80_FR_54834 80 FR 54659 - Scrapie in Sheep and Goats

80 FR 54659 - Scrapie in Sheep and Goats

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 80, Issue 175 (September 10, 2015)

Page Range54659-54692
FR Document2015-21909

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.

Federal Register, Volume 80 Issue 175 (Thursday, September 10, 2015)
[Federal Register Volume 80, Number 175 (Thursday, September 10, 2015)]
[Proposed Rules]
[Pages 54659-54692]
From the Federal Register Online  [www.thefederalregister.org]
[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).
---------------------------------------------------------------------------

    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



                                                                                                          Vol. 80                           Thursday,
                                                                                                          No. 175                           September 10, 2015




                                                                                                          Part II


                                                                                                          Department of Agriculture
                                                                                                          Animal and Plant Health Inspection Service
                                                                                                          9 CFR Parts 54 and 79
                                                                                                          Scrapie in Sheep and Goats; Proposed Rule
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                                                     54660              Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules

                                                     DEPARTMENT OF AGRICULTURE                               hours are 8 a.m. to 4:30 p.m., Monday                 093–5) a final rule amending part 79 by
                                                                                                             through Friday, except holidays. To be                imposing additional restrictions on the
                                                     Animal and Plant Health Inspection                      sure someone is there to help you,                    interstate movement of sheep and goats.
                                                     Service                                                 please call (202) 799–7039 before                     We also added new requirements with
                                                                                                             coming.                                               regard to the identification,
                                                     9 CFR Parts 54 and 79                                   FOR FURTHER INFORMATION CONTACT: Dr.                  recordkeeping, and health status of
                                                     [Docket No. APHIS–2007–0127]                            Diane Sutton, National Scrapie Program                sheep and goats in order to provide a
                                                                                                             Coordinator, Sheep, Goat, Cervid &                    more effective national program for
                                                     RIN 0579–AC92                                                                                                 surveillance of scrapie and for the
                                                                                                             Equine Health Center, Surveillance,
                                                                                                             Preparedness and Response Services,                   tracing of animals affected with scrapie.
                                                     Scrapie in Sheep and Goats                                                                                    In our August 2001 final rule, we also
                                                                                                             VS, APHIS, 4700 River Road, Unit 43,
                                                     AGENCY:  Animal and Plant Health                        Riverdale, MD 20737–1235; (301) 851–                  amended part 54 by reinstating a scrapie
                                                     Inspection Service, USDA.                               3509.                                                 indemnification program for sheep and
                                                     ACTION: Proposed rule.
                                                                                                                                                                   goats. Those changes to parts 54 and 79
                                                                                                             SUPPLEMENTARY INFORMATION:
                                                                                                                                                                   were designed, in part, to provide a
                                                     SUMMARY:   We are proposing to amend                    Background                                            national standard for the control and
                                                     the scrapie regulations by changing the                    Scrapie is a member of a class of                  eradication of scrapie, and to reflect our
                                                     risk groups and categories established                  diseases called transmissible                         commitment to eliminating scrapie from
                                                     for individual animals and for flocks,                  spongiform encephalopathies (TSEs).                   the United States.
                                                     increasing the use of genetic testing as                Scrapie is a degenerative and eventually                 The changes we are proposing in this
                                                     a means of assigning risk levels to                     fatal disease affecting the central                   document are based on our evaluation
                                                     animals, reducing movement                              nervous systems of sheep and goats. To                of input that we have received from the
                                                     restrictions for animals found to be                    control the spread of scrapie within the              regulated industry and the States since
                                                     genetically less susceptible or resistant               United States, the Animal and Plant                   the implementation of the August 2001
                                                     to scrapie, and simplifying, reducing, or               Health Inspection Service (APHIS), U.S.               final rule. A number of regulatory
                                                     removing certain recordkeeping                          Department of Agriculture (USDA),                     changes have been suggested, including
                                                     requirements. We also propose to                        administers regulations at 9 CFR parts                changes to the risk groups and
                                                     provide designated scrapie                              54 and 79 (referred to below as the                   categories established for individual
                                                     epidemiologists with more alternatives                  scrapie regulations), which respectively              animals and flocks, increased use of
                                                     and flexibility when testing animals in                 describe program procedures and                       genetic testing as a means of assigning
                                                     order to determine flock designations                   restrict the interstate movement of                   risk levels to flocks and animals,
                                                     under the regulations. We propose to                    certain sheep and goats. APHIS also                   reduced movement restrictions for
                                                     change the definition of high-risk                      administers the voluntary Scrapie Flock               animals found to be genetically less
                                                     animal, which will change the types of                  Certification Program (the SFCP),1                    susceptible or resistant to scrapie, and
                                                     animals eligible for indemnity, and to                  described in regulations at 9 CFR part                simplification and reduction of
                                                     pay higher indemnity for certain                        54, and produces program standards                    recordkeeping requirements. States have
                                                     pregnant ewes and early maturing ewes.                  documents titled ‘‘Scrapie Program                    also requested that we provide
                                                     The proposed changes would also make                    Standards Volume 2: Scrapie Free Flock                designated scrapie epidemiologists
                                                     the identification and recordkeeping                    Certification Program (SFCP)’’ and                    (DSEs) with more alternatives and
                                                     requirements for goat owners consistent                 ‘‘Scrapie Eradication Uniform Methods                 flexibility in determining how many
                                                                                                             and Rules’’ (UM&R). Copies of the SFCP                and which animals in a flock must be
                                                     with those for sheep owners. These
                                                                                                             Standards and the UM&R are available                  tested in order to determine the flock’s
                                                     changes would affect sheep and goat
                                                                                                             on the APHIS Web site at http://www.                  status under the regulations. We are also
                                                     producers, persons who handle sheep
                                                                                                             aphis.usda.gov/animal_health/animal_                  proposing changes to the procedures for
                                                     and goats in interstate commerce, and
                                                                                                             diseases/scrapie/downloads/sfcp.pdf                   paying indemnity for animals, based on
                                                     State governments.
                                                                                                             and http://www.aphis.usda.gov/animal_                 input from industry on how to equitably
                                                     DATES: We will consider all comments                                                                          decide which animals should qualify
                                                     that we receive on or before November                   health/animal_diseases/scrapie/
                                                                                                             downloads/umr_scrapie.pdf,                            and how payment amounts should be
                                                     9, 2015.                                                                                                      set. This proposed rule addresses all of
                                                                                                             respectively, or by contacting the
                                                     ADDRESSES: You may submit comments                                                                            these areas.
                                                                                                             individual listed under FOR FURTHER
                                                     by either of the following methods:                                                                              The scrapie regulations are quite
                                                                                                             INFORMATION CONTACT. The UM&R has
                                                        • Federal eRulemaking Portal: Go to                                                                        complex, and understanding them is
                                                                                                             been updated to be consistent with
                                                     http://www.regulations.gov/#!docket                                                                           easier when a few overarching
                                                                                                             these proposed changes and has been
                                                     Detail;D=APHIS-2007-0127.                                                                                     principles are kept in mind. One of
                                                                                                             renamed the Scrapie Program Standards
                                                        • Postal Mail/Commercial Delivery:                                                                         these principles is trace back, which in
                                                                                                             Volume 1: National Scrapie Eradication
                                                     Send your comment to Docket No.                                                                               this case means that whenever a sheep
                                                                                                             Program. A draft of this document is
                                                     APHIS–2007–0127, Regulatory Analysis                                                                          or goat is positively diagnosed with
                                                                                                             available on the APHIS Web site at
                                                     and Development, PPD, APHIS, Station                                                                          scrapie, APHIS or a State will
                                                                                                             http://www.aphis.usda.gov/animal-
                                                     3A–03.8, 4700 River Road, Unit 118,                                                                           investigate the past movements of the
                                                                                                             health/scrapie. Comments on this
                                                     Riverdale, MD 20737–1238.                                                                                     animal to identify other animals and
                                                                                                             document are being accepted
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                                                        Supporting documents and any                                                                               flocks that may have been exposed to
                                                                                                             concurrently with this proposed rule.
                                                     comments we receive on this docket                         The last major revision of the scrapie             the scrapie-positive animal. A second
                                                     may be viewed at http://www.                            regulations occurred on August 21,                    principle is trace forward, which means
                                                     regulations.gov/#!docketDetail;D=                       2001, when we published in the Federal                that whenever an exposed sheep or goat
                                                     APHIS-2007-0127 or in our reading                       Register (66 FR 43964, Docket No. 97–                 is identified as having left an infected or
                                                     room, which is located in room 1141 of                                                                        source flock, APHIS or a State will
                                                     the USDA South Building, 14th Street                      1 Formerly the Scrapie Flock Certification          investigate the movements of the animal
                                                     and Independence Avenue SW.,                            Program; this proposal would add the word ‘‘Free’’    to locate the animal for genetic and/or
                                                     Washington, DC. Normal reading room                     to the program’s name.                                scrapie testing and to identify other


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                                                                        Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules                                                54661

                                                     animals and flocks that may have been                   Proposed § 54.11 would ensure official                tested that became infected less than 14
                                                     exposed to scrapie through the lambing                  test results are recorded in the database             months ago affect testing accuracy, and
                                                     of or contact with the lambing area of                  and proposed § 79.2(b) addresses                      as a result the percentage of infected
                                                     the potentially infected animal. This is                linking animal identification numbers                 animals not identified by the tests will
                                                     done so that genetic and/or scrapie                     for sheep and goats in interstate                     be significantly higher than 13 percent.
                                                     testing can be done to determine if any                 commerce to flock of origin in the                      Those principles are all important
                                                     of the animals are or could be infected.                database.                                             factors in the design of the current
                                                        This proposal would improve the                         A third guiding principle in both the              scrapie regulations. Many of the changes
                                                     ability of APHIS and States to trace                    current and proposed regulations is                   we are proposing in this document
                                                     animals. It would do this by changing                   flock risk level, which considers                     incorporate an additional guiding
                                                     requirements for records needed to trace                whether a flock has ever included an                  principle, genetic resistance and
                                                     animals, and by adding provisions to                    animal that is eventually diagnosed                   susceptibility, discussed in detail below.
                                                     link official individual animal                         with scrapie or that was exposed to                   Current Understanding of Genetic
                                                     identification applied by persons other                 scrapie. If so, there is a risk that other            Resistance and Susceptibility to Scrapie
                                                     than the flock owner to the flock of                    animals from that flock may have
                                                     origin in the National Scrapie Database                                                                          The Scrapie Ovine Slaughter
                                                                                                             scrapie. The flock risk level varies                  Surveillance study 2 conducted by
                                                     rather than just the person who applied                 according to many factors. For example,
                                                     the official identification. The current                                                                      APHIS (referred to below as the SOSS
                                                                                                             the flock risk level would be very high               study) provides useful baseline
                                                     regulations address trace forward                       if an animal that was born in the flock
                                                     primarily in § 54.8(f) regarding the                                                                          information on the prevalence of scrapie
                                                                                                             and spent its life in the flock until it was          in the United States and the relationship
                                                     responsibility of flock owners to
                                                                                                             sold was diagnosed with scrapie shortly               of different sheep genotypes to scrapie
                                                     disclose records to APHIS
                                                                                                             after being sold. In contrast, a flock’s              susceptibility. Some of the findings of
                                                     representatives or State representatives
                                                                                                             risk level would be lower if only one                 that study are summarized below.
                                                     for the purpose of tracing animals, in
                                                                                                             purchased exposed animal lambed in                    Please refer to the study for complete
                                                     § 79.2(b) regarding the responsibility of
                                                                                                             the flock, spent only a short time in the             details, including methodology and
                                                     persons applying eartags to maintain
                                                                                                             flock, and then was sent to slaughter                 standard error rates.
                                                     appropriate records that permit
                                                                                                             without testing. A final guiding                         Beginning April 1, 2002, and
                                                     traceback of animals, and in § 79.6(a)(5)
                                                                                                             principle is that testing has limits to its           continuing through March 31, 2003, the
                                                     regarding State responsibilities to do
                                                     epidemiologic investigations of source                  practical utility. Scrapie is a long                  SOSS study collected samples from
                                                     and infected flocks that include tracing                incubation disease, which makes it                    12,508 mature sheep at 22 slaughter
                                                     animals. The proposed rule would                        impossible to detect early infection with             plants and 1 large livestock market.
                                                     ensure that better records are available                currently available tests. While there are            Samples from 33 animals tested positive
                                                     for tracing animals, by adding                          now tests to diagnose scrapie using                   for scrapie. The overall weighted
                                                     requirements in new § 54.8(b), Records                  samples from both live and dead                       national prevalence of scrapie in mature
                                                     for flocks under a flock plan or PEMMP,                 animals, it is almost never practical or              cull sheep was estimated to be 0.20
                                                     § 79.2(f), Records required of persons                  cost effective for APHIS to simply test               percent.
                                                     who purchase, acquire, sell, or dispose                 every animal in a sizeable flock in order                To evaluate the potential relationship
                                                     of animals and § 79.2(g), Records                       to determine whether the flock contains               between scrapie susceptibility and
                                                     required of persons who apply official                  infected animals. The current live                    certain genotypes, approximately one-
                                                     identification to animals.                              animal test for scrapie requires a biopsy             fourth of the negative samples (i.e.,
                                                        In addition to improving the utility of              of the lymphoid tissue from the animal’s              those in which the scrapie prion protein
                                                     records for tracing animals, the                        third eyelid, rectum, tonsil, or a lymph              [PrPsc] was not detected) and all 33 of
                                                     proposed rule would reduce some                         node. Difficulties in sample collection               the scrapie-positive samples were
                                                     recordkeeping, primarily by eliminating                 and processing and the relatively small               submitted for genetic testing.
                                                     the requirement in many cases to read                   amount of third eyelid or rectal                         Susceptibility to scrapie has been
                                                     and record individual identification that               lymphoid tissue in some animals can                   linked to certain codons in the sheep
                                                     was applied before a new owner or                       result in significant numbers of ‘‘no                 genotype. A codon is a set of three
                                                     shipper receives the animal. Further, by                tests’’ (i.e., tests that are not successfully        nucleotides that encode for a specific
                                                     making the regulations easier to                        completed because of insufficient                     amino acid. Codons that encode for
                                                     understand we hope to eliminate cases                   follicles in the sample or other reasons),            amino acids at positions 136 and 171 in
                                                     where owners and markets                                and the test is very labor intensive and              the prion protein (PrP) have been
                                                     unnecessarily keep records or apply                     expensive. Also, a single rectal biopsy               associated with scrapie susceptibility in
                                                     unneeded identification or fail to do so                or third eyelid test using biopsies from              sheep in the United States. However,
                                                     when required through lack of                           both third lids appears to have a                     codon 171 is thought to be the major
                                                     understanding. Also, in cases where                     diagnostic sensitivity of approximately               determinant of scrapie susceptibility in
                                                     genetic testing allows us to determine                  87 percent compared to postmortem                     the United States.
                                                     that all exposed animals in a flock are                 immunohistochemistry testing on obex                     Codon values are stated as the diploid
                                                     genetically resistant, use of genetic                   and lymph node when used in sheep                     PrP genotype for the encoded amino
                                                     testing would allow some flocks to                      over 14 months of age, which means the                acids. The relevant amino acid single-
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                                                     avoid being placed under a flock plan or                rectal biopsy or third eyelid test will not           letter abbreviations are Q (glutamine)
                                                     post-exposure management and                            identify at least 13 percent of infected              and R (arginine) for codon 171, and A
                                                     monitoring plan (PEMMP), thus                           animals. Also, since scrapie is a long                (alanine) and V (valine) for codon 136.
                                                     avoiding the substantial recordkeeping                  incubation disease, it typically takes 14             So, for example, a sheep genotype that
                                                     requirements for such flocks imposed by                 months or more after the animal
                                                                                                                                                                     2 The SOSS study and related information is
                                                     § 54.8.                                                 becomes infected before these tests can
                                                                                                                                                                   available from the person identified under FOR
                                                        The proposal to enhance use of the                   detect the infection. This means that                 FURTHER INFORMATION CONTACT or at http://www.
                                                     National Scrapie Database would also                    both the inherent diagnostic sensitivity              aphis.usda.gov/animal_health/nahms/sheep/
                                                     aid trace back and trace forward.                       of the tests and the number of animals                index.shtml.



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                                                     54662                       Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules

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

                                                                                                             GENOTYPE DISTRIBUTION IN THE GENERAL SHEEP POPULATION
                                                                                    Codon 136                                                                   Codon 171                                                       Percent

                                                                                                                                        QQ ...........................................................       40.
                                                                                                                                        QR ............................................................      44.
                                                                                                                                        RR ............................................................      16.
                                                                                                                                        ..................................................................   Total: 100.
                                                     AA ..........................................................................      ..................................................................   90.
                                                     AV ..........................................................................      ..................................................................   9.
                                                     VV ..........................................................................      ..................................................................   1.
                                                     ................................................................................   ..................................................................   Total: 100.


                                                                                                                 GENOTYPE DISTRIBUTION IN THE SCRAPIE-POSITIVE SHEEP
                                                                                    Codon 136                                                                   Codon 171                                                       Percent

                                                                                                                                        QQ ...........................................................       100.
                                                                                                                                        ..................................................................   Total: 100.
                                                     AA ..........................................................................      ..................................................................   91.
                                                     AV ..........................................................................      ..................................................................   6.
                                                     No test * .................................................................        ..................................................................   3.
                                                     ................................................................................   ..................................................................   Total: 100.
                                                        * Samples could not be genotyped because of insufficient DNA or other reasons.


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


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                                                                         Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules                                                 54663

                                                     U.S. sheep that have been genotyped,                    strain involved and the genotype of the               expensive for owners to obtain genotype
                                                     and it is less common for the scrapie                   animal as additional research becomes                 testing; however, it is also critical that
                                                     prion protein to be found outside the                   available.                                            the sample is from an animal that is
                                                     brains of these sheep. AV QR sheep are                     Genetically susceptible animals                    officially identified and that the sample
                                                     significantly less susceptible to the                   would include all goats, any sheep with               maintains its identity and its association
                                                     scrapie strains that affect them than are               a genotype other than QR or RR (such                  with the correct animal throughout the
                                                     the QQ sheep that are affected by these                 as QQ, HH, QH, QK, KK or KH), and any                 process of collection and submission.
                                                     strains.                                                sheep with an unknown or                              We propose to stress that the form must
                                                                                                             undetermined genotype (i.e., sheep that               be properly completed due to the
                                                     Implications of Genetic Resistance and                  have not been officially genotyped or                 significant percentage of forms
                                                     Susceptibility for Scrapie Program                      sheep that have been tested with                      submitted to approved laboratories that
                                                     Design                                                  inconclusive results). At present, all                are incomplete or undecipherable. To
                                                        The observations discussed above, in                 goats would be considered genetically                 protect against error and tampering, we
                                                     conjunction with APHIS and State                        susceptible because there is insufficient             propose to allow owners or owner
                                                     experience in conducting scrapie                        understanding of genetically based                    agents 4 to collect samples for official
                                                     control pilot projects,3 suggest ways to                scrapie resistance in goats to reliably               genotype testing only by using an
                                                     improve the scrapie regulations’                        assign goat risk categories based on                  APHIS-approved tamper-resistant
                                                     effectiveness and to reduce their costs                 genetics. If ongoing and future research              sampling kit. This kit would be an
                                                     by creating new risk categories for sheep               provides new information about the                    official identification device that, when
                                                     and goats based on their scrapie                        genetic resistance of sheep or goats to               it is attached to the animal, collects and
                                                     resistance or susceptibility, and taking                scrapie that would allow other useful                 ejects a tissue sample in a sealed
                                                     these risk categories into account when                 distinctions in risk between different                container. Both the tissue sample
                                                     imposing regulatory restrictions on                     genotypes of sheep or goats, APHIS will               container and the official identification
                                                     animals. In general, the animals that                   take such research results into account               device that remains attached to the
                                                     could have their status affected by                     in the design of the Scrapie Eradication              animal would bear the same
                                                     genotype test results are exposed or                    Program. The Scrapie Eradication                      identification number, reliably
                                                     potentially exposed animals. Most of the                Program is the cooperative State-                     associating the tissue with the correct
                                                     changes in this area would flow from                    Federal-Industry program administered                 animal. We propose to add a new term
                                                     the establishment of four new categories                by APHIS and States to control and                    to part 54, tamper-resistant sampling
                                                     of exposed animals. Ordered by lowest                   eradicate scrapie, encompassing the                   kit, defined as ‘‘A device or method for
                                                     to highest risk, these categories are:                  SFCP, Federal and State regulations                   collecting DNA samples from sheep or
                                                     Genetically resistant exposed sheep,                    regarding the identification and                      goats that is approved by the
                                                     genetically less susceptible exposed                    movement of sheep and goats and the                   Administrator and that identifies both
                                                     sheep, low-risk exposed animal, and                     control of scrapie, and other associated              the sample and the animal at the time
                                                     genetically susceptible exposed animals.                efforts.                                              the sample is collected. These devices
                                                     As defined in the regulations, the terms                   In order to assign individual sheep to             or methods must ensure that the sample,
                                                     exposed sheep and exposed animal both                   one of these genetic susceptibility                   its corresponding label, and the official
                                                     include embryos.                                        categories, APHIS has established                     ID device or method applied to the
                                                        We would define genetically resistant                procedures to ensure that genotype tests              animal meets the requirements of
                                                     sheep to include most sheep and sheep                   conducted as part of the Scrapie                      § 79.2(k) and that the sample is from the
                                                     embryos with the RR genotype. The                       Eradication Program are reliable. We                  same animal to which the official ID
                                                     exception would be if a sheep with the                  propose to amend the definition of                    device or method was applied. The kit
                                                     RR genotype is ever epidemiologically                   official genotype test to read ‘‘A test to            must include an APHIS-approved
                                                     linked to a scrapie-positive RR sheep or                determine the genotype of a live or dead              official form or another form, device, or
                                                     to a scrapie type that affects RR sheep.                animal conducted at either the National               method acceptable to APHIS for
                                                     A genetically resistant sheep that was                  Veterinary Services Laboratories or at an             transmitting the information required to
                                                     exposed to scrapie would be a                           approved laboratory. The test subject                 APHIS and the approved laboratory.’’
                                                     genetically resistant exposed sheep.                    must be an animal that is officially                  This definition is intended to allow the
                                                     Genetically less susceptible sheep                      identified and the test accurately                    market to develop innovative
                                                     would include most sheep (or sheep                      recorded on an official form supplied or              approaches to the task by allowing the
                                                     embryos) with the AA QR or AV QR                        approved by APHIS, with the samples                   Administrator to approve a wide variety
                                                     genotype. A low-risk exposed animal                     collected and shipped to the laboratory               of potential kits. APHIS also employs
                                                     would be a sheep or goat deemed to                      using a shipping method specified by                  this approach of encouraging market
                                                     present significantly lower risks than a                the laboratory by:                                    innovation and approving successful
                                                     typical exposed animal due to the                          (1) An accredited veterinarian;                    methods in our proposed changes to
                                                     nature of either the exposure or the                       (2) A State or APHIS representative;               § 54.10, ‘‘Program approval of tests for
                                                     animal. The exact definitions for these                 or                                                    scrapie,’’ and § 54.11, ‘‘Approval of
                                                     categories are discussed in more detail                    (3) The animal’s owner or owner’s
                                                                                                                                                                   laboratories to run official scrapie tests
                                                     below. Flexibility has been written into                agent, using a tamper-resistant sampling
                                                                                                                                                                   and official genotype tests,’’ which are
                                                     these definitions to allow the                          kit approved by APHIS for this
                                                                                                                                                                   discussed later in this document.
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                                                     Administrator to adjust the                             purpose.’’                                               Note that in addition to approving
                                                     classification of animals based on the                     The primary change from the previous
                                                                                                                                                                   tamper-resistant sampling kits, test
                                                                                                             definition is that new paragraph (3)
                                                                                                                                                                   methodologies, and laboratories that
                                                        3 Pilot projects have tested, among other things,    would allow owners to collect samples
                                                                                                                                                                   may perform tests, APHIS reserves the
                                                     live animal scrapie tests, alternatives for improving   for official genotype tests and to clarify
                                                     field data collection for animals and flocks,                                                                 right to require confirmatory genotype
                                                                                                             that when a sample is submitted it must
                                                     innovative animal ID devices, use of genotype to
                                                     classify the risk of exposed sheep and new devices
                                                                                                             be accompanied by a properly                            4 APHIS or State representatives or accredited

                                                     and procedures for collecting tissue samples for        completed official form. We believe this              veterinarians would not have to use tamper-
                                                     DNA testing.                                            would make it more convenient and less                resistant sampling kits when collecting samples.



