The U.S. Government Accountability Office (GAO) recently released a report criticizing the Food and Drug Administration’s (FDA’s) oversight of food ingredients determined to be generally recognized as safe (GRAS). Noting that companies are not required to submit their GRAS determinations to regulators, GAO examined whether FDA can vouch for these substances, which increasingly include nanomaterials. The report apparently concludes that not only does FDA’s oversight process fail to ensure the safety of both new and preexisting GRAS determinations, but it allows engineered nanomaterials to enter the food supply without the agency’s knowledge.
According to the report, FDA “has not systematically reconsidered GRAS substances since the 1980s,” nor has it responded to “concerns about GRAS substances, such as salt and the trans fat in partially hydrogenated vegetable oils, that individuals and consumer groups have raised through 11 citizen petitions submitted to the agency between 2004 and 2008.” The findings also fault FDA for relinquishing the additional authority needed to directly regulate nanomaterials used in 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,” states a parallel GAO summary.
The report makes several recommendations to strengthen the GRAS determination process, urging FDA to adopt several obligatory requirements in lieu of voluntary measures. GAO has specifically called on FDA (i) “to require any company that conducts a GRAS determination to provide FDA with basic information” about the substance’s identity and intended uses; (ii) “to minimize potential conflicts of interest” by asking GRAS notices to verify the independence of expert panels; (iii) “to monitor the appropriateness of companies’ GRAS determinations through random audits”; (iv) “to finalize the rule that governs the voluntary notification program” first proposed in 1997; and (v) “to ensure the safety of engineered nanomaterials” by requiring companies “to inform FDA if their GRAS determinations involve engineered nanomaterials.” In addition, the report tasks officials with treating GRAS reassessments “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 GRAS substance, and considering how to collect information from companies on their reconsiderations.” See GAO Summary, February 3, 2010.