[Federal Register Volume 64, Number 229 (Tuesday, November 30, 1999)]
[Proposed Rules]
[Pages 66791-66812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31087]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 54 and 79

[Docket No. 97-093-2]
RIN 0579-AA90


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

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to restrict the interstate movement of sheep 
and goats from States that do not follow effective flock management 
practices for scrapie. We also propose to require animal identification 
for sheep and goats moving interstate and to reinstate a scrapie 
indemnity program to compensate owners of certain animals destroyed due 
to scrapie. These changes would help prevent the interstate spread of 
scrapie, an infectious disease of sheep and goats.

DATES: Consideration will be given only to comments received on or 
before December 30, 1999.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 97-093-2, Regulatory Analysis and Development, PPD, APHIS, 
suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238.

[[Page 66792]]

Please state that your comments refer to Docket No. 97-093-2. Comments 
received may be inspected at USDA, room 1141, South Building, 14th 
Street and Independence Avenue, SW., Washington, DC, between 8 a.m. and 
4:30 p.m., Monday through Friday, except holidays. Persons wishing to 
inspect comments are requested to call ahead on (202) 690-2817 to 
facilitate entry into the comment reading room.

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) 734-7709.

SUPPLEMENTARY INFORMATION: Scrapie is a degenerative and eventually 
fatal disease affecting the central nervous systems of sheep and goats, 
a member of a class of diseases called transmissible spongiform 
encephalopathies (TSEs). Its control is complicated because the disease 
has an extremely long incubation period without clinical signs of 
disease, and because there is no live-animal test for the disease that 
has been validated (demonstrated to be accurate by impartial research).
    Scrapie is not a highly contagious disease; however, transmission 
to uninfected and susceptible animals can sometimes occur following 
exposure to small amounts of tissues from an infected animal. The exact 
conditions favorable to animal-to-animal transmission are not fully 
understood, though some factors that increase the risk are known (e.g., 
contact of a young animal with the afterbirth of an infected female 
animal). The scrapie agent moves from infected to susceptible animals 
by direct animal-to-animal contact, or indirect contact through 
contaminated premises and may enter through the gastrointestinal tract, 
open wounds, or other routes. Consequently, its spread appears to be 
both maternal (mother to offspring) and horizontal (direct contact 
between unrelated sheep).
    There is no evidence that any human has ever contracted scrapie or 
any similar disease by eating lamb or mutton. However, it has been 
theorized that scrapie may have been spread to other animals when whole 
scrapie-positive animals have been rendered and used as animal feed. 
This is a prominent theory for the origin of bovine spongiform 
encephalopathy (BSE) in cattle in the United Kingdom. As a 
precautionary measure to prevent the possible spread of TSEs via 
ruminant feed in the United States, the U.S. Food and Drug 
Administration published a final rule on June 5, 1997 (62 FR 30935-
30978) that prohibited the use of animal protein derived from most 
mammalian tissues in ruminant feed.
    While diseases caused by TSEs do not frequently or easily cross 
species lines, there is reason to be concerned that TSEs infecting one 
species could at some point lead to diseases in other animal species or 
humans, as has been demonstrated with BSE in cattle in the United 
Kingdom. New variant Creutzfeldt Jakob Disease (vCJD) is a human 
neurological disease recently identified in the United Kingdom that is 
believed to have its origins in the BSE outbreak in cattle in the 
United Kingdom. The agent that causes vCJD is indistinguishable from 
the causative agent of BSE. As of September 21, 1999, 46 cases of vCJD 
had been identified in the United Kingdom and one in France. The exact 
means by which the victims were exposed to the agent is uncertain; it 
may have been through eating beef products that contained high risk 
materials (brain and spinal cord) from BSE-positive cattle or through 
some other exposure.
    Based on the above facts, it is reasonable to conclude that control 
of scrapie in the United States, in addition to addressing a disease 
problem in sheep, would also reduce concerns about the apparently low 
but undefined risks that the scrapie agent could lead to diseases in 
other species.
    There are nearly 8 million sheep and lambs in the United States. It 
is impossible to estimate with any accuracy how many of them are 
infected with scrapie. This is because the disease may go undiagnosed. 
Scrapie has a lengthy incubation period, which complicates 
epidemiological studies, and there has been no live-animal test to 
diagnose it. These factors have impeded surveillance programs for 
scrapie, requiring it to be identified by symptoms and postmortem 
examination. However, the following information can be used to develop 
a rough estimate of the number of sheep in the United States that may 
be infected with scrapie: (1) In a 1996 NAHMS report, 1.2 percent of 
participating producers reported that they had seen scrapie in their 
flock in the last 5 years; (2) The average flock size in the United 
States is 105 animals; (3) The number of flocks in the United States is 
68,800; (4) In a flock that has had one case, the percent of animals 
that will come down with scrapie is highly variable. Based on this 
data, it is likely that at least 826 flocks are affected and that at 
least 86,730 sheep have been exposed to and may be infected with 
scrapie. It is likely that the number of exposed and potentially 
infected animals is significantly higher since owners are likely to 
under report disease because it is confused with another 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 
administers the Voluntary Scrapie Flock Certification Program (the 
VSFCP), described in regulations at 9 CFR part 54, and produces a 
program standards document entitled ``Program Standards--Voluntary 
Scrapie Flock Certification Program,'' which is available at http://
www.aphis.usda.gov/vs/scrapie/umr. A hard-copy of the Program Standards 
may be obtained by contacting the individual listed under FOR FURTHER 
INFORMATION CONTACT. The regulations at 9 CFR parts 54 and 79 are 
referred to below as the scrapie regulations.
    For over 40 years USDA has had programs to eradicate or reduce the 
incidence of scrapie in the United States. While comprehensive data on 
the incidence of scrapie has always been hard to assemble due to the 
nature of the disease and its diagnosis, these programs apparently have 
not resulted in a major reduction in the incidence of scrapie. A major 
reason for this result is that State programs for scrapie have varied 
tremendously in their resources and effectiveness, from State to State 
and over time. States where sheep are not a major agricultural 
commodity may not invest sufficient resources to identify infected 
flocks or reduce the incidence of scrapie within that State, and sheep 
with undiagnosed cases of scrapie could then easily move to other 
States, infecting new flocks. Therefore, we believe that to build an 
effective national scrapie program, the current regulations must be 
adjusted to recognize that sheep from States with minimal or 
nonexistent scrapie programs represent a higher risk than sheep from 
other States.
    In an advance notice of proposed rulemaking (ANPR) published in the 
Federal Register on January 26, 1998 (63 FR 3671-3673, Docket No. 97-
093-1), we solicited public comments to help us develop options for 
potential changes to the scrapie regulations. The primary issues on 
which we sought comment were:
     Should APHIS further restrict interstate movement of 
animals from States that do not consider scrapie a reportable disease 
or do not quarantine infected flocks or source flocks? Should APHIS 
define how a State must conduct a quarantine in order to avoid further

[[Page 66793]]

restrictions on interstate movement of animals from that State?
     Should APHIS restrict interstate movement of high-risk 
animals from flocks that are not infected flocks or are not source 
flocks, and if so, how?
     Should any of the definitions in the scrapie regulations 
be revised (e.g., the definitions of source flock, trace flock, and 
high-risk animal)?
     Should there be additional permit or official 
identification requirements for the interstate movement of any classes 
of sheep and goats to allow for a more effective national program for 
surveillance for scrapie and traceback of scrapie-positive animals?
     Should APHIS continue to provide the following information 
on the World Wide Web: The identity of scrapie infected flocks and 
source flocks designated under part 79, and the identity and 
certification status of flocks participating in the VSFCP?
    We solicited comments concerning our ANPR for 60 days ending March 
27, 1998. We received 27 comments by that date. The commenters were 
sheep producers, industry associations, State agencies, and 
individuals. The comments and data submitted were carefully reviewed, 
and helped us develop this proposed rule.
    Briefly, the three major changes we are proposing to the scrapie 
regulations are:
     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 are also 
proposing 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 the 
interstate movement of sheep and goats to allow for a more effective 
national program for surveillance for scrapie and traceback of scrapie-
positive animals. The proposed identification requirements are similar 
to current requirements for cattle and swine.
     Reinstatement of a scrapie indemnification program for 
sheep and goats that owners agree to destroy. 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.

State Quarantine Activities and Interstate Movement Restrictions

    Many commenters supported the idea that States should have 
intrastate quarantines and controls on the movement of sheep and goats 
sufficient to prevent intrastate spread of scrapie from known sources, 
and that States lacking such quarantines and controls should have the 
interstate movement of their sheep and goats further restricted. These 
commenters expressed the opinion that the current regulations do not do 
enough to prevent the spread of scrapie from States with weak scrapie 
programs into States with more effective scrapie programs. Most of 
these commenters supported the idea that an adequate State program is 
one that considers scrapie to be a reportable disease, that quarantines 
scrapie infected and source flocks and maintains them under a flock 
plan, and that imposes intrastate movement restrictions equivalent to 
Federal interstate movement restrictions imposed under current part 79.
    Commenters generally stated that if a State has or develops such an 
intrastate program, and APHIS determines the State program to be 
comparable in effectiveness to its interstate regulations in part 79, 
that State should not be subject to further interstate movement 
restrictions. However, a few commenters suggested that if a State 
implements a program of intrastate restrictions, that should be 
sufficient to avoid further interstate movement restrictions on sheep 
from that State, without an APHIS determination that the State program 
is comparable in effectiveness to the Federal program under part 79.
    Commenters also generally stated that flocks participating in the 
VSFCP should not be subject to further interstate movement 
restrictions, even if they are in a State that does not have an 
adequate intrastate program as described above.
    We believe that programs developed and implemented by States are 
essential to the control and eradication of scrapie, and we encourage 
varying approaches to these programs to meet individual State needs and 
to try and evaluate different control methods. However, we also believe 
APHIS should have a role in determining that each State program 
achieves a minimum level of effectiveness to serve national needs. 
Valid complaints in the past have noted that some State programs exist 
as little more than a name, and are ineffective. This introduces 
unacceptable hazards when sheep and goats from such States move in 
interstate commerce. Additionally, the creation of a uniform minimal 
standard on the national level would be consistent with the 
recommendations of international animal health organizations and the 
World Trade Organization, both of which recommend that a national 
authority establish minimum standards for programs affecting trade.
    Therefore, we are proposing that if a State is to avoid the 
requirements described below under ``Additional Interstate Movement 
Restrictions for Sheep and Goats,'' the State program must be reviewed 
by APHIS and determined to be comparable to the Federal program 
contained in part 79. APHIS would conduct this review by evaluating the 
State statutes, regulations, and directives pertaining to animal health 
activities to determine whether the State has established authority to 
conduct a scrapie control program comparable to the Federal one, and 
would also examine reports and publications of the State animal health 
agency to determine whether the existing authorities are being 
exercised in the form of an effective program. The States would be 
required to submit a written statement containing this information and 
certifying that they are in compliance with this section.

