[Code of Federal Regulations] [Title 9, Volume 1] [Revised as of January 1, 2002] From the U.S. Government Printing Office via GPO Access [CITE: 9CFR79.1] [Page 278-285] TITLE 9--ANIMALS AND ANIMAL PRODUCTS CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE PART 79--SCRAPIE IN SHEEP AND GOATS--Table of Contents Sec. 79.1 Definitions. Accredited veterinarian. A veterinarian approved by the Administrator in accordance with part 161 of this chapter to perform functions specified in subchapters B, C, and D of this chapter. Administrator. The Administrator of the Animal and Plant Health Inspection Service or any employee of the United States Department of Agriculture authorized to act for the Administrator. Animal. A sheep or goat. Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Health Inspection Service of the United States Department of Agriculture. APHIS representative. An individual employed by APHIS in animal health activities who is authorized by the Administrator to perform the function involved. Approved laboratory. A laboratory approved by the Administrator in accordance with Sec. 54.11 of this chapter to conduct one or more scrapie tests, or genotype tests, on one or more tissues. Area veterinarian in charge. The veterinary official of APHIS who is assigned by the Administrator to supervise and perform the official animal health work of APHIS in the State concerned. Blackfaced sheep. Any purebred suffolk, hampshire, shropshire or cross thereof, any non-purebred sheep known to have suffolk, hampshire, or shropshire ancestors, and any non-purebred sheep of unknown ancestry with a black face, except commercial hair sheep. Breed association and registries. Organizations listed in Sec. 151.9 of this chapter that maintain the permanent records of ancestry or pedigrees of animals (including the animal's sire and dam), individual identification of animals, and ownership of animals. Certificate. An official document issued in accordance with Sec. 79.5 by an APHIS representative, State representative, or accredited veterinarian at the point of origin of an interstate movement of animals. Commercial hair sheep. Any commercial sheep with hair rather than wool that is either a full-blooded hair sheep or that resulted from the cross of a hair sheep with a whitefaced wool sheep. Commercial sheep or goat. Any animal from a flock from which animals are moved only either directly to slaughter or through slaughter channels to slaughter or any animal that is raised only for meat or fiber production and that is not registered with a sheep or goat registry or used for exhibition. Commingle, commingled, commingling. Animals grouped together and having physical contact with each other, including contact through a fence, but not limited contacts. Commingling also includes sharing the same section in a transportation unit where there is physical contact. [[Page 279]] Consistent State. (1) A State that the Administrator has determined conducts an active State scrapie control program that either: (i) Meets the requirements of Sec. 79.6; or (ii) Effectively enforces a State designed plan that the Administrator determines is at least as effective in controlling scrapie as the requirements of Sec. 79.6. (2) The Administrator has determined the following States to be Consistent States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming. Designated scrapie epidemiologist. An epidemiologist who has demonstrated the knowledge and ability to perform the functions required and who has been selected by the State animal health official and the area veterinarian in charge. The regional epidemiologist and the APHIS National Scrapie Program Coordinator must concur in the selection and appointment of the designated scrapie epidemiologist. The designated scrapie epidemiologist must satisfactorily complete training designated by APHIS. Direct movement to slaughter. Transported to a facility for slaughter, without stops or unloading except for feeding and watering during which the animals are not commingled with any other animals. Electronic implant. Any radio frequency identification implant device approved for use in the scrapie program by the Administrator. The Administrator will approve an electronic implant after determining that it is tamper resistant, not harmful to the animal, and readable by equipment available to APHIS and State representatives. Exposed animal. (1) Any animal that has been in the same flock at the same time as a scrapie-positive female animal, excluding limited contacts; or (2) Any animal born in a flock after a scrapie-positive animal was born into that flock or lambed in that flock, if born before that flock completes the requirements of a flock plan; or (3) Any animal that was commingled with a scrapie-positive female animal during or up to 30 days after she lambed, kidded, or aborted, or while a visible vaginal discharge was present, or that was commingled with any other scrapie-positive female animal for 24 hours or more, including during activities such as shows and sales or while in marketing channels; or (4) Any animal in a noncompliant flock. Exposed flock. Any flock in which a scrapie-positive animal was born or lambed. Any flock that currently contains a female high-risk, exposed, or suspect animal, or that once contained a female high-risk, exposed, or suspect animal that lambed in the flock and from which tissues were not submitted for official testing and found negative. A flock that has completed a post-exposure management and monitoring plan following the exposure will no longer be an exposed flock. Flock. All animals that are maintained on a single premises and all animals under common ownership or supervision on two or more premises with animal interchange between the premises. Changes in ownership of part or all of a flock do not change the identity of the