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1 Introduction CONgRESSIONAL MANDATE FOR THIS STuDy Congress has been active since the late 19th century in pursuing legisla- tion to protect the welfare of animals used in research (Chapter 2 provides a historical review of federal and state regulatory efforts in this area). Most recently, Senator Daniel Akaka (D-HI), and Representatives Mike Doyle (D-PA) and Phil English (R-PA), responding to public concerns that pet animals were being obtained from owners under fraudulent circumstances introduced in 2007 the Pet Safety and Protection Act (Senate Bill 714 and House of Representatives Bill 1280), “To amend the Animal Welfare Act to ensure that all dogs and cats used by research facilities are obtained legally.” The bill was intended to ensure that dogs and cats used in research and edu- cation are not pets brokered through Class B dealers of random source ani- mals, and would also establish monetary penalties for violations. However, this bill would not have affected the availability of purpose-bred and random source dogs and cats, young and old, genetically uniform and genetically diverse from a variety of other sources, such as Class A dealers, shelters, pounds, research facilities with breeding programs, and individuals. In early 2007 S. 714 was referred to the Committee on Agriculture, Nutrition, and Forestry; H.R. 1280 was referred to the Subcommittee on Livestock, Dairy, and Poultry. However, both the Senate and House bills have received no action and are considered “dead.” Nearly identical Class B dealer legislation was approved as part of both the House and Senate Farm Bills, but it was dropped in conference and the language calling for this study was substituted (Box 1-1). The Senate Fiscal Year 2008 Departments 11

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12 ISSUES IN THE USE OF RANDOM SOURCE DOGS AND CATS IN RESEARCH BOX 1-1 “Class B Animal Dealers—While the Committee recognizes that the use of ani­ mals in research, under certain circumstances, has been beneficial to the advance­ ment of biomedical research, the Committee would like assurances that such research is conducted as humanely as possible. In the case of the use of dogs and cats used in research and obtained from Class B dealers, the Committee is concerned that such dealers have the potential to provide animals that have not been treated in accord with USDA regulations for use in federally supported research. The Committee asks the NIH to seek an independent review by a nation­ ally recognized panel of experts of the use of Class B dogs and cats in federally supported research to determine how frequently such animals are used in NIH research and to propose recommendations outlining the parameters of such use, if determined to be necessary.” of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Bill (S. 1710) report requested a study on this issue. TIMELINE FOR THIS NRC STuDy Based on the Fiscal Year (FY) 2008 Senate and House Appropriations Committee Reports,1 with the Pet Safety and Protection Act of 2007 as an additional impetus, Congress charged the National Institutes of Health (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 a committee of experts to prepare a report that addresses the topic as defined in its statement of task (Box 1-2). In August 2008 the National Academies’ Institute for Laboratory Animal Research (ILAR) formed the Committee on Scientific and Humane Issues in the Use of Random Source Dogs and Cats (see Appendix A for biographies). ANIMAL WELFARE ACT AND uSDA DEFINITIONS The following terms and definitions are used throughout this report. Where appropriate, the source of the definition is provided. The USDA Ani- mal and Plant Health Inspection Service (APHIS) Animal Welfare Regulations (AWR) 9 CFR Ch. 1 (January 2006 Edition) contain the following definitions: 1 House Appropriations Committee Report 110-231 and Senate Appropriations Committee Report 110-107 regarding FY 2008 appropriations to the Department of Health and Human Services

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13 INTRODUCTION BOX 1-2 NIH Statement of Task for the Committee on Scientific and Humane Issues in the Use of Random Source Dogs and Cats in Research The National Academies will form an expert committee to address the use of Class B dogs and cats in research funded by the National Institutes of Health (NIH). Specifically, the committee will: 1. Determine the important biomedical research questions and common research topics in contemporary NIH­funded research where Class B dogs and cats are desirable/necessary as well as the frequency of these various research topics (i.e. number of grants where the potential exists or the source of the animal is identified as coming from a Class B source). 2. Describe the specific characteristics, such as physiological, anatomical, or genetic characteristics, of the animals that make them particularly well­suited for the types of research described under Task #1. 3. Make recommendations, if necessary, for new or revised scientific parameters to guide their use, if these Class B dogs and cats are deemed to be necessary for research. • Dealer (Sec 1.1): means any person who, in commerce, for compen- sation or profit, delivers for transportation, or transports, except as a carrier, buys, or sells, or negotiates the purchase or sale of: Any dog or other animal whether alive or dead (including unborn animals, organs, limbs, blood, serum or other parts), for research, teaching, testing, experimentation, exhibition, or for use as a pet; or any dog at the wholesale level for hunting, security, or breeding purposes. This term does not include: A retail pet store, as defined in this section, unless such store sells any animal to a research facility, an exhibitor, or a dealer (wholesale); any retail outlet where dogs are sold for hunting, breeding, or security purposes; or any person who does not sell or negotiate the purchase or sale of any wild or exotic animal, dog, or cat and who derives no more than $500 gross income from the sale of animals other than wild or exotic animals, dogs, or cats during any calendar year. • Random source (Sec 1.1): dog or cat is one obtained from an animal pound or shelter, auction, or from any person who did not breed and raise them on his or her premises. • Pet animal (Sec 1.1): means any animal that has commonly been kept as a pet in family households in the United States, such as