Additional Interstate Movement Restrictions for Sheep and Goats

    Most commenters supported the idea that APHIS should further 
restrict interstate movement of sheep and goats from States that do not 
consider scrapie a reportable disease, or that do not quarantine 
infected and source flocks. Most commenters also stated APHIS should 
set minimum criteria for how a State must conduct a quarantine. Four 
commenters opposed APHIS setting minimum criteria in this area because 
they were concerned that APHIS would dictate detailed command-and-
control requirements to State programs, rather than minimum 
effectiveness criteria. This is not the intention of APHIS.
    In this proposal, we describe two sets of interstate movement 
restrictions: One set for ``Consistent States'' and another set for 
``Inconsistent States.'' Consistent States would be States that conduct 
an active State scrapie program which effectively enforces certain 
requirements to identify scrapie in flocks and control its spread. We 
propose to establish in the new Sec. 79.6 the requirements a State 
would have to meet to be a Consistent State. These requirements include 
reporting and investigating any scrapie suspect animal, affected 
animal, or scrapie-positive animal; identifying and quarantining 
infected and source flocks; and individually identifying certain 
exposed animals and individually identifying and monitoring certain 
high-risk animals in all flocks, not just source or infected flocks. 
All States that are not Consistent States would be Inconsistent States. 
APHIS believes almost all States currently have the State legislative

[[Page 66794]]

authority and animal health infrastructure to qualify as Consistent 
States. However, this must be confirmed on a State-by-State basis 
through discussions between APHIS and State animal health authorities. 
Before this proposal is finalized, APHIS will develop and publish for 
comment a list of States that qualify as Consistent States. After 
finalizing the rule, APHIS will insert the list of ``Consistent 
States'' in Sec. 79.1. From time to time, APHIS will amend the list 
when it is determined that States meet or do not meet the definition of 
Consistent State in Sec. 79.1.
    While this proposal does not require it, it may also be desirable 
to require all Consistent States to sign a compliance agreement with 
APHIS describing the State scrapie program operations; we would 
appreciate public comment on whether our regulations should require 
such an APHIS-State compliance agreement.
    Such an agreement would provide evidence of the intent of a State 
to impose the requirements and provide the services necessary for it to 
be considered a Consistent State. The agreement could also describe 
cooperative activities between the State and APHIS to support the State 
scrapie regulatory activities. This agreement would be similar to, or 
could be made a part of, the cooperative agreement or memorandum of 
understanding that some States have signed with APHIS to cooperate in a 
number of animal disease control programs, including the VSFCP (see 
Sec. 54.13). Under part 54, some States may have already signed a 
cooperative agreement with APHIS that describes the respective roles of 
APHIS and State personnel in implementing the VSFCP. Such agreements 
also specify the financial, material, and personnel resources to be 
committed by the State and APHIS and assign specific activities to 
APHIS or State personnel.
    APHIS considered adding one other requirement to the standard for a 
State to qualify as a Consistent State. The proposed requirement states 
that Consistent States must report and investigate any scrapie suspect 
animal, affected animal, or scrapie-positive animal, but it does not 
specify any particular level of effectiveness in these investigations, 
nor does it require that States be able, in their investigation, to 
trace back a scrapie-positive animal to its flock of birth, if it was 
born in that State, and otherwise to its State of origin. When an 
animal that has moved through several flocks is identified as scrapie-
positive, e.g., at slaughter, it greatly aids the scrapie control 
program when the animal can be traced back to its flock of birth. This 
is not always possible to do with the records and identification 
required by current State programs. However, it might significantly 
increase the burden on States to upgrade their programs to the point 
where any animal sold for slaughter, breeding, or other purposes can be 
traced back to its flock of birth. Therefore, we would appreciate 
receiving comments on whether the standard for declaring a State to be 
a Consistent State should include a requirement that the State's 
scrapie control program must be able to trace any animal from a flock 
in that State back to its flock of birth, if it was born in that State, 
and otherwise to its State of origin, and whether provisions for 
monitoring and when available live-animal testing of such flocks should 
be required.
    The interstate movement restrictions proposed for Consistent States 
are similar to the regulations in current part 79, except that they 
include additional identification requirements and would restrict the 
interstate movement of high-risk animals and prohibit the interstate 
movement of scrapie positive, affected, and suspect animals (except 
when they are moved for destruction or research under conditions 
approved by the Administrator). The restrictions proposed for 
Inconsistent States are stricter, and are designed to minimize several 
areas of risk associated with the indeterminate scrapie status of sheep 
and goats from these States. Sheep and goats from Inconsistent States 
would be subject to stricter movement conditions to minimize their 
contact with other animals, and stricter identification requirements to 
aid traceback from any scrapie outbreak that may be associated with the 
animals. Also, sheep and goats from Inconsistent States could not move 
interstate for breeding purposes unless they are enrolled in the VSFCP 
or an equivalent APHIS-recognized State flock certification program. An 
equivalent APHIS-recognized State flock certification program does not 
equate to a Consistent State. It is possible, though unlikely, that a 
State might not institute the Statewide controls that would qualify it 
as a Consistent State--investigation and identification of all suspect 
and high-risk animals, quarantine of all source and infected flocks, 
etc.--but would have a program providing VSFCP-like standards for 
particular individual flocks within the State whose owners request it.
    The following chart describes the proposed interstate movement 
conditions.

      Interstate Movement General Restrictions for Sheep and Goats
------------------------------------------------------------------------
                                   Moved from            Moved from
 Type of interstate movement   INCONSISTENT State     CONSISTENT State
------------------------------------------------------------------------
Sale or other movement of
 breeding animals, show
 animals or any other animal
 not specifically addressed
 below:
    High-risk animal,         Prohibited*.........  Prohibited*.
     scrapie positive,
     suspect, or affected
     animal.
    Non-high risk animal      Prohibited*.........  Prohibited*.
     from an infected or
     source flock.
    Other animal............  Flock must be         Individual animal ID
                               enrolled in the       and certificate.
                               Complete Monitored
                               category of the
                               Scrapie Flock
                               Certification
                               Program or
                               equivalent APHIS-
                               recognized program
                               and have
                               certificate.
Sale or other movement
 directly to slaughter or
 through slaughter channels
 to slaughter of animals
 under 6 months of age:
    Scrapie positive,         Prohibited*.........  Prohibited*.
     suspect, or affected
     animal.

[[Page 66795]]

 
    High-risk animals and     Individual animal ID  Individual animal ID
     animals from infected     and permit, or        and permit, or
     or source flock.          sealed conveyance     sealed conveyance
                               and permit (no        and permit (no
                               individual ID) when   individual ID) when
                               moving directly to    moving directly to
                               slaughter, or a       slaughter, or a
                               permit (no            permit (no
                               individual ID) and    individual ID) and
                               an indelible ``S''    an indelible ``S''
                               mark on the left      mark on the left
                               jaw.                  jaw.
    Other animal............  Premises ID** and     None.
                               certificate.
Sale or other movement
 directly to slaughter or
 through slaughter channels
 to slaughter of animals
 over 6 months of age, or
 animals of any age to
 feedlots for later movement
 to slaughter:
    Scrapie positive,         Prohibited*.........  Prohibited*.
     suspect, or affected
     animal.
    High-risk animals and     Individual animal ID  Individual animal ID
     animals from infected     and permit.           and permit.
     or source flock.
    Other exposed animals...  Individual animal ID  Individual animal
                               and permit.           ID.
    Other animals over 1      Individual animal ID  Individual animal
     year of age.              and certificate.      ID.
    Other animals between 6   Individual animal ID  Premises ID* *.
     months and 1 year of      and certificate.
     age, or animals under 6
     months of age moving to
     feedlots for later
     movement to slaughter.
Movement of animals for
 grazing or other management
 purposes without change of
 ownership
    Scrapie positive,         Prohibited*.........  Prohibited*.
     suspect, or affected
     animal.
    High-risk animal or       Prohibited*.........  Prohibited*.
     animal from infected or
     source flock.
    Exposed animals.........  Individual animal ID  Premises ID.
                               and certificate.
    Other animal............  Premises ID and       None.
                               certificate.
------------------------------------------------------------------------
* Animals prohibited movement may be moved interstate only if they are
  moving interstate for destruction or research approved by the
  Administrator.
* * Premises ID is not required for slaughter animals if the animals are
  kept as a group on the same premises on which they were born and are
  not commingled with animals from another premises at any time,
  including throughout the slaughter process, or, if they are commingled
  during the slaughter process, they are officially identified on
  arrival at the slaughter facility such that any animal can be traced
  back to its flock of origin.
 
Note: A CONSISTENT STATE is one whose intrastate identification,
  quarantine and movement restrictions for infected and source flocks
  and high-risk animals are consistent with the APHIS standards for
  State scrapie programs.

