FDA Outlines FSMA Implementation Strategy, Highlights Role of Importers
The Food and Drug Administration on May 2 released a Food Safety Modernization Act (FSMA) Operational Strategy document intended to guide the agency’s efforts as it looks to bring industry into compliance with new regulations and oversee its new programs. “The agency has to design methods to promote widespread voluntary industry compliance with the new rules, as well as establish preventive public health-focused inspection and sampling programs to oversee compliance,” it said in an emailed announcement. “In addition, the FDA is developing effective enforcement strategies to be deployed when producers, processors, distributors and importers fail to comply on a voluntary basis.”
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The strategy document highlights the importance of industry implementation of its new FSMA regulations to achieve its food safety goals. “Food safety depends primarily on the food industry, with top-level management commitment and working in a continuous improvement mode, to: (1) implement science- and risk-based preventive measures at all appropriate points across the farm-to-table spectrum, and (2) manage their operations and supply chains in a manner that provides documented assurances that appropriate preventive measures are being implemented as a matter of routine practice every day,” it said in the strategy document.
Even after it finishes issuing its FSMA regulations, which are currently due by June 2015 under court order (see 13062412), FDA will still have to play a “central leadership and operational role” in the new food safety system, it said. That includes ensuring the food safety system is working correctly and taking corrective action if necessary; working with international partners and other government agencies to create an integrated food safety system; and implementing risk-based decision making, says the strategy document.
An appendix to the strategy document also included import-specific guidelines for FSMA implementation. Once again, it highlights the importance of industry in the modern food safety system: “rather than relying primarily on FDA detecting and stopping food safety problems at the border, the new system relies primarily on importers providing documented assurances that their foreign suppliers have taken proper steps to prevent problems,” it said. FDA will need to reconfigure “current import screening and field exam activities to complement oversight of FSMA’s foreign supplier verification requirement and ensure that FDA is making strategic, risk-based use of its import oversight resources,” says the strategy document. Also key will be “implementing the voluntary qualified importer program and other measures to expedite entries for good performers and thereby allow more resources to be directed toward high-risk imports,” it said.