Recall that the section 321(s) which defines the term “food additive” excludes substances Generally Recognized as Safe. The provision is reproduced below in its entirety.The term “food additive” means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use; except that such term does not include—
(1) a pesticide chemical residue in or on a raw agricultural commodity or processed food; or
(2) a pesticide chemical; or
(3) a color additive; or
(4) any substance used in accordance with a sanction or approval granted prior to September 6, 1958, pursuant to this chapter, the Poultry Products Inspection Act [21 U.S.C. 451 et seq.] or the Meat Inspection Act of March 4, 1907, as amended and extended [21 U.S.C. 601 et seq.];
(5) a new animal drug; or
(6) an ingredient described in paragraph (ff) in, or intended for use in, a dietary supplement.
21 U.S.C. 321(s).
Two groups of substances qualify as GRAS. First, substances used in food prior to 1958 are grandfathered and automatically considered GRAS. 21 C.F.R. 170.30©. The FDA later extended the grandfathered substances to include substances commonly used in foods prior to 1958 outside the United States. 21 C.F.R. 170.30©(2).
Grandfathering, or exempting an already existing class of substances or regulated parties like factories, is a common practice in regulatory policy. It is, however, worth pausing to consider the historical sequence. A massive increase in the use of chemicals in food prompts public concern, congressional investigations, and ultimately federal legislation. The federal legislation governs virtually chemicals added to foods, with one main exception—those chemicals added that are recognized as safe. Which chemicals are generally recognized as safe? All chemicals that are being commonly added to foods in the United States (and soon thereafter, anywhere in the world). Thus, the legislation stopped virtually none of the chemicals that gave rise to fear and legislation from being added to foods in the future. The the use of grandfathering as a regulatory strategy and the use of commonality as a marker of safety combined to allow almost all historical chemical additives to continue to be used in foods.
In addition to chemicals commonly used in foods prior to 1958, a second group of substances are classified as GRAS based on scientific determination via one of two routes. First, a party may request that FDA review scientific information and conclude that a substance is GRAS. Second, a party can engage in “self-determination”—a process which typically involves convening a group of GRAS experts who review all available information about a substance and proper a report concluding that the substance is safe. The latter involves some risk that FDA will agree, but it also allows for the immediate marketing of the food and avoids what can be a time consuming pre approval process for food additives.
In 2010, The United States Government Accountability Office published GaO 10-246, critiquing the FDA's GRAS process. The full report is available at http://www.gao.gov/assets/310/300743.pdf. The report's highlights are below:
The Food and Drug Administration (FDA), which is responsible for ensuring the safety of most of the U.S. food supply, is not required to review substances, such as spices and preservatives, added to food that are generally recognized as safe (GRAS) for their intended use. Currently, companies may determine a substance is GRAS without FDA's approval or knowledge. However, a few substances previously considered GRAS have later been banned; and concerns have been raised about the safety of other GRAS substances, including those containing engineered nanomaterials, materials manufactured at a tiny scale to take advantage of novel properties. GAO was asked to review the extent to which (1) FDA's oversight of new GRAS determinations helps ensure the safety of these substances, (2) FDA ensures the continued safety of current GRAS substances, and (3) FDA's approach to regulating engineered nanomaterials in GRAS substances helps ensure the safety of the food supply. GAO reviewed FDA data on GRAS substances and interviewed a range of stakeholders, among other things.
FDA's oversight process does not help ensure the safety of all new GRAS determinations. FDA only reviews those GRAS determinations that companies submit to the agency's voluntary notification program—the agency generally does not have information about other GRAS determinations companies have made because companies are not required to inform FDA of them. Furthermore, FDA has not taken certain steps that could help ensure the safety of GRAS determinations, particularly those about which the agency has not been notified. FDA has not issued guidance to companies on how to document their GRAS determinations or monitored companies to ensure that they have conducted GRAS determinations appropriately. Lastly, FDA has yet to issue a final regulation for its 1997 proposed rule that sets forth the framework and criteria for the voluntary notification program, potentially detracting from the program's credibility. FDA is not systematically ensuring the continued safety of current GRAS substances. While, according to FDA regulations, the GRAS status of a substance must be reconsidered as new scientific information emerges, the agency has not systematically reconsidered GRAS substances since the 1980s. FDA officials said they keep up with new developments in the scientific literature and, on a case-by-case basis, information brought to the agency's attention could prompt them to reconsider the safety of a GRAS substance. However, FDA has largely not responded to concerns about GRAS substances, such as salt and the trans fats in partially hydrogenated vegetable oils, that individuals and consumer groups have raised through 11 citizen petitions submitted to the agency between 2004 and 2008. In fact, FDA has decided on the validity of these concerns in only 1 of 11 cases. In addition, FDA does not know to what extent, or even whether, companies track evolving scientific information about their GRAS substances. FDA's approach to regulating nanotechnology allows engineered nanomaterials to enter the food supply as GRAS substances without FDA's knowledge. While some uses of engineered nanomaterials have the potential to help ensure food safety, uncertainties remain about how to determine their safety in food. After reviewing the uncertainties associated with the safety of engineered nanomaterials, FDA has decided that it does not need additional authority to regulate products containing such materials. Rather, FDA encourages, but does not require, companies considering using engineered nanomaterials in food to consult with the agency regarding whether such substances might be GRAS. Because GRAS notification is voluntary and companies are not required to identify nanomaterials in their GRAS substances, FDA has no way of knowing the full extent to which engineered nanomaterials have entered the U.S. food supply as part of GRAS substances. In contrast to FDA's approach, all food ingredients that incorporate engineered nanomaterials must be submitted to regulators in Canada and the European Union before they can be marketed.
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.
Although 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.
The 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:
With respect to the procedure for submitting a GRAS notice, we provide:
○ 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); and
With respect to our administration of a GRAS notice, we specify:
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.
The 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.