[Federal Register Volume 59, Number 205 (Tuesday, October 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-26419]


[[Page Unknown]]

[Federal Register: October 25, 1994]


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DEPARTMENT OF AGRICULTURE
9 CFR Part 117

[Docket No. 93-048-1]

 

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

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend the regulations to allow appropriate 
treatment of sick or injured test animals or the human destruction of 
dying animals used in the testing of veterinary biological products. 
The effect of this action would eliminate unnecessary discomfort to 
animals used in vaccine testing. This amendment would provide the firms 
with a previously unauthorized option for test animals that are 
accidentally injured or 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, an option not currently allowed by the regulations for test 
animals as a group.

DATES: Consideration will be given only to comments received on or 
before December 27, 1994.

ADDRESSES: Please send an original and three copies of your comments to 
Chief, Regulatory Analysis and Development, PPD, APHIS, USDA, P.O. 
Drawer 810, Riverdale, MD 20738. Please state that your comments refer 
to Docket No. 93-048-1. Comments received may be inspected at USDA, 
room 1141, South Building, 14th Street and Independence Avenue, SW., 
Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, 
except holidays. Persons wishing to inspect comments are requested to 
call ahead on (202) 690-2817 to facilitate entry into the comment 
reading room.

FOR FURTHER INFORMATION CONTACT:
Dr. David A. Espeseth, Deputy Director, Veterinary Biologics, BBEP, 
APHIS, USDA, room 838, Federal Building, 6505 Belcrest Road, 
Hyattsville, MD 20782, (301) 436-8245.

SUPPLEMENTARY INFORMATION:

Background

    Veterinary biological products 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 may be necessary 
to conduct potency, safety, or efficacy tests in animals.
    The current regulations in 9 CFR part 117 require that once an 
animal test has begun, no treatment which could interfere with a true 
evaluation of the biological product may be used (see Sec. 117.4(c)). 
However, test animals may become accidently injured or ill or exhibit 
unfavorable reactions as a result of factors not due to the test. These 
occurrences are unpredictable, and no provisions are available in the 
current regulations for the appropriate treatment or humane destruction 
of such animals. The proposed rule would provide that test animals 
which exhibit clinical signs of illness, become accidentally injured or 
exhibit unfavorable reactions not associated with the test, may be 
removed from the test and be treated or humanely destroyed.
    When animal tests involve challenge with infectious microorganisms 
in order to establish that the biological product can elicit protection 
against disease, the challenge with infectious microorganisms may 
produce an illness which is characteristic of a natural infection. 
Therefore, we are also proposing to amend Sec. 117.4 by adding new 
paragraphs (d) and (e), to allow for the treatment or humane 
destruction of test animals which show clinical signs of illness 
attributable to the challenge microorganism, which are likely to result 
in death.
    The proposed amendment would have the objective of eliminating 
unnecessary discomfort resulting from injury, unfavorable reactions, or 
illness when conducting tests in animals.


Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been reviewed under Executive Order 12866.
    The effect of the rule would be to provide that animals used in 
testing biological product which become ill, accidentally injured, or 
exhibit unfavorable reactions could be removed from the test and be 
treated or humanely destroyed. The objective of the rule would be to 
eliminate any unnecessary discomfort to animals.
    The rule would require no additional testing of animals. It would 
simply provide an option which was not previously available. 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 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 12778

    This proposed rule has been reviewed under Executive Order 12778, 
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 1980 
(44 U.S.C. 3501 et seq.).

 List of Subjects in 9 CFR Part 117

    Animal biologics, Animals.

    Accordingly, 9 CFR part 117 would be amended as follows:

PART 117--ANIMALS AT LICENSED ESTABLISHMENTS

    1. The authority citation for 9 CFR part 117 would continue 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) would be 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 19th day of October 1994.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 94-26419 Filed 10-24-94; 8:45 am]
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