    As summarized in the above chart, there are different interstate 
movement conditions depending on the State's scrapie program status, 
age of the animal moved, and on whether the animal is moved for 
slaughter or for other purposes. The movement conditions vary with the 
risk of spreading scrapie by the movement, and range from no 
requirements for animals of no known risk moved to slaughter from a 
State with a strong scrapie program, through severe requirements for 
animals of known risk moving from Inconsistent States, to outright 
prohibition of movement for the highest risk categories. The 
requirements employed to control risk in the middle range include 
premises identification (ID), individual animal ID, certificates, 
permits, and sealed conveyances. The meanings of these terms are 
discussed below under ``Changes to Definitions in Parts 54 and 79.''
    The interstate movement of all scrapie-positive animals, suspect 
animals, and affected animals is prohibited unless the Administrator 
approves their movement for destruction or research. Uncontrolled 
movement of these animals always poses a risk that they may come in 
contact with other sheep and goats and spread scrapie to these other 
animals. Therefore, when the Administrator approves movement for 
destruction or research, the animals must be moved and maintained under 
conditions to prevent the spread of scrapie.
    The interstate movement of high-risk animals and animals from 
infected or source flocks is subject to various restrictions that 
depend on the age and source of the animal and the purpose of the 
movement. High-risk animals and animals from infected or source flocks 
are prohibited movement unless they are moving to slaughter or moving 
in slaughter channels. Such animals of any age may be moved to a 
feedlot for later slaughter if they have individual animal ID and a 
permit. High-risk animals and animals from infected or source flocks 
may move directly to slaughter if they are over 6 months old and have 
individual animal ID and a permit. The purpose of the permit is to 
trace the movement of each lot of animals, and the purpose of the 
individual ID is to make it easy to ensure that individual animals are 
not diverted out of slaughter channels, e.g., by becoming mixed with 
other animals at feedlots prior to slaughter.
    High-risk animals and animals from infected or source flocks 
animals under 6 months of age may be moved directly to slaughter if 
they meet one of three conditions: (1) Individual animal ID and a 
permit; (2) A sealed conveyance (no animal ID) and a permit; or (3) A 
permit and an indelible ``S'' mark on the jaw, in lieu of animal ID. 
These additional options are provided for animals under 6 months of age 
due to the large volume of lambs shipped to slaughter, and because it 
is often impractical or uneconomical to individually identify younger 
lambs.
    Animals that are not in the categories described above (i.e., they 
are not scrapie-positive animals, suspect animals, affected animals, or 
high-risk animals) may move interstate to slaughter under conditions 
that vary depending on their age, and whether they are moving from a 
Consistent or

[[Page 66796]]

Inconsistent State. Generally, the older the animal moving to 
slaughter, the more requirements apply, because older animals may have 
had more opportunities to move from one flock to another and thereby 
increase their exposure to scrapie. The program is more likely to need 
records that allow the older animals to be traced back to earlier 
premises. While it would usually be possible to trace the movement of 
an animal from flock to flock in a Consistent State based on flock 
records, individual animal ID makes this task easier for animals over 1 
year of age, which have a longer history than lambs and may have had 
several owners. Also, it is currently impossible to diagnose scrapie in 
animals under 6 months of age, by either a live-animal test or 
necropsy, so there is no opportunity to identify a scrapie-positive 
animal under 6 months of age and trace it back to its origin. 
Therefore, individual animal ID is seldom required for animals under 6 
months of age; it is only required when the point of the identification 
is not traceback, but to ensure individual animals are not commingled 
with animals from other lots (e.g., when they are sent to a feedlot en 
route to slaughter).
    When animals that are not scrapie-positive animals, suspect 
animals, affected animals, or high-risk animals move from a Consistent 
State, the animals may move with no requirements if they are under 6 
months of age and are moving to slaughter. However, if such animals 
under 6 months of age are moving from an Inconsistent State to 
slaughter, they require a premises ID and a certificate. When they are 
over 6 months of age but less than 1 year of age, such animals may move 
from a Consistent State to slaughter, or to a feedlot, with only a 
premises ID; but if they are moving from an Inconsistent State, they 
require individual animal ID and a certificate. In this case the 
individual animal ID is required for animals from Inconsistent States 
because it is sometimes possible to diagnose scrapie in an animal 
between 6 months to 1 year of age, and tracing these animals back to 
origin in an Inconsistent State is not possible with only a premises ID 
because Inconsistent States would not require records that would allow 
the animal to be traced back farther than the premises from which the 
animal was shipped to slaughter. When they are over 1 year of age, such 
animals may move from a Consistent State to slaughter, or to a feedlot, 
only if they have individual animal ID; but if they are moving from an 
Inconsistent State, they require both individual animal ID and a 
certificate. The higher requirements for animals from Inconsistent 
States are largely due to the fact that Consistent States impose 
significant restrictions on movements between flocks within the State 
but Inconsistent States do not, so our regulations must use 
certificates and individual animal ID more extensively for Inconsistent 
States to increase the probability of successful tracebacks.
    The proposed requirements also address interstate movement for 
purposes other than slaughter. Animals that are not scrapie-positive 
animals, suspect animals, affected animals, high-risk animals, or 
animals from infected or source flocks may move interstate from a 
Consistent State for grazing or other management purposes, without 
change of ownership, with no requirements (unless the animal is an 
exposed animal as defined in the regulations, in which case a premises 
ID is required). Such animals moving interstate from an Inconsistent 
State must have a premises ID and certificate, unless they are exposed 
animals, in which case individual animal ID and a certificate is 
required.

Indemnification Program

    We are also proposing to reinstate an indemnification program to 
compensate the owners for destruction of high-risk animals, animals 
diagnosed scrapie-positive by an approved live-animal test, affected 
animals, suspect animals (if the postmortem indicates them to be 
scrapie-positive), and other groups of animals when the Administrator 
determines that their destruction will contribute to the eradication of 
scrapie. We believe indemnification is necessary to contribute to 
scrapie control, mainly by providing the economic incentive to remove 
scrapie-positive and high-risk animals from flocks and reduce the 
number of flocks under quarantine. This economic incentive, combined 
with advances in diagnostic techniques that allow faster and more 
accurate identification of scrapie-positive animals, should contribute 
substantially to reducing the incidence of scrapie in the United 
States.
    The types of animals proposed as eligible for indemnity are animals 
diagnosed with scrapie, or known to be closely associated with animals 
diagnosed with scrapie under conditions where they could contract the 
disease. These animals could potentially cause many new cases of 
scrapie, and, therefore, we believe paying indemnity to destroy them is 
in the interest of effective scrapie control.
    The indemnity payments would be $150 for registered animals and $50 
for other animals. As of January 1, 1999, the national average sale 
price of a sheep was $88; as of January 1, 1998, it was $102. These 
average sale prices reflect the sale of millions of slaughter sheep and 
a few thousand valuable registered breeding sheep. The average price 
for registered breeding sheep is in the range of $300, with some 
selling for thousands of dollars. Therefore, if sale prices persist in 
the range experienced in the past 2 years, the average owners of both 
slaughter and registered sheep who accept indemnity for their animals 
rather than selling them would recover about half the market value of 
the animals.
    The indemnity amounts of $150 and $50 represent an effort to 
provide an indemnity that will be attractive, while also stretching 
available indemnity funds to ultimately remove as large a number of 
diseased animals as possible. The indemnity amounts are not so high, 
compared to fair market value, as to provide a perverse incentive, 
i.e., to encourage flock owners to expose animals to scrapie to obtain 
a higher price. The indemnity amounts were decided based on our past 
experience with industry participation in scrapie indemnity programs, 
and the $150 and $50 amounts are the same indemnities used in our 
previous scrapie indemnity program which expired in 1996, at which time 
the national average sale price of a sheep was $87.
    We considered whether it would be appropriate to pay a lower 
indemnity, either for all eligible animals or for those that test 
positive for scrapie on a future live-animal test, in view of the 
economic fact that sheep infected with scrapie really have little or no 
economic value. However, we believe that reducing the indemnities below 
the proposed values would encourage owners to hide the presence of 
scrapie and thus hurt the effectiveness of the scrapie control program. 
This view is supported by the experience of the British Government in 
controlling BSE. When the British Government increased the indemnity 
for BSE-infected cattle from 50 percent of market value to 100 percent, 
the number of reported BSE cases increased by 73 percent.\1\
---------------------------------------------------------------------------

    \1\ Food Microbiology (1990) 7:253-279.
---------------------------------------------------------------------------

    It should be noted that if this proposal is adopted, the total 
number of animals that can be indemnified each year and the total 
amount of indemnity funds expended will be limited by the amount of 
program funding appropriated for that purpose. We invite comments on 
the total amount of indemnity that should be needed, and on whether the 
payment amounts are appropriate.

[[Page 66797]]

    In deciding to propose this indemnity program, we examined 
alternatives to determine whether the same funds could be expended on 
other activities to control scrapie and achieve a greater reduction in 
the disease. Two activities that could produce substantial reductions 
in scrapie are development of a live-animal test and education of sheep 
producers and veterinarians to recognize and control scrapie. However 
current and planned funds for both of these initiatives appear to be at 
a level that will produce optimal results, and we do not believe 
diverting indemnity funds to them would accelerate their progress. 
Instead, an indemnity program would complement use of a live-animal 
test and education programs. The three approaches together will be 
needed to successfully control scrapie.
    Another alternative we considered, under the assumption that a 
live-animal test for scrapie will soon be available, was to impose a 
large-scale, mandatory live-animal testing requirement of all animals 
moved interstate for other than slaughter purposes. For this approach 
to be effective, we would need to condemn and destroy any animals that 
tested positive, to ensure they do not come in contact with and infect 
other animals in the future. This alternative was rejected because an 
approved live-animal test is not currently available. Once a live-
animal test has been approved and fully evaluated, this option will be 
reconsidered.
    We also considered prohibiting the movement in interstate commerce 
for any purpose of any animal that was considered to be at high risk of 
being scrapie infected. This was rejected because: (1) There is no 
evidence that scrapie is a threat to public health; (2) Scrapie-
infected animals moving to slaughter pose little risk of spreading the 
disease; and (3) Given the past history of scrapie indemnity funding, 
it is likely that we would be unable to indemnify all of these animals 
causing a significant economic hardship on owners of high-risk sheep. 
To mitigate the remote risk that these animals pose when moving in 
slaughter channels, we have proposed to indemnify and destroy them 
whenever possible. Finally, we considered restricting these animals 
without compensation. This option was rejected for the reasons 
discussed under indemnification.

