21 U.S.C. 141-149.
For Animal and Plant Health Inspection Service regulations concerning tubercular cattle, see 9 CFR parts 50 and 77. For Animal and Plant Health Inspection Service regulations, see 9 CFR chapter I. For customs regulations concerning importation of milk and cream, see 19 CFR 12.7. For regulations of the Agricultural Marketing Service (Marketing Agreements and Orders) covering marketing areas for milk, see 7 CFR chapter X.
For the purposes of the regulations in this part the act (44 Stat. 1101; 21 U.S.C. 141-149) “To regulate the importation of milk and cream into the United States for the purpose of promoting the dairy industry of the United States and protecting the public health” shall be known and referred to as “the Federal Import Milk Act.”
The provisions of the act apply to all milk and cream offered for import into the continental United States.
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
Dairy farms and plants from which milk or cream is shipped or transported into the United States shall be open at all reasonable times to authorized agents for necessary examinations and inspections. Failure to permit such examinations and inspections may be considered cause for the suspension or revocation of the permit.
The sanitary conditions of any dairy farm producing milk or cream to be shipped or transported into the United States or to a plant from which milk or cream is to be shipped or transported into the United States must score at least 50 points out of 100 points, according to the methods for scoring as provided by the score card for sanitary inspection of dairy farms in the form prescribed by the Secretary.
(a) Physical examination of any and all cows in herds producing milk or cream which is to be shipped or transported into the United States shall be made by an authorized veterinarian of the United States or of any State or municipality thereof or of the country in which such milk or cream is produced to determine whether such cow or cows are in a healthy condition. Such examination shall be made as often as the Secretary may deem necessary and, in any event, shall have been made within one year previous to the time of the importation.
(b) The result of the physical examination shall be set forth in the form prescribed by the Secretary.
(a) Except as provided in § 1210.27 any and all animals in herds producing milk or cream which is to be shipped or transported raw into the United States shall be free from tuberculosis, as determined by a tuberculin test applied by an official veterinarian of the United States or of any State or municipality thereof or of the country in which such milk or cream is produced. Such test shall be made as often as the Secretary may deem necessary and, in any event, shall have been made within 1 year previous to the time of the importation. All animals showing positive or suspicious reactions to the tuberculin test must be permanently removed from the herd.
(b) The results of the tuberculin test and all facts concerning the disposal of reacting or suspected animals shall be set forth in the form prescribed by the Secretary.
The sanitary conditions of any plant handling milk or cream any part of which is to be shipped or transported into the United States shall score at least 50 points out of 100 points according to the methods for scoring as provided by the score card for sanitary inspection of such plants in the form prescribed by the Secretary.
All dairy farms and plants at which any milk or cream is pasteurized for shipment or transportation into the United States shall employ adequate pasteurization machinery of a type easily cleaned and of sanitary construction capable of holding every portion of the milk or cream at the required temperature for the required time. Such pasteurizing machinery shall be properly equipped with accurate time and temperature recording devices, which shall be kept at all times in good working order. The temperature at the time of heating and holding must invariably be recorded on thermograph charts, initialed, numbered, and dated by the official having jurisdiction over such farms and plants. All thermograph charts shall be held for a period of 2 years unless within that period they have been examined and released by such authorized agents as are designated by the Secretary.
The bacterial count of milk and cream refers to the number of viable bacteria as determined by the standard plate method of the American Public Health Association in use at the time of the examination.
Inspectors engaged in the enforcement of the Federal Import Milk Act are empowered to test for temperature, to take samples of milk or cream, and to use such means as may be necessary for these purposes.
Scoring of sanitary conditions required by §§ 1210.11, 1210.14 shall be done by an official inspector of the United States or of any State or municipality thereof or of the country in which the dairy farm or plant is located.
Application for a permit to ship or transport milk or cream into the United States shall be made by the actual shipper upon forms prescribed by the Secretary. The request for forms of applications for permits should be addressed to Commissioner of Food and Drugs, Food and Drug Administration, Department of Health and Human Services, 5600 Fishers Lane, Rockville, MD 20857.
Each permit issued under the Federal Import Milk Act, including each temporary permit, shall bear an individual number. The right to the use of such number is restricted solely to the permittee.
Each container of milk or cream shipped or transported into the United States by such permittee shall have firmly attached thereto a tag in the following form, bearing the required information in clear and legible type:
Product
(State whether raw milk, pasteurized milk, raw cream, or pasteurized cream.)
Permit number
Federal Import Milk Act, Department of Health and Human Services.
Shipper
Address of shipper
In the discretion of the Secretary, a permit may be granted on a duly certified statement signed by a duly accredited official of an authorized department of any foreign government or of any State of the United States or any municipality thereof. Such statement shall be in the form of a certificate prescribed by the Secretary, and shall have attached thereto, as a part thereof, signed copies of reports prescribed by §§ 1210.12, 1230.13, and also by §§ 1210.11, 1210.14, as applicable. The necessary inspections and examinations upon which the reports are based
A temporary permit will be granted only upon a satisfactory showing that the applicant therefor has been unable to obtain the necessary inspections required by the applicable provisions of section 2 of the Federal Import Milk Act. Temporary permits shall be valid until the Secretary shall provide for inspection to ascertain that clauses 1, 2, and 3 of section 2 of the Federal Import Milk Act have been complied with.
Permits to ship or transport pasteurized milk or cream into the United States will be granted only upon compliance with the requirements of clauses 1 and 3 of section 2 of the Federal Import Milk Act, §§ 1210.11, 1210.12, 1210.14, as applicable.
Except as provided in § 1210.27, permits to ship or transport raw milk or cream into the United States will be granted only when the milk or cream comes from dairy farms or plants where pasteurization is not carried on and then only upon compliance with the requirements of clauses 1, 2, and 3 of section 2 of the Federal Import Milk Act, §§ 1210.11 to 1210.14 as applicable.
A permit to ship or transport raw milk into the United States will contain a waiver of clauses 2 and 5 of section 2 of the Federal Import Milk Act when the shipper is an operator of a creamery or condensery, or is a producer shipping or transporting to a creamery or condensery and the creamery or condensery is located in the United States within a radius of 20 miles of the point of production of such milk, and the milk, prior to its sale, use, or disposal, is pasteurized, condensed, or evaporated.
The Secretary, in his discretion, will issue to a shipper who is an operator of a condensery a permit waiving the requirements of clause 4, of section 2 of the Federal Import Milk Act and allowing milk and cream containing not to exceed 1,200,000 bacteria per cubic centimeter to be shipped or transported into the United States if the condensery is located within a radius of 15 miles of the point of production of the milk and cream and such milk and cream are to be sterilized in the manufacture of condensed milk.
Any person who contests denial, suspension, or revocation of a permit shall have an opportunity for a regulatory hearing before the Food and Drug Administration pursuant to subpart F of part 16 of this chapter.
Before violation of the act is referred to the Department of Justice for prosecution under section 5 of the Federal Import Milk Act, an opportunity to be heard will be given to the party against whom prosecution is under consideration. The hearing will be private and confined to questions of fact. The party notified may present evidence, either oral or written, in person or by attorney, to show cause why he should not be prosecuted. After a hearing is held, if it appears that the law has been violated, the facts will be reported to the Department of Justice.
15 U.S.C. 1261-1276.
For regulations relating to invoices, entry, and assessment of duties, see 19 CFR parts 141, 142, 143, 151, 152. For regulations regarding the examination, classification, and disposition of foods, drugs, devices, cosmetics, insecticides, fungicides, and caustic or corrosive substances, see 19 CFR part 12. For regulations relating to consular invoices, and documentation of merchandise, see 22 CFR parts 91 and 92.
The provisions of the act apply to any container which has been shipped or delivered for shipment in interstate or foreign commerce, as defined in section 2(c) of the act (44 Stat. 1407; 15 U.S.C. 402) or which has been received from shipment in such commerce for sale or exchange, or which is sold or offered for sale or held for sale or exchange in any Territory or possession or in the District of Columbia.
(a) The word
(b) The words
The label or sticker shall be so firmly attached to the container that it will remain thereon while the container is being used, and be so placed as readily to attract attention.
(a) The common name of the dangerous caustic or corrosive substance which shall appear on the label or sticker is the name given in section 2(a) of the act (44 Stat. 1406; 15 U.S.C. 402) or any other name commonly employed to designate and identify such substance.
(b) Preparations within the scope of the act bearing trade or fanciful names shall, in addition, be labeled with the common name of the dangerous caustic or corrosive substance contained therein and comply with all the other requirements of the act and of the regulations in this part.
If the name on the label or sticker is other than that of the manufacturer, it shall be qualified by such words as “packed for,” “packed by,” “sold by,” or “distributed by,” as the case may be, or by other appropriate expression.
