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Research Ethics: Comments Submitted by APAThe Definition of Animal in the Animal Welfare Act (AWA)April 30, 1999 Docket No. 98-106-1 The Committee on Animal Research and Ethics (CARE) of the American Psychological Association (APA) submits these comments on the petition for rulemaking to amend the definition of animal in the Animal Welfare Act (AWA) regulations so as to remove the current exclusion of rats, mice, and birds (Docket No. 98-106-1). As a standing committee of the APA committed to the humane treatment of laboratory animals, CARE has been involved in developing and regularly updating guidelines for the humane care and treatment of animals in research. The Committee urges rejection of the petition. Executive Summary. CARE urges rejection of the petition on the following grounds, with elaboration below:
Intent. The Alternatives Research and Development Foundation (ARDF) is an affiliate of the American Anti-Vivisection Society (AAVS), an international organization that Aworks to end vivisection (the use of animals in biomedical research, dissection, testing and education)@ (www.aavs.org) Although the ARDF nominally focuses on promoting alternatives, it shares with AAVS the intent of eliminating intact laboratory animal research, education, and testing. The petitioners appeal to Congress's intent in enacting the AWA. Yet the petitioners' intent to end research with laboratory animals and their use of this petition toward that end directly contravene congressional intent, to wit, AMeasures which help meet the public concern for laboratory animal care and treatment are important in assuring that research will continue to progress@ (1985 Amendment, point 4; emphasis added). The existence of federal regulation of and funding for research with laboratory animals endorses the very enterprise the petitioners seek to terminate. Moreover, the AAVS assertion that Avivisection actually harms people as well as animals, by wasting time, effort and money on research of little or no benefit@ (AAVS website) directly contradicts the Congress' premise that AThe 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@ (1985 AWA amendment; emphasis added). Congress' plain intent is to support responsible, ethical research with laboratory animals. The petitioners' omnibus denial of the validity and moral rightness of research with laboratory animals is at odds with historical fact and the public will as expressed in congressional action. The petitioners' appeal to the premises and intents of congressional action when they reject key premises and intents of the AWA is logically suspect. Pragmatics. The petitioners would dismiss the practical impact of this decision. To do so would be harmful to any species already covered or to be covered were the petition successful. AWA enforcement for currently covered species is already minimal and would surely suffer with the proposed change. Moreover, the petitioners provide no evidence of the extent to which the well-being of mice, rats, and birds involved in research would be enhanced with the change. Indeed, the high level of protection afforded by federal, state, local, professional, and institutional policies ensures that the proposed change would reap a marginal, if any, return in the animals' well-being. Existing Public Health Service (PHS) regulations, for instance, have a statutory basis and provide protection for all vertebrate animals -- protection more inclusive than would be provided in USDA regulations amended as proposed by the petitioners. Any researcher prone to Adeny[ing] these animals food, water, appropriate housing, and... inflict[ing] excruciating pain without providing an analgesic@ (Petition Part IV. A) is already subject to meaningful sanctions at several levels. Within psychology, all APA journals and an increasing number of other journals require that authors attest to adherence to APA and/or PHS guidelines for the humane care and use of laboratory animals. This is an excellent example of discipline-specific ethical safeguards. Expanding USDA regulations to include rats, mice, and birds will threaten research and teaching involving these animals at many institutions. Small colleges and universities, which typically operate on smaller budgets and at which fewer faculty share vivaria, will be affected most. Small institutions disproportionately generate future PhDs, due in part to the research experiences afforded there. At some such institutions, learning in a rat, mouse, or bird laboratory contributes importantly to the students' success. The animals' well-being is key to the integrity of these experiences, and the success of science education at these institutions attests to it; good work simply cannot be done with stressed or ill animals. Yet a USDA inspector could require rapid infrastructural changes, despite no threat to the well being of the animals (e.g., installation of humidity monitors in Southern California), that could collapse administrative support for the program. At a small institution, inability to comply with unnecessary and/or redundant regulations could result in the closure of the facility. Given USDA's own assessment of the impracticality of the proposed rule change, these effects cannot reasonably be viewed as Aunintended@ consequences of the petitioners' proposal. The petitioners work to exclude pragmatics from consideration of the proposed rule change, invoking legal precedent on their own behalf. Yet, they step down from this moral and legal high ground when they make a prosaic Arestraint of trade@ argument against the exclusion of rats, mice, and birds from USDA regulation: AThis [exclusion] is a significant impediment for the growth of the [alternatives] company@ (Petition Part I). Thus, the petitioners defend their own pecuniary interests while disallowing how expanded USDA enforcement would impact the public coffers or the ability of research