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5 Regulatory Issues Society has established regulations requiring that the welfare of animate used in exper~rnentation be ensured. In addition to the self-nnposed constraints of the researchers, external regulations oc- cur at many levels and In many fonns. These external regulations include formal, legal requirements federal, state, or local legislative and regulatory controls ant! research funding or journal publication contingent on adherence to specific policies. APPROACHES TO }tEGULATION Regulation may center on the nature of the problem under in- vestigation, the procedures used, the setting ~ which the research is conducted, the species of animals used, or the qualifications and training of the investigatory. Although some individuals fee! that regulations should be applied according to the value society places on the expected results of the research, it would be inadvisable to develop regulations on such a basis. Indeed, applying regulations on this basis misses one of the essential aspects of science that is so cru- cial to its success. Almost all major results are the achievements of communities of investigators, who share their results in the scientific literature, build on each other's output, criticize and evaluate each other's work, and finally arrive at collective judgments of the validity of hypotheses based on data. It is not possible to know which results 47

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48 . USE OF LABORATORY AN~ALS will become parts of a final structure and which are scaffolding that will make the final structure possible. Most scientific work turns out to be scaffolding that cannot readily be discerned in the final struc- ture. The concept that scientists should use animals only for studies that leacI to therapeutically useful results is therefore inconsistent with the foundations of science. It is important to emphasize that there is no way to predict In advance what will and will not be productive research What is important to recognize is that at the time it is undertaken, competent research has the potential to be productive. For example, in the early twentieth century, Ehrlich used thou- sands of mice In 605 unsuccessful attempts to develop a chemother- apeutic agent for trypanosome diseases. Compound 606, salvarsan, proved effective against both trypanosomes and spirochetes. There was no way to predict that his sacrifice of mice would lead to the main therapy used in syphilis treatment for 30 years. The therapy came about because of Ehrlich's collaboration with organic chemists and his having read Schaudinn's papers on syphilis (De Kruif, 1926~. To male animal use contingent on an assumed direct route to a predicted therapeutic payoff is to misunderstand the nature of the scientific enterprise. Regulations applied most broadly might cover animal species with well-developed nervous systems or might be narrowed to cover vertebrates or warm-blooded animals. Tradition ally, decisions on this question have been based on the animal's evolutionary relationship to humus and its capacity to super pain. For example, more strin- gent requirements might be imposed on research using nonhuman primates, due to their close biological relationship to humans. These regulations knight also be tempered by societal clemands. Domestic animals, including dogs, cats, and horses, might be afforded a greater degree of consideration clue to the relationship that they share with humans. This issue arises in the use of pound animals in research and attracts considerable public attention (see Chapter 63. Many people consider the amount of pain or suffering, both mental and physical, inflicted on animals to be one of the most important issues surrounding their use in research. This concern has led to recent classifications of categories of biomedical research based on considerations of pain or sufferingfor example, by the New York Academy of Science (1988), the Scientists Center for Animal Welfare (Orians, 1987), and the British government in the Animals (Scientific Procedures) Act of 1986. In general, the more painful the procedure,

