[Federal Register Volume 64, Number 18 (Thursday, January 28, 1999)]
[Proposed Rules]
[Pages 4356-4367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1920]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 1 and 3
[Docket No. 98-106-1]
Animal Welfare; Petition for Rulemaking
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice of petition and request for comments.
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SUMMARY: We are notifying the public of our receipt of a petition for
rulemaking, and we are soliciting public comment on that petition. The
petition, sponsored by several petitioners, requests that the Secretary
of Agriculture amend the definition of ``animal'' in the Animal Welfare
Act regulations to remove the current exclusion of rats and mice bred
for use in research and birds and grant such other relief as the
Secretary deems just and proper.''
DATES: Consideration will be given only to comments received on or
before March 29, 1999.
ADDRESSES: We are accepting comments in two ways--either in hard copy
or via the Internet. However, comments submitted in either method must
be submitted as described below; comments sent to other than the
physical address or the Internet address listed below will not be
considered. For comments submitted in hard copy, please send an
original and three copies to Docket No. 98-106-1, 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. 98-106-1. Anyone wishing to see copies of comments received
or the petition may do so by coming to 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. Please call
ahead on (202) 690-2817 to facilitate entry into the comment reading
room. Any person who wishes to submit a comment electronically must use
a form located on the Internet at http://comments.aphis.usda.gov.
Electronically submitted comments need only be submitted once. These
comments are available for public viewing at the same Internet address.
FOR FURTHER INFORMATION CONTACT: Dr. Jerry DePoyster, Senior Veterinary
Medical Officer, AC, APHIS, 4700 River Road Unit 84, Riverdale, MD
20737-1228, (301) 734-7833.
SUPPLEMENTARY INFORMATION:
Background
Under the Animal Welfare Act (AWA) (7 U.S.C. 2131 et seq.), the
Secretary of Agriculture is authorized to promulgate standards and
other requirements governing the humane handling, care, treatment, and
transportation of certain animals by dealers, research facilities,
exhibitors, and carriers and intermediate handlers. The Secretary has
delegated responsibility for administering the AWA to the Animal and
Plant Health Inspection Service (APHIS) of the U.S. Department of
Agriculture (USDA). Within APHIS, the responsibility for AWA
administration has been delegated to Animal Care. Regulations
established under the Act are contained in the Code of Federal
Regulations (CFR) in 9 CFR parts 1, 2, and 3. Part 1 contains
definitions for terms used in parts 2 and 3; part 2 contains general
requirements for regulated parties; and part 3 contains specific
requirements for the care and handling of certain animals.
The Secretary has received a petition for rulemaking sponsored by
the Alternatives Research and Development Foundation; In Vitro
International and Rich Ulmer, president of In Vitro International;
Barbara Orlans, senior research fellow at the Kennedy Institute of
Ethics at Georgetown University; George K. Russell, professor for the
Department of Biology at Adelphi University; and Ruy Tchao, associate
professor for the Department of Pharmacology and Toxicology at the
Philadelphia College of Pharmacy and Science. The petition requests the
Secretary of Agriculture to take two actions: (1) Initiate rulemaking
proceedings to amend the definition of ``animal'' contained at 9 CFR
1.1 to eliminate the exclusion of birds, rats, and mice; and (2) grant
such other relief as the Secretary deems just and proper.
The term ``animal'' is defined in the AWA as follows: any live
or dead dog, cat, monkey (nonhuman primate mammal), guinea pig,
hamster, rabbit, or such other warmblooded animal as the Secretary
may determine is
[[Page 4357]]
being used, or is intended for use, for research, testing,
experimentation, or exhibition purposes, or as a pet; but such term
excludes horses not used for research purposes and other farm
animals, such as, but not limited to livestock or poultry used or
intended for use for improving animal nutrition, breeding,
management, or production efficiency, or for improving the quality
of food or fiber. With respect to a dog, the term means all dogs
including those used for hunting, security, or breeding purposes.
We believe that the language ``or such other warmblooded animal as the
Secretary may determine'' gives the Secretary broad power to include or
exclude certain animals from AWA regulation, and we further believe
that the legislative history of the AWA supports this conclusion. For
example, a House Committee report on the 1970 amendments to the AWA
demonstrates that Congress intended for the Secretary to have the
authority to determine which warmblooded animals should be included in
coverage under the Act. In promulgating the AWA regulations, the
Secretary used this discretionary authority to exclude all birds and
the types of rats and mice most commonly bred and used for research
from coverage under the AWA. Accordingly, 9 CFR 1.1 defines ``animal''
for purposes of AWA enforcement as:
any live or dead dog, cat, nonhuman primate, guinea pig,
hamster, rabbit, or any other warmblooded animal, which is being
used, or is intended for use for research, teaching, testing,
experimentation, or exhibition purposes, or as a pet. This term
excludes: Birds, rats of the genus Rattus and mice of the genus Mus
bred for use in research, and horses not used for research purposes
and other farm animals, such as, but not limited to livestock or
poultry, used or intended for use as food or fiber, or livestock or
poultry used or intended for use for improving animal nutrition,
breeding, management, or production efficiency, or for improving the
quality of food or fiber. With respect to a dog, the term means all
dogs, including those used for hunting, security, or breeding
purposes.
Through this definition, the AWA regulations since 1972 have excluded
birds and laboratory rats and mice from coverage. Congress has amended
the AWA numerous times since its enactment but has never expressed any
dissatisfaction with this exclusion.
The reason USDA excludes the types of rats and mice commonly bred
and used for research and birds from coverage under the AWA regulations
is for purposes of effective resource management and because we believe
that the majority of these animals are already being afforded certain
protections. AWA enforcement resources are determined annually by
congressional appropriation. In administering the AWA, Animal Care
constantly strives to use this finite amount of resources as prudently
as possible to meet congressional intent under the law. APHIS enforces
the AWA by inspecting the premises of regulated facilities and taking
regulatory action against persons found to be in violation of the AWA
regulations. In fiscal year 1997, a staff of about 73 Animal Care
inspectors conducted almost 16,000 inspections to ensure compliance
with the AWA regulations. Our goal is to provide effective protection
for as many animals covered by the AWA as we can.
For the last 7 years, the appropriation for AWA enforcement has
been basically constant at about $9.2 million; we anticipate that this
appropriation will remain at the current level in the coming years.
However, because of inflation, the purchasing power of the AWA
enforcement budget decreases from year to year. Level funding has
necessitated the elimination of the financial equivalent of three to
five Animal Care positions per year. Additional information about the
Animal Care programs staffing and accomplishments may be obtained from
the Animal Care home page on the Internet at http://www.aphis.usda.gov/
ac/, by reviewing the Animal Care Annual Report to Congress, or by
calling (301) 734-7799.
We believe that the cost of extending AWA enforcement to all
entities and facilities that handle rats of the genus Rattus, mice of
the genus Mus, and birds for purposes covered by the AWA would be
substantial. We want the public to know that we believe that extending
AWA coverage to laboratory rats, laboratory mice, and birds would
significantly affect overall AWA enforcement, as discussed below.
We also want the public to know that we believe that extending AWA
coverage to laboratory rats, laboratory mice, and birds would have a
substantial financial impact on the affected entities and that the vast
majority of rats, mice, and birds being used in biomedical research are
already being afforded certain protections. USDA and the Public Health
Service (PHS) of the U.S. Department of Health and Human Services
estimate that at least 90 percent of the rats, mice, and birds being
used for research in the United States are provided oversight by PHS
assurance, voluntary accreditation, or both. Most biomedical research
in the United States is performed in laboratories funded at least in
part by PHS. The PHS Policy on Humane Care and Use of Laboratory
Animals covers rats, mice, and birds, in addition to all other live,
vertebrate animals that are involved in activities supported by PHS.
