UNITED STATES DEPARTMENT OF AGRICULTURE

ANIMAL AND PLANT HEALTH INSPECTION SERVICE

PETITION FOR RULEMAKING

Submitted to:

Thomas J. Vilsack

Secretary

U.S. Department of Agriculture

Mail Stop 0101

Suite 200A, Whitten Building 

1400 Independence Avenue SW

Washington, DC 20250

tom.vilsack@usda.gov

Kevin A. Shea

Administrator

Animal and Plant Health Inspection Service

U.S. Department of Agriculture

Room 312-E, Whitten Building

1400 Independence Avenue SW

Washington, DC 20250

kevin.a.shea@aphis.usda.gov

Date:

October 30, 2013

Reply to:

Mark Kennedy, Director of Legal Affairs

Physicians Committee for Responsible Medicine

5100 Wisconsin Avenue NW, Suite 400

Washington, DC 20016

(202) 527-7315

mkennedy@pcrm.org
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John J. Pippin, M.D., F.A.C.C., Director of Academic Affairs

Physicians Committee for Responsible Medicine

5100 Wisconsin Avenue NW, Suite 400

Washington, DC 20016

(972) 407-9396

jpippin@pcrm.org
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INTRODUCTION

Pursuant to the Right to Petition clause of the First Amendment of the United States 

Constitution, the Administrative Procedure Act, 5 U.S.C. § 553(e), and U.S. Department of 

Agriculture (“USDA”) regulations, 7 C.F.R. § 1.28, the Physicians Committee for Responsible 

Medicine (“Physicians Committee”) respectfully requests that USDA halt widespread violations 

of the Animal Welfare Act (“AWA”) in medical training exercises by conducting a rulemaking 

to amend USDA regulations regarding the consideration of alternatives to procedures likely to 

produce pain or distress to animals. 

The Physicians Committee is a nonprofit 501(c)(3) organization that advocates for 

preventive medicine, conducts clinical research, and works toward higher ethical standards in 

research. For more than twenty-five years, the Physicians Committee has improved public safety 

and public health by ensuring that 1) federally funded medical research uses the best scientific 

methods consistent with the highest ethical principles and 2) research facilities carry out medical 

research and training involving animals in accordance with the federal Animal Welfare Act and 

its implementing regulations. 

Since 1985, Physicians Committee has conducted an ongoing survey of the use of live 

animal laboratories in research facilities in the United States and Canada. As demonstrated 

below, common usage by the medical community establishes that alternatives to procedures 

likely to produce pain or distress to animals are equivalent or superior to procedures that use 

animals. The Physicians Committee submits this petition on behalf of more than 150,000 

members, including more than 10,000 physicians.

STATEMENT OF GROUNDS

I. Legal Background: The AWA Requires Principal Investigators to Consider 

Alternatives to Procedures Likely to Produce Pain or Distress to Animals

One of the fundamental goals of the AWA is the consideration of alternatives to 

procedures likely to produce pain or distress in animals. This goal is explicit in both the text of 

the AWA and the legislative history of the 1985 amendments that pertain to alternatives. For 

example, in the bill enacting the 1985 amendments, Congress found 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” and that “measures which eliminate or 

minimize the unnecessary duplication of experiments on animals can result in more productive 

use of Federal funds[.]” Pub. L. No. 99-198, § 1751, 99 Stat. 1645 (1985).

Prior to the amendments’ passage, Senator John Chafee of Rhode Island stated that 

Congress “most certainly should not condone the inhumane treatment of animals nor should we 

undertake experiments which sacrifice the lives of animals unnecessarily.” 131 Cong. Rec. 

S10,790 (daily ed. Aug. 1, 1985). Senator Robert Dole of Kansas similarly stated “that we need 

to ensure the public that adequate safeguards are in place to prevent unnecessary abuses to 

animals, and that everything possible is being done to decrease the pain of animals during 

experimentation and testing.” 131 Cong. Rec. S7394 (daily ed. June 4, 1985). According to
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Senator Dole, “The main thrust of the bill is to minimize pain and distress suffered by animals 

used for experiments and tests.” 131 Cong. Rec. S17,923 (daily ed. Dec. 18, 1985).

