The Food and Drug Administration released an 18-page strategy document about how it plans to combine existing regulatory approaches with new import oversight tools available through the Food Safety Modernization Act to limit safety risks from the ever-increasing amount of food coming in from other countries.
According to an agency statement, the U.S. imports approximately 15% of its overall food supply. We get 94% of the seafood, 55% of the fresh fruit and 32% of the fresh vegetables consumed annually from about 125,000 food facilities and farms in 200 countries or territories, the FDA said.
"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 FDA said. "This strategy document describes how FDA is integrating the new import oversight tools with existing tools as part of a comprehensive approach to imported food safety."
The FDA's strategy for enhancing imported food safety includes four goals: To make sure food offered for import meets U.S. food safety requirements, that border surveillance keeps out unsafe foods, that there is a rapid and effective response when unsafe imported food is found, and that the agency has an effective and efficient food import program.
Congress determined more than inspection oversight was needed to control food safety risks, so FSMA gave the agency additional tools and authority to help prevent problems before food arrives in the U.S. Consequently, the four goals will be met by beefing up inspections both here and abroad and using the FDA's mandatory recall authority if needed, the agency said.
These added tools will be needed to keep up with the volume, variety and source of imports, which challenged the FDA's previous regulatory oversight, according to the strategy document. The agency said it expects between 14 and 15 million imported food shipments to enter the U.S. this year.
According to agency figures cited by USA Today, the FDA screens all food electronically before admitting it into the country. However, of more than 13.4 million shipments coming here last year, fewer than 1% — a total of 117,993 — were examined. Of those, only 16,363 were sampled, and 6,910 were refused.
Because of this increasingly complex global supply chain, FSMA's rules regarding food imports created what FDA called a "multilayered safety net" consisting of manufacturers, importers, third-party auditors, foreign regulatory bodies, and the FDA. The law also mandated an "agency shift in perspective," the document noted, meaning an oversight system designed to prevent food safety problems from occurring rather than reacting to them.
This new approach toward regulating and inspecting imported foods may end up having a positive impact on consumer confidence by reducing the number of food-related illnesses and recalls in this country, as well as improving how domestic and foreign manufacturers and importers do business.
One tool the FDA will use to prevent food safety problems overseas is site inspections of foreign food facilities. According to Food Business News, the agency recently began inspecting these facilities under its Foreign Supplier Verification Programs rule requiring importers to show their suppliers meet U.S. food safety standards. For U.S.-based importers, that means they must do hazard analyses, evaluate food risk and assess foreign suppliers and safety verification activities based on identified hazards. It's likely manufacturers and importers will pay closer attention to U.S. food safety standards now they know inspectors will be regularly checking to see if their plants are clean and the food destined for import is safe.
Companies that ship seafood, fresh fruit and vegetables to the U.S. are likely to see the greatest impact from these regulatory changes. According to FDA statistics from 2016, there were 190,418 registered foreign facilities bringing food into the U.S., including manufacturers, processors, warehousers, packers and labelers. Those who want the expedited review and import entry of human and animal foods of the Voluntary Qualified Importer Program need to meet eligibility criteria and pay user fees to cover the agency's costs. Other shippers are inspected based on perceived risk and paid for by taxpayer dollars and industry user fees.
It will be a tough job to oversee so many importers, but the FDA is making the effort as required by FSMA. It's quite possible some foreign facilities won't make the grade and will decide not to import food to the U.S. under this stricter strategy, but the agency's position is that it's better to avoid problems at the source than try and fix them later. The FDA also said it will publish non-confidential information from these foreign supplier and importer inspections in an effort to operate transparently. The result may be greater overall confidence in imported food safety and higher standards from industry.