Scrapie in Sheep and Goats, 11170-11196 [2019-05430]

Download as PDF 11170 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Parts 54 and 79 [Docket No. APHIS–2007–0127] RIN 0579–AC92 Scrapie in Sheep and Goats Animal and Plant Health Inspection Service, USDA. ACTION: Final rule. AGENCY: We are amending the scrapie regulations by changing the risk groups and categories established for individual animals and for flocks, increasing the use of genetic testing as a means of assigning risk levels to animals, reducing movement restrictions for animals found to be genetically less susceptible or resistant to scrapie, and simplifying, reducing, or removing certain recordkeeping requirements. We are also providing designated scrapie epidemiologists with more alternatives and flexibility when testing animals in order to determine flock designations under the regulations. We are changing the definition of high-risk animal, which will change the types of animals eligible for indemnity, and to pay higher indemnity for certain pregnant ewes and does and early maturing ewes and does. The changes will also make the identification and recordkeeping requirements for goat owners consistent with those for sheep owners. These changes affect sheep and goat producers, persons who handle sheep and goats in interstate commerce, and State governments. DATES: Effective April 24, 2019. FOR FURTHER INFORMATION CONTACT: Dr. Diane Sutton, National Scrapie Program Coordinator, Sheep, Goat, Cervid & Equine Health Center, Strategy and Policy, VS, APHIS, 4700 River Road Unit 43, Riverdale, MD 20737–1235; (301) 851–3509. SUPPLEMENTARY INFORMATION: SUMMARY: Background Scrapie is a degenerative and eventually fatal disease affecting the central nervous systems of sheep and goats. Scrapie belongs to the family of diseases known as transmissible spongiform encephalopathies (TSEs). In addition to scrapie, TSEs include, among other diseases, bovine spongiform encephalopathy (BSE) in cattle, chronic wasting disease in deer and elk, and variant Creutzfeldt-Jakob disease in humans. Control of scrapie is complicated because the disease has an VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 extremely long incubation period without clinical signs of the disease. To control the spread of scrapie within the United States, the Animal and Plant Health Inspection Service (APHIS), United States Department of Agriculture (USDA), administers regulations at 9 CFR part 79, which restrict the interstate movement of certain sheep and goats. APHIS also has regulations at 9 CFR part 54, which describe a voluntary scrapie-free flock certification program. On September 10, 2015, we published in the Federal Register (80 FR 54660– 54692, Docket No. APHIS–2007–0127) a proposal 1 to amend the regulations in parts 54 and 79 by changing the requirements for records needed to trace animals, and by adding provisions to link official individual animal identification applied by persons other than the flock owner to the flock of origin in the National Scrapie Database rather than just the person who applied the official identification. The current regulations address tracing exposed animals moved from a flock to another flock primarily in § 54.8(f) (regarding the responsibility of flock owners to disclose records to APHIS representatives or State representatives for the purpose of tracing animals), in § 79.2(b) (regarding the responsibility of persons applying eartags to maintain appropriate records that permit traceback of animals to the flock in which they originated), and in § 79.6(a)(5) (regarding State responsibilities to do epidemiologic investigations of source and infected flocks that include tracing animals). The changes we proposed would ensure that better records are available for tracing animals by adding requirements in new § 54.8(b), ‘‘Records for flocks under a flock plan or PEMMP,’’ § 79.2(f), ‘‘Records required of persons who purchase, acquire, sell, or dispose of animals,’’ and § 79.2(g), ‘‘Records required of persons who apply official identification to animals.’’ We also proposed to reduce some recordkeeping, primarily by eliminating the requirement in many cases to read and record individual identification that was applied before a new owner or shipper receives the animal. Further, by making the regulations easier to understand we hope to eliminate cases where owners and markets unnecessarily keep records or apply unneeded identification, or fail to do so, when required through lack of 1 To view the proposed rule, supporting documents, and the comments we received, go to https://www.regulations.gov/#!docket Detail;D=APHIS-2007-0127. PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 understanding. Also, in cases where genetic testing allows us to determine that all exposed animals in a flock are genetically resistant, use of genetic testing would allow some flocks to avoid being placed under a flock plan or post-exposure management and monitoring plan (PEMMP), thus avoiding the substantial recordkeeping requirements of § 54.8. We solicited comments concerning our proposal for 60 days ending November 9, 2015. We reopened and extended the deadline for comments until December 9, 2015, in a document published in the Federal Register on November 16, 2015 (80 FR 70718, Docket No. APHIS–2007–0127). We received 59 comments by that date. The comments were from private citizens, sheep and goat breeders, operators of livestock markets, a foreign government, and industry associations. Two commenters supported the rule as proposed. Four commenters were generally opposed to the proposed rule but did not address any specific provisions. The remaining commenters raised a number of concerns related to the proposed rule and program standards. Those concerns are discussed below. Definitions One commenter asked us to clarify the definition of exposed animal, which appears in both §§ 54.1 and 79.1. The commenter stated that the phrase ‘‘or in an enclosure off the premises of the flock’’ is particularly confusing. We agree with the commenter and have amended the definition to specify that an exposed animal is any animal or embryo that: • Has been in a flock with a scrapiepositive female animal; • Has been in an enclosure with a scrapie-positive female animal at any location; • Resides in a noncompliant flock; or • Has resided on the premises of a flock before or while it was designated an infected or source flock and before a flock plan was completed. One commenter recommended the definition of exposed animal be revised to clarify that ‘‘a date 2 years before the birth of the oldest scrapie-positive animal(s)’’ means ‘‘a date 2 years before the birth of the oldest scrapie-positive animal(s) born in that flock.’’ We agree and have made the requested change. One commenter stated that the flock identification number could be issued in a State database and then recorded in the National Scrapie Database. The commenter recommended amending the definition of flock identification number to reflect this. E:\FR\FM\25MRR2.SGM 25MRR2 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations We agree with the commenter and will amend the definition in § 79.1 to read ‘‘recorded in’’ instead of ‘‘issued through.’’ One commenter stated that the definition of genetically less susceptible exposed sheep was unclear. Specifically, the commenter stated that currently most sheep are only genotyped at codon 171, so starting the definition with the words ‘‘An exposed sheep or sheep embryo of genotype AA QR’’ does not make sense. The commenter also asked why AA was used in the definition since most sheep are only genotyped at codon 171 and what ‘‘where Q represents any genotype other than R at codon 171’’ means and what it relates to. AA QR is used in the definition because exposed sheep that are epidemiologically linked to a positive animal that has valine at codon 136 are tested at codon 136 and AV QR sheep may be treated differently than AA QR sheep when this occurs. All positive sheep are tested at a minimum for codon 171 and 136. The statement ‘‘where Q represents any genotype other than R at codon 171’’ means that sheep that have H, K or any other amino acid other than R will be treated the same as sheep that are Q at codon 171. We do agree that the definition could be more clearly written, however, and are changing the definition in §§ 54.1 and 79.1 to define a genetically less susceptible exposed sheep as any sheep or sheep embryo that is: • An exposed sheep or sheep embryo of genotype AA QR, unless the Administrator determines that it is epidemiologically linked to a scrapiepositive RR or AA QR sheep or to a scrapie type to which AA QR sheep are not less susceptible; or • An exposed sheep or sheep embryo of genotype AV QR, unless the Administrator determines that it is epidemiologically linked to a scrapiepositive RR or QR sheep, to a flock that the Administrator has determined may be affected by valine-associated scrapie (based on an evaluation of the genotypes of the scrapie-positive animals linked to the flock), or to another scrapie type to which AV QR sheep are not less susceptible; or • An exposed sheep or sheep embryo of a genotype that has been exposed to a scrapie type to which the Administrator has determined that genotype is less susceptible. In this definition R refers to codon 171 and A refers to codon 136, and Q represents any genotype other than R at codon 171 and V represents any genotype other than A at codon 136. VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 One commenter stated that the definition of genetically susceptible animal was unclear and that the phrase ‘‘or sheep or sheep embryo of undetermined genotype where Q represents any genotype other than R at codon 171’’ does not make sense. We agree that this can be more clearly written and are amending the definition in §§ 54.1 and 79.1 to read ‘‘Genetically susceptible animal. Any goat or goat embryo, sheep or sheep embryo of a genotype other than RR or QR, where Q represents any genotype other than R at codon 171 or a sheep or sheep embryo of undetermined genotype.’’ One commenter asked what is meant by ‘‘under continuous inspection’’ in the definition for slaughter channels. Continuous inspection means an inspector examines each animal before slaughter (antemortem inspection) and the carcass and parts after slaughter (postmortem inspection). For clarity we are amending the definition to specify that official slaughter establishments are under Food Safety and Inspection Service (FSIS) jurisdiction per the Federal Meat Inspection Act or under State inspection that FSIS has recognized as at least equal to Federal inspection or to a custom exempt slaughter establishment as defined by FSIS (9 CFR 303.1) for immediate slaughter, or to an individual for immediate slaughter for personal use or to a terminal feedlot. One commenter asked if a definition for tamper-resistant sampling kit needed to be included in part 79 as well as part 54. The term tamper-resistant sampling kit is used only in part 54. Since it is not used in part 79, it does not need to be defined in that part. We have made minor changes to other definitions. Specifically, we have amended the definition of destroyed in § 54.1 to remove the portion of the definition that allowed for animals to be moved to quarantine facilities because we do not use the word in that sense in the regulations. We note that § 54.7(a)(3) provides for the movement of scrapiepositive and suspect animals for which indemnification is sought to an approved research facility. We have amended the definition of flock identification (ID) number in § 79.1 to specify that APHIS may assign Tribal codes to any federally recognized Tribe that maintains sheep or goats on Tribal lands. We made this change to be consistent with the provisions of a final rule published in the Federal Register on January 9, 2013 (78 FR 2040, Docket No. APHIS–2009–0091) that established official identification and documentation requirements for the PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 11171 traceability of livestock moving interstate. We have amended the definition of genetically resistant sheep to specify that the sheep or sheep embryo is of genotype RR at codon 171. We made this change because we had not specified the codon in the proposed rule. We have also amended the definition of official identification device or method to refer to § 79.2(a)(2), since that is where the requirements for sheep and goat identification are found. We have also amended the definition of slaughter channels in § 79.1 to remove provisions regarding the sale of animals in slaughter channels. Those provisions now appear in § 79.3(g). We have also amended the definition of slaughter channels in § 54.1 to be consistent with the changes in § 79.1. In addition, we have made nonsubstantive editorial changes to the definitions of high-risk animal and owner/hauler statement to improve clarity. Non-Classical Scrapie One commenter recommended that any reference to genetic resistance and susceptibility to scrapie, especially in the definitions, should prominently specify that the relationship between genotype and scrapie pertains to classical scrapie and not non-classical scrapie. APHIS disagrees. While it is true that genetic susceptibility is different for classical and non-classical scrapie, the current language addresses this by including the words ‘‘or to a scrapie type to which the sheep are susceptible.’’ Leaving the text as currently written allows maximum flexibility in addressing all types of scrapie. We are making no changes in response to this comment. One commenter recommended continuing monitoring of animals exposed to non-classical scrapie because non-classical scrapie has been shown to be transmitted through oral inoculation and has a peripheral distribution of infectivity despite the absence of the scrapie prion protein. APHIS agrees that continued monitoring of animals exposed to nonclassical scrapie is warranted. We intend to continue monitoring animals exposed to non-classical scrapie by requiring that they be officially identified with official identification devices or methods assigned to the flock of origin in the National Scrapie Database. Four commenters recommended that APHIS continue to require identification of Nor98-like scrapie-exposed animals, and flockmates and offspring of these E:\FR\FM\25MRR2.SGM 25MRR2 11172 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations animals, for a period of 5 years after the positive animal left the flock. APHIS agrees that animals that are in Nor98-like scrapie infected and source flocks and animals originating from these flocks should be identified for a period of 5 years, and the flocks monitored through reporting and testing of clinical suspects and mature animals that die. We note that we have provided for this in the program standards in Part VIII: Flock Cleanup Plans and PEMMPs, so there is no need to make changes to the program standards in response to this comment. Official Identification Several commenters expressed concern that the rule would prohibit the use of registry tattoos as official identification. This is not the case. The rule, through the accompanying program standards, does allow the use of registry tattoos as official identification when the sheep or goat is legibly tattooed and accompanied by a copy of their registration certificate in the name of the current owner or a copy of a completed application for transfer of ownership dated within 60 days of the change in ownership or when accompanied by an interstate certificate of veterinary inspection that lists the flocks of origin and birth, the registry, and the registry tattoo. Two commenters asked that we confirm that registration/recordation tattoos will continue to be allowed for animals in exhibition, educational events, in registry sales, private treaty transfer, and other movements not in slaughter channels or auction markets. Yes, these animals may move with registry tattoos as currently allowed. The only change is that the registry prefix must be recorded in the premises record for the flock in the National Scrapie Database and documentation of this must accompany the animal, or the registry organization must be approved based on their ability and willingness to assist APHIS in tracing animals during a disease investigation. One commenter asked, that for tattoo prefixes containing letters that are prohibited, that the prefix be linked in the National Scrapie Database with the flock identification. APHIS notes that this rule allows, and the program standards encourage, the cross referencing of flock identification numbers with registry prefixes. No change is being made in response to this comment. Several commenters expressed concern about how the identification requirements would apply to certain goat breeds. One commenter expressed concern that tail tags would cause VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 unnecessary medical issues for smalleared or earless breeds of goats, such as La Mancha goats. The rule states that the requirements for use of official identification devices will be maintained on the APHIS website. These requirements are posted on the website as part of the Scrapie Program Standards. There are no approved tags for application to the tail, and the application of an official eartag to any tissue other than the ear is specifically prohibited in the Scrapie Program Standards. APHIS provides for tail fold tattoos, Electronic Implantable Devices (EIDs), and neck collars as acceptable means of identification for very small-eared or earless goats. One commenter expressed the concern that neck collars may pose a strangulation risk. APHIS notes that neck collars are commonly used for dairy goats. We believe that, given this usage, the risk of strangulation is likely minimal or neck collars would not be in general use. Further, because the expectation of durability is the same as for eartags, using collars that will break before causing strangulation is allowed and considered desirable. Also, as we explain below, we are amending the program standards to allow the use of back tags for earless animals moving directly to slaughter as an alternative to using a neck collar. One commenter requested that earless goats be exempted from the ID requirements. We recognize that using tail fold tattoos, EIDs, or neck collars for earless goats may present some challenges for breeders; however, using these devices will result in being able to trace a higher percentage of the animals. Not using them will reduce the traceability of these animals. We agree that allowing the use of back tags for earless animals moving direct to slaughter is an acceptable option and are amending the program standards to reflect this. One commenter stated that eartags are too big for miniature goat breeds and that tattoos should be allowed. As we explained above, the use of registry tattoos and flock identification tattoos as official identification will be allowed. We also note that very small official eartags are available for use on miniature breeds. Some commenters stated that we should not require a specific ear to be used for the eartag. One commenter recommended that the right ear forward edge be used for metal tags. Several other commenters recommended that APHIS standardize the placement of eartags in wool sheep to the left ear half way between base and tip of ear and in PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 the middle between the ridges towards the lower edge. The commenters also stated that metal tags should be avoided in wool or fiber animals to minimize the risk of injury to shearers or damage to shearing equipment. The rule does not require that a specific ear be used for the eartag. We agree that placement on the lower edge of the left ear is preferred for wool or fiber animals and will provide this guidance in the program standards. However, we will not make it a requirement because it would be overly burdensome to producers given the minimal improvement in traceability that would likely result. One commenter asked that epidemiological evidence be independently compiled by an entity such as the Occupational Safety and Health Administration (OSHA) regarding the relative safety risk to shearers in flocks using metal vs. plastic tags. OSHA makes information about planned and accident-related inspections, searchable by Standard Industrial Classification (SIC) codes, available on its website. There are only 17 incidents reported from all causes related to sheep and goat farms (SIC code 0214) in the last 5 years.2 Given this small number of incidents, we do not believe there is sufficient data provided to OSHA on shearing injuries for a meaningful comparison. We will include a question on eartag-related shearing problems in the next sheep National Animal Health Monitoring System (NAHMS) study, which we anticipate doing in Fiscal Year 2022. The prior NAHMS was conducted under OMB control number 0579–0188. One commenter recommended use of a uniform tag color to assist regulatory personnel to quickly and efficiently identify officially tagged sheep and goats. We agree that a uniform official tag color would be beneficial in rapidly identifying official eartags. However, we also believe that there is a significant benefit for producers to have access to multiple tag colors for purposes of sorting their animals by age, sex, or other characteristics, so we will continue to allow the use of various colors of eartags. APHIS changed the color of metal tags provided by APHIS in 2018 to orange to make them more visible. 2 https://www.osha.gov/pls/imis/industry.search? p_logger=1&sic=0214&naics=&State= All&officetype=All&Office=All&endmonth= 01&endday=01&endyear=2011&startmonth= 12&startday=31&startyear=2015&owner=&scope= &FedAgnCode=. E:\FR\FM\25MRR2.SGM 25MRR2 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations Two commenters asked that the program standards be revised to require all sheep and goats at exhibitions be tagged, regardless of whether they come from in or out of State, as an exhibition is a concentration or commingling point. For practical purposes, sexually intact sheep and goats of any age and wethers 18 months of age and older that are exhibited are required to be officially identified. There is an exclusion, which would rarely apply, for animals that have never been in interstate commerce and that have not resided on a premises where animals that have been in interstate commerce have been received or from which animals are moved in interstate commerce, where the animals being moved for exhibition are not owned by a person who engages in the interstate commerce of animals, that are moved to exhibitions that are conducted at premises where the interstate commerce of animals does not occur, and where none of the animals exhibited has been in interstate commerce. We believe that this exclusion is required since if such an exhibit were to occur it would fall within the State’s authority. We are revising the Scrapie Program Standards to clarify this. One commenter opposed requiring identification for all sheep because it would be costly not only to producers, but also to auction markets and the veterinary personnel working at markets. Other commenters also opposed requiring identification for goats because of the additional costs. We are aware that there are costs associated with the application of official identification for both producers and markets. However, the use of official identification is essential for the eradication of scrapie. To achieve scrapie-free status, we must be able to trace mature animals in order to conduct effective slaughter surveillance. Eradication is the goal because achieving scrapie-free status in the United States would significantly enhance trade opportunities and help to stabilize prices for sheep and goats and their products. Since the goal of the program is eradication and not just control of scrapie, maintaining a low prevalence in goats is not an option. Three commenters raised concerns regarding the safety of applying eartags to range goats, particularly mature bucks that have horns. The commenters stated that these goats are wild animals, and that applying eartags to them presents a risk to both the animals and the people applying the eartags. We agree that certain goats may pose a hazard to those applying eartags if VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 appropriate equipment is not available to restrain the animals. The provisions in § 79.3(a)(2) allow these goats to move in single source groups to slaughter without official individual identification including through markets. This is one option for handling these goats. We will also revise the program standards to allow such goats to move direct to slaughter with official backtags as less restraint is required to apply backtags. We are also amending § 79.3(k) to allow compliance agreements or market agreements to include alternative methods for maintaining traceability or achieving acceptable surveillance levels when the Administrator and the State Animal Health Official agree that the application of an allowed official identification device or method is unsuitable for a specific circumstance. Further, we have amended the definition of group/lot identification number (GIN) in § 79.1 to provide that a group lot comprised of animals from a single flock of origin may be subdivided after leaving the premises on which the group lot was formed by adding an S followed by a sequential number to the end of the GIN to create a GIN for each sub group. This will provide additional flexibility in handling unidentified animals moving to slaughter as a single source lot. Three commenters stated that veterinarians should be able to order and use official scrapie tags for use in regulatory testing, interstate certificates of veterinary inspection (ICVI), or any other reason requiring official identification. The commenters also stated that APHIS should maintain this traceability information in a userfriendly database. The commenters also stated that county 4-H sheep and goat offices should be assigned official scrapie tags. In § 79.2(b) of the proposed rule, we proposed to continue to allow State Animal Health Officials and APHIS personnel responsible for States to issue sets of unique serial numbers or flock identification/production numbers for use on official individual identification devices or methods (such as eartags or tattoos). In § 79.2(b)(2), we also proposed to continue to allow the official responsible for issuing eartags in a State to assign serial numbers of official eartags to other responsible persons, such as 4–H leaders, if the State Animal Health Official and APHIS personnel responsible for the State involved agree that such assignments will improve scrapie control and eradication within the State. Distribution of tags is currently managed in the scrapie program utility PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 11173 of the Animal Identification Management System and in certain cases redistributed in the Surveillance Collaboration Services Scrapie (SCS SCR) system. APHIS intends to continue to work to improve the user experience with these systems. One commenter sought clarification regarding whether the proposed rule would require individual animal identification numbers to be read more than once at approved livestock facilities. This requires that eartags be read only when an ICVI is required for movement of the animals from the market in cases where flock identification tags were not used to identify the animals or the flock identification of the animals is unknown and the tags must be read to determine the flock of origin. If flock identification tags are present, the flock identification may be listed instead of the individual tag numbers. In the case of animals that arrive at a market on an ICVI, when allowed by the States involved, the original document may be attached to the new ICVI if the animal IDs of any animals not included in the shipment are struck off the old ICVI. Recordkeeping Several commenters had concerns regarding the recordkeeping associated with goat sales and our ability to trace goats based on these requirements. This rule makes the identification requirements for goats in interstate commerce similar to those currently in place for sheep. The requirements for sheep have been in place since 2002 and have resulted in 82 percent of positive sheep being traced and a 98 percent decrease in the prevalence of scrapiepositive adult sheep slaughtered adjusted for face color.3 We are confident that these requirements will be similarly successful with goats. Several commenters asked that APHIS provide templates with required fields marked for owner/hauler statements and for any other required information or data as in the case of entities that acquire or dispose of animals. We agree that such templates would be useful and will post templates on the APHIS Scrapie Program website when they have been approved. Two commenters opposed the requirement to submit eartagging records to APHIS. Several other commenters indicated that the requirement to submit tagging records could be burdensome if not 3 Historically, prevalence rates of scrapie varied by face color and our prevalence estimate is appropriately weighted to match the face color distribution within the U.S. sheep population. E:\FR\FM\25MRR2.SGM 25MRR2 11174 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations implemented prudently following successful piloting, and that an option should be provided for electronic storage of required documents in an APHIS system rather than requiring the market to store the records long-term. One commenter stated that the regulations should clearly state that maintaining physical copies of these records at the market for 5 years also meets this requirement. We agree with the commenters and have amended § 79.2(b)(3) to indicate that submission is required only when requested by APHIS. This will allow APHIS to work through issues that may negatively impact stakeholders in small pilots and to implement the requirement through the program standards when the process has been tested and the technology allows for efficient compliance. APHIS will also consider the feasibility of providing electronic document storage. With this change maintaining physical copies of these records at the market for 5 years meets the requirement unless the records are requested. Some commenters recommended using an owner/hauler statement and lot/group identification for lots of sheep or goats moving directly to slaughter without official ID. APHIS notes that § 79.3(a)(2) allows single source lots of cull sheep or goats to move unidentified direct to slaughter using an owner/hauler statement without official ID so no changes are being made in response to this comment. We will amend the program standards to improve clarity. One commenter requested that we allow unidentified animals in interstate commerce that do not cross State lines to move unidentified to markets that are not approved markets. APHIS notes that as currently written, the regulations allow unidentified animals to move to unapproved in-State markets for sale, provided that the markets tag the animals once they arrive. However, if the person selling the animal through an unapproved inState market engages in the interstate commerce of animals, they must identify the animals before loading them at their premises. In response to the comment, we are amending § 79.2(a)(1)(iv) to allow producers not already allowed to move animals unidentified to unapproved in-State markets under the regulations to do so if the animals’ owner provides tags assigned to his or her flock for the market to apply. As an alternative, such markets may request approval under § 71.20. We are also amending § 79.2(a)(1)(iv) to add ‘‘or the owner of the animal’’ VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 after ‘‘the owner of the premises’’ since it would be inequitable to apply a different standard to people who rent as opposed to own the premises on which their animals reside. In § 79.2(a)(1), we had proposed to remove paragraph (vi) because the newly amended paragraph (iv) included animals moved across a State line. However, from questions received during the comment period it became apparent that the removal of this paragraph reduced clarity. Therefore, we will not be removing paragraph (vi). We have made nonsubstantive, editorial changes to the paragraph to update and simplify its language. One commenter indicated support for the opportunity for markets to enter into agreements with USDA to receive unidentified animals that cannot be traced to their flock of birth or origin if they place a slaughter only tag on them and sell them through slaughter channels, but did not support the reporting requirement for noncompliant shipments. The commenter stated that this requirement asks markets to act against the interests of their customers. APHIS recognizes that this presents a conflict for markets. Markets may either decline to handle non-compliant shipments or report such shipments to USDA as part of a compliance agreement. No change is being made in response to this comment. Interstate Certificates of Veterinary Inspection One commenter recommended that each copy of an ICVI be signed by the issuing veterinarian. We agree with the commenter and are amending § 79.5(a)(4) to specify that the ICVI must be signed by the issuing State, Federal, Tribal or accredited veterinarian and the signature must be legible on each copy of the ICVI. One commenter asked us to clarify the flock identification exception in § 79.5(a)(2). The commenter specifically asked what animals could move with flock identification that is assigned to the flock of origin and to explain how ‘‘flock of origin tags’’ differ from tags issued to flock owners with individual flock identification numbers. We amended that paragraph to refer to ‘‘official identification devices or methods that include the flock identification number assigned to the flock of origin in the National Scrapie Database and an individual animal number unique within the flock,’’ to clarify the requirements. One commenter asked for clarification of the requirement to record official genotype tests on an ICVI. Another PO 00000 Frm 00006 Fmt 4701 Sfmt 4700 commenter recommended eliminating the requirement to record official genotyping tests on an ICVI in § 79.5(a)(3) as the value of doing so is small and would be impractical to enforce. We agree with the second commenter that recording official genotype test information on the ICVI is not needed and have removed the requirement. Surveillance One commenter stated that the proposed rule does not encourage slaughter surveillance and expressed concern that focus on achieving State sampling minimums will adversely impact slaughter surveillance efforts. We agree that sampling animals at slaughter is critical and needs to be maintained. This work is currently being done almost entirely by APHIS and its contractors. This final rule requires Consistent States to assist APHIS in sampling in slaughter establishments that are under State inspection or that do not engage in interstate commerce and to meet sampling minimums for animals originating in their State. It is critical to get adequate sampling from all areas of the United States to minimize the risk that cases will go undetected. Further, should the State sampling minimums adversely impact overall surveillance, APHIS has the ability under the rule to reduce the minimums. For these reasons no change is being made in response to the comment. Three commenters stated that APHIS should help States ensure their Consistent State status by promoting Regulatory Scrapie Slaughter Surveillance (RSSS) for interstate testing, especially for those States not able to do adequate surveillance testing. The commenters also stated that APHIS should work with State officials to reach out to producers and enlist producer support to alert producers when surveillance levels are not meeting expected levels to retain Consistent State status. The commenters further stated that APHIS or State employees should actively select and test older goats in poor condition for RSSS. APHIS is committed to working with States to exceed State sampling minimums, and we have prioritized RSSS collections. Goats in a thin or wasted condition are among those targeted for collection. One commenter recommended that the breed of exposed animals be considered in deciding whether an animal is designated as a high-risk animal. There is insufficient evidence to demonstrate that any breed of sheep or E:\FR\FM\25MRR2.SGM 25MRR2 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations goat is resistant to scrapie; therefore, no change is being made in response to this comment. One commenter expressed concern that when APHIS lists a breed as having had a case of scrapie, the animal may not be purebred despite being registered, and that this could have a negative impact on the breed. APHIS does rely on registry records to determine the breed of an animal and this may result in animals with incorrect pedigrees being considered purebred. The science is not sufficiently mature to reliably and cost-effectively determine the breed of a sheep based on genotype. We note, however, that the breed of a sheep does not affect the regulatory requirements in any way. One commenter recommended excluding rare breeds that have been historically free of scrapie from being considered high-risk if they are scrapie exposed. The commenter referenced the work of H.B. Parry 4 in support of this recommendation. APHIS notes that rare breeds are by definition few in number. Therefore, they would not be frequently tested for scrapie and would appear to be ‘‘historically free’’ as a result; however, this appearance could be misleading because of the small sample size. Parry’s work did not include the genotypes of the sheep involved and it is unclear if his observations were a widespread breed trait separate from the genotype at codons 171 and 136 or the result of the genotype at these codons. Further, Parry’s work was done in the United Kingdom where the predominant scrapie type is valine dependent, strains to which AA QQ sheep are resistant. As a result, his work may not be relevant to the United States where the predominant scrapie type is valine independent, strains to which AA QQ sheep are susceptible. As the commenter noted, three breeds considered resistant by Parry have contracted scrapie in the United States. We are making no change in response to this comment as there is adequate flexibility through the pilot project provision and the low-risk exposed animal definition to allow such sheep to be exempted if there is sufficient scientific evidence available to warrant an exemption. One commenter raised the concern that selecting for genes associated with resistance may be adversely impacting the sheep industry and may be encouraging crossbreeding to add 4 ‘‘Elimination of natural scrapie in sheep by sire genotype selection,’’ Nature 277 (1979): 127–129, and Scrapie Disease in Sheep (London: Academic Press, 1983). VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 resistance genes to breeds in which they are rare. Several scientific articles have indicated that there is little, if any, difference in production traits between QQ, QR and RR sheep.5 One article indicated that there is an association between QQ at codon 171 and the ability to mobilize fat reserves in Scottish Blackface sheep.6 Another study showed that within one flock there was a higher litter size in QQ Suffolks than in QR or RR Suffolks but no difference in pounds of lamb weaned.7 In the same study, no difference was shown for Columbia, Hampshire, Rambouillet, or western white face sheep. Also, a study showed that as in selecting for any trait, selecting for scrapie resistance may delay progress on other traits, particularly in breeds where R at codon 171 is rare.8 APHIS only requires genetic selection in exposed flocks and other higher risk flocks as part of PEMMPs. Further, breeders wishing to retain Q genes can do so with little impact on genetic resistance to scrapie by breeding RR ewes to QR rams and QR ewes to RR rams. Regarding unacknowledged cross breeding, this has occurred on other occasions when a breed is believed to be lacking a desirable trait and will occur anytime there are unscrupulous breeders and a 5 ‘‘Evaluation of associations between prion haplotypes and growth, carcass, and meat quality traits in a Dorset × Romanov sheep population’’, Journal of Animal Science 84 (2013): 783–788; ‘‘Influence of Prion Protein Genotypes on Milk Production Traits in Spanish Churra Sheep’’, Journal of Dairy Science 89 (2006): 1784–1791; ‘‘Investigation of farmer regard for scrapiesusceptible sheep’’, The Veterinary Record 158 (2006): 732–734; ‘‘Associations between genotypes at codon 171 and 136 of the prion protein gene and production traits in market lambs’’, American Journal of Veterinary Research 68 (2007): 1073– 1078; ‘‘Is there a relationship between prion protein genotype and ovulation rate and litter size in sheep?’’, Animal Reproduction Science 101(2007): 153–157; ‘‘Analysis of prion protein genotypes in relation to reproduction traits in local and cosmopolitan German sheep breeds’’, Animal Reproduction Science 103 (2008): 69–77; ‘‘Scrapie resistance and production traits in Rambouillet rams: Ram performance test 2002–2006’’, Research in Veterinary Science 85 (2008): 345–348; and ‘‘Characterization of the PRNP gene locus in Chios dairy sheep and its association with milk production and reproduction traits’’, Animal Genetics 42 (2011): 406–414. 6 ‘‘Association of the prion protein gene with individual tissue weights in Scottish Blackface sheep’’, Journal of Animal Science 86 (2008): 1737– 1746. 7 ‘‘The incidence of genotypes at codon 171 of the prion protein gene (PRNP) in five breeds of sheep and production traits of ewes associated with those genotypes’’ Journal of Animal Science 83 (2005): 455–459. 8 ‘‘Predicting the consequences of selecting on PrP genotypes on PrP frequencies, performance and inbreeding in commercial meat sheep populations’’, Genet. Sel. Evol. 39 (2007): 711–729. PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 11175 financial incentive. We are not making any changes to the regulations based on this comment. The commenter stated that, in the case of 400 dairy sheep seized and euthanized in 2000–2001, none tested positive for scrapie. The commenter therefore requested that we provide the history, by year, of the number of positives, breed and percentage of individuals of infected/source flocks that were positive after laboratory testing. APHIS notes that in the case of the dairy sheep, the disease of concern was not scrapie but BSE. The information requested by the commenter is provided in the charts in the document titled ‘‘Scrapie Case Information By Breed, Face Color or Type and or Sampling Stream FY 1999 to 2015’’ that accompanies this final rule. Copies of the document are available on the Regulations.gov website (see footnote 1 in this document for a link to Regulations.gov) or by contacting the person listed under FOR FURTHER INFORMATION CONTACT. One commenter agreed with genetic testing to determine risk level and also that AA QR (GLS) & AA RR (GR) should be exempt from destruction and noted that Canada does not exempt AV QR. The commenter stated that male animals are lower risk for transmitting scrapie but are at equal risk of becoming infected and noted that the World Organization for Animal Health does not differentiate male and female animals in their guidelines. No changes are being made in response to this comment. We believe that there is sufficient flexibility in the definitions for high-risk animals, the genetically susceptible exposed animals, and low risk exposed animals for the Administrator to address any issues that may arise with exposed male animals and exposed AV QR sheep. One commenter stated that for rare breeds APHIS should consider KK at codon 171 the same as QR for determining scrapie susceptibility. Unpublished work by USDA Agricultural Research Service has shown that KK171 Barbado sheep are susceptible to scrapie by intracerebral inoculation. A complimentary study using an oronasal route showed that at 70 months post inoculation and at 5 years post inoculation there was no evidence of scrapie in these KK171 sheep. This indicates that KK171 sheep are likely less susceptible to classical scrapie. This rule will give the Administrator the flexibility to address KK171 sheep and any other genotypes in sheep or goats that may prove to be less susceptible or resistant to classical E:\FR\FM\25MRR2.SGM 25MRR2 11176 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations scrapie through the low-risk animal definition, the genetically lesssusceptible animal definition, or through a pilot project once there is sufficient scientific evidence to support such action. In § 79.4, paragraph (c) provides for testing of scrapie-positive animals, highrisk animals, exposed animals, suspect animals, exposed flocks, infected flocks, noncompliant flocks, and source flocks, and paragraph (c)(1) provides for actions that may be taken if a flock owner fails to make animals available for testing. One commenter stated that in § 79.4(c)(1) the statement ‘‘or as mutually agreed’’ was unclear. We agree that this statement could be clearer. We are changing ‘‘or as mutually agreed’’ to ‘‘or as mutually agreed in writing by the Administrator and the owner,’’ to clarify the conditions under which an owner could be considered in violation. Markets and Tagging Seven commenters supported allowing markets to continue to apply white serial tags issued to them to potential breeding sheep and goats. Six commenters stated that markets should be limited to applying only ownerprovided official eartags or blue slaughter-only serial eartags provided by the markets in order to reduce the number of untraceable animals. One commenter opposed these suggestions to limit tagging by markets to slaughteronly tags. That commenter was concerned that markets would have regulatory action taken against them if a blue tagged animal went back to the farm despite being sold for slaughter only. The commenter stated that many smaller-scale sheep and goat producers have limited marketing opportunities and often rely on livestock markets to sell their animals. The commenter stated further that for some of these markets, the profit margin is so small they offer this more as a public service than a business opportunity. Any additional burden on these markets may result in them no longer accepting sheep and goats. The commenter stated that as long as required records are utilized it should be left up to the individual markets whether they will accept unidentified animals, whether they will apply owner-supplied identification, or whether they choose to apply serial or slaughter-only eartags. The same commenter supported continuing to allow livestock markets to receive official tags directly from animal health officials and apply these tags to sheep and goats coming into the market untagged. VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 APHIS believes that while on-farm tagging is ideal, there is a certain percentage of producers who will not choose to do this, whether their reasoning be based on difficulty of tagging, privacy, or other reasons. The model in this rule addresses this concern by allowing these animals to be identified by the market and for records to be kept regarding their movement. Additionally, this model provides a reasonable expectation that the movements will be able to be tracked because the option only applies to sheep and goats direct from a farm. Commingled lots would already have to be identified prior to arriving at the market as is called for in § 79.2(a)(1)(i). In response to these comments we are amending the regulations to allow the State Animal Health Official or the Administrator to limit the assignment of official identification devices or numbers to persons or classes of persons for use on animals that did not originate in a breeding flock owned by them to slaughter-only devices or numbers. This will give the States flexibility to improve traceability, and also give the Administrator the ability to establish a nationwide policy on official eartag distribution should such State programs prove to be successful in increasing traceability. One commenter expressed concern that some owners and haulers will not abide by the requirement for owner/ hauler statements and asked how animals received without an owner/ hauler statement should be handled by markets. Since either an owner or a hauler may complete the statement, the owner or hauler could complete the owner/hauler statement once they arrive at the market. At markets where owners or haulers do not have the required information to complete the statement, the market may either refuse such animals or the market may enter into a compliance agreement as described in § 79.3(k). To clarify the requirements, we have amended § 79.3(k) as follows: ‘‘APHIS may enter into compliance agreements with persons such as dealers and owners of slaughter establishments and markets whereby animals may be received unidentified or without a required owner/hauler statement even if they cannot be identified to their flock of birth or origin because they were moved or commingled while unidentified, in violation of this part or a State requirement as provided by § 79.6.’’ One commenter requested that APHIS allow use of other documents that contain the information required on the owner/hauler statement. PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 The current definition of an owner/ hauler statement allows for the use of other documents if they contain the same information as the owner/hauler statement. However, we have amended the definition to clarify that this is intended. One commenter asked that the animals which would qualify to move for purposes other than slaughter be allowed to be tagged after sale, so that only those animals that are moving for purposes other than slaughter at under 18 months of age would need to be eartagged. In response to this comment, we are amending §§ 79.2(a)(1)(ii) and 79.3(a)(5) to permit approved markets that have the ability to maintain the identity of single source lots through the sale process to tag such animals after sale. Movement, Premises ID, Group Lot Number Several commenters requested clarification of the requirement to provide additional premises of a flock before unidentified animals were moved between those premises. In response we are adding the following clarification to § 79.3(a)(4): ‘‘A request to APHIS to enter additional flock premises in the National Scrapie Database is required before animals are first moved to the premises. Notification is not required for each subsequent movement of animals to that premises. Neither group lot ID nor an owner/hauler statement is required for movements of a flock or its members for flock management purposes within a contiguous premises spanning two or more States. This provision does not include the transiting or sale of animals through such a premises in circumvention of the other requirements of this part.’’ Several commenters requested additional clarification on how group/ lot IDs may be used. Group/lots IDs are used to (1) associate a unique number with movements of single source lots direct to slaughter or to a market to simplify identifying relevant records during a disease investigation, (2) to be able to easily differentiate groups of animals moved for management purposes such as grazing, and (3) to be able to quickly identify the sources of animals in multisource lots such as slaughter lambs to assist in tracing exposed animals out of infected and source flocks to slaughter. One commenter asked for clarification of the requirements in § 79.3(a). The commenter stated that the relationship between paragraph (a) and how that relates to animals over 18 months of age in slaughter channels was confusing. For example, the statement in (a) says E:\FR\FM\25MRR2.SGM 25MRR2 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations that the animals in (1) through (5) may move with an owner/hauler statement and group lot ID, but then in (3) it refers to animals that have individual identification. The commenter asked if these requirements could be reworded. We agree that this can be worded more clearly and have revised § 79.3(a)(3) to clarify that an owner/ hauler statement may be used instead of an ICVI for such animals. Indemnity Four commenters noted that most American ewe lambs can be managed in a way that they can conceive at a young enough age to lamb as yearlings. The commenters believe that indemnifying for ewes that are verified as pregnant, regardless of their age, satisfies the general intention of age and reproduction status of the animals and that would apply to ewe lambs under 12 months of age. The commenters further stated that the proposed categorization of early maturing ewe lambs as yearlings could lead to disputes and mistakes with indemnity payments. The commenters therefore recommended removing the indemnity provision for early-maturing ewes and suggested indemnifying them based on their pregnancy status instead. We agree with the commenters and have revised the program standards to reflect this by allowing animals under 12 months of age to be classified as yearlings only if they are visibly pregnant or have an offspring and not based on owner records indicating that the flock has a history of lambing or kidding at an early age. No changes to the regulations are necessary. While preparing this final rule, we noted that there was substantial overlap between the provisions regarding indemnity in §§ 54.3(b) and 54.6(d). To improve clarity, we have consolidated the provisions in § 54.3(b) and have removed § 54.6(d). We have also moved the provision allowing for the Administrator to waive the requirement for a flock plan or PEMMP from §§ 54.8(j)(3) to 54.8(l). Paperwork One commenter was concerned about the paperwork burden associated with the proposed rule. The commenter also expressed concern that the rule would require markets to provide seller information to all buyers. The rule does increase the paperwork burden associated with maintaining tagging records, but we believe that maintaining these records for additional classes of goats and animals in slaughter channels is necessary to increase traceability of goats and sheep, which in VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 turn is critical for eradicating scrapie. The rule does not require markets to provide seller information to buyers in most cases; the exception is that markets must provide the group lot numbers when the animals are moving unidentified as part of a single source lot in slaughter channels. Program Standards One commenter noted that there are references to the Scrapie SharePoint site throughout the program standards document. The commenter noted that State officials cannot currently access information on this site so another resource needs to be readily available and should replace all references to the Scrapie SharePoint site. A SharePoint site accessible to State employees is now available. One commenter noted that there are many references throughout the document to PEMMPs, particularly in Part VII and VIII and the flowcharts. The commenter stated that sometimes the term ‘‘full PEMMP’’ is used, sometimes the term ‘‘basic PEMMP’’ is used, and sometimes it is not specified. The commenter asked that APHIS clearly spell out what the requirements are for each type of PEMMP, which type is required for each situation, and be consistent with terminology. We have replaced the term ‘‘full PEMMP’’ with ‘‘retained susceptible animal PEMMP’’ throughout the program standards. One commenter stated that some of the program standards definitions are slightly different from those in the rule. Some of the definitions were not updated in the program standards and this has been corrected. Other definitions are slightly different because they need to reference the Code of Federal Regulations, and in some cases they include more specific information to assist the reader. Information that is subject to frequent change, such as the components currently included in the National Scrapie Database, was not put into the regulations. One commenter asked what the purpose of entering low-risk exposed animals into the National Scrapie Database is. The purpose of putting low-risk exposed animals in the database is to be able to search against the database if they should later be determined to be infected so that we can understand whether the criteria for redesignating animals as low-risk are effective and to be able to search against these animals when required for an export certificate or ICVI. One commenter recommended not using Emergency Management and PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 11177 Response System (EMRS) for scrapie tracing. We disagree. EMRS allows a higher degree of accountability for completing scrapie trace investigations and the number of trace outs is currently low enough that use of this system should not be overly burdensome. One commenter asked what ‘‘when an insufficient number of QQ sheep and goats are available . . .’’ in the introduction to the Part VII: Epidemiology A section of the program standards meant. We agree that this can be worded more clearly and are revising the Scrapie Program Standards to read ‘‘When the number of QQ sheep and goats in the flock is insufficient to conduct a reliable flock test, or . . .’’ One commenter indicated that, in the Part VII: Epidemiology B section, the review provision in the note contradicted the table in that it indicates the Sheep and Goat Health Specialist for Epidemiology (SGHSE) must concur with decisions made by the designated scrapie epidemiologist. The commenter is correct. We have corrected the table to list those situations when the SGHSE must approve the designation or redesignation and deleted the note. One commenter stated that Part VII: Epidemiology F. Procedures for Investigation and Monitoring a Flock that Received a High-Risk Animal was hard to follow and should be revised for clarity. We agree that there was room for improvement and have made edits for clarity. One commenter stated that the term ‘‘status’’ had not been updated in places to conform with the change to SCS SCR. We agree and have corrected the terminology to reflect the new nomenclature, which resulted from the migration of the Scrapie Program data from the Scrapie National Generic Database (SNGD) to SCS SCR, throughout the document. What was termed ‘‘status’’ in the SNGD is called a ‘‘program’’ or a ‘‘restriction’’ in SCS SCR. One commenter recommended moving Part VIII: Flock Cleanup Plans and PEMMPs B.3(a)(12), Steps for completing a standard genetic based flock plan for source and infected flocks that retain only AR, HR, KR, and RR ewes and male sheep and male goats, to Part VII: Epidemiology, E. B.3(b)(4) because that section seems procedural and would fit better in Part VII. We agree that this section could reasonably be moved to Part VII; however, we do not believe that it results in an improvement, so no change E:\FR\FM\25MRR2.SGM 25MRR2 11178 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations is being made in response to this comment. One commenter requested that we provide VS Form 5–19c as an appendix to the program standards. The commenter also requested that we allow a State equivalent form. We did not add the form as an appendix to the document to minimize the need to update the standards whenever a form is revised. The form has been approved under OMB control number 0579–0101 and will be available on the APHIS website. We agree that State equivalent forms may also be used and have updated the program standards accordingly. One commenter asked APHIS to work with new and emerging registries to assure that their tattoo and radio frequency identification device implant systems are unique within the registry, retrievable, traceable, and that the registry rules allow for release of information to APHIS for regulatory disease purposes before these registry ID systems are accepted for the National Scrapie Eradication Plan. APHIS intends to work with any new and emerging registries to ensure that their systems meet these requirements. We have also updated Part III: Identification Requirements A(3)(b)(2)(a) of the program standards to clarify the requirements for registry identification devices and methods. Miscellaneous While preparing this final rule, APHIS noted that we had used the phrase ‘‘premises that engages in interstate commerce’’ in several places in §§ 79.2 and 79.3. Since a premises cannot engage in an action, we have replaced that phrase with ‘‘premises where animals are received that have been in interstate commerce or from which animals are moved in interstate commerce.’’ We have made nonsubstantive editorial changes to several sections to improve clarity. For the same reason we have divided § 54.8(j)(3) into two paragraphs. The provisions that appeared in that paragraph now appear in paragraphs (j)(3) and (l). We have moved paragraph (3) of the definition of Consistent State in § 79.1 to a new paragraph (c) in § 79.6 because the provisions in that paragraph are more appropriately placed in that section. One commenter recommended changing the name of the Scrapie Free Flock Certification Program to the Scrapie Certification Program to be consistent with the names of other disease certification programs. VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 We believe that changing the name of the program would be confusing and are making no changes in response to this comment. Three commenters stated that they appreciate APHIS’ outreach efforts to producers, and that APHIS should increase access to educational resources for goat producers and veterinarians. The commenters stated that additional goat-specific resources would help to achieve best participation in the voluntary program and compliance with the regulations. The commenters further stated that APHIS should encourage onfarm submissions for scrapie surveillance and adequate records by producers for possible traceback. APHIS agrees that goat-specific resources should be valuable and is working with the American Goat Federation to improve our education efforts directed to goat producers. Comments Outside the Scope of the Rulemaking One commenter expressed concern that scrapie poses a human health risk and stated that scrapie should be regulated in the same way as BSE. The commenter also stated that U.S. regulations governing BSE are too lax. There is no epidemiologic evidence that scrapie of sheep and goats is transmitted to humans, such as through consumption, contact on the farm, at slaughter plants, or butcher shops. The regulations for control of scrapie and BSE are generally consistent with international guidelines. BSE is a separate disease from scrapie and can be distinguished using laboratory tests or mouse inoculation. Some commenters made recommendations for changes to Scrapie Flock Certification Plan standards. We did not propose to make changes to those standards in this action; however they were taken into consideration when working on the revision of those standards. Some commenters stated that APHIS should encourage future goat and sheep research and continue to collaborate with the Agricultural Research Service (ARS) to research scrapie diagnostic tests in live goats and scrapie control methods specific to goats. The commenters also stated that ARS should continue to research genetic resistance and susceptibility in goats and the pathogenesis and transmission of scrapie in goats and sheep. We agree that these are important fields for research and have communicated these priorities to ARS. Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 rule, with the changes discussed in this document. Executive Orders 12866, 13563, 13771, and Regulatory Flexibility Act This final rule has been determined to be significant for the purposes of Executive Order 12866 and, therefore, has been reviewed by the Office of Management and Budget. This final rule is considered an Executive Order 13771 deregulatory action. Details on the estimated cost savings of this final rule can be found in the rule’s economic analysis. We have prepared an economic analysis for this rule. The economic analysis provides a cost-benefit analysis, as required by Executive Orders 12866 and 13563, which direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The economic analysis also provides a final regulatory flexibility analysis that examines the potential economic effects of this rule on small entities, as required by the Regulatory Flexibility Act. The economic analysis is summarized below. Copies of the full analysis are available on the Regulations.gov website (see footnote 1 in this document for a link to Regulations.gov) or by contacting the person listed under FOR FURTHER INFORMATION CONTACT. APHIS is amending the scrapie regulations to relieve certain restrictions associated with the interstate movement of sheep and goats, reduce the number of exposed sheep and goats that are destroyed, and improve overall program effectiveness. More specifically, genetic testing will be used to identify genetically resistant or less susceptible sheep for exemption from destruction and as qualifying for interstate movement; designated scrapie epidemiologists will be given greater flexibility in determining the testing needs of flocks; the indemnity regulations will be changed to apply only to those animals that are found to be genetically susceptible to scrapie; official identification of goats produced for meat or fiber or that are slaughtered at over 18 months of age will be required; submission of tagging records by individuals who tag sheep or goats that do not originate on their premises will be required when requested; and E:\FR\FM\25MRR2.SGM 25MRR2 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations certain recordkeeping requirements will be reduced, changed, or removed. The primary benefits of this rule for producers and the public will be more rapid progress toward scrapie eradication and the related boost to the Nation’s animal health status, decreased losses for producers, and increased export opportunities for sheep and goats and their products. Most segments and marketing channels of the sheep and goat industries will benefit from being able to operate under the new requirements and by the eradication of scrapie. By enhancing traceability, the rule will shorten the time and reduce the cost of eradication. Producers of goats for meat or fiber and slaughter goats over 18 months of age will incur costs of official identification as a result of the rule. However, we note that close to one-half of goat farms (that is, all dairy and breeding goat farms except low-risk commercial operations) are already required to be in compliance with the identification requirements under current regulations. The rule will affect sheep and goat producers, marketers and dealers, most of which are small entities. As noted in the regulatory impact analysis, individuals may spend about 2 hours a year on recordkeeping, at a time cost of about $34.50, but in fact many of these records of sales and purchases are typically already kept as a normal business practice. Based on 2012 Census of Agriculture data, this cost if incurred would equal about 1.5 percent of average revenue for meat goat producers. We expect these entities to find the rule’s official identification requirements and other conditions well worth the cost. This rule will not pose a large cost burden for entities, large or small. Eradication of scrapie will enable APHIS to negotiate removal of the varying current restrictions and allow an expansion of exports. Based on cited simulation modeling of the economic benefits of eradication of scrapie and certain other animal diseases, gains from trade are expected to exceed the recordkeeping, tagging, and other costs that producers and other entities will incur. The trade gains realized can be interpreted as cost savings from no longer being subject to certain import restrictions imposed by other countries. Based on measures of increased welfare due to expanded exports, and in accordance with guidance on complying with Executive Order 13771, the primary estimate of the rule’s annual cost savings is $115,000, the mid-point VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 estimate annualized in perpetuity using a 7 percent discount rate. Executive Order 12372 This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 2 CFR Chapter IV.) Executive Order 12988 This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are in conflict with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule. Executive Order 13175 This rule has been reviewed in accordance with the requirements of Executive Order 13175 ‘‘Consultation and Coordination with Indian Tribal Governments.’’ Executive 13175 requires Federal agencies to consult and coordinate with tribes on a governmentto-government basis on policies that have Tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. APHIS has assessed the impact of this rule on Indian Tribes and determined that this rule does not, to our knowledge, have tribal implications that require Tribal consultation under Executive Order 13175. If a tribe requests consultation, APHIS will work with the USDA Office of Tribal Relations to ensure meaningful consultation is provided where changes, additions, and modifications identified herein are not expressly mandated by Congress. Paperwork Reduction Act In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), some of the information collection requirements included in this final rule are approved under Office of Management and Budget (OMB) control number 0579–0101. The new information collection requirements included in this final rule, which were filed with comment under OMB control number 0579–0469, have been submitted for approval to OMB. PO 00000 Frm 00011 Fmt 4701 Sfmt 4700 11179 When OMB notifies us of its decision, if approval is denied, we will publish a document in the Federal Register providing notice of what action(s) we plan to take. E-Government Act Compliance The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this rule, please contact Ms. Kimberly Hardy, APHIS’ Information Collection Coordinator, at (301) 851–2483. List of Subjects 9 CFR Part 54 Animal diseases, Goats, Indemnity payments, Scrapie, Sheep. 9 CFR Part 79 Animal diseases, Quarantine, Sheep, Transportation. Accordingly, we are amending 9 CFR parts 54 and 79 as follows: PART 54—CONTROL OF SCRAPIE 1. The authority citation for part 54 continues to read as follows: ■ Authority: 7 U.S.C. 8301–8317; 7 CFR 2.22, 2.80, and 371.4. 2. Section 54.1 is amended as follows: a. By removing the definition for Approved test; ■ b. In the definition for Breed association and registries, by removing the words ‘‘listed in § 151.9 of this chapter’’; ■ c. By removing the definition for Certificate; ■ d. By adding in alphabetical order a definition for Classification or reclassification investigation; ■ e. In the heading of the definition for Designated scrapie epidemiologist, by adding the acronym ‘‘DSE’’ immediately after ‘‘epidemiologist’’; ■ f. By revising the definitions for Destroyed, Exposed animal, and Exposed flock; ■ g. In the definition for Flock, paragraph (2)(v), by adding the word ‘‘Free’’ between the words ‘‘Scrapie’’ and ‘‘Flock’’; ■ h. In the definition for Flock plan, by removing the paragraph designation ‘‘(f)’’ and by adding the paragraph designation ‘‘(j)’’ in its place; ■ i. By revising the definition for Flock sire; ■ j. By adding in alphabetical order definitions for Flock under ■ ■ E:\FR\FM\25MRR2.SGM 25MRR2 11180 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations investigation, Genetically less susceptible exposed sheep, Genetically resistant exposed sheep, Genetically resistant sheep, Genetically susceptible animal, and Genetically susceptible exposed animal; ■ k. By revising the definition for Highrisk animal; ■ l. By adding in alphabetical order a definition for Interstate certificate of veterinary inspection (ICVI); ■ m. In the definition for Limited contacts, by adding the word ‘‘Free’’ between the words ‘‘Scrapie’’ and ‘‘Flock’’ in the last sentence; ■ n. By adding in alphabetical order a definition for Low-risk exposed animal; ■ o. In the definition for National Scrapie Database, by adding the word ‘‘Free’’ between the words ‘‘Scrapie’’ and ‘‘Flock’’; and ■ p. By amending the definition for Noncompliant flock as follows: ■ i. In paragraph (1), by removing the words ‘‘source or infected flock’’ and adding the words ‘‘source, infected, or exposed flock or flock under investigation’’ in their place; ■ ii. In paragraph (2), by adding the words ‘‘or flock under investigation’’ immediately after the words ‘‘exposed flock’’; and ■ iii. In paragraph (3), by removing the words ‘‘owner statement’’ and adding the words ‘‘owner/hauler statement’’ in their place. ■ q. By revising the definition for Official genotype test; ■ r. By adding in alphabetical order definitions for Program approved test and Restricted animal sale or restricted livestock facility; ■ s. In the heading of the definition for Scrapie Flock Certification Program (SFCP), by adding the word ‘‘Free’’ immediately after the word ‘‘Scrapie’’; ■ t. In the heading of the definition for Scrapie Flock Certification Program standards, by adding the word ‘‘Free’’ immediately after the word ‘‘Scrapie’’ and, in footnote 2, by removing the internet address ‘‘https:// www.aphis.usda.gov/vs/scrapie’’ and adding the internet address ‘‘https:// www.aphis.usda.gov/animal-health/ scrapie’’ in its place; ■ u. In the definition for Scrapiepositive animal, in paragraph (2), by adding the words ‘‘, and/or ELISA,’’ immediately after the word ‘‘immunohistochemistry’’ and, in paragraph (5), by removing the words ‘‘test method’’ and adding the words ‘‘method or combination of methods’’ in their place; ■ v. By removing the definition for Separate contemporary lambing group; ■ w. By revising the definition for Slaughter channels; VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 x. By revising paragraph (1) in the definition of Suspect animal; and ■ y. By adding in alphabetical order definitions for Tamper-resistant sampling kit and Terminal feedlot. The additions and revisions read as follows: ■ § 54.1 Definitions. * * * * * Classification or reclassification investigation. An epidemiological investigation conducted or directed by a DSE for the purpose of designating or redesignating the status (e.g., scrapiepositive, exposed, high-risk, suspect, infected, noncompliant, source, etc.) of a flock or animal. In conducting such an investigation, the DSE will evaluate the available records for flocks and individual animals and conduct or direct any testing needed to assess the status of a flock or animal. The status of an animal or flock will be determined based on the applicable definitions in this section and, when needed to make a designation under § 79.4 of this chapter, official genotype test results, exposure risk, scrapie type involved, results of official scrapie testing on live or dead animals, or any combination of these. * * * * * Destroyed. Euthanized and the carcass disposed of by means authorized by the Administrator that will prevent its use as feed or food. * * * * * Exposed animal. Any animal or embryo that: (1) Has been in a flock with a scrapiepositive female animal; (2) Has been in an enclosure with a scrapie-positive female animal at any location; (3) Resides in a noncompliant flock; or (4) Has resided on the premises of a flock before or while it was designated by a DSE an infected or source flock and before a flock plan was completed. An animal shall not be designated an exposed animal if it only resided on the premises before the date that infection was most likely introduced to the premises as determined by a Federal or State representative. If the probable date of infection cannot be determined based on the epidemiologic investigation, a date 2 years before the birth of the oldest scrapie-positive animal born in that flock will be used. If the actual birth date is unknown, the date of birth will be estimated based on examination of the teeth and any available records. If an age estimate cannot be made, the animal will be assumed to have been 48 months of age on the date samples were PO 00000 Frm 00012 Fmt 4701 Sfmt 4700 collected for scrapie diagnosis. Exposed animals will be further designated as genetically resistant exposed sheep, genetically less susceptible exposed sheep, genetically susceptible exposed animals, or low-risk exposed animals. An animal will no longer be an exposed animal if it is redesignated in accordance with § 79.4 of this chapter. Exposed flock. (1) Any flock that was designated by a DSE as an infected or source flock that has completed a flock plan, and that retained a female genetically susceptible exposed animal; (2) Any flock under investigation that retains a female genetically susceptible exposed animal or a suspect animal, or whose owner declines to complete genotyping and live-animal and/or postmortem scrapie testing required by the APHIS or State representative investigating the flock; or (3) Any noncompliant flock or any flock for which a PEMMP is required that is not in compliance with the conditions of the PEMMP. * * * * * Flock sire. A sexually intact male animal that has produced offspring in the preceding 12 months or that was used for breeding during the current breeding cycle. Flock under investigation. Any flock in which an APHIS or State representative has determined that a scrapie-suspect animal, high-risk animal, or scrapie-positive animal resides or may have resided. Genetically less susceptible exposed sheep. Any sheep or sheep embryo that is: (1) An exposed sheep or sheep embryo of genotype AA QR, unless the Administrator determines that it is epidemiologically linked to a scrapiepositive RR or AA QR sheep or to a scrapie type to which AA QR sheep are not less susceptible; or (2) An exposed sheep or sheep embryo of genotype AV QR, unless the Administrator determines that it is epidemiologically linked to a scrapiepositive RR or QR sheep, to a flock that the Administrator has determined may be affected by valine-associated scrapie (based on an evaluation of the genotypes of the scrapie-positive animals linked to the flock), or to another scrapie type to which AV QR sheep are not less susceptible; or (3) An exposed sheep or sheep embryo of a genotype that has been exposed to a scrapie type to which the Administrator has determined that genotype is less susceptible. In this definition R refers to codon 171 and A refers to codon 136, and Q represents any genotype other than R at E:\FR\FM\25MRR2.SGM 25MRR2 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations codon 171 and V represents any genotype other than A at codon 136. Genetically resistant exposed sheep. Any exposed sheep or sheep embryo of genotype RR at codon 171 unless the Administrator determines that it is epidemiologically linked to a scrapiepositive RR sheep or to a scrapie type to which RR sheep are not resistant. Genetically resistant sheep. Any sheep or sheep embryo of genotype RR at codon 171 unless the Administrator determines that it is epidemiologically linked to a scrapie-positive RR sheep or to a scrapie type that affects RR at codon 171 sheep. Genetically susceptible animal. Any goat or goat embryo, sheep or sheep embryo of a genotype other than RR or QR, where Q represents any genotype other than R at codon 171 or sheep or sheep embryo of undetermined genotype. Genetically susceptible exposed animal. Excluding low-risk exposed animals, any exposed animal or embryo that is also: (1) A genetically susceptible animal; or (2) A sheep or sheep embryo of genotype AV QR that the Administrator determines is epidemiologically linked to a scrapie-positive RR or QR sheep, to a flock that the Administrator has determined may be affected by valineassociated scrapie (based on an evaluation of the genotypes of the scrapie-positive animals linked to the flock), or to a scrapie type to which AV QR sheep are susceptible; or (3) A sheep or sheep embryo of genotype AA QR that the Administrator determines is epidemiologically linked to a scrapie-positive RR or AA QR sheep or to a scrapie type to which AA QR sheep are susceptible; or (4) A sheep or sheep embryo of genotype RR that the Administrator determines is epidemiologically linked to a scrapie-positive RR sheep or to a scrapie type to which RR sheep are susceptible. (5) Note: In this definition R refers to codon 171 and A refers to codon 136, and Q represents any genotype other than R at codon 171 and V represents any genotype other than A at codon 136. High-risk animal. The female offspring or embryo of a scrapie-positive female animal, or any suspect animal, or a female genetically susceptible exposed animal, or any exposed animal that the Administrator determines to be a potential risk. The Administrator may base the determination that an exposed animal poses a potential risk on the scrapie type, the epidemiology of the flock or flocks with which it is epidemiologically linked, including VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 genetics of the positive sheep, the prevalence of scrapie in the flock, any history of recurrent infection, and other flock or animal characteristics. An animal will no longer be a high-risk animal if it is redesignated in accordance with § 79.4 of this chapter. * * * * * Interstate certificate of veterinary inspection (ICVI). An official document issued by a Federal, State, Tribal, or accredited veterinarian certifying the inspection of animals in preparation for interstate movement or other uses as described in this part and in accordance with § 79.5 of this chapter. * * * * * Low-risk exposed animal. Any exposed animal to which the Administrator has determined one or more of the following applies: (1) The positive animal that was the source of exposure was not born in the flock and did not lamb in the flock or in an enclosure where the exposed animal resided; (2) The Administrator and State representative concur that the animal is unlikely to be infected due to factors such as, but not limited to, where the animal resided or the time period the animal resided in the flock; (3) The exposed animal is male and was not born in an infected or source flock; (4) The exposed animal is a castrated male; (5) The exposed animal is an embryo of a genetically resistant exposed sheep or a genetically less susceptible exposed sheep unless placed in a recipient that was a genetically susceptible exposed animal; or (6) The animal was exposed to a scrapie type and/or is of a genotype that the Administrator has determined poses low risk of scrapie transmission. * * * * * Official genotype test. A test to determine the genotype of a live or dead animal conducted at either the National Veterinary Services Laboratories or at an approved laboratory. The test subject must be an animal that is officially identified and the test accurately recorded on an official form supplied or approved by APHIS, with the samples collected and shipped to the laboratory using a shipping method specified by the laboratory by: (1) An accredited veterinarian; (2) A State or APHIS representative; or (3) The animal’s owner or owner’s agent, using a tamper-resistant sampling kit approved by APHIS for this purpose. * * * * * Program approved test. A test for the diagnosis of scrapie approved by the PO 00000 Frm 00013 Fmt 4701 Sfmt 4700 11181 Administrator for use in the scrapie eradication or certification program in accordance with § 54.10. Restricted animal sale or restricted livestock facility. A sale where any animals in slaughter channels are maintained separate from other animals not in slaughter channels unless they are from the same flock of origin and are sold in lots that consist entirely of animals sold for slaughter only, or a livestock facility at which all animals are in slaughter channels, and where the sale or facility manager maintains a copy of, or maintains a record of, the information from the owner/hauler statement for all animals entering and leaving the sale or facility. A restricted animal sale may be held at a livestock facility that is not restricted. * * * * * Slaughter channels. Animals in slaughter channels include any animal that is sold, transferred, or moved either directly to or through a restricted animal sale or restricted livestock facility to an official slaughter establishment that is under Food Safety and Inspection Service (FSIS) jurisdiction per the Federal Meat Inspection Act (FMIA) or under State inspection that FSIS has recognized as at least equal to Federal inspection or to a custom exempt slaughter establishment as defined by FSIS (9 CFR 303.1) for immediate slaughter or to an individual for immediate slaughter for personal use or to a terminal feedlot. * * * * * Suspect animal. * * * (1) A mature sheep or goat as evidenced by eruption of the first incisor that has been condemned by FSIS or a State inspection authority for central nervous system (CNS) signs, or that exhibits any of the following clinical signs of scrapie and has been determined to be suspicious for scrapie by an accredited veterinarian or a State or USDA representative, based on one or more of the following signs and the severity of the signs: Weakness of any kind including, but not limited to, stumbling, falling down, or having difficulty rising, not including those with visible traumatic injuries and no other signs of scrapie; behavioral abnormalities; significant weight loss despite retention of appetite or in an animal with adequate dentition; increased sensitivity to noise and sudden movement; tremors; star gazing; head pressing; bilateral gait abnormalities such as but not limited to incoordination, ataxia, high stepping gait of forelimbs, bunny-hop movement of rear legs, or swaying of back end, but not including abnormalities involving E:\FR\FM\25MRR2.SGM 25MRR2 11182 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations only one leg or one front and one back leg; repeated intense rubbing with bare areas or damaged wool in similar locations on both sides of the animal’s body or, if on the head, both sides of the poll; abraded, rough, thickened, or hyperpigmented areas of skin in areas of wool/hair loss in similar locations on both sides of the animal’s body or, if on the head, both sides of the poll; or other signs of CNS disease. An animal will no longer be a suspect animal if it is redesignated in accordance with § 79.4 of this chapter. * * * * * Tamper-resistant sampling kit. A device or method for collecting DNA samples from sheep or goats that is approved by the Administrator and that identifies both the sample and the animal at the time the sample is collected. These devices or methods must ensure that the sample, its corresponding label, and the official ID device or method applied to the animal meets the requirements of § 79.2(k) of this chapter and that the sample is from the same animal to which the official ID device or method was applied. The kit must include an APHIS-approved official form or another form, device, or method acceptable to APHIS for transmitting the information required to APHIS and the approved laboratory. Terminal feedlot. (1) A dry lot approved by a State or APHIS representative or an accredited veterinarian who is authorized by the Administrator to perform this function where animals in the terminal feedlot 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 and must be cleaned of all organic material prior to being used to contain sheep or goats that are not in slaughter channels, where only castrated males are maintained with female animals and from which animals are moved only to another terminal feedlot or directly to slaughter; or (2) A dry lot approved by a State or APHIS representative or an accredited veterinarian who is authorized by the Administrator to perform this function where only animals that either are not pregnant based on the animal being male, an owner certification that any female animals have not been exposed to a male in the preceding 6 months, an ICVI issued by an accredited veterinarian stating the animals are not pregnant, or the animals are under 6 months of age at time of receipt, where only castrated males are maintained with female animals, and all animals in VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 the terminal feedlot are separated from all other animals such that physical contact cannot occur including through a fence and from which animals are moved only to another terminal feedlot or directly to slaughter; or (3) A pasture when approved by and maintained under the supervision of the State and in which only nonpregnant animals are permitted based on the animal being male, an owner certification that any female animals have not been exposed to a male in the preceding 6 months, or an ICVI issued by an accredited veterinarian stating the animals are not pregnant, or the animals are under 6 months of age at time of receipt, where only castrated males are maintained with female animals, 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. (4) Records of all animals entering and leaving a terminal feedlot must be maintained for 5 years after the animal leaves the feedlot and must meet the requirements of § 79.2 of this chapter, including either a copy of the required owner/hauler statements for animals entering and leaving the facility or the information required to be on the statements. Records must be made available for inspection and copying by an APHIS or State representative upon request. * * * * * § 54.2 [Amended] 3. Section 54.2 is amended by adding the word ‘‘Free’’ between the words ‘‘Scrapie’’ and ‘‘Flock’’ each time they appear. ■ 4. Section § 54.3 is amended by revising paragraph (b) and adding an OMB citation at the end of the section to read as follows: ■ § 54.3 Animals eligible for indemnity payments. * * * * * (b) Indemnity will be paid to an owner only for animals actually in a flock at the time indemnity is first offered in writing, and for offspring born to animals in that flock within 60 days after the time indemnity is first offered in writing. Animals removed from the flock as part of an investigation or a post-exposure management and monitoring plan (PEMMP) will be paid indemnity based on the calculated prices at the time an APHIS representative designates, in writing, the animals for removal. If an owner declines to remove an animal within 60 days of when indemnity is first offered the owner will receive the lower value of when indemnity was first offered in PO 00000 Frm 00014 Fmt 4701 Sfmt 4700 writing or when the animal was actually removed. APHIS may withdraw an indemnity offer if an owner does not make animals available for inventory, gestational assessment, and testing within 30 days, does not remove an animal within 60 days of the written indemnity offer or by the date specified in a flock plan or PEMMP, or fails to provide APHIS animal registration certificates, sale and movement records, or other records requested in accordance with § 54.5. No indemnity will be paid for any animal, or the progeny of any animal, that has been moved or handled by the owner in violation of the requirements of the Animal Health Protection Act or the regulations promulgated thereunder. No indemnity will be paid for an animal added to the premises while a flock is under investigation or while it is an infected or source flock other than natural additions. No indemnity will be paid for natural additions born more than 60 days after the owner is notified they are eligible for indemnity unless the Administrator makes a determination that the dam could not be removed within the allowed time as a result of conditions outside the control of the owner. No indemnity will be paid unless the owner has signed and is in compliance with the requirements of a flock plan or post-exposure management and monitoring plan (PEMMP) as described in § 54.8 unless the requirement for a flock plan or PEMMP has been waived by the Administrator. No indemnity will be paid until the premises, including all structures, holding facilities, conveyances, and materials contaminated because of occupation or use by the depopulated animals, have been properly cleaned and disinfected in accordance with § 54.7(e), unless premises or portions of premises have been exempted from the cleaning and disinfecting requirements per § 54.8(j)(1); Except that, partial indemnity may be paid when the Administrator determines that weather or other factors outside the control of the owner make immediate disinfection impractical. No indemnity will be paid to an owner for any animals if the owner established or increased his flock for the purpose of collecting or increasing indemnity. (Approved by the Office of Management and Budget under control number 0579–0101) 5. Section 54.4 is amended by revising paragraph (a)(5) and adding an OMB citation at the end of the section to read as follows: ■ E:\FR\FM\25MRR2.SGM 25MRR2 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 6. Section 54.5 is amended as follows: a. In paragraph (d), by removing the word ‘‘slaughtered,’’; and ■ b. By adding an OMB citation at the end of the section. The addition reads as follows: sexually intact animals in the group to be indemnified, and indemnity for the remainder will be calculated based on the assumption that the remainder of the flock is 80 percent aged 2 to 6 years and 20 percent aged 6 to 8 years. (c) Animal weights. If the owner disagrees with the average weight estimate, he may have the animals weighed at a public scale at his own expense, provided that the animals may not come in contact with other sheep or goats during movement to the public scales, and will be paid based on the actual weight multiplied by the price per pound for the class of animal as calculated in paragraph (a) of this section. § 54.5 (Approved by the Office of Management and Budget under control number 0579–0101) § 54.4 Application by owners for indemnity payments. (a) * * * (5) A copy of the registration papers issued in the name of the owner for any registered animals in the flock (registration papers are not required for the payment of indemnity for animals that are not registered); and * * * * * (Approved by the Office of Management and Budget under control number 0579–0101) ■ ■ * Certification by owners. * * * * (Approved by the Office of Management and Budget under control number 0579–0101) 7. Section 54.6 is revised to read as follows: ■ § 54.6 Amount of indemnity payments. (a) Indemnity. Indemnity paid for sheep and goats in accordance with § 54.3 will be the fair market value of the animals. APHIS’ determination of fair market value will be based on available price report data that most accurately reflect the type of animal being indemnified and the time at which the animal was indemnified. Premiums will be paid for certain types of sheep and goats, including, but not limited to: Registered animals, flock sires, pregnant animals and earlymaturing ewes; Except that, no premium will be added for animals of any age that were in slaughter channels when indemnity was offered. To calculate indemnity, APHIS will use price information provided by the Agricultural Marketing Service (AMS) or other available price information and any other data necessary to establish the value of different types of sheep and goats. A detailed description of the methods APHIS uses to calculate indemnity for sheep and goats is available at https://www.aphis.usda.gov/ animal-health/scrapie. (b) Age and number of animals. If records and identification are inadequate to determine the actual age of animals, an APHIS or State representative will count all sexually intact animals that are apparently under 1 year of age, and those that are apparently at least 1 and under 2 years of age, based on examination of their teeth, and the indemnity for these animals will be calculated. The total number of these animals will be subtracted from the total number of VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 8. Section 54.7 is amended as follows: a. By revising paragraphs (a) and (d); b. In paragraph (e), introductory text, by removing the words ‘‘Scrapie Flock Certification Program standards and the Scrapie Eradication Uniform Methods and Rules’’ adding in their place ‘‘Scrapie Program Standards Volume 1: National Scrapie Eradication Program and Scrapie Program Standards Volume 2: Scrapie Free Flock Certification Program (SFCP)’’; ■ c. In paragraph (e)(1), by removing the words ‘‘animals or wildlife’’ and adding in their place the words ‘‘or wild ruminants’’; ■ d. By revising paragraph (e)(2) introductory text; ■ e. By removing paragraph (e)(2)(i), redesignating paragraphs (e)(2)(ii) and (iii) as paragraphs (e)(2)(i) and (ii), respectively, and by adding new paragraphs (e)(2)(iii) and (iv); and ■ f. By adding an OMB citation at the end of the section. The revisions and additions read as follows: ■ ■ ■ 11183 the animals must present the Veterinary Services, Field Operations, Area Veterinarian in Charge (AVIC) responsible for the State involved with a copy of either a receipt for expenses paid or a bill for services rendered. Any bill for services rendered by the owner must not be greater than the normal fee for similar services provided by a commercial hauler or disposal facility. (e) * * * (2) Cement, wood, metal and other non-earth surfaces, tools, equipment, instruments, feed, hay, bedding, and other materials. Organic and/or inorganic materials may be disposed of by incineration or burial. Inorganic material and wood structures may be cleaned and disinfected. To disinfect, remove all organic material and incinerate, bury, till under, or compost the removed organic material in areas not accessed by domestic or wild ruminants until it can be incinerated, buried, or tilled under. Clean and wash all surfaces, tools, equipment, and instruments using hot water and detergent. Allow all surfaces, tools, equipment, and instruments to dry completely before disinfecting and sanitizing using one of the following methods: * * * * * (iii) Use a product registered by the U.S. Environmental Protection Agency (EPA) specifically for reduction of prion infectivity at these sites in accordance with the label. (iv) Use a product in accordance with an emergency exemption issued by the EPA for reduction of prion infectivity at these sites. (Approved by the Office of Management and Budget under control number 0579–0469) 9. Section 54.8 is revised to read as follows: ■ § 54.7 Procedures for destruction of animals. § 54.8 Requirements for flocks under investigation and flocks subject to flock plans and post-exposure management and monitoring plans. (a) Animals for which indemnification is sought must be destroyed on the premises where they are held, pastured, or penned at the time indemnity is approved or moved to an approved research facility, unless the APHIS representative involved approves in advance of destruction moving the animals to another location for destruction. * * * * * (d) APHIS may pay the reasonable costs of disposal for animals that are indemnified. To obtain reimbursement for disposal costs, animal owners must obtain written approval of the disposal costs from APHIS, prior to disposal. For reimbursement to be made, the owner of (a) For animals in a flock under investigation, flock plan, or postexposure management and monitoring plan (PEMMP), the official identification must provide a unique identification number that is applied by the owner of the flock or his or her agent and must be linked to that flock in the National Scrapie Database. APHIS may specify the type of official identification that may be used in order to maximize retention of the means of identification, identify restricted or test positive animals or to facilitate the testing or inventory of the animals. The owner of the flock or his or her agent must officially identify and maintain the identity of: PO 00000 Frm 00015 Fmt 4701 Sfmt 4700 E:\FR\FM\25MRR2.SGM 25MRR2 11184 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations (1) All animals in the flock while it is subject to a flock plan or PEMMP; (2) Any high-risk or genetically susceptible exposed animals in the flock and any other restricted animals; (3) Any animals designated for testing by an APHIS representative or State representative until testing is completed, results reported, and animals classified; and (4) All sexually intact animals, all exposed animals, and animals 18 months of age and older (as evidenced by the eruption of the second incisor) prior to a change in ownership and before they are moved off the premises of the flock. (b) For flocks under a flock plan or PEMMP, the flock owner must maintain the following records for 5 years or until the flock plan and/or PEMMP is completed, whichever is longer. (1) For acquired animals, the date of acquisition, name and address of the person from whom the animal was acquired, any identifying marks, or identification devices present on the animal including but not limited to the animal’s individual official identification number(s) from its electronic implant, flank tattoo, ear tattoo, tamper-resistant eartag, or, in the case of goats, tail fold tattoo, and any secondary form of identification the owner of the flock may choose to maintain and the records required by § 79.2 of this chapter. (2) For animals leaving the premises of the flock, the disposition of the animal, including, any identifying marks or identification devices present on the animal, including but not limited to the animal’s individual official identification number from its electronic implant, flank tattoo, ear tattoo, tamper-resistant eartag, or, in the case of goats, a tail fold tattoo, and any secondary form of identification the owner of the flock may choose to maintain, the date and cause of death, if known, or date of removal from the flock and name and address of the person to whom the animal was transferred and the records required by § 79.2 of this chapter. (c) Upon request by a State or APHIS representative or as required in a PEMMP, the owner of the flock or his or her agent must have an accredited veterinarian collect tissues from animals for scrapie diagnostic purposes and submit them to a laboratory designated by a State or APHIS representative or collect and submit samples by another method acceptable to APHIS. (d) Upon request by a State or APHIS representative, the owner of the flock or his or her agent must make animals in the flock available for inspection and or VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 testing and the records required to be kept as a part of these plans available for inspection and copying. (e) The owner of the flock or his or her agent must meet requirements found necessary by a DSE to monitor for scrapie and to prevent the recurrence of scrapie in the flock and to prevent the spread of scrapie from the flock. These other requirements may include, but are not limited to: Utilization of a liveanimal screening test; reporting animals found dead and collecting and submitting test samples from them; restrictions on the animals that may be moved from the flock; use of genetically resistant rams; segregated lambing; cleaning and disinfection of lambing facilities; and/or education of the owner of the flock and personnel working with the flock in techniques to recognize clinical signs of scrapie and to control the spread of scrapie. (f) The owner of the flock or his or her agent must immediately report the following animals to a State representative, APHIS representative, or an accredited veterinarian; ensure that samples are properly collected for testing if the animal dies; allow the animals to be tested, and not remove them from a flock without written permission of a State or APHIS representative: (1) Any sheep or goat exhibiting weight loss despite retention of appetite; behavioral abnormalities; pruritus (itching); wool pulling; wool loss; 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; rubbing, or other signs of neurological disease or chronic wasting illness; and (2) Any sheep or goat in the flock 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. (g) An epidemiologic investigation must be conducted to identify high-risk and exposed animals that currently reside in the flock or that previously resided in the flock, and all high-risk animals, scrapie-positive animals, and suspect animals must be removed from the flock except as provided in paragraph (h) of this section. The animals must be removed either by movement to an approved research facility or by euthanasia and disposal of the carcasses by burial, incineration, or other methods approved by the Administrator and in accordance with local, State, and Federal laws, or upon request in individual cases by another PO 00000 Frm 00016 Fmt 4701 Sfmt 4700 means determined by the Administrator to be sufficient to prevent the spread of scrapie. (h) The Administrator may allow high-risk animals that are not suspect animals to be retained under restriction if they are not genetically susceptible animals or if they have tested ‘‘PrPsc not detected’’ on a live animal scrapie test approved for this purpose by the Administrator and are maintained in a manner that the Administrator determines minimizes the risk of scrapie transmission, e.g., bred only to genetically resistant sheep, segregated for lambing, and cleaning and disinfection of the lambing area. Such animals may be retained only if the exempted animal’s official identification and the requirements for minimizing the risk of scrapie transmission are documented in the PEMMP and the owner is in compliance with the PEMMP. All such animals must be tested for scrapie when they are euthanized or die or if they are later determined to be suspect animals. (i) The owner of the flock, or his or her agent, must request breed associations and registries, livestock facilities, and packers to disclose records to APHIS representatives or State representatives, to be used to identify source flocks and trace exposed animals, including high-risk animals. (j) The flock plan will include a description of the types of animals that must be removed from a flock, the timeframes in which they must be removed and any other actions that must be accomplished in order for the flock plan to be completed. Flock plans shall require an owner to agree to: (1) Clean and disinfect the premises in accordance with § 54.7(e). Premises or portions of premises may be exempted from the cleaning and disinfecting requirements if a designated scrapie epidemiologist determines, based on an epidemiologic investigation, that cleaning and disinfection of such buildings, holding facilities, conveyances, or other materials on the premises will not significantly reduce the risk of the spread of scrapie, either because effective disinfection is not possible or because the normal operations on the premises prevent transmission of scrapie. No confined area where a scrapie-positive animal was born, lambed or aborted may be exempted; (2) Agree to conduct a post-exposure management and monitoring plan (PEMMP); and (3) Comply with any other conditions in the flock plan; (k) A PEMMP will be required for exposed flocks and may be required for E:\FR\FM\25MRR2.SGM 25MRR2 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations flocks under investigation that were not source or infected flocks. A PEMMP may also be required for flocks that formerly were exposed flocks or flocks under investigation as a condition for being redesignated. A designated scrapie epidemiologist shall determine when to require a PEMMP and the monitoring requirements for these flocks based on the findings of the classification or reclassification investigation. (l) Provided that, the Administrator may waive the requirement for a flock plan or PEMMP or waive any of the requirements in a flock plan or PEMMP after determining that the flock poses a low risk of scrapie transmission. (Approved by the Office of Management and Budget under control numbers 0579–0101 and 0579–0469) 10. Section 54.10 is revised to read as follows: ■ § 54.10 Program approval of tests for scrapie. (a) The Administrator may approve new tests or test methods for the diagnosis of scrapie conducted on live or dead animals for use in the Scrapie Eradication Program and/or the Scrapie Free Flock Certification Program. The Administrator will base the approval or disapproval of a test on the evaluation by APHIS and, when appropriate, outside scientists, of: (1) A standardized test protocol that must include a description of the test, a description of the reagents, materials, and equipment used for the test, the test methodology, and any control or quality assurance procedures; (2) Data to support repeatability, that is, the ability to reproduce the same result repeatedly on a given sample; (3) Data to support reproducibility, that is, data to show that similar results can be produced when the test is run at other laboratories; (4) Data to support the diagnostic and in the case of assays the analytical sensitivity and specificity of the test; and (5) Any other data or information requested by the Administrator to determine the suitability of the test for program use. This may include but is not limited to past performance, cost of test materials and equipment, ease of test performance, generation of waste, and potential use of existing equipment. (b) To be approved for program use, a scrapie test must be able to be readily and successfully performed at the National Veterinary Services Laboratories. (c) The test must have a reliable, timely, and cost effective method of proficiency testing. VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 (d) The Administrator may decline to evaluate any test kit for program approval that has not been licensed for the intended use and may decline to evaluate any test or test method for program use unless the requester can demonstrate that the new method offers a significant advantage over currently approved methods. (e) A test or combination of tests may be approved for the identification of suspect animals, or scrapie-positive animals, or for other purposes such as flock certification. For a test to be approved for the identification of scrapie-positive animals, the test must demonstrate a diagnostic specificity comparable to that of current programapproved tests, and the sensitivity of the test will also be considered in determining the approved uses of the test within the program. For a test to be approved for the removal of high-risk, exposed, or suspect animal designations the test must have a diagnostic sensitivity at least comparable to that of current program-approved tests used for this purpose. Since the purpose of a screening test is usually to identify a subset of animals for further testing, for a test to be approved as a screening test for the identification of suspect animals, the test must be usually reliable but need not be definitive for diagnosing scrapie. (f) Specific guidelines for use of program-approved tests within the Scrapie Eradication Program or Scrapie Free Flock Certification Program will be made available on the scrapie website at https://www.aphis.usda.gov/animalhealth/scrapie. Guidelines will be based on the characteristics of the test, including specificity, sensitivity, and predictive value in defined groups of animals. (g) If an owner elects to have an unofficial test conducted on an animal for scrapie, or for the proteinase resistant protein associated with scrapie, and that animal tests positive to such a test, the animal will be designated a suspect animal, unless the test is conducted as part of a research protocol and the protocol includes appropriate measures to prevent the spread of scrapie. (h) The Administrator may withdraw or suspend approval of any test or test method if the test or method does not perform at an acceptable level following approval or if a more effective test or test method is subsequently approved. The Administrator shall give written notice of the suspension or proposed withdrawal to the director of the laboratories using the test or method or in the case of test kits to the manufacturer and shall give the director PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 11185 or manufacturer an opportunity to respond. Such action shall become effective upon oral or written notification, whichever is earlier, to the laboratory or manufacturer. If there are conflicts as to any material fact concerning the reason for withdrawal, a hearing may be requested in accordance with the procedure in § 79.4(c)(3) of this chapter. The action under appeal shall continue in effect pending the final determination of the Administrator, unless otherwise ordered by the Administrator. The Administrator’s final determination constitutes final agency action. (Approved by the Office of Management and Budget under control number 0579–0469) 11. Section 54.11 is revised to read as follows: ■ § 54.11 Approval of laboratories to run official scrapie tests and official genotype tests. (a) State, Federal, and university laboratories, or in the case of genotype tests, private laboratories will be approved by the Administrator when he or she determines that the laboratory: (1) Employs personnel assigned to supervise and conduct the testing who are qualified to conduct the test based on education, training, and experience and who have been trained by the National Veterinary Services Laboratories (NVSL) or who have completed equivalent training approved by NVSL; (2) Has adequate facilities and equipment to conduct the test; (3) Follows standard test protocols that are approved or provided by NVSL; (4) Meets check test proficiency requirements and consistently produces accurate test results as determined by NVSL review; (5) Meets recordkeeping requirements; (6) Will retain records, slides, blocks, and other specimens from all cases for at least 1 year and from positive cases and DNA from all genotype tests for at least 5 years and will forward copies of records and any of these materials to NVSL within 5 business days of request; Except that, NVSL may authorize a shorter retention time in a standard operating procedure or contract; (7) Will allow APHIS to inspect the laboratory without notice during normal business hours. An inspection may include, but is not limited to, review and copying of records, examination of slides, review of quality control procedures, observation of sample handling/tracking procedures, observation of the test being conducted, and interviewing of personnel; (8) Will report all test results to State and Federal animal health officials and E:\FR\FM\25MRR2.SGM 25MRR2 11186 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations record them in the National Scrapie Database within timeframes and in the manner and format specified by the Administrator; and (9) Complies with any other written guidance provided to the laboratory by the Administrator. (b) A laboratory may request approval to conduct one or more types of program-approved scrapie test or genotype test on one or more types of tissue. To be approved, a laboratory must meet the requirements in paragraph (a) of this section for each type of test and for each type of tissue for which they request approval. (c) The Administrator may suspend or withdraw approval of any laboratory for failure to meet any of the conditions required by paragraph (a) of this section. The Administrator shall give written notice of the suspension or the proposed withdrawal to the director of the laboratory and shall give the director an opportunity to respond. Such action shall become effective upon oral or written notification, whichever is earlier, to the laboratory or manufacturer. If there are conflicts as to any material fact concerning the reason for withdrawal, a hearing may be requested in accordance with the procedure in § 79.4(c)(3) of this chapter. The action under appeal shall continue in effect pending the final determination of the Administrator, unless otherwise ordered by the Administrator. The Administrator’s final determination constitutes final agency action. (d) The Administrator may require approved laboratories to reimburse APHIS for part or all of the costs associated with the approval and monitoring of the laboratory. (Approved by the Office of Management and Budget under control numbers 0579–0101 and 0579–0469) 12. The heading for subpart B is revised to read as set forth below: ■ Subpart B—Scrapie Free Flock Certification Program 13. Section 54.21 is revised to read as follows: ■ § 54.21 Participation. Any owner of a sheep or goat flock may apply to enter the Scrapie Free Flock Certification Program by sending a written request to a State scrapie certification board or to the Veterinary Services, Field Operations, AVIC responsible for the State involved. A notice containing a current list of flocks participating in the Scrapie Free Flock Certification Program, and the certification status of each flock, may be obtained from the APHIS website at VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 https://www.aphis.usda.gov/animalhealth/scrapie. A list of noncompliant flocks and a list of flocks that sold exposed animals that could not be traced may also be obtained from this site, and these lists may be obtained by writing to the National Scrapie Program Coordinator, Strategy and Policy, VS, APHIS, 4700 River Road Unit 43, Riverdale, MD 20737–1235. (Approved by the Office of Management and Budget under control number 0579–0101) PART 79—SCRAPIE IN SHEEP AND GOATS 14. The authority citation for part 79 continues to read as follows: ■ Authority: 7 U.S.C. 8301–8317; 7 CFR 2.22, 2.80, and 371.4. 15. Section 79.1 is amended as follows: ■ a. By revising the definition for Animal identification number (AIN); ■ b. In the definition for Breed association and registries, by removing the words ‘‘listed in § 151.9 of this chapter’’; ■ c. By removing the definition for Certificate; ■ d. By adding in alphabetical order a definition for Classification or reclassification investigation; ■ e. By revising the definitions for Consistent State, Exposed animal, and Exposed flock; ■ f. By adding in alphabetical order a definition for Flock identification (ID) number; ■ g. In the definition for Flock plan, by removing the citation ‘‘§ 54.8(a)(f)’’ and by adding the words ‘‘§ 54.8(a) through (j)’’ in its place; ■ h. By adding in alphabetical order definitions for Flock under investigation, Genetically less susceptible exposed sheep, Genetically resistant exposed sheep, Genetically resistant sheep, Genetically susceptible animal, Genetically susceptible exposed animal, Group/lot identification number (GIN); ■ i. By revising the definition for Highrisk animal; ■ j. By adding in alphabetical order definitions for Interstate certificate of veterinary inspection (ICVI) and Lowrisk commercial flock; ■ k. By removing the definition for Lowrisk commercial sheep; ■ l. By adding in alphabetical order a definition for Low-risk exposed animal; ■ m. By removing the definition for Low-risk goat; ■ n. By adding in alphabetical order a definition for National Uniform Eartagging System (NUES); ■ o. In the definition for Noncompliant flock, in paragraph (3), by removing the ■ PO 00000 Frm 00018 Fmt 4701 Sfmt 4700 words ‘‘owner statement’’ and adding the words ‘‘owner/hauler statement’’ in their place; ■ p. By revising the definitions for Official eartag, Official genotype test, and Official identification device or method; ■ q. By adding in alphabetical order definitions for Official identification number, Officially identified, and Owner/hauler statement; ■ r. By removing the definition for Owner statement; ■ s. By adding in alphabetical order a definition for Person; ■ t. By revising the definition for Premises identification number (PIN); ■ u. By adding in alphabetical order a definition for Restricted animal sale or restricted livestock facility; ■ v. In the heading of the definition for Scrapie Flock Certification Program (SFCP), by adding the word ‘‘Free’’ immediately after the word ‘‘Scrapie’’; ■ w. In the heading of the definition for Scrapie Flock Certification Program standards, by adding the word ‘‘Free’’ immediately following the word ‘‘Scrapie’’ and, in footnote 2, by removing the internet address ‘‘https:// www.aphis.usda.gov/vs’’ and adding the internet address ‘‘https:// www.aphis.usda.gov/animal-health/ scrapie’’ in its place; ■ x. In the definition for Scrapiepositive animal, in paragraph (2) by adding the words ‘‘, and/or ELISA,’’ immediately after the word ‘‘immunohistochemistry’’ and in paragraph (5) by removing the words ‘‘test method’’ and adding the words ‘‘method or combination of methods’’ in their place; ■ y. By removing the definition for Separate contemporary lambing groups; ■ z. By revising the definition for Slaughter channels; ■ aa. By revising paragraph (1) of the definition for Suspect animal; ■ bb. By revising the definition for Terminal feedlot; and ■ cc. By adding in alphabetical order a definition for Test eligible. The additions and revisions read as follows: § 79.1 Definitions. * * * * * Animal identification number (AIN). This term has the meaning set forth in § 86.1 of this subchapter, except that only AIN devices approved and distributed in accordance with § 79.2(k) and methods approved for use in sheep and goats in accordance with § 79.2(a)(2) are included. * * * * * Classification or reclassification investigation. An epidemiological E:\FR\FM\25MRR2.SGM 25MRR2 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations investigation conducted or directed by a DSE for the purpose of designating or redesignating the status (e.g., exposed, high-risk, infected, source, suspect, etc.) of a flock or animal. In conducting such an investigation, the DSE will evaluate the available records for flocks and individual animals and conduct or direct any testing needed to assess the status of a flock or animal. The status of an animal or flock will be determined based on the applicable definitions in this section and, when needed to make a designation under § 79.4, official genotype test results, exposure risk, scrapie type involved, and/or results of official scrapie testing on live or dead animals. * * * * * Consistent State. (1) A State that the Administrator has determined conducts an active State scrapie control program that meets the requirements of § 79.6 or effectively enforces a State designed plan that the Administrator determines is at least as effective in controlling scrapie as the requirements of § 79.6. (2) A list of Consistent States can be found on the internet at https:// www.aphis.usda.gov/animal-health/ scrapie. * * * * * Exposed animal. Any animal or embryo that: (1) Has been in a flock with a scrapiepositive female animal; (2) Has been in an enclosure with a scrapie-positive female animal at any location; (3) Resides in a noncompliant flock; or (4) Has resided on the premises of a flock before or while it was designated an infected or source flock and before a flock plan was completed. An animal shall not be designated an exposed animal if it only resided on the premises before the date that infection was most likely introduced to the premises as determined by a Federal or State representative. If the probable date of infection cannot be determined based on the epidemiologic investigation, a date 2 years before the birth of the oldest scrapie-positive animal born in that flock will be used. If the actual birth date is unknown, the date of birth will be estimated based on examination of the teeth and any available records. If an age estimate cannot be made, the animal will be assumed to have been 48 months of age on the date samples were collected for scrapie diagnosis. Exposed animals will be further designated as genetically resistant exposed sheep, genetically less susceptible exposed sheep, genetically susceptible exposed animals, or low-risk exposed animals. VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 An animal will no longer be an exposed animal if it is redesignated in accordance with § 79.4. Exposed flock. (1) Any flock that was designated an infected or source flock that has completed a flock plan and that retained a female genetically susceptible exposed animal; (2) Any flock under investigation that retains a female genetically susceptible exposed animal or a suspect animal, or whose owner declines to complete genotyping and live-animal and/or postmortem scrapie testing required by the APHIS or State representative investigating the flock; or (3) Any noncompliant flock or any flock for which a PEMMP is required that is not in compliance with the conditions of the PEMMP. A flock will no longer be an exposed flock if it is redesignated in accordance with § 79.4. * * * * * Flock identification (ID) number. A nationally unique number assigned by a State, federally recognized Tribal or Federal animal health authority to a group of animals that are managed as a unit on one or more premises and are under the same ownership. The flock ID number must begin with the State postal abbreviation or APHIS-assigned Tribal code, must have no more than nine alphanumeric characters, and must not contain the characters ‘‘I’’, ‘‘O’’, or ‘‘Q’’ other than as part of the State postal abbreviation or another standardized format authorized by the administrator and recorded in the National Scrapie Database. APHIS may assign Tribal codes to any federally recognized Tribe that maintains sheep or goats on Tribal lands. The flock ID number must be recorded in and linked to one or more PINs or LIDs in the National Scrapie Database. * * * * * Flock under investigation. Any flock in which an APHIS or State representative has determined that a scrapie suspect animal, high-risk animal, or scrapie-positive animal resides or may have resided. A flock will no longer be a flock under investigation if it is redesignated in accordance with § 79.4. Genetically less susceptible exposed sheep. Any sheep or sheep embryo that is: (1) An exposed sheep or sheep embryo of genotype AA QR, unless the Administrator determines that it is epidemiologically linked to a scrapiepositive RR or AA QR sheep or to a scrapie type to which AA QR sheep are not less susceptible; or (2) An exposed sheep or sheep embryo of genotype AV QR, unless the PO 00000 Frm 00019 Fmt 4701 Sfmt 4700 11187 Administrator determines that it is epidemiologically linked to a scrapiepositive RR or QR sheep, to a flock that the Administrator has determined may be affected by valine-associated scrapie (based on an evaluation of the genotypes of the scrapie-positive animals linked to the flock), or to another scrapie type to which the Administrator has determined AV QR sheep are not less susceptible; or (3) An exposed sheep or sheep embryo of a genotype that has been exposed to a scrapie type to which the Administrator has determined that genotype is less susceptible. (4) Note: In this definition R refers to codon 171 and A refers to codon 136, and Q represents any genotype other than R at codon 171 and V represents any genotype other than A at codon 136. Genetically resistant exposed sheep. Any exposed sheep or sheep embryo of genotype RR at codon 171 unless the Administrator determines that it is epidemiologically linked to a scrapiepositive RR sheep or to a scrapie type to which RR sheep are not resistant. Genetically resistant sheep. Any sheep or sheep embryo of genotype RR at codon 171 unless it is epidemiologically linked to a scrapiepositive RR sheep or to a scrapie type that affects RR at codon 171 sheep. Genetically susceptible animal. Any goat or goat embryo, sheep or sheep embryo of a genotype other than RR or QR, where Q represents any genotype other than R at codon 171 or sheep or sheep embryo of undetermined genotype. Genetically susceptible exposed animal. Excluding low-risk exposed animals, any exposed animal or embryo that is also: (1) A genetically susceptible animal; or (2) A sheep or sheep embryo of genotype AV QR that the Administrator has determined is epidemiologically linked to a scrapie-positive RR or QR sheep, to a flock that the Administrator has determined may be affected by valine-associated scrapie (based on an evaluation of the genotypes of the scrapie-positive animals linked to the flock), or to a scrapie type to which AV QR sheep are susceptible; or (3) A sheep or sheep embryo of genotype AA QR that the Administrator has determined is epidemiologically linked to a scrapie-positive RR or AA QR sheep or to a scrapie type to which AA QR sheep are susceptible; or (4) A sheep or sheep embryo of genotype RR that the Administrator has determined is epidemiologically linked to a scrapie-positive RR sheep or to a E:\FR\FM\25MRR2.SGM 25MRR2 11188 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations scrapie type to which RR sheep are susceptible. (5) Note: In this definition, R refers to codon 171 and A refers to codon 136, and Q represents any genotype other than R at codon 171 and V represents any genotype other than A at codon 136. Group/lot identification number (GIN). The identification number used to uniquely identify a unit of animals that is managed together as one group. The format of the GIN may be either as defined in § 86.1 of this chapter, or the flock identification number followed by a six-digit representation of the date on which the group or lot of animals was assembled (MM/DD/YY). If more than one group is created on the same date a sequential number will be added to the end of the GIN. A group lot comprised of animals from a single flock of origin may be subdivided after leaving the premises on which the group lot was formed by adding an S followed by a sequential number to the end of the GIN to create a GIN for each sub group. If a flock identification number is used, the flock identification number, date, and sequential number(s) will be separated by hyphens. High-risk animal. The female offspring or embryo of a scrapie-positive female animal, or any suspect animal, or a female genetically susceptible exposed animal, or any exposed animal that the Administrator determines to be a potential risk. The Administrator may base the determination that an exposed animal poses a potential risk on the scrapie type, the epidemiology of the flock or flocks with which it is epidemiologically linked, including genetics of the positive sheep, the prevalence of scrapie in the flock, any history of recurrent infection, and other animal or flock characteristics. An animal will no longer be a high-risk animal if it is redesignated in accordance with § 79.4. * * * * * Interstate certificate of veterinary inspection (ICVI). An official document issued by a Federal, State, Tribal, or accredited veterinarian certifying the inspection of animals in preparation for interstate movement or other uses as described in this part and in accordance with § 79.5. * * * * * Low-risk commercial flock. A flock composed of commercial whitefaced, whitefaced cross, or commercial hair sheep or commercial goats that were born in, and have resided throughout their lives in, flocks with no known risk factors for scrapie, including any exposure to female blackfaced sheep other than whiteface crosses born on the VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 premises; that has never contained a scrapie-positive female, suspect female, or high-risk animal; and that has never been an infected, exposed, or source flock or a flock under investigation. The animals are identified with a legible permanent brand or ear notch pattern registered with an official brand registry or with an official flock identification eartag. 