Live-Animal Testing

    While no live-animal test for scrapie has yet been approved, 
several varieties of live-animal tests show promise, and we anticipate 
the availability of a live-animal test in the near future. Therefore, 
this proposed rule includes reference to live-animal tests as a means 
to identify scrapie-positive animals and affected animals, without 
specifying the exact protocols of the live-animal tests. As discussed 
below, the definitions for live-animal screening test (used to identify 
affected animals) and scrapie-positive animal state that the tests must 
use protocols approved by the Administrator and must be performed by 
laboratories approved by the Administrator. Once developed, the 
Administrator will initiate rulemaking in the Federal Register to 
publish these protocols or incorporate them by reference.
    The availability of a validated live-animal test will significantly 
affect the nature of the scrapie control program. Such a test would 
make it possible to identify confirmed infected live animals for 
destruction, reducing the need to destroy large groups or entire flocks 
of suspect animals in order to control the spread of scrapie.

Changes to Definitions in Parts 54 and 79

    Three definitions would be removed because they are no longer 
needed for the proposed regulations (bloodline animal, because this 
category has not been used since termination of an earlier indemnity 
program; department, because we refer instead in this proposal to 
APHIS; and trace flock, because its definition has been absorbed by the 
new definition of source flock discussed below). Nine other definitions 
would be amended (affected animal, destroyed, exposed animal, flock, 
flock plan, high-risk animal, infected flock, scrapie-positive animal, 
and source flock). Some of these changes would be made to adapt the 
regulations to the probability that a validated live-animal test for 
scrapie may be available in the near future. The definition of 
destroyed would be changed to remove movement to slaughter as a means 
of destruction. Animals to be destroyed would have to be euthanized, 
and the carcasses disposed of by means authorized by the Administrator. 
Animals for which an indemnity is paid under the regulations must be 
destroyed, rather than sent to slaughter, for two reasons. First, any 
movement of animals eligible for indemnity represents a potential risk 
of spreading scrapie, and we do not want to encourage movement of these 
animals to slaughter when we have the alternative of destroying them on 
their home premises and disposing of the carcasses safely. Second, if 
animals eligible for indemnity are slaughtered, this may result in the 
scrapie agent entering the animal food chain, and we want to avoid 
this. The Food and Drug Administration has published regulations (62 FR 
30935-30978, June 5, 1997) requiring that ruminant feed must not 
contain animal protein derived from mammalian tissues, in order to 
prevent the possible spread of transmissible spongiform 
encephalopathies, such as scrapie, to ruminants. However, sheep protein 
is still used for other nonruminant animal feed, such as zoo animal 
foods. Research has shown that a variety of species can conceivably 
contract some form of spongiform encephalopathy by oral inoculation 
with protein from a scrapie-positive animal. The wide distribution of 
meat byproducts from slaughter plants makes it likely that if indemnity 
animals were allowed to go to slaughter, some of their protein would be 
used in nonruminant animal feed. The risk that nonruminants could 
contract a transmissible spongiform encephalopathy from consuming 
animal feed containing protein from a scrapie-positive animal is 
extremely small. However, we propose to control this small risk by 
taking the opportunity presented by the indemnity program to order 
indemnity animals to be destroyed, rather than sent for slaughter. The 
Administrator will authorize disposal methods (often incineration or 
burial) that are consistent with local laws and conditions and that 
minimize the dispersal of possibly infectious material. The proposed 
definition of destroyed ties into the proposed Procedures for 
destruction of animals in Sec. 54.7. These procedures include a 
requirement that carcasses may not be processed for animal food unless 
subjected to a treatment process approved by the Administrator and 
known to eliminate the agents of transmissible spongiform 
encephalopathies. This requirement would address the established risk 
that some species of animals conceivably could contract scrapie by 
consuming animal feed generated from scrapie-positive animals.
    Exposed animal would be redefined 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, and 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. The earlier definition of this term also defined limited 
contacts, which would now be defined in a separate definition. The 
earlier definition also did not include animals that were born into a 
flock after the removal of a scrapie-positive animal born into that 
flock. We believe such animals should

[[Page 66798]]

be considered exposed because there is some risk that they may contract 
scrapie from objects or animals the earlier scrapie-positive animal 
came in contact with, unless this risk has been mitigated by the 
completion of a flock plan.
    Because the definition of flock plan currently contains a large 
volume of procedures not appropriate for a definition, this definition 
would be shortened by expanding and moving some of its text to new 
Sec. 54.14, ``Requirements for flock plans and post-exposure management 
monitoring plans.'' The definition of Uniform methods and rules--
voluntary scrapie flock certification would be updated and renamed 
Scrapie Flock Certification Program standards, consistent with the 
program name change discussed elsewhere in this document. For the same 
reason, a definition would be added for the Scrapie Flock Certification 
Program.
    The following new definitions for terms used in the proposed rule 
would also be added to part 54, part 79, or both:
    Area veterinarian in charge would be defined as ``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.'' This definition is needed to identify those veterinarians 
who perform certain duties under the regulations including processing 
of indemnification applications.
    Certificate would be defined as ``An official document issued in 
accordance with Sec. 79.5 of this part by an APHIS representative, 
State representative, or accredited veterinarian at the point of origin 
of an interstate movement of animals, which includes a statement that 
the animals were not exhibiting clinical signs associated with scrapie 
at the time of examination.'' A certificate is required by the 
regulations for interstate movement of certain animals.
    Consistent State would be defined as ``A State which the 
Administrator has determined conducts an active State scrapie control 
program which either: (1) meets the requirements of Sec. 79.6 of this 
part, or (2) 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 of this part.'' This 
definition would be the basis for determining whether animals from a 
particular State qualify for the less restrictive, or more restrictive, 
interstate movement requirements proposed in Sec. 79.3. When the list 
of Consistent States is developed, it will be added to this definition. 
Any State not listed would be an Inconsistent State.
    Designated scrapie epidemiologist would be defined as ``An 
epidemiologist selected by the State animal health official and the 
area veterinarian in charge to reclassify animals already designated as 
high-risk, exposed, or affected with scrapie, based on epidemiologic 
investigation or the results of a live-animal test. The regional 
epidemiologist and the APHIS National Scrapie Program Coordinator must 
concur in the selection and appointment of the designated scrapie 
epidemiologist.'' Designated scrapie epidemiologists would operate 
under proposed Sec. 79.4 to reclassify animals as necessary.
    Electronic implant, one form of allowed animal identification, 
would be defined as ``Any radio frequency identification 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.''
    The definition of flock would be amended to clarify when more than 
one flock may be maintained on a single premises without being 
considered a single flock. This definition considers that flocks on a 
premises are separate if they never commingle, never share facilities 
and equipment, and have separate flock records and identification. To 
address questions raised by flock owners, this revised definition also 
states that changes in ownership of a flock do not change the identity 
of the flock or the regulatory requirements applicable to the flock.
    Individual animal identification would be defined as ``An 
electronic implant, flank tattoo, ear tattoo, or tamper-resistant ear 
tag approved 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 in accordance with instructions 
by an APHIS representative or State representative.''
    Inconsistent State would be defined as ``Any State other than a 
Consistent State.''
    Interstate commerce would be defined as ``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 would be defined as ``Incidental contacts between 
animals 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 with an animal during, or 
up to 60 days after, lambing or kidding. Limited contacts do not 
include any activity where uninhibited contact occurs, such as sharing 
an enclosure, sharing a section of a transport vehicle, or 
transportation to other flocks for breeding, except as allowed by the 
Scrapie Flock Certification Program standards.'' This definition is 
needed to help distinguish between contacts that do not present a 
pronounced risk of spreading scrapie (e.g., casual contacts between 
animals at fairs or shows) and contacts that present a pronounced risk 
(e.g., contacts with animals during or within 60 days following 
lambing, when infectivity is high and infectious materials such as 
afterbirth are present).
    Post-exposure management and monitoring plan would describe an 
agreement written jointly by the flock owner, an accredited 
veterinarian, and an APHIS or State representative in which each 
participant agrees to undertake certain actions to monitor for the 
occurrence or recurrence of scrapie in the flock for at least 5 years 
after the flock was exposed to a scrapie-positive animal, or contained 
a high-risk animal. Experience in monitoring flocks has shown that if 
scrapie recurs from a previous outbreak in a flock, its signs are 
likely to become evident within 5 years. This definition, like the 
definition of flock plan, would refer to new Sec. 54.14, ``Requirements 
for flock plans and post-exposure management monitoring plans.'' 
Federally required post-exposure monitoring is necessary to guard 
against recurrence of scrapie, because flocks whose owners receive 
indemnity payments may or may not be subject to State quarantines, and 
even if they are subject to State quarantine there is great variation 
in the effectiveness of State quarantine procedures in detecting signs 
of scrapie in a timely manner. As discussed in proposed Sec. 54.5, in 
order to receive indemnity an owner must agree to maintain their flock 
under a post-exposure monitoring management plan for 5 years after 
removal of the last high-risk or scrapie-positive animal. Based on the 
typical clinical progress of scrapie, we believe any renewed outbreak 
of

