[Federal Register: August 21, 2001 (Volume 66, Number 162)]
[Rules and Regulations]
[Page 43963-44003]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21au01-20]
[[Page 43963]]
-----------------------------------------------------------------------
Part II
Department of Agriculture
-----------------------------------------------------------------------
Animal and Plant Health Inspection Service
-----------------------------------------------------------------------
9 CFR Parts 54 and 79
Scrapie in Sheep and Goats; Interstate Movement Restrictions and
Indemnity Program; Final Rule
[[Page 43964]]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 54 and 79
[Docket No. 97-093-5]
RIN 0579-AA90
Scrapie in Sheep and Goats; Interstate Movement Restrictions and
Indemnity Program
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: We are amending the regulations for the interstate movement of
sheep and goats by requiring certain animal identification for sheep
and goats moving interstate, by establishing a list of States that
conduct an active State scrapie program that is consistent with Federal
requirements, by establishing requirements for moving sheep and goats
interstate from those States and from States that do not conduct such
programs, by reinstituting an indemnity program for certain sheep and
goats affected by scrapie, and by making other associated changes.
These changes will help prevent the interstate spread of scrapie, an
infectious disease of sheep and goats.
DATES: Effective Date: September 20, 2001. Compliance Dates: The
compliance date for all requirements to identify animals that are not
scrapie-positive animals, suspect animals, high-risk animals, exposed
animals, or animals from an infected or source flock is November 19,
2001. The compliance date for all requirements for the identification
of commercial whitefaced breeding sheep under 18 months of age and
commercial breeding goats is February 18, 2002.
FOR FURTHER INFORMATION CONTACT: Dr. Diane Sutton, Senior Staff
Veterinarian, National Animal Health Programs Staff, 4700 River Road
Unit 43, Riverdale, MD 20737-1235, (301) 734-6954.
SUPPLEMENTARY INFORMATION:
Background
Scrapie is a degenerative and eventually fatal disease affecting
the central nervous systems of sheep and goats. It is a member of a
class of diseases called transmissible spongiform encephalopathies
(TSE's). Its control is complicated because the disease has an
extremely long incubation period without clinical signs of disease.
To control the spread of scrapie within the United States, the
Animal and Plant Health Inspection Service (APHIS), U.S. Department of
Agriculture (USDA), administers regulations at 9 CFR part 79, which
restrict the interstate movement of certain sheep and goats. APHIS also
has regulations at 9 CFR part 54, which describe a voluntary scrapie
free flock certification program.
On November 30, 1999, we published in the Federal Register (64 FR
66791-66812, Docket No. 97-093-2) a proposal (referred to below as the
November 30 proposal) to amend 9 CFR parts 54 and 79. We proposed three
significant areas of change:
Further restrictions on the interstate movement of sheep
and goats from States that do not consider scrapie a reportable disease
or do not quarantine infected flocks or source flocks. We also proposed
standards describing how a State must conduct a quarantine in order to
avoid further restrictions on interstate movement of animals.
Additional official identification requirements for sheep
and goats moved interstate to allow for a more effective national
program for surveillance for scrapie and traceback of scrapie-positive
animals. The proposed identification requirements were similar to
current requirements for cattle and swine.
Reinstatement of a scrapie indemnification program for sheep and
goats that owners agree to destroy. As proposed, the owners of
destroyed high-risk animals and animals diagnosed as scrapie positive
by an approved live-animal test would be eligible for indemnity
payments.
We solicited comments concerning our proposal for 30 days ending
December 30, 1999. We reopened and extended the deadline for comments
until January 14, 2000, in a document published in the Federal Register
on January 7, 2000 (65 FR 1074, Docket No. 97-093-3). We received 171
comments by that date. They were from State agriculture agencies, sheep
and goat industry associations, sheep and goat producers, livestock
auction and slaughter companies, and universities and researchers.
After receiving comments on the November 30 proposal, we published
another proposed rule in the Federal Register on August 15, 2000 (65 FR
49770-49775, Docket No. 97-093-4, referred to below as the August 15
proposal). We solicited comments concerning the August 15 proposal for
30 days ending September 14, 2000. The August 15 proposal to amend 9
CFR part 79 fulfilled a promise made in the November 30 proposal, which
stated that before the November 30 proposal was finalized, APHIS would
develop and publish for comment a list of States that conduct an active
scrapie program that is consistent with Federal requirements and,
therefore, qualify as Consistent States. The August 15 proposal listed
all 50 States as Consistent States and also proposed certain changes to
the criteria by which States may qualify to be designated as Consistent
States.
The comments received on both the November 30 proposal and the
August 15 proposal, and the changes we are making in response to some
of them, are discussed below by topic.
Definition of Certificate
We are making certain changes to the process for issuing
certificates for sheep and goats. These changes are discussed later in
this document in the discussion of Sec. 79.5, ``Issuance of
certificates.'' Because we are moving certain requirements from the
definition of certificate in Secs. 54.1 and 79.1 to Sec. 79.5, we are
also changing the definition of certificate to read, ``An official
document issued in accordance with Sec. 79.5 of this chapter by an
APHIS representative, State representative, or accredited veterinarian
at the point of origin of an interstate movement of animals.''
Definitions of Exposed Animal and Exposed Flock
In the November 30 proposal, we tried to define the term exposed
animal in a manner that would include all animals that were exposed to
conditions that might result in the animal becoming infected with
scrapie. We defined exposed animal in Secs. 54.1 and 79.1 as ``Any
animal that has been in the same flock at the same time within the
previous 60 months as a scrapie-positive animal, excluding limited
contacts. Any animal born in a flock after a scrapie-positive animal
was born into that flock, if born before that flock completes the
requirements of a flock plan.'' Our proposed definition of flock
included ``All animals that are maintained on a single premises and all
animals under common ownership or supervision on two or more premises
with animal interchange between the premises.''
Several commenters were concerned over the effect of these
definitions on shows and sales and asked whether all animals that
attended a show or sale where a scrapie-positive animal was in
attendance would be considered exposed animals, regardless of their
degree of contact with the scrapie-positive animal. That was not our
intention, and we have modified the definition of exposed animal to
include animals that have exposure to scrapie while at shows or sales
without
[[Page 43965]]
classifying all animals at a show or sale as exposed animals. We have
done this by adding to the definition of exposed animal specific means
of exposure that could cause a sheep or goat to contract scrapie and by
revising the definition of flock to specifically exclude animals at
shows and sales. These changes were based on research into the means of
scrapie transmission and our knowledge of the manner in which sheep and
goats are marketed and shown. We added the following language to the
definition of exposed animal: ``Any animal that was commingled with a
scrapie-positive female animal during or up to 30 days after she
lambed, kidded, or aborted, or while a visible vaginal discharge was
present, or that was commingled with any other scrapie-positive female
animal for 24 hours or more, including during activities such as shows
and sales or while in marketing channels.''
Commenters also suggested that we review the scientific basis for
the timeframe requirements in the proposal. We reviewed the assumption
that there is a particular timeframe, during which an animal might
transmit scrapie, between the time it becomes infected and the time it
dies from the disease or shows obvious symptoms and is destroyed. One
of the places the proposal used this assumption is the proposed
definition of exposed animal, which counted exposure if it occurred
``within the previous 60 months.''
We have reviewed research on this matter. One of the sources relied
on for the proposal was Mission Field Trial data. The study monitored
653 sheep and goats that were exposed to the scrapie agent at birth,
and 145 sheep and goats that were exposed post-weaning. Results showed
that 91 percent of the sheep exposed at birth that died of scrapie died
before the age of 54 months and 98 percent died at 67 months or less.
For sheep exposed post-weaning 100 percent of those that died of
scrapie died at an age of 73 months or more. These data suggest that
animals diagnosed with scrapie at an age of 72 months or less were
probably exposed at birth, which suggests that their flock of birth
should be designated a source flock. Upon reexamining these findings we
believe that the assumption that an infected animal has an effective
timeframe for developing signs of scrapie for only 60 months, as
implied by the proposed definition of exposed animal, is too
conservative, since infected sheep might survive longer than this,
particularly if the animals are exposed post-weaning. The results of
the Mission Field Trial suggest that this timeframe should be removed.
Therefore, we have removed this timeframe in the definition of exposed
animal. As discussed below, we have changed a similar timeframe in the
definition of source flock from 54 months to 72 months to be consistent
with the data for animals exposed at birth.
Other commenters noted that the November 30 proposal discussed
actions that were required for flocks exposed to scrapie, particularly
with regard to post-exposure management and monitoring plans, but did
not define exposed flock. We agree that such a definition would be
useful and have added the following definition of exposed flock to
Secs. 54.1 and 79.1: ``Any flock in which a scrapie-positive animal was
born or lambed. Any flock that currently contains a female high-risk,
exposed, or suspect animal, or that once contained a female high-risk,
exposed, or suspect animal that lambed in the flock and from which
tissues were not submitted for official testing and found negative. A
flock that has completed a post-exposure management and monitoring plan
following the exposure will no longer be classified as an exposed
flock.''
Definition of Flock
Comments on the definition of flock in Secs. 54.1 and 79.1 noted
that the proposed definition could be interpreted to consider separate
groups of animals to be a single flock when they are temporarily placed
on the same premises, even when this does not involve close contact or
a significant risk of spreading scrapie. These commenters suggested the
definition be revised to note that animals maintained temporarily on a
premises for activities such as shows and sales or while in marketing
channels are not a flock. We agree, and have made the requested change.
One commenter also indicated the definition of flock is overly
restrictive in addressing when groups of animals on the same premises
can be considered separate flocks. We agree that separate flocks can be
kept in close proximity without risk of spreading scrapie if there is a
physical barrier between the flocks. We are, therefore, adding the
phrase ``or are separated by a solid wall through, over, or under which
fluids cannot pass and through which contact cannot occur'' to this
part of the definition.
Definition of Flock of Origin
Several commenters noted that the term flock of origin was used in
the November 30 proposal without being defined. For scrapie control
purposes, the important consideration for determining the flock of
origin is to identify the flock(s) that are likely to harbor or spread
scrapie as a result of an infected animal ``originating'' in the flock.
In this sense, an infected animal originated in any flock where the
animal gave birth, was bred, or was born. For clarity, we are adding a
definition of flock of origin to Secs. 54.1 and 79.1, to read as
follows: ``The flock in which an animal most recently resided in which
it either was born, gave birth, or was used for breeding purposes. The
determination of an animal's flock of origin may be based either on the
physical presence of the animal in the flock, the presence of official
identification on the animal traceable to the flock, the presence of
other identification on the animal that is listed on the bill of sale,
or other evidence, such as registry records.''
Definition of Infected Flock
Several commenters stated that, in addition to designating as
infected flocks the flocks of origin of scrapie-positive female
animals, we should consider as infected any flock in which a scrapie-
positive ewe lambed. We agree, and have changed the definition of
infected flock in Secs. 54.1 and 79.1 accordingly. The definition of
infected flock has been changed to read: ``The flock of origin of a
female animal that a State or APHIS representative has determined to be
a scrapie-positive animal; or any flock in which a State or APHIS
representative has determined that a scrapie-positive female animal has
resided, unless an epidemiologic investigation conducted by a State or
APHIS representative shows that the animal did not lamb in the flock. A
flock will no longer be considered an infected flock after it has
completed the requirements of a flock plan.''
Definition of Limited Contacts
One commenter suggested that the proposed definition of limited
contacts in Secs. 54.1 and 79.1, intended to define contacts that do
not present a significant risk of spreading scrapie, was overly strict
and would unnecessarily restrict the way in which animals are shown and
transported. The proposed definition stated that a contact was not
limited if it occurred within 60 days after lambing or kidding. We have
reduced this exclusion to 30 days, since tissues and fluids associated
with lambing are unlikely to be prevalent beyond this 30-day period.
However, we have also added that the contact is not limited if it is
with an animal that has aborted within the past 30 days or that had a
vaginal discharge at the time of the contact, since infectious
materials from abortions or discharges may
[[Page 43966]]
contaminate nearby animals. We are changing the text to read ``Limited
contacts do not include any contact, incidental or otherwise, with a
female animal during or up to 30 days after she lambed, kidded, or
aborted or when there is any visible vaginal discharge at the time of
the contact.'' Readers interested in this issue should also note that
the changes in the definitions of flock and exposed animal reduce the
effect of the limited contacts definition on the transport and showing
of animals.
Some commenters stated that they were confused by the language in
the definition of limited contacts that said contact was not limited if
it involved ``uninhibited contact while sharing a section of a
transport vehicle, or transportation to other flocks for breeding.''
The first restriction on sharing a section of a transport vehicle
appears to make the second restriction redundant. For clarity, we have
changed the second restriction to ``residing in other flocks for
breeding or other purposes.''
Definition of Official Eartag
Several comments indicated confusion regarding the relationship of
the terms official eartag and premises identification and questioned
whether the proposal was consistent with existing national
identification standards. We agree that the discussion in the proposal
was unclear, and we are clarifying that the National Uniform Eartagging
system or a combination of premises and individual animal
identification numbers may be used. We have added a definition of
official eartag to Sec. 79.1 that reads ``An identification eartag
approved by APHIS as being sufficiently tamper-resistant for the
intended use and providing unique identification for each animal. An
official eartag may conform to the alphanumeric National Uniform
Eartagging system or another system approved by APHIS, or it may bear a
premises identification number that either contains or is used in
conjunction with the producer's livestock production numbering system
to provide a unique identification number.''
Definition of Official Identification
We used the term official identification in the proposed rule, but
commenters noted that it was undefined. We are adding a definition of
official identification to Sec. 79.1 for clarity. The definition reads
as follows: ``Identification mark or device approved by APHIS for use
in the Scrapie Eradication Program. Examples are listed in
Sec. 79.2(a)(2).''
Definition of Premises Identification
One commenter requested that ear notches that are officially
registered be allowed in addition to brands, and another suggested that
temporary paint brands (where owners of animals that will be
temporarily commingled each mark their own animals with a strips of a
particular paint color, to facilitate later separation of the animals)
were adequate premises identification for animals that move without
changing ownership. We agree and are revising the proposed definition
of premises identification in Sec. 79.1 to allow for the use of ear
notches. We are changing the definition to read, ``An APHIS approved
eartag, backtag, or legible tattoo bearing the premises identification
number, consisting of the State postal abbreviation or code followed by
a unique alphanumeric number or name, assigned by a State or Federal
animal health official to the premises of the flock of origin for the
sheep or goats that, in the judgment of the State animal health
official or area veterinarian in charge, is epidemiologically distinct
from other premises, or a permanent legible brand or ear notch pattern
registered with an official brand registry. Premises identification may
be used when official individual animal identification is required, if
the premises identification method either includes a unique animal
number or is used in conjunction with the producer's livestock
production numbering system to provide a unique identification number
and where, if brands or ear notches are used, the animals are
accompanied by an official brand inspection certificate. Clearly
visible and/or legible paint brands may be used on animals moving
directly to slaughter and on animals moving for grazing or other
management purposes without change in ownership.''
Definition of Separate Contemporary Lambing Groups
Several commenters suggested that we review other APHIS animal
disease eradication programs to improve implementation of the scrapie
program. This review showed that cleaning and disinfection for other
disease programs are carried out under supervision. We agree that
supervision is necessary, and have changed the definition of separate
contemporary lambing groups in Secs. 54.1 and 79.1 accordingly, to
require supervision of cleaning and disinfection by an APHIS or State
representative or an accredited veterinarian, and to require records
documenting animal grouping and documenting cleaning and disinfection.
We have also clarified the proposed definition, which stated that
guidelines for cleaning and disinfection could be found in the Scrapie
Flock Certification Program standards. We have moved requirements for
cleaning and disinfection from the Scrapie Flock Certification Program
standards into Sec. 54.7(e) of the regulations. Guidelines and examples
regarding how to apply these requirements may now be found in both the
Scrapie Flock Certification Program standards and the Scrapie
Eradication Uniform Methods and Rules.
Definition of Source Flock
Several commenters suggested that the definition of source flock in
Secs. 54.1 and 79.1 should be qualified by stating how the
determination that an animal was born in a flock should be made. We
agree and have changed the definition to state that the determination
that an animal was born in a flock will be based on such information as
the presence of official identification on the animal traceable to the
flock, the presence of other identification on the animal that is
listed on the bill of sale, or other evidence, such as registry
records, to show that a scrapie-positive animal originated from the
flock, combined with the absence of any records indicating that the
animal was purchased from outside and added to the flock.
One commenter recommended that only official identification be
accepted for tracebacks. We disagree, because there are often cases
where registry records or bills of sale are adequate for positive
identification of an animal, and sometimes these documents are
available when official identification is not. Commenters also
suggested that DNA comparison be used for positive identification of
traced animals. We agree that an owner should be allowed to request
verification of a traced animal's identity through DNA comparison, at
the owner's expense, when the conditions exist to make such
verification possible and reliable. These conditions exist in those
cases where DNA has been archived at an approved genotyping laboratory,
or if DNA collection and storage are required for breed registration
and the breed registration has appropriate safeguards in place to
ensure the integrity of the banking process, and when adequate records
and identification have been maintained by the owner and the
repository. We have changed the definition of source flock accordingly.
[[Page 43967]]
As discussed above regarding the definition of exposed animal,
commenters suggested we reexamine the scientific basis of the
timeframes in the proposed rule. The proposal assumed that animals
exposed at birth would die by the age of 54 months. We reexamined the
data and concluded that it shows that while almost all animals that
contract scrapie at birth die at an age of 72 months or less, animals
that contract scrapie post-weaning do not die from it until at least
the age of 73 months. Weaning normally occurs 80-90 days after birth.
Therefore, if an animal is diagnosed with scrapie at an age of 73
months or more, it did not contract scrapie at birth, and its flock of
birth should not be considered a source flock based on the diagnosis.
Therefore, we have amended the definition of source flock to state that
it includes flocks where at least one animal was born that was
diagnosed as a scrapie-positive animal at an age of 72 months or less.
As amended according to the comments discussed above, the
definition of source flock in this final rule now reads as follows: ``A
flock in which a State or APHIS representative has determined that at
least one animal was born that was diagnosed as a scrapie-positive
animal at an age of 72 months or less. The determination that an animal
was born in a flock will be based on such information as the presence
of official identification on the animal traceable to the flock, the
presence of other identification on the animal that is listed on the
bill of sale, or other evidence, such as registry records, to show that
a scrapie-positive animal was born in the flock. If DNA from the animal
was previously collected by an accredited veterinarian and stored at an
approved genotyping laboratory, or if DNA collection and storage are
required for breed registration and the breed registration has
appropriate safeguards in place to ensure the integrity of the banking
process, the owner may request verification of the animal's identity
based on DNA comparison if adequate records and identification have
been maintained by the owner and the repository to show that the
archived DNA is that of the animal that has been traced to the flock.
The owner will be responsible for all costs for the DNA comparison. A
flock will no longer be a source flock after it has completed the
requirements of a flock plan.''
Definition of High-Risk Animal
Commenters suggested two specific changes to the definition of
high-risk animal. The first suggestion was that only sexually intact
animals should be considered high-risk, since other animals are
extremely unlikely to spread scrapie. The second suggestion was that an
animal born into the same flock in which a scrapie-positive animal was
born should not be considered high-risk if the animal was born after
the flock completes the requirements of a flock plan, designed to
remove the risk of spreading scrapie.
We agree, and have added language to the definition of high-risk
animal in Secs. 54.1 and 79.1 to accomplish these changes. We have also
made changes to this definition in response to comments suggesting that
the regulations incorporate the most recent scientific research on
animal genetics and resistance to scrapie, discussed below. As revised,
the definition of high-risk animal reads as follows: ``A sexually
intact animal, excluding male sheep that have tested RR at codon 171
and AA at codon 136 using an official genotype test, that is:
(1) The progeny of a scrapie-positive dam; or
(2) Born in the same flock during the same lambing season as
progeny of a scrapie-positive dam, unless the progeny of the scrapie-
positive dam are from separate contemporary lambing groups; or
(3) Born in the same flock during the same lambing season that a
scrapie-positive animal was born, or during any subsequent lambing
season, if born before that flock completes the requirements of a flock
plan; or
(4) An exposed female sheep that has not tested QR, HR, or RR at
codon 171 using an official genotype test.''
Definition of Suspect Animal
Some commenters indicated that the movement restrictions in
proposed Sec. 79.3 were overly complex. In response, we have combined
the categories of suspect animal and affected animal into one category.
We have done this by adding the following to the definition of suspect
animal in Secs. 54.1 and 79.1: ``A sheep or goat that has tested
positive for scrapie or for the proteinase resistant protein associated
with scrapie on a live-animal screening test or any other test is a
suspect animal, unless it is designated a scrapie-positive animal.''
This removes the need to use the term affected animal, which
essentially applied to animals that tested positive to a live-animal
screening test. In the November 30 proposal, the same movement
restrictions applied to suspect animals and affected animals, so this
change will not alter movement restrictions. This change reduces the
complexity of the rule and removes the need for States to change their
regulations to separately address affected animals. It also closes a
loophole that would have allowed sheep and goat owners to use
unofficial tests without any risk that positive results would result in
restrictions on the movement of the animals. Under the new definition,
animals that test positive to unofficial tests would be designated
suspect animals. This designation may be removed in accordance with
Sec. 79.4.
New Definitions of Commercial Sheep or Goat, Low-Risk Goat, and Low-
Risk Commercial Sheep
Several commenters suggested that lesser interstate movement
restrictions were appropriate for animals that are raised primarily for
production and that are of a breed type or cross that has a low
prevalence of scrapie. These commenters suggested that whitefaced
animals from commercial flocks in States where scrapie has not been
reported in whitefaced animals do not represent a substantial scrapie
risk.
We agree, and have added two new definitions to Sec. 79.1 that are
used in the chart of interstate movement restrictions in Sec. 79.3,
commercial sheep or goat and blackfaced sheep. A commercial sheep or
goat is any animal from a flock from which animals are moved only
either directly to slaughter or through slaughter channels to slaughter
or any animal that is raised only for meat or fiber production and that
is not registered with a sheep or goat registry or used for exhibition.
A blackfaced sheep is any purebred suffolk, hampshire, shropshire or
cross thereof, any non-purebred sheep known to have suffolk, hampshire,
or shropshire ancestors, and any non-purebred sheep of unknown ancestry
with a black face, except commercial hair sheep. We are defining
blackfaced sheep in the regulations, rather than whitefaced sheep and
whitefaced crossbreeds, because blackfaced sheep are the higher risk
category and defining this term makes it easier to address risk in the
requirements and exemptions contained in the regulations.
Several commenters suggested that we should simplify the chart of
interstate movement restrictions in Sec. 79.3 and provide lesser
restrictions for certain low-risk goats and commercial sheep. We agree,
and have done so by adding definitions of low-risk goat and low-risk
commercial sheep and then referring to those defined terms in the
chart. We are defining low-risk goat in Sec. 79.1 as a goat that is not
a scrapie-positive, suspect, high-risk, or exposed animal, that has not
been commingled with sheep, and
[[Page 43968]]
that meets certain other requirements that indicate the goat has a low
risk of spreading scrapie. These other requirements are that the goat
must be from:
(1) A State in which scrapie has not been identified in a goat
during the previous 10 years;
(2) A State in which scrapie has been identified in a goat during
the previous 10 years, but the scrapie-positive goat was not born in
the State and resided in the State for less than 72 months and did not
kid while in the State; or,
(3) A State in which scrapie has been identified in a goat during
the previous 10 years, and the scrapie-positive goat was commingled
with sheep, but flock records allowed a complete epidemiologic
investigation to be completed and all resulting infected, source, and
exposed goat herds have completed flock plans and are in compliance
with post-exposure monitoring plans.
Similarly, we are defining low-risk commercial sheep in Sec. 79.1
in a manner that excludes blackfaced sheep, animals that are known to
be at risk of having scrapie or having been exposed to scrapie, and
animals that are not sufficiently identified to determine their flock
of origin. We define low-risk commercial sheep as ``Commercial
whitefaced, whitefaced cross, or commercial hair sheep from a flock
with no known risk factors for scrapie, including any exposure to
female blackfaced sheep, that are identified with a permanent brand or
earnotch pattern registered with an official brand registry and that
are not scrapie-positive, suspect, high-risk, or exposed animals and
are not animals from an infected, source, or exposed flock. The term
brand includes official brand registry brands on eartags in those
States whose brand law or regulation recognizes brands placed on
eartags as official brands. Low-risk commercial sheep may only exist in
a State where scrapie has not been diagnosed in the previous 10 years
in commercial whitefaced, whitefaced cross, or commercial hair sheep
that were not commingled with female blackfaced sheep.''
Additional New Definitions
We are also adding new definitions for the following terms:
commercial hair sheep, ownership brand, official test, official
genotype test, approved laboratory, unofficial test, direct movement to
slaughter, and flock sire.
In order to properly separate risk categories it is necessary to
make distinctions between hair sheep and other types of sheep, making
it necessary to define commercial hair sheep. We are adding a
definition of commercial hair sheep to Sec. 79.1 to read ``Any
commercial sheep with hair rather than wool that is either a full-
blooded hair sheep or that resulted from the cross of a hair sheep with
a whitefaced wool sheep.''
In the proposal ownership brands were not defined. We have added a
definition of ownership brand to Sec. 79.1, using the definition
commonly accepted in livestock industries: ``A unique permanent brand
or earnotch pattern applied to an animal that indicates ownership by a
particular person when the brand pattern is registered with a State's
official brand recording agency.''
Several commenters recommended that there be greater flexibility in
the handling of infected and source flocks. We agree. In order to
organize changes to provide greater flexibility it is necessary to
define a term that includes all approved tests and that indicates where
such tests must be conducted in order to be used for this purpose. We
are adding the following definition of official test to Secs. 54.1 and
79.1: ``Any test for the diagnosis of scrapie in a live or dead animal
that is approved by the Administrator for that use and conducted either
at an approved laboratory or at the National Veterinary Services
Laboratories.'' Commenters also stated that if the rule distinguishes
the risk level of animals based on their genotype, it should define a
means for approving acceptable methods of genotype testing. We agree,
and are adding the following definition of official genotype test to
Secs. 54.1 and 79.1: ``Any test to determine the genotype of a live or
dead animal that is conducted at either an approved laboratory or at
the National Veterinary Services Laboratories, when the animal is
officially identified and the samples used for the test are collected
and shipped to the laboratory by either an accredited veterinarian or a
State or APHIS representative.'' We are also adding a complementary
definition of approved laboratory to Secs. 54.1 and 79.1: ``A
laboratory approved by the Administrator in accordance with Sec. 54.11
to conduct one or more scrapie tests, or genotype tests, on one or more
tissues.''
To clearly distinguish official tests from other tests that owners
may conduct for their own purposes, we are also adding the following
definition of unofficial test to Secs. 54.1 and 79.1: ``Any test for
the diagnosis of scrapie or for the detection of the proteinase
resistant protein associated with scrapie in a live or dead animal that
either has not been approved by the Administrator or that was not
conducted at an approved laboratory or at the National Veterinary
Services Laboratories.''
One commenter stated that, in some circumstances, the proposal
would require that animals be moved directly to slaughter, but did not
define what this means. We agree that clarification would be useful,
and we have added to Sec. 79.1 a definition of direct movement to
slaughter that reads ``Transported to a facility for slaughter, without
stops or unloading except for feeding and watering during which the
animals are not commingled with any other animals.''
We are also adding to Sec. 54.1 the following definition of flock
sire, a type of animal that is eligible for a premium indemnity under
the rule: ``A sexually intact male animal that has ever been used for
breeding in a flock.''
