Article: FDA and USDA sign MOU to allow USDA to exercise DPA authority in FDA-regulated facilities

This article is taken from IEG Policy dated 20/05/20.

In the latest move to shield the food supply chain from impact caused by the COVID-19 pandemic, USDA and FDA announced Tuesday (May 19) the two agencies have signed a Memorandum of Understanding (MOU) outlining a process to prevent interruptions at FDA-regulated food facilities, including fruit and vegetable processing plants.

The new agreement creates a process allowing the two agencies to make determinations about circumstances in which the USDA could exercise its authority under the Defense Production Act (DPA) in domestic food facilities that manufacture, process, pack, or hold foods, including those that grow or harvest food that fall within the FDA's jurisdiction.

Among other facilities, the new process applies to fruit and vegetable processing plants, which are becoming increasingly important with the approaching peak harvesting season when many fruits and vegetables grown across the US are sent to be frozen or canned, USDA Under Secretary for Food Safety Mindy Brashears and FDA Deputy Commissioner for Food Policy and Response Frank Yiannas said in a joint statement on Tuesday (May 19).

Brashears and Yiannas were designated as liaison officers, responsible for ensuring that the agencies carry out the terms of the MOU agreement, which is non-binding.

"This agreement is solely for purposes of coordinating potential use of delegated USDA DPA authorities during the COVID-19 public health emergency," the MOU states. "It represents the broad outline of the Parties' present intent on how they will approach the oversight of food resource facilities and farms that are not subject to USDA's exclusive jurisdiction and how they will approach possible use of the DPA with regard to such entities during the COVID-19 public health emergency."

The new agreement comes as a result of President Donald Trump's Executive Order 13917, Delegating Authority Under the Defense Production Act with Respect to the Food Supply Chain Resources During the National Emergency Caused by the Outbreak of COVID-19, which was signed at the end of April as a way to prevent meat plant closures.

The order delegated the powers of the president under the DPA to Secretary of Agriculture Sonny Perdue to ensure continuity of operations for the US food supply chain, particularly with respect to the meat and poultry industries. The order directed Perdue to take all appropriate actions to ensure that meat and poultry processors continue operations in a manner consistent with safety guidances issued by the Centers for Disease Control and Prevention (CDC) and the US Department of Labor's (DOL) Occupational Safety and Health Administration (OSHA).

The order, however, also stated that under his new authority Perdue may "identify additional specific food supply chain resources that meet the criteria of section 101(b)."

The new MOU lays out how the agencies would work together should that occur.

What's in the agreement?

For instance, it states that FDA will continue to monitor "the integrity and adequacy" of the part of the food supply the agency regulates and work with stakeholders involved in production or distribution of FDA-regulated food to identify potential disruptions. The agency will also ensure that its regulated facilities apply appropriate CDC and OSHA safety guidances for workers on farms and at food resource facilities. FDA will also watch for plant closures or other possible interruptions and "upon identifying a potential or extant disruption to the supply of FDA-regulated food of sufficient likelihood, seriousness or significance, contact USDA to discuss appropriate action, including possibly invoking its delegated DPA authorities."

FDA also will be responsible for educating stakeholders about the MOU and the "potential for use of DPA authority where necessary or appropriate to protect the supply of FDA-regulated food," the agreement states.

USDA, on the other hand, will "retain exclusive delegated authority to issue DPA orders or invoke DPA authorities with regard to food resources and domestic food resource facilities."

"Upon notification by FDA of a potential or extant disruption to the supply of FDA-regulated food of sufficient likelihood, seriousness or significance, consult with FDA about appropriate action, including whether to invoke USDA's DPA delegated authorities," the agreement states. "After consultation with FDA, issue orders related to or utilize other delegated USDA DPA authorities with regard to food resources and food resource facilities."

The two agencies also agreed to work closely together and ensure their staff continues meeting periodically to coordinate, evaluate, and review issues related to the integrity of the food supply in the pandemic.