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 flocks may exist only in a State where in the previous 10 years no flock that had met the definition of a low-risk commercial flock prior to a classification investigation was designated a source or infected flock. Low-risk exposed animal. Any exposed animal to which the Administrator has determined one or more of the following applies: (1) The positive animal that was the source of exposure was not born in the flock and did not lamb in the flock or in an enclosure where the exposed animal resided; (2) The Administrator and State representative concur that the animal is unlikely to be infected due to factors such as, but not limited to, where the animal resided or the time period the animal resided in the flock; (3) The exposed animal is male and was not born in an infected or source flock; (4) The exposed animal is a castrated male; (5) The exposed animal is an embryo of a genetically resistant exposed sheep or a genetically less susceptible exposed sheep unless placed in a recipient that was a genetically susceptible exposed animal; or (6) The animal was exposed to a scrapie type and/or is of a genotype that the Administrator has determined poses low risk of transmission. * * * * * National Uniform Eartagging System (NUES). This term has the meaning set forth in § 86.1 of this subchapter. * * * * * Official eartag. This term has the meaning set forth in § 86.1 of this subchapter, except that only eartags approved and distributed in accordance with § 79.2(k) are included. Official genotype test. A test to determine the genotype of a live or dead animal conducted at either the National Veterinary Services Laboratories or at an approved laboratory. The test subject must be an animal that is officially identified and the test accurately recorded on an official form supplied or PO 00000 Frm 00020 Fmt 4701 Sfmt 4700 approved by APHIS, with the samples collected and shipped to the laboratory using a shipping method specified by the laboratory by: (1) An accredited veterinarian; (2) A State or APHIS representative; or (3) The animal’s owner or owner’s agent, using a tamper-resistant sampling kit approved by APHIS for this purpose. * * * * * Official identification device or method. This term has the meaning set forth in § 86.1 of this subchapter, except that only devices approved and distributed in accordance with § 79.2(k) and methods approved for use in sheep and goats in accordance with § 79.2(a)(2) are included. Official identification number. This term has the meaning set forth in § 86.1 of this subchapter. Officially identified. Identified by means of an official identification device or method approved by the Administrator for use in sheep and goats in accordance with this part. * * * * * Owner/hauler statement. (1) A signed written statement by the owner or hauler that includes: (i) The name, address, and phone number of the owner and, if different, the hauler; (ii) The date the animals were moved; (iii) The flock identification number or PIN assigned to the flock or premises of the animals; (iv) If moving individually unidentified animals or other animals required to move with a group/lot identification number, the group/lot identification number and any information required to officially identify the animals; (v) The number of animals; (vi) The species, breed, and class of animals. If breed is unknown, for sheep the face color and for goats the type (milk, fiber, or meat) must be recorded instead; and (vii) The name and address of point of origin, if different from the owner’s address, and the destination name and address. (2) An existing document that includes the information required in paragraphs (1)(i) to (vii) of this definition and that is signed by the owner or the hauler may be used as an owner/hauler statement. * * * * * Person. An individual, partnership, company, corporation, or any other legal entity. * * * * * Premises identification number (PIN). This term has the meaning set forth in E:\FR\FM\25MRR2.SGM 25MRR2 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations § 86.1 of this subchapter. APHIS may also maintain historical and/or State premises numbers and link them to the premises identification number in records and databases. Such secondary or historical numbers are typically the State’s two-letter postal abbreviation followed by a number assigned by the State. Restricted animal sale or restricted livestock facility. A sale where any animals in slaughter channels are maintained separate from other animals not in slaughter channels other than animals from the same flock of origin and are sold in lots that consist entirely of animals sold for slaughter only or a livestock facility at which all animals are in slaughter channels and where the sale or facility manager maintains a copy of, or maintains a record of, the information from, the owner/hauler statement for all animals entering and leaving the sale or facility. A restricted animal sale may be held at a livestock facility that is not restricted. * * * * * Slaughter channels. Animals in slaughter channels include any animal that is sold, transferred, or moved either directly to or through a restricted animal sale or restricted livestock facility to an official slaughter establishment that is under Food Safety and Inspection Service (FSIS) jurisdiction per the Federal Meat Inspection Act (FMIA) or under State inspection that FSIS has recognized as at least equal to Federal inspection or to a custom exempt slaughter establishment as defined by FSIS (9 CFR 303.1) for immediate slaughter or to an individual for immediate slaughter for personal use or to a terminal feedlot. * * * * * Suspect animal. * * * (1) A mature sheep or goat as evidenced by eruption of the first incisor that has been condemned by FSIS or a State inspection authority for central nervous system (CNS) signs, or that exhibits any of the following clinical signs of scrapie and has been determined to be suspicious for scrapie by an accredited veterinarian or a State or USDA representative, based on one or more of the following signs and the severity of the signs: Weakness of any kind including, but not limited to, stumbling, falling down, or having difficulty rising, not including those with visible traumatic injuries and no other signs of scrapie; behavioral abnormalities; significant weight loss despite retention of appetite or in an animal with adequate dentition; increased sensitivity to noise and sudden movement; tremors; star gazing; VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 head pressing; bilateral gait abnormalities such as but not limited to incoordination, ataxia, high stepping gait of forelimbs, bunny-hop movement of rear legs, or swaying of back end, but not including abnormalities involving only one leg or one front and one back leg; repeated intense rubbing with bare areas or damaged wool in similar locations on both sides of the animal’s body or, if on the head, both sides of the poll; abraded, rough, thickened, or hyperpigmented areas of skin in areas of wool/hair loss in similar locations on both sides of the animal’s body or, if on the head, both sides of the poll; or other signs of CNS disease. An animal will no longer be a suspect animal if it is redesignated in accordance with § 79.4. * * * * * Terminal feedlot. (1) A dry lot approved by a State or APHIS representative or an accredited veterinarian who is authorized by the Administrator to perform this function where animals in the terminal feedlot 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 and must be cleaned of all organic material prior to being used to contain sheep or goats that are not in slaughter channels, where only castrated males are maintained with female animals and from which animals are moved only to another terminal feedlot or directly to slaughter; or (2) A dry lot approved by a State or APHIS representative or an accredited veterinarian authorized by the Administrator to perform this function where only animals that either are not pregnant based on the animal being male, an owner certification that any female animals have not been exposed to a male in the preceding 6 months, an ICVI issued by an accredited veterinarian stating the animals are not pregnant, or the animals are under 6 months of age at time of receipt, where only castrated males are maintained with female animals, and all animals in the terminal feedlot are separated from all other animals such that physical contact cannot occur including through a fence and from which animals are moved only to another terminal feedlot or directly to slaughter; or (3) A pasture when approved by and maintained under the supervision of the State and in which only nonpregnant animals are permitted based on the animal being male, an owner certification that any female animals have not been exposed to a male in the preceding 6 months, or an ICVI issued PO 00000 Frm 00021 Fmt 4701 Sfmt 4700 11189 by an accredited veterinarian stating the animals are not pregnant, or the animals are under 6 months of age at time of receipt, where only castrated males are maintained with female animals, 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. (4) Records of all animals entering and leaving a terminal feedlot must be maintained for 5 years after the animal leaves the feedlot and must meet the requirements of § 79.2, including either a copy of the required owner/hauler statements for animals entering and leaving the facility or the information required to be on the statements. Records must be made available for inspection and copying by an APHIS or State representative upon request. Test eligible. An animal that meets a test protocol’s age and post-exposure elapsed time requirements for the test to be meaningfully applied. * * * * * ■ 16. Section 79.2 is revised to read as follows: § 79.2 Identification and records requirements for sheep and goats in interstate commerce. (a) No sheep or goat that is required to be individually identified or group identified by § 79.3 may be sold, disposed of, acquired, exhibited, transported, received for transportation, offered for sale or transportation, loaded, unloaded, or otherwise handled in interstate commerce or commingled with such animals or be loaded or unloaded at a premises or animal concentration point (including premises that exhibit animals) where animals are received that have been in interstate commerce or from which animals are moved in interstate commerce unless each sheep or goat has been identified in accordance with this section. (1) The sheep or goat must be identified to its flock of origin and to its flock of birth 4 by the owner of the animal or his or her agent, at whichever of the following points in interstate commerce comes first: (i) Prior to the point of first commingling of the sheep or goats with 4 You need not identify an animal to its flock of birth or its flock of origin if this information is unknown because the animal changed ownership while it was exempted from flock of origin identification requirements in accordance with § 79.6(a)(10)(i). Such animals may be moved interstate with individual animal identification that is only traceable to the State of origin and to the owner of the animals at the time they were so identified. To use this exemption the person applying the identification must have supporting documentation indicating that the animals were born and had resided throughout their life in the State. E:\FR\FM\25MRR2.SGM 25MRR2 11190 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations sheep or goats from any other flock of origin; (ii) Upon unloading of the sheep or goats at a livestock facility approved in accordance with § 71.20 of this subchapter and that has agreed to act as an agent for the owner to apply official identification and prior to commingling with animals from another flock of origin. Such facilities may identify animals after sale if the facility maintains unidentified animals from different flocks of origin or, when required, different flocks of birth in separate enclosures until officially identified. The animals must be accompanied by an owner/hauler statement that contains the information needed for the livestock facility to officially identify the animals to their flock of origin and, when required, their flock of birth; (iii) Upon transfer of ownership of the sheep or goats; (iv) If the owner of the premises or the owner of the animal engages in the interstate commerce of animals, then prior to moving a sheep or goat from the premises on which it resides, unless the animals are moving to a livestock facility approved to handle the species and class of animal to be moved as described in § 71.20 of this subchapter that has agreed to act as an agent for the owner to apply official identification and in accordance with paragraph (a)(1)(ii) of this section or to a slaughter plant listed in accordance with § 71.21 of this subchapter as part of a group lot. Unless prohibited by State law or regulation, this does not preclude a person from moving animals as part of a group lot directly to another site in the same State to have official eartags that have been assigned to the animal’s flock of origin in the National Scrapie Database applied to the animals; (v) In the case of animals that have only resided on premises and in flocks owned by persons that do not engage in interstate commerce, upon unloading a sheep or goat at a livestock facility or other premises where animals are received that have been in interstate commerce or from which animals are moved in interstate commerce and prior to commingling with animals from another flock of origin. Such animals must be accompanied by an owner/ hauler statement that contains the information needed to officially identify the animals to their flock of origin and, when required, their flock of birth; or (vi) Before moving a sheep or goat across a State line, unless moving to an approved livestock facility that is approved to handle that species and class of animals as described in § 71.20 of this subchapter that has agreed to act VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 as an agent for the owner to apply official identification, and prior to commingling with animals from another flock of origin. Such animals must be accompanied by an owner/hauler statement that contains the information needed for the livestock facility to officially identify the animals to their flock of origin and, when required, their flock of birth. (2) The sheep or goats must be identified and remain identified using a device or method approved in accordance with paragraph (k) of this section. All animals required to be individually identified by § 79.3 shall be identified with official identification devices or methods. A list of approved identification devices and methods, including restrictions on their use, is available at https://www.aphis.usda.gov/ animal-health/scrapie. Written requests for approval of sheep or goat identification device types or methods not listed at https://www.aphis.usda.gov/ animal-health/scrapie should be sent to the National Scrapie Program Coordinator, Strategy and Policy, VS, APHIS, 4700 River Road Unit 43, Riverdale, MD 20737–1235. If the Administrator determines that an identification device or method will provide an effective means of tracing sheep and goats in interstate commerce, APHIS will provide public notice that the device type or method, along with any restrictions on its use, has been added to the list of approved devices and methods of official sheep and goat identification. (3) No person shall buy or sell, for his or her own account or as the agent of the buyer or seller, transport, receive for transportation, offer for sale or transportation, load, unload, or otherwise handle any animal that is in or has been in interstate commerce that has not been identified as required by this section including loading or unloading at a premises (including premises that exhibit animals) where animals are received that have been in interstate commerce or from which animals are moved in interstate commerce. No person shall commingle animals with any animal that is in or has been in interstate commerce that has not been identified as required by this section. If the person transporting animals is aware of any animal in the shipment that loses its identification to its flock of origin while in interstate commerce, the person transporting the animal is required to inform the receiving party of this fact, and it is the responsibility of the person who has control or possession of the animal upon unloading/delivery to identify the animal or have the animal identified PO 00000 Frm 00022 Fmt 4701 Sfmt 4700 prior to commingling it with any other animals. This shall be done by applying individual animal identification to the animal as required in paragraph (a)(2) of this section and recording the means of identification and the corresponding animal identification number on the waybill or other shipping document. If the flock of origin cannot be determined, all possible flocks of origin shall be listed on the record, or if this cannot be done, the animal must be identified with a slaughter only eartag and may only move in slaughter channels or, in the case of sheep, may be officially identified and moved for other purposes if the animal is inspected by an accredited veterinarian, found free of evidence of infectious or contagious disease and officially genotyped as AA QR or AA RR. (b) The State Animal Health Official or Veterinary Services, Field Operations, Area Veterinarian in Charge (AVIC) responsible for the State involved, whoever is responsible for issuing official identification devices or numbers in that State and for assigning flock identification numbers and premises identification numbers in that State in the National Scrapie Database, may issue sets of unique serial numbers or flock identification/production numbers for use on official individual identification devices (such as eartags or tattoos). Flock identification/production numbers may only be assigned to owners of breeding flocks. (1) Animals not in slaughter channels. Official identification numbers for use on animals not in slaughter channels may only be assigned either directly to the owner of a breeding flock for application to animals that originated in a breeding flock owned by them or, in the case of official serial numbers or serial number devices, to APHIS or State representatives or accredited veterinarians or other responsible individuals as described in paragraphs (b)(2) and (3) of this section APHIS or State representatives may apply official identification to animals or issue official identification to owners of breeding flocks for application to animals in those flocks. APHIS and State personnel who apply or issue official identification must provide to APHIS, in a manner acceptable to APHIS, assignment data associating the serial numbers applied to animals or issued to owners, to the flock of origin and, when required, the flock of birth. Accredited veterinarians who apply official serial numbers or devices when requested by APHIS a must provide to APHIS, in a manner acceptable to APHIS, assignment data associating the serial sequences applied to animals to the E:\FR\FM\25MRR2.SGM 25MRR2 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations flock of origin and, when required, the flock of birth. One such method would be to enter the data into the National Scrapie Database. Such requests may be made directly to a person or persons or to accredited veterinarians as a group through amendment of the Scrapie Program Standards Volume 1: National Scrapie Eradication Program. (2) Assignment of serial numbers. The official responsible for issuing eartags in a State may also assign serial numbers of official eartags to other responsible persons, such as 4–H leaders, if the State Animal Health Official and Veterinary Services, Field Operations, AVIC responsible for the State involved agree that such assignments will improve scrapie control and eradication within the State. Such persons assigned serial numbers may either directly apply eartags to animals, or may reassign eartag numbers to producers. Such persons must maintain appropriate records in accordance with paragraph (g) of this section that permit traceback of animals to their flock of origin, or flock of birth when required, and must either reassign the tags in the National Scrapie Database or, if permitted by the Veterinary Services, Field Operations, AVIC responsible for the State involved, provide a written record of the reassignment to the Field Office or the State Office for entry into the National Scrapie Database. (3) Persons handling sheep and goats in commerce. Sets of unique individual identification serial numbers may be assigned to persons who handle sheep and goats, that did not originate in a breeding flock owned by them, if they apply to and are approved by the State Animal Health Official or the Veterinary Services, Field Operations, AVIC responsible for the State in which the person maintains his or her business location, whichever is responsible for issuing official identification devices or numbers in that State and for assigning flock identification numbers and premises identification numbers in that State in the National Scrapie Database. When requested by APHIS, persons who apply official identification to sheep or goats that did not originate in a breeding flock owned by them must provide, in a manner acceptable to APHIS, assignment data associating assigned serial sequences to the flock of origin and, when required, the flock of birth. One such method would be to enter the data into the National Scrapie Database. The request may be made directly to a person or persons or to a class of persons through amendment of the Scrapie Program Standards Volume 1: National Scrapie Eradication Program. The State Animal Health Official or the VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 Administrator may limit the assignment of official identification devices or numbers to persons, or classes of persons, for use on animals that did not originate in a breeding flock owned by them to slaughter only devices or numbers. (4) Breed registries. Sets of unique individual identification numbers may also be assigned by the Administrator to breed registries that agree to reassign the sequences to the flock of origin and, and when required, the flock of birth and to provide associated registry identifiers such as registry tattoo numbers to APHIS in the National Scrapie Database. (5) Noncompliance. In addition to any applicable criminal or civil penalties any person who fails to comply with the requirements of this section or that makes false statements in order to acquire official identification numbers or devices shall not be assigned official identification numbers or official identification devices for a period of at least 1 year. If a person who is not in compliance with these requirements has already been assigned such numbers, the Administrator may withdraw the assignment by giving notice to such person. Such withdrawal or failure to assign official identification numbers may be appealed in accordance with § 79.4(c)(3). A person shall be subject to criminal and civil penalties if he or she continues to use assigned numbers that have been withdrawn from his or her use. (c) No person shall apply a premises or flock identification number or a brand or earnotch pattern to an animal that did not originate on the premises or flock to which the number was assigned by a State or APHIS representative or to which the brand or earnotch pattern has been assigned by an official brand registry. This includes individual identification such as USDA eartags that have been assigned to a premises or flock and registration tattoos that contain prefixes that have been assigned to a premises or flock for use as premises or flock identification. Unless the number sequence was issued specifically for use on animals born in a flock, this would not preclude the owner of a flock from using an official premises or flock identification number tag assigned to that flock on an animal owned by him or her that resides in that flock but that was born or previously resided on a different premises as long as the records required in paragraph (g) of this section are maintained. (d) No person shall sell or transfer an official identification device or number assigned to his or her premises or flock except when it is transferred with a sheep or goat to which it has been PO 00000 Frm 00023 Fmt 4701 Sfmt 4700 11191 applied as official identification or as directed in writing by an APHIS or State representative. (e) No person shall use an official identification device or number provided for the identification of sheep and goats other than for the identification of a sheep or goat. (f) Persons who engage in the interstate commerce of animals including persons that handle or own animals that have been in interstate commerce or that purchase, acquire, sell, or dispose of sheep and/or goats from or to persons who engage in the interstate commerce of animals, whether or not the animals are required to be officially identified, must maintain business records (such as yarding receipts, sale tickets, invoices, and waybills) for 5 years. These persons must make the records available for inspection and copying by any authorized USDA or State representative upon that representative’s request and presentation of his or her official credentials. The records must include the following information: (1) The number of animals purchased or sold (or transferred without sale); (2) The date of purchase, sale, or other transfer; (3) The name and address of the person from whom the animals were purchased or otherwise acquired or to whom they were sold or otherwise transferred; (4) The species, breed, and class of animal. If breed is unknown, for sheep the face color and for goats the type (milk, fiber, or meat) must be recorded instead; (5) A copy of the brand inspection certificate for animals officially identified with brands or ear notches; (6) A copy of any certificate or owner/ hauler statement required for movement of the animals purchased, sold, or otherwise transferred; and (7) If the flock of origin or the receiving flock is under a flock plan or post-exposure management and monitoring plan, any additional records required by the plan. (g) Persons who apply official individual or group/lot identification to animals must maintain records for 5 years. These persons must make the records available for inspection and copying by any authorized USDA or State representative upon that representative’s request and presentation of his or her official credentials. The records must include the following information: (1) The flock identification number of the flock of origin, the name and address of the person who currently owns the animals, and the name and E:\FR\FM\25MRR2.SGM 25MRR2 11192 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations address of the owner of the flock of origin if different; (2) The name and address of the owner of the flock of birth, if known, for animals in another flock and not already identified to flock of birth; (3) The date the animals were officially identified; (4) The number of sheep and the number of goats identified; (5) The breed and class of the animals. If breed is unknown, for sheep the face color and for goats the type (milk, fiber, or meat) must be recorded instead; (6) The official identification numbers applied to animals by species or the GIN applied in the case of a group lot; (7) Whether the animals were identified with ‘‘Slaughter Only’’ or ‘‘Meat’’ identification devices; and (8) Any GIN with which the animal was previously identified. (h) Official identification devices are intended to provide permanent identification of livestock and to ensure the ability to find the source of animal disease outbreaks. Removal of these devices, including devices applied to imported animals in their countries of origin and recognized by the Administrator as official, is prohibited except at the time of slaughter, at any other location upon the death of the animal, or as otherwise approved by the State or Tribal animal health official or the Veterinary Services, Field Operations, AVIC responsible for the State involved when a device needs to be replaced. (1) All man-made identification devices affixed to sheep or goats moved interstate must be removed at slaughter and correlated with the carcasses through final inspection by means approved by the Food Safety and Inspection Service (FSIS). If diagnostic samples, including whole heads, are taken, the identification devices must be packaged with the samples and must be left attached to approximately 1 inch of tissue or to the whole head to allow for identity testing and be correlated with the carcasses through final inspection by means approved by FSIS. Devices collected at slaughter must be made available to APHIS and FSIS. (2) All official identification devices affixed to sheep or goat carcasses moved interstate for rendering must be removed at the rendering facility and made available to APHIS. If diagnostic samples, including whole heads, are taken, the identification devices must be packaged with the samples and must be left attached to approximately 1 inch of tissue or to the whole head to allow for identity testing. (3) If a sheep or goat loses an official identification device except while in VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 interstate commerce as described in paragraph (a)(3) of this section and needs a new one, the person applying the new official identification device must record the official identification number from the old device, if known, in addition to the information required to be recorded in accordance with paragraph (g) of this section. (i) Replacement of official identification devices for reasons other than loss include: (1) Circumstances under which a State or Tribal animal health official or the Veterinary Services, Field Operations, AVIC responsible for the State involved may authorize replacement of an official identification device include, but are not limited to: (i) Deterioration of the device such that loss of the device appears likely or the number can no longer be read; (ii) Infection at the site where the device is attached, necessitating application of a device at another location (e.g., a slightly different location of an eartag in the ear); (iii) Malfunction of the electronic component of a radio frequency identification (RFID) device; or (iv) Incompatibility or inoperability of the electronic component of an RFID device with the management system or unacceptable functionality of the management system due to use of an RFID device. (2) Any time an official identification device is replaced, as authorized by the State or Tribal animal health official or the Veterinary Services, Field Operations, AVIC responsible for the State involved, the person replacing the device must record the following information about the event and maintain the record for 5 years: (i) The date when the device was removed; (ii) The address of the location and the name, phone number and email address of the person responsible for the location where the device was removed; (iii) The official identification number (to the extent possible) on the device removed; (iv) The type of device removed (e.g., metal eartag, RFID eartag); (v) The reason for the removal of the device; (vi) The new official identification number on the replacement device; and (vii) The type of replacement device applied. (j) Beginning on April 24, 2019, no more than one official eartag may be applied to an animal; except that: (1) Another official eartag may be applied providing it bears the same official identification number as an existing one. PO 00000 Frm 00024 Fmt 4701 Sfmt 4700 (2) In specific cases when the need to maintain the identity of an animal is intensified (e.g., such as for export shipments, quarantined herds, field trials, experiments, or disease surveys), a State or Tribal animal health official or the Veterinary Services, Field Operations, AVIC responsible for the State involved may approve the application of a second official eartag. The person applying the second official eartag must record the following information about the event and maintain the record for 5 years: The date the second official eartag is added; the reason for the additional official eartag device; and the official identification numbers of both official eartags. (3) An eartag with an animal identification number (AIN) beginning with the 840 prefix (either radio frequency identification or visual-only tag) may be applied to an animal that is already officially identified with another eartag. The person applying the AIN eartag must record the date the AIN tag is added and the official identification numbers of all official eartags on the animal and must maintain those records for 5 years. (4) An official eartag that utilizes a flock identification number may be applied to a sheep or goat that is already officially identified with an official eartag if the animal has resided in the flock to which the flock identification number is assigned. (k) Requirements for approval of official identification devices include: (1) The Administrator may approve companies to produce official identification devices for use on sheep or goats. Devices may be plastic, metal, or other suitable materials and must be an appropriate size for use in sheep and goats. Devices must be able to legibly accommodate the required alphanumeric sequences. Devices must resist removal and be difficult to place on another animal once removed unless the construction of the device makes such tampering evident, but need not be tamper-proof. Devices must be readily distinguishable as USDA official sheep and goat identification devices; must carry the alphanumeric sequences, symbols, or logos specified by APHIS; must be an allowed color for the intended use, and must have a means of discouraging counterfeiting, such as use of a unique copyrighted logo or trade mark. Devices for use only on animals in slaughter channels must be medium blue and marked with the words ‘‘Meat’’ or ‘‘Slaughter Only’’. Devices that use RFID must conform to ISO 11784 and ISO 11785 standards unless otherwise approved. The Administrator may specify the color, shape or size of a E:\FR\FM\25MRR2.SGM 25MRR2 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations device for an intended use to make them readily identifiable. (2) Written requests for approval of official identification devices for sheep and goats should be sent to the National Scrapie Program Coordinator, Strategy and Policy, VS, APHIS, 4700 River Road Unit 43, Riverdale, MD 20737–1235. The request must include: (i) The materials used in the device and in the case of RFID the transponder type and data regarding the lifespan and read range. (ii) Any available data regarding the durability of the device, durability and legibility of the identification numbers, rate of adverse reactions such as ear infections, and retention rates of the devices in animals, preferably sheep and/or goats. (iii) A signed statement agreeing to: (A) Send official identification devices only to a State or APHIS representative, to the owner of a premises or to the contact person for a premises at the address listed in the National Scrapie Database, or as directed by APHIS; (B) When requested by APHIS, provide a report by State of all tags produced, including the tag sequences produced and the name and address of the person to whom the tags were shipped, and provide supplemental reports of this information when requested by APHIS; (C) Maintain the security and confidentiality of all tag recipient information acquired as a result of being an approved tag manufacturer and utilize the information only to provide official identification tags; and (D) Enter the sequences of tags shipped in the National Scrapie Database through an internet web page interface or other means specified by APHIS prior to shipping the identification device. (iv) Twenty-five sample devices. Additional tags must be submitted if requested by APHIS. (3) Approval will only be given for devices for which data have been provided supporting high legibility, readability (visual and RFID), and retention rates in sheep and goats that minimize injury throughout their lifespan, or for which there is a reasonable expectation of such performance. Approval to produce official identification devices will be valid for 1 year and must be renewed annually. The Administrator may grant provisional approval to produce devices for periods of less than 1 year in cases where there is limited or incomplete data. The Administrator may decline to renew a company’s approval or suspend or withdraw approval if the devices do VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 not show adequate retention and durability or cause injury in field use or if any of the requirements of this section are not met by the tag company. Companies shall be given 60 days’ written notice of intent to withdraw approval. Any person who is approved to produce official identification tags in accordance with this section and who knowingly produces tags that are not in compliance with the requirements of this section, and any person who is not approved to produce such tags but does so, shall be subject to such civil penalties and such criminal liabilities as are provided by 18 U.S.C. 1001, 7 U.S.C. 8313, or other applicable Federal statutes. Such action may be in addition to, or in lieu of, withdrawal of approval to produce tags. (Approved by the Office of Management and Budget under control numbers 0579–0101 and 0579–0469) 17. Section 79.3 is revised to read as follows: ■ § 79.3 General restrictions. The following prohibitions and movement conditions apply to the movement of or commingling with sheep and goats in interstate commerce, and no sheep or goat may be sold, disposed of, acquired, exhibited, transported, received for transportation, offered for sale or transportation, loaded, unloaded, or otherwise handled in interstate commerce, or commingled with such animals, or be loaded or unloaded at a premises or animal concentration point (including premises that exhibit animals) where animals are received that have been in interstate commerce or from which animals are moved in interstate commerce except in compliance with this part. (a) No sexually intact animal of any age or castrated animal 18 months of age and older (as evidenced by the eruption of the second incisor) may be moved or commingled with animals in interstate commerce unless it is individually identified to its flock of birth 5 and is accompanied by an ICVI, except that an ICVI is not required unless the animal is moved across a State line, and except for the following, which may move with 5 You need not identify an animal to its flock of birth or its flock of origin if this information is unknown because the animal changed ownership while it was exempted from flock of origin identification requirements in accordance with § 79.6(a)(10)(i). Such animals may be moved interstate with individual animal identification that is only traceable to the State of origin and to the owner of the animals at the time they were so identified. To use this exemption the person applying the identification must have supporting documentation indicating that the animals were born and had resided throughout their life in the State. PO 00000 Frm 00025 Fmt 4701 Sfmt 4700 11193 group lot identification and an owner/ hauler statement: (1) Animals in slaughter channels that are under 18 months of age (as evidenced by the eruption of the second incisor); (2) Animals in slaughter channels at 18 months and older (as evidenced by the eruption of the second incisor) if the animals were kept as a group on the same premises on which they were born and have not been maintained in the same enclosure with unidentified animals from another flock at any time, including throughout the feeding, marketing, and slaughter process; (3) An owner/hauler statement may be used instead of an ICVI for mixed source animals in slaughter channels 18 months of age and older (as evidenced by the eruption of the second incisor) that are identified with official individual identification or in the case of animals from flocks that are low-risk commercial flocks that are identified using identification methods or devices approved for this purpose; (4) Animals moving for grazing or other management purposes between two premises both owned or leased by the flock owner and recorded in the National Scrapie Database as additional flock premises and where commingling will not occur with unidentified animals that were born in another flock or any animal that is not part of the flock. A request to APHIS to enter additional flock premises in the National Scrapie Database is required before animals are first moved to the premises. Notification is not required for each subsequent movement of animals to that premises. Neither group lot ID nor an owner/hauler statement is required for movements of a flock or its members for flock management purposes within a contiguous premises spanning two or more States. This provision does not include the transiting or sale of animals through such a premises in circumvention of the other requirements of this part; and (5) Animals moving to a livestock facility approved in accordance with § 71.20 of this subchapter and that has agreed to act as an agent for the owner to apply official identification if the animals have been in the same flock in which they were born and have not been maintained in the same enclosure with unidentified animals born in another flock at any time. Such facilities may identify animals after sale if the facility maintains unidentified animals from different flocks of origin or when required birth in separate enclosures until officially identified. (b) No scrapie-positive or suspect animal may be moved other than by E:\FR\FM\25MRR2.SGM 25MRR2 11194 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations permit to an APHIS approved research or quarantine facility or for destruction under APHIS or State supervision. Such animals must be individually identified and listed on the permit. (c) No indemnified high-risk animal or indemnified sexually intact genetically susceptible exposed animal may be moved other than by permit to an APHIS approved research or quarantine facility or for destruction at another site. Such animals that are not indemnified and are not scrapie-positive or suspect animals may be moved to slaughter under permit. Animals moved in accordance with this paragraph must be individually identified and listed on the permit. (d) No exposed animal may be moved unless it is officially individually identified. (e) No animal may be moved from an infected flock or source flock except as allowed by an approved flock plan. (f) No animal may be moved from an exposed flock, a flock under investigation or a flock subject to a PEMMP except as allowed in a PEMMP or where a PEMMP is not required, as allowed by written instructions from an APHIS or State representative. (g) Animals moved to slaughter: (1) Once an animal enters slaughter channels the animal may not be removed from slaughter channels. An animal is in slaughter channels if it was sold through a restricted animal sale, resided in a terminal feedlot, was sold with a bill of sale marked for slaughter only, was identified with an identification device or tattoo marked ‘‘Slaughter Only’’ or ‘‘MEAT’’ or was moved in a manner not permitted for other classes of animals. Animals in slaughter channels may move either directly to a slaughter establishment that is under Food Safety and Inspection Service (FSIS) jurisdiction per the Federal Meat Inspection Act (FMIA) or under State inspection that FSIS has recognized as at least equal to Federal inspection or to a custom exempt slaughter establishment as defined by FSIS (9 CFR 303.1) for immediate slaughter or to an individual for immediate slaughter for personal use or to a terminal feedlot, or may move indirectly to such a destination through a restricted animal sale or restricted livestock facility. Once an animal has entered slaughter channels it may only be officially identified with an official blue eartag marked with the words ‘‘Meat’’ or ‘‘Slaughter Only’’ or an ear tattoo reading ‘‘Meat.’’ Animals in slaughter channels must be accompanied by an owner/hauler statement. The statement must also include the name and address of the VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 person or livestock facility from which and where they were acquired, if different from the owner; the slaughter establishment, restricted animal sale, restricted livestock facility or terminal feedlot to which they are being moved, and a statement that the animals are in slaughter channels. A copy of the owner/hauler statement must be provided to the slaughter establishment, restricted animal sale, restricted livestock facility or terminal feedlot to which the animals are moved. Any bill of sale regarding the animals must indicate that the animals were sold for slaughter only. (2) Animals that were in slaughter channels before arriving at a sale and animals that cannot meet the ID and ICVI requirements for unrestricted movement prior to leaving a sale may not be sold at an unrestricted sale. This does not preclude animals sold at an unrestricted sale from being moved in slaughter channels after sale if identified as required for animals in slaughter channels. (3) Animals in slaughter channels may not be held in the same enclosure with sexually intact animals from another flock of origin that are not in slaughter channels. (h) No animals designated for testing as part of a classification or reclassification investigation may be moved until testing is completed and results reported, except for movement by permit for testing, slaughter, research, or destruction. Such animals must be individually identified and listed on the permit. (i) The following animals, if not restricted as part of a flock plan or PEMMP, may be moved to any destination without further restriction after being officially identified and designated or redesignated by a DSE to be: (1) Genetically resistant exposed sheep; (2) Genetically less susceptible exposed sheep; or (3) Low-risk exposed animals. (j) Animals moved from Inconsistent States must meet the following requirements in addition to other requirements of this section. (1) Sheep and goats not in slaughter channels must be enrolled in the Scrapie Free Flock Certification Program or an equivalent APHIS recognized program or be sheep that are officially genotyped and determined to be AA QR or AA RR, be officially identified, and be accompanied by an ICVI that also states the individual animal identification numbers, the flock of origin, and the flock of birth, if different. PO 00000 Frm 00026 Fmt 4701 Sfmt 4700 (2) Animals in slaughter channels must be officially identified with an official blue eartag marked with the words ‘‘Meat’’ or ‘‘Slaughter Only’’ and may move only directly to slaughter or to a terminal feedlot. Animals 18 months of age and older (as evidenced by the eruption of the second incisor) in slaughter channels must also be accompanied by an ICVI that states the individual animal identification numbers, and the flock of birth (and the flock of origin, if different). (k) APHIS may enter into compliance agreements with persons such as dealers and owners of slaughter establishments and markets whereby animals may be received unidentified or without a required owner/hauler statement even if they cannot be identified to their flock of birth or origin because they were moved or commingled while unidentified, in violation of this part or a State requirement as provided by § 79.6. Provided that, the agreement requires the person signing the agreement to report the violation to the Veterinary Services, Field Operations, AVIC responsible for the State involved so that corrective action can be taken against the principal violator. In such cases the animal must be identified with a slaughter only tag, and is moved only in slaughter channels or, in the case of sheep, moved for other purposes if the animal is inspected by an accredited veterinarian, found free of evidence of infectious or contagious disease, and officially genotyped as AA QR or AA RR where Q and R refer to codon 171 and A refers to codon 136. APHIS may also enter into compliance agreements with persons or in the case of approved livestock facilities may amend an approved livestock facility agreement to establish alternative methods to maintain the traceability of animals in slaughter channels to their flock of origin or waive the requirement for individual official identification of animals in slaughter channels if adequate surveillance has been conducted on the flock of origin or an alternative plan is in place to conduct surveillance on animals from the flock of origin when the Administrator and the State Animal Health Official agree that the application of an allowed official identification device or method is unsuitable for a specific circumstance. An example of a specific circumstance could be large unruly horned male goats moving through approved livestock facilities. (Approved by the Office of Management and Budget under control numbers 0579–0101 and 0579–0469) E:\FR\FM\25MRR2.SGM 25MRR2 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations 18. Section 79.4 is revised to read as follows: ■ § 79.4 Designation of scrapie-positive animals, high-risk animals, exposed animals, suspect animals, exposed flocks, infected flocks, noncompliant flocks, and source flocks; notice to owners. (a) Designation. Based on a classification investigation as defined in § 79.1, including testing of animals, if needed, a designated scrapie epidemiologist will designate a flock to be an exposed flock, an infected flock, a source flock, a flock under investigation, and/or a non-compliant flock, or designate an animal to be a scrapie-positive animal, high-risk animal, exposed animal, genetically susceptible exposed animal, genetically resistant exposed sheep, genetically less susceptible exposed sheep, low-risk exposed animal, and/or a suspect animal after determining that the flock or animal meets the criteria of the relevant definition in § 79.1. (b) Redesignation. A reclassification investigation as defined in § 79.1 may be conducted to determine whether the current designated status of a flock or animal may be changed or removed. Reclassification investigations will be initiated and conducted, and redesignation decisions will be made, in accordance with procedures approved by the Administrator. These procedures are available at https:// www.aphis.usda.gov/animal-health/ scrapie. (c) Testing and notification procedures. Any animal that may be a high-risk animal, any animal that may have been exposed to the lambing of a high-risk animal, any suspect animal, and any animal that was born in the flock after a high-risk animal may have lambed may be selected for testing by the DSE or an APHIS or State representative working under the direction of a DSE or the Administrator. Which animals are selected and the method of testing selected animals will be based on the risk associated with the flock and the type and number of animals available for test. When flock records are adequate to determine that all high-risk animals that lambed in the flock are available for testing, the testing may be limited to postmortem testing of all high-risk and suspect animals. Testing may also include an official genotype test, live-animal testing using a live-animal official test, the postmortem examination and testing of genetically susceptible animals in the flock that cannot be evaluated by a live animal test, postmortem examination of other animals, and postmortem examination and testing of animals VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 found dead or cull animals at slaughter. Animals may not be tested for scrapie to establish the designation of the flock until they are test eligible. Animals are generally considered test eligible when the animals are over 14 months of age if born after the exposure or are 18 months post exposure. If testing these animals is necessary to establish the status of a flock they must be held for later testing unless sent directly to slaughter or a terminal feedlot. (1) Noncooperation. If an owner does not make his or her animals available for testing within 60 days of notification by an APHIS or State representative, within 60 days of becoming test eligible, or as mutually agreed in writing by the Administrator and the owner, or fails to submit required postmortem samples, the flock will be designated a source, infected, or exposed flock, whichever definition applies and a noncompliant flock. (2) Notice to owner. As soon as possible after making a designation or redesignation determination, a State or APHIS representative will attempt to notify the owner(s) of the flock(s) or animal(s) in writing of the designation. (3) Appeal. The owner of an animal may appeal the designation of an animal as a scrapie-positive animal, high-risk animal, exposed animal, genetically susceptible exposed animal, genetically resistant exposed sheep, genetically less susceptible exposed sheep, low-risk exposed animal, or a suspect animal. The owner of a flock may appeal the designation of the flock as an exposed flock, an infected flock, a source flock, a flock under investigation, or a noncompliant flock. The owner of a laboratory or test manufacturing facility may appeal the suspension or withdrawal of approval for a laboratory or a test. To do so, the owner must appeal by writing to the Administrator within 10 days after being informed of the reasons for the proposed action. The appeal must include all of the facts and reasons upon which the owner relies to show that the proposed action is incorrect or is not supported. The Administrator will grant or deny the appeal in writing as promptly as circumstances permit, stating the reason for his or her decision. If there is a conflict as to any material fact, a hearing will be held to resolve the conflict. Rules of practice concerning the hearing will be adopted by the Administrator. The action under appeal shall continue in effect pending the final determination of the Administrator, unless otherwise ordered by the Administrator. The final determination of the Administrator shall become effective upon oral or written notification, whichever is earlier, to the PO 00000 Frm 00027 Fmt 4701 Sfmt 4700 11195 owner. In the event of oral notification, written confirmation shall be given as promptly as circumstances allow. The Administrator’s final determination constitutes final agency action. (Approved by the Office of Management and Budget under control number 0579–0101) ■ 19. Section 79.5 is revised as follows: § 79.5 Issuance of Interstate Certificates of Veterinary Inspection (ICVI). (a) ICVIs are required as specified by § 79.3 for certain interstate movements of sheep or goats and may be used to meet the requirements for entry into terminal feedlots. An ICVI and all copies must be legible and must show the following information, except when § 79.3 states that the information is not required for the specific type of interstate movement: (1) The ICVI must show the species, breed or, if breed is unknown, the face color of sheep or the type of goats (milk, fiber, or meat), and class of animal, such as replacement ewe lambs, slaughter lambs or kids, cull ewes, club lambs, bred ewes, etc.; the number of animals covered by the ICVI; the purpose for which the animals are to be moved; the address at which the animals were loaded for interstate movement or for movement to a terminal feedlot when an ICVI is required; the address to which the animals are destined; and the names of the consignor and the consignee and their addresses if different from the address at which the animals were loaded or the address to which the animals are destined; and if different the current owner; (2) Each animal’s official individual identification numbers: Provided, that, in the case of animals identified with official identifications devices or methods that include the flock identification number(s) assigned to the flock(s) of origin in the National Scrapie Database and an individual animal number unique within the flock, the flock identification number(s) may be recorded instead of the individual identification numbers, and for animals allowed by § 79.3 to move with group lot identification, the group lot number may be recorded instead of the individual identification numbers. An ICVI may not be issued for any animal that is not officially identified if official identification is required. If the animals are not required by the regulations to be officially identified, the ICVI must state the exemption that applies (e.g., sheep and goats moving for grazing without change of ownership). If the animals are required to be officially identified but the identification number is not required to be recorded on the ICVI, the ICVI must state that all animals to be E:\FR\FM\25MRR2.SGM 25MRR2 11196 Federal Register / Vol. 84, No. 57 / Monday, March 25, 2019 / Rules and Regulations moved under the ICVI are officially identified and state the exemption that applies (e.g. the ewes are identified with flock of origin tags so only the flock ID must be recorded on the ICVI); and (3) A statement by the issuing accredited, State, or Federal veterinarian to the effect that on the date of issuance the animals were free of evidence of infectious or contagious disease and insofar as can be determined exposure thereto. This statement may be made with respect to scrapie for animals exposed to scrapie that’s movement is not restricted that have been designated genetically resistant or less susceptible sheep or low-risk exposed animals. Except as provided in paragraphs (b) and (c) of this section, all information required by this paragraph must be typed or legibly written on the ICVI. Note that in accordance with paragraphs (a), (b), and (e) of § 79.3, scrapiepositive, suspect, and high-risk animals, some exposed animals, and some animals that originated in an infected or source flock require permits rather than ICVIs. (4) The ICVI must be signed by the issuing State, Federal, Tribal or accredited veterinarian and must be legible on all copies. (b) As an alternative to typing or writing individual animal identification on an ICVI, if agreed to by the receiving State or Tribe, another document may be used to provide this information, but only under the following conditions: (1) The document must be a State form or APHIS form that requires individual identification of animals or a printout of official identification numbers generated by computer or other means; (2) A legible copy of the document must be stapled to the original and each copy of the ICVI; (3) Each copy of the document must identify each animal to be moved with the ICVI, but any information pertaining to other animals, and any unused space on the document for recording animal identification, must be crossed out in ink; and (4) The following information must be written in ink in the identification column on the original and each copy of the ICVI and must be circled or boxed, also in ink, so that no additional information can be added: (i) The name of the document; and (ii) Either the unique serial number on the document or, if the document is not imprinted with a serial number, both the name of the person who prepared the document and the date the document was signed. (c) Ownership brands documents attached to ICVIs. As an alternative to VerDate Sep<11>2014 16:51 Mar 22, 2019 Jkt 247001 typing or writing ownership brands on an ICVI, an official brand inspection certificate may be used to provide this information, but only under the following conditions: (1) A legible copy of the official brand inspection certificate must be stapled to the original and each copy of the ICVI; (2) Each copy of the official brand inspection certificate must show the ownership brand of each animal to be moved with the ICVI, but any other ownership brands, and any unused space for recording ownership brands, must be crossed out in ink; and (3) The following information must be typed or written in ink in the official identification column on the original and each copy of the ICVI and must be circled or boxed, also in ink, so that no additional information can be added: (i) The name of the attached document; and (ii) Either the serial number on the official brand inspection certificate or, if the official brand inspection certificate is not imprinted with a serial number, both the name of the person who prepared the official brand inspection certificate and the date it was signed. (d) If more than one page is used each page must be sequentially numbered with the page number and the total number of pages (for example 1 of 2, 2 of 2). (Approved by the Office of Management and Budget under control numbers 0579–0101 and 0579–0469) 20. Section 79.6 is amended as follows: ■ a. In paragraph (a) introductory text by adding the words ‘‘, including scrapie surveillance activities,’’ after the words ‘‘control activities’’; ■ b. By redesignating paragraphs (a)(10)(i) through (vi) as paragraphs (a)(12) through (a)(17), respectively, and by revising paragraph (a)(10); ■ c. By adding paragraph (a)(11); ■ d. In paragraph (b), by adding the words ‘‘from the date the State is notified of the deficiency’’ after the words ‘‘2-year extension’’; ■ e. By adding paragraph (c); and ■ f. By adding an OMB citation at the end of the section. The revision and additions read as follows: ■ § 79.6 Standards for States to qualify as Consistent States. (a) * * * (10) Has effectively implemented ongoing scrapie surveillance that meets the following criteria: (i) Collects and submits surveillance samples from targeted animals slaughtered in State-inspected establishments and from slaughter PO 00000 Frm 00028 Fmt 4701 Sfmt 9990 establishments within the State that are not covered under § 71.21 of this subchapter, or allows and facilitates the collection of such samples by USDA personnel or contractors; and (ii) Transmits required submission and epidemiological information for all scrapie samples using the electronic submission system provided by APHIS for inclusion in the National Scrapie Database and for transmission of the submission information to an approved laboratory; and (iii) Achieves the annual State-level scrapie surveillance minimums for sheep and goats originating from the State as determined annually by the Administrator with input from the States and made available to the public at https://www.aphis.usda.gov/animalhealth/scrapie at least 6 months before the start of the collection period; or (iv) Conducts annual surveillance at a level that will detect scrapie if it is present at a prevalence of 0.1 percent in the population of targeted animals originating in the State, with a 95 percent confidence. (11) If a State does not meet the requirements of paragraph (a)(10) of this section as of April 24, 2019, the State must provide APHIS with a plan and a timeline for complying with all the requirements of paragraph (a)(10) by April 24, 2020, and must meet the requirements of paragraph (a)(10) of this section by April 26, 2021. * * * * * (c) When the Administrator determines that a State should be added to or removed from the list of Consistent States, APHIS will publish a notice in the Federal Register advising the public of the Administrator’s determination, providing the reasons for that determination, and soliciting public comments. After considering any comments we receive, APHIS will publish a second notice either advising the public that the Administrator has decided to add or remove theState from the list of Consistent States or notifying the public that the Administrator has decided not to make any changes to the list of Consistent States, depending on the information presented in the comments. (Approved by the Office of Management and Budget under control number 0579–0101) Done in Washington, DC, this 15th day of March 2019. Greg Ibach, Under Secretary for Marketing and Regulatory Programs. [FR Doc. 2019–05430 Filed 3–22–19; 8:45 am] BILLING CODE 3410–34–P E:\FR\FM\25MRR2.SGM 25MRR2