flock or the regulatory requirements applicable to the flock. Animals maintained temporarily on a premises for activities such as shows and sales or while in marketing channels are not a flock. More than one flock may be maintained on a single premises if: (1) The flocks are enrolled as separate flocks in the SFCP; or (2) A State or APHIS representative determines, based upon examination of flock records, that: (i) There is no interchange of animals between the flocks; (ii) The flocks never commingle and are kept at least 30 feet apart at all times or are separated by a solid wall [[Page 280]] through, over, or under which fluids cannot pass and through which contact cannot occur; (iii) The flocks have separate flock records and identification; (iv) The flocks have separate lambing facilities, including buildings and pastures, and a pasture or building used for lambing by one flock is not used by the other flock at any time; and (v) The flocks do not share equipment without cleaning and disinfection in accordance with Sec. 54.7(e) of this chapter. Additional guidance on acceptable means of cleaning and disinfection is also available in the Scrapie Flock Certification Program standards and the Scrapie Eradication Uniform Methods and Rules. Flock of origin. The flock in which an animal most recently resided in which it either was born, gave birth, or was used for breeding purposes. The determination of an animal's flock of origin may be based either on the physical presence of the animal in the flock, the presence of official identification on the animal traceable to the flock, the presence of other identification on the animal that is listed on the bill of sale, or other evidence, such as registry records. Flock plan. A written flock management agreement signed by the owner of a flock, the accredited veterinarian, if one is employed by the owner, and a State or APHIS representative in which each participant agrees to undertake actions specified in the flock plan to control the spread of scrapie from, and eradicate scrapie in, an infected flock or source flock or to reduce the risk of the occurrence of scrapie in a flock that contains a high-risk or an exposed animal. As part of a flock plan, the flock owner must provide the facilities and personnel needed to carry out the requirements of the flock plan. The flock plan must include the requirements in Sec. 54.8(a)(f) of this chapter. High-risk animal. A sexually intact animal, excluding male sheep that have tested RR at codon 171 and AA at codon 136 using an official genotype test, that is: (1) The progeny of a scrapie-positive dam; or (2) Born in the same flock during the same lambing season as progeny of a scrapie-positive dam, unless the progeny of the scrapie-positive dam are from separate contemporary lambing groups; or (3) Born in the same flock during the same lambing season that a scrapie-positive animal was born, or during any subsequent lambing season, if born before that flock completes the requirements of a flock plan; or (4) An exposed female sheep that has not tested QR, HR, or RR at codon 171 using an official genotype test. Inconsistent State. Any State other than a Consistent State. Infected flock. The flock of origin of a female animal that a State or APHIS representative has determined to be a scrapie-positive animal; or any flock in which a State or APHIS representative has determined that a scrapie-positive female animal has resided unless an epidemiologic investigation conducted by a State or APHIS representative shows that the animal did not lamb or abort in the flock. A flock will no longer be considered an infected flock after it has completed the requirements of a flock plan. Interstate commerce. Trade, traffic, transportation, or other commerce between a place in a State and any place outside of that State, or between points within a State but through any place outside that State. Limited contacts. Incidental contacts between animals from different flocks off the flock's premises such as at fairs, shows, exhibitions and sales; between ewes being inseminated, flushed, or implanted; or between rams at ram test or collection stations. Embryo transfer and artificial insemination equipment and surgical tools must be sterilized between animals for these contacts to be considered limited contacts. Limited contacts do not include any contact, incidental or otherwise, with animals in the same flock or with an animal during or up to 30 days after she lambed, kidded or aborted or when there is any visible vaginal discharge. Limited contacts do not include any activity where uninhibited contact occurs, such as sharing an enclosure, sharing a section of a transport vehicle, or residing in other flocks for [[Page 281]] breeding or other purposes. Examples of limited contacts may be found in the Scrapie Flock Certification Program standards. Live-animal screening test. Any test for the diagnosis of scrapie in a live animal that is approved by the Administrator as usually reliable but not definitive for diagnosing scrapie, and that is conducted in a laboratory approved by the Administrator.