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.
You Might Also Like
Explore This IssueFebruary/March 2018
Also By This Author
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 , 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.
Companies have some flexibility in determining appropriate verification methods, depending upon the hazards needing to be controlled, the foreign supplier’s food safety record, and other factors. Verification methods could include onsite audits and inspections, sampling and testing, and review of the supplier’s safety records, says Hank Karayan, global FSMA program director at SGS, a multi-industry inspection, verification, testing, and certification company.
Importers must also designate a “qualified individual,” defined as someone possessing either appropriate training or job experience with developing a food safety system, to develop and perform FSVP activities for each imported food item. Importers that do not have a qualified individual on staff may outsource FSVP development to a third party, such as Registrar Corp, or outsource verification activities to companies such as SGS.
FDA has staggered FSVP compliance dates based on the size of the foreign supplier (not the size of the U.S. importer) and the dates of other FSMA regulations to which the foreign supplier would be subject. This was to give U.S. importers time to become familiar with their legal responsibilities and develop their FSVPs. It also aligns FSVP compliance dates with other FSMA regulations, particularly the produce safety and preventive controls rules for human and animal food.
“We linked the FSVP compliance dates to the other FSMA rules because we wanted to minimize the likelihood that an importer would be required to comply with the FSVP regulations before its supplier is required to comply with other FSMA safety regulations,” explained Sharon Mayl, senior advisor for policy in FDA’s Office of Foods and Veterinary Medicine.
The first FSVP compliance date was May 30, 2017 for U.S. companies that import food from large foreign suppliers or from suppliers not subject to the preventive controls or produce safety rules. For foreign suppliers that are subject only to the preventive controls rule, the next importer compliance dates are March 19, 2018 for “small businesses” (defined as foreign suppliers with fewer than 500 full-time employees), and March 18, 2019, for “qualified facilities” and “very small businesses” (foreign suppliers with less than $1 million in average annual sales).
For importers whose foreign suppliers are subject only to the produce safety rule, the compliance dates are July 29, 2019 for small business, and July 27, 2020 for very small businesses. All other businesses must comply starting July 26, 2018.
“Remember that, unlike traditional facility inspections, FSVP inspections are based on the review of records, rather than observations of food production,” FDA’s Mayl explained. Most FSVP inspections will occur at the importer’s place of business, where the investigator will ask to see the importer’s FSVP records. In most cases, if deficiencies are found, the importer will be provided an opportunity to correct them.
“Our focus right now is on supporting compliance, except for problems that pose a danger to health or reflect intentional disregard for legal responsibilities,” Mayl said.
But companies that receive a citation for not having a FSVP may find themselves on FDA’s radar. This is because the agency’s risk analysis algorithms may automatically assign companies with prior deficiencies a higher risk score, increasing scrutiny and the potential for enforcement actions, Registrar Corp’s Statman says. “The best way to stay out of trouble with FDA is to stay out of trouble with FDA,” he says. “But if an importer or processor develops a clean record early, later deficiencies may have less effect.”
Beginning this year, U.S. importers can apply to register in FDA’s Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry into the U.S. of food from foreign companies that have been certified by auditors under the Accredited Third-Party Certification rule. “Expedited shipment entry gives importers incentive to adopt robust management of the safety and security of their supply chain,” said Doriliz De Leon, a consumer safety officer in the Food Adulteration Assessment Branch in FDA’s Center for Food Safety and Applied Nutrition.
To be accepted into VQIP, U.S. importers must not only comply with FSVP but also develop and implement a Quality Assurance Program, which includes additional written policies and procedures for food safety and security, including for transportation and food defense. Enrollment in VQIP “will be particularly helpful for those (U.S. companies) importing perishable products or using ‘just in time’ processing, in which ingredients must be at a food facility at a certain time in the manufacturing process,” De Leon explained.
While most FSVP and FSMA provisions have been coming into effect under previously announced timelines, on Jan. 4, 2018 FDA announced it would not be enforcing certain provisions of four FSMA regulations because they would create unanticipated burdens on industry and government. Among the four is an FSVP provision that equates food contact substances, such as packaging and food holding material, with being “food.” Because these substances are already subject to FDA premarket review and other regulations, “FDA does not intend to require importers of food contact substances to comply with FSVP.”
“FSMA has many tentacles and impacts multiple parts of the food industry,” says David Acheson, MD, founder and CEO of The Acheson Group and a former associate FDA commissioner for foods.
For example, FDA can disallow import of food from a foreign supplier that has refused to be inspected. “And that ‘refusal of inspection’ doesn’t just mean answering FDA’s knock, it means anything from not responding to FDA’s request within 24 hours, to agreeing to an inspection start date then requesting a later date without reasonable explanation, to a foreign government not allowing the FDA investigator into the country,” Dr. Acheson explains.
It could take at least one year before FDA can return to do the inspection, depending on other priorities, personnel availability, and other factors. Because of all this, Dr. Acheson recommends that U.S. companies alert their suppliers to the importance of not refusing an FDA inspection.
“It has been our impression that many foreign suppliers really don’t understand the impact of FSMA,” Dr. Acheson says. “So, making sure that they don’t find themselves on a 12-month import alert could be critical to protecting your supply chain integrity as well as their business.”