Destruction by Slaughter of High-Risk, Exposed, and Scrapie-Positive
Animals
Several commenters indicated that high-risk and exposed animals and
animals that test positive to a live-animal screening test should be
permitted to move to slaughter because there is no known human health
risk from scrapie and Food and Drug Administration ((FDA) regulations
provide adequate protection against inclusion of the scrapie agent in
ruminant feed. These commenters argued that sending these animals to
slaughter is usually more economical and less difficult than arranging
other means of disposal.
We agree that there is no evidence that scrapie is a human health
risk and significant evidence that it is not a human health risk. The
World Health Organization recommendation calls for the exclusion of
small ruminants showing signs of a TSE from slaughter to address a
theoretical risk. In keeping with this recommendation small ruminants
with clinical evidence of central nervous system disease are condemned
by the Food Safety Inspection Service (FSIS) on ante-mortem inspection.
Excluding test-positive animals goes one step farther to exclude the
scrapie agent from the food and feed chains. We believe that excluding
from slaughter animals that test positive to a live-animal test is
warranted to maintain consumer confidence and minimize the risk of the
scrapie agent entering the human and animal food chains.
We agree with the commenters that most scrapie-exposed and high-
risk animals do not, in fact, contain the scrapie agent. Under the
proposed rule, high-risk animals would be indemnified but prohibited
from going to slaughter
[[Page 43969]]
while scrapie-exposed animals would not be indemnified and could be
slaughtered. Since both types of animals share the same, low risk of
spreading scrapie, we have now decided that it is not consistent to
keep one set of these animals from slaughter but allow the other set to
go to slaughter. Also, owners of non-indemnified scrapie-exposed and
high-risk animals can recoup much of the animals' economic value by
sending the animals to slaughter, although such animals usually fetch a
discounted price from slaughter plants. Keeping these animals from
slaughter would also present additional environmental problems related
to finding enough landfills and incinerator capacity to deal with the
large number of exposed and high-risk animals. Therefore, we are
changing the definition of destroyed in Sec. 54.1 to allow indemnified
high-risk animals to move to slaughter; however, we continue to
prohibit movement to slaughter of animals that test positive to a live-
animal test in order to minimize the amount of scrapie agent in the
food chain, since these animals are known to contain PrP-sc, which has
been linked to the presence of the scrapie agent. We are also making
corresponding changes in Sec. 54.7, ``Procedures for destruction of
animals,'' to allow indemnified animals (except for scrapie-positive or
suspect animals) to move to slaughter, or to a quarantined research
facility or another location for destruction, if the movement is
approved by APHIS. Note that this change does not affect the FDA
regulations that continue to prohibit the inclusion of animal protein
derived from mammalian tissues in ruminant feed.
We are also amending the definition of destroyed to include
movement to a quarantined research facility when such movement is
authorized by the Administrator. The scrapie program has always
authorized some animals that would otherwise have to be euthanized to
be moved for research purposes, and this change to the definition
acknowledges that such movements satisfy the regulatory requirement to
destroy an animal.
Cooperative Agreements and Memoranda of Understanding With States
The November 30 proposal did not propose regulatory requirements
for cooperative agreements and memoranda of understanding, but it did
solicit comments on whether it would be desirable to require States to
sign a compliance agreement with APHIS describing State scrapie program
operations, cooperative activities with APHIS, and planning and
financing details for these activities. Several commenters suggested
that the final rule should contain a section authorizing and describing
such agreements. We agree, and have added a new Sec. 54.2 describing
cooperative agreements and memoranda of understanding for activities
under both the Scrapie Eradication Program and the Scrapie Flock
Certification Program. Based on suggestions from commenters, this
section states that such agreements will describe the respective roles
of APHIS and State personnel in implementing the Scrapie Eradication
Program and the Scrapie Flock Certification Program. Each agreement may
specify the financial, material, and personnel resources to be
committed to these programs and other scrapie control measures by APHIS
and the State and assign specific activities related to the control of
scrapie within a State to APHIS or State personnel. The agreements may
also establish schedules for APHIS representatives or State
representatives to visit flocks, establish procedures for maintaining
and sharing program records, and specify other responsibilities of
State representatives and APHIS representatives in support of the
Scrapie Eradication Program and the Scrapie Flock Certification
Program.
Indemnity Values and Application for Indemnity
Numerous commenters indicated that the indemnity value set for
sheep was too low and should be based on market value. The indemnity
payments proposed were $150 for registered animals and $50 for other
animals and were significantly lower than the average national sale
price of sheep. After evaluating comments on this issue, we agree that
an indemnity that approximates fair market value would increase
compliance and assist scrapie control. We have considered several
methods for establishing market value and have decided to rely, as
other indemnity programs have done, on the average sale price
information published by the U.S. Department of Agriculture's
Agricultural Marketing Service (AMS). The indemnity value will be set
weekly by APHIS based on the ewe and lamb market prices reported by AMS
and will be posted on the APHIS scrapie web page. We are field testing
this market based method by using it to purchase animals for diagnostic
purposes.
Specifically, we are changing Sec. 54.6, which sets the amounts of
indemnity payments, to state that indemnity for sheep will be set based
on the following AMS price reports: The weekly weighted average Choice/
Prime slaughter lamb prices at Greeley, CO; the weekly weighted average
Utility slaughter ewe prices at San Angelo, TX; the monthly weighted
average commercial western ewe lamb replacement price per head; the
monthly weighted average commercial western yearling ewe replacement
price per head; the monthly weighted average commercial western running
age ewe price per head; and the monthly weighted average commercial
western aged ewe price per head.. If pricing information is unavailable
from these markets during a given week or month, or if the numbers sold
are too low to give an accurate market value, the preceding week or
month's value will be used. The AMS reports from the most recent week
or month prior to the date APHIS first offers to pay an owner indemnity
shall be used to calculate the indemnity for that owner's sheep.
In contrast to indemnities for sheep, indemnities for goats will be
calculated based directly on the value of the goat as indicated by the
producer's purchase records and sales records for the preceding 12 to
24 months, not to exceed the maximum indemnity allowed for sheep. We
are not establishing a complicated, market price-based formula for
calculating indemnities for goats because based on program experience
there will be extremely few goats eligible for indemnity. Program
experience also suggests that sales and purchase records of goats are a
good guide to the fair market value of goats, and it will be cost-
effective to calculate the indemnity individually in each case from
these records.
The amount of indemnities for sheep will be calculated as follows:
For sheep under 1 year of age, the indemnity will equal the weekly
weighted average Choice/Prime slaughter lamb price per pound times 50
lbs, or times the actual weight, whichever is more. (The default weight
of 50 lbs was selected to fairly compensate owners whose sheep were
identified as eligible for indemnity while very young, before they
achieved significant weight gain.) However, for ewe lambs under 1 year
of age, the indemnity will equal the monthly weighted average
commercial western ewe lamb replacement price per head, if this price
is higher, since ewe lambs might have a greater potential value as
breeding animals. For sexually intact sheep 8 years of age or older and
castrated animals 1 year of age or older, the basic indemnity shall
equal the weekly weighted average Utility slaughter ewe price per pound
times 150, based on an average weight of 150 lbs. For mature sexually
intact sheep at
[[Page 43970]]
least 1 year of age and under 2 years of age, the indemnity will equal
the greater of the monthly weighted average commercial western yearling
ewe replacement price per head, or the weekly weighted average Utility
slaughter ewe price per pound times 150, based on an average weight of
150 lbs. For mature sexually intact sheep at least 2 years of age and
under 6 years of age, the basic indemnity will equal the greater of the
monthly weighted average commercial western running age ewe price per
head, or the weekly weighted average Utility slaughter ewe price per
pound times 150, based on an average weight of 150 lbs. For mature
sexually intact sheep at least 6 years of age and under 8 years of age,
the basic indemnity will equal the greater of the monthly weighted
average commercial western aged ewe price per head, or the weekly
weighted average weekly Utility slaughter ewe price per pound times
150, based on an average weight of 150 lbs. If records and
identification are inadequate to determine the actual age of animals,
an APHIS or State representative will count all sexually intact animals
that are apparently under 1 year of age, and those that are apparently
at least 1 and under 2 years of age, based on examination of their
teeth, and the indemnity for these animals will be calculated. The
total number of these animals will be subtracted from the total number
of sexually intact animals in the group to be indemnified, and
indemnity for the remainder will be calculated based on the assumption
that the remainder of the flock is 80 percent aged 2 to 6 years and 20
percent aged 6 to 8 years. This assumed age distribution reflects the
fact that animals tend to die or be culled as they get older. Most ewes
in commercial flocks are eliminated between 6 to 8 years of age.
As many commenters requested, we will increase the indemnity
amounts for registered animals to partially compensate owners for the
greater value of these animals. We will add a premium to the basic
indemnity for each registered animal equal to $100 for each registered
animal under 1 year of age, $200 for each registered animal at least 1
year of age and under 4 years of age, and $100 for each registered
animal at least 4 years of age and under 8 years of age. In addition to
this, we will add a premium of $50 to the indemnity for each flock
sire. Also, any animal that is not registered at the time indemnity is
first offered, but is eligible to be registered, will receive the
registered animal premium reduced by $50. The owner must provide
adequate records to qualify for these premiums.
As a result of the change in the definition of destroyed to allow
high-risk animals eligible for indemnity to be destroyed by slaughter,
it was necessary to address the effect of moneys received from
slaughter plants on the amount of indemnity received by owners of
animals disposed of by being sent to slaughter. We are changing
Sec. 54.6 to provide that, for animals destroyed by slaughter, the
owner will retain the salvage value (the amount paid by a slaughter
plant for the animal) of animals. If the salvage value, less shipping
costs, is less than the slaughter price used to calculate indemnity,
APHIS will pay the owner the difference. APHIS will also indemnify the
owner in the amount of any productivity, registered animal, or flock
sire premiums for which the animal qualifies.
We anticipate that owners will wish to have recourse if they
believe that the average weights used to calculate indemnities do not
fairly represent the weights of animals in their flock. We have revised
Sec. 54.6 to allow an owner who disagrees with the average weight
estimate to have the sheep weighed at a public scale at his own expense
(the usual average weighing fee is less than $1 per animal, though
there will be additional expense if the owner must transport them to be
weighed). In such a case, the owner will be paid based on the actual
weight times the AMS weekly average price.
We have also clarified that indemnity will be paid to an owner only
for animals actually in a flock at the time indemnity is first offered.
Animals removed from the flock as part of a post-exposure management
and monitoring plan will be paid indemnity based on the AMS average
prices at the time an APHIS representative designates the animals for
removal.
We received several comments concerning Sec. 54.4, the section
describing how to submit an application for indemnity. One comment
noted that the proposal stated that normally a State or APHIS
representative would initiate the application for a flock that is
already under a State quarantine. This comment stated that some States
do not actually call the movement restrictions they place on flocks a
``quarantine,'' and the regulations should not use this term here to
avoid confusion. We agree, and have changed ``State quarantine'' to
``State movement restrictions.'' In such cases, the flock owner will
confirm information about the flock's eligibility for indemnity that is
contained in the application submitted by the APHIS or State
representative. Another comment noted that under the proposal, flock
owners could choose to apply directly for indemnity, rather than having
a State or APHIS representative make the application, in all cases,
except for flocks that were under State quarantines (movement
restrictions). The commenter did not see the purpose of excluding
flocks under State movement restrictions from applying directly for
indemnity. Neither do we, and we have removed this restriction.
Another commenter noted that proposed Sec. 54.4(a)(5) required
registration papers for any registered animals in a flock to accompany
the application for indemnity. This commenter stated that the language
did not make it clear that owners may apply for indemnity for
unregistered animals without registration papers. To clarify this, we
have added the phrase ``registration papers are not required for the
payment of indemnity for animals that are not registered'' to this
paragraph.
Certification by Owners Receiving Indemnity
Proposed Sec. 54.5 required owners receiving indemnity to sign an
agreement with APHIS certifying that the owner would cooperate with
certain conditions. One of these conditions was to allow an APHIS
representative, upon request, to review bills of sale and other records
of the flock. One commenter suggested that this agreement should also
allow State representatives to review these records. We agree, and have
made that change.
The proposed agreement would also require flock owners that
maintain a flock after receiving indemnity to maintain that flock under
a post-exposure management and monitoring plan. One commenter suggested
that the agreement should specify how long the flock would have to be
subject to the post-exposure management and monitoring plan. We agree,
and have added ``for 5 years'' to this requirement. Five years of
monitoring is consistent with normal epidemiological practice and
guidance in the Scrapie Flock Certification Program standards.
We have also added to the agreement, based on another comment, that
the owner must allow any animal for which indemnity is paid to be
removed to a U.S. Department of Agriculture facility or a quarantined
research facility, slaughtered, or euthanized and necropsied and
tissues removed for diagnostic or other purposes. This change will
ensure that APHIS has access to animals when they are needed
[[Page 43971]]
for testing to further our knowledge of scrapie transmission patterns.
Identification of Sheep and Goats in Interstate Commerce
Several commenters suggested changes to proposed Sec. 79.2(a)(1),
which specified where and when identification should be attached to
animals that must be identified under the regulations. The proposal
stated that animals must be identified at whichever of the following
occurs first: The point of first commingling of the sheep or goats in
interstate commerce with sheep or goats from any other source; upon
unloading of the sheep or goats in interstate commerce at any livestock
market; upon transfer of ownership of the sheep or goats in interstate
commerce; or upon arrival of the sheep or goats in interstate commerce
at their final destination.
Some commenters stated that animals should always be identified
before being moved from their flock of origin, rather than at any later
stage of movement, because this would minimize chances for errors in
identification and would eliminate the need for markets, slaughter
plants, or other businesses to apply identification. We agree in part
and have changed the wording in Sec. 79.2(a)(1) to require the owner of
the flock of origin or his agent to identify the animals. This does not
preclude the owner of the flock of origin from contracting with a
livestock market, slaughter plant, or other person to act as his agent
for the purpose of applying official identification at the first point
in movement where official identification is required. In response to
comments suggesting that animals be identified to their flock of birth,
not just their flock of origin, we are requiring identification to the
flock of birth for animals born after January 1, 2002. The delay in
this requirement's effective date will give owners an opportunity to
prepare for the new requirement. To further mitigate the impact on
owners and markets, we are allowing animals moving interstate directly
to slaughter to move without flock-of-birth identification until June
1, 2003.
We have also amended Sec. 79.2(a)(1) to note the fact that the
regulations, in Sec. 79.6(a)(10)(i), allow Consistent States to exempt
certain low-risk animals in intrastate commerce from being identified
to their flock of origin or birth. It would be impractical and
unnecessary to require that these animals be identified to their flock
of origin or birth in order to move interstate, so we have amended our
identification requirements for animals in interstate commerce to state
that animals that Consistent States have exempted from flock of origin
identification in intrastate commerce in accordance with
Sec. 79.6(a)(10)(i) may be moved interstate with only individual animal
identification traceable to the State of origin and to the owner of the
animals.
We have also clarified that if an owner fails to arrange required
official identification for his animals, other persons engaged in
moving those animals (shippers, markets, slaughter plants, etc.) may
not move the animals unless the required identification is
accomplished. It would have undesirable effects on compliance with the
regulations if other persons engaging in interstate commerce were free
to move animals that an owner failed to identify. In some cases, this
requirement may result in shippers, markets, or other parties applying
official identification to animals, using information from owners
statements or bills of sale, in order to legally move the animals in
interstate commerce.
Commenters also suggested that identification requirements be kept
to a minimum. In response to this we have identified one case where the
proposed identification requirement appears to be unnecessary. The
proposal required individual identification of animals whose final
destination was a slaughter plant. The proposal also allowed those
animals to be moved interstate without such identification if it was
applied after the animals arrived at the slaughter plant. Since
individual identification would be required at slaughter plants
primarily to allow APHIS to conduct slaughter sampling and trace back
positive animals, we believe that this identification would serve no
purpose on those days when APHIS does not conduct slaughter sampling at
a plant, and we have removed this individual identification requirement
in such cases.
A commenter noted that the requirements for Consistent State status
mean that States will require identification even when animals change
ownership within a State. The commenter also noted that the State
requirement would facilitate identifying animals moving interstate
under the Federal regulations. We agree. No change is necessary in
response to this comment since Sec. 79.2(a)(1)(iv) requires
identification ``upon transfer of ownership of the sheep or goats in
interstate commerce.''
In accordance with the above comments, we have revised
Sec. 79.2(a)(1) to read as follows:
(1) The sheep or goat must be identified to its flock of origin
and, for an animal born after January 1, 2002, to its flock of
birth, by the owner of the flock or his or her agent; at whichever
of the following points in commerce comes first, Except that;
animals born after January 1, 2002, may be moved interstate direct
to slaughter without identification to flock of birth until June 1,
2003, and animals that cannot be identified to their flock of origin
because Consistent States have exempted them from flock of origin
identification in intrastate commerce in accordance with
Sec. 79.6(a)(10)(i) may be moved interstate with only individual
animal identification traceable to the State of origin and to the
owner of the animals at the time they were so identified:
(i) The point of first commingling of the sheep or goats in
interstate commerce with sheep or goats from any other flock of
origin;
(ii) Upon unloading of the sheep or goats in interstate commerce
at any livestock market, except a market described in paragraph
(a)(1)(iii) of this section;
(iii) Upon leaving a livestock market that has been approved in
accordance with this chapter to handle sheep and goats in interstate
commerce and that has agreed to act as an agent for the owner to
apply official identification to the animals. In such cases the
animals must be:
(A) Moved to the market and maintained until officially
identified in distinguishable groups identifiable to their flocks of
origin and when required their flock of birth by means of partitions
or other such maintenance; and,
(B) Accompanied by an owner statement that contains the
information needed to officially identify the animals to their flock
of origin and, when required, their flock of birth;
(iv) Upon transfer of ownership of the sheep or goats in
interstate commerce;
(v) In the case of animals shipped directly to slaughter at a
slaughter plant that has agreed to act as an agent for the owner to
apply official identification to the animals, upon arrival of the
sheep or goats in interstate commerce at the slaughter plant. In
such cases the animals must be:
(A) Moved to the slaughter plant and maintained until officially
identified in distinguishable groups identifiable to their flocks of
origin and when required their flock of birth by means of partitions
or other such maintenance; and,
(B) Accompanied by an owner statement that contains the
information needed to officially identify the animals to their flock
of origin and, when required, their flock of birth. If the slaughter
plant has agreed to allow APHIS to conduct slaughter sampling,
animals need not be identified if they arrive at the plant on days
that an APHIS designated sampler is not available at the plant to
collect samples; or
(vi) Prior to moving a sheep or goat across a State line, unless
the animals are moving to an approved livestock market in accordance
with (a)(1)(iii) of this section or to an approved slaughter plant
in accordance with (a)(1)(v) of this section.
Numerous commenters requested that we acknowledge that some forms
of premises identification could satisfy the
[[Page 43972]]
proposed requirement for identification of animals moving interstate.
It is in some cases less expensive and troublesome for owners and
persons selling and buying animals to apply premises identifications to
the animals, and to maintain records indicating which premises animals
came from, than to maintain records of a unique identifying number for
each animal when a group of animals is moved interstate.
We agree that we can make some changes to the individual animal
identification requirements in proposed Sec. 79.2 to make the process
less burdensome. However, the identification must be sufficient to
allow traceback of individual animals at any point in interstate
commerce or else the disease control purpose of the identification
suffers. To address the concerns of commenters to the extent possible,
we are adding provisions to Sec. 79.2 that will allow interstate
movement of animals marked with a premises identification eartag or
backtag that bears a unique number associated with the animal to which
the tag is applied. Eartags approved for use in the Scrapie Flock
Certification Program (SFCP) are already approved for this use, and
other eartags and backtags may be approved by APHIS.
Specifically, we are changing Sec. 79.2(a)(2), which identifies
acceptable means of identification, by revising paragraphs (ii) and
(iii), which refer to eartags and backtags, respectively.
Paragraph (ii) in the proposal read: ``Official eartags, including
tags approved for use in the SFCP, when used on any sheep or goat.'' We
are changing paragraph (ii) to read: ``Official eartags, including tags
approved for use in the SFCP or APHIS-approved premises identification
number eartags when combined with a unique animal identification
number.''
Paragraph (iii) in the proposal read: ``United States Department of
Agriculture backtags, when used on sheep or goats moving to
slaughter.'' We are changing paragraph (iii) to read: ``United States
Department of Agriculture backtags or official premises identification
backtags that include a unique animal identification number, when used
on sheep or goats moving directly to slaughter and when applied within
3 inches of the poll on the dorsal surface of the head or neck.'' This
change is based on comments that suggested that premises backtags that
include a unique animal identification number are suitable for
individual animal identification, and that suggested a standard
location on the head or neck to make it easy to collect the tag at
slaughter.
Comments on proposed Sec. 79.2(b), which dealt with how serial
numbers and other codes for official identification would be issued,
suggested that APHIS provide more detail on how these codes would be
assigned by USDA to State officials and other intermediaries who could
ultimately assign them for use by particular flocks. These comments
suggested that it would be efficient to allow various animal health
personnel, such as 4-H leaders, to be assigned blocks of codes that
they could reassign to flocks. The comments stated that this means of
assigning codes would be convenient for flock owners and would be
reliable as long as USDA had initial control of the code assignments
and subsequent assignments were identified to the premises on which the
codes are used in a USDA database.
We agree, and have added the following language to Sec. 79.2(b):
``The official responsible for issuing eartags in a State may assign
serial numbers of official eartags to other responsible persons, such
as 4-H leaders, if the State animal health official and the area
veterinarian in charge agree that such assignments will improve scrapie
control and eradication within the State. Persons assigned serial
numbers may either directly apply eartags to animals, or may reassign
eartag numbers to producers. If these persons reassign eartag numbers,
they must maintain appropriate records that permit traceback of animals
to their flock of origin, or flock of birth when required. Premises
identification eartag, backtag, and tattoo numbers (series of
alphanumeric USDA tags and backtags may be assigned as premises
identification if they are linked to the premises in the National
Scrapie Database) will be assigned to animal owners by the State animal
health official or the area veterinarian in charge, whoever is
responsible for assigning premises codes in that State.''
Proposed Sec. 79.2(c) provided that, when animals move interstate,
the buyers, sellers, and transporters would all have to keep records
containing all serial numbers and other approved means of
identification appearing on each sheep or goat. In this final rule,
these requirements have been changed and moved to Sec. 79.2(d). This
paragraph now provides that, when the animals are identified to the
premises of the flock of origin, the records will have to show the
premises identification, which will be the same for all animals from a
premises, rather than the unique identification number associated with
each animal. The eartag or backtag on each animal will have a unique
identification number, which APHIS can use, if necessary, in
combination with the flock owner's records to conduct an epidemiologic
investigation. We have also amended Sec. 79.5, ``Issuance of
Certificates,'' to note that for movements where premises
identification instead of individual animal identification is allowed,
the certificate will record the premises identification number rather
than individual animal identification numbers.
Chart of General Restrictions
Comments have led us to substantially revise the chart in
Sec. 79.3, which contains restrictions and identification requirements
for sheep and goats moved interstate. Many commenters suggested that
the chart in this section should take more note of the fact that
sexually intact female animals present an inherently higher risk of
spreading scrapie than neutered animals, since lambing and kidding have
been identified as chief opportunities for the spread of scrapie.
When consolidated, these comments suggested that the chart should
be organized to provide different levels of identification and
restriction for six different groups of animals. The six groups
represent six different risk levels for spreading scrapie, ranging from
high risk to low risk. The groups are as follows, beginning with the
highest risk group:
Scrapie-positive, suspect, or high-risk animals.
Animals from an infected or source flock that are not
scrapie-positive, suspect, or high-risk animals.
Exposed female animals that are sexually intact and are
not scrapie-positive, suspect, or high-risk animals or from an infected
or source flock.
Sexually intact female animals that are not scrapie-
positive, suspect, high-risk, or exposed animals or animals from an
infected or source flock.
Commercial whitefaced sheep, commercial hair sheep, and
commercial goats when they are in low-risk flocks.
Castrated or spayed animals that are not scrapie-positive
or suspect animals and are not from an infected or source flock.
We have reorganized the chart based on these major groups of
animals, although the chart actually establishes more categories using
risk-based subdivisions of these groups. The restrictions and
identification requirements this final rule requires for the various
categories of animals are similar to the requirements in the chart
[[Page 43973]]
in the proposal, and range from prohibition of movement for the first
group through no requirements for some members of the last group.
Like the chart in the proposed rule, the chart in this final rule
distinguishes the level of restriction and identification required
based on whether an animal is being moved to slaughter, to be bred, to
be displayed at a show, or for other reasons. As commenters pointed
out, it is necessary to preserve these distinctions because each type
of movement presents different opportunities for animals to spread or
contract scrapie, and therefore different levels of risk.
Many commenters also suggested that the identification requirements
for lambs moved to slaughter be relaxed. The proposal required that
lambs moved to slaughter be individually identified if they were over 6
months of age. Some commenters presented economic arguments that it was
simply too expensive and difficult for large production flocks to
individually identify hundreds or thousands of lambs in order to move
them to slaughter. Other commenters presented arguments based on the
age at which scrapie can be first diagnosed. Both types of comments
urged that individual animal identification for animals moving to
slaughter should not be required until animals reach sexual maturity.
The age at which commenters suggested lambs should be identified ranged
from 9 to 18 months.
APHIS agrees that age and sexual maturity are important benchmarks
that can be used to divide animals into different groups characterized
by different risk levels for scrapie transmission or differing
suitability for diagnosis of the disease. We have revised the chart to
take this into account. The chart contains lesser restrictions for
animals under 18 months of age and greater restrictions for animals
over that age. The more severe restrictions will also apply to animals
that have lambed or kidded, even if they did so at less than 18 months
of age. Specifically, the dividing line in the chart will impose
greater restrictions on an animal that has lambed or kidded, or that is
over 18 months of age, as evidenced by eruption of the second incisor.
One commenter recommended that identification not be required for
animals under 14 months of age, whether they are from Consistent or
Inconsistent States, when the animals are in slaughter channels or have
been castrated. We agree in part and have removed the identification
requirement for castrated animals under 18 months of age and for
sexually intact animals that are under 18 months of age when they are
moved directly to slaughter or to a terminal feedlot from an
Inconsistent State. No identification is required for castrated or
sexually intact animals under 18 months of age in slaughter channels
when they are moved from a Consistent State.
Some commenters wanted the identification and permitting
requirements for high-risk animals relaxed. APHIS believes that it is
critical to maintain control of these animals through slaughter to
ensure that they do not return to the farm. No changes were made based
on these comments.
Based on comments that movement restrictions should use newly-
developed genetic tests as a tool, we have added genetic testing as a
requirement for the movement of sexually intact exposed animals that
are moved for breeding, show, grazing, or other purposes. We have added
a requirement to Sec. 79.3(a)(3) and (d)(3) that for female sheep in
these classes, the results of an official genotype test showing QR or
RR at codon 171 must be included on or attached to the permit that is
required to move these animals.
Several other changes to the chart in Sec. 79.3 are discussed
below, in context with the comments which brought them about. These
comments addressed movement restrictions for goats, methods for issuing
certificates and the statements certificates should contain, and other
issues.
