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5 Conclusions and Recommendations The Committee on Scientific and Humane Issues in the Use of Ran- dom Source Dogs and Cats in Research was assigned three specific tasks. The first task required an analysis of the available data to determine the important biomedical research questions and common research topics in contemporary NIH-funded research where dogs and cats from Class B dealers are desirable or necessary as well as the number of grants where the potential exists or the animal is identified as coming from a Class B source. The second task asked for a description of the special character- istics (e.g., physiological, anatomic, or genetic) of the animals that make them particularly well suited for the types of research described in task one. Unfortunately, given the inaccessibility of specific data, it was impossible to ascertain if animals from Class B dealers (as opposed to animals from other sources) were used specifically in these studies. Furthermore, because “Class B” refers to a system of acquisition of random source animals and not the animals themselves, it could not be determined if animals from Class B dealers were desirable for use in these studies (e.g., studies of aging, naturally occurring infectious disease, genetic disease) simply because of their lower cost and availability, or necessary for some other compelling scientific reason. The Committee determined that while there were a few studies that required animals with characteristics not currently provided or available only in limited numbers by Class A dealers (e.g., naturally occur- ring infectious disease, larger size, deeper chest, and older age) these spe- cific characteristics are not unique to random source or animals from Class B dealers, and the demand for animals with these specific characteristics appears to be small. Concerns that the elimination of the Class B dealer 3

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4 ISSUES IN THE USE OF RANDOM SOURCE DOGS AND CATS IN RESEARCH would hamper a few research projects were based largely on speculation that other sources of animals could not meet this very small demand. The third task was to make recommendations, if necessary, for new or revised scientific parameters to guide their use, if Class B dogs and cats are deemed to be necessary for research. Despite passage in 1966 of the Animal Welfare Act (AWA) in response to public concerns about the use of lost or stolen pets in research, these concerns persist. The Committee found that the USDA has made significant strides recently in enforcement of the AWA regulations and that the number of Class B dealers, who obtain some animals (including lost or stolen pets) from shelters and pounds, has decreased dramatically, particularly in the last 15-16 years. Whereas animals from Class B dealers represented 20 per- cent of dogs and cats used in research in 2002, by 2008 they represented only 3 percent and only a fraction of that percentage were used for NIH research. Of that fraction, animals from pounds and shelters, which is the group of animals with potentially valuable or unique attributes for NIH research, accounted for 20 percent of dogs and 61 percent of the very small numbers of cats from Class B dealers. However, testimony provided to the Committee by USDA officials made it clear that despite new enforcement guidelines and intensified inspection efforts, not all origins of animals are or can be traced; therefore the USDA simply cannot ensure that lost or stolen pets do not enter research laboratories via the Class B dealer system. Furthermore, the administrative and judicial procedures necessary to enforce the AWA and ensure remediation of condi- tions that cause animal distress and suffering are inordinately slow, cumber- some, and ineffective. The Committee felt strongly that this is unacceptable. Thus, in evaluating the information provided through testimony and from other sources, the Committee found the following: • Trends in the use of dogs and cats from Class B dealers in research suggest that for a variety of reasons (public opinion, pressure from animal protectionists, regulatory and financial burden, institutional policies, research trends, investigator choice), the Class B dealer system may soon become unavailable as a source of animals for research. • As long as the Class B dealer system persists, the biomedical research community will be subject to “negative press” and public concerns about lost or stolen pets ending up in research, no matter how rare such occurrences are or how well enforced the regulations. • The husbandry standards and humane treatment of animals are unacceptably variable among Class B dealers and not consistent with NIH standards of research animal care and quality. • In the absence of reported data, it is not possible to identify the

