[Federal Register Volume 65, Number 27 (Wednesday, February 9, 2000)]
[Rules and Regulations]
[Pages 6312-6314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-2922]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 1

[Docket No. 98-043-2]


Field Study; Definition

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the Animal Welfare regulations by clarifying 
the definition of the term field study. We will 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 
worded prior to this final rule, the definition of field study could be 
interpreted to mean that a field study may include one of these 
situations. This action will help ensure the proper use and care of 
animals used in field studies.

EFFECTIVE DATE: March 10, 2000.

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 (AWA) (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, chapter I, subchapter A, parts 1, 
2, and 3. Part 1 defines various terms used in parts 2 and 3.
    As defined in Sec. 1.1 of the regulations prior to this final rule, 
field study meant 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 were concerned that 
the definition, as worded above, could be interpreted to mean that a 
field study could include any one of these situations.
    On July 31, 1998, we published in the Federal Register (63 FR 
40844-40845, Docket No. 98-043-1) a proposal to amend the definition of 
field study in Sec. 1.1 of the regulations by defining field study as 
any study conducted on free-living wild animals in their natural 
habitat. We also proposed to 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. This proposed action was based on the need to ensure that 
studies conducted in free-living wild animals in their natural habitat 
are correctly classified as field studies based on the definition of 
field study.
    We solicited comments concerning our proposal for 60 days ending 
September 29, 1998. We received seven comments. They were from 
universities; animal welfare organizations; an association representing 
birds; an association representing fish, reptiles, and amphibians; and 
an association representing zoos and aquariums. Two commenters 
supported the proposal as written. However, one of these commenters and 
the remaining commenters had concerns that are discussed below.
    One commenter stated that the previous definition of field study 
was perfectly clear and unambiguous and did not need to be amended. In 
addition, two commenters stated that the proposed change in the 
definition of field study would exclude all projects that involve 
invasive procedures. One commenter requested that we delay the change 
of the definition. Two commenters stated that any study has the 
potential to harm or materially alter the behavior of the animals under 
study; therefore, no study could be classified as a field study.
    We do not believe that the previous definition was clear to 
everyone. For instance, two commenters stated that the proposed change 
in the definition of field study would exclude all projects that 
involve invasive procedures. However, the previous definition of field 
study always excluded studies that involved invasive procedures, harmed 
the animals under study, or materially altered the behavior of the 
animals under study. In addition, in the past, some entities 
interpreted the definition to mean that a field study may include any 
one of these situations as long as it did not include all of them. In 
our proposed definition of field study, we clarified that a study that 
includes any one of the situations could not be considered a field 
study.
    As to the use of the word potential, we agree that it is 
unnecessary; therefore, we are removing the word

[[Page 6313]]

potential from the definition of field study in this final rule.
    One commenter stated that the definition is internally 
inconsistent. The commenter stated that if a field study is any study 
conducted on free-living wild animals in their natural habitat 
(emphasis added), then the second part of our definition, which 
excludes a subset of those studies (those that involve invasive 
procedures or have the potential to harm or materially alter the 
behavior of an animal), does not make sense.
    This is a question of sentence structure, which we have addressed 
in this final rule by changing the word ``any'' in the first sentence 
to ``an'' and beginning the second sentence with ``However,''. We 
believe that this change solves the sentence structure problem.
    One commenter stated that the words ``harm,'' ``invasive,'' and 
``materially alter'' should be defined or else the determination of 
whether a study should be classified as a field study will be left to 
the discretion of the Institutional Animal Care and Use Committee 
(IACUC) at different facilities. One commenter stated that the Animal 
and Plant Health Inspection Service (APHIS) should provide definitions 
for invasive or noninvasive, and one commenter stated that APHIS should 
provide guidelines or regulations for defining invasive procedure and 
standard animal husbandry procedures. In addition, one commenter stated 
that APHIS should issue guidelines or a policy to state what the Agency 
classifies as a field study.
    We do not believe that the terms ``harm,'' ``invasive,'' and 
``materially alter'' need to be defined. However, we are considering 
the development of a policy statement that would provide examples of 
what APHIS considers invasive or noninvasive procedures. We do not 
believe that guidelines or regulations for defining standard animal 
husbandry procedures are necessary. Standard animal husbandry 
procedures are procedures that are necessary for the health and 
maintenance of animals on a premises.
    One commenter stated that the proposed definition of field study 
obscures rather than clarifies the intent of field studies. This 
commenter stated that restriction of the term field study to exclude 
invasive procedures does not clarify the definition. This commenter 
stated that field studies have no inherent implication of invasiveness 
and should retain the common and professional meaning of ``the study of 
organisms in the field,'' and after classification as a field study, 
the study should then be qualified as invasive or noninvasive.
    The term field study has always excluded any study that involved an 
invasive procedure; therefore, we have not altered the intent of the 
definition. In order to be absolutely clear as to what constitutes a 
field study, the definition of field study had to provide the 
situations that would exclude a study from being considered a field 
study under the AWA regulations.
    One commenter requested clarification that our proposal would not 
make changes in the administration of the AWA regulations by APHIS and 
IACUC's and that it would not prohibit or restrict field studies or 
impose additional requirements on researchers.
    We only clarified the definition of field study by removing the 
word ``and'' and any ambiguity created by the word ``and.'' We did not 
make substantive changes, prohibit or restrict field studies, or impose 
additional requirements on researchers.
    One commenter stated that the composition of the members of the 
IACUC can vary greatly and the expertise of the membership may not 
represent all disciplines that are subject to review. This commenter 
further stated that the IACUC may not have members experienced in the 
activities commonly conducted in field studies or experience in 
performing certain procedures under field conditions. Another commenter 
stated that most IACUC's do not include field researchers who are able 
to appreciate the unique conditions of field research. One commenter 
stated that a growing number of investigators, institutions, and 
granting agencies require any research use of animals in the field or 
laboratory to be reviewed by their IACUC, and self-determination by the 
investigator does not protect him or her or the institution, nor does 
it provide for consistent peer-reviewed determination of invasive 
procedures.
    Comments regarding the membership and function of IACUC's are 
beyond the scope of this rule; however, in accordance with Sec. 2.31(a) 
of the regulations, the Chief Executive Officer of the research 
facility is responsible for appointing the members of the IACUC. 
Members of the IACUC are required to have the experience and expertise 
to assess the research facility's animal programs, facilities, and 
procedures, including the review of all proposed and ongoing research 
projects.
    The principal investigator is responsible for determining whether a 
study is a field study. If the principal investigator reviews a field 
study protocol and has questions regarding whether a procedure is 
invasive or noninvasive, the investigator can consult with the IACUC of 
the facility. In addition, in accordance with the regulations in 
Sec. 2.31(c)(1), at least once every 6 months the IACUC must review the 
research facility's program for the humane care and use of animals by 
using the AWA regulations as a basis for evaluation. Therefore, if a 
study is misclassified as a field study, the IACUC will have the 
opportunity to take action to reclassify the study.
    One commenter stated that there are studies that involve 
implantation of transponders or radiotransmitters and procedures, such 
as marking the animals with minor clipping or branding, that could 
technically be considered invasive procedures and are not conducted 
under sterile conditions. The commenter further stated that trauma to 
subjects is minimized by reducing the handling time.
    An invasive procedure is typically one in which the living animal 
is entered by either perforation or incision in a manner that could 
cause more than short-lived pain or distress and may materially alter 
the behavior of the animal for more than a short period of time. For 
instance, opening the body cavity of an animal would be considered 
invasive and could cause the animal to materially alter its behavior 
until completely healed from the surgery. However, implantations of 
microchips and transponders may not be invasive depending on the site 
and method of implantation.
    One commenter asked if a facility that is currently licensed as an 
exhibitor under the AWA would have to register as a research facility 
if an employee is approved to initiate a noninvasive research project 
in the field. The commenter stated that it was unclear when a research 
project is considered a regulated research project.
    If the research project meets the definition of field study, the 
research project would not fall under the AWA regulations. However, if 
the research project does not meet the definition of field study (i.e., 
includes an invasive procedure, harms, or materially alters the 
behavior of the animals) the research project would need to be 
regulated under the AWA, and the facility would need to be registered 
as a research facility.
    One commenter stated that he could not locate the statutory 
authority given to the U.S. Department of Agriculture (USDA) over 
animal care in the wild, whether or not the animals are involved in 
research. The commenter stated that the AWA assigns APHIS authority 
over specific warm-blooded animals on

