FDA Agrees to Finalize GRAS Rule by August 2016
According to a proposed consent decree filed in a D.C. district court, the U.S. Food and Drug Administration (FDA) will “submit a final rule regarding ‘Substances Generally Recognized as Safe’ [GRAS] to the Federal Register for publication no later than August 31, 2016.” Ctr. for Food Safety v. Burwell, No. 14-0267 (U.S. Dist. Ct., D.D.C., consent decree filed October 20, 2014). The Center for Food Safety apparently brought the action over concerns that food makers have been able to use an interim GRAS process and secure agency approval for allegedly unsafe ingredients, such as volatile oil of mustard, “olestra” and “quorn,” based on self-assessments.
According to the Center’s complaint against the agency, FDA has unlawfully exempted GRAS substances from regulation as food additives under a rule proposed, but never finalized, some 15 years ago. That proposed rule purportedly eliminated a petition process requiring food companies to demonstrate that a substance satisfies GRAS eligibility criteria, “including general scientific agreement about its safety, and provide FDA with all backup information supporting the petition.” The proposed rule allegedly replaced the petition process with “a simplified notification process” under which a person may notify FDA that a substance’s proposed use is GRAS via a “GRAS exemption claim,” which “includes a short description of the substance, the applicable conditions of its use, and the basis for the GRAS determination (i.e., through scientific testing or common use in food). The notifier no longer needs to provide backup information, and instead must only summarize the information and make it available to FDA for review upon FDA’s request.” The Center claimed that “FDA no longer conducts its own detailed analysis to evaluate the data. In fact, FDA no longer affirms whether or not a substance’s use is GRAS at all—it merely issues an opinion on a notifier’s independent determination that it is.”
In the Center’s view, this procedure took effect on publication in the Federal Register in the 1990s, and the public did not have an opportunity to comment on it in violation of the Administrative Procedure Act. Pending court approval of the agreement, the Center has declared victory for consumers, contending that forcing FDA to finalize the rule will render the agency “fully accountable for instituting a GRAS system that adequately protects the public from harmful food additives.” A Center spokesperson said, “Having a final rule in place will open the entire GRAS system to the scrutiny it deserves.” She was also quoted as saying that additional legal action may be considered based on the final rule’s substantive provisions. See Law360, October 23, 2014.
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