Proposed List of Consistent States
In the August 15 proposal we stated that the Administrator had
evaluated the qualifications of States in accordance with the standards
for Consistent States proposed in the November 30 proposal. The
Administrator evaluated State statutes, regulations, and directives
pertaining to animal health activities, reports, and publications of
State animal health agencies, and a written statement from each State
animal health agency describing State scrapie control activities. The
August 15 proposal announced that all 50 States had submitted written
statements indicating their willingness to comply with the proposed
requirements and provided copies of their regulatory authority to carry
out these actions. The August 15 proposal also proposed certain changes
to the standards that a State would have to meet to qualify as a
Consistent State and announced that, based on the Administrator's
evaluation of all State submissions and other information and reports
describing scrapie quarantine and control activities in the States, the
Administrator had determined that all 50 States meet the proposed
standards for Consistent State status. One of the standards for
Consistent State status, in Sec. 79.6(a)(3) of this final rule is that
each State must sign a memorandum of understanding (MOU) between APHIS
and the State that delineates the respective roles of each in National
Scrapie Program implementation. Prior to the August 15 proposal, all
States signed letters of intent to draft and sign an MOU with APHIS.
The designation of all 50 States as Consistent States is contingent on
the State actually signing the MOU. To date, not all States have signed
such an MOU. If any States have not signed the necessary MOU by the
effective date of this final rule, APHIS will publish another final
rule in the Federal Register changing the status of those States to
Inconsistent.
We received eight comments on the proposal to list all 50 States as
Consistent States under the revised standards contained in the August
15 proposal. All of these comments supported the revised qualification
standards and supported designating all 50 States as Consistent States,
although some suggested associated changes to the regulations.
Therefore, this final rule designates all 50 States as Consistent
States contingent upon the signing of the MOU and finalizes the
standards for Consistent State status that were proposed in the August
15 proposal.
One commenter on the August 15 proposal stated that there should be
procedures in the regulations for APHIS to work with individual
producers to allow interstate movement of animals, so that producers
``doing a good job'' are not penalized due to problems in another part
of the State.
We are not making any change in response to this comment because we
believe the problem is addressed by the lighter restrictions on
interstate movements from Consistent States in Sec. 79.3, as well as by
the provision in Sec. 79.6(a)(10)(i)(A) that allows Consistent States
to exempt from identification commercial whitefaced sheep under 18
months of age moving in intrastate commerce if the State has had no
case of scrapie in commercial whitefaced sheep and no commercial
whitefaced flocks in the State have been exposed by a female animal. We
consider it impractical and overly expensive for both APHIS and States
to apply this exemption on a basis smaller than Statewide, or to
develop unique movement requirements for individual flocks. Also, flock
owners would be subject to the most burdensome, Statewide restrictions
only in Inconsistent States, but this rule
[[Page 43974]]
establishes all States as Consistent States, at least for now, if they
sign the appropriate MOU.
Several commenters on the August 15 proposal said that APHIS should
clearly state that entering data in the Generic Database is an
acceptable alternative to entering data in the National Scrapie
Database and would minimize the burden and costs to States.
We agree; in fact, the National Scrapie Database is in fact a
subset of the Generic Database, and States already entering the
required scrapie data in the Generic Database will not have to reenter
it. APHIS will continue to work cooperatively with States to minimize
the data entry burden for scrapie and other animal health databases. To
clarify this point, we have also added to Secs. 54.1 and 79.1 a
definition of National Scrapie Database to read ``A database designated
by the Administrator in which APHIS and State animal health agencies
cooperatively enter data concerning scrapie outbreaks, flocks and
premises affected by scrapie, individual animal identification and
premises identification data, and other data to support the Scrapie
Eradication Program and the Scrapie Flock Certification Program.''
One commenter on the August 15 proposal said that APHIS should
define ``commercial goats'' to clarify which goats must comply with
identification requirements and which are exempted. The same commenter
suggested that we define ``slaughter channels'' to include private
sales of kids to individuals for slaughter.
We agree, and as discussed above, we have added a definition of
commercial sheep or goat to Sec. 79.1. We are also adding to both
Secs. 54.1 and 79.1 a definition of slaughter channels to read as
follows: ``Animals in slaughter channels include any animal that is
sold, transferred, or moved either (1) directly to a slaughter
facility, (2) to an individual for custom slaughter, or (3) for feeding
for the express purpose of improving the animals' condition for
movement to slaughter. Any sexually intact animal that is commingled
with breeding animals or that has been bred is not in slaughter
channels. When selling animals for slaughter, owners should note on the
bill of sale that the animals are sold only for slaughter.''
One commenter on the August 15 proposal requested that APHIS exempt
animals that are removed from feedlots for breeding purposes from the
requirement that animals not in slaughter channels be traceable to
premises of birth. The commenters stated that changing economic
conditions often makes this necessary and maintained that such animals
need to be traced back only to the feedlot for program purposes.
We disagree. Tracing animals to a feedlot is of little
epidemiologic value unless the feedlot maintains records that would
allow the animals to be traced back to their flocks of origin.
Currently this is not the case, and we do not believe imposing such a
recordkeeping burden would be warranted at this time. The primary
purpose of traceback is to locate infected breeding flocks, not to
locate feedlots where animals have temporary residence.
Several commenters on the August 15 proposal suggested that APHIS
should begin now to enhance the education and training of producers and
accredited veterinarians.
We agree and are engaged in activities to support education and
training regarding scrapie control. In addition to projects by APHIS
public information offices, we are cooperating on projects with the
American Sheep Institute and the National Institute of Animal
Agriculture.
One commenter on the August 15 proposal stated that APHIS should
develop the Uniform Methods and Rules (UM&R) with full coordination of
all segments of industry and the pertinent advisory committees.
We agree, and the final rule states that APHIS will consult with
Consistent States and provide an opportunity for industry and public
review of the UM&R. We also intend to provide the United States Animal
Health Association and the public with the opportunity to review the
UM&R in draft form. In regard to this review, it should be noted that
the legal requirements for the interstate movement of sheep and goats
due to scrapie are contained in 9 CFR parts 54 and 79. The UM&R
provides additional guidance to the States regarding the minimum
standards necessary for States to participate in the National Scrapie
Eradication Program. The UM&R also provides examples of how to comply
with those requirements.
One commenter on the August 15 proposal stated that the language
concerning the Paperwork Reduction Act in the proposed rule, stating
that there were ``no new impacts'' associated with the rule, was
inaccurate because livestock markets in particular will have to keep
many new records.
The paperwork statement was accurate for the particular rule in
which it appeared, i.e., the proposal to list 50 States as Consistent
States. That proposal added no new records or forms not already
addressed in the earlier November 30 proposed rule. Please refer to the
Paperwork Reduction Act section of this final rule to see final
analysis of the paperwork issues raised in the November 30 proposed
rule.
One commenter on the August 15 proposal stated that since the risk
of a positive ram transmitting scrapie is effectively zero, the program
should take no regulatory action against a flock based on the presence
of an infected ram that was purchased from another flock.
We agree, and the revised definitions of exposed animal and exposed
flock discussed above require the exposure to be to a scrapie-positive
female animal, not a ram. On the same basis, to update classifications
made under earlier versions of the regulations, Sec. 79.4(b)(8) of the
final rule allows an exposed animal to be reclassified if the exposure
was only by an infected ram, outside of lambing and breeding
situations. This final rule primarily regulates rams by requiring that
they be individually identified in certain circumstances. This
requirement does not reflect a belief that rams may directly spread
scrapie, but rather it exists to allow scrapie-positive rams to be
traced back to their flocks of origin or birth, as required, so that
the necessary regulatory requirements may be imposed on those flocks.
Comments on Goats
Several commenters requested that goats be exempted from part or
all of the regulations due to the low incidence of scrapie in goats. We
have made the following changes in response to these comments.
Since there is no immediate intent to collect diagnostic
specimens from goats at slaughter, we have removed the requirement from
Sec. 79.3(b) to identify goats in slaughter channels, except for goats
that have been exposed to scrapie.
In Sec. 79.3(a) we have exempted commercial goats that are
not in contact with sheep from identification requirements if they
originate in a State that has not had a case of scrapie in goats.
We have allowed Consistent States that have had no cases
of scrapie in goat flocks to exempt commercial goats from
identification while in intrastate movement.
We have partially removed the requirement that breeding
goats moving interstate from Inconsistent States must originate from a
SFCP flock. In this final rule, such goats must originate from a SFCP
flock only if they have commingled with sheep, or are from a State that
has had scrapie diagnosed in goats that were not commingled with sheep.
[[Page 43975]]
Comments on Genetics and Testing
A few commenters recommended that animals that have an R at codon
171 should be exempted from the regulations because of their resistance
to scrapie. APHIS disagrees with exempting all animals with an R at
codon 171 from all regulation, for the following reasons. While Suffolk
sheep with an R at codon 171 are documented in the literature to be
more resistant to clinical scrapie than Suffolks that are QQ at codon
171, there have been several reports of sheep that are QR and one
report of a sheep that is RR at codon 171 that were diagnosed with
scrapie. Also, there has been inadequate work done with other breeds to
know if or to what degree an R at codon 171 increases resistance in
these sheep. It is also unknown whether a carrier state exists in sheep
that are RR or QR at codon 171. However, we believe it is appropriate
to classify highly exposed male sheep that are RR at codon 171 and AA
at codon 136 as exposed, rather than high risk, since the lower risk
from a male sheep combined with the lower genetic susceptibility
associated with this genome lowers the risk of spread to a range
similar to or less than that of other exposed animals. Likewise,
exposed female sheep that are QQ at codon 171 are more susceptible and
therefore of higher risk than other exposed animals and so have been
included in the definition of high risk animals. APHIS is supporting
further research with the U.S. Department of Agriculture's Agricultural
Research Service to assess the utility of genotyping for regulatory
purposes and will propose adjustments to the regulations as appropriate
based on the results.
Several commenters urged the approval of the third eyelid test and
also asked that we specify how tests would be approved by the
Administrator. We are in the final steps of evaluating the third eyelid
test. We have included new Secs. 54.10 and 54.11 describing how APHIS
will approve tests and laboratories in response to this comment.
Essentially, the Administrator will approve new scrapie tests for live
or dead animals after evaluating the test protocols and study data
regarding each test's methodology, sensitivity, specificity, and
reproducibility. The Administrator will approve laboratories after
evaluating them using the same type of standards used to evaluate other
laboratories authorized to conduct official tests under APHIS
regulations. These are well-established standards for evaluating the
methodology, personnel, and quality control procedures of diagnostic
laboratories. For examples of current APHIS regulations for approval of
laboratories, see the equine infectious anemia regulations at
Sec. 75.4(c), pseudorabies regulations at Sec. 85.1, and contagious
equine metritis regulations at Sec. 93.301(i).
Several commenters have objected to references to a live-animal
test that has not been approved yet. We believe that the third eyelid
test will be validated by the time this regulation is finalized and
will be approved by the Administrator soon thereafter. The references
to live-animal tests in this final rule will then aid the speedy and
orderly introduction of the test.
Identifying an Animal's Premises of Birth
Several commenters recommended that breeding animals be marked with
flock of birth identification. We agree that this is an ideal method to
allow complete traceback of animals and encourage its use; however, we
are allowing other forms of identification on breeding sheep since
birth premises identification is impractical in some circumstances,
such as for sheep that no longer reside in their flock of birth or that
lose tags after leaving the flock of birth. We have added a requirement
to the general movement restrictions in Sec. 79.3(a)(3) and (a)(4) and
to the conditions for issuing certificates in Sec. 79.5(a) that, for
breeding sheep born after January 1, 2002, the flock of birth must be
indicated on any health certificate issued for those sheep. This
requirement will make it possible to trace these animals to their flock
of birth. Also, as discussed in the August 15 proposal, we have added a
requirement to the Consistent State qualification requirements at
Sec. 79.6(a)(10)(i), requiring official identification, upon change of
ownership, of all animals of any age not in slaughter channels and any
sheep over 18 months of age. This requirement will help us trace
animals back to their flock of birth in Consistent States. Consistent
States must meet this identification requirement within 2 years of
their designation as Consistent. When Consistent States impose this
identification requirement for intrastate movements, it will
substantially increase our ability to trace animals back to their flock
of birth.
Publication of Lists of Infected Flocks, Source Flocks, and Flocks
Participating in the SFCP
In the past, APHIS has published and has made available through the
Internet lists of all known infected flocks, source flocks, and flocks
participating in the Scrapie Flock Certification Program. APHIS intends
to continue publishing a list of participating flocks, which is
available by writing to us or at URL http://www.aphis.usda.gov/vs/
scrapie. We have amended Sec. 54.21 to state that a list of
noncompliant flocks (defined below) will also be developed and
published at that address. However, we do not intend to continue
publishing lists of infected and source flocks.
Several commenters supported publishing lists of all infected and
source flocks, regardless of whether or not they participate in the
SFCP. We have modified the rule to address this concern by requiring
the scrapie status to be indicated on all certificates of animals
moving for breeding or show purposes, discussed below under ``Comments
on Issuance of Certificates,'' and by defining noncompliant flock in
Secs. 54.1 and 79.1 as ``(1) Any source or infected flock whose owner
declines to enter into a flock plan or post-exposure management and
monitoring plan agreement within 30 days of notification, or whose
owner is not in compliance with either agreement; (2) any exposed flock
whose owner fails to make animals available for testing within 60 days
of notification, or as mutually agreed, or whose owner fails to submit
required postmortem samples; (3) any flock whose owner or manager has
misrepresented, or who employs a person who has misrepresented, the
scrapie status of an animal or any other information on a certificate,
permit, owner statement or other official document within the last 5
years; or (4) any flock whose owner or manager has moved, or who
employs a person who has moved, an animal in violation of this part
within the last 5 years.'' Publishing a list of noncompliant flocks,
rather than lists of infected and source flocks, will protect the
privacy of flock owners who comply with the regulations while listing
those who do not and, therefore, present a risk of spreading scrapie.
Commenters also suggested we take steps to improve our ability to
enforce the requirements of flock plans by taking action against
persons who violate them. To accomplish this, we are slightly changing
the definition of flock plan to require that a flock plan must be
signed by the flock owner and by the accredited veterinarian, if any,
employed by the flock owner. We believe signatures are desirable to
document that participants in a flock plan have committed to follow its
requirements, particularly now that nonperformance could cause a flock
to be designated noncompliant. In the proposed definition of flock
plan, the document did not have to be signed.
[[Page 43976]]
Comments on Issuance of Certificates
As mentioned above, some commenters suggested that all infected and
source flocks should be kept on a list that potential buyers could
consult to obtain information about the scrapie status of animals they
might buy. We believe this need for information regarding animals'
exposure to scrapie can be met by changing the procedure for issuing
certificates to require that certificates include a statement by the
owner documenting any relevant information the owner has about the
scrapie status of the animals, the exposure of the animals to scrapie,
and the status of the animals' flock. This change would also address
comments that suggested that certificates should contain more
information about exposure of animals to scrapie.
Therefore, we are changing Sec. 79.5, which concerns issuance of
certificates, to require that a certificate must include: (1) A
statement by the issuing veterinarian that the animals were not
exhibiting clinical signs associated with scrapie at the time of
examination and (2) an owner statement indicating whether the animal is
or is not a scrapie-positive, suspect, high-risk or exposed animal and
whether the animal originated in an infected, source, exposed or
noncompliant flock. This added information will make the certificate
more useful to persons acquiring these animals and to APHIS and State
representatives enforcing the regulations, especially because the
regulations require permits or prohibit the interstate movement of
scrapie-positive, suspect, and high-risk animals, some exposed animals,
and animals that originated in an infected or source flock.
Other and General Comments
Several commenters recommended that we make the regulations
consistent with the Office International des Epizooties (OIE) draft
chapter on scrapie for the International Animal Health Code. While we
believe that these regulations are in concordance with the spirit of
the OIE draft chapter on scrapie, some requirements in the draft
chapter are impractical for some segments of the U.S. sheep industry.
Since the draft chapter is still being debated by the member countries,
we have decided not to change our regulations in ways that will be
costly to our industry without knowing what the final draft will
include.
Several commenters supported the basic Consistent State
requirements of reportability and movement restrictions but asked that
the States be given up to 2 years to come into compliance with the
other requirements. We agree, and proposed this change in the August 15
proposal. No commenters objected to this change, and we have included a
delayed compliance date for these requirements.
Several commenters stated that ewe lambs sent to feedlots should
not be required to be identified. Their reasoning was that only a small
percentage of ewe lambs are moved out of feedlots other than to
slaughter, and that, in these cases, it would be appropriate to
consider the feedlot to be their flock of origin. We disagree, because
this would create a significant loophole which would encourage
producers worried about their scrapie status to sell their breeding ewe
lambs to feeders for resale to prevent tracebacks.
Several commenters asked that we add a medium risk or exposed flock
classification for flocks with lower levels of risk, particularly those
on pilot project flock plans. We agree and have added an exposed flock
classification in Sec. 79.4. We discussed the new definition of exposed
flock above. This classification will identify animals with some degree
of risk that might otherwise be exempted from necessary movement
restrictions, e.g., as low-risk commercial sheep.
Several commenters recommended that we give designated scrapie
epidemiologists (DSEs), rather than APHIS or State veterinarians, the
responsibility for designating animals scrapie-positive, high-risk, or
exposed, and for designating flocks as infected, source, or exposed
flocks. We agree that a DSE has the appropriate level of technical
expertise for making these determinations, and for making
redesignations when needed, and have made this change in Sec. 79.4(a).
The commenters also suggested we give DSEs increased flexibility in
addressing individual flock situations by customizing requirements for
individual flock plans and post-exposure management plans and by
conducting testing of flocks when test results could justify
redesignation of a flock. We agree and have done this by allowing DSEs
to determine the testing and monitoring needed for exposed flocks and
by allowing them to modify flock plans and post-exposure management and
monitoring plans under certain conditions to meet changing needs. These
changes expanding the role of DSEs are in Sec. 54.3(a) and in
Secs. 54.8(f), (h), and (i). We have also changed Sec. 79.4 to allow
DSEs that are engaged in designating or redesignating a flock's status
to order testing of flock animals if the DSE determines such testing is
needed to properly designate a flock. In such cases the DSE will select
animals for testing in a manner that will provide a 95 percent
confidence of detecting scrapie at a prevalence of 1 percent. Testing
may include live-animal testing using a live-animal official test, the
culling and postmortem examination of genetically susceptible animals
in the flock that cannot be evaluated by a live animal test, and
postmortem examination of animals found dead or cull animals at
slaughter.
One commenter stated that flock plans and post-exposure management
and monitoring plans should allow APHIS or State representatives, when
necessary, to restrict the removal of animals from flocks subject to
those plans. Otherwise, animals might be removed from fear that they
would be officially determined to be scrapie positive. We agree, and
have added appropriate language to Sec. 54.8(d).
Many commenters noted an error in the preamble that stated ``* * *
imported lamb sells at a higher price than domestic lamb and mutton.''
In fact, domestic lamb and mutton sell at a higher price than imported
lamb and mutton, and this has been corrected in our final regulatory
flexibility analysis.
Several commenters supported our proposal to change the name of the
Voluntary Scrapie Flock Certification Program to the Scrapie Flock
Certification Program (SFCP), and a few commenters opposed the change.
Those in favor recognized the trade benefits; those opposed were
concerned that the program would no longer be voluntary. We have made
no changes in rule based on this comment. Participation in the SFCP
will remain voluntary.
Several commenters asked that we review our requirements for
importing sheep and goats in light of this rulemaking to ensure
equitable treatment. That is outside the scope of this rulemaking but
will be considered in making policy and in future changes to the import
regulations.
Several commenters expressed concern over how this regulation would
affect large commercial range flocks. We agree that some of these
concerns are valid and have made several changes to the rule to lessen
adverse effects on these flocks. Some of the changes we have made to
distinguish commercial flocks from other types were discussed above
regarding the definitions of commercial sheep or goat and low-risk
commercial sheep. We have also made changes affecting both intrastate
and interstate movement of commercial sheep and goats. These changes,
to both the interstate movement restrictions in Sec. 79.3 and the
requirements for
[[Page 43977]]
Consistent States in Sec. 79.6, include: (1) Allowing Consistent States
that have had no cases of scrapie in commercial flocks to exempt them
from identification while in intrastate movement under 18 months of
age; (2) allowing commercial sheep and goats to be identified with
brands or earnotches in interstate movement; (3) reducing the
recordkeeping and identification requirements for commercial flocks if
they become infected; (4) not designating flocks as infected if the
positive animal is a purchased ram; (5) allowing the interstate
movement of all animals under 18 months of age in slaughter channels
without identification; and (6) allowing increased options for
commercial flocks if they are designated infected, source, or exposed
and by giving greater latitude to DSEs to modify flock plans and post-
exposure management and monitoring plans.
Several commenters recommended that we differentiate between
blackfaced and whitefaced sheep based on the higher incidence of
reported scrapie cases in blackfaced sheep. We agree in part with this
concept and have changed Secs. 79.3(a)(7) and (c)(5) of the interstate
movement restrictions chart to distinguish between exposure to
whitefaced and blackfaced sheep.
A commenter expressed concern over the number of signs that could
potentially result in an animal being designated a suspect animal. We
believe that this will not be a problem because the definition of
suspect animal in Secs. 54.1 and 79.1 includes the condition ``A sheep
or goat that exhibits any of the following possible signs of scrapie
and that has been determined to be suspicious for scrapie by an
accredited veterinarian, or a State or APHIS representative.'' This
requires not only that the animal exhibit at least one of the signs but
that a veterinarian determine that it is suspicious for scrapie before
it is officially designated a suspect animal for regulatory purposes.
Anyone who suspects that an animal has scrapie is encouraged to report
it to a State, Federal, or accredited veterinarian so that an official
determination can be made. In some States, such reporting is a legal
requirement.
Several commenters commented on the cost of identifying animals.
APHIS will provide alphanumeric tags to accredited veterinarians and
backtags to markets and dealers. Additionally, producers may acquire
alphanumeric eartags and backtags from APHIS at no cost if they have
their premises and the tag sequences recorded in the National Scrapie
Database. Producers may also purchase premises identification tags with
assigned premises numbers from approved vendors. The requirements for
vendors who wish to produce approved tags are contained in
Sec. 79.2(f). Discussions with tag companies suggest that the cost of
these tags will range from $0.06 for metal tags to $1.00 for highly
tamper-resistant plastic flap tags. The type of approved tag used will
be up to the producer and their flock identification needs. Also, we
have eliminated the identification requirements for most sheep under 18
months of age and all slaughter goats, which substantially reduces the
identification cost.
Many commenters also remarked about the cost of applying
identification, in addition to the material cost of the tags. We agree
that there will be a cost to producers and markets to apply
identification and keep records. We have reduced this as much as
possible by reducing the number of animals that must be identified, by
allowing certificates and market and dealer records to record premises
identification rather than individual identification under certain
circumstances, and by allowing several options for identification to
fit different producers' needs.
Some commenters were concerned that the rule does not indicate the
penalties for failing to comply. The maximum criminal and civil
penalties that may be imposed are listed in the statutes that are the
legal authority behind our regulations. Listing penalty amounts in our
regulations is not normal practice for APHIS. In response to this
comment we have indicated some instances when violators will have
privileges under this rule, such as the ability to apply official
identification, revoked. Our intent to publish the identities of
noncompliant flocks should also serve as a deterrent. Finally, action
may be taken under civil and criminal law against violators of the
regulations. Administrative penalties may include warnings, monetary
penalties, or withdrawal of certified flock status.
One commenter indicated that this rule would preclude State scrapie
control programs. The rule does not preclude States from designing
their own scrapie programs for intrastate movements. It would require
that the program either meet the minimum specified requirements or can
be shown to be equally effective in preventing the interstate movement
of scrapie from the State.
Some commenters expressed concern about the effect of burial or
incineration on the environment, when animals are disposed of in
accordance with the requirements of Secs. 54.7(b) or 54.8(f). APHIS
believes that the regulations currently in place are adequate for safe,
environmentally conscious disposal of this material.
All commenters that addressed disposal costs stated that APHIS
should pay the disposal costs for indemnified animals. We agree that
APHIS will pay the disposal costs of scrapie-positive and suspect
animals that cannot be disposed of by slaughter, and we have changed
Sec. 54.7(d) of the rule to provide that APHIS may pay the reasonable
costs of disposal for scrapie-positive and suspect animals that are
indemnified. To obtain reimbursement for disposal costs, animal owners
must obtain written approval of the disposal costs from APHIS, prior to
disposal. This paragraph also states that the Administrator may also
authorize payment of up to half the reasonable disposal costs for
animals that are allowed to be destroyed by slaughter under this
section but for which slaughter is not a practical or cost efficient
means of disposal. However, Sec. 54.7(d) provides that APHIS may pay
more than one-half of the expenses when the Administrator determines
that doing so will contribute to scrapie eradication. For reimbursement
to be made, the owner of the animals must present the veterinarian in
charge with a copy of either a receipt for expenses paid or a bill for
services rendered. Any bill for services rendered by the owner must not
be greater than the normal fee for similar services provided by a
commercial hauler or disposal facility.
Some commenters misinterpreted the indemnity section and were
unsure whether indemnity would be provided for both commercial and
registered animals. Both the November 30 proposal and this rule provide
indemnity for both types of animals, but in differing amounts.
One commenter expressed concern over permitting exposed and high-
risk sheep to go to feedlots, because this might pose a risk of
spreading scrapie. We agree that allowing high-risk animals, exposed
pregnant animals, or exposed animals with a vaginal discharge to go to
feedlots from which they might return to the farm would present a
significant risk, and we have changed Secs. 79.3(b)(3) and (c)(3) of
the rule to restrict the movement of these animals to slaughter or to
terminal feedlots.
One commenter questioned whether the statement in the November 30
proposal regarding Executive Order 12988 that stated the rule
``preempts all State and local laws and regulations that are in
conflict with this rule'' was
[[Page 43978]]
accurate, or was needed. The commenter stated that while State
restrictions on the interstate movement of sheep and goats that were
less stringent than the requirements of the rule will be overruled by
the Federal requirements, State restrictions that are stricter than the
rule's requirements should be allowed, because they would serve to
improve disease control and reduce risks. The commenter also expressed
concern that the statement meant that a State could not require any
conditions for movement of animals into the State over and above the
Federal requirements.
Under Executive Order 12988, a Federal agency that formulates
proposed regulations is required to specify in clear language the
preemptive effect it intends to be given to its legislation or
regulations. The executive order does not specify what that preemptive
effect shall be. Historically, domestic animal health regulations of a
State have not been challenged when they require conditions on
interstate movement that are more stringent than those included in
APHIS regulations. However, State regulations that conflict with or
subvert Federal regulations concerning the interstate movement of
animals and products that are promulgated for the purpose of the
control of diseases of livestock and poultry are preempted by the
Federal regulations. This is a matter of Constitutional law that we
cannot change by regulation.
Scrapie Pilot Projects Final Rule
This final rule also republishes changes to parts 54 and 79 that
were made by another final rule concerning scrapie pilot projects. That
rule was published and effective on June 27, 2000 (Docket No. 99-067-2,
65 FR 39534-39536). That rule amended the regulations to exempt flocks
from certain regulatory requirements when the flocks are participating
in scrapie control pilot projects authorized by APHIS.
Miscellaneous Changes
We have also made miscellaneous minor changes to the November 30
and August 15 proposals in this final rule, such as correcting
misspellings, revising sentences for clarity, and adding explanatory
subject titles to some paragraphs of amendatory language.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, with the
changes discussed in this document.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. The rule
has been determined to be significant for the purposes of Executive
Order 12866 and, therefore, has been reviewed by the Office of
Management and Budget.
