David S. Egilman, MD, MPH, Department of Community Health, Brown University, 8 North Main St., Attleboro, MA 02703, 508-226-5091, degilman@egilman.com and Julie Falender, BA, Never Again Consulting, 8 North Main Street, Suite 404, Attleboro, MA 02703.

The label “Generally Regarded as Safe” (GRAS) given by the industry consortium FEMA is a misleading moniker. FEMA scientists test substances and make designations as to whether a substance is GRAS without peer review, and the Food and Drug Administration (FDA) accepts these designations, allowing GRAS substances to be added to foods. Thus, the GRAS designation may be used to circumvent rigorous and lengthy FDA regulating procedures and workplace safety regulation.

The FDA has ignored the dangers inherent in the GRAS label designation. While some substances are safe to eat in food, they pose risks to workers who are occupationally exposed to GRAS substances through inhalation exposure. For instance, out of over one-thousand substances labeled GRAS by FEMA, only 46 have established threshold limit values (TLVs).

An epidemic of Bronchiolitis Obliterans due to worker inhalation of butter flavoring has occurred as a result of the inadequate evaluation and response to the inhalation risk of a GRAS food additive. GRAS substances may be safe to eat, but they are not always safe to workers who are otherwise exposed through eye, skin and respiratory contact. Using the butter flavoring example, we evaluate the systemic weakness in the GRAS system and suggest changes to the corporate and government response to the hazards of these compounds.

Learning Objectives: