GAO: FDA May Need to Increase Inspections of Foreign Food Facilities
The FDA may need to ramp up the number of food facility inspections abroad to ensure the safety of imported food, according to a Government Accountability Office report released on Jan. 8.
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The report, which looked at the FDA's food inspection efforts both domestically and abroad, called upon Congress to direct the FDA to conduct an analysis of what level of foreign food facility inspections is sufficient on an annual basis to determine what FDA's annual target should be for foreign food facility inspections conducted to ensure the safety of imported food.
The GAO report also recommended that the FDA commissioner take steps to determine the appropriate size and workload of its foreign investigator cadre so that standards safeguarding imported food are met.
The report suggested that the FDA work with the Centers for Disease Control and Prevention to establish new performance measures to estimate the impact of food safety inspections on safeguarding imported foods.
The report, citing FDA sources, says about 15% of the U.S. food supply in March 2023 consisted of imported food. That food came from more than 200 countries and territories and represented 32% of the fresh vegetables, 55% of the fresh fruit and 94% of the seafood that Americans consume annually.
While the FDA doesn't explicitly categorize individual foreign food facilities as high-risk or non-high-risk, it generally gives advance notice to foreign facilities that they will be inspected, according to the FDA. This is because foreign facility inspections require more planning and are more costly to conduct than most domestic inspections, the FDA said.
If a foreign facility doesn't respond to the FDA's notice of inspection, it may eventually be placed on an import alert red list. Facilities on that list are flagged for refusal and may not be allowed entry of products into the U.S.
At the end of fiscal year 2024, there also were approximately 12,400 foreign food facilities listed on the FDA's import alert red list. This total is out of the approximately 125,000 foreign food facilities subject to FDA inspection.
However, the FDA told GAO that it doesn't have the workforce or resources to reach its annual target of 4,695 foreign facility inspections.
"FDA officials stated they have taken steps in recent years to identify the number of foreign inspections the agency can realistically conduct each year as part of its annual planning process. For example, FDA projected it would be able to conduct 1,008 total foreign inspections in fiscal year 2024 based on its existing capacity and resources," GAO said. "While useful for FDA’s planning purposes, this process focuses on the number of inspections FDA has the capacity to conduct rather than, more importantly, the number FDA should be conducting to best ensure the safety of imported food."
GAO recommended that the FDA reassess its annual target so that both the agency and Congress can assess the FDA's performance in safeguarding imported food.