2
Use of Dogs and Cats in Research: Public Perception and Evolution of Laws and Guidelines

Dogs and cats occupy a particularly important place in American society in their roles as companion, work, and hobby animals. In addition, they serve as important animal models for research that has advanced both human and animal health. This multifaceted relationship with humans has fostered an uneasy tension between general society and the scientific community, and this tension has intensified as the stature of pet dogs and cats has risen in many households to that of family member. The specter of lost or stolen pets being used for research has evolved from a galvanizing concern into increasing resistance to the use of any former pet for research. Over the years the public’s concern about the welfare of research animals, and dogs and cats in particular, has been instrumental in the development of laws, guidelines, and policies that affect research with all types of animals.

It is thus not possible to accurately assess the desirability and necessity of using random source dogs and cats, and in particular those from Class B dealers, for research without taking into account public perceptions, the impact of the animal protection movement both on public attitudes and on the availability of these animals for research, changing trends in the use of animal models for research, and responses of the scientific community to all of these factors. The evolution of laws, policies, and guidelines regarding the use of dogs and cats in research has been an accurate barometer of these changing trends.

In particular, in 2007 the Senate considered the Pet Safety and Protection Act, which became the impetus for Congress to charge the National Institutes of Health (NIH) to determine the humane and scientific issues



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2 Use of Dogs and Cats in Research: Public Perception and Evolution of Laws and Guidelines Dogs and cats occupy a particularly important place in American society in their roles as companion, work, and hobby animals. In addition, they serve as important animal models for research that has advanced both human and animal health. This multifaceted relationship with humans has fostered an uneasy tension between general society and the scientific community, and this tension has intensified as the stature of pet dogs and cats has risen in many households to that of family member. The specter of lost or stolen pets being used for research has evolved from a galvanizing concern into increasing resistance to the use of any former pet for research. Over the years the public’s concern about the welfare of research animals, and dogs and cats in particular, has been instrumental in the develop- ment of laws, guidelines, and policies that affect research with all types of animals. It is thus not possible to accurately assess the desirability and necessity of using random source dogs and cats, and in particular those from Class B dealers, for research without taking into account public perceptions, the impact of the animal protection movement both on public attitudes and on the availability of these animals for research, changing trends in the use of animal models for research, and responses of the scientific community to all of these factors. The evolution of laws, policies, and guidelines regard- ing the use of dogs and cats in research has been an accurate barometer of these changing trends. In particular, in 2007 the Senate considered the Pet Safety and Protec- tion Act, which became the impetus for Congress to charge the National Institutes of Health (NIH) to determine the humane and scientific issues 31

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32 ISSUES IN THE USE OF RANDOM SOURCE DOGS AND CATS IN RESEARCH associated with the use of random source dogs and cats in research. Con- sequently, NIH asked the National Academies to assemble a committee of experts to address the statement of task shown in Chapter 1. This chapter provides a review of these issues to set the context for subsequent chapters that focus on the use of random source animals, and animals from Class B dealers in NIH-funded research. PuBLIC PERCEPTIONS OF DOgS AND CATS AND OF THEIR uSE IN RESEARCH The public’s perception of their pets, and of animals in general, has been one of the main driving forces behind the legislation that created and refined the Animal Welfare Act (AWA). It is estimated that nearly half of all U.S. households have at least one dog or cat, with a total population of 72 million dogs and nearly 82 million cats (American Veterinary Medical Association [AVMA] 20071,2). In a survey conducted by the American Ani- mal Hospital Association (20043), approximately 94% of owners attributed human personality traits to their pets and said they would risk their lives for their pet. Indeed, in urban disasters, pet owners risk their lives (and those of rescue workers) when they fail to evacuate or attempt to reenter an unsafe building or area to save a pet (Heath et al. 1998). In addition, pet owners spend over $11 billion per year on veterinary care (American Pet Products Association 2008 survey4), and the pet products industry contributes over $50 billion to the U.S. economy, with the exponential growth of pet super- stores, play parks, day care centers, and training centers. Assessments of pet ownership and the state of affairs of dogs and cats in the U.S. must take into account the plight of homeless animals. However, it is impossible to provide a current or accurate estimate of the numbers of animals that enter shelters or are euthanized because there is no federal requirement to gather or release such data, shelters may obscure or refuse to release data to avoid negative publicity, and there is no reliable public list of shelters. Furthermore, although “shelter” or “pound” is defined in this report as a “facility that operates as a pound or shelter (e.g., a humane soci- ety or other organization established for the purpose of caring for animals), under contract with a state, county, or city, and that releases animals on a voluntary basis” the shelter data provided in this chapter may include statis- tics from other facilities commonly referred to as shelters. In the absence of 1 http://www.hsus.org/pets/animal_shelters/common_questions_about_animal_shelters_and_ animal_control.html#Why_are_there_so_many_animals_in_animal_ 2 http://www.petpopulation.org/index.htm 3 American Animal Hospital Association 2004 Pet Owner Survey; http://www.aahanet.org/ media/graphics/petownersurvey2004.pdf 4 http://www.americanpetproducts.org/press_industrytrends.asp

