Systems Recognition (Food)

Systems Recognition (SR) is a partnership between the U.S. Food and Drug Administration (FDA) and a foreign regulatory counterpart (referred to as participating agency or agencies), in which the agencies have concluded that they operate comparable regulatory programs that yield similar food safety outcomes. The FDA developed and implemented SR with the goal of leveraging global food safety to reduce FDA resources dedicated to food covered by a Systems Recognition Arrangement (SRA). SRAs allow the FDA and participating agencies to prioritize resources in a more risk-based manner and improve and expand information sharing on food safety issues.

Recognizing the potential value in leveraging the expertise of foreign food safety systems, the FDA began exploring SR in 2010 as a tool to set regulatory priorities, establish closer regulatory partnerships, improve efficiency and strengthen our food safety system. Through the SR process, the participating agencies conduct thorough assessments of each other’s domestic food safety systems. If each agency concludes that the food safety systems are comparable, they sign a SRA, indicating that they have confidence in each other’s food safety systems and allowing them to leverage each other’s regulatory systems and activities to manage the safety of foods.

The SR program is voluntary and not a requirement for a country to export foods to the United States. Currently, the FDA has signed SRAs with food safety agencies in three countries: Australia, Canada, and New Zealand.

Australia

Canada

New Zealand

The Systems Recognition Process

Systems Recognition (SR) includes a comprehensive assessment of key elements of each participating agency’s food safety system.
The process consists of:

A pre-submittal evaluation;
SR Assessment: Desk Assessment and In-country Verification Assessment;
If found comparable, execution of an SRA;
SRA implementation including information sharing, regulatory cooperation, improved risk monitoring.
Annual meetings and reassessment of the SRA every five (5) years.

The SR assessment process is preceded by a pre-submittal evaluation. The assessment itself consists of a desk assessment, and an in-country verification assessment. To support SR, the FDA developed the International Comparability Assessment Tool (ICAT), a Web-based tool used to provide information from the FDA and collect information from the foreign regulatory authority. The ICAT provides the framework for the analysis of the two food safety systems in both the desk assessment and in-country verification process.

During the desk assessment, a team of FDA scientists, auditors, and investigators reviews the information submitted through the ICAT system. For the in-country verification, FDA representatives visit the foreign agency’s headquarters, laboratories, and food processing facilities to verify the implementation of their food safety programs and measures as outlined in the ICAT responses. The FDA team completes its analysis and compiles summary reports based on its assessment.
To foster consistency with its domestic approach, the FDA used the United States Manufactured Food Regulatory Program Standards, as a model in developing the ICAT.

The ICAT is divided into 10 sections:

Legal and Regulatory Foundation
Training Program
Inspection Program
Program Assessment and Audit Program
Food-related Illness and Outbreaks
Compliance and Enforcement Program
Industry and Community Relations
Program Resources
International Communication and Harmonization
Laboratory Support

SR is a reciprocal process; the participating agency or agencies conducts their own assessment of the FDA. If the food safety agencies in both countries find each other comparable, they sign and implement an SRA. The participating agencies have annual meetings and five-year reassessments to discuss changes in either country that may require changes to the arrangement.

A comparable food safety system in another country could comprise one or more food safety authorities working in tandem to help ensure the overall safety of foods produced and processed in that country. The SRA focuses on the aspects of the food safety system and foods over which the U.S. FDA has jurisdiction and regulatory authority.

Excluded Product Categories

Systems Recognition (SR) is not intended to cover all commodities. Because of public health or legal considerations that require a specialized regulatory approach, the following product categories have been excluded across all SR assessments: Infant Formula, Grade A Dairy, Dietary Supplements, Cosmetics, Housewares, Animal Food, and Alcohol. While shellfish is currently covered for New Zealand, it will be excluded in the future because the State-Federal cooperative regulatory framework requires that foreign bivalve molluscan shellfish controls be assessed for either compliance with or equivalence to U.S. requirements. Bivalve molluscan shellfish is an excluded commodity in the Canada and Australia arrangements.

Additional Information

Guidance for Food and Drug Administration Staff: FDA Oversight of Food Covered by Systems Recognition Arrangements

The History of Systems Recognition

The FDA developed and implemented Systems Recognition (SR) with the goal of leveraging global food safety to reduce FDA resources dedicated to food covered by a Systems Recognition Arrangement (SRA).

Preliminary FDA discussions considered the design and initial pilot activities for SR assessments. These activities informed further development of the concept under the Food Safety Modernization Act (FSMA) implementation structure. Following the SR Pilot launch in 2010, the FDA held public meetings in 2011 and 2017, where the SR program benefited from stakeholder input on topics including: FDA use of international comparability assessments; SR as a tool in managing food imports; lessons learned in developing the International Comparability Assessment Tool (ICAT); Web-based application systems; country experiences; monitoring plans; and SR in the Food Safety Modernization Act framework.

