[Federal Register Volume 80, Number 175 (Thursday, September 10, 2015)]
[Proposed Rules]
[Pages 54660-54692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21909]



[[Page 54659]]

Vol. 80

Thursday,

No. 175

September 10, 2015

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; Proposed Rule

  Federal Register / Vol. 80 , No. 175 / Thursday, September 10, 2015 / 
Proposed Rules  

[[Page 54660]]


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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: Proposed rule.

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SUMMARY: We are proposing to amend 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 also propose to provide designated scrapie 
epidemiologists with more alternatives and flexibility when testing 
animals in order to determine flock designations under the regulations. 
We propose to change 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 early maturing ewes. The 
proposed changes would also make the identification and recordkeeping 
requirements for goat owners consistent with those for sheep owners. 
These changes would affect sheep and goat producers, persons who handle 
sheep and goats in interstate commerce, and State governments.

DATES: We will consider all comments that we receive on or before 
November 9, 2015.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2007-0127.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2007-0127, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2007-
0127 or in our reading room, which is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 799-7039 before coming.

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

SUPPLEMENTARY INFORMATION: 

Background

    Scrapie is a member of a class of diseases called transmissible 
spongiform encephalopathies (TSEs). Scrapie is a degenerative and 
eventually fatal disease affecting the central nervous systems of sheep 
and goats. To control the spread of scrapie within the United States, 
the Animal and Plant Health Inspection Service (APHIS), U.S. Department 
of Agriculture (USDA), administers regulations at 9 CFR parts 54 and 79 
(referred to below as the scrapie regulations), which respectively 
describe program procedures and restrict the interstate movement of 
certain sheep and goats. APHIS also administers the voluntary Scrapie 
Flock Certification Program (the SFCP),\1\ described in regulations at 
9 CFR part 54, and produces program standards documents titled 
``Scrapie Program Standards Volume 2: Scrapie Free Flock Certification 
Program (SFCP)'' and ``Scrapie Eradication Uniform Methods and Rules'' 
(UM&R). Copies of the SFCP Standards and the UM&R are available on the 
APHIS Web site at http://www.aphis.usda.gov/animal_health/animal_diseases/scrapie/downloads/sfcp.pdf and http://www.aphis.usda.gov/animal_health/animal_diseases/scrapie/downloads/umr_scrapie.pdf, respectively, or by contacting the individual listed 
under FOR FURTHER INFORMATION CONTACT. The UM&R has been updated to be 
consistent with these proposed changes and has been renamed the Scrapie 
Program Standards Volume 1: National Scrapie Eradication Program. A 
draft of this document is available on the APHIS Web site at http://www.aphis.usda.gov/animal-health/scrapie. Comments on this document are 
being accepted concurrently with this proposed rule.
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    \1\ Formerly the Scrapie Flock Certification Program; this 
proposal would add the word ``Free'' to the program's name.
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    The last major revision of the scrapie regulations occurred on 
August 21, 2001, when we published in the Federal Register (66 FR 
43964, Docket No. 97-093-5) a final rule amending part 79 by imposing 
additional restrictions on the interstate movement of sheep and goats. 
We also added new requirements with regard to the identification, 
recordkeeping, and health status of sheep and goats in order to provide 
a more effective national program for surveillance of scrapie and for 
the tracing of animals affected with scrapie. In our August 2001 final 
rule, we also amended part 54 by reinstating a scrapie indemnification 
program for sheep and goats. Those changes to parts 54 and 79 were 
designed, in part, to provide a national standard for the control and 
eradication of scrapie, and to reflect our commitment to eliminating 
scrapie from the United States.
    The changes we are proposing in this document are based on our 
evaluation of input that we have received from the regulated industry 
and the States since the implementation of the August 2001 final rule. 
A number of regulatory changes have been suggested, including changes 
to the risk groups and categories established for individual animals 
and flocks, increased use of genetic testing as a means of assigning 
risk levels to flocks and animals, reduced movement restrictions for 
animals found to be genetically less susceptible or resistant to 
scrapie, and simplification and reduction of recordkeeping 
requirements. States have also requested that we provide designated 
scrapie epidemiologists (DSEs) with more alternatives and flexibility 
in determining how many and which animals in a flock must be tested in 
order to determine the flock's status under the regulations. We are 
also proposing changes to the procedures for paying indemnity for 
animals, based on input from industry on how to equitably decide which 
animals should qualify and how payment amounts should be set. This 
proposed rule addresses all of these areas.
    The scrapie regulations are quite complex, and understanding them 
is easier when a few overarching principles are kept in mind. One of 
these principles is trace back, which in this case means that whenever 
a sheep or goat is positively diagnosed with scrapie, APHIS or a State 
will investigate the past movements of the animal to identify other 
animals and flocks that may have been exposed to the scrapie-positive 
animal. A second principle is trace forward, which means that whenever 
an exposed sheep or goat is identified as having left an infected or 
source flock, APHIS or a State will investigate the movements of the 
animal to locate the animal for genetic and/or scrapie testing and to 
identify other

[[Page 54661]]

animals and flocks that may have been exposed to scrapie through the 
lambing of or contact with the lambing area of the potentially infected 
animal. This is done so that genetic and/or scrapie testing can be done 
to determine if any of the animals are or could be infected.
    This proposal would improve the ability of APHIS and States to 
trace animals. It would do this by changing 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 trace forward 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, and in Sec.  79.6(a)(5) 
regarding State responsibilities to do epidemiologic investigations of 
source and infected flocks that include tracing animals. The proposed 
rule 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.
    In addition to improving the utility of records for tracing 
animals, the proposed rule would 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 for such flocks imposed by Sec.  54.8.
    The proposal to enhance use of the National Scrapie Database would 
also aid trace back and trace forward. Proposed Sec.  54.11 would 
ensure official test results are recorded in the database and proposed 
Sec.  79.2(b) addresses linking animal identification numbers for sheep 
and goats in interstate commerce to flock of origin in the database.
    A third guiding principle in both the current and proposed 
regulations is flock risk level, which considers whether a flock has 
ever included an animal that is eventually diagnosed with scrapie or 
that was exposed to scrapie. If so, there is a risk that other animals 
from that flock may have scrapie. The flock risk level varies according 
to many factors. For example, the flock risk level would be very high 
if an animal that was born in the flock and spent its life in the flock 
until it was sold was diagnosed with scrapie shortly after being sold. 
In contrast, a flock's risk level would be lower if only one purchased 
exposed animal lambed in the flock, spent only a short time in the 
flock, and then was sent to slaughter without testing. A final guiding 
principle is that testing has limits to its practical utility. Scrapie 
is a long incubation disease, which makes it impossible to detect early 
infection with currently available tests. While there are now tests to 
diagnose scrapie using samples from both live and dead animals, it is 
almost never practical or cost effective for APHIS to simply test every 
animal in a sizeable flock in order to determine whether the flock 
contains infected animals. The current live animal test for scrapie 
requires a biopsy of the lymphoid tissue from the animal's third 
eyelid, rectum, tonsil, or a lymph node. Difficulties in sample 
collection and processing and the relatively small amount of third 
eyelid or rectal lymphoid tissue in some animals can result in 
significant numbers of ``no tests'' (i.e., tests that are not 
successfully completed because of insufficient follicles in the sample 
or other reasons), and the test is very labor intensive and expensive. 
Also, a single rectal biopsy or third eyelid test using biopsies from 
both third lids appears to have a diagnostic sensitivity of 
approximately 87 percent compared to postmortem immunohistochemistry 
testing on obex and lymph node when used in sheep over 14 months of 
age, which means the rectal biopsy or third eyelid test will not 
identify at least 13 percent of infected animals. Also, since scrapie 
is a long incubation disease, it typically takes 14 months or more 
after the animal becomes infected before these tests can detect the 
infection. This means that both the inherent diagnostic sensitivity of 
the tests and the number of animals tested that became infected less 
than 14 months ago affect testing accuracy, and as a result the 
percentage of infected animals not identified by the tests will be 
significantly higher than 13 percent.
    Those principles are all important factors in the design of the 
current scrapie regulations. Many of the changes we are proposing in 
this document incorporate an additional guiding principle, genetic 
resistance and susceptibility, discussed in detail below.

Current Understanding of Genetic Resistance and Susceptibility to 
Scrapie

    The Scrapie Ovine Slaughter Surveillance study \2\ conducted by 
APHIS (referred to below as the SOSS study) provides useful baseline 
information on the prevalence of scrapie in the United States and the 
relationship of different sheep genotypes to scrapie susceptibility. 
Some of the findings of that study are summarized below. Please refer 
to the study for complete details, including methodology and standard 
error rates.
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    \2\ The SOSS study and related information is available from the 
person identified under FOR FURTHER INFORMATION CONTACT or at http://www.aphis.usda.gov/animal_health/nahms/sheep/index.shtml.
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    Beginning April 1, 2002, and continuing through March 31, 2003, the 
SOSS study collected samples from 12,508 mature sheep at 22 slaughter 
plants and 1 large livestock market. Samples from 33 animals tested 
positive for scrapie. The overall weighted national prevalence of 
scrapie in mature cull sheep was estimated to be 0.20 percent.
    To evaluate the potential relationship between scrapie 
susceptibility and certain genotypes, approximately one-fourth of the 
negative samples (i.e., those in which the scrapie prion protein 
[PrPsc] was not detected) and all 33 of the scrapie-positive samples 
were submitted for genetic testing.
    Susceptibility to scrapie has been linked to certain codons in the 
sheep genotype. A codon is a set of three nucleotides that encode for a 
specific amino acid. Codons that encode for amino acids at positions 
136 and 171 in the prion protein (PrP) have been associated with 
scrapie susceptibility in sheep in the United States. However, codon 
171 is thought to be the major determinant of scrapie susceptibility in 
the United States.
    Codon values are stated as the diploid PrP genotype for the encoded 
amino acids. The relevant amino acid single-letter abbreviations are Q 
(glutamine) and R (arginine) for codon 171, and A (alanine) and V 
(valine) for codon 136. So, for example, a sheep genotype that

[[Page 54662]]

codes for glutamine in both of its alleles at codon 171 would be 
described as QQ. A very small number of sheep code for histidine (H) or 
lysine (K) at codon 171 and for threonine (T) at codon 136. The 
presence of histidine at 171 is presently thought to be similar to Q 
for scrapie resistance. Lysine at 171 has recently been found in a few 
Barbados sheep and T at 136 has been found in one sheep breed outside 
the United States, but the effects of these variations on scrapie 
resistance has not been fully studied. For this reason H or K at codon 
171 is treated the same as Q and T at codon 136 is treated the same as 
V.
    The following is a simplified summary of the current knowledge of 
how genotype affects susceptibility to scrapie. Two codons of the sheep 
genotype, codons 136 and 171, are especially important to scrapie 
susceptibility or resistance. In general, a glutamine (Q) at codon 171 
of the PrP allele is associated with susceptibility to scrapie. Sheep 
with two alleles with Q at codon 171 (QQ) are markedly susceptible; 
sheep with only one (QR) are rarely susceptible. Sheep that have two 
alleles with arginine at codon 171 (RR) appear to be very resistant. No 
cases of classical scrapie have been reported in 171 (RR) sheep in the 
United States and are rare in other countries.
    Codon 136 also has significant effects on scrapie susceptibility or 
resistance. There are at least two field strains of classical scrapie 
in the United States. When the strain to which a flock was exposed can 
be inferred, and the genotypes of sheep in the flock are known, this 
information can be used to depopulate only those exposed animals 
susceptible to the strain involved. The more prevalent strain, valine-
independent scrapie, accounts for at least 93 percent of scrapie cases 
and affects sheep with either valine (V) or alanine (A) at codon 136, 
but only very rarely affects sheep that also have at least one allele 
with arginine (R) at codon 171.
    The less common strain of classical scrapie in the United States, 
valine-associated scrapie, has only been reported in sheep with at 
least one allele with V at codon 136, and it is significantly more 
likely than the other strain to affect sheep with a single allele with 
R at codon 171, since it affects sheep that are AV at codon 136 and QR 
at codon 171.
    An important observation about the genetic results of the SOSS 
study is that 100 percent of the scrapie-positive sheep were coded QQ 
for codon 171. Other scientific studies and subsequent data collected 
by USDA confirm that U.S. sheep that test positive for scrapie coded QQ 
or QH for codon 171 in more than 99 percent of the cases. As 
illustrated by the following tables adapted from the SOSS study, 
approximately 40 percent of sheep in the United States were coded QQ 
for codon 171.

