00-16219. Scrapie Pilot Projects

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Final rule.

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; [phone].

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 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 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 § 54.1, the following definition is added in alphabetical order to read as follows:

§ 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 § 54.14 is added to read as follows:

§ 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 § 79.1, the following definition is added in alphabetical order to read as follows:

§ 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 § 79.4 is added to read as follows:

§ 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.