Toward these goals, Congress included in the AWA four explicit requirements regarding 

alternatives. The AWA requires USDA to ensure that:

 “the principal investigator considers alternatives to any procedure likely to 

produce pain to or distress in an experimental animal,” 7 U.S.C. § 

2143(a)(3)(B);

 research facilities provide “assurances demonstrating that the principal 

investigator considered alternatives to” procedures likely to produce pain or 

distress to any animal, 7 U.S.C. § 2143(a)(7)(B)(i); 

 research facilities provide training opportunities on “research or testing 

methods that minimize or eliminate the use of animals or limit animal pain or 

distress,” 7 U.S.C. § 2143(d)(2); and

 the National Agricultural Library provide information “on improved methods 

of animal experimentation, including methods which could . . . reduce or 

replace animal use,” 7 U.S.C. § 2143(e)(3)(A).

The AWA requires USDA to set standards regarding the handling, care, treatment, and 

transportation of animals. In subsection 2143(a)(3) of the statute, Congress established minimum 

requirements for regulations regarding animals in research facilities. Subsection (A) requires 

“that animal pain and distress are minimized” in experimental procedures. 7 U.S.C. § 

2143(a)(3)(A). The very next subsection, (B), requires that principal investigators consider 

alternatives to any procedure likely to produce pain to or distress in an experimental animal. 7 

U.S.C. § 2143(a)(3)(B). The subsequent two subsections, (C) and (D), establish requirements for 

painful and major operative procedures involving animals. See 7 U.S.C. § 2143(a)(3)(C)-(D). 

Subsection (E) imposes requirements on exceptions to the standards. 7 U.S.C. § 2143(a)(3)(E).

The only logical reading of these provisions taken together is that researchers may 

undertake procedures likely to produce pain or distress to animals only if no alternatives exist. 

This is precisely the interpretation intended by Congress. As Senator Chafee explained when 

Congress was considering the 1985 amendments regarding alternatives, the new provisions 

“would minimize the use of animals by directing researchers to consider alternatives. . . . In 

those cases which require the use of animals, researchers would be directed to seek the least 

painful methods, and to use pain-relieving drugs and anesthesia to minimize the animals’ 

distress.” 131 Cong. Rec. S10,790 (daily ed. Aug. 1, 1985) (emphasis added).

USDA regulations regarding animals in research appear in regulatory subsection 

2.31(d)(1) and track the requirements in statutory subsection 2143(a)(3). Like the statute, 

regulation 2.31(d)(1)(i) begins by requiring that “[p]rocedures involving animals will avoid or 

minimize discomfort, distress, and pain to the animals.” Compare 9 C.F.R. § 2.31(d)(1)(i)

(emphasis added) with 7 U.S.C. § 2143(a)(3)(A). Again tracking the statute, regulation 

2.31(d)(1)(ii) requires that the “principal investigator has considered alternatives to procedures 

that may cause more than momentary or slight pain or distress to the animals.” Compare 9 

C.F.R. § 2.31(d)(1)(ii) with 7 U.S.C. § 2143(a)(3)(B). The regulation also requires a “written 
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assurance that the activities do not unnecessarily duplicate previous experiments,” in keeping 

with the statutory goal to “prevent unintended duplication of animal experimentation.” Compare

9 C.F.R. § 2.31(d)(1)(iii) with 7 U.S.C. § 2143(e)(2). The subsequent provisions of the regulation 

mimic their counterparts in subsection 2143(a)(3) of the statute by establishing detailed medical 

care and handling requirements for painful and major operative procedures involving animals. 

Compare 9 C.F.R. § 2.31(d)(1)(iv)-(v), (vii), (ix)-(xi) with 7 U.S.C. § 2143(a)(3)(C)-(D).

Principal investigators must do more than merely think about alternatives to comply with 

the AWA mandate to “consider” alternatives. The statute and the regulations unambiguously 

mandate that researchers avoid or minimize pain or distress to animals. 7 U.S.C. § 

2143(a)(3)(A); 9 C.F.R. § 2.31(d)(1)(i). Additionally, USDA has explained that “under the Act, a 

procedure in which pain is relieved is still considered to be a painful procedure, and the 

provisions of the Act which address the conduct of painful procedures apply.” 54 Fed. Reg. 

