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(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.
[52 FR 29514, Aug. 10, 1987, as amended at 57 FR 57344, Dec. 4, 1992] § 1240.62 Turtles intrastate and interstate requirements.
(a) Definition. As used in this section the term “turtles” includes all animals commonly known as turtles, tortoises, terrapins, and all other animals of the order Testudinata, class Reptilia, except marine species (families Dermachelidae and Chelonidae).
(b) Sales; general prohibition. Except as otherwise provided in this section, viable turtle eggs and live turtles with a carapace length of less than 4 inches shall not be sold, held for sale, or offered for any other type of commercial or public distribution.
(c) Destruction of turtles or turtle eggs; criminal penalties. (1) Any 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 or public distribution shall be subject to destruction in a humane manner by or under the supervision of an officer or employee of the Food and Drug Administration in accordance with the following procedures:
(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 or public distribution, shall serve upon the person in whose possession such turtles or turtle eggs are found a written demand that such turtles or turtle eggs be destroyed in a humane manner under the supervision of said District Office, within 10 working days from the date of promulgation of the demand. The demand shall recite with particularity the facts which justify the demand. After service of the demand, the person in possession of the turtles or turtle eggs shall not sell, distribute, or otherwise dispose of any of the turtles or turtle eggs except to destroy them under the supervision of the District Office, unless and until the Director of the Center for Veterinary Medicine withdraws the demand for destruction after an appeal pursuant to paragraph (c)(1)(ii) of this section.
(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 Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. 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 Veterinary Medicine 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 Veterinary Medicine 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 Veterinary Medicine pursuant to appeal), or who fails to comply with the requirement in such a demand that the manner of destruction be humane, shall be subject to a fine of not more than $1,000 or imprisonment for not more than 1 year, or both, for each violation, in accordance with section 368 of the Public Health Service Act (42 U.S.C. 271).
(d) Exceptions. The provisions of this section are not applicable to:
(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) Petitions. The Commissioner of Food and Drugs, either on his own initiative or on behalf of any interested person who has submitted a petition, may publish a proposal to amend this regulation. Any such petition shall include an adequate factual basis to support the petition, and will be published for comment if it contains reasonable grounds for the proposed regulation. A petition requesting such a regulation, which would amend this regulation, shall be submitted to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
[40 FR 22545, May 23, 1975, as amended at 46 FR 8461, Jan. 27, 1981; 48 FR 11431, Mar. 18, 1983; 54 FR 24900, June 12, 1989; 59 FR 14366, Mar. 28, 1994; 66 FR 56035, Nov. 6, 2001; 70 FR 48073, Aug. 18, 2005] § 1240.63 African rodents and other animals that may carry the monkeypox virus.
(a) What Actions Are Prohibited? What Animals Are Affected? (1) Except as provided in paragraph (a)(2) of this section,
(i) You must not capture, offer to capture, transport, offer to transport, sell, barter, or exchange, offer to sell, barter, or exchange, distribute, offer to distribute, or release into the environment, any of the following animals, whether dead or alive:
(A) Prairie dogs (Cynomys sp.),
(B) African Tree squirrels (Helioscirurus sp.),
(C) Rope squirrels (Funisciurus sp.),
(D) African Dormice (Graphiurus sp.),
(E) Gambian giant pouched rats (Cricetomys sp.),
(F) Brush-tailed porcupines (Atherurus sp.),
(G) Striped mice (Hybomys sp.), or
(H) Any other animal so prohibited by order of the Commissioner of Food and Drugs because of that animal's potential to transmit the monkeypox virus; and
(ii) You must not prevent, or attempt to prevent, the Food and Drug Administration (FDA) from causing an animal to be quarantined or destroyed under a written order for the animal's quarantine or destruction.
(2) The prohibitions in paragraph (a)(1) of this section do not apply if you:
(i) Transport an animal listed in paragraph (a)(1) of this section, or covered by an order by the Commissioner of Food and Drugs, to veterinarians or animal control officials for veterinary care, quarantine, or destruction purposes; or
(ii) Have written permission from FDA to capture, offer to capture, transport, offer to transport, sell, barter, or exchange, offer to sell, barter, or exchange, distribute, offer to distribute, and/or release into the environment an animal listed in paragraph (a)(1) of this section, or covered by an order by the Commissioner of Food and Drugs. You may not seek written permission to sell, barter, or exchange, or offer to sell, barter, or exchange, as a pet, an animal listed in paragraph (a)(1) of this section or covered by an order by the Commissioner of Food and Drugs.
(A) To obtain such written permission from FDA, you must send a written request to the Division of Compliance (HFV–230), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, Attn: Listed Animal Permit Official. You may also fax your request to the Division of Compliance (using the same address in the previous sentence) at 301–827–1498.
(B) Your request must state the reasons why you need an exemption, describe the animals involved, describe the number of animals involved, describe how the animals will be transported (including carrying containers or cages, precautions for handlers, types of vehicles used, and other procedures to minimize exposure of animals and precautions to prevent animals from escaping into the environment), describe any holding facilities, quarantine procedures, and/or veterinarian evaluation involved in the animals' movement, and explain why an exemption will not result in the spread of monkeypox within the United States.
(C) We (FDA) will respond, in writing, to all requests, and we also may impose conditions in granting an exemption.
(b) What Actions Can FDA Take? (1) To prevent the monkeypox virus from spreading and becoming established in the United States, we may, in addition to any other authorities under this part:
(i) Issue an order causing an animal to be placed in quarantine,
(ii) Issue an order causing an animal to be destroyed, or
(iii) Take any other action necessary to prevent the spread of the monkeypox virus.
(2) Any order to cause an animal to be placed in quarantine or to cause an animal to be destroyed will be in writing.
(c) How Do I Appeal an Order? (1) If you receive a written order to cause an animal to be placed in quarantine or to cause an animal to be destroyed, you may appeal that order. Your appeal must be in writing and be submitted to the Food and Drug Administration District Director whose office issued the order, and you must submit the appeal within two business days after you receive the order.
(2) As part of your appeal, you may request an informal hearing. Your appeal must include specific facts showing there is a genuine and substantial issue of fact that requires a hearing.
(3) If we grant your request for an informal hearing, we will follow the regulatory hearing requirements at in part 16, except that:
(i) The written order will serve as notice of opportunity for that hearing, for purposes of §16.22(a) of this chapter;
(ii) The presiding officer will issue a decision rather than a report and a recommended decision. The presiding officer's decision constitutes final agency action.
[68 FR 62368, Nov. 4, 2003] § 1240.65 Psittacine birds.
(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. § 1240.75 Garbage.
(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.
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