The DMR Agreements Between The FDA and Four States

Suitable, professional product packaging and sufficient, important food information are crucial in preventing any public health issues. To ensure the safety of domestic food production and supply systems, the Food and Drug Administration (FDA) recently entered into domestic mutual reliance (DMR) pacts. These DMR pacts are currently with the states of Utah, Wisconsin, Florida, and California.

The FDA aims to work and collaborate positively with the states as mentioned above to improve public health protection, reduce problematic foodborne illness outbreaks, and avoid any regulatory duplication.

According to Erik Mettler, assistant commissioner for partnerships and policy in the Office of Regulatory Affairs of the FDA, collaborating with these states will help in making the industry compliant with the food safety regulations. Compliance is particularly important for all future plans and programs to be successful.

What is the Scope of This Endeavor?

Through these domestic mutual reliance agreements, the FDA will be able to work with these states on inspections, data sharing, outbreak investigations, risk prioritization, as well as the monitoring and improvement of laboratory capacity and key metrics. As detailed in a press release, the FDA entered into these agreements as part of its more extensive plans to strengthen its relationships with these states and government affiliates in order to achieve an Integrated Food Safety System. This critical effort is in a bid to achieve what is intended in the New Era of Smarter Food SafetyBlueprint for the Future, Partnership for Food Protection, and the FDA Food Safety Modernization Act.

The FDA predicts that in the near future, more states will enter into DMR agreements. According to Michael Rogers, assistant commissioner for the Office of Human and Animal Food Operations at the FDA, having more states sign the agreements will help lower redundancy and duplication of effort (and) at the same time impact FDA’s collective oversight. By first preparing the stage, they accomplish an essential step toward achieving a flawless integrated food safety system between the state and federal regulators. This smooth integration is genuinely invaluable and will benefit everyone.

What Are The Downsides to These Agreements?

At first glance, the domestic mutual reliance agreements may seem profitable. However, another viewpoint is that this agreement may cause more issues for the states, the FDA, and the industry in practice. For example, while the agreements may reduce repetitiousness and duplication of FDA and state efforts over time, they may also result in regular inspections by state inspectors with different concerns and skill set than the FDA. If state inspectors do not work with exactly the same standards or know and apply the best practices of the FDA, they could likely take actions that don’t support the national regulatory standards.

Yes, this domestic mutual reliance framework is a protective mechanism that, if done correctly, is a great thing. While the goals are manifest and appreciable, it is still unclear how the FDA would decide where to direct its enforcement resources if states discovered violations of the Federal Food, Drug, and Cosmetic Act. More importantly, it is also not clear to whom the food manufacturer would report its corrective and preventive actions between the FDA or the states, or both.