[[Page 66799]]

scrapie in the flock would show signs within 5 years.
    Premises identification, one requirement of proposed Sec. 79.3 for 
moving certain animals interstate, would be defined as ``An APHIS 
approved eartag, backtag, or tattoo bearing the premises identification 
number assigned by a State or Federal animal health official to the 
premises on which the sheep or goats originated, or a brand registered 
with an official brand registry.''
    The definition of scrapie-positive animal would be updated by 
referring to additional laboratory techniques (western blotting, 
bioassay, fibril detection by electron microscopy) that have proven 
useful in confirming scrapie from tissue samples, by allowing 
confirmation of scrapie-positive status by ``any other test method 
approved by the Administrator,'' and by adding a footnote describing 
how the Administrator will approve laboratories to conduct tests for 
scrapie-positive animals.
    The definition of infected flock would be changed to include any 
flock in which a scrapie-positive animal had lambed within the past 18 
months, counted from the time the tissues used to diagnose the scrapie-
positive animal were collected from the scrapie-positive animal. This 
change would be made as a result of evidence that placenta shed 15\1/2\ 
months prior to death may contain infectious agent. Since the progress 
of the disease and the level of infectivity can be expected to vary 
somewhat among individual animals, we set the lambing limit at 18 
months rather than 15\1/2\ months to allow a margin of error, and 
because 18 months is an easier figure than 15\1/2\ months for planning 
and compliance activities of both regulators and sheep producers. Also, 
in the definitions for infected flock and source flock, we are dropping 
a reference limiting their application to cases where the scrapie-
positive diagnosis was made ``after March 31, 1989.'' This date was 
added to the regulations in 1992 to cover a temporary situation where 
diagnoses employed one standard before 1989 and another afterwards. Due 
to the lifespan of sheep and goats, there are no more flock situations 
where a diagnosis prior to that date would be relevant or used, and so 
the date would be deleted as superfluous and confusing.
    The current definition of source flock includes flocks in which at 
least two animals later diagnosed as scrapie-positive are born. Because 
we agree with comments that stated that the birth of a single animal 
later determined to be scrapie-positive indicates that a flock is a 
significant risk as a source of scrapie, we would change this 
definition to include flocks where a single animal later diagnosed as 
scrapie-positive is born.
    The definition of affected animal would be changed to allow the use 
of a live-animal test as a screening test without affecting flock 
status. The designation ``affected animal'' could be used if a live-
animal test is developed that proves to be less specific than the 
current tests used to classify an animal as a scrapie-positive animal 
as defined in Sec. 54.1. The type of test that may be approved to 
identify affected animals is described in a new definition for live-
animal screening test, which reads ``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.'' This 
definition also includes a footnote describing how the Administrator 
will approve laboratories to conduct this test.

Genetics and DNA Testing Issues

    Much current research addresses methods for identifying gene 
sequences in sheep that affect the animal's resistance or 
susceptibility to scrapie, or the length of the incubation period. As 
answers emerge from research, we will propose further changes to our 
scrapie programs to take advantage of new knowledge about the role of 
genetics in the disease-host interaction. In time, it may be possible 
to exempt certain breeds of sheep, or sheep that have been tested for 
particular codon sequences, from some program requirements because of 
their ``natural immunity.'' We are prepared to amend our regulations 
when specific, relevant genetic results are confirmed, but we do not 
believe any such changes to the regulations would be appropriate at the 
current time.

Change of Name--Voluntary Scrapie Flock Certification Program to 
Scrapie Flock Certification Program

    We are proposing to change the name of the Voluntary Scrapie Flock 
Certification Program, described in 9 CFR part 54, to the Scrapie Flock 
Certification Program (SFCP). The purpose of the change is to increase 
acceptance of the program for export purposes. There has been some 
confusion and administrative delay in the acceptance by other national 
governments of health certificates and other documents issued for U.S. 
sheep and goats and sheep and goat products when these documents base 
their determination of health status on a ``voluntary'' program; the 
term is not used consistently in international commerce. In some uses 
it has implied that participants adhere to some standards part of the 
time, rather than meaning that participants voluntarily commit to 
following all standards the entire time they participate in a program. 
Removing the term ``voluntary'' will result in expedited processing of 
these documents, and a clearer understanding that this program is a 
valid determination of flock status that is monitored by the U.S. 
Government. There is no intent to change the voluntary nature of the 
program, as should be clear from the unchanged description of the 
nature of the program contained in Sec. 54.10, ``Administration,'' and 
Sec. 54.11, ``Participation.''

Executive Order 12866 and Regulatory Flexibility Act

    This proposed 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.
    We do not currently have all the data necessary for a comprehensive 
analysis of the effects of this rule on small entities. Therefore, in 
accordance with 5 U.S.C. 603, we have performed an Initial Regulatory 
Flexibility Analysis, which is summarized below. We are inviting 
comments concerning potential effects. In particular, we are interested 
in determining whether sheep and goat producers would be affected 
positively or negatively by this rule, and whether any additional costs 
may result from this rule that are not discussed in this analysis.
    Below is a summary of the economic analysis for the changes to the 
scrapie regulations proposed in this document. The economic analysis 
provides a cost-benefit analysis as required by Executive Order 12866 
and the initial analysis of impacts on small entities as required by 
the Regulatory Flexibility Act. A copy of the full economic analysis is 
available for review at the location listed in the ADDRESSES section at 
the beginning of this document.
    We are considering taking the actions described in this proposed 
rule in order to strengthen scrapie control programs on the national 
level, to reduce the losses that scrapie causes to the sheep and goat 
industries. This action is considered necessary because not all State 
scrapie control programs are effective in identifying animals that may 
be infected with scrapie and controlling

[[Page 66800]]

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 proposed 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 earlier in 
this proposal, it is not a practical option because a live-animal test 
has not been validated and approved and also impractical at this time 
on economic grounds.
    This rule would result in the expenditure of indemnity funds by 
APHIS to compensate the owners of certain animals destroyed to prevent 
the spread of scrapie. This would 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. Finally, because this rule allows certain interstate movements 
only if the flock is enrolled in the Scrapie Flock Certification 
Program or an equivalent State program, this rule would encourage 
producers to enroll in such programs and bear the resulting flock 
management and identification costs.
    The budgetary effects on APHIS of this proposal would fall into 
three categories: A small 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, and the cost of 
providing official eartags and backtags, all within available funds. 
The initial amount of indemnity payments (the first year) is estimated 
to be approximately $384,250, based on an estimated 3,074 animals 
eligible for indemnity in known scrapie-infected and source flocks, but 
may be more than that 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 would 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 would be expected initially as new infected flocks are 
identified.
    Some States would bear additional costs to improve their State 
scrapie programs so that the producers in their States could avoid 
additional interstate movement restrictions proposed for States without 
effective intrastate programs. However, we believe that most States 
already have effective intrastate programs that would qualify them as 
Consistent States and that all but two or three States have the 
necessary authority and infrastructure to run an effective intrastate 
program.

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

    There were 7.822 million sheep and lambs in the United States based 
on 1997 Census of Agriculture reports. In the national inventory, 5.85 
million were breeding sheep and lambs and the rest were market sheep, 
based on National Agricultural Statistics Service reports. Ewes, 1 year 
old or older, totaled 4.57 million during the same period.
    Small farms, as shown in Table 1, 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..........................       35,584         0.54        0.045
25 to 99.........................       20,461         0.31        0.123
100 to 299.......................        6,010         0.09        0.123
300 to 999.......................        2,429         0.04        0.158
1,000 to 2,499...................          820         0.01        0.160
2,500 to 4,999...................          297        0.005        0.128
5,000 or more....................          189        0.003        0.263
                                  -------------
    Total........................      65,790
------------------------------------------------------------------------
Source: USDA, Census of Agriculture 1997.


[[Page 66801]]

    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. About 3.805 million sheep 
were commercially slaughtered in 1997. Additionally, about 57,000 sheep 
were slaughtered on the farms, yielding a total of about 3.861 million 
sheep slaughtered in 1997. About 3.62 million slaughtered sheep were 
Federally inspected, of which 3.46 million were lambs and yearlings and 
about 211,000 were mature sheep.
    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 1997 the United States produced about 267 million pounds of 
mutton, lamb and goat meat. It exported 6.4 million pounds and imported 
about 84 million pounds valued at $145 million. The United States 
exported 1,474,060 sheep and goats valued at $63 million in 1997, of 
which 1,457,144 went to Mexico. The United States imported 47,405 sheep 
and goats valued at $6.684 million in 1997, of which 46,991 were from 
Canada, 364 from New Zealand, 40 from Mexico, and 10 from Australia. 
The United States imported 83,472,084 pounds of sheep and goat meat 
valued at $145.174 million and exported 6,528,605 pounds of sheep and 
goat meat valued at $7.362 million in 1997. 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

    At present, of the approximately 8 million sheep and 2 million 
goats in the United States,\2\ over 90 percent belong to commercial 
flocks (operations rearing sheep for sale, mostly to be slaughtered). 
There are 14 States altogether with 72 flocks that were on the infected 
or source flock list as of June 6, 1999 (66 are scrapie infected 
flocks, 6 are scrapie source flocks). Also, 31 other flocks contained a 
scrapie-positive animal during FY 1998, but the implicated animals were 
destroyed and the flocks are therefore not infected or source flocks. 
Infected and source flocks are potential candidates for destruction and 
indemnity payments. Additionally, over the last 8 years (1990-1997), an 
annual average of 132 individual suspect scrapie cases have been 
reported, of which approximately 48.6 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 1.932 million breeding sheep and lambs in 
the 14 States in which positive cases have occurred in FY 1998 or in 
which a source or infected flock exists. These animals represent 
approximately 33 percent of all breeding sheep and lambs in the United 
States and have a market value of about $185 million.
---------------------------------------------------------------------------

    \2\ USDA, Sheep and Goats. Washington, DC: Agricultural 
Statistics Board, Februrary 1991.
---------------------------------------------------------------------------

    The average size of a flock in an operation in the 14 States was 
86, with between 21 and 479 per operation. Approximately 82.5 percent 
of these sheep are marketed, in most cases across State lines. However, 
nearly 33 percent of the marketed sheep are lambs less than 6 months of 
age, and would be exempt from individual animal identification under 
the proposed rule.

