FDA and EPA to share data on pesticides and toxic substances.

  • FDA and EPA share regulatory authority over substances that are used in food (including animal food and feed), animal drugs, and cosmetics.  For example, the manufacturer of an antimicrobial food wash must demonstrate to FDA that the use of this substance is safe and does not adulterate food.  The manufacturer also may be required to demonstrate to EPA that use of the same substance (which constitutes a pesticide) will not have unreasonable adverse effects on the environment.
  • In recognition of their mutual role in assessing the safety of regulated products, FDA and EPA have entered into a Memorandum of Understanding (MOU) to facilitate the sharing of information (including non-public information) related to the agencies’ regulation of substances over which jurisdiction is shared.
  • Although the MOU specifically addresses the agencies’ plans to use proper safeguards against unauthorized use and disclosure of the non-public information shared under the agreement, the industry understandably may be concerned about appropriate treatment of confidential or commercially sensitive data exempt from disclosure under the Freedom of Information Act (FOIA).  It remains to be seen exactly how FDA and EPA will coordinate their responses to FOIA requests going forward, but future submitters of confidential information to either agency should be aware of the increased potential for inter-agency data sharing.