          Genotype Distribution in the General Sheep Population
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            Codon 136                  Codon 171            Percent
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                                  QQ................  40.
                                  QR................  44.
                                  RR................  16.
                                  ..................  Total: 100.
AA..............................  ..................  90.
AV..............................  ..................  9.
VV..............................  ..................  1.
                                  ..................  Total: 100.
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           Genotype Distribution in the Scrapie-Positive Sheep
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            Codon 136                  Codon 171            Percent
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                                  QQ................  100.
                                  ..................  Total: 100.
AA..............................  ..................  91.
AV..............................  ..................  6.
No test *.......................  ..................  3.
                                  ..................  Total: 100.
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* Samples could not be genotyped because of insufficient DNA or other
  reasons.

    The genotype of a sheep with respect to codons 136 and 171 can be 
represented by two pairs of letters; for example AA RR would indicate a 
sheep where both 136 codons are coded for alanine and both 171 codons 
are coded for arginine. This representation is used to discuss the 
scrapie susceptibility implications of different sheep genotypes.
    QQ sheep (AA QQ, AV QQ, and VV QQ) are susceptible to the more 
common U.S. scrapie strain and, if infected, can transmit the disease 
to susceptible flock mates. AA QQ sheep appear to be resistant to the 
less common valine-associated strain which affects AV QQ, VV QQ, and AV 
QR sheep. All genotypes of sheep and goats appear to be susceptible to 
non-classical scrapie. The United States has had 14 cases of non-
classical scrapie in sheep.
    In contrast, AA RR sheep are nearly completely resistant to, and 
are unlikely to carry or transmit classical scrapie. Only two sheep 
with classical scrapie that were AA RR have been reported worldwide.
    AA QR sheep are rarely susceptible to classical scrapie. In rare 
cases, AA QR sheep in Europe have become infected, and there have been 
two unconfirmed and three confirmed reports in AA QR U.S. sheep. It is 
unknown whether infected AA QR sheep can transmit the disease. The risk 
from exposed AA QR sheep is probably minor, since infected AA QR sheep 
are rare and it is less common for the scrapie prion protein to be 
found outside the brain of these sheep. However, AA QR sheep are 
susceptible to non-classical scrapie.
    AV QR sheep are somewhat susceptible to the valine associated 
scrapie strain. As of June 30, 2015, 11 confirmed positive AV QR sheep 
have been identified in the United States. The risk from exposed AV QR 
sheep is probably small, since infected AV QR sheep are uncommon, 
making up less than 1 percent of the scrapie-positive

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U.S. sheep that have been genotyped, and it is less common for the 
scrapie prion protein to be found outside the brains of these sheep. AV 
QR sheep are significantly less susceptible to the scrapie strains that 
affect them than are the QQ sheep that are affected by these strains.

Implications of Genetic Resistance and Susceptibility for Scrapie 
Program Design

    The observations discussed above, in conjunction with APHIS and 
State experience in conducting scrapie control pilot projects,\3\ 
suggest ways to improve the scrapie regulations' effectiveness and to 
reduce their costs by creating new risk categories for sheep and goats 
based on their scrapie resistance or susceptibility, and taking these 
risk categories into account when imposing regulatory restrictions on 
animals. In general, the animals that could have their status affected 
by genotype test results are exposed or potentially exposed animals. 
Most of the changes in this area would flow from the establishment of 
four new categories of exposed animals. Ordered by lowest to highest 
risk, these categories are: Genetically resistant exposed sheep, 
genetically less susceptible exposed sheep, low-risk exposed animal, 
and genetically susceptible exposed animals. As defined in the 
regulations, the terms exposed sheep and exposed animal both include 
embryos.
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    \3\ Pilot projects have tested, among other things, live animal 
scrapie tests, alternatives for improving field data collection for 
animals and flocks, innovative animal ID devices, use of genotype to 
classify the risk of exposed sheep and new devices and procedures 
for collecting tissue samples for DNA testing.
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    We would define genetically resistant sheep to include most sheep 
and sheep embryos with the RR genotype. The exception would be if a 
sheep with the RR genotype is ever epidemiologically linked to a 
scrapie-positive RR sheep or to a scrapie type that affects RR sheep. A 
genetically resistant sheep that was exposed to scrapie would be a 
genetically resistant exposed sheep. Genetically less susceptible sheep 
would include most sheep (or sheep embryos) with the AA QR or AV QR 
genotype. A low-risk exposed animal would be a sheep or goat deemed to 
present significantly lower risks than a typical exposed animal due to 
the nature of either the exposure or the animal. The exact definitions 
for these categories are discussed in more detail below. Flexibility 
has been written into these definitions to allow the Administrator to 
adjust the classification of animals based on the strain involved and 
the genotype of the animal as additional research becomes available.
    Genetically susceptible animals would include all goats, any sheep 
with a genotype other than QR or RR (such as QQ, HH, QH, QK, KK or KH), 
and any sheep with an unknown or undetermined genotype (i.e., sheep 
that have not been officially genotyped or sheep that have been tested 
with inconclusive results). At present, all goats would be considered 
genetically susceptible because there is insufficient understanding of 
genetically based scrapie resistance in goats to reliably assign goat 
risk categories based on genetics. If ongoing and future research 
provides new information about the genetic resistance of sheep or goats 
to scrapie that would allow other useful distinctions in risk between 
different genotypes of sheep or goats, APHIS will take such research 
results into account in the design of the Scrapie Eradication Program. 
The Scrapie Eradication Program is the cooperative State-Federal-
Industry program administered by APHIS and States to control and 
eradicate scrapie, encompassing the SFCP, Federal and State regulations 
regarding the identification and movement of sheep and goats and the 
control of scrapie, and other associated efforts.
    In order to assign individual sheep to one of these genetic 
susceptibility categories, APHIS has established procedures to ensure 
that genotype tests conducted as part of the Scrapie Eradication 
Program are reliable. We propose to amend the definition of official 
genotype test to read ``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.''
    The primary change from the previous definition is that new 
paragraph (3) would allow owners to collect samples for official 
genotype tests and to clarify that when a sample is submitted it must 
be accompanied by a properly completed official form. We believe this 
would make it more convenient and less expensive for owners to obtain 
genotype testing; however, it is also critical that the sample is from 
an animal that is officially identified and that the sample maintains 
its identity and its association with the correct animal throughout the 
process of collection and submission. We propose to stress that the 
form must be properly completed due to the significant percentage of 
forms submitted to approved laboratories that are incomplete or 
undecipherable. To protect against error and tampering, we propose to 
allow owners or owner agents \4\ to collect samples for official 
genotype testing only by using an APHIS-approved tamper-resistant 
sampling kit. This kit would be an official identification device that, 
when it is attached to the animal, collects and ejects a tissue sample 
in a sealed container. Both the tissue sample container and the 
official identification device that remains attached to the animal 
would bear the same identification number, reliably associating the 
tissue with the correct animal. We propose to add a new term to part 
54, tamper-resistant sampling kit, defined as ``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) 
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.'' This definition is intended to allow the market to 
develop innovative approaches to the task by allowing the Administrator 
to approve a wide variety of potential kits. APHIS also employs this 
approach of encouraging market innovation and approving successful 
methods in our proposed changes to Sec.  54.10, ``Program approval of 
tests for scrapie,'' and Sec.  54.11, ``Approval of laboratories to run 
official scrapie tests and official genotype tests,'' which are 
discussed later in this document.
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    \4\ APHIS or State representatives or accredited veterinarians 
would not have to use tamper-resistant sampling kits when collecting 
samples.
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    Note that in addition to approving tamper-resistant sampling kits, 
test methodologies, and laboratories that may perform tests, APHIS 
reserves the right to require confirmatory genotype

[[Page 54664]]

testing. This is an additional safeguard that may be used to ensure 
result validity when evaluating official genotype test results, e.g., 
when the result of the genotype test is inconclusive for codon 136 or 
171 or as part of a standard quality assurance procedure.
    We propose to amend the regulations in several ways to provide for 
the use of the genotype information, and, with the resulting capability 
to classify exposed animals as genetically susceptible, genetically 
less susceptible, or genetically resistant, would be able to more 
precisely classify the risk that an individual exposed animal may 
spread scrapie. We would incorporate genetic susceptibility into the 
definitions of exposed animal and high-risk animal, reducing the 
percentage of animals subject to the most severe regulatory 
restrictions, including euthanasia and destruction. We would also 
modify Sec.  79.3 to consider genetic susceptibility in its 
restrictions on exposed animal movement, so that the animals most 
resistant to scrapie face fewer restrictions than other exposed 
animals. Laboratories that perform official genotype tests already 
enter the results in the National Scrapie Database to maximize the 
availability and usefulness of genotype information, and we propose to 
include this data entry requirement in Sec.  54.11, the section 
concerning approval of laboratories to perform the test. We also 
propose to add a requirement to Sec.  79.5(a)(3) that Interstate 
Certificates of Veterinary Inspections (ICVIs) or permits used for 
interstate movement of breeding animals record the animals' genetic 
susceptibility category if known. We would take genetic susceptibility 
into account when writing flock plans and PEMMPs. Finally, to make the 
most effective use of limited indemnity funds, when paying indemnity 
for exposed animals we would generally only pay indemnity for exposed 
sheep that are officially genotyped and designated genetically 
susceptible exposed sheep. We would only pay indemnity for non-
genotyped sheep in circumstances such as when the Administrator 
determines that waiting for genotype test results could result in the 
exposure of more animals, or when the cost of testing the sheep and 
indemnifying only those that are genetically susceptible would approach 
or exceed the cost of indemnity for all the exposed sheep involved. We 
would not require that goats be genotyped to be eligible for indemnity 
because, as discussed above, present understanding of genetically based 
scrapie resistance in goats does not allow us to reliably assign goat 
risk categories based on genetics.
    Under the regulations, animals for which indemnity is paid must be 
destroyed. The current definition of destroyed includes euthanasia and 
disposal of the carcass by means authorized by the Administrator, or 
movement to a quarantined research facility when so ordered by the 
Administrator. Currently the definition also states that if the animal 
to be destroyed is an exposed or high-risk animal that is not known to 
be infected, it may be either euthanized or disposed of by slaughter. 
The World Organization for Animal Health guidelines for scrapie control 
recommend that the carcasses of scrapie affected animals be completely 
destroyed to reduce potential scrapie exposure through consumption of 
feed containing animal proteins. Also, in recent years the Food and 
Drug Administration (FDA) and USDA have increased their efforts to 
reduce potential animal or human exposure to TSEs through consumption 
of feed or food containing animal proteins. Changes in this area have 
included \5\ additional restrictions to prevent inclusion of certain 
tissues from cattle (specified risk materials) that present a 
particular risk of containing BSE from being used in animal or human 
food. In support of this effort, we propose to no longer allow the 
carcasses of any sheep or goats indemnified and destroyed under the 
regulations to be used for feed or food.
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    \5\ See, e.g., the FSIS rule ``Prohibition of the Use of 
Specified Risk Materials for Human Food and Requirements for the 
Disposition of Non-Ambulatory Disabled Cattle'' (72 FR 38700; July 
13, 2007) and the FDA rule ``Substances Prohibited From Use in 
Animal Food or Feed'' (73 FR 22719, April 25, 2008).
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    APHIS indemnified and destroyed 235 sheep and goats during the 
first 6 months of 2014 under the regulations, of which 133 were 
destroyed by slaughter. This change would therefore divert on average 
approximately 266 sheep and goats per year from slaughter channels; 
however, it is expected that as the program progresses the number of 
animals indemnified will decrease and thus the number of animals 
diverted will decrease. Postmortem testing of mature scrapie exposed 
sheep and goats in FY 2013 and FY 2014 resulted in 5.6 and 2.7 percent 
of the animals testing positive for scrapie, respectively. In FY 2014, 
a large scrapie source flock with a very low prevalence accounted for 
about half of the animals depopulated in FY 2014. If this flock is 
excluded, the percent of exposed animals that tested positive is 
approximately 4.8 percent. Therefore, this change would likely keep 
approximately 12 to 15 scrapie-positive animals from food or feed uses 
each year.
    To accomplish this change, we propose to revise the definition of 
destroyed to read as follows: ``Euthanized and the carcass disposed of 
by means authorized by the Administrator that will prevent its use as 
feed or food, or moved to a quarantined research facility if the 
movement has been approved by the Administrator.'' This proposed change 
would work in concert with the proposed movement restriction in Sec.  
79.3(c), that indemnified high-risk animals or indemnified sexually 
intact genetically susceptible exposed animals, which pose the most 
risk, may only be moved for destruction. These changes would ensure 
that the riskiest animals are kept from slaughter, without precluding 
movement under permit to slaughter of less risky genetically 
susceptible exposed animals that are not indemnified. This would allow 
animals from flocks under investigation that are not yet known to be 
infected and lambs that are likely too young to have developed 
significant scrapie agent presence to continue to move to slaughter.
    In the following sections, we discuss in detail how genotype 
information would affect the regulations' definitions, movement 
restrictions, indemnity provisions, and other requirements.