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33 PUBLIC PERCEPTION AND EVOLUTION OF LAWS AND GUIDELINES accurate statistics, the estimated number of animals euthanized in shelters was 4.5 and 4.6 million in 1999 and 2000, respectively (Clifton 2002). The inflow of animals into shelters varies considerably by area of the country and even among shelters within an area (Scarlett 2004). Several sources have suggested that 6–12% of the dog population entered shelters in the 1990s and that approximately 50–55% were euthanized (representing 4% of the total dog population) (Patronek and Glickman 1994; Wenstrup and Dowidchuk 1999), and that 5–8% of the estimated population of owned cats entered shelters and 65–80% of those (or roughly 3–6% of the total population of owned cats) were euthanized (Arkow 1994; Wenstrup and Dowidchuk 1999). Although those percentages have likely changed since the 1990s, one might be able to make a rough estimate of the shelter intake numbers for any given year by taking AVMA demographic numbers of owned dogs and cats and multiplying them by the percentages above. According to the 2007 AVMA U.S. Pet Ownership and Demographics Sourcebook, the population of owned dogs in 2006 in the U.S. was 72 million (page 15, Table 1.8) and the number of owned cats was 81.7 million (page 24, Table 1.13). Those figures suggest that 4.3 to 8.6 million dogs and 4.1 to 6.5 million cats may have entered shelters, and as many as 7 million animals may have been euthanized. Consideration of public perceptions was important to the Committee’s analysis, and such information is generally derived from surveys and other sources. Although there is a risk of bias in polls and surveys (see Box 2-1), it BOX 2-1 Using Caution with Survey Results Information on public perceptions is generally derived from a variety of sources, most of which may be subject to bias. Polls and surveys conducted by special inter­ est groups (which in the case of this report are likely to be either animal protection­ ist groups or scientific organizations), in particular, may be biased in the wording of the questions, the selection of the group to be polled, the numbers of respondents, the types of questions, the conditions under which they are answered, and the analysis of the data (Crespi 1989; Herzog et al. 2001). In addition, the decision to release the results of a poll or survey conducted by a special interest group may be influenced by whether the results support the group’s position on the issue in question (Crespi 1989). For all of these reasons, the results of public opinion sur­ veys on the use of animals in research should be interpreted with caution, and polls conducted by third­party organizations (e.g., media research and consulting firms, academic institutions)—especially when they formulate the questions—should be considered more objective (Crespi 1989).

