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YOUR SOURCE ON FOOD LITIGATION AND REGULATION

FDA recently entered into domestic mutual reliance (DMR) agreements with the states of California, Florida, Utah, and Wisconsin to help ensure the safety of domestic food production and distribution systems. FDA’s goal is to coordinate efforts with these states to help decrease human foodborne illness outbreaks, avoid duplication of regulatory oversight, and increase public health protection. Erik Mettler, assistant commissioner for partnerships and policy in FDA’s Office of Regulatory Affairs, noted that the agency is using these partnerships to “improve industry compliance with applicable food safety requirements.”

The DMR agreements will allow FDA to collaborate with these four states on data sharing, risk prioritization, inspections, outbreak investigations, and development and monitoring of key metrics and laboratory capacity. As explained in the agency’s press release, FDA signed the DMR agreements as part of the agency’s greater plans of enhancing existing relationships with states and government counterparts to achieve an Integrated Food Safety System, as intended in the FDA Food Safety Modernization Act, Partnership for Food Protection, and New Era of Smarter Food Safety Blueprint for the Future.

FDA anticipates that more states will soon enter into DMR agreements with the agency. Michael Rogers, assistant commissioner for the Office of Human and Animal Food Operations, noted that FDA expects that “as more states sign mutual reliance agreements, it will help reduce redundancy and duplication of effort [and] optimize the impact of our collective oversight,” which is seen as “a step forward towards achieving a seamless integrated food safety system between the federal and state regulators.”

Potential Impact on Industry

Although the DMR agreements may appear valuable at first glance, in practice, they may result in additional headaches for FDA, states, and industry. For instance, although the agreements may reduce redundancy and duplication of FDA and state efforts in the long term, they are also likely to result in more frequent inspections by state inspectors who have different priorities and level of expertise than FDA. Importantly, it is not clear how FDA would decide where to allocate enforcement resources when states discover violations under the Federal Food, Drug, and Cosmetic Act. It is also vague as to whether, in such cases, the food manufacturer would meet with and report its corrective and preventive actions to the states, FDA, or both.