The Animal Welfare Act at Fifty: Problems and Possibilities in Animal Testing Regulation

• Publication year: 2021
• Citation: Vol. 95

95 Nebraska L. Rev. 194. The Animal Welfare Act at Fifty: Problems and Possibilities in Animal Testing Regulation

The Animal Welfare Act at Fifty: Problems and Possibilities in Animal Testing Regulation

Courtney G. Lee(fn*)

TABLE OF CONTENTS

I. Introduction .......................................... 195

II. Background of the Animal Welfare Act ................ 196
A. Enactment and Evolution .......................... 196
B. Early Amendments ................................ 197
C. Improved Standards for Laboratory Animals Act of 1985 .............................................. 198
D. Institutional Animal Care and Use Committees . . . . 201
E. IACUC Effectiveness .............................. 203

III. Coverage of the AWA .................................. 205
A. What Is an "Animal" under the AWA? .............. 205
B. Legislative Background of the Definition ........... 207
C. Sentience of Unprotected Species .................. 210

IV. The Effectiveness and Necessity of Animal Testing . . . . 217
A. Is Animal Experimentation Effective? .............. 218
B. Alternatives to Animal Testing .................... 221
1. In Vitro Testing ............................... 222
2. In Silico Testing ............................... 223
3. Alternative Testing Advancements in Toxicology ..................................... 226

V. Laboratory Testing in Other Countries ................ 228
A. The European Union .............................. 229
B. Other Countries ................................... 232

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C. Cosmetics Testing in the United States ............ 234

VI. "Spent" Animals ...................................... 236

VII. Recommendations ..................................... 240
A. Expand the Definition of "Animal" ................. 241
B. Increase the Diversity and Power of IACUCs ....... 243
C. Strengthen Commitment to the Three Rs .......... 244
D. Include a Provision Encouraging Adoption for Spent Animals ........................................... 245

VIII. Conclusion ............................................ 247

I. INTRODUCTION

Fifty years ago, lawmakers enacted what was to become the Federal Animal Welfare Act (AWA) with the noble intentions of providing a fundamental groundwork of minimum protections for nonhuman animals used in various contexts, including the focus of this Article-laboratory testing.(fn1) Over that half-century, however, those basic protections have eroded or otherwise proven ineffective. For instance, the species that comprise over 90% of laboratory subjects now are omitted completely from the very definition of "animal" in the statute.(fn2) Further, the law and various paradigms under which many research facilities operate do not reflect current understanding concerning the sentience of those omitted species and their qualifications for protection. The AWA also does not comport with scientific and technological developments that render much of present laboratory testing in the United States unnecessary-testing that many other countries already have enacted laws to prohibit. Also out of step with other countries' laws, the AWA gives no consideration to the futures of living, otherwise adoptable, laboratory animals when they no longer are of use to their research facilities.

There are compelling arguments in favor of animal testing. My mother, herself a proponent of animal welfare, lost a horrible battle with cancer in 2012. Though the medicine she took ultimately was not successful in allowing her to stay here with us, from the many drugs she used initially to fight the disease to the morphine that helped ease her pain at the end, we were grateful for whatever assistance and added time those treatments could provide. Without knowing precisely the procedures involved in licensing those prescriptions, I assume animal testing was involved at least to some extent. Two years later, I

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took a bicycle ride only to wake up a week later with no recollection of the crash that nearly took my life or the days I spent in the ER, where I also likely benefitted from drugs and procedures that had been tested on animals at some point.

As a result, I do not engage in examination and criticism of the AWA and animal testing lightly. Still, the protections afforded by the AWA are just basic, minimum standards of care and treatment. Why are there such drastic distinctions drawn between species as well as other stark limitations in the statute's protections? How necessary and effective is the type of experimentation it endorses in light of today's scientific advancements? Fifty years after enactment, is it time to reevaluate the AWA and make a significant change?

