[20200612]IF11573_美国农业部监管农业生物技术的安全规则.pdf

https:/crsreports.congress.gov June 12, 2020USDAs SECURE Rule to Regulate Agricultural BiotechnologyOn May 18, 2020, the U.S. Department of Agriculture (USDA) published the final rule to revise its regulation of certain genetically engineered (GE) plants and other organisms (85 Federal Register 29790). USDAs Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule revises the regulations at Title 7, Section 340, of the Code of Federal Regulations. Phased implementation begins in June 2020, with full implementation by October 1, 2021. The Coordinated Framework USDAs SECURE rule is one component of the broader federal regulation of biotechnology products (e.g., GE plants, animals, and other organisms). The federal governments Coordinated Framework for Regulation of Biotechnology (the Coordinated Framework, 51 Federal Register 23302, June 26, 1986) outlines how USDA, the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA) apply existing statutes to regulate biotechnology products (Figure 1). A key principle of U.S. biotechnology policy is to regulate products according to their characteristics and unique features rathe