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REGULATORY ISSUES 49 the stricter the regulation proposed. These classifications emphasize that investigators should attempt to reduce pun whenever possible and to explore alternatives to p~nfu] procedures. The issue has also been addressed in a regulatory proposal of the U.S. Department of Agriculture published ~ the Federal Register of March 31, 1987 (pp. 1031~10314) and in a recent American Veterinary Medical Association colloquium on the assessment of pain and distress in animals (Colloquium, 1987~. FE:DE1"L }tEGUIATIONS Congressional interest In the humane treatment of animals is not new; legislation was first passed in 1873. That law, the Twenty-Eight Hour Law, licensed the number of consecutive hours that livestock could be confined for raid transport. Tm 1958, such concerns also led to passage of the Humane Slaughter Act (P.I,. 85-765), which stipulated that animals must be slaughtered by humane means. The Laboratory Animal Welfare Act of 1966 (P.~. 8~544), which was passed primarily to protect pet owners, addressed mounting public concern over the theft and subsequent sale of pets to research facilities. As stated by the original act, ...to protect the owners of dogs and cats, from the theft of such pets, to prevent the sale or use of dogs and cats which have been stolen, and to insure that certain animals intended for use in research facilities are provided humane care and treatment, it is essential to regulate the transportation, purchase, sale, housing, care, handling, and treatment of such animals by persons or organizations engaged in using them for research or experimental purposes or in transporting, buying or selling them for such use. The Annnal Welfare Act of 1970 (P.~. 91-579) broadened references in the Act from dogs and cats to animus more generally defined. In addition to research, it also added exhibition purposes and use as pets as covered activities. In the Annnal Welfare Act Amendments of 1976 (P.~. 94~279), the preamble was reworded to reflect increased emphasis on humane care and treatment for research, exhibition, or pet animals. Although the 1966 law specified six groups of animals as cov- ered~ogs, cats, nonhuman primates, rabbits, hamsters, and guinea pigs- record-keeping requirements applied only to dogs and cats. The law required identification of dogs and cats kept on the premises of animal dealers and laboratories, and it required dealers to be li- censed and laboratories to be registered. Only laboratories that used

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50 USE; OF LABORATORY ANIMALS dogs or cats and either received federal funds or purchased animate in commerce were required to register. The 1970 amendments extended the authority of the secretary of agriculture to protect ah species of warm-blooded animus In laboratories, as well as in the wholesale pet and exhibition trades. To date, however, the secretary of agriculture has not extended coverage under the Act to rats, mice, birds, and farm anunab used in biomedical research, although rats and mice account for about 85 percent of the animals used in research, testing, and education. In 1966 the secretary of agriculture was instructed by Congress to promulgate minimum standards for housing, feeding, watering, sanitation, ventilation, and shelter from weather and temperature extremes. Adequate veterinary care was also mandated; however, the secretary was explicitly prohibited from prescribing standards for the handling, care, or treatment of annnab during actual research or experimentation by a research facility ~ determined by such research facility. Appropriate use of anesthetic, analgesic, or tranquilizing drugs was added to modify the concept of adequate veterinary care in 1970. More significantly, the blanket proviso protecting the conduct of research was altered to require the research facility to demonstrate, at least annually, that professionally acceptable standards governing the care, treatment, and use of animals were being followed during actual research or experimentation. The Anunal Welfare Act Amendments of 1976 focused on trans- portation of animals and animal fighting. Specifically, the changes broadened the law to: . cover regulated carriers, intermediate handlers, and animal brokers, requiring them to adhere to humane standards, protect all dogs, including dogs for hunting, security, or breed- ~ng purposes; restrict transportation of animals by prohibiting C.O.D. shim ment unless the shipper guaranteed round-trip payment of care costs for animals not ciauned at the destination and by prohibiting trans- portation of animals best than a certain age; . require a health certificate signed by a licensed veterinarian to accompany animals transported in commerce; cards; strengthen civil penalties for violations of the humane stan- make criIIiinal the promotion of, sponsorship of, or partici-