The following are styles of uncondensed Gothic capital letters 24-point (type face) size:
Except as provided in § 1230.16, the container shall bear in all cases upon the label or sticker thereof, immediately following the word “Poison,” directions for treatment in the case of internal personal injury; in addition, if the substance may cause external injury, directions for appropriate treatment shall be given. The directions shall prescribe such treatments for personal injury as are sanctioned by competent medical authority, and the materials called for by such directions shall be, whenever practicable, such as are usually available in the household.
A person who receives from a manufacturer or wholesaler any container which under the conditions set forth in section 2(b)(4) of the act and § 1230.16 does not bear at the time of shipment directions for treatment in the case of personal injury must place such directions on the label or sticker if he offers such container for general sale or exchange.
Manufacturers and wholesalers only, at the time of shipment or delivery for shipment, are exempted from placing directions for treatment on the label or sticker of any container for other than household use, but in any event the information required by section 2(b) (1), (2), and (3) of the act (44 Stat. 1407; 15 U.S.C. 402) and the regulations in this part shall be given.
In lieu of a particular guaranty for each lot of dangerous caustic or corrosive substances, a general continuing guaranty may be furnished by the guarantor to actual or prospective purchasers. The following are forms of continuing guaranties:
(a) Substances for both household use and other than household use:
The undersigned guarantees that the retail parcels, packages, or containers of the dangerous caustic or corrosive substance or substances to be sold to _____ are not misbranded within the meaning of the Federal Caustic Poison Act.
(Date)
(b) Substances for other than household use (this form may be issued only by a manufacturer or wholesaler) (§§ 1230.15, 1230.16):
The dangerous caustic or corrosive substance or substances in retail parcels, packages, or containers suitable for household use to be sold to _____ are for other than household use, and guaranteed not to be misbranded within the meaning of the Federal Caustic Poison Act.
(Date)
If a guaranty in respect to any specific lot of dangerous caustic or corrosive substances be given, it shall be incorporated in or attached to the bill of sale, invoice, or other schedule bearing the date and the name and quantity of the substance sold, and shall not appear on the label or package. The following are forms of specific guaranties:
(a) Substances for both household use and other than household use:
The undersigned guarantees that the retail parcels, packages, or containers of the dangerous caustic or corrosive substance or substances listed herein (or specifying the substances) are not misbranded within the meaning of the Federal Caustic Poison Act.
(b) Substances for other than household use (this form may be issued only by a manufacturer or wholesaler (§§ 1230.15, 1230.16):
The dangerous caustic or corrosive substance or substances listed herein (or specifying the substances) in retail parcels, packages, or containers suitable for household use are for other than household use and are guaranteed not to be misbranded within the meaning of the Federal Caustic Poison Act.
Samples for examination by or under the direction and supervision of the Food and Drug Administration shall be collected by:
(a) An authorized agent in the employ of the Department of Health and Human Services;
(b) Any officer of any State, Territory, or possession, or of the District of Columbia, authorized by the Secretary of Health and Human Services.
Caustic or corrosive substances within the scope of this act (44 Stat. 1406; 15 U.S.C. 401-411) may be sampled wherever found.
Samples collected by an authorized agent shall be analyzed at the laboratory designated by the Food and Drug Administration. Only such samples as are collected in accordance with §§ 1230.30, 1230.31 may be analyzed by or under the direction and supervision of the Food and Drug Administration. Upon request one subdivision of the sample, if available, shall be delivered to the party or parties interested.
Authorized agents in the employ of the Department of Health and Human Services may make investigations, including the inspection of premises where dangerous caustic and corrosive substances subject to the act are manufactured, packed, stored, or held for sale or distribution, and make examinations of freight and other transportation records.
(a) The methods of examination or analysis employed shall be those prescribed by the Association of Official Agricultural Chemists, when applicable, provided, however, that any method of analysis or examination satisfactory to the Food and Drug Administration may be employed.
(b) All percentages stated in the definitions in section 2(a) of the Federal Caustic Poison Act shall be determined by weight.
Whenever it appears from the inspection, analysis, or test of any container that the provisions of section 3 or 6 of the Federal Caustic Poison Act (44 Stat. 1407, 1409; 15 U.S.C. 403, 406) have been violated and criminal proceedings are contemplated, notice shall be given to the party or parties against whom prosecution is under consideration and to other interested parties, and a date shall be fixed at which such party or parties may be heard. The hearing shall be held at the office of the Food and Drug Administration designated in the notice and shall be private and confined to questions of fact. The parties notified may present evidence, either oral or written, in person or by attorney, to show cause why the matter should not be referred for prosecution as a violation of the Federal Caustic Poison Act.
No hearing is provided for when the health, medical, or drug officer or agent of any State, Territory, or possession, or of the District of Columbia, acts under the authority contained in section 8 of the Federal Caustic Poison
(a) After judgment of the court in any proceeding under the Federal Caustic Poison Act, notice shall be given by publication. Such notice shall include the findings of the court and may include the findings of the analyst and such explanatory statements of fact as the Secretary of Health and Human Services may deem appropriate.
(b) This publication may be made in the form of a circular, notice, or bulletin, as the Secretary of Health and Human Services may direct.
(c) If an appeal be taken from the judgment of the court before such publication, that fact shall appear.
Containers which are offered for import shall in all cases bear labels or stickers having thereon the information required by section 2(b) (1), (2), and (3) of the Federal Caustic Poison Act and the directions for treatment in the case of personal injury, except such directions need not appear on the label or sticker at the time of shipment by a wholesaler or manufacturer for other than household use.
Containers shall not be delivered to the consignee prior to report of examination, unless a bond has been given on the appropriate form for the amount of the full invoice value of such containers, together with the duty thereon, and the refusal of the consignee to return such containers for any cause to the custody of the District Director of Customs when demanded, for the purpose of excluding them from the country or for any other purpose, the consignee shall pay an amount equal to the sum named in the bond, and such part of the duty, if any, as may be payable, as liquidated damages for failure to return to the District Director of Customs on demand all containers covered by the bond.
As soon as the importer makes entry, the invoices covering containers and the public stores packages shall be made available, with the least possible delay, for inspection by the representative of the district. When no sample is desired the invoice shall be stamped by the district “No sample desired, Food and Drug Administration, Department of Health and Human Services, per (initials of inspecting officer).”
(a)
(b)
(c)
(d)
(2) On the day of receipt of such notice the chief of district shall mail to the District Director of Customs appropriate notice, if no sample is desired. This notice serves as an equivalent to stamping the invoices at district ports with the legend “No sample desired,
(3) If samples are desired, the Chief of district shall immediately notify the District Director of Customs.
(4) The District Director of Customs at once shall forward samples, accompanied by description of shipment.
(5) When samples are desired from each shipment of containers, the chief of district shall furnish to District Director of Customs and deputies at ports within the district's territory a list of such containers, indicating the size of sample necessary. Samples should then be sent promptly on arrival of containers without awaiting special request.
(6) In all other particulars the procedure shall be the same at nonlaboratory ports as at laboratory ports, except that the time consumed in delivery of notices by mail shall be allowed for.
On the same day that samples are requested by the district, the District Director of Customs or appraiser shall notify the importer that samples will be taken, that the containers must be held intact pending a notice of the result of inspection and analysis, and that in case the containers do not comply with the requirements of the Federal Caustic Poison Act, they must be returned to the District Director of Customs for disposition. This notification may be given by the District Director of Customs or appraiser through individual notices to the importer or by suitable bulletin notices posted daily in the customhouse.
As soon as examination of the samples is completed, if no violation of the act is detected, the chief of the district shall send a notice of release to the importer and a copy of this notice to the District Director of Customs for his information.
(a) If a violation of the Federal Caustic Poison Act is disclosed, the chief of the district shall send to the importer due notice of the nature of the violation and of the time and place where evidence may be presented, showing that the containers should not be refused admission. At the same time similar notice regarding detention of the containers shall be sent to the District Director of Customs, requesting him to refuse delivery thereof or to require their return to customs custody if by any chance the containers were released without the bond referred to in § 1230.41. The time allowed the importer for representations regarding the shipment may be extended at his request for a reasonable period to permit him to secure such evidence.
(b) If the importer does not reply to the notice of hearing in person or by letter within the time allowed on the notice, a second notice, marked “second and last notice,” shall be sent at once by the chief of the district, advising him that failure to reply will cause definite recommendation to the District Director of Customs that the containers be refused admission and that the containers be exported within 3 months under customs supervision.
(a) In all cases where the containers are to be refused admission, the chief of the district within 1 day after hearing, or, if the importer does not appear or reply within 3 days after second notice, shall notify the District Director of Customs in duplicate accordingly.