Changes to Flock and Animal Designation Categories

    We propose to make several changes to the definition of the term 
exposed flock and to define two new terms, flock under investigation 
and classification or reclassification investigation. As currently 
defined, the term exposed flock is rather broad and encompasses notably 
different risk levels. For example, a flock could be designated exposed 
because an animal that may be scrapie-positive lambed in the flock, 
which is probably the event that has the single highest probability of 
transmitting scrapie to other animals. However, a flock could also be 
designated as exposed if a single animal in the flock was once briefly 
in a different flock that contained a scrapie-positive animal.
    The current definition of exposed flock was written before 
effective live-animal tests for scrapie were available and before 
genetic testing was widely accepted for evaluating risk. Now that such 
tests are available and accepted, sometimes flocks that would be 
designated exposed under the current definition could avoid such a

[[Page 54665]]

designation under the revisions we propose. For example, an 
investigator may know that a flock has a risk factor, and that we 
should pay attention to the flock, but cannot determine the actual risk 
without testing the animal that caused the potential exposure or, in 
its absence, other animals in the flock. Live animal tests are now 
available to aid in this determination.
    To address these problems, we are developing a new category, flock 
under investigation. A flock under investigation is a flock that may 
have become scrapie infected by exposure to a scrapie-positive, high-
risk, or scrapie-suspect animal, however, further investigation of 
animal records and/or testing of animals in the flock may be necessary 
to make the final determination. A flock under investigation may be 
cleared by demonstrating that it was not in fact exposed, or by taking 
steps to ensure that, whether or not the flock was exposed, there is no 
significant possibility that animals in the flock were infected as a 
result of the exposure. Such steps could include genotyping some or all 
of the animals in the flock, then removing and destroying and/or 
testing the genetically susceptible animals and/or having the flock 
comply with a PEMMP.
    Creating the category of flock under investigation would leave the 
category of exposed flock to apply to only those flocks where there has 
been exposure or potential exposure that could not be adequately 
assessed, and/or the risks of exposure have not been sufficiently 
mitigated, so there is some significant continuing risk that a scrapie-
positive animal might be detected in the flock. An exposed flock could 
be a flock under investigation whose owner declined to complete the 
genotyping or scrapie testing needed to complete the investigation, or 
declined to remove one or more genetically susceptible exposed animals 
or suspect animals identified during the investigation. Thus, the 
category of exposed flock would generally apply to flocks where the 
owner has decided to accept some level of continuing scrapie risk, 
rather than undertake the actions that would resolve the remaining 
risk.
    Specifically, we propose to define these two categories as follows. 
A flock under investigation would be any flock in which an APHIS or 
State representative has determined that a scrapie suspect, positive, 
or high-risk animal resides or may have resided. (Note that mere 
removal of any suspect or high-risk animals is not sufficient grounds 
to end investigation of the flock.) A flock would no longer be a flock 
under investigation if it is redesignated in accordance with Sec.  
79.4. A flock may be redesignated for various reasons, including a 
determination that it is an infected flock, source flock, or exposed 
flock, or that tissues from the suspect and high-risk animals were 
submitted for official testing and no evidence of scrapie is found, or 
because the flock completed any genotyping and live-animal or post-
mortem scrapie testing required by the DSE and is in compliance with a 
PEMMP if one is required by the DSE.
    An exposed flock would be 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. The definition would 
also include 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 investigator, and 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 considered an exposed flock if it is redesignated in 
accordance with Sec.  79.4.
    We also propose to change the definition for noncompliant flock to 
recognize the role of the new category flock under investigation. The 
current definition refers to source, infected, or exposed flocks that 
are not in compliance with the regulations; we propose to also include 
flocks under investigation that are not in compliance.
    We would also add a new defined term, classification or 
reclassification investigation, to consolidate descriptions of 
epidemiological investigation activities that were formerly located in 
several places in the regulations. This defined term would not impose 
new requirements, but would instead help the reader understand what 
epidemiological considerations a DSE would employ when determining the 
designation of an animal or flock under the Scrapie Eradication 
Program. The new term would be defined as follows: ``An epidemiological 
investigation conducted or directed by a DSE for the purpose of 
designating or redesignating the status 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.''
    We also propose to revise the definition of exposed animal so that 
it employs the concepts of genetic resistance or susceptibility 
discussed above. It also includes a standard for estimating a probable 
date of infection for a flock, which is relevant to identifying which 
animals were exposed. Where epidemiologic investigation is 
inconclusive, we use a probable date of infection 2 years before the 
birth of the oldest scrapie-positive animal in the flock. The 2-year 
range is used because the oldest positive animal was likely infected at 
or near birth by another positive animal that died and that positive 
animal likely exposed up to two previous lamb crops before she died 
since most positive animals die 3-to-4 years after infection. The 
revised definition we propose for exposed animal would read ``Any 
animal or embryo that: (1) Has been in a flock or in an enclosure off 
the premises of the flock with a scrapie-positive female animal, (2) 
resides in a noncompliant flock, or (3) 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(s) 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.''
    We also propose to add definitions of several terms related to 
genetic susceptibility and resistance that appear in the defined term 
exposed animal. These new terms reflect the fact, as discussed above, 
that the genetic resistance or susceptibility of an exposed animal 
affects the risk level of

[[Page 54666]]

that exposed animal. Therefore, we propose to add the following 
definitions.
    We would define genetically less susceptible exposed sheep as ``Any 
sheep or sheep embryo that is:
     An exposed sheep or sheep embryo of genotype AA QR, unless 
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 
where Q represents any genotype other than R at codon 171; or
     An exposed sheep or sheep embryo of genotype AV QR, unless 
it is epidemiologically linked to a scrapie-positive RR or QR sheep, to 
a flock that the DSE 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 where Q represents 
any genotype other than R at codon 171 and V represents any genotype 
other than A at codon 136; 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 but not resistant.''
    We would define genetically resistant exposed sheep as ``Any 
exposed sheep or sheep embryo of genotype RR unless it is 
epidemiologically linked to a scrapie-positive RR sheep or to a scrapie 
type to which RR sheep are not resistant.''
    We would define genetically susceptible animal as ``Any goat or 
goat embryo, sheep or sheep embryo of a genotype other than RR or QR, 
or sheep or sheep embryo of undetermined genotype where Q represents 
any genotype other than R at codon 171.''
    We would define genetically susceptible exposed animal as 
``Excluding low-risk exposed animals, any exposed animal or embryo that 
is also:
     A genetically susceptible animal; or
     A sheep or sheep embryo of genotype AV QR that is 
epidemiologically linked to a scrapie-positive RR or QR sheep, to a 
flock that the DSE 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 where Q represents any genotype other than R 
at codon 171 and V represents any genotype other than A at codon 136; 
or
     A sheep or sheep embryo of genotype AA QR that is 
epidemiologically linked to a scrapie-positive RR or AA QR sheep or to 
a scrapie type to which AA QR sheep are susceptible where Q represents 
any genotype other than R at codon 171; or
     A sheep or sheep embryo of genotype RR that is 
epidemiologically linked to a scrapie-positive RR sheep or to a scrapie 
type to which RR sheep are susceptible.''
    We also propose to add the following definition of low-risk exposed 
animal, identifying exposed animals that are of very low-risk of 
transmitting scrapie so that the program can avoid ordering the 
destruction of such animals. For example current science indicates that 
sheep and goats exposed to Nor98-like scrapie are unlikely to transmit 
the disease to other animals. Barring the publication of new data to 
the contrary, the Administrator intends to determine that animals 
exposed to Nor98-like scrapie are low-risk exposed animals.
    We would define low-risk exposed animal as ``Any exposed animal to 
which the DSE has determined one or more of the following applies:
     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;
     The Administrator and State Veterinarian 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;
     The exposed animal is male and was not born in an infected 
or source flock;
     The exposed animal is a castrated male;
     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
     The animal was exposed to a scrapie type and/or is of a 
genotype that the Administrator has determined poses low risk of 
transmission.''
    We also propose to amend the definition of the term high-risk 
animal. The current definition includes most exposed male sheep, 
excluding only male sheep that have been genotyped and found to be 
genetically resistant (RR at codon 171). Both the current and the 
proposed definition include all female progeny of a scrapie-positive 
dam, and all exposed genetically susceptible female sheep. The current 
definition also automatically included all female sheep that were born 
into a flock during the same lambing season that a scrapie-positive 
female lambed in the flock or a scrapie-positive female was born into 
the flock. We now believe that, while many of the female sheep born in 
such a lambing season should be considered high risk, some of them 
should not, based primarily on the genetic susceptibility of the 
animals involved. The proposed new definition generally excludes male 
sheep (except suspect animals that need to be investigated, and 
occasional special cases identified by the Administrator) because 
accumulated epidemiological evidence shows little chance that a male 
sheep could present a high risk of transmitting scrapie.
    The epidemiology and scrapie prevalence of the flock would also be 
considered in determining the risk level of genetically less 
susceptible sheep. We propose to amend the definition of high-risk 
animal to give the Administrator, and persons authorized to act for the 
Administrator (e.g., DSEs) some discretion in whether or not to 
classify genetically less susceptible sheep as high-risk. Specifically, 
we would revise the definition of high-risk animal to read ``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 
based 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.''
    We also propose to amend the definition of suspect animal in parts 
54 and 79. The new definition could apply only to an animal that is a 
``mature sheep or goat as evidenced by eruption of the first incisor.'' 
This change reflects the reality that clinical signs of scrapie do not 
appear in very young animals. The revised definition also notes that a 
suspect animal might be one that was determined to be suspicious for 
scrapie by an accredited veterinarian or a State or APHIS 
representative, as the current definition states, or it might be an 
animal ``condemned by FSIS or a State inspection authority for central 
nervous system signs.'' This change reflects the reality that the 
condemnation process sometimes leads to identification of suspect 
animals.

Updating Other Definitions in Parts 54 and 79

    To support and clarify some of the changes discussed above, we 
propose to

[[Page 54667]]