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REGULATORY ISSUES 51 pation In fights between m~nmals or cocks, except where explicitly perrn~tted by state law; and . require federal agencies to comply with the standards and other requirements of the Act. Regulation Passed in 1985: The Health Research ~t~ion Act and the Food Security Act Two laws enacted ~ 1985 contain provisions that apply to the regulation of animals used In research. The first, the Health Re- search Extension Act of 1985 (P.~. 99 158), popularly called the NIH Reauthorization Act, applies to aD research funded by the PHS. This legmiation served to transform into law many of the provisions con- tained in the Public Health Service Policy on Humane Care and Use of Laboratory Animal by Awarded Institutions. (This publication was reentitled the PUS Policy on Humane Care and Use of L`abora- tory Animals In the September 1986 revision.) Major points of the legmIation require that: ~ research facilities establish institutional animal care and use committees including at least one veterinarian and one individual not affiliated with the institution; ~ animal care committees review the care and treatment of animals at lent semiannually; ~ institutions make available training that includes information on the humane practice of an~rnal care and use and the concept, availability, and use of research or testing methods that minimize animal distress and the number of anneals used; and applicants for NIH funds file assurances with NTH certifying that the investigator and the institution adhere to the NIH guidelines. The law also requires that every applicant for NIH funds include a justification for the use of animals in that research. The Improved Standards for Laboratory Animals Act was passed in December 1985. These amendments to the Anunal Welfare Act were incorporated into the ommibus farm bill reauthorization, the Food Security Act of 1985 (P.~. 9~198~. In addition to provisions directly affecting the care and use of animals in research, these amendments direct that an information service at the National Agri- cultural Library be established to dissern~nate information that will reduce the unintended duplication of animal experiments, to provide information on alternatives to laboratory animals, and to provide

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52 USE: OF LABORATORY ANIMALS information on humane practices for scientists and other research personnel. The concern over minimizing unnecessary duplication is echoed in the findings that preface the legislation: 1. the use of animate is instrumental in certain research and ed- ucation for advancing knowledge of cures and treatment for diseases and injuries which afflict both humans and animals; 2. methods of testing that do not use animals are being and continue to be developed which are faster, less expensive, and more accurate than traditional animal experiments for come purposes, and further opportunities exist for the development of these methods of testing; 3. measures which el~rninate or minimize the unnecessary du- plication of experiments on animals can result in more productive use of federal funds; and 4. measures which help meet the public concern for laboratory animal care and treatment are important in assuring that research will continue to progress. These statements highlight the shift in major emphasis, from prey venting the stealing of pets to protecting laboratory animals, that has occurred through subsequent amendments to the Animal Welfare Act. The law requires that each registered facility appoint an institu- tional animal committee that includes a veterinarian and a person not affiliated with the institution to represent general community in- terests ~ the proper care and treatment of animate. The provisions for committees, present in both 1985 laws, bring the overwhelming majority of experunental animal users in the United States under the oversight of ~ structured, loch review committee (Offlce of Technol- ogy Assessment, 1986~. The Improved Standards for I.aboratory Animals Act provider for some specific standards. Institutional animal committees are required to inspect anunal study areas twice each year and report any deficiencies to the institution for correction. If the institution does not take appropriate action, the U.S. Department of Agriculture and any funding agencies involved must be notified. As a result, grants or contracts may be suspended or revoked. The committee is also responsible for reviewing practices involving pain to animate. Investigators me required to consider alternatives to animal use and to consult with a veterinarian before beginning any experiment

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REGULATORY ISSUl35 53 that could cause pain. The standards Sued by the secretary of agri- culture will include provisions regarding exercise for dogs, en~riron- ments adequate to promote the psychological weD-be~ng of primates, presurgical and postsurgical care, the use of pain-relie~ring drugs, eu- thanasia, prohibition of the use of par~ytics without anesthesia, and prohibition of the use of an anunal for more than one major surgical procedure. Any exceptions to the standards set forth In the law or in the regulations promulgated under the law must be specified in the research protocol and justified in a report filed with the committee. The 1985 amendments mark the first time that the practice of animal experimentation itself has been opened to public scrutiny through the institutional animal committee. Although the Improved Standards for Laboratory Animals Act contains the proviso that nothing shall be construed as authorizing the secretary to promul- gate rules, regulations, or orders with regard to the performance of actual research or experimentation by a research facility as deter- m~ned by that research facility, the new law does require the facility to demonstrate that profemion~y acceptable standards governing animal care, treatment, and use, including the use of anesthetics, analgesics, and tranquilizers, are being followed during exper~rnenta- tion. GOVERNMENT POLICY STATEMENTS Gmde for the Care and Use of Laboratory An;m~s The Guide was developed for NIH by the National Research Council's Institute of Laboratory An~rnal Resources (National Re- search Council, 1985a). The PHS has a long-standing policy of requiring adherence to this document's guidelines by its intramural researchers and by extramural grantees and contractors that use liv- ing warm-blooded vertebrates in research and testing. The Guide provides a framework for the anneal care ~d use policies of many federal agencies, nonfederal government agencies, and private organ- izations. For instance, the American Association for Accreditation of Laboratory Animal Care (AAALAC) uses the tenets of the Guide in evaluating the animal facilities of institutions that are seeking accreditation. The Guide was first developed in 1963, before passage of the Laboratory Animal Welfare Act. It has been revised five times, most recently in 1985. It is considered a living document, subject to

