[Federal Register: August 21, 2001 (Volume 66, Number 162)]
[Rules and Regulations]               
[Page 43963-44003]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21au01-20]                         

[[Page 43963]]

-----------------------------------------------------------------------

Part II

Department of Agriculture
-----------------------------------------------------------------------
Animal and Plant Health Inspection Service
-----------------------------------------------------------------------
9 CFR Parts 54 and 79

Scrapie in Sheep and Goats; Interstate Movement Restrictions and 
Indemnity Program; Final Rule

[[Page 43964]]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 54 and 79
[Docket No. 97-093-5]
RIN 0579-AA90

 
Scrapie in Sheep and Goats; Interstate Movement Restrictions and 
Indemnity Program

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: We are amending the regulations for the interstate movement of 
sheep and goats by requiring certain animal identification for sheep 
and goats moving interstate, by establishing a list of States that 
conduct an active State scrapie program that is consistent with Federal 
requirements, by establishing requirements for moving sheep and goats 
interstate from those States and from States that do not conduct such 
programs, by reinstituting an indemnity program for certain sheep and 
goats affected by scrapie, and by making other associated changes. 
These changes will help prevent the interstate spread of scrapie, an 
infectious disease of sheep and goats.

DATES: Effective Date: September 20, 2001. Compliance Dates: The 
compliance date for all requirements to identify animals that are not 
scrapie-positive animals, suspect animals, high-risk animals, exposed 
animals, or animals from an infected or source flock is November 19, 
2001. The compliance date for all requirements for the identification 
of commercial whitefaced breeding sheep under 18 months of age and 
commercial breeding goats is February 18, 2002.

FOR FURTHER INFORMATION CONTACT: Dr. Diane Sutton, Senior Staff 
Veterinarian, National Animal Health Programs Staff, 4700 River Road 
Unit 43, Riverdale, MD 20737-1235, (301) 734-6954.

SUPPLEMENTARY INFORMATION:

Background

    Scrapie is a degenerative and eventually fatal disease affecting 
the central nervous systems of sheep and goats. It is a member of a 
class of diseases called transmissible spongiform encephalopathies 
(TSE's). Its control is complicated because the disease has an 
extremely long incubation period without clinical signs of disease.
    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 part 79, which 
restrict the interstate movement of certain sheep and goats. APHIS also 
has regulations at 9 CFR part 54, which describe a voluntary scrapie 
free flock certification program.
    On November 30, 1999, we published in the Federal Register (64 FR 
66791-66812, Docket No. 97-093-2) a proposal (referred to below as the 
November 30 proposal) to amend 9 CFR parts 54 and 79. We proposed three 
significant areas of change:
     Further restrictions on the interstate movement of sheep 
and goats from States that do not consider scrapie a reportable disease 
or do not quarantine infected flocks or source flocks. We also proposed 
standards describing how a State must conduct a quarantine in order to 
avoid further restrictions on interstate movement of animals.
     Additional official identification requirements for sheep 
and goats moved interstate to allow for a more effective national 
program for surveillance for scrapie and traceback of scrapie-positive 
animals. The proposed identification requirements were similar to 
current requirements for cattle and swine.
    Reinstatement of a scrapie indemnification program for sheep and 
goats that owners agree to destroy. As proposed, the owners of 
destroyed high-risk animals and animals diagnosed as scrapie positive 
by an approved live-animal test would be eligible for indemnity 
payments.
    We solicited comments concerning our proposal for 30 days ending 
December 30, 1999. We reopened and extended the deadline for comments 
until January 14, 2000, in a document published in the Federal Register 
on January 7, 2000 (65 FR 1074, Docket No. 97-093-3). We received 171 
comments by that date. They were from State agriculture agencies, sheep 
and goat industry associations, sheep and goat producers, livestock 
auction and slaughter companies, and universities and researchers.
    After receiving comments on the November 30 proposal, we published 
another proposed rule in the Federal Register on August 15, 2000 (65 FR 
49770-49775, Docket No. 97-093-4, referred to below as the August 15 
proposal). We solicited comments concerning the August 15 proposal for 
30 days ending September 14, 2000. The August 15 proposal to amend 9 
CFR part 79 fulfilled a promise made in the November 30 proposal, which 
stated that before the November 30 proposal was finalized, APHIS would 
develop and publish for comment a list of States that conduct an active 
scrapie program that is consistent with Federal requirements and, 
therefore, qualify as Consistent States. The August 15 proposal listed 
all 50 States as Consistent States and also proposed certain changes to 
the criteria by which States may qualify to be designated as Consistent 
States.
    The comments received on both the November 30 proposal and the 
August 15 proposal, and the changes we are making in response to some 
of them, are discussed below by topic.

Definition of Certificate

    We are making certain changes to the process for issuing 
certificates for sheep and goats. These changes are discussed later in 
this document in the discussion of Sec. 79.5, ``Issuance of 
certificates.'' Because we are moving certain requirements from the 
definition of certificate in Secs. 54.1 and 79.1 to Sec. 79.5, we are 
also changing the definition of certificate to read, ``An official 
document issued in accordance with Sec. 79.5 of this chapter by an 
APHIS representative, State representative, or accredited veterinarian 
at the point of origin of an interstate movement of animals.''

Definitions of Exposed Animal and Exposed Flock

    In the November 30 proposal, we tried to define the term exposed 
animal in a manner that would include all animals that were exposed to 
conditions that might result in the animal becoming infected with 
scrapie. We defined exposed animal in Secs. 54.1 and 79.1 as ``Any 
animal that has been in the same flock at the same time within the 
previous 60 months as a scrapie-positive animal, excluding limited 
contacts. Any animal born in a flock after a scrapie-positive animal 
was born into that flock, if born before that flock completes the 
requirements of a flock plan.'' Our proposed definition of flock 
included ``All animals that are maintained on a single premises and all 
animals under common ownership or supervision on two or more premises 
with animal interchange between the premises.''
    Several commenters were concerned over the effect of these 
definitions on shows and sales and asked whether all animals that 
attended a show or sale where a scrapie-positive animal was in 
attendance would be considered exposed animals, regardless of their 
degree of contact with the scrapie-positive animal. That was not our 
intention, and we have modified the definition of exposed animal to 
include animals that have exposure to scrapie while at shows or sales 
without

[[Page 43965]]

classifying all animals at a show or sale as exposed animals. We have 
done this by adding to the definition of exposed animal specific means 
of exposure that could cause a sheep or goat to contract scrapie and by 
revising the definition of flock to specifically exclude animals at 
shows and sales. These changes were based on research into the means of 
scrapie transmission and our knowledge of the manner in which sheep and 
goats are marketed and shown. We added the following language to the 
definition of exposed animal: ``Any animal that was commingled with a 
scrapie-positive female animal during or up to 30 days after she 
lambed, kidded, or aborted, or while a visible vaginal discharge was 
present, or that was commingled with any other scrapie-positive female 
animal for 24 hours or more, including during activities such as shows 
and sales or while in marketing channels.''
    Commenters also suggested that we review the scientific basis for 
the timeframe requirements in the proposal. We reviewed the assumption 
that there is a particular timeframe, during which an animal might 
transmit scrapie, between the time it becomes infected and the time it 
dies from the disease or shows obvious symptoms and is destroyed. One 
of the places the proposal used this assumption is the proposed 
definition of exposed animal, which counted exposure if it occurred 
``within the previous 60 months.''
    We have reviewed research on this matter. One of the sources relied 
on for the proposal was Mission Field Trial data. The study monitored 
653 sheep and goats that were exposed to the scrapie agent at birth, 
and 145 sheep and goats that were exposed post-weaning. Results showed 
that 91 percent of the sheep exposed at birth that died of scrapie died 
before the age of 54 months and 98 percent died at 67 months or less. 
For sheep exposed post-weaning 100 percent of those that died of 
scrapie died at an age of 73 months or more. These data suggest that 
animals diagnosed with scrapie at an age of 72 months or less were 
probably exposed at birth, which suggests that their flock of birth 
should be designated a source flock. Upon reexamining these findings we 
believe that the assumption that an infected animal has an effective 
timeframe for developing signs of scrapie for only 60 months, as 
implied by the proposed definition of exposed animal, is too 
conservative, since infected sheep might survive longer than this, 
particularly if the animals are exposed post-weaning. The results of 
the Mission Field Trial suggest that this timeframe should be removed. 
Therefore, we have removed this timeframe in the definition of exposed 
animal. As discussed below, we have changed a similar timeframe in the 
definition of source flock from 54 months to 72 months to be consistent 
with the data for animals exposed at birth.
    Other commenters noted that the November 30 proposal discussed 
actions that were required for flocks exposed to scrapie, particularly 
with regard to post-exposure management and monitoring plans, but did 
not define exposed flock. We agree that such a definition would be 
useful and have added the following definition of exposed flock to 
Secs. 54.1 and 79.1: ``Any flock in which a scrapie-positive animal was 
born or lambed. Any flock that currently contains a female high-risk, 
exposed, or suspect animal, or that once contained a female high-risk, 
exposed, or suspect animal that lambed in the flock and from which 
tissues were not submitted for official testing and found negative. A 
flock that has completed a post-exposure management and monitoring plan 
following the exposure will no longer be classified as an exposed 
flock.''

Definition of Flock

    Comments on the definition of flock in Secs. 54.1 and 79.1 noted 
that the proposed definition could be interpreted to consider separate 
groups of animals to be a single flock when they are temporarily placed 
on the same premises, even when this does not involve close contact or 
a significant risk of spreading scrapie. These commenters suggested the 
definition be revised to note that animals maintained temporarily on a 
premises for activities such as shows and sales or while in marketing 
channels are not a flock. We agree, and have made the requested change.
    One commenter also indicated the definition of flock is overly 
restrictive in addressing when groups of animals on the same premises 
can be considered separate flocks. We agree that separate flocks can be 
kept in close proximity without risk of spreading scrapie if there is a 
physical barrier between the flocks. We are, therefore, adding the 
phrase ``or are separated by a solid wall through, over, or under which 
fluids cannot pass and through which contact cannot occur'' to this 
part of the definition.

Definition of Flock of Origin

    Several commenters noted that the term flock of origin was used in 
the November 30 proposal without being defined. For scrapie control 
purposes, the important consideration for determining the flock of 
origin is to identify the flock(s) that are likely to harbor or spread 
scrapie as a result of an infected animal ``originating'' in the flock. 
In this sense, an infected animal originated in any flock where the 
animal gave birth, was bred, or was born. For clarity, we are adding a 
definition of flock of origin to Secs. 54.1 and 79.1, to read as 
follows: ``The flock in which an animal most recently resided in which 
it either was born, gave birth, or was used for breeding purposes. The 
determination of an animal's flock of origin may be based either on the 
physical presence of the animal in the flock, the presence of official 
identification on the animal traceable to the flock, the presence of 
other identification on the animal that is listed on the bill of sale, 
or other evidence, such as registry records.''

Definition of Infected Flock

    Several commenters stated that, in addition to designating as 
infected flocks the flocks of origin of scrapie-positive female 
animals, we should consider as infected any flock in which a scrapie-
positive ewe lambed. We agree, and have changed the definition of 
infected flock in Secs. 54.1 and 79.1 accordingly. The definition of 
infected flock has been changed to read: ``The flock of origin of a 
female animal that a State or APHIS representative has determined to be 
a scrapie-positive animal; or any flock in which a State or APHIS 
representative has determined that a scrapie-positive female animal has 
resided, unless an epidemiologic investigation conducted by a State or 
APHIS representative shows that the animal did not lamb in the flock. A 
flock will no longer be considered an infected flock after it has 
completed the requirements of a flock plan.''

Definition of Limited Contacts

    One commenter suggested that the proposed definition of limited 
contacts in Secs. 54.1 and 79.1, intended to define contacts that do 
not present a significant risk of spreading scrapie, was overly strict 
and would unnecessarily restrict the way in which animals are shown and 
transported. The proposed definition stated that a contact was not 
limited if it occurred within 60 days after lambing or kidding. We have 
reduced this exclusion to 30 days, since tissues and fluids associated 
with lambing are unlikely to be prevalent beyond this 30-day period. 
However, we have also added that the contact is not limited if it is 
with an animal that has aborted within the past 30 days or that had a 
vaginal discharge at the time of the contact, since infectious 
materials from abortions or discharges may

[[Page 43966]]

contaminate nearby animals. We are changing the text to read ``Limited 
contacts do not include any contact, incidental or otherwise, with a 
female animal during or up to 30 days after she lambed, kidded, or 
aborted or when there is any visible vaginal discharge at the time of 
the contact.'' Readers interested in this issue should also note that 
the changes in the definitions of flock and exposed animal reduce the 
effect of the limited contacts definition on the transport and showing 
of animals.
    Some commenters stated that they were confused by the language in 
the definition of limited contacts that said contact was not limited if 
it involved ``uninhibited contact while sharing a section of a 
transport vehicle, or transportation to other flocks for breeding.'' 
The first restriction on sharing a section of a transport vehicle 
appears to make the second restriction redundant. For clarity, we have 
changed the second restriction to ``residing in other flocks for 
breeding or other purposes.''

Definition of Official Eartag

    Several comments indicated confusion regarding the relationship of 
the terms official eartag and premises identification and questioned 
whether the proposal was consistent with existing national 
identification standards. We agree that the discussion in the proposal 
was unclear, and we are clarifying that the National Uniform Eartagging 
system or a combination of premises and individual animal 
identification numbers may be used. We have added a definition of 
official eartag to Sec. 79.1 that reads ``An identification eartag 
approved by APHIS as being sufficiently tamper-resistant for the 
intended use and providing unique identification for each animal. An 
official eartag may conform to the alphanumeric National Uniform 
Eartagging system or another system approved by APHIS, or it may bear a 
premises identification number that either contains or is used in 
conjunction with the producer's livestock production numbering system 
to provide a unique identification number.''

Definition of Official Identification

    We used the term official identification in the proposed rule, but 
commenters noted that it was undefined. We are adding a definition of 
official identification to Sec. 79.1 for clarity. The definition reads 
as follows: ``Identification mark or device approved by APHIS for use 
in the Scrapie Eradication Program. Examples are listed in 
Sec. 79.2(a)(2).''

Definition of Premises Identification

    One commenter requested that ear notches that are officially 
registered be allowed in addition to brands, and another suggested that 
temporary paint brands (where owners of animals that will be 
temporarily commingled each mark their own animals with a strips of a 
particular paint color, to facilitate later separation of the animals) 
were adequate premises identification for animals that move without 
changing ownership. We agree and are revising the proposed definition 
of premises identification in Sec. 79.1 to allow for the use of ear 
notches. We are changing the definition to read, ``An APHIS approved 
eartag, backtag, or legible tattoo bearing the premises identification 
number, consisting of the State postal abbreviation or code followed by 
a unique alphanumeric number or name, assigned by a State or Federal 
animal health official to the premises of the flock of origin for the 
sheep or goats that, in the judgment of the State animal health 
official or area veterinarian in charge, is epidemiologically distinct 
from other premises, or a permanent legible brand or ear notch pattern 
registered with an official brand registry. Premises identification may 
be used when official individual animal identification is required, if 
the premises identification method either includes a unique animal 
number or is used in conjunction with the producer's livestock 
production numbering system to provide a unique identification number 
and where, if brands or ear notches are used, the animals are 
accompanied by an official brand inspection certificate. Clearly 
visible and/or legible paint brands may be used on animals moving 
directly to slaughter and on animals moving for grazing or other 
management purposes without change in ownership.''

Definition of Separate Contemporary Lambing Groups

    Several commenters suggested that we review other APHIS animal 
disease eradication programs to improve implementation of the scrapie 
program. This review showed that cleaning and disinfection for other 
disease programs are carried out under supervision. We agree that 
supervision is necessary, and have changed the definition of separate 
contemporary lambing groups in Secs. 54.1 and 79.1 accordingly, to 
require supervision of cleaning and disinfection by an APHIS or State 
representative or an accredited veterinarian, and to require records 
documenting animal grouping and documenting cleaning and disinfection.
    We have also clarified the proposed definition, which stated that 
guidelines for cleaning and disinfection could be found in the Scrapie 
Flock Certification Program standards. We have moved requirements for 
cleaning and disinfection from the Scrapie Flock Certification Program 
standards into Sec. 54.7(e) of the regulations. Guidelines and examples 
regarding how to apply these requirements may now be found in both the 
Scrapie Flock Certification Program standards and the Scrapie 
Eradication Uniform Methods and Rules.

Definition of Source Flock

    Several commenters suggested that the definition of source flock in 
Secs. 54.1 and 79.1 should be qualified by stating how the 
determination that an animal was born in a flock should be made. We 
agree and have changed the definition to state that the determination 
that an animal was born in a flock will be based on such information as 
the presence of official identification on the animal traceable to the 
flock, the presence of other identification on the animal that is 
listed on the bill of sale, or other evidence, such as registry 
records, to show that a scrapie-positive animal originated from the 
flock, combined with the absence of any records indicating that the 
animal was purchased from outside and added to the flock.
    One commenter recommended that only official identification be 
accepted for tracebacks. We disagree, because there are often cases 
where registry records or bills of sale are adequate for positive 
identification of an animal, and sometimes these documents are 
available when official identification is not. Commenters also 
suggested that DNA comparison be used for positive identification of 
traced animals. We agree that an owner should be allowed to request 
verification of a traced animal's identity through DNA comparison, at 
the owner's expense, when the conditions exist to make such 
verification possible and reliable. These conditions exist in those 
cases where DNA has been archived at an approved genotyping laboratory, 
or if DNA collection and storage are required for breed registration 
and the breed registration has appropriate safeguards in place to 
ensure the integrity of the banking process, and when adequate records 
and identification have been maintained by the owner and the 
repository. We have changed the definition of source flock accordingly.

[[Page 43967]]

    As discussed above regarding the definition of exposed animal, 
commenters suggested we reexamine the scientific basis of the 
timeframes in the proposed rule. The proposal assumed that animals 
exposed at birth would die by the age of 54 months. We reexamined the 
data and concluded that it shows that while almost all animals that 
contract scrapie at birth die at an age of 72 months or less, animals 
that contract scrapie post-weaning do not die from it until at least 
the age of 73 months. Weaning normally occurs 80-90 days after birth. 
Therefore, if an animal is diagnosed with scrapie at an age of 73 
months or more, it did not contract scrapie at birth, and its flock of 
birth should not be considered a source flock based on the diagnosis. 
Therefore, we have amended the definition of source flock to state that 
it includes flocks where at least one animal was born that was 
diagnosed as a scrapie-positive animal at an age of 72 months or less.
    As amended according to the comments discussed above, the 
definition of source flock in this final rule now reads as follows: ``A 
flock in which a State or APHIS representative has determined that at 
least one animal was born that was diagnosed as a scrapie-positive 
animal at an age of 72 months or less. The determination that an animal 
was born in a flock will be based on such information as the presence 
of official identification on the animal traceable to the flock, the 
presence of other identification on the animal that is listed on the 
bill of sale, or other evidence, such as registry records, to show that 
a scrapie-positive animal was born in the flock. If DNA from the animal 
was previously collected by an accredited veterinarian and stored at an 
approved genotyping laboratory, or if DNA collection and storage are 
required for breed registration and the breed registration has 
appropriate safeguards in place to ensure the integrity of the banking 
process, the owner may request verification of the animal's identity 
based on DNA comparison if adequate records and identification have 
been maintained by the owner and the repository to show that the 
archived DNA is that of the animal that has been traced to the flock. 
The owner will be responsible for all costs for the DNA comparison. A 
flock will no longer be a source flock after it has completed the 
requirements of a flock plan.''

Definition of High-Risk Animal

    Commenters suggested two specific changes to the definition of 
high-risk animal. The first suggestion was that only sexually intact 
animals should be considered high-risk, since other animals are 
extremely unlikely to spread scrapie. The second suggestion was that an 
animal born into the same flock in which a scrapie-positive animal was 
born should not be considered high-risk if the animal was born after 
the flock completes the requirements of a flock plan, designed to 
remove the risk of spreading scrapie.
    We agree, and have added language to the definition of high-risk 
animal in Secs. 54.1 and 79.1 to accomplish these changes. We have also 
made changes to this definition in response to comments suggesting that 
the regulations incorporate the most recent scientific research on 
animal genetics and resistance to scrapie, discussed below. As revised, 
the definition of high-risk animal reads as follows: ``A sexually 
intact animal, excluding male sheep that have tested RR at codon 171 
and AA at codon 136 using an official genotype test, that is:
    (1) The progeny of a scrapie-positive dam; or
    (2) Born in the same flock during the same lambing season as 
progeny of a scrapie-positive dam, unless the progeny of the scrapie-
positive dam are from separate contemporary lambing groups; or
    (3) Born in the same flock during the same lambing season that a 
scrapie-positive animal was born, or during any subsequent lambing 
season, if born before that flock completes the requirements of a flock 
plan; or
    (4) An exposed female sheep that has not tested QR, HR, or RR at 
codon 171 using an official genotype test.''

Definition of Suspect Animal

    Some commenters indicated that the movement restrictions in 
proposed Sec. 79.3 were overly complex. In response, we have combined 
the categories of suspect animal and affected animal into one category. 
We have done this by adding the following to the definition of suspect 
animal in Secs. 54.1 and 79.1: ``A sheep or goat that has tested 
positive for scrapie or for the proteinase resistant protein associated 
with scrapie on a live-animal screening test or any other test is a 
suspect animal, unless it is designated a scrapie-positive animal.'' 
This removes the need to use the term affected animal, which 
essentially applied to animals that tested positive to a live-animal 
screening test. In the November 30 proposal, the same movement 
restrictions applied to suspect animals and affected animals, so this 
change will not alter movement restrictions. This change reduces the 
complexity of the rule and removes the need for States to change their 
regulations to separately address affected animals. It also closes a 
loophole that would have allowed sheep and goat owners to use 
unofficial tests without any risk that positive results would result in 
restrictions on the movement of the animals. Under the new definition, 
animals that test positive to unofficial tests would be designated 
suspect animals. This designation may be removed in accordance with 
Sec. 79.4.

New Definitions of Commercial Sheep or Goat, Low-Risk Goat, and Low-
Risk Commercial Sheep

    Several commenters suggested that lesser interstate movement 
restrictions were appropriate for animals that are raised primarily for 
production and that are of a breed type or cross that has a low 
prevalence of scrapie. These commenters suggested that whitefaced 
animals from commercial flocks in States where scrapie has not been 
reported in whitefaced animals do not represent a substantial scrapie 
risk.
    We agree, and have added two new definitions to Sec. 79.1 that are 
used in the chart of interstate movement restrictions in Sec. 79.3, 
commercial sheep or goat and blackfaced sheep. A commercial sheep or 
goat is any animal from a flock from which animals are moved only 
either directly to slaughter or through slaughter channels to slaughter 
or any animal that is raised only for meat or fiber production and that 
is not registered with a sheep or goat registry or used for exhibition. 
A blackfaced sheep is any purebred suffolk, hampshire, shropshire or 
cross thereof, any non-purebred sheep known to have suffolk, hampshire, 
or shropshire ancestors, and any non-purebred sheep of unknown ancestry 
with a black face, except commercial hair sheep. We are defining 
blackfaced sheep in the regulations, rather than whitefaced sheep and 
whitefaced crossbreeds, because blackfaced sheep are the higher risk 
category and defining this term makes it easier to address risk in the 
requirements and exemptions contained in the regulations.
    Several commenters suggested that we should simplify the chart of 
interstate movement restrictions in Sec. 79.3 and provide lesser 
restrictions for certain low-risk goats and commercial sheep. We agree, 
and have done so by adding definitions of low-risk goat and low-risk 
commercial sheep and then referring to those defined terms in the 
chart. We are defining low-risk goat in Sec. 79.1 as a goat that is not 
a scrapie-positive, suspect, high-risk, or exposed animal, that has not 
been commingled with sheep, and

[[Page 43968]]

that meets certain other requirements that indicate the goat has a low 
risk of spreading scrapie. These other requirements are that the goat 
must be from:
    (1) A State in which scrapie has not been identified in a goat 
during the previous 10 years;
    (2) A State in which scrapie has been identified in a goat during 
the previous 10 years, but the scrapie-positive goat was not born in 
the State and resided in the State for less than 72 months and did not 
kid while in the State; or,
    (3) A State in which scrapie has been identified in a goat during 
the previous 10 years, and the scrapie-positive goat was commingled 
with sheep, but flock records allowed a complete epidemiologic 
investigation to be completed and all resulting infected, source, and 
exposed goat herds have completed flock plans and are in compliance 
with post-exposure monitoring plans.
    Similarly, we are defining low-risk commercial sheep in Sec. 79.1 
in a manner that excludes blackfaced sheep, animals that are known to 
be at risk of having scrapie or having been exposed to scrapie, and 
animals that are not sufficiently identified to determine their flock 
of origin. We define low-risk commercial sheep as ``Commercial 
whitefaced, whitefaced cross, or commercial hair sheep from a flock 
with no known risk factors for scrapie, including any exposure to 
female blackfaced sheep, that are identified with a permanent brand or 
earnotch pattern registered with an official brand registry and that 
are not scrapie-positive, suspect, high-risk, or exposed animals and 
are not animals from an infected, source, or exposed flock. The term 
brand includes official brand registry brands on eartags in those 
States whose brand law or regulation recognizes brands placed on 
eartags as official brands. Low-risk commercial sheep may only exist in 
a State where scrapie has not been diagnosed in the previous 10 years 
in commercial whitefaced, whitefaced cross, or commercial hair sheep 
that were not commingled with female blackfaced sheep.''

Additional New Definitions

    We are also adding new definitions for the following terms: 
commercial hair sheep, ownership brand, official test, official 
genotype test, approved laboratory, unofficial test, direct movement to 
slaughter, and flock sire.
    In order to properly separate risk categories it is necessary to 
make distinctions between hair sheep and other types of sheep, making 
it necessary to define commercial hair sheep. We are adding a 
definition of commercial hair sheep to Sec. 79.1 to read ``Any 
commercial sheep with hair rather than wool that is either a full-
blooded hair sheep or that resulted from the cross of a hair sheep with 
a whitefaced wool sheep.''
    In the proposal ownership brands were not defined. We have added a 
definition of ownership brand to Sec. 79.1, using the definition 
commonly accepted in livestock industries: ``A unique permanent brand 
or earnotch pattern applied to an animal that indicates ownership by a 
particular person when the brand pattern is registered with a State's 
official brand recording agency.''
    Several commenters recommended that there be greater flexibility in 
the handling of infected and source flocks. We agree. In order to 
organize changes to provide greater flexibility it is necessary to 
define a term that includes all approved tests and that indicates where 
such tests must be conducted in order to be used for this purpose. We 
are adding the following definition of official test to Secs. 54.1 and 
79.1: ``Any test for the diagnosis of scrapie in a live or dead animal 
that is approved by the Administrator for that use and conducted either 
at an approved laboratory or at the National Veterinary Services 
Laboratories.'' Commenters also stated that if the rule distinguishes 
the risk level of animals based on their genotype, it should define a 
means for approving acceptable methods of genotype testing. We agree, 
and are adding the following definition of official genotype test to 
Secs. 54.1 and 79.1: ``Any test to determine the genotype of a live or 
dead animal that is conducted at either an approved laboratory or at 
the National Veterinary Services Laboratories, when the animal is 
officially identified and the samples used for the test are collected 
and shipped to the laboratory by either an accredited veterinarian or a 
State or APHIS representative.'' We are also adding a complementary 
definition of approved laboratory to Secs. 54.1 and 79.1: ``A 
laboratory approved by the Administrator in accordance with Sec. 54.11 
to conduct one or more scrapie tests, or genotype tests, on one or more 
tissues.''
    To clearly distinguish official tests from other tests that owners 
may conduct for their own purposes, we are also adding the following 
definition of unofficial test to Secs. 54.1 and 79.1: ``Any test for 
the diagnosis of scrapie or for the detection of the proteinase 
resistant protein associated with scrapie in a live or dead animal that 
either has not been approved by the Administrator or that was not 
conducted at an approved laboratory or at the National Veterinary 
Services Laboratories.''
    One commenter stated that, in some circumstances, the proposal 
would require that animals be moved directly to slaughter, but did not 
define what this means. We agree that clarification would be useful, 
and we have added to Sec. 79.1 a definition of direct movement to 
slaughter that reads ``Transported to a facility for slaughter, without 
stops or unloading except for feeding and watering during which the 
animals are not commingled with any other animals.''
    We are also adding to Sec. 54.1 the following definition of flock 
sire, a type of animal that is eligible for a premium indemnity under 
the rule: ``A sexually intact male animal that has ever been used for 
breeding in a flock.''