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34 ISSUES IN THE USE OF RANDOM SOURCE DOGS AND CATS IN RESEARCH appears that a majority of the American public is generally supportive of the use of animals in biomedical research but that the proportion has declined significantly over the last several decades, from about 85% in 1950 to 50–60% in the late 1990s and early 2000s (Herzog et al. 2001; Moore 2003; Rowan and Loew 2001). The reasons for this decline are unknown, although they appear to reflect changes in public attitudes to a wide variety of animal-related issues over the same period (Herzog et al. 2001). In 2008 the Foundation for Biomedical Research (FBR) commissioned Zogby Inter- national to conduct a nationwide telephone survey. The survey revealed that although a majority of those polled supported the use of animals for medical and scientific research, they were much less supportive than those polled in 2004 (personal communication, FBR). Other survey findings sug- gest that public support for animal research is influenced by the perceived importance of the medical problem being researched and the type of animal used. The use of animals (of any type) to study relatively serious medical problems (e.g., cancer, heart disease, diabetes) tends to garner more sup- port than their use for studying relatively minor problems (e.g., allergies), while research involving the use of dogs and cats receives considerably less support than that involving the use of rodents (Herzog et al. 2001). These findings illustrate the higher value that the American public places on dogs, cats, and other companion animals (Kellert 1989). THE ANIMAL PROTECTION MOVEMENT The animal protection movement has had a profound impact on pub- lic attitudes toward the use of animals in research and on the evolution of laws, policies, and voluntary compliance by the scientific community (as discussed in the section below on the history of U.S. laws and guidelines; also see Rudacille 2000). Jasper and Nelkin (1992) defined three types of animal protectionists: welfarists, pragmatists, and fundamentalists. Welfarists accept most cur- rent uses of animals, but seek to minimize their suffering. Pragmatists and fundamentalists are motivated to invoke fundamental changes in the use of animals by humans, but pragmatists seek to reduce animal use through legal actions, political protests, and negotiation whereas fundamentalists demand the abolition of all exploitation of animals, on the grounds that animals have inherent, inviolable rights. Clearly, it is impossible to classify every individual into one of these categories but this system may be a useful way to understand individual motivations. Since the beginning of the animal protection movement in Europe in the early 1800s up through the present, the iconic species that continue to capture public sympathy are the dog, cat, horse, and nonhuman primate. The U.S. animal protection community is large and varied—in 1994, there

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3 PUBLIC PERCEPTION AND EVOLUTION OF LAWS AND GUIDELINES were over 400 animal advocacy groups, with a combined membership of more than 10 million (Blum 1994), and these figures have likely grown substantially since then. These groups include organizations such as the Animal Welfare Institute (AWI5), which focuses on the welfare of research animals and has published graphic documentation of animal dealer abuse (AWI 2007, which was provided to the committee); the Humane Society of the United States (HSUS6), which seeks to eliminate animal-based research that is harmful to animals; and People for the Ethical Treatment of Ani- mals (PETA7), which seeks to eliminate all exploitive uses (research, food, fiber, and entertainment) of animals by humans. At the extreme end of the spectrum of the animal rights organizations is the Animal Liberation Front (ALF8), which uses acts of intimidation, terrorism, and violence to disrupt the scientific enterprise as well as to “liberate” animals from use in sports, textiles, research, and agriculture. The actions of organizations such as the ALF have been designated as terrorism9 and resulted in passage of the Ani- mal Enterprise Terrorism Act (S. 3880), introduced by Congressman Thomas Petri (R-WI) and signed into law on November 27, 2006. EVOLuTION OF ANIMAL CARE OVERSIgHT WITHIN THE SCIENTIFIC COMMuNITy The scientific community has had a long and contentious relation- ship with animal protection groups since the 1800s (reviewed in Rudacille 2000). In the past, the research community could be described as maintain- ing a somewhat imperious attitude toward the public, with overconfidence that what it was doing was right. Over the years, however, the scientific community has evolved the view that healthy and well-maintained animals are beneficial to and necessary for quality research and, indeed, has pro- mulgated voluntary compliance beyond that which is mandated by law. Since the early 1950s—well before the 1966 Laboratory Animal Welfare Act and the 1985 Research Animals Congressional Mandate10—the bio- medical research community has engaged in organized efforts to improve and ensure the humane care and use of animals in research. Prominent nongovernmental scientific organizations include the National Research 5 http://www.awionline.org 6 http://www.hsus.org 7 http://www.peta.org 8 http://www.animalliberationfront.com 9 John E. Lewis, Deputy Director of the FBI’s Counterterrorism Division, testified before the Senate Committee on Environment and Public Works on May 18, 2005, “One of today’s most serious domestic terrorism threats comes from special interest extremist movements such as the Animal Liberation Front (ALF).…” 10 Public Law 99-158, Health Research Extension Act of 1985, Sec. 495.