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                                                     54664              Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules

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


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                                                                        Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules                                          54665

                                                     designation under the revisions we                      flock under investigation if it is                    needed to make a designation under
                                                     propose. For example, an investigator                   redesignated in accordance with § 79.4.               § 79.4, official genotype test results,
                                                     may know that a flock has a risk factor,                A flock may be redesignated for various               exposure risk, scrapie type involved,
                                                     and that we should pay attention to the                 reasons, including a determination that               and/or results of official scrapie testing
                                                     flock, but cannot determine the actual                  it is an infected flock, source flock, or             on live or dead animals.’’
                                                     risk without testing the animal that                    exposed flock, or that tissues from the                  We also propose to revise the
                                                     caused the potential exposure or, in its                suspect and high-risk animals were                    definition of exposed animal so that it
                                                     absence, other animals in the flock. Live               submitted for official testing and no                 employs the concepts of genetic
                                                     animal tests are now available to aid in                evidence of scrapie is found, or because              resistance or susceptibility discussed
                                                     this determination.                                     the flock completed any genotyping and                above. It also includes a standard for
                                                        To address these problems, we are                    live-animal or post-mortem scrapie                    estimating a probable date of infection
                                                     developing a new category, flock under                  testing required by the DSE and is in                 for a flock, which is relevant to
                                                     investigation. A flock under                            compliance with a PEMMP if one is                     identifying which animals were
                                                     investigation is a flock that may have                  required by the DSE.                                  exposed. Where epidemiologic
                                                     become scrapie infected by exposure to                     An exposed flock would be any flock                investigation is inconclusive, we use a
                                                     a scrapie-positive, high-risk, or scrapie-              that was designated an infected or                    probable date of infection 2 years before
                                                     suspect animal, however, further                        source flock that has completed a flock               the birth of the oldest scrapie-positive
                                                     investigation of animal records and/or                  plan and that retained a female                       animal in the flock. The 2-year range is
                                                     testing of animals in the flock may be                  genetically susceptible exposed animal.               used because the oldest positive animal
                                                     necessary to make the final                             The definition would also include any                 was likely infected at or near birth by
                                                     determination. A flock under                            flock under investigation that retains a              another positive animal that died and
                                                     investigation may be cleared by                         female genetically susceptible exposed                that positive animal likely exposed up
                                                     demonstrating that it was not in fact                   animal or a suspect animal, or whose                  to two previous lamb crops before she
                                                     exposed, or by taking steps to ensure                   owner declines to complete genotyping                 died since most positive animals die 3-
                                                     that, whether or not the flock was                      and live-animal and/or post-mortem                    to-4 years after infection. The revised
                                                     exposed, there is no significant                        scrapie testing required by the                       definition we propose for exposed
                                                     possibility that animals in the flock                   investigator, and any noncompliant                    animal would read ‘‘Any animal or
                                                     were infected as a result of the                        flock or any flock for which a PEMMP                  embryo that: (1) Has been in a flock or
                                                     exposure. Such steps could include                      is required that is not in compliance                 in an enclosure off the premises of the
                                                     genotyping some or all of the animals in                with the conditions of the PEMMP. A                   flock with a scrapie-positive female
                                                     the flock, then removing and destroying                 flock will no longer be considered an                 animal, (2) resides in a noncompliant
                                                     and/or testing the genetically                          exposed flock if it is redesignated in                flock, or (3) has resided on the premises
                                                     susceptible animals and/or having the                   accordance with § 79.4.                               of a flock before or while it was
                                                     flock comply with a PEMMP.                                 We also propose to change the                      designated an infected or source flock
                                                        Creating the category of flock under                 definition for noncompliant flock to                  and before a flock plan was completed.
                                                     investigation would leave the category                  recognize the role of the new category                An animal shall not be designated an
                                                     of exposed flock to apply to only those                 flock under investigation. The current                exposed animal if it only resided on the
                                                     flocks where there has been exposure or                 definition refers to source, infected, or             premises before the date that infection
                                                     potential exposure that could not be                    exposed flocks that are not in                        was most likely introduced to the
                                                     adequately assessed, and/or the risks of                compliance with the regulations; we                   premises as determined by a Federal or
                                                     exposure have not been sufficiently                     propose to also include flocks under                  State representative. If the probable date
                                                     mitigated, so there is some significant                 investigation that are not in compliance.             of infection cannot be determined based
                                                     continuing risk that a scrapie-positive                    We would also add a new defined                    on the epidemiologic investigation, a
                                                     animal might be detected in the flock.                  term, classification or reclassification              date 2 years before the birth of the
                                                     An exposed flock could be a flock under                 investigation, to consolidate                         oldest scrapie-positive animal(s) will be
                                                     investigation whose owner declined to                   descriptions of epidemiological                       used. If the actual birth date is
                                                     complete the genotyping or scrapie                      investigation activities that were                    unknown, the date of birth will be
                                                     testing needed to complete the                          formerly located in several places in the             estimated based on examination of the
                                                     investigation, or declined to remove one                regulations. This defined term would                  teeth and any available records. If an age
                                                     or more genetically susceptible exposed                 not impose new requirements, but                      estimate cannot be made, the animal
                                                     animals or suspect animals identified                   would instead help the reader                         will be assumed to have been 48 months
                                                     during the investigation. Thus, the                     understand what epidemiological                       of age on the date samples were
                                                     category of exposed flock would                         considerations a DSE would employ                     collected for scrapie diagnosis. Exposed
                                                     generally apply to flocks where the                     when determining the designation of an                animals will be further designated as
                                                     owner has decided to accept some level                  animal or flock under the Scrapie                     genetically resistant exposed sheep,
                                                     of continuing scrapie risk, rather than                 Eradication Program. The new term                     genetically less susceptible exposed
                                                     undertake the actions that would                        would be defined as follows: ‘‘An                     sheep, genetically susceptible exposed
                                                     resolve the remaining risk.                             epidemiological investigation                         animals, or low-risk exposed animals.
                                                        Specifically, we propose to define                   conducted or directed by a DSE for the                An animal will no longer be an exposed
                                                     these two categories as follows. A flock                purpose of designating or redesignating               animal if it is redesignated in
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                                                     under investigation would be any flock                  the status of a flock or animal. In                   accordance with § 79.4.’’
                                                     in which an APHIS or State                              conducting such an investigation, the                    We also propose to add definitions of
                                                     representative has determined that a                    DSE will evaluate the available records               several terms related to genetic
                                                     scrapie suspect, positive, or high-risk                 for flocks and individual animals and                 susceptibility and resistance that appear
                                                     animal resides or may have resided.                     conduct or direct any testing needed to               in the defined term exposed animal.
                                                     (Note that mere removal of any suspect                  assess the status of a flock or animal.               These new terms reflect the fact, as
                                                     or high-risk animals is not sufficient                  The status of an animal or flock will be              discussed above, that the genetic
                                                     grounds to end investigation of the                     determined based on the applicable                    resistance or susceptibility of an
                                                     flock.) A flock would no longer be a                    definitions in this section and, when                 exposed animal affects the risk level of


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                                                     54666              Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules

                                                     that exposed animal. Therefore, we                      epidemiologically linked to a scrapie-                a scrapie-positive female was born into
                                                     propose to add the following                            positive RR or AA QR sheep or to a                    the flock. We now believe that, while
                                                     definitions.                                            scrapie type to which AA QR sheep are                 many of the female sheep born in such
                                                        We would define genetically less                     susceptible where Q represents any                    a lambing season should be considered
                                                     susceptible exposed sheep as ‘‘Any                      genotype other than R at codon 171; or                high risk, some of them should not,
                                                     sheep or sheep embryo that is:                             • A sheep or sheep embryo of                       based primarily on the genetic
                                                        • An exposed sheep or sheep embryo                   genotype RR that is epidemiologically                 susceptibility of the animals involved.
                                                     of genotype AA QR, unless it is                         linked to a scrapie-positive RR sheep or              The proposed new definition generally
                                                     epidemiologically linked to a scrapie-                  to a scrapie type to which RR sheep are               excludes male sheep (except suspect
                                                     positive RR or AA QR sheep or to a                      susceptible.’’                                        animals that need to be investigated,
                                                     scrapie type to which AA QR sheep are                      We also propose to add the following               and occasional special cases identified
                                                     not less susceptible where Q represents                 definition of low-risk exposed animal,                by the Administrator) because
                                                     any genotype other than R at codon 171;                 identifying exposed animals that are of               accumulated epidemiological evidence
                                                     or                                                      very low-risk of transmitting scrapie so              shows little chance that a male sheep
                                                        • An exposed sheep or sheep embryo                   that the program can avoid ordering the               could present a high risk of transmitting
                                                     of genotype AV QR, unless it is                         destruction of such animals. For                      scrapie.
                                                     epidemiologically linked to a scrapie-                  example current science indicates that                   The epidemiology and scrapie
                                                     positive RR or QR sheep, to a flock that                sheep and goats exposed to Nor98-like                 prevalence of the flock would also be
                                                     the DSE has determined may be affected                  scrapie are unlikely to transmit the                  considered in determining the risk level
                                                     by valine associated scrapie (based on                  disease to other animals. Barring the                 of genetically less susceptible sheep. We
                                                     an evaluation of the genotypes of the                   publication of new data to the contrary,              propose to amend the definition of high-
                                                     scrapie-positive animals linked to the                  the Administrator intends to determine                risk animal to give the Administrator,
                                                     flock), or to another scrapie type to                   that animals exposed to Nor98-like                    and persons authorized to act for the
                                                     which AV QR sheep are not less                          scrapie are low-risk exposed animals.                 Administrator (e.g., DSEs) some
                                                     susceptible where Q represents any                         We would define low-risk exposed                   discretion in whether or not to classify
                                                     genotype other than R at codon 171 and                  animal as ‘‘Any exposed animal to                     genetically less susceptible sheep as
                                                     V represents any genotype other than A                  which the DSE has determined one or                   high-risk. Specifically, we would revise
                                                     at codon 136; or                                        more of the following applies:                        the definition of high-risk animal to
                                                        • An exposed sheep or sheep embryo                      • The positive animal that was the                 read ‘‘The female offspring or embryo of
                                                     of a genotype that has been exposed to                  source of exposure was not born in the                a scrapie-positive female animal, or any
                                                     a scrapie type to which the                             flock and did not lamb in the flock or                suspect animal, or a female genetically
                                                     Administrator has determined that                       in an enclosure where the exposed                     susceptible exposed animal, or any
                                                     genotype is less susceptible but not                    animal resided;                                       exposed animal that the Administrator
                                                     resistant.’’                                               • The Administrator and State                      determines to be a potential risk based
                                                        We would define genetically resistant                Veterinarian concur that the animal is                on the scrapie type, the epidemiology of
                                                     exposed sheep as ‘‘Any exposed sheep                    unlikely to be infected due to factors                the flock or flocks with which it is
                                                     or sheep embryo of genotype RR unless                   such as, but not limited to, where the                epidemiologically linked, including
                                                     it is epidemiologically linked to a                     animal resided or the time period the                 genetics of the positive sheep, the
                                                     scrapie-positive RR sheep or to a scrapie               animal resided in the flock;                          prevalence of scrapie in the flock, any
                                                     type to which RR sheep are not                             • The exposed animal is male and                   history of recurrent infection, and other
                                                     resistant.’’                                            was not born in an infected or source                 animal or flock characteristics. An
                                                        We would define genetically                          flock;                                                animal will no longer be a high-risk
                                                     susceptible animal as ‘‘Any goat or goat                   • The exposed animal is a castrated                animal if it is redesignated in
                                                     embryo, sheep or sheep embryo of a                      male;                                                 accordance with § 79.4.’’
                                                     genotype other than RR or QR, or sheep                     • The exposed animal is an embryo of                  We also propose to amend the
                                                     or sheep embryo of undetermined                         a genetically resistant exposed sheep or              definition of suspect animal in parts 54
                                                     genotype where Q represents any                         a genetically less susceptible exposed                and 79. The new definition could apply
                                                     genotype other than R at codon 171.’’                   sheep unless placed in a recipient that               only to an animal that is a ‘‘mature
                                                        We would define genetically                          was a genetically susceptible exposed                 sheep or goat as evidenced by eruption
                                                     susceptible exposed animal as                           animal; or                                            of the first incisor.’’ This change reflects
                                                     ‘‘Excluding low-risk exposed animals,                      • The animal was exposed to a                      the reality that clinical signs of scrapie
                                                     any exposed animal or embryo that is                    scrapie type and/or is of a genotype that             do not appear in very young animals.
                                                     also:                                                   the Administrator has determined poses                The revised definition also notes that a
                                                        • A genetically susceptible animal; or               low risk of transmission.’’                           suspect animal might be one that was
                                                        • A sheep or sheep embryo of                            We also propose to amend the                       determined to be suspicious for scrapie
                                                     genotype AV QR that is                                  definition of the term high-risk animal.              by an accredited veterinarian or a State
                                                     epidemiologically linked to a scrapie-                  The current definition includes most                  or APHIS representative, as the current
                                                     positive RR or QR sheep, to a flock that                exposed male sheep, excluding only                    definition states, or it might be an
                                                     the DSE has determined may be affected                  male sheep that have been genotyped                   animal ‘‘condemned by FSIS or a State
                                                     by valine associated scrapie (based on                  and found to be genetically resistant (RR             inspection authority for central nervous
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                                                     an evaluation of the genotypes of the                   at codon 171). Both the current and the               system signs.’’ This change reflects the
                                                     scrapie-positive animals linked to the                  proposed definition include all female                reality that the condemnation process
                                                     flock), or to a scrapie type to which AV                progeny of a scrapie-positive dam, and                sometimes leads to identification of
                                                     QR sheep are susceptible where Q                        all exposed genetically susceptible                   suspect animals.
                                                     represents any genotype other than R at                 female sheep. The current definition
                                                     codon 171 and V represents any                          also automatically included all female                Updating Other Definitions in Parts 54
                                                     genotype other than A at codon 136; or                  sheep that were born into a flock during              and 79
                                                        • A sheep or sheep embryo of                         the same lambing season that a scrapie-                 To support and clarify some of the
                                                     genotype AA QR that is                                  positive female lambed in the flock or                changes discussed above, we propose to


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                                                                        Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules                                           54667

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


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                                                     54668              Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules

                                                     certification that any female animals                   majority of classified flocks or animals.             consistent with APHIS official
                                                     have not been exposed to a male in the                  We would also provide email                           identification requirements in 9 CFR
                                                     preceding 6 months, an ICVI issued by                   notification to State cooperators and                 part 86. We would also change the
                                                     an accredited veterinarian stating the                  other stakeholders through the APHIS                  heading of § 79.2 to read Identification
                                                     animals are open, or the animals are                    Stakeholder Registry. Individuals or                  and records requirements for sheep and
                                                     under 6 months of age at time of receipt,               organizations may be added to this list               goats in interstate commerce. The two
                                                     where only castrated males are                          through GovDelivery, a free email                     new paragraphs (f) and (g) would be
                                                     maintained with female animals, and all                 subscription service. To subscribe to                 titled ‘‘Records required of persons who
                                                     animals in the terminal feedlot are                     this free service go to https://public.               purchase, acquire, sell, or dispose of
                                                     separated from all other animals such                   govdelivery.com/accounts/                             animals’’ and ‘‘Records required of
                                                     that physical contact cannot occur and                  USDAAPHIS/subscriber/new and select                   persons who apply official
                                                     from which animals are moved only to                    ‘‘Animal Health—Sheep and Goats’’ and                 identification to animals.’’
                                                     another terminal feedlot or directly to                 ‘‘Federal Register Publications—Notices                  The new paragraph (f) that addresses
                                                     slaughter.’’                                            Regarding Animal Health.’’                            recordkeeping requirements for people
                                                                                                                As part of this change, we propose to              who acquire or dispose of sheep and
                                                     Changes to the Investigation of Flocks                  reformat the reclassification processes
                                                     and the Designation of a Flock- and                                                                           goats would continue to require, as
                                                                                                             described in current paragraph (b) as a               current § 79.2(d) does, that these
                                                     Animal’s Risk for Scrapie                               chart instead of text, to make it easier              persons—whether or not the animals are
                                                        We propose to make several changes                   to understand. We would also remove                   required to be officially identified—
                                                     to the descriptions in § 79.4 regarding                 some repetitive language concerning                   maintain business records documenting
                                                     the investigation procedures followed                   investigation and testing from the                    the acquisition or disposal (such as
                                                     by officials who are authorized to                      current text in paragraph (b). The                    yarding receipts, sale tickets, invoices,
                                                     designate or redesignate exposed                        proposed chart of reclassification                    and waybills) for 5 years. We also
                                                     animals, suspect animals, high-risk                     procedures, along with other materials                propose to expand on the current
                                                     animals, exposed flocks, infected flocks,               this rule proposes to make available                  § 79.2(d) requirement that such persons
                                                     and source flocks. These proposed                       through the scrapie Web site rather than              must keep ‘‘records relating to the
                                                     changes are to improve the clarity and                  in the regulations, is available by                   transfer of ownership, shipment, or
                                                     practicality of the regulations.                        contacting the person listed under FOR                handling of the sheep or goats’’ by
                                                        We also propose to remove some                       FURTHER INFORMATION CONTACT, on the                   specifically stating that the records must
                                                     repetitive language concerning                          Regulations.gov Web site, or on the                   include the following information:
                                                     investigation and testing from paragraph                scrapie Web site at http://www.aphis.                    • The number of animals purchased
                                                     (a) of § 79.4. This language is no longer               usda.gov/animal-health/scrapie. We                    or sold including animals acquired or
                                                     needed due to the new proposed                          invite public comment on both the                     transferred without sale;
                                                     definition for classification or                        current drafts of these materials and on                 • The date of purchase, sale, or other
                                                     reclassification investigation.                         the concept of making the materials                   transfer;
                                                        In paragraph (b) of § 79.4, we propose               available on the scrapie Web site rather                 • The name and address of the person
                                                     to remove the detailed descriptions of                  than in the Code of Federal Regulations.              from whom the animals were purchased
                                                     the reclassification process and instead                                                                      or otherwise acquired or to whom they
                                                     state that reclassification investigations              Changes to Recordkeeping and
                                                                                                             Identification Requirements                           were sold or otherwise transferred;
                                                     will be conducted in accordance with                                                                             • The species, breed, and class of
                                                     procedures approved by the                                 We propose to consolidate and                      animal, such as replacement ewe lambs,
                                                     Administrator when evidence indicates                   simplify the recordkeeping                            slaughter lambs or kids, cull ewes, club
                                                     that a previous designation can be                      requirements in the regulations.                      lambs, bred ewes, etc. If breed is
                                                     changed.                                                Currently, the description of these                   unknown, for sheep the face color or in
                                                        We would provide the detailed                        requirements is dispersed in several                  the case of goats the type (milk, fiber, or
                                                     reclassification processes to the public                locations in the regulations, including               meat) must be recorded instead;
                                                     on the scrapie Web site at http://www.                  the definition of terminal feedlot, in                   • A copy of the brand inspection
                                                     aphis.usda.gov/animal-health/scrapie.                   paragraphs (c) and (f) through (h) of                 certificate for animals officially
                                                     This will allow us to update the                        § 54.8, Requirements for flock plans and              identified with brands or ear notches;
                                                     reclassification processes easily when                  post-exposure management and                             • A copy of any certificate or owner/
                                                     necessary while providing the public                    monitoring plans, and in paragraphs (b)               hauler statement required for movement
                                                     with notice regarding our policies. For                 through (d) of § 79.2, Identification of              of the animals purchased, sold, or
                                                     major changes to the reclassification                   sheep and goats in interstate commerce.               otherwise transferred; and
                                                     processes, we would publish a notice in                 Some readers also found the current                      • If the flock of origin or the receiving
                                                     the Federal Register describing the                     descriptions of recordkeeping                         flock is under a flock plan or PEMMP,
                                                     proposed change and solicit public                      requirements confusing in terms of what               any additional records required by the
                                                     comments on the change. We would                        types of people or businesses were                    plan.
                                                     then issue a second notice discussing                   required to keep what types of records.                  New paragraph (g) that addresses
                                                     the comments and informing the public                      To aid clarity, we propose to                      recordkeeping requirements for persons
                                                     of our decision regarding the change.                   consolidate and replace the existing                  who apply official identification to
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                                                     For minor changes, updates, or                          recordkeeping language with two new                   animals would require such persons to
                                                     clarifications, we would post notice of                 paragraphs addressing recordkeeping                   maintain the following records:
                                                     the change prominently on the scrapie                   requirements in § 79.2. We also propose                  • The flock identification number, the
                                                     Web site. Examples of major changes                     to add three new paragraphs dealing                   name and address of the person who
                                                     might be a whole new class of live                      with removal, loss, and replacement of                currently owns the animals, and the
                                                     animal test that is cheap, reliable, and                official identification devices, and                  name and address of the owner of the
                                                     effective enough to make testing all                    situations where use of more than one                 flock of origin if different;
                                                     animals practical, or other changes that                official eartag may be allowed. This                     • The name and address of the owner
                                                     might result in reclassification of the                 language would be added to be                         of the flock of birth, if known, for


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                                                                        Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules                                          54669

                                                     animals born after January 1, 2002, in                  warranted by a specific situation. This               applied no later than whenever one of
                                                     another flock and not already identified                is because the use of multiple official               the following situations applies to an
                                                     to flock of birth;                                      eartags with multiple official                        animal:
                                                       • The date the animals were officially                identification numbers for a single                      • Prior to the point of first
                                                     identified;                                             animal can cause confusion and impede                 commingling with sheep or goats from
                                                       • The number of sheep and the                         efforts to track the movements of that                any other flock of origin;
                                                     number of goats identified;                             animal. However, we do propose to                        • Upon transfer of ownership of the
                                                       • The breed and class of animals such                 allow multiple eartags in situations                  sheep or goats;
                                                     as replacement ewe lambs, slaughter                     where they would provide herd                            • Upon unloading at a livestock
                                                     lambs or kids, cull ewes, club lambs,                   management advantages or where                        facility or other premises that engages in
                                                     bred ewes, etc. If breed is unknown, for                allowing only a single tag is impractical.            interstate commerce of animals; or
                                                     sheep the face color or in the case of                  We propose to allow multiple official                    • Prior to moving a sheep or goat
                                                     goats the type (milk, fiber, or meat) must              eartags in the following situations:                  from the premises on which it resides
                                                     be recorded instead;                                       • When the additional eartag bears                 for any other type of movement.
                                                       • The official identification numbers                 the same official identification number                  We would provide an exemption from
                                                     applied to animals by species or the GIN                as an existing one.                                   the requirement to officially identify
                                                     applied in the case of a group lot;                        • In specific cases when the need to               animals before they leave their premises
                                                       • Whether the animals were                            maintain the identity of an animal is                 if they move, as part of a group lot, to
                                                     identified with ‘‘Slaughter Only’’ or                   intensified (e.g., such as for export                 a livestock facility approved in
                                                     ‘‘Meat’’ identification devices; and                    shipments, quarantined herds, field                   accordance with our regulations in 9
                                                       • Any GIN with which the animal                       trials, experiments, or disease surveys),             CFR 71.20 to handle the species and
                                                     was previously identified.                              a State or Tribal animal health official              class of animal moved, provided that
                                                       Each person required to keep records                  or the Veterinary Services, Surveillance              the facility has agreed to act as an agent
                                                     under either of these paragraphs would                  Preparedness and Response Services,                   for the owner to apply official
                                                     have to maintain the records for at least               Assistant Director responsible for the                identification. We would also exempt
                                                     5 years, or longer if the Administrator                 State involved may approve the                        animals that are moved as part of a
                                                     requests it by written notice to the                    application of a second official eartag.              group lot to a slaughter plant listed in
                                                     person, for purposes of any                             The person applying the second official               accordance with 9 CFR 71.21 or for
                                                     investigation or action involving the                   eartag must record the following                      managerial purposes between premises
                                                     sheep or goats identified in the records.               information about the event and                       owned or leased by the same flock
                                                     As in the current requirements, the                     maintain the record for 5 years: The date             owner. We also propose to remove a
                                                     person would have to make the records                   the second official eartag is added; the              provision in § 79.2(a) that expired on
                                                     available for inspection and copying by                 reason for the additional official eartag             June 1, 2003, that allowed movement of
                                                     any authorized USDA or State                            device; and the official identification               certain animals that are not identified to
                                                     representative upon that                                numbers of both official eartags.                     their flock of birth.
                                                     representative’s request and                               • An eartag with an animal                            Paragraph (a)(2) of § 79.2 lists
                                                     presentation of his or her official                     identification number (AIN) beginning                 approved identification methods. We
                                                     credentials.                                            with the 840 prefix (either radio                     are proposing to remove this list from
                                                       New paragraph (h) in § 79.2 addresses                 frequency identification or visual-only               the regulations and instead state in the
                                                     removal or loss of official identification.             tag) may be applied to an animal that is              regulations that sheep or goats must be
                                                     The proposed requirements are                           already officially identified with                    identified and remain identified using a
                                                     consistent with parallel requirements in                another eartag. The person applying the               method approved by the Administrator.
                                                     9 CFR 86.4(d). Official identification is               AIN eartag must record the date the AIN               We would provide a list of approved
                                                     removed at slaughter, and this                          tag is added and the official                         identification methods on the scrapie
                                                     paragraph describes the responsibilities                identification numbers of all official                Web site at http://www.aphis.usda.gov/
                                                     of slaughter plants to keep official                    eartags on the animal and must                        animal-health/scrapie. For major
                                                     identification correlated with carcasses                maintain those records for 5 years.                   changes to the list of approved
                                                     through final inspection and procedures                    • An official eartag that utilizes a               identification methods, we would
                                                     between APHIS and FSIS regarding                        flock identification number may be                    publish a notice in the Federal Register
                                                     collection of identification at the                     applied to a sheep or goat that is already            describing the proposed change and
                                                     slaughter plants. This paragraph also                   officially identified with an official                solicit public comments on the change.
                                                     describes procedures in the event of loss               eartag if the animal has resided in the               We would then issue a second notice
                                                     or destruction of official identification               flock to which the flock identification               discussing the comments and informing
                                                     prior to slaughter.                                     number is assigned.                                   the public of our decision regarding the
                                                       New paragraph (i) addresses                              We also propose to make certain                    change. For minor changes, updates, or
                                                     replacement of official identification                  changes to the system for official animal             clarifications, we would post notice of
                                                     devices for reasons other than loss, such               identification in two sections, § 54.8                the change prominently on the scrapie
                                                     as damage to the device or injury or                    (retitled Requirements for flocks under               Web site. We would also provide email
                                                     infection of the animal that affects the                investigation and flocks subject to flock             notification to State cooperators and
                                                     device. The proposed requirements are                   plans and post-exposure management                    other stakeholders through the APHIS
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                                                     consistent with parallel requirements in                and monitoring plans) and § 79.2                      Stakeholder Registry.
                                                     9 CFR 86.4(e).                                          (Identification and records requirements                 We are proposing this change because
                                                       New paragraph (j) addresses use of                    for sheep and goats in interstate                     identification technologies are
                                                     more than one official eartag on a sheep                commerce). Some of these changes                      continually updated to take advantage
                                                     or goat. The proposed requirements are                  clarify who is responsible for ensuring               of newly available technology and to
                                                     consistent with parallel requirements in                animal identification is applied (the                 meet industry needs. Maintaining a list
                                                     9 CFR 86.4(c). We propose to prohibit                   owner and anyone who has control or                   of approved identification methods in
                                                     the application of additional official                  possession of the animals) and when it                the regulations requires rulemaking to
                                                     eartags to a single animal unless                       must be applied. Identification must be               update that list. Updating the list of