(b) Not later than 1 day after receipt of this notice the District Director of Customs shall sign and transmit to the importer one of the copies, which shall serve as notification to the importer that the containers must be exported under customs supervision within 3 months from such date, as provided by law; the other notice shall be retained as office record and later returned as a report to the chief of the district. In all cases the importer shall return his notice to the District Director of Customs, properly certified as to the information required, as the form provides.
(a) If containers are to be released after relabeling, a notice shall be sent by the chief of district direct to the importer, a carbon copy being sent to the
(b) The importer must return the notice to the District Director of Customs or chief of district, as designated, with the certificate thereon filled out, stating that he has complied with the prescribed conditions and that the containers are ready for inspection at the place named.
(c) This notice will be delivered to the inspection officer, who, after inspection, will endorse the result thereof on the back of the notice and return the same to the District Director of Customs or to the chief of district, as the case may be.
(d) When the conditions to be complied with are under the supervision of the chief of district, and these conditions have been fully met, he shall release the containers to the importer, sending a copy of the notice of release to the District Director of Customs for his information. If the containers have not been properly relabeled within the period allowed, the chief of district shall immediately give notice in duplicate to the District Director of Customs of the results of inspection. The District Director of Customs shall sign and immediately transmit one copy of the notice to the importer and proceed in the usual manner.
(e) If the containers are detained subject to relabeling to be performed under the supervision of the District Director of Customs, the District Director of Customs, as soon as relabeling is accomplished, will notify the importer that the containers are released.
(f) If the containers have not been properly relabeled within the period allowed, their sale after labeling as required by the act or other disposition must be effected by the District Director of Customs.
(g) When the final action has been taken on containers which have been refused admission, sold, or otherwise disposed of as provided for by the act or which have been relabeled under the supervision of the District Director of Customs, he shall send to the chief of district a notice of such final action, giving the date and disposition.
(h) When relabeling is allowed the importer must furnish satisfactory evidence as to the identity of the containers before release is given. The relabeling must be done at a stated place and apart from other containers of a similar nature.
(i) When containers are shipped to another port for relabeling or exportation, they must be shipped under customs carrier's manifest, in the same manner as shipments in bond.
(j) District Directors of Customs will perform the inspection service whenever containers are to be exported, sold, or otherwise disposed of, and in other cases when there is no officer of the district available.
(k) District Directors of Customs and representatives of the district will confer and arrange the apportionment of the inspection service according to local conditions. Officers of the district will, whenever feasible, perform the inspection service in connection with relabeling.
(a) In case of failure to comply with the instructions or recommendations of the chief of district as to conditions under which containers may be disposed of, the District Director of Customs shall notify the chief of district in all cases coming to his attention within 3 days after inspection or after the expiration of the 3 months allowed by law if no action is taken.
(b) The chief of district, upon receipt of the above-described notice, and in all cases of failure to meet the conditions imposed in order to comply with the provisions of the Federal Caustic Poison Act coming directly under his supervision, shall transmit to the District Director of Customs such evidence as he may have at hand tending
(c) The District Director of Customs, within 3 days of the receipt of this recommendation, whether favorable or otherwise, shall notify the importer that, the legal period of 3 months for exportation or relabeling having expired, action will be taken within 30 days to enforce the terms of the bond.
42 U.S.C. 216, 243, 264, 271.
For Department of Health and Human Services regulations relating to foreign quarantine, sanitation measures, and control of communicable diseases, see Centers for Disease Control's requirements as set forth in 42 CFR parts 71 and 72.
As used in this part, terms shall have the following meaning:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(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.
(i)
(j)
(k)
(l)
(m)
(n)
(o)
(p)
(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.
(q)
(r)
(s)
(t)
(u)
Whenever, under the provisions of this part, bactericidal treatment is required, it shall be accomplished by one or more of the following methods:
(a) By immersion of the utensil or equipment for at least 2 minutes in clean hot water at a temperature of at least 170 °F or for one-half minute in boiling water;
(b) By immersion of the utensil or equipment for at least 2 minutes in a lukewarm chlorine bath containing at least 50 ppm of available chlorine if hypochlorites are used or a concentration of equal bactericidal strength if chloramines are used;
(c) By exposure of the utensil or equipment in a steam cabinet at a temperature of at least 170 °F for at least 15 minutes or at a temperature of 200 °F for at least 5 minutes;
(d) By exposure of the utensil or equipment in an oven or hot air cabinet at a temperature of at least 180 °F for at least 20 minutes;
(e) In the case of utensils or equipment so designed or installed as to make immersion or exposure impractical, the equipment may be treated for the prescribed periods of time either at the temperatures or with chlorine solutions as specified above, (1) with live steam from a hose if the steam can be confined, (2) with boiling rinse water, or (3) by spraying or swabbing with chlorine solution;
(f) Any other method determined by the Commissioner of Food and Drugs, upon application of an owner or operator of a conveyance, to be effective to prevent the spread of communicable disease.
The Commissioner of Food and Drugs may issue certificates based upon inspections provided for in this part and part 1250. Such certificates shall be prominently posted on conveyances.
Whenever the Commissioner of Food and Drugs 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 may take such measures to prevent such spread of the diseases as he deems reasonably necessary, including inspection, fumigation, disinfection, sanitation, pest extermination, and destruction of animals or articles believed to be sources of infection.
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.
(a) A person shall not offer for transportation, or transport, in interstate traffic any molluscan shellfish handled or stored in such an insanitary manner, or grown in an area so contaminated, as to render such molluscan shellfish likely to become agents in, and their transportation likely to contribute to the spread of communicable disease from one State or possession to another.
(b) All shellstock shall bear a tag that discloses the date and place they were harvested (by State and site), type and quantity of shellfish, and by whom they were harvested (i.e., the identification number assigned to the harvester by the shellfish control authority, where applicable or, if such identification numbers are not assigned, the name of the harvester or the name or registration number of the harvester's vessel). In place of the tag,
(c) All containers of shucked molluscan shellfish shall bear a label that identifies the name, address, and certification number of the packer or repacker of the molluscan shellfish.
(d) Any molluscan shellfish without such a tag, shipping document, or label, or with a tag, shipping document, or label that does not bear all the information required by paragraphs (b) and (c) of this section, shall be subject to seizure or refusal of entry, and destruction.
(a) No person shall cause to be delivered into interstate commerce or shall sell, otherwise distribute, or hold for sale or other distribution after shipment in interstate commerce any milk or milk product in final package form for direct human consumption unless the product has been pasteurized or is made from dairy ingredients (milk or milk products) that have all been pasteurized, except where alternative procedures to pasteurization are provided for by regulation, such as in part 133 of this chapter for curing of certain cheese varieties.
(b) Except as provided in paragraphs (c) and (d) of this section, the terms “pasteurization,” “pasteurized,” and similar terms shall mean the process of heating every particle of milk and milk product in properly designed and operated equipment to one of the temperatures given in the following table and held continuously at or above that temperature for at least the corresponding specified time:
(c) Eggnog shall be heated to at least the following temperature and time specification:
(d) Neither paragraph (b) nor (c) of this section shall be construed as barring any other pasteurization process that has been recognized by the Food and Drug Administration to be equally efficient in the destruction of microbial organisms of public health significance.
(a)
(b)
(c)
(i) Any District Office of the Food and Drug Administration, upon detecting viable turtle eggs or live turtles with a carapace length of less than 4 inches which are held for sale or offered for any other type of commercial
(ii) The person on whom the demand for destruction is served may either comply with the demand or, within 10 working days from the date of its promulgation, appeal the demand for destruction to the Director of the Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. The demand for destruction may also be appealed within the same period of 10 working days by any other person having a pecuniary interest in such turtles or turtle eggs. In the event of such an appeal, the Center Director shall provide an opportunity for hearing by written notice to the appellant(s) specifying a time and place for the hearing, to be held within 14 days from the date of the notice but not within less than 7 days unless by agreement with the appellant(s).
(iii) Appearance by any appellant at the hearing may be by mail or in person, with or without counsel. The hearing shall be conducted by the Center Director or his designee, and a written summary of the proceedings shall be prepared by the person presiding. Any appellant shall have the right to hear and to question the evidence on which the demand for destruction is based, including the right to cross-examine witnesses, and he may present oral or written evidence in response to the demand.
(iv) If, based on the evidence presented at the hearing, the Center Director finds that the turtles or turtle eggs were held for sale or offered for any other type of commercial or public distribution in violation of this section, he shall affirm the demand that they be destroyed under the supervision of an officer or employee of the Food and Drug Administration; otherwise, the Center Director shall issue a written notice that the prior demand by the District Office is withdrawn. If the Center Director affirms the demand for destruction he shall order that the destruction be accomplished in a humane manner within 10 working days from the date of the promulgation of his decision. The Center Director's decision shall be accompanied by a statement of the reasons for the decision. The decision of the Center Director shall constitute final agency action, reviewable in the courts.