\1\ --------------------------------------------------------------------------- \1\ The names and addresses of laboratories approved by the Administrator to conduct live-animal screening tests will be published in the Notices Section of the Federal Register. A list of approved laboratories is also available upon request from the Animal and Plant Health Inspection Service, Veterinary Services, National Animal Health Programs Staff, 4700 River Road Unit 43, Riverdale, MD 20737-1235. State, Federal, and university laboratories will be approved by the Administrator when he or she determines that the laboratory: (a) Employs personnel trained by the National Veterinary Services Laboratories assigned to supervise the testing; (b) follows standard test protocols; (c) meets check test proficiency requirements; and (d) will report all test results to State and Federal animal health officials. Before the Administrator may withdraw approval of any laboratory for failure to meet any of these conditions, the Administrator will give written notice of the proposed withdrawal to the director of the laboratory, and will give the director an opportunity to respond. If there are conflicts as to any material fact, a hearing will be held to resolve the conflicts. --------------------------------------------------------------------------- Low-risk commercial sheep. Commercial whitefaced, whitefaced cross, or commercial hair sheep from a flock with no known risk factors for scrapie, including any exposure to female blackfaced sheep, that are identified with a legible permanent brand or earnotch pattern registered with an official brand registry and that are not scrapie-positive, suspect, high-risk, or exposed animals and are not animals from an infected, source, or exposed flock. The term brand includes official brand registry brands on eartags in those States whose brand law or regulation recognizes brands placed on eartags as official brands. Low- risk commercial sheep may only exist in a State where scrapie has not been diagnosed in the previous 10 years in commercial whitefaced, whitefaced cross, or commercial hair sheep that were not commingled with female blackfaced sheep. Low-risk goat. A goat that is not a scrapie-positive, suspect, high- risk, or exposed animal, that has not been commingled with sheep, and that is from: (1) A State in which scrapie has not been identified in a goat during the previous 10 years; (2) A State in which scrapie has been identified in a goat during the previous 10 years, but the scrapie-positive goat was not born in the State and resided in the State for less than 54 months and did not kid while in the State; or, (3) A State in which scrapie has been identified in a goat during the previous 10 years, and the scrapie-positive goat was commingled with sheep, but flock records allowed a complete epidemiologic investigation to be completed and all resulting infected, source, and exposed goat herds have completed flock plans and are in compliance with post- exposure monitoring plans. National Scrapie Database. A database designated by the Administrator in which APHIS and State animal health agencies cooperatively enter data concerning scrapie outbreaks, flocks and premises affected by scrapie, individual animal identification and premises identification data, and other data to support the Scrapie Eradication Program and the Scrapie Flock Certification Program. Noncompliant flock. (1) Any source or infected flock whose owner declines to enter into a flock plan or post-exposure management and monitoring plan agreement within 30 days of being so designated, or whose owner is not in compliance with either agreement; (2) Any exposed flock whose owner fails to make animals available for testing within 60 days of notification, or as mutually agreed, or whose owner fails to submit required postmortem samples; (3) Any flock whose owner has misrepresented, or who employs a person who has misrepresented, the scrapie status of an animal or any other information on a certificate, permit, owner statement, or other official document within the last 5 years; or [[Page 282]] (4) Any flock whose owner or manager has moved, or who employs a person who has moved, an animal in violation of this chapter within the last 5 years. Official eartag. An identification eartag approved by APHIS as being sufficiently tamper-resistant for the intended use and providing unique identification for each animal. An official eartag may conform to the alphanumeric National Uniform Eartagging system or another system approved by APHIS, or it may bear a premises identification number that either contains or is used in conjunction with the producer's livestock production numbering system to provide a unique identification number. Official genotype test. Any test to determine the genotype of a live or dead animal that is conducted at either an approved laboratory or at the National Veterinary Services Laboratories, when the animal is officially identified and the samples used for the test are collected and shipped to the laboratory by either an accredited veterinarian or a State or APHIS representative. Official identification. Identification mark or device approved by APHIS for use in the Scrapie Eradication Program. Examples are listed in Sec. 79.2(a)(2). Official test. Any test for the diagnosis of scrapie in a live or dead animal that is approved by the Administrator for that use and conducted either at an approved laboratory or at the National Veterinary Services Laboratories. Owner. A person, partnership, company, corporation, or any other legal entity who has legal or rightful title to animals, whether or not they are subject to a mortgage. Owner statement. A written statement by the owner that includes the owner's name, signature, address, and phone number, date the animals left the flock of origin, the premises identification number assigned to the premises, the number of animals, the premises portion of the premises identification if premises identification is used, and a statement that the animals were either born or were used for breeding purposes on the premises to which the premises identification is assigned. Ownership brand. A unique permanent legible brand or earnotch pattern applied to an animal that indicates ownership by a particular person when the brand pattern is registered with a State's official brand recording agency. Permit. An official document issued in connection with the interstate movement of animals (VS Form 1-27 or a State form that contains the same information) that is issued by an APHIS