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36 ISSUES IN THE USE OF RANDOM SOURCE DOGS AND CATS IN RESEARCH Council’s Institute for Laboratory Animal Research (ILAR); the American College of Laboratory Animal Medicine (ACLAM11), established in 1957 to advance the humane care and responsible use of laboratory animals through certification of veterinary specialists, professional development, education, and research; and the Association for Assessment and Accredita- tion of Laboratory Animal Care International (AAALAC International). Since its creation in 1953, ILAR has played a critical role in develop- ing and publishing numerous science-based guidelines on issues involving animals in research settings. The most important of the ILAR reports is the Guide for the Care and Use of Laboratory Animals, published under the 1963 title 3 years before the Laboratory Animal Welfare Act became law and is periodically updated (see Chapter 1). Since 1965, compliance with the Guide has been the AAALAC International standard for institutions seek- ing accreditation (in 2009, 770 institutions in 31 countries reported having been accredited12), and, as discussed below, the Guide has been incorpo- rated by reference in federal guidelines for government-funded research. The National Institutes of Health has also been at the forefront of efforts to improve both scientific research and laboratory animal care. In 1961 NIH funded a contract to the Animal Care Panel (now AALAS) to “determine and establish a professional standard for laboratory animal care and facilities.” The Panel appointed a Committee on Ethical Considerations in the Care of Laboratory Animals and a Professional Standards Committee to evalu- ate laboratory animal care and use, and their efforts, in collaboration with ILAR, resulted in the 1963 publication of the Guide for Laboratory Animal Facilities and Care (precursor to the ILAR Guide; reviewed in NRC 1996). NIH also led the way in development of the Public Health Serice (PHS) Policy that applies to most federally funded animal research (more on this below). The PHS Policy requires that institutions eligible for PHS funding use the Guide “as a basis for the development and implementation of an institutional program for activities involving animals,” and the U.S. Goern- ment Principles (see below) similarly refer to the Guide. Although the scientific community has come to embrace changes lead- ing to the improved health and welfare of animal research subjects, at the same time the perception within the research community is that it has been under siege (Conn and Parker 2008). Attacks on and intimidation of scien- tists by extremist organizations have increased dramatically in recent years (FBR13 Illegal Incidents Map14). Furthermore, as animal protection groups 11 http://www.aclam.org 12 http://www.aaalac.org/accreditation/index.cfm 13 http://www.fbresearch.org 14 http://www.fbresearch.org/Media/MediaRoom/Backgrounder/IllegalIncidentsMap/ tabid/960/Default.aspx

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3 PUBLIC PERCEPTION AND EVOLUTION OF LAWS AND GUIDELINES have pushed for greater regulation of animal research, the cost of regulatory compliance in terms of dollars and time has become an increasing burden on biomedical research, even though it is not clear that the increased regulatory oversight directly benefits the health and welfare of the animals (Decker et al. 2007; Haywood and Greene 2008; Goldman et al. 2000). When regulations do not improve animal health and well-being, they are no more than regulatory burden. An earlier report (NRC 1988) noted the diminishing availability of random source animals nearly 20 years ago. The research community has attempted to push back against these trends through national science advocacy groups such as the FBR, the National Association for Biomedical Research (NABR15), and Americans for Medical Progress (AMP16), all of which work to educate the public about the impor- tance of animals in research. EFFECTS OF ANIMAL PROTECTION ACTIVITIES ON CLASS B DEALERS AND ON SCIENTIFIC ACCESS TO RANDOM SOuRCE DOgS AND CATS Despite improvements in the biomedical research community, the use of random source dogs and cats, and animals from Class B dealers, remains a divisive and publicly visible issue. The consequences of the animal protec- tion movement and public opinion are (1) reduced access to random source dogs and cats from pounds and shelters, (2) increased USDA efforts to inspect and enforce the AWA in regards to Class B dealers, and (3) pressure on research institutions to use purpose-bred animals from Class A dealers, to explore alternative sources of animals (e.g., donation programs, direct acquisition), to use non-animal models, and to use less iconic species (e.g., pigs, small ruminants, in addition to rats, mice, and other rodents).17 Other causes of the declining use of dogs and cats in research include reduced research funding, changing NIH program priorities, increased regulatory burden, and greater availability of other models. Animal protection activity is one of several factors that have contributed to these trends. HISTORy OF u.S. LAWS AND guIDELINES REgARDINg THE uSE OF DOgS AND CATS IN RESEARCH Many of the changes in societal thinking that eventually led to the U.S. Animal Welfare Act of 1966 (P.L. 89-544) emerged in tandem in 15 http://www.nabr.org 16 http://www.amp.org 17 In addition, although difficult to prove, there is a perception that some members of the scientific community resist termination of the use of Class B dealers as a source of research animals because they regard it as another step by the animal rights movement toward eliminat- ing animal-based research altogether.