Indemnity Costs for Animals Destroyed Due to Scrapie

    The exact number of scrapie-positive and high-risk animals that 
would qualify for indemnity payments is not known. However, an estimate 
of the number of animals potentially eligible for indemnity would be 
48.6 percent of the animals in an average scrapie infected or source 
flock (based on past field experience). There are currently 66 scrapie 
infected flocks and 6 scrapie source flocks. Additionally there were 64 
other infected animals diagnosed in the past year that are no longer in 
flocks on the infected flock list, because the flock owners voluntarily 
destroyed the implicated animals. Thus, based on average flock size and 
the average percentage of scrapie-positive animals in infected and 
source flocks, the number that could be estimated to qualify for 
indemnity payments during the first year would be 3,074 animals 
(=(72 x 86 x .0486+64)). This estimate implies that about 0.15 percent 
of the total number of breeding sheep and goats in the 14 States that 
could potentially move interstate would 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).\3\ Assuming a 75 
percent registered to 25 percent nonregistered animal composition, with 
a $150 and $50 per animal indemnity payments, the estimated indemnity 
expenditure would be about $384,250 
(3.074 x 0.75 x 150+3,074 x 0.25 x 50). If the producer response to 
indemnity payment availability is positive, resulting in an increased 
number of indemnity requests, the expenditure would increase 
accordingly. However, even if a much larger number of animals were to 
be indemnified, the destruction of all known infected animals would 
greatly advance the goal of scrapie eradication, and could only be 
positive in terms of long-term reduced expenditure.
---------------------------------------------------------------------------

    \3\ Based on the composition of 8,199 registered and 2,824 
commercial animals as reported by APHIS personnel.
---------------------------------------------------------------------------

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

    The animal identification that would be required by this proposed 
rule would result in additional costs. Of the approximately 8 million 
sheep and lambs and 2 million goats in the United States, about 82.5 
percent are potentially interstate movers and of these about 33 percent 
are lambs less than 6 months of age, which would not require 
identification tags under the new rule. Currently, the cost of metal 
identification tags for cattle is about $0.15 per animal. Assuming the 
total number of sheep and goats that would need identification tags is 
4.633 million, the tag cost would be approximately $695,000 
(4,633,000 x 0.15) for identifying interstate movers. If the time it 
takes the owner to apply the tag (about 2 minutes per animal) is valued 
at $7.36 per hour (the average wage for livestock workers in April, 
1999), this labor cost represents another $1.137 million. 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

[[Page 66802]]

tags, depending on State regulations. If owners elect to use backtags, 
the costs would be less. Owners will incur the costs of applying 
identification. The impact on goat owners would be less, since about 72 
percent of goats are the angora type, which are raised for their mohair 
and are less frequently moved interstate. Thus the total potential 
identification cost for goat owners would be in the range of $37,000.

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. Canada and Mexico both allow the importation of U.S. sheep 
only if the sheep are from flocks enrolled in the Voluntary Scrapie 
Flock Certification Program or if USDA can certify the flock's scrapie 
status. In 1997 the total earnings from exports of live sheep, goats, 
and sheep and goat meat and meat products was 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, both 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 proposed 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 proposed 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 all submitted 
comments supporting the approach of this proposed rule and also stated 
their associations' opinion that the benefits of the program would 
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 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, adopting this proposal could 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 proposal 
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, there is a perception of risk. This 
perception might be playing a significant role in encouraging U.S. 
imports of over $170 million worth of lamb and mutton, since imported 
lamb sells at a higher price than domestic lamb and mutton.
    In summary, this proposed rule would regulate the interstate 
movement of sheep and goats from States that do not follow effective 
flock 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 proposed rule would 
encourage States to carry out the necessary surveillance and quarantine 
activities quickly, thereby reducing the spread of the disease. The 
process outlined in the proposed rule would encourage these 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 proposed rule would 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 proposed 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 proposed changes to the regulations would result in new 
information collection or recordkeeping requirements, as described 
below under the heading ``Paperwork Reduction Act.'' 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 proposed rule would 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 proposal, 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 would not absolutely impose any new compliance costs on 
State or local governments, but it is true that, if adopted, this rule 
would 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.
    As discussed above, this proposal was preceded by an advance notice 
of proposed rulemaking which sought comments from the public, industry, 
and State and local officials. That notice specifically requested 
comments addressing ``the alignment of Federal interstate movement 
restrictions with State standards.'' The comments that we received and 
considered when drafting

[[Page 66803]]

this proposal, including comments on State issues, are addressed above. 
Additionally, in drafting this proposal, APHIS had many discussions 
with officials of animal health agencies in affected States.
    During these consultations, 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. A 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 have the opportunity to comment on this 
proposed rule, and we encourage them to submit comments on federalism 
concerns or any other issues. As this rulemaking continues, 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 proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this proposed rule is adopted: (1) All State 
and local laws and regulations that are in conflict with this rule will 
be preempted; (2) No retroactive effect will be given to this rule; and 
(3) Administrative proceedings will not be required before parties may 
file suit in court challenging this rule.

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this proposed rule have been 
submitted for approval to the Office of Management and Budget (OMB). 
Please send written comments to the Office of Information and 
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, 
DC 20503. Please state that your comments refer to Docket No. 97-093-2. 
Please send a copy of your comments to: (1) Docket No. 97-093-2, 
Regulatory Analysis and Development, PPD, APHIS, suite 3C03, 4700 River 
Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance Officer, 
OCIO, USDA, room 404-W, 14th Street and Independence Avenue SW., 
Washington, DC 20250. A comment to OMB is best assured of having its 
full effect if OMB receives it within 30 days of publication of this 
proposed rule.
    This proposed rule would revise various recordkeeping and 
notification requirements of APHIS scrapie regulations and the 
Voluntary Scrapie Flock Certification Program. The purpose of these 
requirements is primarily to prevent the uncontrolled interstate 
movement of animals that could spread scrapie, and to identify and 
certify flocks that are free of scrapie in order to prevent the disease 
from spreading.
    Collecting this information necessitates the use of a number of 
information-gathering documents, including certificates and permits, 
that are critical to our ability to locate flocks infected with scrapie 
and to prevent the interstate spread of scrapie. The collection of this 
information is therefore crucial to the success of scrapie control. 
State animal health agencies would also have to submit descriptions of 
their scrapie program activities to assist APHIS in determining whether 
they qualify for Consistent State status.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. We need this outside input to help us:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency's functions, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected;
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submission responses).
    Estimate of burden: The public reporting burden for this collection 
of information is estimated to average 2.5049 hours per response.
    Respondents: Flock owners, State animal health officials, 
accredited veterinarians, State and Federal veterinary medical 
officers, and State and Federal diagnostic laboratory personnel.
    Estimated annual number of respondents: 1,180.
    Estimated annual number of responses per respondent: 5.3610.
    Estimated annual number of responses: 6,326.
    Estimated total annual burden on respondents: 15,846 hours. (Due to 
rounding, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the average reporting 
burden per response.)
    Copies of this information collection can be obtained from: 
Clearance Officer, OCIO, USDA, room 404-W, 14th Street and Independence 
Avenue, SW., Washington, DC 20250.

Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public 
Law 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 202 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 to 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 to the 
private sector, of $100 million or more in any one year. A few States 
may not qualify as Consistent States under this rule unless and until 
they choose to increase their expenditures on scrapie control programs, 
but based on knowledge of current State budgets and our experience with 
the costs involved in conducting sheep and goat disease programs, we 
estimate that the possible increases in expenditures by these States 
will fall far below $100 million. Thus, this rule is not subject to the 
requirements of sections 202 and 205 of the UMRA.

[[Page 66804]]

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 proposing to revise 9 CFR parts 54 and 79 as 
follows:

PART 54--CONTROL OF SCRAPIE

Sec.
54.1  Definitions.

Subpart A--Scrapie Indemnification Program

54.3  Animals eligible for indemnity payments.
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.

Subpart B--Scrapie Flock Certification Program

54.10  Administration.
54.11  Participation.
54.12  State scrapie certification boards.
54.13  Cooperative agreements with States.
54.14  Requirements for flock plans and post-exposure management 
monitoring plans.

    Authority: 21 U.S.C. 111, 114, 114a, and 134a-134h; 7 CAR 2.22, 
2.80, and 371.2(d).


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.
    Affected animal. An animal for which a diagnosis of scrapie has 
been made by an APHIS or State representative based on the results of a 
live-animal screening test approved for this use by the Administrator. 
A live-animal screening test may be approved for this use without also 
being approved for the official diagnosis of a scrapie-positive animal.
    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.
    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 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.
    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 any physical contact.
    Destroyed. Euthanized by means other than slaughter, and the 
carcass disposed of, by means authorized 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. 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.
    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 a 
flock do not change the identity of the flock or the regulatory 
requirements applicable to the 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 an 
APHIS representative determines based upon examination of flock records 
that no animals have moved between the flocks;
    (2) The flocks never commingle and are kept at least 30 feet apart 
at all times;
    (3) The flocks have separate flock records and identification;
    (4) 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;
    (5) The flocks do not share equipment without cleaning and 
disinfection in accordance with the guidelines published in the Scrapie 
Flock Certification Program standards; and
    (6) There is no interchange of animals between the flocks.
    Flock plan. A written flock management agreement designed by the 
owner of a flock, an accredited veterinarian, and an APHIS 
representative or State 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. 54.14 of this part.
    High-risk animal. An animal that is:
    (1) The progeny of a scrapie-positive dam;
    (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.
    Infected flock. Any flock in which an APHIS representative or a 
State representative has determined an animal to be a scrapie-positive 
animal or in which an APHIS representative or a State representative 
has determined that a scrapie-positive animal had lambed within 18 
months of the time at which the tissues used for diagnosis were 
collected from the scrapie-positive animal. 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 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 an 
animal during, or up to 60 days after, lambing or kidding.

