for animals;
(C) Import and export requirements for animals;
(D) USDA animal disease eradication and control programs;
(E) Laboratory support in confirming disease diagnoses;
(F) Ethical/Professional responsibilities of an accredited veterinarian; and,
(G) Animal health procedures, issues, and information resources relevant to the State in which the veterinarian wishes to perform accredited duties.
(b)
(1) Completed Forms 1-36A received by a Veterinarian-in-Charge shall be reviewed by the State Animal Health Official for the State in which the veterinarian wishes to perform accredited duties. Within 14 days after receiving an application, a State Animal Health Official shall either endorse the application or send a written statement to the Administrator explaining why it was not endorsed; but if the State Animal Health Official fails to take one of these actions within 14 days, the Veterinarian-in-Charge shall proceed to review the application. The Administrator will review the application and the written statement, if any, and determine whether the applicant meets the requirements for reaccreditation contained in this part.
(2) The Administrator is hereby authorized to reaccredit a veterinarian when he or she determines that:
(i) The veterinarian is licensed or legally able to practice veterinary medicine in the State in which the veterinarian wishes to perform accredited duties;
(ii) The veterinarian has completed a reaccreditation orientation program approved by the Veterinarian-in-Charge for the State in which the veterinarian wishes to practice, and upon completion of the orientation, has signed a written statement listing the date and place of orientation, the subjects covered in the orientation, and any written materials provided to the veterinarian at the orientation. The Veterinarian-in-Charge shall also give the State Animal Health Official an opportunity to review the contents of the reaccreditation orientation, and invite him or her to participate in developing orientation materials and conducting the orientation. The orientation program shall include topics addressing the subject areas which led to loss of accreditation for the applicant, and subject areas which have changed since the applicant lost accreditation; and,
(iii) The professional integrity and reputation of the applicant support a conclusion that the applicant will
(A) Criminal conviction records adversely reflecting on the honesty or integrity of the applicant with regard to the performance or nonperformance of veterinary medical duties;
(B) Official records of the applicant's actions participating in Federal, State, or local veterinary programs;
(C) Judicial determinations in civil litigation adversely reflecting on the integrity of the applicant; and
(D) Any other evidence reflecting on the professional integrity and reputation of the applicant.
(c)
(d)
(1) Perform physical examinations of individual animals, and visually inspect herds or flocks, to determine whether the animals are free from any clinical signs suggestive of communicable disease;
(2) Recognize the common breeds of livestock so as to be able to record breed information on official documents;
(3) Recognize brucellosis tattoos and calfhood vaccination tags, and determine the state of origin of eartags, to properly identify animals in interstate commerce;
(4) Estimate the age of livestock using a dental formula;
(5) Apply an eartag, tattoo, backtag, and legband;
(6) Certify the disease status of a poultry flock with regard to disease caused by
(7) Properly complete certificates for domestic and international movement of animals;
(8) Apply and remove official seals;
(9) Perform a necropsy on livestock;
(10) Recognize clinical signs and lesions of exotic animal diseases;
(11) Plan a disease control strategy for a livestock unit;
(12) Vaccinate for brucellosis and fill out the vaccination certificate;
(13) Draw and ship blood for testing;
(14) Perform a caudal fold test for tuberculosis;
(15) Develop appropriate cleaning and disinfection plans to control communicable livestock disease spread; and
(16) Explain basic principles for control of diseases for which APHIS or APHIS-State cooperative programs exist, such as brucellosis, pseudorabies, and tuberculosis.
An accredited veterinarian shall perform the functions of an accredited veterinarian only in a State in which the accredited veterinarian is licensed or legally able to practice veterinary medicine. An accredited veterinarian shall perform the functions of an accredited veterinarian and carry out all responsibilities under applicable Federal programs and cooperative programs subject to direction provided by the Veterinarian-in-Charge and in accordance with any regulations and instructions issued to the accredited veterinarian by the Veterinarian-in-Charge, and shall observe the following specific standards:
(a) An accredited veterinarian shall not issue a certificate, form, record or report which reflects the results of any
(1) Following the first two inspections of a herd or flock as part of a regular health maintenance program, an accredited veterinarian shall not issue a certificate, form, record or report which reflects the results of any inspection, test, vaccination or treatment performed by him or her with respect to any animal in that program, unless he or she has personally inspected that animal within 10 days prior to issuance.
