FDA-Mexico Produce Safety Partnership
We are pleased to present the U.S. FDA-Mexico Produce Safety Partnership: A Dynamic Partnership in Action progress report. The Produce Safety Partnership (PSP) is a groundbreaking collaboration to address the evolving nature of the production and distribution practices facing our respective countries. The report highlights how Mexico and the U.S. are working together to ensure the safety of fresh and minimally processed produce. FDA, Departments of Agriculture – National Service for Agroalimentary Public Health, Safety, and Quality (SENASICA) – and Health – Federal Commission for the Production from Sanitary Risks (COFEPRIS) are working collaboratively on institutionalizing approaches that reinforce preventive practices and rapid response to potential outbreaks. As explained in the report, we have worked together to contain potentially serious outbreaks related to produce and lessen consumer exposure to foodborne disease.
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.
- Systems Recognition
- Food and Feed Import Practices of Foreign Governments to Improve Food Safety
- Codex Alimentarius Commission
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.
- Constituent Update: FDA Recognizes Australia as Having a Comparable Food Safety System to the U.S.
- Food Safety Systems Recognition Arrangement Between the Australian Department Of Agriculture and Water Resources and The FDA of The United States of America
- Report of the Systems Recognition Review of Australia by the U.S. FDA (PDF: 605KB)
- Statement by Erik Mettler, Acting Deputy Commissioner for Foods and Veterinary Medicine, on Systems Recognition Arrangement with Australia
- Constituent Update: FDA Recognizes Canada as Having a Comparable Food Safety System to the U.S. May 4, 2016
- Food Safety Systems Recognition Arrangement between the Canadian Food Inspection Agency and the Department of Health of Canada and the Food and Drug Administration of the United States
- Report of the Systems Recognition Assessment of Canada (PDF: 232KB)
- Statement by Michael Taylor, Deputy Commissioner for Foods and Veterinary Medicine, on Systems Recognition Arrangement with Canada May 4, 2016
- Food Safety Systems Recognition Arrangement between The Ministry for Primary Industries of New Zealand and The Food and Drug Administration of the United States
- Report of the Comparability Determination of the Food Safety Component of the New Zealand Ministry for Primary Industries (PDF: 559KB)
- International Comparability Assessment Tool (ICAT)
Imported food products that are determined by FDA to fully comply with U.S. law and regulatory requirements are typically permitted entry to the U.S. market without further conditions. In situations where a foreign food safety system provides the same level of public health protection as the U.S. system for a particular product, the agency may determine that foreign food safety system is equivalent to relevant U.S. requirements. If equivalence applies, imported products produced in accordance with the equivalence determination would be permitted into the U.S. An equivalence determination is made by FDA after in-depth scientific and regulatory analysis of the foreign country’s system. Currently, the FDA has received requests for equivalence for molluscan shellfish and Grade A milk and milk products.
European Union: Raw Bivalve Molluscan Shellfish
- Federal Register Notice: Proposed Equivalence Determination Regarding the European Union Food Safety Control System for Raw Bivalve Molluscan Shellfish
- Questions and Answers Supplementing Information Contained in the Federal Register Notice and Request for Comment Relating to the Proposed Equivalence Determination Regarding the European Food Safety Control System for Raw Bivalve Molluscan Shellfish
- Constituent Update: FDA Announces Proposed Determination that the European Union’s Shellfish Safety Program is Equivalent to That in the United States
Additional information on Equivalence
Article 4 of the World Trade Organization (WTO) Agreement on Sanitary and Phytosanitary Measures (SPS Agreement) states:
Members shall accept the sanitary or phytosanitary measures of other Members as equivalent, even if these measures differ from their own or from those used by other Members trading in the same product, if the exporting Member objectively demonstrates to the importing Member that its measures achieve the importing Member’s appropriate level of sanitary or phytosanitary protection. For this purpose, reasonable access shall be given, upon request, to the importing Member for inspection, testing and other relevant procedures.
WTO obligations are codified in U.S. law through the Uruguay Round Agreements Act (URAA), Pub. L. No. 103-465, 108 Stat. 4809 (1994). The URAA states that U.S. agencies may find foreign SPS measures equivalent if they “provide at least the same level of sanitary or phytosanitary protection as the comparable [SPS] measure established under the authority of Federal law.”
How does the equivalence process work?
Once FDA receives a request that contains adequate information for FDA to evaluate, FDA conducts an assessment to determine whether the sanitary measures included in the exporting country’s regulatory system are “equivalent,” i.e., whether they, despite being different, provide the same level of protection as relevant U.S. food safety requirements.
The process involves primarily two main components:
1) a technical evaluation of the food safety control system, and
2) administrative procedures to finalize an equivalence determination, if appropriate.
The technical component typically includes the FDA’s assessment and reports on the foreign food safety system as applied to the product in question and the resolution of technical issues as they arise. If the FDA technical experts believe that a foreign system provides the same level of food safety protection as the corresponding U.S. system, the experts will recommend or propose a finding of equivalence. The agency then will initiate administrative procedures to finalize the determination, as appropriate.
Is Equivalence Required to Export Products to the United States?
No, a finding of equivalence is not required to export products to the U.S. that fully comply with the applicable U.S. requirements. Specifically with respect to imported shellfish, FDA has entered into a Memorandum of Understanding with exporting countries in the past specifying these products for export comply with U.S. law and current requirements. In such cases, foreign countries ensure that products exported to the U.S. meet the same regulatory requirements as product produced domestically and equivalence is not required. For imported shellfish, this means that the products comply with the requirements of the National Shellfish Sanitation Program (NSSP). For Grade “A” milk and milk product imports, the exported products must satisfy the requirements of the National Conference of Interstate Milk Shippers’ Pasteurized Milk Ordinance.
Formal requests for equivalence recognition can be addressed to:
International Affairs Staff
Center for Food Safety and Applied Nutrition
U.S. Food and Drug Administration
5001 Campus Drive, Mail Stop 550
College Park, MD 20740
Additional Information on Equivalence
Information on the international and U.S. legal framework for equivalence:
- WTO SPS Agreement
- Uruguay Round Agreements Act
- Information on the Codex Alimentarius guidelines on equivalence
- Information on U.S. Standards for Grade “A” Dairy Products
- Information on U.S. Food Safety Requirements for Molluscan Shellfish
Under contract to the U.S. FDA, Eastern Research Group, Inc. (ERG), in collaboration with independent subject matter experts, undertook this study of imported food and feed practices of foreign governments. FDA's objective was to better understand the practices used by other mature food safety systems that have similar public health goals to that of the U.S. and to perform a qualitative analysis of those import practices identified. The contractors reviewed publicly available literature and interviewed country officials involved in the importation of food and feed using a validated semi-structured interview protocol. The study was conducted from January to November 2011.
The countries selected for the study included: Australia, Canada, Chile, Ireland, Israel, Japan, Mexico, New Zealand (NZ), the Netherlands, and South Africa. Interviews were conducted with each country's officials (with the exception of Japan) – either in-person or via digital video conference – and focused on a variety of topics ranging from government authorities and private sector involvement in the safety of imported food and feed to meeting World Trade Organization (WTO) obligations.
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)
- 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)