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14 ISSUES IN THE USE OF RANDOM SOURCE DOGS AND CATS IN RESEARCH dogs, cats, guinea pigs, rabbits, and hamsters. This term excludes exotic animals and wild animals. • Pound or shelter (Sec 1.1): means a facility that accepts and/or seizes animals for the purpose of caring for them, placing them through adoption, or carrying out law enforcement, whether or not the facility is operated for profit. These terms are used interchange- ably in this report. • Animal (Sec 1.1): means any live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or any other warm-blooded animal, which is being used, or is intended for use for research, teaching, testing, experimentation, or exhibition purposes, or as a pet. This term excludes birds, rats of the genus Rattus, and mice of the genus Mus, bred for use in research; horses not used for research purposes; and other farm animals, such as, but not limited to livestock or poultry, used or intended for use as food or fiber, or livestock or poultry used or intended for use for improving animal nutrition, breeding, management or production efficiency, or for improving the quality of food or fiber. With respect to a dog, the term means all dogs, including those used for hunting, security, or breeding purposes. The Committee used the following as working definitions: • Lost pets: pet animals that are missing but not stolen, and the owner would like to reacquire. • Stolen pets: animals that have been illegally removed from the owner’s possession. • Abandoned pets: animals that have been left or discarded by their owners. • Relinquished pets: animals that have been voluntarily released by their owners to shelters and pounds. • Feral animals: animals that have escaped from domestication and returned, partly or wholly, to their wild states. The following definitions were provided directly from the USDA upon questioning by the Committee (January 2009): • Purpose-bred: a dog or cat bred and raised specifically for research purposes; however, this term is not defined in the AWR. • Non-random source: was used to describe animals that were obtained from persons who bred and raised them on their premises, such as hobby breeders. An example of a non-random source ani- mal would be a hobby breeder of purebred working, hunting, or

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1 INTRODUCTION security dogs. This term was deleted from the AWR as a result of a rule change in 2004. • Buncher: a person who collects dogs, cats, or other regulated animals from random sources and supplies these animals to labo- ratory animal dealers. Bunchers are now required to be licensed as Class B dealers. This term is not defined in the AWR, but it is defined in the USDA/APHIS Animal Care Resource Dealer Inspec- tion Guide.2 • Mongrel: a random or non-random source dog of mixed or inde- terminate breed. • Inspection manuals: internal USDA documents which provide spe- cific instructions and definitions for USDA inspectors to use during their inspections. Currently, there are 3 different manuals (USDA 1999, 2001, 2004), one each for dealers, research facilities, and exhibitors. These manuals allow for the application of different standards for each of these groups (e.g., oversight committees [see below regarding institutional animal care and use committees] apply to research facilities but not to dealers). • Contract pound: a private pound or shelter established for the purpose of caring for animals, such as a humane society, or other organization that is under contract with a state, county, or city, that operates as a pound or shelter, and that releases animals on a voluntary basis. • Pound seizure: the legally mandated sale or release of cats and dogs from a pound or shelter to a research, testing or educational facility. It is important for the readers of this report to understand the specific characteristics of the following types of dealers (based on AWR 9 CFR Ch. 1, January 2006 Edition): • uSDA Class A Licensee: a USDA-licensed dealer that breeds ani- mals (i.e., purpose-bred animals) which may include dogs and cats on their own premises, and which are sold to various sources, including research facilities (USDA Sec. 1.1). • uSDA Class B Licensee: a USDA-licensed dealer that purchases and resells animals, which may include dogs and cats. These animals may be random source, or non-random source animals. Regard- less of the source of purchase, once the Class B dealer obtains ownership of an animal, it is considered a random source animal. As USDA licensees, Class B dealers may broker different types of 2 http://www.aphis.usda.gov/animal_welfare/downloads/manuals/dealer/definitions.pdf

