EPA and FDA Agree to Share Confidential Commercial Data

On March 16, 2015, the Environmental Protection Agency ("EPA") and the Food and Drug Administration ("FDA") publicized an agreement to share information with each other as it relates to pesticides and toxic substances. This recent agreement indicates a shared effort by each agency to better inform their assessments of public and environmental risk. Consequently, the FDA and EPA may now coordinate their reviews where a toxin at issue is subject to regulation by both agencies. The greatest impact will be felt on those companies with substances that have both pesticidal and non-pesticidal functions, for example, manufacturers of antimicrobial food washes.

Presently, the agencies have different but connected roles in overseeing the safety of food supply. The FDA is primarily responsible for the regulation of human and animal food, drugs, and cosmetics, while the EPA manages the environmental impact of pesticide and toxic substance use by overseeing the Federal Insecticide, Fungicide, and Rodenticide Act, the Federal Food, Drug and Cosmetic Act, and the Toxic Substances Control Act.

The Memorandum of Understanding ("MOU") between the two agencies establishes a process of disclosure and sharing to facilitate each agency's decision-making as it relates to food safety, cosmetics, and veterinary medicine. It allows the FDA and EPA to exchange the confidential data and information they obtain from companies when a substance present in the company's materials is regulated by both agencies, including in consumer and commercial use chemical substances, pesticides, human food, animal food and feed, drugs (including animal drugs), and cosmetics.

Significantly, the agencies will now share non-public information that may be exempt from public disclosure as confidential business information or confidential commercial information. All information currently in the possession of the FDA previously classified as a "trade secret" will now be reassessed to determine if it is of a type that may be disclosed to the EPA. Therefore, if the EPA requests information from the FDA that is presently identified as a trade secret, the FDA will perform an analysis to see if that information should continue to be categorized as a trade secret.

However, the MOU does not permit each agency to directly access the other's database. The MOU requires a formal, written request and a shared agreement not to further disclose the information. Furthermore, to protect the confidential materials, only hard copies may be exchanged, unless the information is downloaded onto an encrypted disk and is only accessed on a secure computer kept for the exclusive purpose of accessing the confidential data.

Although it is unclear what the exact ramifications of the MOU will be, what is certain is that the FDA and EPA will be allowed to access memoranda, applications, and petitions previously only available to one of the two agencies. As the MOU was signed with the intent of providing more complete information to both agencies during risk assessments and regulatory decisions, it is possible that moving forward, the agencies may coordinate and jointly review certain toxins and substances.