(2) Following the third and subsequent inspections of a herd or flock in a regular health maintenance program, an accredited veterinarian shall not issue a certificate, form, record or report which reflects the results of any inspection, test, vaccination or treatment performed by him or her with respect to any animal in that program, unless he or she has personally inspected that animal within 30 days prior to issuance.
(b) An accredited veterinarian shall not issue, or allow to be used, any certificate, form, record or report, until, and unless, it has been accurately and fully completed, clearly identifying the animals to which it applies, and showing the dates and results of any inspection, test, vaccination, or treatment the accredited veterinarian has conducted, except as provided in paragraph (c) of this section, and the dates of issuance and expiration of the document. Certificates, forms, records, and reports shall be valid for 30 days following the date of inspection of the animal identified on the document, except that origin health certificates may be valid for a longer period of time as provided in § 91.3(a) of this chapter. The accredited veterinarian must distribute copies of certificates, forms, records, and reports according to instructions issued to him or her by the Veterinarian-in-Charge.
(c) An accredited veterinarian shall not issue any certificate, form, record, or report which reflects the results of any inspection, test, vaccination, or treatment performed by another accredited veterinarian, unless:
(1) The signing accredited veterinarian has exercised reasonable care, that is, a standard of care that a reasonably prudent person would use under the circumstances in the course of performing professional duties, to determine that the certificate, form, or report is accurate;
(2) The certificate, form, or report indicates that the inspection, test, vaccination, or treatment was performed by the other accredited veterinarian; identifies the other accredited veterinarian by name; and includes the date and the place where such inspection, test, or vaccination was performed; and,
(3) For a certificate, form, or report indicating results of a laboratory test, the signing accredited veterinarian shall keep a copy of the certificate, form, or report and shall attach to it either a copy of the test results issued by the laboratory, or a written record (including date and participants' names) of a conversation between the signing accredited veterinarian and the laboratory confirming the test results.
(d) An accredited veterinarian shall perform official tests, inspections, treatments, and vaccinations and shall submit specimens to designated laboratories in accordance with Federal and State regulations and instructions issued to the accredited veterinarian by the Veterinarian-in-Charge.
(e) An accredited veterinarian shall identify or be physically present to supervise the identification of reactor animals by tagging or such other method as may be prescribed in instructions issued to him or her by the Veterinarian-in-Charge or by a State Animal
(f) An accredited veterinarian shall immediately report to the Veterinarian-in-Charge and the State Animal Health Official all diagnosed or suspected cases of a communicable animal disease for which a APHIS has a control or eradication program in 9 CFR chapter I, and all diagnosed or suspected cases of any animal disease not known to exist in the United States as provided by § 71.3(b) of this chapter.
(g) While performing accredited work, an accredited veterinarian shall take such measures of sanitation as are necessary to prevent the spread of communicable diseases of animals by the accredited veterinarian.
(h) An accredited veterinarian shall keep himself or herself currently informed on Federal and State regulations that are provided to him or her by the Veterinarian-in-Charge, or by a State official through the Veterinarian-in-Charge, governing the movement of animals, and on procedures applicable to disease control and eradication programs, including emergency programs.
(i) An accredited veterinarian shall not use or dispense in any manner, any pharmaceutical, chemical, vaccine or serum, or other biological product authorized for use under any Federal regulation or cooperative disease eradication program, in contravention of applicable Federal or State statutes, regulations, and policies.
(j) An accredited veterinarian shall be responsible for the security and proper use of all official certificates, forms, records, and reports; tags, bands, or other identification devices; and approved digital signature capabilities used in his or her work as an accredited veterinarian and shall take reasonable care to prevent the misuse thereof. An accredited veterinarian shall immediately report to the Veterinarian-in-Charge the loss, theft, or deliberate or accidental misuse of any such certificate, form, record, or report; tag, band, or other identification device; or approved digital signature capability.
(k) An accredited veterinarian may issue an origin health certificate for export use pursuant to part 91 of this chapter without including test results from a laboratory, if the Veterinarian-in-Charge has determined that such action is necessary to save time in order to meet an exportation schedule and agrees to add the test results to the certificate at a later time. In such cases, the accredited veterinarian shall state on a removable attachment to the certificate that such test results are to be added by the Veterinarian-in-Charge.