The PHS Policy requires an Animal Welfare Assurance, which commits the
research institution to a program of animal care and use that is
consistent with the Guide for the Care and Use of Laboratory Animals, a
publication produced by the National Research Council to assist
institutions in caring for and using animals in ways judged to be
scientifically, technically, and humanely appropriate. The animal care
standards listed in the Guide are at least consistent with and in many
cases exceed the standards specified in the AWA regulations.
In addition to PHS oversight, many U.S. research facilities are
accredited by the Association for Assessment and Accreditation of
Laboratory Animal Care International (AAALAC). This private
organization, through inspections and reviews, accredits laboratories
that meet or exceed the animal care standards specified in the Guide.
Research facilities seek AAALAC accreditation for assistance with
public relations and in receiving grants. AAALAC currently accredits
approximately 600 U.S. research facilities, and approximately 40
percent of USDA-regulated research facilities are AAALAC accredited.
We have seriously considered the issue of bringing laboratory rats,
laboratory mice, and birds under AWA regulation. As a regulatory
agency, we are required to consider the effects of the regulations we
promulgate and enforce on affected entities. Extending AWA coverage to
facilities that use birds, laboratory rats, or laboratory mice would
affect numerous entities, including many small businesses. As stated
above, many of these entities currently meet PHS and AAALAC
requirements. If these entities come under APHIS regulation, they might
not incur costs associated with coming into compliance with the AWA
requirements. However, these entities would incur costs pertaining to
licensing or registration, and we do not necessarily believe that these
new expenses would translate into a higher standard of protection for
the animals, which are already being maintained in conditions that meet
or exceed the AWA requirements.
The AWA requires USDA to perform at least one inspection of each
regulated research facility every year. U.S. research facilities use
vast numbers of rats and mice in research and testing, and many
research facilities use these species exclusively. In 1990, APHIS
conducted a study of the potential effects of extending AWA protection
to
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laboratory rats, laboratory mice, and birds. The estimated annual cost
for conducting inspections of the additional research facilities that
would come under AWA regulation was at least $3.5 million (in 1990
dollars), or roughly one-third of the current Animal Care budget. This
estimate represents only the minimum additional annual funding that
would have been needed by APHIS to inspect research facilities that use
birds, rats, and mice; it does not include the additional funding that
would have been needed to conduct inspections of breeders, dealers,
carriers, and intermediate handlers of birds, rats, and mice. Also
excluded from this estimate are first-year implementation expenditures
(for training, automobile purchases, etc.) and additional annual
enforcement costs.
The following facts were derived from the 1990 study and an
informal survey of Animal Care managers in 1998:
The number of regulated research facilities in the United
States in 1990 was 2,410. If rats and mice bred for use in research had
been brought under AWA regulation that year, an estimated additional
2,324 research sites would have required inspection. Therefore,
extending AWA protection to laboratory rats and mice alone would have
doubled the number of regulated research facilities.
Regulating the research facilities, breeders, dealers, and
exhibitors that handled birds in 1990 would have added an estimated
2,302 facilities to the Animal Care inspection workload.
To maintain the level of AWA inspections conducted in 1990
and conduct inspections of facilities that deal with rats, mice, and
birds, Animal Care would have needed to hire an estimated additional 34
veterinarians and 16 animal health technicians.
As stated previously, past appropriations have necessitated
reductions in Animal Care staffing. Therefore, a staffing increase of
the magnitude projected in 1990 would be an impossibility within the
current and anticipated Animal Care budget. However, we recognize that
the estimates made in the 1990 study are dated at this point, and we
would appreciate more current data. Commenters are encouraged to
provide information on the numbers of facilities that would come under
AWA regulation today if USDA were to regulate the care provided to rats
and mice bred for use in research and birds.
Despite the resource issues, we have examined many possible courses
of action to bring laboratory rats, laboratory mice, and birds under
AWA protection. Four options and the known and anticipated drawbacks of
each are discussed below:
1. Regulate the care provided to all rats, mice, and birds being
used for purposes covered by the AWA at all facilities, including those
not currently being regulated by USDA.
For APHIS: This option would greatly increase the Animal
Care inspection workload and, therefore, would cause inspection
activities for all currently regulated facilities-especially breeders,
dealers, carriers, and zoos and circuses-to be dramatically curtailed.
In addition, developing regulatory standards for the care
of birds would be difficult, time-consuming, and expensive because the
housing and husbandry needs of avian species vary greatly. All Animal
Care inspectors would need additional training in the veterinary and
husbandry care needs of birds.
For the regulated industry: Entities not currently
regulated by APHIS would need to absorb costs associated with AWA
regulation.
2. Regulate the care provided to all rats, mice, and birds at
research facilities only.
This option would increase the number of research sites
for Animal Care to inspect and, therefore, would seriously compromise
inspection activities for other currently regulated facilities, such as
breeders, dealers, carriers, and exhibitors.
As with option 1, entities not currently subject to
regulation by APHIS would become subject to such regulation, and the
additional costs to these entities would not necessarily result in
greater protection for the animals.
3. Regulate the care provided to all rats and mice at research
facilities only.
Again, this option would increase the number of facilities
Animal Care inspects. However, the number would be less than the
numbers that would result from the adoption of options 1 or 2. This
increase in regulated facilities would also result in reduced
inspection activities for currently regulated facilities.
As with options 1 and 2, research facilities not currently
subject to regulation by APHIS would become subject to such regulation.
4. Maintain the status quo. Do not initiate regulation of
facilities dealing with rats of the genus Rattus, mice of the genus
Mus, and birds.
Current AWA inspection activities would not be adversely
affected, and no additional entities would need to bear the costs of
APHIS regulation.
In addition, we are exploring the possibility of obtaining partial
funding for AWA enforcement through user fee authority. USDA is
considering seeking the statutory authority to charge fees for the
services required to issue and renew licenses and registrations for
conducting AWA-regulated activities. Our goal is to recover
approximately 30 to 40 percent of our current operating expenses
through user fees. However, even if such authority is granted, the
amount collected would likely offset a reduction from the current
appropriation and would not enable Animal Care to extend effective
enforcement services to all facilities that use birds and laboratory
rats and mice. In that context, we are seeking public comment on
whether it would be appropriate to seek authority to charge user fees
for costs associated with any services pertaining to the regulation of
the care provided to laboratory rats, laboratory mice, or birds.
Because these would be new, rather than existing, services, they could
be funded by user fees, with no additional cost to the Federal
Government.
In summary, we believe that extending AWA protection to rats and
mice bred for use in research and birds with current AWA enforcement
resources would have serious consequences for the protection of other
species covered by the AWA regulations. To conduct annual inspections
of research facilities that use rats, mice, and birds, we would need to
reduce by approximately one-third the number of inspections in other
areas, such as breeders and dealers of dogs and cats, commercial
carriers, large and small zoos, and circuses. We believe that such a
reduction in inspection services would greatly compromise our efforts
to ensure AWA compliance of all currently regulated facilities and
adequate protection to all currently covered species.
The petition is reprinted below. We invite comments on the proposed
changes discussed in the petition. In particular, we are soliciting
comments addressing the questions listed below before the petition.
While we are providing this list of questions for the convenience of
persons who wish to submit comments, we will accept written comments in
any format or via the electronic form mentioned previously in
ADDRESSES.
Authority: 7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.2(g).
Done in Washington, DC, this 21st day of January 1999.
Craig A. Reed,
Administrator, Animal and Plant Health Inspection Service.