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38 ISSUES IN THE USE OF RANDOM SOURCE DOGS AND CATS IN RESEARCH England and the United States over the past two centuries. In the 1820s, the English Parliament outlawed cruelty to cattle, horses, and other beasts of burden. At about the same time, the precursor to the Royal Society for the Prevention of Cruelty to Animals (RSPCA) was founded. But it was not until some 40 years later (1863–1876) that policies were developed that related to animal experimentation and the RSPCA adopted a policy against painful animal experiments. Shortly thereafter, the British Associa- tion for the Advancement of Science produced guidelines calling for the minimization of animal suffering and discouraging noncompliant experi- mentation (P.L. 89-544). Thomas Huxley and Charles Darwin composed a bill to regulate painful animal experiments and require the licensing of experimenters. Finally, in 1876 the Cruelty to Animals Act required experi- menters to obtain yearly licenses and restricted potentially unnecessary experimental duplication. In the colonies that formed the nucleus of what became the United States, concerns about the treatment of animals emerged early and evolved gradually over the next several centuries. The Massachusetts colony enacted the first humane law in 1641, forbidding cruelty to domestic animals. The history of this state’s actions regarding the prevention of cruelty to animals serves as an example of the changes in thinking about animals in society. In 1829 the state of New York prohibited “misuse” of horses, cows, and sheep, and in 1867 it was the site of pivotal legislation that prohibited animal bait- ing and fighting and required the humane treatment and transportation of impounded animals. Henry Bergh, founder of the American Society for the Prevention of Cruelty to Animals (ASPCA18), was instrumental in persuading New York lawmakers to support this bill. It was not until 1921, however, that all states had animal protection laws. In the 1940s, the National Society for Medical Research helped various states formulate “pound release laws,” requiring states and local munici- palities to have their animal shelters relinquish unclaimed cats and dogs to biomedical research institutions for experimentation and teaching. Minne- sota passed such a law in 1949; other states soon followed. Conflicts over the humane treatment of research dogs and cats arose immediately between animal welfare advocates and those supporting medical research, and these conflicts became more overt in the ensuing years. Federal Legislation 1877–1966 The first federal law prohibiting cruelty to animals took effect in 1877. Known as the “28-hour Law,” it regulated the amount of time and the conditions of confinement for animals transported by the meat packing 18 http://www.aspca.org

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3 PUBLIC PERCEPTION AND EVOLUTION OF LAWS AND GUIDELINES industry (the law required the unloading of such animals for food, water, and rest after no more than 28 hours in transit). The USDA was subsequently tasked with inspection and enforcement in this industry as well as in other instances of animal transportation, use, and processing. During the late 1950s and early 1960s, groups concerned about the humane treatment of animals called for federal regulation of their use in research. These calls were brought into the public spotlight by two highly publicized events, both involving dogs. In 1965, a pet Dalmatian named Pepper was reported missing and was subsequently identified, by her owner, in a newspaper photograph of dogs being unloaded from a dog dealer’s truck; Pepper was never located but may have been used in a medical experiment and euthanized before she could be recovered.19 A bill (H.R. 9743) sponsored that year by Congressman Joseph Resnick (D-NY) to regulate the use of dogs in medical research was, in part, a response to the owner’s plight. Later that same year, Coles Phinizy of Sports Illustrated wrote “The Lost Pets That Stray to Labs,” chronicling the story of Pepper, and on February 4, 1966, “Concentration Camps for Dogs” was published in Life magazine. The text of the Life article was written by Michel Silva, but it was largely a photographic essay by award- winning photographer Stan Wayman, documenting the poor conditions of dogs at the White Hall (Maryland) property of Lester Brown, a Class B dealer, revealed during an investigation by HSUS Chief Investigator Frank McMahon. Heightened public awareness following these exposés catalyzed land- mark legislation in 1966. Congressman W.R. Poage (D-TX) and Senators Warren Magnuson (D-WA) and Joseph Clark (D-PA) shepherded what would become the Laboratory Animal Welfare Act, signed by President Lyndon B. Johnson on August 24 of that year. The Act established standards for the care, housing, sale, and transportation of dogs, cats, and other animals kept by animal dealers and laboratories (it defined “animal” to include only dogs, cats, nonhuman primates, guinea pigs, hamsters, and rabbits, which were thus the so-called “covered species”). It also required the licensing of dog and cat dealers and set standards for the identification of dogs and cats by dealers and research facilities in order to prevent the acquisition of animals that had been obtained inappropriately. Authority was delegated to the Secretary of Agriculture to promulgate regulations for the appropriate treatment of animals intended for research or other purposes such as exhibi- tion and use in teaching. 19 Animal Welfare Act: Historical perspectives and future directions: Symposium Proceed- ings, September 1996, p. 19, http://www.nal.usda.gov/awic/pubs/96symp/awasymp.htm#pet