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16 ISSUES IN THE USE OF RANDOM SOURCE DOGS AND CATS IN RESEARCH animals, including pets for the pet trade, exhibitor animals and laboratory animals for research. Some Class B Laboratory Animal Dealers deal with live animals other than dogs or cats, and some Class B Laboratory Animal Dealers do not deal with live animals (USDA Sec. 1.1). uSDA Class B Laboratory Animal Dealer of Live Random Source and Non- Random Source Dogs and Cats: a specific group of USDA-licensed Labora- tory Animal Dealer that buys and sells live random and non-random source dogs and cats for research. Only a Class B dealer is permitted to acquire random source dogs and cats for resale. The statement of task specifically involves uSDA Class B Laboratory Animal Dealers of Live Random Source and Non-Random Source Dogs and Cats. Because the Committee’s deliberations and recommendations do not pertain to other types of Class B dealers or animals, this designation is important to define as the specific category of dealers under consideration in this report. OVERVIEW OF EXISTINg ANIMAL WELFARE REguLATIONS AND guIDELINES In addition to the Congressional efforts cited above, a number of well- established and widely accepted regulations and guidelines inform the research use of laboratory animals. An abiding principle in biomedical research is that reproducible and valid scientific data require healthy3 and well-cared-for laboratory animals. The biomedical research community is very much aware of this principle, and subscribes to a number of laws, regulations, guidelines, and voluntary compliance measures, summarized below, that ensure humane animal care, but also good science. 3Rs: All laws, guidelines and policies involving sentient research animals incorporate the principles originally put forth in Russell and Burch (1959) and updated in the Guidelines for the Care and Use of Mammals in Neuro- science and Behaioral Research (NRC 2003): • Reduction: Alternatives as methods for obtaining comparable levels of information from the use of fewer animals in scientific proce- dures, or for obtaining more information from the same number of animals. • Refinement: Alternatives as methods which alleviate or minimize 3 See Chapter 3 for discussion on rare exceptions.

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1 INTRODUCTION potential pain, suffering, and distress, which enhance animal well-being. • Replacement: Alternatives as methods which permit a given pur- pose to be achieved without conducting experiments or other sci- entific procedures on animals. Although these principles apply to all animal-related research, they do not apply to either Class A or Class B dealers or their animals until the animals are acquired for research. u.S. Animal Welfare Act (AWA): Originally enacted in 1966, with a num- ber of revisions over the ensuing years, the AWA4 names the USDA as the responsible federal agency for its implementation and enforcement through the USDA Animal and Plant Health Inspection Service (APHIS). The AWA Animal Welfare Regulations (AWR)5 define standards and requirements for animal care and use programs, including research facility registration, estab- lishment and responsibilities of institutional animal care and use commit- tees (IACUCs), requirements for attending veterinarians and veterinary care, record keeping, reporting, and procurement, handling, care, treatment, and transportation of research animals. In addition, APHIS has established Ani- mal Care Policies (AC Policies) that further clarify the intent of the AWA. The AWA specifically applies to any live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or other warm-blooded animal used or intended for use for research, teaching, testing, experimentation, or exhibition pur- poses, or as a pet. This term excludes birds, rats of the genus Rattus, and mice of the genus Mus, bred for use in research; horses not used for research purposes; and other farm animals, such as, but not limited to, livestock or poultry used or intended for use as food or fiber, or livestock or poultry used or intended for use for improving animal nutrition, breeding, management, or production efficiency, or for improving the quality of food or fiber. The term dog, means all dogs, including those used for hunting, security, or breeding purposes. Licensure and compliance of Class B dealers is covered by the AWA through the USDA/APHIS. Public Health Service (PHS) Policy on Humane Care and use of Labora- tory Animals: The PHS Policy originally drafted in 1973, and revised in 1979 and 1986 (NIH/OLAW 2002), applies to all institutions that use live vertebrate animals in research supported by any component of the PHS, including the Agency for Health Care Research and Quality, the Centers for Disease Control and Prevention, the Food and Drug Administration, the 4 http://www.aphis.usda.gov/animal_welfare/downloads/awa/awa.doc 5 http://www.aphis.usda.gov/animal_welfare/downloads/awr/awr.doc

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18 ISSUES IN THE USE OF RANDOM SOURCE DOGS AND CATS IN RESEARCH Health Resources and Service Administration, the Indian Health Service, the National Institutes of Health, and the Substance Abuse and Mental Health Services Administration. Since 1985 PHS Policy has the force of law, requires research institutions that receive federal funds to establish and maintain appropriate programs for the care and use of animals involved in research, research training, and biologic testing. It requires institutions to comply with the AWA and AWR, and requires institutions to follow the National Research Council’s Guide for the Care and Use of Laboratory Animals (NRC 1996). Oversight of PHS Policy is the responsibility of the NIH Office of Laboratory Animal Welfare (OLAW). All covered institutions must register an animal welfare assurance statement with OLAW, assuring compliance with PHS Policy. The PHS Policy also requires and defines the functions of the IACUC, mandates IACUC review of all animal-related research projects that involve federal funds, defines the information required in PHS proposals for research, and stipulates record keeping and reporting requirements. PHS research proposals must include a description and justification of animal use and are subject to review by scientific peers and funding agencies. Guide for the Care and Use of Laboratory Animals (Guide): This NRC report was first published in 1963, under the title Guide for Laboratory Ani- mal Facilities and Care, by the Animal Care Panel,6 a group of profession- als with interest in laboratory animal care, in collaboration with the NRC Institute for Laboratory Animal Resources.7 The Guide was revised in 1965, 1968, 1972, 1978, and 1985. These editions were supported by NIH and published by the Government Printing Office. The most recent edition of the Guide was updated in 1996 by ILAR (which is responsible for execution of this study) of the National Research Council (NRC 1996), and was sup- ported by NIH, the USDA, and the Department of Veterans Affairs, and was published by the National Academies Press. The Guide is currently being updated (in progress). The Guide promotes the humane care of animals used in biomedical research, teaching, and testing. It provides guidelines on institutional policies and responsibilities, and performance-based standards for animal environment, housing, management, veterinary care, and physi- cal plant. As noted above, PHS Policy requires research institutions to base their programs of animal care and use on the Guide. 6 Precursor to the American Association for Laboratory Animal Science, AALAS; http://www. aalas.org 7 Renamed the Institute for Laboratory Animal Research in 1998; http://www.dels.nas. edu/ilar