36,112, 36,117 (1989) (emphasis added). This means that principal investigators cannot comply 

with the regulatory mandate to avoid or minimize pain or distress simply by applying pain-relief 

drugs or anesthesia. Only by implementing alternatives to procedures that use animals—and not 

merely thinking about them—can investigators actually avoid or minimize pain or distress, as 

required by the AWA.

The regulations further support this interpretation, most obviously in the provision 

requiring that principal investigators who intend to use animals in their research first consider 

alternatives to procedures likely to produce pain or distress. That provision mandates that the 

principal investigator “provide[s] a written narrative description of the methods and sources . . . 

used to determine that alternatives were not available.” 9 C.F.R. § 2.31(d)(1)(ii). This language, 

which requires the principal investigator to provide written proof of a good faith effort to identify 

alternatives, makes sense only if the investigator must perform some action of consequence, e.g., 

implementation, upon identifying viable alternatives.

If, after performing the requisite good faith search, the principal investigator determines 

that no alternatives exist, the investigator may employ procedures likely to produce pain or 

distress to animals only if the investigator can “assure that discomfort and pain to animals will 

be limited to that which is unavoidable for the conduct of scientifically valuable research,”

9 C.F.R. § 2.31(e)(4) (emphasis added). This mandate to consider alternatives is so fundamental 

that USDA’s regulations require principal investigators and research facilities to document all of 

the following:

1. “description of the methods and sources . . . used to determine that alternatives 

were not available,” 9 C.F.R. § 2.31(d)(1)(ii);

2. “assurance that the activities do not unnecessarily duplicate previous 

experiments,” 9 C.F.R. § 2.31(d)(1)(iii);

3. “rationale for involving animals, and for the appropriateness of the species and 

numbers of animals to be used,” 9 C.F.R. § 2.31(e)(2);

4. “description of procedures designed to assure that discomfort and pain to animals 

will be limited to that which is unavoidable for the conduct of scientifically 

valuable research,” 9 C.F.R. § 2.31(e)(4); and
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5. “that each principal investigator has considered alternatives to painful 

procedures,” 9 C.F.R. § 2.36(b)(2).

II. Factual Background: Medical Schools and Advanced Trauma Life Support 

Programs Fail to Consider Alternatives to Procedures Likely to Produce Pain or 

Distress to Animals

Despite the statutory mandates of the AWA, medical schools in the United States 

continue to rely on procedures likely to produce pain or distress to animals in teaching their 

students. Among these medical schools are Johns Hopkins University School of Medicine, 

University of Mississippi Medical Center, Oregon Health & Science University School of 

Medicine, and University of Tennessee Health Science Center College of Medicine in 

Chattanooga. Physicians Committee, Medical School Curricula with Live Animal Laboratories, 

PCRM.ORG (Sept. 3, 2013), http://www.pcrm.org/research/edtraining/meded/medicalschools-with-live-animal-laboratories (displaying results of ongoing survey performed 1985-

2013).

In training labs at these medical schools, students place catheters in the arteries, veins, 

and hearts of live pigs; block blood flow to the animals’ hearts to cause the normally painful 

condition known as myocardial ischemia; and inject the animals with drugs. Students open 

animals’ chest cavities and shock and massage the animals’ hearts before the animals are killed.

In other labs, medical students make incisions in the animals’ abdomens to insert endoscopes and 

surgical instruments.

Advanced Trauma Life Support (“ATLS”) programs also continue to use animals to teach 

surgical skills. These programs include those operated by Baystate Medical Center in 

Springfield, Mass., Hartford Hospital in Hartford, Conn., North Dakota State University/Sanford 

Health in Fargo, N.D., and University of Texas Medical Branch in Galveston, Tex. Physicians 

Committee, Survey of ATLS Programs, PCRM.ORG (Feb. 26, 2013), http://www.pcrm.org/

search/?cid=471 (displaying results of ongoing survey performed 2007-2013).

ATLS courses follow a prescribed curriculum provided by the American College of 

Surgeons. In each course involving animals, the same set of surgical procedures are taught, 

including 1) making an incision between an animal’s ribs, through which a tube is inserted into 

the animal’s chest cavity; 2) inserting a needle into the chest cavity; 3) inserting a needle into the 

abdominal cavity; 4) inserting a needle under the breast bone and into the pericardium (the sac 

surrounding the heart); and 5) making incisions in the animal’s throat, into which a breathing 

tube is inserted. The animals are killed after these procedures.