In accordance with 5 U.S.C. 603, we have performed a final
regulatory flexibility analysis for this rule. The economic analysis
for this rule is summarized below, and a full copy is available from
Regulatory Analysis and Development, PPD, APHIS, 4700 River Road Unit
118, Riverdale, MD 20737-1238. The economic analysis provides a cost-
benefit analysis as required by Executive Order 12866 and an analysis
of impacts on small entities as required by the Regulatory Flexibility
Act.
We are taking the actions described in this rule in order to
strengthen scrapie control programs on the national level and to reduce
the losses from scrapie to the sheep and goat industries. This action
is considered necessary because not all State scrapie control programs
may be effective in identifying animals that may be infected with
scrapie and controlling their movement in intrastate and interstate
commerce in a manner that will prevent the further spread of scrapie.
Statutory authorities, including 21 U.S.C. 111, 114, 114a, and 134a-
134h, authorize the Department of Agriculture to conduct programs for
the control of communicable animal diseases and to restrict the
interstate movement of animals that may spread disease.
As alternatives to this action, APHIS considered a complete ban on
interstate movement of sheep and goats from States that do not have
effective scrapie control programs. We also considered adding stricter
certification, recordkeeping, and animal identification requirements
for all sheep and goats moving interstate, without regard to the
effectiveness of individual State scrapie programs. We also considered
setting up a system to employ a prospective live-animal test in
mandatory testing of sheep and goats before they could be sold for any
commercial purpose, with mandatory destruction and disposal of animals
that fail the test. All of these alternatives would impose more costs
and recordkeeping requirements than the selected alternative, and we do
not believe any of these alternatives would control scrapie more
effectively than the selected alternative. A complete ban on movements
from Inconsistent States would hurt the economies of those States, and
while it would provide other States with some protection against
infection from Inconsistent States, it would not eradicate the
reservoirs of scrapie in those States. The alternative of stricter
recordkeeping and identification for all interstate movements would not
be effective as long as some of the information to be recorded is
unknown or dubious, as can frequently happen when the animal originates
in a State with a weak scrapie program. The alternative of mandatory
testing, and destruction of animals that fail, was discussed in the
November 30 proposal. It is not a practical option because a live-
animal test has not been validated and approved and is also impractical
at this time for economic reasons.
This rule will result in the expenditure of indemnity funds by
APHIS to compensate the owners of certain animals destroyed to prevent
the spread of scrapie. This will also encourage certain States to
improve the effectiveness of their State scrapie programs to avoid
additional restrictions on the movement of sheep and goats from their
States.
The budgetary effects on APHIS of this rule will fall into four
categories, all within available funds: An increase in outlays for
staff to work with States and producers as they adapt to the new
scrapie program requirements, a new program for indemnity payments, the
cost of providing official eartags and backtags, and the cost for
disposal (usually by landfill or incineration) of scrapie-positive and
suspect animals that are indemnified. The initial amount of indemnity
payments (the first year) is estimated to be approximately $761,245,
based on an estimated 4,188 animals eligible for indemnity in known
scrapie-infected and source flocks, but may be more if producer
response to the availability of indemnity results in new admissions of
infection that reveal additional cases of scrapie. The amount of
indemnity paid should decline in subsequent years, although, if
slaughter surveillance is initiated or if live-animal tests are
approved and widely used, this decline may not occur for several years,
depending on the number of scrapie-positive animals that are revealed
by initial use of these tests. This indemnity program will be less
costly than some previous indemnity programs since it focuses on
eliminating individual infected and high-risk animals rather than
entire flocks, a focus that should be aided in the near future by the
availability of a validated live-animal test. If a live-animal test is
accepted for official use, an increase in indemnity costs will be
expected initially as new infected flocks are identified.
[[Page 43979]]
APHIS will bear the total reasonable cost for disposing of
indemnified scrapie-positive and suspect animals, and will bear half
the cost for disposal of certain other indemnified animals that are
destroyed rather than sent to slaughter. The cost for disposal of each
animal will range between a low of approximately $15 (for simple burial
in a landfill, the most common method) and a high of approximately $100
(the maximum cost when incineration is required). The method used will
vary depending on local disposal alternatives and requirements. The
total cost for disposing of an estimated 3000 animals the first year
would therefore fall in the range between $30,000 and $300,000, and
would probably be on the order of $150,000. The cost for disposing an
estimated 4200 animals over the lifetime of the program is estimated to
fall in the range between $42,000 and $420,000, probably on the order
of $210,000.
Although this rule lists all States as ``Consistent States,'' any
State that loses this status will bear additional costs to improve its
State scrapie programs so that the producers in that State can avoid
additional interstate movement restrictions established for States
without effective intrastate control programs. However, the designation
of all 50 States as Consistent States indicates that they have already
dedicated the resources needed to conduct effective intrastate
programs. The signing of the MOU will complete this process of
designating a State as a Consistent State.
Overview of U.S. Sheep and Goat Industry Operations, Inventory and
Trade
Much of the data used in this analysis is from the 1997 Census of
Agriculture (USDA, National Agricultural Statistics Service), the last
full census that is available. Where possible, updated 1999 data from
Agricultural Statistics 2000 (USDA, National Agricultural Statistics
Service) are employed.
There were 7.026 million sheep and lambs in the United States in
1999. There were 5.163 million breeding sheep and lambs, of which 4.433
million were ewes and rams 1 year old or older.
In 1997, as shown in Table 1, small farms accounted for over 99
percent of all the farms raising sheep and lambs, while farms
considered to be large accounted for less than 0.3 percent. About 85
percent of the farms had an inventory of less than 100 animals and
accounted for about 17 percent of the total inventory of sheep and
lambs. On the other hand, sheep operations with an inventory of 5,000
sheep or more represented less than 0.3 percent of the farms but
accounted for nearly 26 percent of the total inventory.
Table 1.--Sheep and Lambs: Farms and Inventory by Size, 1997
----------------------------------------------------------------------------------------------------------------
Number of Inventory
Farm inventory farms Farm share share
----------------------------------------------------------------------------------------------------------------
1 to 24......................................................... 35584 0.54 0.045
25 to 99........................................................ 20461 0.31 0.123
100 to 299...................................................... 6010 0.09 0.123
300 to 999...................................................... 2429 0.04 0.158
1,000 to 2,499.................................................. 820 0.01 0.16
2,500 to 4,999.................................................. 297 0.005 0.128
5,000 or more................................................... 189 0.003 0.263
-----------------
Total....................................................... 65790
----------------------------------------------------------------------------------------------------------------
Source: USDA, Census of Agriculture 1997.
Of the total number of operations, about 60 percent were full
owners, about 32 percent were part owners, and about 8 percent were
tenants.
Sheep are produced in all parts of the United States, although
stock levels vary from State to State. Ten States accounted for nearly
73 percent of the total inventory, mostly in western and central areas.
Northern and southeastern States have the smallest sheep populations,
accounting only for 5.2 percent of the total.
There were about 1.99 million goats in the United States in 1997,
of which 52 percent were goats other than Angora or milk goats, 41
percent were Angora goats and about 7 percent were milk goats. The
State of Texas accounted for about 64.3 percent of the goat inventory.
Other States where goats are raised include Arizona, California,
Georgia, New Mexico, North Carolina, Oklahoma, and Tennessee. These
States together represented another 14.2 percent of the U.S. goats
holdings. An average holding was about 35 goats. All goat holdings were
considered to be small.
During 1999 the United States produced about 247 million pounds of
mutton, lamb and goat meat. It exported 5.6 million pounds and imported
about 111 million pounds valued at $189.2 million. The United States
exported 518,257 sheep and goats valued at $21.99 million in 1999, of
which 494,098 went to Mexico. The United States imported 53,165 sheep
and goats valued at $5.33 million in 1999, of which 53,126 were from
Canada. The United States imported 111 million pounds of sheep and goat
meat valued at $190.2 million and exported 5.6 million pounds of sheep
and goat meat valued at $6.46 million in 1999. Most lamb and mutton
imports came from Australia and New Zealand, countries recognized as
being free from scrapie. The United States is a net importer of lamb
and mutton.
Sheep and Goats Affected by Scrapie Interstate Movement
Restrictions
Nearly 6.487 million lambs and sheep are marketed each year, of
which 0.977 million are mature sheep and 5.51 million are lambs less
than 18 months of age.\1\ There are 15 States with 53 flocks that were
on the infected or source flock list as of July 2000. Of these, 47 are
infected flocks and 6 are source flocks. Also, 14 additional flocks
contained a scrapie-positive animal during FY 2000 but were not
considered infected or source flocks in July, either because they had
not been formally categorized yet or because they had completed an
approved flock plan. Infected and source flocks are potential
candidates for destruction and indemnity payments.
---------------------------------------------------------------------------
\1\ USDA/NASS, Agriculture Statistics 2000, U.S. Government
Printing Office, Washington DC, 2000.
---------------------------------------------------------------------------
Additionally, over the last 10 years (1990-1999), an annual average
of 139 animals have been submitted for scrapie diagnosis, of which an
annual average of
[[Page 43980]]
61 (or 44 percent) were determined to be scrapie-positive animals.
However, it is likely that the number of reported cases will increase
as the indemnity payments become available. There are about 1.578
million breeding sheep and lambs in the 15 States in which positive
cases have occurred in FY 2000 or in which a source or infected flock
exists. These animals represent approximately 28 percent of all
breeding sheep and lambs in the United States and have a market value
of about $150 million.
The average size of a flock in an operation in the 15 States was
125, with between 21 and 479 per operation. Approximately 82.9 percent
of these sheep are marketed, in most cases across State lines. However,
nearly 85 percent of the marketed sheep are lambs less than 18 months
of age, and will be exempt from individual animal identification under
this final rule.
Indemnity Costs for Animals Destroyed Due to Scrapie
The exact number of scrapie-positive and high-risk animals that
will qualify for indemnity payments is not known. However, an estimate
of the number of animals potentially eligible for indemnity would be 50
percent (based on field estimates) of the animals in an average
infected or source flock (based on past field experience). As noted
above, there are currently 47 infected flocks and 6 source flocks, and
14 other flocks that currently or recently contained scrapie-positive
animals. Thus, based on average flock size and the average percentage
of high-risk animals in infected and source flocks, the number that can
be estimated to qualify for indemnity payments during the first year
would be 4,188 animals (=(53 + 14) x 125 x 0.50). This estimate
implies that about 0.144 percent of the total number of breeding sheep
and goats in the 15 States that can potentially move interstate will be
designated as high-risk animals and be eligible for indemnity. The
proportion of more expensive registered animals was 74.38 percent
(8,199/11,023) \2\ Assuming a 75 percent registered to 25 percent
nonregistered animal composition, the respective indemnity payments
approximately range between $161 and $322 for registered animals and
between $61 and $122 for nonregistered animals. The payment for
registered animals is the sum of the spot market price and the premium
given in order to adjust for value of these animals. Thus, the $322 per
head payment for yearlings column includes the $122 spot market price
and the $200 premium payment. Nonregistered animals get the spot market
price. The estimated indemnity expenditure will be about $761,245 (See
table 2 for detail). If the producer response to indemnity payment
availability is positive, resulting in an increased number of indemnity
requests, the expenditure will increase accordingly. However, even if a
much larger number of animals were to be indemnified, the destruction
of all known infected animals will greatly advance the goal of scrapie
eradication, and can only be positive in terms of long-term reduced
expenditure.
---------------------------------------------------------------------------
\2\ Based on the composition of 8,199 registered and 2,824
commercial animals that were indemnified in 1990, as reported by
APHIS personnel.
Table 2.--The Indemnity Cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Registered (75%) Non registered (25%)
Group ------------------------------------------------------------------------------------------------ Total
Number $/Head Cost Number $/Head Cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Yearlings (1 to 2 years)................ 431 $322 $138,782 144 $122 $17,568 $156,350
Running ages:
2 to under 4 years.................. 647 290 187,630 216 90 19,440 207,070
4 to 6 years........................ 647 190 122,930 216 90 19,440 142,370
Aged (>6 years)..................... 431 161 69,391 144 61 8,784 78,175
Ewe lambs........................... 985 175 172,375 327 75 4,905 177,280
---------------------------------------------------------------------------------------------------------------
Total............................. 3,141 .............. 691,108 1,047 .............. 70,137 761,245
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note:This chart assumes a distribution based on 1999 flock data for the ages, and resultant indemnity status, of the 4,188 animals estimated to be
eligible for indemnity. We also assumed 75 percent of these animals are registered. We also estimated that 80 percent of non-registered ewe lambs will
go to slaughter, so indemnity cost for this class will be minimal.
Costs to Producers and APHIS for Official Identification of Animals
Moving Interstate
The animal identification required by this rule will result in
additional costs. Of the approximately 7.82 million sheep and lambs in
the United States, about 6.487 million sheep and lambs (or 82.9
percent) are marketed. Nearly 85 percent of these sheep and lambs that
could move interstate are lambs less than 18 months of age in slaughter
channels, which will not require identification tags under the new
rule. Of the 1.99 million goats (=809,391 angora+146,678 milk+1,033,730
goats), about 27.5 percent could potentially be moved interstate. This
assumes that most angora goats do not move interstate, but that about
20 percent of milk goats and 50 percent of other goats might move
interstate. The cost of metal identification tags is between 4 cents
and 6 cents per animal. Thus, assuming the total number of sheep and
goats that will need identification tags is 1.52 million, the tag cost
will be between $60,800 (=1,520,300 x 0.04) and $91,220 (=1,520,300
x 0.06). If the time it takes the owner to apply the tag (about 2
minutes per animal) is valued at $7.61 per hour (the revised average
wage for livestock workers in January, 2000), this labor cost
represents another $385,600 (=1,520,300 x 2 x $7.61/60). In some
States, tags are provided by APHIS free to accredited veterinarians,
while in others, they are purchased by accredited veterinarians through
the State. Generally, wherever APHIS directly distributes tags they are
free; where States distribute them, there may be no charge, a small
processing fee, or a fee covering the full cost of the tags, depending
on State regulations. In this rule there is a mechanism for APHIS or
the State to provide tags direct to producers. If owners elect to use
backtags for direct movements of animals to slaughter instead of
eartags, the costs will be less. In either case, owners will incur the
costs of applying identification. The effect on goat owners will be
less, since about 41 percent of goats are the angora type, which are
raised for their mohair and are less frequently moved interstate. Also,
the
[[Page 43981]]
owners of goats that qualify as ``low-risk goats'' will not have to
individually identify their animals. Thus, the total potential
identification costs for goat owners will be between $3,850 and $5,570.
International Trade Effects
The United States has limited foreign trade both in live sheep and
goats and their products. Australia, a potential major importer of U.S.
sheep for breeding purposes, is scrapie-free and prohibits imports of
sheep from the United States. Australia allows imports of live goats
from the United States only if they undergo a 3-year quarantine upon
arrival. Mexico allows the importation of U.S. sheep only if the sheep
are from flocks enrolled in the Voluntary Scrapie Flock Certification
Program. Canada allows the importation of U.S. sheep only if a
certification statement can be made that no case of scrapie has been
diagnosed in the flock of origin for the last 3 years and the animals
for export are not the progeny of infected animals. In 1997, the total
earnings from exports of live sheep, goats, and sheep and goat meat and
meat products were approximately $65 million. The United States is a
net exporter of live animals, while it is a net importer of mutton,
lamb and goat meat. Both the sources of imports and destinations of
exports are concentrated in a few countries. Scrapie-free animals, and
to some extent their products, are likely to be highly valued in the
domestic and international markets. U.S. breeding stock that can be
certified scrapie-free is expected to be in high demand
internationally. While scrapie-free status would do little to enhance
domestic or export consumption of U.S. mutton and lamb, the lack of
scrapie-free status could seriously reduce demand for these products if
public fears about transmissible spongiform encephalopathies ever
become associated with U.S. sheep products.
The U.S. competitiveness in the domestic and international markets
depends upon its reputation for producing high quality animals and
products. The actual product, as well as the purchasers' perception of
quality, contribute to continued market acceptance. Thus, efforts to
eradicate scrapie and secure the health of U.S. sheep and goats will
continue to serve the economic interests of the industry and Nation.
This rule could give incentive for more rigorous efforts to find
infection and proceed rapidly to eradicate infected animals in order to
preserve a scrapie-free status.
This rule should benefit U.S. producers in a number of ways,
especially by avoiding a number of direct costs and market losses.
Associations representing breeding sheep owners, slaughter sheep
owners, and wool-production sheep owners have submitted comments
supporting the approach of this rule and also stated their
associations' opinion that the benefits of the program will greatly
exceed the costs. Scrapie may cost the sheep industry as much as $20.1
million per year in direct losses ($10 million in lost breeding stock
and embryo export sales, $3.95 million in disposal costs for offal, and
$6.176 million to divert offal from ruminant food chains and in loss of
offal export markets). Scrapie also costs an unknown amount in lost
potential international markets and lost flock productivity.
Additionally, the sheep industry currently loses sales to drug
companies because the U.S. Food and Drug Administration requires
scrapie-free sources of sheep or goat materials for pharmaceutical or
biological products implanted or injected in humans.
Therefore, this rule should make the U.S. sheep industry more
competitive, particularly in live sheep and goat exports, since current
trade shows that the value of live animal exports is almost four times
that of the meat in the global market. This rule also addresses
consumer concerns about the presence of a transmissible spongiform
encephalopathy in food. While there is no evidence that scrapie is a
human health risk, and significant epidemiological evidence that it is
not, there is a perception of risk.
In summary, this rule will further restrict the interstate movement
of sheep and goats from States that do not follow effective management
practices for scrapie. Interstate movement of sheep and goats is
beneficial, as it reduces interstate price differences faced by
consumers of livestock products and allows producers to seek the best
available prices for their products. The rule will encourage States to
carry out the necessary surveillance and quarantine activities quickly,
thereby reducing the spread of the disease. The process outlined in the
rule will encourage States to begin stringent surveillance procedures
immediately to identify any additional infected flocks and help to
realize the goal of eradicating scrapie from the United States. The
rule will also encourage flock owners to participate in State scrapie
programs or the Federal Scrapie Flock Certification Program,
contributing further to the control of scrapie. Apart from the cost of
program activities by APHIS and State agencies, and expenditure of
indemnity funds by APHIS, the cost of identifying animals for
interstate movement is the primary cost imposed by this rule. This cost
will impose some burden upon owners, which will be passed along to
those who are interested in buying these animals, possibly reducing
interstate commerce in sheep and goats slightly.
The changes to the regulations will result in new information
collection or recordkeeping requirements, which have been approved by
the Office of Management and Budget (see ``Paperwork Reduction Act''
below).
Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 7 CFR part 3015, subpart V.)
Executive Order 12612 and Federalism
It has been determined under section 6(a) of Executive Order 12612,
``Federalism,'' that this rule does not have sufficient federalism
implications to warrant the preparation of a federalism assessment. The
provisions contained in this rule will not have a substantial direct
effect on States or their political subdivisions or on the distribution
of power and responsibilities among the various levels of government.
The Administrator has examined the federalism implications of the
requirements in this rule; i.e., different interstate movement
requirements for sheep and goats depending on whether they are moving
from a Consistent State or an Inconsistent State. The Administrator
believes that this action adheres to Constitutional principles for the
exercise of Federal power and is clearly authorized by statutory
authorities delegated to APHIS.
This action will not absolutely impose any new compliance costs on
State or local governments, but it is true that this rule will strongly
encourage some States to expend additional funds to upgrade their State
programs for disease control in sheep and goats. Owners of sheep and
goats in States that do not fund their programs to an extent that
allows them to qualify as Consistent States would face additional
restrictions on the interstate movement of their sheep and goats.
However, this rule designates all States as Consistent States. If one
or more States do not maintain Consistent State status, APHIS will
review the effects on the particular States involved to determine
whether the loss of that status will have a substantial direct effect
on the States or their political
[[Page 43982]]
subdivisions or on the distribution of power and responsibilities among
the various levels of government and, if necessary, prepare a
federalism assessment.
This final rule was preceded by proposed rules and an advance
notice of proposed rulemaking which sought comments from the public,
industry, and State and local officials. Those documents specifically
requested comments addressing ``the alignment of Federal interstate
movement restrictions with State standards.''
Most States supported the proposal's intention to establish a
system to certify that State programs for sheep and goats meet certain
minimum standards, in order to provide a baseline of protection against
the spread of disease when moving sheep and goats in interstate
commerce. Very few officials commented that APHIS should accept any
State animal health program without enforcing minimum standards. APHIS
disagrees with this position because experience in animal health
programs on a national level has shown that the absence of effective
programs for scrapie in a few States can quickly cause animal disease
problems and financial losses affecting many States as animals move in
interstate commerce.
State and local governments had the opportunity to comment on the
proposed rules that preceded this final rule, and we encouraged them to
submit comments on federalism concerns or any other issues. As
implementation of this rule proceeds, APHIS intends to continue active
consultation with State animal health agencies and the elected
officials of affected State and local governments.
Executive Order 12988
This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This rule: (1) Preempts all State and local laws
and regulations that are in conflict with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
Paperwork Reduction Act
The information collection requirements that were contained in the
proposed rule have been approved under OMB control number 0579-0101.
This final rule adds an additional 66,154 burden hours for respondents.
Part of this increase is due to the fact that we underestimated the
paperwork burden associated with the proposed rule, as several
commenters pointed out, and part of the increase results from changes
in this final rule that add additional burden in order to improve the
disease control effects of the rule and to make indemnity payments more
equitable. Our changes in this final rule that made the definitions of
exposed animal, infected flock, and source flock more science-based,
and make the rule in general more risk-averse, will also result in more
flocks being classified in these categories in the first year or two
these regulations are in effect. However, regulated flocks should then
decrease in number rapidly in subsequent years, compared to the
decrease in numbers they would have experienced under the original
proposed rule. In that sense, the changes in this final rule compress
more of the paperwork burden into the first year or two of program
operations, rather than adding more to the total burden. The paperwork
burden estimated for this rule will also decrease significantly as soon
as a valid live-animal test is in use, since such a test would have the
general effect of reducing the number of animals subject to the
regulations, and resolving suspect animal cases more quickly. While
such a test is expected to be approved soon, we do not know exactly how
soon, and therefore have estimated the paperwork burden without
assuming the availability of such a test. Forthcoming advances in
electronic animal identification methods should also reduce the
paperwork burden estimated for this rule.
As noted above, this additional burden resulted partly from changes
to the definitions of exposed animal, infected flock, and source flock
that resulted in more animals placed in these categories, causing
additional identification and recordkeeping. Additional burden also
resulted from changes in the final rule that require flock owners to do
more individual animal identification, and that allowed slaughter
plants and livestock markets to act as an agent for the owner in
applying required official identification. Also, the final rule
expanded the use of owner statements in connection with the movement of
animals, resulting in the preparation of more such owners statements
each year. Finally, changes to the indemnity procedure shifted
indemnity values from a fixed-price approach to a market value
approach, requiring more paperwork to document market prices at any
given time and to base some indemnities on examination of sale records
of flock owners. In accordance with section 3507(d) of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this additional burden
has been submitted for approval to the Office of Management and Budget
(OMB). When OMB notifies us of its decision, we will publish a document
in the Federal Register providing notice of the assigned OMB control
number and expiration date, or, if approval is denied, providing notice
of what action we plan to take.
Unfunded Mandates Reform Act of 1995
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub.
L. 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, tribal
governments, and the private sector. Under section 101 of the UMRA,
APHIS generally must prepare a written statement, including a cost-
benefit analysis, for proposed and final rules with ``Federal
mandates'' that may result in expenditures by State, local, or tribal
governments, in the aggregate, or by the private sector, of $100
million or more in any one year. When such a statement is needed for a
rule, section 205 of the UMRA generally requires APHIS to identify and
consider a reasonable number of regulatory alternatives and adopt the
least costly, more cost-effective, or least burdensome alternative that
achieves the objectives of the rule.
This rule contains no Federal mandates (under the regulatory
provisions of Title II of the UMRA) that may result in expenditures by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100 million or more in any one year. Thus, this
rule is not subject to the requirements of sections 202 and 205 of the
UMRA.
List of Subjects
9 CFR Part 54
Animal diseases, Goats, Indemnity payments, Scrapie, Sheep.
9 CFR Part 79
Animal diseases, Goats, Quarantine, Reporting and recordkeeping
requirements, Scrapie, Sheep, Transportation.
Accordingly, we are amending 9 CFR chapter I as follows:
1. Part 54 is revised to read as follows:
PART 54--CONTROL OF SCRAPIE
Sec.
54.1 Definitions.
54.2 Cooperative agreements and memoranda of understanding with
States.
Subpart A--Scrapie Indemnification Program
54.3 Animals eligible for indemnity payments.
[[Page 43983]]
54.4 Application by owners for indemnity payments.
54.5 Certification by owners.
54.6 Amount of indemnity payments.
54.7 Procedures for destruction of animals.
54.8 Requirements for flock plans and post-exposure management and
monitoring plans.
54.9 Waiver of requirements for scrapie control pilot projects.
54.10 Tests for scrapie.
54.11 Approval of laboratories to run official scrapie tests and
official genotype tests.
Subpart B--Scrapie Flock Certification Program
54.20 Administration.
54.21 Participation.
54.22 State scrapie certification boards.
Authority: 21 U.S.C. 111, 114, 114a, and 134a-134h; 7 CFR 2.22,
2.80, and 371.4.
Sec. 54.1 Definitions.
Accredited veterinarian. A veterinarian approved by the
Administrator in accordance with part 161 of this chapter to perform
functions specified in subchapters B, C, and D of this chapter.
Administrator. The Administrator of the Animal and Plant Health
Inspection Service or any employee of the United States Department of
Agriculture authorized to act for the Administrator.
Animal. A sheep or goat.
Animal and Plant Health Inspection Service (APHIS). The Animal and
Plant Health Inspection Service of the United States Department of
Agriculture.
APHIS representative. An individual employed by APHIS in animal
health activities who is authorized by the Administrator to perform the
function involved.
Approved laboratory. A laboratory approved by the Administrator in
accordance with Sec. 54.11 to conduct one or more scrapie tests, or
genotype tests, on one or more tissues.
Approved test. A test for the diagnosis of scrapie approved by the
Administrator for use in the scrapie eradication or certification
program in accordance with Sec. 54.10.
Area veterinarian in charge. The veterinary official of APHIS who
is assigned by the Administrator to supervise and perform the official
animal health work of APHIS in the State concerned.
Breed association and registries. Organizations listed in
Sec. 151.9 of this chapter that maintain the permanent records of
ancestry or pedigrees of animals (including the animal's sire and dam),
individual identification of animals, and ownership of animals.
Certificate. An official document issued in accordance with
Sec. 79.5 of this chapter by an APHIS representative, State
representative, or accredited veterinarian at the point of origin of an
interstate movement of animals.
Commingle, commingled, commingling. Animals grouped together and
having physical contact with each other, including contact through a
fence, but not limited contacts. Commingling also includes sharing the
same section in a transportation unit where there is physical contact.
Designated scrapie epidemiologist. An epidemiologist who has
demonstrated the knowledge and ability to perform the functions
required and who has been selected by the State animal health official
and the area veterinarian in charge. The regional epidemiologist and
the APHIS National Scrapie Program Coordinator must concur in the
selection and appointment of the designated scrapie epidemiologist. The
designated scrapie epidemiologist must satisfactorily complete training
designated by APHIS.
Destroyed. (1) Euthanized by means other than slaughter, and the
carcass disposed of, by means authorized by the Administrator; or
(2) In the case of exposed or high-risk animals that are not known
to be infected, either euthanized or disposed of by slaughter; or
(3) Moved to a quarantined research facility if the movement has
been approved by the Administrator.