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                                                     54670              Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules

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


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                                                                         Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules                                         54671

                                                     Changes to Indemnity Provisions in Part                 intentions. To alleviate financial                    of how an appraisal is conducted. For
                                                     54                                                      hardship in such cases, we propose to                 example, 9 CFR part 56, which provides
                                                        The changes discussed above that                     amend § 54.3 to state that partial                    for the payment of indemnity for
                                                     would provide for the classification of                 indemnity may be paid when the                        poultry affected by low pathogenic
                                                     animals based on their genetic                          Administrator determines that weather                 avian influenza, states that indemnity
                                                     susceptibility or resistance to scrapie                 or other factors outside the control of               will be paid based on appraisals;
                                                     would likely result in fewer animals                    the owner make immediate disinfection                 however, those regulations do not
                                                     being designated as high-risk animals.                  impractical.                                          include the details of how appraisals are
                                                     Most of the animals eligible for                          In § 54.6, paragraphs (a) and (b) set               conducted, and they are typically
                                                     indemnity in accordance with § 54.3 are                 out procedures for determining what                   conducted by use of spreadsheets
                                                     high-risk animals.6 We believe it is                    indemnity will be paid for sheep and                  showing data on inputs and expected
                                                     appropriate to deny indemnity for                       goats that are eligible for indemnity                 prices. Similarly, the scrapie regulations
                                                     exposed animals that have been                          under § 54.3. Paragraph (a) contains                  provide for calculation of indemnity
                                                     genetically tested and found to be                      detailed information regarding price                  based on broad market data, with a few
                                                     genetically resistant or less susceptible               reports published by the Agricultural                 modifications; we believe it is
                                                     to scrapie. Such animals can generally                  Marketing Service (AMS) that are used                 appropriate to state in the regulations
                                                     be moved interstate with only minor                     to calculate indemnity for sheep.                     that indemnity will be based on those
                                                                                                             Paragraph (b) sets out the process by                 broad market data and provide the
                                                     restrictions, and sold on the open
                                                                                                             which these price reports are used to                 details on the scrapie Web site. We
                                                     market for prices similar to those
                                                                                                             determine indemnity for various classes               invite public comment on this
                                                     obtained for sheep that have never been
                                                                                                             of animals, with premiums paid for                    approach.
                                                     exposed to scrapie. It is not appropriate
                                                                                                             certain types of animals, such as                        We would also reorganize and
                                                     to pay indemnity for animals when their
                                                                                                             registered animals and flock sires.                   renumber the paragraphs in § 54.6 and
                                                     owners have these options.                                We are proposing to remove this
                                                        We also believe it is necessary to                                                                         make other minor changes to the section
                                                                                                             detailed information from the                         to improve its comprehensibility.
                                                     clarify what is meant by a statement in
                                                                                                             regulations. The price reports we use as                 As part of this change, we also
                                                     current § 54.3(b), ‘‘No indemnity will be
                                                                                                             a basis for our indemnity calculations                propose to create a new indemnity
                                                     paid to an owner if the owner assembled
                                                                                                             change frequently, as do the terms used               classification for certain pregnant
                                                     or increased his flock for the purpose of               in those price reports to refer to various            animals and early maturing ewes. At
                                                     collecting or increasing indemnity.’’                   types of sheep and goats. The price                   sales, animals in late pregnancy bring
                                                     Therefore, we propose several changes                   reports listed in paragraphs (a)(1)                   higher prices than animals that are not
                                                     to § 54.3. First, we propose to clearly                 through (a)(6) in § 54.6 are currently out            pregnant because of the additional value
                                                     state that no indemnity will be paid for                of date, and it would require frequent                of the offspring they carry. We believe
                                                     any animal, or the progeny of any                       updates of the regulations to keep them               that indemnity prices should reflect this
                                                     animal, that has been moved or handled                  consistent with the AMS data. In                      increase in value since indemnity is
                                                     by the owner in violation of the                        addition, the process in paragraph (b)                related to the fair market value of
                                                     requirements of 9 CFR chapter I. In line                sets out numerous specific weight                     animals. We would also categorize early
                                                     with this, we would also specifically                   thresholds and sets out dollar amounts                maturing ewe lambs as yearlings, which
                                                     state that no indemnity will be paid for                for premiums. If the sheep and goat                   typically qualify for a higher indemnity
                                                     an animal added to the premises while                   industries change, making these weight                value, because early maturing ewes can
                                                     a flock is under investigation or while                 thresholds obsolete or the premiums                   be bred at about 7 months and lamb at
                                                     it is an infected or source flock other                 inadequate to provide a fair indemnity,               12–14 months, increasing their value.
                                                     than for animals that are natural                       we must update the regulations.                       Descriptions of these classifications as
                                                     additions. We also propose that no                        Rather than use scrapie program                     we would establish them are available
                                                     indemnity will be paid for natural                      resources to continually update § 54.6(a)             by contacting the person listed under
                                                     additions born more than 60 days after                  and (b), we propose to retain only the                FOR FURTHER INFORMATION CONTACT, on
                                                     indemnity is offered in writing unless                  general statement that indemnity paid                 the Regulations.gov Web site, or on the
                                                     the Administrator makes a                               for sheep and goats in accordance with                scrapie Web site at http://
                                                     determination that the animals could                    § 54.3 will be the fair market value for              www.aphis.usda.gov/animal-health/
                                                     not be removed within the allowed time                  the animals, based on available price                 scrapie. We invite public comment on
                                                     as a result of conditions outside the                   report data that most accurately reflect              these classifications.
                                                     control of the owner.                                   the type of animal being indemnified                     Sections 54.3 and 54.5 already require
                                                        One current requirement of § 54.3 is                 and the time at which the animal was                  that to obtain indemnity owners must
                                                     that no indemnity shall be paid until the               indemnified. Paragraph (a) of § 54.6                  make available to APHIS all bills of sale,
                                                     premises, including all structures,                     would also specify that premiums                      pedigree registration certificates, and
                                                     holding facilities, conveyances, and                    would be paid for certain animals and                 other records associated with ownership
                                                     materials contaminated because of                       that APHIS will use AMS price report                  or movement of the animals. We
                                                     occupation or use by the depopulated                    data or other available price information             propose to amend § 54.3 to also state
                                                     animals, has been properly cleaned and                  and any other data necessary to                       that owners applying for indemnity
                                                     disinfected. In enforcing this provision                establish the value of different types of             must, within 30 days of request, make
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                                                     we have become aware that sometimes                     sheep and goats in its calculations. We               the animals in the flock available for
                                                     circumstances beyond an owner’s                         would provide a detailed description of               inventory, evaluation, and testing. We
                                                     control delay the cleaning and                          how we calculate indemnity on the                     propose this change because it is
                                                     disinfection, despite the owner’s best                  scrapie Web site.                                     sometimes necessary to have physical
                                                                                                               This approach would be consistent                   access to the animals to confirm their
                                                       6 Section 54.3(a)(2) also allows indemnity to be
                                                                                                             with some other parts in 9 CFR                        eligibility for indemnity.
                                                     paid for other types of animals when the
                                                     Administrator determines that the destruction of
                                                                                                             subchapter B, which provide that                         Current § 54.6(e) states that indemnity
                                                     these animals will contribute to the eradication of     indemnity will be provided based on                   will be paid to an owner only for
                                                     scrapie.                                                appraisals but do not specify the details             animals actually in a flock at the time


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                                                     54672              Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules

                                                     indemnity is first offered. We propose to               scrapie tests and official genotype                   withdrawal or suspension. The
                                                     add that indemnity would be paid for                    tests.’’ The proposed changes are                     Administrator’s decision would
                                                     offspring born to animals in that flock                 intended to provide more information                  constitute final agency action.
                                                     within 60 days after the time indemnity                 about APHIS procedures in these                          We propose to add ELISA testing to
                                                     is first offered in writing. This change is             matters and to make the testing and                   the definition of scrapie-positive animal
                                                     proposed in response to indemnity                       laboratory approval processes more                    as one of the test methods that may be
                                                     situations that have occurred where                     reliable, flexible, and market-oriented.              used by NVSL when making an official
                                                     owners with ewes nearly ready to give                      We propose to change the section title             diagnosis of scrapie. The current
                                                     birth become eligible for indemnity. We                 of § 54.10 to read ‘‘Program approval of              definition specifically mentions
                                                     also propose to add several other                       tests for scrapie’’ to clarify that the               ‘‘proteinase-resistant protein analysis
                                                     provisions intended to encourage the                    section concerns how tests are                        methods including but not limited to
                                                     prompt removal of animals identified                    approved, and is not merely a list of                 immunohistochemistry and/or western
                                                     for indemnity, to minimize the risks that               tests. We propose to change a sentence                blotting.’’ APHIS is continually
                                                     might result if these animals remained                  that states that specific guidance on the             evaluating scrapie test methods for
                                                     in a flock for long periods. We propose                 use of approved tests ‘‘will be added to              sensitivity, specificity and reliability,
                                                     that if an owner declines to remove an                  this part as tests are approved and will              and ELISA tests are currently one of the
                                                     animal within 60 days of when                           also be contained in the Scrapie                      methods used by NVSL.
                                                     indemnity is first offered in writing the               Eradication UM&R and the Scrapie
                                                                                                                                                                   Changes Affecting Consistent State
                                                     indemnity amount would be                               Flock Certification Program standards.’’
                                                                                                                                                                   Requirements and State Surveillance
                                                     reevaluated using current AMS price                     We would change this to read ‘‘will be
                                                                                                                                                                   Programs
                                                     reports. The owner would then receive                   made available on the scrapie Web site
                                                     the lower value of the indemnities                      at http://www.aphis.usda.gov/animal-                     Surveillance is an important
                                                     calculated from price reports when                      health/scrapie.’’ This change would                   component of the National Scrapie
                                                     indemnity was first offered and when                    allow APHIS to respond more quickly to                Eradication Program because it
                                                     the animal was actually removed. We                     advances in science and in scrapie                    identifies infected animals, and
                                                     also propose that APHIS may withdraw                    testing specifically. For major changes               successful traceback of these animals to
                                                     an indemnity offer if an owner does not                 to how tests are used within the scrapie              their flocks of origin allows us to
                                                     make animals available for inventory,                   program, we would publish a notice in                 identify previously unrecognized
                                                     gestational assessment, and testing                     the Federal Register describing the                   infected flocks for cleanup. As the
                                                     within 30 days or does not remove an                    proposed change and solicit public                    United States progresses toward
                                                     animal within 60 days of the indemnity                  comments on the change. We would                      eradication of scrapie, surveillance is
                                                     offer or by the date specified in a flock               then issue a second notice discussing                 also necessary to measure the
                                                     plan or PEMMP.                                          the comments and informing the public                 effectiveness of control measures and to
                                                        We also propose to revise the                        of our decision regarding the change.                 document when regions achieve
                                                     definition of flock sire in part 54 to                  For the addition of guidance for a new                freedom from disease as defined by
                                                     ensure that only the appropriate animals                test used for purposes similar to an                  international standards affecting trade
                                                     receive the indemnity premium applied                   existing test, or for minor changes,                  in animals and products from the
                                                     to flock sires. The current definition                  updates, or clarifications, we would                  regions.
                                                     reads ‘‘a sexually intact male animal                   post notice of the change prominently                    To support traceback and eradication
                                                     that has ever been used for breeding in                 on the scrapie Web site. We would also                efforts, we propose to add a requirement
                                                     a flock.’’ However, this allows a                       provide email notification to State                   that States must implement effective
                                                     premium to be paid for animals that are                 cooperators and other stakeholders                    scrapie surveillance in order to qualify
                                                     too old to breed, or that were once tried               through GovDelivery, a free email                     as a Consistent State. This requirement
                                                     as sires but were found to produce                      subscription service. To subscribe to                 would include three components:
                                                     inferior progeny. Such animals no                       this free service go to https://public.               Facilitating surveillance at slaughter
                                                     longer have an economic value that                      govdelivery.com/accounts/                             establishments that do not engage in
                                                     justifies an indemnity premium.                         USDAAPHIS/subscriber/new and select                   interstate commerce; reporting
                                                     Therefore, we propose to change the                     ‘‘Animal Health—Sheep and Goats’’ and                 submission information and test results
                                                     definition of flock sire to read ‘‘A                    ‘‘Federal Register Publications—Notices               electronically to the National Scrapie
                                                     sexually intact male animal that has                    Regarding Animal Health.’’ Proposed                   Database administered by APHIS; and
                                                     produced offspring in the preceding 12                  procedures for using tests are in the                 testing an appropriate number of
                                                     months or that was used for breeding                    draft National Scrapie Eradication                    targeted animals annually.
                                                     during the current breeding cycle.’’                    Program Standards. Copies are available                  The first of these three new
                                                        We believe the changes to parts 54                   by contacting the person listed under                 requirements would affect surveillance
                                                     and 79 discussed above would improve                    FOR FURTHER INFORMATION CONTACT, on                   at slaughter establishments. Slaughter
                                                     the effectiveness of the scrapie program,               the Regulations.gov Web site, or on the               surveillance is a major component of the
                                                     reduce the risks associated with moving                 Web site at http://www.aphis.usda.gov/                ongoing scrapie surveillance conducted
                                                     sheep and goats interstate, reduce some                 animal-health/scrapie.                                by APHIS. The regulations in 9 CFR
                                                     identification and recordkeeping                           We also propose to add to both                     71.21 describe the collection of tissues
                                                     requirements while changing others,                     § 54.10 and § 54.11 a standard paragraph              for surveillance purposes at slaughter
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                                                     and make the scrapie indemnity                          stating that the Administrator may                    establishments that receive livestock in
                                                     program more equitable.                                 withdraw or suspend approval of an                    interstate commerce. To achieve the
                                                                                                             official test, or approval of a laboratory            eradication of scrapie, it is important to
                                                     Changes Concerning Tests for Scrapie                    to perform tests. In both § 54.10,                    conduct surveillance in all slaughter
                                                     and Laboratories Approved To Perform                    regarding approved tests, and § 54.11,                establishments that receive targeted
                                                     Tests                                                   regarding approved laboratories, there                animals—including State-inspected and
                                                        We are proposing certain changes to                  would be an opportunity for an appeal                 custom establishments that do not
                                                     § 54.10, ‘‘Tests for scrapie,’’ and § 54.11,            to the Administrator to resolve any                   participate in interstate commerce.
                                                     ‘‘Approval of laboratories to run official              questions of material fact regarding the              Surveillance at these concentration


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                                                                        Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules                                          54673

                                                     points, along with traceability of                      coordination of sampling and testing of               determine that a State should be added
                                                     animals, is key to program effectiveness.               mature sheep at slaughter that have a                 to or removed from the list of Consistent
                                                     Therefore, we propose to provide for                    higher than average probability of being              States, we would publish a notice in the
                                                     scrapie surveillance in slaughter                       infected with scrapie and surveillance                Federal Register advising the public of
                                                     establishments that do not participate in               in targeted animals from other sources                our determination and providing the
                                                     interstate commerce (i.e., State-                       such as veterinary diagnostic                         reasons for that determination. The
                                                     inspected and custom establishments).                   laboratories, public health laboratories,             notice would solicit public comments.
                                                     We propose to add language in                           renderers, dead stock haulers, markets,               After considering any comments we
                                                     § 79.6(a)(10)(i) requiring States that are              feedlots, and farms. The State-level                  receive, we would publish a second
                                                     Consistent States to collect and submit                 minimums will be based on the number                  notice either advising the public that we
                                                     surveillance samples from targeted                      of targeted animals residing in a State,              are adding or removing the State from
                                                     animals slaughtered in State-inspected                  the occurrence of scrapie in sheep and                the list of Consistent States or notifying
                                                     establishments and from slaughter                       goats in the State, and other relevant                the public that we are not making any
                                                     establishments within the State that are                factors such as the percentage of flocks              changes to the list of Consistent States,
                                                     not covered under § 71.21. Typically,                   surveyed. States may contact the                      depending on the information presented
                                                     when sample collection by State                         Administrator within 60 days of                       in the comments.
                                                     personnel is necessary it could be                      publication of their State’s surveillance
                                                     accomplished by State personnel                         minimum to appeal the surveillance                    Other Changes to Parts 54 and 79
                                                     already assigned to such establishments.                minimum if they believe there was any                    We propose to change § 54.21,
                                                     Alternatively, in places where APHIS                    error in the facts used to establish the              ‘‘Participation,’’ which currently states
                                                     has Federal employees or contractors                    minimum. Alternatively, a State could                 that APHIS makes available a list of
                                                     available to collect samples from such                  design and implement its own                          flocks participating in the SFCP and
                                                     plants, the State could instead elect to                surveillance plan as long as the State                another list of flocks that are not in
                                                     allow and facilitate the collection of                  demonstrates that the surveillance is                 compliance with these regulations. We
                                                     such samples by USDA personnel or                       sufficient to detect scrapie if it is                 propose to make available a third list, of
                                                     contractors. The intent of this proposed                present at a prevalence of 0.1 percent in             flocks that sold exposed animals that
                                                     requirement is to ensure that                           the population of targeted animals                    could not be traced, which would be of
                                                     surveillance for scrapie consistently                   originating from within the State, with               potential risk management use to
                                                     occurs in all slaughter establishments                  a 95 percent confidence level, each year.             persons who purchased animals from
                                                     that receive targeted animals.                          This is the level of surveillance                     these flocks.
                                                        The second new requirement would                     currently specified by Article 14.9.2 of                 We propose to add several definitions
                                                     affect the reporting of surveillance data               the World Animal Health Organization                  to part 79 to ensure that readers
                                                     by States. In order to insure the integrity             (the OIE) Terrestrial Animal Health                   understand terms used in those
                                                     of surveillance data and to verify that a               Code to determine a scrapie free country              regulations. These include owner/hauler
                                                     State is conducting adequate                            or zone. These surveillance                           statement, person, restricted animal sale
                                                     surveillance for scrapie, we propose to                 requirements for States would be added                or restricted livestock facility, and test
                                                     add language to § 79.6(a)(10)(ii)                       to § 79.6(a)(10)(iii) and (iv). APHIS                 eligible. The only one of these terms that
                                                     requiring that submission data and                      intends to continue to provide support                may not already be familiar to those
                                                     epidemiological information for all                     to the States in meeting surveillance                 affected by the regulations is owner/
                                                     samples be electronically transmitted by                minimums and to set minimums in line                  hauler statement. We propose to define
                                                     accessing and updating a system                         with funds available for surveillance                 this term, which would replace the
                                                     provided by APHIS. Submission data                      activities. APHIS currently supports                  current term owner statement, as ‘‘A
                                                     will be electronically transmitted to an                surveillance by providing testing for                 signed written statement by the owner
                                                     approved laboratory and the                             scrapie samples through contracts with                or hauler that includes:
                                                     epidemiologic and testing data will be                  State veterinary diagnostic laboratories,                (1) The name, address, and phone
                                                     stored in the National Scrapie Database,                sampling contracts, cooperative                       number of the owner and, if different,
                                                     allowing complete reports concerning                    agreements to support collection                      the hauler;
                                                     scrapie surveillance to be generated for                activities by States, and collection of                  (2) The date the animals were moved;
                                                     each State as well as for the entire                    samples by APHIS personnel.                              (3) The flock identification number or
                                                     United States. This system is currently                                                                       PIN assigned to the flock or premises of
                                                     used to submit information for over 99                  Definition of Consistent State
                                                                                                                                                                   the animals;
                                                     percent of the scrapie samples collected                   The definition of Consistent State in                 (4) If moving individually
                                                     for testing.                                            § 79.1 currently includes criteria for                unidentified animals, the group/lot
                                                        In the third new surveillance                        listing a State as a Consistent State and             identification number and any
                                                     requirement, we propose to determine                    a list of States that meet these criteria.            information required to officially
                                                     the appropriate sample size for                         As the definition itself indicates when               identify the animals;
                                                     surveillance within a State using one of                a State will be listed as a Consistent                   (5) The number of animals;
                                                     two approaches. A State could meet                      State, providing the list of Consistent                  (6) The species, breed, and class of
                                                     annual State-level surveillance                         States in the regulations is not                      animals. If breed is unknown, for sheep
                                                     minimums established by APHIS. These                    necessary. We are proposing to remove                 the face color and for goats the type
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                                                     minimums will be made publicly                          the list of Consistent States from this               (milk, fiber, or meat) must be recorded
                                                     available at http://www.aphis.usda.gov/                 definition and instead indicate that a                instead; and
                                                     animal-health/scrapie. APHIS may                        list of Consistent States can be found on                (7) The name and address of point of
                                                     update the surveillance minimums once                   the scrapie Web site. (Currently, all 50              origin, if different from the owner’s
                                                     a year and will provide them to the                     States are listed as Consistent States; we            address, and the destination.’’
                                                     States at least 6 months before the start               are not proposing to change the list.)                   The changes discussed above,
                                                     of the collection period. These                            We are also proposing to provide in                particularly the use of genetic
                                                     surveillance minimums call for a certain                the regulations a process for updating                information and testing to improve our
                                                     level of activity, including the                        the list of Consistent States. When we                ability to categorize animals by risk


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                                                     54674              Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules