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1 INTRODUCTION U.S. Government Principles for Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training (U.S. Government Principles): The U.S. Goernment Principles (NIH/OLAW 2002) were published in 1985 by the Interagency Research Animal Committee, which consisted of repre- sentatives from federal agencies that use or require the use of animals for research and testing. The U.S. Goernment Principles ensure that the use of animals in research is justified and humane, and mandates compliance with the AWA and other applicable federal laws, guidelines, and policies (including the AWR, PHS Policy and the Guide). In turn, compliance with the U.S. Goernment Principles is mandated by the PHS Policy and recom- mended by the Guide. Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International): AAALAC International8 is a pri- vate, non-profit organization that promotes the humane treatment of ani- mals in science through a program of voluntary inspection, compliance and accreditation. AAALAC International utilizes the Guide as its primary reference document, augmented by current research and professional standards of care. Since the Guide, AWA, AWR and PHS Policy are closely inter-related, AAALAC International also assesses compliance with these regulations and policies through its accreditation process. Certification of compliance with AAALAC International standards is awarded for a 3-year term, and is based on review of a detailed description of the institution’s program of animal care and use, followed by on-site evaluation by a team of experts. Laws, Policies, Principles, and guidelines Pertaining to Class B Dealers: All Class A and Class B dealers are covered by the AWA, but since they do not receive federal funds directly, they are not required to follow PHS Policy or the U.S. Goernment Principles. They may voluntarily elect to follow the Guide and opt for AAALAC accreditation, but none of the existing Class B dealers are AAALAC International accredited. In contrast, some, but not all, Class A dealers are AAALAC International accredited. Therefore, compli- ance and enforcement of humane treatment of dogs and cats from Class A and Class B falls under the AWA only until the animals enter a research institution. 8 Founded in 1965 as the American Association for Accreditation of Laboratory Animal Care; http://www.aaalac.org

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20 ISSUES IN THE USE OF RANDOM SOURCE DOGS AND CATS IN RESEARCH ANIMAL WELFARE ACT PROVISIONS IN REgARD TO DOgS AND CATS uSDA Licensing Any person operating or planning to operate as a dealer must have a valid USDA license. There are three classes of license holder (AWR Sec 2.1), Class A and Class B licensees who are referred to as dealers, and Class C licensees who are referred to as exhibitors. In general, Class A dealers breed animals, Class B dealers purchase and resell animals, and Class C exhibitors display animals. A review of the Animal Care Annual Report of Activities for Fiscal Year 2007 (USDA, APHIS 41-35-075) revealed that, of the over 1,000 Class B dealers licensed in the U.S., only 11 operate as random source Class B dealers that purchase dogs and cats for resale (USDA 2007). Class A dealers breed and raise on their own premises, animals that are then sold to various sources, including research facilities. The animals they breed are referred to as purpose-bred animals. Purpose-bred ani- mals from the same vendor have similar environmental backgrounds and are usually of the same breed-type and temperament. They are typically under an established program of veterinary care including vaccination and de-worming programs. Such factors help to minimize physiological and behavioral research variables (Fox et al. 2002). Purpose-bred dogs are the most common type of dogs and cats used in research. USDA was unable to provide the current number of Class A dealers of dogs and cats (as of April 2009 there are over 4,000 Class A dealers of all animals based on the USDA licensee information), but according to the Lab Animal Buyers Guide of 2008, there were 6 such dealers breeding beagles, hounds and mongrel dogs. Class B dealers purchase animals from various sources and then resell them. Only a Class B dealer may acquire random source dogs and cats for resale. Animals from Class B dealers may be sold to research institutions or to other licensees. According to the AWR, Sec 2.132 (a) Class B dealers may obtain live random source dogs and cats only from (1) Another licensed dealer (this includes auction houses, see below); (2) State, county, or city- owned and operated pounds and shelters; and (3) Contract pounds or shelters. The animals these dealers buy and sell may be random source or non-random source dogs and cats (among other species) and regardless of source once these dogs and cats enter the Class B system, they are col- lectively referred to as random source animals, or Class B animals. Class A or Class B dealers whose business involves dead animals may sell cadavers or tissues including organs, blood, or other body parts for use in various research, teaching, medical, or training institutions. Typically, dogs and cats used as blood donors for privately held blood banks are