[[Page 6314]]

public display or intended for use in research facilities (7 U.S.C. 
2131). The commenter added that it is not clear how USDA has authority 
if the noninvasive research does not involve animals or activities that 
are in interstate or foreign commerce or does not substantially affect 
such commerce or its free flow as provided in the AWA (7 U.S.C. 2131).
    The purpose of defining the term field study in our regulations is 
to exclude from the regulations those activities that meet the 
definition. Thus, if a study is conducted on free-living wild animals 
in their natural habitat and the study does not involve an invasive 
procedure, does not harm the animals under study, and does not 
materially alter the behavior of the animals under study, then that 
activity is not regulated.
    The AWA defines animal as any live or dead dog, cat, nonhuman 
primate, guinea pig, hamster, rabbit, or such other warm-blooded animal 
as the Secretary may determine is being used, or is intended for use, 
for research, testing, experimentation, or exhibition purposes, or as a 
pet. This definition does not exclude animals in the wild. If a 
research facility conducts a study on animals in the wild that does not 
meet the criteria for a field study, then that activity would be 
regulated. The AWA defines research facility as any school (except an 
elementary or secondary school), institution, organization, or person 
that uses or intends to use live animals in research, tests, or 
experiments and that: (1) Purchases or transports live animals in 
commerce; or (2) receives funds under a grant, award, loan, or contract 
from a department, agency, or instrumentality of the United States for 
the purpose of carrying out research, tests, or experiments. * * *''
    One commenter stated that researchers appear to be circumventing 
the AWA by claiming that trap tests performed on wildlife are field 
studies. Trapping, including the testing of traps, is not regulated by 
the AWA.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, with the 
changes discussed in this document.

Executive Order 12866 and Regulatory Flexibility Act

    This final 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 final rule will clarify that a field study cannot include an 
invasive procedure, harm the animals under study, 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. This rule makes no substantive 
changes to the definition. By clarifying the definition of field study, 
this final rule will help ensure that studies that should be covered 
under the Animal Welfare regulations are covered.
    The only entities that will be affected by this rule will be 
entities that perform studies conducted on free-living wild animals in 
their natural habitat. We estimate that at least 50 entities may be 
affected by this final rule. These entities may be considered small and 
large entities by Small Business Administration standards, but this 
final rule will only affect a small portion of the entities' 
activities. As we are not proposing a substantive change in the 
definition, the effect on these entities will not be significant.
    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 12988

    This final 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.

    Accordingly, we are amending 9 CFR part 1 as follows:

PART 1--DEFINITION OF TERMS

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


Sec. 1.1  Definitions.

* * * * *
    Field study means a study conducted on free-living wild animals in 
their natural habitat. However, this term excludes any study that 
involves an invasive procedure, harms, or materially alters the 
behavior of an animal under study.
* * * * *

    Done in Washington, DC, this 3rd day of February 2000.
Richard L. Dunkle,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 00-2922 Filed 2-8-00; 8:45 am]
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