(a) The Administrator is authorized to suspend for a given period of time, or to revoke, the accreditation of a veterinarian when he or she determines that the accredited veterinarian has not complied with the “Standards for Accredited Veterinarian Duties” as set forth in § 161.3 of this part, or, in lieu thereof, to issue a written notice of warning to the accredited veterinarian when the Administrator determines a notice of warning will be adequate to attain compliance with the Standards.
(b) Accreditation shall be automatically terminated when an accredited veterinarian is not licensed or legally able to practice veterinary medicine in at least one State.
(c) Accreditation shall be automatically revoked when an accredited veterinarian is convicted of a crime in either State or Federal court, if such conviction is based on the performance or nonperformance of any act required of the veterinarian in his or her capacity as an accredited veterinarian.
(d) Any accredited veterinarian who knowingly issues or signs a false, incorrect, or mislabeled animal health or inspection certificate, blood sample, official brucellosis vaccination certificate, or official tuberculin test certificate in accordance with this chapter, shall be subject to such civil penalties and such criminal liabilities as are provided by 7 U.S.C. 8313, 18 U.S.C. 1001, or other applicable Federal statutes. Such action may be in addition to, or in lieu
7 U.S.C. 8301-8317; 15 U.S.C. 1828; 7 CFR 2.22, 2.80, and 371.4.
The Uniform Rules of Practice for the Department of Agriculture promulgated in subpart H of part 1, subtitle A, title 7, Code of Federal Regulations, are the Rules of Practice applicable to adjudicatory, administrative proceedings for the revocation or suspension of accreditation of veterinarians (9 CFR parts 160 and 161). In addition, the Supplemental Rules of Practice set forth in subpart B of this part shall be applicable to such proceedings.
In any situation where the Administrator has reason to believe that any veterinarian accredited under the provisions of 9 CFR parts 160 and 161 of this subchapter has not complied with the “Standards for Accredited Veterinarian Duties” set forth in § 161.3 of this subchapter, and deems such action necessary in order to prevent the introduction into the United States or the spread from one State to another of a contagious, infectious, or communicable disease of animals, or to insure that animals intended or offered for export to foreign countries are free from disease, the Administrator may suspend the accreditation of such veterinarian pending final determination in the proceeding, effective upon oral or written notification, whichever is earlier. In the event of oral notification, a written confirmation thereof shall be given to such veterinarian pursuant to § 1.147(b) of the Uniform Rules of Practice (7 CFR 1.147(b)) as promptly as circumstances permit. Such suspension shall have no relevance with respect to the final determination in the proceeding.
The Veterinarian-in-Charge shall notify an accredited veterinarian when there is reason to believe that the accredited veterinarian has not complied with the “Standards for Accredited Veterinarian Duties” as contained in § 161.3 of this subchapter. The notification shall be in writing, with a copy to the State Animal Health Official, and shall include a statement of the basis for the belief that the accredited veterinarian has failed to comply with the Standards and shall notify the accredited veterinarian if the Veterinarian-in-Charge has arranged to hold an informal conference to discuss the matter.
(a) The Veterinarian-in-Charge, in consultation with the State Animal Health Official and the accredited veterinarian, shall designate the time and place for the holding of an informal conference to review the matter, unless the Veterinarian-in-Charge determines that an informal conference is inappropriate. An informal conference is inappropriate only if the Veterinarian-in-Charge decides to dismiss the case based on available facts, or if civil or criminal charges based on the actions or inactions believed to be in violation of the “Standards for Accredited Veterinarian Duties” contained in § 161.3 of this subchapter are pending against the
(b) Prior to, during, or at the conclusion of the informal conference, the Veterinarian-in-Charge may issue a written warning to the accredited veterinarian without further procedure after determining that a warning with appropriate instructions will be adequate to attain compliance with the Standards.
(c) If prior to, during, or at the conclusion of, the informal conference, the accredited veterinarian consents, in writing, to the issuance of an order revoking or suspending his or her accreditation for a specified period of time, in lieu of further procedure, the Veterinarian-in-Charge may issue such a consent order without further procedure.
(d) If prior to, during, or after the informal conference, but prior to the issuance of a formal complaint, the accredited veterinarian is found not to have violated the regulations, the Veterinarian-in-Charge will issue a letter dismissing the case, and provide a copy of the letter to the accredited veterinarian and to the State Animal Health Official. Prior to, during, or after the informal conference, the Veterinarian-in-Charge may issue a letter identifying actions of the accredited veterinarian that were minor violations of the Standards, instructing the accredited veterinarian in proper procedures, and admonishing the accredited veterinarian to use greater care in performing these procedures in the future.