and teaching institutions to prepare the next generation of scientists, health care professionals, and teachers. Incentives. The petitioners assert that, in the absence of USDA enforcement of the AWA, researchers have no incentive to protect their animals, reduce the number of animals used, or explore alternatives. But of course they do. First, there is moral imperative. Second, sick animals and Aunnecessary duplication@ are expensive and time-consuming. Maintaining a vivarium at all is expensive and time consuming. Third, existing federal guidelines to which Institutional Animal Care and Use Committees adhere have a statutory basis and include admonitions to minimize the number of animals used and duplication. Finally, useful data can only be collected from animals who are treated well. Having meaningful data is a terrific incentive to treat animals humanely. According to the ARDF website, Aa comprehensive 1995 Tufts University study [showed that] use of animals in laboratories in the Western world has declined nearly 50% in the last decade.@ Given that the majority of laboratory animals are mice, rats, or birds, this decline must include a decline in use of these species. The Committee realizes that the petitioners are not satisfied with the rate at which research involving laboratory animals is disappearing, but the reduction in numbers used and the rise of the use of alternatives B without USDA regulation B belies the contention that there are no operative incentives to reduce the involvement of laboratory animals in research and teaching. Language. The petitioners seek leverage in word play when they contend that Athe USDA has defined birds, rats, and mice as non-animals@ (Petition Part I). Of course, the USDA has done no such thing. As is typical in legal or legalistic proceedings, the definitional context for Aanimal@ AWA and the USDA regulations provides for a distinction between animals covered by the rules and animals not covered by the rules; no reference to Anon-animals@ appears. The petitioners' use of the term Anon-animals@ in this context is specious and inflammatory. Although the petitioners interpret legislators' comments as Aplainly@ intended to extend protection to these animals, these comments and the final wording of the legislation are open to another interpretation. The petitioners stipulate that Congress was aware in 1970 of the extensive use of mice, rats, and birds in research (Petition Part IV) and infer that Congress refrained from naming these species in the 1970 amendment to ensure that they were covered. This inference is odd, given how unlikely it is that some new, as-yet-unnamed species would burgeon on the research scene. Moreover, the failure to name these species persisted in 1985, casting doubt on the theory that the 1970 wording constituted a Aloophole.@ Contrary to the petitioners' interpretation of the legislative record, the original and subsequent discussions about the AWA demonstrate clear intent to extend coverage selectively, on the basis of species and their use or function. The petitioners' effort to parlay the repeated, conspicuous omission of rats, mice, and birds into evidence of the legislature's Aplain intent@ to afford these species AWA coverage is untenable. The carefully deliberated use of the phrase Amay determine@ to refer to the Secretary's role in enforcement (Aor such other warm-blooded animal as the Secretary may determine is being used...,@ AWA; emphasis added) suggests that Congress did intend to grant the Secretary discretion; otherwise, the phrase Ashall determine@ would have been used. Finally, the petitioners draw on the Supreme Court's ruling concerning congressional intent and individual legislator's comments; the petitioners clearly see some comments sharply limiting the Secretary's discretion as linked to the intent of the final legislation. Another reading, however, is that such suggestions by individuals were ultimately unacceptable to a majority, hence the omission of phrases such as Acertain specific limitations and defined exceptions@ in the final document. Capriciousness. The petitioners allege that exclusion of rats, mice, and birds from USDA regulation is Aarbitrary and capricious.@ If for sake of argument we grant that point, it becomes clear that the proposed change is equally arbitrary and capricious. Under Statements of Fact (Petition Part II), the petitioners wrongly assert that majority of animals used in research are rats, mice, or birds. In fact, the warm-blooded animal most widely used in research, teaching, testing, experimentation, or exhibition in the United States is Homo sapiens. Nonetheless, AWA, USDA regulations, and the petition are silent as to this species' protection. The petitioners' neglect of humans in their proposed redefinition of the term Aanimal@ is arbitrary and capricious. Our point is not that humans should be afforded USDA coverage; human research participants are already protected otherwise B as are rats, mice, and birds. Rather, we wish to illuminate the irony of the petitioners' claim regarding USDA capriciousness. Conclusion. The Committee shares with the petitioners a deep, abiding concern for the health and well-being of laboratory animals. However, the proposed rule change is wrongheaded. It would (1) place unreasonable and unnecessary burdens on colleges and universities, such that providing meaningful laboratory experience would become prohibitively expensive, (2) place additional burdens on the USDA inspection services that would hamper current inspection efforts, (3) not improve the quality of care and treatment of these species of laboratory animals in any substantive way, and (4) by virtue of both covert objectives and unintended consequences, would thwart the public will. For these reasons, we urge that the petition be rejected. Submitted by: APA Committee on Animal Research and Ethics (CARE)
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