Destruction by Slaughter of High-Risk, Exposed, and Scrapie-Positive 
Animals

    Several commenters indicated that high-risk and exposed animals and 
animals that test positive to a live-animal screening test should be 
permitted to move to slaughter because there is no known human health 
risk from scrapie and Food and Drug Administration ((FDA) regulations 
provide adequate protection against inclusion of the scrapie agent in 
ruminant feed. These commenters argued that sending these animals to 
slaughter is usually more economical and less difficult than arranging 
other means of disposal.
    We agree that there is no evidence that scrapie is a human health 
risk and significant evidence that it is not a human health risk. The 
World Health Organization recommendation calls for the exclusion of 
small ruminants showing signs of a TSE from slaughter to address a 
theoretical risk. In keeping with this recommendation small ruminants 
with clinical evidence of central nervous system disease are condemned 
by the Food Safety Inspection Service (FSIS) on ante-mortem inspection. 
Excluding test-positive animals goes one step farther to exclude the 
scrapie agent from the food and feed chains. We believe that excluding 
from slaughter animals that test positive to a live-animal test is 
warranted to maintain consumer confidence and minimize the risk of the 
scrapie agent entering the human and animal food chains.
    We agree with the commenters that most scrapie-exposed and high-
risk animals do not, in fact, contain the scrapie agent. Under the 
proposed rule, high-risk animals would be indemnified but prohibited 
from going to slaughter

[[Page 43969]]

while scrapie-exposed animals would not be indemnified and could be 
slaughtered. Since both types of animals share the same, low risk of 
spreading scrapie, we have now decided that it is not consistent to 
keep one set of these animals from slaughter but allow the other set to 
go to slaughter. Also, owners of non-indemnified scrapie-exposed and 
high-risk animals can recoup much of the animals' economic value by 
sending the animals to slaughter, although such animals usually fetch a 
discounted price from slaughter plants. Keeping these animals from 
slaughter would also present additional environmental problems related 
to finding enough landfills and incinerator capacity to deal with the 
large number of exposed and high-risk animals. Therefore, we are 
changing the definition of destroyed in Sec. 54.1 to allow indemnified 
high-risk animals to move to slaughter; however, we continue to 
prohibit movement to slaughter of animals that test positive to a live-
animal test in order to minimize the amount of scrapie agent in the 
food chain, since these animals are known to contain PrP-sc, which has 
been linked to the presence of the scrapie agent. We are also making 
corresponding changes in Sec. 54.7, ``Procedures for destruction of 
animals,'' to allow indemnified animals (except for scrapie-positive or 
suspect animals) to move to slaughter, or to a quarantined research 
facility or another location for destruction, if the movement is 
approved by APHIS. Note that this change does not affect the FDA 
regulations that continue to prohibit the inclusion of animal protein 
derived from mammalian tissues in ruminant feed.
    We are also amending the definition of destroyed to include 
movement to a quarantined research facility when such movement is 
authorized by the Administrator. The scrapie program has always 
authorized some animals that would otherwise have to be euthanized to 
be moved for research purposes, and this change to the definition 
acknowledges that such movements satisfy the regulatory requirement to 
destroy an animal.

Cooperative Agreements and Memoranda of Understanding With States

    The November 30 proposal did not propose regulatory requirements 
for cooperative agreements and memoranda of understanding, but it did 
solicit comments on whether it would be desirable to require States to 
sign a compliance agreement with APHIS describing State scrapie program 
operations, cooperative activities with APHIS, and planning and 
financing details for these activities. Several commenters suggested 
that the final rule should contain a section authorizing and describing 
such agreements. We agree, and have added a new Sec. 54.2 describing 
cooperative agreements and memoranda of understanding for activities 
under both the Scrapie Eradication Program and the Scrapie Flock 
Certification Program. Based on suggestions from commenters, this 
section states that such agreements will describe the respective roles 
of APHIS and State personnel in implementing the Scrapie Eradication 
Program and the Scrapie Flock Certification Program. Each agreement may 
specify the financial, material, and personnel resources to be 
committed to these programs and other scrapie control measures by APHIS 
and the State and assign specific activities related to the control of 
scrapie within a State to APHIS or State personnel. The agreements may 
also establish schedules for APHIS representatives or State 
representatives to visit flocks, establish procedures for maintaining 
and sharing program records, and specify other responsibilities of 
State representatives and APHIS representatives in support of the 
Scrapie Eradication Program and the Scrapie Flock Certification 
Program.

Indemnity Values and Application for Indemnity

    Numerous commenters indicated that the indemnity value set for 
sheep was too low and should be based on market value. The indemnity 
payments proposed were $150 for registered animals and $50 for other 
animals and were significantly lower than the average national sale 
price of sheep. After evaluating comments on this issue, we agree that 
an indemnity that approximates fair market value would increase 
compliance and assist scrapie control. We have considered several 
methods for establishing market value and have decided to rely, as 
other indemnity programs have done, on the average sale price 
information published by the U.S. Department of Agriculture's 
Agricultural Marketing Service (AMS). The indemnity value will be set 
weekly by APHIS based on the ewe and lamb market prices reported by AMS 
and will be posted on the APHIS scrapie web page. We are field testing 
this market based method by using it to purchase animals for diagnostic 
purposes.
    Specifically, we are changing Sec. 54.6, which sets the amounts of 
indemnity payments, to state that indemnity for sheep will be set based 
on the following AMS price reports: The weekly weighted average Choice/
Prime slaughter lamb prices at Greeley, CO; the weekly weighted average 
Utility slaughter ewe prices at San Angelo, TX; the monthly weighted 
average commercial western ewe lamb replacement price per head; the 
monthly weighted average commercial western yearling ewe replacement 
price per head; the monthly weighted average commercial western running 
age ewe price per head; and the monthly weighted average commercial 
western aged ewe price per head.. If pricing information is unavailable 
from these markets during a given week or month, or if the numbers sold 
are too low to give an accurate market value, the preceding week or 
month's value will be used. The AMS reports from the most recent week 
or month prior to the date APHIS first offers to pay an owner indemnity 
shall be used to calculate the indemnity for that owner's sheep.
    In contrast to indemnities for sheep, indemnities for goats will be 
calculated based directly on the value of the goat as indicated by the 
producer's purchase records and sales records for the preceding 12 to 
24 months, not to exceed the maximum indemnity allowed for sheep. We 
are not establishing a complicated, market price-based formula for 
calculating indemnities for goats because based on program experience 
there will be extremely few goats eligible for indemnity. Program 
experience also suggests that sales and purchase records of goats are a 
good guide to the fair market value of goats, and it will be cost-
effective to calculate the indemnity individually in each case from 
these records.
    The amount of indemnities for sheep will be calculated as follows: 
For sheep under 1 year of age, the indemnity will equal the weekly 
weighted average Choice/Prime slaughter lamb price per pound times 50 
lbs, or times the actual weight, whichever is more. (The default weight 
of 50 lbs was selected to fairly compensate owners whose sheep were 
identified as eligible for indemnity while very young, before they 
achieved significant weight gain.) However, for ewe lambs under 1 year 
of age, the indemnity will equal the monthly weighted average 
commercial western ewe lamb replacement price per head, if this price 
is higher, since ewe lambs might have a greater potential value as 
breeding animals. For sexually intact sheep 8 years of age or older and 
castrated animals 1 year of age or older, the basic indemnity shall 
equal the weekly weighted average Utility slaughter ewe price per pound 
times 150, based on an average weight of 150 lbs. For mature sexually 
intact sheep at

[[Page 43970]]

least 1 year of age and under 2 years of age, the indemnity will equal 
the greater of the monthly weighted average commercial western yearling 
ewe replacement price per head, or the weekly weighted average Utility 
slaughter ewe price per pound times 150, based on an average weight of 
150 lbs. For mature sexually intact sheep at least 2 years of age and 
under 6 years of age, the basic indemnity will equal the greater of the 
monthly weighted average commercial western running age ewe price per 
head, or the weekly weighted average Utility slaughter ewe price per 
pound times 150, based on an average weight of 150 lbs. For mature 
sexually intact sheep at least 6 years of age and under 8 years of age, 
the basic indemnity will equal the greater of the monthly weighted 
average commercial western aged ewe price per head, or the weekly 
weighted average weekly Utility slaughter ewe price per pound times 
150, based on an average weight of 150 lbs. 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. This assumed age distribution reflects the 
fact that animals tend to die or be culled as they get older. Most ewes 
in commercial flocks are eliminated between 6 to 8 years of age.
    As many commenters requested, we will increase the indemnity 
amounts for registered animals to partially compensate owners for the 
greater value of these animals. We will add a premium to the basic 
indemnity for each registered animal equal to $100 for each registered 
animal under 1 year of age, $200 for each registered animal at least 1 
year of age and under 4 years of age, and $100 for each registered 
animal at least 4 years of age and under 8 years of age. In addition to 
this, we will add a premium of $50 to the indemnity for each flock 
sire. Also, any animal that is not registered at the time indemnity is 
first offered, but is eligible to be registered, will receive the 
registered animal premium reduced by $50. The owner must provide 
adequate records to qualify for these premiums.
    As a result of the change in the definition of destroyed to allow 
high-risk animals eligible for indemnity to be destroyed by slaughter, 
it was necessary to address the effect of moneys received from 
slaughter plants on the amount of indemnity received by owners of 
animals disposed of by being sent to slaughter. We are changing 
Sec. 54.6 to provide that, for animals destroyed by slaughter, the 
owner will retain the salvage value (the amount paid by a slaughter 
plant for the animal) of animals. If the salvage value, less shipping 
costs, is less than the slaughter price used to calculate indemnity, 
APHIS will pay the owner the difference. APHIS will also indemnify the 
owner in the amount of any productivity, registered animal, or flock 
sire premiums for which the animal qualifies.
    We anticipate that owners will wish to have recourse if they 
believe that the average weights used to calculate indemnities do not 
fairly represent the weights of animals in their flock. We have revised 
Sec. 54.6 to allow an owner who disagrees with the average weight 
estimate to have the sheep weighed at a public scale at his own expense 
(the usual average weighing fee is less than $1 per animal, though 
there will be additional expense if the owner must transport them to be 
weighed). In such a case, the owner will be paid based on the actual 
weight times the AMS weekly average price.
    We have also clarified that indemnity will be paid to an owner only 
for animals actually in a flock at the time indemnity is first offered. 
Animals removed from the flock as part of a post-exposure management 
and monitoring plan will be paid indemnity based on the AMS average 
prices at the time an APHIS representative designates the animals for 
removal.
    We received several comments concerning Sec. 54.4, the section 
describing how to submit an application for indemnity. One comment 
noted that the proposal stated that normally a State or APHIS 
representative would initiate the application for a flock that is 
already under a State quarantine. This comment stated that some States 
do not actually call the movement restrictions they place on flocks a 
``quarantine,'' and the regulations should not use this term here to 
avoid confusion. We agree, and have changed ``State quarantine'' to 
``State movement restrictions.'' In such cases, the flock owner will 
confirm information about the flock's eligibility for indemnity that is 
contained in the application submitted by the APHIS or State 
representative. Another comment noted that under the proposal, flock 
owners could choose to apply directly for indemnity, rather than having 
a State or APHIS representative make the application, in all cases, 
except for flocks that were under State quarantines (movement 
restrictions). The commenter did not see the purpose of excluding 
flocks under State movement restrictions from applying directly for 
indemnity. Neither do we, and we have removed this restriction.
    Another commenter noted that proposed Sec. 54.4(a)(5) required 
registration papers for any registered animals in a flock to accompany 
the application for indemnity. This commenter stated that the language 
did not make it clear that owners may apply for indemnity for 
unregistered animals without registration papers. To clarify this, we 
have added the phrase ``registration papers are not required for the 
payment of indemnity for animals that are not registered'' to this 
paragraph.

Certification by Owners Receiving Indemnity

    Proposed Sec. 54.5 required owners receiving indemnity to sign an 
agreement with APHIS certifying that the owner would cooperate with 
certain conditions. One of these conditions was to allow an APHIS 
representative, upon request, to review bills of sale and other records 
of the flock. One commenter suggested that this agreement should also 
allow State representatives to review these records. We agree, and have 
made that change.
    The proposed agreement would also require flock owners that 
maintain a flock after receiving indemnity to maintain that flock under 
a post-exposure management and monitoring plan. One commenter suggested 
that the agreement should specify how long the flock would have to be 
subject to the post-exposure management and monitoring plan. We agree, 
and have added ``for 5 years'' to this requirement. Five years of 
monitoring is consistent with normal epidemiological practice and 
guidance in the Scrapie Flock Certification Program standards.
    We have also added to the agreement, based on another comment, that 
the owner must allow any animal for which indemnity is paid to be 
removed to a U.S. Department of Agriculture facility or a quarantined 
research facility, slaughtered, or euthanized and necropsied and 
tissues removed for diagnostic or other purposes. This change will 
ensure that APHIS has access to animals when they are needed

[[Page 43971]]

for testing to further our knowledge of scrapie transmission patterns.

Identification of Sheep and Goats in Interstate Commerce

    Several commenters suggested changes to proposed Sec. 79.2(a)(1), 
which specified where and when identification should be attached to 
animals that must be identified under the regulations. The proposal 
stated that animals must be identified at whichever of the following 
occurs first: The point of first commingling of the sheep or goats in 
interstate commerce with sheep or goats from any other source; upon 
unloading of the sheep or goats in interstate commerce at any livestock 
market; upon transfer of ownership of the sheep or goats in interstate 
commerce; or upon arrival of the sheep or goats in interstate commerce 
at their final destination.
    Some commenters stated that animals should always be identified 
before being moved from their flock of origin, rather than at any later 
stage of movement, because this would minimize chances for errors in 
identification and would eliminate the need for markets, slaughter 
plants, or other businesses to apply identification. We agree in part 
and have changed the wording in Sec. 79.2(a)(1) to require the owner of 
the flock of origin or his agent to identify the animals. This does not 
preclude the owner of the flock of origin from contracting with a 
livestock market, slaughter plant, or other person to act as his agent 
for the purpose of applying official identification at the first point 
in movement where official identification is required. In response to 
comments suggesting that animals be identified to their flock of birth, 
not just their flock of origin, we are requiring identification to the 
flock of birth for animals born after January 1, 2002. The delay in 
this requirement's effective date will give owners an opportunity to 
prepare for the new requirement. To further mitigate the impact on 
owners and markets, we are allowing animals moving interstate directly 
to slaughter to move without flock-of-birth identification until June 
1, 2003.
    We have also amended Sec. 79.2(a)(1) to note the fact that the 
regulations, in Sec. 79.6(a)(10)(i), allow Consistent States to exempt 
certain low-risk animals in intrastate commerce from being identified 
to their flock of origin or birth. It would be impractical and 
unnecessary to require that these animals be identified to their flock 
of origin or birth in order to move interstate, so we have amended our 
identification requirements for animals in interstate commerce to state 
that animals that Consistent States have exempted from flock of origin 
identification in intrastate commerce in accordance with 
Sec. 79.6(a)(10)(i) may be moved interstate with only individual animal 
identification traceable to the State of origin and to the owner of the 
animals.
    We have also clarified that if an owner fails to arrange required 
official identification for his animals, other persons engaged in 
moving those animals (shippers, markets, slaughter plants, etc.) may 
not move the animals unless the required identification is 
accomplished. It would have undesirable effects on compliance with the 
regulations if other persons engaging in interstate commerce were free 
to move animals that an owner failed to identify. In some cases, this 
requirement may result in shippers, markets, or other parties applying 
official identification to animals, using information from owners 
statements or bills of sale, in order to legally move the animals in 
interstate commerce.
    Commenters also suggested that identification requirements be kept 
to a minimum. In response to this we have identified one case where the 
proposed identification requirement appears to be unnecessary. The 
proposal required individual identification of animals whose final 
destination was a slaughter plant. The proposal also allowed those 
animals to be moved interstate without such identification if it was 
applied after the animals arrived at the slaughter plant. Since 
individual identification would be required at slaughter plants 
primarily to allow APHIS to conduct slaughter sampling and trace back 
positive animals, we believe that this identification would serve no 
purpose on those days when APHIS does not conduct slaughter sampling at 
a plant, and we have removed this individual identification requirement 
in such cases.
    A commenter noted that the requirements for Consistent State status 
mean that States will require identification even when animals change 
ownership within a State. The commenter also noted that the State 
requirement would facilitate identifying animals moving interstate 
under the Federal regulations. We agree. No change is necessary in 
response to this comment since Sec. 79.2(a)(1)(iv) requires 
identification ``upon transfer of ownership of the sheep or goats in 
interstate commerce.''
    In accordance with the above comments, we have revised 
Sec. 79.2(a)(1) to read as follows:

    (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, by the owner of the flock or his or her agent; at whichever 
of the following points in commerce comes first, Except that; 
animals born after January 1, 2002, may be moved interstate direct 
to slaughter without identification to flock of birth until June 1, 
2003, and animals that cannot be identified to their flock of origin 
because Consistent States have exempted them from flock of origin 
identification in intrastate commerce in accordance with 
Sec. 79.6(a)(10)(i) may be moved interstate with only individual 
animal identification traceable to the State of origin and to the 
owner of the animals at the time they were so identified:
    (i) The point of first commingling of the sheep or goats in 
interstate commerce with sheep or goats from any other flock of 
origin;
    (ii) Upon unloading of the sheep or goats in interstate commerce 
at any livestock market, except a market described in paragraph 
(a)(1)(iii) of this section;
    (iii) Upon leaving a livestock market that has been approved in 
accordance with this chapter to handle sheep and goats in interstate 
commerce and that has agreed to act as an agent for the owner to 
apply official identification to the animals. In such cases the 
animals must be:
    (A) Moved to the market and maintained until officially 
identified in distinguishable groups identifiable to their flocks of 
origin and when required their flock of birth by means of partitions 
or other such maintenance; and,
    (B) Accompanied by an owner statement that contains the 
information needed to officially identify the animals to their flock 
of origin and, when required, their flock of birth;
    (iv) Upon transfer of ownership of the sheep or goats in 
interstate commerce;
    (v) In the case of animals shipped directly to slaughter at a 
slaughter plant that has agreed to act as an agent for the owner to 
apply official identification to the animals, upon arrival of the 
sheep or goats in interstate commerce at the slaughter plant. In 
such cases the animals must be:
    (A) Moved to the slaughter plant and maintained until officially 
identified in distinguishable groups identifiable to their flocks of 
origin and when required their flock of birth by means of partitions 
or other such maintenance; and,
    (B) Accompanied by an owner statement that contains the 
information needed to officially identify the animals to their flock 
of origin and, when required, their flock of birth. If the slaughter 
plant has agreed to allow APHIS to conduct slaughter sampling, 
animals need not be identified if they arrive at the plant on days 
that an APHIS designated sampler is not available at the plant to 
collect samples; or
    (vi) Prior to moving a sheep or goat across a State line, unless 
the animals are moving to an approved livestock market in accordance 
with (a)(1)(iii) of this section or to an approved slaughter plant 
in accordance with (a)(1)(v) of this section.

    Numerous commenters requested that we acknowledge that some forms 
of premises identification could satisfy the

[[Page 43972]]

proposed requirement for identification of animals moving interstate. 
It is in some cases less expensive and troublesome for owners and 
persons selling and buying animals to apply premises identifications to 
the animals, and to maintain records indicating which premises animals 
came from, than to maintain records of a unique identifying number for 
each animal when a group of animals is moved interstate.
    We agree that we can make some changes to the individual animal 
identification requirements in proposed Sec. 79.2 to make the process 
less burdensome. However, the identification must be sufficient to 
allow traceback of individual animals at any point in interstate 
commerce or else the disease control purpose of the identification 
suffers. To address the concerns of commenters to the extent possible, 
we are adding provisions to Sec. 79.2 that will allow interstate 
movement of animals marked with a premises identification eartag or 
backtag that bears a unique number associated with the animal to which 
the tag is applied. Eartags approved for use in the Scrapie Flock 
Certification Program (SFCP) are already approved for this use, and 
other eartags and backtags may be approved by APHIS.
    Specifically, we are changing Sec. 79.2(a)(2), which identifies 
acceptable means of identification, by revising paragraphs (ii) and 
(iii), which refer to eartags and backtags, respectively.
    Paragraph (ii) in the proposal read: ``Official eartags, including 
tags approved for use in the SFCP, when used on any sheep or goat.'' We 
are changing paragraph (ii) to read: ``Official eartags, including tags 
approved for use in the SFCP or APHIS-approved premises identification 
number eartags when combined with a unique animal identification 
number.''
    Paragraph (iii) in the proposal read: ``United States Department of 
Agriculture backtags, when used on sheep or goats moving to 
slaughter.'' We are changing paragraph (iii) to read: ``United States 
Department of Agriculture backtags or official premises identification 
backtags that include a unique animal identification number, when used 
on sheep or goats moving directly to slaughter and when applied within 
3 inches of the poll on the dorsal surface of the head or neck.'' This 
change is based on comments that suggested that premises backtags that 
include a unique animal identification number are suitable for 
individual animal identification, and that suggested a standard 
location on the head or neck to make it easy to collect the tag at 
slaughter.
    Comments on proposed Sec. 79.2(b), which dealt with how serial 
numbers and other codes for official identification would be issued, 
suggested that APHIS provide more detail on how these codes would be 
assigned by USDA to State officials and other intermediaries who could 
ultimately assign them for use by particular flocks. These comments 
suggested that it would be efficient to allow various animal health 
personnel, such as 4-H leaders, to be assigned blocks of codes that 
they could reassign to flocks. The comments stated that this means of 
assigning codes would be convenient for flock owners and would be 
reliable as long as USDA had initial control of the code assignments 
and subsequent assignments were identified to the premises on which the 
codes are used in a USDA database.
    We agree, and have added the following language to Sec. 79.2(b): 
``The official responsible for issuing eartags in a State may assign 
serial numbers of official eartags to other responsible persons, such 
as 4-H leaders, if the State animal health official and the area 
veterinarian in charge agree that such assignments will improve scrapie 
control and eradication within the State. Persons assigned serial 
numbers may either directly apply eartags to animals, or may reassign 
eartag numbers to producers. If these persons reassign eartag numbers, 
they must maintain appropriate records that permit traceback of animals 
to their flock of origin, or flock of birth when required. Premises 
identification eartag, backtag, and tattoo numbers (series of 
alphanumeric USDA tags and backtags may be assigned as premises 
identification if they are linked to the premises in the National 
Scrapie Database) will be assigned to animal owners by the State animal 
health official or the area veterinarian in charge, whoever is 
responsible for assigning premises codes in that State.''
    Proposed Sec. 79.2(c) provided that, when animals move interstate, 
the buyers, sellers, and transporters would all have to keep records 
containing all serial numbers and other approved means of 
identification appearing on each sheep or goat. In this final rule, 
these requirements have been changed and moved to Sec. 79.2(d). This 
paragraph now provides that, when the animals are identified to the 
premises of the flock of origin, the records will have to show the 
premises identification, which will be the same for all animals from a 
premises, rather than the unique identification number associated with 
each animal. The eartag or backtag on each animal will have a unique 
identification number, which APHIS can use, if necessary, in 
combination with the flock owner's records to conduct an epidemiologic 
investigation. We have also amended Sec. 79.5, ``Issuance of 
Certificates,'' to note that for movements where premises 
identification instead of individual animal identification is allowed, 
the certificate will record the premises identification number rather 
than individual animal identification numbers.

Chart of General Restrictions

    Comments have led us to substantially revise the chart in 
Sec. 79.3, which contains restrictions and identification requirements 
for sheep and goats moved interstate. Many commenters suggested that 
the chart in this section should take more note of the fact that 
sexually intact female animals present an inherently higher risk of 
spreading scrapie than neutered animals, since lambing and kidding have 
been identified as chief opportunities for the spread of scrapie.
    When consolidated, these comments suggested that the chart should 
be organized to provide different levels of identification and 
restriction for six different groups of animals. The six groups 
represent six different risk levels for spreading scrapie, ranging from 
high risk to low risk. The groups are as follows, beginning with the 
highest risk group:
     Scrapie-positive, suspect, or high-risk animals.
     Animals from an infected or source flock that are not 
scrapie-positive, suspect, or high-risk animals.
     Exposed female animals that are sexually intact and are 
not scrapie-positive, suspect, or high-risk animals or from an infected 
or source flock.
     Sexually intact female animals that are not scrapie-
positive, suspect, high-risk, or exposed animals or animals from an 
infected or source flock.
     Commercial whitefaced sheep, commercial hair sheep, and 
commercial goats when they are in low-risk flocks.
     Castrated or spayed animals that are not scrapie-positive 
or suspect animals and are not from an infected or source flock.
    We have reorganized the chart based on these major groups of 
animals, although the chart actually establishes more categories using 
risk-based subdivisions of these groups. The restrictions and 
identification requirements this final rule requires for the various 
categories of animals are similar to the requirements in the chart

[[Page 43973]]

in the proposal, and range from prohibition of movement for the first 
group through no requirements for some members of the last group.
    Like the chart in the proposed rule, the chart in this final rule 
distinguishes the level of restriction and identification required 
based on whether an animal is being moved to slaughter, to be bred, to 
be displayed at a show, or for other reasons. As commenters pointed 
out, it is necessary to preserve these distinctions because each type 
of movement presents different opportunities for animals to spread or 
contract scrapie, and therefore different levels of risk.
    Many commenters also suggested that the identification requirements 
for lambs moved to slaughter be relaxed. The proposal required that 
lambs moved to slaughter be individually identified if they were over 6 
months of age. Some commenters presented economic arguments that it was 
simply too expensive and difficult for large production flocks to 
individually identify hundreds or thousands of lambs in order to move 
them to slaughter. Other commenters presented arguments based on the 
age at which scrapie can be first diagnosed. Both types of comments 
urged that individual animal identification for animals moving to 
slaughter should not be required until animals reach sexual maturity. 
The age at which commenters suggested lambs should be identified ranged 
from 9 to 18 months.
    APHIS agrees that age and sexual maturity are important benchmarks 
that can be used to divide animals into different groups characterized 
by different risk levels for scrapie transmission or differing 
suitability for diagnosis of the disease. We have revised the chart to 
take this into account. The chart contains lesser restrictions for 
animals under 18 months of age and greater restrictions for animals 
over that age. The more severe restrictions will also apply to animals 
that have lambed or kidded, even if they did so at less than 18 months 
of age. Specifically, the dividing line in the chart will impose 
greater restrictions on an animal that has lambed or kidded, or that is 
over 18 months of age, as evidenced by eruption of the second incisor.
    One commenter recommended that identification not be required for 
animals under 14 months of age, whether they are from Consistent or 
Inconsistent States, when the animals are in slaughter channels or have 
been castrated. We agree in part and have removed the identification 
requirement for castrated animals under 18 months of age and for 
sexually intact animals that are under 18 months of age when they are 
moved directly to slaughter or to a terminal feedlot from an 
Inconsistent State. No identification is required for castrated or 
sexually intact animals under 18 months of age in slaughter channels 
when they are moved from a Consistent State.
    Some commenters wanted the identification and permitting 
requirements for high-risk animals relaxed. APHIS believes that it is 
critical to maintain control of these animals through slaughter to 
ensure that they do not return to the farm. No changes were made based 
on these comments.
    Based on comments that movement restrictions should use newly-
developed genetic tests as a tool, we have added genetic testing as a 
requirement for the movement of sexually intact exposed animals that 
are moved for breeding, show, grazing, or other purposes. We have added 
a requirement to Sec. 79.3(a)(3) and (d)(3) that for female sheep in 
these classes, the results of an official genotype test showing QR or 
RR at codon 171 must be included on or attached to the permit that is 
required to move these animals.
    Several other changes to the chart in Sec. 79.3 are discussed 
below, in context with the comments which brought them about. These 
comments addressed movement restrictions for goats, methods for issuing 
certificates and the statements certificates should contain, and other 
issues.