Because the procedures taught in these and similar training exercises would produce pain

or distress to animals in the absence of pain-relief drugs or anesthesia, “the provisions of the Act 

which address the conduct of painful procedures apply.” 54 Fed. Reg. 36,112, 36,117 (1989). As 

such, the written narrative required in each protocol submitted for the use of animals in these 

training exercises must demonstrate that the resulting animal discomfort and pain, in lieu of one 

or more of the identified alternatives, “is unavoidable for the conduct of scientifically valuable 
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research.” See 9 C.F.R. § 2.31(e)(4). As set forth below, it is not possible to make such a 

demonstration.

Routine training exercises involving well-established medical techniques do not 

constitute “scientifically valuable research.” This is clear from AWA regulations, which, in 

defining what constitutes an “[a]ctivity” subject to the AWA, recognize that there are distinctions 

among “research, testing, or teaching procedures.” See 9 C.F.R. § 1.1. Importantly, any 

reasonable and good faith effort to identify alternatives to procedures likely to cause pain or 

distress to animals in medical training exercises will identify validated, widely implemented 

alternatives that are employed by many medical centers.

High-fidelity, lifelike, and programmable human patient simulators are now a mainstay 

of medical education at most U.S. medical schools. Computer-based learning such as interactive 

basic science and clinical programs are used to teach everything from anatomy and physiology to 

surgery techniques. Didactic teaching methods, class and small-group clinical case discussions, 

standardized patient exercises, echocardiography, observed surgeries and other procedures, 

faculty-mentored hands-on training, and many other progressive educational methods have all 

replaced the use of animals. As of 2013, 

 183 of 187 U.S. and Canadian allopathic and osteopathic medical schools use 

nonanimal methods in medical curricula, see Physicians Committee, Medical 

Schools with No Live Animal Laboratories, PCRM.ORG (June 17, 2013), 

http://www.pcrm.org/research/edtraining/meded/medical-schools-with-no-liveanimal-laboratories; Physicians Committee, Medical School Curricula with Live 

Animal Laboratories, PCRM.ORG (Sept. 17, 2013), http://www.pcrm.org/research/

edtraining/meded/medical-schools-with-live-animal-laboratories;

 277 of 281 U.S. and Canadian ATLS courses use nonanimal training models, see

Physicians Committee, Survey of ATLS Programs, PCRM.ORG (Feb. 26, 2013), 

http://www.pcrm.org/search/?cid=471; and

 207 of 209 U.S. and Canadian pediatrics residency programs use nonanimal 

methods to each endotracheal intubation, see Physicians Committee, Survey of 

Animal Use Pediatrics Training, PCRM.ORG (Aug. 19, 2013), http://www.pcrm.org/

search/?cid=1582.

Comparative studies show that both students and instructors prefer simulation-based 

education to the use of animals. Student test scores are equivalent or superior when nonanimal 

methods are used, and student skills testing is improved by using simulation methods compared 

to animals. Medical school course directors, curriculum directors, simulation center directors, 

and other education professionals are on record supporting the replacement of animals. 

The position statements of numerous professional medical associations also agree that 

live animals should not be used in medical training when alternatives exist. The American 

College of Surgeons, which accredits and oversees ATLS programs, has stated that “wherever 

feasible, alternatives to the use of live animals should be developed and employed,” and has 
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endorsed specific simulators to replace animal use in ATLS courses. See, e.g., American College 

of Surgeons, Statement on the Use of Animals in Research, Education, and Teaching, BULLETIN 

OF THE AMERICAN COLLEGE OF SURGEONS, Oct. 2002, at 16, available at http://www.facs.org/

fellows_info/statements/st-10.html. The American Medical Student Association “[s]trongly 

ENCOURAGES the replacement of animal laboratories with non-animal alternatives in 

undergraduate medical education.” American Medical Student Association, AMSA Constitution 

& Bylaws / Internal Affairs Preamble, Purposes and Principles 98 (2013), available at

http://www.amsa.org/AMSA/Libraries/Misc_Docs/2013_PPP.sflb.ashx.

