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USDA and FDA Publish Memorandum to Protect US Food Supply Chain

  • In response to the COVID-19 pandemic, the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) announced a Memorandum of Understanding (MOU) to help prevent interruptions at FDA-regulated food facilities, including fruit and vegetable processing. The MOU creates a process for the two agencies to make determinations about circumstances in which the USDA could exercise its authority under the Defense Production Act (DPA) with regard to certain domestic food resource facilities that manufacture, process, pack, or hold foods, as well as to those that grow or harvest food that fall within the FDA’s jurisdiction.

  • As background, on April 28, 2020, the President issued Executive Order 13917 which delegated authority to USDA under the DPA with respect to food supply chain resources. The President directed the Secretary of Agriculture to take all appropriate actions to ensure that meat and poultry processors continue operations. Additionally, the executive order specified that: “Under the delegation of authority provided in this order, the Secretary of Agriculture may identify additional specific food supply chain resources that meet the criteria of section 101(b).”

  • If the Secretary of Agriculture identifies specific food supply chain resources that are subject to FDA regulation, the agencies will collaborate in the following ways:

    • FDA will:

      • Monitor the integrity and adequacy of the nation’s food supply subject to FDA regulation;

      • Work with stakeholders involved in the domestic production or distribution of FDA-regulated food to identify extant and potential domestic supply chain disruptions;

      • Direct FDA-regulated entities to applicable guidance;

      • Assess potential disruptions to the nation’s supply of FDA-regulated food;

      • Educate domestic stakeholders about this MOU and the potential for use of DPA authority where necessary to protect the supply of FDA-regulated food;

      • Upon identifying a potential or extant disruption to the supply of FDA-regulated food, contact USDA to discuss appropriate action, including possibly invoking its delegated DPA authorities.

    • USDA 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, consult with FDA about appropriate action;

      • After consultation with FDA, issue orders related to or utilize other delegated USDA DPA authorities with regard to food resources and food resource facilities.

  • As stated in the MOU, the agreement is solely for the purposes of coordinating potential use of delegated DPA authorities during the COVID-19 public health emergency. It will continue in effect unless modified by mutual written consent at any time or terminated by either party upon a 60 day advance written notice to the other, or upon the expiration of the presidentially declared emergency, whichever comes first.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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