If a consent order has not been issued, or if, after an informal conference, the Veterinarian-in-Charge has not issued a letter of dismissal or letter of warning to the accredited veterinarian, a formal complaint may be issued by the Administrator in accordance with § 1.135 of the Uniform Rules of Practice (7 CFR 1.135).
The Animal and Plant Health Inspection Service regulations relating to availability of information to the public and disclosure of records under 5 U.S.C. 552, which are set forth in 7 CFR part 370, are incorporated into this subchapter.
7 U.S.C. 3801-3813; 7 CFR 2.22, 2.8, and 371.4
For the purposes of this part, the following terms shall have the meanings assigned them in this section. Unless otherwise required by the context, the singular form shall also import the plural and the masculine form shall also import the feminine, and vice versa. Words undefined in the following paragraphs shall have the meaning attributed to them in general usage as reflected by definitions in a standard dictionary.
(a) No person shall feed or permit the feeding of garbage to swine unless the garbage is treated to kill disease organisms, pursuant to this Part, at a facility operated by a person holding a valid license for the treatment of garbage; except that the treatment and license requirements shall not apply to the feeding or the permitting of the feeding to swine of garbage only because the garbage consists of any of the following: rendered products; bakery waste; candy waste; eggs; domestic dairy products (including milk); fish from the Atlantic Ocean within 200 miles of the continental United States or Canada; or fish from inland waters of the United States or Canada which do not flow into the Pacific Ocean.
(b) No person operating such a facility may be licensed to treat garbage unless he or she meets the requirements of this part designed to prevent the introduction or dissemination of any infectious or communicable disease of animals and unless the facility is so constructed that swine are unable to have access to untreated garbage or equipment and material coming in contact with untreated garbage.
(c) The regulations of this part shall not be construed to repeal or supersede State laws that prohibit feeding of garbage to swine or to prohibit any State from enforcing requirements relating to the treatment of garbage that is to be fed to swine or the feeding thereof which are more stringent than the requirements contained in this part. In a State which prohibits the feeding of garbage to swine, a license under the Act will not be issued to any applicant.
(a) Access by swine to garbage handling and treatment areas shall be prevented by construction of facilities to exclude all ages and sizes of swine.
(b) All areas and drainage therefrom, used for the handling and treatment of untreated garbage shall be inaccessible to swine on the premises. This shall include the roads and areas used to transport and handle untreated garbage on the premises.
(a) Untreated garbage at a treatment facility shall be stored in covered and leakproof containers until treated.
(b) Treated garbage shall be transported to a feeding area from the treatment facility only in (1) containers used only for such treated garbage; (2) containers previously used for garbage which have been cleaned and disinfected in accordance with § 166.14 of
Garbage-treatment facilities shall be maintained as set forth in this section.
(a) Insects and animals shall be controlled. Accumulation of any material at the facility where insects and rodents may breed is prohibited.
(b) Equipment used for handling untreated garbage, except for the containers in which the garbage has been treated, may not be subsequently used in the feeding of swine unless first cleaned and disinfected as set forth in § 166.14(b).
(c) Untreated garbage that is not to be fed to swine and materials in association with such garbage shall be disposed of in a manner consistent with all applicable governmental environmental regulations and in an area inaccessible to swine.
Untreated garbage shall not be allowed into swine feeding areas. Any equipment or material associated with untreated garbage, except for containers holding treated garbage which was treated in such containers, shall not be allowed into swine feeding areas at treatment premises until properly cleaned and disinfected as set forth in § 166.14(b) of this part.
(a) Garbage shall be heated throughout at boiling (212 °F. or 100 °C. at sea level) for 30 (thirty) minutes.
(b) Garbage shall be agitated during cooking, except in steam cooking equipment, to ensure that the prescribed cooking temperature is maintained throughout the cooking container for the prescribed length of time.
Vehicles used by a licensee to transport untreated garbage, except those that have also been used to treat the garbage so moved, shall not be used for hauling animals or treated garbage until cleaned and disinfected as set forth in § 166.14(c) of this part.
(a) Each licensee shall record the destination and date of removal of all treated or untreated garbage removed from the licensee's premises.
