Department of Agriculture December 3, 2024 – Federal Register Recent Federal Regulation Documents

In 1986, the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework) was published by the Office of Science and Technology Policy and explained the regulatory roles for the U.S. Department of Agriculture, the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA), (herein, the Agencies) and how Federal agencies use existing Federal statutes to ensure public health and environmental safety while maintaining regulatory flexibility to avoid impeding the growth of the biotechnology industry. The Coordinated Framework was subsequently updated in 1992 (57 FR 6753-6762; February 27, 1992) and 2017, taking into account advances that had occurred in the field of biotechnology. Within the USDA, the Animal and Plant Health Inspection Service's (APHIS') Biotechnology Regulatory Services unit is responsible for ensuring that organisms developed using genetic engineering, such as genetically modified plants, insects, and microbes do not pose a plant pest risk. APHIS derives its authority to promulgate its biotechnology regulations from provisions of the Plant Protection Act (PPA, 7 U.S.C. 7701 et seq.) and the Virus-Serum-Toxin Act (VRTA, 21 U.S.C. 151-159). The EPA is charged with protecting human health and the environment through ensuring the safety of pesticides and other chemicals, including those developed using genetic engineering. The EPA derives its regulatory authority from provisions of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA, 7 U.S.C. 136 et seq.) and the Toxic Substances Control Act (TSCA, 15 U.S.C. 2601 et seq.). The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation, which includes oversight of food and feed. FDA derives its regulatory authority from provisions of the Federal Food, Drug and Cosmetic Act (FFDCA, 21 U.S.C. 301-392). Together with the USDA's Food Safety and Inspection Service (FSIS), FDA has oversight of certain chemicals modified using genetic engineering. FSIS derives its regulatory authority from the Federal Meat Inspection Act (FMIA, 21 U.S.C. 601 et seq.) and the Poultry Products Protection Act (PPIA, 21 U.S.C. ch.10, 451 et seq.). On September 12, 2022, Executive Order (E.O.) 14081, Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy, was published and directed the Agencies, among other things, to build on the Unified website for Biotechnology Regulation developed pursuant to E.O. 13874, Modernizing the Regulatory Framework for Agricultural Biotechnology Products, June 11, 2019, by including on the website the information developed under subsection (b) of section 8 of E.O. 14081, and by enabling developers of biotechnology products to submit inquiries about a particular product and promptly receive a single, coordinated response that provides, to the extent practicable, information and, when appropriate, informal guidance regarding the process that the developers must follow for Federal regulatory review. Need and Use of Information: The necessity for this information collection arises from E.O. 13874, Section 5, Unified Biotechnology Web-Based Platform, and E.O. 14081, Section 8(d). These provisions seek to ensure that innovators can easily navigate the Federal regulatory system for products of biotechnology by directing USDA, EPA, and FDA to jointly establish a web-based platform that contains and provides links to relevant United States Government regulatory information for biotechnology products. USDA-APHIS, EPA, and FDA will use a web-form on the contact page of the Unified website to enable site visitors to ask questions, make comments, or request a meeting with one or all of the sponsoring agencies. The web-form will collect basic contact information such as the name and email address of contact page respondents, as well as the respondents' questions or comments and their meeting requests. Respondent use of the contact page is voluntary. Description of Respondents: Business. Number of Respondents: 30. Frequency of Responses: Reporting: On occasion; Annual. Total Burden Hours: 15.