Substances Generally Recognized as Safe, Final Rule, 8 Fed. Reg. 54960 (Aug. 17, 2016)

SUMMARY:The Food and Drug Administration (FDA or we) is issuing a final rule that amends and clarifies the criteria in our regulations for when the use of a substance in food for humans or animals is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) because the substance is generally recognized as safe (GRAS) under the conditions of its intended use. We also are amending our regulations to replace the voluntary GRAS affirmation petition process with a voluntary notification procedure under which any person may notify us of a conclusion that a substance is GRAS under the conditions of its intended use. The clarified criteria for GRAS status should help stakeholders draw more informed conclusions about whether the intended conditions of use of a substance in food for humans or animals complies with the FD&C Act, and the notification procedure will enable stakeholders to be aware of whether we have questioned the basis of a conclusion of GRAS status.Executive SummaryPurpose and Coverage of the RuleAlthough we have premarket review authority over food additives, a food manufacturer can intentionally add a substance to human food or animal food without our premarket review or approval if the substance is generally recognized, among qualified experts, to be safe under the conditions of its intended use (GRAS). Since the 1970s, we have had regulations clarifying the statutory provision for eligibility for classification as GRAS. We also have had regulations governing a procedure for any person to voluntarily submit to us a petition asking us to affirm the GRAS status of a substance under the conditions of its intended use, and for us to engage in an intensive rulemaking process in response to that petition. Experience has shown that our regulations need further clarification to help stakeholders understand when a substance is eligible for classification as GRAS in human food or animal food under the conditions of its intended use. Experience also has shown that streamlining our evaluation of conclusions of GRAS status will enable us to evaluate more, and higher priority, substances. We are issuing this final rule to amend and clarify the criteria in our regulations for when a substance is GRAS under the conditions of its intended use in human food or animal food, and to replace the voluntary administrative procedure for petitioning us to affirm the GRAS status of a use of a substance in human food or animal food with a voluntary administrative procedure for notifying us about a conclusion that a substance is GRAS under the conditions of its intended use in human food or animal food.Summary of the Major Provisions of the RuleThe final rule clarifies the criteria for the use of a substance to be eligible for classification as GRAS and establishes a new administrative procedure for any person to notify us of the basis for a conclusion that a substance is GRAS under the conditions of its intended use. With respect to criteria for eligibility for classification as GRAS, in the final rule we clarify that:A substance cannot be classified as GRAS under the conditions of its intended use if the available data and information do not satisfy the safety standard for a food additive under the FD&C Act;General recognition of safety requires common knowledge, throughout the expert scientific community knowledgeable about the safety of substances directly or indirectly added to food, that there is a reasonable certainty that the substance is not harmful under the conditions of its intended use;“Common knowledge” can be based on either “scientific procedures” or on experience based on common use of a substance in food prior to January 1, 1958; andGeneral recognition of safety through scientific procedures must be based upon the application of generally available and accepted scientific data, information, or methods, which ordinarily are published, as well as the application of scientific principles, and may be corroborated by the application of unpublished scientific data, information, or methods.With respect to the procedure for submitting a GRAS notice, we provide:Definitions for certain terms, including amendment, GRAS notice, notified substance, notifier, qualified expert, supplement, we/our/us, and you/your;A clear statement of the opportunity for any person to submit a GRAS notice;Information on available formats (electronic and paper) and where to send a GRAS notice;What data and other information may be incorporated into a GRAS notice;General provisions applicable to a GRAS notice;Specific information you must provide in your GRAS notice, including:○ Signed statements and a certification (Part 1);○ The identity, method of manufacture, specifications, and physical or technical effect of the notified substance (Part 2);○ Dietary exposure (Part 3);○ Self-limiting levels of use, in circumstances where the amount of the notified substance that can be added to human food or animal food is limited because the food containing levels of the notified substance above a particular level would become unpalatable or technologically impractical (Part 4);○ The history of consumption of the substance for food use by a significant number of consumers (or animals in the case of animal food) prior to January 1, 1958, if a conclusion of GRAS status is based on common use of the substance in food prior to 1958 (Part 5);○ A narrative that provides the basis for your conclusion of GRAS status, including why the scientific data, information, methods, and principles Start Printed Page 54962described in the notice provide a basis for your conclusion that the notified substance is generally recognized, among qualified experts, to be safe under the conditions of its intended use (Part 6); and○ A list of the data and information that you discuss in the narrative of your GRAS notice, specifying which of these data and information are generally available, and which of these data and information are not generally available (Part 7); andProcess for you to submit an amendment to your GRAS notice; andProcess for you to request that we cease to evaluate your GRAS notice.With respect to our administration of a GRAS notice, we specify:Information about how we will file a GRAS notice, respond to it, and send subsequent correspondence about it;Our commitment to respond within 180 days of filing of a GRAS notice, with a potential to extend our response timeframe by another 90 days;Our procedures in the event the intended conditions of use of the notified substance include use in a product subject to regulation by the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA); andProvisions governing the public disclosure of a GRAS notice, including the actions we take to make some information regarding a GRAS notice readily accessible to the public.As of the effective date of the final rule, we will close the docket for any pending GRAS affirmation petition. The petitioner may incorporate the applicable petition into a new GRAS notice.COSTS AND BENEFITSThe final rule eliminates the petition process to affirm that a substance is GRAS under the conditions of its intended use and replaces that petition process with a GRAS notification procedure. We estimate that over 10 years with a 7 percent discount rate, the present value of the total costs of the final rule range from $0.9 million to $3.3 million; with a 3 percent discount rate, the present value of the total costs range from $0.9 million to $3.4 million. The annualized costs of the rule range from $0.1 million to $0.4 million with a 7 percent discount rate and range from $0.1 million to $0.5 million with a 3 percent discount rate. We do not quantify the benefits of the final rule, but assume that firms will only participate in the GRAS notification procedure when they expect to receive a non-negative private benefit. The GRAS notification procedure will allow us to complete our evaluation within the timelines specified in the final rule. The following table includes a summary of the benefits and costs of the final rule.Summary of Benefits and Costs of the Final RuleTotal benefitsPresent value of total costs with 7 percent discount rate ($ mil)Present value of total costs with 3 percent discount rate ($ mil)Total annualized costs over 10 years with 7 percent discount rate ($ mil)Total annualized costs over 10 years with 3 percent discount rate ($ mil)Not estimated$0.9 to $3.3$0.9 to $3.4$0.1 to $0.4$0.1 to $0.5.