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United States. Food and Drug Administration -- Administrative agencies, Food supply -- United States -- Safety measures, Bioterrorism -- Effects on food supply, Food -- Safety measures -- Government policy -- United States


An interconnected network of accredited federal, state, local, tribal, and territorial laboratories is critical to ensuring the safety of the U.S. food supply and the development of the Integrated Food Safety System (IFSS). In 2004, as part of a national policy to defend the U.S. food supply against terrorist attacks, major disasters, and other emergencies, the Food Emergency Response Network (FERN) was created to integrate the nation’s multilevel (i.e., federal, state, local, tribal, territorial) food-testing laboratories to detect, identify, respond to, and recover from a bioterrorism act affecting the safety of the food supply, or a public health emergency/outbreak involving the food supply. Since 2004, federal agencies have invested an estimated $200 million in FERN. The majority of this investment has been in the FERN cooperative agreements with FDA and USDA-FSIS investing $95.8 million and $69 million, respectively. FDA has promoted the accreditation of state laboratories through cooperative agreement funding, investing more than $50 million to fund these grants.

On November 11, 2014, the Office of Regulatory Affairs (ORA) requested that the FDA Science Board establish a subcommittee to evaluate current investments in: (1) the FERN cooperative agreement funding program (CAP), and (2) funding for state laboratories to achieve International Organization for Standardization (ISO) accreditation. The goal was to ascertain how ORA can advance and establish an effective integrated laboratory network among ORA, FDA Center, and state public health and food- and feed-testing laboratories. In response to this request, the Science Board created the ORA FERN Cooperative Agreement Evaluation Subcommittee on July 1, 2015. This report summarizes the results of the Subcommittee’s review.


Report of the FDA Science Board Food Emergency Response Network (FERN) Cooperative Agreement Evaluation Subcommittee.

Note: At the time of writing, Mark McLellan was affiliated with Utah State University.

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