[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 http://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.
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    \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=.
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    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.
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    \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.
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    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 
``http://www.aphis.usda.gov/vs/scrapie'' and adding the internet 
address ``http://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 http://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 http://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 http://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 ``http://www.aphis.usda.gov/vs'' and adding the internet 
address ``http://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 
http://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 http://www.aphis.usda.gov/animal-health/scrapie. Written requests for approval 
of sheep or goat identification device types or methods not listed at 
http://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 http://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 http://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