This Article considers these questions and more in the context of animal experimentation under the AWA. Part II summarizes the background of the law, its enactment, and its amendments; Part III discusses the species covered, or not covered, by the AWA; Part IV considers the effectiveness and necessity of current animal testing procedures in light of growing technological advancements; Part V compares laboratory testing in other countries; Part VI explores the fates of laboratory animals no longer needed by their facilities; and Part VII offers some recommendations for improvements to the AWA.

II. BACKGROUND OF THE ANIMAL WELFARE ACT

A. Enactment and Evolution

In the 1960s, Sports Illustrated and Life magazines published disturbing stories documenting a trend whereby people with questionable morals would steal companion animals(fn3) and sell them to scientific research laboratories where the animals not only were subject to painful, often life-ending experiments but were transported and kept in appalling conditions until reaching the laboratory and possibly after.(fn4) In response to the ensuing public outcry, Congress enacted the Labo-

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ratory Animal Welfare Act in 1966, now known simply as the Animal Welfare Act (AWA).(fn5)

This original version of the AWA focused mainly on dogs and cats(fn6) but attempted to regulate animal dealers and research laboratories also handling hamsters, guinea pigs, rabbits, and nonhuman primates.(fn7) Its protections only applied after those entities became licensed or registered, however,(fn8) and they only were required to obtain such certification if they used government funding (research facilities) and engaged in business across state lines (research facilities and dealers).(fn9) If a dealer or research entity operated entirely within state lines, used exclusively nongovernment funds or both, this expanded application of the AWA did not apply.(fn10)

Further, the government body tasked with oversight of AWA compliance, the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) Animal Care program(fn11) had very little authority under the original Act to monitor and regulate the treatment of animals once they reached the laboratories.(fn12) As a previous Deputy Director of APHIS described it, "We only went up to the laboratory door, so to speak."(fn13)

B. Early Amendments

The AWA has been subject to multiple amendments to try to address these and other deficiencies over the fifty years since its enactment-some more comprehensive than others.(fn14) For example, the 1970 Congress updated the AWA's definitions of general terms like "animal," which changed from a specific (though brief) list of species to include all warm-blooded animals used in research except farm ani-

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mals.(fn15) Congress later excepted other particular species used in research.(fn16) The 1970 amendments also added exhibitors to the group of regulated entities-with specific activities such as rodeos and purebred dog and cat shows excluded(fn17) -and increased the authority of the USDA Secretary to conduct inspections and require recordkeeping of those entities subject to AWA regulation.(fn18)

Importantly, these amendments authorized the Secretary to promulgate regulations concerning the humane use and treatment of animals by "dealers, research facilities, and exhibitors," including the "appropriate" use of pain relieving medications during experimentation when determined to be proper by attending veterinarians.(fn19) The Secretary's power was far from absolute, however, and the language deferred substantially to the laboratories, stating that the Secretary could not create regulations regarding "design, outlines, guidelines, or performance of actual research or experimentation by a research facility as determined by such research facility."(fn20) The language did not include explanations of exactly what terms like "performance of actual research or experimentation" mean in this context, allowing for liberal interpretation.(fn21) Although generalized statutory terms can benefit proponents arguing either side of an issue, these exceptions commonly are understood to have granted discretion to research facilities.(fn22) Certain matters are placed outside the regulatory authority of the Secretary when facilities exercise this level of statutory discretion.

C. Improved Standards for Laboratory Animals Act of 1985

In 1976, Congress added animal commerce and transport provisions and addressed the growing problem of organized animal fighting.(fn23) But just under a decade later came some of the most significant research-related amendments to date: the 1985 Improved Standards

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for Laboratory Animals Act (ISLAA).(fn24) ISLAA generated cautious optimism among animal-welfare advocates and vitriol among research scientists participating in animal testing, who feared that the government's intrusion would hamper their progress.(fn25) It seems as if much of this worry was unnecessary, however; while the premise behind IS-LAA, and even its title, gave the impression that it would make great strides in enhancing the humane treatment of...