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Petition for Rulemaking To Amend the USDA Regulation Excluding
Birds, Rats, and Mice From Coverage Under the Animal Welfare Act
Alternatives Research and Development Foundation, 801 Old York
Road, Jenkintown, PA 19046, and Rich Ulmer, President, In Vitro
International, 16632 Milikan Avenue, Irvine, CA 92606, et al. v. Daniel
Glickman, Secretary of Agriculture, U.S. Department of Agriculture,
1400 Independence Ave, S.W., Room 200A, Whitten Building, Washington,
DC 20250.
I. Introduction
Pursuant to the Right to Petition Government Clause contained in
the First Amendment of the United States Constitution,1 the
Administrative Procedure Act,2 and the United States
Department of Agriculture (``USDA'') implementing
regulations,3 petitioners file this petition with the USDA
and respectfully request the Secretary to undertake the following
actions:
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\1\ ``Congress shall make no law * * * abridging * * * the right
of the people * * * to petition Government for a redress of
grievances.'' U.S. Const., amend. I. The right to petition for
redress of grievances is among the most precious of the liberties
safeguarded by the Bill of Rights. United Mine Workers of America,
Dist. 12 v. Illinois State Bar Ass'n, 389 U.S. 217, 222, 88 S. Ct.
353, 356 (1967). It shares the ``preferred place'' accorded in our
system of government to the First Amendment freedoms, and has a
sanctity and a sanction not permitting dubious intrusions. Thomas v.
Collins, 323 U.S. 516, 530, 65 S. Ct. 315, 322 (1945). ``Any attempt
to restrict those First Amendment liberties must be justified by
clear public interest, threatened not doubtful or remotely, but by
clear and present danger.'' Id. The Supreme Court has recognized
that the right to petition is logically implicit in, and fundamental
to, the very idea of a republican form of government. United States
v. Cruikshank, 92 U.S. (2 Otto) 542, 552, 23 L. Ed. 588 (1875).
\2\ 5 U.S.C. 553(e) (1994).
\3\ 7 CFR Subtitle A Sec. 1.28 (1997).
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(1) Initiate rulemaking proceedings to amend the definition of
``animal'' contained at 9 CFR 1.1 to eliminate the exclusion of birds,
rats and mice; and
(2) Grant such other relief as the Secretary deems just and proper.
USDA's regulation excluding ``[b]irds, rats of the genus Rattus,
and mice of the genus Mus bred for use in research'' (hereinafter
referred to as ``birds, rats, and mice'') is arbitrary and capricious,
an abuse of agency discretion and otherwise not in accordance with law.
Petitioners request that a new rulemaking procedure be initiated that
is consistent with the Animal Welfare Act (``AWA'') by regulating
birds, rats, and mice.
I. Petitioners
The AWA, 7 U.S.C. 2131 et seq., is the only federal law regulating
the use of animals in research, testing, and education. The 1985
Amendments, 7 U.S.C. note, to the AWA were passed, in part, because
Congress found that,
(2) methods of testing that do not use animals are being and
continue to be developed which are faster, less expensive, and more
accurate than traditional animal experiments for some purposes and
further opportunities exist for the development of these methods of
testing;
(3) measures which eliminate or minimize the unnecessary
duplication of experiments on animals can result in more productive use
of Federal funds.
Explicit provisions of the AWA require research facilities to
undertake steps in the direction of using alternatives to animals when
an animal experiment causes pain or distress.4 These
requirements must be met whenever ``animals'' are used. Thus, in order
to further the Congressional goals of developing methods of testing
which do not use animals and developing measures which eliminate or
minimize duplication of experiments on animals, the regulatory
definition of ``animal'' is of critical importance. Simply put, if an
animal is defined as not being an animal by regulation, there is no
statutory or regulatory requirement, that alternatives, i.e., non-
animal models, be considered or used instead of that animal. Because
USDA has defined birds, rats, and mice as non-animals, there is no
statutory or regulatory requirement that anyone consider alternatives
to the use of these creatures.
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\4\ 7 U.S.C. 2143(a)(3) and 7 U.S.C. 2143(b)(3).
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This ``Petition for Rulemaking to Amend the USDA Regulation
Excluding Birds, Rats, and Mice from Coverage Under the Animal Welfare
Act'' is filed on behalf of the following petitioners:
Petitioner Alternatives Research and Development Foundation
(``ARDF'') is located at 801 Old York Road, Jenkintown, PA 19046. ARDF
is a four year old nonprofit organization that is affiliated with the
American Anti-Vivisection Society (``AAVS''). ARDF supports the
development and promotes the use of non-animal methods in research,
testing, and education. ARDF has funded numerous in vitro, non-animal
methods, projects to promote the development and use of in vitro
methods. Some of the projects ARDF has funded include, a computer
graphic animations for interactive videodisc alternatives to live
animal teaching, the development of an in vitro alternative to replace
the isolate tissue bath assay, and the development of a simple,
inexpensive alternative to replace mice for small, medium, and large
scale monoclonal antibody production. ARDF also gives the annual Cave
Award to distinguished people who have developed and promoted the use
of alternative methods.
Not only does ARDF sponsor alternative research, but it also works
to educate researchers about the use of in vitro methods. In September
1997, the Johns Hopkins University and The Office for Protection from
Research Risks of the National Institutes of Health (``NIH'') hosted a
workshop on the ``Alternatives in Monoclonal Antibody Production.''
This workshop resulted from ARDF's petition to NIH concerning the
ASCITES method, a painful form of animal research. ARDF also
participated in several workshops sponsored by the organization, Public
Responsibility in Medicine and Research ``PRIM&R'' in March 1998 on
``In Vitro and In Vivo Production of Polyclonal and Monoclonal
Antibodies.'' Petitioner is also organizing workshops for the Third
World Congress on Alternatives and Animal Use in the Life Sciences.
ARDF's programs work to promote the development and use of alternative
methods, however, these programs are frustrated and impeded by USDA's
illegal definition. USDA has illegally defined ``animal'' by excluding
birds, rats, and mice. Consequently, there is no statutory requirement
for researchers to consider alternatives when experimenting on birds,
rats, and mice.
Petitioner Rich Ulmer is the President of In Vitro International
located at 16632 Milikan Avenue, Irvine, CA 92606. Petitioner heads a
science-based, publicly traded company that develops, manufacturers,
and markets laboratory tests to replace animal testing. Agents
represent the company in the United States and around the world.
Petitioner represents one of only three in vitro companies in the
world. In Vitro International, also a petitioner, was established to
protect the well-being of laboratory animals by promoting the
development and use of alternative methods. In Vitro International is
marketing a technology that is intended to minimize animal pain and
distress by promoting ocular and dermal irritation alternatives for
testing the misuse of products such as cosmetics, shampoos, deodorants,
and car wash fluids. Because USDA definition of ``animal'' excludes
birds, rats, and mice from AWA protection, researchers have no
requirement to consider alternative methods before testing,
researching, or experimenting on these ``non-animals.'' This exclusion
affects the company's ability to successfully market non-animal methods
because researchers have no incentive under the AWA to
[[Page 4362]]
consider alternative methods for the excluded animals. As a result, the
company has a limited number of consumers interested in using in vitro
methods. This is a significant impediment for the growth of the company
because birds, rats, and mice encompass the majority of laboratory
animals used in research. Petitioners' interest in preventing inhumane
treatment of these animals is impeded by USDA's failure to require
researchers to consider alternatives before using birds, rats, and
mice.