(v) If there is no appeal to the Director of the Center for Food Safety and Applied Nutrition from the demand by the Food and Drug Administration District Office and the person in possession of the turtles or turtle eggs fails to destroy them within 10 working days, or if the demand is affirmed by the Director of the Center for Food Safety and Applied Nutrition after an appeal and the person in possession of the turtles or turtle eggs fails to destroy them within 10 working days, the District Office shall designate an officer or employee to destroy the turtles or turtle eggs. It shall be unlawful to prevent or to attempt to prevent such destruction of turtles or turtle eggs by the officer or employee designated by the District Office. Such destruction will be stayed if so ordered by a court pursuant to an action for review in the courts as provided in paragraph (c)(1)(iv) of this section.
(2) Any person who violates any provision of this section, including but not limited to any person who sells, offers for sale, or offers for any other type of commercial or public distribution viable turtle eggs or live turtles with a carapace length of less than 4 inches, or who refuses to comply with a valid final demand for destruction of turtles or turtle eggs (either an unappealed demand by an FDA District Office or a demand which has been affirmed by the Director of the Center for Food Safety
(d)
(1) The sale, holding for sale, and distribution of live turtles and viable turtle eggs for bona fide scientific, educational, or exhibitional purposes, other than use as pets.
(2) The sale, holding for sale, and distribution of live turtles and viable turtle eggs not in connection with a business.
(3) The sale, holding for sale, and distribution of live turtles and viable turtle eggs intended for export only, provided that the outside of the shipping package is conspicuously labeled “For Export Only.”
(4) Marine turtles excluded from this regulation under the provisions of paragraph (a) of this section and eggs of such turtles.
(e)
(a) The term psittacine birds shall include all birds commonly known as parrots, Amazons, Mexican double heads, African grays, cocatoos, macaws, parakeets, love birds, lories, lorikeets, and all other birds of the psittacine family.
(b) No person shall transport, or offer for transportation, in interstate traffic any psittacine bird unless the shipment is accompanied by a permit from the State health department of the State of destination where required by such department.
(c) Whenever the Surgeon General finds that psittacine birds or human beings in any area are infected with psittacosis and there is such danger of transmission of psittacosis from such area as to endanger the public health, he may declare it an area of infection. No person shall thereafter transport, or offer for transportation, in interstate traffic any psittacine bird from such area, except shipments authorized by the Surgeon General for purposes of medical research and accompanied by a permit issued by him, until the Surgeon General finds that there is no longer any danger of transmission of psittacosis from such area. As used in this paragraph, the term “area” includes, but is not limited to, specific premises or buildings.
(a) A person shall not transport, receive, or cause to be transported or received, garbage in interstate traffic and feed such garbage to swine unless, prior to the feeding, such garbage has received minimum heat treatment.
(b) A person transporting garbage in interstate traffic shall not make, or agree to make, delivery thereof to any person with knowledge of the intent or customary practice of such person to feed to swine garbage which has not been subjected to minimum heat treatment.
Only potable water shall be provided for drinking and culinary purposes by any operator of a conveyance engaged in interstate traffic, except as provided in § 1250.84(b) of this chapter. Such water shall either have been obtained from watering points approved by the
(a) The Commissioner of Food and Drugs shall approve any watering point if (1) the water supply thereat meets the standards prescribed in the Environmental Protection Agency's Primary Drinking Water Regulations as set forth in 40 CFR part 141, and (2) the methods of and facilities for delivery of such water to the conveyance and the sanitary conditions surrounding such delivery prevent the introduction, transmission, or spread of communicable diseases.
(b) The Commissioner of Food and Drugs may base his approval or disapproval of a watering point upon investigations made by representatives of State departments of health or of the health authorities of contiguous foreign nations.
(c) If a watering point has not been approved, the Commissioner of Food and Drugs may permit its temporary use under such conditions as, in his judgment, are necessary to prevent the introduction, transmission, or spread of communicable diseases.
(d) Upon request of the Commissioner of Food and Drugs, operators of conveyances shall provide information as to watering points used by them.
No vessel engaged in interstate traffic shall make a connection between its nonpotable water system and any pier potable water system unless provisions are made to prevent backflow from the vessel to the pier.
(a) The treatment of water aboard conveyances shall be approved by the Commissioner of Food and Drugs if the apparatus used is of such design and is so operated as to be capable of producing and in fact does produce, potable water.
(b) The Commissioner of Food and Drugs may base his approval or disapproval of the treatment of water upon investigations made by representatives of State departments of health or of the health authorities of contiguous foreign nations.
(c) Overboard water treated on vessels shall be from areas relatively free of contamination and pollution.
No vessel engaged in interstate traffic shall obtain water for drinking and culinary purposes from any water boat unless the tanks, piping, and other appurtenances used by the water boat in the loading, transportation, and delivery of such drinking and culinary water, have been approved by the Commissioner of Food and Drugs.
42 U.S.C. 216, 243, 264, 271.
For Department of Health and Human Services regulations relating to foreign quarantine and control of communicable diseases, see Centers for Disease Control's requirements as set forth in 42 CFR parts 71 and 72.
As used in this part, terms shall have the following meaning:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(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.
(i)
(j)
(k)
(l)
(m)
(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.
(n)
(o)
All conveyances engaged in interstate traffic shall comply with the requirements prescribed in this subpart and § 1240.20 of this chapter.
The Commissioner of Food and Drugs may inspect such conveyance to determine compliance with the requirements of this subpart and § 1240.20 of this chapter.
All food and drink served on conveyances shall be clean, wholesome, and free from spoilage, and shall be prepared, stored, handled, and served in accordance with the requirements prescribed in this subpart and § 1240.20 of this chapter.
(a) Operators of conveyances shall identify, when requested by the Commissioner of Food and Drugs, the vendors, distributors or dealers from whom they have acquired or are acquiring their food supply, including milk, fluid milk products, ice cream and other frozen desserts, butter, cheese, bottled water, sandwiches and box lunches.
(b) The Commissioner of Food and Drugs may inspect any source of such food supply in order to determine whether the requirements of the regulations in this subpart and in § 1240.20 of this chapter are being met, and may utilize the results of inspections of such sources made by representatives of State health departments or of the health authorities of contiguous foreign nations.
Milk, fluid milk products, ice cream and other frozen desserts, butter, cheese, and shellfish served or sold on conveyances shall conform to the following requirements:
(a) Milk and fluid milk products, including cream, buttermilk, skim milk, milk beverages, and reconstituted milk, shall be pasteurized and obtained from a source of supply approved by the Commissioner of Food and Drugs. The Commissioner of Food and Drugs shall approve any source of supply at or from which milk or fluid milk products are produced, processed, and distributed so as to prevent the introduction, transmission, or spread of communicable diseases. If a source of supply of milk or fluid milk products has not been approved, the Commissioner of Food and Drugs may permit its temporary use under such conditions as, in his judgment, are necessary to prevent the introduction, transmission, or spread of communicable diseases. Containers of milk and fluid milk products shall be plainly labeled to show the contents, the word “pasteurized”, and the identity of the plant at which the contents were packaged by name and address, provided that a code may be used in lieu of address.
(b) Ice cream, other frozen desserts, and butter shall be manufactured from milk or milk products that have been pasteurized or subjected to equivalent heat treatment.
(c) Cheese shall be (1) pasteurized or subjected to equivalent heat treatment, (2) made from pasteurized milk products or from milk products which have been subjected to equivalent heat treatment, or (3) cured for not less than 60 days at a temperature not less than 35 °F.
(d) Milk, buttermilk, and milk beverages shall be served in or from the original individual containers in which received from the distributor, or from a bulk container equipped with a dispensing device so designed, constructed, installed, and maintained as to prevent the transmission of communicable diseases.
(e) Shellfish purchased for consumption on any conveyance shall originate from a dealer currently listed by the Public Health Service as holding an unexpired and unrevoked certificate issued by a State authority.
(f) Shucked shellfish shall be purchased in the containers in which they are placed at the shucking plant and shall be kept therein until used. The State abbreviation and the certificate number of the packers shall be permanently recorded on the container.
All perishable food or drink shall be kept at or below 50 °F, except when being prepared or kept hot for serving.
Ice coming in contact with food or drink and not manufactured on the conveyance shall be obtained from sources approved by competent health authorities. All ice coming in contact with food or drink shall be stored and handled in such manner as to avoid contamination.
