[Federal Register Volume 60, Number 161 (Monday, August 21, 1995)]
[Rules and Regulations]
[Pages 43355-43356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20592]



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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

9 CFR Part 117

[Docket No. 93-048-2]


Viruses, Serums, Toxins, and Analogous Products; Test Animals

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the regulations to allow appropriate treatment 
of certain sick or injured test animals and the humane destruction of 
dying animals used in the testing of veterinary biological products. 
The effect of this action is to eliminate unnecessary discomfort to 
animals used in vaccine testing. The amendment provides the firms with 
a previously unauthorized option for handling test animals that are 
accidentally injured, become ill, or exhibit unfavorable reactions for 
reasons not due to the test. These animals may be removed from the test 
and treated or humanely destroyed. In addition, test animals that show 
clinical signs of illness resulting from the test may be treated or 
humanely destroyed when death is certain to occur without therapeutic 
intervention.
    This action is necessary to provide for the treatment or humane 
destruction of ill or injured test animals under defined conditions. 
This option is not currently allowed by the regulations for test 
animals.

EFFECTIVE DATE: September 20, 1995.

FOR FURTHER INFORMATION CONTACT: Dr. David A. Espeseth, Deputy 
Director, Veterinary Biologics, BBEP, APHIS, 4700 River Road Unit 148, 
Riverdale, MD 20737-1237, (301) 734-8245.

SUPPLEMENTARY INFORMATION:

Background

    The regulations in 9 CFR part 117 pertain to veterinary biological 
products that are licensed under the Virus-Serum-Toxin Act on the basis 
of their purity, safety, potency, and efficacy. In the course of 
evaluating a biological product, it is necessary to conduct potency, 
safety, or efficacy tests in animals.
    This amendment is intended to eliminate unnecessary discomfort or 
suffering in the test animals as a result of injury, unfavorable 
reactions, or illness attributable to the test.
    On October 25, 1994, we published in the Federal Register (59 FR 
53612-53613, Docket No. 93-048-1) a proposal to amend the regulations 
in 9 CFR 117.4. We proposed that test animals which exhibit clinical 
signs of illness, become accidentally injured, or exhibit unfavorable 
reactions through events not associated with the test, may be removed 
from the test and be treated or humanely destroyed. We also proposed to 
allow for the treatment of test animals showing illness due to the test 
or humane destruction of test animals which show clinical signs of 
illness attributable to the challenge microorganism, which are likely 
to result in death.
    We solicited comments concerning our proposed amendment for 60 days 
ending December 27, 1994. We received two comments by that date. Both 
comments were from producers of 

[[Page 43356]]
veterinary biological products. We carefully considered the comments we 
received. They are discussed below.
    One commenter supported the proposed rule as written.
    The second commenter believed that the rule should include a 
provision to allow treatment for those animals that show certain 
clinical signs indicative of susceptibility to challenge (defined in an 
Outline of Production), rather than waiting until such animals have 
progressed to a point when death is certain to occur without 
therapeutic intervention.
    The Animal and Plant Health Inspection Service (APHIS) cannot 
accept this recommendation because use of clinical signs as a test 
endpoint may result in a product that is sufficiently potent to protect 
against a mild challenge that causes certain disease symptoms, but not 
sufficiently potent to protect against severe clinical disease or death 
from natural challenge. APHIS notes that the level of challenge used in 
animal potency tests may have a significant effect on the results of 
tests. In order to ensure that a product will have adequate potency to 
protect animals against severe clinical disease or death resulting from 
natural challenge, many standard requirements for veterinary biological 
products currently require a challenge that is strong enough to cause 
death in the test animals. In such cases, assessment of susceptibility 
to challenge based solely on clinical signs would not provide an 
equivalent alternative to one based on death or the expectation of 
death.
    Therefore, based on the rationale set forth in the proposed rule 
and in this document, we are adopting the provisions of the proposal as 
a final rule, without change.

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.
    The rule provides that animals used in testing biological products 
which become ill, accidentally injured, or exhibit unfavorable 
reactions as a result of factors not due to the test could be removed 
from the test and be treated or humanely destroyed. The rule also 
provides for the treatment or humane destruction of animals which are 
expected to die as a result of the testing of a veterinary biologic. 
The objective of the rule is to provide humane alternatives when 
conducting such tests in order to eliminate any unnecessary discomfort 
to animals.
    The rule does not require additional testing of animals. It simply 
provides an option which was not previously available for the treatment 
of test animals under certain conditions. Therefore, the rule is not 
anticipated to increase costs to producers of veterinary biological 
products.
    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 12778

    This final rule has been reviewed under Executive Order 12778, 
Civil Justice Reform. It is not intended to have retroactive effect. 
This rule will not preempt any State or local laws, regulations, or 
policies, unless they present an irreconcilable conflict with this 
rule. There are no administrative procedures which must be exhausted 
prior to a judicial challenge to the provisions of this rule.
Paperwork Reduction Act

    This proposed rule contains no information collection or 
recordkeeping requirements under the Paperwork Reduction Act of 1980 
(44 U.S.C. 3501 et seq.).

List of Subjects in 9 CFR Part 117

    Animal biologics, Animals.

    Accordingly, 9 CFR part 117 is amended as follows:

PART 117--ANIMALS AT LICENSED ESTABLISHMENTS

    1. The authority citation for part 117 continues to read as 
follows:

    Authority: 21 U.S.C. 151-159; 7 CFR 2.17, 2.51, and 371.2(d).

    2. In Sec. 117.4, new paragraphs (d) and (e) are added to read as 
follows:


Sec. 117.4  Test animals.

* * * * *
    (d) During the course of a test, animals that are injured or show 
clinical signs of illness or unfavorable reactions that are not due to 
the test may be removed from the test and treated or humanely 
destroyed. If sufficient animals do not remain for the test to be 
evaluated, the test shall be declared inconclusive and may be repeated.
    (e) Test animals that show clinical signs of illness that are due 
to the test may be treated or humanely destroyed if the illness has 
progressed to a point (defined in the filed Outline of Production) when 
death is certain to occur without therapeutic intervention. When 
interpreting the results of the test, the animals that were treated or 
humanely destroyed because of illness due to the test and the animals 
that have died from illness due to the test prior to being humanely 
destroyed shall be combined into a common statistic of mortality due to 
the test.

    Done in Washington, DC, this 14th day of August 1995.
Terry Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-20592 Filed 8-18-95; 8:45 am]
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