make several changes to the definitions of some of the terms already in 
use in parts 54 and 79. In addition to the new and revised definitions 
discussed above, we would also add or amend the following definitions:
    Low-risk commercial sheep and low-risk goat. These defined terms 
are used only in part 79. We propose to replace the current definition 
of low-risk commercial sheep and low-risk goat with a definition of 
low-risk commercial flock. The current definition of low-risk 
commercial sheep excludes goats, and the regulations use the defined 
term to allow certain movements of sheep that present a low risk. We 
believe that it would be sensible to use definitions that apply to both 
sheep and goats from low-risk flocks, because such sheep and goats are 
both documented to present minimal risk of spreading scrapie. The 
proposed definition of low-risk commercial flock incorporates the 
standards in the current definition of low-risk commercial sheep but 
applies them to goats as well as sheep. This change does not 
significantly affect the treatment of low-risk commercial sheep under 
the regulations and gives equal consideration to goat owners. Note that 
animals that have been in contact with any female animals that do not 
qualify as low-risk commercial animals, or that are of unknown origin, 
would not be considered low-risk commercial animals. These changes, 
coupled with corresponding changes in Sec.  79.3, require the official 
identification of many goats that were previously defined as low-risk 
commercial goats and exempted.
    The proposed definition of low-risk exposed animal also 
acknowledges the concept that some animals may meet the definition of 
an exposed animal but present little risk of scrapie transmission; by 
designating these animals as low-risk exposed animals, they are not 
required to be destroyed and are instead identified to increase 
traceability.
    Premises identification number (PIN). This defined term is used 
only in part 79. The PIN appears on premises records in the National 
Scrapie Database and has been used on official identification devices 
and recorded on ICVIs and other documents related to the Scrapie 
Eradication Program. It is a unique number assigned by a State or 
Federal animal health authority that is associated with a physical 
address and/or legal land description. The current definition of 
premises identification number states that the form of the number must 
be either (1) the State's two-letter postal abbreviation followed by 
the premises' assigned number or (2) a seven-character alphanumeric 
code, with the right-most character being a check digit. The check 
digit number is based upon the ISO 7064 Mod 36/37 check digit 
algorithm.
    We propose to amend this definition to provide uniformity between 
animal disease programs. The clarification is that all premises will 
have either a premises identification number created under the current 
definition's option (2) or a number issued by a State that is a 
nationally unique location identifier, which will identify that 
premises in the National Scrapie Database and related records. USDA and 
the States may also maintain secondary numbers created under option (1) 
to link historical premises numbers to the standardized program 
premises identification number in records and databases. Federal or 
State officials will generate a standardized program premises 
identification number both for existing premises in the National 
Scrapie Database and for any new premises.
    Flock identification (ID) number and group/lot identification 
number. We propose adding a definition of flock identification number 
to part 79 to refer to a number assigned by a State 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. This identifier 
is needed because a flock may move between multiple premises without 
changing ownership. The flock ID number would be nationally unique, 
would begin with the State postal abbreviation, would have no more than 
nine alphanumeric characters, and could not contain the characters 
``I'', ``O'', or ``Q'' other than as part of the State postal 
abbreviation. The flock ID number will be linked to the standardized 
program premises identification number(s) for the premises on which the 
flock resides and may serve as part of the number on an official eartag 
when used in conjunction with an animal number that is unique within 
the flock. We also propose to define a similar group/lot identification 
number to establish unique identification for groups of animals that 
are temporarily assembled from flocks for management purposes and that 
may or may not be under single ownership.
    Slaughter channels. The first sentence of this definition currently 
reads ``Animals in slaughter channels include any animal that is sold, 
transferred, or moved either directly to a slaughter facility, to an 
individual for custom slaughter, or for feeding for the express purpose 
of improving the animals' condition for movement to slaughter.'' We 
propose to change this to read ``. . . moved either directly to or 
through a restricted animal sale or restricted livestock facility to a 
slaughter establishment that is under continuous inspection by the Food 
Safety and Inspection Service (FSIS) 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 for immediate 
slaughter or to an individual for immediate slaughter for personal use 
or to a terminal feedlot. Any animal sold at an unrestricted sale is 
not in slaughter channels. Animals in slaughter channels must be 
accompanied by an owner/hauler statement completed in accordance with 
Sec.  79.3(g) of this chapter.'' This change would make the definition 
more consistent with definitions in other APHIS regulations that 
address slaughter. It would also clarify that animals are in slaughter 
channels whether they are moved to such a destination directly or 
through intermediaries, and may not be removed from slaughter channels, 
a requirement stated in several sections of the regulations, including 
current Sec.  79.3(a) and proposed Sec.  79.3(g). We are also proposing 
to add a definition for restricted animal sale or restricted livestock 
facility to parts 54 and 79 to further clarify slaughter channels.
    We also propose to add a new provision to the definition of 
terminal feedlot in part 79, and to add this definition to part 54 as 
well. The current definition authorizes two types of facilities as 
terminal feedlots. In one, either pregnant or non-pregnant animals may 
be maintained on a dry lot where all animals are separated by either 30 
feet of distance or a solid wall. The second type of facility is 
limited to only non-pregnant animals (males, or ewes that have not been 
exposed to a ram) and is a pasture where no fence-to-fence contact is 
possible between animals in one flock and animals in another. The 
definition reflects the risk-based need for a higher level of security 
and less opportunity for contact where pregnant animals are involved. 
However, the definition does not address situations where only non-
pregnant animals are kept at a dry lot, so the dry lot does not need to 
maintain the additional safeguards used when pregnant animals are 
present. We propose to add a paragraph that allows non-pregnant animals 
to be maintained at a dry lot under conditions similar to those used 
with non-pregnant animals in a pasture. Specifically, we would add 
language stating that one type of terminal feedlot is a dry lot ``. . . 
where only animals that either are not pregnant based on the animal 
being male, an owner

[[Page 54668]]

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 open, 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 and from 
which animals are moved only to another terminal feedlot or directly to 
slaughter.''

Changes to the Investigation of Flocks and the Designation of a Flock- 
and Animal's Risk for Scrapie

    We propose to make several changes to the descriptions in Sec.  
79.4 regarding the investigation procedures followed by officials who 
are authorized to designate or redesignate exposed animals, suspect 
animals, high-risk animals, exposed flocks, infected flocks, and source 
flocks. These proposed changes are to improve the clarity and 
practicality of the regulations.
    We also propose to remove some repetitive language concerning 
investigation and testing from paragraph (a) of Sec.  79.4. This 
language is no longer needed due to the new proposed definition for 
classification or reclassification investigation.
    In paragraph (b) of Sec.  79.4, we propose to remove the detailed 
descriptions of the reclassification process and instead state that 
reclassification investigations will be conducted in accordance with 
procedures approved by the Administrator when evidence indicates that a 
previous designation can be changed.
    We would provide the detailed reclassification processes to the 
public on the scrapie Web site at http://www.aphis.usda.gov/animal-health/scrapie. This will allow us to update the reclassification 
processes easily when necessary while providing the public with notice 
regarding our policies. For major changes to the reclassification 
processes, we would publish a notice in the Federal Register describing 
the proposed change and solicit public comments on the change. We would 
then issue a second notice discussing the comments and informing the 
public of our decision regarding the change. For minor changes, 
updates, or clarifications, we would post notice of the change 
prominently on the scrapie Web site. Examples of major changes might be 
a whole new class of live animal test that is cheap, reliable, and 
effective enough to make testing all animals practical, or other 
changes that might result in reclassification of the majority of 
classified flocks or animals. We would also provide email notification 
to State cooperators and other stakeholders through the APHIS 
Stakeholder Registry. Individuals or organizations may be added to this 
list through GovDelivery, a free email subscription service. To 
subscribe to this free service go to https://public.govdelivery.com/accounts/USDAAPHIS/subscriber/new and select ``Animal Health--Sheep and 
Goats'' and ``Federal Register Publications--Notices Regarding Animal 
Health.''
    As part of this change, we propose to reformat the reclassification 
processes described in current paragraph (b) as a chart instead of 
text, to make it easier to understand. We would also remove some 
repetitive language concerning investigation and testing from the 
current text in paragraph (b). The proposed chart of reclassification 
procedures, along with other materials this rule proposes to make 
available through the scrapie Web site rather than in the regulations, 
is available by contacting the person listed under FOR FURTHER 
INFORMATION CONTACT, on the Regulations.gov Web site, or on the scrapie 
Web site at http://www.aphis.usda.gov/animal-health/scrapie. We invite 
public comment on both the current drafts of these materials and on the 
concept of making the materials available on the scrapie Web site 
rather than in the Code of Federal Regulations.

Changes to Recordkeeping and Identification Requirements

    We propose to consolidate and simplify the recordkeeping 
requirements in the regulations. Currently, the description of these 
requirements is dispersed in several locations in the regulations, 
including the definition of terminal feedlot, in paragraphs (c) and (f) 
through (h) of Sec.  54.8, Requirements for flock plans and post-
exposure management and monitoring plans, and in paragraphs (b) through 
(d) of Sec.  79.2, Identification of sheep and goats in interstate 
commerce. Some readers also found the current descriptions of 
recordkeeping requirements confusing in terms of what types of people 
or businesses were required to keep what types of records.
    To aid clarity, we propose to consolidate and replace the existing 
recordkeeping language with two new paragraphs addressing recordkeeping 
requirements in Sec.  79.2. We also propose to add three new paragraphs 
dealing with removal, loss, and replacement of official identification 
devices, and situations where use of more than one official eartag may 
be allowed. This language would be added to be consistent with APHIS 
official identification requirements in 9 CFR part 86. We would also 
change the heading of Sec.  79.2 to read Identification and records 
requirements for sheep and goats in interstate commerce. The two new 
paragraphs (f) and (g) would be titled ``Records required of persons 
who purchase, acquire, sell, or dispose of animals'' and ``Records 
required of persons who apply official identification to animals.''
    The new paragraph (f) that addresses recordkeeping requirements for 
people who acquire or dispose of sheep and goats would continue to 
require, as current Sec.  79.2(d) does, that these persons--whether or 
not the animals are required to be officially identified--maintain 
business records documenting the acquisition or disposal (such as 
yarding receipts, sale tickets, invoices, and waybills) for 5 years. We 
also propose to expand on the current Sec.  79.2(d) requirement that 
such persons must keep ``records relating to the transfer of ownership, 
shipment, or handling of the sheep or goats'' by specifically stating 
that the records must include the following information:
     The number of animals purchased or sold including animals 
acquired or transferred without sale;
     The date of purchase, sale, or other transfer;
     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;
     The species, breed, and class of animal, such as 
replacement ewe lambs, slaughter lambs or kids, cull ewes, club lambs, 
bred ewes, etc. If breed is unknown, for sheep the face color or in the 
case of goats the type (milk, fiber, or meat) must be recorded instead;
     A copy of the brand inspection certificate for animals 
officially identified with brands or ear notches;
     A copy of any certificate or owner/hauler statement 
required for movement of the animals purchased, sold, or otherwise 
transferred; and
     If the flock of origin or the receiving flock is under a 
flock plan or PEMMP, any additional records required by the plan.
    New paragraph (g) that addresses recordkeeping requirements for 
persons who apply official identification to animals would require such 
persons to maintain the following records:
     The flock identification number, the name and address of 
the person who currently owns the animals, and the name and address of 
the owner of the flock of origin if different;
     The name and address of the owner of the flock of birth, 
if known, for

[[Page 54669]]

animals born after January 1, 2002, in another flock and not already 
identified to flock of birth;
     The date the animals were officially identified;
     The number of sheep and the number of goats identified;
     The breed and class of animals such as replacement ewe 
lambs, slaughter lambs or kids, cull ewes, club lambs, bred ewes, etc. 
If breed is unknown, for sheep the face color or in the case of goats 
the type (milk, fiber, or meat) must be recorded instead;
     The official identification numbers applied to animals by 
species or the GIN applied in the case of a group lot;
     Whether the animals were identified with ``Slaughter 
Only'' or ``Meat'' identification devices; and
     Any GIN with which the animal was previously identified.
    Each person required to keep records under either of these 
paragraphs would have to maintain the records for at least 5 years, or 
longer if the Administrator requests it by written notice to the 
person, for purposes of any investigation or action involving the sheep 
or goats identified in the records. As in the current requirements, the 
person would have to 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.
    New paragraph (h) in Sec.  79.2 addresses removal or loss of 
official identification. The proposed requirements are consistent with 
parallel requirements in 9 CFR 86.4(d). Official identification is 
removed at slaughter, and this paragraph describes the responsibilities 
of slaughter plants to keep official identification correlated with 
carcasses through final inspection and procedures between APHIS and 
FSIS regarding collection of identification at the slaughter plants. 
This paragraph also describes procedures in the event of loss or 
destruction of official identification prior to slaughter.
    New paragraph (i) addresses replacement of official identification 
devices for reasons other than loss, such as damage to the device or 
injury or infection of the animal that affects the device. The proposed 
requirements are consistent with parallel requirements in 9 CFR 
86.4(e).
    New paragraph (j) addresses use of more than one official eartag on 
a sheep or goat. The proposed requirements are consistent with parallel 
requirements in 9 CFR 86.4(c). We propose to prohibit the application 
of additional official eartags to a single animal unless warranted by a 
specific situation. This is because the use of multiple official 
eartags with multiple official identification numbers for a single 
animal can cause confusion and impede efforts to track the movements of 
that animal. However, we do propose to allow multiple eartags in 
situations where they would provide herd management advantages or where 
allowing only a single tag is impractical. We propose to allow multiple 
official eartags in the following situations:
     When the additional eartag bears the same official 
identification number as an existing one.
     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, 
Surveillance Preparedness and Response Services, Assistant Director 
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.
     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.
     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.
    We also propose to make certain changes to the system for official 
animal identification in two sections, Sec.  54.8 (retitled 
Requirements for flocks under investigation and flocks subject to flock 
plans and post-exposure management and monitoring plans) and Sec.  79.2 
(Identification and records requirements for sheep and goats in 
interstate commerce). Some of these changes clarify who is responsible 
for ensuring animal identification is applied (the owner and anyone who 
has control or possession of the animals) and when it must be applied. 
Identification must be applied no later than whenever one of the 
following situations applies to an animal:
     Prior to the point of first commingling with sheep or 
goats from any other flock of origin;
     Upon transfer of ownership of the sheep or goats;
     Upon unloading at a livestock facility or other premises 
that engages in interstate commerce of animals; or
     Prior to moving a sheep or goat from the premises on which 
it resides for any other type of movement.
    We would provide an exemption from the requirement to officially 
identify animals before they leave their premises if they move, as part 
of a group lot, to a livestock facility approved in accordance with our 
regulations in 9 CFR 71.20 to handle the species and class of animal 
moved, provided that the facility has agreed to act as an agent for the 
owner to apply official identification. We would also exempt animals 
that are moved as part of a group lot to a slaughter plant listed in 
accordance with 9 CFR 71.21 or for managerial purposes between premises 
owned or leased by the same flock owner. We also propose to remove a 
provision in Sec.  79.2(a) that expired on June 1, 2003, that allowed 
movement of certain animals that are not identified to their flock of 
birth.
    Paragraph (a)(2) of Sec.  79.2 lists approved identification 
methods. We are proposing to remove this list from the regulations and 
instead state in the regulations that sheep or goats must be identified 
and remain identified using a method approved by the Administrator. We 
would provide a list of approved identification methods on the scrapie 
Web site at http://www.aphis.usda.gov/animal-health/scrapie. For major 
changes to the list of approved identification methods, we would 
publish a notice in the Federal Register describing the proposed change 
and solicit public comments on the change. We would then issue a second 
notice discussing the comments and informing the public of our decision 
regarding the change. For minor changes, updates, or clarifications, we 
would post notice of the change prominently on the scrapie Web site. We 
would also provide email notification to State cooperators and other 
stakeholders through the APHIS Stakeholder Registry.
    We are proposing this change because identification technologies 
are continually updated to take advantage of newly available technology 
and to meet industry needs. Maintaining a list of approved 
identification methods in the regulations requires rulemaking to update 
that list. Updating the list of