Petitioner Barbara Orlans resides at 7106 Laverock Lane, Bethesda,
MD 20817. Petitioner is a Senior Research Fellow at the Kennedy
Institute of Ethics at Georgetown University. She received a Bachelor
of Science degree in Physiology and a Masters in Science and a Ph.D.
degree in Physiology. Petitioner is the author of the books Animal
Care: From Protozoa to Small Mammals, In the Name of Science: Issues in
Responsible Animal Experimentation, and the co-author of The Human Use
of Animals: Case Studies in Ethical Choice. She has also written
numerous articles on animals published in peer-reviewed scientific
journals including, ``Animal Pain Scales in Public Policy'',
``Regulation and Ethics of Animal Experiments: An International
Comparison'', and ``Ethical Decision-Making About Animal Experiments.''
Petitioner teaches a course on ethical issues of animal research at
Georgetown University because of her interest in the humane treatment
of animals. She was also founding president of the Scientists Center
for Animal Welfare, a non-profit organization dedicated to educating
scientists about animal issues including the ``three R's,'' reduction,
refinement, and replacement of animal testing methods. For over thirty
years, Orlans has worked to protect the well-being of laboratory
animals. USDA's failure to regulate the use of birds, rats, and mice
provides a disincentive for researchers to use alternatives and thus,
harms and impedes petitioners ability to educate and encourage
researchers and students to use non-animal alternatives.
Petitioner George K. Russell is a professor for the Department of
Biology at Adelphi University, Garden City, NY 11530. He has an A.B.
and a Ph.D. in biology. Petitioner is one of the first to develop a
non-animal approach to teaching undergraduate biology courses. He is
also editor of Orion: People and Nature. The publication is dedicated
to a deeper understanding of human relationships to the environment.
For the past twenty-five years, petitioner has been dedicated to
protecting the well-being of laboratory animals. He has written several
articles urging teachers to avoid experiments that cause harm to
animals. Due to USDA's wrongful exclusion of birds, rats, and mice from
AWA protection, universities are not required under the AWA to consider
the availability of alternatives or the treatment of these ``non-
animals'' when used in animal testing. As a result, students are not
educated about the humane treatment of animals or the use and
availability of alternative methods.
Petitioner Ruy Tchao resides at 404 Cedar Lane, Flourtown, PA
19031. He has a Bachelor of Science degree in Chemistry and a Ph.D. in
Biochemistry. He is an Associate Professor at the Philadelphia College
of Pharmacy and Science in the Department of Pharmacology and
Toxicology. He has written several articles on the research and
development of in vitro methods and the use of these methods as a
viable alternative to animal testing. He has worked with in vitro
methods for seventeen years because he believes that this type of
research can provide more relevant data than the data derived from
animals. The AWA requires research facilities to consider alternatives
when experimentation on an animal may cause pain or distress. However,
USDA has defined birds, rats, and mice as non-animals and as a result,
research facilities are not required to consider alternatives for these
creatures. Thus, petitioner's promotion of the valuable data obtained
from in vitro methods is frustrated and impeded by USDA's definition of
``animal.''
II. Statement of Facts
In 1966, Congress enacted the Federal Laboratory Animal Welfare Act
to address the abuses that develop as a result of experimenting with
animals.5 This Act is the only federal statute designed to
protect animals used in all research facilities.
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\5\ Pub.L. 89-544, 80 Stat. 359 (1966).
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The 1970 amendments enacted a broad definition of animal which
covers ``warm-blooded animals, as the Secretary may determine is being
used, or is intended for use, for research, testing, experimentation or
exhibition purposes.'' 6 This language has remained
throughout both the 1976 and 1985 amendments. Despite this broad
statutory definition, the USDA has excluded birds, rats, and mice from
its regulation defining ``animal.'' 7 As a result of this
exclusion, the majority of all animals used in research are not
protected by the AWA.8
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\6\ 7 U.S.C. 2132(g) (1994).
\7\ 9 C.F.R. 1.1.
\8\ U.S. Congress, Office of Technology Assessment, Alternatives
to Animal Use in Research, Testing, and Education 5 (Washington,
D.C., 1986) (reporting that ``the best data source available--the
USDA/APHIS census--suggests that at least 17 million to 22 million
animals were used in research and testing in the United States in
1983. The majority of animals used--between 12 million and 15
million--were rats and mice.''). Also see USDA's August 6, 1997
response to AAVS' petition (explaining that in 1990 USDA analyzed
the impact of covering mice, rats, and birds and concluded that it
would represent ``a 96 percent increase in the number of animal
research sites under USDA inspection authority'') [hereinafter
``USDA response''].
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Under the AWA, research facilities must meet requirements for
animal care and treatment in order to minimize animal pain and
distress.9 Investigators must also consider alternatives to
any procedure that is likely to produce pain or distress in animals
used for research.10 Contrary to Congressional intent,
USDA's animal welfare regulations do not affect the vast majority of
research facilities because USDA has excluded the majority of
laboratory animals from AWA protection. Consequently, researchers may
research, test, and experiment on birds, rats, and mice without
considering the use of any non-animal alternative methods.
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\9\ 7 U.S.C. 2143(a)(3)(A).
\10\ Id. sec. 2143(a)(3)(B).
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On April 23, 1997, AAVS petitioned USDA requesting the agency to
amend its animal welfare regulations. USDA denied the petition by
claiming that it does not have the resources to regulate these animals
at this time.11 This response is similar to the reply
received by the Humane Society of the United States (``HSUS'') and the
Animal Legal Defense Fund's (``ALDF'') petition requesting USDA to
amend its definition of ``animal.'' A United States District Court
examined the validity of USDA's denial of this petition in Animal Legal
Defense Fund v. Madigan.12 The court held that USDA's denial
of ALDF's rulemaking petition was arbitrary and capricious because USDA
focused on availability of resources and personnel rather than whether
these animals are used for purposes that allow them to receive AWA
protection.13 The court also addressed whether USDA has the
discretion to exclude birds, rats, and mice from AWA coverage. The
court held that USDA's exclusion of these
[[Page 4363]]
animals is arbitrary and capricious and violates the AWA.14
---------------------------------------------------------------------------
\11\ USDA response.
\12\ Animal Legal Defense Fund v. Madigan, 781 F.
Supp.797(D.D.C. 1992), vacated sub nom. Animal Legal Defense Fund v.
Espy, 23 F.3d 496 (D.C. Cir. 1994) (decision vacated because the
court held that plaintiffs lacked standing to sue).
\13\ Madigan, 781 F. Supp. at 805-806.
\14\ Id. at 806.
---------------------------------------------------------------------------
Despite the holding in Madigan, USDA continues to exclude birds,
rats, and mice. Petitioners file this petition because USDA's
regulation defining ``animal'' fails to require the use and development
of non-animal laboratory research alternatives for the majority of
animals used in research, testing, and experimentation. Petitioners are
working to further the AWA's purpose by developing and using
alternative non-animal methods but are impeded due to USDA's definition
of ``animal.'' As long as USDA excludes birds, rats, and mice, all
parts of the AWA and the regulations which mandate consideration about
the use of alternative methods and the minimization or elimination of
painful procedures on animals bypass birds, rats, and mice.
Once USDA promulgates rules that are consistent with the AWA by
regulating birds, rats, and mice, then the new regulatory protection
afforded the majority of laboratory animals will require researchers to
minimize animal distress and pain by considering alternative methods.
As a result, researchers will have an incentive to use in vitro
methods. Thus, in vitro marketers, users, and advocators, including
petitioners, will have an opportunity to promote and encourage the use
of non-animal methods.