Electronic implant. Any radio frequency identification implant
device approved for use in the scrapie program by the Administrator.
The Administrator will approve an electronic implant after determining
that it is tamper resistant, not harmful to the animal, and readable by
equipment available to APHIS and State representatives.
Exposed animal. (1) Any animal that has been in the same flock at
the same time as a scrapie-positive female animal, excluding limited
contacts; or
(2) Any animal born in a flock after a scrapie-positive animal was
born into that flock or lambed in that flock, if born before that flock
completes the requirements of a flock plan; or
(3) Any animal that was commingled with a scrapie-positive female
animal during or up to 30 days after she lambed, kidded, or aborted, or
while a visible vaginal discharge was present, or that was commingled
with any other scrapie-positive female animal for 24 hours or more,
including during activities such as shows and sales or while in
marketing channels; or
(4) Any animal in a noncompliant flock.
Exposed flock. Any flock in which a scrapie-positive animal was
born or lambed. Any flock that currently contains a female high-risk,
exposed, or suspect animal, or that once contained a female high-risk,
exposed, or suspect animal that lambed in the flock and from which
tissues were not submitted for official testing and found negative. A
flock that has completed a post-exposure management and monitoring plan
following the exposure will no longer be an exposed flock.
Flock. All animals that are maintained on a single premises and all
animals under common ownership or supervision on two or more premises
with animal interchange between the premises. Changes in ownership of
part or all of a flock do not change the identity of the flock or the
regulatory requirements applicable to the flock. Animals maintained
temporarily on a premises for activities such as shows and sales or
while in marketing channels are not a flock. More than one flock may be
maintained on a single premises if:
(1) The flocks are enrolled as separate flocks in the SFCP; or
(2) A State or APHIS representative determines, based upon
examination of flock records, that:
(i) There is no interchange of animals between the flocks;
(ii) The flocks never commingle and are kept at least 30 feet apart
at all times or are separated by a solid wall through, over, or under
which fluids cannot pass and through which contact cannot occur;
(iii) The flocks have separate flock records and identification;
(iv) The flocks have separate lambing facilities, including
buildings and pastures, and a pasture or building used for lambing by
one flock is not used by the other flock at any time; and
(v) The flocks do not share equipment without cleaning and
disinfection in accordance with Sec. 54.7(e). Additional guidance on
acceptable means of cleaning and disinfection is also available in the
Scrapie Flock Certification Program standards and the Scrapie
Eradication Uniform Methods and Rules.
Flock of origin. The flock in which an animal most recently resided
in which it either was born, gave birth, or was used for breeding
purposes. The determination of an animal's flock of origin may be based
either on the physical presence of the animal in the flock, the
presence of official identification on the animal traceable to the
flock, the presence of other identification on the animal that is
listed on the bill of sale, or other evidence, such as registry
records.
[[Page 43984]]
Flock plan. A written flock management agreement signed by the
owner of a flock, the accredited veterinarian, if one is employed by
the owner, and a State or APHIS representative in which each
participant agrees to undertake actions specified in the flock plan to
control the spread of scrapie from, and eradicate scrapie in, an
infected flock or source flock or to reduce the risk of the occurrence
of scrapie in a flock that contains a high-risk or an exposed animal.
As part of a flock plan, the flock owner must provide the facilities
and personnel needed to carry out the requirements of the flock plan.
The flock plan must include the requirements in Sec. 54.8(a) through
(f).
Flock sire. A sexually intact male animal that has ever been used
for breeding in a flock.
High-risk animal. A sexually intact animal, excluding male sheep
that have tested RR at codon 171 and AA at codon 136 using an official
genotype test, that is:
(1) The progeny of a scrapie-positive dam; or
(2) Born in the same flock during the same lambing season as
progeny of a scrapie-positive dam, unless the progeny of the scrapie-
positive dam are from separate contemporary lambing groups; or
(3) Born in the same flock during the same lambing season that a
scrapie-positive animal was born, or during any subsequent lambing
season, if born before that flock completes the requirements of a flock
plan; or
(4) An exposed female sheep that has not tested QR, HR, or RR at
codon 171 using an official genotype test.
Infected flock. The flock of origin of a female animal that a State
or APHIS representative has determined to be a scrapie-positive animal;
or any flock in which a State or APHIS representative has determined
that a scrapie-positive female animal has resided unless an
epidemiologic investigation conducted by a State or APHIS
representative shows that the animal did not lamb or abort in the
flock. A flock will no longer be considered an infected flock after it
has completed the requirements of a flock plan.
Limited contacts. Incidental contacts between animals from
different flocks off the flock's premises such as at fairs, shows,
exhibitions and sales; between ewes being inseminated, flushed, or
implanted; or between rams at ram test or collection stations. Embryo
transfer and artificial insemination equipment and surgical tools must
be sterilized between animals for these contacts to be considered
limited contacts. Limited contacts do not include any contact,
incidental or otherwise, with animals in the same flock or with a
female animal during or up to 30 days after she lambed, kidded or
aborted or when there is any visible vaginal discharge. Limited
contacts do not include any activity where uninhibited contact occurs,
such as sharing an enclosure, sharing a section of a transport vehicle,
or residing in other flocks for breeding or other purposes. Examples of
limited contacts may be found in the Scrapie Flock Certification
Program standards.
Live-animal screening test. Any test for the diagnosis of scrapie
in a live animal that is approved by the Administrator as usually
reliable but not definitive for diagnosing scrapie, and that is
conducted in a laboratory approved by the Administrator.\1\
---------------------------------------------------------------------------
\1\ The names and addresses of laboratories approved by the
Administrator to conduct live-animal screening tests will be
published in the Notices Section of the Federal Register. A list of
approved laboratories is also available upon request from the Animal
and Plant Health Inspection Service, Veterinary Services, National
Animal Health Programs Staff, 4700 River Road Unit 43, Riverdale, MD
20737-1235. State, Federal, and university laboratories will be
approved by the Administrator when he or she determines that the
laboratory: (a) Employs personnel trained by the National Veterinary
Services Laboratories assigned to supervise the testing; (b) follows
standard test protocols; (c) meets check test proficiency
requirements; and (d) will report all test results to State and
Federal animal health officials. Before the Administrator may
withdraw approval of any laboratory for failure to meet any of these
conditions, the Administrator must give written notice of the
proposed withdrawal to the director of the laboratory and must give
the director an opportunity to respond. If there are conflicts as to
any material fact, a hearing will be held to resolve the conflicts.
---------------------------------------------------------------------------
Mortgage. Any mortgage, lien, or other security or interest held by
any person other than the one claiming indemnity.
National Scrapie Database. A database designated by the
Administrator in which APHIS and State animal health agencies
cooperatively enter data concerning scrapie outbreaks, flocks and
premises affected by scrapie, individual animal identification and
premises identification data, and other data to support the Scrapie
Eradication Program and the Scrapie Flock Certification Program.
National Veterinary Services Laboratories (NVSL). The National
Veterinary Services Laboratories, APHIS, U.S. Department of
Agriculture, or an NVSL cooperating or contract laboratory.
Noncompliant flock. (1) Any source or infected flock whose owner
declines to enter into a flock plan or post-exposure management and
monitoring plan agreement within 30 days of being so designated, or
whose owner is not in compliance with either agreement;
(2) Any exposed flock whose owner fails to make animals available
for testing within 60 days of notification, or as mutually agreed, or
whose owner fails to submit required postmortem samples;
(3) Any flock whose owner has misrepresented, or who employs a
person who has misrepresented, the scrapie status of an animal or any
other information on a certificate, permit, owner statement, or other
official document within the last 5 years; or
(4) Any flock whose owner or manager has moved, or who employs a
person who has moved, an animal in violation of this chapter within the
last 5 years.
Official genotype test. Any test to determine the genotype of a
live or dead animal that is conducted at either an approved laboratory
or at the National Veterinary Services Laboratories, when the animal is
officially identified and the samples used for the test are collected
and shipped to the laboratory by either an accredited veterinarian or a
State or APHIS representative
Official test. Any test for the diagnosis of scrapie in a live or
dead animal that is approved by the Administrator for that use and
conducted either at an approved laboratory or at the National
Veterinary Services Laboratories.
Owner. A person, partnership, company, corporation, or any other
legal entity who has legal or rightful title to animals, whether or not
they are subject to a mortgage.
Post-exposure management and monitoring plan. A written agreement
signed by the owner of a flock, any accredited veterinarian employed by
the owner, and a State or APHIS representative in which each
participant agrees to undertake actions specified in the agreement to
monitor for the occurrence of scrapie in the flock for at least 5 years
after the last high-risk or scrapie-positive animal is removed from the
flock or after the last exposure of the flock to a scrapie-positive
animal, unless otherwise specified by a State or APHIS representative.
As part of a post-exposure management and monitoring plan, the flock
owner must provide the facilities and personnel needed to carry out the
requirements of the plan. The plan must include the requirements in
Sec. 54.8.
Scrapie control pilot project. A pilot project authorized by the
Administrator in writing, designed to test or improve program
procedures or to facilitate research, in order to control and eradicate
scrapie. In addition to APHIS, participants may include State animal
[[Page 43985]]
health agencies, flock owners, and other parties as necessary.
Scrapie Eradication Program. The cooperative State-Federal program
administered by APHIS and Consistent States to control and eradicate
scrapie.
Scrapie Eradication Uniform Methods and Rules (UM&R). Cooperative
procedures and standards adopted by APHIS and Consistent States for
controlling and eradicating scrapie. The UM&R will be reviewed at least
annually by representatives of the livestock industry and appropriate
State and Federal agencies and the public and will be revised, and
published as needed by APHIS.
Scrapie Flock Certification Program (SFCP). The cooperative
Federal-State-industry voluntary program for the control of scrapie
conducted in accordance with this subpart.
Scrapie Flock Certification Program standards. Cooperative
procedures and standards adopted by APHIS and State scrapie
certification boards for reducing the incidence and controlling the
spread of scrapie through flock certification.\2\
---------------------------------------------------------------------------
\2\ Individual copies of the Scrapie Flock Certification Program
standards may be obtained on the World Wide Web at URL http://
www.aphis.usda.gov/vs/scrapie, or from the Animal and Plant Health
Inspection Service, National Animal Health Programs Staff, 4700
River Road Unit 43, Riverdale, MD 20737-1235.
---------------------------------------------------------------------------
Scrapie-positive animal. An animal for which a diagnosis of scrapie
has been made by the National Veterinary Services Laboratories or
another laboratory authorized by the Administrator to conduct scrapie
tests in accordance with this part, through:
(1) Histopathological examination of central nervous system (CNS)
tissues from the animal for characteristic microscopic lesions of
scrapie;
(2) The use of proteinase-resistant protein analysis methods
including but not limited to immunohistochemistry and/or western
blotting on CNS and/or peripheral tissue samples from a live or a dead
animal for which a given method has been approved by the Administrator
for use on that tissue;
(3) Bioassay;
(4) Scrapie associated fibrils (SAF) detected by electron
microscopy; or
(5) Any other test method approved by the Administrator in
accordance with Sec. 54.10.\3\
---------------------------------------------------------------------------
\3\ The names and addresses of laboratories approved by the
Administrator to conduct tests are published in the Notices Section
of the Federal Register. A list of approved laboratories is also
available upon request from the Animal and Plant Health Inspection
Service, Veterinary Services, National Animal Health Programs Staff,
4700 River Road Unit 43, Riverdale, MD 20737-1235. State, Federal,
and university laboratories will be approved by the Administrator
when he or she determines that the laboratory: (a) Employs personnel
trained by the National Veterinary Services Laboratories assigned to
supervise the testing; (b) follows standard test protocols; (c)
meets check test proficiency requirements; and (d) will report all
test results to State and Federal animal health officials. Before
the Administrator may withdraw approval of any laboratory for
failure to meet any of these conditions, the Administratr must give
written notice of the proposed withdrawal to the director of the
laboratory and must give the director an opportunity to respond. If
there are conflicts as to any material fact, a hearing will be held
to resolve the conflict.
---------------------------------------------------------------------------
Separate contemporary lambing groups. To be a separate contemporary
lambing group, the group must be maintained separately such that the
animals cannot come into physical contact with other lambs, kids, ewes
or does or birth fluids or placenta from other ewes or does. This
separate maintenance must preclude contact through a fence, during
lambing and for 60 days following the date the last lamb or kid is born
in a lambing season, and must preclude using the same lambing facility
as other ewes or does, unless the lambing facility is cleaned and
disinfected under supervision by an APHIS representative, State
representative, or an accredited veterinarian between lambings in
accordance with Sec. 54.7(e). Additional guidance on acceptable means
of cleaning and disinfection is also available in the Scrapie Flock
Certification Program standards and the Scrapie Eradication Uniform
Methods and Rules. The flock owner must maintain adequate records to
document which animals were maintained in each contemporary lambing
group and to document when cleaning and disinfection was performed and
who supervised it.
Slaughter channels. Animals in slaughter channels include any
animal that is sold, transferred, or moved either directly to a
slaughter facility, to an individual for custom slaughter, or for
feeding for the express purpose of improving the animals' condition for
movement to slaughter. Any sexually intact animal that is commingled
with breeding animals or that has been bred is not in slaughter
channels. When selling animals for slaughter, owners should note on the
bill of sale that the animals are sold only for slaughter.
Source flock. A flock in which a State or APHIS representative has
determined that at least one animal was born that was diagnosed as a
scrapie-positive animal at an age of 72 months or less. The
determination that an animal was born in a flock will be based on such
information as the presence of official identification on the animal
traceable to the flock, the presence of other identification on the
animal that is listed on the bill of sale, or other evidence, such as
registry records, to show that a scrapie-positive animal was born in
the flock, combined with the absence of records indicating that the
animal was purchased from outside and added to the flock. If DNA from
the animal was previously collected by an accredited veterinarian and
stored at an approved genotyping laboratory, or if DNA collection and
storage are required for breed registration and the breed registration
has appropriate safeguards in place to ensure the integrity of the
banking process, the owner may request verification of the animal's
identity based on DNA comparison if adequate records and identification
have been maintained by the owner and the repository to show that the
archived DNA is that of the animal that has been traced to the flock.
The owner will be responsible for all costs for the DNA comparison. A
flock will no longer be a source flock after it has completed the
requirements of a flock plan.
State. Each of the 50 States, the District of Columbia, the
Northern Mariana Islands, Puerto Rico, and all territories or
possessions of the United States.
State representative. An individual employed in animal health
activities by a State or a political subdivision of a State and who is
authorized by the State or political subdivision to perform the
function involved.
Suspect animal. An animal will be designated a suspect animal in
accordance with Sec. 79.4 of this chapter if it is:
(1) A sheep or goat that exhibits any of the following possible
signs of scrapie and that has been determined to be suspicious for
scrapie by an accredited veterinarian or a State or APHIS
representative: Weight loss despite retention of appetite; behavioral
abnormalities; pruritus (itching); wool pulling; biting at legs or
side; lip smacking; motor abnormalities such as incoordination, high
stepping gait of forelimbs, bunny hop movement of rear legs, or swaying
of back end; increased sensitivity to noise and sudden movement;
tremor, ``star gazing,'' head pressing, recumbency, or other signs of
neurological disease or chronic wasting.
(2) A sheep or goat that has tested positive for scrapie or for the
proteinase resistant protein associated with scrapie on a live-animal
screening test or any other test, unless the animal is designated a
scrapie-positive animal.
(3) A sheep or goat that has tested inconclusive or suggestive on
an official test for scrapie.
Unofficial test. Any test for the diagnosis of scrapie or for the
detection
[[Page 43986]]
of the proteinase resistant protein associated with scrapie in a live
or dead animal that either has not been approved by the Administrator
or that was not conducted at an approved laboratory or at the National
Veterinary Services Laboratories.
Sec. 54.2 Cooperative agreements and memoranda of understanding with
States.
APHIS will execute cooperative agreements and/or memoranda of
understanding with the animal health agency of any State in order to
cooperatively administer the Scrapie Eradication Program and the
Scrapie Flock Certification Program within that State. These agreements
will describe the respective roles of APHIS and State personnel in
implementing the Scrapie Eradication Program and the Scrapie Flock
Certification Program. Each agreement may specify the financial,
material, and personnel resources to be committed to these programs and
other scrapie control measures by APHIS and the State; assign specific
activities related to the control of scrapie within a State to APHIS or
State personnel; establish schedules for APHIS representatives or State
representatives to visit flocks; establish procedures for maintaining
and sharing program records specified in this part, and specify other
responsibilities of State representatives and APHIS representatives in
support of the Scrapie Eradication Program and the Scrapie Flock
Certification Program.
(Approved by the Office of Management and Budget under control number
0579-0101)
Subpart A--Scrapie Indemnification Program
Sec. 54.3 Animals eligible for indemnity payments.
(a) Indemnity may be paid for an animal only after the owner of the
animal has applied for indemnification and been approved in accordance
with Sec. 54.4. Indemnity may be paid only for the following:
(1) Destruction of high-risk animals;
(2) Destruction of animals based on an epidemiologic investigation,
when the Administrator determines that the destruction of these animals
will contribute to the eradication of scrapie;
(3) Destruction of live scrapie-positive animals;
(4) Destruction of animals that test positive on a live-animal
screening test; and
(5) Destruction of suspect animals that are destroyed at the
request of an APHIS representative.
(b) No indemnity will be paid for an animal if the owner of the
animal fails to provide APHIS, within 30 days of request, animal
registration certificates, sale and movement records, or other records
requested in accordance with Sec. 54.5. No indemnity will be paid until
the premises, including all structures, holding facilities,
conveyances, and materials contaminated because of occupation or use by
the depopulated animals, have been properly cleaned and disinfected in
accordance with Sec. 54.7(e). Additional guidance on acceptable means
of cleaning and disinfection is also available in the Scrapie Flock
Certification Program standards and the Scrapie Eradication Uniform
Methods and Rules. Premises or portions of premises may be exempted
from the cleaning and disinfecting requirements if a designated scrapie
epidemiologist determines, based on epidemiologic investigation, that
cleaning and disinfection of such buildings, holding facilities,
conveyances, or other materials on the premises will not significantly
reduce the risk of the spread of scrapie, either because effective
disinfection is not possible or because the normal operations on the
premises prevent transmission of scrapie. No indemnity will be paid to
an owner if the owner assembled or increased his flock for the purpose
of collecting or increasing indemnity.
Sec. 54.4 Application by owners for indemnity payments.
(a) Normally, an application for indemnification will be initiated
by a State or APHIS representative who is working with the owner of a
flock that has already been determined to be an infected flock or
source flock, or that is already under a State movement restriction. In
such cases, the flock owner will confirm information about the flock's
eligibility for indemnity that is contained in the application
submitted by the State or APHIS representative. However, the owner of
any flock may apply directly to receive indemnification by submitting
to the Administrator a written request containing the following
information:
(1) Name, address, and social security number of the flock owner;
(2) Number and breed(s) of animals in the flock, including a
current inventory;
(3) Location of flock premises;
(4) Reasons the owner believes animals in his or her flock may be
eligible for indemnification, including any diagnosis of scrapie made
for animals in the flock; any signs of scrapie observed in the flock by
the owner; and any movement of animals into the flock from flocks
infected with or exposed to scrapie;
(5) A copy of the registration papers issued in the name of the
owner for any registered animals in the flock (registration papers are
not required for the payment of indemnity for animals that are not
registered). If the registration papers are unavailable, the owner may
choose to accept a lesser indemnity in accordance with Sec. 54.6(b)(2)
or the area veterinarian in charge may grant a 60-day extension or the
Administrator may grant an extension longer than 60 days for the
presentation of registration papers; and
(6) Signed release letters addressed to any sheep or goat registry
associations that maintain records of the owner's sheep or goats
requesting the associations to release to APHIS all records maintained
by the association on sheep or goats currently or formerly owned by the
applicant.
(b) APHIS will evaluate each application to determine whether the
owner's flock contains animals eligible for indemnity in accordance
with Sec. 54.3.
Sec. 54.5 Certification by owners.
Before any indemnity is paid to an owner, the owner must sign a
written agreement with APHIS, certifying the following:
(a) The owner will make available for review upon request by a
State or APHIS representative all bills of sale, pedigree registration
certificates, and other records regarding movement of animals into and
from the flock;
(b) If the owner maintains any flock after the payment of indemnity
or acquires a new flock that is housed on the same premises within 5
years after the last high-risk or scrapie-positive animal is removed,
the owner will maintain the flock in accordance with a post-exposure
management and monitoring plan for 5 years;
(c) If the animal for which indemnity is paid is subject to any
mortgage, the owner consents to the payment of the indemnity, up to the
value of the mortgage, to the person(s) holding the mortgage;
(d) That the animal may be removed to a U.S. Department of
Agriculture facility or a quarantined research facility, slaughtered,
or euthanized and necropsied and tissues removed for diagnostic or
other purposes.
Sec. 54.6 Amount of indemnity payments.
(a) Indemnity paid for sheep in accordance with Sec. 54.3 will be
set based on the following price reports published by the Agricultural
Marketing Service (AMS). If pricing information is unavailable from
these markets during a
[[Page 43987]]
given week or month or if the numbers of animals sold are too low to
give an accurate market value, the preceding week or month's value will
be used. The AMS reports from the most recent week or month prior to
the date APHIS offers to pay an owner indemnity shall be used to
calculate the indemnity for that owner's sheep:
(1) The weekly weighted average Choice/Prime slaughter lamb price
per pound at Greeley, CO;
(2) The weekly weighted average Utility slaughter ewe price per
pound at San Angelo, TX;
(3) The monthly weighted average commercial western ewe lamb
replacement price per head;
(4) The monthly weighted average commercial western yearling ewe
replacement price per head;
(5) The monthly weighted average commercial western running age ewe
price per head.
(6) The monthly weighted average commercial western aged ewe price
per head.
(b) For animals under 1 year of age, the basic indemnity shall
equal the price per pound from paragraph (a)(1) of this section times
the greater of 50 lbs or the actual weight of the animal; except that,
for ewe lambs under 1 year of age, the indemnity shall equal the per-
head price from paragraph (a)(3) of this section if that price is
higher. For sexually intact sheep 8 years of age or older and castrated
animals 1 year of age or older, the basic indemnity shall equal the
price per pound from paragraph (a)(2) of this section times 150, based
on an average weight of 150 lbs. For sexually intact sheep at least 1
year of age and under 2 years of age, the indemnity shall equal the
greater of the price per head from paragraph (a)(4) of this section, or
the price per pound from paragraph (a)(2) of this section times 150,
based on an average weight of 150 lbs. For sexually intact sheep at
least 2 years of age and under 6 years of age, the basic indemnity
shall equal the greater of the price per head from paragraph (a)(5) of
this section or the price per pound from paragraph (a)(2) of this
section times 150, based on an average weight of 150 lbs. For sexually
intact sheep at least 6 years of age and under 8 years of age, the
basic indemnity will equal the greater of the price per head from
paragraph (a)(6) of this section or the price per pound from paragraph
(a)(2) of this section times 150, based on an average weight of 150
lbs. A premium shall be added to the basic indemnity for each
registered animal, equal to $100 for each registered animal under 1
year of age, $200 for each registered animal at least 1 year of age and
under 4 years of age, and $100 for each registered animal at least 4
years of age and under 8 years of age. An additional premium of $50
will be added to the basic indemnity for each flock sire. The owner
must provide adequate records to qualify for these premiums. When the
animals to be indemnified are goats, or are sheep that fall outside the
classes covered previously in this paragraph, the Administrator may
take into consideration the producer's purchase records and sales
records for the preceding 12 to 24 months in determining the indemnity
amount, but the indemnity shall not exceed the maximum indemnity
calculated for registered sheep in accordance with this section.
(1) If records and identification are inadequate to determine the
actual age of animals, an APHIS or State representative will count all
sexually intact animals that are apparently under 1 year of age, and
those that are apparently at least 1 and under 2 years of age, based on
examination of their teeth, and the indemnity for these animals will be
calculated. The total number of these animals will be subtracted from
the total number of sexually intact animals in the group to be
indemnified, and indemnity for the remainder will be calculated based
on the assumption that the remainder of the flock is 80 percent aged 2
to 6 years and 20 percent aged 6 to 8 years.
(2) Any animal that is not registered at the time indemnity is
first offered, but is eligible to be registered, will receive the
registered animal premium reduced by $50.
(c) For animals destroyed by slaughter, the owner will retain the
salvage value (the amount paid by a slaughter plant for the animal) of
the animals in lieu of receiving the base indemnity. If the salvage
value, less transport costs, is less than the base indemnity, APHIS
will pay the owner the difference. APHIS will also indemnify the owner
in the amount of any registered animal or flock sire premiums for which
the animal qualifies.
(d) If the owner disagrees with the average weight estimate, he may
have the sheep weighed at a public scale at his own expense, provided
that the sheep may not come in contact with other sheep or goats during
movement to the public scales, and will be paid based on the actual
weight times the AMS weekly average price.
(e) Indemnity will be paid to an owner only for animals actually in
a flock at the time indemnity is first offered. Animals removed from
the flock as part of a post-exposure management and monitoring plan
will be paid indemnity based on the AMS average prices at the time an
APHIS representative designates the animals for removal.
Sec. 54.7 Procedures for destruction of animals.
(a) Scrapie-positive and suspect animals for which indemnification
is sought must be destroyed on the premises where they are held,
pastured, or penned at the time indemnity is approved or moved to an
approved research facility, unless the APHIS representative involved
approves in advance of destruction moving the animals to another
location for destruction. Animals that are not scrapie-positive or
suspect animals for which indemnification is sought may be:
(1) Slaughtered when moved in accordance with part 79 of this
chapter and with the prior written approval of the APHIS representative
involved;
(2) Destroyed on the premises where they are held, pastured, or
penned at the time indemnity is approved;
(3) Moved to an approved research facility; or
(4) Moved to another location for destruction if an APHIS
representative approves the movement in advance.
(b) The carcasses of animals destroyed in accordance with this
section are authorized by the Administrator to be buried, incinerated,
or disposed of by other methods in accordance with local, State, and
Federal laws. The carcasses of scrapie-positive and suspect animals may
not be processed for human or animal food.
(c) The destruction of animals and disposition of their carcasses
in accordance with this part must be monitored by an APHIS
representative who will prepare and transmit to the Administrator a
report identifying the animals and showing their disposition.
(d) APHIS may pay the reasonable costs of disposal for scrapie-
positive and suspect animals that are indemnified. To obtain
reimbursement for disposal costs, animal owners must obtain written
approval of the disposal costs from APHIS, prior to disposal. The
Administrator may also authorize payment of up to half the reasonable
disposal costs for animals that are eligible to be destroyed by
slaughter under this section but for which slaughter is not a practical
or cost efficient means of disposal; Provided that, APHIS may pay more
than one-half of the expenses when the Administrator determines that
doing so will contribute to scrapie eradication. For
[[Page 43988]]
reimbursement to be made, the owner of the animals must present the
area veterinarian in charge with a copy of either a receipt for
expenses paid or a bill for services rendered. Any bill for services
rendered by the owner must not be greater than the normal fee for
similar services provided by a commercial hauler or disposal facility.
(e) Cleaning and disinfection of premises and equipment. When
required, cleaning and disinfection shall be conducted under the
supervision of a State or APHIS representative as follows. Additional
guidance on acceptable means of cleaning and disinfection is also
available in the Scrapie Flock Certification Program standards and the
Scrapie Eradication Uniform Methods and Rules:
(1) Drylot areas. When required, remove the manure and top 1-2
inches of soil to reduce contamination. Bury, till under, or compost
the removed material in areas not accessed by domestic animals or
wildlife.