[[Page 54670]]

approved identification methods without completing rulemaking will 
allow for more frequent and timely updates to the list, while 
continuing to ensure that all animal identification methods are 
approved by the Administrator.
    As part of this rulemaking, we are also soliciting comments on 
changes to the current list of approved identification methods in Sec.  
79.2. Copies of the list as we would establish it on the scrapie Web 
site are available by contacting the person listed under FOR FURTHER 
INFORMATION CONTACT, on the Regulations.gov Web site, or on the scrapie 
Web site at http://www.aphis.usda.gov/animal-health/scrapie. Some of 
the changes to the current approved identification methods would ensure 
that identification devices, in addition to providing official 
identification numbers, also provide information about the status of 
the animal when appropriate, i.e., whether the animal is scrapie-
positive, permanently restricted (confined to its premises by a State 
or APHIS representative until it dies or is redesignated by a State or 
APHIS representative), or for slaughter only.
    Finally, we are proposing to move the current description of the 
process for approving new methods of identification in Sec.  79.2(g) 
into paragraph (a)(2) and amend the current text of paragraph (g) and 
move it to a new paragraph (k) to reflect these changes. This paragraph 
indicates that written requests for approval of sheep or goat 
identification methods not listed in paragraph (a)(2) of Sec.  79.2 
should be sent to the National Scrapie Program Coordinator, Sheep, 
Goat, Cervid & Equine Health Center, Surveillance, Preparedness and 
Response Services, VS, APHIS, 4700 River Road Unit 43, Riverdale, MD 
20737-1235. If the Administrator determines that the identification 
method will provide a means of tracing sheep and goats in interstate 
commerce, notice will be published in the Federal Register adding the 
devices and markings to the list of approved means of sheep and goat 
identification.
    To be consistent with the other proposed changes we have discussed, 
we would replace the reference to paragraph (a)(2) in current paragraph 
(g) with a reference to the scrapie Web site, where the approved 
identification methods would be listed. We would also replace the 
reference to publishing a notice in the Federal Register with a 
reference to providing public notice that the devices and markings have 
been added to the list of approved identification methods, to allow us 
flexibility to add methods without necessarily publishing a notice in 
the Federal Register.
    With respect to responsibility for identifying animals, in Sec.  
79.2(a)(3) we propose to more clearly restate the current requirement 
that when an animal that is required to be identified is moved to a 
place where it will be put in the same enclosure with animals from a 
different flock of origin, the person who owns the animal, the person 
who transports or delivers that animal, and the person who accepts 
delivery of the animal are all responsible for ensuring that the animal 
is officially identified prior to commingling.
    We are particularly seeking comment regarding the provisions in the 
regulations that allow some animals to be officially identified upon 
arrival at certain livestock facilities, rather than before leaving 
their premises, and that allow the identification to be applied by the 
livestock facility rather than the animals' owner. These provisions are 
found in Sec.  79.2(a)(1)(ii) and Sec.  79.2(a)(3) of the current 
regulations and appear in the regulatory text at the end of this 
proposed rule as Sec.  79.2(a)(1)(ii) and Sec.  79.3(a)(5). In both 
cases the livestock facility may apply the official identification if 
it has agreed to act as an agent for the owner to apply official 
identification, and has the necessary information and keeps the 
necessary records about the animals to correctly apply the 
identification, and does so before the animals are commingled with any 
other, unidentified animals at the facility. We seek comments on 
whether this provision is effective as written, or whether it should be 
eliminated (thereby making it a violation of the regulations to unload 
unidentified animals at an approved market) or amended, e.g., to 
require the owner of the animals to maintain the records and provide 
the livestock facility with the required identification tags for the 
market personnel to apply.
    In addition to the proposed changes affecting animal identification 
in Sec.  54.8, we propose to make minor changes to paragraph Sec.  
54.8(e), which requires the owner of a flock under a flock plan or 
PEMMP to meet requirements, including but not limited to those listed 
in that paragraph, to monitor for scrapie and to prevent the recurrence 
or spread of scrapie in the flock. We propose to add that owners must 
report animals found dead and collect and submit test samples from them 
if an APHIS or State representative requests it. The regulations 
already assume owners will do this, and the requirement has appeared in 
the text of flock plans and PEMMPs, but we wish to add it to the 
regulations to ensure all owners are aware of it. We also propose to 
add that the owner of a flock under a flock plan or PEMMP must use 
genetically resistant rams if the DSE determines it is necessary to 
reduce the risk of the occurrence of scrapie in the flock. The use of 
such rams has become more common due to increased knowledge of sheep 
genetics, so we think it is worthwhile to add it to this paragraph as 
something that may be required in a flock.
    We also propose to add a new paragraph (h) to Sec.  54.8 discussing 
the types of animals that may be retained in a flock under a flock plan 
or PEMMP. This new paragraph would build on the changes discussed above 
that resulted from increased understanding of the genetics of scrapie 
resistance and the use of genetic testing as a means of assigning risk 
levels to animals. The result of this change would be that certain 
animals that previous flock plans would have removed from a flock may 
be allowed to remain in the flock. Proposed new paragraph (h) would 
read ``The Administrator may allow high-risk animals that are not 
suspect animals to be permanently retained under restriction in the 
flock 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. All such animals must be tested for scrapie when they are 
euthanized or die or if they are later determined to be suspect 
animals. These requirements will be documented in the PEMMP.''
    We also propose to add a statement to Sec.  54.8(j), which 
describes the requirements for flock plans. As discussed above, we 
added a new definition for low-risk exposed animal that applies to 
sheep or goats deemed to present significantly lower risks due to the 
nature of either the exposure or the animal. To adjust the flock plan 
requirement accordingly, we propose that in individual cases or for a 
class of cases the Administrator may waive the requirement for a flock 
plan or waive any of the requirements in a flock plan after determining 
that the flock contains only low-risk exposed animals and poses a low 
risk of scrapie transmission. Barring the publication of new data to 
the contrary, the Administrator intends to waive the requirements of a 
flock plan and to modify the PEMMP for flocks affected by Nor98-like 
scrapie.

[[Page 54671]]

Changes to Indemnity Provisions in Part 54

    The changes discussed above that would provide for the 
classification of animals based on their genetic susceptibility or 
resistance to scrapie would likely result in fewer animals being 
designated as high-risk animals. Most of the animals eligible for 
indemnity in accordance with Sec.  54.3 are high-risk animals.\6\ We 
believe it is appropriate to deny indemnity for exposed animals that 
have been genetically tested and found to be genetically resistant or 
less susceptible to scrapie. Such animals can generally be moved 
interstate with only minor restrictions, and sold on the open market 
for prices similar to those obtained for sheep that have never been 
exposed to scrapie. It is not appropriate to pay indemnity for animals 
when their owners have these options.
---------------------------------------------------------------------------

    \6\ Section 54.3(a)(2) also allows indemnity to be paid for 
other types of animals when the Administrator determines that the 
destruction of these animals will contribute to the eradication of 
scrapie.
---------------------------------------------------------------------------

    We also believe it is necessary to clarify what is meant by a 
statement in current Sec.  54.3(b), ``No indemnity will be paid to an 
owner if the owner assembled or increased his flock for the purpose of 
collecting or increasing indemnity.'' Therefore, we propose several 
changes to Sec.  54.3. First, we propose to clearly state that 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 9 CFR chapter I. In line with this, we would also 
specifically state that 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 for animals that are natural 
additions. We also propose that no indemnity will be paid for natural 
additions born more than 60 days after indemnity is offered in writing 
unless the Administrator makes a determination that the animals could 
not be removed within the allowed time as a result of conditions 
outside the control of the owner.
    One current requirement of Sec.  54.3 is that no indemnity shall be 
paid until the premises, including all structures, holding facilities, 
conveyances, and materials contaminated because of occupation or use by 
the depopulated animals, has been properly cleaned and disinfected. In 
enforcing this provision we have become aware that sometimes 
circumstances beyond an owner's control delay the cleaning and 
disinfection, despite the owner's best intentions. To alleviate 
financial hardship in such cases, we propose to amend Sec.  54.3 to 
state 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.
    In Sec.  54.6, paragraphs (a) and (b) set out procedures for 
determining what indemnity will be paid for sheep and goats that are 
eligible for indemnity under Sec.  54.3. Paragraph (a) contains 
detailed information regarding price reports published by the 
Agricultural Marketing Service (AMS) that are used to calculate 
indemnity for sheep. Paragraph (b) sets out the process by which these 
price reports are used to determine indemnity for various classes of 
animals, with premiums paid for certain types of animals, such as 
registered animals and flock sires.
    We are proposing to remove this detailed information from the 
regulations. The price reports we use as a basis for our indemnity 
calculations change frequently, as do the terms used in those price 
reports to refer to various types of sheep and goats. The price reports 
listed in paragraphs (a)(1) through (a)(6) in Sec.  54.6 are currently 
out of date, and it would require frequent updates of the regulations 
to keep them consistent with the AMS data. In addition, the process in 
paragraph (b) sets out numerous specific weight thresholds and sets out 
dollar amounts for premiums. If the sheep and goat industries change, 
making these weight thresholds obsolete or the premiums inadequate to 
provide a fair indemnity, we must update the regulations.
    Rather than use scrapie program resources to continually update 
Sec.  54.6(a) and (b), we propose to retain only the general statement 
that indemnity paid for sheep and goats in accordance with Sec.  54.3 
will be the fair market value for the animals, 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. Paragraph 
(a) of Sec.  54.6 would also specify that premiums would be paid for 
certain animals and that APHIS will use AMS price report data or other 
available price information and any other data necessary to establish 
the value of different types of sheep and goats in its calculations. We 
would provide a detailed description of how we calculate indemnity on 
the scrapie Web site.
    This approach would be consistent with some other parts in 9 CFR 
subchapter B, which provide that indemnity will be provided based on 
appraisals but do not specify the details of how an appraisal is 
conducted. For example, 9 CFR part 56, which provides for the payment 
of indemnity for poultry affected by low pathogenic avian influenza, 
states that indemnity will be paid based on appraisals; however, those 
regulations do not include the details of how appraisals are conducted, 
and they are typically conducted by use of spreadsheets showing data on 
inputs and expected prices. Similarly, the scrapie regulations provide 
for calculation of indemnity based on broad market data, with a few 
modifications; we believe it is appropriate to state in the regulations 
that indemnity will be based on those broad market data and provide the 
details on the scrapie Web site. We invite public comment on this 
approach.
    We would also reorganize and renumber the paragraphs in Sec.  54.6 
and make other minor changes to the section to improve its 
comprehensibility.
    As part of this change, we also propose to create a new indemnity 
classification for certain pregnant animals and early maturing ewes. At 
sales, animals in late pregnancy bring higher prices than animals that 
are not pregnant because of the additional value of the offspring they 
carry. We believe that indemnity prices should reflect this increase in 
value since indemnity is related to the fair market value of animals. 
We would also categorize early maturing ewe lambs as yearlings, which 
typically qualify for a higher indemnity value, because early maturing 
ewes can be bred at about 7 months and lamb at 12-14 months, increasing 
their value. Descriptions of these classifications as we would 
establish them are available by contacting the person listed under FOR 
FURTHER INFORMATION CONTACT, on the Regulations.gov Web site, or on the 
scrapie Web site at http://www.aphis.usda.gov/animal-health/scrapie. We 
invite public comment on these classifications.
    Sections 54.3 and 54.5 already require that to obtain indemnity 
owners must make available to APHIS all bills of sale, pedigree 
registration certificates, and other records associated with ownership 
or movement of the animals. We propose to amend Sec.  54.3 to also 
state that owners applying for indemnity must, within 30 days of 
request, make the animals in the flock available for inventory, 
evaluation, and testing. We propose this change because it is sometimes 
necessary to have physical access to the animals to confirm their 
eligibility for indemnity.
    Current Sec.  54.6(e) states that indemnity will be paid to an 
owner only for animals actually in a flock at the time

