Is Ethanol (CAS# 64-17-5) that is added to foods or alcoholic beverages exempt from the Emergency Planning and Community Right-to-Know Act (EPCRA) section 312 chemical inventory (i.e., Tier I/II) reporting requirements?
EPCRA Section 312 requires facility owners or operators to submit annual chemical inventory reports (Tier I/Tier II Forms) for any Occupational Safety and Health Administration (OSHA) defined hazardous chemical subject to OSHA's Hazard Communication Standard (29 CFR section 1910.1200) when present at a facility above threshold amounts at any one time during the previous calendar year (40 CFR section 370.10). However, EPCRA Section 311(e)(1) exempts from the definition of hazardous chemical any food, food additive, drug, or cosmetic regulated by the Food and Drug Administration (FDA) (40 CFR 370.13(a)).
EPA considers a substance to be regulated by the FDA as long as the substance is used in a manner which is consistent with the FDA regulations.Ethanol (ethyl alcohol) is regulated by the FDA as a food ingredient (i.e., additive) in two instances. Ethyl alcohol is considered a Generally Recognized As Safe (GRAS) ingredient for use as an antimicrobial agent in pizza crust at levels not to exceed 2.0% (21 CFR 184.1293). Ethanol is also considered as a GRAS ingredient when used as a preservative in the fillings of croissants at a level of 0.3%. Ethanol used per these requirements would be exempt from the definition of hazardous chemical and not subject to EPCRA section 312 chemical inventory (i.e., Tier I/II) reporting requirements.
Ethyl alcohol produced in the manufacture of beer, wine, and distilled spirits is under the purview of Alcohol and Tobacco Tax and Trade Bureau and not FDA. Therefore, ethyl alcohol is not exempt from EPCRA Section 312 chemical inventory (i.e., Tier I/II) reporting requirements when added to food or alcoholic beverages.
