DEPARTMENT OF AGRICULTURE
Interstate/International Quarantine Order; Prohibition of Rendering of Domestic Animals Euthanized with Pentobarbital
[50 Pa.B. 6676]
[Saturday, November 21, 2020]
A. The Pennsylvania Department of Agriculture, Bureau of Animal Health and Diagnostic Services (Depart-ment), under the authority of the Domestic Animal Law (3 Pa.C.S.A. §§ 2301—2389), has the authority to protect the health of domestic animals and establish and enforce quarantine orders, ''Whenever a dangerous transmissible disease or contamination by hazardous substances exists anywhere within or outside of the Commonwealth or whenever it is deemed advisable to test or treat an domestic animal upon the reasonable suspicion that it has. . .been exposed to. . .or is contaminated with a hazardous substance,. . .the department shall have the power to establish and enforce quarantines of any such infected, exposed, contaminated, suspected or susceptible domestic animal. In addition to the aforedescribed domestic animals, a quarantine may apply to any goods, products, facilities, containers, vehicles or materials that may. . .or may be contaminated with a hazardous substance and may be applied on or in or against any premises, area or locality as define in this chapter.'' (3 Pa.C.S.A. § 2329(a))
B. The Department may establish three different types of quarantine orders; ''. . .(1) interstate and/or international; (2) general; and (3) special; and shall continue in effect for such lengths of time as the department deems necessary or advisable.'' (3 Pa.C.S.A. § 2329(b))
C. According to the United States Department of Justice, Drug Enforcement Administration (DEA) pentobarbital is a Schedule II barbiturate substance (Schedule II drugs, substances, or chemicals are defined as drugs with a high potential for abuse, with use potentially leading to severe psychological or physical dependence in humans).
D. Pentobarbital is commonly used in animals as a sedative, anesthetic, or for euthanasia, in the form of pentobarbital sodium. An overdose of pentobarbital sodium administered by rapid intravenous injection is an effective, fast, and humane method of euthanasia, and is approved by the American Veterinary Medical Association.
E. Rendered commercial feed or pet food products come from a process that converts animal tissues to commercial feed or pet food ingredients.
F. The Pennsylvania Department of Agriculture (Department) has authority under the Domestic Animal Law (3 Pa.C.S. § 2351) to regulate dead animal disposal ''. . .to cause the sanitary and safe disposal of dead domestic animals, domestic animal products and domestic animal parts, tissues, excrement and other wastes to prevent the spread of transmissible diseases or dangerous transmissible diseases or the spread of contamination by hazardous substances. This subchapter shall not apply to the disposal of carcasses of domestic animals slaughtered for human food nor to the premises or the rendering operations on the premises of a licensed slaughter establishment subject to official Federal or State inspection, provided that such inspection includes inspection of the rendering operations.''
G. Rendering is an approved method of dead animal disposal in Pennsylvania, per the Domestic Animal Law.
H. The Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) is responsible for the regulation of animal feed (food) products and considers animal feed, including pet food, containing pentobarbital residues to be adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FDA Food Safety Modernization Act (FSMA) preventive controls for animal food (PCAF) regulations.
I. The Pennsylvania Department of Agriculture, Bureau of Plant Industry, under the authority of the Commercial Feed Act (3 Pa.C.S.A. §§ 5101—5115), regulates commercial animal feed, including pet food. Pentobarbital residues may be considered an adulterant in accordance with section 5106(1) or 5106(2) of the Commercial Feed Act, ''No person shall distribute adulterated feed. A commercial feed, customer-formula feed or exempted material shall be deemed to be adulterated if it meets any of the following criteria: (1) It bears or contains any poisonous or deleterious substance which may render it injurious to the health of humans or animals. If the substance is not an added substance, the commercial feed shall not be considered adulterated under this paragraph if the quantity of the substance in the commercial feed does not ordinarily render it injurious to health. (2) It bears or contains any added poisonous, added deleterious or added nonnutritive substance which is unsafe within the meaning of section 406 of the Federal Food, Drug, and Cosmetic Act (52 Stat. 1040, 21 U.S.C. § 301 et seq.) other than a pesticide chemical in or on a raw agricultural commodity or a food additive.'' (3 Pa.C.S.A. § 5106(1) and (2)).