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21 INTRODUCTION maintained by Class B dealers, but not necessarily Class B dealers of live random source dogs and cats. Sellers of such blood products also require a Class B license as they deal in parts of animals that have otherwise not been tested. The USDA established the annual license renewal fee for a Class B dealer by calculating the total amount received from the sale of animals to research facilities, dealers, exhibitors, retail pet stores and persons for use as pets, either directly or through an auction sale, during the preceding business year (calendar or fiscal) less the amount paid for the animals by the dealer or applicant.9 Class B dealers include brokers and operators of auctions, since these individuals negotiate or arrange for the purchase, sale, or transport of animals in commerce (see definition of dealer). An auction may not take physical pos- session or control of the animals, nor hold animals in any facilities. Auction houses are licensed as Class B dealers, but they are not considered random source Class B dealers because they do not take possession of the animals. Typically, dogs and cats from Class B dealers are of various breed-types and ages, and have variable environmental and microbial backgrounds, and have variable vaccination and medical treatment histories. The health status of these animals may be the same quality as purpose-bred animals, or it may be unknown. Random source animals that have been treated and vaccinated in preparation for use in research are termed “conditioned” ani- mals. Non-conditioned random source animals are useful in only a limited number of research studies, such as non-survival training preparations (Fox et al. 2002). There are a number of exemptions to the Class B licensing requirement including: • Retail pet stores (unless they sell for research, exhibition, or sell wild or exotic animals); • Any person who derives no more than $500 gross income from the annual sale to exhibitors, dealers, or pet stores of animals other than wild or exotic animals, dogs or cats, and dogs or cats sold to research; • Any person who maintains three or fewer breeding females of dogs, cats, and/or small exotic or wild mammals sold as pets or for exhibition; • Any person who sells fewer than 25 dogs and/or cats that were bred and raised on their premises per year; 9 Title 9 – Animals and Animal Products. Chapter 1 – APHIS USDA Subchapter A – Animal Welfare Part 2 – Regulations, Subpart a – Licensing. 2.6 – Annual license fee.

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22 ISSUES IN THE USE OF RANDOM SOURCE DOGS AND CATS IN RESEARCH • Any person who transports animals for breeding, exhibition in purebred shows, participation in competitions, and the like; • Any person who buys, sells, or transports animals used only for the purposes of food or fiber; • Any person who breeds and raises domestic animals for direct retail sales to another person for the buyer’s personal use and; • Any person who buys animals solely for their own use or enjoyment. Prior to 2004, these exemptions allowed individuals (bunchers) to traffic in dogs and cats for profit and without a license. Bunchers provided a mechanism for animals not bred and raised on an individual’s premises to enter the Class B system. Bunchers were a difficult entity to regulate. Changes were proposed in 1987 to the AWR with a final rule issued in 1989, to prohibit the purchase, sale, use or transportation of stolen animals (Section 2.60); added a requirement that dealers record the driver’s license number and state for every individual from whom a dog or cat is purchased (Sec 2.75); and a requirement that all operators of auction sales be licensed as Class B dealers. To further strengthen oversight of bunchers, the USDA issued the “Animal Welfare; Inspection, Licensing and Procurement of Animals” docket, which was proposed in 2000 and finalized in 2004. This policy prohibits Class B dealers from acquiring animals through bunchers who are operating as unlicensed dealers. Currently, anyone who sells “any dogs and cats not born and raised on the premises for research purposes requires a license” (AWA Subpart A, 2.1 (3) (iv)). Furthermore, the USDA fact sheet Animal Welfare Act (AWA) Proisions Regarding Animal Dealers10 states that “Anyone importing, buying, selling, or trading laboratory ani- mals, either directly to research institutions or through other dealers, must be licensed. This licensing requirement includes “bunchers,” who supply dealers with dogs, cats, and other regulated animals collected from random sources . . .” (emphasis added). Random source dogs and cats by definition may come from individual entities that did not breed or raise the dog or cat on their own premises. A Class B dealer may not obtain dogs and cats from an unlicensed individual who did not breed and raise the animal on his/ her premises or by use of false pretenses, misrepresentations, or deception (9 CFR 2.132(b) and (d)). Research facilities may obtain dogs and cats from Class A or Class B dealers, directly from pounds or shelters, or from persons who have bred and raised the animals on their premises and fall within the exemption requirements (listed above) (Letter to the Committee, from Chester Gipson, USDA/APHIS, January 2009). An institution that sells or exchanges dogs or 10 http://www.aphis.usda.gov/animal_welfare/downloads/aw/awlicreg.pdf