                                                     categories, would allow us to greatly                   therefore, has been reviewed by the                   would be required; and certain
                                                     simplify and shorten § 79.3, which                      Office of Management and Budget.                      recordkeeping requirements would be
                                                     describes the basic restrictions on the                    We have prepared an economic                       reduced, changed or removed.
                                                     movement and commingling of                             analysis for this rule. The economic                     The primary benefits of this proposed
                                                     regulated sheep and goats. We propose                   analysis provides a cost-benefit analysis,            rule for producers and the public would
                                                     to replace the chart in § 79.3 with a                   as required by Executive Orders 12866                 be more rapid progress toward scrapie
                                                     simpler, less repetitive format that                    and 13563, which direct agencies to                   eradication and the related boost to the
                                                     preserves the movement restrictions but                 assess all costs and benefits of available            Nation’s animal health status, decreased
                                                     describes them using the improved                       regulatory alternatives and, if regulation            losses for owners of exposed herds, and
                                                     animal category definitions and terms                   is necessary, to select regulatory                    increased export opportunities for sheep
                                                     proposed in this document.                              approaches that maximize net benefits                 and goats and their products. All
                                                        We are also proposing to revise § 79.5               (including potential economic,                        segments and marketing channels of the
                                                     (retitled Issuance of Interstate                        environmental, public health and safety               sheep and goat industries would benefit
                                                     Certificates of Veterinary Inspection                   effects, and equity). Executive Order                 from being able to operate under fewer
                                                     (ICVI)) to replace the term ‘‘certificates’’            13563 emphasizes the importance of                    restrictions while still complying with
                                                     with reference to ICVIs for consistency                 quantifying both costs and benefits, of               the scrapie eradication program. By
                                                     with other areas of the regulations.                    reducing costs, of harmonizing rules,                 enhancing traceability, the proposed
                                                     Section 79.5 would also revise the                      and of promoting flexibility. The                     rule would shorten the time and reduce
                                                     information that must be contained in a                 economic analysis also provides an                    the cost of eradication.
                                                     certificate now termed an ICVI. In                      initial regulatory flexibility analysis that             Costs associated with the proposed
                                                     addition, we are revising the section to                examines the potential economic effects               rule would be borne by APHIS and the
                                                     make the requirements and terms in it                   of this rule on small entities, as required           regulated industry. APHIS would incur
                                                     match those proposed elsewhere in this                  by the Regulatory Flexibility Act. The                the costs of genotyping exposed sheep
                                                     document and, to the degree                             economic analysis is summarized                       and testing genetically susceptible
                                                     appropriate, those in 9 CFR part 86                     below. Copies of the full analysis are
                                                                                                                                                                   animals for scrapie. The total laboratory
                                                     (Animal Disease Traceability) e.g., by                  available by contacting the person listed
                                                                                                                                                                   cost to APHIS for testing an average-
                                                     changing ‘‘premises identification’’ to                 under FOR FURTHER INFORMATION
                                                                                                                                                                   sized exposed flock is estimated to be
                                                     ‘‘flock identification number.’’ In                     CONTACT or on the Regulations.gov Web
                                                                                                                                                                   around $610. This Federal cost may be
                                                     support of this proposal’s goal of using                site (see ADDRESSES above for
                                                                                                                                                                   largely offset by a reduction in
                                                     available genetic information to better                 instructions for accessing
                                                                                                                                                                   indemnity payments; genotyping is
                                                     characterize risks, we would also add a                 Regulations.gov).
                                                                                                                Based on the information we have,                  expected to result in the destruction of
                                                     statement in paragraph (a) that, if any
                                                                                                             there is no reason to conclude that                   fewer animals.
                                                     animals covered by a ICVI are intended
                                                     for breeding and have undergone an                      adoption of this proposed rule would                     Producers of goats for meat or fiber
                                                     official genotype test, the name of the                 result in any significant economic effect             would incur costs of official
                                                     testing laboratory and the date and                     on a substantial number of small                      identification as a result of the proposed
                                                     result of the test must be included.                    entities. However, we do not currently                rule. However, close to one-half of the
                                                                                                             have all of the data necessary for a                  goat farms reported in the 2012 Census
                                                     Miscellaneous Changes                                   comprehensive analysis of the effects of              of Agriculture are already in compliance
                                                        We are also proposing to make                        this proposed rule on small entities.                 with the proposed identification
                                                     miscellaneous changes, particularly in                  Therefore, we are inviting comments on                requirements.
                                                     the definitions sections of parts 54 and                potential effects. In particular, we are                 The proposed rule would affect sheep
                                                     79, and in the description of cleaning                  interested in determining the number                  and goat producers, as well as marketers
                                                     and disinfection of premises in § 54.7, to              and kind of small entities that may                   and dealers. Most of these entities are
                                                     make terminology and citations                          incur benefits or costs from the                      small. However, in that costs of
                                                     consistent throughout the regulations.                  implementation of this proposed rule.                 genotyping, testing, and provision of
                                                     We are changing the definitions of                         APHIS is proposing to amend the                    eartags would be borne by the Federal
                                                     several terms to make them consistent                   scrapie regulations to relieve certain                Government, we do not believe this rule
                                                     with the definitions in new animal                      restrictions associated with the                      would pose a significant cost burden for
                                                     disease traceability regulations in 9 CFR               interstate movement of sheep and goats,               producers.
                                                     part 86. In § 54.7, we propose to expand                reduce the number of exposed sheep
                                                                                                                                                                   Executive Order 12372
                                                     the brief description of cleaning and                   and goats that are destroyed, and
                                                     disinfection procedures to include more                 improve overall program effectiveness.                  This program/activity is listed in the
                                                     information about burial and                            More specifically, genetic testing would              Catalog of Federal Domestic Assistance
                                                     composting options for organic and/or                   be used to identify genetically resistant             under No. 10.025 and is subject to
                                                     inorganic materials. We also propose                    or less susceptible sheep for exemption               Executive Order 12372, which requires
                                                     minor changes throughout the                            from destruction and as qualifying for                intergovernmental consultation with
                                                     regulations to consistently use the term                interstate movement; designated scrapie               State and local officials. (See 2 CFR
                                                     ‘‘identification devices’’ instead of                   epidemiologists would be given greater                chapter IV)
                                                     referring to ‘‘devices’’ in some sections               flexibility in determining the testing
                                                                                                                                                                   Executive Order 12988
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                                                     and ‘‘tags’’ in others, to correct outdated             needs of flocks; the indemnity
                                                     Internet addresses, and to otherwise                    regulations would be changed to apply                   This proposed rule has been reviewed
                                                     improve accuracy and readability.                       only to those animals that are found to               under Executive Order 12988, Civil
                                                                                                             be genetically susceptible to scrapie;                Justice Reform. If this proposed rule is
                                                     Executive Orders 12866 and 13563 and                    official identification of goats produced             adopted: (1) All State and local laws and
                                                     Regulatory Flexibility Act                              for meat or fiber would be required;                  regulations that are in conflict with this
                                                       This proposed rule has been                           submission of tagging records by                      rule will be preempted; (2) no
                                                     determined to be significant for the                    individuals who tag sheep or goats that               retroactive effect will be given to this
                                                     purposes of Executive Order 12866 and,                  do not originate on their premises                    rule; and (3) administrative proceedings


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                                                                        Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules                                           54675

                                                     will not be required before parties may                 State officials, terminal feedlot owners,             number of responses multiplied by the
                                                     file suit in court challenging this rule.               laboratories, test kit manufacturers,                 reporting burden per response.)
                                                                                                             slaughter plant/establishment owners,                   Copies of this information collection
                                                     Executive Order 13175
                                                                                                             and other persons who apply official                  can be obtained from Ms. Kimberly
                                                        This rule has been reviewed in                       identification to sheep and goats. These              Hardy, APHIS’ Information Collection
                                                     accordance with the requirements of                     changes will primarily affect persons                 Coordinator, at (301) 851–2727.
                                                     Executive Order 13175, Consultation                     who own or handle goats in interstate
                                                     and Coordination with Indian Tribal                                                                           E-Government Act Compliance
                                                                                                             commerce. Some of this information
                                                     Governments. The review reveals that                    would be entered in the Scrapie                          The Animal and Plant Health
                                                     this rule will not have substantial and                 National Database, and persons who                    Inspection Service is committed to
                                                     direct effects on Tribal governments and                apply official identification for animal              compliance with the E-Government Act
                                                     will not have significant Tribal                        owners such as livestock markets would                to promote the use of the Internet and
                                                     implications.                                           have the option of entering the                       other information technologies, to
                                                        As part of this review, APHIS sent                   information through a Web site into the               provide increased opportunities for
                                                     letters to Tribal leaders describing the                Scrapie National Database or completing               citizen access to Government
                                                     proposed rule, asking the leaders to                    and submitting a form. These changes                  information and services, and for other
                                                     consider and inform us of any potential                 would also eliminate requirements to                  purposes. For information pertinent to
                                                     impacts or possible outcomes for their                  record individual identification                      E-Government Act compliance related
                                                     tribes, and offering further discussion or              numbers for certain classes of sheep and              to this proposed rule, please contact Ms.
                                                     consultation if desired. No Tribe                       goats.                                                Kimberly Hardy, APHIS’ Information
                                                     identified issues of concern or requested                  We are soliciting comments from the                Collection Coordinator, at (301) 851–
                                                     further consultation. We believe that the               public (as well as affected agencies)                 2727.
                                                     issue in this proposed rule that is of                  concerning our proposed information
                                                     most potential concern to Tribes is                                                                           List of Subjects
                                                                                                             collection and recordkeeping
                                                     animal identification and traceability.                 requirements. These comments will                     9 CFR Part 54
                                                     That issue has been addressed in a                      help us:
                                                     previous proposed rule concerning                                                                               Animal diseases, Goats, Indemnity
                                                                                                                (1) Evaluate whether the proposed                  payments, Scrapie, Sheep.
                                                     traceability for livestock moving                       information collection is necessary for
                                                     interstate (Docket No. APHIS–2009–                      the proper performance of our agency s                9 CFR Part 79
                                                     0091, 76 FR 50082, published August                     functions, including whether the
                                                     11, 2011). The Tribal summary impact                                                                            Animal diseases, Quarantine, Sheep,
                                                                                                             information will have practical utility;              Transportation.
                                                     statement for that proposed rule is                        (2) Evaluate the accuracy of our
                                                     available at http://www.regulations.gov/                                                                        Accordingly, we are proposing to
                                                                                                             estimate of the burden of the proposed                amend 9 CFR parts 54 and 79 as follows:
                                                     #!documentDetail;D=APHIS-2009-0091-                     information collection, including the
                                                     0474.                                                   validity of the methodology and                       PART 54—CONTROL OF SCRAPIE
                                                     Paperwork Reduction Act                                 assumptions used;
                                                                                                                (3) Enhance the quality, utility, and              ■ 1. The authority citation for part 54
                                                        In accordance with section 3507(d) of                clarity of the information to be                      continues to read as follows:
                                                     the Paperwork Reduction Act of 1995                     collected; and
                                                     (44 U.S.C. 3501 et seq.), the information                                                                       Authority: 7 U.S.C. 8301–8317; 7 CFR
                                                                                                                (4) Minimize the burden of the                     2.22, 2.80, and 371.4.
                                                     collection or recordkeeping                             information collection on those who are
                                                     requirements included in this proposed                  to respond (such as through the use of                ■  2. Section 54.1 is amended as follows:
                                                     rule have been submitted for approval to                appropriate automated, electronic,                    ■  a. Revise the heading of the definition
                                                     the Office of Management and Budget                     mechanical, or other technological                    for approved test to read program
                                                     (OMB). Please send written comments                     collection techniques or other forms of               approved test and place in alphabetical
                                                     to the Office of Information and                        information technology; e.g., permitting              order.
                                                     Regulatory Affairs, OMB, Attention:                                                                           ■ b. In the definition for breed
                                                                                                             electronic submission of responses).
                                                     Desk Officer for APHIS, Washington, DC                     Estimate of Burden: Public reporting               association and registries, by removing
                                                     20503. Please state that your comments                  burden for this collection of information             the words ‘‘listed in § 151.9 of this
                                                     refer to Docket No. APHIS–2007–0127.                    is estimated to average 0.24 hours per                chapter’’.
                                                     Please send a copy of your comments to:                 response.                                             ■ c. Removing the definition for
                                                     (1) Docket No. APHIS–2007–0127,                            Respondents: Market operators,                     certificate.
                                                     Regulatory Analysis and Development,                    dealers, accredited veterinarians, tag                ■ d. Adding a definition for
                                                     PPD, APHIS, Station 3A–03.8, 4700                       manufacturers, flock owners, haulers,                 classification or reclassification
                                                     River Road Unit 118, Riverdale, MD                      State officials, terminal feedlot owners,             investigation.
                                                     20737–1238, and (2) Clearance Officer,                  laboratories, test kit manufacturers,                 ■ e. In the heading of the definition for
                                                     OCIO, USDA, room 404–W, 14th Street                     slaughter plant/establishment owners,                 designated scrapie epidemiologist, add
                                                     and Independence Avenue SW.,                            and other persons who apply official                  the acronym ‘‘DSE’’ immediately after
                                                     Washington, DC 20250. A comment to                      identification to sheep and goats.                    ‘‘epidemiologist’’.
                                                     OMB is best assured of having its full                     Estimated Annual Number of                         ■ f. Revising the definitions for
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                                                     effect if OMB receives it within 30 days                Respondents: 157,053.                                 destroyed, exposed animal, and exposed
                                                     of publication of this proposed rule.                      Estimated Annual Number of                         flock.
                                                        Implementing the requirements of the                 Responses per Respondent: 2.89.                       ■ g. In the definition for flock,
                                                     proposed rule would change                                 Estimated Annual Number of                         paragraph (2)(v), by adding the word
                                                     information collection and                              Responses: 454,061.                                   ‘‘Free’’ between the words ‘‘Scrapie’’
                                                     recordkeeping burden for persons such                      Estimated Total Annual Burden on                   and ‘‘Flock’’.
                                                     as animal market operators, dealers,                    Respondents: 108,981 hours. (Due to                   ■ h. In the definition for flock plan, last
                                                     accredited veterinarians, tag                           averaging, the total annual burden hours              sentence, by removing ‘‘(f)’’ and by
                                                     manufacturers, flock owners, haulers,                   may not equal the product of the annual               adding ‘‘(j)’’ in its place.


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                                                     54676              Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules

                                                     ■  i. Revising the definition for flock sire.           ■ x. Adding definitions for tamper-                   An animal will no longer be an exposed
                                                     ■  j. Adding definitions for flock under                resistant sampling kit and terminal                   animal if it is redesignated in
                                                     investigation, genetically less                         feedlot.                                              accordance with § 79.4 of this chapter.
                                                     susceptible exposed sheep, genetically                    The additions and revisions read as                    Exposed flock. (1) Any flock that was
                                                     resistant exposed sheep, genetically                    follows:                                              designated an infected or source flock
                                                     resistant sheep, genetically susceptible                                                                      that has completed a flock plan and that
                                                     animal, and genetically susceptible                     § 54.1   Definitions.                                 retained a female genetically susceptible
                                                     exposed animal.                                         *     *      *    *     *                             exposed animal;
                                                     ■ k. Revising the definition for high-risk                Classification or reclassification                     (2) Any flock under investigation that
                                                     animal.                                                 investigation. An epidemiological                     retains a female genetically susceptible
                                                     ■ l. Adding a definition for interstate                 investigation conducted or directed by a              exposed animal or a suspect animal, or
                                                     certificate of veterinary inspection                    DSE for the purpose of designating or                 whose owner declines to complete
                                                     (ICVI).                                                 redesignating the status of a flock or                genotyping and live-animal and/or post-
                                                     ■ m. In the definition for limited                      animal. In conducting such an                         mortem scrapie testing required by the
                                                     contacts, last sentence, by adding the                  investigation, the DSE will evaluate the              APHIS or State representative
                                                     word ‘‘Free’’ between the words                         available records for flocks and                      investigating the flock; or
                                                     ‘‘Scrapie’’ and ‘‘Flock’’.                              individual animals and conduct or                        (3) Any noncompliant flock or any
                                                     ■ n. Adding a definition for low-risk                   direct any testing needed to assess the               flock for which a PEMMP is required
                                                     exposed animal.                                         status of a flock or animal. The status of            that is not in compliance with the
                                                     ■ o. In the definition for National                     an animal or flock will be determined                 conditions of the PEMMP. A flock will
                                                     Scrapie Database, by adding the word                    based on the applicable definitions in                no longer be an exposed flock if it is
                                                     ‘‘Free’’ between the words ‘‘Scrapie’’                  this section and, when needed to make                 redesignated in accordance with § 79.4
                                                     and ‘‘Flock’’.                                          a designation under § 79.4 of this                    of this chapter.
                                                     ■ p. The definition for noncompliant                    chapter, official genotype test results,              *      *     *     *     *
                                                     flock is amended as follows:                            exposure risk, scrapie type involved,
                                                     ■ i. In paragraph (1), by removing the
                                                                                                                                                                      Flock sire. A sexually intact male
                                                                                                             and/or results of official scrapie testing            animal that has produced offspring in
                                                     words ‘‘source or infected flock’’ and                  on live or dead animals
                                                     adding the words ‘‘source, infected, or                                                                       the preceding 12 months or that was
                                                                                                             *     *      *    *     *                             used for breeding during the current
                                                     exposed flock or flock under                              Destroyed. Euthanized and the carcass
                                                     investigation’’;                                                                                              breeding cycle.
                                                                                                             disposed of by means authorized by the                   Flock under investigation. Any flock
                                                     ■ ii. In paragraph (2), by adding the
                                                                                                             Administrator that will prevent its use               in which an APHIS or State
                                                     words ‘‘or flock under investigation’’                  as feed or food, or moved to a
                                                     immediately after the words ‘‘exposed                                                                         representative has determined that a
                                                                                                             quarantined research facility if the                  scrapie-suspect animal, high-risk
                                                     flock’’; and                                            movement has been approved by the
                                                     ■ iii. In paragraph (3), by removing the                                                                      animal, or scrapie-positive animal
                                                                                                             Administrator.                                        resides or may have resided. A flock
                                                     words ‘‘owner statement’’ and adding
                                                     the words ‘‘owner/hauler statement’’ in                 *     *      *    *     *                             will no longer be a flock under
                                                     their place.                                              Exposed animal. Any animal or                       investigation if it is redesignated in
                                                     ■ q. Revising the definition for official               embryo that has been in a flock or in an              accordance with § 79.4 of this chapter.
                                                     genotype test.                                          enclosure off the premises of the flock                  Genetically less susceptible exposed
                                                     ■ r. Adding a definition for restricted                 with a scrapie-positive female animal;                sheep. Any sheep or sheep embryo that
                                                     animal sale or restricted livestock                     resides in a noncompliant flock; or has               is:
                                                     facility.                                               resided on the premises of a flock before                (1) An exposed sheep or sheep
                                                     ■ s. In the heading of the definition for               or while it was designated an infected                embryo of genotype AA QR, unless it is
                                                     Scrapie Flock Certification Program                     or source flock and before a flock plan               epidemiologically linked to a scrapie-
                                                     (SFCP), by adding the word ‘‘Free’’                     was completed. An animal shall not be                 positive RR or AA QR sheep or to a
                                                     immediately after the word ‘‘Scrapie’’.                 designated an exposed animal if it only               scrapie type to which AA QR sheep are
                                                     ■ t. In the heading of the definition for               resided on the premises before the date               not less susceptible where Q represents
                                                     Scrapie Flock Certification Program                     that infection was most likely                        any genotype other than R at codon 171;
                                                     standards, by adding the word ‘‘Free’’                  introduced to the premises as                         or
                                                     immediately after the word ‘‘Scrapie’’                  determined by a Federal or State                         (2) An exposed sheep or sheep
                                                     and, in footnote 2, by removing the                     representative. If the probable date of               embryo of genotype AV QR, unless it is
                                                     Internet address ‘‘http://www.aphis.                    infection cannot be determined based                  epidemiologically linked to a scrapie-
                                                     usda.gov/vs/scrapie’’ and adding the                    on the epidemiologic investigation, a                 positive RR or QR sheep, to a flock that
                                                     Internet address ‘‘www.aphis.usda.gov/                  date 2 years before the birth of the                  the DSE has determined may be affected
                                                     animal-health/scrapie’’ in its place.                   oldest scrapie-positive animal(s) will be             by valine associated scrapie (based on
                                                     ■ u. In the definition for scrapie-positive             used. If the actual birth date is                     an evaluation of the genotypes of the
                                                     animal, in paragraph (2), by adding the                 unknown, the date of birth will be                    scrapie-positive animals linked to the
                                                     words ‘‘, and/or ELISA,’’ immediately                   estimated based on examination of the                 flock), or to another scrapie type to
                                                     after the word ‘‘immunohistochemistry’’                 teeth and any available records. If an age            which AV QR sheep are not less
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                                                     and, in paragraph (5), by removing the                  estimate cannot be made, the animal                   susceptible where Q represents any
                                                     words ‘‘test method’’ and adding the                    will be assumed to have been 48 months                genotype other than R at codon 171 and
                                                     words ‘‘method or combination of                        of age on the date samples were                       V represents any genotype other than A
                                                     methods’’ in their place.                               collected for scrapie diagnosis. Exposed              at codon 136; or
                                                     ■ v. By removing the definitions for                    animals will be further designated as                    (3) An exposed sheep or sheep
                                                     separate contemporary lambing group.                    genetically resistant exposed sheep,                  embryo of a genotype that has been
                                                     ■ w. Revising the definition for                        genetically less susceptible exposed                  exposed to a scrapie type to which the
                                                     slaughter channels and paragraph (1) in                 sheep, genetically susceptible exposed                Administrator has determined that
                                                     the definition of suspect animal.                       animals, or low-risk exposed animals.                 genotype is less susceptible.