(2) Cement, wood, metal, and other non-earth surfaces, tools,
equipment, instruments, feed, hay, bedding, and other materials. Remove
all organic material and compost or incinerate.
Clean and wash all surfaces, tools, equipment, and instruments
using hot water and detergent. Allow all surfaces, tools, equipment,
and instruments to dry completely before disinfecting and sanitizing
using the following methods:
(i) Incinerate items by high-temperature incineration methods;
(ii) Autoclave instruments, small tools, and other items at 136
deg.C for 1 hour;
(iii) To clean dry surfaces, apply a 2-percent chlorine bleach
solution at room temperature (at least 18.3 deg.C for 1 hour, or apply
a 1-molar solution of sodium hydroxide (approximately 5 oz. of sodium
hydroxide dissolved in l gallon water) at room temperature for at least
1 hour. Note: A 2-molar solution is more effective than a 1-molar
solution and should be used when circumstances permit.
Sec. 54.8 Requirements for flock plans and post-exposure management
and monitoring plans.
(a) The owner of the flock or his or her agent must identify all
animals 1 year of age or over within the flock. All animals less than 1
year of age must be identified when a change of ownership occurs, with
the exception of those animals under 1 year of age moving within
slaughter channels that must be identified in accordance with
Secs. 79.2 and 79.3 of this chapter. The form of identification must be
an electronic implant, flank tattoo, ear tattoo, or tamper-resistant
ear tag approved for this use by APHIS. In the case of goats, the form
of identification may alternatively be a tail fold tattoo. The official
identification must provide a unique identification number that is
applied by the owner of the flock or his or her agent and must be
linked to that flock in the National Scrapie Database.
(b) Upon request by a State or APHIS representative, the owner of
the flock or his or her agent must have an accredited veterinarian
collect tissues from animals for scrapie diagnostic purposes and submit
them to a laboratory designated by a State or APHIS representative.
(c) Upon request by a State or APHIS representative, the owner of
the flock or his or her agent must make animals in the flock and the
records required to be kept as a part of these plans available for
inspection.
(d) The owner of the flock or his or her agent must meet
requirements found necessary by a State or APHIS representative to
monitor for scrapie and to prevent the recurrence of scrapie in the
flock and to prevent the spread of scrapie from the flock. These other
requirements may include, but are not limited to: Utilization of a
live-animal screening test; restrictions on the animals that may be
moved from the flock; segregated lambing; cleaning and disinfection of
lambing facilities; and/or education of the owner of the flock and
personnel working with the flock in techniques to recognize clinical
signs of scrapie and to control the spread of scrapie.
(e) The owner of the flock or his or her agent must immediately
report the following animals to a State representative, APHIS
representative, or an accredited veterinarian, and not remove them from
a flock without written permission of a State or APHIS representative:
(1) Any sheep or goat exhibiting weight loss despite retention of
appetite; behavioral abnormalities; pruritus (itching); wool pulling;
biting at legs or side; lip smacking; motor abnormalities such as
incoordination, high stepping gait of forelimbs, bunny hop movement of
rear legs, swaying of back end; increased sensitivity to noise and
sudden movement; tremor, ``star gazing,'' head pressing, recumbency, or
other signs of neurological disease or chronic wasting illness; and
(2) Any sheep or goat in the flock that has tested positive for
scrapie or for the proteinase resistant protein associated with scrapie
on a live-animal screening test or any other test.
(f) Requirements for flock plans only. (1) An epidemiologic
investigation must be conducted to identify high-risk and exposed
animals that currently reside in the flock or that previously resided
in the flock, and all high-risk animals, scrapie-positive animals, and
suspect animals must be removed from the flock. The animals must be
removed either by movement to an approved research facility or by
euthanization and disposal of the carcasses by burial, incineration, or
other methods in accordance with local, State, and Federal laws, or, in
the case of high-risk animals, by movement to slaughter in accordance
with the provisions of part 79 of this chapter, or upon request in
individual cases by another means determined by the Administrator to be
sufficient to prevent the spread of scrapie;
(2) The premises of a flock under a flock plan must be cleaned and
disinfected in accordance with Sec. 54.7(e). Additional guidance on
acceptable means of cleaning and disinfection is also available in the
Scrapie Flock Certification Program standards and the Scrapie
Eradication Uniform Methods and Rules. Premises or portions of premises
may be exempted from the cleaning and disinfecting requirements if a
designated scrapie epidemiologist determines, based on epidemiologic
investigation, that cleaning and disinfection of such buildings,
holding facilities, conveyances, or other materials on the premises
will not significantly reduce the risk of the spread of scrapie, either
because effective disinfection is not possible or because the normal
operations on the premises prevent transmission of scrapie. No area
where a scrapie-positive animal lambed or aborted may be exempted;
(3) The owner of the flock, or his or her agent, must request breed
associations and registries, livestock markets, and packers to disclose
records to APHIS representatives or State representatives, to be used
to identify source flocks and trace exposed animals, including high-
risk animals; and
(4) The flock owner must agree to conduct post-exposure management
and monitoring.
(g) Requirements for post-exposure management and monitoring plans
only: The plan must require that a State or APHIS representative
inspect the flock and flock records at least once every 12 months. The
owner of the flock or his or her agent must maintain, and keep for a
minimum of 5 years after an animal dies or is otherwise removed from a
flock, the following records for each animal in the flock:
(1) Any identifying marks or tags present on the animal, including
the
[[Page 43989]]
animal's individual official identification number from its electronic
implant, flank tattoo, ear tattoo, tamper resistant ear tag, or, in the
case of goats, tail fold tattoo, and any secondary form of
identification the owner of the flock may choose to maintain;
(2) Sex, year of birth, breed, and when possible to determine, the
following: sire, dam, and offspring of the animal;
(3) Date of acquisition and previous flock, if the animal was not
born in the flock; and
(4) Disposition of the animal, including the date and cause of
death, if known, or date of removal from the flock and name and address
of the person to whom the animal was transferred.
(h) Modification of flock plans and post-exposure management and
monitoring plans. A designated scrapie epidemiologist may modify the
requirements of a flock plan or post-exposure management and monitoring
plan to accommodate the situation of a particular flock if the modified
plan requires:
(1) That a State or APHIS representative inspect the flock and
flock records at least once every 12 months;
(2) The testing of animals at a level that will result in 99
percent confidence of detecting a 1 percent prevalence in the flock
(for flock plans only);
(3) The official identification of all animals upon leaving the
premises of the flock for purposes other than slaughter and of all
animals over 18 months of age (as evidenced by the eruption of the
second incisor) in slaughter channels; and
(4) Recordkeeping including:
(i) For acquired animals, the date of acquisition, name and address
of the person from whom the animal was acquired, any identifying marks
or tags present on the animal including the animal's individual
official identification number from its electronic implant, flank
tattoo, ear tattoo, tamper resistant ear tag, or, in the case of goats,
tail fold tattoo, and any secondary form of identification the owner of
the flock may choose to maintain.
(ii) For animals leaving the premises of the flock, the disposition
of the animal, including, for those animals that are required to be
identified, any identifying marks or tags present on the animal,
including the animal's individual official identification number from
its electronic implant, flank tattoo, ear tattoo, tamper resistant ear
tag, or, in the case of goats, a tail fold tattoo, and any secondary
form of identification the owner of the flock may choose to maintain,
the date and cause of death, if known, or date of removal from the
flock and name and address of the person to whom the animal was
transferred.
(iii) Maintenance of these records for 5 years.
(5) Requirements equivalent to those contained in paragraphs (b),
(c), (d), and (e) of this section.
(i) Post-exposure management and monitoring plans for exposed
flocks that were not source flocks and in which a scrapie infected
animal did not lamb. A designated scrapie epidemiologist shall
determine the testing and monitoring requirements for these flocks
based on the exposure risk of the individual flock.
Sec. 54.9 Waiver of requirements for scrapie control pilot projects.
The Administrator may waive the following requirements of this part
for participants in a scrapie control pilot project by recording the
requirements waived in the scrapie control pilot project plan:
(a) The determination that an animal is a high-risk animal, if the
scrapie control pilot project plan contains testing or other procedures
that indicate that an animal, despite meeting the definition of high-
risk animal, is unlikely to spread scrapie; and
(b) The requirement that high-risk animals must be removed from a
flock if the scrapie control pilot project plan contains alternative
procedures to prevent the further spread of scrapie without removing
high-risk animals from the flock.
Sec. 54.10 Tests for scrapie.
(a) The Administrator may approve new tests for the diagnosis of
scrapie conducted on live or dead animals for use in the Scrapie
Eradication Program. The Administrator will base the approval or
disapproval of a test on the evaluation by APHIS and, when appropriate,
outside scientists, of:
(1) A standardized test protocol that must include a description of
the test, a description of the reagents, materials, and equipment used
for the test, the test methodology, and any control or quality
assurance procedures;
(2) Data to support reproducibility, that is, the ability to
reproduce the same result repeatedly on a given sample;
(3) Data to support suitability, that is, data to show that similar
results can be produced when the test is run at other laboratories;
(4) Data to support the sensitivity and specificity of the test;
and
(5) Any other data requested by the Administrator to determine the
suitability of the test for program use.
(b) To be approved, a scrapie test must be able to be replicated at
the National Veterinary Services Laboratories, or another reliable,
timely, and cost effective method of check testing must be available to
APHIS.
(c) A test or combination of tests may be approved for the
identification of suspect animals, for the identification of scrapie-
positive animals, or for other purposes such as flock certification.
For a test to be approved for the identification of scrapie-positive
animals, the test must have a specificity comparable to the specificity
of the currently approved tests. For a test to be approved as a live
animal screening test for the identification of suspect animals, the
test must be usually reliable but need not be definitive for diagnosing
scrapie.
(d) Specific guidelines for use of approved scrapie tests within
the Scrapie Eradication Program or Scrapie Flock Certification Program
will be added to this part as tests are approved and will also be
contained in the Scrapie Eradication UM&R and the Scrapie Flock
Certification Program standards based on the characteristics of the
test, including specificity, sensitivity, and predictive value.
(e) If an owner elects to have an unofficial test conducted on an
animal for scrapie, or for the proteinase resistant protein associated
with scrapie, and that animal tests positive to such a test, the animal
will be designated a suspect animal, unless:
(1) The test was run as part of a bona fide research protocol
designed to evaluate an unapproved test in which the owner is not
informed of the test result; or
(2) The test protocol includes appropriate measures to prevent the
spread of scrapie.
Sec. 54.11 Approval of laboratories to run official scrapie tests and
official genotype tests.
(a) State, Federal, and university laboratories, or in the case of
genotype tests, private laboratories will be approved by the
Administrator when he or she determines that the laboratory:
(1) Employs personnel assigned to supervise the testing who are
qualified to conduct the test based on education, training, and
experience and who have been trained by the National Veterinary
Services Laboratories (NVSL) or who have completed equivalent training
approved by NVSL;
(2) Has adequate facilities and equipment to conduct the test;
[[Page 43990]]
(3) Follows standard test protocols;
(4) Meets check test proficiency requirements;
(5) Meets recordkeeping requirements;
(6) Will retain records, slides, blocks, and other specimens from
all cases for at least 1 year and from positive cases for 5 years;
(7) Will allow APHIS to inspect the laboratory without notice
during normal business hours; and
(8) Will report all test results to State and Federal animal health
officials within agreed timeframes. An inspection may include, but is
not limited to, review and copying of records, examination of slides,
observation of the test being conducted, and interviewing of personnel.
(b) A laboratory may request approval to conduct one or more types
of scrapie test or genotype test on one or more types of tissue. To be
approved, a laboratory must meet the requirements in paragraph (a) of
this section for each type of test and for each type of tissue for
which they request approval.
(c) The Administrator may withdraw approval of any laboratory for
failure to meet any of the conditions required by paragraph (a) of this
section. The Administrator shall give written notice of the proposed
withdrawal to the director of the laboratory and shall give the
director an opportunity to respond. If there are conflicts as to any
material fact concerning the reason for withdrawal, a hearing will be
held to resolve the conflicts.
Subpart B--Scrapie Flock Certification Program
Sec. 54.20 Administration.
The Scrapie Flock Certification Program is a cooperative effort
between APHIS; members of the sheep and goat industry, including owners
of flocks, slaughtering and rendering establishments, and breed
associations and registries; accredited veterinarians; and State
governments. APHIS coordinates with State scrapie certification boards
and State animal health agencies to encourage flock owners to certify
their flocks as free of scrapie by being in continuous compliance with
the Scrapie Flock Certification Program standards.
Sec. 54.21 Participation.
Any owner of a sheep or goat flock may apply to enter the Scrapie
Flock Certification Program by sending a written request to a State
scrapie certification board or to the area veterinarian in charge. A
notice containing a current list of flocks participating in the Scrapie
Flock Certification Program, and the certification status of each
flock, may be obtained from the APHIS web site at URL http://
www.aphis.usda.gov/vs/scrapie. A list of noncompliant flocks may also
be obtained from this site, and either list may be obtained by writing
to the Animal and Plant Health Inspection Service, National Animal
Health Programs Staff, VS, APHIS, 4700 River Road Unit 43, Riverdale,
MD 20737-1235.
(Approved by the Office of Management and Budget under control number
0579-0101)
Sec. 54.22 State scrapie certification boards.
An area veterinarian in charge, after consulting with a State
representative and industry representatives, may appoint a State
scrapie certification board for the purpose of coordinating activities
for the Scrapie Flock Certification Program, including making decisions
to admit flocks to the Scrapie Flock Certification Program and to
change flock status in accordance with the Scrapie Flock Certification
Program standards. These boards are not appointed for the purpose of
providing APHIS with consensus advice or policy recommendations. No
more than one State scrapie certification board may be formed in each
State. Each State scrapie certification board shall include as members
the area veterinarian in charge, one or more State representatives, one
or more accredited veterinarians, when possible, and one or more owners
of flocks, and, at the discretion of the area veterinarian in charge,
may include other members.
* * * * *
2. Part 79 is revised to read as follows:
PART 79--SCRAPIE IN SHEEP AND GOATS
Sec.
79.1 Definitions.
79.2 Identification of sheep and goats in interstate commerce.
79.3 General restrictions.
79.4 Designation of scrapie-positive animals, high-risk animals,
exposed animals, suspect animals, exposed flocks, infected flocks,
noncompliant flocks, and source flocks; notice to owners.
79.5 Issuance of certificates.
79.6 Standards for States to qualify as Consistent States.
79.7 Waiver of requirements for scrapie control pilot projects.
Authority: 21 U.S.C. 111-113, 115, 117, 120, 121, 123-126, 134b,
and 134f; 7 CFR 2.22, 2.80, and 371.4.
Sec. 79.1 Definitions.
Accredited veterinarian. A veterinarian approved by the
Administrator in accordance with part 161 of this chapter to perform
functions specified in subchapters B, C, and D of this chapter.
Administrator. The Administrator of the Animal and Plant Health
Inspection Service or any employee of the United States Department of
Agriculture authorized to act for the Administrator.
Animal. A sheep or goat.
Animal and Plant Health Inspection Service (APHIS). The Animal and
Plant Health Inspection Service of the United States Department of
Agriculture.
APHIS representative. An individual employed by APHIS in animal
health activities who is authorized by the Administrator to perform the
function involved.
Approved laboratory. A laboratory approved by the Administrator in
accordance with Sec. 54.11 of this chapter to conduct one or more
scrapie tests, or genotype tests, on one or more tissues.
Area veterinarian in charge. The veterinary official of APHIS who
is assigned by the Administrator to supervise and perform the official
animal health work of APHIS in the State concerned.
Blackfaced sheep. Any purebred suffolk, hampshire, shropshire or
cross thereof, any non-purebred sheep known to have suffolk, hampshire,
or shropshire ancestors, and any non-purebred sheep of unknown ancestry
with a black face, except commercial hair sheep.
Breed association and registries. Organizations listed in
Sec. 151.9 of this chapter that maintain the permanent records of
ancestry or pedigrees of animals (including the animal's sire and dam),
individual identification of animals, and ownership of animals.
Certificate. An official document issued in accordance with
Sec. 79.5 by an APHIS representative, State representative, or
accredited veterinarian at the point of origin of an interstate
movement of animals.
Commercial hair sheep. Any commercial sheep with hair rather than
wool that is either a full-blooded hair sheep or that resulted from the
cross of a hair sheep with a whitefaced wool sheep.
Commercial sheep or goat. Any animal from a flock from which
animals are moved only either directly to slaughter or through
slaughter channels to slaughter or any animal that is raised only for
meat or fiber production and that is not registered with a sheep or
goat registry or used for exhibition.
Commingle, commingled, commingling. Animals grouped together and
having physical contact with each other, including contact through a
fence,
[[Page 43991]]
but not limited contacts. Commingling also includes sharing the same
section in a transportation unit where there is physical contact.
Consistent State. (1) A State that the Administrator has determined
conducts an active State scrapie control program that either:
(i) Meets the requirements of Sec. 79.6; or
(ii) Effectively enforces a State designed plan that the
Administrator determines is at least as effective in controlling
scrapie as the requirements of Sec. 79.6.
(2) The Administrator has determined the following States to be
Consistent States: Alabama, Alaska, Arizona, Arkansas, California,
Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho,
Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland,
Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana,
Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York,
North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania,
Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah,
Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.
Designated scrapie epidemiologist. An epidemiologist who has
demonstrated the knowledge and ability to perform the functions
required and who has been selected by the State animal health official
and the area veterinarian in charge. The regional epidemiologist and
the APHIS National Scrapie Program Coordinator must concur in the
selection and appointment of the designated scrapie epidemiologist. The
designated scrapie epidemiologist must satisfactorily complete training
designated by APHIS.
Direct movement to slaughter. Transported to a facility for
slaughter, without stops or unloading except for feeding and watering
during which the animals are not commingled with any other animals.
Electronic implant. Any radio frequency identification implant
device approved for use in the scrapie program by the Administrator.
The Administrator will approve an electronic implant after determining
that it is tamper resistant, not harmful to the animal, and readable by
equipment available to APHIS and State representatives.
Exposed animal. (1) Any animal that has been in the same flock at
the same time as a scrapie-positive female animal, excluding limited
contacts; or
(2) Any animal born in a flock after a scrapie-positive animal was
born into that flock or lambed in that flock, if born before that flock
completes the requirements of a flock plan; or
(3) Any animal that was commingled with a scrapie-positive female
animal during or up to 30 days after she lambed, kidded, or aborted, or
while a visible vaginal discharge was present, or that was commingled
with any other scrapie-positive female animal for 24 hours or more,
including during activities such as shows and sales or while in
marketing channels; or
(4) Any animal in a noncompliant flock.
Exposed flock. Any flock in which a scrapie-positive animal was
born or lambed. Any flock that currently contains a female high-risk,
exposed, or suspect animal, or that once contained a female high-risk,
exposed, or suspect animal that lambed in the flock and from which
tissues were not submitted for official testing and found negative. A
flock that has completed a post-exposure management and monitoring plan
following the exposure will no longer be an exposed flock.
Flock. All animals that are maintained on a single premises and all
animals under common ownership or supervision on two or more premises
with animal interchange between the premises. Changes in ownership of
part or all of a flock do not change the identity of the flock or the
regulatory requirements applicable to the flock. Animals maintained
temporarily on a premises for activities such as shows and sales or
while in marketing channels are not a flock. More than one flock may be
maintained on a single premises if:
(1) The flocks are enrolled as separate flocks in the SFCP; or
(2) A State or APHIS representative determines, based upon
examination of flock records, that:
(i) There is no interchange of animals between the flocks;
(ii) The flocks never commingle and are kept at least 30 feet apart
at all times or are separated by a solid wall through, over, or under
which fluids cannot pass and through which contact cannot occur;
(iii) The flocks have separate flock records and identification;
(iv) The flocks have separate lambing facilities, including
buildings and pastures, and a pasture or building used for lambing by
one flock is not used by the other flock at any time; and
(v) The flocks do not share equipment without cleaning and
disinfection in accordance with Sec. 54.7(e) of this chapter.
Additional guidance on acceptable means of cleaning and disinfection is
also available in the Scrapie Flock Certification Program standards and
the Scrapie Eradication Uniform Methods and Rules.
Flock of origin. The flock in which an animal most recently resided
in which it either was born, gave birth, or was used for breeding
purposes. The determination of an animal's flock of origin may be based
either on the physical presence of the animal in the flock, the
presence of official identification on the animal traceable to the
flock, the presence of other identification on the animal that is
listed on the bill of sale, or other evidence, such as registry
records.
Flock plan. A written flock management agreement signed by the
owner of a flock, the accredited veterinarian, if one is employed by
the owner, and a State or APHIS representative in which each
participant agrees to undertake actions specified in the flock plan to
control the spread of scrapie from, and eradicate scrapie in, an
infected flock or source flock or to reduce the risk of the occurrence
of scrapie in a flock that contains a high-risk or an exposed animal.
As part of a flock plan, the flock owner must provide the facilities
and personnel needed to carry out the requirements of the flock plan.
The flock plan must include the requirements in Sec. 54.8(a)(f) of this
chapter.
High-risk animal. A sexually intact animal, excluding male sheep
that have tested RR at codon 171 and AA at codon 136 using an official
genotype test, that is:
(1) The progeny of a scrapie-positive dam; or
(2) Born in the same flock during the same lambing season as
progeny of a scrapie-positive dam, unless the progeny of the scrapie-
positive dam are from separate contemporary lambing groups; or
(3) Born in the same flock during the same lambing season that a
scrapie-positive animal was born, or during any subsequent lambing
season, if born before that flock completes the requirements of a flock
plan; or
(4) An exposed female sheep that has not tested QR, HR, or RR at
codon 171 using an official genotype test.
Inconsistent State. Any State other than a Consistent State.
Infected flock. The flock of origin of a female animal that a State
or APHIS representative has determined to be a scrapie-positive animal;
or any flock in which a State or APHIS representative has determined
that a scrapie-positive female animal has resided unless an
epidemiologic investigation conducted by a State or APHIS
representative shows that the animal did not lamb or abort in the
flock. A flock will no longer
[[Page 43992]]
be considered an infected flock after it has completed the requirements
of a flock plan.
Interstate commerce. Trade, traffic, transportation, or other
commerce between a place in a State and any place outside of that
State, or between points within a State but through any place outside
that State.
Limited contacts. Incidental contacts between animals from
different flocks off the flock's premises such as at fairs, shows,
exhibitions and sales; between ewes being inseminated, flushed, or
implanted; or between rams at ram test or collection stations. Embryo
transfer and artificial insemination equipment and surgical tools must
be sterilized between animals for these contacts to be considered
limited contacts. Limited contacts do not include any contact,
incidental or otherwise, with animals in the same flock or with an
animal during or up to 30 days after she lambed, kidded or aborted or
when there is any visible vaginal discharge. Limited contacts do not
include any activity where uninhibited contact occurs, such as sharing
an enclosure, sharing a section of a transport vehicle, or residing in
other flocks for breeding or other purposes. Examples of limited
contacts may be found in the Scrapie Flock Certification Program
standards.
Live-animal screening test. Any test for the diagnosis of scrapie
in a live animal that is approved by the Administrator as usually
reliable but not definitive for diagnosing scrapie, and that is
conducted in a laboratory approved by the Administrator.\1\
---------------------------------------------------------------------------
\1\ The names and addresses of laboratories approved by the
Administrator to conduct live-animal screening tests will be
published in the Notices Section of the Federal Register. A list of
approved laboratories is also available upon request from the Animal
and Plant Health Inspection Service, Veterinary Services, National
Animal Health Programs Staff, 4700 River Road Unit 43, Riverdale, MD
20737-1235. State, Federal, and university laboratories will be
approved by the Administrator when he or she determines that the
laboratory: (a) Employs personnel trained by the National Veterinary
Services Laboratories assigned to supervise the testing; (b) follows
standard test protocols; (c) meets check test proficiency
requirements; and (d) will report all test results to State and
Federal animal health officials. Before the Administrator may
withdraw approval of any laboratory for failure to meet any of these
conditions, the Administrator will give written notice of the
proposed withdrawal to the director of the laboratory, and will give
the director an opportunity to respond. If there are conflicts as to
any material fact, a hearing will be held to resolve the conflicts.
---------------------------------------------------------------------------
Low-risk commercial sheep. Commercial whitefaced, whitefaced cross,
or commercial hair sheep from a flock with no known risk factors for
scrapie, including any exposure to female blackfaced sheep, that are
identified with a legible permanent brand or earnotch pattern
registered with an official brand registry and that are not scrapie-
positive, suspect, high-risk, or exposed animals and are not animals
from an infected, source, or exposed flock. The term brand includes
official brand registry brands on eartags in those States whose brand
law or regulation recognizes brands placed on eartags as official
brands. Low-risk commercial sheep may only exist in a State where
scrapie has not been diagnosed in the previous 10 years in commercial
whitefaced, whitefaced cross, or commercial hair sheep that were not
commingled with female blackfaced sheep.
Low-risk goat. A goat that is not a scrapie-positive, suspect,
high-risk, or exposed animal, that has not been commingled with sheep,
and that is from:
(1) A State in which scrapie has not been identified in a goat
during the previous 10 years;
(2) A State in which scrapie has been identified in a goat during
the previous 10 years, but the scrapie-positive goat was not born in
the State and resided in the State for less than 54 months and did not
kid while in the State; or,
(3) A State in which scrapie has been identified in a goat during
the previous 10 years, and the scrapie-positive goat was commingled
with sheep, but flock records allowed a complete epidemiologic
investigation to be completed and all resulting infected, source, and
exposed goat herds have completed flock plans and are in compliance
with post-exposure monitoring plans.
National Scrapie Database. A database designated by the
Administrator in which APHIS and State animal health agencies
cooperatively enter data concerning scrapie outbreaks, flocks and
premises affected by scrapie, individual animal identification and
premises identification data, and other data to support the Scrapie
Eradication Program and the Scrapie Flock Certification Program.
Noncompliant flock. (1) Any source or infected flock whose owner
declines to enter into a flock plan or post-exposure management and
monitoring plan agreement within 30 days of being so designated, or
whose owner is not in compliance with either agreement;
(2) Any exposed flock whose owner fails to make animals available
for testing within 60 days of notification, or as mutually agreed, or
whose owner fails to submit required postmortem samples;
(3) Any flock whose owner has misrepresented, or who employs a
person who has misrepresented, the scrapie status of an animal or any
other information on a certificate, permit, owner statement, or other
official document within the last 5 years; or
(4) Any flock whose owner or manager has moved, or who employs a
person who has moved, an animal in violation of this chapter within the
last 5 years.
Official eartag. An identification eartag approved by APHIS as
being sufficiently tamper-resistant for the intended use and providing
unique identification for each animal. An official eartag may conform
to the alphanumeric National Uniform Eartagging system or another
system approved by APHIS, or it may bear a premises identification
number that either contains or is used in conjunction with the
producer's livestock production numbering system to provide a unique
identification number.
Official genotype test. Any test to determine the genotype of a
live or dead animal that is conducted at either an approved laboratory
or at the National Veterinary Services Laboratories, when the animal is
officially identified and the samples used for the test are collected
and shipped to the laboratory by either an accredited veterinarian or a
State or APHIS representative.
Official identification. Identification mark or device approved by
APHIS for use in the Scrapie Eradication Program. Examples are listed
in Sec. 79.2(a)(2).
Official test. Any test for the diagnosis of scrapie in a live or
dead animal that is approved by the Administrator for that use and
conducted either at an approved laboratory or at the National
Veterinary Services Laboratories.