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 CONCLUSIONS AND RECOMMENDATIONS actual number of random source dogs and cats or animals from Class B dealers with the unique characteristics needed for or used in specific NIH research projects. However, the number of random source animals from pounds and shelters used in research is very small, and the number used in NIH-based research is smaller. Nonetheless, this small number of animals may have potentially high value to the NIH mission. • Alternatives are available for filling much if not all of this limited need. It is therefore not necessary to continue to obtain random source dogs and cats for NIH research from Class B dealers, pro- vided that alternative sources of animals with similar characteristics can continue to be assured. The Committee cautions that NIH must either respond with alternate approaches or accept that random source animals are increasingly difficult to obtain, whether through direct acquisition or through Class B dealers. the Committee identified the following existing options to ensure the con- tinued availability of random source dogs and cats in the absence of Class B dealers: • Direct acquisition from pounds and shelters. Some institutions acquire random source animals directly from pounds and shelters in the three states that mandate pound seizure and from some municipal shelters in the 21 states that have no formal policy. While it is impossible to know with any degree of certainty until the ques- tion is posed, direct acquisition is most likely to occur at pounds that have inadequate funding, a high euthanasia rate, a strong animal control component, a weak adoption program, and/or an apathetic animal welfare community. It is unlikely that private shelters or humane societies that receive public funding would ever relinquish animals for research. However, it is important to note that Class B dealers are not a solution for the diminishing access to animals of this type. Furthermore, research institutions that engage in direct acquisition take on not only the responsibility and added cost of conditioning and veterinary care but also the responsibility of ensuring the animals’ welfare. • Donation programs. Direct acquisition of animals by research insti- tutions from small breeders, hobby clubs, and individual owners is a source that is already in use and represents a significant percentage of the animals acquired by Class B dealers. There is no reason such animals cannot be acquired directly rather than through Class B dealers. • Cooperative preclinical consortia. The current use of pet animals

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6 ISSUES IN THE USE OF RANDOM SOURCE DOGS AND CATS IN RESEARCH with owner consent for comparative preclinical investigations is a viable model for both human and veterinary medical research. An outstanding example is the NIH/NCI Canine Comparative Oncol- ogy Program (CCOP), a multicenter collaborative network of 18 veterinary teaching hospitals that provides controlled preclinical trials of new cancer drugs with the goal of supporting the design of human studies. In addition, the Canine Comparative Oncology and Genomics Consortium (CCOGC) includes a broad array of pri- vate and academic entities focused on the biology and genetics of canine cancers. Cooperative efforts such as these capitalize on the rich genetic diversity and variety of cancers that arise in the canine population as well as dogs’ anatomic and disease characteristics, which more accurately reflect the human condition than those of rodents. In addition, these programs ensure the outstanding clinical care of the animals and are free of the constraints of human phase I, II, and III clinical trial designs. Such consortia could be readily developed for virtually any comparative disease research of interest to categorical institutes of NIH. • Class A dealers. Class A dealers of laboratory animals breed pri- marily beagles, hounds, and mongrel dogs that typically range in size from 15 to 27 kg (33-60 lbs) and in age from 6 to 12 months. However, some of these vendors indicated that larger dogs, 27-37 kg (60-80 lbs), are available or in some cases could be bred if needed. In addition, although most dogs sold for research are less than 1 year old, a small number of older (2-5 years) retired breeding animals are available (personal communication with Class A vendors). If more of these animals are needed, Class A vendors could provide them, albeit at a greater cost. In addition, a significant number of dogs from Class B dealers are hounds obtained from hobby breeders, and these animals overlap with those available through Class A dealers. The number of cats provided by Class B dealers is so small that they are likely to be available through other mechanisms such as Class A dealers. • NIH-supported resource and research development. Random source animals from shelters, pounds, or Class B dealers do not address the need for capitalizing on the plethora of potentially valuable genetic animal models in the general pet population, yet this is often used as an argument for continued access to random source animals (Chapter 3). In addition to the CCOP mentioned above, programs such as the Referral Center for Animal Models of Human Genetic Diseases at the University of Pennsylvania School of Veterinary Medicine (Chapter 4) directly address the needs of NIH for discovery, accurate characterization, and access to these