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                                                                        Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules                                          54677

                                                        Genetically resistant exposed sheep.                 issued by a Federal, State, Tribal, or                from, the owner/hauler statement for all
                                                     Any exposed sheep or sheep embryo of                    accredited veterinarian certifying the                animals entering and leaving the sale or
                                                     genotype RR unless it is                                inspection of animals in preparation for              facility. A restricted animal sale may be
                                                     epidemiologically linked to a scrapie-                  interstate movement or other uses as                  held at a livestock facility that is not
                                                     positive RR sheep or to a scrapie type                  described in this part and in accordance              restricted.
                                                     to which RR sheep are not resistant.                    with § 79.5 of this chapter.                          *      *     *     *     *
                                                        Genetically resistant sheep. Any                     *      *     *    *     *                                Slaughter channels. Animals in
                                                     sheep or sheep embryo of genotype RR                       Low-risk exposed animal. Any                       slaughter channels include any animal
                                                     unless it is epidemiologically linked to                exposed animal to which the DSE has                   that is sold, transferred, or moved either
                                                     a scrapie-positive RR sheep or to a                     determined one or more of the following               directly to or through a restricted animal
                                                     scrapie type that affects RR sheep.                     applies:                                              sale or restricted livestock facility to a
                                                        Genetically susceptible animal. Any                     (1) The positive animal that was the               slaughter establishment that is under
                                                     goat or goat embryo, sheep or sheep                     source of exposure was not born in the                continuous inspection by the Food
                                                     embryo of a genotype other than RR or                   flock and did not lamb in the flock or                Safety and Inspection Service (FSIS) or
                                                     QR, or sheep or sheep embryo of                         in an enclosure where the exposed                     under State inspection that FSIS has
                                                     undetermined genotype where Q                           animal resided;                                       recognized as at least equal to Federal
                                                     represents any genotype other than R at                    (2) The Administrator and State                    inspection or to a custom exempt
                                                     codon 171.                                              representative concur that the animal is              slaughter establishment as defined by
                                                        Genetically susceptible exposed
                                                                                                             unlikely to be infected due to factors                FSIS for immediate slaughter or to an
                                                     animal. Excluding low-risk exposed
                                                                                                             such as, but not limited to, where the                individual for immediate slaughter for
                                                     animals, any exposed animal or embryo
                                                                                                             animal resided or the time period the                 personal use or to a terminal feedlot.
                                                     that is also:
                                                        (1) A genetically susceptible animal;                animal resided in the flock;                          Any animal sold at an unrestricted sale
                                                                                                                (3) The exposed animal is male and                 is not in slaughter channels. Animals in
                                                     or
                                                        (2) A sheep or sheep embryo of                       was not born in an infected or source                 slaughter channels must be
                                                     genotype AV QR that is                                  flock;                                                accompanied by an owner/hauler
                                                     epidemiologically linked to a scrapie-                     (4) The exposed animal is a castrated              statement completed in accordance with
                                                     positive RR or QR sheep, to a flock that                male;                                                 § 79.3(g) of this chapter. Animals in
                                                     the DSE has determined may be affected                     (5) The exposed animal is an embryo                slaughter channels may not be held in
                                                     by valine associated scrapie (based on                  of a genetically resistant exposed sheep              the same enclosure with sexually intact
                                                     an evaluation of the genotypes of the                   or a genetically less susceptible exposed             animals from another flock of origin that
                                                     scrapie-positive animals linked to the                  sheep unless placed in a recipient that               are not in slaughter channels. When
                                                     flock), or to a scrapie type to which AV                was a genetically susceptible exposed                 selling animals that do not meet the
                                                     QR sheep are susceptible where Q                        animal; or                                            requirements to move as breeding
                                                     represents any genotype other than R at                    (6) The animal was exposed to a                    animals, owners must note on the bill of
                                                     codon 171 and V represents any                          scrapie type and/or is of a genotype that             sale that the animals are sold only for
                                                     genotype other than A at codon 136; or                  the Administrator has determined poses                slaughter.
                                                        (3) A sheep or sheep embryo of                       low risk of scrapie transmission.                     *      *     *     *     *
                                                     genotype AA QR that is                                  *      *     *    *     *                                Suspect animal. * * *
                                                     epidemiologically linked to a scrapie-                     Official genotype test. A test to                     (1) A mature sheep or goat as
                                                     positive RR or AA QR sheep or to a                      determine the genotype of a live or dead              evidenced by eruption of the first
                                                     scrapie type to which AA QR sheep are                   animal conducted at either the National               incisor that has been condemned by
                                                     susceptible where Q represents any                      Veterinary Services Laboratories or at an             FSIS or a State inspection authority for
                                                     genotype other than R at codon 171; or                  approved laboratory. The test subject                 central nervous system (CNS) signs, or
                                                        (4) A sheep or sheep embryo of                       must be an animal that is officially                  that exhibits any of the following
                                                     genotype RR that is epidemiologically                   identified and the test accurately                    clinical signs of scrapie and has been
                                                     linked to a scrapie-positive RR sheep or                recorded on an official form supplied or              determined to be suspicious for scrapie
                                                     to a scrapie type to which RR sheep are                 approved by APHIS, with the samples                   by an accredited veterinarian or a State
                                                     susceptible.                                            collected and shipped to the laboratory               or USDA representative, based on one or
                                                        High-risk animal. The female                         using a shipping method specified by                  more of the following signs and the
                                                     offspring or embryo of a scrapie-positive               the laboratory by:                                    severity of the signs: Weakness of any
                                                     female animal, or any suspect animal, or                   (1) An accredited veterinarian;                    kind including, but not limited to,
                                                     a female genetically susceptible exposed                   (2) A State or APHIS representative;               stumbling, falling down, or having
                                                     animal, or any exposed animal that the                  or                                                    difficulty rising, not including those
                                                     Administrator determines to be a                           (3) The animal’s owner or owner’s                  with visible traumatic injuries and no
                                                     potential risk based on the scrapie type,               agent, using a tamper-resistant sampling              other signs of scrapie; behavioral
                                                     the epidemiology of the flock or flocks                 kit approved by APHIS for this purpose.               abnormalities; significant weight loss
                                                     with which it is epidemiologically                      *      *     *    *     *                             despite retention of appetite or in an
                                                     linked, including genetics of the                          Restricted animal sale or restricted               animal with adequate dentition;
                                                     positive sheep, the prevalence of scrapie               livestock facility. A sale where any                  increased sensitivity to noise and
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                                                     in the flock, any history of recurrent                  animals in slaughter channels are                     sudden movement; tremors; star gazing;
                                                     infection, and other flock                              maintained separate from other animals                head pressing; bilateral gait
                                                     characteristics. An animal will no                      not in slaughter channels and are sold                abnormalities such as but not limited to
                                                     longer be a high-risk animal if it is                   in lots that consist entirely of animals              incoordination, ataxia, high stepping
                                                     redesignated in accordance with § 79.4                  sold for slaughter only or a livestock                gait of forelimbs, bunny-hop movement
                                                     of this chapter.                                        facility at which all animals are in                  of rear legs, or swaying of back end, but
                                                     *      *     *     *     *                              slaughter channels and where the sale                 not including abnormalities involving
                                                        Interstate certificate of veterinary                 or facility manager maintains a copy of,              only one leg or one front and one back
                                                     inspection (ICVI). An official document                 or maintains a record of, the information             leg; repeated intense rubbing with bare


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                                                     54678              Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules

                                                     areas or damaged wool in similar                        are moved only to another terminal                    that the dam could not be removed
                                                     locations on both sides of the animal’s                 feedlot or directly to slaughter; or                  within the allowed time as a result of
                                                     body or, if on the head, both sides of the                (3) A pasture when approved by and                  conditions outside the control of the
                                                     poll; abraded, rough, thickened, or                     maintained under the supervision of the               owner. No indemnity will be paid
                                                     hyperpigmented areas of skin in areas of                State and in which only nonpregnant                   unless the owner has signed and is in
                                                     wool/hair loss in similar locations on                  animals are permitted based on the                    compliance with the requirements of a
                                                     both sides of the animal’s body or, if on               animal being male, an owner                           flock plan or post-exposure management
                                                     the head, both sides of the poll; or other              certification that any female animals                 and monitoring plan (PEMMP) as
                                                     signs of CNS disease. An animal will no                 have not been exposed to a male in the                described in § 54.8. No indemnity will
                                                     longer be a suspect animal if it is                     preceding 6 months, or an ICVI issued                 be paid until the premises, including all
                                                     redesignated in accordance with § 79.4                  by an accredited veterinarian stating the             structures, holding facilities,
                                                     of this chapter.                                        animals are open, or the animals are                  conveyances, and materials
                                                     *      *    *     *     *                               under 6 months of age at time of receipt,             contaminated because of occupation or
                                                                                                             where only castrated males are                        use by the depopulated animals, have
                                                        Tamper-resistant sampling kit. A                     maintained with female animals, where                 been properly cleaned and disinfected
                                                     device or method for collecting DNA                     there is no direct fence-to-fence contact             in accordance with § 54.7(e); Except
                                                     samples from sheep or goats that is                     with another flock, and from which                    that, partial indemnity may be paid
                                                     approved by the Administrator and that                  animals are moved only to another                     when the Administrator determines that
                                                     identifies both the sample and the                      terminal feedlot or directly to slaughter.            weather or other factors outside the
                                                     animal at the time the sample is                          (4) Records of all animals entering                 control of the owner make immediate
                                                     collected. These devices or methods                     and leaving a terminal feedlot must be                disinfection impractical. Premises or
                                                     must ensure that the sample, its                        maintained for 5 years after the animal               portions of premises may be exempted
                                                     corresponding label, and the official ID                leaves the feedlot and must meet the                  from the cleaning and disinfecting
                                                     device or method applied to the animal                  requirements of § 79.2 of this chapter,               requirements if a designated scrapie
                                                     meets the requirements of § 79.2(k) of                  including either a copy of the required               epidemiologist determines, based on
                                                     this chapter and that the sample is from                owner/hauler statements for animals                   epidemiologic investigation, that
                                                     the same animal to which the official ID                entering and leaving the facility or the              cleaning and disinfection of such
                                                     device or method was applied. The kit                   information required to be on the                     buildings, holding facilities,
                                                     must include an APHIS-approved                          statements. Records must be made                      conveyances, or other materials on the
                                                     official form or another form, device, or               available for inspection and copying by               premises will not significantly reduce
                                                     method acceptable to APHIS for                          an APHIS or State representative upon                 the risk of the spread of scrapie, either
                                                     transmitting the information required to                request.                                              because effective disinfection is not
                                                     APHIS and the approved laboratory.                      *     *     *     *     *                             possible or because the normal
                                                        Terminal feedlot. (1) A dry lot                                                                            operations on the premises prevent
                                                     approved by a State or APHIS                            § 54.2   [Amended]
                                                                                                                                                                   transmission of scrapie. No indemnity
                                                     representative or an accredited                         ■  3. Section 54.2 is amended by adding               will be paid to an owner if the owner
                                                     veterinarian who is authorized to                       the word ‘‘Free’’ between the words                   established or increased his flock for the
                                                     perform this function where animals in                  ‘‘Scrapie’’ and ‘‘Flock’’ each time they              purpose of collecting or increasing
                                                     the terminal feedlot are separated from                 appear.                                               indemnity.
                                                     all other animals by at least 30 feet at                ■ 4. In § 54.3, paragraph (b) is revised to           ■ 5. In § 54.4, paragraph (a)(5) is revised
                                                     all times or are separated by a solid wall              read as follows:                                      to read as follows:
                                                     through, over, or under which fluids                    § 54.3 Animals eligible for indemnity
                                                     cannot pass and contact cannot occur                                                                          § 54.4 Application by owners for indemnity
                                                                                                             payments.                                             payments.
                                                     and must be cleaned of all organic                      *      *     *     *    *
                                                     material prior to being used to contain                                                                          (a) * * *
                                                                                                                (b) USDA may withdraw an offer of                     (5) A copy of the registration papers
                                                     sheep or goats that are not in slaughter                indemnity if the owner of the animal
                                                     channels, where only castrated males                                                                          issued in the name of the owner for any
                                                                                                             fails to, within 30 days of request, make             registered animals in the flock
                                                     are maintained with female animals and                  the animals in the flock available for
                                                     from which animals are moved only to                                                                          (registration papers are not required for
                                                                                                             inventory, evaluation, and testing or to              the payment of indemnity for animals
                                                     another terminal feedlot or directly to                 provide APHIS animal registration
                                                     slaughter; or                                                                                                 that are not registered); and
                                                                                                             certificates, sale and movement records,
                                                        (2) A dry lot approved by a State or                 or other records requested in accordance              *      *    *     *     *
                                                     APHIS representative or an accredited                   with § 54.5. No indemnity will be paid                § 54.5   [Amended]
                                                     veterinarian authorized to perform this                 for any animal, or the progeny of any                 ■ 6. In § 54.5, paragraph (d) is amended
                                                     function where only animals that either                 animal, that has been moved or handled                by removing the word ‘‘slaughtered,’’.
                                                     are not pregnant based on the animal                    by the owner in violation of the                      ■ 7. Section 54.6 is revised to read as
                                                     being male, an owner certification that                 requirements of the Animal Health                     follows:
                                                     any female animals have not been                        Protection Act or the regulations
                                                     exposed to a male in the preceding 6                    promulgated thereunder. No indemnity                  § 54.6   Amount of indemnity payments.
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                                                     months, an ICVI issued by an accredited                 will be paid for an animal added to the                 (a) Indemnity. Indemnity paid for
                                                     veterinarian stating the animals are                    premises while a flock is under                       sheep and goats in accordance with
                                                     open, or the animals are under 6 months                 investigation or while it is an infected              § 54.3 will be the fair market value of
                                                     of age at time of receipt, where only                   or source flock other than natural                    the animals. APHIS’ determination of
                                                     castrated males are maintained with                     additions. No indemnity will be paid for              fair market value will be based on
                                                     female animals, and all animals in the                  natural additions born more than 60                   available price report data that most
                                                     terminal feedlot are separated from all                 days after the owner is notified they are             accurately reflect the type of animal
                                                     other animals such that physical contact                eligible for indemnity unless the                     being indemnified and the time at
                                                     cannot occur and from which animals                     Administrator makes a determination                   which the animal was indemnified.


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                                                                        Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules                                           54679

                                                     Premiums will be paid for certain types                 writing or when the animal was actually               other materials. Organic and/or
                                                     of sheep and goats, including, but not                  removed. APHIS may withdraw an                        inorganic materials may be disposed of
                                                     limited to: Registered animals, flock                   indemnity offer if an owner does not                  by incineration or burial. Inorganic
                                                     sires, pregnant animals and early-                      make animals available for inventory,                 material and wood structures may be
                                                     maturing ewes; Except that, no                          gestational assessment, and testing                   cleaned and disinfected. To disinfect,
                                                     premium will be added for animals of                    within 30 days or does not remove an                  remove all organic material and
                                                     any age that were in slaughter channels                 animal within 60 days of the written                  incinerate, bury, till under, or compost
                                                     when indemnity was offered. To                          indemnity offer or by the date specified              the removed organic material in areas
                                                     calculate indemnity, APHIS will use                     in a flock plan or PEMMP.                             not accessed by domestic or wild
                                                     price information provided by the                       ■ 8. Section 54.7 is amended as follows:              ruminants until it can be incinerated,
                                                     Agricultural Marketing Service (AMS)                    ■ a. By revising paragraphs (a) and (d).              buried, or tilled under. Clean and wash
                                                     or other available price information and                ■ b. In paragraph (e) introductory text,              all surfaces, tools, equipment, and
                                                     any other data necessary to establish the               by removing the words ‘‘Scrapie Flock                 instruments using hot water and
                                                     value of different types of sheep and                   Certification Program standards and the               detergent. Allow all surfaces, tools,
                                                     goats. A detailed description of the                    Scrapie Eradication Uniform Methods                   equipment, and instruments to dry
                                                     methods APHIS uses to calculate                         and Rules’’ and adding in their place                 completely before disinfecting and
                                                     indemnity for sheep and goats is                        ‘‘Scrapie Program Standards Volume 1:                 sanitizing using one of the following
                                                     available at http://www.aphis.usda.gov/                 National Scrapie Eradication Program                  methods:
                                                     animal-health/scrapie.                                  and Scrapie Program Standards Volume                  *       *    *     *     *
                                                        (b) Age and number of animals. If                    2: Scrapie Free Flock Certification
                                                                                                                                                                      (iii) Use a product registered by the
                                                     records and identification are                          Program (SFCP)’’.
                                                                                                                                                                   U.S. Environmental Protection Agency
                                                     inadequate to determine the actual age                  ■ c. In paragraph (e)(1), by removing the
                                                     of animals, an APHIS or State                                                                                 (EPA) specifically for reduction of prion
                                                                                                             words ‘‘animals or wildlife’’ and adding
                                                     representative will count all sexually                                                                        infectivity at these sites in accordance
                                                                                                             in their place the words ‘‘or wild
                                                     intact animals that are apparently under                                                                      with the label.
                                                                                                             ruminants’’.
                                                     1 year of age, and those that are                       ■ d. By revising paragraph (e)(2)                        (iv) Use a product in accordance with
                                                     apparently at least 1 and under 2 years                 introductory text.                                    an emergency exemption issued by the
                                                     of age, based on examination of their                   ■ e. By removing paragraph (e)(2)(i),                 EPA for reduction of prion infectivity at
                                                     teeth, and the indemnity for these                      redesignating paragraphs (e)(2)(ii) and               these sites.
                                                     animals will be calculated. The total                   (iii) as paragraphs (e)(2)(i) and (ii),               ■ 9. Section 54.8 is revised to read as
                                                     number of these animals will be                         respectively, and by adding new                       follows:
                                                     subtracted from the total number of                     paragraphs (e)(2)(iii) and (iv).                      § 54.8 Requirements for flocks under
                                                     sexually intact animals in the group to                    The additions and revisions read as                investigation and flocks subject to flock
                                                     be indemnified, and indemnity for the                   follows:                                              plans and post-exposure management and
                                                     remainder will be calculated based on                                                                         monitoring plans.
                                                                                                             § 54.7 Procedures for destruction of
                                                     the assumption that the remainder of                                                                            (a) Identification of animals in a flock
                                                                                                             animals.
                                                     the flock is 80 percent aged 2 to 6 years                                                                     under investigation, flock plan, or post-
                                                     and 20 percent aged 6 to 8 years.                         (a) Animals for which
                                                                                                             indemnification is sought must be                     exposure management and monitoring
                                                        (c) Animal weights. If the owner
                                                                                                             destroyed on the premises where they                  plan (PEMMP). The official
                                                     disagrees with the average weight
                                                                                                             are held, pastured, or penned at the time             identification must provide a unique
                                                     estimate, he may have the animals
                                                                                                             indemnity is approved or moved to an                  identification number that is applied by
                                                     weighed at a public scale at his own
                                                                                                             approved research facility, unless the                the owner of the flock or his or her agent
                                                     expense, provided that the animals may
                                                                                                             APHIS representative involved approves                and must be linked to that flock in the
                                                     not come in contact with other sheep or
                                                                                                             in advance of destruction moving the                  National Scrapie Database. APHIS may
                                                     goats during movement to the public
                                                                                                             animals to another location for                       specify the type of official identification
                                                     scales, and will be paid based on the
                                                     actual weight times the price per pound                 destruction.                                          that may be used in order to maximize
                                                     for the class of animal as reported in the              *      *     *     *    *                             retention of the means of identification,
                                                     appropriate price report or other                         (d) APHIS may pay the reasonable                    identify restricted or test positive
                                                     available price information.                            costs of disposal for animals that are                animals or to facilitate the testing or
                                                        (d) Eligibility for indemnity.                       indemnified. To obtain reimbursement                  inventory of the animals. The owner of
                                                     Indemnity will be paid to an owner only                 for disposal costs, animal owners must                the flock or his or her agent must
                                                     for animals actually in a flock at the                  obtain written approval of the disposal               officially identify and maintain the
                                                     time indemnity is first offered in                      costs from APHIS, prior to disposal. For              identity of:
                                                     writing, and for offspring born to                      reimbursement to be made, the owner of                  (1) All animals in the flock while it is
                                                     animals in that flock within 60 days                    the animals must present the Veterinary               subject to a flock plan or PEMMP;
                                                     after the time indemnity is first offered               Services, Surveillance Preparedness and                 (2) Any high-risk or genetically
                                                     in writing. Animals removed from the                    Response Services, Assistant Director                 susceptible exposed animals in the flock
                                                     flock as part of an investigation or a                  responsible for the State involved with               and any other restricted animals;
                                                     post-exposure management and                            a copy of either a receipt for expenses                 (3) Any animals designated for testing
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                                                     monitoring plan (PEMMP) will be paid                    paid or a bill for services rendered. Any             by an APHIS representative or State
                                                     indemnity based on the calculated                       bill for services rendered by the owner               representative until testing is
                                                     prices at the time an APHIS                             must not be greater than the normal fee               completed, results reported, and
                                                     representative designates, in writing, the              for similar services provided by a                    animals classified, and
                                                     animals for removal. If an owner                        commercial hauler or disposal facility.                 (4) All sexually intact animals, all
                                                     declines to remove an animal within 60                    (e) * * *                                           exposed animals, and animals 18
                                                     days of when indemnity is first offered                   (2) Cement, wood, metal and other                   months of age and older (as evidenced
                                                     the owner will receive the lower value                  non-earth surfaces, tools, equipment,                 by the eruption of the second incisor)
                                                     of when indemnity was first offered in                  instruments, feed, hay, bedding, and                  prior to a change in ownership and


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                                                     54680              Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules

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


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                                                                        Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules                                              54681

                                                     the findings of the classification or                   test will also be considered in                       § 54.11 Approval of laboratories to run
                                                     reclassification investigation.                         determining the approved uses of the                  official scrapie tests and official genotype
                                                     ■ 10. Section 54.10 is revised to read as               test within the program. For a test to be             tests.
                                                     follows:                                                approved for the removal of high-risk,                   (a) State, Federal, and university
                                                                                                             exposed, or suspect animal designations               laboratories, or in the case of genotype
                                                     § 54.10 Program approval of tests for                                                                         tests, private laboratories will be
                                                                                                             the test must have a diagnostic
                                                     scrapie.                                                                                                      approved by the Administrator when he
                                                                                                             sensitivity at least comparable to that of
                                                        (a) The Administrator may approve                    current program-approved tests used for               or she determines that the laboratory:
                                                     new tests or test methods for the                       this purpose. Since the purpose of a                     (1) Employs personnel assigned to
                                                     diagnosis of scrapie conducted on live                  screening test is usually to identify a               supervise and conduct the testing who
                                                     or dead animals for use in the Scrapie                  subset of animals for further testing, for            are qualified to conduct the test based
                                                     Eradication Program and/or the Scrapie                  a test to be approved as a screening test             on education, training, and experience
                                                     Free Flock Certification Program. The                   for the identification of suspect animals,            and who have been trained by the
                                                     Administrator will base the approval or                 the test must be usually reliable but                 National Veterinary Services
                                                     disapproval of a test on the evaluation                 need not be definitive for diagnosing                 Laboratories (NVSL) or who have
                                                     by APHIS and, when appropriate,                         scrapie.                                              completed equivalent training approved
                                                     outside scientists, of:                                                                                       by NVSL;
                                                        (1) A standardized test protocol that                   (f) Specific guidelines for use of                    (2) Has adequate facilities and
                                                     must include a description of the test,                 program-approved tests within the                     equipment to conduct the test;
                                                     a description of the reagents, materials,               Scrapie Eradication Program or Scrapie                   (3) Follows standard test protocols
                                                     and equipment used for the test, the test               Free Flock Certification Program will be              that are approved or provided by NVSL;
                                                     methodology, and any control or quality                 made available on the scrapie Web site                   (4) Meets check test proficiency
                                                     assurance procedures;                                   at http://www.aphis.usda.gov/animal-                  requirements and consistently produces
                                                        (2) Data to support repeatability, that              health/scrapie. Guidelines will be based              accurate test results as determined by
                                                     is, the ability to reproduce the same                   on the characteristics of the test,                   NVSL review;
                                                     result repeatedly on a given sample;                    including specificity, sensitivity, and                  (5) Meets recordkeeping requirements;
                                                        (3) Data to support reproducibility,                 predictive value in defined groups of                    (6) Will retain records, slides, blocks,
                                                     that is, data to show that similar results              animals.                                              and other specimens from all cases for
                                                     can be produced when the test is run at                    (g) If an owner elects to have an                  at least 1 year and from positive cases
                                                     other laboratories;                                     unofficial test conducted on an animal                and DNA from all genotype tests for at
                                                        (4) Data to support the diagnostic and               for scrapie, or for the proteinase                    least 5 years and will forward copies of
                                                     in the case of assays the analytical                    resistant protein associated with                     records and any of these materials to
                                                     sensitivity and specificity of the test;                scrapie, and that animal tests positive to            NVSL within 5 business days of request;
                                                     and                                                     such a test, the animal will be                       Except that, NVSL may authorize a
                                                        (5) Any other data or information                    designated a suspect animal, unless the               shorter retention time in a standard
                                                     requested by the Administrator to                       test is conducted as part of a research               operating procedure or contract.
                                                     determine the suitability of the test for               protocol and the protocol includes                       (7) Will allow APHIS to inspect the
                                                     program use. This may include but is                    appropriate measures to prevent the                   laboratory without notice during normal
                                                     not limited to past performance, cost of                spread of scrapie.                                    business hours. An inspection may
                                                     test materials and equipment, ease of                                                                         include, but is not limited to, review
                                                                                                                (h) The Administrator may withdraw
                                                     test performance, generation of waste,                                                                        and copying of records, examination of
                                                                                                             or suspend approval of any test or test
                                                     and potential use of existing equipment.                                                                      slides, review of quality control
                                                        (b) To be approved for program use,                  method if the test or method does not
                                                                                                                                                                   procedures, observation of sample
                                                     a scrapie test must be able to be readily               perform at an acceptable level following
                                                                                                                                                                   handling/tracking procedures,
                                                     and successfully performed at the                       approval or if a more effective test or
                                                                                                                                                                   observation of the test being conducted,
                                                     National Veterinary Services                            test method is subsequently approved.
                                                                                                                                                                   and interviewing of personnel;
                                                     Laboratories.                                           The Administrator shall give written
                                                                                                                                                                      (8) Will report all test results to State
                                                        (c) The test must have a reliable,                   notice of the suspension or proposed
                                                                                                                                                                   and Federal animal health officials and
                                                     timely, and cost effective method of                    withdrawal to the director of the
                                                                                                                                                                   record them in the National Scrapie
                                                     proficiency testing.                                    laboratories using the test or method or
                                                                                                                                                                   Database within timeframes and in the
                                                        (d) The Administrator may decline to                 in the case of test kits to the
                                                                                                                                                                   manner and format specified by the
                                                     evaluate any test kit for program                       manufacturer and shall give the director
                                                                                                                                                                   Administrator; and
                                                     approval that has not been licensed for                 or manufacturer an opportunity to                        (9) Complies with any other written
                                                     the intended use and may decline to                     respond. Such action shall become                     guidance provided to the laboratory by
                                                     evaluate any test or test method for                    effective upon oral or written                        the Administrator.
                                                     program use unless the requester can                    notification, whichever is earlier, to the               (b) A laboratory may request approval
                                                     demonstrate that the new method offers                  laboratory or manufacturer. If there are              to conduct one or more types of
                                                     a significant advantage over currently                  conflicts as to any material fact                     program-approved scrapie test or
                                                     approved methods.                                       concerning the reason for withdrawal, a               genotype test on one or more types of
                                                        (e) A test or combination of tests may               hearing may be requested in accordance                tissue. To be approved, a laboratory
                                                                                                             with the procedure in § 79.4(c)(3) of this
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                                                     be approved for the identification of                                                                         must meet the requirements in
                                                     suspect animals, or scrapie-positive                    chapter. The action under appeal shall                paragraph (a) of this section for each
                                                     animals, or for other purposes such as                  continue in effect pending the final                  type of test and for each type of tissue
                                                     flock certification. For a test to be                   determination of the Administrator,                   for which they request approval.
                                                     approved for the identification of                      unless otherwise ordered by the                          (c) The Administrator may suspend or
                                                     scrapie-positive animals, the test must                 Administrator. The Administrator’s                    withdraw approval of any laboratory for
                                                     demonstrate a diagnostic specificity                    decision constitutes final agency action.             failure to meet any of the conditions
                                                     comparable to that of current program-                  ■ 11. Section 54.11 is revised to read as             required by paragraph (a) of this section.
                                                     approved tests, and the sensitivity of the              follows:                                              The Administrator shall give written


