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GAO Report Questions FDA’s Import Alert Removal Process and Criticizes the Lack of Federal Agency Cooperation to Address Evasion

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By Milthon Lujan

USA.- Last week, the U.S. Government Accountability Office (“GAO”) publicly released a report of its audit of the U.S. Food and Drug Administration’s (“FDA”) management of import alerts covering seafood – Imported Seafood Safety: Actions Needed to Improve FDA Oversight of Import Alert Removal Decisions (GAO-20-62, Nov. 2019).

The GAO’s new report raises two major concerns regarding the FDA’s oversight of seafood imports.

First, the GAO explains that the FDA routinely and continuously falls short of the agency’s own audit goals with respect to its determinations to remove firms from import alerts.

Second, the GAO notes that the FDA and U.S. Customs and Border Protection (“CBP”) have failed to implement a GAO recommendation made in 2009 that the two agencies develop mechanisms to share information related to the evasion of import alerts.

The GAO’s review looked at 274 decisions to remove companies from seven different import alerts covering seafood products between October 1, 2011 and July 3, 2018. In the course of its review, the GAO found that:

Although the FDA establishes an audit goal of auditing at least one of the (minimum) five shipment samples used by a private laboratory to support a company’s request for removal from an import alert, the “FDA did not conduct any sampling, including audit sampling, within 1 year prior to removal for 260 (or 95 percent) of the 274 removal decisions” reviewed.

Although the FDA establishes an audit goal of auditing at least ten percent of each private laboratory’s work in support of removal requests “to ensure that each laboratory submits scientifically sound data,” the agency audited one to two percent of the work of private laboratories between fiscal years 2003 and 2013 and had managed to audit just three percent of the work of private laboratories in fiscal year 2018.

The FDA conducted inspections of the importer or foreign processing facility in just 28 of the 274 removal decisions.

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32 of the companies involved in the 274 removal decisions had been previously inspected and received a finding of “official action indicated” (“OAI”) which “indicates that an establishment failed to meet regulatory or administrative requirements and may pose a hazard to public health.” Although the FDA issued a directive in December 2011 that required the agency to conduct a follow-up inspection within six months of the OAI finding, “FDA did not conduct a follow-up inspection for 31 of these firms before removing them from an import alert.”

After removal, the FDA obtained samples of products on just six percent of the companies and conducted inspections for just thirteen percent of the importers or foreign processing facilities within one year following the companies’ removal from an import alert.

The FDA explained to the GAO that when it relied on documentation provided by a firm to support a removal decision or where a facility has not been inspected prior to removal from an import alert, “the agency relied on subsequent sampling and inspections to have confidence in continued compliance.” But as the GAO discovered, the FDA conducts only a very small amount of sampling and inspections following a firm’s removal from an import alert. Moreover, despite the FDA’s explanation of how post-removal monitoring compensated for the lack of inspections and sampling prior to removal, “FDA officials were not aware of the extent to which the products and foreign processing facilities associated with removal decisions were subsequently sampled and inspected.”

With regard to cooperation between the FDA and CBP, the GAO explains that a memorandum of understanding, effective May 2013, between the two agencies did “not address CBP sharing information on potential evasion of import alerts with FDA regularly or the agencies working proactively to identify such evasion.” The GAO attempted to determine what, if anything, the two agencies did to share information. “According to CBP officials, FDA and CBP do not coordinate specifically on targeting to detect evasion, but CBP would be willing to coordinate with FDA and provide any applicable expertise in this area.” The GAO warns that until the agencies develop mechanisms to “formally coordinate on identifying evasion of seafood import alerts . . . they may be missing opportunities to share information regularly that could benefit each agency’s efforts to detect illegal transshipment and help FDA proactively identify and prevent evasion of seafood import alerts.”

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A review of trade shipment data indicates that foreign shrimp exporters and U.S. shrimp importers likely continue to engage in significant evasion of import alerts. In fact, in connection with a formal allegation of evasion of antidumping duties, the Southern Shrimp Alliance has recently presented CBP with information demonstrating that Indian shrimp exporters who are subject to import alerts because of banned antibiotics ship shrimp to Vietnamese seafood exporters. These Vietnamese companies, in turn, export shrimp out of Vietnam, including to the United States.

Throughout the report, the GAO notes that the FDA repeatedly cited limited resources as playing a substantial factor in the agency’s approach to regulating seafood imports. But an analysis of the FDA’s entry line refusal data demonstrates that, in the import alert context, the agency confronts a limited number of firms that repeatedly run afoul of U.S. food and safety controls. Yet these companies, again and again, are permitted to re-enter the U.S. market.

Since 2002, the FDA has reported refusing 6,113 entry lines of shrimp products for a wide variety of reasons. Over that timeframe, these refused entry lines have been attributed to 1,165 shippers – an average of 5.2 entry line refusals per shipper. However, the distribution of entry line refusals amongst shippers is skewed and incredibly concentrated. The top 99 shippers (8.5 percent of the total) cumulatively account for almost half (47.9 percent or 2,931 out of 6,113) of all shrimp entry line refusals; the top 50 shippers (4.3 percent of the total) cumulatively account for over a third (33.7 percent or 2,059 out of 6,113) of all shrimp entry line refusals. Several of the companies with large numbers of refusals have been repeatedly found to be in violation of food safety laws, such that they are placed on an import alert, removed from that import alert, and then placed on it again in a continuous, unbroken cycle. The GAO’s report indicates that such companies likely did not merit removal from an import alert in the first instance and that it can take an inordinate amount of time before the FDA will identify and correct errors.

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Read the full GAO report here: https://www.gao.gov/products/GAO-20-62 

Source: Southern Shrimp Alliance

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