III. Statement of the Law
A. AWA Policies and Congressional Findings
1. Congressional Statement of Policy
The Congress finds that animals and activities which are regulated
under this Act (citation omitted) are either in interstate or foreign
commerce or substantially affect such commerce or the free flow
thereof, and that regulation of animals and activities as provided in
this Act (citation omitted) is necessary to prevent and eliminate
burdens upon such commerce and to effectively regulate such commerce,
in order--
(1) To insure that animals intended for use in research facilities
or for exhibition purposes or for use as pets are provided humane care
and treatment;
(2) To assure the humane treatment of animals during transportation
in commerce; and
(3) To protect the owners of animals from the theft of their
animals by preventing the sale or use of animals which have been
stolen.
The Congress further finds that it is essential to regulate, as
provided in this Act (citation omitted), the transportation, purchase,
sale, housing, care, handling, and treatment of animals by carriers or
by persons or organizations engaged in using them for research or
experimental purposes or for exhibition purposes or holding them for
sale as pets or for any such purpose or use.15
---------------------------------------------------------------------------
\15\ 7 U.S.C. 2131 (emphasis added).
---------------------------------------------------------------------------
2. Congressional Findings for 1985 Amendment
(1) The use of animals is instrumental in certain research and
education for advancing knowledge of cures and treatment for diseases
and injuries which afflict both humans and animals;
(2) Methods of testing that do not use animals are being and
continue to be developed which are faster, less expensive, and more
accurate than traditional animal experiments for some purposes and
further opportunities exist for the development of these methods of
testing;
(3) Measures which eliminate or minimize the unnecessary
duplication of experiments on animals can result in more productive use
of Federal funds; and
(4) Measures which help meet the public concern for laboratory
animal care and treatment are important in assuring that research will
continue to progress.16
---------------------------------------------------------------------------
\16\ Id. sec. 2131 note (emphasis added).
---------------------------------------------------------------------------
B. Definitions of ``Animal'' Under AWA and USDA Regulations
1. Animal Welfare Act
The term ``animal'' means any live or dead dog, cats, monkey
(nonhuman primate mammal), 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; but such term excludes horses not
used for research purposes and other farm animals, such as, but not
limited to livestock or poultry used or intended for use for improving
animal nutrition, breeding, management, or production efficiency, or
for improving the quality of food or fiber. With respect to a dog, the
term means all dogs including those used for hunting, security, or
breeding purposes; 17
---------------------------------------------------------------------------
\17\ Id. sec 2132(g).
---------------------------------------------------------------------------
2. USDA Regulations
Animal means any live or dead dog, cat, nonhuman primate, guinea
pig, hamster, rabbit, or any other warm-blooded animal, which is being
used, or is intended for use for research, teaching, testing,
experimentation, or exhibition purposes, or as a pet. This term
excludes: Birds, rats of the genus Rattus and mice of the genus Mus
bred for use in research, and horses not used for research purposes and
other farm animals, such as, but not limited to livestock or poultry,
sed or intended for use as food or fiber, or livestock or poultry used
or intended for use for improving animal nutrition, breeding,
management, or production efficiency, or for improving the quality of
food or fiber. With respect to a dog, the term means all dogs,
including those used for hunting, security, or breeding
purposes.18
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\18\ 9 CFR 1.1 (1997) (emphasis added).
---------------------------------------------------------------------------
C. AWA Standards and Certification Process for Humane Handling, Care,
Treatment and Transportation of Animals
(a)(1) The Secretary shall promulgate standards to govern the
humane handling, care, treatment, and transportation of animals by
dealers, research facilities, and exhibitors.
(3) In addition to the requirements under paragraph (2), the
standards described in paragraph (1) shall, with respect to animals in
research facilities, include requirements--
(A) For animal care, treatment, and practices in experimental
procedures to ensure that animal pain and distress are minimized,
including adequate veterinary care and the appropriate use of
anesthetic, analgesic, tranquilizing drugs, or euthanasia;
(B) That the principal investigator considers alternatives to any
procedure likely to produce pain to or distress in an experimental
animal.
(6)(A) Nothing in this Act (citation omitted)--
(I) Except as provided in paragraphs (7) of this subsection, shall
be construed as authorizing the Secretary to promulgate rules,
regulations, or orders with regard to the design, outlines, or
guidelines of actual research or experimentation by a research facility
as determined by such research facility;
(ii) Except as provided subparagraphs (A) and (C) (ii) through (v)
of paragraph (3) and paragraph (7) of this subsection, shall be
construed as authorizing the Secretary to promulgate rules,
regulations, or orders with regard to the performance of actual
research or experimentation by a research facility as determined by
such research facility;
(7)(A) The Secretary shall require each research facility to show
upon inspection, and to report at least
[[Page 4364]]
annually, that the provisions of this Act (citation omitted) are being
followed and that professionally acceptable standards governing the
care, treatment, and use of animal are being followed by the research
facility during actual research or experimentation.
(B) In complying with subparagraph (A), such research facilities
shall provide--
(I) Information on procedures likely to produce pain or distress in
any animal and assurances demonstrating that the principal investigator
considered alternatives to those procedures;
(ii) Assurances satisfactory to the Secretary that such facility is
adhering to the standards described in this section * * * .
(d) Each research facility shall provide for the training of
scientists, animal technicians, and other personnel involved with
animal care and treatment in such facility as required by the
Secretary. Such training shall include instruction on--
(1) The humane practice of animal maintenance and experimentation;
(2) Research or testing methods that minimize or eliminate the use
of animals or limit animal pain or distress * * * .
(e) The Secretary shall establish an information service at the
National Agricultural Library. Such service shall, in cooperation with
the National Library of Medicine, provide information--
(2) Which could prevent unintended duplication of animal
experimentation as determined by the needs of the research facility;
and
(3) On improved methods of animal experimentation, including
methods which could
(A) Reduce or replace animal use; and
(B) Minimize pain and distress to animals, such as anesthetic and
analgesic procedures.
(f) In any case in which a Federal agency funding a research
project determines that conditions of animal care, treatment, or
practice in a particular project have not been in compliance with
standards promulgated under this Act (citation omitted), despite
notification by the Secretary or such Federal agency to the research
facility and an opportunity for correction, such agency shall suspend
or revoke Federal support for the project * * * 19
---------------------------------------------------------------------------
\19\ 7 U.S.C. 2143 (emphasis added).
---------------------------------------------------------------------------
IV. Consistent With Congressional Intent Under the Animal Welfare
Act, USDA Should Initiate Rulemaking Proceedings To Redefine
``Animal'' To Include Birds, Rats, and Mice
Congress enacted the Animal Welfare Act (``AWA'') and subsequent
amendments to protect animals used in research.20 In order
to further congressional intent, petitioners request that USDA
promulgate regulations that are consistent with the AWA's definition of
``animal.'' The AWA states that:
\20\ Id. Secs. 2131-2157.
---------------------------------------------------------------------------
The term ``animal'' means any live or dead dog, cat, monkey
(nonhuman primate mammal), 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; but such term
excludes horses not used for research purposes and other farm
animals, such as but not limited to livestock or poultry, used or
intended for use as food or fiber, or livestock or poultry used or
intended for improving animal nutrition, breeding, management or
production efficiency, or for improving the quality of food or
fiber. With respect to a dog the term means all dogs including those
used for hunting, security, or breeding purposes.21
---------------------------------------------------------------------------
\21\ Id. sec. 2132(g).