Agencies

[Federal Register Volume 84, Number 57 (Monday, March 25, 2019)]
[Rules and Regulations]
[Pages 11170-11196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05430]

[[Page 11169]]

Vol. 84

Monday,

No. 57

March 25, 2019

Part II

Department of Agriculture

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Animal and Plant Health Inspection Service

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9 CFR Parts 54 and 79

Scrapie in Sheep and Goats; Final Rule

Federal Register / Vol. 84 , No. 57 / Monday, March 25, 2019 / Rules
and Regulations

[[Page 11170]]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 54 and 79

[Docket No. APHIS-2007-0127]
RIN 0579-AC92

Scrapie in Sheep and Goats

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the scrapie regulations by changing the risk
groups and categories established for individual animals and for
flocks, increasing the use of genetic testing as a means of assigning
risk levels to animals, reducing movement restrictions for animals
found to be genetically less susceptible or resistant to scrapie, and
simplifying, reducing, or removing certain recordkeeping requirements.
We are also providing designated scrapie epidemiologists with more
alternatives and flexibility when testing animals in order to determine
flock designations under the regulations. We are changing the
definition of high-risk animal, which will change the types of animals
eligible for indemnity, and to pay higher indemnity for certain
pregnant ewes and does and early maturing ewes and does. The changes
will also make the identification and recordkeeping requirements for
goat owners consistent with those for sheep owners. These changes
affect sheep and goat producers, persons who handle sheep and goats in
interstate commerce, and State governments.

DATES: Effective April 24, 2019.

FOR FURTHER INFORMATION CONTACT: Dr. Diane Sutton, National Scrapie
Program Coordinator, Sheep, Goat, Cervid & Equine Health Center,
Strategy and Policy, VS, APHIS, 4700 River Road Unit 43, Riverdale, MD
20737-1235; (301) 851-3509.

