Last year, the Food and Drug Administration agreed to finalized its rule for the process of determining food substances as “generally recognized as safe” (GRAS). Now, a coalition of consumer advocacy groups has submitted an 80-page regulatory comment to the agency requesting that FDA make changes to the rule before it becomes final. FDA’s 1997 proposed rule on GRAS replaced the traditional petitioning process for a manufacturer seeking GRAS status for an additive with a “procedure whereby any person may notify FDA of a determination that a particular use of a substance is GRAS.” Although FDA never finalized the rule, both the agency and the food industry have been operating under the proposed procedure as an interim since 1997. In the regulatory comment submitted Wednesday, the Center for Science in the Public Interest (CSPI), the Consumers Union, the Environmental Working Group (EWG) and the Natural Resources Defense Council (NRDC) wrote that “the 1997 proposal is an invalid interpretation of the Food Additives Amendment of 1958 (FAA),” adding that, “to achieve its congressionally intended purpose of protecting the public from unsafe chemical additives and come into compliance with the FAA, FDA has an affirmative obligation to fix its proposal.” There are approximately 10,000 additives currently used in food, and it’s estimated that 3,000 have never been reviewed by FDA. An estimated 1,000 chemicals are used under GRAS without notifying the agency. Many have argued that GRAS allows companies to avoid the required statutory food additive petition process and add substances to food without any assurance of their safety. The organizations think this regulatory comment is probably the first time a detailed case has been laid out for why the current GRAS process is actually illegal. CSPI, the Consumers Union, EWG and NRDC want FDA to change the language in the 1997 proposal to limit what’s eligible for the GRAS exemption, require companies to notify FDA about all GRAS determinations, and publish their updated exposure data and reporting of adverse events on a periodic basis. The groups suggested that new ingredients shouldn’t be eligible for GRAS status because there hasn’t been enough time for a scientific consensus on their safety to develop and that GRAS should not apply to substances flagged as possible risks to human health. They also argued that GRAS determinations should not be made on unpublished research or by experts with conflicts of interest. “FDA’s current system for GRAS is … an abrogation of its responsibilities under the FAA, and undermines consumer confidence in food additive safety,” wrote the consumer groups. “Taken together, the changes we urge would transform the GRAS system from badly broken to functional.” Laura MacCleery, CSPI’s chief regulatory affairs attorney, told Food Safety News, “I really do feel that we should fix this problem and that we can fix it.”