Background

Systems Recognition (SR) is a risk-based, reciprocal process through which the FDA and a foreign regulatory counterpart evaluate whether they operate comparable regulatory programs that yield similar food safety outcomes. Through the SR process, the participating agencies conduct thorough assessments of each other’s domestic food safety systems. If each agency concludes that the systems are comparable, they sign a SRA, which allows them to leverage each other’s regulatory systems to manage the safety of foods.  

The FDA has SRAs with three countries: Canada, New Zealand, and Australia. It is important to note that not every food product from the SRA countries is necessarily covered by the SRA. For example, the FDA’s SRA with Canada does not cover dietary supplements and Grade A Milk Products, among other things. It is therefore important to review the scope of each specific agreement when evaluating any impacts for a given food from the three current SRA countries.  

FDA’s regulatory oversight activities for foods subject to SRAs

The draft guidance[1] announces that for food products covered by an SRA and imported from a country with an active SRA, the FDA intends to adjust its regulatory oversight activities as follows:  

In-country food establishment inspections

• The FDA does not intend to prioritize foreign establishment inspections in countries with an SRA. Inspections will be rare, and limited to certain situations, including: 
  • To inspect establishments manufacturing, packing, or holding an FDA-regulated food product not covered by the SRA;
  • On a for-cause basis to address a public health concern or food safety issue; and
  • Responding to a request by the foreign authority. 

Automated screening and risk targeting and review of imported food

• The FDA intends to adjust its risk-based screening and targeting criteria for import entries of food products covered by an SRA. This will allow more efficient and effective use of the FDA’s import investigation and screening resources. 
• Regarding Import Alerts (IAs): 
  • 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. The FDA will consider evidence provided by the foreign authority regarding corrective actions taken when assessing removal from IAs. 
  • Future IAs: The FDA may recommend that an establishment or food product from a food safety system covered by an SRA for DWPE, and will provide prompt notification, when appropriate, of a food safety concern to the foreign competent authority. The FDA may consider evidence provided by a foreign authority that is relevant to the FDA’s decision about whether to list a food product or establishment on an IA. 

Examination and sampling of imported food

• The FDA will not prioritize import samples and field examination of food products covered by an SRA. The FDA may prioritize sampling a shipment of food products in certain situations, including: 
  • Food the FDA is targeting for sampling on a surveillance basis;
  • Food that is not covered by a countries’ SRA; and
  • On a for-cause basis to address specific food safety issue or violation. 

Relevance of importer verification programs

• The FDA does not intend to prioritize inspections of importers for Foreign Supplier Verification Program (FSVP) compliance or compliance with juice and seafood HACCP importer requirements for foods covered by an SRA. However, the FDA may periodically verify that the importers are in compliance with FSVP and HACCP requirements. 
• The FDA will prioritize FSVP and HACCP inspections for products imported from countries that do not have an SRA in place. 

Regulatory Compliance Actions

• The FDA may pursue regulatory actions (e.g., issuing warning letters, adding establishments/food products to DWPE, and refusing products offered for import) to products not covered by an SRA, and food covered by an SRA that appears violative and is offered for import in the U.S.  

Next steps    

Comments on the draft guidance are due 10 September 2021 under the docket number FDA-FRDOC-0001-10774. 

References

1    Draft Guidance: FDA Oversight of Food Products Covered by Systems Recognition Arrangements (July 2021), available at https://www.fda.gov/media/150676/download.