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23 INTRODUCTION cats that it no longer needs, may be acting as a Class B dealer and needs to be licensed as such. However, the AWR do allow for some de minimis exceptions in this area upon consultation with the USDA for a specific determination. This provides a mechanism that allows academic institu- tions to trade with each other in unwanted or unused dogs and cats without obtaining a license. Specific AWR Proisions Holding periods: Holding periods for Class B dealers were established to ensure that lost or potentially stolen dogs and cats had adequate time to be reunited with their owners. Holding periods range from 24 hours to 10 days, depending on the source (pound versus private individual versus other USDA licensee) and age of the animal (9 CFR 2.101). If the dog or cat came from another USDA licensed individual or from a private individual who bred and raised the dog or cat on his/her premises, and it is less than or equal to 120 days of age, the holding period is 24 hours. If the dog or cat came from a government-operated pound or shelter or a hobby breeder, and is 120 days of age or older, it must be held for 5 days. If it came from a private or contract pound, it must be held by the Class B dealer for 10 days. According to the AWR Sec. 2.133, the sources from which Class B dealers may obtain random source dogs and cats from (another licensed dealer, pound or shelter; Sec. 2.132 (a) (1) – (3)) must hold and care for the animal for a period of not less than 5 full days (including one Saturday). And a Class B dealer who obtains a random source dog or cat from a private or contract pound or shelter, must hold and care for the animal for a period of at least 10 full days (AWR Sec. 2.101 (a) (1)). Certification requirements (AWR Sec. 2.133 (b) (1)-(6)): Upon selling a random source dog or cat to any person or institution, the Class B dealer must provide the recipient with certification that contains the following information: • The name, address, USDA license number, and signature of the Class B dealer; • The name, address, USDA license or registration number (as appli- cable), and signature of the recipient; • A description of each dog or cat sold that includes the breed-type, sex, date of birth or approximate age, color and/or distinctive mark- ings, and any official USDA approved identification number; • The name and address of the person, pound, or shelter from which the dog or cat was acquired by the Class B dealer and an assurance

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24 ISSUES IN THE USE OF RANDOM SOURCE DOGS AND CATS IN RESEARCH that this source was notified that the dog or cat might be used for research; • The date the dealer acquired the dog or cat; and • If acquired from a pound or shelter, a signed assurance that it met all of the holding requirements. Traceback Investigations: The source of animals sold by Class B dealers, specifically random source animals, has been the subject of continuing pub- lic concern and scrutiny. Although the regulations clearly state the sources from which Class B dealers may obtain animals, there remains a public perception that Class B dealers obtain lost, stolen, or fraudulently acquired pets. Given the public concern regarding random source dogs and cats sold to research facilities, the USDA has maintained a heightened awareness of these particular licensees (Letter to the Committee from Chester Gipson, October 2008). Although the AWA and USDA AWR and Animal Care Policies provisions cover both Class A and Class B dealers, the USDA inspects Class B dealers with more scrutiny and more frequency than other dealers (internal USDA Standard Operating Procedure (SOP) for Conducting Tracebacks from Ran- dom Source B Dealers; implemented in October, 2008) and at considerable cost. Whereas the AWA mandates annual inspections for research facilities, the frequency of Class A and Class B dealer inspections are determined by the USDA/APHIS risk-based inspection system (personal communica- tion, USDA/APHIS) which currently suggests annual inspections for Class A dealers and quarterly for Class B dealers. The visits are unannounced and therefore may require more than one attempt to gain access to the facility. A major focus of these inspections is tracing the acquisition of random and non-random source animals (tracebacks). The traceback process is designed to determine where an animal came from and who sold it, to ensure regulatory compliance. The number of tracebacks conducted depends on the number of dogs or cats acquired since the previous inspection, but at a minimum of 4 dogs and/or cats and up to 10 percent of those acquired since the last inspection are traced back. The legality of acquisition is evaluated by conducting tracebacks on a representative sampling of animals. All dogs and cats whose acquisition appears suspicious will be traced back. Because the number of Class B dealers is small, the USDA is currently performing a 100 percent traceback on a rotational basis; that is, once a year each dealer will have 100 percent of its acquisitions since the previous quarterly inspection traced back. However, due to turnover, not all animals that pass through a dealer’s facility will be the subject of a traceback. As part of the traceback, inspectors are encouraged to visit the original seller’s place of business when practical. Telephone tracebacks are permis-

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2 INTRODUCTION sible only under specific circumstances when, for example, the seller is a licensed dealer, a pound, or a person or broker recognizable to the inspec- tor. Sellers identified outside a particular area will be inspected by other USDA inspectors and the results provided to the originating inspector. If the last seller is determined to be another Class B dealer, a second traceback is performed for the previous seller to that dealer. Once contact with a seller is made, the individual is questioned by the inspector to ensure that the individual listed on the records did actually sell the dog or cat and bred and raised the animal. If the seller did not breed or raise the dog or cat, they are questioned about the source of the animal. During the early 1990s tracebacks were 40-50 percent successful at correctly identifying the seller; by 2000-2001, this estimate was 95 percent (personal communication, Ron DeHaven, formerly of the USDA, October 2008). However, the traceback for dogs and cats acquired from an auction ends at the auction house; these animals are not traced back to the person who sold them. During an inspection of a Class B dealer, the inspector will determine whether the acquisition and disposition records meet all of the requirements set forth in AWR Sec. 2.75(a). The required records must include: • The name and address of the person from whom the dog or cat was purchased by the dealer; • The USDA license or registration number of the seller if he/she is USDA licensed or registered; • The vehicle license number and state, and the driver’s license num- ber and state of the seller, if he/she is not licensed; • The name and address of the person to whom a dog or cat was sold or given by the dealer and that person’s USDA license; • The date the dog or cat was acquired or disposed of; • The USDA tag number or tattoo assigned to the dog or cat; • A description of each dog or cat; and • The method(s) of transportation, including the name(s) of the initial and intermediate handlers. All records must be held and made available for inspection for 1 year after an animal is disposed of or euthanized. Records may be kept longer if required to comply with federal, state, or local law or if APHIS requests. If a review of traceback records shows that an unlicensed person does not meet the exemptions listed under Section 2.1 the name and address of this person is forwarded to the USDA Regional Office for further investigation. The inspection also includes an evaluation of the animals (e.g., for malnutri- tion or dehydration), husbandry conditions, and medical records.

