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NewsFood TypeManagementRegulatorySupply ChainInternationalSeafoodFDAInternational Standards/HarmonizationImports/Exports

FDA Signs First-of-its-Kind Arrangement with Ecuador to Ensure Safety of Shrimp Exported to U.S.

shrimp on a fork

Image credit: Fernando Andrade via Unsplash

August 25, 2023

On August 24, 2023, the U.S. Food and Drug Administration (FDA) signed a Regulatory Partnership Arrangement (RPA) with Ecuador’s Vice Ministry of Aquaculture and Fisheries (VMAF) to strengthen the safety of Ecuadorian shrimp intended for sale in the U.S. market.

Shrimp is the most widely consumed seafood in the U.S, most of which is imported. Ecuador is one of the leading exporters of aquacultured shrimp to the U.S. In 2021, U.S. Congress mandated FDA to consider and develop new options for enhancing the regulation of imported aquacultured shrimp, including setting up an RPA with each of the three largest exporting countries by volume—India, Indonesia, and Ecuador.

The regulatory partnership with Ecuador is the first of its kind and serves as an arrangement between FDA and VMAF to collaborate on reinforcing food safety practices along the entire supply chain. Such arrangements aim to leverage commodity-specific oversight systems, as well as data and information, to strengthen food safety before and at the port of entry into the U.S.

To prepare for the RPA with Ecuador, in August 2022, FDA and VMAF signed a confidentiality commitment (CC) that allows for the exchange of confidential information, including inspection records, sample findings, and other non-public documents. Additionally, FDA conducted a thorough assessment of the strength of Ecuador’s aquacultured seafood safety system and examined relevant areas of VMAF’s programs and capabilities. FDA assessed key aspects of Ecuador’s regulatory framework for shrimp, including its:

  • Legal framework
  • Inspection and enforcement capabilities
  • Verification and audit programs
  • Aquatic animals’ disease prevention and surveillance programs
  • Illness outbreak responses
  • Training
  • Laboratory resources.

Through the assessment, FDA is confident that Ecuador adequately maintains key components of a food safety oversight system for shrimp and shrimp products intended for export to the U.S. As a result of the assessment, FDA will be able to leverage data and information from Ecuador for its regulatory decision-making. Ecuador will leverage data analytics from FDA to inform its regulatory activities as well.

The new RPA with Ecuador sets forth how FDA and VMAF intend to collaborate with one another to:

  • Share information on best practices, food safety policies, and regulatory approaches to address the safety of shrimp
  • Ensure prompt notification and response to adverse food safety events such as illnesses, recalls, and outbreaks
  • Promote and conduct training, including FDA Import Operations, basic Hazards Analysis and Critical Control points (HACCP), Train-the-Trainer HACCP, Good Aquaculture Practices, Good Fishing Vessel Practices, and seafood decomposition detection
  • Participate in shrimp inspections, audits, and investigations.

FDA has already been sharing information with VMAF since the CC was signed, including import refusals, compliance actions, and detailed sampling results. In response, VMAF has provided information to FDA on Ecuador’s regulatory follow-up to these events.

KEYWORDS: FDA imports and exports regulatory relationships seafood

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