Under the AWA, USDA must provide protection to all warm-blooded
animals used in research. Instead of complying with this mandate,
USDA's regulation excludes birds, rats, and mice from AWA protection
despite the fact that these animals encompass the majority of animals
used in laboratory research. USDA's exclusion of these animals is
arbitrary and capricious and not in accordance with law based upon the
Supreme Court's holding in Chevron U.S.A., Inc. v. Natural Resources
Defense Council, Inc.22 The holding in Chevron directs a
court to apply a two-part test when reviewing an agency's construction
of a statute. First, the court is to look at the plain meaning of the
statute.23 If the statute is unambiguous, then the court and
the agency must give effect to Congress' intent.24 Only if a
statute is silent or ambiguous must the court then move to the second
step under Chevron which requires the court to look at whether the
agencies interpretation of the statute is reasonable.25
---------------------------------------------------------------------------
\22\ 467 U.S. 837 (1984)
\23\ Id. at 842-3.
\24\ Id.
\25\ Id. at 843.
---------------------------------------------------------------------------
A. The First Step of the Chevron Analysis Shows That the Purpose and
Plain Meaning of the Animal Welfare Act Does Not Support the USDA's
Definition of ``Animal''
When promulgating a regulation, an agency must first determine
whether Congress has directly addressed the subject matter at issue.
Under Chevron, an agency must make this decision by determining the
plain meaning of the statute. Ordinarily, the words of a statute must
be interpreted in light of the purpose that Congress intended to serve.
In this case, Congress specifically passed the AWA to provide for the
humane care and treatment of animals used in research, for exhibition,
and as pets.26
---------------------------------------------------------------------------
\26\ 7 U.S.C. 2131.
---------------------------------------------------------------------------
USDA's exclusion of birds, rats, and mice from AWA protection
directly contravenes the AWA's statutory purpose of assuring the humane
treatment of laboratory animals. The effect of USDA's regulation is
that the regulated industry will never be in violation of the AWA
regardless of how it treats birds, rats, and mice. For example, under
the AWA, research facilities can deny these animals food, water,
appropriate housing and can also inflict excruciating pain without
providing an analgesic. In this case, not only does the exclusion of
these animals have no relevance to any of the stated purposes of the
Act, but the inclusion of these animals would insure that animals used
in research facilities are provided humane care and treatment as the
AWA requires.
Furthermore, the Congressional findings for the 1985 amendments
state that ``methods of testing that do not use animals are being and
continue to be developed which are faster, less expensive, and more
accurate than traditional animal experiments for some purposes and
further opportunities exist for the development of these methods of
testing.'' 27 Due to USDA's failure to provide birds, rats,
and mice AWA protection, the use of alternative methods for these
species is rarely, if ever, undertaken. In fact, in USDA's response to
the AAVS petition, the agency stated that regulating birds, rats, and
mice would constitute a ninety-six percent increase in regulated
research facilities. USDA's own figure indicates that the majority of
researchers are choosing to use birds, rats, or mice instead of
alternatives. By using these animals, facilities can escape inspection
and bypass the Act's requirement that they consider alternatives.
Because
[[Page 4365]]
USDA has exempted these animals from the definition of ``animal'',
there is no incentive for the use or advancement of alternative methods
for the majority of animals used in research. This practice is contrary
to the AWA's purpose of advancing alternatives. Therefore, in light of
the general tenet ``to favor interpretation which would render
statutory design effective in terms of policies behind its enactment
and to avoid interpretation which would make such policies more
difficult of fulfillment,'' 28 the AWA's purpose supports
the definition of birds, rats, and mice as animals and their regulation
in research.
---------------------------------------------------------------------------
\27\ Id. sec. 2131 note (emphasis added).
\28\ Motor & Equipment Manufacturers Ass'n, Inc. v. E.P.A., 627
F.2d 1095 (D.C. Cir. 1979), cert. denied, General Motors Corp. v.
Costle, 446 U.S. 952 (1980).
---------------------------------------------------------------------------
The plain meaning of the AWA also shows that USDA's regulation
defining ``animal'' is inconsistent with the statute. The AWA indicates
that if an animal is warm-blooded and used for research, testing, or
experimentation, then the animal is an ``animal'' for AWA purposes.
Furthermore, Congress has explicitly stated which limited subset of
animals the Secretary is authorized to exclude by stating:
Such term (animal) excludes horses not used for research
purposes and other farm animals, such as, but not limited to
livestock or poultry, used or intended for use as food or fiber, or
livestock or poultry used or intended for improving animal
nutrition, breeding, management or production efficiency, or for
improving the quality of food or fiber. With respect to a dog the
term means all dogs including those used for hunting, security, or
breeding purposes.29
---------------------------------------------------------------------------
\29\ Id. sec. 2132(g).
Although, birds, rats, and mice are not included in this list of
excluded animals, the Secretary has arbitrarily decided to exclude them
from the protections of this Act.
A Congressional report issued in 1986 provides further evidence
that USDA's regulation contradicts the AWA's plain meaning. The Office
of Technology Assessment (``OTA'') conducted a study to analyze the
scientific, regulatory, economic, legal, and ethical considerations
involved in alternative technologies in biomedical and behavioral
research, toxicity testing, and education.30 The report lays
out numerous policy issues and options for Congressional action and
reiterates the AWA's inconsistency with USDA's regulation. The OTA
report concludes that the exclusion of mice and rats from the
protections of the AWA is inconsistent with the language of the Act and
``appears to frustrate the policy Congress sought to implement in 1970
and consequently to be beyond the Secretarys authority.'' 31
---------------------------------------------------------------------------
\30\ U.S. Congress, Office of Technology Assessment,
Alternatives to Animal Use in Research, Testing, and Education
(1986) [hereinafter OTA Report].
\31\ Id. at 278.
---------------------------------------------------------------------------
In support of its exclusion of birds, rats, and mice, the USDA
argues in its response to the AAVS petition that the AWA ``gives the
Secretary of Agriculture broad discretionary authority to exclude rats
of the genus Rattus, mice of the genus Mus, and birds.'' 32
This argument, however, is in direct contrast to USDA's prior position
where it stated that it had no discretion to exclude warm-blooded
animals used in research. The agency previously explained:
---------------------------------------------------------------------------
\32\ USDA response at 1.
* * * Gerbils became a regulated species when the 1970
amendments to the Act expanded the definition of ``animal'' to
include ``such other warm-blooded animal, as the Secretary may
determine is being used, or is intended for use for research,
testing * * * .'' We do not have the authority to remove these
animals from the coverage of the regulations.33
---------------------------------------------------------------------------
\33\ 54 FR 10824 (March 15, 1989).
USDA admits in the gerbil example that it has no discretionary
authority to deny protection to warm-blooded animals used in research
under the AWA. In fact, the Secretary has promulgated an entire subset
of generic animal welfare regulations that govern the care and handling
of animals not specifically mentioned in the statute but are covered by
the AWA because they are warm-blooded and used for
research.34 These generic regulations address animal care
including feeding, watering, temperature, cage space, and handling.
---------------------------------------------------------------------------
\34\ 9 CFR 3.125 (subpart f).
---------------------------------------------------------------------------
USDA has also admitted that birds, rats, and mice are used for the
purposes described in the AWA.35 However, USDA's generic
animal care regulations do not cover birds, rats, and mice. This
exclusion leaves these species with no minimum standards for their
care, no protections under the Act, and no legal barriers preventing
cruelty, intentional or negligent deprivation of food, water, shelter
or veterinary care. These effects are contrary to Congress' stated
purpose under the AWA of providing humane care and treatment for
animals used in research.36
---------------------------------------------------------------------------
\35\ Madigan, 781 F. supp. at 801.
\36\ U.S.C. 2131.