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26 ISSUES IN THE USE OF RANDOM SOURCE DOGS AND CATS IN RESEARCH Animal Care Policies Since the early 1990s USDA has supplemented the AWR with Animal Care (AC) Policies to enhance Class B dealer accountability under the regu- lations and to guide APHIS officers in reducing the number of unlicensed dealers. The AWR broadly defines those business entities or relations that may be affected in order to have a wide impact. AC Policy #1 (April 14, 1997): Denial of AWA License Applications strengthens the regulations that entitle APHIS to deny licensure if an appli- cant does not comply with AWR Section 2.11(a)(3): “Applicant has been fined or sentenced to jail under state or local animal cruelty laws as speci- fied in Section 2.11(a)(4),” or “Applicant is under investigation by state or local authorities for animal cruelty.” These provide additional tools by which a license could be revoked if a fine has been issued or the business entity was under investigation. AC Policy #8 (May 8, 2001): Guidelines for the Confiscation of Ani- mals provides guidance to APHIS officers for the confiscation of regulated animals if they are suffering. This policy states who defines suffering and how suffering is defined, and establishes the authority to require proper care and relief “as soon as possible, but typically not to exceed 24 hours.” In the event of confiscation, APHIS has the power to immediately suspend an agent’s license. COMMITTEE APPROACH TO ITS CHARgE To address the charge set forth in the Statement of Task, the Commit- tee assessed the use of dogs and cats in research based on reporting data from the USDA. Then, using information from the NIH, the USDA, and the scientific literature, the Committee attempted to relate the use of animals from Class B dealers with particular areas of research. In reviewing this information, the Committee struggled in much the same way as the rest of society with the issues related to the perceived care and well-being of animals in the hands of Class B dealers. The emotionality of the topic and the polarization of opinion and information presented a challenge to the Committee in the objective evaluation of the data and testimony (both oral and written). Each member of the Committee dealt with mental images and writings spanning more than 40 years on this topic and considered the information in the context of American culture, laws, regulations, practices, and science related to the care and use of laboratory animals. The Commit- tee was further challenged in its efforts to understand the process of animal acquisition and sale by Class B dealers. The relationship of these small businesses to local pounds, shelters, and small volume breeders as sources of animals for research is a complicated tangle of trade. Finally, the short

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2 INTRODUCTION timeline for the Committee to wrestle with these difficult issues and scarce data compounded the challenge. In the end, it was impossible to identify specific research projects that used animals from Class B dealers, since NIH does not maintain records of specific sources or numbers of animals nor of grants that use animals from Class B dealers, and individual grants and publications do not iden- tify sources of animals. Nevertheless, the Committee used available data provided by the USDA and NIH to assess overall dog and cat use, areas of research using dogs and cats, and numbers of animals sold to research insti- tutions by Class B dealers. The Committee was able to partially ascertain “the important … questions and common research topics … where Class B dogs and cats are desirable/necessary” and to estimate “the frequency of these various research topics.” Through the testimony provided by the scientific community, the Committee was able to “describe the specific characteristics, such as physiological, anatomical, or genetic characteris- tics” of random source animals “that make them particularly well-suited for the types of research.” Those characteristics are reflected in dogs and cats that represent a resource of significant morphological and physiological diversity. This diversity has been used in the development of animal models for the study of both human and animal diseases. The Committee found that dogs and cats represent only 8.7 percent11 of the total number of research animals covered by the AWA (non-covered species include mice, rats, and birds). Table 1-1 summarizes the numbers of each species covered by the AWA that were used in research from 2001- 2007. For dogs and cats used in research in 2002, 20 percent came from Class B dealers, 70 percent were purpose-bred animals from Class A dealers, and 10 percent were random source animals obtained directly from shelters or pounds (Federal Register 69 (134), July 14, 2004 page 42098/National Association for Biomedical Research12). FOCuS AND ORgANIZATION OF THIS REPORT It is important to point out that there are over a thousand Class B dealers licensed with the USDA, but there are currently only 11 Class B dealers that sell live random source dogs and cats for research. USDA Class B licensed dealers may operate in different capacities such as dealing in ani- mals destined for the pet industry or for exhibition, or brokering animals for laboratory research. Furthermore, some Class B dealers do not deal with live animals, and some Class B Laboratory Animal Dealers broker live 11 Percentages are estimates based on USDA data both in references cited and provided to the committee. 12 http://bulk.resource.org/gpo.gov/register/2004/2004_42098.pdf

