Saturday, November 5, 2011
According to the Pew Health Group, safety decisions regarding a third of the more than 10,000 chemicals and additives that can be put in food were made by food manufacturers and a trade association without any formal review by the U.S. Food and Drug Administration. The findings were published Wednesday Comprehensive Reviews in Food Science and Food Safety, a peer-reviewed journal.
"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 shift away from public involvement in FDA's safety decisions led to an influx of food chemicals for the agency to review -- requests for approval doubled, according to the analysis.
"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 in a release. "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."
Congress' Food Additives Amendment of 1958 created a structure that has "limited FDA's ability to effectively regulate substances added to food," according to Pew. The group points to two tenets of the law:
- It allows manufacturers to determine that the use of an additive is "generally recognized as safe" (GRAS), and then use that substance without notifying the 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.
- It does not require that manufacturers inform the 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 Therefore, the agency has no access to unpublished reports and must expend limited resources sifting through published information to identify potential problems and set priorities.
The report is the beginning of a broader effort to assess FDA's regulatory system for ensuring chemicals added to food are safe. Future articles will examine scientific analysis and law and provide case studies that illustrate weaknesses in the system, which will ultimately lead to policy recommendations, according to Pew.
The non-profit is already highly engaged on food and agriculture issues, including industrial farming, school lunch, and food safety reform.