42 U.S.C. 216, 243, 264, 271.
65 FR 49908, Aug. 16, 2000, unless otherwise noted.
As used in this part, terms shall have the following meaning:
(a)
(b)
(c)
(d)
(e)
(1) The movement of any conveyance or the transportation of persons or property, including any portion of such movement or transportation that is entirely within a State or possession—
(i) From a point of origin in any State or possession to a point of destination in any other State or possession; or
(ii) Between a point of origin and a point of destination in the same State or possession but through any other State, possession, or contiguous foreign country.
(2) Interstate traffic does not include the following:
(i) The movement of any conveyance which is solely for the purpose of unloading persons or property transported from a foreign country, or loading persons or property for transportation to a foreign country.
(ii) The movement of any conveyance which is solely for the purpose of effecting its repair, reconstruction, rehabilitation, or storage.
(f)
(g)
(h)
(1) Fishing boats including those used for shell-fishing;
(2) Tugs which operate only locally in specific harbors and adjacent waters;
(3) Barges without means of self-propulsion;
(4) Construction-equipment boats and dredges; and
(5) Sand and gravel dredging and handling boats.
Whenever the Director of the Centers for Disease Control and Prevention determines that the measures taken by health authorities of any State or possession (including political subdivisions thereof) are insufficient to prevent the spread of any of the communicable diseases from such State or possession to any other State or possession, he/she may take such measures to prevent such spread of the diseases as he/she deems reasonably necessary, including inspection, fumigation, disinfection, sanitation, pest extermination, and destruction of animals or articles believed to be sources of infection.
A person who has a communicable disease in the communicable period shall not travel from one State or possession to another without a permit from the health officer of the State, possession, or locality of destination, if such permit is required under the law applicable to the place of destination. Stop-overs other than those necessary for transportation connections shall be considered as places of destination.
The master of any vessel or person in charge of any conveyance engaged in interstate traffic, on which a case or suspected case of a communicable disease develops shall, as soon as practicable, notify the local health authority at the next port of call, station, or stop, and shall take such measures to prevent the spread of the disease as the local health authority directs.
The following provisions are applicable with respect to any person who is in the communicable period of cholera, plague, smallpox, typhus or yellow fever, or who, having been exposed to any such disease, is in the incubation period thereof:
(a)
(2) Application for a permit may be made directly to the Surgeon General or to his/her representative authorized to issue permits.
(3) Upon receipt of an application, the Surgeon General or his/her authorized representative shall, taking into consideration the risk of introduction, transmission, or spread of the disease from one State or possession to another, reject it, or issue a permit that may be conditioned upon compliance with such precautionary measures as he/she shall prescribe.
(4) A person to whom a permit has been issued shall retain it in his/her possession throughout the course of his/her authorized travel and comply with all conditions prescribed therein, including presentation of the permit to the operators of conveyances as required by its terms.
(b)
(i) Accept for transportation any person who fails to present a permit as required by paragraph (a) of this section; or
(ii) Transport any person in violation of conditions prescribed in his/her permit.
(2) Whenever a person subject to the provisions of this section is transported on a conveyance engaged in interstate traffic, the operator thereof shall take such measures to prevent the spread of the disease, including submission of the conveyance to inspection, disinfection and the like, as an officer of the Public Health Service designated by the Surgeon General for such purposes deems reasonably necessary and directs.
Regulations prescribed in this part are not applicable to the apprehension, detention, or conditional release of individuals except for the purpose of preventing the introduction, transmission, or spread of the following diseases: Anthrax, chancroid, cholera, dengue, diphtheria, granuloma inguinale, infectious encephalitis, favus, gonorrhea, leprosy, lymphogranuloma venereum, meningococcus meningitis, plague, poliomyelitis, psittacosis, relapsing fever, ringworm of the scalp, scarlet fever, streptococcic sore throat, smallpox, syphilis, trachoma, tuberculosis, typhoid fever, typhus, and yellow fever.
A parent, guardian, physician, nurse, or other such person shall not transport, or procure or furnish transportation for any minor child or ward, patient or other such person who is in the communicable period of a communicable disease, except in accordance with provisions of this part.
The provisions of §§ 70.3, 70.4, 70.5, 70.7, and this section shall not apply to members of the military or naval forces, and medical care or hospital beneficiaries of the Army, Navy, Veterans' Administration, or Public Health Service, when traveling under competent orders:
Sec. 215 of Public Health Service (PHS) Act, as amended (42 U.S.C. 216); secs. 361-369, PHS Act, as amended (42 U.S.C. 264-272); E.O. 12452 of December 22, 1983, 48 FR 56927.
50 FR 1519, Jan. 11, 1985, unless otherwise noted.
(a) The provisions of this part contain the regulations to prevent the introduction, transmission, and spread of communicable disease from foreign countries into the States or possessions of the United States. Regulations pertaining to preventing the interstate spread of communicable diseases are contained in 21 CFR parts 1240 and 1250.
(b) As used in this part the term:
(1) Has a temperature of 100 °F. (or 38 °C.) or greater, accompanied by a rash, glandular swelling, or jaundice, or which has persisted for more than 48 hours; or
(2) Has diarrhea, defined as the occurrence in a 24-hour period of three or more loose stools or of a greater than normal (for the person) amount of loose stools.
Any person violating any provision of these regulations shall be subject to a fine of not more than $1,000 or to imprisonment for not more than 1 year, or both, as provided in section 368 of the Public Health Service Act (42 U.S.C. 271).
(a)
(2) A designated yellow fever vaccination center shall comply with the instruction issued by the Director or by a delegated officer or employee of a State or territorial health department for the handling, storage, and administration of yellow fever vaccine. If a designated center fails to comply with such instruction, after notice to the center, the Director or, for non-Federal centers, a State or territorial health department, may revoke designation.
(b)
(1) The Seal of the Public Health Service; or
(2) The Seal of the Department of State; or
(3) The stamp of the Department of Defense; or
(4) The stamp issued to the National Aeronautics and Space Administration; or
(5) The stamp issued by a State or territorial health department; or
(6) An official stamp of a design and size approved by the Director for such purpose.
A carrier at any foreign port clearing or departing for any U.S. port shall not be required to obtain or deliver a bill of health.
(a) The master of a ship destined for a U.S. port shall report immediately to the quarantine station at or nearest the port at which the ship will arrive, the occurrence, on board, of any death or any ill person among passengers or crew (including those who have disembarked or have been removed) during the 15-day period preceding the date of expected arrival or during the period since departure from a U.S. port (whichever period of time is shorter).
