Coordinated Framework Documents
- Coordinated Framework I (1986)
- Coordinated Framework II (1992)
- 2017 Update to the Coordinated Framework for the Regulation of Biotechnology
- National Strategy for Modernizing the Regulatory System for Biotechnology Products (2016)
Interagency Task Force on Agriculture and Rural Prosperity
The Interagency Task Force on Agriculture and Rural Prosperity was formed in April 2017 “to ensure the informed exercise of regulatory authority that impacts agriculture and rural communities.” The Task Force issued its report in January 2018 identifying several recommendations and calls for action, including harnessing technological innovation in agricultural production. EPA, FDA and USDA APHIS worked closely with other federal agencies to provide input to the Task Force on ongoing biotechnology activities and to help identify concrete future actions. The three agencies look forward to continuing to work with our federal partners to implement the biotechnology-related recommendations identified in this report. We expect implementation of these activities will help enhance the existing federal regulatory processes by increasing transparency and predictability while providing a framework for assessing advancing innovation.
USDA's Website on Biotechnology
USDA's website on biotechnology provides information about the uses and regulation of biotechnology in the United States and in trade. It also provides useful Frequently Asked Questions.
USDA's Economic Research Service
USDA's ERS examines trends and emerging issues in agriculture, food, the environment, and rural America to conduct economic research that informs and enhances public and private decision-making. Their website provides information on biotechnology farming trends in the United States.
USDA’s Agricultural Marketing Service Bioengineered Labeling
The National Bioengineered Food Disclosure Law, passed by Congress in July of 2016, directed USDA to establish this national mandatory standard for disclosing human foods that are or may be bioengineered.
FDA’s Veterinary Innovation Program
This website describes FDA’s pilot program aimed at facilitating advancements in development of innovative animal biotechnology products.
FDA Regulation of Plant and Animal Biotechnology Products
This website provides an overview of FDA’s regulation of plant and animal biotechnology products.
Regulation of Mosquito-Related Products
FDA issued guidance to provide information on FDA and U.S. Environmental Protection Agency (EPA) jurisdiction over the regulation of mosquito-related products, including those produced through the use of biotechnology.
Agricultural Biotechnology Education and Outreach Initiative
Under this Initiative, FDA is working with USDA and EPA to provide education and outreach to the public on agricultural biotechnology and food and animal feed ingredients derived from biotechnology.
- FDA Commissioner Blog on Advancing Biotechnology Innovation
- FDA Blog on Plant Biotechnology Consultation Program
- FDA: Foods Derived From Plants Produced Using Genome Editing
- FDA: Animals with Intentional Genomic Alterations
- USDA Statement on Plant Breeding Innovations
Preparing for Future Products of Biotechnology (2017, National Academies of Sciences, Engineering, and Medicine)
The NASEM report provides analysis and recommendations for future products of biotechnology, the challenges that the regulatory agencies might face, and the opportunities for enhancing the regulatory system to be prepared for what might be coming.
- Federal Insecticide, Fungicide, and Rodenticide Act
- Toxic Substances Control Act
- EPA Biotechnology Regulation Information and Guidance
- Endangered Species Act
- Federal Food, Drug, and Cosmetic Act
- Public Health Service Act
- Animals with Intentional Genomic Alterations
- FDA 1992 Statement of Policy – Foods from New Plant Varieties
- FDA Consultation Procedures