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40 ISSUES IN THE USE OF RANDOM SOURCE DOGS AND CATS IN RESEARCH The Animal Welfare Act and Related Legislation since 1970 The Animal Welfare Act (AWA) of 1970 (P.L. 91-579)20 was essen- tially a revision of the Laboratory Animal Welfare Act of 1966, expanded to include all species of warm-blooded animals intended for or used in research or exhibition, under the purview of the Secretary of Agriculture, as well as the sale of pet animals other than in stores. The Act also requires the licensing of all animal dealers and the humane treatment of animals in all phases of experimentation (i.e., transportation, purchase, sale, hous- ing, care, handling, and treatment). The AWA excludes horses not used in research and farm animals used for improving animal nutrition, breeding, management, production efficiency, and the quality of food and fiber. In 1976 amendments to the AWA categorized research institutions, exhibitors, and dealers similarly in determining fines for violations. The amendments also held government research facilities to the same standards as private institutions. Amendments to the AWA in 2002 excluded mice, rats, and birds as well as some farm animals from regulation by the Secre- tary of Agriculture. These species had not been regulated because they were not defined previously as “animals” and with the 2002 AWA amendments they were specifically excluded for regulatory purposes. The AWR was amended in 2004 to reflect the 2002 AWA changes. The Food Security Act of 1985 (Subtitle F, Animal Welfare, P.L. 99- 198;21 also known as the Improved Standards for Laboratory Animals Act) defines humane care to include specific criteria such as sanitation, ventila- tion, and housing. It directs the Secretary of Agriculture to establish, and the USDA to enforce, regulations covering, for example, exercise for dogs and a physical environment that promotes the psychological well-being of nonhuman primates. The Act notably establishes the requirement for an institutional animal care and use committee (IACUC). Details of the current requirements are incorporated in the AWA Regulations (AWR; 9 CFR Part 1, Subpart C, 2.3122), which charge those involved in animal care and use to minimize pain and distress in animals by using appropriate veterinary care, anesthesia, analgesia, tranquilizers, and euthanasia. The regulations also require principal investigators to consider alternatives to any procedure likely to cause pain or distress. In commenting on the Act, Senator Robert Dole observed that “the farm bill contains legislation dealing with the humane treatment of animals. The main thrust of the bill is to minimize pain and distress suffered by animals used for experiments and tests. In so doing, biomedical research will gain in accuracy and humanity. We owe much to laboratory animals and that debt can best be repaid by good treatment 20 http://awic.nal.usda.gov/ 21 http://awic.nal.usda.gov/ 22 http://www.nal.usda.gov/awic/pubs/Legislat/awafin.shtml

