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Regulatory Framework

In 1986, the United States government published the Coordinated Framework for the Regulation of Biotechnology (51 FR 23302). This policy statement detailed an approach for the regulation of products of modern biotechnology using existing statutes administered by the U.S. Food and Drug Administration (FDA) Exit Disclaimer, the U.S. Department of Agriculture (USDA) Exit Disclaimer, and EPA.

EPA administers three statutes that are used to regulate products of biotechnology:

FIFRA and section 408 of FFDCA are administered by the Office of Pesticide Programs (OPP), while TSCA is administered by the Office of Pollution, Prevention, and Toxics (OPPT).


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