Proposed List of Consistent States

    In the August 15 proposal we stated that the Administrator had 
evaluated the qualifications of States in accordance with the standards 
for Consistent States proposed in the November 30 proposal. The 
Administrator evaluated State statutes, regulations, and directives 
pertaining to animal health activities, reports, and publications of 
State animal health agencies, and a written statement from each State 
animal health agency describing State scrapie control activities. The 
August 15 proposal announced that all 50 States had submitted written 
statements indicating their willingness to comply with the proposed 
requirements and provided copies of their regulatory authority to carry 
out these actions. The August 15 proposal also proposed certain changes 
to the standards that a State would have to meet to qualify as a 
Consistent State and announced that, based on the Administrator's 
evaluation of all State submissions and other information and reports 
describing scrapie quarantine and control activities in the States, the 
Administrator had determined that all 50 States meet the proposed 
standards for Consistent State status. One of the standards for 
Consistent State status, in Sec. 79.6(a)(3) of this final rule is that 
each State must sign a memorandum of understanding (MOU) between APHIS 
and the State that delineates the respective roles of each in National 
Scrapie Program implementation. Prior to the August 15 proposal, all 
States signed letters of intent to draft and sign an MOU with APHIS. 
The designation of all 50 States as Consistent States is contingent on 
the State actually signing the MOU. To date, not all States have signed 
such an MOU. If any States have not signed the necessary MOU by the 
effective date of this final rule, APHIS will publish another final 
rule in the Federal Register changing the status of those States to 
Inconsistent.
    We received eight comments on the proposal to list all 50 States as 
Consistent States under the revised standards contained in the August 
15 proposal. All of these comments supported the revised qualification 
standards and supported designating all 50 States as Consistent States, 
although some suggested associated changes to the regulations. 
Therefore, this final rule designates all 50 States as Consistent 
States contingent upon the signing of the MOU and finalizes the 
standards for Consistent State status that were proposed in the August 
15 proposal.
    One commenter on the August 15 proposal stated that there should be 
procedures in the regulations for APHIS to work with individual 
producers to allow interstate movement of animals, so that producers 
``doing a good job'' are not penalized due to problems in another part 
of the State.
    We are not making any change in response to this comment because we 
believe the problem is addressed by the lighter restrictions on 
interstate movements from Consistent States in Sec. 79.3, as well as by 
the provision in Sec. 79.6(a)(10)(i)(A) that allows Consistent States 
to exempt from identification commercial whitefaced sheep under 18 
months of age moving in intrastate commerce if the State has had no 
case of scrapie in commercial whitefaced sheep and no commercial 
whitefaced flocks in the State have been exposed by a female animal. We 
consider it impractical and overly expensive for both APHIS and States 
to apply this exemption on a basis smaller than Statewide, or to 
develop unique movement requirements for individual flocks. Also, flock 
owners would be subject to the most burdensome, Statewide restrictions 
only in Inconsistent States, but this rule

[[Page 43974]]

establishes all States as Consistent States, at least for now, if they 
sign the appropriate MOU.
    Several commenters on the August 15 proposal said that APHIS should 
clearly state that entering data in the Generic Database is an 
acceptable alternative to entering data in the National Scrapie 
Database and would minimize the burden and costs to States.
    We agree; in fact, the National Scrapie Database is in fact a 
subset of the Generic Database, and States already entering the 
required scrapie data in the Generic Database will not have to reenter 
it. APHIS will continue to work cooperatively with States to minimize 
the data entry burden for scrapie and other animal health databases. To 
clarify this point, we have also added to Secs. 54.1 and 79.1 a 
definition of National Scrapie Database to read ``A database designated 
by the Administrator in which APHIS and State animal health agencies 
cooperatively enter data concerning scrapie outbreaks, flocks and 
premises affected by scrapie, individual animal identification and 
premises identification data, and other data to support the Scrapie 
Eradication Program and the Scrapie Flock Certification Program.''
    One commenter on the August 15 proposal said that APHIS should 
define ``commercial goats'' to clarify which goats must comply with 
identification requirements and which are exempted. The same commenter 
suggested that we define ``slaughter channels'' to include private 
sales of kids to individuals for slaughter.
    We agree, and as discussed above, we have added a definition of 
commercial sheep or goat to Sec. 79.1. We are also adding to both 
Secs. 54.1 and 79.1 a definition of slaughter channels to read as 
follows: ``Animals in slaughter channels include any animal that is 
sold, transferred, or moved either (1) directly to a slaughter 
facility, (2) to an individual for custom slaughter, or (3) for feeding 
for the express purpose of improving the animals' condition for 
movement to slaughter. Any sexually intact animal that is commingled 
with breeding animals or that has been bred is not in slaughter 
channels. When selling animals for slaughter, owners should note on the 
bill of sale that the animals are sold only for slaughter.''
    One commenter on the August 15 proposal requested that APHIS exempt 
animals that are removed from feedlots for breeding purposes from the 
requirement that animals not in slaughter channels be traceable to 
premises of birth. The commenters stated that changing economic 
conditions often makes this necessary and maintained that such animals 
need to be traced back only to the feedlot for program purposes.
    We disagree. Tracing animals to a feedlot is of little 
epidemiologic value unless the feedlot maintains records that would 
allow the animals to be traced back to their flocks of origin. 
Currently this is not the case, and we do not believe imposing such a 
recordkeeping burden would be warranted at this time. The primary 
purpose of traceback is to locate infected breeding flocks, not to 
locate feedlots where animals have temporary residence.
    Several commenters on the August 15 proposal suggested that APHIS 
should begin now to enhance the education and training of producers and 
accredited veterinarians.
    We agree and are engaged in activities to support education and 
training regarding scrapie control. In addition to projects by APHIS 
public information offices, we are cooperating on projects with the 
American Sheep Institute and the National Institute of Animal 
Agriculture.
    One commenter on the August 15 proposal stated that APHIS should 
develop the Uniform Methods and Rules (UM&R) with full coordination of 
all segments of industry and the pertinent advisory committees.
    We agree, and the final rule states that APHIS will consult with 
Consistent States and provide an opportunity for industry and public 
review of the UM&R. We also intend to provide the United States Animal 
Health Association and the public with the opportunity to review the 
UM&R in draft form. In regard to this review, it should be noted that 
the legal requirements for the interstate movement of sheep and goats 
due to scrapie are contained in 9 CFR parts 54 and 79. The UM&R 
provides additional guidance to the States regarding the minimum 
standards necessary for States to participate in the National Scrapie 
Eradication Program. The UM&R also provides examples of how to comply 
with those requirements.
    One commenter on the August 15 proposal stated that the language 
concerning the Paperwork Reduction Act in the proposed rule, stating 
that there were ``no new impacts'' associated with the rule, was 
inaccurate because livestock markets in particular will have to keep 
many new records.
    The paperwork statement was accurate for the particular rule in 
which it appeared, i.e., the proposal to list 50 States as Consistent 
States. That proposal added no new records or forms not already 
addressed in the earlier November 30 proposed rule. Please refer to the 
Paperwork Reduction Act section of this final rule to see final 
analysis of the paperwork issues raised in the November 30 proposed 
rule.
    One commenter on the August 15 proposal stated that since the risk 
of a positive ram transmitting scrapie is effectively zero, the program 
should take no regulatory action against a flock based on the presence 
of an infected ram that was purchased from another flock.
    We agree, and the revised definitions of exposed animal and exposed 
flock discussed above require the exposure to be to a scrapie-positive 
female animal, not a ram. On the same basis, to update classifications 
made under earlier versions of the regulations, Sec. 79.4(b)(8) of the 
final rule allows an exposed animal to be reclassified if the exposure 
was only by an infected ram, outside of lambing and breeding 
situations. This final rule primarily regulates rams by requiring that 
they be individually identified in certain circumstances. This 
requirement does not reflect a belief that rams may directly spread 
scrapie, but rather it exists to allow scrapie-positive rams to be 
traced back to their flocks of origin or birth, as required, so that 
the necessary regulatory requirements may be imposed on those flocks.

Comments on Goats

    Several commenters requested that goats be exempted from part or 
all of the regulations due to the low incidence of scrapie in goats. We 
have made the following changes in response to these comments.
     Since there is no immediate intent to collect diagnostic 
specimens from goats at slaughter, we have removed the requirement from 
Sec. 79.3(b) to identify goats in slaughter channels, except for goats 
that have been exposed to scrapie.
     In Sec. 79.3(a) we have exempted commercial goats that are 
not in contact with sheep from identification requirements if they 
originate in a State that has not had a case of scrapie in goats.
     We have allowed Consistent States that have had no cases 
of scrapie in goat flocks to exempt commercial goats from 
identification while in intrastate movement.
     We have partially removed the requirement that breeding 
goats moving interstate from Inconsistent States must originate from a 
SFCP flock. In this final rule, such goats must originate from a SFCP 
flock only if they have commingled with sheep, or are from a State that 
has had scrapie diagnosed in goats that were not commingled with sheep.

[[Page 43975]]

Comments on Genetics and Testing

    A few commenters recommended that animals that have an R at codon 
171 should be exempted from the regulations because of their resistance 
to scrapie. APHIS disagrees with exempting all animals with an R at 
codon 171 from all regulation, for the following reasons. While Suffolk 
sheep with an R at codon 171 are documented in the literature to be 
more resistant to clinical scrapie than Suffolks that are QQ at codon 
171, there have been several reports of sheep that are QR and one 
report of a sheep that is RR at codon 171 that were diagnosed with 
scrapie. Also, there has been inadequate work done with other breeds to 
know if or to what degree an R at codon 171 increases resistance in 
these sheep. It is also unknown whether a carrier state exists in sheep 
that are RR or QR at codon 171. However, we believe it is appropriate 
to classify highly exposed male sheep that are RR at codon 171 and AA 
at codon 136 as exposed, rather than high risk, since the lower risk 
from a male sheep combined with the lower genetic susceptibility 
associated with this genome lowers the risk of spread to a range 
similar to or less than that of other exposed animals. Likewise, 
exposed female sheep that are QQ at codon 171 are more susceptible and 
therefore of higher risk than other exposed animals and so have been 
included in the definition of high risk animals. APHIS is supporting 
further research with the U.S. Department of Agriculture's Agricultural 
Research Service to assess the utility of genotyping for regulatory 
purposes and will propose adjustments to the regulations as appropriate 
based on the results.
    Several commenters urged the approval of the third eyelid test and 
also asked that we specify how tests would be approved by the 
Administrator. We are in the final steps of evaluating the third eyelid 
test. We have included new Secs. 54.10 and 54.11 describing how APHIS 
will approve tests and laboratories in response to this comment. 
Essentially, the Administrator will approve new scrapie tests for live 
or dead animals after evaluating the test protocols and study data 
regarding each test's methodology, sensitivity, specificity, and 
reproducibility. The Administrator will approve laboratories after 
evaluating them using the same type of standards used to evaluate other 
laboratories authorized to conduct official tests under APHIS 
regulations. These are well-established standards for evaluating the 
methodology, personnel, and quality control procedures of diagnostic 
laboratories. For examples of current APHIS regulations for approval of 
laboratories, see the equine infectious anemia regulations at 
Sec. 75.4(c), pseudorabies regulations at Sec. 85.1, and contagious 
equine metritis regulations at Sec. 93.301(i).
    Several commenters have objected to references to a live-animal 
test that has not been approved yet. We believe that the third eyelid 
test will be validated by the time this regulation is finalized and 
will be approved by the Administrator soon thereafter. The references 
to live-animal tests in this final rule will then aid the speedy and 
orderly introduction of the test.

Identifying an Animal's Premises of Birth

    Several commenters recommended that breeding animals be marked with 
flock of birth identification. We agree that this is an ideal method to 
allow complete traceback of animals and encourage its use; however, we 
are allowing other forms of identification on breeding sheep since 
birth premises identification is impractical in some circumstances, 
such as for sheep that no longer reside in their flock of birth or that 
lose tags after leaving the flock of birth. We have added a requirement 
to the general movement restrictions in Sec. 79.3(a)(3) and (a)(4) and 
to the conditions for issuing certificates in Sec. 79.5(a) that, for 
breeding sheep born after January 1, 2002, the flock of birth must be 
indicated on any health certificate issued for those sheep. This 
requirement will make it possible to trace these animals to their flock 
of birth. Also, as discussed in the August 15 proposal, we have added a 
requirement to the Consistent State qualification requirements at 
Sec. 79.6(a)(10)(i), requiring official identification, upon change of 
ownership, of all animals of any age not in slaughter channels and any 
sheep over 18 months of age. This requirement will help us trace 
animals back to their flock of birth in Consistent States. Consistent 
States must meet this identification requirement within 2 years of 
their designation as Consistent. When Consistent States impose this 
identification requirement for intrastate movements, it will 
substantially increase our ability to trace animals back to their flock 
of birth.

Publication of Lists of Infected Flocks, Source Flocks, and Flocks 
Participating in the SFCP

    In the past, APHIS has published and has made available through the 
Internet lists of all known infected flocks, source flocks, and flocks 
participating in the Scrapie Flock Certification Program. APHIS intends 
to continue publishing a list of participating flocks, which is 
available by writing to us or at URL http://www.aphis.usda.gov/vs/
scrapie. We have amended Sec. 54.21 to state that a list of 
noncompliant flocks (defined below) will also be developed and 
published at that address. However, we do not intend to continue 
publishing lists of infected and source flocks.
    Several commenters supported publishing lists of all infected and 
source flocks, regardless of whether or not they participate in the 
SFCP. We have modified the rule to address this concern by requiring 
the scrapie status to be indicated on all certificates of animals 
moving for breeding or show purposes, discussed below under ``Comments 
on Issuance of Certificates,'' and by defining noncompliant flock in 
Secs. 54.1 and 79.1 as ``(1) Any source or infected flock whose owner 
declines to enter into a flock plan or post-exposure management and 
monitoring plan agreement within 30 days of notification, or whose 
owner is not in compliance with either agreement; (2) any exposed flock 
whose owner fails to make animals available for testing within 60 days 
of notification, or as mutually agreed, or whose owner fails to submit 
required postmortem samples; (3) any flock whose owner or manager has 
misrepresented, or who employs a person who has misrepresented, the 
scrapie status of an animal or any other information on a certificate, 
permit, owner statement or other official document within the last 5 
years; or (4) any flock whose owner or manager has moved, or who 
employs a person who has moved, an animal in violation of this part 
within the last 5 years.'' Publishing a list of noncompliant flocks, 
rather than lists of infected and source flocks, will protect the 
privacy of flock owners who comply with the regulations while listing 
those who do not and, therefore, present a risk of spreading scrapie.
    Commenters also suggested we take steps to improve our ability to 
enforce the requirements of flock plans by taking action against 
persons who violate them. To accomplish this, we are slightly changing 
the definition of flock plan to require that a flock plan must be 
signed by the flock owner and by the accredited veterinarian, if any, 
employed by the flock owner. We believe signatures are desirable to 
document that participants in a flock plan have committed to follow its 
requirements, particularly now that nonperformance could cause a flock 
to be designated noncompliant. In the proposed definition of flock 
plan, the document did not have to be signed.

[[Page 43976]]

Comments on Issuance of Certificates

    As mentioned above, some commenters suggested that all infected and 
source flocks should be kept on a list that potential buyers could 
consult to obtain information about the scrapie status of animals they 
might buy. We believe this need for information regarding animals' 
exposure to scrapie can be met by changing the procedure for issuing 
certificates to require that certificates include a statement by the 
owner documenting any relevant information the owner has about the 
scrapie status of the animals, the exposure of the animals to scrapie, 
and the status of the animals' flock. This change would also address 
comments that suggested that certificates should contain more 
information about exposure of animals to scrapie.
    Therefore, we are changing Sec. 79.5, which concerns issuance of 
certificates, to require that a certificate must include: (1) A 
statement by the issuing veterinarian that the animals were not 
exhibiting clinical signs associated with scrapie at the time of 
examination and (2) an owner statement indicating whether the animal is 
or is not a scrapie-positive, suspect, high-risk or exposed animal and 
whether the animal originated in an infected, source, exposed or 
noncompliant flock. This added information will make the certificate 
more useful to persons acquiring these animals and to APHIS and State 
representatives enforcing the regulations, especially because the 
regulations require permits or prohibit the interstate movement of 
scrapie-positive, suspect, and high-risk animals, some exposed animals, 
and animals that originated in an infected or source flock.

Other and General Comments

    Several commenters recommended that we make the regulations 
consistent with the Office International des Epizooties (OIE) draft 
chapter on scrapie for the International Animal Health Code. While we 
believe that these regulations are in concordance with the spirit of 
the OIE draft chapter on scrapie, some requirements in the draft 
chapter are impractical for some segments of the U.S. sheep industry. 
Since the draft chapter is still being debated by the member countries, 
we have decided not to change our regulations in ways that will be 
costly to our industry without knowing what the final draft will 
include.
    Several commenters supported the basic Consistent State 
requirements of reportability and movement restrictions but asked that 
the States be given up to 2 years to come into compliance with the 
other requirements. We agree, and proposed this change in the August 15 
proposal. No commenters objected to this change, and we have included a 
delayed compliance date for these requirements.
    Several commenters stated that ewe lambs sent to feedlots should 
not be required to be identified. Their reasoning was that only a small 
percentage of ewe lambs are moved out of feedlots other than to 
slaughter, and that, in these cases, it would be appropriate to 
consider the feedlot to be their flock of origin. We disagree, because 
this would create a significant loophole which would encourage 
producers worried about their scrapie status to sell their breeding ewe 
lambs to feeders for resale to prevent tracebacks.
    Several commenters asked that we add a medium risk or exposed flock 
classification for flocks with lower levels of risk, particularly those 
on pilot project flock plans. We agree and have added an exposed flock 
classification in Sec. 79.4. We discussed the new definition of exposed 
flock above. This classification will identify animals with some degree 
of risk that might otherwise be exempted from necessary movement 
restrictions, e.g., as low-risk commercial sheep.
    Several commenters recommended that we give designated scrapie 
epidemiologists (DSEs), rather than APHIS or State veterinarians, the 
responsibility for designating animals scrapie-positive, high-risk, or 
exposed, and for designating flocks as infected, source, or exposed 
flocks. We agree that a DSE has the appropriate level of technical 
expertise for making these determinations, and for making 
redesignations when needed, and have made this change in Sec. 79.4(a). 
The commenters also suggested we give DSEs increased flexibility in 
addressing individual flock situations by customizing requirements for 
individual flock plans and post-exposure management plans and by 
conducting testing of flocks when test results could justify 
redesignation of a flock. We agree and have done this by allowing DSEs 
to determine the testing and monitoring needed for exposed flocks and 
by allowing them to modify flock plans and post-exposure management and 
monitoring plans under certain conditions to meet changing needs. These 
changes expanding the role of DSEs are in Sec. 54.3(a) and in 
Secs. 54.8(f), (h), and (i). We have also changed Sec. 79.4 to allow 
DSEs that are engaged in designating or redesignating a flock's status 
to order testing of flock animals if the DSE determines such testing is 
needed to properly designate a flock. In such cases the DSE will select 
animals for testing in a manner that will provide a 95 percent 
confidence of detecting scrapie at a prevalence of 1 percent. Testing 
may include live-animal testing using a live-animal official test, the 
culling and postmortem examination of genetically susceptible animals 
in the flock that cannot be evaluated by a live animal test, and 
postmortem examination of animals found dead or cull animals at 
slaughter.
    One commenter stated that flock plans and post-exposure management 
and monitoring plans should allow APHIS or State representatives, when 
necessary, to restrict the removal of animals from flocks subject to 
those plans. Otherwise, animals might be removed from fear that they 
would be officially determined to be scrapie positive. We agree, and 
have added appropriate language to Sec. 54.8(d).
    Many commenters noted an error in the preamble that stated ``* * * 
imported lamb sells at a higher price than domestic lamb and mutton.'' 
In fact, domestic lamb and mutton sell at a higher price than imported 
lamb and mutton, and this has been corrected in our final regulatory 
flexibility analysis.
    Several commenters supported our proposal to change the name of the 
Voluntary Scrapie Flock Certification Program to the Scrapie Flock 
Certification Program (SFCP), and a few commenters opposed the change. 
Those in favor recognized the trade benefits; those opposed were 
concerned that the program would no longer be voluntary. We have made 
no changes in rule based on this comment. Participation in the SFCP 
will remain voluntary.
    Several commenters asked that we review our requirements for 
importing sheep and goats in light of this rulemaking to ensure 
equitable treatment. That is outside the scope of this rulemaking but 
will be considered in making policy and in future changes to the import 
regulations.
    Several commenters expressed concern over how this regulation would 
affect large commercial range flocks. We agree that some of these 
concerns are valid and have made several changes to the rule to lessen 
adverse effects on these flocks. Some of the changes we have made to 
distinguish commercial flocks from other types were discussed above 
regarding the definitions of commercial sheep or goat and low-risk 
commercial sheep. We have also made changes affecting both intrastate 
and interstate movement of commercial sheep and goats. These changes, 
to both the interstate movement restrictions in Sec. 79.3 and the 
requirements for

[[Page 43977]]

Consistent States in Sec. 79.6, include: (1) Allowing Consistent States 
that have had no cases of scrapie in commercial flocks to exempt them 
from identification while in intrastate movement under 18 months of 
age; (2) allowing commercial sheep and goats to be identified with 
brands or earnotches in interstate movement; (3) reducing the 
recordkeeping and identification requirements for commercial flocks if 
they become infected; (4) not designating flocks as infected if the 
positive animal is a purchased ram; (5) allowing the interstate 
movement of all animals under 18 months of age in slaughter channels 
without identification; and (6) allowing increased options for 
commercial flocks if they are designated infected, source, or exposed 
and by giving greater latitude to DSEs to modify flock plans and post-
exposure management and monitoring plans.
    Several commenters recommended that we differentiate between 
blackfaced and whitefaced sheep based on the higher incidence of 
reported scrapie cases in blackfaced sheep. We agree in part with this 
concept and have changed Secs. 79.3(a)(7) and (c)(5) of the interstate 
movement restrictions chart to distinguish between exposure to 
whitefaced and blackfaced sheep.
    A commenter expressed concern over the number of signs that could 
potentially result in an animal being designated a suspect animal. We 
believe that this will not be a problem because the definition of 
suspect animal in Secs. 54.1 and 79.1 includes the condition ``A sheep 
or goat that exhibits any of the following possible signs of scrapie 
and that has been determined to be suspicious for scrapie by an 
accredited veterinarian, or a State or APHIS representative.'' This 
requires not only that the animal exhibit at least one of the signs but 
that a veterinarian determine that it is suspicious for scrapie before 
it is officially designated a suspect animal for regulatory purposes. 
Anyone who suspects that an animal has scrapie is encouraged to report 
it to a State, Federal, or accredited veterinarian so that an official 
determination can be made. In some States, such reporting is a legal 
requirement.
    Several commenters commented on the cost of identifying animals. 
APHIS will provide alphanumeric tags to accredited veterinarians and 
backtags to markets and dealers. Additionally, producers may acquire 
alphanumeric eartags and backtags from APHIS at no cost if they have 
their premises and the tag sequences recorded in the National Scrapie 
Database. Producers may also purchase premises identification tags with 
assigned premises numbers from approved vendors. The requirements for 
vendors who wish to produce approved tags are contained in 
Sec. 79.2(f). Discussions with tag companies suggest that the cost of 
these tags will range from $0.06 for metal tags to $1.00 for highly 
tamper-resistant plastic flap tags. The type of approved tag used will 
be up to the producer and their flock identification needs. Also, we 
have eliminated the identification requirements for most sheep under 18 
months of age and all slaughter goats, which substantially reduces the 
identification cost.
    Many commenters also remarked about the cost of applying 
identification, in addition to the material cost of the tags. We agree 
that there will be a cost to producers and markets to apply 
identification and keep records. We have reduced this as much as 
possible by reducing the number of animals that must be identified, by 
allowing certificates and market and dealer records to record premises 
identification rather than individual identification under certain 
circumstances, and by allowing several options for identification to 
fit different producers' needs.
    Some commenters were concerned that the rule does not indicate the 
penalties for failing to comply. The maximum criminal and civil 
penalties that may be imposed are listed in the statutes that are the 
legal authority behind our regulations. Listing penalty amounts in our 
regulations is not normal practice for APHIS. In response to this 
comment we have indicated some instances when violators will have 
privileges under this rule, such as the ability to apply official 
identification, revoked. Our intent to publish the identities of 
noncompliant flocks should also serve as a deterrent. Finally, action 
may be taken under civil and criminal law against violators of the 
regulations. Administrative penalties may include warnings, monetary 
penalties, or withdrawal of certified flock status.
    One commenter indicated that this rule would preclude State scrapie 
control programs. The rule does not preclude States from designing 
their own scrapie programs for intrastate movements. It would require 
that the program either meet the minimum specified requirements or can 
be shown to be equally effective in preventing the interstate movement 
of scrapie from the State.
    Some commenters expressed concern about the effect of burial or 
incineration on the environment, when animals are disposed of in 
accordance with the requirements of Secs. 54.7(b) or 54.8(f). APHIS 
believes that the regulations currently in place are adequate for safe, 
environmentally conscious disposal of this material.
    All commenters that addressed disposal costs stated that APHIS 
should pay the disposal costs for indemnified animals. We agree that 
APHIS will pay the disposal costs of scrapie-positive and suspect 
animals that cannot be disposed of by slaughter, and we have changed 
Sec. 54.7(d) of the rule to provide that APHIS may pay the reasonable 
costs of disposal for scrapie-positive and suspect 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. This paragraph also states that the Administrator may also 
authorize payment of up to half the reasonable disposal costs for 
animals that are allowed to be destroyed by slaughter under this 
section but for which slaughter is not a practical or cost efficient 
means of disposal. However, Sec. 54.7(d) provides that APHIS may pay 
more than one-half of the expenses when the Administrator determines 
that doing so will contribute to scrapie eradication. For reimbursement 
to be made, the owner of the animals must present the veterinarian in 
charge 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.
    Some commenters misinterpreted the indemnity section and were 
unsure whether indemnity would be provided for both commercial and 
registered animals. Both the November 30 proposal and this rule provide 
indemnity for both types of animals, but in differing amounts.
    One commenter expressed concern over permitting exposed and high-
risk sheep to go to feedlots, because this might pose a risk of 
spreading scrapie. We agree that allowing high-risk animals, exposed 
pregnant animals, or exposed animals with a vaginal discharge to go to 
feedlots from which they might return to the farm would present a 
significant risk, and we have changed Secs. 79.3(b)(3) and (c)(3) of 
the rule to restrict the movement of these animals to slaughter or to 
terminal feedlots.
    One commenter questioned whether the statement in the November 30 
proposal regarding Executive Order 12988 that stated the rule 
``preempts all State and local laws and regulations that are in 
conflict with this rule'' was

[[Page 43978]]

accurate, or was needed. The commenter stated that while State 
restrictions on the interstate movement of sheep and goats that were 
less stringent than the requirements of the rule will be overruled by 
the Federal requirements, State restrictions that are stricter than the 
rule's requirements should be allowed, because they would serve to 
improve disease control and reduce risks. The commenter also expressed 
concern that the statement meant that a State could not require any 
conditions for movement of animals into the State over and above the 
Federal requirements.
    Under Executive Order 12988, a Federal agency that formulates 
proposed regulations is required to specify in clear language the 
preemptive effect it intends to be given to its legislation or 
regulations. The executive order does not specify what that preemptive 
effect shall be. Historically, domestic animal health regulations of a 
State have not been challenged when they require conditions on 
interstate movement that are more stringent than those included in 
APHIS regulations. However, State regulations that conflict with or 
subvert Federal regulations concerning the interstate movement of 
animals and products that are promulgated for the purpose of the 
control of diseases of livestock and poultry are preempted by the 
Federal regulations. This is a matter of Constitutional law that we 
cannot change by regulation.