Under the circumstances, it is not possible for a principal investigator’s written narrative 

to demonstrate that animal pain or distress in the context of training “is unavoidable for the 

conduct of scientifically valuable research” because objective evaluation and common usage by 

the medical community establishes that alternatives are equivalent or superior to procedures that 

use animals. Yet in the absence of regulatory guidance defining what it means, under the AWA, 

to “consider” alternatives to procedures likely to produce pain or distress to animals, research 

facilities continue to approve procedures using animals in medical training exercises.

III. Action Requested: Amend USDA Regulations to Ensure Compliance with the AWA

The AWA grants USDA, which in turn has delegated to its Animal and Plant Health 

Inspection Service (“APHIS”), the authority to promulgate regulations regarding the 

consideration of alternatives to procedures likely to produce pain or distress to animals. Although 

the AWA prohibits USDA from acting with respect to “the design, outlines, or guidelines” and 

“the performance of actual research or experimentation,” 7 U.S.C. § 2143(a)(6)(A), USDA 

retains the authority to regulate institutional animal care and use committee (“IACUC”) “review 

of activities involving animals,” 9 C.F.R. § 2.31(d) (emphasis added), and any “proposal to 

conduct an activity involving animals, or to make a significant change in an ongoing activity

involving animals,” 9 C.F.R. § 2.31(e) (emphasis added). “Activity means . . . those elements of 

research, testing, or teaching procedures that involve the care and use of animals.” 9 C.F.R. § 

1.1. This term appears in the regulations “in lieu of ‘protocol’ to avoid any misunderstanding or 

implication that APHIS intends to become involved in the evaluation of the design, outlines, 

guidelines, and scientific merit of proposed research.” 54 Fed. Reg. 36,112, 36,114 (1989)

(discussing the terms “animal care and use procedure” and “activity”). Thus, USDA is 

authorized to regulate “how the research will treat or affect an animal, the condition of an 

animal, and the circumstances under which an animal is maintained.” See id. 

A. Amend 9 C.F.R. § 1.1 to Define “Alternatives”

The AWA and its implementing regulations do not define the word “alternatives,” but it 

is widely recognized, and Policy #12 of USDA’s Animal Care Resources Guide confirms, that 

“[a]lternatives or alternative methods are generally regarded as those that incorporate some 

aspect of replacement, reduction, or refinement of animal use in pursuit of the minimization of 

animal pain and distress consistent with the goals of the research.” USDA, Animal Care 

Resource Guide 12.1 (Mar. 25, 2011), http://www.aphis.usda.gov/animal_welfare/downloads/

policy/Policy 12 Final.pdf (hereinafter “Policy #12”). The Animal Care Resources Guide is an 

internal USDA reference document intended only to assist inspectors in carrying out their duties 
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under the AWA. As the Guide is neither statute nor regulation, USDA should amend 9 C.F.R. § 

1.1 to define “alternative” as set forth in Policy #12.

B. Amend 9 C.F.R. § 1.1 to Clarify Definition of “Painful Procedure”

According to current USDA regulations, “Painful procedure as applied to any animal 

means any procedure that would reasonably be expected to cause more than slight or momentary 

pain or distress in a human being to which that procedure was applied, that is, pain in excess of 

that caused by injections or other minor procedures.” 9 C.F.R. § 1.1. As noted above, USDA has 

clarified in the Federal Register that “under the Act, a procedure in which pain is relieved is still 

considered to be a painful procedure, and the provisions of the Act which address the conduct of 

painful procedures apply.” 54 Fed. Reg. 36,112, 36,117 (1989). 

USDA has explicitly rejected the notion that a procedure involving animals is not

“painful” when pain is relieved through anesthesia. Id. This means that principal investigators 

cannot comply with the regulatory mandate to employ methods that minimize or eliminate pain 

or distress simply by applying pain-relief drugs or anesthesia. Because current regulations fail to 

make this clear, however, USDA should amend the definition, in 9 C.F.R. § 1.1, of “[p]ainful 

procedure” as follows: 

Painful procedure as applied to any animal means any procedure that would 

reasonably be expected to cause more than slight or momentary pain or distress in 

a human being to which that procedure was applied, that is, pain in excess of that 

caused by injections or other minor procedures. A procedure in which pain is 

relieved is still considered to be a painful procedure, and the provisions of the Act 

that address the conduct of painful procedures apply.