---------------------------------------------------------------------------
Based on this information, the purpose and plain meaning of the AWA
indicates that USDA's exclusion of birds, rats, and mice contradicts
and frustrates the AWA. Furthermore, the interpretation of the AWA as
explained in the OTA report, USDA's admissions, and USDA`s own
regulations indicates that the exclusion is inconsistent with the
statute. A Chevron step one analysis shows that the statute is
unambiguous and, therefore, USDA should immediately redefine the term
``animal'' and regulate birds, rats, and mice.
B. The Second Step of the Chevron Analysis Shows That the Definition of
``Animal'' Is Not Reasonable
The second step of the Chevron analysis is only necessary if the
statute is ambiguous. The key issue is ``whether the agency's view that
[its construction] is appropriate in the context of this particular
program is a reasonable one.'' 37 In this case, even if the
AWA statutory language is ambiguous, USDA's regulation is not
reasonable. Applying Chevron to this case presents the issue of whether
USDA has the discretion to exclude birds, rats, and mice from the
definition of ``animal.''
---------------------------------------------------------------------------
\37\ Chevron, 467 U.S. at 845.
---------------------------------------------------------------------------
1. The Animal Welfare Act's Legislative History Does Not Support USDA's
Regulation Defining ``Animal''
Congress first passed the AWA in 1966 and defined ``animal'' as a
``live dog, cat, monkey (nonhuman primate mammal), guinea pig, hamster
and rabbit.'' 38 This language limited AWA protection to six
specific species. However in 1970, Congress amended the statute to
include ``such other warm-blooded animal as the Secretary may determine
is being used, or intended for use, for research, testing,
experimentation.'' 39 This language broadened the number of
species protected under the Act and has remained throughout both the
1976 and 1985 amendments.
---------------------------------------------------------------------------
\38\ 80 Stat. 350, 351 (1966).
\39\ 7 U.S.C. 2132(g).
---------------------------------------------------------------------------
The legislative history of the AWA provides no indication that
Congress authorized the Secretary's regulation excluding birds, rats,
and mice. When the AWA was amended in 1970, Congress was aware of the
wide use of birds, rats, and mice in research but did not explicitly
deny these animals protection under the Act. Instead, Congress used the
phrase ``warm-blooded animal'' in order to expand the species of
animals protected by the Act.
If Congress had intended for the Secretary to have unlimited
discretion to designate which warm-blooded animals were to be protected
under the Act, then the legislature would have specifically stated it
in the statute. Not
[[Page 4366]]
only is there no statutory language granting USDA unlimited discretion,
but the legislative history also reveals that Congress did not intend
for the Secretary to have broad discretion. This intent is evident by
Congress' rejection of Representative Whitehurst's proposed amendment
which defined ``animal'' to include ``any warm-blooded animal, as
determined by the Secretary.'' 40 This amendment would have
given the Secretary the discretion to choose which warm-blooded animals
would be protected by the Act and thus would support USDA's exclusion
of birds, rats, and mice.
---------------------------------------------------------------------------
\40\ Hearings before the Subcommittee on Livestock and Grains of
the House Agricultural Committee on H.R. 13957 to Amend the 1966
Act, 91st Cong., 2d Sess. 84 (1970).
---------------------------------------------------------------------------
Instead of amending the AWA to give the Secretary broad discretion
to exclude animals, Congress wanted to expand the definition of
``animal'' to include more species while specifically delineating which
animals would be exempted. The house and floor discussions support this
assertion:
Rep. Thomas Foley (D-Washington), speaking on behalf of the
House Agriculture Committee, remarked that ``(t)his bill, within its
definition includes all warm-blooded animals designated by the
Secretary, with certain specific limitations and defined
exceptions.'' 41
---------------------------------------------------------------------------
\41\ 116 Cong. Rec. H40154 (Dec. 7, 1970) (emphasis added).
---------------------------------------------------------------------------
Rep. Catherine May (R-Washington), urging her colleagues to
approve the legislation described the bill: ``First, it expands the
definition of the term `animal' to include more species. The present
law applies only to live dogs, cats, rabbits, hamsters, guinea pigs,
and monkeys. All warm-blooded animals designated by the Secretary of
Agriculture, with limited exceptions would be included.''
42
---------------------------------------------------------------------------
\42\ 116 Cong. Rec. H40156 (Dec. 7, 1970) (emphasis added).
---------------------------------------------------------------------------
Rep. Wiley Mayne (R-Iowa) agreed that the bill ``expands the
definition of covered animals to include all warm-blooded animals
designated by the Secretary, rather than just live dogs, cats,
rabbits, hamsters, guinea pigs, and monkeys.'' 43
---------------------------------------------------------------------------
\43\ 116 Cong. Rec. H40158 (Dec. 7, 1970) (emphasis added).
---------------------------------------------------------------------------
Rep. Wilmer Mizell (R-North Carolina) explained that ``[t]his
bill includes provisions regulating the transportation, purchase,
sale, housing, care, handling and treatment of warm-blooded animals
used in research * * * (m)ore species of animals will be protected:
all warm-blooded animals designated by the Secretary of Agriculture,
with but a few specific exceptions.'' 44
---------------------------------------------------------------------------
\44\ 116 Cong. Rec. H40159 (Dec. 7, 1970) (emphasis added).
---------------------------------------------------------------------------
Rep. Robert Price (R-Texas) remarked that the bill ``extends the
definition to include all warm-blooded animals designated by the
Secretary of Agriculture, with certain specific limitations and
defined exceptions.'' 45
---------------------------------------------------------------------------
\45\ 116 Cong. Rec. H40159 (Dec. 7, 1970) (emphasis added).
The Supreme Court has stated that when ``statements of individual
legislators * * * are consistent with the statutory language and
legislative history, they provide evidence of Congress' intent.''
46 The statements from these individual legislatures all
indicate that Congress intended the AWA to cover all warm-blooded
animals used in research, including birds, rats, and mice with only a
few specific exceptions.
---------------------------------------------------------------------------
\46\ Brock v. Pierce County, 476 U.S. 253, 106 S.Ct. 1834
(1986).
---------------------------------------------------------------------------
A House Committee on Agriculture report which accompanied the
proposed bill also supports this premise: ``This bill includes within
its definition all warm-blooded animals designated by the Secretary
with only limited and specifically defined exceptions.'' 47
Additionally, a letter from then Secretary of Agriculture J. Phil
Campbell to W.R. Poage, Chairman of the Committee on Agriculture,
explained that ``(i)f Federal regulation of laboratory animals is
extended to all warm-blooded animals, we suggest it would be
appropriate and consistent to extend the species of animals presently
regulated under (the AWA) to include all warm-blooded animals.'' Not
only does the legislative history show Congress' intent in expanding
the number of animals protected by the AWA, but it also shows that the
Secretary of Agriculture understood and supported Congress' purpose.
---------------------------------------------------------------------------
\47\ H.R. Rep. No. 1651, 91st Cong., 2d Sess., reprinted in 1970
U.S.C.C.A.N. 5103, 5104 (emphasis added).
---------------------------------------------------------------------------
Based on the legislative history, it is unreasonable to conclude
that Congress amended the AWA in order to provide more animals
protection while also giving the Secretary the broad discretion to
exclude the majority of animals used in research, testing, and
experimentation. The only discretion Congress granted the Secretary was
the authority to determine whether warm-blooded animals are being used
for research, testing, or experimentation. Indeed, in Madigan, the
court looked at USDA's discretionary authority and found that, ``since
the USDA does not dispute that birds, rats, and mice are used for
[research] purposes, it is inconsistent with the plain meaning of the
statute and `the unambiguously expressed intent of Congress to exclude
them from coverage under the Act.' '' 48 The court also
conducted a Chevron step two analysis and found that the agency's
definition of ``animal'' was not supported by the legislative
history.49
---------------------------------------------------------------------------
\48\ 781 F. Supp. at 801 (citation omitted).
