The United States imported approximately 17% of its food supply in 2021, according to USDA’s Economic Research Service. The amount of imported food has continued to rise over the last 15 years, in both the total volume of products and the number of discreet line items submitted for import. Currently, approximately 125,000 food facilities and farms located in more than 200 countries and territories supply about 32% of the fresh vegetables, 55% of the fresh fruit, and 94% of the seafood that Americans consume annually.
“When these foods are imported, there may be a greater chance for biological, chemical, and physical hazards to occur due to agricultural practices, growing conditions, infrastructure, and transportation in foreign countries,” says Ben Miller, PhD, MPH, vice president of scientific and regulatory affairs at The Acheson Group in Northfield, Minn. “Each of these food categories has experienced both domestic and international outbreaks.”
In 2022, approximately 15 million imported food shipments entered the United States. “This increasingly globalized and complex marketplace has placed new challenges on America’s food safety system,” says Robert Tuverson, a retired international policy analyst for FDA’s Center for Food Safety and Applied Nutrition in College Park, Md., and USDA’s Food Safety and Inspection Service (FSIS) in Washington, D.C.
Foods imported into the U.S. are regulated by two agencies, Tuverson says. Imports of meat, poultry, and certain egg products are the jurisdiction of USDA’s FSIS. FSIS regulations necessitate that imported products only come from establishments that fully comply with food safety requirements in countries maintaining foreign food safety control systems evaluated by FSIS and determined to be equivalent to that of the U.S. All other imported food products are regulated by FDA and may enter U.S. commerce from FDA-registered foreign facilities located in any country, as long as they comply with the requirements of the Food, Drug and Cosmetic Act of 1938 and, since 2011, The Food Safety Modernization Act (FSMA).
Prior to 2011, FDA relied on physical inspections at the port of entry to screen imported foods for product safety. Years of budget limitations to hire inspectors, along with the increase in imported goods, resulted in an inspection rate of lower than 2%. To increase oversight without significantly increasing inspection staff, FDA has taken many other steps to ensure the safety of foods that enter the U.S. A series of large multi-state outbreaks in the U.S. during the early to mid 2000s also contributed to the passage of FSMA. Its rules specify that foreign companies that export food into the U.S. must meet the same regulatory requirements as companies that produce food domestically, Dr. Miller says. Until the passage of FSMA, compliance to U.S. laws and regulations was not required or verified, a gap that surprised many.
The U.S. Congress tasked FDA to develop specific regulations for food importers to improve oversight and prevent future outbreaks. The FSMA final rule on Foreign Supplier Verification Programs (FSVP), published by FDA in 2015, the rule applies to both human and animal food. “FSVP is in place to protect consumers and to prevent a problem from arriving at the port of entry,” says Tracy Fink, MSc, PCQI, director of Scientific Programs and Science and Policy Initiatives at the Institute of Food Technologists in Chicago. “U.S. importers that haven’t developed or implemented FSVPs for their products to meet the FSVP regulation are subject to warning letters, import alerts, and other regulatory actions by the FDA.”
By requiring U.S. food importers to ensure their overseas suppliers’ compliance with FSMA’s preventive controls for food safety requirements, FSMA legislation has shifted the burden to importers and producers to ensure that food products are safe before they’re shipped, rather than relying exclusively on port-of-entry inspection to ensure food safety. “Product-by-product inspection of import shipments is not possible given FDA’s finite resources and the current volume of food imports,” Tuverson says.
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