Scrapie Pilot Projects Final Rule

    This final rule also republishes changes to parts 54 and 79 that 
were made by another final rule concerning scrapie pilot projects. That 
rule was published and effective on June 27, 2000 (Docket No. 99-067-2, 
65 FR 39534-39536). That rule amended the regulations to exempt flocks 
from certain regulatory requirements when the flocks are participating 
in scrapie control pilot projects authorized by APHIS.

Miscellaneous Changes

    We have also made miscellaneous minor changes to the November 30 
and August 15 proposals in this final rule, such as correcting 
misspellings, revising sentences for clarity, and adding explanatory 
subject titles to some paragraphs of amendatory language.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, with the 
changes discussed in this document.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866. The 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.
    In accordance with 5 U.S.C. 603, we have performed a final 
regulatory flexibility analysis for this rule. The economic analysis 
for this rule is summarized below, and a full copy is available from 
Regulatory Analysis and Development, PPD, APHIS, 4700 River Road Unit 
118, Riverdale, MD 20737-1238. The economic analysis provides a cost-
benefit analysis as required by Executive Order 12866 and an analysis 
of impacts on small entities as required by the Regulatory Flexibility 
Act.
    We are taking the actions described in this rule in order to 
strengthen scrapie control programs on the national level and to reduce 
the losses from scrapie to the sheep and goat industries. This action 
is considered necessary because not all State scrapie control programs 
may be effective in identifying animals that may be infected with 
scrapie and controlling their movement in intrastate and interstate 
commerce in a manner that will prevent the further spread of scrapie. 
Statutory authorities, including 21 U.S.C. 111, 114, 114a, and 134a-
134h, authorize the Department of Agriculture to conduct programs for 
the control of communicable animal diseases and to restrict the 
interstate movement of animals that may spread disease.
    As alternatives to this action, APHIS considered a complete ban on 
interstate movement of sheep and goats from States that do not have 
effective scrapie control programs. We also considered adding stricter 
certification, recordkeeping, and animal identification requirements 
for all sheep and goats moving interstate, without regard to the 
effectiveness of individual State scrapie programs. We also considered 
setting up a system to employ a prospective live-animal test in 
mandatory testing of sheep and goats before they could be sold for any 
commercial purpose, with mandatory destruction and disposal of animals 
that fail the test. All of these alternatives would impose more costs 
and recordkeeping requirements than the selected alternative, and we do 
not believe any of these alternatives would control scrapie more 
effectively than the selected alternative. A complete ban on movements 
from Inconsistent States would hurt the economies of those States, and 
while it would provide other States with some protection against 
infection from Inconsistent States, it would not eradicate the 
reservoirs of scrapie in those States. The alternative of stricter 
recordkeeping and identification for all interstate movements would not 
be effective as long as some of the information to be recorded is 
unknown or dubious, as can frequently happen when the animal originates 
in a State with a weak scrapie program. The alternative of mandatory 
testing, and destruction of animals that fail, was discussed in the 
November 30 proposal. It is not a practical option because a live-
animal test has not been validated and approved and is also impractical 
at this time for economic reasons.
    This rule will result in the expenditure of indemnity funds by 
APHIS to compensate the owners of certain animals destroyed to prevent 
the spread of scrapie. This will also encourage certain States to 
improve the effectiveness of their State scrapie programs to avoid 
additional restrictions on the movement of sheep and goats from their 
States.
    The budgetary effects on APHIS of this rule will fall into four 
categories, all within available funds: An increase in outlays for 
staff to work with States and producers as they adapt to the new 
scrapie program requirements, a new program for indemnity payments, the 
cost of providing official eartags and backtags, and the cost for 
disposal (usually by landfill or incineration) of scrapie-positive and 
suspect animals that are indemnified. The initial amount of indemnity 
payments (the first year) is estimated to be approximately $761,245, 
based on an estimated 4,188 animals eligible for indemnity in known 
scrapie-infected and source flocks, but may be more if producer 
response to the availability of indemnity results in new admissions of 
infection that reveal additional cases of scrapie. The amount of 
indemnity paid should decline in subsequent years, although, if 
slaughter surveillance is initiated or if live-animal tests are 
approved and widely used, this decline may not occur for several years, 
depending on the number of scrapie-positive animals that are revealed 
by initial use of these tests. This indemnity program will be less 
costly than some previous indemnity programs since it focuses on 
eliminating individual infected and high-risk animals rather than 
entire flocks, a focus that should be aided in the near future by the 
availability of a validated live-animal test. If a live-animal test is 
accepted for official use, an increase in indemnity costs will be 
expected initially as new infected flocks are identified.

[[Page 43979]]

    APHIS will bear the total reasonable cost for disposing of 
indemnified scrapie-positive and suspect animals, and will bear half 
the cost for disposal of certain other indemnified animals that are 
destroyed rather than sent to slaughter. The cost for disposal of each 
animal will range between a low of approximately $15 (for simple burial 
in a landfill, the most common method) and a high of approximately $100 
(the maximum cost when incineration is required). The method used will 
vary depending on local disposal alternatives and requirements. The 
total cost for disposing of an estimated 3000 animals the first year 
would therefore fall in the range between $30,000 and $300,000, and 
would probably be on the order of $150,000. The cost for disposing an 
estimated 4200 animals over the lifetime of the program is estimated to 
fall in the range between $42,000 and $420,000, probably on the order 
of $210,000.
    Although this rule lists all States as ``Consistent States,'' any 
State that loses this status will bear additional costs to improve its 
State scrapie programs so that the producers in that State can avoid 
additional interstate movement restrictions established for States 
without effective intrastate control programs. However, the designation 
of all 50 States as Consistent States indicates that they have already 
dedicated the resources needed to conduct effective intrastate 
programs. The signing of the MOU will complete this process of 
designating a State as a Consistent State.

Overview of U.S. Sheep and Goat Industry Operations, Inventory and 
Trade

    Much of the data used in this analysis is from the 1997 Census of 
Agriculture (USDA, National Agricultural Statistics Service), the last 
full census that is available. Where possible, updated 1999 data from 
Agricultural Statistics 2000 (USDA, National Agricultural Statistics 
Service) are employed.
    There were 7.026 million sheep and lambs in the United States in 
1999. There were 5.163 million breeding sheep and lambs, of which 4.433 
million were ewes and rams 1 year old or older.
    In 1997, as shown in Table 1, small farms accounted for over 99 
percent of all the farms raising sheep and lambs, while farms 
considered to be large accounted for less than 0.3 percent. About 85 
percent of the farms had an inventory of less than 100 animals and 
accounted for about 17 percent of the total inventory of sheep and 
lambs. On the other hand, sheep operations with an inventory of 5,000 
sheep or more represented less than 0.3 percent of the farms but 
accounted for nearly 26 percent of the total inventory.

                          Table 1.--Sheep and Lambs: Farms and Inventory by
Size, 1997
---------------------------------------------------------------------------
-------------------------------------
                                                                     Number
of                       Inventory
                         Farm inventory                               
farms        Farm share         share
---------------------------------------------------------------------------
-------------------------------------
1 to 24.........................................................          
35584           0.54            0.045
25 to 99........................................................          
20461           0.31            0.123
100 to 299......................................................           
6010           0.09            0.123
300 to 999......................................................           
2429           0.04            0.158
1,000 to 2,499..................................................            
820           0.01            0.16
2,500 to 4,999..................................................            
297           0.005           0.128
5,000 or more...................................................            
189           0.003           0.263
                                                                
-----------------
    Total.......................................................          
65790
---------------------------------------------------------------------------
-------------------------------------
 Source: USDA, Census of Agriculture 1997.

    Of the total number of operations, about 60 percent were full 
owners, about 32 percent were part owners, and about 8 percent were 
tenants.
    Sheep are produced in all parts of the United States, although 
stock levels vary from State to State. Ten States accounted for nearly 
73 percent of the total inventory, mostly in western and central areas. 
Northern and southeastern States have the smallest sheep populations, 
accounting only for 5.2 percent of the total.
    There were about 1.99 million goats in the United States in 1997, 
of which 52 percent were goats other than Angora or milk goats, 41 
percent were Angora goats and about 7 percent were milk goats. The 
State of Texas accounted for about 64.3 percent of the goat inventory. 
Other States where goats are raised include Arizona, California, 
Georgia, New Mexico, North Carolina, Oklahoma, and Tennessee. These 
States together represented another 14.2 percent of the U.S. goats 
holdings. An average holding was about 35 goats. All goat holdings were 
considered to be small.
    During 1999 the United States produced about 247 million pounds of 
mutton, lamb and goat meat. It exported 5.6 million pounds and imported 
about 111 million pounds valued at $189.2 million. The United States 
exported 518,257 sheep and goats valued at $21.99 million in 1999, of 
which 494,098 went to Mexico. The United States imported 53,165 sheep 
and goats valued at $5.33 million in 1999, of which 53,126 were from 
Canada. The United States imported 111 million pounds of sheep and goat 
meat valued at $190.2 million and exported 5.6 million pounds of sheep 
and goat meat valued at $6.46 million in 1999. Most lamb and mutton 
imports came from Australia and New Zealand, countries recognized as 
being free from scrapie. The United States is a net importer of lamb 
and mutton.

Sheep and Goats Affected by Scrapie Interstate Movement 
Restrictions

    Nearly 6.487 million lambs and sheep are marketed each year, of 
which 0.977 million are mature sheep and 5.51 million are lambs less 
than 18 months of age.\1\ There are 15 States with 53 flocks that were 
on the infected or source flock list as of July 2000. Of these, 47 are 
infected flocks and 6 are source flocks. Also, 14 additional flocks 
contained a scrapie-positive animal during FY 2000 but were not 
considered infected or source flocks in July, either because they had 
not been formally categorized yet or because they had completed an 
approved flock plan. Infected and source flocks are potential 
candidates for destruction and indemnity payments.
---------------------------------------------------------------------------

    \1\ USDA/NASS, Agriculture Statistics 2000, U.S. Government 
Printing Office, Washington DC, 2000.
---------------------------------------------------------------------------

    Additionally, over the last 10 years (1990-1999), an annual average 
of 139 animals have been submitted for scrapie diagnosis, of which an 
annual average of

[[Page 43980]]

61 (or 44 percent) were determined to be scrapie-positive animals. 
However, it is likely that the number of reported cases will increase 
as the indemnity payments become available. There are about 1.578 
million breeding sheep and lambs in the 15 States in which positive 
cases have occurred in FY 2000 or in which a source or infected flock 
exists. These animals represent approximately 28 percent of all 
breeding sheep and lambs in the United States and have a market value 
of about $150 million.
    The average size of a flock in an operation in the 15 States was 
125, with between 21 and 479 per operation. Approximately 82.9 percent 
of these sheep are marketed, in most cases across State lines. However, 
nearly 85 percent of the marketed sheep are lambs less than 18 months 
of age, and will be exempt from individual animal identification under 
this final rule.

Indemnity Costs for Animals Destroyed Due to Scrapie

    The exact number of scrapie-positive and high-risk animals that 
will qualify for indemnity payments is not known. However, an estimate 
of the number of animals potentially eligible for indemnity would be 50 
percent (based on field estimates) of the animals in an average 
infected or source flock (based on past field experience). As noted 
above, there are currently 47 infected flocks and 6 source flocks, and 
14 other flocks that currently or recently contained scrapie-positive 
animals. Thus, based on average flock size and the average percentage 
of high-risk animals in infected and source flocks, the number that can 
be estimated to qualify for indemnity payments during the first year 
would be 4,188 animals (=(53 + 14)  x  125  x  0.50). This estimate 
implies that about 0.144 percent of the total number of breeding sheep 
and goats in the 15 States that can potentially move interstate will be 
designated as high-risk animals and be eligible for indemnity. The 
proportion of more expensive registered animals was 74.38 percent 
(8,199/11,023) \2\ Assuming a 75 percent registered to 25 percent 
nonregistered animal composition, the respective indemnity payments 
approximately range between $161 and $322 for registered animals and 
between $61 and $122 for nonregistered animals. The payment for 
registered animals is the sum of the spot market price and the premium 
given in order to adjust for value of these animals. Thus, the $322 per 
head payment for yearlings column includes the $122 spot market price 
and the $200 premium payment. Nonregistered animals get the spot market 
price. The estimated indemnity expenditure will be about $761,245 (See 
table 2 for detail). If the producer response to indemnity payment 
availability is positive, resulting in an increased number of indemnity 
requests, the expenditure will increase accordingly. However, even if a 
much larger number of animals were to be indemnified, the destruction 
of all known infected animals will greatly advance the goal of scrapie 
eradication, and can only be positive in terms of long-term reduced 
expenditure.
---------------------------------------------------------------------------

    \2\ Based on the composition of 8,199 registered and 2,824 
commercial animals that were indemnified in 1990, as reported by 
APHIS personnel.

                                                              Table 2.--The
Indemnity Cost
---------------------------------------------------------------------------
---------------------------------------------------------------------------
--
                                                         Registered (75%)   
                          Non registered (25%)
                  Group                 
---------------------------------------------------------------------------
---------------------      Total
                                              Number          $/Head        
  Cost           Number          $/Head           Cost
---------------------------------------------------------------------------
---------------------------------------------------------------------------
--
Yearlings (1 to 2 years)................             431            $322    
   $138,782             144            $122         $17,568        $156,350
Running ages:
    2 to under 4 years..................             647             290    
    187,630             216              90          19,440         207,070
    4 to 6 years........................             647             190    
    122,930             216              90          19,440         142,370
    Aged (>6 years).....................             431             161    
     69,391             144              61           8,784          78,175
    Ewe lambs...........................             985             175    
    172,375             327              75           4,905         177,280
                                        
---------------------------------------------------------------------------
------------------------------------
      Total.............................           3,141  ..............    
    691,108           1,047  ..............          70,137        761,245
---------------------------------------------------------------------------
---------------------------------------------------------------------------
--
Note:This chart assumes a distribution based on 1999 flock data for the
ages, and resultant indemnity status, of the 4,188 animals estimated to be
  eligible for indemnity. We also assumed 75 percent of these animals are
registered. We also estimated that 80 percent of non-registered ewe lambs
will
  go to slaughter, so indemnity cost for this class will be minimal.

Costs to Producers and APHIS for Official Identification of Animals 
Moving Interstate

    The animal identification required by this rule will result in 
additional costs. Of the approximately 7.82 million sheep and lambs in 
the United States, about 6.487 million sheep and lambs (or 82.9 
percent) are marketed. Nearly 85 percent of these sheep and lambs that 
could move interstate are lambs less than 18 months of age in slaughter 
channels, which will not require identification tags under the new 
rule. Of the 1.99 million goats (=809,391 angora+146,678 milk+1,033,730 
goats), about 27.5 percent could potentially be moved interstate. This 
assumes that most angora goats do not move interstate, but that about 
20 percent of milk goats and 50 percent of other goats might move 
interstate. The cost of metal identification tags is between 4 cents 
and 6 cents per animal. Thus, assuming the total number of sheep and 
goats that will need identification tags is 1.52 million, the tag cost 
will be between $60,800 (=1,520,300  x  0.04) and $91,220 (=1,520,300 
x  0.06). If the time it takes the owner to apply the tag (about 2 
minutes per animal) is valued at $7.61 per hour (the revised average 
wage for livestock workers in January, 2000), this labor cost 
represents another $385,600 (=1,520,300  x  2  x  $7.61/60). In some 
States, tags are provided by APHIS free to accredited veterinarians, 
while in others, they are purchased by accredited veterinarians through 
the State. Generally, wherever APHIS directly distributes tags they are 
free; where States distribute them, there may be no charge, a small 
processing fee, or a fee covering the full cost of the tags, depending 
on State regulations. In this rule there is a mechanism for APHIS or 
the State to provide tags direct to producers. If owners elect to use 
backtags for direct movements of animals to slaughter instead of 
eartags, the costs will be less. In either case, owners will incur the 
costs of applying identification. The effect on goat owners will be 
less, since about 41 percent of goats are the angora type, which are 
raised for their mohair and are less frequently moved interstate. Also, 
the

[[Page 43981]]

owners of goats that qualify as ``low-risk goats'' will not have to 
individually identify their animals. Thus, the total potential 
identification costs for goat owners will be between $3,850 and $5,570.

International Trade Effects

    The United States has limited foreign trade both in live sheep and 
goats and their products. Australia, a potential major importer of U.S. 
sheep for breeding purposes, is scrapie-free and prohibits imports of 
sheep from the United States. Australia allows imports of live goats 
from the United States only if they undergo a 3-year quarantine upon 
arrival. Mexico allows the importation of U.S. sheep only if the sheep 
are from flocks enrolled in the Voluntary Scrapie Flock Certification 
Program. Canada allows the importation of U.S. sheep only if a 
certification statement can be made that no case of scrapie has been 
diagnosed in the flock of origin for the last 3 years and the animals 
for export are not the progeny of infected animals. In 1997, the total 
earnings from exports of live sheep, goats, and sheep and goat meat and 
meat products were approximately $65 million. The United States is a 
net exporter of live animals, while it is a net importer of mutton, 
lamb and goat meat. Both the sources of imports and destinations of 
exports are concentrated in a few countries. Scrapie-free animals, and 
to some extent their products, are likely to be highly valued in the 
domestic and international markets. U.S. breeding stock that can be 
certified scrapie-free is expected to be in high demand 
internationally. While scrapie-free status would do little to enhance 
domestic or export consumption of U.S. mutton and lamb, the lack of 
scrapie-free status could seriously reduce demand for these products if 
public fears about transmissible spongiform encephalopathies ever 
become associated with U.S. sheep products.
    The U.S. competitiveness in the domestic and international markets 
depends upon its reputation for producing high quality animals and 
products. The actual product, as well as the purchasers' perception of 
quality, contribute to continued market acceptance. Thus, efforts to 
eradicate scrapie and secure the health of U.S. sheep and goats will 
continue to serve the economic interests of the industry and Nation. 
This rule could give incentive for more rigorous efforts to find 
infection and proceed rapidly to eradicate infected animals in order to 
preserve a scrapie-free status.
    This rule should benefit U.S. producers in a number of ways, 
especially by avoiding a number of direct costs and market losses. 
Associations representing breeding sheep owners, slaughter sheep 
owners, and wool-production sheep owners have submitted comments 
supporting the approach of this rule and also stated their 
associations' opinion that the benefits of the program will greatly 
exceed the costs. Scrapie may cost the sheep industry as much as $20.1 
million per year in direct losses ($10 million in lost breeding stock 
and embryo export sales, $3.95 million in disposal costs for offal, and 
$6.176 million to divert offal from ruminant food chains and in loss of 
offal export markets). Scrapie also costs an unknown amount in lost 
potential international markets and lost flock productivity. 
Additionally, the sheep industry currently loses sales to drug 
companies because the U.S. Food and Drug Administration requires 
scrapie-free sources of sheep or goat materials for pharmaceutical or 
biological products implanted or injected in humans.
    Therefore, this rule should make the U.S. sheep industry more 
competitive, particularly in live sheep and goat exports, since current 
trade shows that the value of live animal exports is almost four times 
that of the meat in the global market. This rule also addresses 
consumer concerns about the presence of a transmissible spongiform 
encephalopathy in food. While there is no evidence that scrapie is a 
human health risk, and significant epidemiological evidence that it is 
not, there is a perception of risk.
    In summary, this rule will further restrict the interstate movement 
of sheep and goats from States that do not follow effective management 
practices for scrapie. Interstate movement of sheep and goats is 
beneficial, as it reduces interstate price differences faced by 
consumers of livestock products and allows producers to seek the best 
available prices for their products. The rule will encourage States to 
carry out the necessary surveillance and quarantine activities quickly, 
thereby reducing the spread of the disease. The process outlined in the 
rule will encourage States to begin stringent surveillance procedures 
immediately to identify any additional infected flocks and help to 
realize the goal of eradicating scrapie from the United States. The 
rule will also encourage flock owners to participate in State scrapie 
programs or the Federal Scrapie Flock Certification Program, 
contributing further to the control of scrapie. Apart from the cost of 
program activities by APHIS and State agencies, and expenditure of 
indemnity funds by APHIS, the cost of identifying animals for 
interstate movement is the primary cost imposed by this rule. This cost 
will impose some burden upon owners, which will be passed along to 
those who are interested in buying these animals, possibly reducing 
interstate commerce in sheep and goats slightly.
    The changes to the regulations will result in new information 
collection or recordkeeping requirements, which have been approved by 
the Office of Management and Budget (see ``Paperwork Reduction Act'' 
below).

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 7 CFR part 3015, subpart V.)

Executive Order 12612 and Federalism

    It has been determined under section 6(a) of Executive Order 12612, 
``Federalism,'' that this rule does not have sufficient federalism 
implications to warrant the preparation of a federalism assessment. The 
provisions contained in this rule will not have a substantial direct 
effect on States or their political subdivisions or on the distribution 
of power and responsibilities among the various levels of government.
    The Administrator has examined the federalism implications of the 
requirements in this rule; i.e., different interstate movement 
requirements for sheep and goats depending on whether they are moving 
from a Consistent State or an Inconsistent State. The Administrator 
believes that this action adheres to Constitutional principles for the 
exercise of Federal power and is clearly authorized by statutory 
authorities delegated to APHIS.
    This action will not absolutely impose any new compliance costs on 
State or local governments, but it is true that this rule will strongly 
encourage some States to expend additional funds to upgrade their State 
programs for disease control in sheep and goats. Owners of sheep and 
goats in States that do not fund their programs to an extent that 
allows them to qualify as Consistent States would face additional 
restrictions on the interstate movement of their sheep and goats. 
However, this rule designates all States as Consistent States. If one 
or more States do not maintain Consistent State status, APHIS will 
review the effects on the particular States involved to determine 
whether the loss of that status will have a substantial direct effect 
on the States or their political

[[Page 43982]]

subdivisions or on the distribution of power and responsibilities among 
the various levels of government and, if necessary, prepare a 
federalism assessment.
    This final rule was preceded by proposed rules and an advance 
notice of proposed rulemaking which sought comments from the public, 
industry, and State and local officials. Those documents specifically 
requested comments addressing ``the alignment of Federal interstate 
movement restrictions with State standards.''
    Most States supported the proposal's intention to establish a 
system to certify that State programs for sheep and goats meet certain 
minimum standards, in order to provide a baseline of protection against 
the spread of disease when moving sheep and goats in interstate 
commerce. Very few officials commented that APHIS should accept any 
State animal health program without enforcing minimum standards. APHIS 
disagrees with this position because experience in animal health 
programs on a national level has shown that the absence of effective 
programs for scrapie in a few States can quickly cause animal disease 
problems and financial losses affecting many States as animals move in 
interstate commerce.
    State and local governments had the opportunity to comment on the 
proposed rules that preceded this final rule, and we encouraged them to 
submit comments on federalism concerns or any other issues. As 
implementation of this rule proceeds, APHIS intends to continue active 
consultation with State animal health agencies and the elected 
officials of affected State and local governments.

Executive Order 12988

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

Paperwork Reduction Act

    The information collection requirements that were contained in the 
proposed rule have been approved under OMB control number 0579-0101. 
This final rule adds an additional 66,154 burden hours for respondents. 
Part of this increase is due to the fact that we underestimated the 
paperwork burden associated with the proposed rule, as several 
commenters pointed out, and part of the increase results from changes 
in this final rule that add additional burden in order to improve the 
disease control effects of the rule and to make indemnity payments more 
equitable. Our changes in this final rule that made the definitions of 
exposed animal, infected flock, and source flock more science-based, 
and make the rule in general more risk-averse, will also result in more 
flocks being classified in these categories in the first year or two 
these regulations are in effect. However, regulated flocks should then 
decrease in number rapidly in subsequent years, compared to the 
decrease in numbers they would have experienced under the original 
proposed rule. In that sense, the changes in this final rule compress 
more of the paperwork burden into the first year or two of program 
operations, rather than adding more to the total burden. The paperwork 
burden estimated for this rule will also decrease significantly as soon 
as a valid live-animal test is in use, since such a test would have the 
general effect of reducing the number of animals subject to the 
regulations, and resolving suspect animal cases more quickly. While 
such a test is expected to be approved soon, we do not know exactly how 
soon, and therefore have estimated the paperwork burden without 
assuming the availability of such a test. Forthcoming advances in 
electronic animal identification methods should also reduce the 
paperwork burden estimated for this rule.
    As noted above, this additional burden resulted partly from changes 
to the definitions of exposed animal, infected flock, and source flock 
that resulted in more animals placed in these categories, causing 
additional identification and recordkeeping. Additional burden also 
resulted from changes in the final rule that require flock owners to do 
more individual animal identification, and that allowed slaughter 
plants and livestock markets to act as an agent for the owner in 
applying required official identification. Also, the final rule 
expanded the use of owner statements in connection with the movement of 
animals, resulting in the preparation of more such owners statements 
each year. Finally, changes to the indemnity procedure shifted 
indemnity values from a fixed-price approach to a market value 
approach, requiring more paperwork to document market prices at any 
given time and to base some indemnities on examination of sale records 
of flock owners. In accordance with section 3507(d) of the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this additional burden 
has been submitted for approval to the Office of Management and Budget 
(OMB). When OMB notifies us of its decision, we will publish a document 
in the Federal Register providing notice of the assigned OMB control 
number and expiration date, or, if approval is denied, providing notice 
of what action we plan to take.

Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub. 
L. 104-4, establishes requirements for Federal agencies to assess the 
effects of their regulatory actions on State, local, tribal 
governments, and the private sector. Under section 101 of the UMRA, 
APHIS generally must prepare a written statement, including a cost-
benefit analysis, for proposed and final rules with ``Federal 
mandates'' that may result in expenditures by State, local, or tribal 
governments, in the aggregate, or by the private sector, of $100 
million or more in any one year. When such a statement is needed for a 
rule, section 205 of the UMRA generally requires APHIS to identify and 
consider a reasonable number of regulatory alternatives and adopt the 
least costly, more cost-effective, or least burdensome alternative that 
achieves the objectives of the rule.
    This rule contains no Federal mandates (under the regulatory 
provisions of Title II of the UMRA) that may result in expenditures by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million or more in any one year. Thus, this 
rule is not subject to the requirements of sections 202 and 205 of the 
UMRA.

List of Subjects

9 CFR Part 54

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

9 CFR Part 79

    Animal diseases, Goats, Quarantine, Reporting and recordkeeping 
requirements, Scrapie, Sheep, Transportation.

    Accordingly, we are amending 9 CFR chapter I as follows:
    1. Part 54 is revised to read as follows:

PART 54--CONTROL OF SCRAPIE

Sec.
54.1   Definitions.
54.2   Cooperative agreements and memoranda of understanding with 
States.
Subpart A--Scrapie Indemnification Program
54.3   Animals eligible for indemnity payments.

[[Page 43983]]

54.4   Application by owners for indemnity payments.
54.5   Certification by owners.
54.6   Amount of indemnity payments.
54.7   Procedures for destruction of animals.
54.8   Requirements for flock plans and post-exposure management and 
monitoring plans.
54.9   Waiver of requirements for scrapie control pilot projects.
54.10   Tests for scrapie.
54.11   Approval of laboratories to run official scrapie tests and 
official genotype tests.
Subpart B--Scrapie Flock Certification Program
54.20   Administration.
54.21   Participation.
54.22   State scrapie certification boards.

    Authority: 21 U.S.C. 111, 114, 114a, and 134a-134h; 7 CFR 2.22, 
2.80, and 371.4.

Sec. 54.1  Definitions.