(a) All kitchens, galleys, pantries, and other places where food is prepared, served, or stored shall be adequately lighted and ventilated:
(b) Such places shall not be used for sleeping or living quarters.
(c) Water of satisfactory sanitary quality, under head or pressure, and adequate in amount and temperature, shall be easily accessible to all rooms in which food is prepared and utensils are cleaned.
(d) All plumbing shall be so designed, installed, and maintained as to prevent contamination of the water supply, food, and food utensils.
(a) All food-handling operations shall be accomplished so as to minimize the possibility of contaminating food, drink, or utensils.
(b) The hands of all persons shall be kept clean while engaged in handling food, drink, utensils, or equipment.
(a) All utensils and working surfaces used in connection with the preparation, storage, and serving of food or beverages, and the cleaning of food utensils, shall be so constructed as to be easily cleaned and self-draining and shall be maintained in good repair. Adequate facilities shall be provided for the cleaning and bactericidal treatment of all multiuse eating and drinking utensils and equipment used in the preparation of food and beverages. An indicating thermometer, suitably located, shall be provided to permit the determination of the hot water temperature when and where hot water is used as the bactericidal agent.
(b) All multiuse eating and drinking utensils shall be thoroughly cleaned in warm water and subjected to an effective bactericidal treatment after each use. All other utensils that come in contact with food and drink shall be similarly treated immediately following the day's operation. All equipment shall be kept clean.
(c) After bactericidal treatment, utensils shall be stored and handled in such manner as to prevent contamination before reuse.
Each refrigerator shall be equipped with a thermometer located in the warmest portion thereof. Waste water drains from ice boxes, refrigerating equipment, and refrigerated spaces shall be so installed as to prevent backflow of contaminating liquids.
(a) Any person who is known or suspected to be in a communicable period or a carrier of any communicable disease shall not be permitted to engage in the preparation, handling, or serving of water, other beverages, or food.
(b) Any person known or suspected to be suffering from gastrointestinal disturbance or who has on the exposed portion of the body an open lesion or an infected wound shall not be permitted to engage in the preparation, handling, or serving of food or beverages.
(a) Toilet and lavatory facilities of suitable design and construction shall be provided for use of food-handling employees. Railroad dining car crew lavatory facilities are regulated under § 1250.45.
(b) Signs directing food-handling employees to wash their hands after each use of toilet facilities shall be posted so as to be readily observable by such employees. Hand washing facilities shall include soap, sanitary towels and hot and cold running water or warm running water in lieu of hot and cold running water.
(c) All toilet rooms shall be maintained in a clean condition.
Watertight, readily cleanable nonabsorbent containers with close-fitting covers shall be used to receive and store garbage. Garbage and refuse shall be disposed of as frequently as is necessary and practicable.
The sanitary equipment and facilities on land and air conveyances engaged in interstate traffic and the use of such equipment and facilities shall comply with the requirements prescribed in this subpart.
Plans for the construction or major reconstruction of sanitary equipment or facilities for such conveyances shall be submitted to the Commissioner of Food and Drugs for review of the conformity of such plans with the requirements of this subpart, except that submittal of plans shall not be required for any conveyance under reconstruction if the owner or operator thereof has made arrangements satisfactory to the Commissioner of Food and Drugs for inspections of such conveyances while under
(a) The water system, whether of the pressure or gravity type, shall be complete and closed from the filling ends to the discharge taps, except for protected vent openings. The water system shall be protected against backflow.
(b) Filling pipes or connections through which water tanks are supplied shall be provided on both sides of all new railway conveyances and on existing conveyances when they undergo heavy repairs. All filling connections shall be easily cleanable and so located and protected as to minimize the hazard of contamination of the water supply.
(c) On all new or reconstructed conveyances, water coolers shall be an integral part of the closed system.
(d) Water filters if used on dining cars and other conveyances will be permitted only if they are so operated and maintained at all times as to prevent contamination of the water.
(e) Constant temperature bottles and other containers used for storing or dispensing potable water shall be kept clean at all times and shall be subjected to effective bactericidal treatment as often as may be necessary to prevent the contamination of water so stored and dispensed.
Ice shall not be permitted to come in contact with water in coolers or constant temperature bottles.
(a) No cup, glass, or other drinking utensil which may be used by more than one person shall be provided on any conveyance unless such cup, glass, or drinking utensil shall have been thoroughly cleaned and subjected to effective bactericidal treatment after each individual use.
(b) Towels, combs, or brushes for common use shall not be provided.
(a) Both kitchens and pantries of cars hereafter constructed or reconstructed shall be equipped with double sinks, one of which shall be of sufficient size and depth to permit complete immersion of a basket of dishes during bactericidal treatment; in the pantry a dishwashing machine may be substituted for the double sinks. If chemicals are used for bactericidal treatment, 3-compartment sinks shall be provided.
(b) A sink shall be provided for washing and handling cracked ice used in food or drink and shall be used for no other purpose.
(c) Lavatory facilities for the use of the dining car crew shall be provided on each dining car. Such facilities shall be conveniently located and used for hand and face washing only:
(d) Wherever toilet and lavatory facilities required by paragraph (c) of this section are not on the dining car, a lavatory shall be provided on the dining car for the use of employees. The lavatory shall be conveniently located and used only for the purpose for which it is installed.
Conveyances while in transit shall be kept clean and free of flies and mosquitoes. A conveyance which becomes infected with vermin shall be placed out of service until such time as it shall have been effectively treated for the destruction of the vermin.
Where toilet and lavatory facilities are provided on conveyances they shall be so designed as to permit ready cleaning. On conveyances not equipped with retention facilities, toilet hoppers shall be of such design and so located as to prevent spattering of water filling pipes or hydrants.
(a)
(b)
(c)
(d)
(e)
(1) Company name and address.
(2) Name, title, and address of the company's chief operating official.
(3) Name, title, address, and telephone number of the person designated by the company to be directly responsible for compliance with this section.
(4) A statement that all new railroad conveyances placed into service after July 1, 1972 meet the requirements of this section.
(5) A complete, factual, narrative statement explaining why retrofitting of noncomplying nonnew conveyances is incomplete, if it is incomplete.
(6) A statement of the percentage of conveyances retrofitted with waste discharge facilities in compliance with this section as of the reporting date and the percentage expected to be completed by December 31st of the following year.
(7) A tabular report with the following vertical columns: equipment type, e.g., locomotive, caboose, passenger car, and any others having toilets; number of toilets per conveyance;
(f)
(2)
(3)
(i) A detailed description of the proposed deviation from the requirements of paragraphs (b) or (d) of this section.
(ii) A report, current to the date of the request for a variance or extension, containing the information required by paragraph (e) of this section.
(4)
(ii) A public file of requested variances and extensions, their disposition, and information relating to pending actions will be maintained in the Dockets Management Branch, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
(iii) After notice to the railroad company and opportunity for hearing in accordance with part 16 of this chapter, a variance or extension may be withdrawn prior to its scheduled termination if the Director, Center for Food Safety and Applied Nutrition, determines that such withdrawal is necessary to protect the public health.
For statutory exemptions for “intercity rail passenger service,” see section 306(i) of 45 U.S.C. 546(i).
For a document staying the effectiveness of § 1250.51 (b) and (d), see 42 FR 57122, Nov. 1, 1977.
There shall be no discharge of excrement, garbage, or waste water from a highway conveyance except at servicing areas approved by the Commissioner of Food and Drugs.
There shall be no discharge of excrement or garbage from any air conveyance except at servicing areas approved by the Commissioner of Food and Drugs.
Land and air conveyances engaged in interstate traffic shall use only such servicing areas within the United
The Commissioner of Food and Drugs may inspect any such areas to determine whether they shall be approved. He may base his approval or disapproval on investigations made by representatives of State departments of health.
Plans for construction or major reconstruction of sanitation facilities at servicing areas shall be submitted to the Commissioner of Food and Drugs for review of the conformity of the proposed facilities with the requirements of this subpart.
Servicing areas shall be provided with all necessary sanitary facilities so operated and maintained as to prevent the spread of communicable diseases.
All platforms and other places at which water or food supplies are loaded onto or removed from conveyances shall be adequately drained so as to prevent pooling.
(a)
(b)
(c)
(a) There shall be adequate toilet, washroom, locker, and other essential sanitary facilities readily accessible for use of employees adjacent to places or areas where land and air conveyances are serviced, maintained, and cleaned. These facilities shall be maintained in a clean and sanitary condition at all times.
(b) In the case of diners not in a train but with a crew on board, adequate toilet facilities shall be available to the crew within a reasonable distance but not exceeding 500 feet of such diners.
