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Animal Biotechnology: Science-Based Concerns
POLICIES AND OTHER GUIDANCE
The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (1986) describes the general standards and procedures to be used by institutions to comply with the provisions of the Health Research Extension Act, including approval of research activities involving animals by an Institutional Animal Care and Use Committee. The PHS policy also requires compliance with the Animal Welfare Act and the standards outlined in the Guide for the Care and Use of Laboratory Animals (1998) published by the Institute for Laboratory Animal Resources.
The Federation of Animal Sciences Societies has issued guidance for the oversight of food and fiber research and teaching using animals, the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching (the Ag Guide). Adoption of these guidelines by an institution is voluntary. The Ag Guide is recognized as a resource document by USDA-APHIS and in the Guide for the Care and Use of Laboratory Animals, and as a primary reference document by the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALACI), the major animal care accrediting body for U.S. research institutions.
CVM has issued informal guidance through articles and speeches on its general approach to overseeing animal biotechnology under its animal drug authority but has not issued any formal policy statements or guidance.
CBER has issued scientific guidance to the industry in the form of “Points to Consider in the Manufacture and Testing of Therapeutic Products for Human Use Derived From Transgenic Animals” (1995).
FSIS has issued a points-to-consider document on “Safety Evaluation of Transgenic Animals from Transgenic Animal Research.”