(b) Such records shall be legible and indelible.
(c) Each entry in a record shall be certified as correct by initials or signature of the licensee or an authorized agent or employee of the licensee.
(d) Such records shall be maintained by the licensee for a period of 1 year from the date made and shall be made available to inspectors upon request during normal business hours at that treatment facility.
(a)
(b)
(c)
(2) The licensee shall make the premises, facilities, and equipment available during normal business hours for inspections by an inspector to determine continuing compliance with the Act and regulations.
(3) The facilities and equipment of an applicant for a license shall be in compliance with all applicable governmental environmental regulations before the applicant will be licensed.
(d)
(a)
(b)
(c) The license of a person shall be automatically revoked, without action of the Administrator, upon the final effective date of the second criminal conviction of such person, as is stated in section 5(c) of the Act. The licensee will be notified in writing of such revocation by the Area Veterinarian in Charge or, in States having primary enforcement responsibility, by the State animal health official.
(d) Any person whose license has been suspended or revoked for any reason shall not be licensed in such person's own name or in any other manner, nor shall any of such person's employees be licensed for the purpose of operating the facility owned or operated by said licensee while the order of suspension or revocation is in effect. Any person whose license has been revoked shall not be eligible to apply for a new license for a period of 1 year from the effective date of such revocation. Any person who desires the reinstatement of a license that has been revoked must follow the procedure for new licensees set forth in § 166.10 of this part.
(a) The Area Veterinarian in Charge or, in States listed in § 166.15(d) of this part, the State animal health official shall cancel the license of a licensee when the Area Veterinarian in Charge or, in States listed in § 166.15(d) of this part, the State animal health official finds that no garbage has been treated for a period of 4 consecutive months at the facility operated by the licensee. Before such action is taken, the licensee of the facility will be informed in writing of the reasons for the proposed action and be given an opportunity to respond in writing. In those instances where there is a conflict as to the facts, the licensee shall, upon request, be afforded a hearing in accordance with rules of practice which shall be adopted for the proceeding.
(b) Any licensee may voluntarily have his or her license canceled by requesting such cancellation in writing and sending such request to the Area Veterinarian in Charge,
(c) Any person whose license is canceled in accordance with paragraph (a) or (b) of this section may apply for a new license at any time by following the procedure for obtaining a license set forth in § 166.10 of this part.
(a) A licensed facility shall be subject to inspections. Each inspector will be furnished with an official badge or identification card, either of which shall be sufficient identification to entitle access during normal business hours to the facility for the purposes of inspection. At such time the inspector is duly authorized to:
(1) Inspect the facility, including cooker function;
(2) Take samples of garbage;
(3) Observe and physically inspect the health status of all species of animals on the premises;
(4) Review records and make copies of such records; and
(5) Take photographs. A copy of each photograph will be provided to the licensee within 14 days.
(b) A licensee shall notify an inspector immediately upon detection of illness or death not normally associated with the licensee's operation in any animal species on the licensee's premises.
(c) A licensee shall notify an inspector or the State animal health official
(d) A licensee shall supply, upon request by an inspector, information concerning sources of garbage. Such information shall include the dates of supply and the names and addresses of the person and/or organization from which the garbage was received.
(a)
(1) A permitted brand of sodium orthophenylphenate that is used in accordance with directions on the Environmental Protection Agency (EPA) approved label.
(2) A permitted cresylic disinfectant that is used in accordance with directions on the EPA-approved label, provided such disinfectant also meets the requirements set forth in §§ 71.10(b) and 71.11 of this chapter.
(3) Distinfectants which are registered under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136
(b) All premises at which garbage has been fed to swine in violation of the Act or regulations in this part shall, prior to continued use for swine feeding purposes, be cleaned and disinfected under the supervision of an inspector or an accredited veterinarian as defined in Part 160 of this chapter as follows: Empty all troughs and other feeding and watering appliances, remove all litter, garbage, manure, and other organic material from the floors, posts, or other parts of such equipment, and handle such litter, garbage, manure, and other organic material in such manner as not to allow animal contact with such material; clean all surfaces with water and detergent and saturate the entire surface of the equipment, fencing, troughs, chutes, floors, walls, and all other parts of the facilities, with a disinfectant prescribed in paragraph (a) of this section. An exemption to the requirements of this paragraph may be given by the Administrator or, in States with primary enforcement responsibility, by the State animal health official, when it is determined that a threat to the swine industry does not exist.
