This week, the U.S. Food and Drug Administration (FDA) issued final guidance concerning regulatory oversight of food imported from Systems Recognition Arrangement (SRA) countries. FDA employs a Systems Recognition (SR) approach with foreign regulatory counterparts that operate comparable regulatory programs and yield similar food safety results (currently, New Zealand, Canada, and Australia). This approach allows FDA to leverage the work done by foreign regulatory authorities to help ensure the safety of imported foods. The final guidance is substantively the same as the draft guidance issued in July 2021. It directs FDA to deprioritize oversight activities for covered food from SRA partner countries and to engage in greater information sharing with foreign competent authorities over these foods. As explained in more detail below, this approach is intended to help FDA refocus regulatory resources on higher-risk foods not covered by SRAs.
Background
As background, Systems Recognition is a risk-based approach to regulating the safety of imported food. SRAs allow FDA to partner officially with a foreign regulatory counterpart after both agencies have mutually concluded that the countries operate comparable regulatory programs that yield similar food safety outcomes. SR leverages the work done by foreign competent authorities to help ensure the safety of imported foods.
Multi-year assessments take place before FDA and another country’s food safety authority enter an SRA. 1FDA has signed SRAs with three countries: New Zealand 2(2012), Canada 3(2016), and Australia 4(2017). The SRAs vary in scope, not covering all categories of food.
FDA’s Regulatory Oversight Activities for Foods Subject to SRAs
On 21 June 2022, FDA published final guidance 5(Guidance) regarding regulatory oversight of food covered by SRAs. Consistent with the draft guidance issued in July 2021, the final Guidance addresses how FDA should shift the scope and frequency of oversight activities away from SRA covered imports and toward other foods as follows:
In-Country Food Establishment Inspections
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FDA’s routine inspections of foreign food establishments for food covered by an SRA will be rare.
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Inspections will continue for imports from SRA countries, especially:
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For food categories not covered by the SRA,
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On a “for-cause” basis (e.g. specific public health or food safety issues), or
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In response to a request by the foreign competent body.
Automated Screening and Risk Targeting and Review of Imported Food
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FDA intends to adjust its risk-based screening and targeting criteria for import entries of food covered by an SRA to reflect the comparability of the regulatory system covered by the SRA.
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Regarding Import Alerts (IAs):
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Existing IAs: Food subject to Detention Without Physical Examination (DWPE) under an existing IA will not be automatically removed from the IA when an SRA is signed. Establishments and food products may be removed from DWPE when the conditions that gave rise to the appearance of the violation have been resolved. FDA will consider evidence provided by the foreign authority regarding corrective actions taken when assessing removal from IAs.
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Future IAs: FDA may recommend an establishment or food from a food safety system covered by an SRA for DWPE, and FDA will provide prompt notification, when appropriate, of a food safety concern to the foreign competent authority. FDA may consider evidence provided by a foreign authority that is relevant to FDA’s decision about whether to list a food product or establishment on an IA.
Examination and Sampling of Imported Food
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FDA will not prioritize foods covered by the SRA in the agency’s annual sampling field work plan.
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FDA may prioritize sampling a shipment of food products in certain scenarios, which include:
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Food categories not covered by the SRA,
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Particular commodities for which FDA is conducting surveillance, and
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On a “for-cause” basis, to address specific food safety issues or other violations.
Relevance of Importer Verification Programs
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FDA does not intend to prioritize inspections of importers for Foreign Supplier Verification Program (FSVP) compliance or compliance with juice and seafood Hazard Analysis Critical Control Point (HACCP) importer requirements. However, FDA may periodically verify that SRA importers are compliant with FSVP and HACCP importer requirements.
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FDA will prioritize FSVP and HACCP inspections for products from food safety systems that FDA has not recognized under a SRA.
Regulatory Compliance Actions
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The existence of a SRA facilitates FDA’s ability to consider information or data provided by the foreign authority as FDA considers regulatory action.
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The agency may still pursue regulatory action (e.g., Warning Letters, adding establishments or food products to DWPE, or refusing products offered for import) regardless of SRA coverage.
References
1 This involves a pre-submittal evaluation, SR Assessment (via desk research and in-country evaluation), SRA execution, SRA implementation, and regular meetings to assess progress. Once SRAs are executed and implemented, FDA engages in an annual review alongside a reassessment every 5-years. See Systems Recognition (Food), U.S. Food & Drug Administration (“The Systems Recognition Process”), https://www.fda.gov/food/international-cooperation-food-safety/systems-recognition-food (current as of Dec. 21, 2020).
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