FDA’s FSVP deadline shaping up as chaotic

By: | Issue #649 | at 08:00 AM | Channel(s): International Trade  

Confusion reigns among importers over compliance.

Many U.S. importers are required to comply with the U.S. Food and Drug Administration (FDA) Foreign Supplier Verification Program (FSVP) rule by May 30, 2017, and indications are that confusion and chaos reign in the trade. Comments on the FDA website indicate importers are less than thrilled with the experience of searching the agency’s databases for information on suppliers—a required compliance activity—and a major industry group wrote the FDA concerned over the lack of preparation among importers for compliance with the regulations.

Misunderstandings range from who is subject to the regulations, what must be done to comply, and when compliance is mandatory. What qualify as appropriate verification activities under the regulation for a particular supplier depends on the types of foods being imported and the supplier’s compliance history.

There’s also confusion over when the regulations kick in. The good news is that not all importers are subject to compliance by the end of this month. Compliance dates vary depending on the size and nature of the importer and its suppliers, the commodities being imported, and other factors. Deferred compliance dates range from March 2018 to July 2019. (This page from the FDA website (https://www.fda.gov/food/guidanceregulation/fsma/ucm503822.htm) explains more.)

Verifying Foreign Suppliers

Finalized in November 2015 under the Food Safety Modernization Act (FSMA), FDA’s FSVP rule requires FSVP Importers to verify that foreign suppliers are producing food in a manner that meets U.S. safety standards and that they are achieving the same level of food safety as domestic farms and food facilities. In 2013, the US Department of Agriculture estimated that imported food accounted for about 19 percent of the U.S. food supply, including about 52 percent of fresh fruits and 22 percent of fresh vegetables.

The FSVP rule mandates that importers conduct verification activities—such as audits of a supplier’s facility, sampling and testing of food, and a review of the supplier’s relevant food safety records—based on risks linked to the imported food and the performance of the foreign supplier. To approve a supplier, an FSVP Importer must consider the supplier’s compliance with FDA food safety regulations, including whether the supplier is the subject of an FDA warning letter, import alert, or other FDA compliance action related to food safety.

Once the regulations kick in, a new section, titled FSVP Importer, will appear in the US government’s electronic customs system, the Automated Customs Environment (ACE). The information entered in this section will be compiled in a database and the FDA will send electronic records requests to FSVP importers. The importers will be expected to provide the food safety data for the shipment. If all the fields are not filled out, ACE will automatically reject the filing.

Comments on the final rule regarding verification requirements reflect industry concern that FDA’s website and compliance databases can be hard to navigate. To evaluate a supplier’s compliance using FDA’s website, an FSVP Importer has to search each of FDA’s applicable databases for each individual supplier.

NBCFAA Weighs in

The National Customs Brokers & Forwarders Association of America (NCBFAA) has expressed concern about the trade’s readiness to meet FSVP requirements. NBCFAA “members report widespread misunderstanding and confusion about the FSVP requirements among their importing clients and others in the supply chain,” NCBFAA President Geoffrey Powell wrote the FDA last month.

FDA’s former director of import operations Domenic Veneziano, now a consultant with the law firm Sandler, Travis & Rosenberg, said that a common misconception is that only large food importers are required to create a foreign supplier verification program. “Nothing could be further from the truth,” he added. “The statute does make some concessions for smaller companies, but there are still requirements to be met.”

Some are under the false impression that only the importer of record is required to comply with the regulation. “But the definition of importer under the Food Safety Modernization Act is much broader,” said Veneziano, “and can include the actual CBP importer, as well as the owner or consignee of food being offered for import, and even the U.S. agent of the importer.”

At the core of FSVP compliance is creating a plan that meets government requirements. “What you want to show the FDA,” said Veneziano, “is that you are taking steps to ensure that foreign-produced food is safe and that the food entering the commerce of the United States is not adulterated or misbranded.”

Key to such a program is selecting a qualified individual to perform required FSVP activities. “The individual creating the program must have the education, training, and experience necessary to conduct a sophisticated review of all records,” said Veneziano. “You need an expert who can not only develop the actual program, but conduct hazard analyses, evaluate risks specific to the food being imported, verify supplier activities, monitor corrective actions, and maintain records.”

Labeling errors are a major cause for FDA actions, and the recipient of a warning letter could be disqualified as a supplier to a US importer. Should an FSVP Importer become aware of non-compliance by a supplier, the importer take corrective action, which could take the form of petitioning the FDA to rescind an action against a supplier. All this requires specific expertise.

For importers required to comply by May 30 and without a program in place, it’s now a little late to get things in order. But by taking action now, they can get their programs in place sooner rather than later, thereby minimizing enforcement actions that might be taken by the FDA. Also, as is the case with other new regulations, it’s possible the FDA will grant grace to violators for a limited period of time after the regulations become effective, although the FDA has yet to make any announcement to that effect.

In any event, the time to act is now, and there are a number of consulting and educational organizations that can help importers put their programs in place and train their personnel.

For importers ultimately out of compliance the consequences will be dire. “It could result,” said Veneziano, “in disruption of your supply chain, delays in entry processing and the exclusion of your products from the U.S.”

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American Journal of Transportation

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Peter Buxbaum has been writing about international trade and transportation, as well as security, defense, technology, and foreign policy, for over 20 years. Besides contributing to the AJOT, Buxbaum's work has appeared in such leading publications as Fortune, Forbes, Chief Executive, Computerworld, and Jane's Defence Weekly. He was educated at Columbia University.