FDA Begins Implementing the Food Safety Modernization Act’s Import Safety Provisions

By Ricardo Carvajal - 

In an upcoming issue of the Federal Register, FDA is announcing a public meeting scheduled for March 29 to solicit comment on the import safety provisions of the Food Safety Modernization Act ("FSMA").  At the meeting, appropriately titled “Food Safety Modernization Act; Title III – A New Paradigm for Importers,” attendees will have “multiple opportunities . . . to actively express their views by making presentations at the meeting, participating in break-out sessions . . . , and submitting comments to the docket” on the four major import safety provisions of the FSMA:

• The foreign supplier verification program under section 301, which “requires importers to conduct risk-based foreign supplier verification activities to verify that imported food is not adulterated under [FDC Act section 402] or misbranded under [FDC Act section 403(w)] (relating to allergens) and is produced in compliance with FDA’s preventive controls requirements and produce safety standards, where applicable;"

• The voluntary qualified importer program under section 302, which “requires FDA to establish a voluntary, user-fee funded program to expedite entry into the United States of imported food from eligible, qualified importers;”

• The mandatory import certification authority under section 303, which authorizes FDA, “based on risk considerations, to require an article of food offered for import into the United States to be accompanied by certifications or other assurances that the food complies with relevant provisions” of the FDC Act; and

• The third-party auditor accreditation system provided for by section 307, which “directs FDA to establish a system for the recognition of accreditation bodies that accredit third-party auditors to issue certifications for purposes of” the import certification provision and the voluntary qualified importer program.

FDA is also announcing a public hearing scheduled for March 30-31 to solicit views on international comparability assessments and equivalence determinations, and to obtain information on “policies, practices, and programs used by foreign regulators to ensure the safety of imported foods and animal feed.”  FDA expects that “initiatives discussed at the 2-day hearing will align with and help support FSMA implementation.”

The scheduling of these hearings within three months of the FSMA’s enactment suggests that FDA intends to adhere to an aggressive timetable for the new law’s implementation – resources permitting.