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54 USE OF LABORATORY ANIMALS modification in the light of changing conditions and new information. The guidelines are based on established scientific principles, expert opinion, ~d experience with methods and practices consistent with humane, high-quality animal care. The Guide ~ written In general terms, so that it can be adapted to suit the needs of the widely varying scientific institutions that use live vertebrates. It is important to note that application of professional judgment is an essential component of the Guide. Public Health Sernce Policy on Hnrn~ne Care and Use of Laboratory Animus The PHS policy on humane care en c! use of laboratory an~rnals, which was revised in 1985 and 1986, requires institutions to establish and maintain proper measures to ensure the appropriate care and use of all animals involved in research, research training, and biological testing activities conducted or supported by the PHS. The PHS policy (Public Health Service, 1985) requires compliance tenth the Animal Welfare Act ant] its implementing regulations as well as with the current edition of the Guide for the Care and Use of Laboratory Animal. The 1986 revision of the policy incorporated the changes in the Public Health Service Act mandated by the Heaith Research Extension Act of 1985 (discussed earlier). It now specifies criteria and procedures for providing institutional "animal welfare assurance" to the NIH Office for Protection from Research Risks, which administers the assurance program. The Health Research Extension Act places the force of law behind much of the PHS policy. The PHS policy mandates that an institutional animal care and use committee (lACUC) be appointed by the chief executive officer of each institution. Each [ACUC must have at least five members and include at least one doctor of veterinary medicine, one practic- ing scientist experienced in research involving anunab, one member whose prunary concerns are nonscientific, and one member who is not affiliated with the institution in any way (other than as a member of the lACUC) and ~ not a member of the immediate family of a person who is affiliated with the institution. Among the committee's functions are reviewing the animal care and use program, inspecting animal facilities at least twice a year, preparing reports, and review- ing specific activities and concerns. The lACUC is also empowered to suspend an~rnal-related activities that are not in compliance with the requirements of the policy.

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REGULATORY ISSUES 55 The policy specifies procedures for reviewing, applying for, and reporting PHS-conducted or PHS-supported research involving the care and use of laboratory animals. Each institution must assure the PHS that it is accredited by AAALAC or another accrediting body recognized by the PHS (in addition to being evaluated by the lACUC and reevaluated periodically by the accrediting body) or is evaluated only by its lACUC and reevaluated at least once every six months. PHS staff and advisors can Pro review each awardee institution (which may include site visits) at any tone to assess the adequacy or accuracy of the institution's compliance or expressed compliance with the policy. The PHS policy endorses and is intended to implement and sum plement the "U.S. Government Principles for the Utilization and Care of Vertebrate Animab Used in Testing, Research and Twang developed by the Interagency Research Animal Committee (IRAC). This one-page document, containing nine numbered principles, in- corporates by reference the Guide for the Care and Use of Laboratory Animals. IRAC, which was established by the federal government in 1983, serves as a focal point for discussions by federal agencies of issues involving animal species needed for biomedical research and testing. Its primary concerns are the conservation, use, care, and welfare of research animate. Its responsibilities include "formation exchange, program coordination, and contribution to policy develop meet. Good Laboratory Practices Reg~atione The Good Laboratory Practices (GEP) regulations of the Food and Drug Administration (effective as of June 1979) and Environ- menta] Protection Agency (effective as of September 1985) are aimed primarily at ensuring efficiency and accuracy in testing procedures and do not address animal welfare directly. However, In requiring sanitation and proper maintenance of test animals, they address and influence the well-being of animals. Facilities, including those for animals, are covered in the GEP regulations that require rooms to allow for separation of species or test systems, isolation of individual projects, quarantine of animals, and routine and specialized housing of animals. Ancillary space is required for food, bedding, diagnostic purposes, and veterinary medical treatment and control. Procedures for animal care and record retention are also specified.

