FDA, EPA sign data-sharing agreement
March 16, 2015
by Erica Shaffer
WASHINGTON – The Food and Drug Agency and the Environmental Protection Agency have established a process for sharing information to better inform risk assessments and decision making related to food safety, veterinary medicine and cosmetics.
The Memorandum of Understanding
(MOU) details the process of disclosure and sharing databases in instances where the agencies share oversight of a given substance. “For example, a manufacturer of an antimicrobial food wash is required to demonstrate to the FDA that its use is safe and does not adulterate food,” the agencies said. The manufacturer may also be required to demonstrate to EPA that use of the same substance [labeled as a pesticide] will not hurt the environment.”
Under the MOU “...FDA and EPA may share with each other non-public information that may be exempt from public disclosure as confidential business information and/or confidential commercial information subject to applicable limitations...” Information to be shared includes memoranda, data from petitions and notifications, communications and other documents. The MOU encompasses regulated substances that may be present in human food, animal food and feed, animal drugs and cosmetics.
The agencies agreed to designate a liaison to exchange inquiries and determine resources needed to address inquiries. FDA and EPA also agreed the implement proper safeguards against unauthorized use of the non-public information.