By Benjamin Policicchio, PhD and Suzanne M. Sensabaugh, MS, MBA

In part 1 of this mini-series discussing the newly-released 2017 Update to the Coordinate Framework for the Regulation of Biotechnology, we discussed some of the background relevant to understanding this document and how it came about., This second blog post will discuss the Roles and Responsibilities of the Primary Agencies that Regulate the Products of Biotechnology.

As mentioned in part 1, the “primary agencies” include the U.S. Food and Drug Administration (FDA), U.S. Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA). These three agencies act both independently and alongside each other to regulate various biotechnological products. Each agency overlooks several statutes that guide that specific agencies’ agenda, with each statute having a specific protection goal (not mentioned in this post). Briefly, the statutes for each agency are:

FDA – Federal Food, Drug, and Cosmetic (FD&C) Act; Public Health Service (PHS) Act

EPA – Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); Federal Food, Drug, and Cosmetic Act; Toxic Substances Control Act (TSCA)

USDA – Animal Health Protection Act (AHPA); Plant Protection Act (PPA); Federal Meat Inspection Act (FMIA); Poultry Products Inspection Act (PPIA); Egg Products Inspection Act (EPIA); Virus-Serum-Toxin Act (VSTA)

The FDA regulates a wide variety of products, including human and animal foods (including dietary supplements), cosmetics, human and veterinary drugs, human biological products and medical devices. Some of the key regulatory framework associated with the FDA includes: human and animal foods derived from genetically-engineered (GE) plants; GE animals; human drugs; biologics; and medical devices derived from GE sources.

The EPA is responsible for protecting human health and the environment. Some of the key regulatory framework associated with the EPA includes: FIFRA FD&C Act, section 408, and TSCA. Under FIFRA, EPA regulates pesticides; under section 408 of the FD&C Act, EPA establishes the amount of pesticide chemical residues that may be present in foods; under the TSCA, EPA regulates biotechnology products that are new organisms not specifically excluded by the statute.

The USDA is responsible for developing and executing federal laws related to farming, agriculture, forestry, and food. Some of the key regulatory framework associated with the USDA includes: the Animal and Plant Health Inspection Service (APHIS) and the Food Safety and Inspection Service (FSIS). Under APHIS, USDA regulates products of biotechnology that may pose a risk to agricultural plant and animal health through the PPA and AHPA, respectively. Further, through the VSTA, again contained within APHIS, USDA oversees the regulation of products of biotechnology that are included in veterinary biologics, including the manufacturing and distribution and the purity, safety, potency, and effectiveness of these products. Under the FSIS, USDA ensures that the United States’ commercial supply of meat, poultry, egg products, and fish of the Order Siluriformes is safe, wholesome, and correctly labeled through the FMIA, PPA, and EPIA.

The 2017 Update to the Coordinated Framework contains a very descriptive table (Table 2) summarizing the current responsibilities and relevant coordination across EPA, FDA, and USDA for the regulatory oversight of biotechnology products, effectively identifying the responsible agency or agencies for different products and their applications. A list of the product areas and agencies involved for each product outlined in the table include:

 

Product Area
Agency(s) Involved
Specific Reason(s) for Agency Oversight

Food for humans

USDA

FDA

EPA

USDA: if plant/animal poses a plant pest risk or health risk to livestock

FDA

EPA: regulation of pesticide substance and related genetic material for human/environmental safety

Food for animals (i.e. pet and livestock food)

USDA

FDA

EPA

USDA: if plant/animal poses a plant pest risk or health risk to livestock

FDA

EPA: regulation of pesticide substance and related genetic material for human/environmental safety

Drug for humans

FDA

USDA

FDA

USDA: if plant poses a plant pest risk

 

Biologics for humans

FDA

USDA

FDA

USDA: if plant poses a plant pest risk

Medical device or medical diagnostic for humans

FDA

USDA

FDA

USDA: if plant poses a plant pest risk

Drug for animals (including farm animals and pets)

FDA

USDA

FDA

USDA: if plant poses a plant pest risk

Biologics for animals (veterinary biologics) (i.e. vaccines, etc.)

FDA

USDA

FDA: if rDNA construct itself does not meet veterinary biologic definition

USDA: if plant poses a plant pest risk

Medical device for animals

FDA

USDA

FDA

USDA: if plant poses a plant pest risk

Cosmetics

FDA

USDA

FDA

USDA: if plant poses a plant pest risk

Industrial or consumer chemicals, including pesticide intermediates

USDA

FDA

EPA

USDA: if plant poses a plant pest risk

FDA

EPA: if microbe is intergeneric and is manufactured/processed for commercial production purposes for a use that is not excluded under TSCA and is not otherwise exempt from reporting

Biomass conversion for chemical production, microbial fuel cells, mining and resource extraction, building materials, waste remediation and pollution control, non-pesticidal agriculture applications, and all other applications of intergeneric microbes not otherwise excluded under TSCA

EPA

EPA: if microbe is intergeneric and is manufactured/processed for commercial production purposes for a use that is not excluded under TSCA and is not otherwise exempt from reporting

Other (non-food, non-chemical producing, non-drug producing, non-biologic producing, non-pesticidal organisms)

 

USDA

FDA

EPA

USDA: for ornamental, silvicultural, or turfgrass crops, if plant poses a plant pest or noxious weed risk; if animal poses a plant pest risk or health risk to livestock; if plant-associated microorganism poses a plant pest risk

FDA

EPA: if microbe is intergeneric and is manufactured/processed for commercial production purposes for a use that is not excluded under TSCA and is not otherwise exempt from reporting

Pesticide

USDA

FDA

EPA

USDA: if plant/animal/microbe poses a plant pest risk

FDA: if human/animal food, FDA oversees non-EPA-regulated aspects of the food for safety of human/animal consumption

EPA: regulation of microbial pesticide, pesticide substance and related genetic material produced by plants/animals for human/environmental safety, including the safety of dietary exposure to pesticide residues in human/animal food

 

This concludes part 2 of our mini-series. In part 3, we will discuss interagency communication and coordination. Please contact us if you have any questions about this Update to the Coordinated Framework!

 

 

Suzanne Sensabaugh

Suzanne M. Sensabaugh has advanced the development of over 130 biologics, biosimilars, and combination products since 2009. She can be reached at smsensabaugh@hw-fda.com