[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]



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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.

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    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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