Much of FSMA Implementation Still in Progress, say FDA Officials
RANCHO MIRAGE, Calif. -- Many of the Food and Drug Administration's efforts to implement the Food Safety Modernization Act (FSMA) that affect importers are ongoing, said FDA officials during the National Customs Brokers and Forwarders Association of America conference April 10. Some of the major parts of the law, such as a new prior notice rule, reinspection fees and foreign supplier verifications, may still be far from full implementation. FSMA became law in 2011. The officials urged the trade to be patient when working with FDA as it works through a reorganization of the Office of Regulatory Affairs (see 12101501).
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Proposed rules for the Foreign Supplier Verification Program that would require importers to verify certain food safety requirements from their suppliers remain at the Office of Management and Budget (OMB), said Anthony Taube, director of the Division of Food Defense Targeting (formerly the Prior Notice Center). The FDA can't determine OMB's workload and timing, but Taube hopeful the proposal will come out "soon," he said.
A final rule adding a data element to prior notice requiring a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry is still in the clearance process, said Taube. The Department of Homeland Security must still give approval to the rule and then it will "get in line" at OMB, he said. The FDA has been operating under an interim final rule (see 11050516 and 11090106). The FDA is also still working to develop internal procedures and hasn't yet issued a single invoice to U.S. agents for foreign reinspections, said Taube. The fees have been in effect since October 2011 and the agency has said it has started to track and assess the inspections fees (see 12101902).
There's a huge number of facilities that are subject to invalidation due to a failure to renew their registration as required biannually, meaning the FDA could impose penalties and/or hold the goods from such facilities at the border, said Taube. Before the renewal period there were 252,000 foreign and 166,000 domestic facilities registered, he said. Following the close of the renewal period in February, there were 73,000 foreign registered facilities and 54,000 domestic facilities, he said. Facilities that missed that renewal period will have to complete a whole new registration, he said. CBP previously said there has been a significant drop off in renewals, but had not said how many (see 13022829). The FDA recently released draft policies for handling food imports from facilities with lapsed registrations (see 13040415).
The FDA's filer evaluations that are posted online are meant to show "a filer ability to consistently file accurate data," though it's still "kind of a nebulous concept," said John Verbeten, director of the FDA's Program Development and Implementation branch. If you're going to transmit information to FDA, there needs to be" some kind of basis, he said. The FDA said last year it would begin posting filer evaluations for filers using the agency's automated filing program (see 12032003).