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Stirring Up Food Safety Discussions On HHS Officials’ Agenda In Beijing

This article was originally published in The Tan Sheet

Executive Summary

Department of Health and Human Services senior officials are consulting with Chinese food and drug regulators in China to "pave the way" for discussions on developing U.S.-China agreements for increased safety of food and feed and on drugs and medical devices, according to HHS Secretary Michael Leavitt

Department of Health and Human Services senior officials are consulting with Chinese food and drug regulators in China to "pave the way" for discussions on developing U.S.-China agreements for increased safety of food and feed and on drugs and medical devices, according to HHS Secretary Michael Leavitt.

The meetings in Beijing and the agreements "we hope to develop are important steps forward in addressing problems with food and other imports from China," Leavitt asserts in a July 30 release. "I am hopeful that we can achieve two strong, action-oriented documents by December," he adds.

HHS's latest step in promoting food and drug safety cooperation with China comes a month after Sen. Dick Durbin, D-Ill., and Rep. Rosa DeLauro, D-Conn., told the agency that FDA's import ban on five species of fish from China, announced June 28, added to the urgency for establishing a food safety memorandum of understanding with the country.

In a letter to HHS and the Department of Agriculture, Durbin - assistant majority leader in the Senate - and DeLauro - chairwoman of the House Appropriations subcommittee with oversight of USDA and FDA - asked the agencies to "make it a top priority to develop a comprehensive, legally binding" MOU on food safety with China (1 (Also see "Congress Pushes Food Safety Pact With China As FDA Lauds European Deal" - Pink Sheet, 9 Jul, 2007.), p 7).

DeLauro said HHS's efforts to initiate food safety discussions are a good sign. "A comprehensive [MOU] between the U.S. and China would represent an important component of such a regulatory framework," she told "The Tan Sheet" July 31.

"Having Secretary Leavitt acknowledge the need to open discussions with China about the safety of food, as well drugs and medical devices, is a positive step forward," DeLauro said.

"These discussions need to be undertaken with the seriousness they deserve," she said, adding, "An avalanche of unsafe foods and products are entering the U.S. on a daily basis, and we need a regulatory system with the ability to manage and restrict this flow."

"I would urge HHS to insist on equivalency standards for food safety between the U.S. and China, as well as strong terms that would prevent any impediments to FDA investigations when a crisis occurs."

FDA's ban on some farm-raised Chinese seafood products followed its April 27 order for vegetable protein products from China to be detained without physical examination due to the presence of melamine and melamine analogs in pet food ingredients labeled as wheat gluten and rice protein (2 (Also see "Costs Mount For Firms As Amino Acids, Vegetable Proteins Sit On Docks" - Pink Sheet, 14 May, 2007.), p. 8).

During the countries' Strategic Economic Dialogue in Washington May 22-24, HHS and USDA officials asked Chinese officials to provide results, on an ongoing basis, of tests for melamine in ingredients destined for human or animal consumption, according to HHS.

HHS says the agencies are asking China to require mandatory registration of its firms that intend to export food and feed products to the U.S., including those to be used in dietary supplements, and to prohibit unregistered firms from exporting products to the U.S.

The U.S. also is seeking detailed information about the Chinese government's procedures, methodology and technology for testing and quarantine; information about its control measures; and raw data and results of Chinese government agencies' testing of regulated products.

Furthermore, HHS is asking Chinese officials for a list of all registered Chinese firms, with periodic updates.

HHS is soliciting input on the clearances necessary - such as multi-year, multi-entry visas - for FDA and other personnel to inspect Chinese facilities for the purpose of ensuring the safety of food products exported to the U.S.

Similarly, HHS is asking for information on clearances that would allow U.S. officials to conduct systems audits to confirm that registered Chinese firms meet U.S. food safety requirements.

Leavitt's announcement also comes a week after President Bush established the Interagency Working Group on Import Safety to help guarantee the safety of food and other products shipped to the U.S. (3 (Also see "Bush Establishes Import Safety Group As Congress Grills FDA On Food Safety" - Pink Sheet, 23 Jul, 2007.), p. 7).

Leavitt says while the working group "is not focused just on China or on food and drugs, I am sure what my team learns on its trip this week will feed into the recommendations" the group will make to the president in September.

- Malcolm Spicer ([email protected])

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