[Federal Register Volume 64, Number 242 (Friday, December 17, 1999)]
[Proposed Rules]
[Pages 70608-70610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32734]
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Proposed Rules
Federal Register
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This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 64, No. 242 / Friday, December 17, 1999 /
Proposed Rules
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 54 and 79
[Docket No. 99-067-1]
Scrapie Pilot Projects
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: We are proposing to amend 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 would affect a small number of flock owners participating
in scrapie control pilot projects.
DATES: We invite you to comment on this docket. We will consider all
comments that we receive by January 18, 2000.
ADDRESSES: Please send your comment and three copies to: Docket No. 99-
067-1, Regulatory Analysis and Development, PPD, APHIS, Suite 3C03,
4700 River Road, Unit 118, Riverdale, MD 20737-1238.
Please state that your comment refers to Docket No. 99-067-1.
You may read any comments that we receive on this docket in our
reading room. The reading room is located in room 1141 of the USDA
South Building, 14th Street and Independence Avenue, SW., Washington,
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 690-2817 before coming.
APHIS documents published in the Federal Register, and related
information, including the names of organizations and individuals who
have commented on APHIS rules, are available on the Internet at http://
www.aphis.usda.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Dr. Diane Sutton, Senior Staff
Veterinarian, National Animal Health Programs Staff, 4700 River Road
Unit 43, Riverdale, MD 20737-1235; (301) 734-7709.
SUPPLEMENTARY INFORMATION:
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.
For more than 40 years, USDA has had programs to eradicate or
reduce the incidence of scrapie in the United States, using a variety
of approaches. APHIS is continually working to develop new and more
effective approaches to control scrapie. As part of this effort, APHIS
is currently working with flock owners to develop pilot projects that
may involve using techniques and procedures different from those
contained in the current regulations. Some of the pilot projects under
development cannot proceed unless the current regulations are waived
for the participating flocks. For example, current flock plans require
that animals identified as high-risk animals be removed from flocks,
while some pilot project protocols would allow high-risk animals to
remain in flocks so that alternative flock cleanup strategies can be
studied.
APHIS will develop pilot projects in States in which State animal
health agencies have indicated a willingness to change their usual
requirements and procedures in order to try pilot approaches for
scrapie management. In order for a flock owner to participate in a
pilot project, the State agency must be willing to modify requirements
for flock management, quarantine and movement of animals, and animal
identification, to the extent that these matters are affected by the
protocol of the particular pilot project. A flock owner who chooses to
participate in a pilot project must agree to follow the procedures
identified for the project, and must have the necessary records,
personnel, and facilities to maintain the flock in accordance with the
terms of the pilot project. Flock owners who are interested in
exploring the idea of participating in a pilot project can contact
APHIS or their State animal health agency to discuss the possibility,
and State or APHIS inspectors who already work with flock owners may
also ask owners of flocks that are likely candidates if they want to be
involved in a pilot project.
Pilot projects are conducted under the close supervision and
control of APHIS and are carefully designed to mitigate the risk of the
further spread of scrapie. We believe that providing waivers for
participants in pilot projects is essential to achieve more effective
approaches to control scrapie. Therefore, we propose to amend the
regulations to define 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.
We propose to define scrapie control pilot project in parts 54 and
79 as follows: ``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.''
We propose to add a provision to parts 54 and 79 that permits the
Administrator to waive certain requirement of parts 54 and 79, and the
Scrapie Flock Certification Program Standards referenced by them, for
participants in a scrapie control pilot project. We propose that the
Administrator may waive either or both of the following requirements
when a particular pilot project makes them unnecessary to control
scrapie:
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
[[Page 70609]]
2. The requirement that high-risk animals must be removed from a
flock in accordance with a flock plan, 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.
This change would primarily affect flock owners who volunteer to
participate in pilot projects. In general, these owners would be
relieved of specified regulatory restrictions that would otherwise
apply to them and would be able to retain or move their animals more
freely than they could if certain requirements of the regulations were
not waived for pilot projects. Currently these owners are losing the
economic value of sheep that may not be scrapie infected. The pilot
projects may correct this situation so that flock owners can retain the
animals.
Executive Order 12866 and Regulatory Flexibility Act
This proposed 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 proposed rule would 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 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. 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
proposed rule would probably affect no more than 20 flocks the first
year. The primary effects on these flock owners would 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 would 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 would
not 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 proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are in conflict with this rule will
be preempted; (2) no retroactive effect will be given to this rule; and
(3) administrative proceedings will not be required before parties may
file suit in court challenging this rule.
Paperwork Reduction Act
This proposed rule contains no 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 propose to amend 9 CFR parts 54 and 79 as follows:
PART 54--CONTROL OF SCRAPIE
1. The authority citation for part 54 would continue 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 would be 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 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.
* * * * *
3. A new Sec. 54.14 would be 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 would continue to read as
follows:
Authority: 21 U.S.C. 111-113, 115, 117, 120, 121, 123-126, 134b,
and 134f; 7 CFR 2.20, 2.80, and 371.2(d).
2. In Sec. 79.1, the following definition would be 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 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.
* * * * *
3. A new Sec. 79.4 would be 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]
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Done in Washington, DC, this 13th day of December 1999.
Craig A. Reed,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 99-32734 Filed 12-16-99; 8:45 am]
BILLING CODE 3410-34-U