    Accredited veterinarian. A veterinarian approved by the 
Administrator in accordance with part 161 of this chapter to perform 
functions specified in subchapters B, C, and D of this chapter.
    Administrator. The Administrator of the Animal and Plant Health 
Inspection Service or any employee of the United States Department of 
Agriculture authorized to act for the Administrator.
    Animal. A sheep or goat.
    Animal and Plant Health Inspection Service (APHIS). The Animal and 
Plant Health Inspection Service of the United States Department of 
Agriculture.
    APHIS representative. An individual employed by APHIS in animal 
health activities who is authorized by the Administrator to perform the 
function involved.
    Approved laboratory. A laboratory approved by the Administrator in 
accordance with Sec. 54.11 to conduct one or more scrapie tests, or 
genotype tests, on one or more tissues.
    Approved test. A test for the diagnosis of scrapie approved by the 
Administrator for use in the scrapie eradication or certification 
program in accordance with Sec. 54.10.
    Area veterinarian in charge. The veterinary official of APHIS who 
is assigned by the Administrator to supervise and perform the official 
animal health work of APHIS in the State concerned.
    Breed association and registries. Organizations listed in 
Sec. 151.9 of this chapter that maintain the permanent records of 
ancestry or pedigrees of animals (including the animal's sire and dam), 
individual identification of animals, and ownership of animals.
    Certificate. An official document issued in accordance with 
Sec. 79.5 of this chapter by an APHIS representative, State 
representative, or accredited veterinarian at the point of origin of an 
interstate movement of animals.
    Commingle, commingled, commingling. Animals grouped together and 
having physical contact with each other, including contact through a 
fence, but not limited contacts. Commingling also includes sharing the 
same section in a transportation unit where there is physical contact.
    Designated scrapie epidemiologist. An epidemiologist who has 
demonstrated the knowledge and ability to perform the functions 
required and who has been selected by the State animal health official 
and the area veterinarian in charge. The regional epidemiologist and 
the APHIS National Scrapie Program Coordinator must concur in the 
selection and appointment of the designated scrapie epidemiologist. The 
designated scrapie epidemiologist must satisfactorily complete training 
designated by APHIS.
    Destroyed. (1) Euthanized by means other than slaughter, and the 
carcass disposed of, by means authorized by the Administrator; or
    (2) In the case of exposed or high-risk animals that are not known 
to be infected, either euthanized or disposed of by slaughter; or
    (3) Moved to a quarantined research facility if the movement has 
been approved by the Administrator.
    Electronic implant. Any radio frequency identification implant 
device approved for use in the scrapie program by the Administrator. 
The Administrator will approve an electronic implant after determining 
that it is tamper resistant, not harmful to the animal, and readable by 
equipment available to APHIS and State representatives.
    Exposed animal. (1) Any animal that has been in the same flock at 
the same time as a scrapie-positive female animal, excluding limited 
contacts; or
    (2) Any animal born in a flock after a scrapie-positive animal was 
born into that flock or lambed in that flock, if born before that flock 
completes the requirements of a flock plan; or
    (3) Any animal that was commingled with a scrapie-positive female 
animal during or up to 30 days after she lambed, kidded, or aborted, or 
while a visible vaginal discharge was present, or that was commingled 
with any other scrapie-positive female animal for 24 hours or more, 
including during activities such as shows and sales or while in 
marketing channels; or
    (4) Any animal in a noncompliant flock.
    Exposed flock. Any flock in which a scrapie-positive animal was 
born or lambed. Any flock that currently contains a female high-risk, 
exposed, or suspect animal, or that once contained a female high-risk, 
exposed, or suspect animal that lambed in the flock and from which 
tissues were not submitted for official testing and found negative. A 
flock that has completed a post-exposure management and monitoring plan 
following the exposure will no longer be an exposed flock.
    Flock. All animals that are maintained on a single premises and all 
animals under common ownership or supervision on two or more premises 
with animal interchange between the premises. Changes in ownership of 
part or all of a flock do not change the identity of the flock or the 
regulatory requirements applicable to the flock. Animals maintained 
temporarily on a premises for activities such as shows and sales or 
while in marketing channels are not a flock. More than one flock may be 
maintained on a single premises if:
    (1) The flocks are enrolled as separate flocks in the SFCP; or
    (2) A State or APHIS representative determines, based upon 
examination of flock records, that:
    (i) There is no interchange of animals between the flocks;
    (ii) The flocks never commingle and are kept at least 30 feet apart 
at all times or are separated by a solid wall through, over, or under 
which fluids cannot pass and through which contact cannot occur;
    (iii) The flocks have separate flock records and identification;
    (iv) The flocks have separate lambing facilities, including 
buildings and pastures, and a pasture or building used for lambing by 
one flock is not used by the other flock at any time; and
    (v) The flocks do not share equipment without cleaning and 
disinfection in accordance with Sec. 54.7(e). Additional guidance on 
acceptable means of cleaning and disinfection is also available in the 
Scrapie Flock Certification Program standards and the Scrapie 
Eradication Uniform Methods and Rules.
    Flock of origin. The flock in which an animal most recently resided 
in which it either was born, gave birth, or was used for breeding 
purposes. The determination of an animal's flock of origin may be based 
either on the physical presence of the animal in the flock, the 
presence of official identification on the animal traceable to the 
flock, the presence of other identification on the animal that is 
listed on the bill of sale, or other evidence, such as registry 
records.

[[Page 43984]]

    Flock plan. A written flock management agreement signed by the 
owner of a flock, the accredited veterinarian, if one is employed by 
the owner, and a State or APHIS representative in which each 
participant agrees to undertake actions specified in the flock plan to 
control the spread of scrapie from, and eradicate scrapie in, an 
infected flock or source flock or to reduce the risk of the occurrence 
of scrapie in a flock that contains a high-risk or an exposed animal. 
As part of a flock plan, the flock owner must provide the facilities 
and personnel needed to carry out the requirements of the flock plan. 
The flock plan must include the requirements in Sec. 54.8(a) through 
(f).
    Flock sire. A sexually intact male animal that has ever been used 
for breeding in a flock.
    High-risk animal. A sexually intact animal, excluding male sheep 
that have tested RR at codon 171 and AA at codon 136 using an official 
genotype test, that is:
    (1) The progeny of a scrapie-positive dam; or
    (2) Born in the same flock during the same lambing season as 
progeny of a scrapie-positive dam, unless the progeny of the scrapie-
positive dam are from separate contemporary lambing groups; or
    (3) Born in the same flock during the same lambing season that a 
scrapie-positive animal was born, or during any subsequent lambing 
season, if born before that flock completes the requirements of a flock 
plan; or
    (4) An exposed female sheep that has not tested QR, HR, or RR at 
codon 171 using an official genotype test.
    Infected flock. The flock of origin of a female animal that a State 
or APHIS representative has determined to be a scrapie-positive animal; 
or any flock in which a State or APHIS representative has determined 
that a scrapie-positive female animal has resided unless an 
epidemiologic investigation conducted by a State or APHIS 
representative shows that the animal did not lamb or abort in the 
flock. A flock will no longer be considered an infected flock after it 
has completed the requirements of a flock plan.
    Limited contacts. Incidental contacts between animals from 
different flocks off the flock's premises such as at fairs, shows, 
exhibitions and sales; between ewes being inseminated, flushed, or 
implanted; or between rams at ram test or collection stations. Embryo 
transfer and artificial insemination equipment and surgical tools must 
be sterilized between animals for these contacts to be considered 
limited contacts. Limited contacts do not include any contact, 
incidental or otherwise, with animals in the same flock or with a 
female animal during or up to 30 days after she lambed, kidded or 
aborted or when there is any visible vaginal discharge. Limited 
contacts do not include any activity where uninhibited contact occurs, 
such as sharing an enclosure, sharing a section of a transport vehicle, 
or residing in other flocks for breeding or other purposes. Examples of 
limited contacts may be found in the Scrapie Flock Certification 
Program standards.
    Live-animal screening test. Any test for the diagnosis of scrapie 
in a live animal that is approved by the Administrator as usually 
reliable but not definitive for diagnosing scrapie, and that is 
conducted in a laboratory approved by the Administrator.\1\
---------------------------------------------------------------------------

    \1\ The names and addresses of laboratories approved by the 
Administrator to conduct live-animal screening tests will be 
published in the Notices Section of the Federal Register. A list of 
approved laboratories is also available upon request from the Animal 
and Plant Health Inspection Service, Veterinary Services, National 
Animal Health Programs Staff, 4700 River Road Unit 43, Riverdale, MD 
20737-1235. State, Federal, and university laboratories will be 
approved by the Administrator when he or she determines that the 
laboratory: (a) Employs personnel trained by the National Veterinary 
Services Laboratories assigned to supervise the testing; (b) follows 
standard test protocols; (c) meets check test proficiency 
requirements; and (d) will report all test results to State and 
Federal animal health officials. Before the Administrator may 
withdraw approval of any laboratory for failure to meet any of these 
conditions, the Administrator must give written notice of the 
proposed withdrawal to the director of the laboratory and must give 
the director an opportunity to respond. If there are conflicts as to 
any material fact, a hearing will be held to resolve the conflicts.
---------------------------------------------------------------------------

    Mortgage. Any mortgage, lien, or other security or interest held by 
any person other than the one claiming indemnity.
    National Scrapie Database. A database designated by the 
Administrator in which APHIS and State animal health agencies 
cooperatively enter data concerning scrapie outbreaks, flocks and 
premises affected by scrapie, individual animal identification and 
premises identification data, and other data to support the Scrapie 
Eradication Program and the Scrapie Flock Certification Program.
    National Veterinary Services Laboratories (NVSL). The National 
Veterinary Services Laboratories, APHIS, U.S. Department of 
Agriculture, or an NVSL cooperating or contract laboratory.
    Noncompliant flock. (1) Any source or infected flock whose owner 
declines to enter into a flock plan or post-exposure management and 
monitoring plan agreement within 30 days of being so designated, or 
whose owner is not in compliance with either agreement;
    (2) Any exposed flock whose owner fails to make animals available 
for testing within 60 days of notification, or as mutually agreed, or 
whose owner fails to submit required postmortem samples;
    (3) Any flock whose owner has misrepresented, or who employs a 
person who has misrepresented, the scrapie status of an animal or any 
other information on a certificate, permit, owner statement, or other 
official document within the last 5 years; or
    (4) Any flock whose owner or manager has moved, or who employs a 
person who has moved, an animal in violation of this chapter within the 
last 5 years.
    Official genotype test. Any test to determine the genotype of a 
live or dead animal that is conducted at either an approved laboratory 
or at the National Veterinary Services Laboratories, when the animal is 
officially identified and the samples used for the test are collected 
and shipped to the laboratory by either an accredited veterinarian or a 
State or APHIS representative
    Official test. Any test for the diagnosis of scrapie in a live or 
dead animal that is approved by the Administrator for that use and 
conducted either at an approved laboratory or at the National 
Veterinary Services Laboratories.
    Owner. A person, partnership, company, corporation, or any other 
legal entity who has legal or rightful title to animals, whether or not 
they are subject to a mortgage.
    Post-exposure management and monitoring plan. A written agreement 
signed by the owner of a flock, any accredited veterinarian employed by 
the owner, and a State or APHIS representative in which each 
participant agrees to undertake actions specified in the agreement to 
monitor for the occurrence of scrapie in the flock for at least 5 years 
after the last high-risk or scrapie-positive animal is removed from the 
flock or after the last exposure of the flock to a scrapie-positive 
animal, unless otherwise specified by a State or APHIS representative. 
As part of a post-exposure management and monitoring plan, the flock 
owner must provide the facilities and personnel needed to carry out the 
requirements of the plan. The plan must include the requirements in 
Sec. 54.8.
    Scrapie control pilot project. A pilot project authorized by the 
Administrator in writing, designed to test or improve program 
procedures or to facilitate research, in order to control and eradicate 
scrapie. In addition to APHIS, participants may include State animal

[[Page 43985]]

health agencies, flock owners, and other parties as necessary.
    Scrapie Eradication Program. The cooperative State-Federal program 
administered by APHIS and Consistent States to control and eradicate 
scrapie.
    Scrapie Eradication Uniform Methods and Rules (UM&R). Cooperative 
procedures and standards adopted by APHIS and Consistent States for 
controlling and eradicating scrapie. The UM&R will be reviewed at least 
annually by representatives of the livestock industry and appropriate 
State and Federal agencies and the public and will be revised, and 
published as needed by APHIS.
    Scrapie Flock Certification Program (SFCP). The cooperative 
Federal-State-industry voluntary program for the control of scrapie 
conducted in accordance with this subpart.
    Scrapie Flock Certification Program standards. Cooperative 
procedures and standards adopted by APHIS and State scrapie 
certification boards for reducing the incidence and controlling the 
spread of scrapie through flock certification.\2\
---------------------------------------------------------------------------

    \2\ Individual copies of the Scrapie Flock Certification Program 
standards may be obtained on the World Wide Web at URL http://
www.aphis.usda.gov/vs/scrapie, or from the Animal and Plant Health 
Inspection Service, National Animal Health Programs Staff, 4700 
River Road Unit 43, Riverdale, MD 20737-1235.
---------------------------------------------------------------------------

    Scrapie-positive animal. An animal for which a diagnosis of scrapie 
has been made by the National Veterinary Services Laboratories or 
another laboratory authorized by the Administrator to conduct scrapie 
tests in accordance with this part, through:
    (1) Histopathological examination of central nervous system (CNS) 
tissues from the animal for characteristic microscopic lesions of 
scrapie;
    (2) The use of proteinase-resistant protein analysis methods 
including but not limited to immunohistochemistry and/or western 
blotting on CNS and/or peripheral tissue samples from a live or a dead 
animal for which a given method has been approved by the Administrator 
for use on that tissue;
    (3) Bioassay;
    (4) Scrapie associated fibrils (SAF) detected by electron 
microscopy; or
    (5) Any other test method approved by the Administrator in 
accordance with Sec. 54.10.\3\
---------------------------------------------------------------------------

    \3\ The names and addresses of laboratories approved by the 
Administrator to conduct tests are published in the Notices Section 
of the Federal Register. A list of approved laboratories is also 
available upon request from the Animal and Plant Health Inspection 
Service, Veterinary Services, National Animal Health Programs Staff, 
4700 River Road Unit 43, Riverdale, MD 20737-1235. State, Federal, 
and university laboratories will be approved by the Administrator 
when he or she determines that the laboratory: (a) Employs personnel 
trained by the National Veterinary Services Laboratories assigned to 
supervise the testing; (b) follows standard test protocols; (c) 
meets check test proficiency requirements; and (d) will report all 
test results to State and Federal animal health officials. Before 
the Administrator may withdraw approval of any laboratory for 
failure to meet any of these conditions, the Administratr must give 
written notice of the proposed withdrawal to the director of the 
laboratory and must give the director an opportunity to respond. If 
there are conflicts as to any material fact, a hearing will be held 
to resolve the conflict.
---------------------------------------------------------------------------

    Separate contemporary lambing groups. To be a separate contemporary 
lambing group, the group must be maintained separately such that the 
animals cannot come into physical contact with other lambs, kids, ewes 
or does or birth fluids or placenta from other ewes or does. This 
separate maintenance must preclude contact through a fence, during 
lambing and for 60 days following the date the last lamb or kid is born 
in a lambing season, and must preclude using the same lambing facility 
as other ewes or does, unless the lambing facility is cleaned and 
disinfected under supervision by an APHIS representative, State 
representative, or an accredited veterinarian between lambings in 
accordance with Sec. 54.7(e). Additional guidance on acceptable means 
of cleaning and disinfection is also available in the Scrapie Flock 
Certification Program standards and the Scrapie Eradication Uniform 
Methods and Rules. The flock owner must maintain adequate records to 
document which animals were maintained in each contemporary lambing 
group and to document when cleaning and disinfection was performed and 
who supervised it.
    Slaughter channels. Animals in slaughter channels include any 
animal that is sold, transferred, or moved either directly to a 
slaughter facility, to an individual for custom slaughter, or for 
feeding for the express purpose of improving the animals' condition for 
movement to slaughter. Any sexually intact animal that is commingled 
with breeding animals or that has been bred is not in slaughter 
channels. When selling animals for slaughter, owners should note on the 
bill of sale that the animals are sold only for slaughter.
    Source flock. A flock in which a State or APHIS representative has 
determined that at least one animal was born that was diagnosed as a 
scrapie-positive animal at an age of 72 months or less. The 
determination that an animal was born in a flock will be based on such 
information as the presence of official identification on the animal 
traceable to the flock, the presence of other identification on the 
animal that is listed on the bill of sale, or other evidence, such as 
registry records, to show that a scrapie-positive animal was born in 
the flock, combined with the absence of records indicating that the 
animal was purchased from outside and added to the flock. If DNA from 
the animal was previously collected by an accredited veterinarian and 
stored at an approved genotyping laboratory, or if DNA collection and 
storage are required for breed registration and the breed registration 
has appropriate safeguards in place to ensure the integrity of the 
banking process, the owner may request verification of the animal's 
identity based on DNA comparison if adequate records and identification 
have been maintained by the owner and the repository to show that the 
archived DNA is that of the animal that has been traced to the flock. 
The owner will be responsible for all costs for the DNA comparison. A 
flock will no longer be a source flock after it has completed the 
requirements of a flock plan.
    State. Each of the 50 States, the District of Columbia, the 
Northern Mariana Islands, Puerto Rico, and all territories or 
possessions of the United States.
    State representative. An individual employed in animal health 
activities by a State or a political subdivision of a State and who is 
authorized by the State or political subdivision to perform the 
function involved.
    Suspect animal. An animal will be designated a suspect animal in 
accordance with Sec. 79.4 of this chapter if it is:
    (1) A sheep or goat that exhibits any of the following possible 
signs of scrapie and that has been determined to be suspicious for 
scrapie by an accredited veterinarian or a State or APHIS 
representative: Weight loss despite retention of appetite; behavioral 
abnormalities; pruritus (itching); wool pulling; biting at legs or 
side; lip smacking; motor abnormalities such as incoordination, high 
stepping gait of forelimbs, bunny hop movement of rear legs, or swaying 
of back end; increased sensitivity to noise and sudden movement; 
tremor, ``star gazing,'' head pressing, recumbency, or other signs of 
neurological disease or chronic wasting.
    (2) A sheep or goat that has tested positive for scrapie or for the 
proteinase resistant protein associated with scrapie on a live-animal 
screening test or any other test, unless the animal is designated a 
scrapie-positive animal.
    (3) A sheep or goat that has tested inconclusive or suggestive on 
an official test for scrapie.
    Unofficial test. Any test for the diagnosis of scrapie or for the 
detection

[[Page 43986]]

of the proteinase resistant protein associated with scrapie in a live 
or dead animal that either has not been approved by the Administrator 
or that was not conducted at an approved laboratory or at the National 
Veterinary Services Laboratories.

Sec. 54.2  Cooperative agreements and memoranda of understanding with 
States.

    APHIS will execute cooperative agreements and/or memoranda of 
understanding with the animal health agency of any State in order to 
cooperatively administer the Scrapie Eradication Program and the 
Scrapie Flock Certification Program within that State. These agreements 
will describe the respective roles of APHIS and State personnel in 
implementing the Scrapie Eradication Program and the Scrapie Flock 
Certification Program. Each agreement may specify the financial, 
material, and personnel resources to be committed to these programs and 
other scrapie control measures by APHIS and the State; assign specific 
activities related to the control of scrapie within a State to APHIS or 
State personnel; establish schedules for APHIS representatives or State 
representatives to visit flocks; establish procedures for maintaining 
and sharing program records specified in this part, and specify other 
responsibilities of State representatives and APHIS representatives in 
support of the Scrapie Eradication Program and the Scrapie Flock 
Certification Program.

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

Subpart A--Scrapie Indemnification Program

Sec. 54.3  Animals eligible for indemnity payments.

    (a) Indemnity may be paid for an animal only after the owner of the 
animal has applied for indemnification and been approved in accordance 
with Sec. 54.4. Indemnity may be paid only for the following:
    (1) Destruction of high-risk animals;
    (2) Destruction of animals based on an epidemiologic investigation, 
when the Administrator determines that the destruction of these animals 
will contribute to the eradication of scrapie;
    (3) Destruction of live scrapie-positive animals;
    (4) Destruction of animals that test positive on a live-animal 
screening test; and
    (5) Destruction of suspect animals that are destroyed at the 
request of an APHIS representative.
    (b) No indemnity will be paid for an animal if the owner of the 
animal fails to provide APHIS, within 30 days of request, animal 
registration certificates, sale and movement records, or other records 
requested in accordance with Sec. 54.5. 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). Additional guidance on acceptable means 
of cleaning and disinfection is also available in the Scrapie Flock 
Certification Program standards and the Scrapie Eradication Uniform 
Methods and Rules. 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 assembled or increased his flock for the purpose 
of collecting or increasing indemnity.

Sec. 54.4  Application by owners for indemnity payments.

    (a) Normally, an application for indemnification will be initiated 
by a State or APHIS representative who is working with the owner of a 
flock that has already been determined to be an infected flock or 
source flock, or that is already under a State movement restriction. In 
such cases, the flock owner will confirm information about the flock's 
eligibility for indemnity that is contained in the application 
submitted by the State or APHIS representative. However, the owner of 
any flock may apply directly to receive indemnification by submitting 
to the Administrator a written request containing the following 
information:
    (1) Name, address, and social security number of the flock owner;
    (2) Number and breed(s) of animals in the flock, including a 
current inventory;
    (3) Location of flock premises;
    (4) Reasons the owner believes animals in his or her flock may be 
eligible for indemnification, including any diagnosis of scrapie made 
for animals in the flock; any signs of scrapie observed in the flock by 
the owner; and any movement of animals into the flock from flocks 
infected with or exposed to scrapie;
    (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). If the registration papers are unavailable, the owner may 
choose to accept a lesser indemnity in accordance with Sec. 54.6(b)(2) 
or the area veterinarian in charge may grant a 60-day extension or the 
Administrator may grant an extension longer than 60 days for the 
presentation of registration papers; and
    (6) Signed release letters addressed to any sheep or goat registry 
associations that maintain records of the owner's sheep or goats 
requesting the associations to release to APHIS all records maintained 
by the association on sheep or goats currently or formerly owned by the 
applicant.
    (b) APHIS will evaluate each application to determine whether the 
owner's flock contains animals eligible for indemnity in accordance 
with Sec. 54.3.

Sec. 54.5  Certification by owners.

    Before any indemnity is paid to an owner, the owner must sign a 
written agreement with APHIS, certifying the following:
    (a) The owner will make available for review upon request by a 
State or APHIS representative all bills of sale, pedigree registration 
certificates, and other records regarding movement of animals into and 
from the flock;
    (b) If the owner maintains any flock after the payment of indemnity 
or acquires a new flock that is housed on the same premises within 5 
years after the last high-risk or scrapie-positive animal is removed, 
the owner will maintain the flock in accordance with a post-exposure 
management and monitoring plan for 5 years;
    (c) If the animal for which indemnity is paid is subject to any 
mortgage, the owner consents to the payment of the indemnity, up to the 
value of the mortgage, to the person(s) holding the mortgage;
    (d) That the animal may be removed to a U.S. Department of 
Agriculture facility or a quarantined research facility, slaughtered, 
or euthanized and necropsied and tissues removed for diagnostic or 
other purposes.

Sec. 54.6  Amount of indemnity payments.

    (a) Indemnity paid for sheep in accordance with Sec. 54.3 will be 
set based on the following price reports published by the Agricultural 
Marketing Service (AMS). If pricing information is unavailable from 
these markets during a

[[Page 43987]]

given week or month or if the numbers of animals sold are too low to 
give an accurate market value, the preceding week or month's value will 
be used. The AMS reports from the most recent week or month prior to 
the date APHIS offers to pay an owner indemnity shall be used to 
calculate the indemnity for that owner's sheep:
    (1) The weekly weighted average Choice/Prime slaughter lamb price 
per pound at Greeley, CO;
    (2) The weekly weighted average Utility slaughter ewe price per 
pound at San Angelo, TX;
    (3) The monthly weighted average commercial western ewe lamb 
replacement price per head;
    (4) The monthly weighted average commercial western yearling ewe 
replacement price per head;
    (5) The monthly weighted average commercial western running age ewe 
price per head.
    (6) The monthly weighted average commercial western aged ewe price 
per head.
    (b) For animals under 1 year of age, the basic indemnity shall 
equal the price per pound from paragraph (a)(1) of this section times 
the greater of 50 lbs or the actual weight of the animal; except that, 
for ewe lambs under 1 year of age, the indemnity shall equal the per-
head price from paragraph (a)(3) of this section if that price is 
higher. For sexually intact sheep 8 years of age or older and castrated 
animals 1 year of age or older, the basic indemnity shall equal the 
price per pound from paragraph (a)(2) of this section times 150, based 
on an average weight of 150 lbs. For sexually intact sheep at least 1 
year of age and under 2 years of age, the indemnity shall equal the 
greater of the price per head from paragraph (a)(4) of this section, or 
the price per pound from paragraph (a)(2) of this section times 150, 
based on an average weight of 150 lbs. For sexually intact sheep at 
least 2 years of age and under 6 years of age, the basic indemnity 
shall equal the greater of the price per head from paragraph (a)(5) of 
this section or the price per pound from paragraph (a)(2) of this 
section times 150, based on an average weight of 150 lbs. For sexually 
intact sheep at least 6 years of age and under 8 years of age, the 
basic indemnity will equal the greater of the price per head from 
paragraph (a)(6) of this section or the price per pound from paragraph 
(a)(2) of this section times 150, based on an average weight of 150 
lbs. A premium shall be added to the basic indemnity for each 
registered animal, equal to $100 for each registered animal under 1 
year of age, $200 for each registered animal at least 1 year of age and 
under 4 years of age, and $100 for each registered animal at least 4 
years of age and under 8 years of age. An additional premium of $50 
will be added to the basic indemnity for each flock sire. The owner 
must provide adequate records to qualify for these premiums. When the 
animals to be indemnified are goats, or are sheep that fall outside the 
classes covered previously in this paragraph, the Administrator may 
take into consideration the producer's purchase records and sales 
records for the preceding 12 to 24 months in determining the indemnity 
amount, but the indemnity shall not exceed the maximum indemnity 
calculated for registered sheep in accordance with this section.
    (1) 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.
    (2) Any animal that is not registered at the time indemnity is 
first offered, but is eligible to be registered, will receive the 
registered animal premium reduced by $50.
    (c) For animals destroyed by slaughter, the owner will retain the 
salvage value (the amount paid by a slaughter plant for the animal) of 
the animals in lieu of receiving the base indemnity. If the salvage 
value, less transport costs, is less than the base indemnity, APHIS 
will pay the owner the difference. APHIS will also indemnify the owner 
in the amount of any registered animal or flock sire premiums for which 
the animal qualifies.
    (d) If the owner disagrees with the average weight estimate, he may 
have the sheep weighed at a public scale at his own expense, provided 
that the sheep 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 AMS weekly average price.
    (e) Indemnity will be paid to an owner only for animals actually in 
a flock at the time indemnity is first offered. Animals removed from 
the flock as part of a post-exposure management and monitoring plan 
will be paid indemnity based on the AMS average prices at the time an 
APHIS representative designates the animals for removal.

Sec. 54.7  Procedures for destruction of animals.