C. Amend 9 C.F.R. § 2.31(d)(1)(ii) to Provide Guidance on Considering

Alternatives to Procedures Likely to Produce Pain or Distress to Animals

Neither the AWA nor USDA’s implementing regulations set forth exactly what must

occur when “the principal investigator considers alternatives to any procedure likely to produce 

pain to or distress in an experimental animal,” 7 U.S.C. § 2143(a)(3)(B). As shown above, this 

glaring lack of regulatory guidance contributes to the use of procedures that cause pain or 

distress to animals, contrary to the goals of the AWA.

One dictionary defines “consider” as “to think about carefully.” Consider Definition, 

MERRIAM-WEBSTER.COM, http://www.merriam-webster.com/dictionary/consider (last visited 

Oct. 7, 2013). It is clear from the legislative history and the text of the AWA, however, that 

Congress intended for principal investigators to do much more than carefully think about 

alternatives to procedures likely to cause pain or distress to animals. USDA has recognized 

Congress’s intent by including, in Policy #12 of the Animal Care Resources Guide, the following 

step-by-step guidance regarding the consideration of alternatives:

The Animal Welfare Act (AWA) regulations require principal investigators to 

consider alternatives to procedures that may cause more than momentary or slight 
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pain or distress to the animals and provide a written narrative of the methods used 

and sources consulted to determine the availability of alternatives, including 

refinements, reductions, and replacements.

. . .

Alternatives should be considered in the planning phase of the animal use 

proposal. As indicated when these regulations were finalized in 1989, APHIS 

continues to recommend a database search as the most effective and efficient 

method for demonstrating compliance with the requirement to consider 

alternatives to painful/distressful procedures. However, in some circumstances (as 

in highly specialized fields of study), conferences, colloquia, subject expert 

consultants, or other sources may provide relevant and up-to-date information 

regarding alternatives in lieu of, or in addition to, a database search. Sufficient 

documentation, such as the consultant’s name and qualifications and the date and 

content of the consult, should be provided to the IACUC to demonstrate the 

expert’s knowledge of the availability of alternatives in the specific field of study. 

For example, an immunologist cited as a subject expert may or may not possess 

expertise concerning alternatives to in vivo antibody production.

When a database search is the primary means of meeting this requirement, the 

narrative should include:

1. the name(s) of the databases searched (due to the variation in subject

coverage and sources used, one database is seldom adequate);

2. the date the search was performed;

3. the time period covered by the search; and

4. the search strategy (including scientifically relevant terminology) used.

. . .

Regardless of the alternatives sources(s) used, the written narrative should include 

adequate information for the IACUC to assess that a reasonable and good faith 

effort was made to determine the availability of alternatives or alternative 

methods. If a database search or other source identifies a bona fide alternative 

method (one that could be used to accomplish the goals of the animal use 

proposal), the written narrative should justify why this alternative was not used.

. . .

Although additional attempts to identify alternatives or alternative methods are 

not required by Animal Care at the time of each annual review of an animal 

protocol, Animal Care would normally expect the principal investigator to 

reconsider alternatives at least once every 3 years, consistent with the triennial de 

novo review requirements of the Public Health Service Policy on Humane Care 

and Use of Laboratory Animals (IV,C,5). 

Policy #12, supra, at 12.1–12.3. 

As noted above, the Animal Care Resources Guide is an internal reference document 

intended only to assist USDA inspectors in carrying out their duties under the AWA. It is neither 

statute nor regulation, and it is not widely available to the public. As a result, many research 
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facilities, IACUCs, and principal investigators are unaware of USDA’s expectations regarding 

the consideration of alternatives to procedures likely to cause pain or distress to animals. Even 

when they are aware of the content of the Animal Care Resources Guide, research facilities and 

their staff may interpret USDA’s somewhat vague regulations in a manner that does not reflect 

the spirit of the statute. USDA should correct this deficiency in its regulations by amending 9 

C.F.R. § 2.31(d)(1)(ii) to include all of the requirements set forth in Policy #12.