(b) The commander of an aircraft destined for a U.S. airport shall report immediately to the quarantine station at or nearest the airport at which the aircraft will arrive, the occurrence, on board, of any death or ill person among passengers or crew.
(c) In addition to paragraph (a) of this section, the master of a ship carrying 13 or more passengers must report by radio 24 hours before arrival the number of cases (including zero) of diarrhea in passengers and crew recorded in the ship's medical log during the current cruise. All cases of diarrhea that occur after the 24 hour report must also be reported not less than 4 hours before arrival.
(a) Upon arrival at a U.S. port, a carrier will not undergo inspection unless the Director determines that a failure to inspect will present a threat of introduction of communicable diseases into the United States, as may exist when the carrier has on board individual(s) reportable in accordance with § 71.21 or meets the circumstances described in § 71.42. Carriers not subject to inspection under this section will be subject to sanitary inspection under § 71.41 of this part.
(b) The Director may require detention of a carrier until the completion of the measures outlined in this part that are necessary to prevent the introduction or spread of a communicable disease. The Director may issue a controlled free pratique to the carrier stipulating what measures are to be met, but such issuance does not prevent the periodic boarding of a carrier and the inspection of persons and records to verify that the conditions have been met for granting the pratique.
(a) Whenever the Director has reason to believe that any arriving person is infected with or has been exposed to any of the communicable diseases listed in paragraph (b) of this section, he/she may detain, isolate, or place the person under surveillance and may order disinfection or disinfestation as he/she considers necessary to prevent the introduction, transmission, or spread of the listed communicable diseases.
(b) The communicable diseases authorizing the application of sanitary, detention, and/or isolation measures under paragraph (a) of this section are: cholera or suspected cholera, diphtheria, infectious tuberculosis, plague, suspected smallpox, yellow fever, or suspected viral hemorrhagic fevers (Lassa, Marburg, Ebola, Congo-Crimean, and others not yet isolated or named).
(c) Whenever the Director has reason to believe that any arriving carrier or article or thing on board the carrier is or may be infected or contaminated with a communicable disease, he/she may require detention, disinsection, disinfection, disinfestation, fumigation, or other related measures respecting the carrier or article or thing as he/she considers necessary to prevent the introduction, transmission, or spread of communicable diseases.
(a) Persons held in isolation under this subpart may be held in facilities suitable for isolation and treatment.
(b) The Director may require isolation where surveillance is authorized in this subpart whenever the Director considers the risk of transmission of infection to be exceptionally serious.
(c) Every person who is placed under surveillance by authority of this subpart shall, during the period of surveillance:
(1) Give information relative to his/her health and his/her intended destination and report, in person or by telephone, to the local health officer having jurisdiction over the areas to be visited, and report for medical examinations as may be required;
(2) Upon arrival at any address other than that stated as the intended destination when placed under surveillance, or prior to departure from the United States, inform, in person or by telephone, the health officer serving the health jurisdiction from which he/she is departing.
(d) From time to time the Director may, in accordance with section 322 of the Public Health Service Act, enter into agreements with public or private medical or hospital facilities for providing care and treatment for persons detained under this part.
(a) Carriers belonging to or operated by the military services of the United States may be exempted from inspection if the Director is satisfied that they have complied with regulations of
(b) Notwithstanding exemption from inspection of carriers under this section, animals or articles on board shall be required to comply with the applicable requirements of subpart F of this part.
The master of any carrier at a U.S. port shall report immediately to the quarantine station at or nearest the port the occurrence, on board, of any death or any ill person among passengers or crew.
Carriers arriving at a U.S. port from a foreign area shall be subject to a sanitary inspection to determine whether there exists rodent, insect, or other vermin infestation, contaminated food or water, or other insanitary conditions requiring measures for the prevention of the introduction, transmission, or spread of communicable disease.
When the cargo manifest of a carrier lists articles which may require disinfection under the provisions of this part, the Director shall disinfect them on board or request the appropriate customs officer to keep the articles separated from the other cargo pending appropriate disposition.
Except to the extent that mail contains any article or thing subject to restrictions under subpart F of this part, nothing in the regulations in this part shall render liable to detention, disinfection, or destruction any mail conveyed under the authority of the postal administration of the United States or of any other Government.
(a) The Director may require disinsection of an aircraft if it has left a foreign area that is infected with insect-borne communicable disease and the aircraft is suspected of harboring insects of public health importance.
(b) Disinsection shall be the responsibility of the air carrier or, in the case of aircraft not for hire, the pilot in command, and shall be subject to monitoring by the Director.
(c) Disinsection of the aircraft shall be accomplished immediately after landing and blocking.
(1) The cargo compartment shall be disinsected before the mail, baggage, and other cargo are discharged.
(2) The rest of the aircraft shall be disinsected after passengers and crew deplane.
(d) Disinsection shall be performed with an approved insecticide in accordance with the manufacturer's instructions. The current list of approved insecticides and sources may be obtained from the Division of Quarantine, Center for Prevention Services, Centers for Disease Control, Atlanta, GA 30333.
(a) Every seaport and airport shall be provided with a supply of potable water from a watering point approved by the Commissioner of Food and Drugs, Food and Drug Administration, in accordance with standards established in title 21, Code of Federal Regulations, parts 1240 and 1250.
(b) All food and potable water taken on board a ship or aircraft at any seaport or airport intended for human consumption thereon shall be obtained from sources approved in accordance with regulations cited in paragraph (a) of this section.
(c) Aircraft inbound or outbound on an international voyage shall not discharge over the United States any excrement, or waste water or other polluting materials. Arriving aircraft shall discharge such matter only at
Valid Deratting Certificates or Deratting Exemption Certificates are not required for ships to enter a U.S. seaport. In accordance with Article 17 of the International Health Regulations, the Public Health Service may perform rodent infestation inspections and issue Deratting Certificates and Deratting Exemption Certificates.
Each U.S. airport which receives international traffic shall provide without cost to the Government suitable office, isolation, and other exclusive space for carrying out the Federal responsibilities under this part.
Carriers, on an international voyage, which are in traffic between U.S. ports, shall be subject to inspection as described in §§ 71.31 and 71.41 when there occurs on board, among passengers or crew, any death, or any ill person, or when illness is suspected to be caused by insanitary conditions.
(a)
As used in this section the term:
(1) Identifies a dog on the basis of breed, sex, age, color, markings, and other identifying information.
(2) Specifies a date of rabies vaccination at least 30 days before the date of arrival of the dog at a U.S. port.
(3) Specifies a date of expiration which is after the date of arrival of the dog at a U.S. port. If no date of expiration is specified, then the date of vaccination shall be no more than 12 months before the date of arrival at a U.S. port.