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56 USE OF LABORATORY ANIMALS A 1984 memorandum of understanding among NTH, the U.S. Department of Agriculture, and the Food and Drug Adm~n~tration provides for the sharing of information based on observations made by the several agencies in site visits or inspections. STATE 1lEGU[ATIONS General ~ticrueity laws were passed in every state between 1828 and 1913. However, 23 states specifically exclude animal experunents conducted in scientific institutions from the provisions of the anti- cruelty statutes. State laws were passed in the years after World War II to re- quire recede of impounded dogs to research institutions on request (this subject is discussed in greater detail in Chapter 6~. Most states have since repealed those laws, Though 5 states and the District of Columbia still require release on request. Twelve states prohibit ret lease of impounded animals for research, and Massachusetts prohibits exper~rnental use of impounded dogs not only from Massachusetts but from jurisdictions outside the state. It also provides for inspections of laboratories by licensed humane offlcere from the Massachusetts Society for the Prevention of Cruelty to Animals and the Boston Animal Rescue League. There ~ an increasing trend toward regulation of research facili- ties at the state level. The New York State Department of Health's Wadsworth Center for Laboratories and Research first rogued regu- lations in 1952 under Title 5 of the Public Health Law for approval of laboratories that use living animads ~ research. These regulations were most recently revised in 1983. The standards follow the federal Animal Welfare Act and the Guide for the Care and Use of Labora- tory Animal. Twenty states and the District of Columbia have state laws for the licensing of research facilities (National Association for Biomedical Research, 1987~. Instances of suffering inflicted on anunals In projects for science fairs have led to the enactment of state laws that prohibit painful experiments on animals by students below college level. Such laws have been passed in California (1973), Maine (1975), Massachusetts (1979), Florida (1985), and New Hampshire (1985~. In addition, voluntary guidelines have been adopted by many organizations that ~ . sponsor science tarry.

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REGULATORY ISSUES 57 APPROACHES TO 1lEGU[AIION Grating Agency Approadl to Regulation o An example of the granting agency approach to regulation is provided by the PHS. The PHS requires that each institution provide assurance to the NTH Office for Protection from Research Risks that its arsenal use is ~ compliance with the standards set by the Guide for the Care and Use of Laboratory Animal. This places the responsibility for compliance and for providing assurances at the local level, with the institution itself. If an institution is not in compliance, it is ineligible to receive funds for research involving animus. The risk of such punishment can be most effective, given the dependence of biomedical researchers on federal funds. ~ previous years, animal welfare advocates have felt that the PHS assurance program was relatively ineffective in monitoring the use of both human and animal subjects. Recently, NTH has under- taken a series of unannounced site visits to institutions to review their animal-use prograrr's for compliance with stated assurances. Some of these visits have led to suspension or temporary withdrawal of NTH funds and permission for some uses of laboratory animals at several major institutions. The recent inspections by NTH and the halting of research at major institutions have alerted the biomedical community to the ~ riousne" of NTH's intent to require adherence to standards. When a major institution is cited for deficiencies and research funds are withheld, Al institutions are reminded of the necessity to follow reg- ulations. By the same token, the recent disclosures of violations at several institutions have aDowed some individuals to reempha- size their contention that animal research should not be conducted and that the existing national regulations are neither effective nor sufficient. Recent statutory changes have given NIH policies, which were originally intended to serve as guidelines, the authority of regulations. One effect of thm has been to give the Guide to the Care and Use of Laboratory Animals the force of law. This poses problems that go beyond the dilemuna of reaching a balance between the demands of humane treatment toward animals and research needs. For the most part, problems arise from the fact that the Guide was drafted initially ~ a codification of Hood practice" and an aid to self-regulation. As such, it has served the community of m~i~ridu~s using laboratory animals well, providing helpful guidelines for animal use and care in