[[Page 66805]]

Limited contacts do not include any activity where uninhibited contact 
occurs, such as sharing an enclosure, sharing a section of a transport 
vehicle, or transportation to other flocks for breeding, except as 
allowed by 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 conflict.
---------------------------------------------------------------------------

    Mortgage. Any mortgage, lien, or other security or beneficial 
interest held by any person other than the one claiming indemnity.
    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 
designed by the owner of a flock, an accredited veterinarian, and an 
APHIS representative or State representative in which each participant 
agrees to undertake actions specified in the agreement to monitor for 
the recurrence 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 
to monitor for occurrence of scrapie for 5 years after the last 
exposure of the flock to a scrapie-positive animal, unless otherwise 
specified by an APHIS or state animal health official. 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. 54.14 of this part.
    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, United 
States Department of Agriculture, 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 protease-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.\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 between lambings in accordance with the guidelines 
published in the Scrapie Flock Certification Program standards.
    Source flock. A flock in which an APHIS representative or a State 
representative has determined that at least one animal was born that 
was diagnosed as a scrapie-positive animal at an age of 54 months or 
less. 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. A sheep or goat exhibiting any of the following 
possible signs of scrapie and that has been determined to be suspicious 
for scrapie by an accredited veterinarian, an APHIS representative, or 
a State 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. A suspect animal will 
no longer be a suspect animal upon determination by an APHIS 
representative or a State representative that it no longer exhibits 
such signs, or that the signs are not caused by scrapie.

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 54.4 of this part. Indemnity may be paid only for the following:
    (1) Destruction of high-risk animals;

[[Page 66806]]

    (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 affected animals; and
    (5) Destruction of suspect animals that are subsequently determined 
to be scrapie-positive animals.
    (b) No indemnity will be paid for an animal if the owner of the 
animal fails to provide APHIS, within 30 days of request, with animal 
registration certificates, sale and movement records, or other records 
requested in accordance with Sec. 54.5 of this part. 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 the guidelines published in 
the Scrapie Flock Certification Program standards. Premises or portions 
of premises may be exempted from such cleaning and disinfecting 
requirements if the APHIS or State representative determines that the 
exempted buildings, holding facilities, conveyances, or other materials 
on the premises do not require cleaning and disinfection to prevent the 
spread of scrapie.


Sec. 54.4  Application by owners for indemnity payments.

    (a) Normally, an application for indemnification will be initiated 
by an APHIS or State 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 quarantine. 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. However, an owner of a 
flock that has or has not been determined to be an infected flock or 
source flock, and is not under a State quarantine, 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. If the registration 
papers are unavailable or if the animals are less than 1 year old and 
are not registered at the time the claim for indemnity is submitted, 
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 54.3 of this part.


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 an 
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;
    (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.


Sec. 54.6  Amount of indemnity payments.

    Indemnity paid in accordance with 54.3 of this part will be $150 
for each registered animal destroyed and $50 for each unregistered 
animal destroyed.


Sec. 54.7  Procedures for destruction of animals.

    (a) Animals for which indemnification is sought must be destroyed 
on the premises where held, pastured, or penned at the time indemnity 
is approved, unless the APHIS representative involved approves in 
advance of destruction moving the animals to another location for 
destruction.
    (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, or 
Federal law. The carcasses must not be processed for animal food, 
unless subjected to a treatment process approved by the Administrator 
and known to eliminate the agents of transmissible spongiform 
encephalopathies. The carcasses may not be processed for human 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 will not be responsible for any costs or charges for the 
destruction and disposal of animals in accordance with this part.

Subpart B--Scrapie Flock Certification Program


Sec. 54.10  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 reduce 
the incidence of scrapie by voluntarily complying with the Scrapie 
Flock Certification Program standards.


Sec. 54.11  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 Administrator. 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 website at URL http://www.aphis.usda.gov/vs/
scrapie, and may also 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.


[[Page 66807]]


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


Sec. 54.12  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. 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, and one or 
more owners of flocks, and, at the discretion of the area veterinarian 
in charge, may include other members.


Sec. 54.13  Cooperative agreements with States.

    APHIS may execute a cooperative agreement with the animal health 
agency of any State to cooperatively administer the Scrapie Flock 
Certification Program within that State. These cooperative agreements 
will describe the respective roles of APHIS and State personnel in 
implementing the Scrapie Flock Certification Program standards and 
other scrapie control measures. The agreement may specify the 
financial, material, and personnel resources to be committed to the 
Scrapie Flock Certification Program and other scrapie control measures 
by APHIS and the State; assign specific Scrapie Flock Certification 
Program activities and other 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 
participating flocks; establish procedures for maintaining and sharing 
Scrapie Flock Certification Program records specified in the Scrapie 
Flock Certification Program standards, and specify other 
responsibilities of State representatives and APHIS representatives in 
support of the Scrapie Flock Certification Program and the State 
scrapie control program.

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


Sec. 54.14  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 6 months of age moving within 
slaughter channels that must be identified in accordance with Sec. 79.2 
of this chapter. The form of identification must be an electronic 
implant, flank tattoo, ear tattoo, or tamper-resistant ear tag approved 
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.
    (b) Upon request of an APHIS or State representative, the owner of 
the flock or his or her agent must have an accredited veterinarian 
collect and submit tissues from animals for scrapie diagnostic purposes 
to a laboratory designated by an APHIS or State representative.
    (c) The owner of the flock or his or her agent, upon request, must 
make animals in the flock and the records required to be kept as a part 
of these plans available for inspection by APHIS representatives and 
State representatives.
    (d) The owner of the flock or his or her agent must meet 
requirements found necessary by the APHIS representative or State 
representative to monitor for scrapie and to prevent the recurrence of 
scrapie in the flock. These other requirements may include, but are not 
limited to: Utilization of an approved live-animal test, 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 to a State representative, APHIS representative, or an 
accredited veterinarian any animals in the flock exhibiting the 
following: 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. Such animals must not 
be removed from the flock without written permission of an APHIS 
representative or State representative.
    (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, affected animals, and suspect animals must be 
removed from the flock. The animals must be removed by euthanization 
and disposal of the carcasses by burial, incineration, or other methods 
in accordance with State or Federal law, or, in the case of high-risk 
animals, by movement to slaughter (slaughtered animals are not eligible 
for indemnity) 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 the guidelines published in the Scrapie 
Flock Certification Program standards;
    (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 will require that an APHIS representative or State 
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 animal's individual official identification number from its 
electronic implant, flank tattoo, ear tattoo tamper resistant ear tag, 
or, in the case of goats, it may be a tail fold tattoo, and any 
secondary form of identification the owner of the flock may choose to 
maintain;
    (2) Sex, breed, 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.

[[Page 66808]]

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, affected animals, 
high-risk animals, exposed animals, suspect animals, source flocks, 
and infected flocks; notice to owners.
79.5  Issuance of certificates.
79.6  Standards for State programs to qualify as Consistent States.

    Authority: 21 U.S.C. 111-113, 115, 117, 120, 121, 123-126, 134b, 
and 134f; 7 CFR 2.22, 2.80, and 371.2(d).


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.
    Affected animal. An animal for which a diagnosis of scrapie has 
been made by an APHIS or State representative based on the results of a 
live-animal screening test approved for this use by the Administrator. 
A live-animal screening test may be approved for this use without also 
being approved for the diagnosis of a scrapie-positive animal.
    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.
    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 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 part by an APHIS representative, State 
representative, or accredited veterinarian at the point of origin of an 
interstate movement of animals, which includes a statement that the 
animals were not exhibiting clinical signs associated with scrapie at 
the time of examination.
    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.
    Consistent State. A State that the Administrator has determined 
conducts an active State scrapie control program that either:
    (1) Meets the requirements of Sec. 79.6 of this part; or
    (2) 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 of this part.
    Designated scrapie epidemiologist. An epidemiologist selected by 
the State animal health official and the area veterinarian in charge to 
reclassify animals already designated as high-risk, exposed, or 
affected with scrapie, based on epidemiologic investigation or the 
results of a live-animal test. The regional epidemiologist and the 
APHIS National Scrapie Program Coordinator must concur in the selection 
and appointment of the designated scrapie epidemiologist.
    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. 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.
    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 a 
flock do not change the identity of the flock or the regulatory 
requirements applicable to the 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 an 
APHIS representative determines based upon examination of flock records 
that no animals have moved between the flocks;
    (2) The flocks never commingle and are kept at least 30 feet apart 
at all times;
    (3) The flocks have separate flock records and identification;
    (4) 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;
    (5) The flocks do not share equipment without cleaning and 
disinfection in accordance with the guidelines published in the Scrapie 
Flock Certification Program standards; and
    (6) There is no interchange of animals between the flocks.
    Flock plan. A written flock management agreement designed by the 
owner of a flock, an accredited veterinarian, and an APHIS 
representative or State 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. 54.14 of this chapter.
    High-risk animal. An animal that is:
    (1) The progeny of a scrapie-positive dam;
    (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.
    Inconsistent State. Any State other than a Consistent State.
    Infected flock. Any flock in which an APHIS representative or a 
State representative has determined an animal to be a scrapie-positive 
animal or in which an APHIS representative or a State representative 
has determined that a scrapie-positive animal had lambed within 18 
months of the time at which the tissues used for diagnosis were 
collected from the scrapie-positive animal. A flock will no longer 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

[[Page 66809]]

outside of that State, or between points within a State but through any 
place outside that State.
    Limited contacts. Incidental contacts between animals 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 an 
animal during, or up to 60 days after, lambing or kidding. Limited 
contacts do not include any activity where uninhibited contact occurs, 
such as sharing an enclosure, sharing a section of a transport vehicle, 
or transportation to other flocks for breeding, except as allowed by 
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 conflict.
---------------------------------------------------------------------------

    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.
    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 
infected flock or a source flock, 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 
tattoo bearing the premises identification number assigned by a State 
or Federal animal health official to the premises on which the sheep or 
goats originated, or a brand registered with an official brand 
registry.
    Scrapie Flock Certification Program (SFCP). The cooperative 
Federal-State-industry voluntary program for the control of scrapie 
conducted in accordance with 9 CAR part 54, subpart B.
    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 Program 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, United 
States Department of Agriculture, 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) By the use of protease-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) Another test method approved by the Administrator.
    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 between lambings in accordance with the guidelines 
published in Scrapie Flock Certification Program standards.
    Source flock. A flock in which an APHIS representative or a State 
representative has determined that at least one animal was born that 
was diagnosed as a scrapie-positive animal at an age of 54 months or 
less. 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. A sheep or goat exhibiting any of the following 
possible signs of scrapie and that has been determined to be suspicious 
for scrapie by an accredited veterinarian, an APHIS representative, or 
a State 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. A suspect animal will 
no longer be a suspect animal upon determination by an APHIS 
representative or a State representative that it no longer exhibits 
such signs, or that the signs are not caused by scrapie.