(4) Bears the signature of a licensed veterinarian.
(b)
(2)
(3)
(ii) When, upon inspection, a dog or cat appears healthy but, during shipment, has been exposed to a sick or dead animal suspected of having a communicable disease, the exposed dog or cat shall be admitted only if examination or tests made on arrival reveal no evidence that the animal may be infected with a communicable disease. The provisions of paragraph (b)(2) of this section shall be applicable to the examination or tests.
(4)
(c)
(i) If a dog is less than 6 months of age, it has been only in a country determined by the Director to be rabies-free (a current list of rabies-free countries may be obtained from the Division of Quarantine, Center for Prevention Services, Centers for Disease Control, Atlanta, GA 30333); or
(ii) If a dog is 6 months of age or older, for the 6 months before arrival, it has been only in a country determined by the Director to be rabies-free; or
(iii) The dog is to be taken to a research facility to be used for research purposes and vaccination would interfere with its use for such purposes.
(2) Regardless of the provisions of paragraph (c)(1) of this section, the Director may authorize admission as follows:
(i) If the date of vaccination shown on the vaccination certificate is less than 30 days before the date of arrival, the dog may be admitted, but must be confined until at least 30 days have elapsed since the date of vaccination;
(ii) If the dog is less than 3 months of age, it may be admitted, but must be confined until vaccinated against rabies at 3 months of age and for at least 30 days after the date of vaccination;
(iii) If the dog is 3 months of age or older, it may be admitted, but must be confined until it is vaccinated against rabies. The dog must be vaccinated within 4 days after arrival at destination but no more than 10 days after arrival at a U.S. port. It must be kept in confinement for at least 30 days after the date of vaccination.
(3) When a dog is admitted under paragraph (c)(2) of this section, the Director shall notify the health department or other appropriate agency having jurisdiction at the point of destination and shall provide the address of the specified place of confinement and other pertinent information to facilitate surveillance and other appropriate action.
(d)
(e)
(f)
(1) Dogs and cats that appear healthy, but have been exposed to a sick or dead animal suspected of having a communicable disease, need not undergo examination or tests as provided in paragraph (b)(3) of this section if the Director determines that the conditions under which they are being transported will afford adequate protection against introduction of communicable disease.
(2) Rabies vaccination is not required for dogs that are transported by aircraft or ship and retained in custody of the carrier under conditions that would prevent transmission of rabies.
(g)
(a)
As used in this section the term:
(b)
(c)
(2) Seven or more live turtles with a carapace length of less than 4 inches, or seven or more viable turtle eggs or any combination of turtles and turtle eggs totaling seven or more, may be imported into the United States for bona fide scientific or educational purposes or for exhibition when accompanied by a permit issued by the Director.
(3) The requirements in paragraphs (c)(1) and (c)(2) of this section shall not apply to the eggs of marine turtles excluded from these regulations under § 71.52(a).
(d)
(e)
(f)
(g)
(a)
As used in this section the term:
(b)
(c)
(d)
(2) Documentary evidence that an importer will use all nonhuman primates solely for the permitted purposes is required.
(3) Registration shall inlcude certification that the nonhuman primates will not be shipped, sold, or otherwise transferred to other persons or organizations without adequate proof that the primates will be used only for the permitted purposes.
(4) Registration shall be for 2 years, effective the date the application for registration is approved by the Director.
(5) Registration may be renewed by filing a registration application form with the Director not less than 30 days nor more than 60 days before expiration of the current registration.
(e)
(2) Importers shall report to the Director by telephone within 24 hours the occurrence of any illness in nonhuman primates that is suspected of being yellow fever, monkeypox, or Marburg/Ebola disease.
(3) Importers also shall report to the Director by telephone within 24 hours the occurrence of illness in any member of their staff suspected of having an infectious disease acquired from nonhuman primates.
(f)
(g)
(h)
(2) The importer may file an answer within 20 days after receipt of the notice. Answers shall admit or deny specifically, and in detail, each allegation in the notice. Allegations in the notice not denied by answer shall be deemed admitted. Matters alleged as affirmative defenses shall be separately stated and numbered. Failure of the importer to file an answer within 20 days after receipt of the notice may be deemed an admission of all allegations of fact recited in the notice.
(3) The importer shall be entitled to a hearing with respect to the revocation upon filing a written request, either in the answer or in a separate document, with the Director within 20 days after the effective date of revocation. Failure to request a hearing shall be deemed a waiver of hearing and as consent to the submission of the case to the Director for decision based on the written record. The failure both to file an answer and to request a hearing shall be deemed to constitute consent to the making of a decision on the basis of available information.
(4) As soon as practicable after the completion of any hearing conducted pursuant to the provisions of this section, the Director shall render a final decision. A copy of such decision shall be served on the importer.
(5) An importer's registration which has been revoked may be reinstated by the Director upon inspection, examination of records, conference with the importer, and receipt of information and assurances of compliance with the requirements of this section.
(i)
(a) A person may not import into the United States, nor distribute after importation, any etiological agent or any arthropod or other animal host or vector of human disease, or any exotic living arthropod or other animal capable of being a host or vector of human disease unless accompanied by a permit issued by the Director.
(b) Any import coming within the provisions of this section will not be released from custody prior to receipt by the District Director of the U.S. Customs Service of a permit issued by the Director.
The remains of a person who died of a communicable disease listed in § 71.32(b) may not be brought into a U.S. port unless the body is (a) properly embalmed and placed in a hermetically sealed casket, (b) cremated, or (c) accompanied by a permit issued by the Director.
42 U.S.C. 264, 271; 31 U.S.C. 9701; 18 U.S.C. 3559, 3571; 42 U.S.C. 262 note.
45 FR 48627, July 21, 1980, unless otherwise noted.
As used in this part:
No person may knowingly transport or cause to be transported in interstate traffic, directly or indirectly, any material including, but not limited to, diagnostic specimens and biological products which such person reasonably believes may contain an etiologic agent unless such material is packaged to withstand leakage of contents, shocks, pressure changes, and other conditions incident to ordinary handling in transportation.
Notwithstanding the provisions of § 72.2, no person may knowingly transport or cause to be transported in interstate traffic, directly or indirectly, any material (other than biological products) known to contain, or reasonably believed by such person to contain, one or more of the following etiologic agents unless such material is packaged, labeled, and shipped in accordance with the requirements specified in paragraphs (a) through (f) of this section:
(a)
(b)
(c)
(d)(1) The outer shipping container of all materials containing etiologic agents transported in interstate traffic must bear a label as illustrated and described below:
(2) The color of material on which the label is printed must be white, the symbol red, and the printing in red or white as illustrated.