[[Page 54672]]

indemnity is first offered. We propose to add that indemnity would be 
paid for offspring born to animals in that flock within 60 days after 
the time indemnity is first offered in writing. This change is proposed 
in response to indemnity situations that have occurred where owners 
with ewes nearly ready to give birth become eligible for indemnity. We 
also propose to add several other provisions intended to encourage the 
prompt removal of animals identified for indemnity, to minimize the 
risks that might result if these animals remained in a flock for long 
periods. We propose that if an owner declines to remove an animal 
within 60 days of when indemnity is first offered in writing the 
indemnity amount would be reevaluated using current AMS price reports. 
The owner would then receive the lower value of the indemnities 
calculated from price reports when indemnity was first offered and when 
the animal was actually removed. We also propose that APHIS may 
withdraw an indemnity offer if an owner does not make animals available 
for inventory, gestational assessment, and testing within 30 days or 
does not remove an animal within 60 days of the indemnity offer or by 
the date specified in a flock plan or PEMMP.
    We also propose to revise the definition of flock sire in part 54 
to ensure that only the appropriate animals receive the indemnity 
premium applied to flock sires. The current definition reads ``a 
sexually intact male animal that has ever been used for breeding in a 
flock.'' However, this allows a premium to be paid for animals that are 
too old to breed, or that were once tried as sires but were found to 
produce inferior progeny. Such animals no longer have an economic value 
that justifies an indemnity premium. Therefore, we propose to change 
the definition of flock sire to read ``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.''
    We believe the changes to parts 54 and 79 discussed above would 
improve the effectiveness of the scrapie program, reduce the risks 
associated with moving sheep and goats interstate, reduce some 
identification and recordkeeping requirements while changing others, 
and make the scrapie indemnity program more equitable.

Changes Concerning Tests for Scrapie and Laboratories Approved To 
Perform Tests

    We are proposing certain changes to Sec.  54.10, ``Tests for 
scrapie,'' and Sec.  54.11, ``Approval of laboratories to run official 
scrapie tests and official genotype tests.'' The proposed changes are 
intended to provide more information about APHIS procedures in these 
matters and to make the testing and laboratory approval processes more 
reliable, flexible, and market-oriented.
    We propose to change the section title of Sec.  54.10 to read 
``Program approval of tests for scrapie'' to clarify that the section 
concerns how tests are approved, and is not merely a list of tests. We 
propose to change a sentence that states that specific guidance on the 
use of approved tests ``will be added to this part as tests are 
approved and will also be contained in the Scrapie Eradication UM&R and 
the Scrapie Flock Certification Program standards.'' We would change 
this to read ``will be made available on the scrapie Web site at http://www.aphis.usda.gov/animal-health/scrapie.'' This change would allow 
APHIS to respond more quickly to advances in science and in scrapie 
testing specifically. For major changes to how tests are used within 
the scrapie program, we would publish a notice in the Federal Register 
describing the proposed change and solicit public comments on the 
change. We would then issue a second notice discussing the comments and 
informing the public of our decision regarding the change. For the 
addition of guidance for a new test used for purposes similar to an 
existing test, or for minor changes, updates, or clarifications, we 
would post notice of the change prominently on the scrapie Web site. We 
would also provide email notification to State cooperators and other 
stakeholders through GovDelivery, a free email subscription service. To 
subscribe to this free service go to https://public.govdelivery.com/accounts/USDAAPHIS/subscriber/new and select ``Animal Health--Sheep and 
Goats'' and ``Federal Register Publications--Notices Regarding Animal 
Health.'' Proposed procedures for using tests are in the draft National 
Scrapie Eradication Program Standards. Copies are available by 
contacting the person listed under FOR FURTHER INFORMATION CONTACT, on 
the Regulations.gov Web site, or on the Web site at http://www.aphis.usda.gov/animal-health/scrapie.
    We also propose to add to both Sec.  54.10 and Sec.  54.11 a 
standard paragraph stating that the Administrator may withdraw or 
suspend approval of an official test, or approval of a laboratory to 
perform tests. In both Sec.  54.10, regarding approved tests, and Sec.  
54.11, regarding approved laboratories, there would be an opportunity 
for an appeal to the Administrator to resolve any questions of material 
fact regarding the withdrawal or suspension. The Administrator's 
decision would constitute final agency action.
    We propose to add ELISA testing to the definition of scrapie-
positive animal as one of the test methods that may be used by NVSL 
when making an official diagnosis of scrapie. The current definition 
specifically mentions ``proteinase-resistant protein analysis methods 
including but not limited to immunohistochemistry and/or western 
blotting.'' APHIS is continually evaluating scrapie test methods for 
sensitivity, specificity and reliability, and ELISA tests are currently 
one of the methods used by NVSL.

Changes Affecting Consistent State Requirements and State Surveillance 
Programs

    Surveillance is an important component of the National Scrapie 
Eradication Program because it identifies infected animals, and 
successful traceback of these animals to their flocks of origin allows 
us to identify previously unrecognized infected flocks for cleanup. As 
the United States progresses toward eradication of scrapie, 
surveillance is also necessary to measure the effectiveness of control 
measures and to document when regions achieve freedom from disease as 
defined by international standards affecting trade in animals and 
products from the regions.
    To support traceback and eradication efforts, we propose to add a 
requirement that States must implement effective scrapie surveillance 
in order to qualify as a Consistent State. This requirement would 
include three components: Facilitating surveillance at slaughter 
establishments that do not engage in interstate commerce; reporting 
submission information and test results electronically to the National 
Scrapie Database administered by APHIS; and testing an appropriate 
number of targeted animals annually.
    The first of these three new requirements would affect surveillance 
at slaughter establishments. Slaughter surveillance is a major 
component of the ongoing scrapie surveillance conducted by APHIS. The 
regulations in 9 CFR 71.21 describe the collection of tissues for 
surveillance purposes at slaughter establishments that receive 
livestock in interstate commerce. To achieve the eradication of 
scrapie, it is important to conduct surveillance in all slaughter 
establishments that receive targeted animals--including State-inspected 
and custom establishments that do not participate in interstate 
commerce. Surveillance at these concentration

[[Page 54673]]

points, along with traceability of animals, is key to program 
effectiveness. Therefore, we propose to provide for scrapie 
surveillance in slaughter establishments that do not participate in 
interstate commerce (i.e., State-inspected and custom establishments). 
We propose to add language in Sec.  79.6(a)(10)(i) requiring States 
that are Consistent States to collect and submit 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. Typically, when sample collection by State personnel 
is necessary it could be accomplished by State personnel already 
assigned to such establishments. Alternatively, in places where APHIS 
has Federal employees or contractors available to collect samples from 
such plants, the State could instead elect to allow and facilitate the 
collection of such samples by USDA personnel or contractors. The intent 
of this proposed requirement is to ensure that surveillance for scrapie 
consistently occurs in all slaughter establishments that receive 
targeted animals.
    The second new requirement would affect the reporting of 
surveillance data by States. In order to insure the integrity of 
surveillance data and to verify that a State is conducting adequate 
surveillance for scrapie, we propose to add language to Sec.  
79.6(a)(10)(ii) requiring that submission data and epidemiological 
information for all samples be electronically transmitted by accessing 
and updating a system provided by APHIS. Submission data will be 
electronically transmitted to an approved laboratory and the 
epidemiologic and testing data will be stored in the National Scrapie 
Database, allowing complete reports concerning scrapie surveillance to 
be generated for each State as well as for the entire United States. 
This system is currently used to submit information for over 99 percent 
of the scrapie samples collected for testing.
    In the third new surveillance requirement, we propose to determine 
the appropriate sample size for surveillance within a State using one 
of two approaches. A State could meet annual State-level surveillance 
minimums established by APHIS. These minimums will be made publicly 
available at http://www.aphis.usda.gov/animal-health/scrapie. APHIS may 
update the surveillance minimums once a year and will provide them to 
the States at least 6 months before the start of the collection period. 
These surveillance minimums call for a certain level of activity, 
including the coordination of sampling and testing of mature sheep at 
slaughter that have a higher than average probability of being infected 
with scrapie and surveillance in targeted animals from other sources 
such as veterinary diagnostic laboratories, public health laboratories, 
renderers, dead stock haulers, markets, feedlots, and farms. The State-
level minimums will be based on the number of targeted animals residing 
in a State, the occurrence of scrapie in sheep and goats in the State, 
and other relevant factors such as the percentage of flocks surveyed. 
States may contact the Administrator within 60 days of publication of 
their State's surveillance minimum to appeal the surveillance minimum 
if they believe there was any error in the facts used to establish the 
minimum. Alternatively, a State could design and implement its own 
surveillance plan as long as the State demonstrates that the 
surveillance is sufficient to detect scrapie if it is present at a 
prevalence of 0.1 percent in the population of targeted animals 
originating from within the State, with a 95 percent confidence level, 
each year. This is the level of surveillance currently specified by 
Article 14.9.2 of the World Animal Health Organization (the OIE) 
Terrestrial Animal Health Code to determine a scrapie free country or 
zone. These surveillance requirements for States would be added to 
Sec.  79.6(a)(10)(iii) and (iv). APHIS intends to continue to provide 
support to the States in meeting surveillance minimums and to set 
minimums in line with funds available for surveillance activities. 
APHIS currently supports surveillance by providing testing for scrapie 
samples through contracts with State veterinary diagnostic 
laboratories, sampling contracts, cooperative agreements to support 
collection activities by States, and collection of samples by APHIS 
personnel.

Definition of Consistent State

    The definition of Consistent State in Sec.  79.1 currently includes 
criteria for listing a State as a Consistent State and a list of States 
that meet these criteria. As the definition itself indicates when a 
State will be listed as a Consistent State, providing the list of 
Consistent States in the regulations is not necessary. We are proposing 
to remove the list of Consistent States from this definition and 
instead indicate that a list of Consistent States can be found on the 
scrapie Web site. (Currently, all 50 States are listed as Consistent 
States; we are not proposing to change the list.)
    We are also proposing to provide in the regulations a process for 
updating the list of Consistent States. When we determine that a State 
should be added to or removed from the list of Consistent States, we 
would publish a notice in the Federal Register advising the public of 
our determination and providing the reasons for that determination. The 
notice would solicit public comments. After considering any comments we 
receive, we would publish a second notice either advising the public 
that we are adding or removing the State from the list of Consistent 
States or notifying the public that we are not making any changes to 
the list of Consistent States, depending on the information presented 
in the comments.

