Taken straight from the press release. This type of data-sharing is critically important to the future of chemical risk assessment and adheres to M³'s core principles of
- MANAGEMENT: managing risks starting with using all available information (which this agreement expands); and
- MODE: A larger "chemical space" allows for more refined predictive utility of computational models.
I'm encouraged by the collaborative spirit in regulating antimicrobials moving forward.
@@@@@@@@@@@@@@@@@@@
Data Sharing Memorandum of Understanding (MOU) between EPA and FDA
EPA and the Food and Drug Administration are pleased to announce a Memorandum of Understanding to share data on pesticides and toxic substances. This sharing of information will better inform both agencies’ assessments of the risks to the public and the environment.
FDA and EPA have complementary roles in their regulatory authority for some substances incorporated into food (including animal food and feed), animal drugs, and cosmetics. FDA is responsible for protecting and promoting the public health by ensuring, among other things, the safety of food (including animal food and feed), animal drugs, and cosmetics by enforcing the Food, Drug and Cosmetic Act and several related public health laws. EPA is responsible for managing the pesticides and toxic substances programs under the Federal Insecticide, Fungicide, and Rodenticide Act, the FD&C Act, and the Toxic Substances Control Act. The MOU establishes a process of disclosure and sharing of their respective databases that will facilitate the decisions of each agency related to food safety, veterinary medications, and cosmetics. This data sharing will provide the most up-to-date information and assist in coordinating reviews between agencies.
Sometimes a given substance may be regulated by both agencies. For example, a manufacturer of an antimicrobial food wash is required to demonstrate to FDA that its use is safe and does not adulterate food. 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. This agreement regarding information sharing and opening channels of communication between the agencies will serve to facilitate the accomplishment of our respective missions. The MOU is available at www.regulations.gov. Enter the following docket number in the Search field: EPA-HQ-OPPT-2003-0004. Read the Federal Register Notice announcing this MOU at:
https://www.federalregister.gov/articles/2015/02/27/2015-04149/access-to-confidential-business-information-by-the-food-and-drug-administration-office-of-foods-and