(3) The label must be a rectangle measuring 51 millimeters (mm) (2 inches) high by 102.5 mm (4 inches) long.
(4) The red symbol measuring 38 mm (1
(5) Type size of the letters of label shall be as follows:
(e)
(f)
When notice of delivery of materials known to contain or reasonably believed to contain etiologic agents listed in § 72.3(f) is not received by the sender within 5 days following anticipated delivery of the package, the sender shall notify the Director, Center for Disease Control, 1600 Clifton Road, NE., Atlanta, GA 30333 (telephone (404) 633-5313).
The Director, Center for Disease Control, may approve variations from the requirements of this section if, upon review and evaluation, it is found that such variations provide protection at least equivalent to that provided by compliance with the requirements specified in this section and such findings are made a matter of official record.
(a)
(2) Registration will include:
(i) Sufficient information provided by the responsible facility official indicating that the applicant facility, and its laboratory or laboratories, are equipped and capable of handling the agents at BL 2, 3, or 4, depending upon the agent, and the type of work being performed with the agents;
(ii) Inspection of the applicant facility at the discretion of the Secretary or the registering entity in consultation with the Secretary;
(iii) Issuance by the registering entity of a registration number unique to each facility;
(iv) Collection of a periodic site registration fee by the registering entity or the Secretary.
A schedule of fees collected by the Secretary to cover the direct costs (e.g., salaries, equipment, travel) and indirect costs (e.g., rent, telephone service and a proportionate share of management and administration costs) related to administration of this part will be published in the
(v) Follow-up inspections of the facility by the registering entity or the Secretary, as appropriate, to ensure the facility continues to meet approved standards and recordkeeping requirements.
(3) Such registration shall remain effective until relinquished by the facility or withdrawn by the Secretary or the registering entity.
(4) The registration may be denied or withdrawn by the registering entity or the Secretary based on:
(i) Evidence that the facility is not or is no longer capable of handling covered agents at the applicable biosafety level;
(ii) Evidence that the facility has handled covered agents in a manner in contravention of the applicable biosafety level requirements;
(iii) Evidence that the facility has or intends to use covered agents in a manner harmful to the health of humans;
(iv) Evidence that the facility has failed to comply with any provisions of this part or has acted in a manner in contravention of this part; or
(v) Failure to pay any required registration fee.
(5) The requirements for BSL-2, 3, and 4 operations pertaining to this section are contained in the CDC/NIH publication, “Biosafety in Microbiological and Biomedical Laboratories,” Third Edition, May 1993 which is hereby incorporated by reference. The Director of the Federal Register has approved under 5 U.S.C. 552(a) and 1 C.F.R. Part 51 the incorporation by reference of the above publication. Copies may be obtained from the Superintendent of Documents, U.S. Government Printing Office, Washington D.C. 20402. Copies may be inspected at the Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, Georgia, or at the Office of the Federal Register, 800 North Capitol Street N.W., Suite 700, Washington D.C.
(6) Additional specific requirements for handling toxins subject to this part must be met and are found in 29 CFR § 1910.1450, “Occupational Exposure to Hazardous Chemicals in Laboratories.”
(b)
(c)
(2) A registering entity shall maintain:
(i) A database of all facilities formerly and currently registered as BL 2, 3, or 4 and capable of working with agents in Appendix A of this part. The database shall include the name and address of the registered facility, the date the facility was registered, the facility's registration number, and the name and phone number of the responsible facility official.
(ii) A copy of each CDC Form EA-101 transmitted by each transferor registered by that registering entity. Such forms shall be made readily accessible to the Secretary and to appropriate federal law enforcement authorities and/or authorized local law enforcement authorities.
(3) In the event the Secretary authorizes more than one registering entity, or if otherwise necessary, the Secretary may require the establishment of a consolidated database to carry out the provisions of § 72.6(c)(2).
(d)
(i) The name of the requestor and requesting facility;
(ii) The name of the transferor and transferring facility;
(iii) The names of the responsible facility officials for both the transferor and requestor;
(iv) The requesting facility's registration number;
(v) The transferring facility's registration number;
(vi) The name of the agent(s) being shipped;
(vii) The proposed use of the agent(s); and
(viii) The quantity (number of containers and amount per container) of the agent(s) being shipped.
(2) The form must be signed by the transferor and requestor, and the responsible facility officials representing both the transferring and requesting facilities.
(3) A copy of the completed CDC Form EA-101 must be retained by both transferring and requesting facilities for a period of five (5) years after the date of shipment or for five (5) years after the agents are consumed or properly disposed, whichever is longer.
(4) All CDC forms EA-101 must be produced upon request to appropriate federal and authorized local law enforcement authorities, officials authorized by the Secretary, and officials of the registering entity.
(e)
(i) That the requesting facility retains a valid, current registration;
(ii) That the requestor is an employee of the requesting facility; and
(iii) That the proposed use of the agent by the requestor is correctly indicated on CDC Form EA-101.
(2) In the event that any party is unable to verify the information required in paragraph (e)(1) of this section, or there is suspicion that the agent may not be used for the requested purpose, then the party shall immediately notify CDC.
(f)
(2) The requesting facility's responsible official must acknowledge receipt of the agent telephonically or otherwise electronically within 36 hours of receipt and provide a paper copy or facsimile transmission of receipt to the transferor within 3 business days of receipt of the agent.
(3) Upon telephonic acknowledgment of receipt of the agent, the transferor shall provide a completed paper copy or facsimile transmission of CDC Form EA-101 within 24 hours to the registering entity (holding that facility's registration), in accordance with § 72.6(c)(2) for filing in a centralized repository.
(g)
(2) In addition, the Secretary may conduct inspections of registering entities, and/or any consolidated database established in accordance with § 72.6(c)(3), to assure compliance with this part.
(h)
(i) The agent is part of a clinical specimen intended for diagnostic, reference, or verification purposes. Isolates of covered agents from clinical specimens shall be disposed of in accordance with § 72.6(i) after diagnostic, reference, or verification procedures have been completed;
(ii) The agent is a toxin having an LD
(iii) The agent(s) is an exempted strain specified in Appendix A of this part and/or CDC Form EA-101. Additional exemptions for otherwise covered strains will be considered when CDC reviews and updates the list of select agents (Appendix A of this part). Individuals seeking additions to the list of exemptions should submit a request to CDC that specifies the agent or strain to be exempted and explains why such an exemption should be granted. Future changes to the list of exemptions will be published in the
(2)
(3)
(i) Prior to transferring a select agent subject to this part to a CLIA laboratory for diagnostic, reference, verification, or proficiency testing purposes, the
(A) Provide the following information on CDC Form EA-101:
(
(
(
(
(
(
(
(
(B) Verify receipt of the agent with the CLIA laboratory and note such receipt on CDC Form EA-101;
(C) Transmit a copy of the form, signed by the transferror and the responsible facility official representing the transfering facility, to the registering entity holding the transferring facility's registration; and
(D) Retain a copy of CDC Form EA-101 in accordance with § 72.6(d)(3) and § 72.6(d)(4).