Other Changes to Parts 54 and 79

    We propose to change Sec.  54.21, ``Participation,'' which 
currently states that APHIS makes available a list of flocks 
participating in the SFCP and another list of flocks that are not in 
compliance with these regulations. We propose to make available a third 
list, of flocks that sold exposed animals that could not be traced, 
which would be of potential risk management use to persons who 
purchased animals from these flocks.
    We propose to add several definitions to part 79 to ensure that 
readers understand terms used in those regulations. These include 
owner/hauler statement, person, restricted animal sale or restricted 
livestock facility, and test eligible. The only one of these terms that 
may not already be familiar to those affected by the regulations is 
owner/hauler statement. We propose to define this term, which would 
replace the current term owner statement, as ``A signed written 
statement by the owner or hauler that includes:
    (1) The name, address, and phone number of the owner and, if 
different, the hauler;
    (2) The date the animals were moved;
    (3) The flock identification number or PIN assigned to the flock or 
premises of the animals;
    (4) If moving individually unidentified animals, the group/lot 
identification number and any information required to officially 
identify the animals;
    (5) The number of animals;
    (6) 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
    (7) The name and address of point of origin, if different from the 
owner's address, and the destination.''
    The changes discussed above, particularly the use of genetic 
information and testing to improve our ability to categorize animals by 
risk

[[Page 54674]]

categories, would allow us to greatly simplify and shorten Sec.  79.3, 
which describes the basic restrictions on the movement and commingling 
of regulated sheep and goats. We propose to replace the chart in Sec.  
79.3 with a simpler, less repetitive format that preserves the movement 
restrictions but describes them using the improved animal category 
definitions and terms proposed in this document.
    We are also proposing to revise Sec.  79.5 (retitled Issuance of 
Interstate Certificates of Veterinary Inspection (ICVI)) to replace the 
term ``certificates'' with reference to ICVIs for consistency with 
other areas of the regulations. Section 79.5 would also revise the 
information that must be contained in a certificate now termed an ICVI. 
In addition, we are revising the section to make the requirements and 
terms in it match those proposed elsewhere in this document and, to the 
degree appropriate, those in 9 CFR part 86 (Animal Disease 
Traceability) e.g., by changing ``premises identification'' to ``flock 
identification number.'' In support of this proposal's goal of using 
available genetic information to better characterize risks, we would 
also add a statement in paragraph (a) that, if any animals covered by a 
ICVI are intended for breeding and have undergone an official genotype 
test, the name of the testing laboratory and the date and result of the 
test must be included.

Miscellaneous Changes

    We are also proposing to make miscellaneous changes, particularly 
in the definitions sections of parts 54 and 79, and in the description 
of cleaning and disinfection of premises in Sec.  54.7, to make 
terminology and citations consistent throughout the regulations. We are 
changing the definitions of several terms to make them consistent with 
the definitions in new animal disease traceability regulations in 9 CFR 
part 86. In Sec.  54.7, we propose to expand the brief description of 
cleaning and disinfection procedures to include more information about 
burial and composting options for organic and/or inorganic materials. 
We also propose minor changes throughout the regulations to 
consistently use the term ``identification devices'' instead of 
referring to ``devices'' in some sections and ``tags'' in others, to 
correct outdated Internet addresses, and to otherwise improve accuracy 
and readability.

Executive Orders 12866 and 13563 and Regulatory Flexibility Act

    This proposed 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.
    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 an initial 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 by 
contacting the person listed under FOR FURTHER INFORMATION CONTACT or 
on the Regulations.gov Web site (see ADDRESSES above for instructions 
for accessing Regulations.gov).
    Based on the information we have, there is no reason to conclude 
that adoption of this proposed rule would result in any significant 
economic effect on a substantial number of small entities. However, we 
do not currently have all of the data necessary for a comprehensive 
analysis of the effects of this proposed rule on small entities. 
Therefore, we are inviting comments on potential effects. In 
particular, we are interested in determining the number and kind of 
small entities that may incur benefits or costs from the implementation 
of this proposed rule.
    APHIS is proposing to amend 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 would be used to identify genetically 
resistant or less susceptible sheep for exemption from destruction and 
as qualifying for interstate movement; designated scrapie 
epidemiologists would be given greater flexibility in determining the 
testing needs of flocks; the indemnity regulations would 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 would be required; submission of tagging records by 
individuals who tag sheep or goats that do not originate on their 
premises would be required; and certain recordkeeping requirements 
would be reduced, changed or removed.
    The primary benefits of this proposed rule for producers and the 
public would be more rapid progress toward scrapie eradication and the 
related boost to the Nation's animal health status, decreased losses 
for owners of exposed herds, and increased export opportunities for 
sheep and goats and their products. All segments and marketing channels 
of the sheep and goat industries would benefit from being able to 
operate under fewer restrictions while still complying with the scrapie 
eradication program. By enhancing traceability, the proposed rule would 
shorten the time and reduce the cost of eradication.
    Costs associated with the proposed rule would be borne by APHIS and 
the regulated industry. APHIS would incur the costs of genotyping 
exposed sheep and testing genetically susceptible animals for scrapie. 
The total laboratory cost to APHIS for testing an average-sized exposed 
flock is estimated to be around $610. This Federal cost may be largely 
offset by a reduction in indemnity payments; genotyping is expected to 
result in the destruction of fewer animals.
    Producers of goats for meat or fiber would incur costs of official 
identification as a result of the proposed rule. However, close to one-
half of the goat farms reported in the 2012 Census of Agriculture are 
already in compliance with the proposed identification requirements.
    The proposed rule would affect sheep and goat producers, as well as 
marketers and dealers. Most of these entities are small. However, in 
that costs of genotyping, testing, and provision of eartags would be 
borne by the Federal Government, we do not believe this rule would pose 
a significant cost burden for producers.

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 proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this proposed rule is adopted: (1) All State 
and local laws and regulations that are in conflict with this rule will 
be preempted; (2) no retroactive effect will be given to this rule; and 
(3) administrative proceedings

[[Page 54675]]

will not be required 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. The review reveals that this rule will not have 
substantial and direct effects on Tribal governments and will not have 
significant Tribal implications.
    As part of this review, APHIS sent letters to Tribal leaders 
describing the proposed rule, asking the leaders to consider and inform 
us of any potential impacts or possible outcomes for their tribes, and 
offering further discussion or consultation if desired. No Tribe 
identified issues of concern or requested further consultation. We 
believe that the issue in this proposed rule that is of most potential 
concern to Tribes is animal identification and traceability. That issue 
has been addressed in a previous proposed rule concerning traceability 
for livestock moving interstate (Docket No. APHIS-2009-0091, 76 FR 
50082, published August 11, 2011). The Tribal summary impact statement 
for that proposed rule is available at http://www.regulations.gov/#!documentDetail;D=APHIS-2009-0091-0474.

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this proposed rule have been 
submitted for approval to the Office of Management and Budget (OMB). 
Please send written comments to the Office of Information and 
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, 
DC 20503. Please state that your comments refer to Docket No. APHIS-
2007-0127. Please send a copy of your comments to: (1) Docket No. 
APHIS-2007-0127, Regulatory Analysis and Development, PPD, APHIS, 
Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238, 
and (2) Clearance Officer, OCIO, USDA, room 404-W, 14th Street and 
Independence Avenue SW., Washington, DC 20250. A comment to OMB is best 
assured of having its full effect if OMB receives it within 30 days of 
publication of this proposed rule.
    Implementing the requirements of the proposed rule would change 
information collection and recordkeeping burden for persons such as 
animal market operators, dealers, accredited veterinarians, tag 
manufacturers, flock owners, haulers, State officials, terminal feedlot 
owners, laboratories, test kit manufacturers, slaughter plant/
establishment owners, and other persons who apply official 
identification to sheep and goats. These changes will primarily affect 
persons who own or handle goats in interstate commerce. Some of this 
information would be entered in the Scrapie National Database, and 
persons who apply official identification for animal owners such as 
livestock markets would have the option of entering the information 
through a Web site into the Scrapie National Database or completing and 
submitting a form. These changes would also eliminate requirements to 
record individual identification numbers for certain classes of sheep 
and goats.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. These comments will help us:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency s functions, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of Burden: Public reporting burden for this collection of 
information is estimated to average 0.24 hours per response.
    Respondents: Market operators, dealers, accredited veterinarians, 
tag manufacturers, flock owners, haulers, State officials, terminal 
feedlot owners, laboratories, test kit manufacturers, slaughter plant/
establishment owners, and other persons who apply official 
identification to sheep and goats.
    Estimated Annual Number of Respondents: 157,053.
    Estimated Annual Number of Responses per Respondent: 2.89.
    Estimated Annual Number of Responses: 454,061.
    Estimated Total Annual Burden on Respondents: 108,981 hours. (Due 
to averaging, the total annual burden hours may not equal the product 
of the annual number of responses multiplied by the reporting burden 
per response.)
    Copies of this information collection can be obtained from Ms. 
Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 
851-2727.

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 proposed rule, please contact Ms. Kimberly 
Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.

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 proposing to amend 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. Revise the heading of the definition for approved test to read 
program approved test and place in alphabetical order.
0
b. In the definition for breed association and registries, by removing 
the words ``listed in Sec.  151.9 of this chapter''.
0
c. Removing the definition for certificate.
0
d. Adding a definition for classification or reclassification 
investigation.
0
e. In the heading of the definition for designated scrapie 
epidemiologist, add the acronym ``DSE'' immediately after 
``epidemiologist''.
0
f. 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, last sentence, by removing ``(f)'' 
and by adding ``(j)'' in its place.

[[Page 54676]]

0
i. Revising the definition for flock sire.
0
j. Adding definitions for flock under investigation, genetically less 
susceptible exposed sheep, genetically resistant exposed sheep, 
genetically resistant sheep, genetically susceptible animal, and 
genetically susceptible exposed animal.
0
k. Revising the definition for high-risk animal.
0
l. Adding a definition for interstate certificate of veterinary 
inspection (ICVI).
0
m. In the definition for limited contacts, last sentence, by adding the 
word ``Free'' between the words ``Scrapie'' and ``Flock''.
0
n. Adding 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''.
0
p. The definition for noncompliant flock is amended 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'';
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. Revising the definition for official genotype test.
0
r. Adding a definition for 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 ``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 definitions for separate contemporary lambing group.
0
w. Revising the definition for slaughter channels and paragraph (1) in 
the definition of suspect animal.
0
x. Adding 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 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, and/or results of 
official scrapie testing on live or dead animals
* * * * *
    Destroyed. Euthanized and the carcass disposed of by means 
authorized by the Administrator that will prevent its use as feed or 
food, or moved to a quarantined research facility if the movement has 
been approved by the Administrator.
* * * * *
    Exposed animal. Any animal or embryo that has been in a flock or in 
an enclosure off the premises of the flock with a scrapie-positive 
female animal; 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. 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(s) 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 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 of this chapter.
* * * * *
    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. A flock 
will no longer be a flock under investigation if it is redesignated in 
accordance with Sec.  79.4 of this chapter.
    Genetically less susceptible exposed sheep. Any sheep or sheep 
embryo that is:
    (1) An exposed sheep or sheep embryo of genotype AA QR, unless 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 where Q 
represents any genotype other than R at codon 171; or
    (2) An exposed sheep or sheep embryo of genotype AV QR, unless it 
is epidemiologically linked to a scrapie-positive RR or QR sheep, to a 
flock that the DSE 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 where Q represents any 
genotype other than R at codon 171 and V represents any genotype other 
than A at codon 136; 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.

[[Page 54677]]

    Genetically resistant exposed sheep. Any exposed sheep or sheep 
embryo of genotype RR unless 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 unless it is epidemiologically linked to a scrapie-positive RR sheep 
or to a scrapie type that affects RR sheep.
    Genetically susceptible animal. Any goat or goat embryo, sheep or 
sheep embryo of a genotype other than RR or QR, or sheep or sheep 
embryo of undetermined genotype where Q represents any genotype other 
than R at codon 171.
    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 is 
epidemiologically linked to a scrapie-positive RR or QR sheep, to a 
flock that the DSE 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 where Q represents any genotype other than R 
at codon 171 and V represents any genotype other than A at codon 136; 
or
    (3) A sheep or sheep embryo of genotype AA QR that is 
epidemiologically linked to a scrapie-positive RR or AA QR sheep or to 
a scrapie type to which AA QR sheep are susceptible where Q represents 
any genotype other than R at codon 171; or
    (4) A sheep or sheep embryo of genotype RR that is 
epidemiologically linked to a scrapie-positive RR sheep or to a scrapie 
type to which RR sheep are susceptible.
    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 based 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 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 DSE 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.
* * * * *
    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 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 a 
slaughter establishment that is under continuous inspection by the Food 
Safety and Inspection Service (FSIS) 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 for immediate 
slaughter or to an individual for immediate slaughter for personal use 
or to a terminal feedlot. Any animal sold at an unrestricted sale is 
not in slaughter channels. Animals in slaughter channels must be 
accompanied by an owner/hauler statement completed in accordance with 
Sec.  79.3(g) of this chapter. 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. When selling 
animals that do not meet the requirements to move as breeding animals, 
owners must note on the bill of sale that the animals are sold only for 
slaughter.
* * * * *
    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

[[Page 54678]]

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 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 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 open, 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 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 
open, 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. In Sec.  54.3, paragraph (b) is revised to read as follows:


Sec.  54.3  Animals eligible for indemnity payments.

