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Food industry found to rely on self-policing when it comes to food additives.

Safety decisions concerning one-third of the more than 10,000 substances that may be added to human food have been made by food manufacturers and a trade association without any reviews by the Food and Drug Administration, according to an analysis headed by the Pew Health Group.

The report, which was published in the Oct. 26 peer-reviewed journal Comprehensive Reviews in Food Science and Food Safety, illustrates potential problems with the U.S. food additive regulatory program, according to a statement from the authors.

"Congress established our food additive regulatory program more than 50 years ago, and it does not stand up well to scrutiny based on today's standards of science and public transparency," said Tom Neltner, Food Additives Project director in the Pew Health Group.

The research also found that FDA developed an expedited process in the mid-1990's that essentially eliminated the opportunity for public involvement in decision making prior to FDA's safety determination. According to the report, the shift doubled the rate of industry requests for FDA review. In contrast, standard operating procedure for other federal regulatory decisions regarding drug, workplace, and environmental safety requires public notice and an opportunity to comment.

"While the shift to a new regulatory process--one in which companies make safety decisions and ask FDA to confirm them--has sped up agency review, it has also bypassed the public," Neltner said. "Subjecting safety decisions to comment from competitors, academic scientists, public interest groups, and the general public can result in stronger protections for consumers," he added. "In an age of growing demand for government transparency, there is virtually no meaningful opportunity for participation in decisions about large classes of substances added to the food supply."

According to the report, when Congress passed the Food Additives Amendment of 1958, it created a structure that has limited FDA's ability to effectively regulate substances added to food because the law:

Allows manufacturers to determine that the use of an additive is "generally recognized as safe" (GRAS), and then use that substance without notifying FDA. As a result, the agency is unaware of many substances that may be added to food and lacks the ability to ensure that safety decisions were properly made.

Does not require that manufacturers inform FDA when health reports suggest new hazards associated with additives already used in food. Therefore, the agency has no access to unpublished reports and must expend limited resources sifting through published information to identify potential problems and set priorities.
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Publication:The Food & Fiber Letter
Date:Nov 7, 2011
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