Letter to Andrew C. von Eschenbach, M.D., Commissioner, U.S. Food and Drug Administration

Letter

Letter to Andrew C. von Eschenbach, M.D., Commissioner, U.S. Food and Drug Administration

Durbin Asks FDA About Lack of Import Alerts in Thailand, Vietnam & Indonesia

U.S. Senator Dick Durbin (D-IL) today sent the following letter to FDA urging them to look into contaminated fish found in Thailand, Vietnam and Indonesia. On June 28th, FDA issued an import alert banning five species of fish imported from China. While recent news reports highlight the presence of similar contaminants found in fish imported from Thailand, Vietnam and Indonesia, the FDA has not pursued similar regulatory actions for these countries.

The text of the letter appears below:

September 17, 2007

Andrew C. von Eschenbach, M.D.
Commissioner
U.S. Food and Drug Administration
U.S. Department of Health and Human Services
5600 Fishers Lane
Rockville, Maryland 20857

Dear Dr. von Eschenbach:

I am writing in response to a newspaper story that appeared in The Chicago Tribune on September 16, 2007, that questions the effectiveness of the Food and Drug Administration's (FDA) recent actions to protect consumers from contaminated seafood imports. The article raises the point that although imported seafood products from Indonesia, Vietnam, Thailand, and China have all been found to contain unapproved antimicrobials, the FDA has only taken steps to detain and require testing for shipments of seafood imported from China.

On June 28, 2007, the FDA issued an import alert to detain and require the testing of farm-raised seafood from China due to the presence of the antimicrobials nitrofuran, malachite green, gentian violent, and fluroquinolone. Under this import alert, shipments are stopped at points of entry until at least five consecutive shipments have been accepted by FDA based on third-party laboratory analysis and documentation has been provided that shows that the seafood was processed in compliance with FDA's Seafood Hazard Analysis and Critical Control Point (HACCP) regulations and Chinese government requirements for exporting seafood to the United States.

It appears that this import alert was issued following a period of testing and investigation that included targeted sampling, site visits to China, and the issuance of interim alerts. According to documents on the FDA website, this investigative process revealed that China's residue control program was ineffective and that inspections repeatedly found residues of unapproved substances in seafood imported from China. During the same period of time, FDA inspections of seafood from Thailand, Vietnam, and Indonesia were finding residues of similar contaminants and other major seafood-importing countries were taking steps to prevent these contaminated imports from entering their countries. However, unlike the June 28, 2007, import alert for Chinese seafood, FDA has not pursued similar regulatory actions for imports from Thailand, Vietnam, and Indonesia.
In order to better understand the reasons for this discrepancy, I ask that you answer the following questions:

1) What were the methodologies and results of the targeted sampling of Chinese seafood products from October 2006 to May 2007?

2) Over the last 18 months, how many import alerts has the FDA issued for seafood imports from China, Thailand, Vietnam, and Indonesia?

3) Over the last 18 months, how many shipments of seafood products from China, Thailand, Vietnam, and Indonesia have been refused by FDA?

4) With regard to this investigation, how did FDA use information from the Prior Notice System to target sampling and inspections?

5) What percentage of shipments of seafood from China, Indonesia, Thailand, and Vietnam are inspected by FDA?

6) What are the major differences in the regulatory systems, residue management standards, and export controls in place in China, Indonesia, Thailand, and Vietnam? Is FDA pursuing efforts to harmonize residue standards with these countries?

7) What percentage of shipments of seafood from China, Indonesia, Thailand, and Vietnam are inspected by the regulatory agencies of Japan and the European Union?

8) What steps has FDA taken to engage the governments of China, Indonesia, Thailand, and Vietnam in order to improve the quality of their seafood exports?

Thank you for your attention to this matter. I ask that you provide a response within 20 days. If you have any questions, please contact my staff.

Sincerely,

Richard J. Durbin
United States Senator

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