The Food Safety and Inspection Service (FSIS) released a notice on Friday that describes a modified three-part approach to verifying the equivalence of foreign food regulatory systems that export meat, poultry, or processed egg products to the United States. In line with recent trends toward making food regulatory systems increasingly “risk-based,” including FDA’s implementation of the Food Safety Modernization Act (FSMA), the new verification method will make the frequency and scope of on-site FSIS audits vary based on prior results of FSIS’s country performance assessment.
FSIS regulations currently list 46 countries as eligible to export meat, nine countries as eligible to export poultry, and two countries as eligible to export egg products. See 9 C.F.R. § 327.2(b). Once a country receives an equivalence listing, FSIS continues to monitor that country’s food regulatory system to ensure that equivalence is maintained through a three-part process: (1) document reviews, (2) on-site system audits, and (3) port-of-entry (POE) reinspections.
The three-part process is designed to evaluate whether the foreign government is imposing equivalent requirements with regard to six areas: (1) government oversight, (2) statutory authority, and food safety regulations, (3) sanitation, (4) hazard analysis and critical control points (HAACP), (5) chemical residues, and (6) microbiological testing programs.
FSIS has been transitioning to the new verification method since 2009, but opted to wait until “the transition [was] fully in place” before announcing it to the public. Under the new system, FSIS will utilize data from its newly developed Self-Reporting Tool (SRT) to conduct more comprehensive and up-to-date document reviews. These country performance assessments will inform the frequency and scope of the second part of the equivalence verification process, FSIS on-site audits. FSIS plans to perform on-site audits at minimum once every three years, with adequately performing countries receiving audits every year and average-performing countries receiving audits every two years.
Finally, FSIS will also use the country performance assessment, along with factors relating to product type and species, to determine the scope and frequency of POE reinspections. While all shipments of meat, poultry and egg products are inspected by FSIS for certification by the foreign government and labeling compliance, a limited number of products are subject to more detailed inspection activities, including pathogen testing, food chemistry sampling, and species verification. In order to support the risk-informed POE reinspection program, FSIS launched on May 29, 2012 the Public Health Information System (PHIS) “to collect, consolidate, and analyze data.”
The notice by FSIS precedes release of a much anticipated FDA rule on third-party accreditation for foreign facilities. A September 2012 report by the Government Accountability Office (GAO) on FDA’s approach to comparability assessments cited FSIS’s approach to equivalence as a helpful model that determines “the safety of imported food by examining whether a country’s systems for ensuring the safety of a specific food product are equivalent.”
Comments on the FSIS notice should be submitted by March 26, 2013.