(c) Drinking fountains and coolers shall be constructed of impervious, nonoxidizing material, and shall be so designed and constructed as to be easily cleaned. The jet of a drinking fountain shall be slanting and the orifice of the jet shall be protected by a guard in such a manner as to prevent contamination thereof by droppings from the mouth. The orifice of such a jet shall be located a sufficient distance above the rim of the basin to prevent backflow.
(a) At servicing areas and at stations where land and air conveyances are occupied by passengers the operations shall be so conducted as to avoid contamination of such areas and stations by human wastes.
(b) Toilet wastes shall be disposed of through sanitary sewers or by other methods assuring sanitary disposal of such wastes. All soil cans and removable containers shall be thoroughly cleaned before being returned to use. Equipment for cleaning such containers and for flushing nonremovable containers and waste carts shall be so designed as to prevent backflow into
(c) All persons who have handled soil cans or other containers which have come in contact with human wastes shall be required to wash their hands thoroughly with soap and warm water and to remove any garments which have become soiled with such wastes before engaging in any work connected with the loading, unloading, transporting or other handling of food, water or ice.
(a) Water-tight, readily cleanable, nonabsorbent containers with close-fitting covers shall be used to receive and store garbage.
(b) Can washing and draining facilities shall be provided.
(c) Garbage cans shall be emptied daily and shall be thoroughly washed before being returned for use.
The sanitation facilities and the sanitary conditions on vessels engaged in interstate traffic shall comply with the requirements prescribed in this subpart, provided that no major structural change will be required on existing vessels.
The Commissioner of Food and Drugs may inspect such vessels to determine compliance with the requirements of this subpart.
The following conditions must be met by vessel water systems used for the storage and distribution of water which has met the requirements of § 1240.80 of this chapter.
(a) The potable water system, including filling hose and lines, pumps, tanks, and distributing pipes, shall be separate and distinct from other water systems and shall be used for no other purposes.
(b) All potable water tanks shall be independent of any tanks holding nonpotable water or other liquid. All potable water tanks shall be independent of the shell of the ship unless (1) the bottom of the tank is at least 2 feet above the maximum load water line, (2) the seams in the shell are continuously welded, and (3) there are no rivets in that part of the shell which forms a side of a tank. A deck may be used as the top of a tank provided there are no access or inspection openings or rivets therein, and the seams are continuously welded. No toilet or urinal shall be installed immediately above that part of the deck which forms the top of a tank. All potable water tanks shall be located at a sufficient height above the bilge to allow for draining and to prevent submergence in bilge water.
(c) Each potable water tank shall be provided with a means of drainage and, if it is equipped with a manhole, overflow, vent, or a device for measuring depth of water, provision shall be made to prevent entrance into the tank of any contaminating substance. No deck or sanitary drain or pipe carrying any nonpotable water or liquid shall be permitted to pass through the tank.
(d) Tanks and piping shall bear clear marks of identification.
(e) There shall be no backflow or cross connection between potable water systems and any other systems. Pipes and fittings conveying potable water to any fixture, apparatus, or equipment shall be installed in such way that backflow will be prevented. Waste pipes from any part of the potable water system, including treatment devices, discharging to a drain, shall be suitably protected against backflow.
(f) Water systems shall be cleaned, disinfected, and flushed whenever the Commissioner of Food and Drugs shall find such treatment necessary to prevent the introduction, transmission, or spread of communicable diseases.
The following requirements with respect to the storage of water on vessels prior to treatment must be met in
(a) The tank, whether independent or formed by the skin of the ship, deck, tank top, or partitions common with other tanks, shall be free of apparent leakage.
(b) No sanitary drain shall pass through the tank.
(c) The tank shall be adequately protected against both the backflow and discharge into it of bilge or highly contaminated water.
(a) Potable water, hot and cold, shall be available in the galley and pantry except that, when potable water storage is inadequate, nonpotable water may be piped to the galley for deck washing and in connection with garbage disposal. Any tap discharging nonpotable water which is installed for deck washing purposes shall not be more than 18 inches above the deck and shall be distinctly marked “For deck washing only”.
(b) In the case of existing vessels on which heat treated wash water has been used for the washing of utensils prior to the effective date of the regulations in this part, such water may continue to be so used provided controls are employed to insure the heating of all water to at least 170 °F before discharge from the heater.
(c) Potable water, hot and cold, shall be available in medical care spaces for hand-washing and for medical care purposes excluding hydrotherapy.
(a) Drinking fountains and coolers shall be constructed of impervious, nonoxidizing material, and shall be so designed and constructed as to be easily cleaned. The jet of a drinking fountain shall be slanting and the orifice of the jet shall be protected by a guard in such a manner as to prevent contamination thereof by droppings from the mouth. The orifice of such a jet shall be located a sufficient distance above the rim of the basin to prevent backflow.
(b) Ice shall not be permitted to come in contact with water in coolers or constant temperature bottles.
(c) Constant temperature bottles and other containers used for storing or dispensing potable water shall be kept clean at all times and shall be subjected to effective bactericidal treatment after each occupancy of the space served and at intervals not exceeding one week.
Only potable water shall be piped into a freezer for making ice for drinking and culinary purposes.
Where systems installed on vessels for wash water, as defined in § 1250.3(n), do not comply with the requirements of a potable water system, prescribed in § 1250.82, they shall be constructed so as to minimize the possibility of the water therein being contaminated. The storage tanks shall comply with the requirements of § 1250.83, and the distribution system shall not be cross connected to a system carrying water of a lower sanitary quality. All faucets shall be labeled “Unfit for drinking”.
(a) Fill and draw swimming pools shall not be installed or used.
(b) Swimming pools of the recirculation type shall be equipped so as to provide complete circulation, replacement, and filtration of the water in the pool every six hours or less. Suitable means of chlorination and, if necessary, other treatment of the water shall be provided to maintain the residual chlorine in the pool water at not less than 0.4 part per million and the pH (a measure of the hydrogen ion concentration) not less than 7.0.
(c) Flowing-through types of salt water pools shall be so operated that complete circulation and replacement of the water in the pool will be effected every 6 hours or less. The water delivery pipe to the pool shall be independent of all other pipes and shall originate at a point where maximum flushing of the pump and pipe line is effected after leaving polluted waters.
Toilet and lavatory equipment and spaces shall be maintained in a clean condition.
Vessels operating on fresh water lakes or rivers shall not discharge sewage, or ballast or bilge water, within such areas adjacent to domestic water intakes as are designated by the Commissioner of Food and Drugs.
For Environmental Protection Agency's regulations for vessel sanitary discharges as related to authority under the Federal Water Pollution Control Act, as amended (33 U.S.C. 1314
Vessels shall be maintained free of infestation by flies, mosquitoes, fleas, lice, and other insects known to be vectors in the transmission of communicable diseases, through the use of screening, insecticides, and other generally accepted methods of insect control.
Vessels shall be maintained free of rodent infestation through the use of traps, poisons, and other generally accepted methods of rodent control.
42 U.S.C. 216, 243, 264, 271.
(a) The regulations in this part apply to human tissue and to establishments or persons engaged in the recovery, screening, testing, processing, storage, or distribution of human tissue.
(b) Regulations in this chapter as they apply to drugs, biologics, devices, or other FDA-regulated commodities do not apply to human tissue, except as specified in this part.
(c) Regulations in this chapter do not apply to autologous human tissue.
(d) Regulations in this chapter do not apply to hospitals or other clinical facilities that receive and store human tissue only for transplantation within the same facility.
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(1) Is intended for transplantation to another human for the diagnosis, cure, mitigation, treatment, or prevention of any condition or disease;
(2) Is recovered, processed, stored, or distributed by methods that do not change tissue function or characteristics;
(3) Is not currently regulated as a human drug, biological product, or medical device;
(4) Excludes kidney, liver, heart, lung, pancreas, or any other vascularized human organ; and
(5) Excludes semen or other reproductive tissue, human milk, and bone marrow.
(k)
(l)
(m)
(n)
(o)
(p)
(q)
(r)
(s)
(t)
(u)
(v)
(w)
(x)
(a) Donor specimens shall be tested for the following communicable viruses, using Food and Drug Administration (FDA) licensed donor screening tests in accordance with manufacturers’ instructions:
(1) Human immunodeficiency virus, Type 1 (e.g., FDA licensed screening test for anti-HIV-1);
(2) Human immunodeficiency virus, Type 2 (e.g., FDA licensed screening test for anti-HIV-2);
(3) Hepatitis B (e.g., FDA licensed screening test for HBsAg); and
(4) Hepatitis C (e.g., FDA licensed screening test for anti-HCV).
(b) In the case of a neonate, the mother's specimen is acceptable for testing.