representative, State representative, or an accredited veterinarian authorized to sign such permits. A new permit is required for each change in destination for an animal. A permit lists the owner's name and address; points of origin and destination; number of animals covered; purpose of the movement; whether the animals are from an exposed, noncompliant, infected, or source flock; whether the animal is a high- risk, exposed, scrapie-positive, or scrapie suspect animal; transportation vehicle license number or other identification number; and seal number (if a seal is required). A permit also lists all official identification on the animals covered, including the official eartag number, individual animal registered breed association registration tattoo, individual animal registered breed association registration brand, United States Department of Agriculture backtag (when applied serially, only the beginning and the ending numbers need be recorded), individual animal registered breed association registration number, or any other form of official identification present on the animal. Premises identification. An APHIS approved eartag, backtag, or legible tattoo bearing the premises identification number, consisting of the State postal abbreviation or code followed by a unique alphanumeric number or name, assigned by a State or Federal animal health official to the premises of the flock of origin for the sheep or goats that, in the judgment of the State animal health official or area veterinarian in charge, is epidemiologically distinct from other premises, or a legible permanent brand or ear notch pattern registered with an official brand registry. Premises identification may be used when official individual animal identification is required, if the premises [[Page 283]] identification method either includes a unique animal number or is used in conjunction with the producer's livestock production numbering system to provide a unique identification number and where, if brands or ear notches are used, the animals are accompanied by an official brand inspection certificate. Clearly visible and/or legible paint brands may be used on animals moving directly to slaughter and on animals moving for grazing or other management purposes without change in ownership. Scrapie Eradication Program. The cooperative State-Federal program administered by APHIS and Consistent States to control and eradicate scrapie. Scrapie Eradication Uniform Methods and Rules (UM&R). Cooperative procedures and standards adopted by APHIS and Consistent States for controlling and eradicating scrapie. The UM&R will be reviewed at least annually by representatives of the livestock industry, appropriate State and Federal agencies, and the public and will be drafted, revised, and published as needed by APHIS. Scrapie Flock Certification Program (SFCP). The cooperative Federal- State-industry voluntary program for the control of scrapie conducted in accordance with subpart B of part 54 of this chapter. Scrapie Flock Certification Program standards. Cooperative procedures and standards adopted by APHIS and State Scrapie Certification Boards for reducing the incidence and controlling the spread of scrapie through flock certification.\2\ --------------------------------------------------------------------------- \2\ Individual copies of the SFCP standards may be obtained on the World Wide Web at URL http://www.aphis.usda.gov/vs, or from the Animal and Plant Health Inspection Service, National Animal Health Programs Staff, 4700 River Road Unit 43, Riverdale, MD 20737-1235. --------------------------------------------------------------------------- Scrapie-positive animal. An animal for which a diagnosis of scrapie has been made by the National Veterinary Services Laboratories or another laboratory authorized by the Administrator to conduct scrapie tests in accordance with this chapter, through: (1) Histopathological examination of central nervous system (CNS) tissues from the animal for characteristic microscopic lesions of scrapie; (2) The use of proteinase-resistant protein analysis methods including but not limited to immunohistochemistry and/or western blotting on CNS and/or peripheral tissue samples from a live or a dead animal for which a given method has been approved by the Administrator for use on that tissue; (3) Bioassay; (4) Scrapie associated fibrils (SAF) detected by electron microscopy; or (5) Any other test method approved by the Administrator in accordance with Sec. 54.10 of this chapter.\3\ --------------------------------------------------------------------------- \3\ The names and addresses of laboratories approved by the Administrator to conduct tests are published in the Notices Section of the Federal Register. A list of approved laboratories is also available upon request from the Animal and Plant Health Inspection Service, Veterinary Services, National Animal Health Programs Staff, 4700 River Road Unit 43, Riverdale, MD 20737-1235. State, Federal, and university laboratories will be approved by the Administrator when he or she determines that the laboratory: (a) Employs personnel trained by the National Veterinary Services Laboratories assigned to supervise the testing; (b) follows standard test protocols; (c) meets check test proficiency requirements; and (d) will report all test results to State and Federal animal health officials. Before the Administrator may withdraw approval of any laboratory for failure to meet any of these conditions, the Administrator must give written notice of the proposed withdrawal to the director of the laboratory and must give the director an opportunity to respond. If there are conflicts as to any material fact, a hearing will be held to resolve the conflict. --------------------------------------------------------------------------- Separate contemporary lambing groups. To be