\49\ Id. at 802.
---------------------------------------------------------------------------
The legislative history along with the reasoning in the Madigan
decision shows that USDA does not have the discretion to choose which
warm-blooded animals used in research it will deny AWA protection. The
effect of USDA's exclusion demonstrates its illegality, because the
majority of laboratory animals are not presently covered by USDA's
animal welfare regulations. Based on this information, USDA's exclusion
of birds, rats, and mice is ultra vires because Congress has not
specifically granted the agency authority to decide on a matter that
Congress has already addressed.
2. USDA Has Not Reasonably Justified Its Regulation Excluding Birds,
Rats, and Mice From Animal Welfare Protection
USDA's interpretation of the AWA is not reasonable because it does
not satisfy the Chevron step-two framework. In Chevron, the Supreme
Court found that EPA's construction of the Clean Air Act was reasonable
because the agency: (1) Advanced a reasonable explanation for its
conclusion that the regulations serve the statutory objectives; (2)
balanced competing statutory concerns in a technical and complex
regulatory scheme; and (3) engaged consistently and historically in a
search to review and question its policy on a continuing
basis.50
---------------------------------------------------------------------------
\50\ Chevron, 467 U.S. 863-65.
---------------------------------------------------------------------------
In this case, USDA has failed to show the reasonableness of its
regulation. In fact, USDA enacted its regulation excluding birds, rats,
and mice in 1971 without any explanation showing how the exclusion of
these animals meets the AWA's objective in providing for the humane
treatment of animals. 51 In 1989, when questioned about the
exclusion, the agency stated ``we do have the authority to regulate
these animals, though except for wild rats and mice, we have never
covered them in our regulations. However, * * * we are considering
developing regulations and standards for them.'' 52 Nine
years have passed since this statement and during this time, the agency
has failed to initiate any rulemaking proceedings to regulating birds,
rats, and mice. USDAs failure to give any explanation for its arbitrary
exclusion of these animals does not demonstrate reasoned decision-
making. The Supreme Court addressed the issue of agency deference by
stating:
\51\ 36 FR 24917-27 (Dec. 24, 1971).
\52\ 54 FR 10823 (March 15, 1989).
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[[Page 4367]]
Agency deference has not come so far that we will uphold
regulations wherever it is possible to conceive a basis for
administrative action * * * Thus the mere fact that there is ``some
rational basis within the knowledge and experience of the
(regulators)'' under which they ``might have concluded'' that the
regulation was necessary to discharge their statutorily authorized
mission, will not suffice to validate agency decisionmaking * * *
Our recognition of Congress need to vest administrative agencies
with ample power to assist in the difficult task of governing a vast
and complex industrial Nation carries with it the correlative
responsibility of the agency to explain the rationale and factual
basis for its decision, even though we show respect for the agency's
judgement in both.53
---------------------------------------------------------------------------
\53\ Bowen v. Am. Hosp. Ass'n., 476 U.S. 610, 627 (1986)
(citations omitted).
Whether USDA has discretionary authority under the AWA to exclude these
animals was addressed in Madigan. Judge Richey found that USDA's
argument for discretionary authority under the Act was ``strained and
unlikely.'' 54 USDA has not shown that excluding birds,
rats, and mice is reasonable. Therefore, USDA should redefine
``animal'' in accordance with the AWA.
---------------------------------------------------------------------------
\54\ Animal Legal Defense Fund, 781 F. Supp. at 800-806
---------------------------------------------------------------------------
C. USDA Was Arbitrary and Capricious in Refusing AAVS's Petition To
Initiate Rulemaking Proceedings
The only explanation USDA gave for denying AAVS' petition for
rulemaking was that it was not economically practical.55 In
denying AAVS' petition, USDA analyzed the increase cost that would
result from regulating birds, rats, and mice. Based on that
information, USDA decided not to grant these animals AWA protection.
USDA's reliance on budgetary constraints is arbitrary and capricious
because the agency failed to consider the many parts of the Act that
are self implementing.56
---------------------------------------------------------------------------
\55\ USDA response at 1-2.
\56\ See eg., 7 U.S.C. 2143 (a)(7)(A) (requiring each research
facility to provide information on procedures that may produce pain
or distress in animals and also provide assurances that alternatives
were considered) 7 U.S.C. 2136 (every research facility shall
register with the Secretary).
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In Madigan, the court explained that ``birds, rats, and mice could
be included in the definition without requiring the expenditure of
significant agency resources'' because the AWA includes many provisions
that are self-implementing by the regulated industry.57 By
regulating these animals, researchers would be required to treat
animals humanely without any action from the agency. In Madigan, the
court held that USDA's denial of ALDF's rulemaking petition based upon
the availability of resources and increase cost was arbitrary and
capricious and not in accordance with law.58 Based upon the
Madigan decision, USDA's denial of a rulemaking petition to redefine
``animal'' based solely on economic reasons is not valid. Therefore,
USDA should grant this petition by initiating rulemaking proceedings to
regulate birds, rats, and mice consistently with the AWA.
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\57\ 781 F. Supp. at 803.
\58\ Id.
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V. Agency Action Requested
The AWA's purpose and plain meaning, Congress' legislative intent,
and the reasoning in Madigan show that birds, rats, and mice should be
granted protection under the AWA. Furthermore, the USDA has
acknowledged that it has the authority to regulate rats and mice and
has admitted that the agency was considering developing regulations for
these animals.59 However, the agency's continual delay in
addressing this matter along with its justification for denying these
animals protection is unreasonable and demands further consideration.
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\59\ 54 FR 10,823.
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Therefore, for the reasons cited in this petition, the petitioner
requests that the USDA immediately amend its current definition to
include mice, rats, and birds under the AWA. The proposed regulation
should be amended to read as follows:
Animal means any live or dead dog, cat, nonhuman primate, guinea
pig, hamster, rabbit, or any other warm-blooded animal, which is being
used, or is intended for use for research, teaching, testing,
experimentation, or exhibition purposes, or as a pet. This term
excludes horses not used for research purposes and other farm animals,
such as, but not limited to livestock or poultry, used or intended for
use as food or fiber, or livestock or poultry used or intended for use
for improving animal nutrition, breeding, management, or production
efficiency, or for improving the quality of food or fiber. With respect
to a dog, the term means all dogs, including those used for hunting,
security, or breeding purposes.
Except as described above, petitioners know of no other similar
issue, act, or transaction to this petition currently being considered
or investigated by any USDA office, other federal agency, department,
or instrumentality, state municipal agency or court, or by any law
enforcement agency.
As required by 7 CFR Subtitle A Sec. 1.28, the USDA is required to
give this petition prompt consideration. Petitioner is requesting a
substantive response to this petition within ninety (90) calendar days.
In the absence of an affirmative response, petitioners will be
compelled to consider litigation in order to achieve the agency actions
requested.
The undersigned certifies that, to the best knowledge and belief of
the undersigned, this petition includes all information and views on
which the petition relies, and that it includes representative data
known to the petitioner which are unfavorable to the petition.
On behalf of the petitioners,
Andrew Kimbrell, Esq.,
Joseph Mendelson, III, Esq.,
Tracie Letterman, Esq.,
International Center for Technology Assessment, 310 D Street, NE,
Washington, DC 20002, (202) 547-9359.
Of Counsel,
Valerie Stanley,
Animal Legal Defense Fund, 401 East Jefferson Street, Suite 206,
Rockville, MD 20850.
Attorneys for Petitioners.
[FR Doc. 99-1920 Filed 1-27-99; 8:45 am]
BILLING CODE 3410-34-P
