Furthermore, FDA has not taken certain steps that could help ensure the  safety of GRAS determinations, particularly those for which the agency  has not been notified. FDA Generally Has No Information about GRAS Determinations That Are Not Submitted to Its Notification Program

Although FDA’s voluntary notification program allows the agency to  review those GRAS determinations companies submit, FDA generally does  not have information about other GRAS substances in the marketplace  because companies are not required to provide information to FDA  regarding their GRAS determinations. However, FDA has expressed concerns about the food safety regulatory  systems of some foreign countries. FDA Is Not Systematically Ensuring the Continued Safety of Current GRAS Substances

FDA does not systematically reconsider the safety of GRAS substances as  new information or new methods for evaluating safety become available. FDA  officials also said they keep up with new developments in the scientific  literature as part of their professional responsibility as scientists and, on a  case-by-case basis, information brought to the agency’s attention could  prompt it to reconsider the safety of a GRAS substance. FDA has not, however, revoked the GRAS status of these oils. However, we found that FDA has largely not responded to the concerns  that individuals and consumer groups have raised through 11 citizen  petitions submitted to the agency between 2004 and 2008. FDA Is Generally Not Aware of Companies’ Reconsiderations of their GRAS Determinations

FDA generally does not know to what extent, or even whether, companies  track the evolving scientific information regarding substances the  companies have determined are GRAS. Most of these studies have been published. In Canada and the European Union, any such engineered nanomaterials  are required to undergo review by government regulators before they can  be marketed. After reviewing the uncertainties associated with the safety of  food ingredients containing engineered nanomaterials, FDA has decided  that, at this time, it does not need additional authority to regulate such  products, nor does it need to significantly alter its regulatory approach. FDA has, instead, encouraged companies considering using nanomaterials  in food and food packaging to consult with the agency about which  regulatory track to follow, including whether such a substance might be  GRAS. The extent to which GRAS substances incorporating engineered  nanomaterials have entered the U.S. food supply is unclear. However, because  companies are not specifically required to identify whether substances  they submit to FDA contain engineered nanomaterials and GRAS  notification is voluntary, FDA has no way of knowing the full extent to  which engineered nanomaterials have entered the U.S. food supply in  GRAS substances. Recommendations for Executive Action

To better ensure FDA’s oversight of the safety of GRAS substances, we  recommend that the Commissioner of FDA take the following six actions:    develop a strategy to require any company that conducts a GRAS  determination to provide FDA with basic information—as defined by the  agency to allow for adequate oversight—about this determination, such as  the substance’s identity and intended uses, and to incorporate such  information into relevant agency databases and its public Web site;    develop a strategy to minimize the potential for conflicts of interest in  companies’ GRAS determinations, including taking steps such as issuing  guidance for companies on conflict of interest and requiring information in  GRAS notices regarding expert panelists’ independence;    develop a strategy to monitor the appropriateness of companies’ GRAS  determinations through random audits or some other means, including  issuing guidance on how to document GRAS determinations;    develop a strategy to finalize the rule that governs the voluntary  notification program, including taking into account the experience of the  program to date, incorporating input from a new public comment period,  and reporting to Congress and the public the agency’s timeline for making  it final;    develop a strategy to conduct reconsiderations of the safety of GRAS  substances in a more systematic manner, including taking steps such as  allocating sufficient resources to respond to citizen petitions in a timely  manner, developing criteria for the circumstances under which the agency  will reconsider the safety of a GRAS substance, and considering how to  collect information from companies on their reconsiderations; and    develop a strategy to help ensure the safety of engineered nanomaterials  that companies market as GRAS substances without the agency’s  knowledge, including taking steps such as issuing guidance recommended  by the agency’s nanotechnology taskforce, developing an agency definition  of engineered nanomaterials, and requiring companies to inform FDA if  their GRAS determinations involve engineered nanomaterials. Trans Fats in Partially Hydrogenated Vegetable Oils

		Dietary Guidelines for Americans

Health effects. Specifically, we assessed 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 as new scientific information emerges; and (3) FDA’s approach  to regulating engineered nanomaterials in GRAS substances helps ensure  the safety of the food supply. To assess whether FDA’s approach to regulating engineered nanomaterials  as GRAS helps ensure the safety of the food supply, we reviewed FDA’s  policies related to regulating engineered nanomaterials in food.
Why GAO Did This Study

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.

What GAO Found

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.