[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\
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\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.
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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