(c) Any vehicle or other means of conveyance and its associated equipment which has been used by the licensee to move garbage, except any vehicle or other means of conveyance which also has been used to treat the garbage so moved, shall, prior to use for livestock-related or treated garbage hauling purposes, be cleaned and disinfected as follows: Remove all litter, garbage, manure, and other organic material from all portions of each means of conveyance, including all ledges and framework inside and outside, and handle such litter, garbage, manure, and other organic material in such manner as not to allow animal contact with such material; clean the interior and the exterior of such vehicle or other means of conveyance and its associated equipment with water and detergent; and saturate the entire interior surface, including all doors, endgates, portable chutes, and similar equipment with a disinfectant prescribed in paragraph (a) of this section.
(d) The owner of such facilities and vehicles shall be responsible for cleaning and disinfecting as required under this section, and the cleaning and disinfecting shall be done without expense to the United States Department of Agriculture.
(a) The following States prohibit the feeding of garbage to swine: Alabama, Delaware, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Nebraska, New
(b) The following States and Puerto Rico permit the feeding of treated garbage to swine: Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Hawaii, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nevada, New Hampshire, New Jersey, New Mexico, North Carolina, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, Texas, Utah, Vermont, Washington, West Virginia, and Wyoming.
(c) The following States have primary enforcement responsibility under the Act: Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New York, North Dakota, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Utah, Virginia, West Virginia, and Wisconsin.
(d) The following States issue licenses under cooperative agreements with the Animal and Plant Health Inspection Service, but do not have primary enforcement responsibility under the Act: Maryland, Puerto Rico, Texas, and Washington.
(e) The public may contact the Area Veterinarian in Charge, Animal and Plant Health Inspection Service, United States Department of Agiculture or State animal health official, or the Animal and Plant Health Inspection Service, Veterinary Services, Swine Health, 4700 River Road, Unit 37, Riverdale, Maryland 20737-1231, concerning the feeding of garbage to swine.
7 U.S.C. 3804, 3805, and 3811; 7 CFR 2.22, 2.80, and 371.4.
The Uniform Rules of Practice for the Department of Agriculture promulgated in subpart H of part 1, subtitle A, title 7, Code of Federal Regulations, are the Rules of Practice applicable to adjudicatory, administrative proceedings under sections 5 and 6 of the Swine Health Protection Act (7 U.S.C. 3804, 3805). In addition, the Supplemental Rules of Practice set forth in subpart B of this part shall be applicable to such proceedings.
(a) At any time prior to the issuance of a complaint seeking a civil penalty under the Act, the Administrator, in his discretion, may enter into a stipulation with any person in which:
(1) The Administrator or the Administrator's delegate gives notice of an apparent violation of the Act, or the regulations issued thereunder, by such person and affords such person an opportunity for a hearing regarding the matter as provided by the Act;
(2) Such person expressly waives hearing and agrees to a specified order which may include an agreement to pay a specified penalty within a designated time; and
(3) The Administrator agrees to accept the order in settlement of the particular matter conditioned upon timely payment of the penalty if the order includes an agreement to pay a penalty.
(b) If the order includes an agreement to pay a penalty and the penalty is not paid within the time designated in such a stipulation, the amount of the penalty shall not be relevant in any respect to the penalty which may be assessed after issuance of a complaint.
A list of CFR titles, subtitles, chapters, subchapters and parts and an alphabetical list of agencies publishing in the CFR are included in the CFR Index and Finding Aids volume of the Code of Federal Regulations which is published separately and revised annually.
Material Approved for Incorporation by Reference
Table of CFR Titles and Chapters
Alphabetical List of Agencies Appearing in the CFR
List of CFR Sections Affected
The Director of the Federal Register has approved under 5 U.S.C. 552(a) and 1 CFR Part 51 the incorporation by reference of the following publications. This list contains only those incorporations by reference effective as of the revision date of this volume. Incorporations by reference found within a regulation are effective upon the effective date of that regulation. For more information on incorporation by reference, see the preliminary pages of this volume.
All changes in this volume of the Code of Federal Regulations that were made by documents published in the
For the period before January 1, 2001, see the “List of CFR Sections Affected, 1949-1963, 1964-1972, 1973-1985, and 1986-2000” published in 11 separate volumes.