[Federal Register Volume 65, Number 124 (Tuesday, June 27, 2000)]
[Rules and Regulations]
[Pages 39534-39536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16219]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 54 and 79
[Docket No. 99-067-2]
Scrapie Pilot Projects
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending the regulations concerning the voluntary
scrapie flock certification program and the interstate movement of
sheep and goats to exempt flocks from certain regulatory requirements
when the flocks are participating in scrapie control pilot projects
authorized by the Animal and Plant Health Inspection Service. We
believe this action is necessary so that pilot projects can achieve
their goal of furthering progress toward the eradication of scrapie.
This action will affect a small number of flock owners participating in
scrapie control pilot projects.
EFFECTIVE DATE: June 27, 2000.
FOR FURTHER INFORMATION CONTACT: Dr. Diane Sutton, Senior Staff
Veterinarian, National Animal Health Programs Staff, VS, APHIS, 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. To control the spread
of scrapie within the United States, the Animal and Plant Health
Inspection Service (APHIS), U.S. Department of Agriculture (USDA),
administers regulations at 9 CFR part 79, which restrict the interstate
movement of certain sheep and goats. APHIS also administers the
Voluntary Scrapie Flock Certification Program (the VSFCP), described in
the regulations at 9 CFR part 54.
On December 17, 1999, we published in the Federal Register (64 FR
70608-70610, Docket No. 99-067-1) a proposal to amend 9 CFR parts 54
and 79 to add a definition of the term scrapie control pilot project
and to allow the Administrator to waive specified requirements of parts
54 and 79 for flocks participating in scrapie control pilot projects.
The purpose of the proposal was to enhance the ability of APHIS to work
with flock owners to develop pilot projects for scrapie control that
may involve using techniques and procedures different from those
contained in the current regulations.
We solicited comments concerning our proposal for 30 days ending
January 18, 2000. We received seven comments by that date. They were
from a State government, an association representing veterinarians, two
associations representing the U.S. sheep industry, and three individual
sheep producers. Six commenters generally supported the proposed rule,
but several suggested changes to improve it. One commenter opposed the
proposed rule. Several of the commenters also raised issues outside the
scope of the proposed rule. All issues raised by the comments pertinent
to the proposed rule are discussed below by topic.
Pilot Projects will Preserve Infected Sheep and Delay Eradication
of Scrapie
The comment opposed to the proposed rule stated that pilot
projects, by lessening restrictions, could result in the movement of
sheep that were potentially infected with scrapie, spreading the
disease and delaying its eradication. This commenter stated that sheep
allowed movement by the pilot projects would be quarantined or
destroyed under the previous regulations. Another commenter urged APHIS
to be conservative in its approval of pilot projects to guard against
projects that may actually contribute to the spread of scrapie.
We are not making any change in response to these comments.
Historically, scrapie control has not been successful in part because
producers of sheep with valuable genetic lines were often left with few
alternatives other than flock depopulation. This was discouraging and
often influenced producers not to report scrapie. The pilot projects
will allow us to evaluate methods that may provide alternatives to
flock depopulation while minimizing the spread of disease. It is
essential to use pilot projects to evaluate different tests and control
methods. It is our belief that these projects will assist us in
adjusting our control and eradication programs to be more effective and
acceptable to producers and will, therefore, accelerate, not delay,
progress toward the eradication of scrapie. Each pilot project will
have restrictions on the movement of sheep in the project that are
commensurate with the risk that the sheep might spread scrapie, and
these movement restrictions and other precautions in pilot project
design should prevent the spread of scrapie as a result of the pilot
projects.
Definition of Scrapie Control Pilot Project
The definition proposed for the term scrapie control pilot project
was ``A pilot project authorized by the Administrator in writing,
designed to perform research or test or improve program procedures for
scrapie control. In addition to APHIS, participants may include State
animal health agencies, flock owners, and other parties as necessary.''
Two commenters suggested that pilot projects could contribute to the
eradication as well as the control of scrapie, and noted that eventual
eradication of the disease is an important goal of scrapie programs and
should be stressed. We agree.
One commenter questioned including ``designed to perform research''
in the
[[Page 39535]]
definition, in light of the fact that research is not a primary APHIS
mission and that other agencies have research as their primary mission.
While it is not the mission of APHIS to conduct pure research,
APHIS has historically conducted projects that have examined the
practicality of implementing new testing techniques and control
strategies. The scrapie pilot project initiative expands our role in
this effort as a means to enhance scrapie control with the goal of
eventual eradication. This effort also will allow flocks and animals to
be kept alive for use by other entities whose sole mission is to
conduct research. However, we agree that by encouraging pilot projects,
APHIS will not be directly conducting research, but instead
facilitating research by other parties.
In response to the above comments, we are changing the definition
of scrapie control pilot project to read ``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
health agencies, flock owners, and other parties as necessary.''
Further Restrictions Needed on Movement of Sheep from Pilot
Projects
One commenter stated that animals from flocks in a pilot project
should be allowed to move intrastate or interstate only with permission
from State animal health officials, and should be required to be
individually identified with official identification.
We are not making any change in response to this comment. As our
goal is to control and eventually eradicate scrapie, movement of sheep
from flocks participating in the pilot project will be done in
accordance with pilot project designs that minimize the risk of scrapie
spread and ensure that these animals will be monitored after movement
from the flock of origin. State animal health officials will be
involved in establishing and approving pilot projects, including the
terms under which animals from pilot projects may be moved. Individual
animal identification will be used whenever it is necessary to allow
continued monitoring of animals after they have been moved from a pilot
project flock.
