Given the enormous challenges that inspection poses as a regulatory strategy for ensuring food safety, the past sevearl decades have seen a push towards alternative tools to protect the food supply.  Three themes are commonly observed in policy debates.  First, an emphasis on risk estimation.  Although sometimes connoting particular quantitative methods, the basic idea is straightforward.  The particular risks posed to the food supply should be identified and estiamted. Without knowing—and often quantifying—what the risks of contamination or adulteration are, it is difficult to protect against them.   Second, resources should be allocated to points in the food chain that are particularly vulnerable.  Rather than inspecting every egg both before and after cracking, target locations or moments of particular vulnerability to contamination. Or, rely more extensively on auditing and sampling methods.  Third, decentralize the formulation of hazard prevention and response to regulated parties. Most food etablishments must today parepare a Hazard Analysis Critical Control Point plan. An overview is included below. While a HACCP sounds technical, it is really nothing more than working through what and where the risks to food safety are in a given facility and making a plan on how to prevent and respond.  Over time, federal agencies increasingly oversee the formulation and adoption of these private plans for food safety action rather than imposing particular requirements in rules or regulations.  One way of understanding this trend is as a shift away from command and control regulatory tools.  In the environmental policy domain, this has meant relying on performance controls that leave it up to regulated parties to decide how to best reduce pollution to a given level, rather than technology controls that demand a particular kind of scrubber be used to reduce pollution.   In the food context, rather than relying on finished product inspectino, the HACCP model is a systematic preventative appraoch to food safety that addresses physical, chemical, and biological hazards at each stage of the food production process. HACCP is thus a methodological innovation and it is used by both USDA and FDA.  

Although HACCP has only recently found favor with government regulators, it has been around at least since the 1950s, apparently developed jointly by the Pillsbury Company and the National Aeronautics and Space Administration (NASA), who needed safe food that could be consumed in space. See Food Code 2001, Recommendations of the United States Public Health Service, Food and Drug Administration 424 (2001). Down on earth, Pillsbury introduced the HACCP system after food safety problems with their baby food. See William H. Sperber and Richard F. Stier, Happy 50th Birthday to HACCP: Retrospective and Prospective, Food Sfaety Mag. (2009/2010). In the mid 1980's, the National Academy of Sciences (NAS) wrote that “government agencies responsible for control of microbiological hazards in foods should promulgate appropriate regulations that would require industry to utilize the HACCP systems in their food protection programs.” An Evaluation of the Role of Microbiological Criteria for Foods and Food Ingredients 329, National Research Council, National Academy of Sciences (1985).  FDA adopted the HACCP principles for seafood inspection in 1995, followed by the USDA for meat and poultry inspection in 1997. Roberts, Food Law at 142.       

Although the ultimate responsibility for promulgating and enforcing state and local food laws lies with the states and municipalities, the FDA has long taken a leading role by providing guidance to states. Contrary to the conventional view the states provide “laboratories of democracy” in which different laws and policies can be implemented and evaluated, in food law there is a surprising amount of uniformity and consistency.

At least since the 1920's with FDA's Guidance on milk pasteurization, FDA has provided guidance on virtually every segment of the retail food industry. In 1993, FDA issued the first full incarnation of its comprehensive Food Code, the most recent incarnation of which was issued in 2013.

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.

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 Summary

Purpose and Coverage of the Rule

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.

Summary of the Major Provisions of the Rule

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:

• 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; and
• General 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); and

• Process for you to submit an amendment to your GRAS notice; and
• Process 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); and
• Provisions 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 BENEFITS

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.

In 1992, FDA announced a new policy under which the agency would presume that all GE foods were GRAS and therefore not subject to regulation as food additives. See Statement of Policy—Foods Derived from new Plant Varieties, 57 Fed. Reg 22984, 22986 (May 29, 1992). The policy did not require companies to submit products for review prior to bringing them to market.

The key premise of FDA's policy is that the safety is best protected by focusing not on the means of production—genetic engineer or conventional techniques—but rather on the characteristics and features of a food. This so-called “product/process” distinction has resulted in the “substantial equivalence” doctrine. If the GE product is substantially the same as its conventional equivalent, it is not subject to differential regulation. Rather, the FDA simply advises that producers voluntarily consult with the agency prior to marketing.

Recall that the two major federal statutes pertaining to food and drugs in the first half of the twentieth century were the 1906 Pure Food and Drug Act (PFDA) and the 1938 Food, Drug, and Cosmetic Act (FDCA). Although the 1938 statute attempted to fix many of the earlier law's failings, many legal requirements and doctrinal frameworks carried over from the PFDA to the FDCA.

The PFDA made it illegal to manufacture or transport any food that is “misbranded.” Pure Food and Drug Act of 1906, sections 1-2, 34 Stat.. 768, 768-72 (repealed 1938). The purpose of the PFDA's misbranding provision was “to make it possible that the consumer should know that an article purchased was what it purported to be; that it might be bought for what it really was, and not under misrepresentations and to character and quality.” United States v. Johnson, 221 U.S. 488, 497 (1911).