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5. Regulatory Issues
Pages 47-63

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From page 47...
... 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.
From page 48...
... , the Scientists Center for Animal Welfare (Orians, 1987) , and the British government in the Animals (Scientific Procedures)
From page 49...
... The Laboratory Animal Welfare Act of 1966 (P.~.
From page 50...
... 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 transportation of animals and animal fighting.
From page 51...
... 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.~.
From page 52...
... 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 institutional animal committee that includes a veterinarian and a person not affiliated with the institution to represent general community interests ~ the proper care and treatment of animate.
From page 53...
... Although the Improved Standards for Laboratory Animals Act contains the proviso that nothing shall be construed as authorizing the secretary to promulgate rules, regulations, or orders with regard to the performance of actual research or experimentation by a research facility as determ~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~rnentation. 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 Research Council, 1985a)
From page 54...
... 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)
From page 55...
... 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.
From page 56...
... 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 Laboratory Animal.
From page 57...
... 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.
From page 58...
... 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.
From page 59...
... Many professional societies, agencies, and research institutions have established and are establishing policies on anunal experunentation; examples include the American Physiological Society, the Society for Neuroscience, and the American Psychological Association. Editors of some journals have required adherence to policies of relevant societies ~ a condition of publication.
From page 60...
... 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 Laboratory Animal Resources (National Research Council, 1980)
From page 61...
... 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.
From page 62...
... 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, sanitation, 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.
From page 63...
... 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.


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