FDA Aims for FSVP Enforcement, Enhanced Screening in New Import Strategy Document
Food and Drug Administration Commissioner Scott Gottlieb on Feb. 25 unveiled the agency’s new strategy to improve its oversight of imported food. Consisting of four pillars -- including prevention of food safety problems in the foreign supply chain, detection and refusal of unsafe foods at the border, rapid response and measuring progress on efficiency improvements -- FDA’s “modern strategy is designed to leverage our different authorities and tools to provide a multi-layered, data-driven, smarter approach to imported food safety,” Gottlieb said.
Many of the tools outlined in the strategy document are already in use by FDA, including the Foreign Supplier Verification Program, foreign inspections and third-party certification bodies. But the agency envisions refining them by, among other things, enhancing use of data and fully implementing programs created in the Food Safety Modernization Act.
A key part of FDA’s new strategy is enforcing FSVP requirements on importers. The document says FDA will “deter noncompliance through strategic enforcement of foreign supplier verification programs and supply chain controls requirements.” FDA will also “use import screening to prevent entry of food shipments by importers lacking adequate foreign supplier verification programs,” the agency said. FDA will likely begin issuing import alerts and warning letters for FSVP violations beginning this year, a recently retired FDA import official has said (see 1812130046).
FDA also aims to improve its Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) screening system. “As part of our new strategy, the FDA intends to optimize this tool by incorporating new sources of data from foreign supplier verification programs, voluntary importer incentive programs, accredited third-party auditors, foreign regulatory authorities and domestic supply chain activities. This will allow us to form a more complete picture of the risk of imported food in a new era of smarter food safety,” Gottlieb said in the announcement.
FDA also hopes to improve the efficiency of its import sampling and testing, sharpening its focus on higher risk products. “Sampling and testing food before admitting it into the country can be an effective method for detecting contamination; however, it is labor-intensive and costly to industry as well as to the agency,” it said in the strategy document. “FDA will use an approach to examination and sampling that targets the highest-risk products, allows regular monitoring and surveillance of imported products, facilitates targeted assignments to collect data that informs oversight activities, and assists with verification of other related programs.”
FDA will improve its measures of import safety and compliance so it can check its progress in implementing the strategy. “To make our imported food safety program as efficient as possible, we’ll assess our performance of imported food safety activities and take additional steps to improve our performance based on those assessments,” Gottlieb said. “We’re already in the process of developing performance measures and outcome indicators for imported food safety and intend to publish our measures and non-confidential data about imported food, foreign suppliers, FSVP importers and other importers to the public as it becomes available.”