SUPPLEMENTARY INFORMATION:

Background

Scrapie is a degenerative and eventually fatal disease affecting
the central nervous systems of sheep and goats. Scrapie belongs to the
family of diseases known as transmissible spongiform encephalopathies
(TSEs). In addition to scrapie, TSEs include, among other diseases,
bovine spongiform encephalopathy (BSE) in cattle, chronic wasting
disease in deer and elk, and variant Creutzfeldt-Jakob disease in
humans. Control of scrapie is complicated because the disease has an
extremely long incubation period without clinical signs of the disease.
To control the spread of scrapie within the United States, the
Animal and Plant Health Inspection Service (APHIS), United States
Department of Agriculture (USDA), administers regulations at 9 CFR part
79, which restrict the interstate movement of certain sheep and goats.
APHIS also has regulations at 9 CFR part 54, which describe a voluntary
scrapie-free flock certification program.
On September 10, 2015, we published in the Federal Register (80 FR
54660-54692, Docket No. APHIS-2007-0127) a proposal \1\ to amend the
regulations in parts 54 and 79 by changing the requirements for records
needed to trace animals, and by adding provisions to link official
individual animal identification applied by persons other than the
flock owner to the flock of origin in the National Scrapie Database
rather than just the person who applied the official identification.
The current regulations address tracing exposed animals moved from a
flock to another flock primarily in Sec. 54.8(f) (regarding the
responsibility of flock owners to disclose records to APHIS
representatives or State representatives for the purpose of tracing
animals), in Sec. 79.2(b) (regarding the responsibility of persons
applying eartags to maintain appropriate records that permit traceback
of animals to the flock in which they originated), and in Sec.
79.6(a)(5) (regarding State responsibilities to do epidemiologic
investigations of source and infected flocks that include tracing
animals). The changes we proposed would ensure that better records are
available for tracing animals by adding requirements in new Sec.
54.8(b), ``Records for flocks under a flock plan or PEMMP,'' Sec.
79.2(f), ``Records required of persons who purchase, acquire, sell, or
dispose of animals,'' and Sec. 79.2(g), ``Records required of persons
who apply official identification to animals.''
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\1\ To view the proposed rule, supporting documents, and the
comments we received, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2007-0127.
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We also proposed to reduce some recordkeeping, primarily by
eliminating the requirement in many cases to read and record individual
identification that was applied before a new owner or shipper receives
the animal. Further, by making the regulations easier to understand we
hope to eliminate cases where owners and markets unnecessarily keep
records or apply unneeded identification, or fail to do so, when
required through lack of understanding. Also, in cases where genetic
testing allows us to determine that all exposed animals in a flock are
genetically resistant, use of genetic testing would allow some flocks
to avoid being placed under a flock plan or post-exposure management
and monitoring plan (PEMMP), thus avoiding the substantial
recordkeeping requirements of Sec. 54.8.
We solicited comments concerning our proposal for 60 days ending
November 9, 2015. We reopened and extended the deadline for comments
until December 9, 2015, in a document published in the Federal Register
on November 16, 2015 (80 FR 70718, Docket No. APHIS-2007-0127). We
received 59 comments by that date. The comments were from private
citizens, sheep and goat breeders, operators of livestock markets, a
foreign government, and industry associations. Two commenters supported
the rule as proposed. Four commenters were generally opposed to the
proposed rule but did not address any specific provisions. The
remaining commenters raised a number of concerns related to the
proposed rule and program standards. Those concerns are discussed
below.

Definitions

One commenter asked us to clarify the definition of exposed animal,
which appears in both Sec. Sec. 54.1 and 79.1. The commenter stated
that the phrase ``or in an enclosure off the premises of the flock'' is
particularly confusing.
We agree with the commenter and have amended the definition to
specify that an exposed animal is any animal or embryo that:
Has been in a flock with a scrapie-positive female animal;
Has been in an enclosure with a scrapie-positive female
animal at any location;
Resides in a noncompliant flock; or
Has resided on the premises of a flock before or while it
was designated an infected or source flock and before a flock plan was
completed.
One commenter recommended the definition of exposed animal be
revised to clarify that ``a date 2 years before the birth of the oldest
scrapie-positive animal(s)'' means ``a date 2 years before the birth of
the oldest scrapie-positive animal(s) born in that flock.'' We agree
and have made the requested change.
One commenter stated that the flock identification number could be
issued in a State database and then recorded in the National Scrapie
Database. The commenter recommended amending the definition of flock
identification number to reflect this.

[[Page 11171]]

We agree with the commenter and will amend the definition in Sec.
79.1 to read ``recorded in'' instead of ``issued through.''
One commenter stated that the definition of genetically less
susceptible exposed sheep was unclear. Specifically, the commenter
stated that currently most sheep are only genotyped at codon 171, so
starting the definition with the words ``An exposed sheep or sheep
embryo of genotype AA QR'' does not make sense. The commenter also
asked why AA was used in the definition since most sheep are only
genotyped at codon 171 and what ``where Q represents any genotype other
than R at codon 171'' means and what it relates to.
AA QR is used in the definition because exposed sheep that are
epidemiologically linked to a positive animal that has valine at codon
136 are tested at codon 136 and AV QR sheep may be treated differently
than AA QR sheep when this occurs. All positive sheep are tested at a
minimum for codon 171 and 136. The statement ``where Q represents any
genotype other than R at codon 171'' means that sheep that have H, K or
any other amino acid other than R will be treated the same as sheep
that are Q at codon 171.
We do agree that the definition could be more clearly written,
however, and are changing the definition in Sec. Sec. 54.1 and 79.1 to
define a genetically less susceptible exposed sheep as any sheep or
sheep embryo that is:
An exposed sheep or sheep embryo of genotype AA QR, unless
the Administrator determines that it is epidemiologically linked to a
scrapie-positive RR or AA QR sheep or to a scrapie type to which AA QR
sheep are not less susceptible; or
An exposed sheep or sheep embryo of genotype AV QR, unless
the Administrator determines that it is epidemiologically linked to a
scrapie-positive RR or QR sheep, to a flock that the Administrator has
determined may be affected by valine-associated scrapie (based on an
evaluation of the genotypes of the scrapie-positive animals linked to
the flock), or to another scrapie type to which AV QR sheep are not
less susceptible; or
An exposed sheep or sheep embryo of a genotype that has
been exposed to a scrapie type to which the Administrator has
determined that genotype is less susceptible. In this definition R
refers to codon 171 and A refers to codon 136, and Q represents any
genotype other than R at codon 171 and V represents any genotype other
than A at codon 136.
One commenter stated that the definition of genetically susceptible
animal was unclear and that the phrase ``or sheep or sheep embryo of
undetermined genotype where Q represents any genotype other than R at
codon 171'' does not make sense.
We agree that this can be more clearly written and are amending the
definition in Sec. Sec. 54.1 and 79.1 to read ``Genetically
susceptible animal. Any goat or goat embryo, sheep or sheep embryo of a
genotype other than RR or QR, where Q represents any genotype other
than R at codon 171 or a sheep or sheep embryo of undetermined
genotype.''
One commenter asked what is meant by ``under continuous
inspection'' in the definition for slaughter channels.
Continuous inspection means an inspector examines each animal
before slaughter (antemortem inspection) and the carcass and parts
after slaughter (postmortem inspection). For clarity we are amending
the definition to specify that official slaughter establishments are
under Food Safety and Inspection Service (FSIS) jurisdiction per the
Federal Meat Inspection Act or under State inspection that FSIS has
recognized as at least equal to Federal inspection or to a custom
exempt slaughter establishment as defined by FSIS (9 CFR 303.1) for
immediate slaughter, or to an individual for immediate slaughter for
personal use or to a terminal feedlot.
One commenter asked if a definition for tamper-resistant sampling
kit needed to be included in part 79 as well as part 54.
The term tamper-resistant sampling kit is used only in part 54.
Since it is not used in part 79, it does not need to be defined in that
part.
We have made minor changes to other definitions. Specifically, we
have amended the definition of destroyed in Sec. 54.1 to remove the
portion of the definition that allowed for animals to be moved to
quarantine facilities because we do not use the word in that sense in
the regulations. We note that Sec. 54.7(a)(3) provides for the
movement of scrapie-positive and suspect animals for which
indemnification is sought to an approved research facility.
We have amended the definition of flock identification (ID) number
in Sec. 79.1 to specify that APHIS may assign Tribal codes to any
federally recognized Tribe that maintains sheep or goats on Tribal
lands. We made this change to be consistent with the provisions of a
final rule published in the Federal Register on January 9, 2013 (78 FR
2040, Docket No. APHIS-2009-0091) that established official
identification and documentation requirements for the traceability of
livestock moving interstate.
We have amended the definition of genetically resistant sheep to
specify that the sheep or sheep embryo is of genotype RR at codon 171.
We made this change because we had not specified the codon in the
proposed rule. We have also amended the definition of official
identification device or method to refer to Sec. 79.2(a)(2), since
that is where the requirements for sheep and goat identification are
found.
We have also amended the definition of slaughter channels in Sec.
79.1 to remove provisions regarding the sale of animals in slaughter
channels. Those provisions now appear in Sec. 79.3(g). We have also
amended the definition of slaughter channels in Sec. 54.1 to be
consistent with the changes in Sec. 79.1.
In addition, we have made nonsubstantive editorial changes to the
definitions of high-risk animal and owner/hauler statement to improve
clarity.

Non-Classical Scrapie

One commenter recommended that any reference to genetic resistance
and susceptibility to scrapie, especially in the definitions, should
prominently specify that the relationship between genotype and scrapie
pertains to classical scrapie and not non-classical scrapie.
APHIS disagrees. While it is true that genetic susceptibility is
different for classical and non-classical scrapie, the current language
addresses this by including the words ``or to a scrapie type to which
the sheep are susceptible.'' Leaving the text as currently written
allows maximum flexibility in addressing all types of scrapie. We are
making no changes in response to this comment.
One commenter recommended continuing monitoring of animals exposed
to non-classical scrapie because non-classical scrapie has been shown
to be transmitted through oral inoculation and has a peripheral
distribution of infectivity despite the absence of the scrapie prion
protein.
APHIS agrees that continued monitoring of animals exposed to non-
classical scrapie is warranted. We intend to continue monitoring
animals exposed to non-classical scrapie by requiring that they be
officially identified with official identification devices or methods
assigned to the flock of origin in the National Scrapie Database.
Four commenters recommended that APHIS continue to require
identification of Nor98-like scrapie-exposed animals, and flockmates
and offspring of these

[[Page 11172]]

animals, for a period of 5 years after the positive animal left the
flock.
APHIS agrees that animals that are in Nor98-like scrapie infected
and source flocks and animals originating from these flocks should be
identified for a period of 5 years, and the flocks monitored through
reporting and testing of clinical suspects and mature animals that die.
We note that we have provided for this in the program standards in Part
VIII: Flock Cleanup Plans and PEMMPs, so there is no need to make
changes to the program standards in response to this comment.

Official Identification

Several commenters expressed concern that the rule would prohibit
the use of registry tattoos as official identification. This is not the
case. The rule, through the accompanying program standards, does allow
the use of registry tattoos as official identification when the sheep
or goat is legibly tattooed and accompanied by a copy of their
registration certificate in the name of the current owner or a copy of
a completed application for transfer of ownership dated within 60 days
of the change in ownership or when accompanied by an interstate
certificate of veterinary inspection that lists the flocks of origin
and birth, the registry, and the registry tattoo.
Two commenters asked that we confirm that registration/recordation
tattoos will continue to be allowed for animals in exhibition,
educational events, in registry sales, private treaty transfer, and
other movements not in slaughter channels or auction markets.
Yes, these animals may move with registry tattoos as currently
allowed. The only change is that the registry prefix must be recorded
in the premises record for the flock in the National Scrapie Database
and documentation of this must accompany the animal, or the registry
organization must be approved based on their ability and willingness to
assist APHIS in tracing animals during a disease investigation.
One commenter asked, that for tattoo prefixes containing letters
that are prohibited, that the prefix be linked in the National Scrapie
Database with the flock identification.
APHIS notes that this rule allows, and the program standards
encourage, the cross referencing of flock identification numbers with
registry prefixes. No change is being made in response to this comment.
Several commenters expressed concern about how the identification
requirements would apply to certain goat breeds. One commenter
expressed concern that tail tags would cause unnecessary medical issues
for small-eared or earless breeds of goats, such as La Mancha goats.
The rule states that the requirements for use of official
identification devices will be maintained on the APHIS website. These
requirements are posted on the website as part of the Scrapie Program
Standards. There are no approved tags for application to the tail, and
the application of an official eartag to any tissue other than the ear
is specifically prohibited in the Scrapie Program Standards. APHIS
provides for tail fold tattoos, Electronic Implantable Devices (EIDs),
and neck collars as acceptable means of identification for very small-
eared or earless goats.
One commenter expressed the concern that neck collars may pose a
strangulation risk.
APHIS notes that neck collars are commonly used for dairy goats. We
believe that, given this usage, the risk of strangulation is likely
minimal or neck collars would not be in general use. Further, because
the expectation of durability is the same as for eartags, using collars
that will break before causing strangulation is allowed and considered
desirable. Also, as we explain below, we are amending the program
standards to allow the use of back tags for earless animals moving
directly to slaughter as an alternative to using a neck collar.
One commenter requested that earless goats be exempted from the ID
requirements.
We recognize that using tail fold tattoos, EIDs, or neck collars
for earless goats may present some challenges for breeders; however,
using these devices will result in being able to trace a higher
percentage of the animals. Not using them will reduce the traceability
of these animals. We agree that allowing the use of back tags for
earless animals moving direct to slaughter is an acceptable option and
are amending the program standards to reflect this.
One commenter stated that eartags are too big for miniature goat
breeds and that tattoos should be allowed.
As we explained above, the use of registry tattoos and flock
identification tattoos as official identification will be allowed. We
also note that very small official eartags are available for use on
miniature breeds.
Some commenters stated that we should not require a specific ear to
be used for the eartag. One commenter recommended that the right ear
forward edge be used for metal tags. Several other commenters
recommended that APHIS standardize the placement of eartags in wool
sheep to the left ear half way between base and tip of ear and in the
middle between the ridges towards the lower edge. The commenters also
stated that metal tags should be avoided in wool or fiber animals to
minimize the risk of injury to shearers or damage to shearing
equipment.
The rule does not require that a specific ear be used for the
eartag. We agree that placement on the lower edge of the left ear is
preferred for wool or fiber animals and will provide this guidance in
the program standards. However, we will not make it a requirement
because it would be overly burdensome to producers given the minimal
improvement in traceability that would likely result.
One commenter asked that epidemiological evidence be independently
compiled by an entity such as the Occupational Safety and Health
Administration (OSHA) regarding the relative safety risk to shearers in
flocks using metal vs. plastic tags.
OSHA makes information about planned and accident-related
inspections, searchable by Standard Industrial Classification (SIC)
codes, available on its website. There are only 17 incidents reported
from all causes related to sheep and goat farms (SIC code 0214) in the
last 5 years.\2\ Given this small number of incidents, we do not
believe there is sufficient data provided to OSHA on shearing injuries
for a meaningful comparison. We will include a question on eartag-
related shearing problems in the next sheep National Animal Health
Monitoring System (NAHMS) study, which we anticipate doing in Fiscal
Year 2022. The prior NAHMS was conducted under OMB control number 0579-
0188.
---------------------------------------------------------------------------

\2\ https://www.osha.gov/pls/imis/industry.search?p_logger=1&sic=0214&naics=&State=All&officetype=All&Office=All&endmonth=01&endday=01&endyear=2011&startmonth=12&startday=31&startyear=2015&owner=&scope=&FedAgnCode=.
---------------------------------------------------------------------------

One commenter recommended use of a uniform tag color to assist
regulatory personnel to quickly and efficiently identify officially
tagged sheep and goats.
We agree that a uniform official tag color would be beneficial in
rapidly identifying official eartags. However, we also believe that
there is a significant benefit for producers to have access to multiple
tag colors for purposes of sorting their animals by age, sex, or other
characteristics, so we will continue to allow the use of various colors
of eartags. APHIS changed the color of metal tags provided by APHIS in
2018 to orange to make them more visible.

[[Page 11173]]

Two commenters asked that the program standards be revised to
require all sheep and goats at exhibitions be tagged, regardless of
whether they come from in or out of State, as an exhibition is a
concentration or commingling point.
For practical purposes, sexually intact sheep and goats of any age
and wethers 18 months of age and older that are exhibited are required
to be officially identified. There is an exclusion, which would rarely
apply, for animals that have never been in interstate commerce and that
have not resided on a premises where animals that have been in
interstate commerce have been received or from which animals are moved
in interstate commerce, where the animals being moved for exhibition
are not owned by a person who engages in the interstate commerce of
animals, that are moved to exhibitions that are conducted at premises
where the interstate commerce of animals does not occur, and where none
of the animals exhibited has been in interstate commerce. We believe
that this exclusion is required since if such an exhibit were to occur
it would fall within the State's authority. We are revising the Scrapie
Program Standards to clarify this.
One commenter opposed requiring identification for all sheep
because it would be costly not only to producers, but also to auction
markets and the veterinary personnel working at markets. Other
commenters also opposed requiring identification for goats because of
the additional costs.
We are aware that there are costs associated with the application
of official identification for both producers and markets. However, the
use of official identification is essential for the eradication of
scrapie. To achieve scrapie-free status, we must be able to trace
mature animals in order to conduct effective slaughter surveillance.
Eradication is the goal because achieving scrapie-free status in the
United States would significantly enhance trade opportunities and help
to stabilize prices for sheep and goats and their products. Since the
goal of the program is eradication and not just control of scrapie,
maintaining a low prevalence in goats is not an option.
Three commenters raised concerns regarding the safety of applying
eartags to range goats, particularly mature bucks that have horns. The
commenters stated that these goats are wild animals, and that applying
eartags to them presents a risk to both the animals and the people
applying the eartags.
We agree that certain goats may pose a hazard to those applying
eartags if appropriate equipment is not available to restrain the
animals. The provisions in Sec. 79.3(a)(2) allow these goats to move
in single source groups to slaughter without official individual
identification including through markets. This is one option for
handling these goats. We will also revise the program standards to
allow such goats to move direct to slaughter with official backtags as
less restraint is required to apply backtags. We are also amending
Sec. 79.3(k) to allow compliance agreements or market agreements to
include alternative methods for maintaining traceability or achieving
acceptable surveillance levels when the Administrator and the State
Animal Health Official agree that the application of an allowed
official identification device or method is unsuitable for a specific
circumstance. Further, we have amended the definition of group/lot
identification number (GIN) in Sec. 79.1 to provide that a group lot
comprised of animals from a single flock of origin may be subdivided
after leaving the premises on which the group lot was formed by adding
an S followed by a sequential number to the end of the GIN to create a
GIN for each sub group. This will provide additional flexibility in
handling unidentified animals moving to slaughter as a single source
lot.
Three commenters stated that veterinarians should be able to order
and use official scrapie tags for use in regulatory testing, interstate
certificates of veterinary inspection (ICVI), or any other reason
requiring official identification. The commenters also stated that
APHIS should maintain this traceability information in a user-friendly
database. The commenters also stated that county 4-H sheep and goat
offices should be assigned official scrapie tags.
In Sec. 79.2(b) of the proposed rule, we proposed to continue to
allow State Animal Health Officials and APHIS personnel responsible for
States to issue sets of unique serial numbers or flock identification/
production numbers for use on official individual identification
devices or methods (such as eartags or tattoos). In Sec. 79.2(b)(2),
we also proposed to continue to allow the official responsible for
issuing eartags in a State to assign serial numbers of official eartags
to other responsible persons, such as 4-H leaders, if the State Animal
Health Official and APHIS personnel responsible for the State involved
agree that such assignments will improve scrapie control and
eradication within the State. Distribution of tags is currently managed
in the scrapie program utility of the Animal Identification Management
System and in certain cases redistributed in the Surveillance
Collaboration Services Scrapie (SCS SCR) system. APHIS intends to
continue to work to improve the user experience with these systems.
One commenter sought clarification regarding whether the proposed
rule would require individual animal identification numbers to be read
more than once at approved livestock facilities.
This requires that eartags be read only when an ICVI is required
for movement of the animals from the market in cases where flock
identification tags were not used to identify the animals or the flock
identification of the animals is unknown and the tags must be read to
determine the flock of origin. If flock identification tags are
present, the flock identification may be listed instead of the
individual tag numbers. In the case of animals that arrive at a market
on an ICVI, when allowed by the States involved, the original document
may be attached to the new ICVI if the animal IDs of any animals not
included in the shipment are struck off the old ICVI.

Recordkeeping

Several commenters had concerns regarding the recordkeeping
associated with goat sales and our ability to trace goats based on
these requirements.
This rule makes the identification requirements for goats in
interstate commerce similar to those currently in place for sheep. The
requirements for sheep have been in place since 2002 and have resulted
in 82 percent of positive sheep being traced and a 98 percent decrease
in the prevalence of scrapie-positive adult sheep slaughtered adjusted
for face color.\3\ We are confident that these requirements will be
similarly successful with goats.
---------------------------------------------------------------------------

\3\ Historically, prevalence rates of scrapie varied by face
color and our prevalence estimate is appropriately weighted to match
the face color distribution within the U.S. sheep population.
---------------------------------------------------------------------------

Several commenters asked that APHIS provide templates with required
fields marked for owner/hauler statements and for any other required
information or data as in the case of entities that acquire or dispose
of animals.
We agree that such templates would be useful and will post
templates on the APHIS Scrapie Program website when they have been
approved.
Two commenters opposed the requirement to submit eartagging records
to APHIS. Several other commenters indicated that the requirement to
submit tagging records could be burdensome if not

[[Page 11174]]

implemented prudently following successful piloting, and that an option
should be provided for electronic storage of required documents in an
APHIS system rather than requiring the market to store the records
long-term. One commenter stated that the regulations should clearly
state that maintaining physical copies of these records at the market
for 5 years also meets this requirement.
We agree with the commenters and have amended Sec. 79.2(b)(3) to
indicate that submission is required only when requested by APHIS. This
will allow APHIS to work through issues that may negatively impact
stakeholders in small pilots and to implement the requirement through
the program standards when the process has been tested and the
technology allows for efficient compliance. APHIS will also consider
the feasibility of providing electronic document storage. With this
change maintaining physical copies of these records at the market for 5
years meets the requirement unless the records are requested.
Some commenters recommended using an owner/hauler statement and
lot/group identification for lots of sheep or goats moving directly to
slaughter without official ID.
APHIS notes that Sec. 79.3(a)(2) allows single source lots of cull
sheep or goats to move unidentified direct to slaughter using an owner/
hauler statement without official ID so no changes are being made in
response to this comment. We will amend the program standards to
improve clarity.
One commenter requested that we allow unidentified animals in
interstate commerce that do not cross State lines to move unidentified
to markets that are not approved markets.
APHIS notes that as currently written, the regulations allow
unidentified animals to move to unapproved in-State markets for sale,
provided that the markets tag the animals once they arrive. However, if
the person selling the animal through an unapproved in-State market
engages in the interstate commerce of animals, they must identify the
animals before loading them at their premises. In response to the
comment, we are amending Sec. 79.2(a)(1)(iv) to allow producers not
already allowed to move animals unidentified to unapproved in-State
markets under the regulations to do so if the animals' owner provides
tags assigned to his or her flock for the market to apply. As an
alternative, such markets may request approval under Sec. 71.20.
We are also amending Sec. 79.2(a)(1)(iv) to add ``or the owner of
the animal'' after ``the owner of the premises'' since it would be
inequitable to apply a different standard to people who rent as opposed
to own the premises on which their animals reside.
In Sec. 79.2(a)(1), we had proposed to remove paragraph (vi)
because the newly amended paragraph (iv) included animals moved across
a State line. However, from questions received during the comment
period it became apparent that the removal of this paragraph reduced
clarity. Therefore, we will not be removing paragraph (vi). We have
made nonsubstantive, editorial changes to the paragraph to update and
simplify its language.
One commenter indicated support for the opportunity for markets to
enter into agreements with USDA to receive unidentified animals that
cannot be traced to their flock of birth or origin if they place a
slaughter only tag on them and sell them through slaughter channels,
but did not support the reporting requirement for non-compliant
shipments. The commenter stated that this requirement asks markets to
act against the interests of their customers.
APHIS recognizes that this presents a conflict for markets. Markets
may either decline to handle non-compliant shipments or report such
shipments to USDA as part of a compliance agreement. No change is being
made in response to this comment.

Interstate Certificates of Veterinary Inspection

One commenter recommended that each copy of an ICVI be signed by
the issuing veterinarian.
We agree with the commenter and are amending Sec. 79.5(a)(4) to
specify that the ICVI must be signed by the issuing State, Federal,
Tribal or accredited veterinarian and the signature must be legible on
each copy of the ICVI.
One commenter asked us to clarify the flock identification
exception in Sec. 79.5(a)(2). The commenter specifically asked what
animals could move with flock identification that is assigned to the
flock of origin and to explain how ``flock of origin tags'' differ from
tags issued to flock owners with individual flock identification
numbers.
We amended that paragraph to refer to ``official identification
devices or methods that include the flock identification number
assigned to the flock of origin in the National Scrapie Database and an
individual animal number unique within the flock,'' to clarify the
requirements.
One commenter asked for clarification of the requirement to record
official genotype tests on an ICVI. Another commenter recommended
eliminating the requirement to record official genotyping tests on an
ICVI in Sec. 79.5(a)(3) as the value of doing so is small and would be
impractical to enforce.
We agree with the second commenter that recording official genotype
test information on the ICVI is not needed and have removed the
requirement.

Surveillance

One commenter stated that the proposed rule does not encourage
slaughter surveillance and expressed concern that focus on achieving
State sampling minimums will adversely impact slaughter surveillance
efforts.
We agree that sampling animals at slaughter is critical and needs
to be maintained. This work is currently being done almost entirely by
APHIS and its contractors. This final rule requires Consistent States
to assist APHIS in sampling in slaughter establishments that are under
State inspection or that do not engage in interstate commerce and to
meet sampling minimums for animals originating in their State. It is
critical to get adequate sampling from all areas of the United States
to minimize the risk that cases will go undetected. Further, should the
State sampling minimums adversely impact overall surveillance, APHIS
has the ability under the rule to reduce the minimums. For these
reasons no change is being made in response to the comment.
Three commenters stated that APHIS should help States ensure their
Consistent State status by promoting Regulatory Scrapie Slaughter
Surveillance (RSSS) for interstate testing, especially for those States
not able to do adequate surveillance testing. The commenters also
stated that APHIS should work with State officials to reach out to
producers and enlist producer support to alert producers when
surveillance levels are not meeting expected levels to retain
Consistent State status. The commenters further stated that APHIS or
State employees should actively select and test older goats in poor
condition for RSSS.
APHIS is committed to working with States to exceed State sampling
minimums, and we have prioritized RSSS collections. Goats in a thin or
wasted condition are among those targeted for collection.
One commenter recommended that the breed of exposed animals be
considered in deciding whether an animal is designated as a high-risk
animal.
There is insufficient evidence to demonstrate that any breed of
sheep or

[[Page 11175]]

goat is resistant to scrapie; therefore, no change is being made in
response to this comment.
One commenter expressed concern that when APHIS lists a breed as
having had a case of scrapie, the animal may not be purebred despite
being registered, and that this could have a negative impact on the
breed.
APHIS does rely on registry records to determine the breed of an
animal and this may result in animals with incorrect pedigrees being
considered purebred. The science is not sufficiently mature to reliably
and cost-effectively determine the breed of a sheep based on genotype.
We note, however, that the breed of a sheep does not affect the
regulatory requirements in any way.
One commenter recommended excluding rare breeds that have been
historically free of scrapie from being considered high-risk if they
are scrapie exposed. The commenter referenced the work of H.B. Parry
\4\ in support of this recommendation.
---------------------------------------------------------------------------

\4\ ``Elimination of natural scrapie in sheep by sire genotype
selection,'' Nature 277 (1979): 127-129, and Scrapie Disease in
Sheep (London: Academic Press, 1983).
---------------------------------------------------------------------------

APHIS notes that rare breeds are by definition few in number.
Therefore, they would not be frequently tested for scrapie and would
appear to be ``historically free'' as a result; however, this
appearance could be misleading because of the small sample size.
Parry's work did not include the genotypes of the sheep involved
and it is unclear if his observations were a widespread breed trait
separate from the genotype at codons 171 and 136 or the result of the
genotype at these codons. Further, Parry's work was done in the United
Kingdom where the predominant scrapie type is valine dependent, strains
to which AA QQ sheep are resistant. As a result, his work may not be
relevant to the United States where the predominant scrapie type is
valine independent, strains to which AA QQ sheep are susceptible. As
the commenter noted, three breeds considered resistant by Parry have
contracted scrapie in the United States. We are making no change in
response to this comment as there is adequate flexibility through the
pilot project provision and the low-risk exposed animal definition to
allow such sheep to be exempted if there is sufficient scientific
evidence available to warrant an exemption.
One commenter raised the concern that selecting for genes
associated with resistance may be adversely impacting the sheep
industry and may be encouraging crossbreeding to add resistance genes
to breeds in which they are rare.
Several scientific articles have indicated that there is little, if
any, difference in production traits between QQ, QR and RR sheep.\5\
One article indicated that there is an association between QQ at codon
171 and the ability to mobilize fat reserves in Scottish Blackface
sheep.\6\ Another study showed that within one flock there was a higher
litter size in QQ Suffolks than in QR or RR Suffolks but no difference
in pounds of lamb weaned.\7\ In the same study, no difference was shown
for Columbia, Hampshire, Rambouillet, or western white face sheep.
Also, a study showed that as in selecting for any trait, selecting for
scrapie resistance may delay progress on other traits, particularly in
breeds where R at codon 171 is rare.\8\ APHIS only requires genetic
selection in exposed flocks and other higher risk flocks as part of
PEMMPs. Further, breeders wishing to retain Q genes can do so with
little impact on genetic resistance to scrapie by breeding RR ewes to
QR rams and QR ewes to RR rams. Regarding unacknowledged cross
breeding, this has occurred on other occasions when a breed is believed
to be lacking a desirable trait and will occur anytime there are
unscrupulous breeders and a financial incentive. We are not making any
changes to the regulations based on this comment.
---------------------------------------------------------------------------

\5\ ``Evaluation of associations between prion haplotypes and
growth, carcass, and meat quality traits in a Dorset x Romanov sheep
population'', Journal of Animal Science 84 (2013): 783-788;
``Influence of Prion Protein Genotypes on Milk Production Traits in
Spanish Churra Sheep'', Journal of Dairy Science 89 (2006): 1784-
1791; ``Investigation of farmer regard for scrapie-susceptible
sheep'', The Veterinary Record 158 (2006): 732-734; ``Associations
between genotypes at codon 171 and 136 of the prion protein gene and
production traits in market lambs'', American Journal of Veterinary
Research 68 (2007): 1073-1078; ``Is there a relationship between
prion protein genotype and ovulation rate and litter size in
sheep?'', Animal Reproduction Science 101(2007): 153-157; ``Analysis
of prion protein genotypes in relation to reproduction traits in
local and cosmopolitan German sheep breeds'', Animal Reproduction
Science 103 (2008): 69-77; ``Scrapie resistance and production
traits in Rambouillet rams: Ram performance test 2002-2006'',
Research in Veterinary Science 85 (2008): 345-348; and
``Characterization of the PRNP gene locus in Chios dairy sheep and
its association with milk production and reproduction traits'',
Animal Genetics 42 (2011): 406-414.
\6\ ``Association of the prion protein gene with individual
tissue weights in Scottish Blackface sheep'', Journal of Animal
Science 86 (2008): 1737-1746.
\7\ ``The incidence of genotypes at codon 171 of the prion
protein gene (PRNP) in five breeds of sheep and production traits of
ewes associated with those genotypes'' Journal of Animal Science 83
(2005): 455-459.
\8\ ``Predicting the consequences of selecting on PrP genotypes
on PrP frequencies, performance and inbreeding in commercial meat
sheep populations'', Genet. Sel. Evol. 39 (2007): 711-729.
---------------------------------------------------------------------------

The commenter stated that, in the case of 400 dairy sheep seized
and euthanized in 2000-2001, none tested positive for scrapie. The
commenter therefore requested that we provide the history, by year, of
the number of positives, breed and percentage of individuals of
infected/source flocks that were positive after laboratory testing.
APHIS notes that in the case of the dairy sheep, the disease of
concern was not scrapie but BSE. The information requested by the
commenter is provided in the charts in the document titled ``Scrapie
Case Information By Breed, Face Color or Type and or Sampling Stream FY
1999 to 2015'' that accompanies this final rule. Copies of the document
are available on the Regulations.gov website (see footnote 1 in this
document for a link to Regulations.gov) or by contacting the person
listed under FOR FURTHER INFORMATION CONTACT.
One commenter agreed with genetic testing to determine risk level
and also that AA QR (GLS) & AA RR (GR) should be exempt from
destruction and noted that Canada does not exempt AV QR. The commenter
stated that male animals are lower risk for transmitting scrapie but
are at equal risk of becoming infected and noted that the World
Organization for Animal Health does not differentiate male and female
animals in their guidelines.
No changes are being made in response to this comment. We believe
that there is sufficient flexibility in the definitions for high-risk
animals, the genetically susceptible exposed animals, and low risk
exposed animals for the Administrator to address any issues that may
arise with exposed male animals and exposed AV QR sheep.
One commenter stated that for rare breeds APHIS should consider KK
at codon 171 the same as QR for determining scrapie susceptibility.
Unpublished work by USDA Agricultural Research Service has shown
that KK171 Barbado sheep are susceptible to scrapie by intracerebral
inoculation. A complimentary study using an oronasal route showed that
at 70 months post inoculation and at 5 years post inoculation there was
no evidence of scrapie in these KK171 sheep. This indicates that KK171
sheep are likely less susceptible to classical scrapie. This rule will
give the Administrator the flexibility to address KK171 sheep and any
other genotypes in sheep or goats that may prove to be less susceptible
or resistant to classical

[[Page 11176]]

scrapie through the low-risk animal definition, the genetically less-
susceptible animal definition, or through a pilot project once there is
sufficient scientific evidence to support such action.
In Sec. 79.4, paragraph (c) provides for testing of scrapie-
positive animals, high-risk animals, exposed animals, suspect animals,
exposed flocks, infected flocks, noncompliant flocks, and source
flocks, and paragraph (c)(1) provides for actions that may be taken if
a flock owner fails to make animals available for testing. One
commenter stated that in Sec. 79.4(c)(1) the statement ``or as
mutually agreed'' was unclear.
We agree that this statement could be clearer. We are changing ``or
as mutually agreed'' to ``or as mutually agreed in writing by the
Administrator and the owner,'' to clarify the conditions under which an
owner could be considered in violation.

Markets and Tagging

Seven commenters supported allowing markets to continue to apply
white serial tags issued to them to potential breeding sheep and goats.
Six commenters stated that markets should be limited to applying only
owner-provided official eartags or blue slaughter-only serial eartags
provided by the markets in order to reduce the number of untraceable
animals. One commenter opposed these suggestions to limit tagging by
markets to slaughter-only tags. That commenter was concerned that
markets would have regulatory action taken against them if a blue
tagged animal went back to the farm despite being sold for slaughter
only. The commenter stated that many smaller-scale sheep and goat
producers have limited marketing opportunities and often rely on
livestock markets to sell their animals. The commenter stated further
that for some of these markets, the profit margin is so small they
offer this more as a public service than a business opportunity. Any
additional burden on these markets may result in them no longer
accepting sheep and goats. The commenter stated that as long as
required records are utilized it should be left up to the individual
markets whether they will accept unidentified animals, whether they
will apply owner-supplied identification, or whether they choose to
apply serial or slaughter-only eartags.
The same commenter supported continuing to allow livestock markets
to receive official tags directly from animal health officials and
apply these tags to sheep and goats coming into the market untagged.
APHIS believes that while on-farm tagging is ideal, there is a
certain percentage of producers who will not choose to do this, whether
their reasoning be based on difficulty of tagging, privacy, or other
reasons. The model in this rule addresses this concern by allowing
these animals to be identified by the market and for records to be kept
regarding their movement. Additionally, this model provides a
reasonable expectation that the movements will be able to be tracked
because the option only applies to sheep and goats direct from a farm.
Commingled lots would already have to be identified prior to arriving
at the market as is called for in Sec. 79.2(a)(1)(i). In response to
these comments we are amending the regulations to allow the State
Animal Health Official or the Administrator to limit the assignment of
official identification devices or numbers to persons or classes of
persons for use on animals that did not originate in a breeding flock
owned by them to slaughter-only devices or numbers. This will give the
States flexibility to improve traceability, and also give the
Administrator the ability to establish a nationwide policy on official
eartag distribution should such State programs prove to be successful
in increasing traceability.
One commenter expressed concern that some owners and haulers will
not abide by the requirement for owner/hauler statements and asked how
animals received without an owner/hauler statement should be handled by
markets.
Since either an owner or a hauler may complete the statement, the
owner or hauler could complete the owner/hauler statement once they
arrive at the market. At markets where owners or haulers do not have
the required information to complete the statement, the market may
either refuse such animals or the market may enter into a compliance
agreement as described in Sec. 79.3(k). To clarify the requirements,
we have amended Sec. 79.3(k) as follows: ``APHIS may enter into
compliance agreements with persons such as dealers and owners of
slaughter establishments and markets whereby animals may be received
unidentified or without a required owner/hauler statement even if they
cannot be identified to their flock of birth or origin because they
were moved or commingled while unidentified, in violation of this part
or a State requirement as provided by Sec. 79.6.''
One commenter requested that APHIS allow use of other documents
that contain the information required on the owner/hauler statement.
The current definition of an owner/hauler statement allows for the
use of other documents if they contain the same information as the
owner/hauler statement. However, we have amended the definition to
clarify that this is intended.
One commenter asked that the animals which would qualify to move
for purposes other than slaughter be allowed to be tagged after sale,
so that only those animals that are moving for purposes other than
slaughter at under 18 months of age would need to be eartagged.
In response to this comment, we are amending Sec. Sec.
79.2(a)(1)(ii) and 79.3(a)(5) to permit approved markets that have the
ability to maintain the identity of single source lots through the sale
process to tag such animals after sale.