Miscellaneous
One commenter noted the statement in the economic analysis section
of the proposed rule that ``APHIS expects to engage in scrapie pilot
projects over approximately the next 5 years.'' He commented that 5
years is not long enough to fully evaluate the role of genetics in
scrapie resistance and how knowledge of genetics can assist control
efforts.
That time estimate was only an approximation, and we agree that it
may take longer. Also, followup monitoring of animals involved in pilot
projects may occur for much longer. For instance, we intend to continue
monitoring high risk animals from pilot projects throughout their
lifetimes and to conduct necropsies of each high risk animal and
examine it for any evidence of scrapie.
Two commenters questioned the statement in the economic analysis
that the proposed rule would affect ``no more than 75 sheep flocks
containing approximately 3,400 sheep that may be engaged in pilot
projects in any given year.'' The number 75 was not meant to be a limit
on the total number of pilot project flocks but was our projection of
the number of flocks that may participate based on the number of
infected and source flocks known to exist in the United States. The
actual number will depend upon the amount of Federal funding available.
Additional participation may be permitted if some costs are borne by
States or producers.
One commenter stated that premises contamination studies are
vitally needed to gain better understanding of the degree to which
contaminated premises might spread scrapie and the effectiveness of
decontamination techniques for premises. We agree, and APHIS has asked
the Agricultural Research Service, USDA, to conduct such studies.
One commenter suggested that animals in pilot projects should be
awarded a flock status under the Voluntary Scrapie Flock Certification
Program that would allow them to be eligible for export in order to
minimize adverse financial impacts on their owners. We did not make any
change in response to this comment. The intent of the pilot project is
to evaluate the effectiveness of certain tests, procedures, and
alternative methods, not to certify animals for export. Animals in
pilot projects are not necessarily in the same category, in terms of
risk of scrapie or demonstrated freedom from scrapie, with animals in
any of the flock categories established by the Voluntary Scrapie Flock
Certification Program. The pilot projects may eventually lead to
methods that enhance our ability to certify animals for export, but
there is no basis at this stage for certifying animals in pilot
projects for export.
Therefore, for the reasons given in the proposed rule and in this
final rule, we are adopting the proposed rule as a final rule, with the
changes discussed above.
Effective Date
This is a substantive rule that relieves restrictions and, pursuant
to the provisions of 5 U.S.C. 553, may be made effective less than 30
days after publication in the Federal Register.
Immediate implementation of this rule is necessary to provide
relief to those persons involved in scrapie pilot projects who are
adversely affected by restrictions we no longer find warranted. Making
this rule effective immediately will allow participating sheep
producers and others in the marketing chain to move and sell animals
during this year's slaughter season. Therefore, the Administrator of
the Animal and Plant Health Inspection Service has determined that this
rule should be effective upon publication in the Federal Register.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. The rule
has been determined to be not significant for the purposes of Executive
Order 12866 and, therefore, has not been reviewed by the Office of
Management and Budget.
This rule will allow the Administrator to exempt sheep and goat
flocks participating in scrapie control pilot projects from certain
requirements of the regulations. Because APHIS resources will allow us
to develop and administer only a limited number of pilot projects, this
rule is unlikely to affect more than 75 sheep flocks containing
approximately 3,400 sheep that may be engaged in pilot projects in any
given year. It could affect substantially fewer if owners of flocks
eligible for pilot projects decline to participate. APHIS expects to
engage in scrapie pilot projects over approximately the next 5 years.
Based on current plans for pilot projects, this rule will probably
affect no more than 20 flocks the first year. The primary effects on
these flock owners should be beneficial, in that animal testing and
genotyping under the pilot projects would allow them to keep animals
that would otherwise have to be destroyed under the regulations. All
flock owners should eventually accrue long-term benefits from the
control or eradication of scrapie in the form of reduced loss of
animals from the disease and opening of additional international
markets.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action will
not
[[Page 39536]]
have a significant economic impact on a substantial number of small
entities.
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 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
This rule contains no new information collection or recordkeeping
requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.).
List of Subjects
9 CFR Part 54
Animal diseases, Goats, Indemnity payments, Scrapie, Sheep.
9 CFR Part 79
Animal diseases, Quarantine, Sheep, Transportation.
Accordingly, we are amending 9 CFR parts 54 and 79 as follows:
PART 54--CONTROL OF SCRAPIE
1. The authority citation for part 54 continues to read as follows:
Authority: 21 U.S.C. 111, 114, 114a, and 134a-134h; 7 CFR 2.22,
2.80, and 371.2(d).
2. In Sec. 54.1, the following definition is added in alphabetical
order to read as follows:
Sec. 54.1 Definitions.
* * * * *
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
health agencies, flock owners, and other parties as necessary.
* * * * *
3. A new Sec. 54.14 is added to read as follows:
Sec. 54.14 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]
PART 79--SCRAPIE IN SHEEP AND GOATS
1. The authority citation for part 79 continues to read as follows:
Authority: 21 U.S.C. 111-113, 115, 117, 120, 121, 123-126, 134b,
and 134f; 7 CFR 2.22, 2.80, and 371.2(d).
2. In Sec. 79.1, the following definition is added in alphabetical
order to read as follows:
Sec. 79.1 Definitions.
* * * * *
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
health agencies, flock owners, and other parties as necessary.
* * * * *
3. A new Sec. 79.4 is added to read as follows:
Sec. 79.4 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 21st day of June 2000.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 00-16219 Filed 6-26-00; 8:45 am]
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