REGULATIONSStatutory and Policy Bases for Consideration of AlternativesThe citations below are drawn from the Health Research Extension Act, PHS Policy, U.S. Government Principles, the Animal Welfare Act, and Animal Welfare Regulations that address alternatives. Although many of these citations are not explicit in the use of the word "alternatives," they do speak of minimizing pain and distress. This list of citations was part of a Nov. 17, 1997 "Dear Colleague letter" from the Office for Protection for Research Risks (OPRR) of the National Institutes of Health. (Note: OPRR is now OLAW—the Office of Laboratory Animal Welfare.) The OPRR letter states that "The federal mandate to avoid or minimize discomfort, pain, and distress in experimental animals, consistent with sound scientific practices, is, for all practical purposes, synonymous with a requirement to consider alternative methods that reduce, refine, or replace the use of animals." The full letter is available online here. Health Research Extension Act of 1985, Public Law 99-158, at Sec. 495(c): "The Director of NIH shall require each applicant for a grant, contract, or cooperative agreement involving research on animals which is administered by the National Institutes of Health... to include in its application... "(1)...assurances satisfactory to the Director, NIH that..." (B) scientists, animal technicians, and other personnel involved with animal care, treatment, and use... have available to them instruction or training in the... concept, availability, and use of research or testing methods that limit the use of animals or limit animal distress; and "(2)...a statement of the reasons for the use of animals in research to be conducted with funds provided under such grant or contract.
U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, Principles III, IV, and V: "III. The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered. IV. Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative... V. Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia..."
PHS Policy on Humane Care and Use of Laboratory Animals, IV.A.1.g: [the Assurance shall fully describe...] "a synopsis of training or instruction in the humane practice of animal care and use, as well as training or instruction in research or testing methods that minimize the number of animals required to obtain valid results and minimize animal distress, offered to scientists, animal technicians, and other personnel involving in animal care, treatment, or use;"
PHS Policy on Humane Care and Use of Laboratory Animals, IV.C.1.a: [In order to approve proposed research... the IACUC shall determine that...] "Procedures with animals will avoid or minimize discomfort, distress, and pain to the animals, consistent with sound research design."
Guide for the Care and Use of Laboratory Animals, 1996, National Academy of Sciences: "Although scientists have also developed non-animal models for research, teaching, and testing... these models often cannot completely mimic the complex human or animal body, and continued progress in human and animal health and well-being requires the use of living animals. Nevertheless, efforts to develop and use scientifically valid alternatives, adjuncts, and refinements to animal research should continue." (page 1) "The following topics should be considered in the preparation and review of animal care and use protocols... Availability or appropriateness of the use of less-invasive procedures, other species, isolated organ preparation, cell or tissue culture, or computer simulation..." (page 10)
Animal Welfare Act, as amended by the Food Security Act of 1985, Public Law 99-198: "[The Secretary shall promulgate... requirements]... for animal care, treatment, and practices in experimental procedures to ensure that animal pain and distress are minimized... that the principal investigator considers alternatives to any procedure likely to produce pain or distress in an experimental animal..." (Section 13 (a)(3)(A)&(B))
CFR, Title 9, Chapter 1, Subchapter A—Animal Welfare, Sec. 231(d): "Training and instruction of personnel must include guidance in... (2) The concept, availability, and use of research or testing methods that limit the use of animals or minimize animal distress."
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