D. Amend 9 C.F.R. § 2.31(a) to Acknowledge USDA’s Authority to Enforce 

Regulations Regarding the Consideration of Alternatives to Procedures

Likely to Produce Pain or Distress to Animals

The AWA requires the Secretary of USDA to “make such investigations or inspections as 

he deems necessary to determine whether any . . . research facility . . . has violated or is violating 

any provision of [the AWA] or any regulation or standard issued thereunder.” 7 U.S.C. § 

2146(a). USDA must “inspect each research facility at least once each year and, in the case of 

deficiencies or deviations[,] . . . conduct such follow-up inspections as may be necessary until all 

deficiencies or deviations from such standards are corrected.” Id. See also 9 C.F.R. § 2.38(b)(iv). 

The AWA also authorizes USDA to assess civil penalties on research facilities that violate the 

AWA or its regulations and to issue cease and desist orders to stop continuing violations. 7 

U.S.C. § 2149(b).

USDA is authorized to regulate IACUC “review of activities involving animals,” 9 

C.F.R. § 2.31(d), and any “proposal to conduct an activity involving animals,” 9 C.F.R. § 

2.31(e). At the same time, the AWA prohibits USDA from acting with respect to “the design, 

outlines, or guidelines” and “the performance of actual research or experimentation.” 7 U.S.C. § 

2143(a)(6)(A). USDA has defined “activity” to include “those elements of research, testing, or 

teaching procedures that involve the care and use of animals,” but has not defined “design, 

outlines, or guidelines.” 9 C.F.R. § 1.1. 

In a 1989 Federal Register notice regarding USDA’s regulatory definitions, USDA 

explained the distinction among the terms, noting that “activity” appears in the regulations “in 

lieu of ‘protocol’ to avoid any misunderstanding or implication that APHIS intends to become 

involved in the evaluation of the design, outlines, guidelines, and scientific merit of proposed 

research.” 54 Fed. Reg. 36,112, 36,114 (1989). According to USDA, “activity” “is descriptive of 

the areas with which we [USDA] are concerned under the regulations, namely, how the research 

will treat or affect an animal, the condition of an animal, and the circumstances under which an 

animal is maintained.” Id. This clarification is absent from USDA’s regulations, however.

To optimize enforcement of the AWA, USDA’s authority to regulate how “research will 

treat or affect an animal, the condition of an animal, and the circumstances under which an 

animal is maintained” should be explicitly set forth in USDA’s regulations. USDA should amend 

9 C.F.R. § 2.31(a) by adding, as a final sentence, the following: “APHIS is authorized to issue 

orders to correct deficiencies or deviations from the standards set forth in this section.”
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CONCLUSION

A principal investigator must conduct and demonstrate a reasonable and good faith effort 

to identify alternatives to procedures likely to produce pain or distress to animals. Only if the 

principal investigator determines that no such alternatives exist and demonstrates that discomfort 

and pain to animals is unavoidable for the conduct of scientifically valuable research may the 

principal investigator employ a procedure likely to produce pain or distress to animals. The 

AWA authorizes USDA to ensure not only that a search for alternatives and an accompanying 

narrative is provided but that both are adequate by current professionally acceptable standards. 

To reverse the widespread abuse of the AWA and USDA regulations, the Physicians 

Committee respectfully requests that USDA conduct a rulemaking to clarify and amend its 

regulations involving the consideration of alternatives to procedures likely to produce pain or 

distress to animals. Specifically, the Physicians Committee requests that USDA, in the manner 

set forth above:

1. Amend 9 C.F.R. § 1.1 to define “Alternatives”;

2. Amend 9 C.F.R. § 1.1 to clarify definition of “Painful procedure”; and

3. Amend 9 C.F.R. § 2.31(d)(1)(ii) to include specific requirements for the 

consideration of alternatives to procedures likely to produce pain or distress to 

animals.

4. Amend 9 C.F.R. § 2.31(a) by adding, as a final sentence, “APHIS is authorized 

to issue orders to correct deficiencies or deviations from the standards set forth 

in this section.”

As provided for in 7 C.F.R. § 1.28, the Physicians Committee requests “prompt consideration” of 

this petition.