Animal Welfare; Petition for Rulemaking

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

[[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

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\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.

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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

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\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

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\16\ Id. sec. 2131 note (emphasis added).

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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

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\17\ Id. sec 2132(g).

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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.

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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

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\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

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\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).

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

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]

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