Owner. A person, partnership, company, corporation, or any other
legal entity who has legal or rightful title to animals, whether or not
they are subject to a mortgage.
Owner statement. A written statement by the owner that includes the
owner's name, signature, address, and phone number, date the animals
left the flock of origin, the premises identification number assigned
to the premises, the number of animals, the premises portion of the
premises identification if premises identification is used, and a
statement that the animals were either born or were used for breeding
purposes on the premises to which the premises identification is
assigned.
Ownership brand. A unique permanent legible brand or earnotch
pattern applied to an animal that indicates ownership by a particular
person when the brand pattern is registered with a State's official
brand recording agency.
[[Page 43993]]
Permit. An official document issued in connection with the
interstate movement of animals (VS Form 1-27 or a State form that
contains the same information) that is issued by an APHIS
representative, State representative, or an accredited veterinarian
authorized to sign such permits. A new permit is required for each
change in destination for an animal. A permit lists the owner's name
and address; points of origin and destination; number of animals
covered; purpose of the movement; whether the animals are from an
exposed, noncompliant, infected, or source flock; whether the animal is
a high-risk, exposed, scrapie-positive, or scrapie suspect animal;
transportation vehicle license number or other identification number;
and seal number (if a seal is required). A permit also lists all
official identification on the animals covered, including the official
eartag number, individual animal registered breed association
registration tattoo, individual animal registered breed association
registration brand, United States Department of Agriculture backtag
(when applied serially, only the beginning and the ending numbers need
be recorded), individual animal registered breed association
registration number, or any other form of official identification
present on the animal.
Premises identification. An APHIS approved eartag, backtag, or
legible tattoo bearing the premises identification number, consisting
of the State postal abbreviation or code followed by a unique
alphanumeric number or name, assigned by a State or Federal animal
health official to the premises of the flock of origin for the sheep or
goats that, in the judgment of the State animal health official or area
veterinarian in charge, is epidemiologically distinct from other
premises, or a legible permanent brand or ear notch pattern registered
with an official brand registry. Premises identification may be used
when official individual animal identification is required, if the
premises identification method either includes a unique animal number
or is used in conjunction with the producer's livestock production
numbering system to provide a unique identification number and where,
if brands or ear notches are used, the animals are accompanied by an
official brand inspection certificate. Clearly visible and/or legible
paint brands may be used on animals moving directly to slaughter and on
animals moving for grazing or other management purposes without change
in ownership.
Scrapie Eradication Program. The cooperative State-Federal program
administered by APHIS and Consistent States to control and eradicate
scrapie.
Scrapie Eradication Uniform Methods and Rules (UM&R). Cooperative
procedures and standards adopted by APHIS and Consistent States for
controlling and eradicating scrapie. The UM&R will be reviewed at least
annually by representatives of the livestock industry, appropriate
State and Federal agencies, and the public and will be drafted,
revised, and published as needed by APHIS.
Scrapie Flock Certification Program (SFCP). The cooperative
Federal-State-industry voluntary program for the control of scrapie
conducted in accordance with subpart B of part 54 of this chapter.
Scrapie Flock Certification Program standards. Cooperative
procedures and standards adopted by APHIS and State Scrapie
Certification Boards for reducing the incidence and controlling the
spread of scrapie through flock certification.\2\
---------------------------------------------------------------------------
\2\ Individual copies of the SFCP standards may be obtained on
the World Wide Web at URL http://www.aphis.usda.gov/vs, or from the
Animal and Plant Health Inspection Service, National Animal Health
Programs Staff, 4700 River Road Unit 43, Riverdale, MD 20737-1235.
---------------------------------------------------------------------------
Scrapie-positive animal. An animal for which a diagnosis of scrapie
has been made by the National Veterinary Services Laboratories or
another laboratory authorized by the Administrator to conduct scrapie
tests in accordance with this chapter, through:
(1) Histopathological examination of central nervous system (CNS)
tissues from the animal for characteristic microscopic lesions of
scrapie;
(2) The use of proteinase-resistant protein analysis methods
including but not limited to immunohistochemistry and/or western
blotting on CNS and/or peripheral tissue samples from a live or a dead
animal for which a given method has been approved by the Administrator
for use on that tissue;
(3) Bioassay;
(4) Scrapie associated fibrils (SAF) detected by electron
microscopy; or
(5) Any other test method approved by the Administrator in
accordance with Sec. 54.10 of this chapter.\3\
---------------------------------------------------------------------------
\3\ The names and addresses of laboratories approved by the
Administrator to conduct tests are published in the Notices Section
of the Federal Register. A list of approved laboratories is also
available upon request from the Animal and Plant Health Inspection
Service, Veterinary Services, National Animal Health Programs Staff,
4700 River Road Unit 43, Riverdale, MD 20737-1235. State, Federal,
and university laboratories will be approved by the Administrator
when he or she determines that the laboratory: (a) Employs personnel
trained by the National Veterinary Services Laboratories assigned to
supervise the testing; (b) follows standard test protocols; (c)
meets check test proficiency requirements; and (d) will report all
test results to State and Federal animal health officials. Before
the Administrator may withdraw approval of any laboratory for
failure to meet any of these conditions, the Administrator must give
written notice of the proposed withdrawal to the director of the
laboratory and must give the director an opportunity to respond. If
there are conflicts as to any material fact, a hearing will be held
to resolve the conflict.
---------------------------------------------------------------------------
Separate contemporary lambing groups. To be a separate contemporary
lambing group, the group must be maintained separately such that the
animals cannot come into physical contact with other lambs, kids, ewes
or does or birth fluids or placenta from other ewes or does. This
separate maintenance must preclude contact through a fence, during
lambing and for 60 days following the date the last lamb or kid is born
in a lambing season, and must preclude using the same lambing facility
as other ewes or does, unless the lambing facility is cleaned and
disinfected under supervision by an APHIS representative, State
representative, or an accredited veterinarian between lambings in
accordance with Sec. 54.7(e) of this chapter. Additional guidance on
acceptable means of cleaning and disinfection is also available in the
Scrapie Flock Certification Program standards and the Scrapie
Eradication Uniform Methods and Rules. The flock owner must maintain
adequate records to document which animals were maintained in each
contemporary lambing group and to document when cleaning and
disinfection was performed and who supervised it.
Slaughter channels. Animals in slaughter channels include any
animal that is sold, transferred, or moved either directly to a
slaughter facility, to an individual for custom slaughter, or for
feeding for the express purpose of improving the animals' condition for
movement to slaughter. Any sexually intact animal that is commingled
with breeding animals or that has been bred is not in slaughter
channels. When selling animals for slaughter, owners should note on the
bill of sale that the animals are sold only for slaughter.
Source flock. A flock in which a State or APHIS representative has
determined that at least one animal was born that was diagnosed as a
scrapie-positive animal at an age of 72 months or less. The
determination that an animal was born in a flock will be based on such
information as the presence of official identification on the animal
traceable to the flock, the presence of other identification on the
animal that is listed on the bill of sale, or other evidence, such as
registry records, to
[[Page 43994]]
show that a scrapie-positive animal was born in the flock, combined
with the absence of records indicating that the animal was purchased
from outside and added to the flock. If DNA from the animal was
previously collected by an accredited veterinarian and stored at an
approved genotyping laboratory, or if DNA collection and storage are
required for breed registration and the breed registration has
appropriate safeguards in place to ensure the integrity of the banking
process, the owner may request verification of the animal's identity
based on DNA comparison if adequate records and identification have
been maintained by the owner and the repository to show that the
archived DNA is that of the animal that has been traced to the flock.
The owner will be responsible for all costs for the DNA comparison. A
flock will no longer be a source flock after it has completed the
requirements of a flock plan.
State. Each of the 50 States, the District of Columbia, the
Northern Mariana Islands, Puerto Rico, and all territories or
possessions of the United States.
State representative. An individual employed in animal health
activities by a State or a political subdivision of a State and who is
authorized by the State or political subdivision to perform the
function involved.
Suspect animal. An animal will be designated a suspect animal in
accordance with Sec. 79.4 if it is:
(1) A sheep or goat that exhibits any of the following possible
signs of scrapie and that has been determined to be suspicious for
scrapie by an accredited veterinarian or a State or APHIS
representative: Weight loss despite retention of appetite; behavioral
abnormalities; pruritus (itching); wool pulling; biting at legs or
side; lip smacking; motor abnormalities such as incoordination, high
stepping gait of forelimbs, bunny hop movement of rear legs, or swaying
of back end; increased sensitivity to noise and sudden movement;
tremor, ``star gazing,'' head pressing, recumbency, or other signs of
neurological disease or chronic wasting.
(2) A sheep or goat that has tested positive for scrapie or for the
proteinase resistant protein associated with scrapie on a live-animal
screening test or any other test, unless the animal is designated a
scrapie-positive animal.
(3) A sheep or goat that has tested inconclusive or suggestive on
an official test for scrapie.
Terminal feedlot. (1) A dry lot approved by a State or APHIS
representative or an accredited veterinarian authorized to perform this
function where animals are separated from all other animals by at least
30 feet at all times or are separated by a solid wall through, over, or
under which fluids cannot pass and contact cannot occur and from which
animals are moved only to another terminal feedlot or directly to
slaughter; or
(2) A pasture when approved by and maintained under the supervision
of the State and in which only nonpregnant animals are permitted, where
there is no direct fence-to-fence contact with another flock, and from
which animals are moved only to another terminal feedlot or directly to
slaughter.
(3) Records of all animals entering and leaving a terminal feedlot
must be maintained for 1 year after the animal leaves the feedlot and
must include the person from whom the animals were acquired and the
slaughtering facility in which they were slaughtered. Records must be
made available for inspection by an APHIS or State representative upon
request.
Unofficial test. Any test for the diagnosis of scrapie or for the
detection of the proteinase resistant protein associated with scrapie
in a live or dead animal that either has not been approved by the
Administrator or that was not conducted at an approved laboratory or at
the National Veterinary Services Laboratories.
Sec. 79.2 Identification of sheep and goats in interstate commerce.
(a) No sheep or goat that is required to be individually identified
or premises identified by Sec. 79.3 may be sold, transported, received
for transportation, or offered for sale or transportation in interstate
commerce unless each sheep or goat is identified in accordance with
this section.
(1) The sheep or goat must be identified to its flock of origin
and, for an animal born after January 1, 2002, to its flock of birth,
by the owner of the flock or his or her agent; at whichever of the
following points in commerce comes first, Except that; animals born
after January 1, 2002, may be moved interstate direct to slaughter
without identification to flock of birth until June 1, 2003, and
animals that cannot be identified to their flock of origin because
Consistent States have exempted them from flock of origin
identification in intrastate commerce in accordance with
Sec. 79.6(a)(10)(i) may be moved interstate with only individual animal
identification traceable to the State of origin and to the owner of the
animals at the time they were so identified:
(i) The point of first commingling of the sheep or goats in
interstate commerce with sheep or goats from any other flock of origin;
(ii) Upon unloading of the sheep or goats in interstate commerce at
any livestock market, except a market described in paragraph
(a)(1)(iii) of this section;
(iii) Upon leaving a livestock market that has been approved in
accordance with this chapter to handle sheep and goats in interstate
commerce and that has agreed to act as an agent for the owner to apply
official identification to the animals. In such cases the animals must
be:
(A) Moved to the market and maintained until officially identified
in distinguishable groups identifiable to their flocks of origin and
when required their flock of birth by means of partitions or other such
maintenance; and,
(B) Accompanied by an owner statement that contains the information
needed to officially identify the animals to their flock of origin and,
when required, their flock of birth;
(iv) Upon transfer of ownership of the sheep or goats in interstate
commerce;
(v) In the case of animals shipped directly to slaughter at a
slaughter plant that has agreed to act as an agent for the owner to
apply official identification to the animals, upon arrival of the sheep
or goats in interstate commerce at the slaughter plant. In such cases
the animals must be:
(A) Moved to the slaughter plant and maintained until officially
identified in distinguishable groups identifiable to their flocks of
origin and when required their flock of birth by means of partitions or
other such maintenance; and,
(B) Accompanied by an owner statement that contains the information
needed to officially identify the animals to their flock of origin and,
when required, their flock of birth. If the slaughter plant has agreed
to allow APHIS to conduct slaughter sampling, animals need not be
identified if they arrive at the plant on days that an APHIS designated
sampler is not available at the plant to collect samples; or
(vi) Prior to moving a sheep or goat across a State line, unless
the animals are moving to an approved livestock market in accordance
with paragraph (a)(1)(iii) of this section or to an approved slaughter
plant in accordance with paragraph (a)(1)(v) of this section.
(2) The sheep or goats must be identified by one of the following
means of identification, and must remain so identified until they reach
their final destination:
[[Page 43995]]
(i) Electronic implants for animals required to be identified by
the SFCP, when used in a flock participating in the SFCP and when
accompanied by a certificate or owner statement that includes the
electronic implant numbers and the name of the chip manufacturer;
(ii) Official eartags, including tags approved for use in the SFCP
or APHIS-approved premises identification number eartags when combined
with a unique animal identification number;
(iii) United States Department of Agriculture backtags or official
premises identification backtags that include a unique animal
identification number, when used on sheep or goats moving directly to
slaughter and when applied within 3 inches of the poll on the dorsal
surface of the head or neck;
(iv) Legible official registry tattoos that have been recorded in
the book of record of a sheep or goat registry association when the
animal is accompanied by either a registration certificate or a
certificate of veterinary inspection. These tattoos may also be used as
premises identification if they contain a unique premises prefix that
has been linked in the National Scrapie Database with the assigned
premises identification number of the flock of origin;
(v) Premises identification eartags or tattoos, if the premises
identification method includes a unique animal number or is combined
with a flock eartag that has a unique animal number and the animal is
accompanied by an owner statement; or
(vi) Premises identification when premises identification is
allowed by Sec. 79.3 and the animal is accompanied by an owner
statement.
(3) The owner of the flock of origin is responsible for the
identification of animals required to be identified by this section. No
person who buys or sells, for his or her own account or as the agent of
the buyer or seller, transports, receives for transportation, offers
for sale or transportation, or otherwise handles sheep or goats in
interstate commerce shall receive or otherwise handle any animal in
interstate commerce that has not been identified as required by this
section. If an animal loses its identification to its flock of origin
while in interstate commerce it is the responsibility of the person who
has control or possession of the animal to identify the animal prior to
commingling it with any other animals. This shall be done by applying
individual animal identification to the animal as required in paragraph
(a)(2) of this section and recording the means of identification and
the corresponding animal identification number. If the flock of origin
cannot be determined, all possible flocks of origin shall be listed on
the record.
(b) Serial numbers for use in official identification will be
assigned to each person who applies to the State animal health official
or the area veterinarian in charge for the State in which that person
maintains his or her place of business. Serial numbers of official
eartags will be assigned to each accredited veterinarian or State or
APHIS representative who requests official eartags from the State
animal health official or the area veterinarian in charge, whoever is
responsible for issuing official eartags in that State. The official
responsible for issuing eartags in a State may assign serial numbers of
official eartags to other responsible persons, such as 4-H leaders, if
the State animal health official and the area veterinarian in charge
agree that such assignments will improve scrapie control and
eradication within the State. Persons assigned serial numbers may
either directly apply eartags to animals, or may reassign eartag
numbers to producers. If these persons reassign eartag numbers, they
must maintain appropriate records that permit traceback of animals to
their flock of origin, or flock of birth when required. Premises
identification eartag, backtag, and tattoo numbers (series of
alphanumeric USDA tags and backtags may be assigned as premises
identification if they are linked to the premises in the National
Scrapie Database) will be assigned to animal owners by the State animal
health official or the area veterinarian in charge, whoever is
responsible for assigning premises codes in that State. Persons
assigned serial numbers of United States Department of Agriculture
backtags, official sheep and goat tattoos, official eartags, and
premises identification numbers must:
(1) If the person assigned the numbers is a flock owner, so that
the assigned numbers are directly linked to the flock of origin in the
national scrapie database, record the following information on a
document:
(i) The premises identification number or serial numbers;
(ii) The number of animals so identified;
(iii) The date the animals were identified;
(iv) For animals born after January 1, 2002, that were not born in
the flock of origin and that are not identified to the previous flock
of origin, the individual identification number applied and the name,
street address, including the city and State, or the township, county,
and State, and the telephone number, if the telephone number is
available, of the flock of birth if known.
(2) If the person assigned the numbers is a veterinarian, extension
agent, auction market operator, dealer, or any person other than the
owner of the flock of origin, record the following information on a
document:
(i) All serial numbers applied to a sheep or goat;
(ii) Any other serial numbers and approved identification appearing
on the sheep or goat;
(iii) The street address, including the city and State, or the
township, county, and State, of the premises where the approved means
of identification was applied;
(iv) The date the identification was applied;
(v) The name, street address, including the city and State, or the
township, county, and State, and the telephone number if the telephone
number is available, of the owner of the flock of origin and, if
different, the person who owns or possesses the sheep or goat, and
(vi) For animals born after January 1, 2002, that were not born in
the flock of origin and that are not identified to the previous flock
of origin, the individual identification number applied and the name,
street address, including the city and State, or the township, county,
and State, and the telephone number if the telephone number is
available, of the flock of birth if known.
(vii) The serial numbers, the manufacturer, and the type and color
of all official tags received. Usually maintaining the tag invoice will
meet this requirement.
(3) Maintain these records for 5 years; and
(4) Make these records available for inspection and copying during
ordinary business hours (8 a.m. to 5:30 p.m., Monday through Friday)
upon request by any authorized employee of the United States Department
of Agriculture or the State, and presentation of his or her official
credentials.
(5) Any person who fails to comply with these requirements shall
not be assigned serial numbers of United States Department of
Agriculture backtags, official sheep and goat tattoos, official
eartags, or premises identification numbers. If a person who is not in
compliance with these requirements has already been assigned such
serial numbers, the Administrator may withdraw the assignment by giving
notice to such person. After such notice the person shall be subject to
criminal and civil penalties if he continues to use those assigned
serial numbers.
[[Page 43996]]
(c) No person shall apply a premises identification number or a
brand or earnotch pattern to an animal that did not originate on the
premises to which the number was assigned by a State or APHIS
representative or to which the brand or earnotch pattern has been
assigned by an official brand registry. This includes individual
identification such as USDA tags and backtags that have been assigned
to a premises for use as premises identification and registration
tattoos that contain prefixes that have been assigned to a premises for
use as premises identification. This does not preclude the owner of a
flock from using a premises identification number tag assigned to that
flock on an animal owned by him that resides in that flock but that was
born or previously resided on a different premises as long as the
records required in paragraph (b)(1)(iv) of this section are
maintained.
(d) Each person who buys or sells, for his or her own account or as
the agent of the buyer or seller, transports, receives for
transportation, offers for sale or transportation, or otherwise handles
sheep or goats in interstate commerce must ensure that the animals are
identified as required in this part and must keep records relating to
the transfer of ownership, shipment, or handling of the sheep or goats,
such as yarding receipts, sale tickets, invoices, and waybills.
(1) If official individual animal identification is required, the
records must include the number of sheep and/or goats; the breed or
cross if known; the name, street address, including city and State, or
the township, county, and State, and the telephone number if the
telephone number is available, of the owner of the flock of origin and,
if different, the person from whom the sheep or goats were purchased or
otherwise obtained; and a copy of any documents required to accompany
the animal including any certificate, owner statement, letter, or
permit; and
(i) For animals not in slaughter channels the records must include
all serial numbers and other approved means of identification appearing
on the sheep or goat. This requirement may usually be met by
maintaining a copy of the certificate that accompanied the animals. The
premises number may be recorded instead of the individual numbers in
the case of animals identified with premises identification if:
(A) The premises identification meets the requirements of paragraph
(a)(2)(v) of this section for individual animal identification; or
(B) The animals are allowed to move interstate with only premises
identification in accordance with Sec. 79.3.
(ii) For animals in slaughter channels that are identified with
individual animal identification traceable to the flock of origin or
that are identified to the flock of origin with official premises
identification that meets the requirements for individual animal
identification, no additional records are required;
(iii) For animals in slaughter channels that are identified with
individual animal identification traceable to a previous flock but not
to the flock of origin, or that are identified with official premises
identification that meets the requirements for individual animal
identification that is traceable to a previous flock but not to the
flock of origin, the records must include all serial numbers and other
approved means of identification appearing on the sheep or goat;
(iv) For animals that are not required to be identified until they
reach their final destination, the records must include the final
destination.
(2) If official premises identification is required or allowed, the
records must include:
(i) The premises identification number(s) and the number of animals
identified with each premises number;
(ii) Copies of any required documents such as the brand inspection
certificate, an owner's statement, an accredited veterinarian's
statement, or a health certificate;
(iii) The name, street address, including city and State, or the
township, county, and State, and the telephone number if the telephone
number is available, of the owner of the flock of origin and, if
different, the person from whom the sheep or goats were purchased or
otherwise obtained.
(3) Each person required to keep records under this paragraph must
maintain the records for at least 5 years after the person has sold or
otherwise disposed of the sheep or goat to another person, and for such
further period as the Administrator may require by written notice to
the person, for purposes of any investigation or action involving the
sheep or goat identified in the records. The person must make the
records available for inspection and copying during ordinary business
hours (8 a.m. to 5:30 p.m., Monday through Friday) by any authorized
employee of the United States Department of Agriculture or the State,
upon that employee's request and presentation of his or her official
credentials.
(e) No person may remove or tamper with any means of identification
required to be on sheep or goats pursuant to this section while the
animals are in interstate commerce, and, at the time of slaughter,
animal identification must be maintained throughout postmortem
inspection in accordance with regulations of the Food Safety and
Inspection Service, U.S. Department of Agriculture, in chapter III of
this title.
(f) Requirements for approval of official premises and individual
identification tags. (1) The Administrator may approve tag companies to
produce official premises and/or individual identification tags for use
on sheep or goats. Tags may be plastic or metal and must be an
appropriate size for use in sheep and goats. Tags must be able to
legibly accommodate the required alphanumeric sequences. Tags must
resist removal and be difficult to place on another animal once
removed, but need not be tamper-proof. Tags must be readily
distinguishable as USDA official sheep and goat tags, must carry the
alphanumeric sequences, symbols, or logos specified by APHIS, and must
have a means of discouraging counterfeiting, such as use of a unique
copywrited logo or trade mark. Tags for use only on animals in
slaughter channels must be marked with the words ``Meat'' or ``For
Slaughter Only,'' or else must be used in conjunction with an ear
tattoo of the word ``Meat.''
(2) Written requests for approval of official premises
identification tags for sheep and goats should be sent to the Animal
and Plant Health Inspection Service, Veterinary Services, National
Animal Health Programs Staff, Attention: National Scrapie Program
Coordinator, 4700 River Road Unit 43, Riverdale, MD 20737-1235. The
request must include:
(i) Data supporting the durability of the tag and durability and
legibility of the identification numbers and high retention rates of
the tags in animals, preferably sheep and/or goats. Preference will be
given to tags with high legibility and retention rates in sheep and
goats that minimize injury to the ear.
(ii) A signed statement agreeing to:
(A) Send official eartags only to a State or APHIS representative,
to a flock owner at the address to which the premises number or tag
sequence was assigned by a State or APHIS representative, or as
directed by APHIS;
(B) Provide a monthly report by State of all tags produced,
including the tag sequences produced and the person's and address to
which the tags were shipped; and
[[Page 43997]]
(C) When required by APHIS, enter the sequences of tags shipped
into the National Scrapie Database through a web page interface or
other means specified by APHIS.
(iii) Twenty-five sample tags. Additional tags must be submitted if
requested by APHIS.
(3) Approval to produce official premises and/or individual
identification tags will be valid for 1 year and must be renewed
annually. The Administrator may also grant approval to produce tags for
periods of less than 1 year in cases where all of the submissions
required by this section have not been received or evaluated but there
is substantial evidence that the tags meet the requirements of this
section. The Administrator may decline to renew a company's approval if
the tags do not show adequate retention and durability in field use or
if any of the requirements of this section are not met by the tag
company. If a company's tags do not show adequate retention and
durability in field use or if any of the requirements of this section
are not met by the tag company, the approval may be withdrawn with 60
days written notice. Any person who is approved to produce official
premises or individual identification tags in accordance with this
section and who knowingly produces tags that are not in compliance with
the requirements of this section, and any person who is not approved to
produce such tags but does so, shall be subject to such civil penalties
and such criminal liabilities as are provided by 18 U.S.C. 1001, 21
U.S.C. 122 and 134e, or other applicable Federal statutes. Such action
may be in addition to, or in lieu of, withdrawal of approval to produce
tags.
(g) New types of identification. Written requests for approval of
sheep or goat identification devices and markings not listed in
paragraph (a)(2) of this section should be sent to the Animal and Plant
Health Inspection Service, Veterinary Services, National Animal Health
Programs Staff, 4700 River Road Unit 43, Riverdale, MD 20737-1235. If
the Administrator determines that the devices and markings will provide
a means of tracing sheep and goats in interstate commerce, a proposal
will be published in the Federal Register to add the devices and
markings to the list of approved means of sheep and goat
identification.
Sec. 79.3 General restrictions.
The following prohibitions and movement conditions apply to the
interstate movement of sheep and goats, and no sheep or goat may move
interstate except in compliance with them.
Interstate Movement General Restrictions for Sheep and Goats
Note: A CONSISTENT STATE is one whose intrastate identification,
reporting, and movement restrictions for infected and source flocks and
high-risk animals are consistent with the APHIS standards for State
scrapie programs.
------------------------------------------------------------------------
Moved from Moved from
Type of interstate movement INCONSISTENT state CONSISTENT state
------------------------------------------------------------------------
(a) Sale or other movement
of breeding animals, show
animals or any other animal
not specifically addressed
in this chart. General
Condition: No animal may be
removed from slaughter
channels in interstate
commerce if it was sold at
a slaughter-only auction,
is identified with a tag or
ear tattoo marked ``meat''
or ``slaughter only,'' or
was sold with a bill of
sale marked for slaughter
only, and other animals may
be removed from slaughter
channels in interstate
commerce only if they are
identified to their flock
of birth.--
(1) High-risk, scrapie- Prohibited \1\...... Prohibited \1\
positive, or suspect
animals, or animals
from a noncompliant
flock.
(2) Non-high-risk Prohibited \1\...... Prohibited,\1\
animals from an except as allowed
infected or source in an approved
flock that are not scrapie control
scrapie-positive or pilot project flock
suspect animals. plan and must meet
the requirements
for exposed
animals.
(3) Sexually intact Flock must be Official individual
exposed animals that enrolled in the animal
are not scrapie- Complete Monitored identification and
positive, suspect, or category of the a permit.\2\ For
high-risk animals and Scrapie Flock any female exposed
are not animals from an Certification sheep the results
infected or source Program or of an official
flock. equivalent APHIS genotype test must
recognized program, be included on or
have official attached to the
individual animal permit and must be
identification, and QR or RR at codon
a permit.\2\ For 171. For any female
any female exposed animal moving for
sheep the results exhibition, the
of an official permit must include
genotype test must a statement by both
be included on or the owner and an
attached to the accredited
permit and must be veterinarian that
QR or RR at codon the animal has not
171. For any female lambed or aborted
animal moving for within 30 days of
exhibition, the being exhibited and
permit must include is not due to lamb
a statement by both within 30 days of
the owner and the being exhibited and
accredited that there is no
veterinarian that visible vaginal
the animal has not discharge. For any
lambed or aborted animal born after 1-
within 30 days of 1-2002, the permit
being exhibited and must include the
is not due to lamb flock of birth and
within 30 days of the flock of
being exhibited and origin, if
that there is no different.
visible vaginal
discharge. For any
animal born after 1-
1-2002, the
certificate must
include the flock
of birth and the
flock of origin, if
different.
