Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

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[USA] FDA, Concluded the signing of a Regulatory Partnership Arrangement (RPA) (2023-08-25)
  • Registration Date 2023-09-05
  • Hit 510

The U.S. Food and Drug Administration (FDA) has concluded the signing of a Regulatory Partnership Arrangement (RPA) with Ecuador’s seafood regulatory authority to enhance the safety of shrimp imported to the United States. A first-of-its-kind, the RPA serves as an arrangement between the FDA and the Vice Ministry of Aquaculture and Fisheries (VMAF) to work more closely to reinforce food safety practices along the entire supply chain. Such arrangements aim to leverage commodity-specific oversight systems — in this case, imported aquacultured shrimp — along with data and information, to strengthen food safety before and at the port of entry. In remarks during the signing ceremony on August 24, Don Prater, Acting Director of the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) described the RPA as the “culmination of a lot of work and relationshipbuilding between both of our agencies.” To prepare for the RPA, the FDA and VMAF signed a confidentiality commitment (CC) in August 2022 that allows for the exchange of confidential information, including inspection records, sample findings, and other non-public documents. In addition, the FDA conducted a rigorous assessment of Ecuador’s aquacultured seafood safety system and examined important parts of VMAF’s programs and capabilities.



The FDA found that Ecuador’s food safety controls for shrimp is science-based; is comprised of the basic food safety system key elements; has ongoing processes to ensure the sustainability of preventive controls; provides competent oversight throughout the supply chain; and has a public health focus. Through this assessment, the FDA became confident that Ecuador has key components of a food safety oversight system for shrimp and shrimp products intended for export to the United States. Thus, the FDA will be able to leverage data and information from Ecuador for the FDA’s regulatory decision making. And, vice versa, Ecuador will leverage data analytics from the FDA to inform their regulatory activities. Since 94% of the seafood consumed by volume in the United States is imported, one of the agency’s tasks has been to ensure that imported seafood is held to the same food safety requirements as food produced domestically. In the past, that’s primarily meant intercepting unsafe food at the border and preventing its entrance in the U.S. marketplace. In 2021, the U.S. Congress highlighted the importance of food safety related to shrimp – the most popular seafood in the United States - by mandating that the FDA consider and develop new options for enhancing the regulation of imported aquacultured shrimp, including an RPA with the three largest shrimp exporting countries by volume. Ecuador is one of those countries. Such an arrangement would provide an opportunity for the FDA and its regulatory counterpart to proactively learn about both country’s regulations and food safety initiatives, identify potential areas for collaboration, prioritize activities, and engage in specific regulatory and program evaluations. With the signing of this first RPA with Ecuador, the FDA is delivering on this congressional mandate and is making progress on implementing the mandate with the two other countries, India and Indonesia. “Ecuador may be a small country, but it is an important supplier of food to the United States, especially of seafood,” FDA Latin America Office Acting Director Michelle Rodriguez said at the signing ceremony. “To achieve our joint food safety goals, collaboration and information sharing is essential.” The new RPA with Ecuador sets forth how the 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 HACCP, Train-the-Trainer HACCP, Good Aquaculture Practices, Good Fishing Vessel Practices, and seafood decomposition detection

• Participate in shrimp inspections, audits, and investigations



The FDA is already sharing information with VMAF, as a result of the 2022 CC, including import refusals, compliance actions, outbreak investigation information, and detailed sampling results. In response, VMAF has provided the FDA with information on Ecuador’s regulatory follow up to these events. “This free flow of information yielded important food safety benefits for consumers in both of our countries, while demonstrating the trust we place in the Vice Ministry,” Rodriguez said. FDA Associate Commissioner Mark Abdoo signed the RPA on behalf of the FDA while Vice Minister Andrés Ahrens signed the arrangement for VMAF. Both an English and a Spanish language version of the RPA have been posted on the FDA’s website. The RPA signing was scheduled so it would coincide with a day-long commemoration of the sixth anniversary of the creation of the Undersecretariat for Quality and Safety (Subsecretaría de calidad y inocuidad or SCI). The commemoration featured a series of presentations on scientific and technical topics, including presentations by Julie Moss, Director of CFSAN’s Office of International Engagement, and by Steve Bloodgood, Director of CFSAN’s Office of Seafood Safety. SCI is the office within VMAF that is responsible for ensuring the health of fishery and aquaculture products, including those for export. For more information: Enhancing the Safety of Imported Shrimp Through Regulatory Partnerships International Cooperation on Food Safety Imported Seafood Safety Program.

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