[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 3410-34-P