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                                                     54682              Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules

                                                     notice of the suspension or the proposed                ■  15. Section 79.1 is amended as                     ‘‘Scrapie’’ and, in footnote 2, by
                                                     withdrawal to the director of the                       follows:                                              removing the Internet address ‘‘http://
                                                     laboratory and shall give the director an               ■ a. Revise the definition for animal                 www.aphis.usda.gov/vs’’ and adding the
                                                     opportunity to respond. Such action                     identification number (AIN).                          Internet address ‘‘http://
                                                     shall become effective upon oral or                     ■ b. In the definition for breed                      www.aphis.usda.gov/animal-health/
                                                     written notification, whichever is                      association and registries, by removing               scrapie’’ in its place.
                                                     earlier, to the laboratory or                           the words ‘‘listed in § 151.9 of this                 ■ x. In the definition for scrapie-positive
                                                     manufacturer. If there are conflicts as to              chapter’’.                                            animal, in paragraph (2) by adding the
                                                     any material fact concerning the reason                 ■ c. By removing the definition for                   words ‘‘, and/or ELISA,’’ immediately
                                                     for withdrawal, a hearing may be                        certificate.                                          after the word ‘‘immunohistochemistry’’
                                                     requested in accordance with the                        ■ d. Add a definition for classification              and in paragraph (5) by removing the
                                                     procedure in § 79.4(c)(3) of this chapter.              or reclassification investigation.                    words ‘‘test method’’ and adding the
                                                     The action under appeal shall continue                  ■ e. Revise the definitions for consistent            words ‘‘method or combination of
                                                     in effect pending the final determination               State, exposed animal, and exposed                    methods’’ in their place.
                                                     of the Administrator, unless otherwise                  flock.                                                ■ y. By removing the definition for
                                                     ordered by the Administrator. The                       ■ f. Add a definition for flock                       separate contemporary lambing groups.
                                                                                                             identification (ID) number.                           ■ z. Revise the definition for slaughter
                                                     Administrator’s decision constitutes
                                                     final agency action                                     ■ g. In the definition for flock plan, by             channels, paragraph (1) of the definition
                                                                                                             removing the citation ‘‘§ 54.8(a)(f)’’ and            for suspect animal, and the definition
                                                        (d) The Administrator may require
                                                                                                             by adding the words ‘‘§ 54.8(a) through               for terminal feedlot.
                                                     approved laboratories to reimburse                                                                            ■ aa. Add a definition for test eligible.
                                                     APHIS for part or all of the costs                      (j)’’ in its place.
                                                                                                             ■ h. Add definitions for flock under                     The additions and revisions read as
                                                     associated with the approval and                                                                              follows:
                                                                                                             investigation, genetically less
                                                     monitoring of the laboratory.
                                                                                                             susceptible exposed sheep, genetically                § 79.1   Definitions.
                                                     Subpart B—Scrapie Free Flock                            resistant exposed sheep, genetically
                                                                                                             resistant sheep, genetically susceptible              *      *     *     *      *
                                                     Certification Program                                                                                            Animal identification number (AIN).
                                                                                                             animal, genetically susceptible exposed
                                                                                                                                                                   This term has the meaning set forth in
                                                     ■ 12. In part 54, the heading for subpart               animal, group/lot identification number
                                                                                                                                                                   § 86.1 of this subchapter, except that
                                                     B is revised to read as set forth above.                (GIN).
                                                                                                                                                                   only AIN devices approved and
                                                     ■ 13. Section 54.21 is revised to read as               ■ i. Revise the definition for high-risk
                                                                                                                                                                   distributed in accordance with § 79.2(k)
                                                     follows:                                                animal.
                                                                                                             ■ j. Add definitions for interstate
                                                                                                                                                                   and methods approved for use in sheep
                                                     § 54.21   Participation.                                certificate of veterinary inspection                  and goats in accordance with
                                                                                                             (ICVI) and low-risk commercial flock.                 § 79.2(a)(2) are included.
                                                        Any owner of a sheep or goat flock
                                                                                                             ■ k. Remove the definition for low-risk               *      *     *     *      *
                                                     may apply to enter the Scrapie Free                                                                              Classification or reclassification
                                                     Flock Certification Program by sending                  commercial sheep.
                                                                                                             ■ l. Add a definition for low-risk                    investigation. An epidemiological
                                                     a written request to a State scrapie                                                                          investigation conducted or directed by a
                                                     certification board or to the Veterinary                exposed animal.
                                                                                                             ■ m. Remove the definition for low-risk               DSE for the purpose of designating or
                                                     Services, Surveillance Preparedness and                                                                       redesignating the status of a flock or
                                                     Response Services, Assistant Director                   goat.
                                                                                                             ■ n. Add a definition for National                    animal. In conducting such an
                                                     responsible for the State involved. A                                                                         investigation, the DSE will evaluate the
                                                     notice containing a current list of flocks              Uniform Eartagging System (NUES).
                                                                                                             ■ o. In the definition for noncompliant               available records for flocks and
                                                     participating in the Scrapie Free Flock                                                                       individual animals and conduct or
                                                     Certification Program, and the                          flock, in paragraph (3), by removing the
                                                                                                             words ‘‘owner statement’’ and adding                  direct any testing needed to assess the
                                                     certification status of each flock, may be                                                                    status of a flock or animal. The status of
                                                     obtained from the APHIS Web site at                     the words ‘‘owner/hauler statement’’ in
                                                                                                             their place.                                          an animal or flock will be determined
                                                     http://www.aphis.usda.gov/animal-                                                                             based on the applicable definitions in
                                                                                                             ■ p. Revise the definitions for official
                                                     health/scrapie. A list of noncompliant                                                                        this section and, when needed to make
                                                                                                             eartag, official genotype test, and official
                                                     flocks and a list of flocks that sold                                                                         a designation under § 79.4, official
                                                                                                             identification device or method.
                                                     exposed animals that could not be                                                                             genotype test results, exposure risk,
                                                                                                             ■ q. Add definitions for official
                                                     traced may also be obtained from this                                                                         scrapie type involved, and/or results of
                                                                                                             identification number, officially
                                                     site, and these lists may be obtained by                                                                      official scrapie testing on live or dead
                                                                                                             identified, and owner/hauler statement.
                                                     writing to the National Scrapie Program                                                                       animals.
                                                                                                             ■ r. Remove the definition for owner
                                                     Coordinator, Surveillance Preparedness
                                                                                                             statement.                                            *      *     *     *      *
                                                     and Response Services, VS, APHIS,                       ■ s. Add a definition for person.                        Consistent State. (1) A State that the
                                                     4700 River Road Unit 43, Riverdale, MD                  ■ t. Revise the definition for premises               Administrator has determined conducts
                                                     20737–1235.                                             identification number (PIN).                          an active State scrapie control program
                                                     (Approved by the Office of Management                   ■ u. Add a definition for restricted                  that meets the requirements of § 79.6 or
                                                     and Budget under control number 0579–                   animal sale or restricted livestock                   effectively enforces a State-designed
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                                                     0101)                                                   facility.                                             plan that the Administrator determines
                                                                                                             ■ v. In the heading of the definition for             is at least as effective in controlling
                                                     PART 79—SCRAPIE IN SHEEP AND                            Scrapie Flock Certification Program                   scrapie as the requirements of § 79.6.
                                                     GOATS                                                   (SFCP), by adding the word ‘‘Free’’                      (2) A list of Consistent States can be
                                                                                                             immediately after the word ‘‘Scrapie’’.               found on the Internet at http://
                                                     ■ 14. The authority citation for part 79                ■ w. In the heading of the definition for             www.aphis.usda.gov/animal-health/
                                                     continues to read as follows:                           Scrapie Flock Certification Program                   scrapie.
                                                       Authority: 7 U.S.C. 8301–8317; 7 CFR                  standards, by adding the word ‘‘Free’’                   (3) When the Administrator
                                                     2.22, 2.80, and 371.4.                                  immediately following the word                        determines that a State should be added


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                                                                        Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules                                         54683

                                                     to or removed from the list of Consistent               that is not in compliance with the                       Genetically resistant exposed sheep.
                                                     States, APHIS will publish a notice in                  conditions of the PEMMP. A flock will                 Any exposed sheep or sheep embryo of
                                                     the Federal Register advising the public                no longer be an exposed flock if it is                genotype RR unless it is
                                                     of the Administrator’s determination,                   redesignated in accordance with § 79.4.               epidemiologically linked to a scrapie-
                                                     providing the reasons for that                          *      *     *      *      *                          positive RR sheep or to a scrapie type
                                                     determination, and soliciting public                       Flock identification (ID) number. A                to which RR sheep are not resistant.
                                                     comments. After considering any                         nationally unique number assigned by a                   Genetically resistant sheep. Any
                                                     comments we receive, APHIS will                         State or Federal animal health authority              sheep or sheep embryo of genotype RR
                                                     publish a second notice either advising                 to a group of animals that are managed                unless it is epidemiologically linked to
                                                     the public that the Administrator has                   as a unit on one or more premises and                 a scrapie-positive RR sheep or to a
                                                     decided to add or remove the State from                 are under the same ownership. The                     scrapie type that affects RR sheep.
                                                     the list of Consistent States or notifying              flock ID number must begin with the                      Genetically susceptible animal. Any
                                                     the public that the Administrator has                   State postal abbreviation, must have no               goat or goat embryo, sheep or sheep
                                                     decided not to make any changes to the                  more than nine alphanumeric                           embryo of a genotype other than RR or
                                                     list of Consistent States, depending on                 characters, and must not contain the                  QR, or sheep or sheep embryo of
                                                     the information presented in the                        characters ‘‘I’’, ‘‘O’’, or ‘‘Q’’ other than          undetermined genotype where Q
                                                     comments.                                               as part of the State postal abbreviation              represents any genotype other than R at
                                                                                                             or another standardized format                        codon 171.
                                                     *      *     *     *    *
                                                                                                                                                                      Genetically susceptible exposed
                                                        Exposed animal. Any animal or                        authorized by the administrator and
                                                                                                                                                                   animal. Excluding low-risk exposed
                                                     embryo that has been in a flock or in an                issued through the National Scrapie
                                                                                                                                                                   animals, any exposed animal or embryo
                                                     enclosure off the premises of the flock                 Database. Flock identification numbers
                                                                                                                                                                   that is also:
                                                     with a scrapie-positive female animal;                  will be linked in the National Scrapie                   (1) A genetically susceptible animal;
                                                     resides in a noncompliant flock; or has                 Database to one or more PINs and may                  or
                                                     resided on the premises of a flock before               be used in conjunction with an animal                    (2) A sheep or sheep embryo of
                                                     or while it was designated an infected                  number unique within the flock to                     genotype AV QR that is
                                                     or source flock and before a flock plan                 provide a unique official identification              epidemiologically linked to a scrapie-
                                                     was completed. An animal shall not be                   number for an animal, or may be used                  positive RR or QR sheep, to a flock that
                                                     designated an exposed animal if it only                 in conjunction with the date and a                    the DSE has determined may be affected
                                                     resided on the premises before the date                 sequence number to provide a GIN for                  by valine associated scrapie (based on
                                                     that infection was most likely                          a group of animals when group                         an evaluation of the genotypes of the
                                                     introduced to the premises as                           identification is permitted.                          scrapie-positive animals linked to the
                                                     determined by a Federal or State                        *      *     *      *      *                          flock), or to a scrapie type to which AV
                                                     representative. If the probable date of                    Flock under investigation. Any flock               QR sheep are susceptible where Q
                                                     infection cannot be determined based                    in which an APHIS or State                            represents any genotype other than R at
                                                     on the epidemiologic investigation, a                   representative has determined that a                  codon 171 and V represents any
                                                     date 2 years before the birth of the                    scrapie suspect animal, high-risk                     genotype other than A at codon 136; or
                                                     oldest scrapie-positive animal(s) will be               animal, or scrapie-positive animal                       (3) A sheep or sheep embryo of
                                                     used. If the actual birth date is                       resides or may have resided. A flock                  genotype AA QR that is
                                                     unknown, the date of birth will be                      will no longer be a flock under                       epidemiologically linked to a scrapie-
                                                     estimated based on examination of the                   investigation if it is redesignated in                positive RR or AA QR sheep or to a
                                                     teeth and any available records. If an age              accordance with § 79.4.                               scrapie type to which AA QR sheep are
                                                     estimate cannot be made, the animal                        Genetically less susceptible exposed               susceptible where Q represents any
                                                     will be assumed to have been 48 months                  sheep. Any sheep or sheep embryo that                 genotype other than R at codon 171; or
                                                     of age on the date samples were                         is:                                                      (4) A sheep or sheep embryo of
                                                     collected for scrapie diagnosis. Exposed                   (1) An exposed sheep or sheep                      genotype RR that is epidemiologically
                                                     animals will be further designated as                   embryo of genotype AA QR, unless it is                linked to a scrapie-positive RR sheep or
                                                     genetically resistant exposed sheep,                    epidemiologically linked to a scrapie-                to a scrapie type to which RR sheep are
                                                     genetically less susceptible exposed                    positive RR or AA QR sheep or to a                    susceptible.
                                                     sheep, genetically susceptible exposed                  scrapie type to which AA QR sheep are                    Group/lot identification number
                                                     animals, or low-risk exposed animals.                   not less susceptible where Q represents               (GIN). The identification number used
                                                     An animal will no longer be an exposed                  any genotype other than R at codon 171;               to uniquely identify a unit of animals
                                                     animal if it is redesignated in                         or                                                    that is managed together as one group.
                                                     accordance with § 79.4.                                    (2) An exposed sheep or sheep                      The format of the GIN may be either as
                                                        Exposed flock. (1) Any flock that was                embryo of genotype AV QR, unless it is                defined in § 71.1 of this chapter, or the
                                                     designated an infected or source flock                  epidemiologically linked to a scrapie-                flock identification number followed by
                                                     that has completed a flock plan and that                positive RR or QR sheep, to a flock that              a six-digit representation of the date on
                                                     retained a female genetically susceptible               the DSE has determined may be affected                which the group or lot of animals was
                                                     exposed animal;                                         by valine associated scrapie, or to                   assembled (MM/DD/YY). If more than
                                                        (2) Any flock under investigation that               another scrapie type to which AV QR                   one group is created on the same date
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                                                     retains a female genetically susceptible                sheep are not less susceptible where Q                a sequential number will be added to
                                                     exposed animal or a suspect animal, or                  represents any genotype other than R at               the end of the GIN. If a flock
                                                     whose owner declines to complete                        codon 171 and V represents any                        identification number is used, the flock
                                                     genotyping and live-animal and/or post-                 genotype other than A at codon 136; or                identification number, date, and
                                                     mortem scrapie testing required by the                     (3) An exposed sheep or sheep                      sequential number will be separated by
                                                     APHIS or State representative                           embryo of a genotype that has been                    hyphens.
                                                     investigating the flock; or                             exposed to a scrapie type to which the                   High-risk animal. The female
                                                        (3) Any noncompliant flock or any                    Administrator has determined that                     offspring or embryo of a scrapie-positive
                                                     flock for which a PEMMP is required                     genotype is less susceptible.                         female animal, or any suspect animal, or


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                                                     54684              Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules

                                                     a female genetically susceptible exposed                   (3) The exposed animal is male and                    (4) If moving individually
                                                     animal, or any exposed animal that the                  was not born in an infected or source                 unidentified animals, the group/lot
                                                     Administrator determines to be a                        flock;                                                identification number and any
                                                     potential risk based on the scrapie type,                  (4) The exposed animal is a castrated              information required to officially
                                                     the epidemiology of the flock or flocks                 male;                                                 identify the animals;
                                                     with which it is epidemiologically                         (5) The exposed animal is an embryo                   (5) The number of animals;
                                                     linked, including genetics of the                       of a genetically resistant exposed sheep                 (6) The species, breed, and class of
                                                     positive sheep, the prevalence of scrapie               or a genetically less susceptible exposed             animals. If breed is unknown, for sheep
                                                     in the flock, any history of recurrent                  sheep unless placed in a recipient that               the face color and for goats the type
                                                     infection, and other animal or flock                    was a genetically susceptible exposed                 (milk, fiber, or meat) must be recorded
                                                     characteristics. An animal will no                      animal; or                                            instead; and
                                                     longer be a high-risk animal if it is                      (6) The animal was exposed to a                       (7) The name and address of point of
                                                     redesignated in accordance with § 79.4.                 scrapie type and/or is of a genotype that             origin, if different from the owner’s
                                                                                                             the Administrator has determined poses                address, and the destination.
                                                     *      *     *     *     *                              low risk of transmission.
                                                        Interstate certificate of veterinary                                                                       *      *     *     *    *
                                                                                                             *      *     *     *     *                               Person. An individual, partnership,
                                                     inspection (ICVI). An official document                    National Uniform Eartagging System
                                                     issued by a Federal, State, Tribal, or                                                                        company, corporation, or any other legal
                                                                                                             (NUES). This term has the meaning set                 entity.
                                                     accredited veterinarian certifying the                  forth in § 86.1 of this subchapter.
                                                     inspection of animals in preparation for                                                                      *      *     *     *    *
                                                                                                             *      *     *     *     *                               Premises identification number (PIN).
                                                     interstate movement or other uses as
                                                                                                                Official eartag. This term has the                 This term has the meaning set forth in
                                                     described in this part and in accordance
                                                                                                             meaning set forth in § 86.1 of this                   § 86.1 of this subchapter. APHIS may
                                                     with § 79.5.                                            subchapter, except that only eartags                  also maintain historical and/or State
                                                     *      *     *     *     *                              approved and distributed in accordance                premises numbers and link them to the
                                                        Low-risk commercial flock. A flock                   with § 79.2(k) are included.                          premises identification number in
                                                     composed of commercial whitefaced,                         Official genotype test. A test to                  records and databases. Such secondary
                                                     whitefaced cross, or commercial hair                    determine the genotype of a live or dead              or historical numbers are typically the
                                                     sheep or commercial goats that were                     animal conducted at either the National               State’s two-letter postal abbreviation
                                                     born in, and have resided throughout                    Veterinary Services Laboratories or at an             followed by a number assigned by the
                                                     their lives in, flocks with no known risk               approved laboratory. The test subject                 State.
                                                     factors for scrapie, including any                      must be an animal that is officially                     Restricted animal sale or restricted
                                                     exposure to female blackfaced sheep                     identified and the test accurately                    livestock facility. A sale where any
                                                     other than whiteface crosses born on the                recorded on an official form supplied or              animals in slaughter channels are
                                                     premises; that has never contained a                    approved by APHIS, with the samples                   maintained separate from other animals
                                                     scrapie-positive female, suspect female,                collected and shipped to the laboratory               not in slaughter channels and are sold
                                                     or high-risk animal; and that has never                 using a shipping method specified by                  in lots that consist entirely of animals
                                                     been an infected, exposed, or source                    the laboratory by:                                    sold for slaughter only or a livestock
                                                     flock or a flock under investigation. The                  (1) An accredited veterinarian;
                                                                                                                (2) A State or APHIS representative;               facility at which all animals are in
                                                     animals are identified with a legible                                                                         slaughter channels and where the sale
                                                     permanent brand or ear notch pattern                    or
                                                                                                                (3) The animal’s owner or owner’s                  or facility manager maintains a copy of,
                                                     registered with an official brand registry                                                                    or maintains a record of, the information
                                                     or with an official flock identification                agent, using a tamper-resistant sampling
                                                                                                             kit approved by APHIS for this purpose.               from, the owner/hauler statement for all
                                                     eartag. The term ‘‘brand’’ includes                                                                           animals entering and leaving the sale or
                                                     official brand registry brands on eartags               *      *     *     *     *
                                                                                                                                                                   facility. A restricted animal sale may be
                                                     in those States whose brand law or                         Official identification device or
                                                                                                                                                                   held at a livestock facility that is not
                                                     regulation recognizes brands placed on                  method. This term has the meaning set
                                                                                                                                                                   restricted.
                                                     eartags as official brands. Low-risk                    forth in § 86.1 of this subchapter, except
                                                                                                             that only devices approved and                        *      *     *     *    *
                                                     commercial flocks may exist only in a
                                                                                                             distributed in accordance with § 79.2(k)                 Slaughter channels. Animals in
                                                     State where in the previous 10 years no
                                                                                                             are included.                                         slaughter channels include any animal
                                                     flock that had met the definition of a
                                                                                                                Official identification number. This               that is sold, transferred, or moved either
                                                     low-risk commercial flock prior to a
                                                                                                             term has the meaning set forth in § 86.1              directly to or through a restricted animal
                                                     classification investigation was
                                                                                                             of this subchapter.                                   sale or restricted livestock facility to a
                                                     designated a source or infected flock.
                                                                                                                Officially identified. Identified by               slaughter establishment that is under
                                                        Low-risk exposed animal. Any                                                                               continuous inspection by the Food
                                                                                                             means of an official identification
                                                     exposed animal to which the DSE has                                                                           Safety and Inspection Service (FSIS) or
                                                                                                             device or method approved by the
                                                     determined one or more of the following                                                                       under State inspection that FSIS has
                                                                                                             Administrator for use in sheep and goats
                                                     applies:                                                                                                      recognized as at least equal to Federal
                                                                                                             in accordance with this part.
                                                        (1) The positive animal that was the                                                                       inspection or to a custom exempt
                                                                                                             *      *     *     *     *
                                                     source of exposure was not born in the                     Owner/hauler statement. A signed                   slaughter establishment as defined by
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                                                     flock and did not lamb in the flock or                  written statement by the owner or                     FSIS for immediate slaughter or to an
                                                     in an enclosure where the exposed                       hauler that includes:                                 individual for immediate slaughter for
                                                     animal resided;                                            (1) The name, address, and phone                   personal use or to a terminal feedlot.
                                                        (2) The Administrator and State                      number of the owner and, if different,                Any animal sold at an unrestricted sale
                                                     representative concur that the animal is                the hauler;                                           is not in slaughter channels. Animals in
                                                     unlikely to be infected due to factors                     (2) The date the animals were moved;               slaughter channels must be
                                                     such as, but not limited to, where the                     (3) The flock identification number or             accompanied by an owner/hauler
                                                     animal resided or the time period the                   PIN assigned to the flock or premises of              statement completed in accordance with
                                                     animal resided in the flock;                            the animals;                                          § 79.3(g). Animals in slaughter channels


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                                                                        Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules                                                     54685

