“Optimizing our FSMA implementation activities, as well as our longstanding tools and authorities, will provide for an even more comprehensive approach to help ensure imported food safety,” said FDA Commissioner Scott Gottlieb and Deputy Commissioner Frank Yiannas in a joint statement.
U.S. food imports from around the world have continued to increase during the past 15 years, with about 32 percent of fresh vegetables, 55 percent of fresh fruit and 94 percent of seafood consumed by Americans annually now imported. These imports originate in more than 200 countries from about 125,000 different food export facilities. This year alone, FDA expects the U.S. to import between 14 million and 15 million food shipments.
FSMA has allowed the FDA to expand its regulatory focus from responding to food contamination to preventing it.
“Determining the best way to use the full range of available tools across the different segments of the international food-supply chain — in ways that decrease public health risks while maintaining a level playing field for domestic and foreign producers — requires both dexterity and pragmatism,” the agency said in its FDA Strategy for the Safety of Imported Food, which it released this week.
• Preventing food safety problems in the foreign supply chain before U.S. entry;
• Detecting and refusing entry of unsafe foods at U.S. borders;
• Responding quickly when the FDA learns of unsafe food imports;
• Measuring the agency’s progress to ensure that its imported food safety program remains efficient.
The FDA will continue its onsite inspections of foreign food facilities. “These valuable inspections are resource-intensive, so our strategy will involve a more modern focus on tools for risk-informed prioritization of firms for inspection. Our decisions will be informed by an increasing amount of data and information from other oversight activities and partners,” the two senior FDA officials said.
This also includes inspections for the agency’s foreign supplier verification program rule, which requires importers to verify that their suppliers are meeting U.S. food safety standards. Some key requirements under this rule include obligating U.S.-based importers to conduct hazard analyses, perform evaluations of the risk of the food and foreign suppliers, and conduct safety verification activities based on the identified hazards, including the use of third-party audits as appropriate.
The FDA’s effort to prevent unsafe food imports from entering the U.S. also includes its accredited third-party certification program. This program provides a framework for audits of foreign food facilities to verify compliance with U.S. food safety standards, which can be used by importers to establish eligibility in the voluntary qualified importer program. It offers importers expedited review and entry of their food based on the safety assurances from the audits.
FDA also encourages more foreign food safety regulators to match U.S. programs. According to the agency, Canada, New Zealand and Australia have food safety programs comparable to the U.S.
“By leveraging partnerships between the U.S. and other countries with very strong food safety systems through our systems recognition program, we’re able to prioritize our inspection and border screening activities on foods imported from higher-risk areas,” they added.
The FDA’s second imported food safety goal includes optimizing its Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) system, including the addition of new data sources 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. By enhancing our access to various data streams, we’ll be better positioned to catch issues with imported foods before they are made available in the U.S. marketplace,” Gottlieb and Yiannas said.
The FDA officials said the increased use of myriad data streams will allow it to achieve its third goal of quickly responding to unsafe imported food.
“Overall, our 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 and Yiannas said.