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41 PUBLIC PERCEPTION AND EVOLUTION OF LAWS AND GUIDELINES and keeping painful experiments to a minimum” (Congressional Record, December 17, 1985, U.S. Government Printing Office, Washington, DC). In 1985, an Interagency Research Animal Committee representing the Department of Health and Human Services (with PHS components includ- ing the Alcohol, Drug Abuse, and Mental Health Administration, Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), NIH, and Office of International Health), USDA, Department of State, Department of the Interior, Environmental Protection Agency, National Aeronautics and Space Administration, National Science Foundation, and Veterans Administration formulated and published the U.S. Goernment Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training.23 These U.S. Goernment Principles were universally adopted by U.S. government agencies that either develop requirements for or sponsor procedures involving the use of all vertebrate animals. Also that year, the Health Research Extension Act of 1985 (P.L. 99- 158), Animals in Research, became law (November 20, 1985), mandating establishment by the PHS of an overarching Policy on Humane Care and Use of Laboratory Animals (PHS Policy).24 The U.S. Goernment Principles were incorporated in the PHS Policy in 1986 and provide a framework for conducting research in accordance with the PHS Policy. PHS Policy requires institutions to establish and maintain proper measures to ensure the appro- priate care and use of all vertebrate animals (including those excluded under the AWA) involved in research, research training, and biological testing activities conducted or supported by the PHS, whether performed at a PHS agency, an awardee institution, or any other institution (the PHS agencies include the CDC, NIH, and FDA). The NIH Office of Laboratory Animal Welfare (OLAW) is responsible for the administration and coordination of PHS Policy. In 1990 the AWA was amended by the Food, Agriculture, Conserva- tion, and Trade Act to improve the humane handling, care, treatment, and transportation of dogs and cats. This amendment was in response to public attitudes (as determined through public comments) and APHIS’ experi - ence in administering and enforcing the regulations.25 Specifically, the Act strengthened regulations to prohibit the use of stolen pets in research and to provide owners the opportunity to locate their animals.26 These amend- 23 http://grants.nih.gov/grants/olaw/references/phspol.htm#USGovPrinciples 24 http://grants.nih.gov/grants/olaw/references/phspol.htm 25 Animal Welfare; Standards, Proposed Rule. Federal Register Vol. 55, No. 158 [15 August 1990], 33448-33531; Food, Agriculture, Conseration, and Trade Act of 10 [P.L. 101-624], U.S. Statutes at Large, § 2503—Protection of Pets, Approved 28 November 1990, http://www. nal.usda.gov/awic/legislat/pl101624.htm 26 Random Source Dogs and Cats, Final Rule. Federal Register Vol. 58, No. 139 22 July 1993, http://www.nal.usda.gov/awic/legislat/cat1.htm

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42 ISSUES IN THE USE OF RANDOM SOURCE DOGS AND CATS IN RESEARCH ments established a minimum 5-day holding period (including one weekend day) before the sale to a USDA-licensed Class B dealer or research facility of dogs and cats acquired by (1) pounds and shelters owned and operated by states, counties, and cities, (2) private entities established for the pur- pose of caring for animals, such as humane societies or contract pounds or shelters, and (3) research facilities licensed by the USDA, before being sold to a [Class B] dealer. They also require Class B dealers to provide written certification of each animal’s background to the recipient. (For additional information about the Pet Theft Act of 1988, Pet Protection Act of 1990, and public perception about pet theft, see Animal Welfare Act: Historical perspecties and future directions (Symposium Proceedings), September 1996, pp. 32-34.27) The Farm Bill of 2002 included an amendment by Senator Jesse Helms (R-NC) to legally redefine “animal” in the AWA to match the 1972 change in the AWR that excludes “birds, mice of the genus Mus, and rats of the genus Rattus, bred for use in research.” This version of the Farm Bill was passed by Congress in May 2002. On June 4, 2004, USDA published the “Final Rule” in the Federal Register to include the language contained in the 2002 Farm Bill excluding mice, rats, and birds bred for use in research from regulation by USDA under the AWA. unsuccessful Legislative Efforts In addition to these laws, there have been numerous unsuccessful attempts at legislation to further protect animals (Table 2-1). On Febru- ary 28, 2007, Senator Daniel Akaka (D-HI) introduced a bill (S. 714) that proposed amendments to the AWA “to ensure that all dogs and cats used by research facilities are obtained legally.” The proposed Pet Safety and Protec- tion Act of 2007 (S. 714) was intended to modify the AWA (7 USC 2137) and was part of a series of legislative efforts to ensure that dogs and cats used in research are obtained by appropriate means. The bill never became law, although it received two readings and was referred to the Senate Committee on Agriculture, Nutrition, and Forestry. The Pet Safety and Protection Act of 2007 became the impetus for Congress to charge the NIH to determine the humane and scientific issues associated with the use of random source dogs and cats in research. In turn, NIH asked the National Academies to assemble this committee of experts to compile a report that addresses the statement of task found in this document. 27 http://www.nal.usda.gov/awic/pubs/96symp/awasymp.htm#pet

