Regulatory Partnership Arrangements (Food)

The FDA uses several mechanisms to encourage international cooperation for enhancing the safety of imported foods. Regulatory Partnership Arrangements (RPAs) are one such tool, and in August 2023, the FDA signed the first of its kind RPA to strengthen the safety of shrimp intended for the U.S. market. The FDA expects to use RPAs for additional imported food commodities and program areas in the future.

An RPA is a collaborative arrangement between the FDA and a foreign regulatory counterpart that sets a framework for FDA to leverage another country’s food safety export programs for a specific commodity or program area. The RPA facilitates information exchange to support FDA’s risk-based decision making and offers another tool to help ensure that imports meet U.S. safety standards, working collaboratively with regulatory counterparts.

The FDA begins the RPA process by first assessing a foreign country’s food safety regulatory oversight and systems for a specific commodity or program area. Through a rigorous assessment of the foreign country’s food safety laws, regulations, authorities and oversight, the FDA determines if the country has ample food safety controls and has the appropriate level of regulatory oversight throughout that commodity’s supply chain.

The FDA uses the results of the assessment to determine if the foreign regulatory counterpart has appropriate regulatory authority, oversight, and support to maintain a food safety program for a specific commodity that is science-based, has ongoing processes to ensure the sustainability of preventive controls, and has a public health focus. An established RPA can help inform FDA’s risk-based decisions with respect to oversight and surveillance of imported food. The FDA could leverage the RPA for a specific commodity or program area, for example, when planning foreign inspections, import examinations and sampling at the point of entry, and responding to food safety incidents if an outbreak involves the commodity of focus for the RPA.

Both the FDA and the participating regulatory counterpart benefit from the arrangement, recognizing the opportunity to exchange more data and information and collaborate closer on root cause investigations and adverse findings. This cooperative information exchange is an important tool to enhance the safety of food exported to the U.S.

RPA with Ecuador’s Seafood Regulatory Authority

On August 24, 2023, the FDA signed its first RPA with Ecuador’s Vice Ministry of Aquaculture and Fisheries (VMAF) to support oversight of the safety of shrimp intended for the U.S. market and has identified areas of proposed work during the first year of implementation of the RPA, which are summarized below. Shrimp is the most consumed seafood in the United States, the vast majority of which is imported. Ecuador is one of the leading exporters of shrimp to the U.S. This regulatory partnership is an arrangement that allows both parties to work more closely to reinforce food safety practices along the entire supply chain. In preparing for the RPA with Ecuador, in August 2022, the FDA and VMAF signed a confidentiality commitment that allows for the exchange of confidential information, including inspection records, sample findings, and other non-public documents.

In addition, the FDA conducted an assessment of Ecuador’s aquaculture seafood safety system and examined important parts of VMAF’s programs and capabilities. The FDA assessed key aspects of Ecuador’s regulatory framework for shrimp, including a review of its:

Legal framework;
Inspection and enforcement capabilities;
Verification and audit programs;
Disease prevention and surveillance programs for aquatic animals;
Foodborne illness outbreak response;
Training; and
Laboratory resources.

Through this assessment, the FDA is confident that Ecuador has 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, the FDA is confident it will be able to leverage data and information from Ecuador for its regulatory decision making, and Ecuador will leverage data analytics from the FDA to inform their regulatory activities.

Progress and Accomplishments for the RPA with Ecuador

This new RPA with Ecuador describes how the FDA and VMAF intend to collaborate with one another.

Since the signing of the RPA, the FDA and Ecuador’s Seafood Regulatory Authority have initiated the development and implementation of a plan of action to carry out the RPA. Several areas of intended cooperation identified in the RPA have been selected based on capabilities in place and planned regulatory activities relating to shrimp exports from Ecuador for the year, including:

Exchange of information on best practices, changes to food safety laws, regulations or guidance that may impact shrimp exports from Ecuador, including those related to animal foods and drugs;
Prompt notification and response to adverse food safety events such as illnesses, recalls, and outbreaks;
Receipt of results of Ecuador’s sampling program for residue monitoring in aquaculture shrimp by VMAF certified laboratories, which helps ensure the use of animal drugs at aquaculture operations is managed and monitored throughout the supply chain;
Maintenance and sharing of information by VMAF related to approved supply chain from feed and hatcheries through farms to processors and exporters for aquaculture shrimp;
Additional training delivery as resources permit; and
Sharing of information on shrimp inspections, audits, and investigations, and participation when feasible. This includes information related to follow-up investigations conducted by VMAF on FDA notifications of adverse food safety events from shrimp exported to the U.S.

To date, the FDA has provided seven seafood safety trainings in Ecuador, including Seafood HACCP, HACCP train the trainer, FDA import requirements, Sensory/Decomposition training and Good Aquaculture Practices. In addition, the FDA has been sharing information with VMAF under the confidentiality commitment, including import refusals, product recalls, compliance actions and detailed sampling results. In response, VMAF has provided information to the FDA on Ecuador’s regulatory follow-up to these events.

The FDA and VMAF will meet to evaluate progress and identify area areas where adjustment may be needed.

Other Mechanisms for International Cooperation

The FDA has other mechanisms for international cooperation besides RPAs, including the FDA-SENASICA-Cofepris Food Safety Partnership, Systems Recognition, and Equivalence. The FDA also works through the Codex Alimentarium Commission to promote coordination of all food standards and work undertaken by international governmental and non-governmental organizations.

Resources

For more information about Regulatory Partnerships, contact regulatorypartnership@fda.hhs.gov