FDA Rules Tripping Up Food Importers

Despite Foreign Supplier Verification Program (FSVP) regulations having been in effect for only four months during 2017, violations of that rule were among the 20-most common infractions issued by FDA investigators during routine inspections of U.S. food facilities during the last fiscal year.

FSVP requires all U.S. food importers (not just those registered with FDA) to develop plans to and actively monitor their foreign suppliers’ compliance with Food Safety Modernization Act (FSMA) provisions. This year, as more U.S. importers of foreign food products come under FSVP’s purview, violations of the rule are expected to skyrocket.

“The first FSVP compliance deadline (May 30, 2017) was only in effect for about four months in fiscal year 2017, and FSVP made its way into the top-20 most frequent inspection violations,” says Russell Statman, executive director of Registrar Corp, a consultancy that helps companies comply with FDA regulations.

“With the second FSVP deadline passing in March [2018], I foresee it making its way into the top-5 in fiscal year 2018,” Statman tells Food Quality & Safety magazine. (Fiscal 2018 runs from Oct. 1, 2017 through Sept. 30, 2018.) Until last year, FDA did not inspect U.S. importers unless the firm also processed food. “With the advent of FSVP, importers now will be introduced to this process as FDA inspects for compliance with the new rule,” he says.

Late last year, FDA’s Office of Regulatory Affairs released summaries of routine field inspections and enforcement activities conducted during fiscal year 2017 (Oct. 1, 2016 through Sept. 30, 2017). The summaries identify the statutory areas under which thousands of Form 483s were issued to companies having conditions or practices that may violate FDA requirements. As in previous years, the following were the top-five areas in terms of number of citations issued:

• Lack of effective pest exclusion/screening. Not taking effective measures to protect from contamination from pests or excluding pests from food production areas (541 violations).
• Sanitation monitoring. Not monitoring sanitation conditions and practices frequently enough to conform to current Good Manufacturing Practices. Includes conditions of food contact surfaces and measures to prevent cross-contamination (516 violations).
• Plant cleanliness. Failing to maintain cleanliness of the premises or the facility is not constructed in such a way as to allow proper sanitation or maintenance (368 violations).
• HACCP plan implementation. Seafood or juice manufacturers fail to implement procedures in their HACCP plans (162 violations).
• Reasonable precautions. Failing to take precautions to prevent production procedures from contaminating food. Reasonable precautions include monitoring food processing time and temperature or monitoring freezing and heat processing (146 violations).

“Failure to develop an FSVP” was cited 108 times last year, placing that violation among the top-20, even though the rule was in effect for only four months.

“It’s apparent that FDA is checking for FSVP compliance, and non-compliance is a prohibited act,” Statman says. Food imported by a non-compliant importer is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act.

What FSVP Requires

FSVP requires U.S. importers to verify that the food they import meets the same safety standards as domestically produced items. U.S. importers are required to develop, maintain, and follow a foreign supplier verification plan (also called an FSVP) for each food they import, unless an exemption applies (such as for juice and seafood, which are covered by separate HACCP regulations, and certain low-acid canned foods).

Each FSVP must include a hazard analysis, an evaluation of risk and supplier performance, documented supplier verification activities, and a plan for corrective action, if needed. Multiple foods from a single supplier or multiple units of a single food from multiple suppliers each require individual FSVPs.