[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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