(ii) Prior to receiving a select agent listed in Appendix A of this part from a CLIA laboratory, the
(A) Provide the following information on the CDC Form EA-101:
(
(
(
(
(
(
(
(
(B) Upon receiving the agent, note such receipt on CDC Form EA-101;
(C) Transmit a copy of CDC Form EA-101, signed by the requestor and the responsible facility official representing the requesting facility, to the registering entity holding the requesting facility's registration;
(D) Retain a copy of the CDC Form EA-101 in accordance with §§ 72.6(d)(3) and 72.6(d)(4);
(E) Comply with the disposal requirements of § 72.6(i) and all other sections of this part when subsequently transferring the agent.
(i)
(i) Securely stored in accordance with prudent laboratory practices,
(ii) Transferred to another registered facility in accordance with this part, or
(iii) Destroyed on-site by autoclaving, incineration, or another recognized sterilization or neutralization process.
(2) When an agent, previously transferred to a facility in accordance with this part, is consumed or destroyed, the responsible facility official must formally notify the registering entity. Formal notification must be noted on CDC Form EA-101 and a copy kept on record by the responsible facility official for a period of five (5) years and is subject to paragraph (g) of this section.
(j)
(1) Genetically modified microorganisms or genetic elements from organisms on Appendix A of this part, shown to produce or encode for a factor associated with a disease, and
(2) Genetically modified microorganisms or genetic elements that contain nucleic acid sequences coding for any of the toxins on Appendix A of this part, or their toxic submits.
(1) The conveyance or movement from a point or origination to a point of destination either:
(i) From one state or territory to another or;
(ii) Entirely within one contiguous state or territory.
(2) Intrafacility transfers within a registered facility located at a single geographic site are not covered by the provisions of § 72.6 (d), (e), and (f) provided that:
(i) The intended use of the agent remains consistent with that specified in the most current transfer form; and
(ii) For each intrafacility transfer, the facility maintains records that include the name and location of the recipient; the amount of agent transferred, and the date transferred. Such records must be maintained for a period of five (5) years after the date of transfer or for five (5) years after the agents are consumed or properly disposed, whichever is longer.
Individuals in violation of this part are subject to a fine of no more than $250,000 or one year in jail, or both. Violations by organizations are subject to a fine or no more than $500,000 per event. A false, fictitious, or fraudulent statement or representation on the Government forms required in the part for registration of facilities or for transfers of select agents is subject to a fine or imprisonment for not more than five years, or both for an individual; and a fine for an organization.
1. Genetically modified microorganisms or genetic elements from organisms on Appendix A, shown to produce or encode for a factor associated with a disease.
2. Genetically modified microorganisms or genetic elements that contain nucleic acid sequences coding for any of the toxins listed in this Appendix, or their toxic subunits.
The deliberate transfer of a drug resistance trait to microorganisms listed in this Appendix that are not known to acquire the trait naturally is prohibited by NIH “Guidelines for Research Involving Recombinant DNA Molecules,” if such acquisition could compromise the use of the drug to control these disease agents in humans or veterinary medicine.
1. Products subject to regulation under the Federal Insecticide Fungicide and Rodenticide Act (7 U.S.C. 136
2. Additional exemptions for otherwise covered strains will be considered when CDC reviews and updates the list of select agents in this Appendix. Individuals seeking an exemption should submit a request to CDC that specifies the agent or strain to be exempted and explains why such an exemption should be granted. Future exemptions will be published in the
Sec. 979 of the Consumer-Patient Radiation Health and Safety Act of 1981, Pub. L. 97-35, 95 Stat. 599-600 (42 U.S.C. 10004).
50 FR 50717, Dec. 11, 1985, unless otherwise noted.
(a) The purpose of these regulations is to implement the provisions of section 979 of the Consumer-Patient Radiation Health and Safety Act of 1981, 42 U.S.C. 10004, which requires the establishment by the Secretary of Health and Human Services of standards for the accreditation of programs for the education of certain persons who administer radiologic procedures and for the credentialing of such persons.
(b) Section 979 requires the Secretary, after consultation with specified Federal agencies, appropriate agencies of States, and appropriate professional organizations, to promulgate by regulation the minimum standards described above. These standards distinguish between the occupations of (1) radiographer, (2) dental hygienist, (3) dental assistant, (4) nuclear medicine technologist, and (5) radiation therapy technologist. In the interest of public safety and to prevent the hazards of improper use of medical radiation identified by Congress in its determination of the need for standards, the Secretary is also authorized to prepare standards for other occupational groups utilizing ionizing and non-ionizing radiation as he/she finds appropriate. However, the standards set out below are limited to the five occupational groups listed above, utilizing ionizing radiation. Nothing in these accreditation standards is intended to discriminate against proprietary schools.
All terms not defined herein shall have the meaning given them in the Act. As used in this part:
(a)
(1)
(2)
(3)
(4)
(5)
(6) The following persons are deemed to have met the requirements of these standards:
(i) Persons employed by the Federal government as radiologic personnel prior to the effective date of this regulation and who show evidence of current or fully satisfactory performance or certification of such from a licensed practitioner:
(ii) Uniformed military personnel who receive radiologic training from or through the Armed Forces of the United States and who meet standards established by the Department of Defense or components thereof, provided that those standards are determined by such Department or component to offer equivalent protection of patient health and safety:
(iii) Foreign national employed by the Federal government in positions outside of the United States who show evidence of training, experience, and competence determined by the employing agency to be equally protective of patients health and safety; and
(iv) Persons first employed by the Federal government as radiologic personnel after the effective date of this regulation who (
(7) The following persons are exempted from these standards:
(i) Persons who are trained to perform, or perform, covered radiologic procedures in emergency situations which preclude use of fully qualified personnel; and
(ii) Students in approved training programs.
(8) A department, agency, or instrumentality of the Federal government may, after consultation with the Secretary, use alternative criteria which it determines would offer equivalent protection of patient health and safety.
(b)
The radiographer shall perform effectively by:
1. Applying knowledge of the principles of radiation protection for the patient, self, and others.
2. Applying knowledge of anatomy, positioning, and radiographic techniques to accurately demonstrate anatomical structures on a radiograph.