(c) Such infectious disease testing shall be performed by a laboratory certified under the Clinical Laboratories Improvement Amendments of 1988 (CLIA).
(d) Human tissue shall be accompanied by records indicating that the donor's specimen has been tested and found negative using FDA licensed screening tests for HIV-1, HIV-2, hepatitis B, and hepatitis C. FDA licensed screening tests labeled for cadaveric specimens must be used when available.
(e) Human tissue for transplantation shall be accompanied by a summary of records or copies of the original records of the donor's relevant medical records as defined in § 1270.3(t) which documents freedom from risk factors for and clinical evidence of hepatitis B, hepatitis C, or HIV infection. There shall be a responsible person designated and identified in the original record and summary of records as having made the determination that the human tissue is suitable for transplantation.
(f) Determination by the responsible person that a donor of human tissue intended for transplantation is suitable shall include ascertainment of the donor's identity, and accurately recorded relevant medical records (as defined in § 1270.3(t)) which documents freedom from risk factors for and clinical evidence of hepatitis B, hepatitis C, and HIV infection.
(g) For corneal tissue procured under legislative consent where a donor medical history screening interview has not occurred, a physical assessment of the donor is required and other available information shall be reviewed. The corneal tissue shall be accompanied by the summary of records documenting that the corneal tissue was determined to be suitable for transplantation in the absence of the donor medical history interview. Corneal tissue procured under legislative consent shall be documented as such in the summary of records.
(h) Human tissue shall be determined to be not suitable for transplantation if from:
(1) A donor whose specimen has tested repeatedly reactive on a screening test for HIV, hepatitis B, or hepatitis C;
(2) A donor where blood loss is known or suspected to have occurred and transfusion/infusion of more than 2,000 milliliters (mL) of blood (i.e., whole blood, reconstituted blood, or red blood cells), or colloids within 48 hours; or more than 2,000 mL of crystalloids within 1 hour; or any combination thereof prior to the collection of a
(i) A pretransfusion or preinfusion blood specimen from the tissue donor is available for infectious disease testing; or
(ii) An algorithm is utilized that evaluates the volumes administered in the 48 hours prior to collecting the blood specimen from the tissue donor to ensure that there has not been plasma dilution sufficient to affect test results; or
(3) A donor who is 12 years of age or less and has been transfused or infused at all, unless:
(i) A pretransfusion or preinfusion blood specimen from the tissue donor is available for infectious disease testing; or
(ii) An algorithm is utilized that evaluates the volumes administered in the 48 hours prior to collecting the blood specimen from the tissue donor to ensure that there has not been plasma dilution sufficient to affect test results.
(a) There shall be written procedures prepared and followed for all significant steps in the infectious disease testing process under § 1270.21 which shall conform to the manufacturers’ instructions for use contained in the package inserts for the required tests. These procedures shall be readily available to the personnel in the area where the procedures are performed unless impractical. Any deviation from the written procedures shall be recorded and justified.
(b) There shall be written procedures prepared and followed for all significant steps for obtaining, reviewing, and assessing the relevant medical records of the donor as provided in § 1270.21. Such procedures shall be readily available to personnel who may perform the procedures. Any deviation from the written procedures shall be recorded and justified.
(c) There shall be written procedures prepared and followed for designating and identifying quarantined tissue.
(d) There shall be written procedures prepared, validated, and followed for prevention of infectious disease contamination or cross-contamination by tissue during processing.
(e) In conformity with this section, any facility may use current standard written procedures such as those in a technical manual prepared by another organization, provided the procedures are consistent with and at least as stringent as the requirements of this part.
(a) Records shall be maintained concurrently with the performance of each significant step required in this part in the performance of infectious disease screening and testing of donors of human tissue. All records shall be accurate, indelible, and legible. The records shall identify the person performing the work, the dates of the various entries, and shall be as detailed as necessary to provide a complete history of the work performed and to relate the records to the particular tissue involved.
(b) All human tissue shall be quarantined until the following criteria for donor suitability are satisfied:
(1) All infectious disease testing under § 1270.21 has been completed, reviewed by the responsible person, and found to be negative; and
(2) Donor screening has been completed, reviewed by the responsible person, and determined to assure freedom from risk factors for and clinical evidence of HIV infection, hepatitis B, and hepatitis C.
(c) All human tissue processed or shipped prior to determination of donor suitability must be under quarantine, accompanied by records assuring identification of the donor and indicating that the tissue has not been determined to be suitable for transplantation.
(d) All human tissue determined to be suitable for transplantation must be accompanied by a summary of records, or copies of such original records, documenting that all infectious disease testing and screening under § 1270.21 has been completed, reviewed by the responsible person, and found to be
(e) Human tissue shall be quarantined until the tissue is either determined to be suitable for transplantation or appropriate disposition is accomplished.
(f) All persons or establishments that generate records used in determining the suitability of the donor shall retain such records and make them available for authorized inspection or upon request by FDA. The person(s) or establishment(s) making the determination regarding the suitability of the donor shall retain all records, or true copies of such records required under § 1270.21, including all testing and screening records, and shall make them available for authorized inspection or upon request from FDA. Records that can be retrieved from another location by electronic means meet the requirements of this paragraph.
(g) Records required under this part may be retained electronically, or as original paper records, or as true copies such as photocopies, microfiche, or microfilm, in which case suitable reader and photocopying equipment shall be readily available.
(h) Records shall be retained at least 10 years beyond the date of transplantation if known, distribution, disposition, or expiration, of the tissue, whichever is latest.
Records shall be maintained that include, but are not limited to:
(a) Documentation of results and interpretation of all required infectious disease tests;
(b) Information on the identity and relevant medical records of the donor, as required by § 1270.21(e) in English or, if in another language translated to English and accompanied by a statement of authenticity by the translator which specifically identifies the translated document;
(c) Documentation of the receipt and/or distribution of human tissue; and
(d) Documentation of the destruction or other disposition of human tissue.
(a) An establishment covered by these regulations in this part, including any location performing contract services, shall permit an authorized inspector of the Food and Drug Administration (FDA) to make at any reasonable time and in a reasonable manner such inspection of the establishment, its facilities, equipment, processes, products, and records as may be necessary to determine compliance with the provisions of this part. Such inspections may be made with or without notice and will ordinarily be made during regular business hours.
(b) The frequency of inspection will be at the agency's discretion.
(c) The inspector shall call upon a responsible person of the establishment and may question the personnel of the establishment as the inspector deems necessary.
(d) The inspector may review and copy any records required to be kept pursuant to part 1270.
(e) The public disclosure of records containing the name or other positive identification of donors or recipients of human tissue will be handled in accordance with FDA's procedures on disclosure of information as set forth in 21 CFR part 20 of this chapter.
(a) When human tissue is offered for entry, the importer of record must notify the director of the district of the Food and Drug Administration having jurisdiction over the port of entry through which the tissue is imported or offered for import, or such officer of the district as the director may designate to act in his or her behalf in administering and enforcing this part.
(b) Human tissue offered for import must be quarantined until the human tissue is released by FDA.
(a) Upon a finding that human tissue may be in violation of the regulations in this part, an authorized Food and
(1) Serve upon the person who distributed the tissue a written order that the tissue be recalled and/or destroyed, as appropriate, and upon persons in possession of the tissue that the tissue shall be retained until it is recalled by the distributor, destroyed, or disposed of as agreed by FDA, or the safety of the tissue is confirmed; and/or
(2) Take possession of and/or destroy the violative tissue.
(b) The written order will ordinarily provide that the human tissue be recalled and/or destroyed within 5 working days from the date of receipt of the order and will state with particularity the facts that justify the order.
(c) After receipt of an order under this part, the person in possession of the human tissue shall not distribute or dispose of the tissue in any manner except to recall and/or destroy the tissue consistent with the provisions of the order, under the supervision of an authorized official of FDA.
(d) In lieu of paragraphs (b) and (c) of this section, other arrangements for assuring the proper disposition of the tissue may be agreed upon by the person receiving the written order and an authorized official of FDA. Such arrangements may include providing FDA with records or other written information that adequately assure that the tissue has been recovered, screened, tested, processed, stored, and distributed in conformance with part 1270.
(e) Within 5 working days of receipt of a written order for retention, recall, and/or destruction of tissue (or within 5 working days of the agency's possession of such tissue), the recipient of the written order or prior possessor of such tissue shall request a hearing on the matter in accordance with part 16 of this chapter. The order for destruction will be held in abeyance pending resolution of the hearing request.
