Proposed in July 2013 and finalized in November 2015, the Foreign Supplier Verification Program (FSVP) and Accredited Third-Party Certification Program rules of FSMA both focus on foreign production of food intended for consumption in the U.S. However, the two differ in significant respects: While the Third-Party Certification Rule establishes a voluntary program for third-party food safety auditing of foreign entities, the FSVP Rule not only sets requirements for a U.S. entity’s review of its foreign suppliers, but violations of it topped the list of FDA noncompliance inspection observations in 2020.
To ensure that food produced outside the U.S. meets the same food safety standards as those produced domestically, the FSVP Rule requires that importers verify that suppliers’ food production “provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate.” It also requires that a foreign supplier’s food be verified as not adulterated and not misbranded with respect to allergen labeling.
The rule has been in effect since 2017, although during the pandemic, FDA has temporarily conducted remote inspections by requesting that importers send the FSVP-required data to FDA electronically (or by other prompt means). But even having had three years to get records in order, the industry’s top noncompliance on FDA’s 2020 Inspection Observations was the non-existence of an FSVP. Along with the complete lack of development of an FSVP, the observations include not maintaining or following an existing FSVP, and not providing assurances that the foreign supplier follows processes and procedures that provide the required level of public health protection.
But getting a tick mark on an inspection observation for lack of an FSVP is only the tip of the issue, as the U.S. Customs and Border Protection (CBP) can — and will — reject food entries that do not have the required FSVP documentation data.
With all the FSMA rules and requirements a food facility needs to understand and follow for compliance, why would a business add a voluntary program to the list? In this case, it would be to enable the company’s imported foods to jump the line.
That is, the certification attained through the program establishes eligibility for participation in the Voluntary Qualified Importer Program (VQIP), which offers expedited review entry of food. Participation in VQIP requires that all the food facilities for which the company wants expedited entry of foods have a food safety certification from an accredited third party and implement other measures that “support a high level of confidence in the safety and security of the food they import.”
The FDA-recognized accreditation bodies (of which there are currently four) have the responsibility of accrediting the third-party certification bodies, of which there are 12. (See the FDA dashboard for the lists.)
As one might suspect, there is an FDA fee for this benefit, currently set at $17,000 per year, as well as fees for the accreditation itself. With all this, only three companies are currently listed as participating in the program: Costco Wholesale Corp., Pacific Seafood Co. and Sovena USA.
While the rule is primarily voluntary, it is important to note that, in specific circumstances, FDA can require that a food offered for import be accompanied by a certification from an accredited third-party certification body.