"A Party will immediately notify the other Party if it is unable to carry out any or all of its responsibilities under this MOU," the agreement states.

Brashears and Yiannas said they welcomed the new agreement as a natural extension of Trump's executive order and noted that while FDA will continue to work with state and local regulators, further action under the DPA may follow, if necessary, to ensure the continuity of the food supply.

"The Executive Order gave the Secretary of Agriculture the authority to utilize the DPA if needed to require the fulfillment of contracts at food processing facilities," the two officials said.

The MOU, they said, clarifies that FDA will work with stakeholders to monitor the food supply for food resources not under the USDA's exclusive jurisdiction in order to prevent interruptions at FDA-regulated food facilities. Additionally, FDA will work with state, local, and public health partners, as well as industry and other stakeholders, to "chart a path toward resuming and/or maintaining operations while keeping employees safe," Brashears and Yiannas said.

"We are extremely grateful to essential workers for everything they do every day to keep our pantries, refrigerators and freezers stocked," the two officials said. "All of the food and agriculture sector - whether it is regulated by the USDA or FDA - are considered critical infrastructure, and it is vital for the public health that they continue to operate in accordance with guidelines from the CDC and OSHA regarding worker health and safety."

FDA, USDA stress commitment to worker safety

The MOU is the latest in series of actions that the agencies have taken during the pandemic to protect the food supply from interruptions, Brashears and Yiannas said, stressing that the agencies are committed to ensuring the safety of workers and continue to seek ways to support the food industry and its employees.

"Our nation's food and agriculture facilities and workers play an integral role in the continuity of our food supply chain," the two officials said. "The USDA and FDA have been working to ensure that frontline workers in food facilities and retailers that have remained on the job during this crisis have the information and resources they need for business continuity and to continue working safely, which includes mitigating the risk of spreading COVID-19."

As one way to support industry, both FDA and USDA have continued to post information about COVID-19-related challenges and to update frequently asked questions on both agencies' websites. The agencies will also continue to work with plants and farms to ensure they are implementing appropriate guidelines to ensure worker safety.

The agencies are also working closely with federal partners to develop information on protecting worker health and are also working to address shortages of personal protective equipment (PPE), such as cloth face coverings, disinfectants and sanitation supplies, Brashears and Yiannas said.

The agencies have also been looking closely for potential food supply interruptions and shortages and have issued guidances that make it easier to safely "reroute food that typically would be bought in bulk by food facilities and restaurants, like eggs and flour, directly to consumers," the officials noted.

Stressing again that there has been no evidence that COVID-19 has been transmitted by food or food packaging, the two officials also noted the two agencies have not shifted their focus away from food safety and "continue to use their respective authorities, including conducting inspections, as appropriate."

"The agencies also continue to monitor foods for hazards, work with industry on any potential or reported issues in their facilities, and conduct food recalls when appropriate," Brashears and Yiannas said. "This applies to both domestically produced food and food that is imported from other countries."

With respect to foodborne pathogens, CDC, FDA and FSIS continue to investigate foodborne illness and outbreaks, the two officials stressed. "[W]e will continue to operate to prepare for, coordinate and carry out response activities to incidents of foodborne illness in both human and animal food," Brashears and Yiannas said.

NFI welcomes MOU

At least one industry group, the National Fisheries Institute (NFI) welcomed the agreement.

"Recognizing that the FDA draws its jurisdiction from the Federal Food, Drug, and Cosmetic Act and the USDA regulates via the Federal Meat Inspection Act, it is more important than ever to have these vital agencies communicating and collaborating," NFI said May 20.

Though the seafood supply chain has not experienced shortages, NFI thanked the agencies for planning ahead.

"NFI members are taking the needed steps to keep our essential workers safe and continuing to provide consumers with healthy seafood," the group said. "This memorandum of understanding will benefit frontline food safety and help avoid interruptions that might unnecessarily disrupt seafood production."

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