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FSIS, FDA Sign New MOU Involving Dual Jurisdiction
Monday, August 9, 2021
  • Certain food establishments, referred to as dual jurisdiction establishments (DJEs), are under the jurisdiction of both the Food and Drug Administration (FDA) and the U.S. Department of Agriculture’s Food Safety Inspection Service (FSIS).  In January 2018, the FDA and FSIS announced a formal agreement, i.e., memorandum of understanding (MOU) 225-99-2001, to make the oversight of food more efficient and effective by bolstering coordination between the two Agencies.

  • In an August 6, 2021 Constituent Update, FSIS announced an updated agreement, MOU 225-20-2019, signed July 28, 2021, to further facilitate the exchange of information about DJEs.  DJEs under this MOU are limited to human food operations and exclude animal food operations, which are regulated by FDA.  The new MOU improves upon previous information exchange by:

    • Adding headquarters-level contacts for each agency to improve awareness of findings or emerging issues that may warrant more than local or regional coordination.

    • Updating the types of findings to be shared to reflect advances in understanding microbiological food hazards, including microbiological or other sampling findings in DJEs or products, which may provide information about sanitary conditions in those establishments or indicate serious adverse health consequences of products under either agency’s jurisdiction.  These results will include microbe characteristics (e.g., serotype, whole genome sequence, antimicrobial resistance profile, etc.) where applicable, and other information related to categorizing and tracking pathogens.

  • The new MOU 226-20-2019 supersedes the earlier MOU 225-99-2001 as well as MOU 225-14-0009, a formal agreement on the examination and inspection of Siluriformes fish and fish products, which was entered on April 30, 2014 following the handover of jurisdiction of Siluriformes species from FDA to USDA.

 

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