J. Pentobarbital residues are not affected by rendering or canning temperatures and pressures (such as heat treatments capable of killing pathogenic organisms). Because of this, to avoid the potential for residues in commercial feed and pet food, the FDA does not allow the use of animals euthanized with a chemical substance such as pentobarbital in the manufacture of animal foods. There is currently no set tolerance for pentobarbital in commercial feed or pet food.
K. Pentobarbital has been identified by the FDA in certain pet foods in recent years. Presently, it is assumed that the pentobarbital residues are entering pet foods from cattle or horses which were euthanized with pentobarbital and then rendered. The FDA reported finding pentobarbital in the tallow ingredient used in the affected pet food products.
L. If animals euthanized with pentobarbital are not disposed of properly there is the potential for exposure of scavenging domestic and wild animals to pentobarbital residues.
M. Possible harmful effects of pentobarbital residue in commercial feed and pet food and in contaminated carcasses which are consumed by other animals include drowsiness, dizziness, nausea and at high levels may lead to coma and death of the animal which consumed the food or carcass.
N. In Pennsylvania, pentobarbital has been identified in commercial feed, including pet food, most recently in 2019. The Department of Agriculture Bureau of Plant Industry traced the contaminant back to a slaughter and rendering plant that was selling tallow contaminated with the substance to commercial feed and pet food manufacturers.
O. In Pennsylvania, pentobarbital was identified as the cause of death in several Bald Eagles (Haliaeetus leucocephalus) in April 2020.
P. The Department has broad authority under the Domestic Animal Law to establish and enforce an Interstate and International quarantine against any place or places outside the Commonwealth of Pennsylvania (Commonwealth) to exclude, contain or eliminate dangerous transmissible diseases and hazardous substances. (3 Pa.C.S.A. § 2329(c)).
Order of Quarantine
With the foregoing recitals incorporated into this Order by reference, the Pennsylvania Department of Agriculture under authority of the Domestic Animal Law, at 3 Pa.C.S.A. § 2329(c) and § 1702 of the Administrative Code of 1929 (71 P.S. § 442), hereby establishes an Interstate and International Order of Quarantine related to the hazardous substance pentobarbital and the proper disposal of animals euthanized with pentobarbital. Compliance and assurance of compliance with the provisions and terms of this Quarantine Order shall be the responsibility of all persons, individuals and entities subject to its terms. The terms of this Order are as follows:
1. Quarantine Area. This Interstate and International Order of Quarantine is applicable to all States, Commonwealths and territories of the United States of America and any foreign country in which pentobarbital is used for euthanasia of animals.
2. Applicable definitions.
''Cat''—A carnivorous mammal scientifically known as Felis Catus.
''Commercial feed''—All materials distributed or intended to be distributed for use as feed or for mixing in feed. The term does not include unmixed whole seeds and physically altered entire unmixed seeds when the seeds are not adulterated within the meaning of section 5106 (relating to adulteration). The department by regulation may exempt from this definition or specific provisions of his chapter specific commodities, individual chemical compounds or substances when the commodities, compounds or substances are not mixed with other materials and are not adulterated within the meaning of section 5106.
''Dog''—The genus and species known as Canis familiaris.
''Domestic animal''—An animal maintained in captivity. The term also includes the germ plasm, embryos and fertile ova of such animals.
''Pet food''—Any commercial feed prepared and distributed for consumption by pets.
''Hazardous substance''—Any element, compound or material which threatens the health of domestic animals or humans.
''Relay toxicity''—Secondary poisoning which results when one organism comes into contact with or ingests another organism that has poison in its system. It typically occurs when a predator eats an animal which has previously been poisoned by a pesticide or other substance.
''Rendering''—The cooking or heating of dead domestic animals or parts of such dead animals until all such cooked or heated material is incapable of transmitting dangerous transmissible disease.
''Tallow''—A hard fatty substance made from rendered animal fat, used in making candles and soap.