    (a) Scrapie-positive and suspect 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. Animals that are not scrapie-positive or 
suspect animals for which indemnification is sought may be:
    (1) Slaughtered when moved in accordance with part 79 of this 
chapter and with the prior written approval of the APHIS representative 
involved;
    (2) Destroyed on the premises where they are held, pastured, or 
penned at the time indemnity is approved;
    (3) Moved to an approved research facility; or
    (4) Moved to another location for destruction if an APHIS 
representative approves the movement in advance.
    (b) The carcasses of animals destroyed in accordance with this 
section are authorized by the Administrator to be buried, incinerated, 
or disposed of by other methods in accordance with local, State, and 
Federal laws. The carcasses of scrapie-positive and suspect animals may 
not be processed for human or animal food.
    (c) The destruction of animals and disposition of their carcasses 
in accordance with this part must be monitored by an APHIS 
representative who will prepare and transmit to the Administrator a 
report identifying the animals and showing their disposition.
    (d) APHIS may pay the reasonable costs of disposal for scrapie-
positive and suspect 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. The 
Administrator may also authorize payment of up to half the reasonable 
disposal costs for animals that are eligible to be destroyed by 
slaughter under this section but for which slaughter is not a practical 
or cost efficient means of disposal; Provided that, APHIS may pay more 
than one-half of the expenses when the Administrator determines that 
doing so will contribute to scrapie eradication. For

[[Page 43988]]

reimbursement to be made, the owner of the animals must present the 
area veterinarian in charge 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) Cleaning and disinfection of premises and equipment. When 
required, cleaning and disinfection shall be conducted under the 
supervision of a State or APHIS representative as follows. Additional 
guidance on acceptable means of cleaning and disinfection is also 
available in the Scrapie Flock Certification Program standards and the 
Scrapie Eradication Uniform Methods and Rules:
    (1) Drylot areas. When required, remove the manure and top 1-2 
inches of soil to reduce contamination. Bury, till under, or compost 
the removed material in areas not accessed by domestic animals or 
wildlife.
    (2) Cement, wood, metal, and other non-earth surfaces, tools, 
equipment, instruments, feed, hay, bedding, and other materials. Remove 
all organic material and compost or incinerate.
    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 the following methods:
    (i) Incinerate items by high-temperature incineration methods;
    (ii) Autoclave instruments, small tools, and other items at 136 
deg.C for 1 hour;
    (iii) To clean dry surfaces, apply a 2-percent chlorine bleach 
solution at room temperature (at least 18.3  deg.C for 1 hour, or apply 
a 1-molar solution of sodium hydroxide (approximately 5 oz. of sodium 
hydroxide dissolved in l gallon water) at room temperature for at least 
1 hour. Note: A 2-molar solution is more effective than a 1-molar 
solution and should be used when circumstances permit.

Sec. 54.8  Requirements for flock plans and post-exposure management 
and monitoring plans.

    (a) The owner of the flock or his or her agent must identify all 
animals 1 year of age or over within the flock. All animals less than 1 
year of age must be identified when a change of ownership occurs, with 
the exception of those animals under 1 year of age moving within 
slaughter channels that must be identified in accordance with 
Secs. 79.2 and 79.3 of this chapter. The form of identification must be 
an electronic implant, flank tattoo, ear tattoo, or tamper-resistant 
ear tag approved for this use by APHIS. In the case of goats, the form 
of identification may alternatively be a tail fold tattoo. 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.
    (b) Upon request by a State or APHIS representative, 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.
    (c) Upon request by a State or APHIS representative, the owner of 
the flock or his or her agent must make animals in the flock and the 
records required to be kept as a part of these plans available for 
inspection.
    (d) The owner of the flock or his or her agent must meet 
requirements found necessary by a State or APHIS representative 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; restrictions on the animals that may be 
moved from the flock; 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.
    (e) 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, 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; 
biting at legs or side; lip smacking; motor abnormalities such as 
incoordination, high stepping gait of forelimbs, bunny hop movement of 
rear legs, swaying of back end; increased sensitivity to noise and 
sudden movement; tremor, ``star gazing,'' head pressing, recumbency, or 
other signs of neurological disease or chronic wasting 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.
    (f) Requirements for flock plans only. (1) 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. The animals must be 
removed either by movement to an approved research facility or by 
euthanization and disposal of the carcasses by burial, incineration, or 
other methods in accordance with local, State, and Federal laws, or, in 
the case of high-risk animals, by movement to slaughter in accordance 
with the provisions of part 79 of this chapter, or upon request in 
individual cases by another means determined by the Administrator to be 
sufficient to prevent the spread of scrapie;
    (2) The premises of a flock under a flock plan must be cleaned and 
disinfected in accordance with Sec. 54.7(e). Additional guidance on 
acceptable means of cleaning and disinfection is also available in the 
Scrapie Flock Certification Program standards and the Scrapie 
Eradication Uniform Methods and Rules. 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 area 
where a scrapie-positive animal lambed or aborted may be exempted;
    (3) The owner of the flock, or his or her agent, must request breed 
associations and registries, livestock markets, 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; and
    (4) The flock owner must agree to conduct post-exposure management 
and monitoring.
    (g) Requirements for post-exposure management and monitoring plans 
only: The plan must require that a State or APHIS representative 
inspect the flock and flock records at least once every 12 months. The 
owner of the flock or his or her agent must maintain, and keep for a 
minimum of 5 years after an animal dies or is otherwise removed from a 
flock, the following records for each animal in the flock:
    (1) Any identifying marks or tags present on the animal, including 
the

[[Page 43989]]

animal's individual official identification number from its electronic 
implant, flank tattoo, ear tattoo, tamper resistant ear tag, or, in the 
case of goats, tail fold tattoo, and any secondary form of 
identification the owner of the flock may choose to maintain;
    (2) Sex, year of birth, breed, and when possible to determine, the 
following: sire, dam, and offspring of the animal;
    (3) Date of acquisition and previous flock, if the animal was not 
born in the flock; and
    (4) Disposition of the animal, including 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.
    (h) Modification of flock plans and post-exposure management and 
monitoring plans. A designated scrapie epidemiologist may modify the 
requirements of a flock plan or post-exposure management and monitoring 
plan to accommodate the situation of a particular flock if the modified 
plan requires:
    (1) That a State or APHIS representative inspect the flock and 
flock records at least once every 12 months;
    (2) The testing of animals at a level that will result in 99 
percent confidence of detecting a 1 percent prevalence in the flock 
(for flock plans only);
    (3) The official identification of all animals upon leaving the 
premises of the flock for purposes other than slaughter and of all 
animals over 18 months of age (as evidenced by the eruption of the 
second incisor) in slaughter channels; and
    (4) Recordkeeping including:
    (i) For acquired animals, the date of acquisition, name and address 
of the person from whom the animal was acquired, any identifying marks 
or tags present on the animal including the animal's individual 
official identification number from its electronic implant, flank 
tattoo, ear tattoo, tamper resistant ear tag, or, in the case of goats, 
tail fold tattoo, and any secondary form of identification the owner of 
the flock may choose to maintain.
    (ii) For animals leaving the premises of the flock, the disposition 
of the animal, including, for those animals that are required to be 
identified, any identifying marks or tags present on the animal, 
including the animal's individual official identification number from 
its electronic implant, flank tattoo, ear tattoo, tamper resistant ear 
tag, 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.
    (iii) Maintenance of these records for 5 years.
    (5) Requirements equivalent to those contained in paragraphs (b), 
(c), (d), and (e) of this section.
    (i) Post-exposure management and monitoring plans for exposed 
flocks that were not source flocks and in which a scrapie infected 
animal did not lamb. A designated scrapie epidemiologist shall 
determine the testing and monitoring requirements for these flocks 
based on the exposure risk of the individual flock.

Sec. 54.9  Waiver of requirements for scrapie control pilot projects.

    The Administrator may waive the following requirements of this part 
for participants in a scrapie control pilot project by recording the 
requirements waived in the scrapie control pilot project plan:
    (a) The determination that an animal is a high-risk animal, if the 
scrapie control pilot project plan contains testing or other procedures 
that indicate that an animal, despite meeting the definition of high-
risk animal, is unlikely to spread scrapie; and
    (b) The requirement that high-risk animals must be removed from a 
flock if the scrapie control pilot project plan contains alternative 
procedures to prevent the further spread of scrapie without removing 
high-risk animals from the flock.

Sec. 54.10  Tests for scrapie.

    (a) The Administrator may approve new tests for the diagnosis of 
scrapie conducted on live or dead animals for use in the Scrapie 
Eradication 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 reproducibility, that is, the ability to 
reproduce the same result repeatedly on a given sample;
    (3) Data to support suitability, that is, data to show that similar 
results can be produced when the test is run at other laboratories;
    (4) Data to support the sensitivity and specificity of the test; 
and
    (5) Any other data requested by the Administrator to determine the 
suitability of the test for program use.
    (b) To be approved, a scrapie test must be able to be replicated at 
the National Veterinary Services Laboratories, or another reliable, 
timely, and cost effective method of check testing must be available to 
APHIS.
    (c) A test or combination of tests may be approved for the 
identification of suspect animals, for the identification of 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 have a specificity comparable to the specificity 
of the currently approved tests. For a test to be approved as a live 
animal screening test for the identification of suspect animals, the 
test must be usually reliable but need not be definitive for diagnosing 
scrapie.
    (d) Specific guidelines for use of approved scrapie tests within 
the Scrapie Eradication Program or Scrapie Flock Certification Program 
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 based on the characteristics of the 
test, including specificity, sensitivity, and predictive value.
    (e) 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:
    (1) The test was run as part of a bona fide research protocol 
designed to evaluate an unapproved test in which the owner is not 
informed of the test result; or
    (2) The test protocol includes appropriate measures to prevent the 
spread of scrapie.

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 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;

[[Page 43990]]

    (3) Follows standard test protocols;
    (4) Meets check test proficiency requirements;
    (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 for 5 years;
    (7) Will allow APHIS to inspect the laboratory without notice 
during normal business hours; and
    (8) Will report all test results to State and Federal animal health 
officials within agreed timeframes. An inspection may include, but is 
not limited to, review and copying of records, examination of slides, 
observation of the test being conducted, and interviewing of personnel.
    (b) A laboratory may request approval to conduct one or more types 
of 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 withdraw approval of any laboratory for 
failure to meet any of the conditions required by paragraph (a) of this 
section. The Administrator shall give written notice of the proposed 
withdrawal to the director of the laboratory and shall give the 
director an opportunity to respond. If there are conflicts as to any 
material fact concerning the reason for withdrawal, a hearing will be 
held to resolve the conflicts.

Subpart B--Scrapie Flock Certification Program

Sec. 54.20  Administration.

    The Scrapie Flock Certification Program is a cooperative effort 
between APHIS; members of the sheep and goat industry, including owners 
of flocks, slaughtering and rendering establishments, and breed 
associations and registries; accredited veterinarians; and State 
governments. APHIS coordinates with State scrapie certification boards 
and State animal health agencies to encourage flock owners to certify 
their flocks as free of scrapie by being in continuous compliance with 
the Scrapie Flock Certification Program standards.

Sec. 54.21  Participation.

    Any owner of a sheep or goat flock may apply to enter the Scrapie 
Flock Certification Program by sending a written request to a State 
scrapie certification board or to the area veterinarian in charge. A 
notice containing a current list of flocks participating in the Scrapie 
Flock Certification Program, and the certification status of each 
flock, may be obtained from the APHIS web site at URL http://
www.aphis.usda.gov/vs/scrapie. A list of noncompliant flocks may also 
be obtained from this site, and either list may be obtained by writing 
to the Animal and Plant Health Inspection Service, National Animal 
Health Programs Staff, VS, APHIS, 4700 River Road Unit 43, Riverdale, 
MD 20737-1235.

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

Sec. 54.22  State scrapie certification boards.

    An area veterinarian in charge, after consulting with a State 
representative and industry representatives, may appoint a State 
scrapie certification board for the purpose of coordinating activities 
for the Scrapie Flock Certification Program, including making decisions 
to admit flocks to the Scrapie Flock Certification Program and to 
change flock status in accordance with the Scrapie Flock Certification 
Program standards. These boards are not appointed for the purpose of 
providing APHIS with consensus advice or policy recommendations. No 
more than one State scrapie certification board may be formed in each 
State. Each State scrapie certification board shall include as members 
the area veterinarian in charge, one or more State representatives, one 
or more accredited veterinarians, when possible, and one or more owners 
of flocks, and, at the discretion of the area veterinarian in charge, 
may include other members.
* * * * *

    2. Part 79 is revised to read as follows:

PART 79--SCRAPIE IN SHEEP AND GOATS

Sec.
79.1   Definitions.
79.2   Identification of sheep and goats in interstate commerce.
79.3   General restrictions.
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.
79.5   Issuance of certificates.
79.6   Standards for States to qualify as Consistent States.
79.7   Waiver of requirements for scrapie control pilot projects.

    Authority: 21 U.S.C. 111-113, 115, 117, 120, 121, 123-126, 134b, 
and 134f; 7 CFR 2.22, 2.80, and 371.4.

Sec. 79.1  Definitions.

    Accredited veterinarian. A veterinarian approved by the 
Administrator in accordance with part 161 of this chapter to perform 
functions specified in subchapters B, C, and D of this chapter.
    Administrator. The Administrator of the Animal and Plant Health 
Inspection Service or any employee of the United States Department of 
Agriculture authorized to act for the Administrator.
    Animal. A sheep or goat.
    Animal and Plant Health Inspection Service (APHIS). The Animal and 
Plant Health Inspection Service of the United States Department of 
Agriculture.
    APHIS representative. An individual employed by APHIS in animal 
health activities who is authorized by the Administrator to perform the 
function involved.
    Approved laboratory. A laboratory approved by the Administrator in 
accordance with Sec. 54.11 of this chapter to conduct one or more 
scrapie tests, or genotype tests, on one or more tissues.
    Area veterinarian in charge. The veterinary official of APHIS who 
is assigned by the Administrator to supervise and perform the official 
animal health work of APHIS in the State concerned.
    Blackfaced sheep. Any purebred suffolk, hampshire, shropshire or 
cross thereof, any non-purebred sheep known to have suffolk, hampshire, 
or shropshire ancestors, and any non-purebred sheep of unknown ancestry 
with a black face, except commercial hair sheep.
    Breed association and registries. Organizations listed in 
Sec. 151.9 of this chapter that maintain the permanent records of 
ancestry or pedigrees of animals (including the animal's sire and dam), 
individual identification of animals, and ownership of animals.
    Certificate. An official document issued in accordance with 
Sec. 79.5 by an APHIS representative, State representative, or 
accredited veterinarian at the point of origin of an interstate 
movement of animals.
    Commercial hair sheep. Any commercial sheep with hair rather than 
wool that is either a full-blooded hair sheep or that resulted from the 
cross of a hair sheep with a whitefaced wool sheep.
    Commercial sheep or goat. Any animal from a flock from which 
animals are moved only either directly to slaughter or through 
slaughter channels to slaughter or any animal that is raised only for 
meat or fiber production and that is not registered with a sheep or 
goat registry or used for exhibition.
    Commingle, commingled, commingling. Animals grouped together and 
having physical contact with each other, including contact through a 
fence,

[[Page 43991]]

but not limited contacts. Commingling also includes sharing the same 
section in a transportation unit where there is physical contact.
    Consistent State. (1) A State that the Administrator has determined 
conducts an active State scrapie control program that either:
    (i) Meets the requirements of Sec. 79.6; or
    (ii) Effectively enforces a State designed plan that the 
Administrator determines is at least as effective in controlling 
scrapie as the requirements of Sec. 79.6.
    (2) The Administrator has determined the following States to be 
Consistent States: Alabama, Alaska, Arizona, Arkansas, California, 
Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, 
Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, 
Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, 
Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, 
North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, 
Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, 
Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.
    Designated scrapie epidemiologist. An epidemiologist who has 
demonstrated the knowledge and ability to perform the functions 
required and who has been selected by the State animal health official 
and the area veterinarian in charge. The regional epidemiologist and 
the APHIS National Scrapie Program Coordinator must concur in the 
selection and appointment of the designated scrapie epidemiologist. The 
designated scrapie epidemiologist must satisfactorily complete training 
designated by APHIS.
    Direct movement to slaughter. Transported to a facility for 
slaughter, without stops or unloading except for feeding and watering 
during which the animals are not commingled with any other animals.
    Electronic implant. Any radio frequency identification implant 
device approved for use in the scrapie program by the Administrator. 
The Administrator will approve an electronic implant after determining 
that it is tamper resistant, not harmful to the animal, and readable by 
equipment available to APHIS and State representatives.
    Exposed animal. (1) Any animal that has been in the same flock at 
the same time as a scrapie-positive female animal, excluding limited 
contacts; or
    (2) Any animal born in a flock after a scrapie-positive animal was 
born into that flock or lambed in that flock, if born before that flock 
completes the requirements of a flock plan; or
    (3) Any animal that was commingled with a scrapie-positive female 
animal during or up to 30 days after she lambed, kidded, or aborted, or 
while a visible vaginal discharge was present, or that was commingled 
with any other scrapie-positive female animal for 24 hours or more, 
including during activities such as shows and sales or while in 
marketing channels; or
    (4) Any animal in a noncompliant flock.
    Exposed flock. Any flock in which a scrapie-positive animal was 
born or lambed. Any flock that currently contains a female high-risk, 
exposed, or suspect animal, or that once contained a female high-risk, 
exposed, or suspect animal that lambed in the flock and from which 
tissues were not submitted for official testing and found negative. A 
flock that has completed a post-exposure management and monitoring plan 
following the exposure will no longer be an exposed flock.
    Flock. All animals that are maintained on a single premises and all 
animals under common ownership or supervision on two or more premises 
with animal interchange between the premises. Changes in ownership of 
part or all of a flock do not change the identity of the flock or the 
regulatory requirements applicable to the flock. Animals maintained 
temporarily on a premises for activities such as shows and sales or 
while in marketing channels are not a flock. More than one flock may be 
maintained on a single premises if:
    (1) The flocks are enrolled as separate flocks in the SFCP; or
    (2) A State or APHIS representative determines, based upon 
examination of flock records, that:
    (i) There is no interchange of animals between the flocks;
    (ii) The flocks never commingle and are kept at least 30 feet apart 
at all times or are separated by a solid wall through, over, or under 
which fluids cannot pass and through which contact cannot occur;
    (iii) The flocks have separate flock records and identification;
    (iv) The flocks have separate lambing facilities, including 
buildings and pastures, and a pasture or building used for lambing by 
one flock is not used by the other flock at any time; and
    (v) The flocks do not share equipment without cleaning and 
disinfection in accordance with Sec. 54.7(e) of this chapter. 
Additional guidance on acceptable means of cleaning and disinfection is 
also available in the Scrapie Flock Certification Program standards and 
the Scrapie Eradication Uniform Methods and Rules.
    Flock of origin. The flock in which an animal most recently resided 
in which it either was born, gave birth, or was used for breeding 
purposes. The determination of an animal's flock of origin may be based 
either on the physical presence of the animal in the flock, the 
presence of official identification on the animal traceable to the 
flock, the presence of other identification on the animal that is 
listed on the bill of sale, or other evidence, such as registry 
records.
    Flock plan. A written flock management agreement signed by the 
owner of a flock, the accredited veterinarian, if one is employed by 
the owner, and a State or APHIS representative in which each 
participant agrees to undertake actions specified in the flock plan to 
control the spread of scrapie from, and eradicate scrapie in, an 
infected flock or source flock or to reduce the risk of the occurrence 
of scrapie in a flock that contains a high-risk or an exposed animal. 
As part of a flock plan, the flock owner must provide the facilities 
and personnel needed to carry out the requirements of the flock plan. 
The flock plan must include the requirements in Sec. 54.8(a)(f) of this 
chapter.
    High-risk animal. A sexually intact animal, excluding male sheep 
that have tested RR at codon 171 and AA at codon 136 using an official 
genotype test, that is:
    (1) The progeny of a scrapie-positive dam; or
    (2) Born in the same flock during the same lambing season as 
progeny of a scrapie-positive dam, unless the progeny of the scrapie-
positive dam are from separate contemporary lambing groups; or
    (3) Born in the same flock during the same lambing season that a 
scrapie-positive animal was born, or during any subsequent lambing 
season, if born before that flock completes the requirements of a flock 
plan; or
    (4) An exposed female sheep that has not tested QR, HR, or RR at 
codon 171 using an official genotype test.
    Inconsistent State. Any State other than a Consistent State.
    Infected flock. The flock of origin of a female animal that a State 
or APHIS representative has determined to be a scrapie-positive animal; 
or any flock in which a State or APHIS representative has determined 
that a scrapie-positive female animal has resided unless an 
epidemiologic investigation conducted by a State or APHIS 
representative shows that the animal did not lamb or abort in the 
flock. A flock will no longer

[[Page 43992]]

be considered an infected flock after it has completed the requirements 
of a flock plan.
    Interstate commerce. Trade, traffic, transportation, or other 
commerce between a place in a State and any place outside of that 
State, or between points within a State but through any place outside 
that State.
    Limited contacts. Incidental contacts between animals from 
different flocks off the flock's premises such as at fairs, shows, 
exhibitions and sales; between ewes being inseminated, flushed, or 
implanted; or between rams at ram test or collection stations. Embryo 
transfer and artificial insemination equipment and surgical tools must 
be sterilized between animals for these contacts to be considered 
limited contacts. Limited contacts do not include any contact, 
incidental or otherwise, with animals in the same flock or with an 
animal during or up to 30 days after she lambed, kidded or aborted or 
when there is any visible vaginal discharge. Limited contacts do not 
include any activity where uninhibited contact occurs, such as sharing 
an enclosure, sharing a section of a transport vehicle, or residing in 
other flocks for breeding or other purposes. Examples of limited 
contacts may be found in the Scrapie Flock Certification Program 
standards.
    Live-animal screening test. Any test for the diagnosis of scrapie 
in a live animal that is approved by the Administrator as usually 
reliable but not definitive for diagnosing scrapie, and that is 
conducted in a laboratory approved by the Administrator.\1\
---------------------------------------------------------------------------

    \1\ The names and addresses of laboratories approved by the 
Administrator to conduct live-animal screening tests will be 
published in the Notices Section of the Federal Register. A list of 
approved laboratories is also available upon request from the Animal 
and Plant Health Inspection Service, Veterinary Services, National 
Animal Health Programs Staff, 4700 River Road Unit 43, Riverdale, MD 
20737-1235. State, Federal, and university laboratories will be 
approved by the Administrator when he or she determines that the 
laboratory: (a) Employs personnel trained by the National Veterinary 
Services Laboratories assigned to supervise the testing; (b) follows 
standard test protocols; (c) meets check test proficiency 
requirements; and (d) will report all test results to State and 
Federal animal health officials. Before the Administrator may 
withdraw approval of any laboratory for failure to meet any of these 
conditions, the Administrator will give written notice of the 
proposed withdrawal to the director of the laboratory, and will give 
the director an opportunity to respond. If there are conflicts as to 
any material fact, a hearing will be held to resolve the conflicts.
---------------------------------------------------------------------------

    Low-risk commercial sheep. Commercial whitefaced, whitefaced cross, 
or commercial hair sheep from a flock with no known risk factors for 
scrapie, including any exposure to female blackfaced sheep, that are 
identified with a legible permanent brand or earnotch pattern 
registered with an official brand registry and that are not scrapie-
positive, suspect, high-risk, or exposed animals and are not animals 
from an infected, source, or exposed flock. The term brand includes 
official brand registry brands on eartags in those States whose brand 
law or regulation recognizes brands placed on eartags as official 
brands. Low-risk commercial sheep may only exist in a State where 
scrapie has not been diagnosed in the previous 10 years in commercial 
whitefaced, whitefaced cross, or commercial hair sheep that were not 
commingled with female blackfaced sheep.
    Low-risk goat. A goat that is not a scrapie-positive, suspect, 
high-risk, or exposed animal, that has not been commingled with sheep, 
and that is from:
    (1) A State in which scrapie has not been identified in a goat 
during the previous 10 years;
    (2) A State in which scrapie has been identified in a goat during 
the previous 10 years, but the scrapie-positive goat was not born in 
the State and resided in the State for less than 54 months and did not 
kid while in the State; or,
    (3) A State in which scrapie has been identified in a goat during 
the previous 10 years, and the scrapie-positive goat was commingled 
with sheep, but flock records allowed a complete epidemiologic 
investigation to be completed and all resulting infected, source, and 
exposed goat herds have completed flock plans and are in compliance 
with post-exposure monitoring plans.
    National Scrapie Database. A database designated by the 
Administrator in which APHIS and State animal health agencies 
cooperatively enter data concerning scrapie outbreaks, flocks and 
premises affected by scrapie, individual animal identification and 
premises identification data, and other data to support the Scrapie 
Eradication Program and the Scrapie Flock Certification Program.
    Noncompliant flock. (1) Any source or infected flock whose owner 
declines to enter into a flock plan or post-exposure management and 
monitoring plan agreement within 30 days of being so designated, or 
whose owner is not in compliance with either agreement;
    (2) Any exposed flock whose owner fails to make animals available 
for testing within 60 days of notification, or as mutually agreed, or 
whose owner fails to submit required postmortem samples;
    (3) Any flock whose owner has misrepresented, or who employs a 
person who has misrepresented, the scrapie status of an animal or any 
other information on a certificate, permit, owner statement, or other 
official document within the last 5 years; or
    (4) Any flock whose owner or manager has moved, or who employs a 
person who has moved, an animal in violation of this chapter within the 
last 5 years.
    Official eartag. An identification eartag approved by APHIS as 
being sufficiently tamper-resistant for the intended use and providing 
unique identification for each animal. An official eartag may conform 
to the alphanumeric National Uniform Eartagging system or another 
system approved by APHIS, or it may bear a premises identification 
number that either contains or is used in conjunction with the 
producer's livestock production numbering system to provide a unique 
identification number.
    Official genotype test. Any test to determine the genotype of a 
live or dead animal that is conducted at either an approved laboratory 
or at the National Veterinary Services Laboratories, when the animal is 
officially identified and the samples used for the test are collected 
and shipped to the laboratory by either an accredited veterinarian or a 
State or APHIS representative.
    Official identification. Identification mark or device approved by 
APHIS for use in the Scrapie Eradication Program. Examples are listed 
in Sec. 79.2(a)(2).
    Official test. Any test for the diagnosis of scrapie in a live or 
dead animal that is approved by the Administrator for that use and 
conducted either at an approved laboratory or at the National 
Veterinary Services Laboratories.
    Owner. A person, partnership, company, corporation, or any other 
legal entity who has legal or rightful title to animals, whether or not 
they are subject to a mortgage.
    Owner statement. A written statement by the owner that includes the 
owner's name, signature, address, and phone number, date the animals 
left the flock of origin, the premises identification number assigned 
to the premises, the number of animals, the premises portion of the 
premises identification if premises identification is used, and a 
statement that the animals were either born or were used for breeding 
purposes on the premises to which the premises identification is 
assigned.
    Ownership brand. A unique permanent legible brand or earnotch 
pattern applied to an animal that indicates ownership by a particular 
person when the brand pattern is registered with a State's official 
brand recording agency.