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43 PUBLIC PERCEPTION AND EVOLUTION OF LAWS AND GUIDELINES TABLE 2-1 Congressional Legislation Proposed (But Not Passed) to Amend Permissible Sources for Obtaining Dogs and Cats for Research, 1997–2007.* Number of Year Congress Number Introduced Sponsor Co-Sponsors 2007 110 H.R. 1280 1-Mar-07 Rep. Michael Doyle [D-PA] 130 2007 110 S. 714 28-Feb-07 Sen. Daniel Akaka [D-HI] 19 2005 109 S. 451 17-Feb-05 Sen. Daniel Akaka [D-HI] 2 2005 109 H.R. 5229 27-Apr-06 Rep. Philip English [R-PA] 61 2004 108 S. 2346 26-Apr-04 Sen. Daniel Akaka [D-HI] 0 2002 107 H.R. 4039 20-Mar-02 Rep. Michael Doyle [D-PA] 44 2001 107 S. 668 30-Mar-01 Sen. Daniel Akaka [D-HI] 3 1999 106 S. 1522 5-Aug-99 Sen. Daniel Akaka [D-HI] 1 1999 106 H.R. 453 2-Feb-99 Rep. Charles Canady [R-FL] 77 1998 105 S. 2202 23-Jun-98 Sen. Daniel Akaka [D-HI] 8 1997 105 H.R. 594 5-Feb-97 Rep. Charles Canady [R-FL] 71 *At the end of the 2-year session of Congress all proposed bills and resolutions that had not passed are cleared from the books and are eligible to be reintroduced for debate under a new number in the next session. Source: http://www.govtrack.us/congress. REFERENCES Arkow, P. 1994. A new look at pet “overpopulation.” Anthrozoos 7:202-205. AVMA (American Veterinary Medical Association). 2007. U.S. Pet Ownership and Demographics Sourcebook. Schaumburg, Illinois: AVMA. http://www.avma.org/reference/marketstats/ ownership.asp AWI (Animal Welfare Institute). 2007. The Animal Dealers: Eidence of Abuse in the Commer- cial Trade 12-1. Mary Ellen Drayer, ed. Washington, DC: AWI. Blum, D. 1994. The Monkey Wars. Oxford: Oxford University Press. Clifton, M. 2002. Latest U.S. data shows shelter killing down to 4.4 million a year. Animal People. (Sept) 14. Conn, P. M. and J. V. Parker. 2008. The Animal Research War. New York: Palgrave Macmillan. pp. 224. Crespi, I. 1989. Public Opinion, Polls and Democracy. Boulder, CO: Westview Press. pp. 40-91. Decker, R. S., L. Wimsatt, A. G. Trice, and J. A. Konstan. 2007. A profile of federal grant administratie burden among federal demonstration partnership faculty. Standing Com- mittee of the Federal Demonstration Partnership. The National Academies. www.thefdp. org/Faculty%20burden%20Survey%20report.pdf Goldman, C. A., T. Williams, D. Adamson, and K. Rosenblatt. 2000. Rand Report: Paying for Uniersity Research Facilities and Administration. Rand Corp. www.rand.org/pubs/ monograph_reports/MR1135-1/index.html Haywood, J. R. and M. Greene. 2008. Avoiding an overzealous approach: A perspective on regulatory burden. Institute for Laboratory Animal Research Journal. 49:426-434. Heath, S. E., P. Kass, and L. Hart. 1998. Epidemiologic study of cats and dogs affected by the 1991 Oakland fire. Journal of the American Veterinary Medical Association. 212(4):504-511.

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