Animal Biotechnology Science-Based Concerns (2002) / Chapter Skim
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Appendix B: Regulatory Framework for Animal Biotechnology
Appendix B: Regulatory Framework for Animal Biotechnology
Pages 161-165
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From page 161... ...
The regulatory framework's standards and procedures for making market access decisions are particularly important to the study because they establish the general scope of the questions regulatory agencies will need to ask about the commercial products of animal biotechnology. This discussion assumes that the initial products of animal biotechnology will involve: (1)
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From page 162... ...
has responsibility for the general administration and coordination of the Public Health Service Policy (1996) on the Humane Care and Use of Laboratory Animals, including livestock and poultry used in biomedicallyrelated research activities.
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From page 163... ...
The Health Research Extension Act provided the statutory mandate for adoption of the Public Health Service Policy (see below)
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From page 164... ...
NEPA does not override the market entry standards of the FDCA, and CVM is not legally empowered to deny approval of an animal drug based on its NEPA assessment. CVM asserts that its animal drug authority permits it to regulate the environmental impacts of genetically modified animals to the extent they adversely affect, directly or indirectly, the health of humans or animals.
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From page 165... ...
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)
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