[[Page 43993]]

    Permit. An official document issued in connection with the 
interstate movement of animals (VS Form 1-27 or a State form that 
contains the same information) that is issued by an APHIS 
representative, State representative, or an accredited veterinarian 
authorized to sign such permits. A new permit is required for each 
change in destination for an animal. A permit lists the owner's name 
and address; points of origin and destination; number of animals 
covered; purpose of the movement; whether the animals are from an 
exposed, noncompliant, infected, or source flock; whether the animal is 
a high-risk, exposed, scrapie-positive, or scrapie suspect animal; 
transportation vehicle license number or other identification number; 
and seal number (if a seal is required). A permit also lists all 
official identification on the animals covered, including the official 
eartag number, individual animal registered breed association 
registration tattoo, individual animal registered breed association 
registration brand, United States Department of Agriculture backtag 
(when applied serially, only the beginning and the ending numbers need 
be recorded), individual animal registered breed association 
registration number, or any other form of official identification 
present on the animal.
    Premises identification. An APHIS approved eartag, backtag, or 
legible tattoo bearing the premises identification number, consisting 
of the State postal abbreviation or code followed by a unique 
alphanumeric number or name, assigned by a State or Federal animal 
health official to the premises of the flock of origin for the sheep or 
goats that, in the judgment of the State animal health official or area 
veterinarian in charge, is epidemiologically distinct from other 
premises, or a legible permanent brand or ear notch pattern registered 
with an official brand registry. Premises identification may be used 
when official individual animal identification is required, if the 
premises identification method either includes a unique animal number 
or is used in conjunction with the producer's livestock production 
numbering system to provide a unique identification number and where, 
if brands or ear notches are used, the animals are accompanied by an 
official brand inspection certificate. Clearly visible and/or legible 
paint brands may be used on animals moving directly to slaughter and on 
animals moving for grazing or other management purposes without change 
in ownership.
    Scrapie Eradication Program. The cooperative State-Federal program 
administered by APHIS and Consistent States to control and eradicate 
scrapie.
    Scrapie Eradication Uniform Methods and Rules (UM&R). Cooperative 
procedures and standards adopted by APHIS and Consistent States for 
controlling and eradicating scrapie. The UM&R will be reviewed at least 
annually by representatives of the livestock industry, appropriate 
State and Federal agencies, and the public and will be drafted, 
revised, and published as needed by APHIS.
    Scrapie Flock Certification Program (SFCP). The cooperative 
Federal-State-industry voluntary program for the control of scrapie 
conducted in accordance with subpart B of part 54 of this chapter.
    Scrapie Flock Certification Program standards. Cooperative 
procedures and standards adopted by APHIS and State Scrapie 
Certification Boards for reducing the incidence and controlling the 
spread of scrapie through flock certification.\2\
---------------------------------------------------------------------------

    \2\ Individual copies of the SFCP standards may be obtained on 
the World Wide Web at URL http://www.aphis.usda.gov/vs, or from the 
Animal and Plant Health Inspection Service, National Animal Health 
Programs Staff, 4700 River Road Unit 43, Riverdale, MD 20737-1235.
---------------------------------------------------------------------------

    Scrapie-positive animal. An animal for which a diagnosis of scrapie 
has been made by the National Veterinary Services Laboratories or 
another laboratory authorized by the Administrator to conduct scrapie 
tests in accordance with this chapter, through:
    (1) Histopathological examination of central nervous system (CNS) 
tissues from the animal for characteristic microscopic lesions of 
scrapie;
    (2) The use of proteinase-resistant protein analysis methods 
including but not limited to immunohistochemistry and/or western 
blotting on CNS and/or peripheral tissue samples from a live or a dead 
animal for which a given method has been approved by the Administrator 
for use on that tissue;
    (3) Bioassay;
    (4) Scrapie associated fibrils (SAF) detected by electron 
microscopy; or
    (5) Any other test method approved by the Administrator in 
accordance with Sec. 54.10 of this chapter.\3\
---------------------------------------------------------------------------

    \3\ The names and addresses of laboratories approved by the 
Administrator to conduct tests are published in the Notices Section 
of the Federal Register. A list of approved laboratories is also 
available upon request from the Animal and Plant Health Inspection 
Service, Veterinary Services, National Animal Health Programs Staff, 
4700 River Road Unit 43, Riverdale, MD 20737-1235. State, Federal, 
and university laboratories will be approved by the Administrator 
when he or she determines that the laboratory: (a) Employs personnel 
trained by the National Veterinary Services Laboratories assigned to 
supervise the testing; (b) follows standard test protocols; (c) 
meets check test proficiency requirements; and (d) will report all 
test results to State and Federal animal health officials. Before 
the Administrator may withdraw approval of any laboratory for 
failure to meet any of these conditions, the Administrator must give 
written notice of the proposed withdrawal to the director of the 
laboratory and must give the director an opportunity to respond. If 
there are conflicts as to any material fact, a hearing will be held 
to resolve the conflict.
---------------------------------------------------------------------------

    Separate contemporary lambing groups. To be a separate contemporary 
lambing group, the group must be maintained separately such that the 
animals cannot come into physical contact with other lambs, kids, ewes 
or does or birth fluids or placenta from other ewes or does. This 
separate maintenance must preclude contact through a fence, during 
lambing and for 60 days following the date the last lamb or kid is born 
in a lambing season, and must preclude using the same lambing facility 
as other ewes or does, unless the lambing facility is cleaned and 
disinfected under supervision by an APHIS representative, State 
representative, or an accredited veterinarian between lambings in 
accordance with Sec. 54.7(e) of this chapter. Additional guidance on 
acceptable means of cleaning and disinfection is also available in the 
Scrapie Flock Certification Program standards and the Scrapie 
Eradication Uniform Methods and Rules. The flock owner must maintain 
adequate records to document which animals were maintained in each 
contemporary lambing group and to document when cleaning and 
disinfection was performed and who supervised it.
    Slaughter channels. Animals in slaughter channels include any 
animal that is sold, transferred, or moved either directly to a 
slaughter facility, to an individual for custom slaughter, or for 
feeding for the express purpose of improving the animals' condition for 
movement to slaughter. Any sexually intact animal that is commingled 
with breeding animals or that has been bred is not in slaughter 
channels. When selling animals for slaughter, owners should note on the 
bill of sale that the animals are sold only for slaughter.
    Source flock. A flock in which a State or APHIS representative has 
determined that at least one animal was born that was diagnosed as a 
scrapie-positive animal at an age of 72 months or less. The 
determination that an animal was born in a flock will be based on such 
information as the presence of official identification on the animal 
traceable to the flock, the presence of other identification on the 
animal that is listed on the bill of sale, or other evidence, such as 
registry records, to

[[Page 43994]]

show that a scrapie-positive animal was born in the flock, combined 
with the absence of records indicating that the animal was purchased 
from outside and added to the flock. If DNA from the animal was 
previously collected by an accredited veterinarian and stored at an 
approved genotyping laboratory, or if DNA collection and storage are 
required for breed registration and the breed registration has 
appropriate safeguards in place to ensure the integrity of the banking 
process, the owner may request verification of the animal's identity 
based on DNA comparison if adequate records and identification have 
been maintained by the owner and the repository to show that the 
archived DNA is that of the animal that has been traced to the flock. 
The owner will be responsible for all costs for the DNA comparison. A 
flock will no longer be a source flock after it has completed the 
requirements of a flock plan.
    State. Each of the 50 States, the District of Columbia, the 
Northern Mariana Islands, Puerto Rico, and all territories or 
possessions of the United States.
    State representative. An individual employed in animal health 
activities by a State or a political subdivision of a State and who is 
authorized by the State or political subdivision to perform the 
function involved.
    Suspect animal. An animal will be designated a suspect animal in 
accordance with Sec. 79.4 if it is:
    (1) A sheep or goat that exhibits any of the following possible 
signs of scrapie and that has been determined to be suspicious for 
scrapie by an accredited veterinarian or a State or APHIS 
representative: Weight loss despite retention of appetite; behavioral 
abnormalities; pruritus (itching); wool pulling; biting at legs or 
side; lip smacking; motor abnormalities such as incoordination, high 
stepping gait of forelimbs, bunny hop movement of rear legs, or swaying 
of back end; increased sensitivity to noise and sudden movement; 
tremor, ``star gazing,'' head pressing, recumbency, or other signs of 
neurological disease or chronic wasting.
    (2) A sheep or goat that has tested positive for scrapie or for the 
proteinase resistant protein associated with scrapie on a live-animal 
screening test or any other test, unless the animal is designated a 
scrapie-positive animal.
    (3) A sheep or goat that has tested inconclusive or suggestive on 
an official test for scrapie.
    Terminal feedlot. (1) A dry lot approved by a State or APHIS 
representative or an accredited veterinarian authorized to perform this 
function where animals are separated from all other animals by at least 
30 feet at all times or are separated by a solid wall through, over, or 
under which fluids cannot pass and contact cannot occur and from which 
animals are moved only to another terminal feedlot or directly to 
slaughter; or
    (2) A pasture when approved by and maintained under the supervision 
of the State and in which only nonpregnant animals are permitted, where 
there is no direct fence-to-fence contact with another flock, and from 
which animals are moved only to another terminal feedlot or directly to 
slaughter.
    (3) Records of all animals entering and leaving a terminal feedlot 
must be maintained for 1 year after the animal leaves the feedlot and 
must include the person from whom the animals were acquired and the 
slaughtering facility in which they were slaughtered. Records must be 
made available for inspection by an APHIS or State representative upon 
request.
    Unofficial test. Any test for the diagnosis of scrapie or for the 
detection of the proteinase resistant protein associated with scrapie 
in a live or dead animal that either has not been approved by the 
Administrator or that was not conducted at an approved laboratory or at 
the National Veterinary Services Laboratories.

Sec. 79.2  Identification of sheep and goats in interstate commerce.

    (a) No sheep or goat that is required to be individually identified 
or premises identified by Sec. 79.3 may be sold, transported, received 
for transportation, or offered for sale or transportation in interstate 
commerce unless each sheep or goat is 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, 
by the owner of the flock or his or her agent; at whichever of the 
following points in commerce comes first, Except that; animals born 
after January 1, 2002, may be moved interstate direct to slaughter 
without identification to flock of birth until June 1, 2003, and 
animals that cannot be identified to their flock of origin because 
Consistent States have exempted them from flock of origin 
identification in intrastate commerce in accordance with 
Sec. 79.6(a)(10)(i) may be moved interstate with only individual animal 
identification traceable to the State of origin and to the owner of the 
animals at the time they were so identified:
    (i) The point of first commingling of the sheep or goats in 
interstate commerce with sheep or goats from any other flock of origin;
    (ii) Upon unloading of the sheep or goats in interstate commerce at 
any livestock market, except a market described in paragraph 
(a)(1)(iii) of this section;
    (iii) Upon leaving a livestock market that has been approved in 
accordance with this chapter to handle sheep and goats in interstate 
commerce and that has agreed to act as an agent for the owner to apply 
official identification to the animals. In such cases the animals must 
be:
    (A) Moved to the market and maintained until officially identified 
in distinguishable groups identifiable to their flocks of origin and 
when required their flock of birth by means of partitions or other such 
maintenance; and,
    (B) Accompanied by an owner statement that contains the information 
needed to officially identify the animals to their flock of origin and, 
when required, their flock of birth;
    (iv) Upon transfer of ownership of the sheep or goats in interstate 
commerce;
    (v) In the case of animals shipped directly to slaughter at a 
slaughter plant that has agreed to act as an agent for the owner to 
apply official identification to the animals, upon arrival of the sheep 
or goats in interstate commerce at the slaughter plant. In such cases 
the animals must be:
    (A) Moved to the slaughter plant and maintained until officially 
identified in distinguishable groups identifiable to their flocks of 
origin and when required their flock of birth by means of partitions or 
other such maintenance; and,
    (B) Accompanied by an owner statement that contains the information 
needed to officially identify the animals to their flock of origin and, 
when required, their flock of birth. If the slaughter plant has agreed 
to allow APHIS to conduct slaughter sampling, animals need not be 
identified if they arrive at the plant on days that an APHIS designated 
sampler is not available at the plant to collect samples; or
    (vi) Prior to moving a sheep or goat across a State line, unless 
the animals are moving to an approved livestock market in accordance 
with paragraph (a)(1)(iii) of this section or to an approved slaughter 
plant in accordance with paragraph (a)(1)(v) of this section.
    (2) The sheep or goats must be identified by one of the following 
means of identification, and must remain so identified until they reach 
their final destination:

[[Page 43995]]

    (i) Electronic implants for animals required to be identified by 
the SFCP, when used in a flock participating in the SFCP and when 
accompanied by a certificate or owner statement that includes the 
electronic implant numbers and the name of the chip manufacturer;
    (ii) Official eartags, including tags approved for use in the SFCP 
or APHIS-approved premises identification number eartags when combined 
with a unique animal identification number;
    (iii) United States Department of Agriculture backtags or official 
premises identification backtags that include a unique animal 
identification number, when used on sheep or goats moving directly to 
slaughter and when applied within 3 inches of the poll on the dorsal 
surface of the head or neck;
    (iv) Legible official registry tattoos that have been recorded in 
the book of record of a sheep or goat registry association when the 
animal is accompanied by either a registration certificate or a 
certificate of veterinary inspection. These tattoos may also be used as 
premises identification if they contain a unique premises prefix that 
has been linked in the National Scrapie Database with the assigned 
premises identification number of the flock of origin;
    (v) Premises identification eartags or tattoos, if the premises 
identification method includes a unique animal number or is combined 
with a flock eartag that has a unique animal number and the animal is 
accompanied by an owner statement; or
    (vi) Premises identification when premises identification is 
allowed by Sec. 79.3 and the animal is accompanied by an owner 
statement.
    (3) The owner of the flock of origin is responsible for the 
identification of animals required to be identified by this section. No 
person who buys or sells, for his or her own account or as the agent of 
the buyer or seller, transports, receives for transportation, offers 
for sale or transportation, or otherwise handles sheep or goats in 
interstate commerce shall receive or otherwise handle any animal in 
interstate commerce that has not been identified as required by this 
section. If an animal loses its identification to its flock of origin 
while in interstate commerce it is the responsibility of the person who 
has control or possession of the animal to identify the animal 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. If the flock of origin 
cannot be determined, all possible flocks of origin shall be listed on 
the record.
    (b) Serial numbers for use in official identification will be 
assigned to each person who applies to the State animal health official 
or the area veterinarian in charge for the State in which that person 
maintains his or her place of business. Serial numbers of official 
eartags will be assigned to each accredited veterinarian or State or 
APHIS representative who requests official eartags from the State 
animal health official or the area veterinarian in charge, whoever is 
responsible for issuing official eartags in that State. The official 
responsible for issuing eartags in a State may assign serial numbers of 
official eartags to other responsible persons, such as 4-H leaders, if 
the State animal health official and the area veterinarian in charge 
agree that such assignments will improve scrapie control and 
eradication within the State. Persons assigned serial numbers may 
either directly apply eartags to animals, or may reassign eartag 
numbers to producers. If these persons reassign eartag numbers, they 
must maintain appropriate records that permit traceback of animals to 
their flock of origin, or flock of birth when required. Premises 
identification eartag, backtag, and tattoo numbers (series of 
alphanumeric USDA tags and backtags may be assigned as premises 
identification if they are linked to the premises in the National 
Scrapie Database) will be assigned to animal owners by the State animal 
health official or the area veterinarian in charge, whoever is 
responsible for assigning premises codes in that State. Persons 
assigned serial numbers of United States Department of Agriculture 
backtags, official sheep and goat tattoos, official eartags, and 
premises identification numbers must:
    (1) If the person assigned the numbers is a flock owner, so that 
the assigned numbers are directly linked to the flock of origin in the 
national scrapie database, record the following information on a 
document:
    (i) The premises identification number or serial numbers;
    (ii) The number of animals so identified;
    (iii) The date the animals were identified;
    (iv) For animals born after January 1, 2002, that were not born in 
the flock of origin and that are not identified to the previous flock 
of origin, the individual identification number applied and the name, 
street address, including the city and State, or the township, county, 
and State, and the telephone number, if the telephone number is 
available, of the flock of birth if known.
    (2) If the person assigned the numbers is a veterinarian, extension 
agent, auction market operator, dealer, or any person other than the 
owner of the flock of origin, record the following information on a 
document:
    (i) All serial numbers applied to a sheep or goat;
    (ii) Any other serial numbers and approved identification appearing 
on the sheep or goat;
    (iii) The street address, including the city and State, or the 
township, county, and State, of the premises where the approved means 
of identification was applied;
    (iv) The date the identification was applied;
    (v) The name, street address, including the city and State, or the 
township, county, and State, and the telephone number if the telephone 
number is available, of the owner of the flock of origin and, if 
different, the person who owns or possesses the sheep or goat, and
    (vi) For animals born after January 1, 2002, that were not born in 
the flock of origin and that are not identified to the previous flock 
of origin, the individual identification number applied and the name, 
street address, including the city and State, or the township, county, 
and State, and the telephone number if the telephone number is 
available, of the flock of birth if known.
    (vii) The serial numbers, the manufacturer, and the type and color 
of all official tags received. Usually maintaining the tag invoice will 
meet this requirement.
    (3) Maintain these records for 5 years; and
    (4) Make these records available for inspection and copying during 
ordinary business hours (8 a.m. to 5:30 p.m., Monday through Friday) 
upon request by any authorized employee of the United States Department 
of Agriculture or the State, and presentation of his or her official 
credentials.
    (5) Any person who fails to comply with these requirements shall 
not be assigned serial numbers of United States Department of 
Agriculture backtags, official sheep and goat tattoos, official 
eartags, or premises identification numbers. If a person who is not in 
compliance with these requirements has already been assigned such 
serial numbers, the Administrator may withdraw the assignment by giving 
notice to such person. After such notice the person shall be subject to 
criminal and civil penalties if he continues to use those assigned 
serial numbers.

[[Page 43996]]

    (c) No person shall apply a premises identification number or a 
brand or earnotch pattern to an animal that did not originate on the 
premises 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 tags and backtags that have been assigned 
to a premises for use as premises identification and registration 
tattoos that contain prefixes that have been assigned to a premises for 
use as premises identification. This does not preclude the owner of a 
flock from using a premises identification number tag assigned to that 
flock on an animal owned by him that resides in that flock but that was 
born or previously resided on a different premises as long as the 
records required in paragraph (b)(1)(iv) of this section are 
maintained.
    (d) Each person who buys or sells, for his or her own account or as 
the agent of the buyer or seller, transports, receives for 
transportation, offers for sale or transportation, or otherwise handles 
sheep or goats in interstate commerce must ensure that the animals are 
identified as required in this part and must keep records relating to 
the transfer of ownership, shipment, or handling of the sheep or goats, 
such as yarding receipts, sale tickets, invoices, and waybills.
    (1) If official individual animal identification is required, the 
records must include the number of sheep and/or goats; the breed or 
cross if known; the name, street address, including city and State, or 
the township, county, and State, and the telephone number if the 
telephone number is available, of the owner of the flock of origin and, 
if different, the person from whom the sheep or goats were purchased or 
otherwise obtained; and a copy of any documents required to accompany 
the animal including any certificate, owner statement, letter, or 
permit; and
    (i) For animals not in slaughter channels the records must include 
all serial numbers and other approved means of identification appearing 
on the sheep or goat. This requirement may usually be met by 
maintaining a copy of the certificate that accompanied the animals. The 
premises number may be recorded instead of the individual numbers in 
the case of animals identified with premises identification if:
    (A) The premises identification meets the requirements of paragraph 
(a)(2)(v) of this section for individual animal identification; or
    (B) The animals are allowed to move interstate with only premises 
identification in accordance with Sec. 79.3.
    (ii) For animals in slaughter channels that are identified with 
individual animal identification traceable to the flock of origin or 
that are identified to the flock of origin with official premises 
identification that meets the requirements for individual animal 
identification, no additional records are required;
    (iii) For animals in slaughter channels that are identified with 
individual animal identification traceable to a previous flock but not 
to the flock of origin, or that are identified with official premises 
identification that meets the requirements for individual animal 
identification that is traceable to a previous flock but not to the 
flock of origin, the records must include all serial numbers and other 
approved means of identification appearing on the sheep or goat;
    (iv) For animals that are not required to be identified until they 
reach their final destination, the records must include the final 
destination.
    (2) If official premises identification is required or allowed, the 
records must include:
    (i) The premises identification number(s) and the number of animals 
identified with each premises number;
    (ii) Copies of any required documents such as the brand inspection 
certificate, an owner's statement, an accredited veterinarian's 
statement, or a health certificate;
    (iii) The name, street address, including city and State, or the 
township, county, and State, and the telephone number if the telephone 
number is available, of the owner of the flock of origin and, if 
different, the person from whom the sheep or goats were purchased or 
otherwise obtained.
    (3) Each person required to keep records under this paragraph must 
maintain the records for at least 5 years after the person has sold or 
otherwise disposed of the sheep or goat to another person, and for such 
further period as the Administrator may require by written notice to 
the person, for purposes of any investigation or action involving the 
sheep or goat identified in the records. The person must make the 
records available for inspection and copying during ordinary business 
hours (8 a.m. to 5:30 p.m., Monday through Friday) by any authorized 
employee of the United States Department of Agriculture or the State, 
upon that employee's request and presentation of his or her official 
credentials.
    (e) No person may remove or tamper with any means of identification 
required to be on sheep or goats pursuant to this section while the 
animals are in interstate commerce, and, at the time of slaughter, 
animal identification must be maintained throughout postmortem 
inspection in accordance with regulations of the Food Safety and 
Inspection Service, U.S. Department of Agriculture, in chapter III of 
this title.
    (f) Requirements for approval of official premises and individual 
identification tags. (1) The Administrator may approve tag companies to 
produce official premises and/or individual identification tags for use 
on sheep or goats. Tags may be plastic or metal and must be an 
appropriate size for use in sheep and goats. Tags must be able to 
legibly accommodate the required alphanumeric sequences. Tags must 
resist removal and be difficult to place on another animal once 
removed, but need not be tamper-proof. Tags must be readily 
distinguishable as USDA official sheep and goat tags, must carry the 
alphanumeric sequences, symbols, or logos specified by APHIS, and must 
have a means of discouraging counterfeiting, such as use of a unique 
copywrited logo or trade mark. Tags for use only on animals in 
slaughter channels must be marked with the words ``Meat'' or ``For 
Slaughter Only,'' or else must be used in conjunction with an ear 
tattoo of the word ``Meat.''
    (2) Written requests for approval of official premises 
identification tags for sheep and goats should be sent to the Animal 
and Plant Health Inspection Service, Veterinary Services, National 
Animal Health Programs Staff, Attention: National Scrapie Program 
Coordinator, 4700 River Road Unit 43, Riverdale, MD 20737-1235. The 
request must include:
    (i) Data supporting the durability of the tag and durability and 
legibility of the identification numbers and high retention rates of 
the tags in animals, preferably sheep and/or goats. Preference will be 
given to tags with high legibility and retention rates in sheep and 
goats that minimize injury to the ear.
    (ii) A signed statement agreeing to:
    (A) Send official eartags only to a State or APHIS representative, 
to a flock owner at the address to which the premises number or tag 
sequence was assigned by a State or APHIS representative, or as 
directed by APHIS;
    (B) Provide a monthly report by State of all tags produced, 
including the tag sequences produced and the person's and address to 
which the tags were shipped; and

[[Page 43997]]

    (C) When required by APHIS, enter the sequences of tags shipped 
into the National Scrapie Database through a web page interface or 
other means specified by APHIS.
    (iii) Twenty-five sample tags. Additional tags must be submitted if 
requested by APHIS.
    (3) Approval to produce official premises and/or individual 
identification tags will be valid for 1 year and must be renewed 
annually. The Administrator may also grant approval to produce tags for 
periods of less than 1 year in cases where all of the submissions 
required by this section have not been received or evaluated but there 
is substantial evidence that the tags meet the requirements of this 
section. The Administrator may decline to renew a company's approval if 
the tags do not show adequate retention and durability in field use or 
if any of the requirements of this section are not met by the tag 
company. If a company's tags do not show adequate retention and 
durability in field use or if any of the requirements of this section 
are not met by the tag company, the approval may be withdrawn with 60 
days written notice. Any person who is approved to produce official 
premises or individual identification tags in accordance with this 
section and who knowingly produces tags that are not in compliance with 
the requirements of this section, and any person who is not approved to 
produce such tags but does so, shall be subject to such civil penalties 
and such criminal liabilities as are provided by 18 U.S.C. 1001, 21 
U.S.C. 122 and 134e, or other applicable Federal statutes. Such action 
may be in addition to, or in lieu of, withdrawal of approval to produce 
tags.
    (g) New types of identification. Written requests for approval of 
sheep or goat identification devices and markings not listed in 
paragraph (a)(2) of this section should be sent to the Animal and Plant 
Health Inspection Service, Veterinary Services, National Animal Health 
Programs Staff, 4700 River Road Unit 43, Riverdale, MD 20737-1235. If 
the Administrator determines that the devices and markings will provide 
a means of tracing sheep and goats in interstate commerce, a proposal 
will be published in the Federal Register to add the devices and 
markings to the list of approved means of sheep and goat 
identification.

Sec. 79.3  General restrictions.

    The following prohibitions and movement conditions apply to the 
interstate movement of sheep and goats, and no sheep or goat may move 
interstate except in compliance with them.

      Interstate Movement General Restrictions for Sheep and Goats
    Note: A CONSISTENT STATE is one whose intrastate identification,
 reporting, and movement restrictions for infected and source flocks and
   high-risk animals are consistent with the APHIS standards for State
                            scrapie programs.
------------------------------------------------------------------------
                                   Moved from            Moved from
 Type of interstate movement   INCONSISTENT state     CONSISTENT state
------------------------------------------------------------------------
(a) Sale or other movement
 of breeding animals, show
 animals or any other animal
 not specifically addressed
 in this chart. General
 Condition: No animal may be
 removed from slaughter
 channels in interstate
 commerce if it was sold at
 a slaughter-only auction,
 is identified with a tag or
 ear tattoo marked ``meat''
 or ``slaughter only,'' or
 was sold with a bill of
 sale marked for slaughter
 only, and other animals may
 be removed from slaughter
 channels in interstate
 commerce only if they are
 identified to their flock
 of birth.--
    (1) High-risk, scrapie-   Prohibited \1\......  Prohibited \1\
     positive, or suspect
     animals, or animals
     from a noncompliant
     flock.
    (2) Non-high-risk         Prohibited \1\......  Prohibited,\1\
     animals from an                                 except as allowed
     infected or source                              in an approved
     flock that are not                              scrapie control
     scrapie-positive or                             pilot project flock
     suspect animals.                                plan and must meet
                                                     the requirements
                                                     for exposed
                                                     animals.
    (3) Sexually intact       Flock must be         Official individual
     exposed animals that      enrolled in the       animal
     are not scrapie-          Complete Monitored    identification and
     positive, suspect, or     category of the       a permit.\2\ For
     high-risk animals and     Scrapie Flock         any female exposed
     are not animals from an   Certification         sheep the results
     infected or source        Program or            of an official
     flock.                    equivalent APHIS      genotype test must
                               recognized program,   be included on or
                               have official         attached to the
                               individual animal     permit and must be
                               identification, and   QR or RR at codon
                               a permit.\2\ For      171. For any female
                               any female exposed    animal moving for
                               sheep the results     exhibition, the
                               of an official        permit must include
                               genotype test must    a statement by both
                               be included on or     the owner and an
                               attached to the       accredited
                               permit and must be    veterinarian that
                               QR or RR at codon     the animal has not
                               171. For any female   lambed or aborted
                               animal moving for     within 30 days of
                               exhibition, the       being exhibited and
                               permit must include   is not due to lamb
                               a statement by both   within 30 days of
                               the owner and the     being exhibited and
                               accredited            that there is no
                               veterinarian that     visible vaginal
                               the animal has not    discharge. For any
                               lambed or aborted     animal born after 1-
                               within 30 days of     1-2002, the permit
                               being exhibited and   must include the
                               is not due to lamb    flock of birth and
                               within 30 days of     the flock of
                               being exhibited and   origin, if
                               that there is no      different.
                               visible vaginal
                               discharge. For any
                               animal born after 1-
                               1-2002, the
                               certificate must
                               include the flock
                               of birth and the
                               flock of origin, if
                               different.

