Friday, March 20, 2015

Dynamic Duo Coming Soon? (FDA and EPA Talk About Teaming Up and Sharing Info)


John Bucksath
President and CEO
ABC Laboratories, Inc.


The U.S. Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) have recently communicated they will be teaming up to improve effectiveness by sharing information between the two agencies. This agreement was announced when a Memorandum of Understanding was completed and released to the public announcing the EPA will share data on pesticides and toxic substances with the FDA. It was noted that this information will better inform their assessments of risks to the public and the environment.

FDA is responsible for protecting and promoting the public health by ensuring the safety of food (including animal food and feed), human drugs, 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. Arguably, both FDA and EPA are the world's most respected regulatory authorities. 

Industry has long known these independent agencies and the ever increasing scrutiny they apply in their respective areas of responsibility to protect the public. Industry realizes that 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. However, it is probably safe to assume the general public would find the complexity of this process a bit daunting. The responsibilities of these agencies  are becoming increasing complex as new product development technology is increasingly pushing new limits almost daily.

In today's "information at your fingertips society," the agencies may appear to be teaming up to take advantage of the wealth of information accumulated over decades of regulatory development and finding new ways to share information. More importantly, I believe there is a sense of urgency in finding new ways to communicate information in a way that their collective stakeholders (the public, industry, government, etc.) can understand. After all, isn't the real measure of communication the recipients' ability to apply what has been received and use responsibly? 

As most in industry know, both FDA and EPA have been under tremendous pressure to continually improve the efficiency in the way they perform their work. The rapidly expanding global market, increased number of products being developed and imported into the U.S. and a relative shrinking budget has challenged both agencies to innovate at a blistering pace. Yes, I said it, the EPA and FDA are innovating at a blistering pace. Does the future hold even more teamwork between the two agencies? Will the halls of history echo such dynamic duos as Batman and Robin, Thelma and Louise and FDA and EPA?  Stay tuned...




For technical information contact: Colby Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 564-1404; email address: lintner.colby@epa.gov.



Additional information on this activity can be obtained from: Scott M. Sherlock, Attorney Advisor, Office of Pollution Prevention and Toxics (OPPT), Office of Chemical Safety, Pesticides and Prevention (OCSPP), Environmental Protection Agency, 1200 Pennsylvania Ave., Washington, DC 20460-0001; telephone number (202) 564-8257; email address: sherlock.scott@epa.gov.


For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: TSCA-Hotline@epa.gov



1 comment:

  1. Interested in the future of a possible data-sharing partnership between the FDA and the EPA? Check out this blog by ABC's CEO, John Bucksath: "Dynamic Duo Coming Soon?":

    http://abclabs.blogspot.com/2015/03/dynamic-duo.html

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