On August 24, 2023, the FDA signed the first of its kind Regulatory Partnership Arrangement (RPA) with Ecuador’s seafood regulatory authority to strengthen food safety in shrimp intended for the U.S. market. 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 aquacultured shrimp to the United States.
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Pursuant to its obligations under the World Trade Organization (WTO), the FDA works with foreign governments and international standard-setting bodies to harmonize food safety laws, regulations and standards based on science. The FDA also establishes arrangements with regulatory partners to harmonize food safety standards and eliminate duplication or overlap in food safety controls. The FDA maintains two mechanisms in furtherance of these efforts: 1) Systems Recognition – whereby the FDA recognizes that a foreign food safety system achieves food safety outcomes comparable to those of the FDA; and 2) Equivalence – whereby the FDA recognizes that a foreign food safety system achieves the same level of public health protection as the U.S. despite having different food safety controls.
The FDA-SENASICA-Cofepris Food Safety Partnership (FSP) was established in September 2020, through a new Statement of Intent (SOI) between the US Food and Drug Administration (FDA) and Mexico’s National Service of Agro-Alimentary Health, Safety and Quality (SENASICA) and the Federal Commission for Protection against Sanitary Risk (Cofepris).
A Regulatory Partnership Arrangement (RPA) is an arrangement between the FDA and a foreign regulatory counterpart for collaboration to enhance the safety of imported foods. By leveraging another country’s food safety export programs for a specific commodity or program area, such as shrimp, the FDA can work with a regulatory counterpart to ensure that imports meet U.S. safety standards. Through a rigorous assessment, the FDA determines if the country has robust food safety controls and has the appropriate level of regulatory oversight throughout its supply chain. The FDA uses the results of the assessment to make risk-based decisions with respect to oversight and surveillance of imported food.
On August 24, 2023, the FDA signed its first Regulatory Partnership Arrangement with Ecuador to strengthen the safety of shrimp intended for the U.S. market.
For more information about the Regulatory Partnership, contact email@example.com.
Systems recognition, previously referred to as comparability, involves reviewing a foreign country’s food safety regulatory system to determine if it provides a similar set of protections to that of the FDA. Outcomes of these reviews may be used by the FDA to make risk-based decisions regarding foreign inspections, import examination, and responses to food safety incidents.
Once systems recognition assessments are completed, the arrangement leads the way to a new level of regulatory cooperation between FDA and our regulatory partners in other countries, allowing us to avoid duplication of effort while leveraging the high quality work done by regulatory authorities in each country.
Equivalence is the process of determining whether a country’s food safety controls achieve at least the same level of public health protection as measures required by U.S. law. This means that a foreign country is not required to develop and implement the same exact procedures and food safety controls that FDA requires, but rather the country must objectively demonstrate how its food safety controls meet at least the same level of public health protection achieved by U.S. measures.
The Codex Alimentarius Commission (CAC), created in 1963, is an intergovernmental body with over 170 members within the framework of the Joint Food Standards Programme established by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO). The Commission’s purpose is to protect the health of consumers and to ensure fair practices in the food trade. It also promotes coordination of all food standards work undertaken by international governmental and non-governmental organizations.
The Codex Alimentarius, a result of the Commission's work, is a collection of internationally adopted food standards, guidelines, codes of practice and other recommendations and is the major international mechanism for encouraging fair international trade in food while promoting the health and economic interest of consumers.
- U.S. Office for Codex Alimentarius (USDA/FSIS)
- Codex Alimentarius Commission
- FDA's Participation in Codex
- The Joint FAO/WHO Expert Committee on Food Additives (JECFA)
- The Joint FAO/WHO Meeting on Pesticide Residues (JMPR)
- The Joint FAO/WHO Expert Meetings on Microbiological Risk Assessment (JEMRA)
- Conversation with FDA Experts: International Collaboration on Food Safety is a Top Priority for the FDA
- World Health Organization (WHO)
- Food and Agriculture Organization of the United Nations
- Pan American Health Organization (PAHO)
- World Organization for Animal Health (OIE)
- International Plant Protection Convention
- Organization for Economic Cooperation and Development (OECD)
- International Programme on Chemical Safety (IPCS)