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 CONCLUSIONS AND RECOMMENDATIONS valuable dog and cat models of human disease that arise in the general dog and cat population. These programs are examples of the public’s willing contribution of animals for research in order to advance both animal and human health, and they foster a positive public image for NIH. If there is a need for genetic or other disease models, NIH should invest in the expansion of such programs and in technology for the improved preservation and archiving of germplasm of important models, but additional, directed funding for such resources would be needed. In addition to these options, the Committee recommends consideration of the following means to ensure access to random source animals or ani- mals with the attributes thereof: • Existing NIH-supported and privately owned colonies. Some NIH categorical institutes support dog colonies at U.S. research insti- tutions, including defined-age animals for use in aging research. Indeed, the purpose-bred beagle is the dominant aging dog model. In addition, other privately supported colonies at academic institu- tions include mixed breed and large breed dogs such as golden retrievers. Similarly, there are colonies of mixed breed cats. Since most of these colonies are not supported by NIH, the Committee was unable to determine how many exist. If access to such animals is important to the NIH mission, NIH should make a “trans-NIH” effort to coordinate such access and offer subsidies to cooperating institutions to maintain access to animals. • NIH request for proposal. Various NIH categorical institutes com- monly use the request for proposal (RFP) mechanism to acquire needed items or to perform research and development on a con- tractual basis. This mechanism has several merits. Examples of NIH animal-related RFPs include contracts to develop specific animal models, operate NIH animal facilities or other animal facilities that serve NIH, provide quality animals for NIH research programs, develop animal-related reagents that enhance research, and explore the application of animal models to test the efficacy of vaccines or therapeutic regimens, among many others. A variety of labora- tory animals, ranging from rodents to nonhuman primates, are the subject of RFPs, and since the RFPs are NIH-supported, all such animals fall under PHS Policy. Thus the RFP mechanism is quite suitable for fulfilling the need for random source animals. The RFP can define the specific criteria for acquisition, hus- bandry, traceback assurance, and veterinary care of animals in keeping with PHS Policy. Respondents to the RFP would need

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8 ISSUES IN THE USE OF RANDOM SOURCE DOGS AND CATS IN RESEARCH to provide a detailed Animal Welfare Assurance, similar to any research institution that receives NIH funds, also in keeping with PHS Policy. The RFP statement of work can also include specifics of number, age, breed, and size, and can be flexible in response to changing needs of NIH. Under the RFP, animals destined for research would immediately become the responsibility of NIH, an arrangement that would both ensure the optimal care and welfare of the animals and enhance NIH’s research through the use of healthier animals. Continuation of the contract would be subject to periodic (usually quarterly) review. The contractor’s failure to meet the statement of work, including accurate traceback docu- mentation, could result in the immediate curtailment of support, in contrast to AWA/APHIS enforcement, which requires substantial effort to “build a case,” suspend a license, or correct violations. Thus, there is a far higher incentive for, and more rapid response to, compliance compared to contractors working with the existing Class B dealer system. To reiterate, the RFP mechanism would not be equivalent to a Class B dealer, as animals acquired through the RFP would become NIH property and thus be subject to the U.S. Goernment Prin- ciples and PHS Policy (as well as the AWA). Furthermore, the RFP mechanism could allow coordination of scientific need with avail- ability of specific types of animals from geographically diverse sources. The Committee acknowledges that NIH will need supplemental funding to facilitate these options and, in the absence of specific allocations from Congress, anticipates that NIH will be reluctant to take on these responsi- bilities at a time when the NIH budget is uncertain. As noted throughout the report, the Class B dealer system is declining, and availability of random source animals from pounds and shelters is diminishing, independent of the decline of Class B dealers. Therefore, if NIH deems random source animals, or their qualities, necessary for research, it will need to explore and support alternatives before these animals become altogether unavailable from either Class B dealers or pounds and shelters.