Movement, Premises ID, Group Lot Number

Several commenters requested clarification of the requirement to
provide additional premises of a flock before unidentified animals were
moved between those premises. In response we are adding the following
clarification to Sec. 79.3(a)(4): ``A request to APHIS to enter
additional flock premises in the National Scrapie Database is required
before animals are first moved to the premises. Notification is not
required for each subsequent movement of animals to that premises.
Neither group lot ID nor an owner/hauler statement is required for
movements of a flock or its members for flock management purposes
within a contiguous premises spanning two or more States. This
provision does not include the transiting or sale of animals through
such a premises in circumvention of the other requirements of this
part.''
Several commenters requested additional clarification on how group/
lot IDs may be used.
Group/lots IDs are used to (1) associate a unique number with
movements of single source lots direct to slaughter or to a market to
simplify identifying relevant records during a disease investigation,
(2) to be able to easily differentiate groups of animals moved for
management purposes such as grazing, and (3) to be able to quickly
identify the sources of animals in multi-source lots such as slaughter
lambs to assist in tracing exposed animals out of infected and source
flocks to slaughter.
One commenter asked for clarification of the requirements in Sec.
79.3(a). The commenter stated that the relationship between paragraph
(a) and how that relates to animals over 18 months of age in slaughter
channels was confusing. For example, the statement in (a) says

[[Page 11177]]

that the animals in (1) through (5) may move with an owner/hauler
statement and group lot ID, but then in (3) it refers to animals that
have individual identification. The commenter asked if these
requirements could be reworded.
We agree that this can be worded more clearly and have revised
Sec. 79.3(a)(3) to clarify that an owner/hauler statement may be used
instead of an ICVI for such animals.

Indemnity

Four commenters noted that most American ewe lambs can be managed
in a way that they can conceive at a young enough age to lamb as
yearlings. The commenters believe that indemnifying for ewes that are
verified as pregnant, regardless of their age, satisfies the general
intention of age and reproduction status of the animals and that would
apply to ewe lambs under 12 months of age. The commenters further
stated that the proposed categorization of early maturing ewe lambs as
yearlings could lead to disputes and mistakes with indemnity payments.
The commenters therefore recommended removing the indemnity provision
for early-maturing ewes and suggested indemnifying them based on their
pregnancy status instead.
We agree with the commenters and have revised the program standards
to reflect this by allowing animals under 12 months of age to be
classified as yearlings only if they are visibly pregnant or have an
offspring and not based on owner records indicating that the flock has
a history of lambing or kidding at an early age. No changes to the
regulations are necessary.
While preparing this final rule, we noted that there was
substantial overlap between the provisions regarding indemnity in
Sec. Sec. 54.3(b) and 54.6(d). To improve clarity, we have
consolidated the provisions in Sec. 54.3(b) and have removed Sec.
54.6(d). We have also moved the provision allowing for the
Administrator to waive the requirement for a flock plan or PEMMP from
Sec. Sec. 54.8(j)(3) to 54.8(l).

Paperwork

One commenter was concerned about the paperwork burden associated
with the proposed rule. The commenter also expressed concern that the
rule would require markets to provide seller information to all buyers.
The rule does increase the paperwork burden associated with
maintaining tagging records, but we believe that maintaining these
records for additional classes of goats and animals in slaughter
channels is necessary to increase traceability of goats and sheep,
which in turn is critical for eradicating scrapie. The rule does not
require markets to provide seller information to buyers in most cases;
the exception is that markets must provide the group lot numbers when
the animals are moving unidentified as part of a single source lot in
slaughter channels.

Program Standards

One commenter noted that there are references to the Scrapie
SharePoint site throughout the program standards document. The
commenter noted that State officials cannot currently access
information on this site so another resource needs to be readily
available and should replace all references to the Scrapie SharePoint
site.
A SharePoint site accessible to State employees is now available.
One commenter noted that there are many references throughout the
document to PEMMPs, particularly in Part VII and VIII and the
flowcharts. The commenter stated that sometimes the term ``full PEMMP''
is used, sometimes the term ``basic PEMMP'' is used, and sometimes it
is not specified. The commenter asked that APHIS clearly spell out what
the requirements are for each type of PEMMP, which type is required for
each situation, and be consistent with terminology.
We have replaced the term ``full PEMMP'' with ``retained
susceptible animal PEMMP'' throughout the program standards.
One commenter stated that some of the program standards definitions
are slightly different from those in the rule.
Some of the definitions were not updated in the program standards
and this has been corrected. Other definitions are slightly different
because they need to reference the Code of Federal Regulations, and in
some cases they include more specific information to assist the reader.
Information that is subject to frequent change, such as the components
currently included in the National Scrapie Database, was not put into
the regulations.
One commenter asked what the purpose of entering low-risk exposed
animals into the National Scrapie Database is.
The purpose of putting low-risk exposed animals in the database is
to be able to search against the database if they should later be
determined to be infected so that we can understand whether the
criteria for redesignating animals as low-risk are effective and to be
able to search against these animals when required for an export
certificate or ICVI.
One commenter recommended not using Emergency Management and
Response System (EMRS) for scrapie tracing.
We disagree. EMRS allows a higher degree of accountability for
completing scrapie trace investigations and the number of trace outs is
currently low enough that use of this system should not be overly
burdensome.
One commenter asked what ``when an insufficient number of QQ sheep
and goats are available . . .'' in the introduction to the Part VII:
Epidemiology A section of the program standards meant.
We agree that this can be worded more clearly and are revising the
Scrapie Program Standards to read ``When the number of QQ sheep and
goats in the flock is insufficient to conduct a reliable flock test, or
. . .''
One commenter indicated that, in the Part VII: Epidemiology B
section, the review provision in the note contradicted the table in
that it indicates the Sheep and Goat Health Specialist for Epidemiology
(SGHSE) must concur with decisions made by the designated scrapie
epidemiologist.
The commenter is correct. We have corrected the table to list those
situations when the SGHSE must approve the designation or re-
designation and deleted the note.
One commenter stated that Part VII: Epidemiology F. Procedures for
Investigation and Monitoring a Flock that Received a High-Risk Animal
was hard to follow and should be revised for clarity.
We agree that there was room for improvement and have made edits
for clarity.
One commenter stated that the term ``status'' had not been updated
in places to conform with the change to SCS SCR.
We agree and have corrected the terminology to reflect the new
nomenclature, which resulted from the migration of the Scrapie Program
data from the Scrapie National Generic Database (SNGD) to SCS SCR,
throughout the document. What was termed ``status'' in the SNGD is
called a ``program'' or a ``restriction'' in SCS SCR.
One commenter recommended moving Part VIII: Flock Cleanup Plans and
PEMMPs B.3(a)(12), Steps for completing a standard genetic based flock
plan for source and infected flocks that retain only AR, HR, KR, and RR
ewes and male sheep and male goats, to Part VII: Epidemiology, E.
B.3(b)(4) because that section seems procedural and would fit better in
Part VII.
We agree that this section could reasonably be moved to Part VII;
however, we do not believe that it results in an improvement, so no
change

[[Page 11178]]

is being made in response to this comment.
One commenter requested that we provide VS Form 5-19c as an
appendix to the program standards. The commenter also requested that we
allow a State equivalent form.
We did not add the form as an appendix to the document to minimize
the need to update the standards whenever a form is revised. The form
has been approved under OMB control number 0579-0101 and will be
available on the APHIS website. We agree that State equivalent forms
may also be used and have updated the program standards accordingly.
One commenter asked APHIS to work with new and emerging registries
to assure that their tattoo and radio frequency identification device
implant systems are unique within the registry, retrievable, traceable,
and that the registry rules allow for release of information to APHIS
for regulatory disease purposes before these registry ID systems are
accepted for the National Scrapie Eradication Plan.
APHIS intends to work with any new and emerging registries to
ensure that their systems meet these requirements. We have also updated
Part III: Identification Requirements A(3)(b)(2)(a) of the program
standards to clarify the requirements for registry identification
devices and methods.

Miscellaneous

While preparing this final rule, APHIS noted that we had used the
phrase ``premises that engages in interstate commerce'' in several
places in Sec. Sec. 79.2 and 79.3. Since a premises cannot engage in
an action, we have replaced that phrase with ``premises where animals
are received that have been in interstate commerce or from which
animals are moved in interstate commerce.''
We have made nonsubstantive editorial changes to several sections
to improve clarity. For the same reason we have divided Sec.
54.8(j)(3) into two paragraphs. The provisions that appeared in that
paragraph now appear in paragraphs (j)(3) and (l).
We have moved paragraph (3) of the definition of Consistent State
in Sec. 79.1 to a new paragraph (c) in Sec. 79.6 because the
provisions in that paragraph are more appropriately placed in that
section.
One commenter recommended changing the name of the Scrapie Free
Flock Certification Program to the Scrapie Certification Program to be
consistent with the names of other disease certification programs.
We believe that changing the name of the program would be confusing
and are making no changes in response to this comment.
Three commenters stated that they appreciate APHIS' outreach
efforts to producers, and that APHIS should increase access to
educational resources for goat producers and veterinarians. The
commenters stated that additional goat-specific resources would help to
achieve best participation in the voluntary program and compliance with
the regulations. The commenters further stated that APHIS should
encourage on-farm submissions for scrapie surveillance and adequate
records by producers for possible traceback.
APHIS agrees that goat-specific resources should be valuable and is
working with the American Goat Federation to improve our education
efforts directed to goat producers.

Comments Outside the Scope of the Rulemaking

One commenter expressed concern that scrapie poses a human health
risk and stated that scrapie should be regulated in the same way as
BSE. The commenter also stated that U.S. regulations governing BSE are
too lax.
There is no epidemiologic evidence that scrapie of sheep and goats
is transmitted to humans, such as through consumption, contact on the
farm, at slaughter plants, or butcher shops. The regulations for
control of scrapie and BSE are generally consistent with international
guidelines. BSE is a separate disease from scrapie and can be
distinguished using laboratory tests or mouse inoculation.
Some commenters made recommendations for changes to Scrapie Flock
Certification Plan standards. We did not propose to make changes to
those standards in this action; however they were taken into
consideration when working on the revision of those standards.
Some commenters stated that APHIS should encourage future goat and
sheep research and continue to collaborate with the Agricultural
Research Service (ARS) to research scrapie diagnostic tests in live
goats and scrapie control methods specific to goats. The commenters
also stated that ARS should continue to research genetic resistance and
susceptibility in goats and the pathogenesis and transmission of
scrapie in goats and sheep.
We agree that these are important fields for research and have
communicated these priorities to ARS.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, with the
changes discussed in this document.

Executive Orders 12866, 13563, 13771, and Regulatory Flexibility Act

This final rule has been determined to be significant for the
purposes of Executive Order 12866 and, therefore, has been reviewed by
the Office of Management and Budget. This final rule is considered an
Executive Order 13771 deregulatory action. Details on the estimated
cost savings of this final rule can be found in the rule's economic
analysis.
We have prepared an economic analysis for this rule. The economic
analysis provides a cost-benefit analysis, as required by Executive
Orders 12866 and 13563, which direct agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, and equity). Executive Order 13563 emphasizes the importance
of quantifying both costs and benefits, of reducing costs, of
harmonizing rules, and of promoting flexibility. The economic analysis
also provides a final regulatory flexibility analysis that examines the
potential economic effects of this rule on small entities, as required
by the Regulatory Flexibility Act. The economic analysis is summarized
below. Copies of the full analysis are available on the Regulations.gov
website (see footnote 1 in this document for a link to Regulations.gov)
or by contacting the person listed under FOR FURTHER INFORMATION
CONTACT.
APHIS is amending the scrapie regulations to relieve certain
restrictions associated with the interstate movement of sheep and
goats, reduce the number of exposed sheep and goats that are destroyed,
and improve overall program effectiveness. More specifically, genetic
testing will be used to identify genetically resistant or less
susceptible sheep for exemption from destruction and as qualifying for
interstate movement; designated scrapie epidemiologists will be given
greater flexibility in determining the testing needs of flocks; the
indemnity regulations will be changed to apply only to those animals
that are found to be genetically susceptible to scrapie; official
identification of goats produced for meat or fiber or that are
slaughtered at over 18 months of age will be required; submission of
tagging records by individuals who tag sheep or goats that do not
originate on their premises will be required when requested; and

[[Page 11179]]

certain recordkeeping requirements will be reduced, changed, or
removed.
The primary benefits of this rule for producers and the public will
be more rapid progress toward scrapie eradication and the related boost
to the Nation's animal health status, decreased losses for producers,
and increased export opportunities for sheep and goats and their
products. Most segments and marketing channels of the sheep and goat
industries will benefit from being able to operate under the new
requirements and by the eradication of scrapie. By enhancing
traceability, the rule will shorten the time and reduce the cost of
eradication.
Producers of goats for meat or fiber and slaughter goats over 18
months of age will incur costs of official identification as a result
of the rule. However, we note that close to one-half of goat farms
(that is, all dairy and breeding goat farms except low-risk commercial
operations) are already required to be in compliance with the
identification requirements under current regulations.
The rule will affect sheep and goat producers, marketers and
dealers, most of which are small entities. As noted in the regulatory
impact analysis, individuals may spend about 2 hours a year on
recordkeeping, at a time cost of about $34.50, but in fact many of
these records of sales and purchases are typically already kept as a
normal business practice. Based on 2012 Census of Agriculture data,
this cost if incurred would equal about 1.5 percent of average revenue
for meat goat producers. We expect these entities to find the rule's
official identification requirements and other conditions well worth
the cost. This rule will not pose a large cost burden for entities,
large or small.
Eradication of scrapie will enable APHIS to negotiate removal of
the varying current restrictions and allow an expansion of exports.
Based on cited simulation modeling of the economic benefits of
eradication of scrapie and certain other animal diseases, gains from
trade are expected to exceed the recordkeeping, tagging, and other
costs that producers and other entities will incur.
The trade gains realized can be interpreted as cost savings from no
longer being subject to certain import restrictions imposed by other
countries. Based on measures of increased welfare due to expanded
exports, and in accordance with guidance on complying with Executive
Order 13771, the primary estimate of the rule's annual cost savings is
$115,000, the mid-point estimate annualized in perpetuity using a 7
percent discount rate.

Executive Order 12372

This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 2 CFR Chapter IV.)

Executive Order 12988

This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This rule: (1) Preempts all State and local laws
and regulations that are in conflict with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.

Executive Order 13175

This rule has been reviewed in accordance with the requirements of
Executive Order 13175 ``Consultation and Coordination with Indian
Tribal Governments.'' Executive 13175 requires Federal agencies to
consult and coordinate with tribes on a government-to-government basis
on policies that have Tribal implications, including regulations,
legislative comments or proposed legislation, and other policy
statements or actions that have substantial direct effects on one or
more Indian Tribes, on the relationship between the Federal Government
and Indian Tribes or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes.
APHIS has assessed the impact of this rule on Indian Tribes and
determined that this rule does not, to our knowledge, have tribal
implications that require Tribal consultation under Executive Order
13175. If a tribe requests consultation, APHIS will work with the USDA
Office of Tribal Relations to ensure meaningful consultation is
provided where changes, additions, and modifications identified herein
are not expressly mandated by Congress.

Paperwork Reduction Act

In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), some of the information collection
requirements included in this final rule are approved under Office of
Management and Budget (OMB) control number 0579-0101. The new
information collection requirements included in this final rule, which
were filed with comment under OMB control number 0579-0469, have been
submitted for approval to OMB. When OMB notifies us of its decision, if
approval is denied, we will publish a document in the Federal Register
providing notice of what action(s) we plan to take.

E-Government Act Compliance

The Animal and Plant Health Inspection Service is committed to
compliance with the E-Government Act to promote the use of the internet
and other information technologies, to provide increased opportunities
for citizen access to Government information and services, and for
other purposes. For information pertinent to E-Government Act
compliance related to this rule, please contact Ms. Kimberly Hardy,
APHIS' Information Collection Coordinator, at (301) 851-2483.

List of Subjects

9 CFR Part 54

Animal diseases, Goats, Indemnity payments, Scrapie, Sheep.

9 CFR Part 79

Animal diseases, Quarantine, Sheep, Transportation.

Accordingly, we are amending 9 CFR parts 54 and 79 as follows:

PART 54--CONTROL OF SCRAPIE

0
1. The authority citation for part 54 continues to read as follows:

Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

0
2. Section 54.1 is amended as follows:
0
a. By removing the definition for Approved test;
0
b. In the definition for Breed association and registries, by removing
the words ``listed in Sec. 151.9 of this chapter'';
0
c. By removing the definition for Certificate;
0
d. By adding in alphabetical order a definition for Classification or
reclassification investigation;
0
e. In the heading of the definition for Designated scrapie
epidemiologist, by adding the acronym ``DSE'' immediately after
``epidemiologist'';
0
f. By revising the definitions for Destroyed, Exposed animal, and
Exposed flock;
0
g. In the definition for Flock, paragraph (2)(v), by adding the word
``Free'' between the words ``Scrapie'' and ``Flock'';
0
h. In the definition for Flock plan, by removing the paragraph
designation ``(f)'' and by adding the paragraph designation ``(j)'' in
its place;
0
i. By revising the definition for Flock sire;
0
j. By adding in alphabetical order definitions for Flock under

[[Page 11180]]

investigation, Genetically less susceptible exposed sheep, Genetically
resistant exposed sheep, Genetically resistant sheep, Genetically
susceptible animal, and Genetically susceptible exposed animal;
0
k. By revising the definition for High-risk animal;
0
l. By adding in alphabetical order a definition for Interstate
certificate of veterinary inspection (ICVI);
0
m. In the definition for Limited contacts, by adding the word ``Free''
between the words ``Scrapie'' and ``Flock'' in the last sentence;
0
n. By adding in alphabetical order a definition for Low-risk exposed
animal;
0
o. In the definition for National Scrapie Database, by adding the word
``Free'' between the words ``Scrapie'' and ``Flock''; and
0
p. By amending the definition for Noncompliant flock as follows:
0
i. In paragraph (1), by removing the words ``source or infected flock''
and adding the words ``source, infected, or exposed flock or flock
under investigation'' in their place;
0
ii. In paragraph (2), by adding the words ``or flock under
investigation'' immediately after the words ``exposed flock''; and
0
iii. In paragraph (3), by removing the words ``owner statement'' and
adding the words ``owner/hauler statement'' in their place.
0
q. By revising the definition for Official genotype test;
0
r. By adding in alphabetical order definitions for Program approved
test and Restricted animal sale or restricted livestock facility;
0
s. In the heading of the definition for Scrapie Flock Certification
Program (SFCP), by adding the word ``Free'' immediately after the word
``Scrapie'';
0
t. In the heading of the definition for Scrapie Flock Certification
Program standards, by adding the word ``Free'' immediately after the
word ``Scrapie'' and, in footnote 2, by removing the internet address
``https://www.aphis.usda.gov/vs/scrapie'' and adding the internet
address ``https://www.aphis.usda.gov/animal-health/scrapie'' in its
place;
0
u. In the definition for Scrapie-positive animal, in paragraph (2), by
adding the words ``, and/or ELISA,'' immediately after the word
``immunohistochemistry'' and, in paragraph (5), by removing the words
``test method'' and adding the words ``method or combination of
methods'' in their place;
0
v. By removing the definition for Separate contemporary lambing group;
0
w. By revising the definition for Slaughter channels;
0
x. By revising paragraph (1) in the definition of Suspect animal; and
0
y. By adding in alphabetical order definitions for Tamper-resistant
sampling kit and Terminal feedlot.
The additions and revisions read as follows:

Sec. 54.1 Definitions.

* * * * *
Classification or reclassification investigation. An
epidemiological investigation conducted or directed by a DSE for the
purpose of designating or redesignating the status (e.g., scrapie-
positive, exposed, high-risk, suspect, infected, noncompliant, source,
etc.) of a flock or animal. In conducting such an investigation, the
DSE will evaluate the available records for flocks and individual
animals and conduct or direct any testing needed to assess the status
of a flock or animal. The status of an animal or flock will be
determined based on the applicable definitions in this section and,
when needed to make a designation under Sec. 79.4 of this chapter,
official genotype test results, exposure risk, scrapie type involved,
results of official scrapie testing on live or dead animals, or any
combination of these.
* * * * *
Destroyed. Euthanized and the carcass disposed of by means
authorized by the Administrator that will prevent its use as feed or
food.
* * * * *
Exposed animal. Any animal or embryo that:
(1) Has been in a flock with a scrapie-positive female animal;
(2) Has been in an enclosure with a scrapie-positive female animal
at any location;
(3) Resides in a noncompliant flock; or
(4) Has resided on the premises of a flock before or while it was
designated by a DSE an infected or source flock and before a flock plan
was completed. An animal shall not be designated an exposed animal if
it only resided on the premises before the date that infection was most
likely introduced to the premises as determined by a Federal or State
representative. If the probable date of infection cannot be determined
based on the epidemiologic investigation, a date 2 years before the
birth of the oldest scrapie-positive animal born in that flock will be
used. If the actual birth date is unknown, the date of birth will be
estimated based on examination of the teeth and any available records.
If an age estimate cannot be made, the animal will be assumed to have
been 48 months of age on the date samples were collected for scrapie
diagnosis. Exposed animals will be further designated as genetically
resistant exposed sheep, genetically less susceptible exposed sheep,
genetically susceptible exposed animals, or low-risk exposed animals.
An animal will no longer be an exposed animal if it is redesignated in
accordance with Sec. 79.4 of this chapter.
Exposed flock. (1) Any flock that was designated by a DSE as an
infected or source flock that has completed a flock plan, and that
retained a female genetically susceptible exposed animal;
(2) Any flock under investigation that retains a female genetically
susceptible exposed animal or a suspect animal, or whose owner declines
to complete genotyping and live-animal and/or post-mortem scrapie
testing required by the APHIS or State representative investigating the
flock; or
(3) Any noncompliant flock or any flock for which a PEMMP is
required that is not in compliance with the conditions of the PEMMP.
* * * * *
Flock sire. A sexually intact male animal that has produced
offspring in the preceding 12 months or that was used for breeding
during the current breeding cycle.
Flock under investigation. Any flock in which an APHIS or State
representative has determined that a scrapie-suspect animal, high-risk
animal, or scrapie-positive animal resides or may have resided.
Genetically less susceptible exposed sheep. Any sheep or sheep
embryo that is:
(1) An exposed sheep or sheep embryo of genotype AA QR, unless the
Administrator determines that it is epidemiologically linked to a
scrapie-positive RR or AA QR sheep or to a scrapie type to which AA QR
sheep are not less susceptible; or
(2) An exposed sheep or sheep embryo of genotype AV QR, unless the
Administrator determines that it is epidemiologically linked to a
scrapie-positive RR or QR sheep, to a flock that the Administrator has
determined may be affected by valine-associated scrapie (based on an
evaluation of the genotypes of the scrapie-positive animals linked to
the flock), or to another scrapie type to which AV QR sheep are not
less susceptible; or
(3) An exposed sheep or sheep embryo of a genotype that has been
exposed to a scrapie type to which the Administrator has determined
that genotype is less susceptible.
In this definition R refers to codon 171 and A refers to codon 136,
and Q represents any genotype other than R at

[[Page 11181]]

codon 171 and V represents any genotype other than A at codon 136.
Genetically resistant exposed sheep. Any exposed sheep or sheep
embryo of genotype RR at codon 171 unless the Administrator determines
that it is epidemiologically linked to a scrapie-positive RR sheep or
to a scrapie type to which RR sheep are not resistant.
Genetically resistant sheep. Any sheep or sheep embryo of genotype
RR at codon 171 unless the Administrator determines that it is
epidemiologically linked to a scrapie-positive RR sheep or to a scrapie
type that affects RR at codon 171 sheep.
Genetically susceptible animal. Any goat or goat embryo, sheep or
sheep embryo of a genotype other than RR or QR, where Q represents any
genotype other than R at codon 171 or sheep or sheep embryo of
undetermined genotype.
Genetically susceptible exposed animal. Excluding low-risk exposed
animals, any exposed animal or embryo that is also:
(1) A genetically susceptible animal; or
(2) A sheep or sheep embryo of genotype AV QR that the
Administrator determines is epidemiologically linked to a scrapie-
positive RR or QR sheep, to a flock that the Administrator has
determined may be affected by valine-associated scrapie (based on an
evaluation of the genotypes of the scrapie-positive animals linked to
the flock), or to a scrapie type to which AV QR sheep are susceptible;
or
(3) A sheep or sheep embryo of genotype AA QR that the
Administrator determines is epidemiologically linked to a scrapie-
positive RR or AA QR sheep or to a scrapie type to which AA QR sheep
are susceptible; or
(4) A sheep or sheep embryo of genotype RR that the Administrator
determines is epidemiologically linked to a scrapie-positive RR sheep
or to a scrapie type to which RR sheep are susceptible.
(5) Note: In this definition R refers to codon 171 and A refers to
codon 136, and Q represents any genotype other than R at codon 171 and
V represents any genotype other than A at codon 136.
High-risk animal. The female offspring or embryo of a scrapie-
positive female animal, or any suspect animal, or a female genetically
susceptible exposed animal, or any exposed animal that the
Administrator determines to be a potential risk. The Administrator may
base the determination that an exposed animal poses a potential risk on
the scrapie type, the epidemiology of the flock or flocks with which it
is epidemiologically linked, including genetics of the positive sheep,
the prevalence of scrapie in the flock, any history of recurrent
infection, and other flock or animal characteristics. An animal will no
longer be a high-risk animal if it is redesignated in accordance with
Sec. 79.4 of this chapter.
* * * * *
Interstate certificate of veterinary inspection (ICVI). An official
document issued by a Federal, State, Tribal, or accredited veterinarian
certifying the inspection of animals in preparation for interstate
movement or other uses as described in this part and in accordance with
Sec. 79.5 of this chapter.
* * * * *
Low-risk exposed animal. Any exposed animal to which the
Administrator has determined one or more of the following applies:
(1) The positive animal that was the source of exposure was not
born in the flock and did not lamb in the flock or in an enclosure
where the exposed animal resided;
(2) The Administrator and State representative concur that the
animal is unlikely to be infected due to factors such as, but not
limited to, where the animal resided or the time period the animal
resided in the flock;
(3) The exposed animal is male and was not born in an infected or
source flock;
(4) The exposed animal is a castrated male;
(5) The exposed animal is an embryo of a genetically resistant
exposed sheep or a genetically less susceptible exposed sheep unless
placed in a recipient that was a genetically susceptible exposed
animal; or
(6) The animal was exposed to a scrapie type and/or is of a
genotype that the Administrator has determined poses low risk of
scrapie transmission.
* * * * *
Official genotype test. A test to determine the genotype of a live
or dead animal conducted at either the National Veterinary Services
Laboratories or at an approved laboratory. The test subject must be an
animal that is officially identified and the test accurately recorded
on an official form supplied or approved by APHIS, with the samples
collected and shipped to the laboratory using a shipping method
specified by the laboratory by:
(1) An accredited veterinarian;
(2) A State or APHIS representative; or
(3) The animal's owner or owner's agent, using a tamper-resistant
sampling kit approved by APHIS for this purpose.
* * * * *
Program approved test. A test for the diagnosis of scrapie approved
by the Administrator for use in the scrapie eradication or
certification program in accordance with Sec. 54.10.
Restricted animal sale or restricted livestock facility. A sale
where any animals in slaughter channels are maintained separate from
other animals not in slaughter channels unless they are from the same
flock of origin and are sold in lots that consist entirely of animals
sold for slaughter only, or a livestock facility at which all animals
are in slaughter channels, and where the sale or facility manager
maintains a copy of, or maintains a record of, the information from the
owner/hauler statement for all animals entering and leaving the sale or
facility. A restricted animal sale may be held at a livestock facility
that is not restricted.
* * * * *
Slaughter channels. Animals in slaughter channels include any
animal that is sold, transferred, or moved either directly to or
through a restricted animal sale or restricted livestock facility to an
official slaughter establishment that is under Food Safety and
Inspection Service (FSIS) jurisdiction per the Federal Meat Inspection
Act (FMIA) or under State inspection that FSIS has recognized as at
least equal to Federal inspection or to a custom exempt slaughter
establishment as defined by FSIS (9 CFR 303.1) for immediate slaughter
or to an individual for immediate slaughter for personal use or to a
terminal feedlot.
* * * * *
Suspect animal. * * *
(1) A mature sheep or goat as evidenced by eruption of the first
incisor that has been condemned by FSIS or a State inspection authority
for central nervous system (CNS) signs, or that exhibits any of the
following clinical signs of scrapie and has been determined to be
suspicious for scrapie by an accredited veterinarian or a State or USDA
representative, based on one or more of the following signs and the
severity of the signs: Weakness of any kind including, but not limited
to, stumbling, falling down, or having difficulty rising, not including
those with visible traumatic injuries and no other signs of scrapie;
behavioral abnormalities; significant weight loss despite retention of
appetite or in an animal with adequate dentition; increased sensitivity
to noise and sudden movement; tremors; star gazing; head pressing;
bilateral gait abnormalities such as but not limited to incoordination,
ataxia, high stepping gait of forelimbs, bunny-hop movement of rear
legs, or swaying of back end, but not including abnormalities involving

[[Page 11182]]

only one leg or one front and one back leg; repeated intense rubbing
with bare areas or damaged wool in similar locations on both sides of
the animal's body or, if on the head, both sides of the poll; abraded,
rough, thickened, or hyperpigmented areas of skin in areas of wool/hair
loss in similar locations on both sides of the animal's body or, if on
the head, both sides of the poll; or other signs of CNS disease. An
animal will no longer be a suspect animal if it is redesignated in
accordance with Sec. 79.4 of this chapter.
* * * * *
Tamper-resistant sampling kit. A device or method for collecting
DNA samples from sheep or goats that is approved by the Administrator
and that identifies both the sample and the animal at the time the
sample is collected. These devices or methods must ensure that the
sample, its corresponding label, and the official ID device or method
applied to the animal meets the requirements of Sec. 79.2(k) of this
chapter and that the sample is from the same animal to which the
official ID device or method was applied. The kit must include an
APHIS-approved official form or another form, device, or method
acceptable to APHIS for transmitting the information required to APHIS
and the approved laboratory.
Terminal feedlot. (1) A dry lot approved by a State or APHIS
representative or an accredited veterinarian who is authorized by the
Administrator to perform this function where animals in the terminal
feedlot 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 and must be cleaned of all
organic material prior to being used to contain sheep or goats that are
not in slaughter channels, where only castrated males are maintained
with female animals and from which animals are moved only to another
terminal feedlot or directly to slaughter; or
(2) A dry lot approved by a State or APHIS representative or an
accredited veterinarian who is authorized by the Administrator to
perform this function where only animals that either are not pregnant
based on the animal being male, an owner certification that any female
animals have not been exposed to a male in the preceding 6 months, an
ICVI issued by an accredited veterinarian stating the animals are not
pregnant, or the animals are under 6 months of age at time of receipt,
where only castrated males are maintained with female animals, and all
animals in the terminal feedlot are separated from all other animals
such that physical contact cannot occur including through a fence and
from which animals are moved only to another terminal feedlot or
directly to slaughter; or
(3) A pasture when approved by and maintained under the supervision
of the State and in which only nonpregnant animals are permitted based
on the animal being male, an owner certification that any female
animals have not been exposed to a male in the preceding 6 months, or
an ICVI issued by an accredited veterinarian stating the animals are
not pregnant, or the animals are under 6 months of age at time of
receipt, where only castrated males are maintained with female animals,
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.
(4) Records of all animals entering and leaving a terminal feedlot
must be maintained for 5 years after the animal leaves the feedlot and
must meet the requirements of Sec. 79.2 of this chapter, including
either a copy of the required owner/hauler statements for animals
entering and leaving the facility or the information required to be on
the statements. Records must be made available for inspection and
copying by an APHIS or State representative upon request.
* * * * *

Sec. 54.2 [Amended]

0
3. Section 54.2 is amended by adding the word ``Free'' between the
words ``Scrapie'' and ``Flock'' each time they appear.

0
4. Section Sec. 54.3 is amended by revising paragraph (b) and adding
an OMB citation at the end of the section to read as follows:

Sec. 54.3 Animals eligible for indemnity payments.

* * * * *
(b) Indemnity will be paid to an owner only for animals actually in
a flock at the time indemnity is first offered in writing, and for
offspring born to animals in that flock within 60 days after the time
indemnity is first offered in writing. Animals removed from the flock
as part of an investigation or a post-exposure management and
monitoring plan (PEMMP) will be paid indemnity based on the calculated
prices at the time an APHIS representative designates, in writing, the
animals for removal. If an owner declines to remove an animal within 60
days of when indemnity is first offered the owner will receive the
lower value of when indemnity was first offered in writing or when the
animal was actually removed. APHIS may withdraw an indemnity offer if
an owner does not make animals available for inventory, gestational
assessment, and testing within 30 days, does not remove an animal
within 60 days of the written indemnity offer or by the date specified
in a flock plan or PEMMP, or fails to provide APHIS animal registration
certificates, sale and movement records, or other records requested in
accordance with Sec. 54.5. No indemnity will be paid for any animal,
or the progeny of any animal, that has been moved or handled by the
owner in violation of the requirements of the Animal Health Protection
Act or the regulations promulgated thereunder. No indemnity will be
paid for an animal added to the premises while a flock is under
investigation or while it is an infected or source flock other than
natural additions. No indemnity will be paid for natural additions born
more than 60 days after the owner is notified they are eligible for
indemnity unless the Administrator makes a determination that the dam
could not be removed within the allowed time as a result of conditions
outside the control of the owner. No indemnity will be paid unless the
owner has signed and is in compliance with the requirements of a flock
plan or post-exposure management and monitoring plan (PEMMP) as
described in Sec. 54.8 unless the requirement for a flock plan or
PEMMP has been waived by the Administrator. No indemnity will be paid
until the premises, including all structures, holding facilities,
conveyances, and materials contaminated because of occupation or use by
the depopulated animals, have been properly cleaned and disinfected in
accordance with Sec. 54.7(e), unless premises or portions of premises
have been exempted from the cleaning and disinfecting requirements per
Sec. 54.8(j)(1); Except that, partial indemnity may be paid when the
Administrator determines that weather or other factors outside the
control of the owner make immediate disinfection impractical. No
indemnity will be paid to an owner for any animals if the owner
established or increased his flock for the purpose of collecting or
increasing indemnity.

(Approved by the Office of Management and Budget under control
number 0579-0101)

0
5. Section 54.4 is amended by revising paragraph (a)(5) and adding an
OMB citation at the end of the section to read as follows:

[[Page 11183]]

Sec. 54.4 Application by owners for indemnity payments.

(a) * * *
(5) A copy of the registration papers issued in the name of the
owner for any registered animals in the flock (registration papers are
not required for the payment of indemnity for animals that are not
registered); and
* * * * *

(Approved by the Office of Management and Budget under control
number 0579-0101)

0
6. Section 54.5 is amended as follows:
0
a. In paragraph (d), by removing the word ``slaughtered,''; and
0
b. By adding an OMB citation at the end of the section.
The addition reads as follows:

Sec. 54.5 Certification by owners.

* * * * *

(Approved by the Office of Management and Budget under control
number 0579-0101)

0
7. Section 54.6 is revised to read as follows:

Sec. 54.6 Amount of indemnity payments.

(a) Indemnity. Indemnity paid for sheep and goats in accordance
with Sec. 54.3 will be the fair market value of the animals. APHIS'
determination of fair market value will be based on available price
report data that most accurately reflect the type of animal being
indemnified and the time at which the animal was indemnified. Premiums
will be paid for certain types of sheep and goats, including, but not
limited to: Registered animals, flock sires, pregnant animals and
early-maturing ewes; Except that, no premium will be added for animals
of any age that were in slaughter channels when indemnity was offered.
To calculate indemnity, APHIS will use price information provided by
the Agricultural Marketing Service (AMS) or other available price
information and any other data necessary to establish the value of
different types of sheep and goats. A detailed description of the
methods APHIS uses to calculate indemnity for sheep and goats is
available at https://www.aphis.usda.gov/animal-health/scrapie.
(b) Age and number of animals. If records and identification are
inadequate to determine the actual age of animals, an APHIS or State
representative will count all sexually intact animals that are
apparently under 1 year of age, and those that are apparently at least
1 and under 2 years of age, based on examination of their teeth, and
the indemnity for these animals will be calculated. The total number of
these animals will be subtracted from the total number of sexually
intact animals in the group to be indemnified, and indemnity for the
remainder will be calculated based on the assumption that the remainder
of the flock is 80 percent aged 2 to 6 years and 20 percent aged 6 to 8
years.
(c) Animal weights. If the owner disagrees with the average weight
estimate, he may have the animals weighed at a public scale at his own
expense, provided that the animals may not come in contact with other
sheep or goats during movement to the public scales, and will be paid
based on the actual weight multiplied by the price per pound for the
class of animal as calculated in paragraph (a) of this section.

(Approved by the Office of Management and Budget under control
number 0579-0101)

0
8. Section 54.7 is amended as follows:
0
a. By revising paragraphs (a) and (d);
0
b. In paragraph (e), introductory text, by removing the words ``Scrapie
Flock Certification Program standards and the Scrapie Eradication
Uniform Methods and Rules'' adding in their place ``Scrapie Program
Standards Volume 1: National Scrapie Eradication Program and Scrapie
Program Standards Volume 2: Scrapie Free Flock Certification Program
(SFCP)'';
0
c. In paragraph (e)(1), by removing the words ``animals or wildlife''
and adding in their place the words ``or wild ruminants'';
0
d. By revising paragraph (e)(2) introductory text;
0
e. By removing paragraph (e)(2)(i), redesignating paragraphs (e)(2)(ii)
and (iii) as paragraphs (e)(2)(i) and (ii), respectively, and by adding
new paragraphs (e)(2)(iii) and (iv); and
0
f. By adding an OMB citation at the end of the section.
The revisions and additions read as follows:

Sec. 54.7 Procedures for destruction of animals.

