[Federal Register Volume 64, Number 18 (Thursday, January 28, 1999)]
[Proposed Rules]
[Pages 4356-4367]
From the Federal Register Online via the Government Printing 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

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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

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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).
---------------------------------------------------------------------------

    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
---------------------------------------------------------------------------

    \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).

---------------------------------------------------------------------------

[[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
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    \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