3. Determining exposure factors to achieve optimum radiographic technique with a minimum of radiation exposure to the patient.
4. Examining radiographs for the purpose of evaluating technique, positioning, and other pertinent technical qualities.
5. Exercising discretion and judgment in the performance of medical imaging procedures.
6. Providing patient care essential to radiologic procedures.
7. Recognizing emergency patient conditions and initiating lifesaving first aid.
1. Accreditation will be granted to the institution that assumes primary responsibility for curriculum planning and selection of course content; coordinates classroom teaching and supervised clinical education; appoints faculty to the program; receives and processes applications for admission; and grants the degree or certificate documenting completion of the program.
2. Educational programs may be established in:
(a) Community and junior colleges, senior colleges, and universities;
(b) Hospitals;
(c) Medical schools;
(d) Postsecondary vocational/technical schools and institutions; and
(e) Other acceptable institutions which meet comparable standards.
3. The sponsoring institutions and affiliate(s) must be accredited by a recognized agency. When the sponsoring institution and affilitate(s) are not so recognized, they may be considered as meeting the requirements of accreditation if the institution meets or exceeds established equivalent standards.
1.
2.
3.
1. The clinical phase of the educational program shall provide an environment for supervised competency-based clinical education and experience and offer a sufficient and well-balanced variety of radiographic examinations and equipment.
2. An acceptable ratio of students to registered technologists shall be maintained in the clinical teaching environment.
3. A clinical instructor(s), who shall be responsible for supervising students according to objectives, shall be identified for each primary clinical education center.
4. The maximum student enrollment shall not exceed the capacity recommended on the basis of volume and variety of radiographic procedures, resources, and personnel available for teaching purposes.
5. In programs where didactic and clinical experience are not provided in the same institution, accreditation shall be given only to the institution responsible for admissions, curriculum, and academic credit. The accredited institution shall be responsible for coordinating the program and assuring that the activities assigned to the students in the clinical setting are educational. There shall be a uniform contract between the accredited institution and each of its affiliate hospitals, clearly defining the responsibilities and obligations of each.
1. The structure of the curriculum shall be based on not less than two calendar years of full-time study or its equivalent.
2. Instruction shall follow a planned outline that includes:
(a) The assignment of appropriate instructional materials;
(b) Classroom presentations, discussions and demonstrations; and
(c) Examinations in the didactic and clinical aspects of the program.
3. All professional courses, including clinical education, must include specific curriculum content that shall include, but shall not be limited to:
(a) Introduction to radiologic technology;
(b) Medical ethics;
(c) Imaging;
(d) Radiographic processing technique;
(e) Human structure and function;
(f) Medical terminology;
(g) Principals of radiographic exposure;
(h) Radiographic procedures;
(i) Principles of radiation protection;
(j) Radiographic film evaluation;
(k) Methods of patient care;
(l) Pathology;
(m) Radiologic physics; and
(n) Radiation biology.
Related subjects added to the professional curriculum shall meet the requirements of the degree-granting institution.
Financial resources for operation for the educational program shall be assured through regular budgets, gifts, grants, endowments, or fees.
1.
(a)
(b)
(2) Opportunities for continuing education shall be provided for all faculty members.
2.
(b)
3.
(a) Candidates for admission shall satisfy the following minimum requirements: Completion of four years of high school; successful completion of a standard equivalency test; or certification of equivalent education by an organization recognized by the United States Department of Education. Courses in physics, chemistry, biology, algebra, and geometry are strongly recommended.
(b) The number of students enrolled in each class shall be commensurate with the most effective learning and teaching practices and should also be consistent with acceptable student-teacher ratios.
Records shall be maintained as dictated by good educational practices.
Educational programs accredited by an organization recommended by the United States Department of Education are considered to have met these standards.
Sponsorship must be by an entity that assumes primary responsibility for the planning and conduct of competency-based didactic and clinical training in dental radiography.
1. This responsibility must include: defining the curriculum in terms of program goals, instructional objectives, learning experiences designed to achieve goals and objectives, and evaluation procedures to assess attainment of goals and objectives; coordinating classroom teaching and supervised clinical experiences; appointing faculty; receiving and processing applications for admission; and granting documents of successful completion of the program.
2. The formal training in dental radiography may be a part of a total program of dental hygiene education accredited by an organization recognized by the United States Department of Education.
3. The sponsoring entity and the dental radiography training must be approved by the State entity responsible for approving dental hygiene education programs or the State entity responsible for credentialing dental personnel in radiography.
Dental radiography training for dental hygienists must provide sufficient content and instructional time to assure competent performance.
1. The dental radiography curriculum content and learning experiences must include the theoretical aspects of the subject as well as practical application of techniques. The theoretical aspects should provide content necessary for dental hygienists to understand the critical nature of the radiological procedures they perform and of the judgments they make as related to patient and operator radiation safety.
2. The dental radiography curriculum must include content in seven areas: radiation physics; radiation biology; radiation health,
3. The curriculum must also include clinical practice assignments.
Evaluation procedures must be developed to assess performance and achievement of dental radiography program objectives.
The dental radiography training must be conducted by faculty who are qualified in the curriculum subject matter.
1. This may include a D.D.S./D.M.D. degree; graduation from an accredited dental assisting or dental hygiene education program with a certificate or an associate or baccalaureate degree; status as a Certified Dental Assistant certified by the Dental Assisting National Board; or recognition as equivalently qualified by the State entity which approved the training program in dental radiography.
2. The faculty-to-student ratio must be adequate to achieve the stated objectives of the curriculum.
Adequate radiographic facilities must be available to permit achievement of the dental radiography training objectives. The design, location, and construction of radiographic facilities must provide optimum protection from X-radiation for patients and operators. Equipment shall meet State and Federal laws related to radiation. Monitoring devices shall be worn by dental personnel. Lead aprons must be placed to protect patients. Safe storage for films must be provided. Darkroom facilities and equipment must be available and of a quality that assures that films will not be damaged or lost.
A wide range of printed materials, instructional aids, and equipment must be available to support instruction. Current specialized
Educational programs accredited by an organization recognized by the United States Department of Education are considered to have met these standards. Under existing licensure provisions in all States, becoming a dental hygienist requires graduation from a dental hygiene education program accredited by an organization recognized by the United States Department of Education. In lieu of this requirement, Alabama accepts graduation from a State-approved preceptorship program.
Sponsorship must be an entity that assumes primary responsibility for the planning and conduct of competency-based didactic and clinical training in dental radiography.
1. This responsibility must include: Defining the curriculum in terms of program goals, instructional objectives, learning experiences designed to achieve goals and objectives, and evaluation procedures to assess attainment of goals and objectives; coordinating classroom teaching and supervised clinical experiences; appointing faculty; receiving and processing applications for admission; and granting documents of successful completion of the program.