a separate contemporary lambing group, the group must be maintained separately such that the animals cannot come into physical contact with other lambs, kids, ewes or does or birth fluids or placenta from other ewes or does. This separate maintenance must preclude contact through a fence, during lambing and for 60 days following the date the last lamb or kid is born in a lambing season, and must preclude using the same lambing facility as other ewes or does, unless the lambing facility is cleaned and disinfected under supervision by an [[Page 284]] APHIS representative, State representative, or an accredited veterinarian between lambings in accordance with Sec. 54.7(e) of this chapter. Additional guidance on acceptable means of cleaning and disinfection is also available in the Scrapie Flock Certification Program standards and the Scrapie Eradication Uniform Methods and Rules. The flock owner must maintain adequate records to document which animals were maintained in each contemporary lambing group and to document when cleaning and disinfection was performed and who supervised it. Slaughter channels. Animals in slaughter channels include any animal that is sold, transferred, or moved either directly to a slaughter facility, to an individual for custom slaughter, or for feeding for the express purpose of improving the animals' condition for movement to slaughter. Any sexually intact animal that is commingled with breeding animals or that has been bred is not in slaughter channels. When selling animals for slaughter, owners should note on the bill of sale that the animals are sold only for slaughter. Source flock. A flock in which a State or APHIS representative has determined that at least one animal was born that was diagnosed as a scrapie-positive animal at an age of 72 months or less. The determination that an animal was born in a flock will be based on such information as the presence of official identification on the animal traceable to the flock, the presence of other identification on the animal that is listed on the bill of sale, or other evidence, such as registry records, to show that a scrapie-positive animal was born in the flock, combined with the absence of records indicating that the animal was purchased from outside and added to the flock. If DNA from the animal was previously collected by an accredited veterinarian and stored at an approved genotyping laboratory, or if DNA collection and storage are required for breed registration and the breed registration has appropriate safeguards in place to ensure the integrity of the banking process, the owner may request verification of the animal's identity based on DNA comparison if adequate records and identification have been maintained by the owner and the repository to show that the archived DNA is that of the animal that has been traced to the flock. The owner will be responsible for all costs for the DNA comparison. A flock will no longer be a source flock after it has completed the requirements of a flock plan. State. Each of the 50 States, the District of Columbia, the Northern Mariana Islands, Puerto Rico, and all territories or possessions of the United States. State representative. An individual employed in animal health activities by a State or a political subdivision of a State and who is authorized by the State or political subdivision to perform the function involved. Suspect animal. An animal will be designated a suspect animal in accordance with Sec. 79.4 if it is: (1) A sheep or goat that exhibits any of the following possible signs of scrapie and that has been determined to be suspicious for scrapie by an accredited veterinarian or a State or APHIS representative: Weight loss despite retention of appetite; behavioral abnormalities; pruritus (itching); wool pulling; biting at legs or side; lip smacking; motor abnormalities such as incoordination, high stepping gait of forelimbs, bunny hop movement of rear legs, or swaying of back end; increased sensitivity to noise and sudden movement; tremor, ``star gazing,'' head pressing, recumbency, or other signs of neurological disease or chronic wasting. (2) A sheep or goat that has tested positive for scrapie or for the proteinase resistant protein associated with scrapie on a live-animal screening test or any other test, unless the animal is designated a scrapie-positive animal. (3) A sheep or goat that has tested inconclusive or suggestive on an official test for scrapie. Terminal feedlot. (1) A dry lot approved by a State or APHIS representative or an accredited veterinarian authorized to perform this function where animals are separated from all other animals by at least 30 feet at all times or are separated by a solid wall through, over, or under which fluids cannot pass and contact cannot occur [[Page 285]] and from which animals are moved only to another terminal feedlot or directly to slaughter; or (2) A pasture when approved by and maintained under the supervision of the State and in which only nonpregnant animals are permitted, where there is no direct fence-to-fence contact with another flock, and from which animals are moved only to another terminal feedlot or directly to slaughter. (3) Records of all animals entering and leaving a terminal feedlot must be maintained for 1 year after the animal leaves the feedlot and must include the person from whom the animals were acquired and the slaughtering facility in which they were slaughtered. Records must be made available for inspection by an APHIS or State representative upon request. Unofficial test. Any test for the diagnosis of scrapie or for the detection of the proteinase resistant protein associated with scrapie in a live or dead animal that either has not been approved by the Administrator or that was not conducted at an approved laboratory or at the National Veterinary Services Laboratories.