The proposed Update to the Coordinated Framework for the Regulation of Biotechnology (“proposed Update”) provides a summary of the roles and responsibilities of the three primary agencies with regulatory authority over biotechnology products—the Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA). The proposed Update does not create new authorities, processes, or regulatory proposals. It simply aims to clarify the current practices of the primary agencies to inform the public on how biotechnology products are evaluated, help businesses and academic institutions navigate the regulatory process, support biotechnology innovation, protect health and the environment, and promote public trust in the biotechnology product regulatory system.
The proposed Update is a sequel to the 1986 Coordinated Framework for the Regulation of Biotechnology (“Coordinated Framework”) and the 1992 Update to the Coordinated Framework (“1992 Update”). It relies on the same guiding principles for biotechnology regulation established in those documents. Notable principles include:
- Regulatory oversight is based on specific product uses, allowing multiple products with the same use to go through the same regulatory process;
- Product, application, and environment characteristics determine a product’s risk (or lack thereof); and
- Level of agency oversight depends on the associated risk of introduction, not on any process or technique used to create or alter the product.
The proposed Update outlined four objectives:
- Clarify agency authority and responsibility for biotechnology product areas;
- Clarify agency roles for different product areas, particularly for areas within the responsibility of multiple agencies;
- Clarify the standard mechanism for communication and coordination among agencies; and
- Clarify the mechanism and timeline for reviewing and updating the Coordinated Framework to minimize delays, support innovation, protect health and the environment, and promote the public trust in the regulatory systems for biotechnology products.
To achieve these objectives, the proposed Update presents information about agency roles and responsibilities in several forms, including illustrative graphics, product development case studies, and a comprehensive table of statutory authorities. This information was previously scattered among statutes, regulatory guidance documents, and agency websites (FDA Biotechnology Guidance, FDA Food, FDA Animals, EPA, USDA). The proposed Update concludes with a summary of public comments solicited during the drafting process and a table of key terms and definitions within the various statutes discussed. A summary of the stated roles and responsibilities follows.
EPA regulates biotechnology product areas including pesticides, plant-incorporated protectants, and microorganisms and bio-chemicals. EPA authority to regulate these products arises from the Federal Insecticide, Fungicide, and Rodenticide Act, the FD&C Act, and the Toxic Substances Control Act. EPA responsibilities under these statutes include the following:
Notably, EPA has oversight for a wide range of commercial, industrial, and consumer applications of microbial biotechnology under the Toxic Substances Control Act.
FDA regulates a wide variety of biotechnology product areas including human and animal foods derived from genetically-engineered (GE) plants, GE animals, as well as drugs, biological products, and medical devices for both humans and animals that are derived from a GE source. FDA authority to regulate these products arises under several provisions of the Food, Drug, and Cosmetic (FD&C) Act and other statutes. FDA has the following responsibilities under the Act for biotechnology products:
Notably, FDA regulates GE animals under the new animal drug provisions of the FD&C Act because the regulated article is the recombinant DNA construct inserted into a specific site in the genome of the animal.
USDA has two divisions engaged in biotechnology product regulation, the Animal and Plant Health Inspection Service (APHIS), and the Food Safety and Inspection Service (FSIS). APHIS regulates any biotechnology product that may risk agricultural plant and animal health including products with plant pesticide components, GE animals, and products with animal pathogens. APHIS authority to regulate these products primarily arises out of the Plant Protection Act, the Animal Health Protection Act, and the Virus-Serum-Toxin Act. APHIS has the following responsibilities under these statutes:
- Licensing and permitting of the import, transport, and dissemination of pests or diseases harmful to livestock and organisms that may transmit pests or diseases to livestock;
- Regulation and authorization of plant pests; and
- Regulation and authorization of veterinary biological products used to prevent, diagnose, or treat animal diseases.
FSIS ensures the safety and correct labeling of the commercial food supply, specifically for meat, poultry, and egg products derived from GE sources. FSIS authority to regulate these products arises under the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act. FSIS has the following responsibilities under these statutes:
- Inspection and assessment of all meat, poultry, and processed egg products in interstate commerce; and
- Preapproval for product labels.
The three agencies also operate under a set of formal Memoranda of Understanding (MOUs) to enhance and coordinate interagency information exchange. Each principal agency also calls upon other secondary agencies on a case-by-case basis to obtain the necessary expertise to conduct a full biotechnology product assessment.