[[Page 43998]]

    (4) (i) Sexually intact   Flock must be         Official individual
     sheep except as allowed   enrolled in the       animal
     in (a)(7). (ii)           Complete Monitored    identification and
     Sexually intact goats,    category of the       a certificate. For
     except for low-risk       Scrapie Flock         any animal born
     goats.                    Certification         after 1-1-2002, the
                               Program or            certificate must
                               equivalent APHIS-     include the flock
                               recognized program,   of birth and the
                               have official         flock of origin, if
                               individual animal     different.
                               identification, and
                               a certificate. For
                               any animal born
                               after 1-1-2002, the
                               certificate must
                               include the flock
                               of birth and the
                               flock of origin, if
                               different.
    (5) Sexually intact low-  Official individual   Official individual
     risk goats.               animal                animal
                               identification and    identification and
                               a certificate. For    a certificate. For
                               any animal born       any animal born
                               after 1-1-2002, the   after 1-1-2002, the
                               certificate must      certificate must
                               include the flock     include the flock
                               of birth and the      of birth and the
                               flock of origin, if   flock of origin, if
                               different.            different.
    (6) Castrated animals     Official individual   None, except for
     that are not scrapie-     animal                exposed animals
     positive or suspect       identification and    that must have
     animals.                  a certificate.        official individual
                                                     animal
                                                     identification.
    (7) Low-risk commercial   Official individual   (i) Official
     sheep.                    animal                premises
                               identification and    identification that
                               a certificate, and    is a permanent
                               the flock must be     brand or ear notch
                               enrolled in the       pattern registered
                               Complete Monitored    with an official
                               category of the       brand registry;
                               Scrapie Flock        (ii) A brand
                               Certification         inspection
                               Program or an         certificate;
                               equivalent APHIS-    (iii) An owner
                               recognized program.   statement dated
                               For any animal born   within 30 days
                               after 1-1-2002, the   stating that the
                               certificate must      animals were born
                               include the flock     in the flock, that
                               of birth and the      the flock does not
                               flock of origin, if   contain any animal
                               different.            exhibiting signs of
                                                     scrapie, that to
                                                     the best of his or
                                                     her knowledge the
                                                     flock has no risk
                                                     factors for or
                                                     exposure to
                                                     scrapie, and that
                                                     the flock has never
                                                     contained: (A) Any
                                                     animal diagnosed as
                                                     having scrapie; (B)
                                                     any female
                                                     blackfaced sheep;
                                                     or (C) any female
                                                     blackfaced cross
                                                     sheep that were not
                                                     born in the flock;
                                                     and
                                                    (iv) An accredited
                                                     veterinarian's
                                                     statement issued
                                                     within 12 months of
                                                     the date of
                                                     movement indicating
                                                     that, to the best
                                                     of his or her
                                                     knowledge, the
                                                     flock has no known
                                                     risk factors for or
                                                     exposure to
                                                     scrapie, and that
                                                     he or she has
                                                     inspected the flock
                                                     and it does not
                                                     contain: (A) Any
                                                     animal exhibiting
                                                     signs of scrapie;
                                                     (B) any female
                                                     blackfaced sheep;
                                                     or (C) any female
                                                     blackfaced cross
                                                     sheep that were not
                                                     born in the flock.
                                                     The statements must
                                                     include the owner's
                                                     name, address, and
                                                     the premises
                                                     identification
                                                     number and a
                                                     drawing of the
                                                     owner's registered
                                                     brand or ear notch
                                                     pattern.
    (8) Commercial low-risk   Official individual   None.
     goats..                   animal
                               identification and
                               a certificate. For
                               any animal born
                               after 1-1-2002, the
                               certificate must
                               include the flock
                               of birth and the
                               flock of origin, if
                               different.
(b) Sale or other movement
 directly to slaughter,
 through slaughter channels
 to slaughter, or to
 feedlots for later movement
 to slaughter of animals
 that are under 18 months of
 age as evidenced by
 eruption of the second
 incisor, not pregnant, and
 have not lambed or kidded.
 General Condition: No
 animal may be removed from
 slaughter channels in
 interstate slaughter
 channels in interstate
 commerce if it was sold at
 a slaughter-only auction,
 is identified with a tag or
 ear tattoo marked ``meat''
 or ``slaughter only,'' or
 was sold with a bill of
 sale marked for slaughter
 only, and other animals may
 be removed from slaughter
 channels in interstate
 commerce only if they are
 identified to their flock
 of birth.--
    (1) Scrapie-positive or   Prohibited \1\......  Prohibited.\1\
     suspect animal.

[[Page 43999]]

    (2) Sexually intact high- Official individual   Official individual
     risk animals and          animal                animal
     sexually intact animals   identification and    identification and
     from infected or source   a permit, or a        a permit, or a
     flocks that are not       permit and an         permit and an
     scrapie-positive or       indelible ``S''       indelible ``S''
     suspect animals.          mark on the left      mark on the left
                               jaw, or sealed        jaw, or sealed
                               conveyance and a      conveyance and a
                               permit. (Note:        permit. (Note:
                               these animals may     these animals may
                               only be permitted     only be permitted
                               to slaughter or to    to slaughter or to
                               terminal              terminal
                               feedlots.\3\)         feedlots.\3\)
    (3) Exposed sexually      Official individual   Official individual
     intact animals that are   animal                animal
     not scrapie-positive,     identification for    identification for
     suspect, or high-risk.    any animal that is    any animal that is
     animals and that are      not moving directly   not moving direct
     not animals from an       to slaughter or to    to slaughter or to
     infected or source        a terminal            a terminal
     flock.                    feedlot.3, 4 (Note:   feedlot.3, 4 (Note:
                               pregnant animals      Pregnant animals
                               and animals with a    and animals with a
                               visible vaginal       visible vaginal
                               discharge may only    discharge may only
                               be permitted to       be permitted to
                               slaughter or to       slaughter or to
                               terminal feedlots.).  terminal feedlots.)
    (4) Sexually intact       Official premises     None.
     sheep that are not        identification or
     scrapie-positive,         official individual
     suspect, high-risk, or    animal
     exposed animals and are   identification for
     not animals from an       any animal that is
     infected or source        not moving direct
     flock.                    to slaughter or to
                               a terminal
                               feedlot.3
    (5) Sheep enrolled in     None................  None.
     the selective monitored
     or complete monitored
     category of the SFCP
     that are not scrapie-
     positive, suspect, high-
     risk, or exposed
     animals.
    (6) Castrated animals     None................  None.
     that are not scrapie-
     positive, or suspect
     animals.
    (7) Sexually intact       None................  None.
     goats that are not
     scrapie-positive,
     suspect, high-risk, or
     exposed animals and are
     not animals from an
     infected or source
     flock.
(c) Sale or other movement
 directly to slaughter,
 through slaughter channels
 to slaughter, or to
 feedlots for later movement
 to slaughter of animals
 that are over 18 months of
 age, as evidenced by
 eruption of the second
 incisor, or that are
 pregnant or that have
 lambed or kidded. General
 Condition: No animal may be
 removed from slaughter
 channels in interstate
 commerce if it was sold at
 a slaughter-only auction,
 is identified with a tag or
 ear tattoo marked ``meat''
 or ``slaughter only,'' or
 was sold with a bill of
 sale marked for slaughter
 only, and other animals may
 be removed from slaughter
 channels in interstate
 commerce only if they are
 identified to their flock
 of birth.--
    (1) Scrapie-positive or   Prohibited1.........  Prohibited.1
     suspect animal.
    (2) Sexually intact high- Official individual   Official individual
     risk animals and          animal                animal
     sexually intact animals   identification and    identification and
     from an infected or       a permit, or a        a permit, or a
     source flock that are     permit and an         permit and an
     not scrapie-positive,     indelible ``S''       indelible ``S''
     or suspect animals.       mark on the left      mark on the left
                               jaw, or sealed        jaw, or sealed
                               conveyance and a      conveyance and a
                               permit. (Note:        permit. (Note:
                               these animals may     These animals may
                               only be permitted     only be permitted
                               to slaughter or to    to slaughter or to
                               terminal feedlots.3   terminal feedlots.3
    (3) Sexually intact       Official individual   Official individual
     exposed animals that      animal                animal
     are not scrapie-          identification and    identification.
     positive, suspect, or     a permit, or a        (Note: pregnant
     high-risk animals and     permit and an         animals and animals
     are not animals from an   indelible ``S''       with a visible
     infected or source        mark on the left      vaginal discharge
     flock.                    jaw, or sealed        may only be moved
                               conveyance and a      directly to
                               permit when moving    slaughter or to
                               directly to           terminal
                               slaughter. (Note:     feedlots.3, 4
                               pregnant animals
                               and animals with a
                               visible vaginal
                               discharge may only
                               be permitted to
                               slaughter or to
                               terminal
                               feedlots.3, 4
    (4) Sheep over 18 months  Official individual   Official individual
     of age that are not       animal                animal
     scrapie-positive,         identification and    identification.\4\
     suspect, sexually         a certificate.\4\.
     intact high-risk, or
     sexually intact exposed
     animals and that are
     not sexually intact
     animals from an
     infected or source
     flock.
    (5) Low-risk commercial   Official individual   (i) Official
     sheep.                    animal                premises
                               identification and    identification that
                               a certificate \4\.    is a permanent
                                                     legible brand or
                                                     ear notch pattern
                                                     registered with an
                                                     official brand
                                                     registry or, in the
                                                     case of animals
                                                     moving directly to
                                                     slaughter, may be a
                                                     legible paint brand
                                                     registered with an
                                                     official brand
                                                     registry;
                                                    (ii) A brand
                                                     inspection
                                                     certificate;

[[Page 44000]]

                                                    (iii) An owner
                                                     statement dated
                                                     within 30 days of
                                                     the movement
                                                     stating that the
                                                     flock does not
                                                     contain any animal
                                                     exhibiting signs of
                                                     scrapie, and that,
                                                     to the best of his
                                                     or her knowledge,
                                                     the flock has no
                                                     risk factors for or
                                                     exposure to scrapie
                                                     and has never
                                                     contained: (A) Any
                                                     animal diagnosed as
                                                     having scrapie; (B)
                                                     any female
                                                     blackfaced sheep;
                                                     or (C) any female
                                                     blackfaced cross
                                                     sheep that was not
                                                     born in the flock;
                                                    (iv) An accredited
                                                     veterinarian's
                                                     statement issued
                                                     within 12 months of
                                                     the date of
                                                     movement indicating
                                                     that, to the best
                                                     of his or her
                                                     knowledge, the
                                                     flock has no known
                                                     risk factors for or
                                                     exposure to
                                                     scrapie, and that
                                                     he or she has
                                                     inspected the flock
                                                     and it does not
                                                     contain: (A) Any
                                                     animal exhibiting
                                                     signs of scrapie;
                                                     (B) any female
                                                     blackfaced sheep;
                                                     or (C) any female
                                                     blackfaced cross
                                                     sheep that was not
                                                     born in the flock.
                                                     The statements must
                                                     include the owner's
                                                     name, address, and
                                                     the premises
                                                     identification
                                                     number and a
                                                     drawing of the
                                                     owner's registered
                                                     brand or ear notch
                                                     pattern.\4\
    (6) Goats that are not    None................  None.
     scrapie-positive,
     suspect, sexually
     intact high-risk, or
     sexually intact exposed
     animals and that are
     not sexually intact
     animals from an
     infected or source
     flock.
(d) Movement of animals for
 grazing or other management
 purposes without change of
 ownership.--
    (1) Scrapie-positive,     Prohibited \1\......  Prohibited.\1\
     suspect, or sexually
     intact high-risk
     animals.
    (2) Non-high-risk         Prohibited \1\......  Prohibited,\1\
     animals from an                                 except as allowed
     infected or source                              in an approved
     flock.                                          scrapie control
                                                     pilot project flock
                                                     plan and must meet
                                                     the requirements
                                                     for exposed
                                                     animals.
    (3) Sexually intact       Official individual   Official individual
     exposed animals that      animal                animal
     are not scrapie-          identification and    identification and
     positive, suspect, or     a permit.\2\ For      a permit.\2\ For
     high-risk animals and     any female exposed    any female exposed
     that are not animals      sheep the results     sheep the results
     from an infected or       of an official        of an official
     source flock.             genotype test must    genotype test must
                               be included on or     be included on or
                               attached to the       attached to the
                               permit and must be    permit and must be
                               QR or RR at codon     QR or RR at codon
                               171.                  171.
    (4) Sexually intact       Official premises     None.
     sheep or sexually         identification and
     intact goats that have    a certificate..
     been commingled with
     sheep and that are not
     scrapie-positive,
     suspect, high-risk, or
     exposed animals and are
     not animals from an
     infected or source
     flock.
    (5) Sexually intact       None................  None.
     goats that have not
     been commingled with
     sheep and that are not
     scrapie-positive,
     suspect, high-risk, or
     exposed animals and are
     not animals from an
     infected or source
     flock.
    (6) Castrated animals     None................  None.
     that are not scrapie-
     positive or suspect
     animals and are not an
     animal from an infected
     or source flock.
------------------------------------------------------------------------
\1\ Animals prohibited movement may be moved interstate only if they are
  moving interstate for destruction or research as approved by the
  Administrator.
\2\ A copy of the permit must be sent to the State veterinarian and the
  AVIC of the receiving State prior to movement of animals.
\3\ No exposed or high-risk animal from any State or any animal from an
  Inconsistent State shall be removed from slaughter channels once it
  has entered interstate commerce.
\4\ Official individual animal identification or official premises
  identification is not required for these slaughter animals if the
  animals are kept as a group on the same premises on which they were
  born or used for breeding purposes and are not commingled with animals
  from another premises at any time, including throughout the feeding,
  marketing, and slaughter process.

[[Page 44001]]

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. A designated scrapie epidemiologist will designate 
an animal to be a scrapie-positive animal, high-risk animal, exposed 
animal, or suspect animal after determining that the animal meets the 
criteria of the relevant definition in Sec. 79.1.
    (1) A State or APHIS veterinarian will designate an animal to be a 
suspect animal after determining that the animal meets the criteria of 
the relevant definition in Sec. 79.1.
    (2) A designated scrapie epidemiologist will designate a flock to 
be a source, infected, or exposed flock after reviewing sale, movement, 
and breeding records that indicate the flock meets the criteria of the 
relevant definition in Sec. 79.1.
    (i) A designated scrapie epidemiologist may conduct testing of 
animals if he or she determines such testing is needed to properly 
designate a flock to be a source, infected, or exposed flock. The 
designated scrapie epidemiologist will select animals for testing in a 
manner that will provide a 95 percent confidence of detecting scrapie 
at a prevalence of 1 percent or, when flock records are adequate and 
all exposed animals that lambed in the flock are available for testing, 
may limit the testing to all exposed and suspect animals. Flocks 
meeting the definition of infected or source flocks that are designated 
as exposed flocks must complete a post exposure monitoring and 
management plan. Testing may include live-animal testing using a live-
animal official test, an official genotype test, the culling and 
postmortem examination and testing of genetically susceptible animals 
in the flock that cannot be evaluated by a live animal test, and 
postmortem examination and testing of animals found dead or cull 
animals at slaughter.
    (ii) If an owner does not make his or her animals available for 
testing within 60 days of notification 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. Any 
flock that is pending designation must comply with the movement 
restrictions for infected flocks.
    (3) A designated scrapie epidemiologist will designate a flock to 
be a noncompliant flock after determining that the flock meets the 
definition of a noncompliant flock in Sec. 79.1.
    (b) Redesignation. (1) A designated scrapie epidemiologist may 
reclassify an animal designated a high-risk animal as an exposed animal 
after receiving negative results from an official test or in accordance 
with an approved Scrapie Control Pilot Project.
    (2) A State or APHIS veterinarian may remove the suspect animal 
designation from an animal that had clinical signs of scrapie and that 
did not test positive for scrapie or for the proteinase resistant 
protein associated with scrapie upon determination that it is alive and 
no longer exhibits such signs, or that the signs are not caused by 
scrapie.
    (3) A designated scrapie epidemiologist may remove the suspect 
animal designation from an animal that has tested positive for scrapie 
or for the proteinase resistant protein associated with scrapie on an 
unofficial test based on knowledge of the test used or based on an 
epidemiologic investigation which may include additional testing of the 
suspect animal and or animals that have been commingled with the 
suspect animal.
    (4) A designated scrapie epidemiologist may remove the suspect 
animal designation from an animal that tested positive on a live-animal 
screening test based on an epidemiologic investigation which includes 
additional official testing of the suspect animal and when appropriate, 
animals that have been commingled with the suspect animal.
    (5) A designated scrapie epidemiologist may remove the exposed 
flock designation after completing an epidemiologic investigation or 
upon completion of a post-exposure management and monitoring plan. As 
part of the epidemiologic investigation the designated scrapie 
epidemiologist may conduct testing of animals if he or she determines 
such testing is needed to properly redesignate the flock. The 
designated scrapie epidemiologist will select animals for testing in a 
manner that will provide a 95 percent confidence of detecting scrapie 
at a prevalence of 1 percent or, when flock records are adequate and 
all exposed animals that lambed in the flock are available for testing, 
may limit the testing to all exposed and suspect animals. Testing may 
include live-animal testing using a live-animal official test, an 
official genotype test, the culling and postmortem examination and 
testing of genetically susceptible animals in the flock that cannot be 
evaluated by a live animal test, and postmortem examination and testing 
of animals found dead or cull animals at slaughter. A designated 
scrapie epidemiologist shall redesignate an exposed flock as a 
noncompliant flock if the owner fails to make his animals available for 
testing within 60 days of notification or as mutually agreed or fails 
to submit required postmortem samples.
    (6) Based on an epidemiologic investigation and testing, a 
designated scrapie epidemiologist may redesignate an infected flock or 
source flock as an exposed flock. The designated scrapie epidemiologist 
may only use this option when the epidemiologic investigation reveals 
that the scrapie exposure was minor or could not be confirmed due to 
inadequate records. The designated scrapie epidemiologist will select 
animals for testing in a manner that will provide a 95 percent 
confidence of detecting scrapie at a prevalence of 1 percent or, when 
flock records are adequate and all exposed animals that lambed in the 
flock are available for testing, may limit the testing to all exposed 
and suspect animals. Testing may include live-animal testing using a 
live-animal official test, an official genotype test, the culling and 
postmortem examination and testing of genetically susceptible animals 
in the flock that cannot be evaluated by a live animal test, and 
postmortem examination and testing of animals found dead or cull 
animals at slaughter. Infected or source flocks that are redesignated 
as exposed flocks must complete a post exposure monitoring and 
management plan. If an owner does not make his or her animals available 
for testing within 60 days of notification or as mutually agreed or 
fails to submit required postmortem samples, the flock designation will 
remain unchanged.
    (7) A designated scrapie epidemiologist may remove the noncompliant 
flock designation after reviewing any required testing of the flock and 
determining that the flock has complied with the required testing or no 
longer meets the definition of a noncompliant flock.
    (8) A designated scrapie epidemiologist may redesignate an exposed 
animal, exposed flock, or infected flock by removing that designation 
after completing an epidemiologic investigation and determining that 
the exposure was limited to a scrapie-positive male animal that was not 
born in the flock (the owner must have adequate records and animal 
identification to show that the scrapie-positive male animal was 
purchased).
    (c) Notice to owner. As soon as possible after making such a 
determination, a State or APHIS representative will attempt to notify 
the owner(s) of the flock(s) in writing that

[[Page 44002]]

their flock contained or contains a scrapie-positive animal, a suspect 
animal, a high-risk animal or an exposed animal, or that the flock is 
an infected, source, exposed, or noncompliant flock or that the flock 
is pending designation as an infected, source, exposed, or noncompliant 
flock. The notice will include:
    (1) A description of the interstate movement restrictions and 
identification requirements;
    (2) Reporting requirements;
    (3) Sample submission requirements for suspect and high-risk 
animals contained in this part;
    (4) Options for controlling the spread of scrapie from, and 
eradicating scrapie in, an infected flock or source flock or to reduce 
the risk of the occurrence of scrapie in a flock that contains a high-
risk or an exposed animal; and
    (5) In the case of flocks that are pending designation the 
notification shall include the testing options available to them and 
the designation their flock will receive if they decline to test.

Sec. 79.5  Issuance of certificates.

    (a) Certificates are required as specified by Sec. 79.3 for certain 
interstate movements of animals. A certificate must show the official 
ear tag number, individual animal registered breed association 
registration tattoo, individual animal registered breed association 
registration brand, individual animal registered breed association 
registration number, and any other official individual identification 
of each animal to be moved; provided that, in the case of animals 
identified with premises identification \4\ that is assigned to the 
flock of origin and that meets the requirements for individual animal 
identification, the premises number may be recorded instead of the 
individual identification numbers. A certificate must also show the 
number of animals covered by the certificate; the purpose for which the 
animals are to be moved; the points of origin and destination; the 
consignor, and the consignee. Certificates must indicate the flock of 
birth for any breeding sheep born after January 1, 2002, that are 
covered by the certificate. The certificate must include a statement by 
the issuing accredited or State or Federal veterinarian that the 
animals were not exhibiting clinical signs associated with scrapie at 
the time of examination and an owner statement indicating whether the 
animal is or is not a scrapie-positive, suspect, high-risk or exposed 
animal and whether it originated in an infected, source, exposed, or 
noncompliant flock. Except as provided in paragraphs (b) and (c) of 
this section, all of the information required by this paragraph must be 
typed or written on the certificate. Note that in accordance with 
Sec. 79.3(a), (b), and (c), scrapie-positive, suspect, and high-risk 
animals, some exposed animals, and animals that originated in an 
infected or source flock require permits rather than certificates.
---------------------------------------------------------------------------

    \4\ Ownership brands may be used on certificates for sheep and 
goats moved interstate when premises identification is required 
under this part, provided the ownership brands are legible and are 
registered with the official brand recording agency and the animals 
are accompanied by a brand inspection certificate.
---------------------------------------------------------------------------

    (b) Animal identification documents attached to certificates. As an 
alternative to typing or writing individual animal identification on a 
certificate, 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;
    (2) A legible copy of the document must be stapled to the original 
and each copy of the certificate;
    (3) Each copy of the document must identify each animal to be moved 
with the certificate, 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 typed or written in ink in 
the identification column on the original and each copy of the 
certificate 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 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 certificates. As an 
alternative to typing or writing ownership brands on a certificate, 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 certificate;
    (2) Each copy of the official brand inspection certificate must 
show the ownership brand of each animal to be moved with the 
certificate, 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 
certificate 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.

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

    (a) In reviewing a State for Consistent State status, the 
Administrator will evaluate the State statutes, regulations, and 
directives pertaining to animal health activities; reports and 
publications of the State animal health agency; and a written statement 
from the State animal health agency describing State scrapie control 
activities and certifying that these activities meet the requirements 
of this section. In determining whether a State is a Consistent State, 
the Administrator will determine whether the State:
    (1) Has the authority, based on State law or regulation, to 
restrict the movement of all scrapie-infected and source flocks.
    (2) Has the authority, based on State law or regulation, to require 
the reporting of any animal suspected of having scrapie and test 
results for any animals tested for scrapie to State or Federal animal 
health authorities.
    (3) Has, in cooperation with APHIS personnel, drafted and signed a 
memorandum of understanding between APHIS and the State that delineates 
the respective roles of each in the National Scrapie Program 
implementation.
    (4) Has placed all known scrapie-infected and source flocks under 
movement restrictions, with movement of animals only to slaughter, to 
feedlots under permit and movement restrictions that ensure later 
movement to slaughter, for destruction, or for research. Scrapie-
positive and suspect animals may be moved only for transport to an 
approved research facility or for purposes of destruction.
    (5) Has effectively implemented policies to:
    (i) Investigate all animals reported as scrapie suspect animals 
within 7 days of notification;
    (ii) Designate a flock's status, within 15 days of notification 
that the flock contains a scrapie-positive animal, based on an 
investigation by State or

[[Page 44003]]

Federal animal health authorities and in accordance with this part;
    (iii) Restrict the movement, in accordance with paragraph (a)(4) of 
this section, of newly designated scrapie-infected and source flocks 
within 7 days after they are designated in accordance with Sec. 79.4;
    (iv) Relieve infected and source flock movement restrictions only 
after completion of a flock plan created in accordance with Sec. 54.14 
of this chapter or a flock plan created in accordance with an approved 
scrapie control pilot project, or as permitted by the conditions of 
such a flock plan, and after agreement by the owner to comply with a 5-
year post-exposure management and monitoring plan;
    (v) Conduct an epidemiologic investigation of source and infected 
flocks that includes the designation of high-risk and exposed animals 
and that identifies animals to be traced;
    (vi) Conduct tracebacks of scrapie-positive animals and traceouts 
of high-risk and exposed animals and report any out-of-State traces to 
the appropriate State within 45 days of receipt of notification of a 
scrapie-positive animal; and
    (vii) Conduct tracebacks based on slaughter sampling within 15 days 
of receipt of notification of a scrapie-positive animal at slaughter.
    (6) Effectively monitors and enforces quarantines.
    (7) Effectively enforces State reporting laws and regulations for 
scrapie.
    (8) Has designated at least one APHIS or State animal health 
official to coordinate scrapie program activities in the State and to 
serve as the designated scrapie epidemiologist in the State.
    (9) Has educated those engaged in the interstate movement of sheep 
and goats regarding the identification and recordkeeping requirements 
of this part.
    (10) Has provided APHIS with a plan and timeline for complying with 
the following additional requirements, which must be met within 2 years 
of designation of the State as a Consistent State \5\:
---------------------------------------------------------------------------

    \5\ This provision would apply until January 1, 2003. Any State 
designated as a Consistent State after that date would have to meet 
all requirements prior to designation.
---------------------------------------------------------------------------

    (i) Requires, based on State law or regulation, and effectively 
enforces official identification upon change of ownership of all 
animals of any age not in slaughter channels and any sheep over 18 
months of age as evidenced by eruption of the second incisor such that 
the animal may be traced to its flock of birth; provided that:
    (A) A State may exempt commercial goats in intrastate commerce that 
have not been in contact with sheep from this identification 
requirement if there has been in that State no case of scrapie in a 
commercial goat in the past 10 years that originated in that State and 
cannot be attributed to exposure to infected sheep, and there are no 
exposed commercial goat herds in that State; and
    (B) A State may exempt commercial whitefaced sheep or commercial 
hair sheep under 18 months of age in intrastate commerce from this 
identification requirement if there has been in that State no case of 
scrapie in the exempted class that originated from that State, and 
there are no exposed commercial whitefaced or hair sheep flocks in that 
State that have been exposed by a female animal.
    (C) States that exempt these types of commercial animals must put 
in place the regulations necessary to require identification of these 
animals within 90 days of these conditions no longer existing.
    (ii) Maintains in the National Scrapie Database administered by 
APHIS, or in a State database approved by the Administrator as 
compatible with the National Scrapie Database, the State's:
    (A) Premises information and assigned premises numbers and 
individual identification number sequences assigned for use as premises 
identification;
    (B) Individual animal information on all scrapie-positive, suspect, 
high-risk, and exposed animals in the State;
    (C) Individual animal information on all out-of-State animals to be 
traced; and
    (D) Accurate flock status data.
    (iii) Requires official individual identification of any live 
scrapie-positive, suspect, or high-risk animal of any age and of any 
sexually intact exposed animal of more than 1 year of age or any 
sexually intact exposed animal of less than 1 year of age upon change 
of ownership (except for exposed animals moving in slaughter channels 
at less than 1 year of age), whether or not the animal resides in a 
source or infected flock.
    (iv) Effectively enforces movement restrictions on all scrapie-
positive, suspect, and high-risk animals throughout their lives unless 
they are moved in accordance with Sec. 79.3.
    (v) Requires that tissues from all scrapie-positive or suspect 
animals and female high-risk animals that have lambed (when they have 
died or have been destroyed) be submitted to a laboratory authorized by 
the Administrator to conduct scrapie tests and requires complete 
destruction of the carcasses of scrapie-positive and suspect animals.
    (vi) Prohibits any animal from being removed from slaughter 
channels unless it is identified to the flock of birth, is not from an 
Inconsistent State, and is not scrapie-exposed or from an infected or 
source flock.
    (b) If the Administrator determines that statutory changes are 
needed to bring a State into full compliance, the Administrator may 
grant up to a 2-year extension to allow a State to acquire additional 
authorities before removing a State's Consistent Status. The decision 
to grant an extension will be based on the State's ability to prevent 
the movement of scrapie-infected animals out of the State and on the 
progress being made in making the needed statutory changes.

Sec. 79.7  Waiver of requirements for scrapie control pilot projects.

    (a) The Administrator may waive the following requirements of this 
part for participants in a scrapie control pilot project by recording 
the requirements waived in the scrapie control pilot project plan:
    (1) The determination that an animal is a high-risk animal, if the 
scrapie control pilot project plan contains testing or other procedures 
that indicate that an animal, despite meeting the definition of high-
risk animal, is unlikely to spread scrapie; and
    (2) The requirement that high-risk animals must be removed from a 
flock, if the scrapie control pilot project plan contains alternative 
procedures to prevent the further spread of scrapie without removing 
high-risk animals from the flock.
    (b) [Reserved]

    Done in Washington, DC, this 9th day of August 2001.
Bill Hawks,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 01-20693 Filed 8-20-01; 8:45 am]
BILLING CODE 3410-34-P