2. Dental radiography training may be freestanding (as a continuing education course offered by State dental/dental auxiliary societies, or by dental/dental auxiliary education programs); or be a part of an educational program in dental assisting. Such dental assisting education programs may be accredited by an organization recognized by the United States Department of Education; or located in a school accredited by an institutional accrediting agency recognized by the the United States Department of Education or approved by the State agency responsible for secondary and postsecondary education, or approved by a Federal agency conducting dental assistant education in that Agency.
3. The sponsoring entity and the dental radiography training must be approved by the State entity responsible for approving dental assisting education programs, or the State entity responsible for credentialing dental personnel in radiography.
Dental radiography training for dental assistants must provide sufficient content and instructional time to assure competent performance.
1. The dental radiography curriculum content and learning experiences must include the theoretical aspects of the subject as well as practical application of techniques. The theoretical aspects should provide content necessary for dental assistants to understand the critical nature of the radiological procedures they perform and of the judgments they make as related to patient and operator radiation safety.
2. The dental radiography curriculum must include content in seven areas: radiation physics; radiation biology; radiation health, safety, and protection; X-ray films and radiographic film quality; radiographic techniques; darkroom and processing techniques; and film mounting.
3. The curriculum must also include clinical practice assignments.
Evaluation procedures must be developed to assess performance and achievement of dental radiography program objectives.
The dental radiography training must be conducted by faculty who are qualified in the curriculum subject matter.
1. This may include a D.D.S./D.M.D. degree; graduation from an accredited dental assisting or dental hygiene education program with a certificate or an associate or baccalaureate degree; status as a Certified Dental Assistant certified by the Dental Assisting National Board; or recognition as equivalently qualified by the State entity (or Federal agency where appropriate) which approves the educational program in dental radiography.
2. The faculty-to-student ratio must be adequate to achieve the stated objectives of the curriculum.
Adequate radiographic facilities must be available to permit achievement of the dental radiography training objectives. The design, location, and construction of radiographic facilities must provide optimum protection from X-radiation for patients and operators. Equipment shall meet State and Federal laws related to radiation. Monitoring devices shall be worn by dental personnel. Lead aprons must be placed to protect patients. Safe storage for films must be provided. Darkroom facilities and equipment must be available and of a quality that assures that films will not be damaged or lost.
A wide range of printed materials, instructional aids, and equipment must be available to support instruction. Current specialized reference texts should be provided; and models, replicas, slides, and films which depict current techniques should be available for use in instruction. As appropriate self-instructional materials become available, they should be provided for the student's use.
Educational programs accredited by an organization recognized by the United States Department of Education are considered to have met these standards.
1. Accreditation will be granted to the institution that assumes primary responsibility for curriculum planning and selection of course content; coordinates classroom teaching and supervised clinical education; appoints faculty to the program; receives and processes applications for admission; and grants the degree or certificate documenting completion of the program.
2. Educational programs may be established in:
(a) Community and junior colleges, senior colleges, and universities;
(b) Hospitals and clinics;
(c) Laboratories;
(d) Medical schools;
(e) Postsecondary vocational/technical schools and institutions; and
(f) Other acceptable institutions which meet comparable standards.
3. The sponsoring institution and affiliate(s) must be accredited by a recognized agency. When the sponsoring institution and
4. Responsibilities of the sponsor and each affiliate for program administration, instruction, supervision, etc., must be carefully described in written affiliation agreements.
Instruction must follow a plan which documents:
1. A structured curriculum including clinical education with clearly written syllabi which describe learning objectives and competencies to be achieved. The curriculum shall be based on not less than one calendar year of full-time study or its equivalent.
2. The minimum professional curriculum that includes the following:
(a) Methods of patient care;
(b) Radiation safety and protection;
(c) Nuclear medicine physics;
(d) Radiation physics;
(e) Nuclear instrumentation;
(f) Statistics;
(g) Radionuclide chemistry;
(h) Radiopharmacology;
(i) Departmental organization and function;
(j) Radiation biology;
(k) Nuclear medicine
(l) Radionuclide therapy;
(m) Computer applications; and
(n) Clinical practicum.
3. Assignment of appropriate instructional materials.
4. Classroom presentations, discussions, and demonstrations.
5. Supervised practice, experience, and discussions. This shall include the following:
(a) Patient care and patient recordkeeping;
(b) Participation in the quality assurance program;
(c) The preparation, calculation, identification, administration, and disposal of radiopharmaceuticals;
(d) Radiation safety techniques that will minimize radiation exposure to the patient, public, fellow workers, and self;
(e) The performance of an adequate number and variety of imaging and non-imaging procedures; and
(f) Clinical correlation of nuclear medicine procedures.
6. Evaluation of student's knowledge, problem-solving skills, and motor and clinical competencies.
7. The competencies necessary for graduation.
1. The program must have qualified program officials. Primary responsibilities shall include program development, organization, administration, evaluation, and revision. The following program officials must be identified:
(a)
(2)
(b)
(2)
(c)
(1)
(2)
2.
(b)
(c)
(d)
3. Financial resoures for continued operation of the educational program must be assured.
4.
(b)
(c)
(d)
5.
Persons admitted into nuclear medicine technology programs shall have completed high school or its equivalent. They shall have completed postsecondary courses in the following areas:
(1) Human anatomy and physiology;
(2) Physics;
(3) Mathematics;
(4) Medical terminology;
(5) Oral and written communications;
(6) General chemistry; and
(7) Medical ethics.
Prerequisites may be completed during nuclear medicine training. Educational institutions such as junior colleges, universities, and technical vocational institutes may provide these prerequisite courses as part of an integrated program in nuclear medicine technology (i.e., two to four years).
Students may not take the responsibility nor the place of qualified staff. However, students may be permitted to perform procedures after demonstrating proficiency, with careful supervision.
1. Periodic and systematic review of the program's effectiveness must be documented.
2. One element of program evaluation shall be the initial employment of graduates of the program.
Educational programs accredited by an organization recognized by the United States Department of Education are considered to have met these standards.
1. Educational programs may be established in:
(a) Community and junior colleges, senior colleges, and universities;
(b) Hospitals, clinics, or autonomous radiation oncology centers meeting the criteria for major cancer management centers or meeting demonstrably equivalent standards;
(c) Medical schools; and
(d) Postsecondary vocational/technical schools and institutions.
2. The sponsoring institution and affiliates, if any, must be accredited by recognized agencies or meet equivalent standards. When more than one clinical education center is used, each must meet the standards of a major cancer management center.