The FDA conducted its Pilot SR assessment with the New Zealand Ministry for Primary Industries (MPI) and signed an SRA in 2012. Since then, assessments and SRAs were completed with the Canadian Food Inspection Agency (CFIA) and Health Canada (HC) in 2016, and with the Australian Department of Agriculture, Water, and the Environment in 2017. The FDA is currently assessing food safety systems of certain countries in the European Union.

Program Benefits

The Systems Recognition (SR) program allows the FDA and participating agencies to prioritize resources in a more risk-based manner and to improve and expand information sharing on food safety issues, including data on foodborne outbreaks, inspections, and sampling results.

For example, with a Systems Recognition Arrangement in place, a participating agency could reduce sampling activity for a covered product and increase sampling for products not covered by an SRA. Both participating agencies may also choose to reduce routine foreign inspections for covered commodities and redirect those resources to higher risk commodities.

For consumers, SR supports public health by enhancing information sharing about food facilities and outbreaks and leveraging resources so that each agency can redirect resources in a more risk-based manner. SR contributes to a safer global food supply, in alignment with the FDA’s mission to protect public health.

Systems Recognition vs. Equivalence

Systems Recognition (SR) is not the same as Equivalence.

SR creates a regulatory partnership between the FDA and a participating agency in which each agency agrees that the other operates a comparable regulatory program that yields similar food safety outcomes.

The key principle of SR is that comparable regulatory programs yield similar food safety outcomes. Consumers can have increased confidence in the safety of the foods regulated by participating agencies because the FDA has determined, after a rigorous assessment, that these agencies have strong food safety controls. The outcome of a positive assessment by both agencies is the creation of a regulatory partnership. SR is a voluntary program and not required for access to the U.S. market.

In contrast, Equivalence is a trade-facilitating mechanism established by the World Trade Organization Agreement on Sanitary and Phytosanitary Measures (SPS Agreement) and is described as a unilateral exercise with one country seeking access to another country’s market, often for a particular commodity.

The SPS Agreement requires an importing country, upon request of an exporting country, to undertake an assessment of whether the exporting country’s applicable measures, though different from comparable measures in the importing country, provide at least the same level of public health protection. Once equivalence has been established, exporting firms may only comply with their domestic (exporting country) requirements as opposed to the importing country’s requirements. For example, in 2020, the FDA finalized equivalence determinations for raw bivalve molluscan shellfish, initially between Washington and Massachusetts and Spain and the Netherlands, which opened the markets for trade of oysters, clams, mussels and scallops based on the equivalence of the relevant portions of each countries’ regulatory systems for these products. The FDA also has received requests for equivalence determinations for Grade A milk and milk products.

Systems Recognition and the Food Safety Modernization Act

Systems Recognition is a tool used to support the Food Safety Modernization Act (FSMA) initiatives. FSMA provides the FDA with options that can be applied to imported food to help ensure its safety. While not a product FSMA, SR is another option that can be used to support our understanding of regulatory systems in foreign countries to ensure their exports align with U.S. food safety standards for designated foods. Additionally, section 305 of FSMA allows the FDA to leverage the food safety capacity of foreign governments, such as by negotiating bilateral and multilateral arrangements and agreements.

The Foreign Supplier Verification Program (FSVP) is a FSMA mandate that requires U.S. domestic importers to verify that their foreign suppliers of food for human and animal consumption in the United States meet applicable FDA requirements. The FSVP regulation provides modified requirements for an importer of certain foods from a country officially recognized as comparable or equivalent. The modified requirements apply to foods that are not intended for further manufacturing/processing, including packaged food products and raw agricultural commodities that will not be commercially processed further before consumption. Under these modified requirements:

The importer must document that the foreign supplier is in a country whose food safety system is officially recognized by the FDA as comparable to that of the United States.
The importer must document that the food is covered by such arrangement.
The importer must determine and document whether the foreign supplier of the food is in good compliance standing with the food safety authority of the country in which the foreign supplier is located.
The importer does not have to conduct a hazard analysis, evaluate the foreign supplier’s performance and the risk posed by the food, or determine and conduct foreign supplier verification activities (e.g., audit, sampling and testing of the food, and review of food safety records).
The importer must continue to monitor whether the foreign supplier is in good compliance standing.

Consistent with other FSVP requirements, the importer must also document any corrective actions taken, use a qualified individual to develop and perform FSVP activities, ensure that the importer is identified as a FSVP importer at entry, and maintain applicable FSVP records.

Resources for Industry About Systems Recognition and FSVP