Study calls for review of additive approval process

by Keith Nunes
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WASHINGTON — A study published in the Oct. 25 edition of the peer reviewed journal Comprehensive Reviews in Food Science and Food Safety has raised concerns about the amount of transparency in the U.S. food additive regulatory program. The study found that safety decisions relating to one-third of the more than 10,000 substances that may be added to food and beverages were made by food manufacturers and related associations without review by the Food and Drug Administration.

“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 for the Pew Health Group, an arm of the Pew Charitable Trusts.

The review also noted that the expedited process developed by the F.D.A. in the 1990s eliminated the opportunity for public involvement in decision making prior to the F.D.A.’s determination of safety. The study noted the practice is counter to the procedures used by other federal regulatory decisions regarding drug, workplace and environmental safety, which require public notice and comment before a decision is made.

“While the shift to a new regulatory process — one in which companies make safety decisions and ask F.D.A. to confirm them — has sped up agency review, it has also bypassed the public,” Mr. 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. 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.”

This past April, the Institute of Food Technologists and the scientific journal Nature co-sponsored a two-day workshop to review how the F.D.A. evaluates the potential hazards posed by substances added to food. In a separate article published in the Oct. 25 issue of Comprehensive Reviews in Food Science and Safety issues discussed at the workshop were reviewed.

The I.F.T. meeting identified several areas of review, including the need for clear procedures to develop validated toxicological tests and regularly revise guidance documents to reflect advances in science; opportunities to improve academic research to make it more usable for regulatory decision making and enhance coordination between federal agencies; and the challenges to reassessing a chemical’s safety after it is on the market.

“As a scientific society, one of I.F.T.’s goals is to ensure food policy and regulations are based on sound science, and the workshop was designed to foster an interactive dialogue to share a variety of opinions on the issues surrounding food additives,” said William Fisher, I.F.T. vice-president of science and policy initiatives.

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