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28 TABLE 1-1 Numbers of Animals Used in Research, by Type and Year, 2001-2007 2001 2002 2003 2004 2005 2006 2007 Cats 22,755 24,222 25,997 23,640 22,921 21,637 22,687 Dogs 70,082 68,253 67,875 64,932 66,610 66,314 72,037 Guinea pigs 256,193 245,576 260,809 244,104 221,286 204,809 207,257 Hamsters 167,231 180,000 177,991 175,721 176,988 167,571 172,498 Rabbits 267,351 243,838 236,250 261,573 245,786 239,720 236,511 Nonhuman Primates 49,382 52,279 53,586 54,998 57,531 62,315 69,990 Farm Animals 161,658 143,061 166,135 105,678 155,004 105,780 109,961 All Other Covered Speciesa 242,251 180,351 199,826 171,312 231,440 144,567 136,509 Total 1,236,903 1,137,718 1,188,469 1,101,958 1,177,566 1,012,713 1,027,450 a Any live or dead warm-blooded animal, which is being used, or is intended for use for research, teaching, testing, experimentation, or exhibition purposes, or as a pet. This term excludes birds, rats of the genus Rattus, and mice of the genus Mus, bred for use in research; horses not used for research purposes; and other farm animals, such as, but not limited to livestock or poultry, used or intended for use as food or fiber, or livestock or poultry used or intended for use for improving animal nutrition, breeding, management or production efficiency, or for improving the quality of food or fiber. Source: (AWR) 9 CFR Ch. 1 (January 2006 Edition) Section 1.1. Source: Animal Care Annual Report of Actiities, Fiscal Year 200, United States Department of Agriculture Animal and Plant Health Inspection Serice APHIS 41–3–0 (2001-200). http://www.aphis.usda.gov/animal_welfare/publications_and_reports.shtml

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2 INTRODUCTION animals other than dogs and cats. This report focuses on the small number of USDA Class B Licensed Laboratory Animal Dealers that supply lie dogs and cats for NIH-funded research. The Committee emphasizes the narrow focus of this perspective, which does not address the role of random source animals for industry, education, training, or veterinary medical and other basic research. In an effort to place these issues into their proper perspective, this report provides specific definitions of dealers of dogs and cats, summarizes the various laws, principles and guidelines that pertain to the use of dogs and cats in research and which are crucial to understanding the nuances of the USDA regulations (Chapter 1); surveys the history of U.S. animal welfare regulations and their intent (Chapter 2); examines the characteristics of random source animals for research (Chapter 3); assesses Class B dealers and animals from Class B specifically (Chapter 4); and provides recommen- dations in regard to Class B dealers for supplying random source dogs and cats for NIH-based research (Chapter 5). REFERENCES Federal Register. Vol. 69, No. 134. Wednesday, July 14, 2004. Rules and Regulations page 42098. http://bulk.resource.org/gpo.gov/register/2004/2004_42098.pdf Fox, A., L. C. Anderson, F. Loew, and F. W. Quimby. 2002. Laboratory Animal Medicine 2nd Edition. American College of Laboratory Animal Medicine Series. Chapter 11, Biology and Diseases of Dog by Dysko, Nemzek, Levin, DeMarco, and Moalli. New York: Aca- demic Press. NIH/OLAW (National Institutes of Health Office of Laboratory Animal Welfare). Public Health Serice Policy on Humane Care and Use of Laboratory Animals. Last update August 2002. http://grants1.nih.gov/grants/olaw/references/phspol.htm NRC (National Research Council). 2003. Guidelines for the Care and Use of Mammals in Neuroscience and Behaioral Research. Washington, DC: The National Academies Press. pp. 10. NRC. 1996. Guide for the Care and Use of Laboratory Animals. Washington, DC: National Academy Press. Russell, W. M. S., and R. L. Burch. 1959. The Principles of Humane Experimental Technique. London: Methuen & Co. Reprinted by Universities Federation for Animal Welfare, UK. 1992. USDA (U.S. Department of Agriculture). 1999. Animal Care’s Dealer Manual. http://www.aphis. usda.gov/animal_welfare/downloads/manuals/dealer/dealerguidepdf.html USDA. 2001. Animal Care Resource Guide: Research Facility Inspection Guide. http://www. aphis.usda.gov/animal_welfare/rig.shtml USDA. 2004. Animal Care Resource Guide: Exhibitor Inspection Guide. http://www.aphis.usda. gov/animal_welfare/eig.shtml USDA. 2007. Animal Care Annual Report of Actiities, Fiscal Year 200. United States Depart- ment of Agriculture Animal and Plant Health Inspection Service APHIS 41–35–075 http:// www.aphis.usda.gov/animal_welfare/publications_and_reports.shtml

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