[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