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

[[Page 66810]]

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

    (a) No sheep or goat that is required to be individually identified 
by Sec. 79.3 of this part 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 at whichever of the 
following comes first:
    (i) The point of first commingling of the sheep or goats in 
interstate commerce with sheep or goats from any other source;
    (ii) Upon unloading of the sheep or goats in interstate commerce at 
any livestock market;
    (iii) Upon transfer of ownership of the sheep or goats in 
interstate commerce; or
    (iv) Upon arrival of the sheep or goats in interstate commerce at 
their final destination.
    (2) The sheep or goats must be identified by one of the following 
means of identification, and must remain so identified while they are 
in interstate commerce:
    (i) Electronic implants for animals required to be identified by 
the SFCP, when used in a flock participating in the SFCP;
    (ii) Official eartags, including tags approved for use in the SFCP, 
when used on any sheep or goat;
    (iii) United States Department of Agriculture backtags, when used 
on sheep or goats moving to slaughter;
    (iv) Official sheep or goat tattoos, when used on sheep or goats 
participating in the SFCP; or
    (v) Official registry tattoos that have been recorded in the book 
of record of a sheep or goat registry association.
    (3) 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 is responsible for the 
identification of the sheep or goats as provided by this section.
    (b) Serial numbers of United States Department of Agriculture 
backtags and official sheep and goat tattoos 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 Federal 
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. Premises 
identification numbers will be assigned to participants in the SFCP 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, and official 
eartags must:
    (1) Record the following information on a document:
    (i) All serial numbers applied to the 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; and
    (iv) The telephone number, if available, of the person who owns or 
possesses the sheep or goat;
    (2) Maintain these records for 5 years; and
    (3) 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, and presentation of his or her official credentials.
    (c) 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 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) The records must include:
    (i) If individual animal identification is required, all serial 
numbers and other approved means of identification appearing on the 
sheep or goat; and
    (ii) The street address, including city and State, or the township, 
county, and State, and the telephone number, if available, of the 
person from whom the sheep or goats were purchased or otherwise 
obtained.
    (2) 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, upon that 
employee's request and presentation of his or her official credentials.
    (d) No person may remove or tamper with any approved 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 
Inspection Service in chapter III of this title.
    (e) Written requests for approval of sheep or goat identification 
devices and markings not listed in paragraph (b) 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.

[[Page 66811]]



      Interstate Movement General Restrictions for Sheep and Goats
------------------------------------------------------------------------
                                   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
 below:
    (1) High-risk animal,     Prohibited*.........  Prohibited.*
     scrapie positive,
     suspect, or affected
     animal.
    (2) Non-high risk animal  Prohibited*.........  Prohibited.*
     from an infected or
     source flock.
    (3) Other animal........  Flock must be         Individual animal ID
                               enrolled in the       and certificate.
                               Complete Monitored
                               category of the
                               Scrapie Flock
                               Certification
                               Program or
                               equivalent APHIS-
                               recognized program
                               and have
                               certificate.
(b) Sale or other movement
 directly to slaughter, or
 through slaughter channels
 to slaughter, of animals
 under 6 months of age:
    (1) Scrapie positive,     Prohibited*.........  Prohibited.*
     suspect, or affected
     animal.
    (2) High-risk animals     Individual animal ID  Individual animal ID
     and animals from          and permit or         and permit or
     infected or source        sealed conveyance     sealed conveyance
     flock.                    and permit when       and permit when
                               moving directly to    moving directly to
                               slaughter, or a       slaughter, or a
                               permit and an         permit and an
                               indelible''S'' mark   indelible ``S''
                               on the left jaw.      mark on the left
                                                     jaw.
    (3) Other animal........  Premises ID** and     None.
                               certificate.
(c) Sale or other movement
 directly to slaughter, or
 through slaughter channels
 to slaughter, of animals
 over 6 months of age, or
 animals of any age to
 feedlots for later movement
 to slaughter:
    (1) Scrapie positive,     Prohibited*.........  Prohibited.*
     suspect, or affected
     animal.
    (2) High-risk animals     Individual animal ID  Individual animal ID
     and animals from          and permit.           and permit.
     infected or source
     flock.
    (3) Other exposed         Individual animal ID  Individual animal
     animals.                  and permit.           ID.
    (4) Other animals over 1  Individual animal ID  Individual animal
     year of age.              and certificate.      ID.
    (5) Other animals         Individual animal ID  Premises ID.**
     between 6 months and 1    and certificate.
     year of age, or animals
     under 6 months of age
     moving to feedlots for
     later movement to
     slaughter.
(d) Movement of animals for
 grazing or other management
 purposes without change of
 ownership:
    (1) Scrapie positive,     Prohibited*.........  Prohibited.*
     suspect, or affected
     animal.
    (2) High-risk animal or   Prohibited*.........  Prohibited.*
     animal from infected or
     source flock.
    (3) Exposed animals.....  Individual animal ID  Premises ID.
                               and certificate.
    (4) Other animal........  Premises ID and       None.
                               certificate.
------------------------------------------------------------------------
*Animals prohibited movement may be moved interstate only if they are
  moving interstate for destruction or research as approved by the
  Administrator.
**Premises ID is not required for slaughter animals if the animals are
  kept as a group on the same premises on which they were born and are
  not commingled with animals from another premises at any time,
  including throughout the slaughter process, or, if they are commingled
  during the slaughter process, they are officially identified on
  arrival at the slaughter facility such that any animal can be traced
  back to its flock of origin.
Note: A CONSISTENT STATE is one whose intrastate identification,
  quarantine and movement restrictions for infected and source flocks
  and high-risk animals are consistent with the APHIS standards for
  State scrapie programs.

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

    (a) Designation. An APHIS representative or State representative 
will designate an animal to be a scrapie-positive animal, affected 
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 of this part. An APHIS representative or State 
representative will designate a flock to be a source flock after 
reviewing sale, movement, and breeding records that indicate the flock 
meets the definition of a source flock in Sec. 79.1 of this part. An 
APHIS representative or State representative will designate a flock to 
be an infected flock after determining that the flock meets the 
definition of an infected flock in Sec. 79.1 of this part.
    (b) Reclassification. A designated scrapie epidemiologist may 
reclassify an exposed animal 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 scrapie-positive animal must have individual 
animal identification traceable to the flock of origin), and was not 
housed in lambing facilities or commingled with lambs while in the 
flock. A designated scrapie epidemiologist may reclassify an animal 
designated a high-risk animal as an exposed animal after receiving 
negative results from an approved live-animal test.
    (c) Notice to owner. As soon as possible after making such a 
determination, an APHIS representative or State representative will 
attempt to notify the owner(s) of the flock(s) in

[[Page 66812]]

writing that their flock contained or contains a scrapie-positive 
animal, an affected animal, a suspect animal, a high-risk animal or an 
exposed animal, or that the flock is an infected flock, or source 
flock. The notice will include a description of the interstate movement 
restrictions and identification requirements contained in this part.


Sec. 79.5  Issuance of certificates.

    (a) Certificates are required as specified by Sec. 79.3 of this 
part 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; 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. Ownership brands or other premises identification may be 
used in place of individual animal identification on certificates for 
sheep and goats moved interstate when premises identification is 
required under this part, provided the ownership brands are registered 
with the official brand recording agency. 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.
    (b) 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) 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 State programs 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 consider whether the State's scrapie control 
program:
    (1) Requires the reporting of and investigation of any suspect 
animal, affected animal, or scrapie-positive animal;
    (2) Requires the official permanent individual identification of 
any live scrapie-positive, affected, or suspect animal of any age, and 
of any exposed animal, including high-risk animals, 1 year of age or 
over and any exposed animals less than 1 year of age when a change of 
ownership occurs, except those animals under 6 months of age moving 
within slaughter channels in accordance with this part (whether or not 
the exposed animal resides in a source or infected flock);
    (3) Effectively enforces quarantines of all source and infected 
flocks;
    (4) Effectively enforces quarantines of all high-risk, affected, 
suspect, and scrapie-positive animals throughout their lives unless 
moved in accordance with this part;
    (5) If an affected, suspect or scrapie-positive animal dies or is 
destroyed, requires that tissues be submitted for diagnostic testing to 
a laboratory authorized by the Administrator to conduct scrapie tests 
in accordance with this part and that the carcass be completely 
destroyed; and
    (6) Releases quarantines of these flocks only upon completion of a 
flock plan and agreement by the owner to participate in a post-exposure 
monitoring and management plan as defined in part 54 of this chapter.
    (b) [Reserved]

    Done in Washington, DC, this 23rd day of November 1999.
Craig A. Reed,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 99-31087 Filed 11-29-99; 8:45 am]
BILLING CODE 3410-34-U