May 20, 2020

FDA, USDA Coordinate to Bring FDA-Regulated Facilities Under DPA Authority

On May 18, 2020, the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) agreed to a Memorandum of Understanding (MOU) about the possible use of USDA’s Defense Protection Act (DPA) authority over FDA-regulated facilities that manufacture, process, pack, grow, harvest or hold foods. The MOU describes the circumstances for how USDA will use its DPA authority delegated by President Trump to help ensure FDA-regulated facilities continue operations despite disruptions caused by COVID-19.

On April 28, President Trump signed Executive Order 13917, which delegated authority under the DPA to USDA to ensure that meat and poultry processors continue operations. The Order focused on meat and poultry facilities, but also noted that “the Secretary of Agriculture may identify additional specific food supply chain resources that meet the criteria of section 101(b).” In its press release, FDA notes that the timing of the MOU — which aligns with the start of the current harvesting season for many fruits and vegetables — is relevant.

The MOU lays out the process for USDA and FDA to coordinate with one another, as well as with other stakeholders. For entities outside of the USDA’s purview, FDA will monitor for disruptions at FDA-regulated entities and coordinate with USDA to consider exercising USDA authority under DPA to take actions to safeguard the food supply chain. To assist with its monitoring efforts, FDA provides a dedicated email for reporting disruptions:

Anticipated disruptions noted in the FDA announcement include COVID-19 cases emerging in worker populations and facility closures ordered by states or localities. Both USDA and FDA continue to note that guidance from the Centers for Disease Control and Prevention (CDC) and the Occupational Safety and Health Administration (OSHA) provide the fundamental information needed for keeping these critical facilities open while maintaining worker safety.

As the number of cases around the world grows, Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.

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