T97-15 Judith Foulke (202) 205-4144 April 17, 1997 Consumer Hotline: (800) 532-4440 FDA PROPOSES SIMPLIFIED GRAS NOTIFICATION SYSTEM FDA has proposed a replacement for the current system by which manufacturers may get affirmation from FDA that a food substance is generally recognized as safe (GRAS). The streamlining would allow FDA resources to be redirected, among other priorities, to food additive questions that involve public health issues. Food ingredients whose use is generally recognized as safe by qualified experts are not required by law to receive FDA approval before marketing. Under current procedures, a manufacturer may determine that use of a food substance is GRAS without formally petitioning to FDA. However, if a manufacturer wants FDA affirmation of its determination, the company must submit a petition and go through a rule-making process. Today, the agency has proposed to establish a notification procedure that would replace that lengthy rule-making process. Manufacturers may still make a self-determined GRAS declaration, claiming exemption from the premarket approval requirement for food additives. However, instead of petitioning FDA for affirmation, they would simply notify FDA of their GRAS determination and provide evidence that supports their decision. After evaluating the notification, FDA would respond to the manufacturer within 90 days. The manufacturers' notification would serve as a basis for informing FDA without the need for rule-making. Under the proposal, any GRAS affirmation petition that is pending, when a rule establishing a GRAS notification procedure is finalized, would be converted into a notification or dropped from review. The proposal allows for notification to be revisited if new information indicates a reason for concern. Because the proposed notification procedure is considerably simpler than the current affirmation process, manufacturers would have greater incentive to inform FDA of their GRAS determinations. Therefore, FDA would gain increased awareness of ingredients in the nation's food supply and the cumulative dietary exposure to GRAS substances. The simplified notification procedure would also redirect FDA resources from the resource-intensive GRAS affirmation process to questions that may have a greater impact on public health protection. Resources could also be directed to the preparation of documents that would provide the industry with guidance on complex food ingredient safety issues, such as those posed by novel proteins, carbohydrates, fats and oils, or other substances used in food. This proposal reflects FDA's commitment to achieving the goals for the Reinventing Food Regulations part of the President's National Performance Review. FDA will accept comments on the proposed regulation for 90 days following its publication in the Federal Register. Written comments may be submitted to FDA Dockets Management Branch, (HFA-305), 12420 Parklawn Drive, Rockville, MD. 20857-0001 ####**
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