                                                     may not be held in the same enclosure                   are maintained with female animals and                loaded, unloaded, or otherwise handled
                                                     with sexually intact animals from                       from which animals are moved only to                  in interstate commerce or commingled
                                                     another flock of origin that are not in                 another terminal feedlot or directly to               with such animals or be loaded or
                                                     slaughter channels. When selling                        slaughter; or                                         unloaded at a premises or animal
                                                     animals that do not meet the                              (2) A dry lot approved by a State or                concentration point (including premises
                                                     requirements to move as breeding                        APHIS representative or an accredited                 that exhibit animals) that engages in
                                                     animals, owners must note on the bill of                veterinarian authorized to perform this               interstate commerce of animals unless
                                                     sale that the animals are sold only for                 function where only animals that either               each sheep or goat has been identified
                                                     slaughter.                                              are not pregnant based on the animal                  in accordance with this section.
                                                     *      *     *     *     *                              being male, an owner certification that                  (1) The sheep or goat must be
                                                        Suspect animal. * * *                                any female animals have not been                      identified to its flock of origin and, for
                                                        (1) A mature sheep or goat as                        exposed to a male in the preceding 6                  an animal born after January 1, 2002, to
                                                     evidenced by eruption of the first                      months, an ICVI issued by an accredited               its flock of birth 4 by the owner of the
                                                     incisor that has been condemned by                      veterinarian stating the animals are                  animal or his or her agent, at whichever
                                                     FSIS or a State inspection authority for                open, or the animals are under 6 months               of the following points in interstate
                                                     central nervous system (CNS) signs, or                  of age at time of receipt, where only                 commerce comes first:
                                                     that exhibits any of the following                      castrated males are maintained with                      (i) Prior to the point of first
                                                     clinical signs of scrapie and has been                  female animals, and all animals in the                commingling of the sheep or goats with
                                                     determined to be suspicious for scrapie                 terminal feedlot are separated from all               sheep or goats from any other flock of
                                                     by an accredited veterinarian or a State                other animals such that physical contact              origin;
                                                                                                             cannot occur and from which animals                      (ii) Upon unloading of the sheep or
                                                     or USDA representative, based on one or
                                                                                                             are moved only to another terminal                    goats at an approved livestock facility
                                                     more of the following signs and the
                                                                                                             feedlot or directly to slaughter; or                  that is approved to handle that species
                                                     severity of the signs: Weakness of any
                                                                                                               (3) A pasture when approved by and                  and class of animals as described in
                                                     kind including, but not limited to,
                                                                                                             maintained under the supervision of the               § 71.20 of this subchapter that has
                                                     stumbling, falling down, or having
                                                                                                             State and in which only nonpregnant                   agreed to act as an agent for the owner
                                                     difficulty rising, not including those
                                                                                                             animals are permitted based on the                    to apply official identification and prior
                                                     with visible traumatic injuries and no
                                                                                                             animal being male, an owner                           to commingling with animals from
                                                     other signs of scrapie; behavioral
                                                                                                             certification that any female animals                 another flock of origin. Such animals
                                                     abnormalities; significant weight loss                                                                        must be accompanied by an owner/
                                                     despite retention of appetite or in an                  have not been exposed to a male in the
                                                                                                             preceding 6 months, or an ICVI issued                 hauler statement that contains the
                                                     animal with adequate dentition;                                                                               information needed for the livestock
                                                     increased sensitivity to noise and                      by an accredited veterinarian stating the
                                                                                                             animals are open, or the animals are                  facility to officially identify the animals
                                                     sudden movement; tremors; star gazing;                                                                        to their flock of origin and, when
                                                     head pressing; bilateral gait                           under 6 months of age at time of receipt,
                                                                                                             where only castrated males are                        required, their flock of birth;
                                                     abnormalities such as but not limited to                                                                         (iii) Upon transfer of ownership of the
                                                     incoordination, ataxia, high stepping                   maintained with female animals, where
                                                                                                             there is no direct fence-to-fence contact             sheep or goats;
                                                     gait of forelimbs, bunny-hop movement                                                                            (iv) Prior to moving a sheep or goat
                                                     of rear legs, or swaying of back end, but               with another flock, and from which
                                                                                                                                                                   from the premises on which it resides if
                                                     not including abnormalities involving                   animals are moved only to another
                                                                                                                                                                   the owner of the premises engages in the
                                                     only one leg or one front and one back                  terminal feedlot or directly to slaughter.
                                                                                                               (4) Records of all animals entering                 interstate commerce of animals unless
                                                     leg; repeated intense rubbing with bare                                                                       the animals are moving to a livestock
                                                     areas or damaged wool in similar                        and leaving a terminal feedlot must be
                                                                                                             maintained for 5 years after the animal               facility approved to handle the species
                                                     locations on both sides of the animal’s                                                                       and class of animal to be moved as
                                                     body or, if on the head, both sides of the              leaves the feedlot and must meet the
                                                                                                                                                                   described in § 71.20 of this subchapter
                                                     poll; abraded, rough, thickened, or                     requirements of § 79.2, including either
                                                                                                                                                                   that has agreed to act as an agent for the
                                                     hyperpigmented areas of skin in areas of                a copy of the required owner/hauler
                                                                                                                                                                   owner to apply official identification
                                                     wool/hair loss in similar locations on                  statements for animals entering and
                                                                                                                                                                   and in accordance with paragraph
                                                     both sides of the animal’s body or, if on               leaving the facility or the information
                                                                                                                                                                   (a)(1)(ii) of this section or to a slaughter
                                                     the head, both sides of the poll; or other              required to be on the statements.
                                                                                                                                                                   plant listed in accordance with § 71.21
                                                     signs of CNS disease. An animal will no                 Records must be made available for
                                                                                                                                                                   of this subchapter as part of a group lot.
                                                     longer be a suspect animal if it is                     inspection and copying by an APHIS or                    (v) In the case of animals that have
                                                     redesignated in accordance with § 79.4                  State representative upon request.                    only resided on premises and in flocks
                                                                                                               Test eligible. An animal that meets a
                                                     of this part.
                                                                                                             test protocol’s age and post-exposure                    4 You need not identify an animal to its flock of
                                                     *      *     *     *     *                              elapsed time requirements for the test to             birth or its flock of origin if this information is
                                                        Terminal feedlot. (1) A dry lot                      be meaningfully applied.                              unknown because the animal changed ownership
                                                     approved by a State or APHIS                                                                                  while it was exempted from flock of origin
                                                     representative or an accredited                         *     *     *     *     *                             identification requirements in accordance with
                                                                                                             ■ 16. Section 79.2 is revised to read as              § 79.6(a)(10)(i). Such animals may be moved
                                                     veterinarian who is authorized to
                                                                                                             follows:                                              interstate with individual animal identification that
                                                     perform this function where animals in                                                                        is only traceable to the State of origin and to the
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                                                     the terminal feedlot are separated from                 § 79.2 Identification and records                     owner of the animals at the time they were so
                                                     all other animals by at least 30 feet at                requirements for sheep and goats in                   identified. To use this exemption the person
                                                     all times or are separated by a solid wall              interstate commerce.                                  applying the identification must have supporting
                                                                                                                                                                   documentation indicating that the animals were
                                                     through, over, or under which fluids                       (a) No sheep or goat that is required              born and had resided throughout their life in the
                                                     cannot pass and contact cannot occur                    to be individually identified or group                State. Likewise, animals born before January 1,
                                                     and must be cleaned of all organic                      identified by § 79.3 may be sold,                     2002, need only be identified to their flock of origin
                                                                                                                                                                   and, for animals not required to be identified prior
                                                     material prior to being used to contain                 disposed of, acquired, exhibited,                     to [effective date of final rule] may, be identified to
                                                     sheep or goats that are not in slaughter                transported, received for transportation,             the owner of the animals and the flock of residence
                                                     channels, where only castrated males                    offered for sale or transportation,                   as of [effective date of final rule].



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                                                     54686              Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules

                                                     owned by persons that do not engage in                  prior to commingling it with any other                that such assignments will improve
                                                     interstate commerce, upon unloading a                   animals. This shall be done by applying               scrapie control and eradication within
                                                     sheep or goat at a livestock facility or                individual animal identification to the               the State. Such persons assigned serial
                                                     other premises that engages in interstate               animal as required in paragraph (a)(2) of             numbers may either directly apply
                                                     commerce of animals and prior to                        this section and recording the means of               eartags to animals, or may reassign
                                                     commingling with animals from another                   identification and the corresponding                  eartag numbers to producers. Such
                                                     flock of origin. Such animals must be                   animal identification number on the                   persons must maintain appropriate
                                                     accompanied by an owner/hauler                          waybill or other shipping document. If                records in accordance with paragraph
                                                     statement that contains the information                 the flock of origin cannot be                         (g) of this section that permit traceback
                                                     needed to officially identify the animals               determined, all possible flocks of origin             of animals to their flock of origin, or
                                                     to their flock of origin and, when                      shall be listed on the record, or if this             flock of birth when required, and must
                                                     required, their flock of birth;                         cannot be done, the animal must be                    either reassign the tags in the National
                                                        (2) The sheep or goats must be                       identified with a slaughter only eartag               Scrapie Database or, if permitted by the
                                                     identified and remain identified using a                and may only move in slaughter                        Veterinary Services, Surveillance
                                                     device or method approved by the                        channels or in the case of sheep may                  Preparedness and Response Services
                                                     Administrator. All animals required to                  move for other purposes if the animal is              Field Office for the State involved,
                                                     be individually identified by § 79.3 shall              inspected by an accredited veterinarian,              provide a written record of the
                                                     be identified with official identification              found free of evidence of infectious or               reassignment to the Field Office or the
                                                     devices or methods. A list of approved                  contagious disease and officially                     State Office for entry into the National
                                                     identification devices and methods,                     genotyped as AA QR or AA RR.                          Scrapie Database.
                                                     including restrictions on their use, is                    (b) Individual identification numbers.                (3) Persons handling sheep and goats
                                                     available at http://www.aphis.usda.gov/                 The State animal health official or                   in commerce. Sets of unique individual
                                                     animal-health/scrapie. Written requests                 Veterinary Services, Surveillance                     identification serial numbers may be
                                                     for approval of sheep or goat                           Preparedness and Response Services,                   assigned to persons who handle sheep
                                                     identification device types or methods                  Assistant Director responsible for the                and goats, but who do not own breeding
                                                     not listed at http://www.aphis.usda.gov/                State involved, whoever is responsible                flocks, if they apply to and are approved
                                                     animal-health/scrapie should be sent to                 for issuing official identification devices           by the State animal health official or the
                                                     the National Scrapie Program                            or numbers in that State and for                      Veterinary Services, Surveillance
                                                     Coordinator, Surveillance Preparedness                  assigning flock identification numbers                Preparedness and Response Services,
                                                     and Response Services, VS, APHIS,                       and premises identification numbers in                Assistant Director responsible for the
                                                     4700 River Road, Unit 43, Riverdale,                    that State in the National Scrapie                    State in which the person maintains his
                                                     MD 20737–1235. If the Administrator                     Database, may issue sets of unique serial             or her business location, whichever is
                                                     determines that an identification device                numbers or flock identification/                      responsible for issuing official
                                                     or method will provide an effective                     production numbers for use on official                identification devices or numbers in
                                                     means of tracing sheep and goats in                     individual identification devices (such               that State and for assigning flock
                                                     interstate commerce, APHIS will                         as eartags or tattoos). Flock                         identification numbers and premises
                                                     provide public notice that the device                   identification/production numbers may                 identification numbers in that State in
                                                     type or method, along with any                          only be assigned to owners of breeding                the National Scrapie Database. Such
                                                     restrictions on its use, has been added                 flocks.                                               persons must provide, in a manner
                                                     to the list of approved devices and                        (1) Official identification numbers for            acceptable to APHIS, assignment data
                                                     methods of official sheep and goat                      use on animals not in slaughter                       associating assigned serial sequences to
                                                     identification.                                         channels may only be assigned either                  the flock of origin and, when required,
                                                        (3) No person shall buy or sell, for his             directly to the owner of a breeding flock             the flock of birth. One such method
                                                     or her own account or as the agent of the               or, in the case of official serial numbers            would be to enter the data into the
                                                     buyer or seller, transport, receive for                 or serial number devices, to APHIS or                 online animal identification number
                                                     transportation, offer for sale or                       State representatives or accredited                   (AIN) management system module of
                                                     transportation, load, unload, or                        veterinarians or other responsible                    the National Scrapie Database.
                                                     otherwise handle any animal that is in                  individuals as described in paragraphs                   (4) Breed registries. Sets of unique
                                                     or has been in interstate commerce that                 (b)(2) and (3) of this section for                    individual identification numbers may
                                                     has not been identified as required by                  reassignment to owners of breeding                    also be assigned by the Administrator to
                                                     this section including loading or                       flocks. APHIS or State representatives or             breed registries that agree to reassign the
                                                     unloading at a premises (including                      accredited veterinarians that reissue                 sequences to the flock of origin and, and
                                                     premises that exhibit animals) that                     official serial numbers or devices must               when required, the flock of birth and to
                                                     engages in interstate commerce of                       provide, in a manner acceptable to                    provide associated registry identifiers
                                                     animals. No person shall commingle                      APHIS, assignment data associating                    such as registry tattoo numbers to
                                                     animals with any animal that is in or                   assigned serial sequences to the flock of             APHIS in the online animal
                                                     has been in interstate commerce that has                origin and, when required, the flock of               identification number (AIN)
                                                     not been identified as required by this                 birth. One such method would be to                    management system module of the
                                                     section. If the person transporting                     enter the data into the AIN module of                 National Scrapie Database.
                                                     animals is aware of any animal in the                   the National Scrapie Database.                           (5) Noncompliance. In addition to any
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                                                     shipment that loses its identification to                  (2) The official responsible for issuing           applicable criminal or civil penalties
                                                     its flock of origin while in interstate                 eartags in a State may also assign serial             any person who fails to comply with the
                                                     commerce, the person transporting the                   numbers of official eartags to other                  requirements of this section or that
                                                     animal is required to inform the                        responsible persons, such as 4–H                      makes false statements in order to
                                                     receiving party of this fact, and it is the             leaders, if the State animal health                   acquire official identification numbers
                                                     responsibility of the person who has                    official and Veterinary Services,                     or devices shall not be assigned official
                                                     control or possession of the animal                     Surveillance Preparedness and                         identification numbers or official
                                                     upon unloading/delivery to identify the                 Response Services, Assistant Director                 identification devices for a period of at
                                                     animal or have the animal identified                    responsible for the State involved agree              least 1 year. If a person who is not in


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                                                                        Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules                                           54687

                                                     compliance with these requirements has                  representative’s request and                             (h) Removal or loss of official
                                                     already been assigned such numbers,                     presentation of his or her official                   identification devices. Official
                                                     the Administrator may withdraw the                      credentials. The records must include                 identification devices are intended to
                                                     assignment by giving notice to such                     the following information:                            provide permanent identification of
                                                     person. Such withdrawal or failure to                      (1) The number of animals purchased                livestock and to ensure the ability to
                                                     assign official identification numbers                  or sold (or transferred without sale);                find the source of animal disease
                                                     may be appealed in accordance with                         (2) The date of purchase, sale, or other           outbreaks. Removal of these devices,
                                                     § 79.4(c)(3). A person shall be subject to              transfer;                                             including devices applied to imported
                                                     criminal and civil penalties if he or she                  (3) The name and address of the                    animals in their countries of origin and
                                                     continues to use assigned numbers that                  person from whom the animals were                     recognized by the Administrator as
                                                     have been withdrawn from his or her                     purchased or otherwise acquired or to                 official, is prohibited except at the time
                                                     use.                                                    whom they were sold or otherwise                      of slaughter, at any other location upon
                                                        (c) No person shall apply a premises                 transferred;                                          the death of the animal, or as otherwise
                                                     or flock identification number or a                        (4) The species, breed, and class of               approved by the State or Tribal animal
                                                     brand or earnotch pattern to an animal                  animal. If breed is unknown, for sheep                health official or the Veterinary
                                                     that did not originate on the premises or               the face color and for goats the type                 Services, Surveillance Preparedness and
                                                     flock to which the number was assigned                  (milk, fiber, or meat) must be recorded               Response Services, Assistant Director
                                                     by a State or APHIS representative or to                instead;                                              responsible for the State involved when
                                                     which the brand or earnotch pattern has                    (5) A copy of the brand inspection                 a device needs to be replaced.
                                                     been assigned by an official brand                      certificate for animals officially                       (1) All man-made identification
                                                     registry. This includes individual                      identified with brands or ear notches;                devices affixed to sheep or goats moved
                                                     identification such as USDA eartags that                   (6) A copy of any certificate or owner/            interstate must be removed at slaughter
                                                     have been assigned to a premises or                     hauler statement required for movement                and correlated with the carcasses
                                                     flock and registration tattoos that                     of the animals purchased, sold, or                    through final inspection by means
                                                     contain prefixes that have been assigned                otherwise transferred; and                            approved by the Food Safety and
                                                     to a premises or flock for use as                          (7) If the flock of origin or the                  Inspection Service (FSIS). If diagnostic
                                                     premises or flock identification. Unless                receiving flock is under a flock plan or              samples, including whole heads, are
                                                     the number sequence was issued                          post-exposure management and                          taken, the identification devices must be
                                                     specifically for use on animals born in                 monitoring plan, any additional records               packaged with the samples and must be
                                                     a flock, this would not preclude the                    required by the plan.                                 left attached to approximately 1 inch of
                                                     owner of a flock from using an official                    (g) Records required of persons who                tissue or to the whole head to allow for
                                                     premises or flock identification number                 apply official identification to animals.             identity testing and be correlated with
                                                     tag assigned to that flock on an animal                 Persons who apply official individual or              the carcasses through final inspection
                                                     owned by him or her that resides in that                group/lot identification to animals must              by means approved by FSIS. Devices
                                                     flock but that was born or previously                   maintain records for 5 years. These                   collected at slaughter must be made
                                                     resided on a different premises as long                 persons must make the records available               available to APHIS and FSIS.
                                                     as the records required in paragraph (g)                for inspection and copying by any                        (2) All official identification devices
                                                     of this section are maintained.                         authorized USDA or State representative               affixed to sheep or goat carcasses moved
                                                        (d) No person shall sell or transfer an              upon that representative’s request and                interstate for rendering must be
                                                     official identification device or number                presentation of his or her official                   removed at the rendering facility and
                                                     assigned to his or her premises or flock                credentials. The records must include                 made available to APHIS. If diagnostic
                                                     except when it is transferred with a                    the following information:                            samples, including whole heads, are
                                                     sheep or goat to which it has been                         (1) The flock identification number of             taken, the identification devices must be
                                                     applied as official identification or as                the flock of origin, the name and                     packaged with the samples and must be
                                                     directed in writing by an APHIS or State                address of the person who currently                   left attached to approximately 1 inch of
                                                     representative.                                         owns the animals, and the name and                    tissue or to the whole head to allow for
                                                        (e) No person shall use an official                  address of the owner of the flock of                  identity testing.
                                                     identification device or number                         origin if different;                                     (3) If a sheep or goat loses an official
                                                     provided for the identification of sheep                   (2) The name and address of the                    identification device except while in
                                                     and goats other than for the                            owner of the flock of birth, if known, for            interstate commerce as described in
                                                     identification of a sheep or goat.                      animals born after January 1, 2002, in                paragraph (a)(3) of this section and
                                                        (f) Records required of persons who                  another flock and not already identified              needs a new one, the person applying
                                                     purchase, acquire, sell, or dispose of                  to flock of birth;                                    the new official identification device
                                                     animals. Persons who engage in the                         (3) The date the animals were                      must record the official identification
                                                     interstate commerce of animals                          officially identified;                                number on the old device if known in
                                                     including persons that handle or own                       (4) The number of sheep and the                    addition to the information required to
                                                     animals that have been in interstate                    number of goats identified;                           be recorded in accordance with
                                                     commerce or that purchase, acquire,                        (5) The breed and class of the animals.            paragraph (g) of this section.
                                                     sell, or dispose of sheep and/or goats to               If breed is unknown, for sheep the face                  (i) Replacement of official
                                                     persons who engage in the interstate                    color and for goats the type (milk, fiber,            identification devices for reasons other
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                                                     commerce of animals, whether or not                     or meat) must be recorded instead;                    than loss. (1) Circumstances under
                                                     the animals are required to be officially                  (6) The official identification numbers            which a State or Tribal animal health
                                                     identified, must maintain business                      applied to animals by species or the GIN              official or the Veterinary Services,
                                                     records (such as yarding receipts, sale                 applied in the case of a group lot;                   Surveillance Preparedness and
                                                     tickets, invoices, and waybills) for 5                     (7) Whether the animals were                       Response Services, Assistant Director
                                                     years. These persons must make the                      identified with ‘‘Slaughter Only’’ or                 responsible for the State involved may
                                                     records available for inspection and                    ‘‘Meat’’ identification devices; and                  authorize replacement of an official
                                                     copying by any authorized USDA or                          (8) Any GIN with which the animal                  identification device include, but are
                                                     State representative upon that                          was previously identified.                            not limited to:


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                                                     54688              Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules

                                                        (i) Deterioration of the device such                 device; and the official identification               legibility of the identification numbers,
                                                     that loss of the device appears likely or               numbers of both official eartags.                     rate of adverse reactions such as ear
                                                     the number can no longer be read;                          (3) An eartag with an animal                       infections, and retention rates of the
                                                        (ii) Infection at the site where the                 identification number (AIN) beginning                 devices in animals, preferably sheep
                                                     device is attached, necessitating                       with the 840 prefix (either radio                     and/or goats.
                                                     application of a device at another                      frequency identification or visual-only                  (iii) A signed statement agreeing to:
                                                     location (e.g., a slightly different                    tag) may be applied to an animal that is                 (A) Send official identification
                                                     location of an eartag in the ear);                      already officially identified with                    devices only to a State or APHIS
                                                        (iii) Malfunction of the electronic                  another eartag. The person applying the               representative, to the owner of a
                                                     component of a radio frequency                          AIN eartag must record the date the AIN               premises or to the contact person for a
                                                     identification (RFID) device; or                        tag is added and the official                         premises at the address listed in the
                                                        (iv) Incompatibility or inoperability of             identification numbers of all official                National Scrapie Database, or as
                                                     the electronic component of an RFID                     eartags on the animal and must                        directed by APHIS;
                                                     device with the management system or                    maintain those records for 5 years.                      (B) When requested by APHIS,
                                                     unacceptable functionality of the                          (4) An official eartag that utilizes a             provide a report by State of all tags
                                                     management system due to use of an                      flock identification number may be                    produced, including the tag sequences
                                                     RFID device.                                            applied to a sheep or goat that is already            produced and the name and address of
                                                                                                             officially identified with an official                the person to whom the tags were
                                                        (2) Any time an official identification
                                                                                                             eartag if the animal has resided in the               shipped, and provide supplemental
                                                     device is replaced, as authorized by the
                                                                                                             flock to which the flock identification               reports of this information when
                                                     State or Tribal animal health official or
                                                                                                             number is assigned.                                   requested by APHIS;
                                                     the Veterinary Services, Surveillance                                                                            (C) Maintain the security and
                                                                                                                (k) Requirements for approval of
                                                     Preparedness and Response Services,                                                                           confidentiality of all tag recipient
                                                                                                             official identification devices. (1) The
                                                     Assistant Director responsible for the                                                                        information acquired as a result of being
                                                                                                             Administrator may approve companies
                                                     State involved, the person replacing the                                                                      an approved tag manufacturer and
                                                                                                             to produce official identification devices
                                                     device must record the following                                                                              utilize the information only to provide
                                                                                                             for use on sheep or goats. Devices may
                                                     information about the event and                         be plastic, metal, or other suitable                  official identification tags; and
                                                     maintain the record for 5 years:                        materials and must be an appropriate                     (D) Enter the sequences of tags
                                                        (i) The date on which the device was                 size for use in sheep and goats. Devices              shipped into the online animal
                                                     removed;                                                must be able to legibly accommodate the               identification number (AIN)
                                                        (ii) Contact information for the                     required alphanumeric sequences.                      management system module of the
                                                     location where the device was removed;                  Devices must resist removal and be                    National Scrapie Database through an
                                                        (iii) The official identification number             difficult to place on another animal                  Internet Web page interface or other
                                                     (to the extent possible) on the device                  once removed unless the construction of               means specified by APHIS prior to
                                                     removed;                                                the device makes such tampering                       shipping the identification device.
                                                        (iv) The type of device removed (e.g.,               evident, but need not be tamper-proof.                   (iv) Twenty-five sample devices.
                                                     metal eartag, RFID eartag);                             Devices must be readily distinguishable               Additional tags must be submitted if
                                                        (v) The reason for the removal of the                as USDA official sheep and goat                       requested by APHIS.
                                                     device;                                                 identification devices; must carry the                   (3) Approval will only be given for
                                                        (vi) The new official identification                 alphanumeric sequences, symbols, or                   devices for which data have been
                                                     number on the replacement device; and                   logos specified by APHIS; must be an                  provided supporting high legibility,
                                                        (vii) The type of replacement device                 allowed color for the intended use, and               readability (visual and RFID), and
                                                     applied.                                                must have a means of discouraging                     retention rates in sheep and goats that
                                                        (j) Use of more than one official                    counterfeiting, such as use of a unique               minimize injury throughout their
                                                     eartag. Beginning on [effective date of                 copyrighted logo or trade mark. Devices               lifespan, or for which there is a
                                                     final rule], no more than one official                  for use only on animals in slaughter                  reasonable expectation of such
                                                     eartag may be applied to an animal;                     channels must be medium blue and                      performance. Approval to produce
                                                     except that:                                            marked with the words ‘‘Meat’’ or                     official identification devices will be
                                                        (1) Another official eartag may be                   ‘‘Slaughter Only’’. Devices that use RFID             valid for 1 year and must be renewed
                                                     applied providing it bears the same                     must conform to ISO 11784 and ISO                     annually. The Administrator may grant
                                                     official identification number as an                    11785 standards unless otherwise                      provisional approval to produce devices
                                                     existing one.                                           approved. The Administrator may                       for periods of less than 1 year in cases
                                                        (2) In specific cases when the need to               specify the color, shape or size of a                 where there is limited or incomplete
                                                     maintain the identity of an animal is                   device for an intended use to make them               data. The Administrator may decline to
                                                     intensified (e.g., such as for export                   readily identifiable.                                 renew a company’s approval or suspend
                                                     shipments, quarantined herds, field                        (2) Written requests for approval of               or withdraw approval if the devices do
                                                     trials, experiments, or disease surveys),               official identification devices for sheep             not show adequate retention and
                                                     a State or Tribal animal health official                and goats should be sent to the National              durability or cause injury in field use or
                                                     or the Veterinary Services, Surveillance                Scrapie Program Coordinator,                          if any of the requirements of this section
                                                     Preparedness and Response Services,                     Surveillance Preparedness and                         are not met by the tag company.
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                                                     Assistant Director responsible for the                  Response Services, VS, APHIS, 4700                    Companies shall be given 60 days’
                                                     State involved may approve the                          River Road Unit 43, Riverdale, MD                     written notice of intent to withdraw
                                                     application of a second official eartag.                20737–1235. The request must include:                 approval. Any person who is approved
                                                     The person applying the second official                    (i) The materials used in the device               to produce official identification tags in
                                                     eartag must record the following                        and in the case of RFID the transponder               accordance with this section and who
                                                     information about the event and                         type and data regarding the lifespan and              knowingly produces tags that are not in
                                                     maintain the record for 5 years: The date               read range.                                           compliance with the requirements of
                                                     the second official eartag is added; the                   (ii) Any available data regarding the              this section, and any person who is not
                                                     reason for the additional official eartag               durability of the device, durability and              approved to produce such tags but does


