[Federal Register Volume 63, Number 147 (Friday, July 31, 1998)]
[Proposed Rules]
[Pages 40844-40845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20499]
[[Page 40844]]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 1
[Docket No. 98-043-1]
Field Study; Definition
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: We are proposing to amend the Animal Welfare regulations by
clarifying the definition of the term field study. We want to clarify
that a field study cannot involve an invasive procedure, harm the
animals under study, or materially alter the behavior of the animals
under study. As currently worded, the definition of field study could
be interpreted to mean that a field study may include one of these
situations. This action would help ensure the proper use and care of
animals used in field studies.
DATES: Consideration will be given only to comments received on or
before September 29, 1998.
ADDRESSES: Please send an original and three copies of your comments to
Docket No. 98-043-1, Regulatory Analysis and Development, PPD, APHIS,
suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please
state that your comments refer to Docket No. 98-043-1. 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. Jerry DePoyster, Senior Veterinary
Medical Officer, Animal Care, APHIS, 4700 River Road Unit 84,
Riverdale, MD 20737-1228, (301) 734-7586.
SUPPLEMENTARY INFORMATION: The Animal Welfare Act (the Act) (7 U.S.C.
2131 et seq.) authorizes the Secretary of Agriculture to promulgate
standards and other requirements governing the humane handling,
housing, care, treatment, and transportation of certain animals by
dealers, research facilities, exhibitors, carriers, and intermediate
handlers.
The regulations established under the Act are contained in title 9
of the Code of Federal Regulations (9 CFR), chapter I, subchapter A,
parts 1, 2, and 3. Part 1 defines various terms used in parts 2 and 3.
We are proposing to amend the definition of field study. Currently,
a field study, as defined in Sec. 1.1 of the regulations, is any study
that is ``conducted on free-living wild animals in their natural
habitat, which does not involve an invasive procedure, and which does
not harm or materially alter the behavior of the animals under study.''
We have always intended that field studies not include any invasive
procedures, harm the animals under study, or materially alter the
behavior of the animals under study. However, we are concerned that, as
currently worded, the definition could be interpreted to mean that a
field study may include any one of these situations.
Determining whether a study should be classified as a field study
is essential because a field study is not subject to the regulations in
Sec. 2.31(d). In Sec. 2.31, paragraph (d) requires the Institutional
Animal Care and Use Committee (IACUC) for each research facility to
review all studies, except field studies, to ensure that the planned
care and use of the animals comply with the Act and the regulations in
9 CFR parts 2 and 3. However, if the definition of a field study is not
clear, a study that involves an invasive procedure or harms or
materially alters the behavior of the animals under study may be
misclassified as a field study and, accordingly, would not be reviewed
by the IACUC.
We are, therefore, proposing to amend the definition of field study
in Sec. 1.1. We would define field study as any study conducted on
free-living wild animals in their natural habitat. We would also add
the provision that the term field study excludes any study that
involves an invasive procedure or has the potential to harm or
materially alter the behavior of the animals under study.
Executive Order 12866 and Regulatory Flexibility Act
This proposed 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 proposed rule would clarify the definition of field study.
Currently, a field study, as defined in Sec. 1.1 of the regulations, is
any study that is ``conducted on free-living wild animals in their
natural habitat, which does not involve an invasive procedure, and
which does not harm or materially alter the behavior of the animals
under study.''
We have always intended that field studies not include any invasive
procedures, harm the animals under study, or materially alter the
behavior of the animals under study. However, we are concerned that, as
currently worded, the definition could be interpreted to mean that a
field study may include any one of these situations. By clarifying the
definition of field study, this proposed rule would help ensure that
studies that should be subject to the Animal Welfare regulations are
subject to the Animal Welfare regulations.
The only entities that would be affected by this proposed rule
would be entities that perform studies conducted on free-living wild
animals in their natural habitat. We estimate that at least 50 entities
may be impacted by this proposed rule; however, we do not have an exact
number. These entities may be considered small and large entities by
Small Business Administration standards, but this proposed rule would
only affect a small portion of the entities' activities. As we are not
proposing a substantive change in the definition, the impact on these
entities should not be significant.
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 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. It is not intended to have retroactive effect.
This rule would not preempt any State and local laws, regulations, or
policies, unless they present an irreconcilable conflict with this
rule. The Act does not provide 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 1995
(44 U.S.C. 3501 et seq.).
List of Subjects in 9 CFR Part 1
Animal welfare, Pets, Reporting and recordkeeping requirements,
Research.
[[Page 40845]]
Accordingly, we propose to amend 9 CFR part 1 as follows:
PART 1--DEFINITION OF TERMS
1. The authority citation for part 1 would continue to read as
follows:
Authority: 7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.2(g).
2. In Sec. 1.1, the definition of field study would be revised to
read as follows:
Sec. 1.1 Definitions.
* * * * *
Field study means any study conducted on free-living wild animals
in their natural habitat. This term excludes any study that involves an
invasive procedure or has the potential to harm or materially alter the
behavior of an animal under study.
* * * * *
Done in Washington, DC, this 27th day of July 1998.
Alfred S. Elder,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 98-20499 Filed 7-30-98; 8:45 am]
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