42 U.S.C. 216, 243, 264, 271.
(a)
(b)
(2) If you are an establishment that manufactures HCT/P's that are regulated as drugs, devices and/or biological products under section 351 of the PHS Act and/or the Federal Food, Drug, and Cosmetic Act, §§ 207.20(f) and 807.20(d) of this chapter require you to register and list your HCT/P's following the procedures in subpart B of this part. Sections 210.1(c), 210.2, 211.1(b), and 820.1(a) of this chapter require you to comply with the donor-suitability procedures in subpart C of this part and the current good tissue practice procedures in subpart D of this part, in addition to all other applicable regulations.
The following definitions apply only to this part:
(a)
(b)
(1) Any individual, partnership, corporation, association, or other legal entity engaged in the manufacture of human cells, tissues, and cellular and tissue-based products; and
(2) Facilities that engage in contract manufacturing services for a manufacturer of human cells, tissues, and cellular and tissue-based products.
(c)
(d)(1)
(2)
(i) Vascularized human organs for transplantation;
(ii) Whole blood or blood components or blood derivative products subject to listing under parts 607 and 207 of this chapter, respectively;
(iii) Secreted or extracted human products, such as milk, collagen, and cell factors; except that semen is considered an HCT/P;
(iv) Minimally manipulated bone marrow for homologous use and not combined with a drug or a device (except for a sterilizing, preserving, or storage agent, if the addition of the agent does not raise new clinical safety concerns with respect to the bone marrow);
(v) Ancillary products used in the manufacture of HCT/P;
(vi) Cells, tissues, and organs derived from animals other than humans; and
(vii) In vitro diagnostic products as defined in § 809.3(a) of this chapter.
(e)
(f)
(1) For structural tissue, processing that does not alter the original relevant characteristics of the tissue relating to the tissue's utility for reconstruction, repair, or replacement; and
(2) For cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of cells or tissues.
(g)
At 66 FR 5466, Jan. 19, 2001, part 1271, consisting of §§ 1271.1-1271.37, was added, effective Apr. 4, 2001, except for § 1271.3(d)(2) which is effective Jan. 21, 2003. At 68 FR 2689, Jan. 21, 2003, the effective date was delayed until Jan. 21, 2004.
(a) An HCT/P is regulated solely under section 361 of the PHS Act and the regulations in this part if it meets all of the following criteria:
(1) The HCT/P is minimally manipulated;
(2) The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent;
(3) The manufacture of the HCT/P does not involve the combination of the cell or tissue component with a drug or a device, except for a sterilizing, preserving, or storage agent, if the addition of the agent does not raise new clinical safety concerns with respect to the HCT/P; and
(4) Either:
(i) The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or
(ii) The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:
(
(
(
(b) If you are a domestic or foreign establishment that manufactures an HCT/P described in paragraph (a) of this section:
(1) You must register with FDA;
(2) You must submit to FDA a list of each HCT/P manufactured; and
(3) You must comply with the other requirements contained in this part.
(a) You are not required to comply with the requirements of this part if you are an establishment that uses HCT/P's solely for nonclinical scientific or educational purposes.
(b) You are not required to comply with the requirements of this part if you are an establishment that removes HCT/P's from an individual and implants such HCT/P's into the same individual during the same surgical procedure.
(c) You are not required to comply with the requirements of this part if you are a carrier who accepts, receives, carries, or delivers HCT/P's in the usual course of business as a carrier.
(d) You are not required to comply with the requirements of this part if you are an establishment that does not recover, screen, test, process, label, package, or distribute, but only receives or stores HCT/P's solely for implantation, transplantation, infusion, or transfer within your facility.
(e) You are not required to comply with the requirements of this part if you are an establishment that only recovers reproductive cells or tissue and immediately transfers them into a sexually intimate partner of the cell or tissue donor.
(f) You are not required to register or list your HCT/P's independently, but you must comply with all other applicable requirements in this part, if you are an individual under contract, agreement, or other arrangement with a registered establishment and engaged solely in recovering cells or tissues and sending the recovered cells or tissues to the registered establishment.
If you are an establishment that manufactures an HCT/P that does not meet the criteria set out in § 1271.10(a), and you do not qualify for any of the exceptions in § 1271.15, your HCT/P will be regulated as a drug, device, and/or biological product under the act and/or section 351 of the PHS Act, and applicable regulations in title 21, chapter I. Applicable regulations include, but are not limited to, §§ 207.20(f), 210.1(c), 210.2, 211.1(b), 807.20(d), and 820.1(a) of this chapter, which require you to follow the procedures in subparts B, C, and D of this part.
(a) You must register and submit a list of every HCT/P that your establishment manufactures within 5 days after beginning operations or within 30 days of the effective date of this regulation, whichever is later.
(b) You must update your establishment registration annually in December, except as required by § 1271.26. You may accomplish your annual registration in conjunction with updating your HCT/P list under paragraph (c) of this section.
(c)(i) If no change described in § 1271.25(c) has occurred since youpreviously submitted an HCT/P list, you are not required to update your listing.
(ii) If a change described in § 1271.25(c) has occurred, you must update your HCT/P listing with the new information:
(
(
(a) You must use Form FDA 3356 for:
(i) Establishment registration,
(ii) HCT/P listings, and
(iii) Updates of registration and HCT/P listing.
(b) You may obtain Form FDA 3356:
(i) By writing to the Center for Biologics Evaluation and Research (HFM-305), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, Attention: Tissue Establishment Registration Coordinator;
(ii) By contacting any Food and Drug Administration district office;
(iii) By calling the CBER Voice Information System at 1-800-835-4709 or 301-827--1800;
(iv) By calling the Fax Information System at 1-888-CBER-FAX or 301-827-3844; or
(v) By connecting to http://forms.psc.gov/forms/FDA/fda.html on the Internet.
(c)(i) You may submit Form FDA 3356 to the Center for BiologicsEvaluation and Research (HFM-305), Food and Drug Administration, 1401 Rockville, Pike, Rockville, MD 20852-1448, Attention: Tissue Establishment Registration Coordinator; or
(ii) You may submit Form FDA 3356 electronically in accordance with the instructions provided with the form.
(a) Your establishment registration Form FDA 3356 must include:
(1) The legal name(s) of the establishment;
(2) Each location, including the street address of the establishment and the postal service zip code;
(3) The name, address, and title of the reporting official; and
(4) A dated signature by the reporting official affirming that all information contained in the establishment registration and HCT/P listing form is true and accurate, to the best of his or her knowledge.
(b) Your HCT/P listing must include all HCT/P's (including the established name and the proprietary name) that you recover, process, store, label, package, distribute, or for which you perform donor screening or testing. You must also state whether each HCT/P meets the criteria set out in § 1271.10.
(c) Your HCT/P listing update must include:
(1) A list of each HCT/P that you have begun recovering, processing, storing, labeling, packaging, distributing, or for which you have begun donor screening or testing, that has not been included in any list previously submitted. You must provide all of the information required by § 1271.25(b) for each new HCT/P.
(2) A list of each HCT/P formerly listed in accordance with § 1271.21(a) for which you have discontinued recovery, processing, storage, labeling, packaging, distribution, or donor screening or testing, including for each HCT/P so listed, the identity by established name and proprietary name, and the date of discontinuance. We request but do not require that you include the reason for discontinuance with this information.
(3) A list of each HCT/P for which a notice of discontinuance was submitted under paragraph (c)(2) of this section and for which you have resumed recovery, processing, storage, labeling, packaging, distribution, or donor screening or testing, including the identity by established name and proprietary name, the date of resumption, and any other information required by § 1271.25(b) not previously submitted.
(4) Any material change in any information previously submitted. Material changes include any change in information submitted on Form FDA 3356, such as whether the HCT/P meets the criteria set out in § 1271.10.
If the ownership or location of your establishment changes, you must submit an amendment to registration within 5 days of the change.
(a) FDA will assign each location a permanent registration number.
(b) FDA acceptance of an establishment registration and HCT/P listing form does not constitute a determination that an establishment is in compliance with applicable rules and regulations or that the HCT/P is licensed or approved by FDA.
(a) A copy of the Form FDA 3356 filed by each establishment will be available for public inspection at the Office of Communication, Training, and Manufacturers Assistance (HFM-48), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. In addition, there will be available for inspection at each of the Food and Drug Administration district offices the same information for firms within the geographical area of such district office. Upon request and receipt of a self-addressed stamped envelope, verification of a registration number or the location of a registered establishment will be provided. The following information submitted under the HCT/P requirements is illustrative of the type of information that will be available for public disclosure when it is compiled:
(1) A list of all HCT/P's;
(2) A list of all HCT/P's manufactured by each establishment;
(3) A list of all HCT/P's discontinued; and
(4) All data or information that has already become a matter of public record.
(b) You should direct your requests for information regarding HCT/P establishment registrations and HCT/P listings to the Office of Communication, Training and Manufacturers Assistance (HFM-48), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448.