* * * * *
    (b) USDA may withdraw an offer of indemnity if the owner of the 
animal fails to, within 30 days of request, make the animals in the 
flock available for inventory, evaluation, and testing or 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. 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); 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. Premises or portions of premises 
may be exempted from the cleaning and disinfecting requirements if a 
designated scrapie epidemiologist determines, based on 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 
indemnity will be paid to an owner if the owner established or 
increased his flock for the purpose of collecting or increasing 
indemnity.
0
5. In Sec.  54.4, paragraph (a)(5) is revised to read as follows:


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
* * * * *


Sec.  54.5  [Amended]

0
6. In Sec.  54.5, paragraph (d) is amended by removing the word 
``slaughtered,''.
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.

[[Page 54679]]

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 times the price per pound for the class of 
animal as reported in the appropriate price report or other available 
price information.
    (d) Eligibility for indemnity. 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 or 
does not remove an animal within 60 days of the written indemnity offer 
or by the date specified in a flock plan or PEMMP.
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'' and 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).
    The additions and revisions 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, Surveillance Preparedness 
and Response Services, Assistant Director 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.
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) Identification of 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:
    (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

[[Page 54680]]

before they are moved off the premises of the flock.
    (b) Records 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. All such animals must be tested 
for scrapie when they are euthanized or die or if they are later 
determined to be suspect animals. These requirements will be documented 
in the PEMMP.
    (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) Requirement for flock plans only. 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; 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.
    (k) Post-exposure management and monitoring plans for exposed 
flocks and flocks under investigation that were not source or infected 
flocks. A PEMMP will be required for exposed flocks and may be required 
for flocks under investigation. 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

[[Page 54681]]

the findings of the classification or reclassification investigation.
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 Web site 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 decision constitutes final agency action.
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 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

[[Page 54682]]

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 decision 
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.

Subpart B--Scrapie Free Flock Certification Program

0
12. In part 54, the heading for subpart B is revised to read as set 
forth above.
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, 
Surveillance Preparedness and Response Services, Assistant Director 
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 Web site 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, Surveillance Preparedness and Response 
Services, 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. Revise 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. Add a definition for classification or reclassification 
investigation.
0
e. Revise the definitions for consistent State, exposed animal, and 
exposed flock.
0
f. Add 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. Add 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. Revise the definition for high-risk animal.
0
j. Add definitions for interstate certificate of veterinary inspection 
(ICVI) and low-risk commercial flock.
0
k. Remove the definition for low-risk commercial sheep.
0
l. Add a definition for low-risk exposed animal.
0
m. Remove the definition for low-risk goat.
0
n. Add 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. Revise the definitions for official eartag, official genotype test, 
and official identification device or method.
0
q. Add definitions for official identification number, officially 
identified, and owner/hauler statement.
0
r. Remove the definition for owner statement.
0
s. Add a definition for person.
0
t. Revise the definition for premises identification number (PIN).
0
u. Add 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. Revise the definition for slaughter channels, paragraph (1) of the 
definition for suspect animal, and the definition for terminal feedlot.
0
aa. Add 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 investigation conducted or directed by a DSE for the 
purpose of designating or redesignating the status 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.
    (3) When the Administrator determines that a State should be added

[[Page 54683]]

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 the 
State 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.
* * * * *
    Exposed animal. Any animal or embryo that has been in a flock or in 
an enclosure off the premises of the flock with a scrapie-positive 
female animal; 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. 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(s) 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 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, 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 issued through 
the National Scrapie Database. Flock identification numbers will be 
linked in the National Scrapie Database to one or more PINs and may be 
used in conjunction with an animal number unique within the flock to 
provide a unique official identification number for an animal, or may 
be used in conjunction with the date and a sequence number to provide a 
GIN for a group of animals when group identification is permitted.
* * * * *
    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 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 where Q 
represents any genotype other than R at codon 171; or
    (2) An exposed sheep or sheep embryo of genotype AV QR, unless it 
is epidemiologically linked to a scrapie-positive RR or QR sheep, to a 
flock that the DSE has determined may be affected by valine associated 
scrapie, or to another scrapie type to which AV QR sheep are not less 
susceptible where Q represents any genotype other than R at codon 171 
and V represents any genotype other than A at codon 136; 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.
    Genetically resistant exposed sheep. Any exposed sheep or sheep 
embryo of genotype RR unless 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 unless it is epidemiologically linked to a scrapie-positive RR sheep 
or to a scrapie type that affects RR sheep.
    Genetically susceptible animal. Any goat or goat embryo, sheep or 
sheep embryo of a genotype other than RR or QR, or sheep or sheep 
embryo of undetermined genotype where Q represents any genotype other 
than R at codon 171.
    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 is 
epidemiologically linked to a scrapie-positive RR or QR sheep, to a 
flock that the DSE 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 where Q represents any genotype other than R 
at codon 171 and V represents any genotype other than A at codon 136; 
or
    (3) A sheep or sheep embryo of genotype AA QR that is 
epidemiologically linked to a scrapie-positive RR or AA QR sheep or to 
a scrapie type to which AA QR sheep are susceptible where Q represents 
any genotype other than R at codon 171; or
    (4) A sheep or sheep embryo of genotype RR that is 
epidemiologically linked to a scrapie-positive RR sheep or to a scrapie 
type to which RR sheep are susceptible.
    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.  71.1 
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. If a 
flock identification number is used, the flock identification number, 
date, and sequential number will be separated by hyphens.
    High-risk animal. The female offspring or embryo of a scrapie-
positive female animal, or any suspect animal, or

[[Page 54684]]

a female genetically susceptible exposed animal, or any exposed animal 
that the Administrator determines to be a potential risk based 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 DSE 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) 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. A signed written statement by the owner or 
hauler that includes:
    (1) The name, address, and phone number of the owner and, if 
different, the hauler;
    (2) The date the animals were moved;
    (3) The flock identification number or PIN assigned to the flock or 
premises of the animals;
    (4) If moving individually unidentified animals, the group/lot 
identification number and any information required to officially 
identify the animals;
    (5) The number of animals;
    (6) 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
    (7) The name and address of point of origin, if different from the 
owner's address, and the destination.
* * * * *
    Person. An individual, partnership, company, corporation, or any 
other legal entity.
* * * * *
    Premises identification number (PIN). This term has the meaning set 
forth in 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 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 a 
slaughter establishment that is under continuous inspection by the Food 
Safety and Inspection Service (FSIS) 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 for immediate 
slaughter or to an individual for immediate slaughter for personal use 
or to a terminal feedlot. Any animal sold at an unrestricted sale is 
not in slaughter channels. Animals in slaughter channels must be 
accompanied by an owner/hauler statement completed in accordance with 
Sec.  79.3(g). Animals in slaughter channels

[[Page 54685]]

may not be held in the same enclosure with sexually intact animals from 
another flock of origin that are not in slaughter channels. When 
selling animals that do not meet the requirements to move as breeding 
animals, owners must note on the bill of sale that the animals are sold 
only for slaughter.
* * * * *
    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 of this part.
* * * * *
    Terminal feedlot. (1) A dry lot approved by a State or APHIS 
representative or an accredited veterinarian who is authorized 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 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 open, 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 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 
open, 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) that engages in interstate commerce of animals 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, for an animal born after January 1, 2002, 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. Likewise, animals 
born before January 1, 2002, need only be identified to their flock 
of origin and, for animals not required to be identified prior to 
[effective date of final rule] may, be identified to the owner of 
the animals and the flock of residence as of [effective date of 
final rule].
---------------------------------------------------------------------------

    (i) Prior to the point of first commingling of the sheep or goats 
with sheep or goats from any other flock of origin;
    (ii) Upon unloading of the sheep or goats at 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;
    (iii) Upon transfer of ownership of the sheep or goats;
    (iv) Prior to moving a sheep or goat from the premises on which it 
resides if the owner of the premises engages in the interstate commerce 
of animals 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.
    (v) In the case of animals that have only resided on premises and 
in flocks

[[Page 54686]]

owned by persons that do not engage in interstate commerce, upon 
unloading a sheep or goat at a livestock facility or other premises 
that engages in interstate commerce of animals 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;
    (2) The sheep or goats must be identified and remain identified 
using a device or method approved by the Administrator. 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, Surveillance Preparedness and Response Services, 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) that engages in interstate commerce of animals. 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 move 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) Individual identification numbers. The State animal health 
official or Veterinary Services, Surveillance Preparedness and Response 
Services, Assistant Director 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) Official identification numbers for use on animals not in 
slaughter channels may only be assigned either directly to the owner of 
a breeding flock 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 for reassignment to owners of 
breeding flocks. APHIS or State representatives or accredited 
veterinarians that reissue official serial numbers or devices 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 
AIN module of the National Scrapie Database.
    (2) 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, Surveillance Preparedness and Response Services, 
Assistant Director 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, Surveillance Preparedness and Response Services 
Field Office 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, but who do not own breeding flocks, if they 
apply to and are approved by the State animal health official or the 
Veterinary Services, Surveillance Preparedness and Response Services, 
Assistant Director 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. Such persons 
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 online animal identification number (AIN) management 
system module of the National Scrapie Database.
    (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 online 
animal identification number (AIN) management system module of 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

[[Page 54687]]

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) Records required of persons who purchase, acquire, sell, or 
dispose of animals. 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 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) Records required of persons who apply official identification 
to animals. 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 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 born after January 1, 2002, 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) Removal or loss of official identification devices. 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, Surveillance Preparedness and Response Services, 
Assistant Director 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 on 
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. (1) Circumstances under which a State or Tribal animal 
health official or the Veterinary Services, Surveillance Preparedness 
and Response Services, Assistant Director responsible for the State 
involved may authorize replacement of an official identification device 
include, but are not limited to:

[[Page 54688]]

    (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, Surveillance Preparedness and Response Services, 
Assistant Director 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 on which the device was removed;
    (ii) Contact information 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) Use of more than one official eartag. Beginning on [effective 
date of final rule], 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, Surveillance 
Preparedness and Response Services, Assistant Director 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. 
(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 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, Surveillance Preparedness and Response Services, 
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 into the online animal 
identification number (AIN) management system module of 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

[[Page 54689]]

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.
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) that engages in interstate commerce of animals 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. Likewise, animals 
born before January 1, 2002, need only be identified to their flock 
of origin and, for animals not required to be identified prior to 
[Effective date of final rule] may, be identified to the owner of 
the animals and the flock of residence as of [Effective date of 
final rule].
---------------------------------------------------------------------------

    (1) Animals in slaughter channels that are under 18 months of age;
    (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) 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; 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.
    (b) No scrapie-positive or suspect animal may be moved other than 
by 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 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. 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 continuous inspection by the Food Safety 
and Inspection Service (FSIS) 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 for immediate 
slaughter or to an individual for immediate slaughter for personal use, 
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 
indicating the owner's name and address; 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.
    (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) Additional requirements for animals moved from Inconsistent 
States. Such animals must meet the following

[[Page 54690]]

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, for any animal born 
after January 1, 2002, 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, for any animal born after January 1, 2002, 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 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 regulation or an intrastate 
regulation as provided by Sec.  79.6, if the violation is reported to 
the Veterinary Services, Surveillance Preparedness and Response 
Services, Assistant Director 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.
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. Which animals are selected and the method of testing 
selected 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 
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, within 60 days of 
becoming test eligible, or as mutually agreed, 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 reasons for the proposed action are incorrect 
or do not support the action. 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. Such action 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 decision constitutes final 
agency action.
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 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

[[Page 54691]]

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 flock 
identification that is assigned to the flock of origin and that meets 
the requirements for individual animal identification, the flock 
identification number 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 
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);
    (3) If any animals intended for breeding have undergone an official 
genotype test, the name of the testing laboratory, date the sample was 
taken, and result of the test; and
    (4) 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.
    (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.
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 (17), respectively, and 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''.
    The revision and addition 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 
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.

[[Page 54692]]

    (11) If a State does not meet the requirements of paragraph (a)(10) 
of this section as of [EFFECTIVE DATE OF FINAL RULE], the State must 
provide APHIS with a plan and a timeline for complying with all the 
requirements of paragraph (a)(10) by [DATE 12 MONTHS AFTER EFFECTIVE 
DATE OF FINAL RULE] and must meet the requirements of paragraph (a)(10) 
by [DATE 2 YEARS AFTER EFFECTIVE DATE OF FINAL RULE].
* * * * *

    Done in Washington, DC, this 28th day of August 2015.
Gary Woodward,
Deputy Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2015-21909 Filed 9-9-15; 8:45 am]
BILLING CODE 3410-34-P