Status of regulatory approval of biotechnology‐derived plants and animals

Abstract

Development of new technology brings with it decisions regarding regulation to ensure safety in technology transfer. Properly formulated and administrated, such regulations can act as a catalyst for the transfer of new technology, not a barrier. Such regulations must be based on sound scientific principles, and are intended to provide protection for the public, engender public acceptance, and foster communication with the various segments of society. To develop this new technology in a safe and orderly manner field testing of the products/ organisms of biotechnology, especially genetic engineering, has been permitted by the U.S. Department of Agriculture (USD A). USD A permits certify the environmental safety of field testing of plants and microorganisms developed through the use of material derived from plant pests. Permits are issued based upon analyses of the biology of the organism, the affected environment, and the precautions taken to ensure environmental protection. Licenses for the use of veterinary biologies, including recombinant vaccines, are also issued.

Key words:

• biotechnology regulation
• biotechnology products (environmental safety of)
• deliberate release (safety assurance/regulation of)
• genetic engineering
• genetically modified organisms (safety assurance/regulation of)

Notes

New Food and Food Chemicals: Safety and Regulatory Considerations, sponsored by the Association of Government Toxicologists, Society of Toxicology, Food and Drug Administration, and Hosted by the National Academy of Sciences, May 1–2, 1990.