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58 USE OF LABORATORY ANIMALS the 25 years since it was first published. The Guide was not intended to have the force of law for setting minimum standards. It has always been intended to be used with professional judgment. Despite the fact that the contents of the present Guide are not substantially different from recent versions, it ~ now being used to set minimum standards for inspection and may in some respects be too rigidly interpreted for example, its requirements for cage sizes and multiple separate areas and rooms for performing aseptic surgery. With the new role of the Guide, the drafting of the rules and their interpretation need reasoned discussion and clarification. Greater efforts also should be made to publicize NIH decisions on interpretation of the Guide, so that the research community can take advantage of the common-law method of learning from experience and decisions. Self-Reg~ation There are many laws and regulations covering the use of animals in research, testing, and education. However, a great deal of activity involving laboratory an~rnals entails self-regulation. This ~ true in many areas of research candy partly controlled by federal regulation, including the use of human subjects and biosafety, and results from the desire to encourage free and creative inquiry within a framework of regulation. For example, the Annnal Welfare Act and the Health Research Extension Act cover the care and treatment of animate in laboratory animal facilities, but neither affect, except by inference, the design of research protocols that involve animals. By law, animal care and the minimization of pain and hatred are the primary objectives of institutional review. As a practical matter, however, it is difficult for committees to separate animal welfare objectives from protocol requirements and scientific content during the review process. Nevertheless, this system is intended to ensure that the use of animals in experimentation will remain the responsibility of local institutional review committees and individual investigators. The protocol review system that now exists kiss been a subject of much debate. ~ some instances, the need to receive a prelirn~nary approval of a research protocol can be disruptive to the researcher because efficiency may be reduced, costs may increase, ant! progress may be slowed. On the other hand, protocol review can help the researcher when it provides an opportunity for hm or her peers to over advice and assistance. This advice may result in ~ better-planned

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REGULATORY ISSUES 59 experiment that not only improves animal care and rn~nimizes pain but may also lead to more instructive results. Self-regulation appeals to many institutions and individual in- vestigators because it can allow for graduad change in response to societad and peer pressures rather than forcing compliance. Regu- lations can only complement, not substitute for, ~ strong sense of stewardship by the investigator who handles anunals and conducts experunents. Self-regulation is indispensable both for the proper care of anunals and for the success of any research that requires we0-treated an~rnals. Many professional societies, agencies, and research institutions have established and are establishing policies on anunal experunen- tation; examples include the American Physiological Society, the Society for Neuroscience, and the American Psychological Associa- tion. Editors of some journals have required adherence to policies of relevant societies ~ a condition of publication. The policies generally require adherence to existing laws; the use of anesthetics, analgesics, and tranquilizers for interventive or painful procedures, unless they would impede the experiment; provision for bodily needs; and legal acquisition of the arsenals. Some voluntary codes adopted by pro- fessional societies and other groups also refer to alternatives. For example, the Society of Toxicology (1986) Encourages and supports the development of Raid, scientific alternatives to current animal research testing procedures. E:FF1DCTS OF llEGUl;ATIONS Effects on Tra~n;r~g and E:dllcation If costs continue to escalate and if regulations become more strin- gent, animal use will be further reduced in education and training for undergraduate, graduate, and medical students. The unp act of this is unclear, ~ some scientists already fee] that an~rnal experi- mentation is of only lirruted value in education and accordingly have greatly reduced their use in teaching. In one large medical school, for example, the use of dogs in teaching has been reduced by 75 percent and ~ another no animals are used for this purpose. Other scientists and clinicians [eel strongly that such a reduction will have, and has had, a major negative impact on training.