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                                                                         Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules                                         54689

                                                     so, shall be subject to such civil                          (3) Animals in slaughter channels 18              identified with an identification device
                                                     penalties and such criminal liabilities as               months of age and older (as evidenced                or tattoo marked ‘‘slaughter only’’ or
                                                     are provided by 18 U.S.C. 1001, 7 U.S.C.                 by the eruption of the second incisor)               ‘‘MEAT’’ or was moved in a manner not
                                                     8313, or other applicable Federal                        that are identified with official                    permitted for other classes of animals.
                                                     statutes. Such action may be in addition                 individual identification or in the case             Animals in slaughter channels may
                                                     to, or in lieu of, withdrawal of approval                of animals from flocks that are low-risk             move either directly to a slaughter
                                                     to produce tags.                                         commercial flocks that are identified                establishment that is under continuous
                                                     ■ 17. Section 79.3 is revised to read as                 using identification methods or devices              inspection by the Food Safety and
                                                     follows:                                                 approved for this purpose;                           Inspection Service (FSIS) or under State
                                                                                                                 (4) Animals moving for grazing or                 inspection that FSIS has recognized as
                                                     § 79.3   General restrictions.                           other management purposes between                    at least equal to Federal inspection or to
                                                        The following prohibitions and                        two premises both owned or leased by                 a custom exempt slaughter
                                                     movement conditions apply to the                         the flock owner and recorded in the                  establishment as defined by FSIS for
                                                     movement of or commingling with                          National Scrapie Database as additional              immediate slaughter or to an individual
                                                     sheep and goats in interstate commerce,                  flock premises and where commingling                 for immediate slaughter for personal
                                                     and no sheep or goat may be sold,                        will not occur with unidentified                     use, to a terminal feedlot, or may move
                                                     disposed of, acquired, exhibited,                        animals that were born in another flock              indirectly to such a destination through
                                                     transported, received for transportation,                or any animal that is not part of the                a restricted animal sale or restricted
                                                     offered for sale or transportation,                      flock; and                                           livestock facility. Once an animal has
                                                     loaded, unloaded, or otherwise handled                      (5) Animals moving to a livestock                 entered slaughter channels it may only
                                                     in interstate commerce, or commingled                    facility approved in accordance with                 be officially identified with an official
                                                     with such animals, or be loaded or                       § 71.20 of this subchapter and that has              blue eartag marked with the words
                                                     unloaded at a premises or animal                         agreed to act as an agent for the owner              ‘‘Meat’’ or ‘‘Slaughter Only’’ or an ear
                                                     concentration point (including premises                  to apply official identification if the              tattoo reading ‘‘Meat.’’ Animals in
                                                     that exhibit animals) that engages in                    animals have been in the same flock in               slaughter channels must be
                                                     interstate commerce of animals except                    which they were born and have not                    accompanied by an owner/hauler
                                                     in compliance with this part.                            been maintained in the same enclosure                statement indicating the owner’s name
                                                        (a) No sexually intact animal of any                  with unidentified animals born in                    and address; the name and address of
                                                     age or castrated animal 18 months of age                 another flock at any time.                           the person or livestock facility from
                                                     and older (as evidenced by the eruption                     (b) No scrapie-positive or suspect                which and where they were acquired, if
                                                     of the second incisor) may be moved or                   animal may be moved other than by                    different from the owner; the slaughter
                                                     commingled with animals in interstate                    permit to an APHIS approved research                 establishment, restricted animal sale,
                                                     commerce unless it is individually                       or quarantine facility or for destruction            restricted livestock facility or terminal
                                                     identified to its flock of birth 5 and is                under APHIS or State supervision. Such               feedlot to which they are being moved,
                                                     accompanied by an ICVI, except that an                   animals must be individually identified              and a statement that the animals are in
                                                     ICVI is not required unless the animal                   and listed on the permit.                            slaughter channels. A copy of the
                                                     is moved across a state line, and except                    (c) No indemnified high-risk animal
                                                                                                                                                                   owner/hauler statement must be
                                                     for the following, which may move with                   or indemnified sexually intact
                                                                                                                                                                   provided to the slaughter establishment,
                                                     group lot identification and an owner/                   genetically susceptible exposed animal
                                                                                                                                                                   restricted animal sale, restricted
                                                     hauler statement:                                        may be moved other than by permit to
                                                                                                                                                                   livestock facility or terminal feedlot to
                                                        (1) Animals in slaughter channels that                an APHIS approved research or
                                                                                                                                                                   which the animals are moved. Any bill
                                                     are under 18 months of age;                              quarantine facility or for destruction at
                                                                                                                                                                   of sale regarding the animals must
                                                        (2) Animals in slaughter channels at                  another site. Such animals that are not
                                                                                                                                                                   indicate that the animals were sold for
                                                     18 months and older (as evidenced by                     indemnified may be moved to slaughter
                                                                                                                                                                   slaughter only.
                                                     the eruption of the second incisor) if the               under permit. Animals moved in
                                                                                                                                                                      (h) No animals designated for testing
                                                     animals were kept as a group on the                      accordance with this paragraph must be
                                                                                                                                                                   as part of a classification or
                                                     same premises on which they were born                    individually identified and listed on the
                                                                                                                                                                   reclassification investigation may be
                                                     and have not been maintained in the                      permit.
                                                                                                                 (d) No exposed animal may be moved                moved until testing is completed and
                                                     same enclosure with unidentified                                                                              results reported, except for movement
                                                     animals from another flock at any time,                  unless it is officially individually
                                                                                                              identified.                                          by permit for testing, slaughter,
                                                     including throughout the feeding,                                                                             research, or destruction. Such animals
                                                     marketing, and slaughter process;                           (e) No animal may be moved from an
                                                                                                              infected flock or source flock except as             must be individually identified and
                                                                                                              allowed by an approved flock plan.                   listed on the permit.
                                                        5 You need not identify an animal to its flock of
                                                                                                                 (f) No animal may be moved from an                   (i) The following animals, if not
                                                     birth or its flock of origin if this information is
                                                     unknown because the animal changed ownership             exposed flock, a flock under                         restricted as part of a flock plan or
                                                     while it was exempted from flock of origin               investigation or a flock subject to a                PEMMP, may be moved to any
                                                     identification requirements in accordance with           PEMMP except as allowed in a PEMMP                   destination without further restriction
                                                     § 79.6(a)(10)(i). Such animals may be moved                                                                   after being officially identified and
                                                     interstate with individual animal identification that    or where a PEMMP is not required, as
                                                     is only traceable to the State of origin and to the      allowed by written instructions from an              designated or redesignated by a DSE to
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                                                     owner of the animals at the time they were so            APHIS or State representative.                       be:
                                                     identified. To use this exemption the person                (g) Animals moved to slaughter. Once                 (1) Genetically resistant exposed
                                                     applying the identification must have supporting                                                              sheep;
                                                     documentation indicating that the animals were
                                                                                                              an animal enters slaughter channels the
                                                     born and had resided throughout their life in the        animal may not be removed from                          (2) Genetically less susceptible
                                                     State. Likewise, animals born before January 1,          slaughter channels. An animal is in                  exposed sheep; or
                                                     2002, need only be identified to their flock of origin   slaughter channels if it was sold through               (3) Low-risk exposed animals.
                                                     and, for animals not required to be identified prior
                                                     to [Effective date of final rule] may, be identified
                                                                                                              a restricted animal sale, resided in a                  (j) Additional requirements for
                                                     to the owner of the animals and the flock of             terminal feedlot, was sold with a bill of            animals moved from Inconsistent States.
                                                     residence as of [Effective date of final rule].          sale marked for slaughter only, was                  Such animals must meet the following


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                                                     54690              Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules

                                                     requirements in addition to other                       investigation, and/or a non-compliant                 samples, the flock will be designated a
                                                     requirements of this section.                           flock, or designate an animal to be a                 source, infected, or exposed flock,
                                                       (1) Sheep and goats not in slaughter                  scrapie-positive animal, high-risk                    whichever definition applies and a
                                                     channels must be enrolled in the                        animal, exposed animal, genetically                   noncompliant flock.
                                                     Scrapie Free Flock Certification Program                susceptible exposed animal, genetically                  (2) Notice to owner. As soon as
                                                     or an equivalent APHIS recognized                       resistant exposed sheep, genetically less             possible after making a designation or
                                                     program or be sheep that are officially                 susceptible exposed sheep, low-risk                   redesignation determination, a State or
                                                     genotyped and determined to be AA QR                    exposed animal, and/or a suspect                      APHIS representative will attempt to
                                                     or AA RR, be officially identified, and                 animal after determining that the flock               notify the owner(s) of the flock(s) or
                                                     be accompanied by an ICVI that also                     or animal meets the criteria of the                   animal(s) in writing of the designation.
                                                     states the individual animal                            relevant definition in § 79.1.                           (3) Appeal. The owner of an animal
                                                     identification numbers, the flock of                       (b) Redesignation. A reclassification              may appeal the designation of an animal
                                                     origin and, for any animal born after                   investigation as defined in § 79.1 may be             as a scrapie-positive animal, high-risk
                                                     January 1, 2002, the flock of birth, if                 conducted to determine whether the                    animal, exposed animal, genetically
                                                     different.                                              current designated status of a flock or               susceptible exposed animal, genetically
                                                       (2) Animals in slaughter channels                     animal may be changed or removed.                     resistant exposed sheep, genetically less
                                                     must be officially identified with an                   Reclassification investigations will be               susceptible exposed sheep, low-risk
                                                     official blue eartag marked with the                    initiated and conducted, and                          exposed animal, or a suspect animal.
                                                     words ‘‘Meat’’ or ‘‘Slaughter Only’’ and                redesignation decisions will be made in               The owner of a flock may appeal the
                                                     may move only directly to slaughter or                  accordance with procedures approved                   designation of the flock as an exposed
                                                     to a terminal feedlot. Animals 18                       by the Administrator. These procedures                flock, an infected flock, a source flock,
                                                     months of age and older (as evidenced                   are available at http://                              a flock under investigation, or a non-
                                                     by the eruption of the second incisor) in               www.aphis.usda.gov/animal-health/                     compliant flock. The owner of a
                                                     slaughter channels must also be                         scrapie.                                              laboratory or test manufacturing facility
                                                     accompanied by an ICVI that states the                     (c) Testing and notification                       may appeal the suspension or
                                                     individual animal identification                        procedures. Any animal that may be a                  withdrawal of approval for a laboratory
                                                     numbers and, for any animal born after                  high-risk animal, any animal that may                 or a test. To do so, the owner must
                                                     January 1, 2002, the flock of birth (and                have been exposed to the lambing of a                 appeal by writing to the Administrator
                                                     the flock of origin, if different).                     high-risk animal, any suspect animal,                 within 10 days after being informed of
                                                       (k) APHIS may enter into compliance                   and any animal that was born in the                   the reasons for the proposed action. The
                                                     agreements with persons such as dealers                 flock after a high-risk animal may have               appeal must include all of the facts and
                                                     and owners of slaughter establishments                  lambed may be selected for testing.                   reasons upon which the owner relies to
                                                     and markets whereby animals may be                      Which animals are selected and the                    show that the reasons for the proposed
                                                     received unidentified even if they                      method of testing selected will be based              action are incorrect or do not support
                                                     cannot be identified to their flock of                  on the risk associated with the flock and             the action. The Administrator will grant
                                                     birth or origin because they were moved                 the type and number of animals                        or deny the appeal in writing as
                                                     or commingled while unidentified, in                    available for test. When flock records                promptly as circumstances permit,
                                                     violation of this regulation or an                      are adequate to determine that all high-              stating the reason for his or her
                                                     intrastate regulation as provided by                    risk animals that lambed in the flock are             decision. If there is a conflict as to any
                                                     § 79.6, if the violation is reported to the             available for testing, the testing may be             material fact, a hearing will be held to
                                                     Veterinary Services, Surveillance                       limited to postmortem testing of all                  resolve the conflict. Rules of practice
                                                     Preparedness and Response Services,                     high-risk and suspect animals. Testing                concerning the hearing will be adopted
                                                     Assistant Director responsible for the                  may include an official genotype test,                by the Administrator. The action under
                                                     State involved so that corrective action                live-animal testing using a live-animal               appeal shall continue in effect pending
                                                                                                             official test, the postmortem                         the final determination of the
                                                     can be taken against the principal
                                                                                                             examination and testing of genetically                Administrator, unless otherwise ordered
                                                     violator. In such cases the animal must
                                                                                                             susceptible animals in the flock that                 by the Administrator. Such action shall
                                                     be identified with a slaughter only tag,
                                                                                                             cannot be evaluated by a live animal                  become effective upon oral or written
                                                     and is moved only in slaughter channels
                                                                                                             test, postmortem examination of other                 notification, whichever is earlier, to the
                                                     or, in the case of sheep, moved for other
                                                                                                             animals, and postmortem examination                   owner. In the event of oral notification,
                                                     purposes if the animal is inspected by
                                                                                                             and testing of animals found dead or                  written confirmation shall be given as
                                                     an accredited veterinarian, found free of
                                                                                                             cull animals at slaughter. Animals may                promptly as circumstances allow. The
                                                     evidence of infectious or contagious
                                                                                                             not be tested for scrapie to establish the            Administrator’s decision constitutes
                                                     disease, and officially genotyped as AA
                                                                                                             designation of the flock until they are               final agency action.
                                                     QR or AA RR.                                            test eligible. Animals are generally
                                                     ■ 18. Section 79.4 is revised to read as                                                                      ■ 19. Section 79.5 is revised as follows:
                                                                                                             considered test eligible when the
                                                     follows:
                                                                                                             animals are over 14 months of age if                  § 79.5 Issuance of Interstate Certificates of
                                                     § 79.4 Designation of scrapie-positive                  born after the exposure or are 18 months              Veterinary Inspection (ICVI).
                                                     animals, high-risk animals, exposed                     post exposure. If testing these animals is              (a) ICVIs are required as specified by
                                                     animals, suspect animals, exposed flocks,               necessary to establish the status of a                § 79.3 for certain interstate movements
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                                                     infected flocks, noncompliant flocks, and               flock they must be held for later testing             of sheep or goats and may be used to
                                                     source flocks; notice to owners.                        unless sent directly to slaughter or a                meet the requirements for entry into
                                                        (a) Designation. Based on a                          terminal feedlot.                                     terminal feedlots. An ICVI must show
                                                     classification investigation as defined in                 (1) Noncooperation. If an owner does               the following information, except when
                                                     § 79.1, including testing of animals, if                not make his or her animals available                 § 79.3 states that the information is not
                                                     needed, a designated scrapie                            for testing within 60 days of                         required for the specific type of
                                                     epidemiologist will designate a flock to                notification, within 60 days of becoming              interstate movement:
                                                     be an exposed flock, an infected flock,                 test eligible, or as mutually agreed, or                (1) The ICVI must show the species,
                                                     a source flock, a flock under                           fails to submit required postmortem                   breed or, if breed is unknown, the face


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                                                                        Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules                                            54691

                                                     color of sheep or the type of goats (milk,              and (c) of this section, all information                 (i) The name of the attached
                                                     fiber, or meat), and class of animal, such              required by this paragraph must be                    document; and
                                                     as replacement ewe lambs, slaughter                     typed or legibly written on the ICVI.                    (ii) Either the serial number on the
                                                     lambs or kids, cull ewes, club lambs,                   Note that in accordance with paragraphs               official brand inspection certificate or, if
                                                     bred ewes, etc.; the number of animals                  (a), (b), and (e) of § 79.3, scrapie-                 the official brand inspection certificate
                                                     covered by the ICVI; the purpose for                    positive, suspect, and high-risk animals,             is not imprinted with a serial number,
                                                     which the animals are to be moved; the                  some exposed animals, and some                        both the name of the person who
                                                     address at which the animals were                       animals that originated in an infected or             prepared the official brand inspection
                                                     loaded for interstate movement or for                   source flock require permits rather than              certificate and the date it was signed.
                                                     movement to a terminal feedlot when an                  ICVIs.                                                ■ 20. Section 79.6 is amended as
                                                     ICVI is required; the address to which                     (b) As an alternative to typing or
                                                                                                                                                                   follows:
                                                     the animals are destined; and the names                 writing individual animal identification
                                                                                                                                                                   ■ a. In paragraph (a) introductory text,
                                                     of the consignor and the consignee and                  on an ICVI, if agreed to by the receiving
                                                     their addresses if different from the                   State or Tribe, another document may                  by adding the words ‘‘, including
                                                     address at which the animals were                       be used to provide this information, but              scrapie surveillance activities,’’ after the
                                                     loaded or the address to which the                      only under the following conditions:                  words ‘‘control activities’’.
                                                     animals are destined; and if different the                 (1) The document must be a State                   ■ b. By redesignating paragraphs
                                                     current owner;                                          form or APHIS form that requires                      (a)(10)(i) through (vi) as paragraphs
                                                        (2) Each animal’s official individual                individual identification of animals or a             (a)(12) through (17), respectively, and
                                                     identification numbers: Provided, that,                 printout of official identification                   revising paragraph (a)(10).
                                                     in the case of animals identified with                  numbers generated by computer or other                ■ c. By adding paragraph (a)(11).
                                                     flock identification that is assigned to                means;                                                ■ d. In paragraph (b), by adding the
                                                     the flock of origin and that meets the                     (2) A legible copy of the document                 words ‘‘from the date the State is
                                                     requirements for individual animal                      must be stapled to the original and each              notified of the deficiency’’ after the
                                                     identification, the flock identification                copy of the ICVI;                                     words ‘‘2-year extension’’.
                                                     number may be recorded instead of the                      (3) Each copy of the document must
                                                                                                             identify each animal to be moved with                    The revision and addition read as
                                                     individual identification numbers, and                                                                        follows:
                                                     for animals allowed by § 79.3 to move                   the ICVI, but any information pertaining
                                                     with group lot identification, the group                to other animals, and any unused space                § 79.6 Standards for States to qualify as
                                                     lot number may be recorded instead of                   on the document for recording animal                  Consistent States.
                                                     the individual identification numbers.                  identification, must be crossed out in                   (a) * * *
                                                     An ICVI may not be issued for any                       ink; and
                                                                                                                (4) The following information must be                 (10) Has effectively implemented
                                                     animal that is not officially identified if                                                                   ongoing scrapie surveillance that meets
                                                     official identification is required. If the             written in ink in the identification
                                                                                                             column on the original and each copy                  the following criteria:
                                                     animals are not required by the                                                                                  (i) Collects and submits surveillance
                                                     regulations to be officially identified,                of the ICVI and must be circled or
                                                                                                             boxed, also in ink, so that no additional             samples from targeted animals
                                                     the ICVI must state the exemption that                                                                        slaughtered in State-inspected
                                                     applies (e.g., sheep and goats moving for               information can be added:
                                                                                                                (i) The name of the document; and                  establishments and from slaughter
                                                     grazing without change of ownership). If                   (ii) Either the unique serial number on            establishments within the State that are
                                                     the animals are required to be officially               the document or, if the document is not               not covered under § 71.21 of this
                                                     identified but the identification number                imprinted with a serial number, both                  subchapter, or allows and facilitates the
                                                     is not required to be recorded on the                   the name of the person who prepared                   collection of such samples by USDA
                                                     ICVI, the ICVI must state that all                      the document and the date the                         personnel or contractors; and
                                                     animals to be moved under the ICVI are                  document was signed.
                                                     officially identified and state the                                                                              (ii) Transmits required submission
                                                                                                                (c) Ownership brands documents                     and epidemiological information for all
                                                     exemption that applies (e.g., the ewes                  attached to ICVIs. As an alternative to
                                                     are identified with flock of origin tags so                                                                   scrapie samples using the electronic
                                                                                                             typing or writing ownership brands on                 submission system provided by APHIS
                                                     only the flock ID must be recorded on                   an ICVI, an official brand inspection
                                                     the ICVI);                                                                                                    for inclusion in the National Scrapie
                                                                                                             certificate may be used to provide this               Database and for transmission of the
                                                        (3) If any animals intended for                      information, but only under the
                                                     breeding have undergone an official                                                                           submission information to an approved
                                                                                                             following conditions:                                 laboratory; and
                                                     genotype test, the name of the testing                     (1) A legible copy of the official brand
                                                     laboratory, date the sample was taken,                  inspection certificate must be stapled to                (iii) Achieves the annual State-level
                                                     and result of the test; and                             the original and each copy of the ICVI;               scrapie surveillance minimums for
                                                        (4) A statement by the issuing                          (2) Each copy of the official brand                sheep and goats originating from the
                                                     accredited, State, or Federal veterinarian              inspection certificate must show the                  State as determined annually with input
                                                     to the effect that on the date of issuance              ownership brand of each animal to be                  from the States and made available to
                                                     the animals were free of evidence of                    moved with the ICVI, but any other                    the public at http://
                                                     infectious or contagious disease and                    ownership brands, and any unused                      www.aphis.usda.gov/animal-health/
                                                     insofar as can be determined exposure                   space for recording ownership brands,                 scrapie at least 6 months before the start
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                                                     thereto. This statement may be made                     must be crossed out in ink; and                       of the collection period; or
                                                     with respect to scrapie for animals                        (3) The following information must be                 (iv) Conducts annual surveillance at a
                                                     exposed to scrapie that’s movement is                   typed or written in ink in the official               level that will detect scrapie if it is
                                                     not restricted that have been designated                identification column on the original                 present at a prevalence of 0.1 percent in
                                                     genetically resistant or less susceptible               and each copy of the ICVI and must be                 the population of targeted animals
                                                     sheep or low-risk exposed animals.                      circled or boxed, also in ink, so that no             originating in the State, with a 95
                                                     Except as provided in paragraphs (b)                    additional information can be added:                  percent confidence.




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                                                     54692              Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Proposed Rules

                                                       (11) If a State does not meet the                     MONTHS AFTER EFFECTIVE DATE OF                          Done in Washington, DC, this 28th day of
                                                     requirements of paragraph (a)(10) of this               FINAL RULE] and must meet the                         August 2015.
                                                     section as of [EFFECTIVE DATE OF                        requirements of paragraph (a)(10) by                  Gary Woodward,
                                                     FINAL RULE], the State must provide                     [DATE 2 YEARS AFTER EFFECTIVE                         Deputy Under Secretary for Marketing and
                                                     APHIS with a plan and a timeline for                    DATE OF FINAL RULE].                                  Regulatory Programs.
                                                     complying with all the requirements of                                                                        [FR Doc. 2015–21909 Filed 9–9–15; 8:45 am]
                                                                                                             *    *    *     *    *
                                                     paragraph (a)(10) by [DATE 12                                                                                 BILLING CODE 3410–34–P
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Document Created: 2015-12-15 10:03:47
Document Modified: 2015-12-15 10:03:47
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule.
DatesWe will consider all comments that we receive on or before November 9, 2015.
ContactDr. 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.
FR Citation80 FR 54659 
RIN Number0579-AC92
CFR Citation9 CFR 54
9 CFR 79
CFR AssociatedAnimal Diseases; Goats; Indemnity Payments; Scrapie; Sheep; Quarantine and Transportation

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