(a) Animals for which indemnification is sought must be destroyed
on the premises where they are held, pastured, or penned at the time
indemnity is approved or moved to an approved research facility, unless
the APHIS representative involved approves in advance of destruction
moving the animals to another location for destruction.
* * * * *
(d) APHIS may pay the reasonable costs of disposal for animals that
are indemnified. To obtain reimbursement for disposal costs, animal
owners must obtain written approval of the disposal costs from APHIS,
prior to disposal. For reimbursement to be made, the owner of the
animals must present the Veterinary Services, Field Operations, Area
Veterinarian in Charge (AVIC) responsible for the State involved with a
copy of either a receipt for expenses paid or a bill for services
rendered. Any bill for services rendered by the owner must not be
greater than the normal fee for similar services provided by a
commercial hauler or disposal facility.
(e) * * *
(2) Cement, wood, metal and other non-earth surfaces, tools,
equipment, instruments, feed, hay, bedding, and other materials.
Organic and/or inorganic materials may be disposed of by incineration
or burial. Inorganic material and wood structures may be cleaned and
disinfected. To disinfect, remove all organic material and incinerate,
bury, till under, or compost the removed organic material in areas not
accessed by domestic or wild ruminants until it can be incinerated,
buried, or tilled under. Clean and wash all surfaces, tools, equipment,
and instruments using hot water and detergent. Allow all surfaces,
tools, equipment, and instruments to dry completely before disinfecting
and sanitizing using one of the following methods:
* * * * *
(iii) Use a product registered by the U.S. Environmental Protection
Agency (EPA) specifically for reduction of prion infectivity at these
sites in accordance with the label.
(iv) Use a product in accordance with an emergency exemption issued
by the EPA for reduction of prion infectivity at these sites.

(Approved by the Office of Management and Budget under control
number 0579-0469)

0
9. Section 54.8 is revised to read as follows:

Sec. 54.8 Requirements for flocks under investigation and flocks
subject to flock plans and post-exposure management and monitoring
plans.

(a) For animals in a flock under investigation, flock plan, or
post-exposure management and monitoring plan (PEMMP), the official
identification must provide a unique identification number that is
applied by the owner of the flock or his or her agent and must be
linked to that flock in the National Scrapie Database. APHIS may
specify the type of official identification that may be used in order
to maximize retention of the means of identification, identify
restricted or test positive animals or to facilitate the testing or
inventory of the animals. The owner of the flock or his or her agent
must officially identify and maintain the identity of:

[[Page 11184]]

(1) All animals in the flock while it is subject to a flock plan or
PEMMP;
(2) Any high-risk or genetically susceptible exposed animals in the
flock and any other restricted animals;
(3) Any animals designated for testing by an APHIS representative
or State representative until testing is completed, results reported,
and animals classified; and
(4) All sexually intact animals, all exposed animals, and animals
18 months of age and older (as evidenced by the eruption of the second
incisor) prior to a change in ownership and before they are moved off
the premises of the flock.
(b) For flocks under a flock plan or PEMMP, the flock owner must
maintain the following records for 5 years or until the flock plan and/
or PEMMP is completed, whichever is longer.
(1) For acquired animals, the date of acquisition, name and address
of the person from whom the animal was acquired, any identifying marks,
or identification devices present on the animal including but not
limited to the animal's individual official identification number(s)
from its electronic implant, flank tattoo, ear tattoo, tamper-resistant
eartag, or, in the case of goats, tail fold tattoo, and any secondary
form of identification the owner of the flock may choose to maintain
and the records required by Sec. 79.2 of this chapter.
(2) For animals leaving the premises of the flock, the disposition
of the animal, including, any identifying marks or identification
devices present on the animal, including but not limited to the
animal's individual official identification number from its electronic
implant, flank tattoo, ear tattoo, tamper-resistant eartag, or, in the
case of goats, a tail fold tattoo, and any secondary form of
identification the owner of the flock may choose to maintain, the date
and cause of death, if known, or date of removal from the flock and
name and address of the person to whom the animal was transferred and
the records required by Sec. 79.2 of this chapter.
(c) Upon request by a State or APHIS representative or as required
in a PEMMP, the owner of the flock or his or her agent must have an
accredited veterinarian collect tissues from animals for scrapie
diagnostic purposes and submit them to a laboratory designated by a
State or APHIS representative or collect and submit samples by another
method acceptable to APHIS.
(d) Upon request by a State or APHIS representative, the owner of
the flock or his or her agent must make animals in the flock available
for inspection and or testing and the records required to be kept as a
part of these plans available for inspection and copying.
(e) The owner of the flock or his or her agent must meet
requirements found necessary by a DSE to monitor for scrapie and to
prevent the recurrence of scrapie in the flock and to prevent the
spread of scrapie from the flock. These other requirements may include,
but are not limited to: Utilization of a live-animal screening test;
reporting animals found dead and collecting and submitting test samples
from them; restrictions on the animals that may be moved from the
flock; use of genetically resistant rams; segregated lambing; cleaning
and disinfection of lambing facilities; and/or education of the owner
of the flock and personnel working with the flock in techniques to
recognize clinical signs of scrapie and to control the spread of
scrapie.
(f) The owner of the flock or his or her agent must immediately
report the following animals to a State representative, APHIS
representative, or an accredited veterinarian; ensure that samples are
properly collected for testing if the animal dies; allow the animals to
be tested, and not remove them from a flock without written permission
of a State or APHIS representative:
(1) Any sheep or goat exhibiting weight loss despite retention of
appetite; behavioral abnormalities; pruritus (itching); wool pulling;
wool loss; 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; rubbing, or other signs of neurological disease or chronic
wasting illness; and
(2) Any sheep or goat in the flock 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.
(g) An epidemiologic investigation must be conducted to identify
high-risk and exposed animals that currently reside in the flock or
that previously resided in the flock, and all high-risk animals,
scrapie-positive animals, and suspect animals must be removed from the
flock except as provided in paragraph (h) of this section. The animals
must be removed either by movement to an approved research facility or
by euthanasia and disposal of the carcasses by burial, incineration, or
other methods approved by the Administrator and in accordance with
local, State, and Federal laws, or upon request in individual cases by
another means determined by the Administrator to be sufficient to
prevent the spread of scrapie.
(h) The Administrator may allow high-risk animals that are not
suspect animals to be retained under restriction if they are not
genetically susceptible animals or if they have tested ``PrPsc not
detected'' on a live animal scrapie test approved for this purpose by
the Administrator and are maintained in a manner that the Administrator
determines minimizes the risk of scrapie transmission, e.g., bred only
to genetically resistant sheep, segregated for lambing, and cleaning
and disinfection of the lambing area. Such animals may be retained only
if the exempted animal's official identification and the requirements
for minimizing the risk of scrapie transmission are documented in the
PEMMP and the owner is in compliance with the PEMMP. All such animals
must be tested for scrapie when they are euthanized or die or if they
are later determined to be suspect animals.
(i) The owner of the flock, or his or her agent, must request breed
associations and registries, livestock facilities, and packers to
disclose records to APHIS representatives or State representatives, to
be used to identify source flocks and trace exposed animals, including
high-risk animals.
(j) The flock plan will include a description of the types of
animals that must be removed from a flock, the timeframes in which they
must be removed and any other actions that must be accomplished in
order for the flock plan to be completed. Flock plans shall require an
owner to agree to:
(1) Clean and disinfect the premises in accordance with Sec.
54.7(e). Premises or portions of premises may be exempted from the
cleaning and disinfecting requirements if a designated scrapie
epidemiologist determines, based on an epidemiologic investigation,
that cleaning and disinfection of such buildings, holding facilities,
conveyances, or other materials on the premises will not significantly
reduce the risk of the spread of scrapie, either because effective
disinfection is not possible or because the normal operations on the
premises prevent transmission of scrapie. No confined area where a
scrapie-positive animal was born, lambed or aborted may be exempted;
(2) Agree to conduct a post-exposure management and monitoring plan
(PEMMP); and
(3) Comply with any other conditions in the flock plan;
(k) A PEMMP will be required for exposed flocks and may be required
for

[[Page 11185]]

flocks under investigation that were not source or infected flocks. A
PEMMP may also be required for flocks that formerly were exposed flocks
or flocks under investigation as a condition for being redesignated. A
designated scrapie epidemiologist shall determine when to require a
PEMMP and the monitoring requirements for these flocks based on the
findings of the classification or reclassification investigation.
(l) Provided that, the Administrator may waive the requirement for
a flock plan or PEMMP or waive any of the requirements in a flock plan
or PEMMP after determining that the flock poses a low risk of scrapie
transmission.

(Approved by the Office of Management and Budget under control
numbers 0579-0101 and 0579-0469)

0
10. Section 54.10 is revised to read as follows:

Sec. 54.10 Program approval of tests for scrapie.

(a) The Administrator may approve new tests or test methods for the
diagnosis of scrapie conducted on live or dead animals for use in the
Scrapie Eradication Program and/or the Scrapie Free Flock Certification
Program. The Administrator will base the approval or disapproval of a
test on the evaluation by APHIS and, when appropriate, outside
scientists, of:
(1) A standardized test protocol that must include a description of
the test, a description of the reagents, materials, and equipment used
for the test, the test methodology, and any control or quality
assurance procedures;
(2) Data to support repeatability, that is, the ability to
reproduce the same result repeatedly on a given sample;
(3) Data to support reproducibility, that is, data to show that
similar results can be produced when the test is run at other
laboratories;
(4) Data to support the diagnostic and in the case of assays the
analytical sensitivity and specificity of the test; and
(5) Any other data or information requested by the Administrator to
determine the suitability of the test for program use. This may include
but is not limited to past performance, cost of test materials and
equipment, ease of test performance, generation of waste, and potential
use of existing equipment.
(b) To be approved for program use, a scrapie test must be able to
be readily and successfully performed at the National Veterinary
Services Laboratories.
(c) The test must have a reliable, timely, and cost effective
method of proficiency testing.
(d) The Administrator may decline to evaluate any test kit for
program approval that has not been licensed for the intended use and
may decline to evaluate any test or test method for program use unless
the requester can demonstrate that the new method offers a significant
advantage over currently approved methods.
(e) A test or combination of tests may be approved for the
identification of suspect animals, or scrapie-positive animals, or for
other purposes such as flock certification. For a test to be approved
for the identification of scrapie-positive animals, the test must
demonstrate a diagnostic specificity comparable to that of current
program-approved tests, and the sensitivity of the test will also be
considered in determining the approved uses of the test within the
program. For a test to be approved for the removal of high-risk,
exposed, or suspect animal designations the test must have a diagnostic
sensitivity at least comparable to that of current program-approved
tests used for this purpose. Since the purpose of a screening test is
usually to identify a subset of animals for further testing, for a test
to be approved as a screening test for the identification of suspect
animals, the test must be usually reliable but need not be definitive
for diagnosing scrapie.
(f) Specific guidelines for use of program-approved tests within
the Scrapie Eradication Program or Scrapie Free Flock Certification
Program will be made available on the scrapie website at https://www.aphis.usda.gov/animal-health/scrapie. Guidelines will be based on
the characteristics of the test, including specificity, sensitivity,
and predictive value in defined groups of animals.
(g) If an owner elects to have an unofficial test conducted on an
animal for scrapie, or for the proteinase resistant protein associated
with scrapie, and that animal tests positive to such a test, the animal
will be designated a suspect animal, unless the test is conducted as
part of a research protocol and the protocol includes appropriate
measures to prevent the spread of scrapie.
(h) The Administrator may withdraw or suspend approval of any test
or test method if the test or method does not perform at an acceptable
level following approval or if a more effective test or test method is
subsequently approved. The Administrator shall give written notice of
the suspension or proposed withdrawal to the director of the
laboratories using the test or method or in the case of test kits to
the manufacturer and shall give the director or manufacturer an
opportunity to respond. Such action shall become effective upon oral or
written notification, whichever is earlier, to the laboratory or
manufacturer. If there are conflicts as to any material fact concerning
the reason for withdrawal, a hearing may be requested in accordance
with the procedure in Sec. 79.4(c)(3) of this chapter. The action
under appeal shall continue in effect pending the final determination
of the Administrator, unless otherwise ordered by the Administrator.
The Administrator's final determination constitutes final agency
action.

(Approved by the Office of Management and Budget under control
number 0579-0469)

0
11. Section 54.11 is revised to read as follows:

Sec. 54.11 Approval of laboratories to run official scrapie tests and
official genotype tests.

(a) State, Federal, and university laboratories, or in the case of
genotype tests, private laboratories will be approved by the
Administrator when he or she determines that the laboratory:
(1) Employs personnel assigned to supervise and conduct the testing
who are qualified to conduct the test based on education, training, and
experience and who have been trained by the National Veterinary
Services Laboratories (NVSL) or who have completed equivalent training
approved by NVSL;
(2) Has adequate facilities and equipment to conduct the test;
(3) Follows standard test protocols that are approved or provided
by NVSL;
(4) Meets check test proficiency requirements and consistently
produces accurate test results as determined by NVSL review;
(5) Meets recordkeeping requirements;
(6) Will retain records, slides, blocks, and other specimens from
all cases for at least 1 year and from positive cases and DNA from all
genotype tests for at least 5 years and will forward copies of records
and any of these materials to NVSL within 5 business days of request;
Except that, NVSL may authorize a shorter retention time in a standard
operating procedure or contract;
(7) Will allow APHIS to inspect the laboratory without notice
during normal business hours. An inspection may include, but is not
limited to, review and copying of records, examination of slides,
review of quality control procedures, observation of sample handling/
tracking procedures, observation of the test being conducted, and
interviewing of personnel;
(8) Will report all test results to State and Federal animal health
officials and

[[Page 11186]]

record them in the National Scrapie Database within timeframes and in
the manner and format specified by the Administrator; and
(9) Complies with any other written guidance provided to the
laboratory by the Administrator.
(b) A laboratory may request approval to conduct one or more types
of program-approved scrapie test or genotype test on one or more types
of tissue. To be approved, a laboratory must meet the requirements in
paragraph (a) of this section for each type of test and for each type
of tissue for which they request approval.
(c) The Administrator may suspend or withdraw approval of any
laboratory for failure to meet any of the conditions required by
paragraph (a) of this section. The Administrator shall give written
notice of the suspension or the proposed withdrawal to the director of
the laboratory and shall give the director an opportunity to respond.
Such action shall become effective upon oral or written notification,
whichever is earlier, to the laboratory or manufacturer. If there are
conflicts as to any material fact concerning the reason for withdrawal,
a hearing may be requested in accordance with the procedure in Sec.
79.4(c)(3) of this chapter. The action under appeal shall continue in
effect pending the final determination of the Administrator, unless
otherwise ordered by the Administrator. The Administrator's final
determination constitutes final agency action.
(d) The Administrator may require approved laboratories to
reimburse APHIS for part or all of the costs associated with the
approval and monitoring of the laboratory.

(Approved by the Office of Management and Budget under control
numbers 0579-0101 and 0579-0469)

0
12. The heading for subpart B is revised to read as set forth below:

Subpart B--Scrapie Free Flock Certification Program

0
13. Section 54.21 is revised to read as follows:

Sec. 54.21 Participation.

Any owner of a sheep or goat flock may apply to enter the Scrapie
Free Flock Certification Program by sending a written request to a
State scrapie certification board or to the Veterinary Services, Field
Operations, AVIC responsible for the State involved. A notice
containing a current list of flocks participating in the Scrapie Free
Flock Certification Program, and the certification status of each
flock, may be obtained from the APHIS website at https://www.aphis.usda.gov/animal-health/scrapie. A list of noncompliant flocks
and a list of flocks that sold exposed animals that could not be traced
may also be obtained from this site, and these lists may be obtained by
writing to the National Scrapie Program Coordinator, Strategy and
Policy, VS, APHIS, 4700 River Road Unit 43, Riverdale, MD 20737-1235.

(Approved by the Office of Management and Budget under control
number 0579-0101)

PART 79--SCRAPIE IN SHEEP AND GOATS

0
14. The authority citation for part 79 continues to read as follows:

Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

0
15. Section 79.1 is amended as follows:
0
a. By revising the definition for Animal identification number (AIN);
0
b. In the definition for Breed association and registries, by removing
the words ``listed in Sec. 151.9 of this chapter'';
0
c. By removing the definition for Certificate;
0
d. By adding in alphabetical order a definition for Classification or
reclassification investigation;
0
e. By revising the definitions for Consistent State, Exposed animal,
and Exposed flock;
0
f. By adding in alphabetical order a definition for Flock
identification (ID) number;
0
g. In the definition for Flock plan, by removing the citation ``Sec.
54.8(a)(f)'' and by adding the words ``Sec. 54.8(a) through (j)'' in
its place;
0
h. By adding in alphabetical order definitions for Flock under
investigation, Genetically less susceptible exposed sheep, Genetically
resistant exposed sheep, Genetically resistant sheep, Genetically
susceptible animal, Genetically susceptible exposed animal, Group/lot
identification number (GIN);
0
i. By revising the definition for High-risk animal;
0
j. By adding in alphabetical order definitions for Interstate
certificate of veterinary inspection (ICVI) and Low-risk commercial
flock;
0
k. By removing the definition for Low-risk commercial sheep;
0
l. By adding in alphabetical order a definition for Low-risk exposed
animal;
0
m. By removing the definition for Low-risk goat;
0
n. By adding in alphabetical order a definition for National Uniform
Eartagging System (NUES);
0
o. In the definition for Noncompliant flock, in paragraph (3), by
removing the words ``owner statement'' and adding the words ``owner/
hauler statement'' in their place;
0
p. By revising the definitions for Official eartag, Official genotype
test, and Official identification device or method;
0
q. By adding in alphabetical order definitions for Official
identification number, Officially identified, and Owner/hauler
statement;
0
r. By removing the definition for Owner statement;
0
s. By adding in alphabetical order a definition for Person;
0
t. By revising the definition for Premises identification number (PIN);
0
u. By adding in alphabetical order a definition for Restricted animal
sale or restricted livestock facility;
0
v. In the heading of the definition for Scrapie Flock Certification
Program (SFCP), by adding the word ``Free'' immediately after the word
``Scrapie'';
0
w. In the heading of the definition for Scrapie Flock Certification
Program standards, by adding the word ``Free'' immediately following
the word ``Scrapie'' and, in footnote 2, by removing the internet
address ``https://www.aphis.usda.gov/vs'' and adding the internet
address ``https://www.aphis.usda.gov/animal-health/scrapie'' in its
place;
0
x. In the definition for Scrapie-positive animal, in paragraph (2) by
adding the words ``, and/or ELISA,'' immediately after the word
``immunohistochemistry'' and in paragraph (5) by removing the words
``test method'' and adding the words ``method or combination of
methods'' in their place;
0
y. By removing the definition for Separate contemporary lambing groups;
0
z. By revising the definition for Slaughter channels;
0
aa. By revising paragraph (1) of the definition for Suspect animal;
0
bb. By revising the definition for Terminal feedlot; and
0
cc. By adding in alphabetical order a definition for Test eligible.
The additions and revisions read as follows:

Sec. 79.1 Definitions.

* * * * *
Animal identification number (AIN). This term has the meaning set
forth in Sec. 86.1 of this subchapter, except that only AIN devices
approved and distributed in accordance with Sec. 79.2(k) and methods
approved for use in sheep and goats in accordance with Sec. 79.2(a)(2)
are included.
* * * * *
Classification or reclassification investigation. An
epidemiological

[[Page 11187]]

investigation conducted or directed by a DSE for the purpose of
designating or redesignating the status (e.g., exposed, high-risk,
infected, source, suspect, etc.) of a flock or animal. In conducting
such an investigation, the DSE will evaluate the available records for
flocks and individual animals and conduct or direct any testing needed
to assess the status of a flock or animal. The status of an animal or
flock will be determined based on the applicable definitions in this
section and, when needed to make a designation under Sec. 79.4,
official genotype test results, exposure risk, scrapie type involved,
and/or results of official scrapie testing on live or dead animals.
* * * * *
Consistent State. (1) A State that the Administrator has determined
conducts an active State scrapie control program that meets the
requirements of Sec. 79.6 or 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) A list of Consistent States can be found on the internet at
https://www.aphis.usda.gov/animal-health/scrapie.
* * * * *
Exposed animal. Any animal or embryo that:
(1) Has been in a flock with a scrapie-positive female animal;
(2) Has been in an enclosure with a scrapie-positive female animal
at any location;
(3) Resides in a noncompliant flock; or
(4) Has resided on the premises of a flock before or while it was
designated an infected or source flock and before a flock plan was
completed. An animal shall not be designated an exposed animal if it
only resided on the premises before the date that infection was most
likely introduced to the premises as determined by a Federal or State
representative. If the probable date of infection cannot be determined
based on the epidemiologic investigation, a date 2 years before the
birth of the oldest scrapie-positive animal born in that flock will be
used. If the actual birth date is unknown, the date of birth will be
estimated based on examination of the teeth and any available records.
If an age estimate cannot be made, the animal will be assumed to have
been 48 months of age on the date samples were collected for scrapie
diagnosis. Exposed animals will be further designated as genetically
resistant exposed sheep, genetically less susceptible exposed sheep,
genetically susceptible exposed animals, or low-risk exposed animals.
An animal will no longer be an exposed animal if it is redesignated in
accordance with Sec. 79.4.
Exposed flock. (1) Any flock that was designated an infected or
source flock that has completed a flock plan and that retained a female
genetically susceptible exposed animal;
(2) Any flock under investigation that retains a female genetically
susceptible exposed animal or a suspect animal, or whose owner declines
to complete genotyping and live-animal and/or post-mortem scrapie
testing required by the APHIS or State representative investigating the
flock; or
(3) Any noncompliant flock or any flock for which a PEMMP is
required that is not in compliance with the conditions of the PEMMP. A
flock will no longer be an exposed flock if it is redesignated in
accordance with Sec. 79.4.
* * * * *
Flock identification (ID) number. A nationally unique number
assigned by a State, federally recognized Tribal or Federal animal
health authority to a group of animals that are managed as a unit on
one or more premises and are under the same ownership. The flock ID
number must begin with the State postal abbreviation or APHIS-assigned
Tribal code, must have no more than nine alphanumeric characters, and
must not contain the characters ``I'', ``O'', or ``Q'' other than as
part of the State postal abbreviation or another standardized format
authorized by the administrator and recorded in the National Scrapie
Database. APHIS may assign Tribal codes to any federally recognized
Tribe that maintains sheep or goats on Tribal lands. The flock ID
number must be recorded in and linked to one or more PINs or LIDs in
the National Scrapie Database.
* * * * *
Flock under investigation. Any flock in which an APHIS or State
representative has determined that a scrapie suspect animal, high-risk
animal, or scrapie-positive animal resides or may have resided. A flock
will no longer be a flock under investigation if it is redesignated in
accordance with Sec. 79.4.
Genetically less susceptible exposed sheep. Any sheep or sheep
embryo that is:
(1) An exposed sheep or sheep embryo of genotype AA QR, unless the
Administrator determines that it is epidemiologically linked to a
scrapie-positive RR or AA QR sheep or to a scrapie type to which AA QR
sheep are not less susceptible; or
(2) An exposed sheep or sheep embryo of genotype AV QR, unless the
Administrator determines that it is epidemiologically linked to a
scrapie-positive RR or QR sheep, to a flock that the Administrator has
determined may be affected by valine-associated scrapie (based on an
evaluation of the genotypes of the scrapie-positive animals linked to
the flock), or to another scrapie type to which the Administrator has
determined AV QR sheep are not less susceptible; or
(3) An exposed sheep or sheep embryo of a genotype that has been
exposed to a scrapie type to which the Administrator has determined
that genotype is less susceptible.
(4) Note: In this definition R refers to codon 171 and A refers to
codon 136, and Q represents any genotype other than R at codon 171 and
V represents any genotype other than A at codon 136.
Genetically resistant exposed sheep. Any exposed sheep or sheep
embryo of genotype RR at codon 171 unless the Administrator determines
that it is epidemiologically linked to a scrapie-positive RR sheep or
to a scrapie type to which RR sheep are not resistant.
Genetically resistant sheep. Any sheep or sheep embryo of genotype
RR at codon 171 unless it is epidemiologically linked to a scrapie-
positive RR sheep or to a scrapie type that affects RR at codon 171
sheep.
Genetically susceptible animal. Any goat or goat embryo, sheep or
sheep embryo of a genotype other than RR or QR, where Q represents any
genotype other than R at codon 171 or sheep or sheep embryo of
undetermined genotype.
Genetically susceptible exposed animal. Excluding low-risk exposed
animals, any exposed animal or embryo that is also:
(1) A genetically susceptible animal; or
(2) A sheep or sheep embryo of genotype AV QR that the
Administrator has determined is epidemiologically linked to a scrapie-
positive RR or QR sheep, to a flock that the Administrator has
determined may be affected by valine-associated scrapie (based on an
evaluation of the genotypes of the scrapie-positive animals linked to
the flock), or to a scrapie type to which AV QR sheep are susceptible;
or
(3) A sheep or sheep embryo of genotype AA QR that the
Administrator has determined is epidemiologically linked to a scrapie-
positive RR or AA QR sheep or to a scrapie type to which AA QR sheep
are susceptible; or
(4) A sheep or sheep embryo of genotype RR that the Administrator
has determined is epidemiologically linked to a scrapie-positive RR
sheep or to a

[[Page 11188]]

scrapie type to which RR sheep are susceptible.
(5) Note: In this definition, R refers to codon 171 and A refers to
codon 136, and Q represents any genotype other than R at codon 171 and
V represents any genotype other than A at codon 136.
Group/lot identification number (GIN). The identification number
used to uniquely identify a unit of animals that is managed together as
one group. The format of the GIN may be either as defined in Sec. 86.1
of this chapter, or the flock identification number followed by a six-
digit representation of the date on which the group or lot of animals
was assembled (MM/DD/YY). If more than one group is created on the same
date a sequential number will be added to the end of the GIN. A group
lot comprised of animals from a single flock of origin may be
subdivided after leaving the premises on which the group lot was formed
by adding an S followed by a sequential number to the end of the GIN to
create a GIN for each sub group. If a flock identification number is
used, the flock identification number, date, and sequential number(s)
will be separated by hyphens.
High-risk animal. The female offspring or embryo of a scrapie-
positive female animal, or any suspect animal, or a female genetically
susceptible exposed animal, or any exposed animal that the
Administrator determines to be a potential risk. The Administrator may
base the determination that an exposed animal poses a potential risk on
the scrapie type, the epidemiology of the flock or flocks with which it
is epidemiologically linked, including genetics of the positive sheep,
the prevalence of scrapie in the flock, any history of recurrent
infection, and other animal or flock characteristics. An animal will no
longer be a high-risk animal if it is redesignated in accordance with
Sec. 79.4.
* * * * *
Interstate certificate of veterinary inspection (ICVI). An official
document issued by a Federal, State, Tribal, or accredited veterinarian
certifying the inspection of animals in preparation for interstate
movement or other uses as described in this part and in accordance with
Sec. 79.5.
* * * * *
Low-risk commercial flock. A flock composed of commercial
whitefaced, whitefaced cross, or commercial hair sheep or commercial
goats that were born in, and have resided throughout their lives in,
flocks with no known risk factors for scrapie, including any exposure
to female blackfaced sheep other than whiteface crosses born on the
premises; that has never contained a scrapie-positive female, suspect
female, or high-risk animal; and that has never been an infected,
exposed, or source flock or a flock under investigation. The animals
are identified with a legible permanent brand or ear notch pattern
registered with an official brand registry or with an official flock
identification eartag. 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 flocks may exist only in a State where in the previous
10 years no flock that had met the definition of a low-risk commercial
flock prior to a classification investigation was designated a source
or infected flock.
Low-risk exposed animal. Any exposed animal to which the
Administrator has determined one or more of the following applies:
(1) The positive animal that was the source of exposure was not
born in the flock and did not lamb in the flock or in an enclosure
where the exposed animal resided;
(2) The Administrator and State representative concur that the
animal is unlikely to be infected due to factors such as, but not
limited to, where the animal resided or the time period the animal
resided in the flock;
(3) The exposed animal is male and was not born in an infected or
source flock;
(4) The exposed animal is a castrated male;
(5) The exposed animal is an embryo of a genetically resistant
exposed sheep or a genetically less susceptible exposed sheep unless
placed in a recipient that was a genetically susceptible exposed
animal; or
(6) The animal was exposed to a scrapie type and/or is of a
genotype that the Administrator has determined poses low risk of
transmission.
* * * * *
National Uniform Eartagging System (NUES). This term has the
meaning set forth in Sec. 86.1 of this subchapter.
* * * * *
Official eartag. This term has the meaning set forth in Sec. 86.1
of this subchapter, except that only eartags approved and distributed
in accordance with Sec. 79.2(k) are included.
Official genotype test. A test to determine the genotype of a live
or dead animal conducted at either the National Veterinary Services
Laboratories or at an approved laboratory. The test subject must be an
animal that is officially identified and the test accurately recorded
on an official form supplied or approved by APHIS, with the samples
collected and shipped to the laboratory using a shipping method
specified by the laboratory by:
(1) An accredited veterinarian;
(2) A State or APHIS representative; or
(3) The animal's owner or owner's agent, using a tamper-resistant
sampling kit approved by APHIS for this purpose.
* * * * *
Official identification device or method. This term has the meaning
set forth in Sec. 86.1 of this subchapter, except that only devices
approved and distributed in accordance with Sec. 79.2(k) and methods
approved for use in sheep and goats in accordance with Sec. 79.2(a)(2)
are included.
Official identification number. This term has the meaning set forth
in Sec. 86.1 of this subchapter.
Officially identified. Identified by means of an official
identification device or method approved by the Administrator for use
in sheep and goats in accordance with this part.
* * * * *
Owner/hauler statement. (1) A signed written statement by the owner
or hauler that includes:
(i) The name, address, and phone number of the owner and, if
different, the hauler;
(ii) The date the animals were moved;
(iii) The flock identification number or PIN assigned to the flock
or premises of the animals;
(iv) If moving individually unidentified animals or other animals
required to move with a group/lot identification number, the group/lot
identification number and any information required to officially
identify the animals;
(v) The number of animals;
(vi) The species, breed, and class of animals. If breed is unknown,
for sheep the face color and for goats the type (milk, fiber, or meat)
must be recorded instead; and
(vii) The name and address of point of origin, if different from
the owner's address, and the destination name and address.
(2) An existing document that includes the information required in
paragraphs (1)(i) to (vii) of this definition and that is signed by the
owner or the hauler may be used as an owner/hauler statement.
* * * * *
Person. An individual, partnership, company, corporation, or any
other legal entity.
* * * * *
Premises identification number (PIN). This term has the meaning set
forth in

[[Page 11189]]

Sec. 86.1 of this subchapter. APHIS may also maintain historical and/
or State premises numbers and link them to the premises identification
number in records and databases. Such secondary or historical numbers
are typically the State's two-letter postal abbreviation followed by a
number assigned by the State.
Restricted animal sale or restricted livestock facility. A sale
where any animals in slaughter channels are maintained separate from
other animals not in slaughter channels other than animals from the
same flock of origin and are sold in lots that consist entirely of
animals sold for slaughter only or a livestock facility at which all
animals are in slaughter channels and where the sale or facility
manager maintains a copy of, or maintains a record of, the information
from, the owner/hauler statement for all animals entering and leaving
the sale or facility. A restricted animal sale may be held at a
livestock facility that is not restricted.
* * * * *
Slaughter channels. Animals in slaughter channels include any
animal that is sold, transferred, or moved either directly to or
through a restricted animal sale or restricted livestock facility to an
official slaughter establishment that is under Food Safety and
Inspection Service (FSIS) jurisdiction per the Federal Meat Inspection
Act (FMIA) or under State inspection that FSIS has recognized as at
least equal to Federal inspection or to a custom exempt slaughter
establishment as defined by FSIS (9 CFR 303.1) for immediate slaughter
or to an individual for immediate slaughter for personal use or to a
terminal feedlot.
* * * * *
Suspect animal. * * *
(1) A mature sheep or goat as evidenced by eruption of the first
incisor that has been condemned by FSIS or a State inspection authority
for central nervous system (CNS) signs, or that exhibits any of the
following clinical signs of scrapie and has been determined to be
suspicious for scrapie by an accredited veterinarian or a State or USDA
representative, based on one or more of the following signs and the
severity of the signs: Weakness of any kind including, but not limited
to, stumbling, falling down, or having difficulty rising, not including
those with visible traumatic injuries and no other signs of scrapie;
behavioral abnormalities; significant weight loss despite retention of
appetite or in an animal with adequate dentition; increased sensitivity
to noise and sudden movement; tremors; star gazing; head pressing;
bilateral gait abnormalities such as but not limited to incoordination,
ataxia, high stepping gait of forelimbs, bunny-hop movement of rear
legs, or swaying of back end, but not including abnormalities involving
only one leg or one front and one back leg; repeated intense rubbing
with bare areas or damaged wool in similar locations on both sides of
the animal's body or, if on the head, both sides of the poll; abraded,
rough, thickened, or hyperpigmented areas of skin in areas of wool/hair
loss in similar locations on both sides of the animal's body or, if on
the head, both sides of the poll; or other signs of CNS disease. An
animal will no longer be a suspect animal if it is redesignated in
accordance with Sec. 79.4.
* * * * *
Terminal feedlot. (1) A dry lot approved by a State or APHIS
representative or an accredited veterinarian who is authorized by the
Administrator to perform this function where animals in the terminal
feedlot 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 and must be cleaned of all
organic material prior to being used to contain sheep or goats that are
not in slaughter channels, where only castrated males are maintained
with female animals and from which animals are moved only to another
terminal feedlot or directly to slaughter; or
(2) A dry lot approved by a State or APHIS representative or an
accredited veterinarian authorized by the Administrator to perform this
function where only animals that either are not pregnant based on the
animal being male, an owner certification that any female animals have
not been exposed to a male in the preceding 6 months, an ICVI issued by
an accredited veterinarian stating the animals are not pregnant, or the
animals are under 6 months of age at time of receipt, where only
castrated males are maintained with female animals, and all animals in
the terminal feedlot are separated from all other animals such that
physical contact cannot occur including through a fence and from which
animals are moved only to another terminal feedlot or directly to
slaughter; or
(3) A pasture when approved by and maintained under the supervision
of the State and in which only nonpregnant animals are permitted based
on the animal being male, an owner certification that any female
animals have not been exposed to a male in the preceding 6 months, or
an ICVI issued by an accredited veterinarian stating the animals are
not pregnant, or the animals are under 6 months of age at time of
receipt, where only castrated males are maintained with female animals,
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.
(4) Records of all animals entering and leaving a terminal feedlot
must be maintained for 5 years after the animal leaves the feedlot and
must meet the requirements of Sec. 79.2, including either a copy of
the required owner/hauler statements for animals entering and leaving
the facility or the information required to be on the statements.
Records must be made available for inspection and copying by an APHIS
or State representative upon request.
Test eligible. An animal that meets a test protocol's age and post-
exposure elapsed time requirements for the test to be meaningfully
applied.
* * * * *

0
16. Section 79.2 is revised to read as follows:

Sec. 79.2 Identification and records requirements for sheep and goats
in interstate commerce.

