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

t om. v ilsack@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 S W Washington, DC 20250

k evin.a.shea@aphis.usda.go v

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.org2 of 12

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.org3 of 12

INTRODUCTION

Pursuant to the Right to Petition c lause 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 ” ) regulation s , 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 conduct ing 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 , a nd works toward higher ethical standards in research. For more than twenty

- five years, the Physicians Committee has improve d public safety and public health by ensuring that 1) federally funded medical research uses the best scientific

methods consistent w ith 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 ani mals 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: T he AWA Requires Principal Investigators to Consider

Alternatives to Procedures Likely to Produce Pain or Distress to Animals

One of the fundamental goals of the AW A is the consider ation of alternatives to procedures likely to produce pain or distress in animals. This go al 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 prod uctive

use of Fed eral funds[.] ” Pub. L. No. 99

- 198, § 1751, 99 Stat. 1645 (1985).

Prior to the amendments’ passage, Se nator 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 test ing. ” 131 Cong. Rec. S7394 (daily ed. June 4, 1985). A ccording to4 of 12

Senator Dole, “ The main thrust of the bill is to minimize pain a nd 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 pai n or distress

, ” 7 U.S.C. § 2143(d)(2); and

 the National Agricultural Library provide information “ on improved methods of animal experimentation, in cluding methods which could . . . reduce or replace animal use

, ” 7 U.S.C. § 2143(e)(3)(A)

.

T he 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. Subse ction (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 require ments 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.

T his is p recisely 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) (emp hasis 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 in vestigator 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 “ written5 of 12

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)(ii i ) 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 m inimize 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 Ac t 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

- r elief 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 provi sion 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 inves tigator 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 e mploy procedures likely to produc e pain or distress to animals only if the investigator can “ assure that discomfort and pain to animals will

be limit ed to that which is unavoidable for the conduct of scientifically valuable research

, ” 9 C.F.R. § 2.31(e)(4) (emphasis added ). Th is 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

exp eriments, ” 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); and6 of 12

5. “ that each principal investigator has considered alt ernatives to painful procedures, ” 9 C.F.R. § 2.36(b)(2)

.

II. Factual Background: Medical Schools and Advanced Trauma Life Support Programs Fail to C onsider Alternatives to Procedures Likely to Produce Pain or

Distress to Animals

Despite the statutory mandates of the AWA, m edical schools in the United States

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

students. Among t hese medical schools ar e Johns Hopkins University School of Medicine, University of Mississippi Medical Center, Oregon Health & Science University Scho ol 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/medical

schools

- with

- live

- animal

- laboratories (displaying results of ongoing survey performed 198 5

- 2013).

In training labs at these medical schools

, students place catheters in the arteries, veins,

and heart s of live pigs ; block blood flow to the animals’ heart s 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’ heart s before the anima l s are killed. In other labs, medical students make incisions in the animal s’ abdomen s to insert endoscopes and surgical instruments.

Advanced Trauma Life Support ( “ ATLS ” ) programs also continue to use animals to teach surgical skills. T hese programs incl ud e 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 o

f 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 a n animal ’s ribs, through which a tube is inserted into the animal’s chest cavity; 2) insert ing a needle into the chest cavity; 3) insert ing a needle into the

abdominal cavit y; 4) insert ing a needle under the breast bone and into the pericardium ( the sac surrounding the heart); and 5) mak ing 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 exercise s would produc e 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

. R eg. 36,112

, 36,117 (1989). As such, the written narrative required in each protoc ol submitted for the use of animals in th ese training exercise s must demonstrate that the resulting animal discomfort and pain, in lieu of one

or more of the identified altern atives, “ is unavoida ble for the conduct of scientifically valuable7 of 12

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 me dical 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

sur gery 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 education al methods have all replaced the use of animals. A s of 2013,

 18 3 of 18 7 U.S. and Canadian allopathic a nd osteopathic medical schools use nonanimal methods in medical curricula

, see Physicians Committee, Medical

Schools with No Live Animal Laboratories

, P CRM. ORG (June 17, 2013), http://www.pcrm.org/research/edtraining/meded/medical

- schools

- with

- no

- live

animal

- 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

.

Comparat ive 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.

T he position statements of numerous professional medical associ ations 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 sh ould be developed and employed

, ” and has8 of 12

endorsed specific simulators to repl ace animal use in ATLS courses. See, e.g.

, American College of Surgeons

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

, B ULLETIN

OF THE A MERICAN C OLLEGE OF S URGEONS , 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 e ducation

. ” American Medical Student Association, A MSA 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 po ssible 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 scientificall y 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 i n the absence of regulatory guidance defining what it means, under the AWA,

to “ consider ” a lternatives to procedure s likely to produce pain or distress to animal s
, research

facilities continue to approve procedures using animals in medical training exercises

.

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

T he AWA grant s 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 us e committee ( “ IACUC ” ) “ review

of activities involving animals, ” 9 C.F.R. § 2.31(d) (emphasis added), and an y “ 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 impli cation 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 i d.

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

The AWA and its implemen ting regulations do not define the word “ alternative s, ” but it

is widel y 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 i n carrying out their duties9 of 12

under the AWA . As t he 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 explicit ly rejected the notion that a procedure involving animals is not

“ painful ” when pain is relieved through anesthesia. I d. This means that p rincipal investigators

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

or distress simply by applying pain

- relief drugs or anesthesia

. Because c urrent regulations fail to

make this clear

, howe ver, 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

t h at address the conduct of painful procedures apply.

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

A lternatives 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 contribut e s to the use of procedures that ca use pain or distress to animals, contrary to the goals of the AWA.

One dictionary defines “ consider ” as “ to think about carefully

. ” Consider Definition

, M ERRIAM

- W EBSTER

. C OM

, 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

alterna tives 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

s tep

- 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 slight10 of 12

pain or distress to the animals and provide a written narrative of the methods used

and sources con sulted 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 specialize d 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 consulta nt’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 va riation 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 da tabase 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, co nsistent 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 research11 of 12

facilities, IACUCs, and principal investig ators 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 t hat 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 A lternatives 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 the reunder.” 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 st andards are corrected.” Id. S ee 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 an y “ 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 respec t 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 regul ations “ 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 maintai ned.” 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 fort h in this section.”12 of 12

CONCLUSION

A principal investigator must conduct and demonstrate a reasonable and good faith effort to identify alternativ es 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 investigat or employ a procedure likely to produc e pain or distress to animals. T he

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

narrative is provided but that both ar e adequate by current professionally accept able standar ds.

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 pr oduce 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 d efine “ Alternatives ” ;

2. A mend 9 C.F.R. § 1.1 to c larify d efinition of “ Painful p rocedure ” ; and

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

consideration of alternative s 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 o rders 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.