Worldwide Ramifications Unclear Until FDA Releases New Import Criteria for Methyl Mercury
The U.S. Food and Drug Administration (FDA) confirmed today that the agency cancelled Import Alert number 16-08. According to FDAImports.com’s daily-tracking records on all import alerts, FDA took this unexpected and rare step backwards on or about April 8, 2015. FDA’s Import Alert 16-08 was for the “Detention Without Physical Examination (Automatic Detention) of Swordfish For Methyl Mercury” and it gave the agency’s FDA field import personnel the authority to detain automatically all imported shipments of swordfish and processed swordfish products from any foreign country unless they were from shippers on the FDA Green List.
Officials at FDA headquarters confirmed that the program has been cancelled, and the import alert is no longer accessible on FDA’s website. When questioned about what the new criteria would be, and when industry would be informed about the new criteria for imports of swordfish, FDA indicated that a decision was made not to publish that information at this time. We speculate FDA is not making the new criteria public because the agency has yet to identify what that criteria should be for imported swordfish. In an email from FDA today, FDAImports.com learned that for the present time FDA is “not enforcing the action level of 1 ppm for mercury in swordfish; therefore, [Import Alert] 16-08 would not apply.” We note that statement is a slightly more nuanced policy than saying the import alert is “cancelled.” It seems the policy is evolving.
In talking with staff at a number of FDA district offices, there appears to be confusion in the field as to how FDA import inspectors and compliance officers should be handling imported swordfish shipments. FDA has been releasing some imported swordfish shipments that originate from suppliers that were never on FDA’s Green List. In other cases, FDA has examined and visually inspected, but not sampled or detained, swordfish entries.
As we develop more information on this important issue, we will make it available to industry.
