SOURCE: FDAImports.com

FDAImports.com

January 09, 2010 13:21 ET

FDA Says "No Way" to Chinese Shrimp Imports: FDA Ignores Its Own Inspection Data and Refuses Chinese Shrimp Exports to the U.S., According to FDAImports.com, LLC

WASHINGTON, DC--(Marketwire - January 9, 2010) - According to Benjamin L. England of FDAImports.com, in a surprise policy shift the U.S. Food & Drug Administration's Office of Seafood today stated unequivocally that it will continue to prohibit most Chinese seafood firms from shipping certain products like shrimp and catfish to the United States, simply because it was "too cumbersome" for FDA to comply efficiently with its own rules or to apply its own recent Chinese inspection data to assess compliance with agency requirements. England said, "FDA told me today that none of the inspections recently conducted in China will be used to exempt any new Chinese seafood processors from FDA import alert 16-131," which has been in effect since August 2007. "This comes as a real shock," continued England. "Everyone in the industry thought FDA was busy reviewing the inspection audits from late 2009 in order to assess which firms FDA could exempt from [import alert] 16-131. Those Chinese firms have been sitting on the edges of their seats waiting for the new expanded exemption list and a new hope of exporting freely to the U.S. FDA even told me and some of my clients in the early spring of 2009 that its inspectors would be going to China to conduct inspections for the purpose of expanding the exemption list. This is a disaster for the Chinese seafood industry."

Prior to August 2007, a Chinese seafood processor could ship seafood to the U.S. for sale, as long as it had a good history and there was no evidence of a problem with that firm's product. Suddenly, it became next to impossible to do so without greater expenses in testing and storage and delays. In August 2007, FDA issued Import Alert 16-131: "Detention Without Physical Examination of Aquacultured Catfish, Basa, Shrimp, Dace and Eel from China." Under that alert all shipments of Chinese shrimp and catfish were detained automatically, requiring importers to test the product to prove it was not contaminated with unapproved animal drugs. England explained, "Those automatic Chinese seafood detentions cost money in terms of testing and storage and extensive delays, sometimes months at a time, before FDA would release the shipments one by one."

The import alert, which remains in effect today, states that a Chinese seafood processor can be exempted from the alert if the firm successfully shipped five clean shipments to the U.S. (proven clean by private laboratory testing) and the firm submitted an inspection report conducted by an "appropriate" third party inspection company or government agency. It became clear soon after FDA issued that guidance, however, that there was no such thing as an "appropriate" third party inspection company or government agency -- not even the U.S. Department of Commerce's Seafood Inspection Service (USDC/SIS), a sister federal agency, was "appropriate" in the eyes of FDA's Office of Seafood. This "appropriate" third party inspection requirement, according to FDA Commissioner Dr. Margaret Hamburg, may not even be within FDA's authority. FDA has repeatedly testified that it needs broader authority to create third party inspection programs for food firms, and Congress has offered that broadened authority in several bills, including the Food Safety Enhancement Act of 2009. None of those bills have become law.

In the summer of 2008, and without any new grant of authority from Congress, FDA sent inspectors to China to audit AQSIQ -- a Chinese agency similar to FDA -- and USDC/SIS, who routinely inspect Chinese seafood processors. Although FDA did not inspect any seafood facility, FDA did use the information obtained from these third party inspection services coupled with FDA's own observations during the inspections to assess the compliance status of each processor. "FDA was auditing the auditors but able to see the actual operations because FDA was present during the audit," England explained. After those visits FDA concluded that neither AQSIQ nor USDC/SIS were "appropriate" third party inspectors because they could not perform the inspections to FDA's satisfaction. However, in November 2008, FDA used the third party inspections and the agency's own observations to place about a dozen Chinese seafood processors on the import alert's exemption list, sparing them from the costs and delays caused by the import alert.

In January 2009, FDA published a new program for using third party inspection data, even though FDA had not been given any new authority to do so. Soon thereafter FDA initiated a third party certification pilot program and accepted five private firms who applied to be third party inspectors. FDA still had received no new authority from Congress to do so. Finally, in autumn 2009, FDA sent agents to China again to supervise third party inspection services under this new pilot program and a number of Chinese seafood processors were inspected, again with FDA present during the inspections. Every industry participant believed FDA would again use its own observations, if necessary, to assess the compliance of the firms being inspected and exempt those seafood processors that were found to be in compliance.

However, today, during a conversation with FDA's Office of Seafood, FDA reports the inspections were only to advance the new third party certification pilot program which it hopes to implement; and nothing else. Therefore, none of the facilities inspected by FDA in 2009 will be evaluated for exemption from import alert 16-131. FDAimports.com owner, Benjamin England notes, "This shift in policy is wholly unknown to and unexpected by the Chinese seafood industry or U.S. seafood importers or, I dare say, the Chinese government. Everyone is waiting for FDA to issue its new exemption list. Apparently, FDA would rather travel to China to do what it does not have the authority to do and not do what it clearly has the authority to do. It makes no sense to me whatsoever."

At this point, no firm can be added to the exemption list without an inspection by an "appropriate" third party. Still, however, none exists. And rather than performing the functions FDA has the authority to perform, namely conducting inspections of seafood processors, FDA spent its resources traveling to China to perform functions it does not have the authority to perform, namely advancing a pilot third party inspection program that even the agency's Commissioner doubts FDA has the statutory authority to implement.

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