FDA, Industry Expect Use of Third-Party Auditors for FSVP Activities to Reduce Burdens, Risk

Despite the Food and Drug Administration’s recent release of its long anticipated final rule on the Foreign Supplier Verification Program, some major questions remain as to the implementation of the new regulations, said industry lawyers during a webinar held by the Food and Drug Law Institute on Nov. 19. Food importers both small and large are still digesting the rule’s requirements, and further clarification will come in the form of a draft guidance on FSVP issued by FDA early next year, according to FDA Senior Policy Advisor Brian Pendleton. A major challenge will be getting the word out to importers, who could benefit from training programs currently being developed with FDA input by the Food Safety Preventive Controls Alliance, said Pendleton.

One feature of FDA’s FSVP final rule, set for publication on Nov. 27 (see 1511160014), is increased flexibility, said Pendleton during the webinar. Key changes from the agency’s 2013 proposed rule include the agency’s clear mandate that importers may rely on verification activities performed by other parties, as well as provisions that say importers do not have to perform verification activities in cases where their downstream customers treat the food, such as with green coffee.

Nonetheless, FSVP marks a “significant” shift in responsibility for food safety onto the shoulders of importers, said Erik Lieberman of U.S. Food Imports. That enhanced responsibility also carries increased liability, with noncompliance with FSVP requirements added as a new type of violation of the Federal Food, Drug and Cosmetic Act. Criminal fines reach up to $250,000 per violation for individuals, and $500,000 for organizations. Courts have held corporate officers liable for food safety violations even if they didn’t engage in the unlawful activity or have knowledge.

One strategy importers may choose to employ to reduce the burdens of compliance as well as these new risks is the use of third-party auditors that will be accredited under FDA’s concurrently-released final rule on third-party accreditation bodies (see 1511130006). Not only could the importer rely on the third-party’s work instead of having to itself perform verification activities, but FDA oversight of accredited auditors means importers won’t have to worry about the quality of the audit, said Lieberman.

Though the third-party accreditation rule is also set for publication on Nov. 27, some work still remains to be done before the accreditation scheme comes into operation, said Bruce Silverglade of Olsson Frank. FDA has yet to issue a guidance document on standards for auditors, and must also finalize regulations establishing user fees that will fund the program. If no accreditation bodies have been recognized by FDA within two years, the agency will have the ability to itself accredit third-party auditors. FDA has said its Voluntary Qualified Importer Program, which will require use of third-party auditors, is hoped to begin in 2017 (see 1503260014).

A slight change in FDA’s final third-party accreditation regulations could promote more use of third-party auditors to perform FSVP functions, said Silverman. In the proposed rule, auditors that discover serious risks to the public health would have been required to disclose their finding to FDA in all circumstances, whether the audit was “regulatory” (which must always be unscheduled) or merely “consultative” (which may be scheduled or unscheduled). In the final rule, FDA slightly amended the regulations to provide that auditors do not have to disclose the problem to FDA if the issue was found during the course of an unscheduled consultative audit. The change could mean importers and their suppliers will be less reluctant to use third-party auditors, paving the way for auditors to perform training and consulting activities.