3. When didactic preparation and supervised clinical education are not provided in the same institution, accreditation must be obtained by the sponsoring institution for the total program. This institution will be the one responsible for admission, curriculum, and academic credit. The accredited institution shall be responsible for coordinating the program and assuring that the activities assigned to the student in the clinical setting are educational. There shall be a uniform, written, affiliation agreement between the accredited institution and each clinical education center, clearly defining the responsibilities and obligations of each.
Educational programs of 24 months and 12 months or their equivalents may be developed. A 24-month program shall admit those candidates with a high school diploma (or equivalent) as outlined in D.1. The 12-month program shall be designed for those students admitted with backgrounds as outlined in D.2.
Instruction must follow a plan which documents:
1. A structured curriculum with clearly written course syllabi which describe competencies and learning objectives to be achieved. The curriculum shall include but not necessarily be limited to the following:
(a) Orientation to radiation therapy technology;
(b) Medical ethics and law;
(c) Methods of patient care;
(d) Medical terminology;
(e) Human structure and function;
(f) Oncologic pathology;
(g) Radiation oncology;
(h) Radiobiology;
(i) Mathematics;
(j) Radiation physics;
(k) Radiation protection;
(l) Radiation oncology technique;
(m) Radiographic imaging; and
(n) Clinical dosimetry.
2. Assignment of appropriate instructional materials.
3. Classroom presentations, discussions, and demonstrations.
4. Supervised clinical education and laboratory practicum.
5. Evaluation of students to assess knowledge, problem-solving skills, and motor and clinical competencies.
6. Program graduates must demonstrate competencies including, but not limited to, the following:
(a) Practice oral and written communications;
(b) Maintain records of treatment administered;
(c) Perform basic mathematical functions;
(d) Demonstrate knowledge of human structure, function, and pathology;
(e) Demonstrate knowledge of radiation physics in radiation interactions and radiation protection techniques;
(f) Provide basic patient care and cardiopulmonary resuscitation;
(g) Deliver a planned course of radiation therapy;
(h) Verify physician's prescribed course of radiation therapy and recognize errors in computation;
(i) Demonstrate awareness of patterns of physical and emotional stress exhibited by patients;
(j) Produces and utilize immobilization and beam directional devices;
(k) Prepare commonly used brachytherapy sources;
(l) Demonstrate knowledge of methods of calibration of equipment, and quality assurance;
(m) Prepare isodose summations;
(n) Detect malfunctioning equipment;
(o) Apply rules and regulations for radiation safety, and detect defects which might pose a radiation hazard;
(p) Understand the function of equipment and accessories;
(q) Demonstrate knowledge of methods of continuing patient evaluation (follow up);
(r) Apply wedge and compensating filters;
(s) Recognize patients' clinical progress, complications, and demonstrate knowledge of when to withhold treatment until consultation with the physician; and
(t) Interact with patients and families concerning the physical and psychological needs of patients.
1.
(a)
(2)
(b)
(1)
(2)
(c)
(1)
(2)
2.
(b)
(c)
(d)
3.
4.
(b)
(c)
(d)
(e)
5.
1. Applicants must be high school graduates (or equivalent) with an educational background in basic science and mathematics.
2. For admission to a 12-month program, the candidate must satisfy one of the following requirements:
(a) Graduation from an accredited or equivalent program in radiography.
(b) Successful completion or challenge of courses in the following prerequisite content areas:
(c) Successful demonstration of the following competencies:
1. A process for periodic and systematic review of the program's effectiveness must be documented and reflected in policies.
2. Program evaluation shall include the employment performance of recent graduates.
The following section describes basic elements to be incorporated in credentialing programs of States that choose to regulate personnel who perform radiologic procedures.
1. Only eligible applicants who have passed the licensure examination shall be licensed as Radiographers, Nuclear Medicine Technologists, or Radiation Therapy Technologists.
2. Licenses shall be renewed at periodic intervals.
1. For regular eligibility to take the licensure examination, applicants shall have successfully completed an accredited program of formal education in radiography, nuclear medicine technology, or radiation therapy technology.
2. Special eligibility to take the licensure examination shall be provided for applicants whose training and/or experience are equal
A criterion-referenced examination in radiography, nuclear medicine technology, or radiation therapy technology shall be utilized to test the knowledge and competencies of applicants.
The licensed Radiographer, Nuclear Medicine Technologist, or Radiation Therapy Technologist shall maintain continuing competency in the area in which he/she is practicing.
An organization that seeks to be recognized for the certifying of personnel shall adopt definite policies to ensure validity, objectivity, and fairness in the certifying process. The National Commission for Health Certifying Agencies (NCHCA) has published suitable criteria for a certifying organization to adopt with respect to policies for: (1) Determination of appropriate examination content (but not the actual content for any specific occupation); (2) construction of examinations; (3) administration of examinations; and (4) fulfilling responsibilities to applicants. An organization (whether an NCHCA member or not) that adopts these or equivalent criteria will meet all of the requirements of this section of these standards.
The following section describes basic elements to be incorporated in credentialing programs of States that choose to regulate personnel who perform radiologic procedures.
Currently, Dental Hygienists are credentialed through individual State licensure processes, all of which include assessment of competence in dental radiography. In all States, Dental Hygienists are required to be licensed prior to practicing. The existing State dental hygiene licensure processes meet the intent and purpose of the Consumer-Patient Radiation Health and Safety Act of 1981 and the standards for licensing Dental Hygienists in dental radiography set forth below.
1. To those who have passed a licensure or designated dental radiography examination, a license or permit shall be issued by the State entity responsible for credentialing dental personnel.
2. Licenses or permits shall be renewed at periodic intervals.
1. An individual shall provide proof of graduating student status or graduation from an accredited or approved dental hygiene or dental assisting education program.
2. For dental assistants, special eligibility to take the examination shall be provided to applicants with appropriate combinations of training and/or experience.
A criterion-referenced examination in dental radiography shall be utilized to test the knowledge and competencies of applicants.
The Dental Hygienist or Dental Assistant shall be required to maintain continuing competency in the area in which he/she is practicing.
An organization that seeks to be recognized for the certifying of personnel shall adopt definite policies to ensure validity, objectivity, and fairness in the certifying process. The National Commission for Health Certifying Agencies (NCHCA) has published suitable criteria for a certifying organization to adopt with respect to policies for: (1) Determination of appropriate examination content (but not the actual content for any specific occupation); (2) construction of examinations; (3) administration of examinations; and (4) fulfilling responsibilities to applicants. An organization (whether an NCHCA member or not) that adopts these or equivalent criteria will meet all of the requirements of this section of these standards.