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60 USE OF LABORATORY ANIMALS Effects on E"er~mental Re~ts Where regulations lead to even greater care to ensure that am propriate conditions exist, they can be viewed as benefiting the investigation. Animal experiments generally must be performed in a manner that peanuts unnnpeded study of the effects of a single "challenge." For example, an experiment in which the polio virus is the challenge must not be confounded by the presence of other viruses. This fact of exper~rnental design means that anunal experi- ments properly are performed under hygienic conditions to avoid the presence of adventitious infectious agents or poor environmental con- ditions, thus ensuring the health of the animal and the reliability of the research. In some cases where lifelong observation of the animal is required, the good health of the animal Is essential so that it will live its normal life ~pan. Effects on Direct Extreme of Research The cost of doing anunal research Is increasing, and nonprofit biomedical research organizations face rising costs for facilities and a reduced ability to recover totally the costs of animal care. The 1978 survey by the National Research Council's Institute of Labora- tory Animal Resources (National Research Council, 1980) identified a need for $350 million at 480 institutions to bring those institutions up to the standards of the Guide for the Care and Use of Laboratory Animal. An additional $407 million was estimated to be needed for remodeling, additions, and space replacement through fiscal year 1988. Sixteen percent of all the biomedical research institutions sur- veyed needed to replace current animal facilities, 38 percent needed to remodel facilities, and 43 percent needed to provide additional space. The surveyed organizations also reported a need of $43 mil- lion for equipment renovation, replacement, or additions. At that . , , time, a lack of space and equipment may have been the resow why 18 percent of the organizations In the confidential survey were unable to comply ~ toto with federal guidelines for animal care. The lI,AR survey data showed that of the $2.27 billion spent by nonprofit institutions In 1978 for biomedical ~d behavioral research, 35 percent ($797 million) was for projects involving animals. That decrease from the 44 percent reported In 1968 suggests that the costs of other aspects of research may be increasing, but it might also reflect decrease in the use of particular aIlimals in research. According to the ILAR surveys, between 1967 and 1978 the numbers of acquired

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REGULATORY ISSUES 61 research animals of all species Secreted, except for swine, cattle, horses, and rodents other than mice, rats, hamsters, and guinea pigs. Factors contributing to the decrease were diminished funding, led available space, an inability to comply with federal guidelines, a shift in research methods from short- to longer-term anunal studies, ~d increased use of alternatives. The substantial decrease (47 percent) in the use of nonhuman primates was also due at least in part to the higher costs of the animals and of their maintenance and their reduced availability caused by export restriction. The costs of acquiring and caring for laboratory annals have continued to increase smce 1978. In large institutions, due In part to animal care regulations, animals used in research me commonly kept in centralized animal resource facilities. The cost of maintain- ing such a facility depends on may factors, including adm~rristra- tion, the operation and maintenance of vehicles, animal purchasing, cag~w~hing, refuse disposal, feed and bedding, laboratory services, animal health care, surgical and x-ray services, research services, an- imal husbandry, and capital and amortization costs. Such costs are usually included In assessments of per diem charges for animals. Although it is difficult to compare charges among institutions because procedures for determining costs and charges vary, one can get an iclea of the changes that have occurred over time by looking at a single institution. For example, at one university, per diem charges for mice rose from 5.5 cents in 1978 to 14 cents In 1987an increase of over 150 percent while the Consumer Price Index rose by 74.1 percent (U.S. Department of Labor). Over the same period, the per diem charges increased for dogs (from $3.60 to $~.61), for monkeys (from $1.05 to $2.71), and for cats (Tom $1.30 to $3.20~. At another university, the per diem charge for dogs rose Tom $2.37 in 1981 to $3.50 ~ 198~a 48 percent increase. The average per diem charge for rriice increased during the same period from 5 cents to 9 cents an 80 percent increase. During the same period, the Consumer Price Index went up by 18 percent. The cost of acquiring anunals has also risen. For example, at one medical center the average purchase cost per random-source dog was $S in 1964, $96 in 1981, and $154 in 1986. In addition, as more restrictions are placed on the use of pound animals, which have an average purchase cost of $5 to $55 and then cost perhaps an additional $100 to prepare for research use, more animals will have to be acquired from commercial breeders, who may charge between $275 and $600 for a 1~kg adult dog. Not included in this figure is

