When U.S. shrimpers see Gulf Coast restaurants serving Argentine red shrimp falsely marketed as domestic Royal Red shrimp, the story of how that shrimp came to the United States never fails to astound. Large volumes of shrimp landed by commercial fishermen in Argentina in the Atlantic Ocean is then shipped across the Pacific Ocean to be processed in Chinese plants before being put back on a container ship and sent across the ocean to the United States.
If this shrimp cannot be processed in Argentina, wonder fishermen, why is it processed in China before sale to the United States rather than processed in this country?
Part of the answer to that question was highlighted by the U.S. Government Accountability Office (GAO) in a report to Congress publicly released on Wednesday, Food Safety: FDA Should Strengthen Inspection Efforts to Protect the U.S. Food Supply, GAO-25-107571 (Jan. 8, 2025). In short, the GAO continued to find that the U.S. Food and Drug Administration (FDA) applies far more scrutiny to U.S.-based seafood processors than it does to their foreign competitors.
According to the FDA, there are approximately 75,000 food facilities in the United States that are subject to agency inspection requirements under the Food Safety Modernization Act (FSMA) compared to roughly 125,000 food facilities overseas that supply the U.S. market and are also subject to FSMA inspection requirements. Accordingly, 63 percent of the FDA-regulated facilities producing food for the United States market are located outside of this country.
Nevertheless, over the six-year period spanning from fiscal year 2018 to fiscal year 2023, the FDA inspected an average of 8,353 domestic food facilities per year versus just 917 foreign food facilities. Thus, while almost two-thirds of the food facilities supplying American consumers are located overseas, these foreign plants account for less than ten percent of the annual inspections being conducted by the FDA.
According to the FDA, on the whole, just fifteen percent of this country’s food supply comes from overseas. But this figure covers all food, including products that are regulated under the much more strict controls of the U.S. Department of Agriculture (USDA). For seafood specifically, the FDA estimates that 94 percent of what Americans consume comes from overseas.
Because seafood is considered a higher risk food, seafood production plants were the most inspected by the FDA both in the United States and abroad. In total, one out of every six inspections (or seventeen percent) conducted by the FDA over the six-year period targeted seafood products.
This math means that more inspections targeting seafood are conducted annually (1,545) than there are inspections conducted of foreign facilities (917). Thus, even if all of the foreign facilities inspected each year were seafood plants, forty percent of the FDA’s annual inspections of seafood producers (628) would be of U.S. companies responsible for producing just six percent of the seafood consumed by Americans each year.
If, at best, the FDA is allocating its inspection resources such that two out of every five inspections are conducted of production plants that, at most, supply only six percent of our market, this discrepancy in regulatory approach is astonishing and impossible to justify.
Through enacting FSMA, the FDA believes that Congress has instructed the agency to conduct 19,200 inspections of foreign food facilities each year. Because the FDA, in fact, only conducts an average of 917 each year, the agency achieves less than five percent of the inspections called for by Congress on an annual basis.
According to the GAO, the FDA does not believe that it would be feasible to conduct 19,200 inspections of foreign food facilities each year, as it lacks sufficient resources. As of July 2024, the FDA employed just twenty investigators dedicated to conducting foreign inspections. Moreover, despite the fact that the FDA provides prior notice to foreign food facilities before it conducts an inspection – a courtesy not granted to U.S.-based food facilities, which are subject to unannounced inspections – the agency estimates that a foreign plant inspection costs $38,700, while the inspection of a high-risk U.S. food facility has an average price tag of $28,600. Because of this, during the six-year period, the single largest number of inspections completed of foreign food facilities was 1,727 – still five times smaller than the average number of domestic food facilities inspected by the FDA each year (8,353). Reviewing its resources, the FDA informed the GAO that it believed the agency could conduct a total of 1,008 inspections of foreign food facilities each year.
At the same time, the FDA conducted an analysis in May 2023 “that determined 4,695 annual foreign inspections represented an optimal performance target for ensuring the safety of imported food when combined with multiple other safety efforts and programs.” In other words, the FDA’s own internal analysis indicates that its foreign inspection regime is well below what is needed to ensure the safety of imported food.
When asked by the GAO whether the agency would inform Congress that it was unable to meet the inspection targets established by FSMA or the agency’s own internal analysis as to the level of foreign plant inspections required to ensure the safety of our imported food, “FDA officials told us in August 2024 – nearly 10 years after we made our recommendation – that they do not intend to take any further action to address it.”
The threat posed to U.S. consumers by this approach can be easily confirmed through the FDA’s new data dashboard. At the end of last year, the Southern Shrimp Alliance requested that Rongcheng Sanyue Foodstuff Co., Ltd. be added to the Entity List maintained under the Uyghur Forced Labor Prevention Act (UFLPA) because the processor and exporter of Argentine Red Shrimp had refused to allow FDA inspection of its facility. However, it is highly unusual that the FDA would ever even attempt to inspect a Chinese seafood processor and exporter. For example, Zhangzhou Hongwei Foods Company is a major processor and exporter of Argentine Red Shrimp to the United States. According to the FDA’s FSMA data dashboard, the agency has never conducted an inspection of the company’s facility. Similarly, another Chinese processor and exporter of Argentine Red Shrimp, Zhoushan City Shengtai Aquatic Co., Ltd., has never been inspected despite having multiple entry lines of seafood refused at the border by the FDA.
Other major Chinese suppliers of Argentine Red Shrimp either do not show up in the FDA’s FSMA database at all or are associated with multiple FEI numbers. For example, there is no firm profile in the FDA’s data dashboard associated with Zhoushan Greenfood Co., Ltd., a Chinese company that exports large quantities of Argentine Red Shrimp to the United States. Further, another major Chinese processor and exporter of Argentine Red Shrimp, Zhanjiang Guolian Aquatic Products Co., Ltd., has adopted two distinct FEI numbers for the same facility (3015653548 and 3004097215) and the FDA’s FSMA data dashboard indicates that under both numbers only one inspection of the production facility has been conducted by the agency, in 2015.
Combined, the GAO’s report this week and the FDA’s own data demonstrate that foreign seafood producers are highly unlikely to be subject to scrutiny by the agency, while, on the other hand, domestic seafood producers must expect to be subject to regular inspection by government authorities.
Conscious of the resource challenges confronting the FDA, the Southern Shrimp Alliance has continuously advocated for the specific allocation of federal funds to support the inspection of foreign seafood facilities and field examinations of imported seafood. Consistent with these efforts, bills providing for appropriations of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies have included language such as the following from the FY2025 House Ag Appropriations bill: “Provided further, That of the total amount appropriated: (1) $1,185,989,000 shall be for the Center for Food Safety and Applied Nutrition and related field activities in the Office of Inspections and Investigations, of which no less than $15,000,000 shall be used for inspections of foreign seafood manufacturers and field examinations of imported seafood,” with the same language appearing in the FY2025 Senate Ag Appropriations bill.
“The U.S. shrimp industry is grateful to the GAO for its continued efforts to draw attention to the FDA’s very different approaches to American and foreign seafood producers selling to U.S. consumers,” said John Williams, the executive director of the Southern Shrimp Alliance. “By primarily focusing on domestic producers while giving a pass to their foreign competitors, the FDA has played an instrumental role in the development of a market where 94 percent of our seafood comes from overseas despite having massive marine resources at our fingertips.”