3. General provisions. The following applies to domestic animals which are euthanized using pentobarbital:
a. All rendering, slaughter or other domestic animal processing establishments, producing commercial feed or pet food, are prohibited from processing dead domestic animals that have been euthanized using pentobarbital and the parts, offal and animal waste from such animals.
b. An animal and the parts, offal and waste of an animal bearing a mark indicating it was euthanized with pentobarbital and may contain pentobarbital residues, or otherwise known to contain pentobarbital residues may not be rendered or processed for commercial feed or pet food.
c. Domestic animals euthanized using pentobarbital shall be marked in the manner set forth in subsections d. and e. of this Order.
d. Veterinarians shall ensure that all domestic animals, excluding dogs and cats and other small companion animals which are euthanized with pentobarbital are visibly identified by placing readily visible paint marks using livestock paint on the animal's head, on at least one side of the animal's thorax, and on all hooves or feet as follows:
i. The head of the domestic animal shall be marked with a large letter ''P'' placed between the eyes to indicate the carcass and the parts are ineligible for rendering or processing to produce any commercial feed or pet food products in the Commonwealth of Pennsylvania.
ii. The thorax and any parts of the domestic animal shall be marked with a large letter ''P'' to indicate the carcass and the parts are ineligible for rendering or processing to produce any commercial feed or pet food products in the Commonwealth of Pennsylvania.
iii. The hooves or feet of the domestic animal shall be marked to indicate the carcass and the parts are ineligible for rendering or processing to produce any commercial feed or pet food products in the Commonwealth of Pennsylvania.
iv. The offal and animal waste such as viscera from a domestic animal euthanized with pentobarbital, excluding dogs, cats, and other small companion animals, shall be kept separate and shall be disposed of in a manner complying with section 2352(a) of the Domestic Animal Law (3 Pa.C.S. § 2352(a)), except that such materials may not be disposed of through rendering.
v. The veterinarian shall explain to the owner that carcasses must be properly disposed of within 48 hours in compliance with the Domestic Animal Law.
e. Owners or caretakers of domestic animals which are euthanized with pentobarbital shall ensure the animals are properly disposed of within 48 hours in compliance with the Domestic Animal Law, excluding disposal by rendering for commercial feed or pet food, to avoid potential relay toxicity to domestic animals, scavengers and raptors. If proper disposal is not immediate, animal carcasses shall be covered or concealed in such a manner as to assure the prevention of access to the carcass, parts, offal and animal waste of such dead domestic animal by other domestic and wild animals.
f. Dead domestic animal haulers shall be prohibited from delivering any dead domestic animal, dead domestic animal carcass, parts, offal or waste, from animals euthanized with pentobarbital to rendering or other processing facilities for the production of commercial feed or pet food products.
g. If markings applied to indicate euthanasia with pentobarbital are not easily visible, the markings shall be reapplied prior to transfer of ownership or possession of the dead domestic animal, dead domestic animal carcass, parts, offal or waste.
h. It shall be unlawful for any person to remove a marking indicating the animal was euthanized using pentobarbital from any dead domestic animal, dead domestic animal carcass, parts, offal or waste.
4. Violations and Penalties. Any person violating the requirements of this Order shall be subject to enforcement and penalties as are allowed under the provisions of the Domestic Animal Law (3 Pa.C.S.A. § 2301 et seq.), which include revocation of license, criminal prosecution, civil penalties of up to $10,000 per violation, injunctive relief or any combination of such penalties.
5. No Restriction on Further Action by the Department. This Order shall not be construed as limiting the Department's authority to establish additional quarantine or testing requirements or take any actions otherwise permitted under applicable statute or regulation.
6. Contact information. Questions regarding this Interstate/International Quarantine Order may be addressed to the Commonwealth of Pennsylvania, Department of Agriculture, Bureau of Animal Health, 2301 North Cameron Street, Harrisburg, PA 17110 (717-772-2852); or by email at RAemail@example.com. Questions about commercial feed or pet food may be addressed to the Commonwealth of Pennsylvania, Bureau of Plant Industry, 2301 North Cameron Street, Harrisburg, PA 17110 (717-787-4843).
7. Effective Date. This Order shall become effective immediately upon publication in the Pennsylvania Bulletin and shall remain in effect unless rescinded or modified by subsequent Order.
RUSSELL C. REDDING,
[Pa.B. Doc. No. 20-1609. Filed for public inspection November 20, 2020, 9:00 a.m.]
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