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62 USE OF LABORATORY ANIMALS the shipping cost or the additional per diem charges incurred because the health of the animal must be maintained in anticipation of the exper~rnent. Another indicator of the cost of compliance with PHS policy on animal care and use can be seen ~ the response to an initiative of the Animal Resources Program of the NTH Division of Research Resources. Announced In December 1984, the initiative provided funds to share renovation costs with the awardees on a 5~50 match- ing basis. The renovations were to enable institutions to comply or continue to comply with PHS policy. Ninety-nine applications were received, requesting $3S,59B,558; 74 were approved. However, money was available to fund only 17 of the approved projects ($7,369,000~. All the causes of the increased costs may be debated. Yet what- ever the causes, the results are clear: it is expensive to use laboratory animals in biomedical ~d behavioral research. That expense might ultimately have great influence on the numbers ant} kinds of animads used in research. Effects on the finale Animab are the intended beneficiaries of regulation. What needs to be assessed ~ to what extent animals are more humanely treated as a result of such regulations. Although difficult to measure, the following observations provide some feeling for the impact of legisia- tion. When the first federa^1 law on animal experimentation, the I`a~ oratory Animal Welfare Act of 1966, was enacted, many clog dealers ceased business because they did not wish to adhere to the required m~rnum standards of handling, housing, feeding, watering, sanita- tion, ventilation, shelter from extremes of weather and temperatures, and adequate veterinary care. While few, if any, registered research facilities stopped using finals, many discarded outdated, damaged, unsanitary, and unsanitizable cages and food and water containers and discontinued use of cages that were too small to allow animus to stand up and make normal postural adjustments. Large numbers of substandard cages were removed before the compliance deadline. ENFORCEMENT AND ENACTMENT O1? REGULATIONS AND LAWS No discussion of regulations and their impact would be complete without some discussion of the enforcement of existing regulations

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REGULATORY ISSUES 63 and laws and the enactment of further regulations and laws. As mentioned earlier, NTH is beginning to male unannounced visits to laboratories, and the USDA has been making such visits for many years. These visits sometimes have revealed violations of the regula- tions. Many violations have been minor, but a few have been more serious. The more serious ones have resulted in suspension of funding and/or imposition of fines. While it is necessary for such inspections to continue and for regulations to be enforced, it ~ led clear that more regulations need to be promulgated. At present, the USDA is developing regulations based on the 1985 amendments to the Animal Welfare Act. When these regulations are enacted, the scientific community should be given sufficient tune to adjust to them, and their impact should be assessed before any new regulations are considered. As undesirable as the violations have been, they do not jus- tify break-ins at animad care facilities and laboratories, which have increased in recent years. These break-ms, for which radical ani- mat rights groups have often claimed responsibility, have resulted in vandalism that ho been costly for the institution, the individual investigator, and society, which loses the benefits of the research. Such violations of the law are not tolerable, and the offenders must be made to realize the fuD implications of their actions and punched accordingly.