[[Page 43998]]
(4) (i) Sexually intact Flock must be Official individual
sheep except as allowed enrolled in the animal
in (a)(7). (ii) Complete Monitored identification and
Sexually intact goats, category of the a certificate. For
except for low-risk Scrapie Flock any animal born
goats. Certification after 1-1-2002, the
Program or certificate must
equivalent APHIS- include the flock
recognized program, of birth and the
have official flock of origin, if
individual animal different.
identification, and
a certificate. For
any animal born
after 1-1-2002, the
certificate must
include the flock
of birth and the
flock of origin, if
different.
(5) Sexually intact low- Official individual Official individual
risk goats. animal animal
identification and identification and
a certificate. For a certificate. For
any animal born any animal born
after 1-1-2002, the after 1-1-2002, the
certificate must certificate must
include the flock include the flock
of birth and the of birth and the
flock of origin, if flock of origin, if
different. different.
(6) Castrated animals Official individual None, except for
that are not scrapie- animal exposed animals
positive or suspect identification and that must have
animals. a certificate. official individual
animal
identification.
(7) Low-risk commercial Official individual (i) Official
sheep. animal premises
identification and identification that
a certificate, and is a permanent
the flock must be brand or ear notch
enrolled in the pattern registered
Complete Monitored with an official
category of the brand registry;
Scrapie Flock (ii) A brand
Certification inspection
Program or an certificate;
equivalent APHIS- (iii) An owner
recognized program. statement dated
For any animal born within 30 days
after 1-1-2002, the stating that the
certificate must animals were born
include the flock in the flock, that
of birth and the the flock does not
flock of origin, if contain any animal
different. exhibiting signs of
scrapie, that to
the best of his or
her knowledge the
flock has no risk
factors for or
exposure to
scrapie, and that
the flock has never
contained: (A) Any
animal diagnosed as
having scrapie; (B)
any female
blackfaced sheep;
or (C) any female
blackfaced cross
sheep that were not
born in the flock;
and
(iv) An accredited
veterinarian's
statement issued
within 12 months of
the date of
movement indicating
that, to the best
of his or her
knowledge, the
flock has no known
risk factors for or
exposure to
scrapie, and that
he or she has
inspected the flock
and it does not
contain: (A) Any
animal exhibiting
signs of scrapie;
(B) any female
blackfaced sheep;
or (C) any female
blackfaced cross
sheep that were not
born in the flock.
The statements must
include the owner's
name, address, and
the premises
identification
number and a
drawing of the
owner's registered
brand or ear notch
pattern.
(8) Commercial low-risk Official individual None.
goats.. animal
identification and
a certificate. For
any animal born
after 1-1-2002, the
certificate must
include the flock
of birth and the
flock of origin, if
different.
(b) Sale or other movement
directly to slaughter,
through slaughter channels
to slaughter, or to
feedlots for later movement
to slaughter of animals
that are under 18 months of
age as evidenced by
eruption of the second
incisor, not pregnant, and
have not lambed or kidded.
General Condition: No
animal may be removed from
slaughter channels in
interstate slaughter
channels in interstate
commerce if it was sold at
a slaughter-only auction,
is identified with a tag or
ear tattoo marked ``meat''
or ``slaughter only,'' or
was sold with a bill of
sale marked for slaughter
only, and other animals may
be removed from slaughter
channels in interstate
commerce only if they are
identified to their flock
of birth.--
(1) Scrapie-positive or Prohibited \1\...... Prohibited.\1\
suspect animal.
[[Page 43999]]
(2) Sexually intact high- Official individual Official individual
risk animals and animal animal
sexually intact animals identification and identification and
from infected or source a permit, or a a permit, or a
flocks that are not permit and an permit and an
scrapie-positive or indelible ``S'' indelible ``S''
suspect animals. mark on the left mark on the left
jaw, or sealed jaw, or sealed
conveyance and a conveyance and a
permit. (Note: permit. (Note:
these animals may these animals may
only be permitted only be permitted
to slaughter or to to slaughter or to
terminal terminal
feedlots.\3\) feedlots.\3\)
(3) Exposed sexually Official individual Official individual
intact animals that are animal animal
not scrapie-positive, identification for identification for
suspect, or high-risk. any animal that is any animal that is
animals and that are not moving directly not moving direct
not animals from an to slaughter or to to slaughter or to
infected or source a terminal a terminal
flock. feedlot.3, 4 (Note: feedlot.3, 4 (Note:
pregnant animals Pregnant animals
and animals with a and animals with a
visible vaginal visible vaginal
discharge may only discharge may only
be permitted to be permitted to
slaughter or to slaughter or to
terminal feedlots.). terminal feedlots.)
(4) Sexually intact Official premises None.
sheep that are not identification or
scrapie-positive, official individual
suspect, high-risk, or animal
exposed animals and are identification for
not animals from an any animal that is
infected or source not moving direct
flock. to slaughter or to
a terminal
feedlot.3
(5) Sheep enrolled in None................ None.
the selective monitored
or complete monitored
category of the SFCP
that are not scrapie-
positive, suspect, high-
risk, or exposed
animals.
(6) Castrated animals None................ None.
that are not scrapie-
positive, or suspect
animals.
(7) Sexually intact None................ None.
goats that are not
scrapie-positive,
suspect, high-risk, or
exposed animals and are
not animals from an
infected or source
flock.
(c) Sale or other movement
directly to slaughter,
through slaughter channels
to slaughter, or to
feedlots for later movement
to slaughter of animals
that are over 18 months of
age, as evidenced by
eruption of the second
incisor, or that are
pregnant or that have
lambed or kidded. General
Condition: No animal may be
removed from slaughter
channels in interstate
commerce if it was sold at
a slaughter-only auction,
is identified with a tag or
ear tattoo marked ``meat''
or ``slaughter only,'' or
was sold with a bill of
sale marked for slaughter
only, and other animals may
be removed from slaughter
channels in interstate
commerce only if they are
identified to their flock
of birth.--
(1) Scrapie-positive or Prohibited1......... Prohibited.1
suspect animal.
(2) Sexually intact high- Official individual Official individual
risk animals and animal animal
sexually intact animals identification and identification and
from an infected or a permit, or a a permit, or a
source flock that are permit and an permit and an
not scrapie-positive, indelible ``S'' indelible ``S''
or suspect animals. mark on the left mark on the left
jaw, or sealed jaw, or sealed
conveyance and a conveyance and a
permit. (Note: permit. (Note:
these animals may These animals may
only be permitted only be permitted
to slaughter or to to slaughter or to
terminal feedlots.3 terminal feedlots.3
(3) Sexually intact Official individual Official individual
exposed animals that animal animal
are not scrapie- identification and identification.
positive, suspect, or a permit, or a (Note: pregnant
high-risk animals and permit and an animals and animals
are not animals from an indelible ``S'' with a visible
infected or source mark on the left vaginal discharge
flock. jaw, or sealed may only be moved
conveyance and a directly to
permit when moving slaughter or to
directly to terminal
slaughter. (Note: feedlots.3, 4
pregnant animals
and animals with a
visible vaginal
discharge may only
be permitted to
slaughter or to
terminal
feedlots.3, 4
(4) Sheep over 18 months Official individual Official individual
of age that are not animal animal
scrapie-positive, identification and identification.\4\
suspect, sexually a certificate.\4\.
intact high-risk, or
sexually intact exposed
animals and that are
not sexually intact
animals from an
infected or source
flock.
(5) Low-risk commercial Official individual (i) Official
sheep. animal premises
identification and identification that
a certificate \4\. is a permanent
legible brand or
ear notch pattern
registered with an
official brand
registry or, in the
case of animals
moving directly to
slaughter, may be a
legible paint brand
registered with an
official brand
registry;
(ii) A brand
inspection
certificate;
[[Page 44000]]
(iii) An owner
statement dated
within 30 days of
the movement
stating that the
flock does not
contain any animal
exhibiting signs of
scrapie, and that,
to the best of his
or her knowledge,
the flock has no
risk factors for or
exposure to scrapie
and has never
contained: (A) Any
animal diagnosed as
having scrapie; (B)
any female
blackfaced sheep;
or (C) any female
blackfaced cross
sheep that was not
born in the flock;
(iv) An accredited
veterinarian's
statement issued
within 12 months of
the date of
movement indicating
that, to the best
of his or her
knowledge, the
flock has no known
risk factors for or
exposure to
scrapie, and that
he or she has
inspected the flock
and it does not
contain: (A) Any
animal exhibiting
signs of scrapie;
(B) any female
blackfaced sheep;
or (C) any female
blackfaced cross
sheep that was not
born in the flock.
The statements must
include the owner's
name, address, and
the premises
identification
number and a
drawing of the
owner's registered
brand or ear notch
pattern.\4\
(6) Goats that are not None................ None.
scrapie-positive,
suspect, sexually
intact high-risk, or
sexually intact exposed
animals and that are
not sexually intact
animals from an
infected or source
flock.
(d) Movement of animals for
grazing or other management
purposes without change of
ownership.--
(1) Scrapie-positive, Prohibited \1\...... Prohibited.\1\
suspect, or sexually
intact high-risk
animals.
(2) Non-high-risk Prohibited \1\...... Prohibited,\1\
animals from an except as allowed
infected or source in an approved
flock. scrapie control
pilot project flock
plan and must meet
the requirements
for exposed
animals.
(3) Sexually intact Official individual Official individual
exposed animals that animal animal
are not scrapie- identification and identification and
positive, suspect, or a permit.\2\ For a permit.\2\ For
high-risk animals and any female exposed any female exposed
that are not animals sheep the results sheep the results
from an infected or of an official of an official
source flock. genotype test must genotype test must
be included on or be included on or
attached to the attached to the
permit and must be permit and must be
QR or RR at codon QR or RR at codon
171. 171.
(4) Sexually intact Official premises None.
sheep or sexually identification and
intact goats that have a certificate..
been commingled with
sheep and that are not
scrapie-positive,
suspect, high-risk, or
exposed animals and are
not animals from an
infected or source
flock.
(5) Sexually intact None................ None.
goats that have not
been commingled with
sheep and that are not
scrapie-positive,
suspect, high-risk, or
exposed animals and are
not animals from an
infected or source
flock.
(6) Castrated animals None................ None.
that are not scrapie-
positive or suspect
animals and are not an
animal from an infected
or source flock.
------------------------------------------------------------------------
\1\ Animals prohibited movement may be moved interstate only if they are
moving interstate for destruction or research as approved by the
Administrator.
\2\ A copy of the permit must be sent to the State veterinarian and the
AVIC of the receiving State prior to movement of animals.
\3\ No exposed or high-risk animal from any State or any animal from an
Inconsistent State shall be removed from slaughter channels once it
has entered interstate commerce.
\4\ Official individual animal identification or official premises
identification is not required for these slaughter animals if the
animals are kept as a group on the same premises on which they were
born or used for breeding purposes and are not commingled with animals
from another premises at any time, including throughout the feeding,
marketing, and slaughter process.
[[Page 44001]]
Sec. 79.4 Designation of scrapie-positive animals, high-risk animals,
exposed animals, suspect animals, exposed flocks, infected flocks,
noncompliant flocks, and source flocks; notice to owners.
(a) Designation. A designated scrapie epidemiologist will designate
an animal to be a scrapie-positive animal, high-risk animal, exposed
animal, or suspect animal after determining that the animal meets the
criteria of the relevant definition in Sec. 79.1.
(1) A State or APHIS veterinarian will designate an animal to be a
suspect animal after determining that the animal meets the criteria of
the relevant definition in Sec. 79.1.
(2) A designated scrapie epidemiologist will designate a flock to
be a source, infected, or exposed flock after reviewing sale, movement,
and breeding records that indicate the flock meets the criteria of the
relevant definition in Sec. 79.1.
(i) A designated scrapie epidemiologist may conduct testing of
animals if he or she determines such testing is needed to properly
designate a flock to be a source, infected, or exposed flock. The
designated scrapie epidemiologist will select animals for testing in a
manner that will provide a 95 percent confidence of detecting scrapie
at a prevalence of 1 percent or, when flock records are adequate and
all exposed animals that lambed in the flock are available for testing,
may limit the testing to all exposed and suspect animals. Flocks
meeting the definition of infected or source flocks that are designated
as exposed flocks must complete a post exposure monitoring and
management plan. Testing may include live-animal testing using a live-
animal official test, an official genotype test, the culling and
postmortem examination and testing of genetically susceptible animals
in the flock that cannot be evaluated by a live animal test, and
postmortem examination and testing of animals found dead or cull
animals at slaughter.
(ii) If an owner does not make his or her animals available for
testing within 60 days of notification or as mutually agreed or fails
to submit required postmortem samples, the flock will be designated a
source, infected, or exposed flock, whichever definition applies. Any
flock that is pending designation must comply with the movement
restrictions for infected flocks.
(3) A designated scrapie epidemiologist will designate a flock to
be a noncompliant flock after determining that the flock meets the
definition of a noncompliant flock in Sec. 79.1.
(b) Redesignation. (1) A designated scrapie epidemiologist may
reclassify an animal designated a high-risk animal as an exposed animal
after receiving negative results from an official test or in accordance
with an approved Scrapie Control Pilot Project.
(2) A State or APHIS veterinarian may remove the suspect animal
designation from an animal that had clinical signs of scrapie and that
did not test positive for scrapie or for the proteinase resistant
protein associated with scrapie upon determination that it is alive and
no longer exhibits such signs, or that the signs are not caused by
scrapie.
(3) A designated scrapie epidemiologist may remove the suspect
animal designation from an animal that has tested positive for scrapie
or for the proteinase resistant protein associated with scrapie on an
unofficial test based on knowledge of the test used or based on an
epidemiologic investigation which may include additional testing of the
suspect animal and or animals that have been commingled with the
suspect animal.
(4) A designated scrapie epidemiologist may remove the suspect
animal designation from an animal that tested positive on a live-animal
screening test based on an epidemiologic investigation which includes
additional official testing of the suspect animal and when appropriate,
animals that have been commingled with the suspect animal.
(5) A designated scrapie epidemiologist may remove the exposed
flock designation after completing an epidemiologic investigation or
upon completion of a post-exposure management and monitoring plan. As
part of the epidemiologic investigation the designated scrapie
epidemiologist may conduct testing of animals if he or she determines
such testing is needed to properly redesignate the flock. The
designated scrapie epidemiologist will select animals for testing in a
manner that will provide a 95 percent confidence of detecting scrapie
at a prevalence of 1 percent or, when flock records are adequate and
all exposed animals that lambed in the flock are available for testing,
may limit the testing to all exposed and suspect animals. Testing may
include live-animal testing using a live-animal official test, an
official genotype test, the culling and postmortem examination and
testing of genetically susceptible animals in the flock that cannot be
evaluated by a live animal test, and postmortem examination and testing
of animals found dead or cull animals at slaughter. A designated
scrapie epidemiologist shall redesignate an exposed flock as a
noncompliant flock if the owner fails to make his animals available for
testing within 60 days of notification or as mutually agreed or fails
to submit required postmortem samples.
(6) Based on an epidemiologic investigation and testing, a
designated scrapie epidemiologist may redesignate an infected flock or
source flock as an exposed flock. The designated scrapie epidemiologist
may only use this option when the epidemiologic investigation reveals
that the scrapie exposure was minor or could not be confirmed due to
inadequate records. The designated scrapie epidemiologist will select
animals for testing in a manner that will provide a 95 percent
confidence of detecting scrapie at a prevalence of 1 percent or, when
flock records are adequate and all exposed animals that lambed in the
flock are available for testing, may limit the testing to all exposed
and suspect animals. Testing may include live-animal testing using a
live-animal official test, an official genotype test, the culling and
postmortem examination and testing of genetically susceptible animals
in the flock that cannot be evaluated by a live animal test, and
postmortem examination and testing of animals found dead or cull
animals at slaughter. Infected or source flocks that are redesignated
as exposed flocks must complete a post exposure monitoring and
management plan. If an owner does not make his or her animals available
for testing within 60 days of notification or as mutually agreed or
fails to submit required postmortem samples, the flock designation will
remain unchanged.
(7) A designated scrapie epidemiologist may remove the noncompliant
flock designation after reviewing any required testing of the flock and
determining that the flock has complied with the required testing or no
longer meets the definition of a noncompliant flock.
(8) A designated scrapie epidemiologist may redesignate an exposed
animal, exposed flock, or infected flock by removing that designation
after completing an epidemiologic investigation and determining that
the exposure was limited to a scrapie-positive male animal that was not
born in the flock (the owner must have adequate records and animal
identification to show that the scrapie-positive male animal was
purchased).
(c) Notice to owner. As soon as possible after making such a
determination, a State or APHIS representative will attempt to notify
the owner(s) of the flock(s) in writing that
[[Page 44002]]
their flock contained or contains a scrapie-positive animal, a suspect
animal, a high-risk animal or an exposed animal, or that the flock is
an infected, source, exposed, or noncompliant flock or that the flock
is pending designation as an infected, source, exposed, or noncompliant
flock. The notice will include:
(1) A description of the interstate movement restrictions and
identification requirements;
(2) Reporting requirements;
(3) Sample submission requirements for suspect and high-risk
animals contained in this part;
(4) Options for controlling the spread of scrapie from, and
eradicating scrapie in, an infected flock or source flock or to reduce
the risk of the occurrence of scrapie in a flock that contains a high-
risk or an exposed animal; and
(5) In the case of flocks that are pending designation the
notification shall include the testing options available to them and
the designation their flock will receive if they decline to test.
Sec. 79.5 Issuance of certificates.
(a) Certificates are required as specified by Sec. 79.3 for certain
interstate movements of animals. A certificate must show the official
ear tag number, individual animal registered breed association
registration tattoo, individual animal registered breed association
registration brand, individual animal registered breed association
registration number, and any other official individual identification
of each animal to be moved; provided that, in the case of animals
identified with premises identification \4\ that is assigned to the
flock of origin and that meets the requirements for individual animal
identification, the premises number may be recorded instead of the
individual identification numbers. A certificate must also show the
number of animals covered by the certificate; the purpose for which the
animals are to be moved; the points of origin and destination; the
consignor, and the consignee. Certificates must indicate the flock of
birth for any breeding sheep born after January 1, 2002, that are
covered by the certificate. The certificate must include a statement by
the issuing accredited or State or Federal veterinarian that the
animals were not exhibiting clinical signs associated with scrapie at
the time of examination and an owner statement indicating whether the
animal is or is not a scrapie-positive, suspect, high-risk or exposed
animal and whether it originated in an infected, source, exposed, or
noncompliant flock. Except as provided in paragraphs (b) and (c) of
this section, all of the information required by this paragraph must be
typed or written on the certificate. Note that in accordance with
Sec. 79.3(a), (b), and (c), scrapie-positive, suspect, and high-risk
animals, some exposed animals, and animals that originated in an
infected or source flock require permits rather than certificates.
---------------------------------------------------------------------------
\4\ Ownership brands may be used on certificates for sheep and
goats moved interstate when premises identification is required
under this part, provided the ownership brands are legible and are
registered with the official brand recording agency and the animals
are accompanied by a brand inspection certificate.
---------------------------------------------------------------------------
(b) Animal identification documents attached to certificates. As an
alternative to typing or writing individual animal identification on a
certificate, another document may be used to provide this information,
but only under the following conditions:
(1) The document must be a State form or APHIS form that requires
individual identification of animals;
(2) A legible copy of the document must be stapled to the original
and each copy of the certificate;
(3) Each copy of the document must identify each animal to be moved
with the certificate, but any information pertaining to other animals,
and any unused space on the document for recording animal
identification, must be crossed out in ink; and
(4) The following information must be typed or written in ink in
the identification column on the original and each copy of the
certificate and must be circled or boxed, also in ink, so that no
additional information can be added:
(i) The name of the document; and
(ii) Either the serial number on the document or, if the document
is not imprinted with a serial number, both the name of the person who
prepared the document and the date the document was signed.
(c) Ownership brands documents attached to certificates. As an
alternative to typing or writing ownership brands on a certificate, an
official brand inspection certificate may be used to provide this
information, but only under the following conditions:
(1) A legible copy of the official brand inspection certificate
must be stapled to the original and each copy of the certificate;
(2) Each copy of the official brand inspection certificate must
show the ownership brand of each animal to be moved with the
certificate, but any other ownership brands, and any unused space for
recording ownership brands, must be crossed out in ink; and
(3) The following information must be typed or written in ink in
the official identification column on the original and each copy of the
certificate and must be circled or boxed, also in ink, so that no
additional information can be added:
(i) The name of the attached document; and
(ii) Either the serial number on the official brand inspection
certificate or, if the official brand inspection certificate is not
imprinted with a serial number, both the name of the person who
prepared the official brand inspection certificate and the date it was
signed.
Sec. 79.6 Standards for States to qualify as Consistent States.
(a) In reviewing a State for Consistent State status, the
Administrator will evaluate the State statutes, regulations, and
directives pertaining to animal health activities; reports and
publications of the State animal health agency; and a written statement
from the State animal health agency describing State scrapie control
activities and certifying that these activities meet the requirements
of this section. In determining whether a State is a Consistent State,
the Administrator will determine whether the State:
(1) Has the authority, based on State law or regulation, to
restrict the movement of all scrapie-infected and source flocks.
(2) Has the authority, based on State law or regulation, to require
the reporting of any animal suspected of having scrapie and test
results for any animals tested for scrapie to State or Federal animal
health authorities.
(3) Has, in cooperation with APHIS personnel, drafted and signed a
memorandum of understanding between APHIS and the State that delineates
the respective roles of each in the National Scrapie Program
implementation.
(4) Has placed all known scrapie-infected and source flocks under
movement restrictions, with movement of animals only to slaughter, to
feedlots under permit and movement restrictions that ensure later
movement to slaughter, for destruction, or for research. Scrapie-
positive and suspect animals may be moved only for transport to an
approved research facility or for purposes of destruction.
(5) Has effectively implemented policies to:
(i) Investigate all animals reported as scrapie suspect animals
within 7 days of notification;
(ii) Designate a flock's status, within 15 days of notification
that the flock contains a scrapie-positive animal, based on an
investigation by State or
[[Page 44003]]
Federal animal health authorities and in accordance with this part;
(iii) Restrict the movement, in accordance with paragraph (a)(4) of
this section, of newly designated scrapie-infected and source flocks
within 7 days after they are designated in accordance with Sec. 79.4;
(iv) Relieve infected and source flock movement restrictions only
after completion of a flock plan created in accordance with Sec. 54.14
of this chapter or a flock plan created in accordance with an approved
scrapie control pilot project, or as permitted by the conditions of
such a flock plan, and after agreement by the owner to comply with a 5-
year post-exposure management and monitoring plan;
(v) Conduct an epidemiologic investigation of source and infected
flocks that includes the designation of high-risk and exposed animals
and that identifies animals to be traced;
(vi) Conduct tracebacks of scrapie-positive animals and traceouts
of high-risk and exposed animals and report any out-of-State traces to
the appropriate State within 45 days of receipt of notification of a
scrapie-positive animal; and
(vii) Conduct tracebacks based on slaughter sampling within 15 days
of receipt of notification of a scrapie-positive animal at slaughter.
(6) Effectively monitors and enforces quarantines.
(7) Effectively enforces State reporting laws and regulations for
scrapie.
(8) Has designated at least one APHIS or State animal health
official to coordinate scrapie program activities in the State and to
serve as the designated scrapie epidemiologist in the State.
(9) Has educated those engaged in the interstate movement of sheep
and goats regarding the identification and recordkeeping requirements
of this part.
(10) Has provided APHIS with a plan and timeline for complying with
the following additional requirements, which must be met within 2 years
of designation of the State as a Consistent State \5\:
---------------------------------------------------------------------------
\5\ This provision would apply until January 1, 2003. Any State
designated as a Consistent State after that date would have to meet
all requirements prior to designation.
---------------------------------------------------------------------------
(i) Requires, based on State law or regulation, and effectively
enforces official identification upon change of ownership of all
animals of any age not in slaughter channels and any sheep over 18
months of age as evidenced by eruption of the second incisor such that
the animal may be traced to its flock of birth; provided that:
(A) A State may exempt commercial goats in intrastate commerce that
have not been in contact with sheep from this identification
requirement if there has been in that State no case of scrapie in a
commercial goat in the past 10 years that originated in that State and
cannot be attributed to exposure to infected sheep, and there are no
exposed commercial goat herds in that State; and
(B) A State may exempt commercial whitefaced sheep or commercial
hair sheep under 18 months of age in intrastate commerce from this
identification requirement if there has been in that State no case of
scrapie in the exempted class that originated from that State, and
there are no exposed commercial whitefaced or hair sheep flocks in that
State that have been exposed by a female animal.
(C) States that exempt these types of commercial animals must put
in place the regulations necessary to require identification of these
animals within 90 days of these conditions no longer existing.
(ii) Maintains in the National Scrapie Database administered by
APHIS, or in a State database approved by the Administrator as
compatible with the National Scrapie Database, the State's:
(A) Premises information and assigned premises numbers and
individual identification number sequences assigned for use as premises
identification;
(B) Individual animal information on all scrapie-positive, suspect,
high-risk, and exposed animals in the State;
(C) Individual animal information on all out-of-State animals to be
traced; and
(D) Accurate flock status data.
(iii) Requires official individual identification of any live
scrapie-positive, suspect, or high-risk animal of any age and of any
sexually intact exposed animal of more than 1 year of age or any
sexually intact exposed animal of less than 1 year of age upon change
of ownership (except for exposed animals moving in slaughter channels
at less than 1 year of age), whether or not the animal resides in a
source or infected flock.
(iv) Effectively enforces movement restrictions on all scrapie-
positive, suspect, and high-risk animals throughout their lives unless
they are moved in accordance with Sec. 79.3.
(v) Requires that tissues from all scrapie-positive or suspect
animals and female high-risk animals that have lambed (when they have
died or have been destroyed) be submitted to a laboratory authorized by
the Administrator to conduct scrapie tests and requires complete
destruction of the carcasses of scrapie-positive and suspect animals.
(vi) Prohibits any animal from being removed from slaughter
channels unless it is identified to the flock of birth, is not from an
Inconsistent State, and is not scrapie-exposed or from an infected or
source flock.
(b) If the Administrator determines that statutory changes are
needed to bring a State into full compliance, the Administrator may
grant up to a 2-year extension to allow a State to acquire additional
authorities before removing a State's Consistent Status. The decision
to grant an extension will be based on the State's ability to prevent
the movement of scrapie-infected animals out of the State and on the
progress being made in making the needed statutory changes.
Sec. 79.7 Waiver of requirements for scrapie control pilot projects.
(a) The Administrator may waive the following requirements of this
part for participants in a scrapie control pilot project by recording
the requirements waived in the scrapie control pilot project plan:
(1) The determination that an animal is a high-risk animal, if the
scrapie control pilot project plan contains testing or other procedures
that indicate that an animal, despite meeting the definition of high-
risk animal, is unlikely to spread scrapie; and
(2) The requirement that high-risk animals must be removed from a
flock, if the scrapie control pilot project plan contains alternative
procedures to prevent the further spread of scrapie without removing
high-risk animals from the flock.
(b) [Reserved]
Done in Washington, DC, this 9th day of August 2001.
Bill Hawks,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 01-20693 Filed 8-20-01; 8:45 am]
BILLING CODE 3410-34-P
This archive was generated by hypermail 2b29 : 2001/08/21 EST