(a) No sheep or goat that is required to be individually identified
or group identified by Sec. 79.3 may be sold, disposed of, acquired,
exhibited, transported, received for transportation, offered for sale
or transportation, loaded, unloaded, or otherwise handled in interstate
commerce or commingled with such animals or be loaded or unloaded at a
premises or animal concentration point (including premises that exhibit
animals) where animals are received that have been in interstate
commerce or from which animals are moved in interstate commerce unless
each sheep or goat has been identified in accordance with this section.
(1) The sheep or goat must be identified to its flock of origin and
to its flock of birth \4\ by the owner of the animal or his or her
agent, at whichever of the following points in interstate commerce
comes first:
---------------------------------------------------------------------------

\4\ You need not identify an animal to its flock of birth or its
flock of origin if this information is unknown because the animal
changed ownership while it was exempted from flock of origin
identification requirements in accordance with Sec. 79.6(a)(10)(i).
Such animals may be moved interstate with individual animal
identification that is only traceable to the State of origin and to
the owner of the animals at the time they were so identified. To use
this exemption the person applying the identification must have
supporting documentation indicating that the animals were born and
had resided throughout their life in the State.
---------------------------------------------------------------------------

(i) Prior to the point of first commingling of the sheep or goats
with

[[Page 11190]]

sheep or goats from any other flock of origin;
(ii) Upon unloading of the sheep or goats at a livestock facility
approved in accordance with Sec. 71.20 of this subchapter and that has
agreed to act as an agent for the owner to apply official
identification and prior to commingling with animals from another flock
of origin. Such facilities may identify animals after sale if the
facility maintains unidentified animals from different flocks of origin
or, when required, different flocks of birth in separate enclosures
until officially identified. The animals must be accompanied by an
owner/hauler statement that contains the information needed for the
livestock facility to officially identify the animals to their flock of
origin and, when required, their flock of birth;
(iii) Upon transfer of ownership of the sheep or goats;
(iv) If the owner of the premises or the owner of the animal
engages in the interstate commerce of animals, then prior to moving a
sheep or goat from the premises on which it resides, unless the animals
are moving to a livestock facility approved to handle the species and
class of animal to be moved as described in Sec. 71.20 of this
subchapter that has agreed to act as an agent for the owner to apply
official identification and in accordance with paragraph (a)(1)(ii) of
this section or to a slaughter plant listed in accordance with Sec.
71.21 of this subchapter as part of a group lot. Unless prohibited by
State law or regulation, this does not preclude a person from moving
animals as part of a group lot directly to another site in the same
State to have official eartags that have been assigned to the animal's
flock of origin in the National Scrapie Database applied to the
animals;
(v) In the case of animals that have only resided on premises and
in flocks owned by persons that do not engage in interstate commerce,
upon unloading a sheep or goat at a livestock facility or other
premises where animals are received that have been in interstate
commerce or from which animals are moved in interstate commerce and
prior to commingling with animals from another flock of origin. Such
animals must be accompanied by an owner/hauler statement that contains
the information needed to officially identify the animals to their
flock of origin and, when required, their flock of birth; or
(vi) Before moving a sheep or goat across a State line, unless
moving to an approved livestock facility that is approved to handle
that species and class of animals as described in Sec. 71.20 of this
subchapter that has agreed to act as an agent for the owner to apply
official identification, and prior to commingling with animals from
another flock of origin. Such animals must be accompanied by an owner/
hauler statement that contains the information needed for the livestock
facility to officially identify the animals to their flock of origin
and, when required, their flock of birth.
(2) The sheep or goats must be identified and remain identified
using a device or method approved in accordance with paragraph (k) of
this section. All animals required to be individually identified by
Sec. 79.3 shall be identified with official identification devices or
methods. A list of approved identification devices and methods,
including restrictions on their use, is available at https://www.aphis.usda.gov/animal-health/scrapie. Written requests for approval
of sheep or goat identification device types or methods not listed at
https://www.aphis.usda.gov/animal-health/scrapie should be sent to the
National Scrapie Program Coordinator, Strategy and Policy, VS, APHIS,
4700 River Road Unit 43, Riverdale, MD 20737-1235. If the Administrator
determines that an identification device or method will provide an
effective means of tracing sheep and goats in interstate commerce,
APHIS will provide public notice that the device type or method, along
with any restrictions on its use, has been added to the list of
approved devices and methods of official sheep and goat identification.
(3) No person shall buy or sell, for his or her own account or as
the agent of the buyer or seller, transport, receive for
transportation, offer for sale or transportation, load, unload, or
otherwise handle any animal that is in or has been in interstate
commerce that has not been identified as required by this section
including loading or unloading at a premises (including premises that
exhibit animals) where animals are received that have been in
interstate commerce or from which animals are moved in interstate
commerce. No person shall commingle animals with any animal that is in
or has been in interstate commerce that has not been identified as
required by this section. If the person transporting animals is aware
of any animal in the shipment that loses its identification to its
flock of origin while in interstate commerce, the person transporting
the animal is required to inform the receiving party of this fact, and
it is the responsibility of the person who has control or possession of
the animal upon unloading/delivery to identify the animal or have the
animal identified prior to commingling it with any other animals. This
shall be done by applying individual animal identification to the
animal as required in paragraph (a)(2) of this section and recording
the means of identification and the corresponding animal identification
number on the waybill or other shipping document. If the flock of
origin cannot be determined, all possible flocks of origin shall be
listed on the record, or if this cannot be done, the animal must be
identified with a slaughter only eartag and may only move in slaughter
channels or, in the case of sheep, may be officially identified and
moved for other purposes if the animal is inspected by an accredited
veterinarian, found free of evidence of infectious or contagious
disease and officially genotyped as AA QR or AA RR.
(b) The State Animal Health Official or Veterinary Services, Field
Operations, Area Veterinarian in Charge (AVIC) responsible for the
State involved, whoever is responsible for issuing official
identification devices or numbers in that State and for assigning flock
identification numbers and premises identification numbers in that
State in the National Scrapie Database, may issue sets of unique serial
numbers or flock identification/production numbers for use on official
individual identification devices (such as eartags or tattoos). Flock
identification/production numbers may only be assigned to owners of
breeding flocks.
(1) Animals not in slaughter channels. Official identification
numbers for use on animals not in slaughter channels may only be
assigned either directly to the owner of a breeding flock for
application to animals that originated in a breeding flock owned by
them or, in the case of official serial numbers or serial number
devices, to APHIS or State representatives or accredited veterinarians
or other responsible individuals as described in paragraphs (b)(2) and
(3) of this section APHIS or State representatives may apply official
identification to animals or issue official identification to owners of
breeding flocks for application to animals in those flocks. APHIS and
State personnel who apply or issue official identification must provide
to APHIS, in a manner acceptable to APHIS, assignment data associating
the serial numbers applied to animals or issued to owners, to the flock
of origin and, when required, the flock of birth. Accredited
veterinarians who apply official serial numbers or devices when
requested by APHIS a must provide to APHIS, in a manner acceptable to
APHIS, assignment data associating the serial sequences applied to
animals to the

[[Page 11191]]

flock of origin and, when required, the flock of birth. One such method
would be to enter the data into the National Scrapie Database. Such
requests may be made directly to a person or persons or to accredited
veterinarians as a group through amendment of the Scrapie Program
Standards Volume 1: National Scrapie Eradication Program.
(2) Assignment of serial numbers. The official responsible for
issuing eartags in a State may also assign serial numbers of official
eartags to other responsible persons, such as 4-H leaders, if the State
Animal Health Official and Veterinary Services, Field Operations, AVIC
responsible for the State involved agree that such assignments will
improve scrapie control and eradication within the State. Such persons
assigned serial numbers may either directly apply eartags to animals,
or may reassign eartag numbers to producers. Such persons must maintain
appropriate records in accordance with paragraph (g) of this section
that permit traceback of animals to their flock of origin, or flock of
birth when required, and must either reassign the tags in the National
Scrapie Database or, if permitted by the Veterinary Services, Field
Operations, AVIC responsible for the State involved, provide a written
record of the reassignment to the Field Office or the State Office for
entry into the National Scrapie Database.
(3) Persons handling sheep and goats in commerce. Sets of unique
individual identification serial numbers may be assigned to persons who
handle sheep and goats, that did not originate in a breeding flock
owned by them, if they apply to and are approved by the State Animal
Health Official or the Veterinary Services, Field Operations, AVIC
responsible for the State in which the person maintains his or her
business location, whichever is responsible for issuing official
identification devices or numbers in that State and for assigning flock
identification numbers and premises identification numbers in that
State in the National Scrapie Database. When requested by APHIS,
persons who apply official identification to sheep or goats that did
not originate in a breeding flock owned by them must provide, in a
manner acceptable to APHIS, assignment data associating assigned serial
sequences to the flock of origin and, when required, the flock of
birth. One such method would be to enter the data into the National
Scrapie Database. The request may be made directly to a person or
persons or to a class of persons through amendment of the Scrapie
Program Standards Volume 1: National Scrapie Eradication Program. The
State Animal Health Official or the Administrator may limit the
assignment of official identification devices or numbers to persons, or
classes of persons, for use on animals that did not originate in a
breeding flock owned by them to slaughter only devices or numbers.
(4) Breed registries. Sets of unique individual identification
numbers may also be assigned by the Administrator to breed registries
that agree to reassign the sequences to the flock of origin and, and
when required, the flock of birth and to provide associated registry
identifiers such as registry tattoo numbers to APHIS in the National
Scrapie Database.
(5) Noncompliance. In addition to any applicable criminal or civil
penalties any person who fails to comply with the requirements of this
section or that makes false statements in order to acquire official
identification numbers or devices shall not be assigned official
identification numbers or official identification devices for a period
of at least 1 year. If a person who is not in compliance with these
requirements has already been assigned such numbers, the Administrator
may withdraw the assignment by giving notice to such person. Such
withdrawal or failure to assign official identification numbers may be
appealed in accordance with Sec. 79.4(c)(3). A person shall be subject
to criminal and civil penalties if he or she continues to use assigned
numbers that have been withdrawn from his or her use.
(c) No person shall apply a premises or flock identification number
or a brand or earnotch pattern to an animal that did not originate on
the premises or flock to which the number was assigned by a State or
APHIS representative or to which the brand or earnotch pattern has been
assigned by an official brand registry. This includes individual
identification such as USDA eartags that have been assigned to a
premises or flock and registration tattoos that contain prefixes that
have been assigned to a premises or flock for use as premises or flock
identification. Unless the number sequence was issued specifically for
use on animals born in a flock, this would not preclude the owner of a
flock from using an official premises or flock identification number
tag assigned to that flock on an animal owned by him or her that
resides in that flock but that was born or previously resided on a
different premises as long as the records required in paragraph (g) of
this section are maintained.
(d) No person shall sell or transfer an official identification
device or number assigned to his or her premises or flock except when
it is transferred with a sheep or goat to which it has been applied as
official identification or as directed in writing by an APHIS or State
representative.
(e) No person shall use an official identification device or number
provided for the identification of sheep and goats other than for the
identification of a sheep or goat.
(f) Persons who engage in the interstate commerce of animals
including persons that handle or own animals that have been in
interstate commerce or that purchase, acquire, sell, or dispose of
sheep and/or goats from or to persons who engage in the interstate
commerce of animals, whether or not the animals are required to be
officially identified, must maintain business records (such as yarding
receipts, sale tickets, invoices, and waybills) for 5 years. These
persons must make the records available for inspection and copying by
any authorized USDA or State representative upon that representative's
request and presentation of his or her official credentials. The
records must include the following information:
(1) The number of animals purchased or sold (or transferred without
sale);
(2) The date of purchase, sale, or other transfer;
(3) The name and address of the person from whom the animals were
purchased or otherwise acquired or to whom they were sold or otherwise
transferred;
(4) The species, breed, and class of animal. If breed is unknown,
for sheep the face color and for goats the type (milk, fiber, or meat)
must be recorded instead;
(5) A copy of the brand inspection certificate for animals
officially identified with brands or ear notches;
(6) A copy of any certificate or owner/hauler statement required
for movement of the animals purchased, sold, or otherwise transferred;
and
(7) If the flock of origin or the receiving flock is under a flock
plan or post-exposure management and monitoring plan, any additional
records required by the plan.
(g) Persons who apply official individual or group/lot
identification to animals must maintain records for 5 years. These
persons must make the records available for inspection and copying by
any authorized USDA or State representative upon that representative's
request and presentation of his or her official credentials. The
records must include the following information:
(1) The flock identification number of the flock of origin, the
name and address of the person who currently owns the animals, and the
name and

[[Page 11192]]

address of the owner of the flock of origin if different;
(2) The name and address of the owner of the flock of birth, if
known, for animals in another flock and not already identified to flock
of birth;
(3) The date the animals were officially identified;
(4) The number of sheep and the number of goats identified;
(5) The breed and class of the animals. If breed is unknown, for
sheep the face color and for goats the type (milk, fiber, or meat) must
be recorded instead;
(6) The official identification numbers applied to animals by
species or the GIN applied in the case of a group lot;
(7) Whether the animals were identified with ``Slaughter Only'' or
``Meat'' identification devices; and
(8) Any GIN with which the animal was previously identified.
(h) Official identification devices are intended to provide
permanent identification of livestock and to ensure the ability to find
the source of animal disease outbreaks. Removal of these devices,
including devices applied to imported animals in their countries of
origin and recognized by the Administrator as official, is prohibited
except at the time of slaughter, at any other location upon the death
of the animal, or as otherwise approved by the State or Tribal animal
health official or the Veterinary Services, Field Operations, AVIC
responsible for the State involved when a device needs to be replaced.
(1) All man-made identification devices affixed to sheep or goats
moved interstate must be removed at slaughter and correlated with the
carcasses through final inspection by means approved by the Food Safety
and Inspection Service (FSIS). If diagnostic samples, including whole
heads, are taken, the identification devices must be packaged with the
samples and must be left attached to approximately 1 inch of tissue or
to the whole head to allow for identity testing and be correlated with
the carcasses through final inspection by means approved by FSIS.
Devices collected at slaughter must be made available to APHIS and
FSIS.
(2) All official identification devices affixed to sheep or goat
carcasses moved interstate for rendering must be removed at the
rendering facility and made available to APHIS. If diagnostic samples,
including whole heads, are taken, the identification devices must be
packaged with the samples and must be left attached to approximately 1
inch of tissue or to the whole head to allow for identity testing.
(3) If a sheep or goat loses an official identification device
except while in interstate commerce as described in paragraph (a)(3) of
this section and needs a new one, the person applying the new official
identification device must record the official identification number
from the old device, if known, in addition to the information required
to be recorded in accordance with paragraph (g) of this section.
(i) Replacement of official identification devices for reasons
other than loss include:
(1) Circumstances under which a State or Tribal animal health
official or the Veterinary Services, Field Operations, AVIC responsible
for the State involved may authorize replacement of an official
identification device include, but are not limited to:
(i) Deterioration of the device such that loss of the device
appears likely or the number can no longer be read;
(ii) Infection at the site where the device is attached,
necessitating application of a device at another location (e.g., a
slightly different location of an eartag in the ear);
(iii) Malfunction of the electronic component of a radio frequency
identification (RFID) device; or
(iv) Incompatibility or inoperability of the electronic component
of an RFID device with the management system or unacceptable
functionality of the management system due to use of an RFID device.
(2) Any time an official identification device is replaced, as
authorized by the State or Tribal animal health official or the
Veterinary Services, Field Operations, AVIC responsible for the State
involved, the person replacing the device must record the following
information about the event and maintain the record for 5 years:
(i) The date when the device was removed;
(ii) The address of the location and the name, phone number and
email address of the person responsible for the location where the
device was removed;
(iii) The official identification number (to the extent possible)
on the device removed;
(iv) The type of device removed (e.g., metal eartag, RFID eartag);
(v) The reason for the removal of the device;
(vi) The new official identification number on the replacement
device; and
(vii) The type of replacement device applied.
(j) Beginning on April 24, 2019, no more than one official eartag
may be applied to an animal; except that:
(1) Another official eartag may be applied providing it bears the
same official identification number as an existing one.
(2) In specific cases when the need to maintain the identity of an
animal is intensified (e.g., such as for export shipments, quarantined
herds, field trials, experiments, or disease surveys), a State or
Tribal animal health official or the Veterinary Services, Field
Operations, AVIC responsible for the State involved may approve the
application of a second official eartag. The person applying the second
official eartag must record the following information about the event
and maintain the record for 5 years: The date the second official
eartag is added; the reason for the additional official eartag device;
and the official identification numbers of both official eartags.
(3) An eartag with an animal identification number (AIN) beginning
with the 840 prefix (either radio frequency identification or visual-
only tag) may be applied to an animal that is already officially
identified with another eartag. The person applying the AIN eartag must
record the date the AIN tag is added and the official identification
numbers of all official eartags on the animal and must maintain those
records for 5 years.
(4) An official eartag that utilizes a flock identification number
may be applied to a sheep or goat that is already officially identified
with an official eartag if the animal has resided in the flock to which
the flock identification number is assigned.
(k) Requirements for approval of official identification devices
include:
(1) The Administrator may approve companies to produce official
identification devices for use on sheep or goats. Devices may be
plastic, metal, or other suitable materials and must be an appropriate
size for use in sheep and goats. Devices must be able to legibly
accommodate the required alphanumeric sequences. Devices must resist
removal and be difficult to place on another animal once removed unless
the construction of the device makes such tampering evident, but need
not be tamper-proof. Devices must be readily distinguishable as USDA
official sheep and goat identification devices; must carry the
alphanumeric sequences, symbols, or logos specified by APHIS; must be
an allowed color for the intended use, and must have a means of
discouraging counterfeiting, such as use of a unique copyrighted logo
or trade mark. Devices for use only on animals in slaughter channels
must be medium blue and marked with the words ``Meat'' or ``Slaughter
Only''. Devices that use RFID must conform to ISO 11784 and ISO 11785
standards unless otherwise approved. The Administrator may specify the
color, shape or size of a

[[Page 11193]]

device for an intended use to make them readily identifiable.
(2) Written requests for approval of official identification
devices for sheep and goats should be sent to the National Scrapie
Program Coordinator, Strategy and Policy, VS, APHIS, 4700 River Road
Unit 43, Riverdale, MD 20737-1235. The request must include:
(i) The materials used in the device and in the case of RFID the
transponder type and data regarding the lifespan and read range.
(ii) Any available data regarding the durability of the device,
durability and legibility of the identification numbers, rate of
adverse reactions such as ear infections, and retention rates of the
devices in animals, preferably sheep and/or goats.
(iii) A signed statement agreeing to:
(A) Send official identification devices only to a State or APHIS
representative, to the owner of a premises or to the contact person for
a premises at the address listed in the National Scrapie Database, or
as directed by APHIS;
(B) When requested by APHIS, provide a report by State of all tags
produced, including the tag sequences produced and the name and address
of the person to whom the tags were shipped, and provide supplemental
reports of this information when requested by APHIS;
(C) Maintain the security and confidentiality of all tag recipient
information acquired as a result of being an approved tag manufacturer
and utilize the information only to provide official identification
tags; and
(D) Enter the sequences of tags shipped in the National Scrapie
Database through an internet web page interface or other means
specified by APHIS prior to shipping the identification device.
(iv) Twenty-five sample devices. Additional tags must be submitted
if requested by APHIS.
(3) Approval will only be given for devices for which data have
been provided supporting high legibility, readability (visual and
RFID), and retention rates in sheep and goats that minimize injury
throughout their lifespan, or for which there is a reasonable
expectation of such performance. Approval to produce official
identification devices will be valid for 1 year and must be renewed
annually. The Administrator may grant provisional approval to produce
devices for periods of less than 1 year in cases where there is limited
or incomplete data. The Administrator may decline to renew a company's
approval or suspend or withdraw approval if the devices do not show
adequate retention and durability or cause injury in field use or if
any of the requirements of this section are not met by the tag company.
Companies shall be given 60 days' written notice of intent to withdraw
approval. Any person who is approved to produce official identification
tags in accordance with this section and who knowingly produces tags
that are not in compliance with the requirements of this section, and
any person who is not approved to produce such tags but does so, shall
be subject to such civil penalties and such criminal liabilities as are
provided by 18 U.S.C. 1001, 7 U.S.C. 8313, or other applicable Federal
statutes. Such action may be in addition to, or in lieu of, withdrawal
of approval to produce tags.

(Approved by the Office of Management and Budget under control
numbers 0579-0101 and 0579-0469)

0
17. Section 79.3 is revised to read as follows:

Sec. 79.3 General restrictions.

The following prohibitions and movement conditions apply to the
movement of or commingling with sheep and goats in interstate commerce,
and no sheep or goat may be sold, disposed of, acquired, exhibited,
transported, received for transportation, offered for sale or
transportation, loaded, unloaded, or otherwise handled in interstate
commerce, or commingled with such animals, or be loaded or unloaded at
a premises or animal concentration point (including premises that
exhibit animals) where animals are received that have been in
interstate commerce or from which animals are moved in interstate
commerce except in compliance with this part.
(a) No sexually intact animal of any age or castrated animal 18
months of age and older (as evidenced by the eruption of the second
incisor) may be moved or commingled with animals in interstate commerce
unless it is individually identified to its flock of birth \5\ and is
accompanied by an ICVI, except that an ICVI is not required unless the
animal is moved across a State line, and except for the following,
which may move with group lot identification and an owner/hauler
statement:
---------------------------------------------------------------------------

\5\ You need not identify an animal to its flock of birth or its
flock of origin if this information is unknown because the animal
changed ownership while it was exempted from flock of origin
identification requirements in accordance with Sec. 79.6(a)(10)(i).
Such animals may be moved interstate with individual animal
identification that is only traceable to the State of origin and to
the owner of the animals at the time they were so identified. To use
this exemption the person applying the identification must have
supporting documentation indicating that the animals were born and
had resided throughout their life in the State.
---------------------------------------------------------------------------

(1) Animals in slaughter channels that are under 18 months of age
(as evidenced by the eruption of the second incisor);
(2) Animals in slaughter channels at 18 months and older (as
evidenced by the eruption of the second incisor) if the animals were
kept as a group on the same premises on which they were born and have
not been maintained in the same enclosure with unidentified animals
from another flock at any time, including throughout the feeding,
marketing, and slaughter process;
(3) An owner/hauler statement may be used instead of an ICVI for
mixed source animals in slaughter channels 18 months of age and older
(as evidenced by the eruption of the second incisor) that are
identified with official individual identification or in the case of
animals from flocks that are low-risk commercial flocks that are
identified using identification methods or devices approved for this
purpose;
(4) Animals moving for grazing or other management purposes between
two premises both owned or leased by the flock owner and recorded in
the National Scrapie Database as additional flock premises and where
commingling will not occur with unidentified animals that were born in
another flock or any animal that is not part of the flock. A request to
APHIS to enter additional flock premises in the National Scrapie
Database is required before animals are first moved to the premises.
Notification is not required for each subsequent movement of animals to
that premises. Neither group lot ID nor an owner/hauler statement is
required for movements of a flock or its members for flock management
purposes within a contiguous premises spanning two or more States. This
provision does not include the transiting or sale of animals through
such a premises in circumvention of the other requirements of this
part; and
(5) Animals moving to a livestock facility approved in accordance
with Sec. 71.20 of this subchapter and that has agreed to act as an
agent for the owner to apply official identification if the animals
have been in the same flock in which they were born and have not been
maintained in the same enclosure with unidentified animals born in
another flock at any time. Such facilities may identify animals after
sale if the facility maintains unidentified animals from different
flocks of origin or when required birth in separate enclosures until
officially identified.
(b) No scrapie-positive or suspect animal may be moved other than
by

[[Page 11194]]

permit to an APHIS approved research or quarantine facility or for
destruction under APHIS or State supervision. Such animals must be
individually identified and listed on the permit.
(c) No indemnified high-risk animal or indemnified sexually intact
genetically susceptible exposed animal may be moved other than by
permit to an APHIS approved research or quarantine facility or for
destruction at another site. Such animals that are not indemnified and
are not scrapie-positive or suspect animals may be moved to slaughter
under permit. Animals moved in accordance with this paragraph must be
individually identified and listed on the permit.
(d) No exposed animal may be moved unless it is officially
individually identified.
(e) No animal may be moved from an infected flock or source flock
except as allowed by an approved flock plan.
(f) No animal may be moved from an exposed flock, a flock under
investigation or a flock subject to a PEMMP except as allowed in a
PEMMP or where a PEMMP is not required, as allowed by written
instructions from an APHIS or State representative.
(g) Animals moved to slaughter:
(1) Once an animal enters slaughter channels the animal may not be
removed from slaughter channels. An animal is in slaughter channels if
it was sold through a restricted animal sale, resided in a terminal
feedlot, was sold with a bill of sale marked for slaughter only, was
identified with an identification device or tattoo marked ``Slaughter
Only'' or ``MEAT'' or was moved in a manner not permitted for other
classes of animals. Animals in slaughter channels may move either
directly to a slaughter establishment that is under Food Safety and
Inspection Service (FSIS) jurisdiction per the Federal Meat Inspection
Act (FMIA) or under State inspection that FSIS has recognized as at
least equal to Federal inspection or to a custom exempt slaughter
establishment as defined by FSIS (9 CFR 303.1) for immediate slaughter
or to an individual for immediate slaughter for personal use or to a
terminal feedlot, or may move indirectly to such a destination through
a restricted animal sale or restricted livestock facility. Once an
animal has entered slaughter channels it may only be officially
identified with an official blue eartag marked with the words ``Meat''
or ``Slaughter Only'' or an ear tattoo reading ``Meat.'' Animals in
slaughter channels must be accompanied by an owner/hauler statement.
The statement must also include the name and address of the person or
livestock facility from which and where they were acquired, if
different from the owner; the slaughter establishment, restricted
animal sale, restricted livestock facility or terminal feedlot to which
they are being moved, and a statement that the animals are in slaughter
channels. A copy of the owner/hauler statement must be provided to the
slaughter establishment, restricted animal sale, restricted livestock
facility or terminal feedlot to which the animals are moved. Any bill
of sale regarding the animals must indicate that the animals were sold
for slaughter only.
(2) Animals that were in slaughter channels before arriving at a
sale and animals that cannot meet the ID and ICVI requirements for
unrestricted movement prior to leaving a sale may not be sold at an
unrestricted sale. This does not preclude animals sold at an
unrestricted sale from being moved in slaughter channels after sale if
identified as required for animals in slaughter channels.
(3) Animals in slaughter channels may not be held in the same
enclosure with sexually intact animals from another flock of origin
that are not in slaughter channels.
(h) No animals designated for testing as part of a classification
or reclassification investigation may be moved until testing is
completed and results reported, except for movement by permit for
testing, slaughter, research, or destruction. Such animals must be
individually identified and listed on the permit.
(i) The following animals, if not restricted as part of a flock
plan or PEMMP, may be moved to any destination without further
restriction after being officially identified and designated or
redesignated by a DSE to be:
(1) Genetically resistant exposed sheep;
(2) Genetically less susceptible exposed sheep; or
(3) Low-risk exposed animals.
(j) Animals moved from Inconsistent States must meet the following
requirements in addition to other requirements of this section.
(1) Sheep and goats not in slaughter channels must be enrolled in
the Scrapie Free Flock Certification Program or an equivalent APHIS
recognized program or be sheep that are officially genotyped and
determined to be AA QR or AA RR, be officially identified, and be
accompanied by an ICVI that also states the individual animal
identification numbers, the flock of origin, and the flock of birth, if
different.
(2) Animals in slaughter channels must be officially identified
with an official blue eartag marked with the words ``Meat'' or
``Slaughter Only'' and may move only directly to slaughter or to a
terminal feedlot. Animals 18 months of age and older (as evidenced by
the eruption of the second incisor) in slaughter channels must also be
accompanied by an ICVI that states the individual animal identification
numbers, and the flock of birth (and the flock of origin, if
different).
(k) APHIS may enter into compliance agreements with persons such as
dealers and owners of slaughter establishments and markets whereby
animals may be received unidentified or without a required owner/hauler
statement even if they cannot be identified to their flock of birth or
origin because they were moved or commingled while unidentified, in
violation of this part or a State requirement as provided by Sec.
79.6. Provided that, the agreement requires the person signing the
agreement to report the violation to the Veterinary Services, Field
Operations, AVIC responsible for the State involved so that corrective
action can be taken against the principal violator. In such cases the
animal must be identified with a slaughter only tag, and is moved only
in slaughter channels or, in the case of sheep, moved for other
purposes if the animal is inspected by an accredited veterinarian,
found free of evidence of infectious or contagious disease, and
officially genotyped as AA QR or AA RR where Q and R refer to codon 171
and A refers to codon 136. APHIS may also enter into compliance
agreements with persons or in the case of approved livestock facilities
may amend an approved livestock facility agreement to establish
alternative methods to maintain the traceability of animals in
slaughter channels to their flock of origin or waive the requirement
for individual official identification of animals in slaughter channels
if adequate surveillance has been conducted on the flock of origin or
an alternative plan is in place to conduct surveillance on animals from
the flock of origin when the Administrator and the State Animal Health
Official agree that the application of an allowed official
identification device or method is unsuitable for a specific
circumstance. An example of a specific circumstance could be large
unruly horned male goats moving through approved livestock facilities.

(Approved by the Office of Management and Budget under control
numbers 0579-0101 and 0579-0469)

[[Page 11195]]

0
18. Section 79.4 is revised to read as follows:

Sec. 79.4 Designation of scrapie-positive animals, high-risk animals,
exposed animals, suspect animals, exposed flocks, infected flocks,
noncompliant flocks, and source flocks; notice to owners.

(a) Designation. Based on a classification investigation as defined
in Sec. 79.1, including testing of animals, if needed, a designated
scrapie epidemiologist will designate a flock to be an exposed flock,
an infected flock, a source flock, a flock under investigation, and/or
a non-compliant flock, or designate an animal to be a scrapie-positive
animal, high-risk animal, exposed animal, genetically susceptible
exposed animal, genetically resistant exposed sheep, genetically less
susceptible exposed sheep, low-risk exposed animal, and/or a suspect
animal after determining that the flock or animal meets the criteria of
the relevant definition in Sec. 79.1.
(b) Redesignation. A reclassification investigation as defined in
Sec. 79.1 may be conducted to determine whether the current designated
status of a flock or animal may be changed or removed. Reclassification
investigations will be initiated and conducted, and redesignation
decisions will be made, in accordance with procedures approved by the
Administrator. These procedures are available at https://www.aphis.usda.gov/animal-health/scrapie.
(c) Testing and notification procedures. Any animal that may be a
high-risk animal, any animal that may have been exposed to the lambing
of a high-risk animal, any suspect animal, and any animal that was born
in the flock after a high-risk animal may have lambed may be selected
for testing by the DSE or an APHIS or State representative working
under the direction of a DSE or the Administrator. Which animals are
selected and the method of testing selected animals will be based on
the risk associated with the flock and the type and number of animals
available for test. When flock records are adequate to determine that
all high-risk animals that lambed in the flock are available for
testing, the testing may be limited to postmortem testing of all high-
risk and suspect animals. Testing may also include an official genotype
test, live-animal testing using a live-animal official test, the
postmortem examination and testing of genetically susceptible animals
in the flock that cannot be evaluated by a live animal test, postmortem
examination of other animals, and postmortem examination and testing of
animals found dead or cull animals at slaughter. Animals may not be
tested for scrapie to establish the designation of the flock until they
are test eligible. Animals are generally considered test eligible when
the animals are over 14 months of age if born after the exposure or are
18 months post exposure. If testing these animals is necessary to
establish the status of a flock they must be held for later testing
unless sent directly to slaughter or a terminal feedlot.
(1) Noncooperation. If an owner does not make his or her animals
available for testing within 60 days of notification by an APHIS or
State representative, within 60 days of becoming test eligible, or as
mutually agreed in writing by the Administrator and the owner, or fails
to submit required postmortem samples, the flock will be designated a
source, infected, or exposed flock, whichever definition applies and a
noncompliant flock.
(2) Notice to owner. As soon as possible after making a designation
or redesignation determination, a State or APHIS representative will
attempt to notify the owner(s) of the flock(s) or animal(s) in writing
of the designation.
(3) Appeal. The owner of an animal may appeal the designation of an
animal as a scrapie-positive animal, high-risk animal, exposed animal,
genetically susceptible exposed animal, genetically resistant exposed
sheep, genetically less susceptible exposed sheep, low-risk exposed
animal, or a suspect animal. The owner of a flock may appeal the
designation of the flock as an exposed flock, an infected flock, a
source flock, a flock under investigation, or a non-compliant flock.
The owner of a laboratory or test manufacturing facility may appeal the
suspension or withdrawal of approval for a laboratory or a test. To do
so, the owner must appeal by writing to the Administrator within 10
days after being informed of the reasons for the proposed action. The
appeal must include all of the facts and reasons upon which the owner
relies to show that the proposed action is incorrect or is not
supported. The Administrator will grant or deny the appeal in writing
as promptly as circumstances permit, stating the reason for his or her
decision. If there is a conflict as to any material fact, a hearing
will be held to resolve the conflict. Rules of practice concerning the
hearing will be adopted by the Administrator. The action under appeal
shall continue in effect pending the final determination of the
Administrator, unless otherwise ordered by the Administrator. The final
determination of the Administrator shall become effective upon oral or
written notification, whichever is earlier, to the owner. In the event
of oral notification, written confirmation shall be given as promptly
as circumstances allow. The Administrator's final determination
constitutes final agency action.

(Approved by the Office of Management and Budget under control
number 0579-0101)

0
19. Section 79.5 is revised as follows:

Sec. 79.5 Issuance of Interstate Certificates of Veterinary
Inspection (ICVI).

(a) ICVIs are required as specified by Sec. 79.3 for certain
interstate movements of sheep or goats and may be used to meet the
requirements for entry into terminal feedlots. An ICVI and all copies
must be legible and must show the following information, except when
Sec. 79.3 states that the information is not required for the specific
type of interstate movement:
(1) The ICVI must show the species, breed or, if breed is unknown,
the face color of sheep or the type of goats (milk, fiber, or meat),
and class of animal, such as replacement ewe lambs, slaughter lambs or
kids, cull ewes, club lambs, bred ewes, etc.; the number of animals
covered by the ICVI; the purpose for which the animals are to be moved;
the address at which the animals were loaded for interstate movement or
for movement to a terminal feedlot when an ICVI is required; the
address to which the animals are destined; and the names of the
consignor and the consignee and their addresses if different from the
address at which the animals were loaded or the address to which the
animals are destined; and if different the current owner;
(2) Each animal's official individual identification numbers:
Provided, that, in the case of animals identified with official
identifications devices or methods that include the flock
identification number(s) assigned to the flock(s) of origin in the
National Scrapie Database and an individual animal number unique within
the flock, the flock identification number(s) may be recorded instead
of the individual identification numbers, and for animals allowed by
Sec. 79.3 to move with group lot identification, the group lot number
may be recorded instead of the individual identification numbers. An
ICVI may not be issued for any animal that is not officially identified
if official identification is required. If the animals are not required
by the regulations to be officially identified, the ICVI must state the
exemption that applies (e.g., sheep and goats moving for grazing
without change of ownership). If the animals are required to be
officially identified but the identification number is not required to
be recorded on the ICVI, the ICVI must state that all animals to be

[[Page 11196]]

moved under the ICVI are officially identified and state the exemption
that applies (e.g. the ewes are identified with flock of origin tags so
only the flock ID must be recorded on the ICVI); and
(3) A statement by the issuing accredited, State, or Federal
veterinarian to the effect that on the date of issuance the animals
were free of evidence of infectious or contagious disease and insofar
as can be determined exposure thereto. This statement may be made with
respect to scrapie for animals exposed to scrapie that's movement is
not restricted that have been designated genetically resistant or less
susceptible sheep or low-risk exposed animals. Except as provided in
paragraphs (b) and (c) of this section, all information required by
this paragraph must be typed or legibly written on the ICVI. Note that
in accordance with paragraphs (a), (b), and (e) of Sec. 79.3, scrapie-
positive, suspect, and high-risk animals, some exposed animals, and
some animals that originated in an infected or source flock require
permits rather than ICVIs.
(4) The ICVI must be signed by the issuing State, Federal, Tribal
or accredited veterinarian and must be legible on all copies.
(b) As an alternative to typing or writing individual animal
identification on an ICVI, if agreed to by the receiving State or
Tribe, another document may be used to provide this information, but
only under the following conditions:
(1) The document must be a State form or APHIS form that requires
individual identification of animals or a printout of official
identification numbers generated by computer or other means;
(2) A legible copy of the document must be stapled to the original
and each copy of the ICVI;
(3) Each copy of the document must identify each animal to be moved
with the ICVI, but any information pertaining to other animals, and any
unused space on the document for recording animal identification, must
be crossed out in ink; and
(4) The following information must be written in ink in the
identification column on the original and each copy of the ICVI and
must be circled or boxed, also in ink, so that no additional
information can be added:
(i) The name of the document; and
(ii) Either the unique serial number on the document or, if the
document is not imprinted with a serial number, both the name of the
person who prepared the document and the date the document was signed.
(c) Ownership brands documents attached to ICVIs. As an alternative
to typing or writing ownership brands on an ICVI, an official brand
inspection certificate may be used to provide this information, but
only under the following conditions:
(1) A legible copy of the official brand inspection certificate
must be stapled to the original and each copy of the ICVI;
(2) Each copy of the official brand inspection certificate must
show the ownership brand of each animal to be moved with the ICVI, but
any other ownership brands, and any unused space for recording
ownership brands, must be crossed out in ink; and
(3) The following information must be typed or written in ink in
the official identification column on the original and each copy of the
ICVI and must be circled or boxed, also in ink, so that no additional
information can be added:
(i) The name of the attached document; and
(ii) Either the serial number on the official brand inspection
certificate or, if the official brand inspection certificate is not
imprinted with a serial number, both the name of the person who
prepared the official brand inspection certificate and the date it was
signed.
(d) If more than one page is used each page must be sequentially
numbered with the page number and the total number of pages (for
example 1 of 2, 2 of 2).

(Approved by the Office of Management and Budget under control
numbers 0579-0101 and 0579-0469)

0
20. Section 79.6 is amended as follows:
0
a. In paragraph (a) introductory text by adding the words ``, including
scrapie surveillance activities,'' after the words ``control
activities'';
0
b. By redesignating paragraphs (a)(10)(i) through (vi) as paragraphs
(a)(12) through (a)(17), respectively, and by revising paragraph
(a)(10);
0
c. By adding paragraph (a)(11);
0
d. In paragraph (b), by adding the words ``from the date the State is
notified of the deficiency'' after the words ``2-year extension'';
0
e. By adding paragraph (c); and
0
f. By adding an OMB citation at the end of the section.
The revision and additions read as follows:

Sec. 79.6 Standards for States to qualify as Consistent States.

(a) * * *
(10) Has effectively implemented ongoing scrapie surveillance that
meets the following criteria:
(i) Collects and submits surveillance samples from targeted animals
slaughtered in State-inspected establishments and from slaughter
establishments within the State that are not covered under Sec. 71.21
of this subchapter, or allows and facilitates the collection of such
samples by USDA personnel or contractors; and
(ii) Transmits required submission and epidemiological information
for all scrapie samples using the electronic submission system provided
by APHIS for inclusion in the National Scrapie Database and for
transmission of the submission information to an approved laboratory;
and
(iii) Achieves the annual State-level scrapie surveillance minimums
for sheep and goats originating from the State as determined annually
by the Administrator with input from the States and made available to
the public at https://www.aphis.usda.gov/animal-health/scrapie at least
6 months before the start of the collection period; or
(iv) Conducts annual surveillance at a level that will detect
scrapie if it is present at a prevalence of 0.1 percent in the
population of targeted animals originating in the State, with a 95
percent confidence.
(11) If a State does not meet the requirements of paragraph (a)(10)
of this section as of April 24, 2019, the State must provide APHIS with
a plan and a timeline for complying with all the requirements of
paragraph (a)(10) by April 24, 2020, and must meet the requirements of
paragraph (a)(10) of this section by April 26, 2021.
* * * * *
(c) When the Administrator determines that a State should be added
to or removed from the list of Consistent States, APHIS will publish a
notice in the Federal Register advising the public of the
Administrator's determination, providing the reasons for that
determination, and soliciting public comments. After considering any
comments we receive, APHIS will publish a second notice either advising
the public that the Administrator has decided to add or remove theState
from the list of Consistent States or notifying the public that the
Administrator has decided not to make any changes to the list of
Consistent States, depending on the information presented in the
comments.

(Approved by the Office of Management and Budget under control
number 0579-0101)

Done in Washington, DC, this 15th day of March 2019.
Greg Ibach,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2019-05430 Filed 3-22-19; 8:45 am]
BILLING CODE 3410-34-P

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