Industry Comments Challenge EPA’s Use of Aspartame in Methanol Risk Assessment
The Environmental Protection Agency (EPA) published its toxicological review of methanol in early 2010, and comments recently filed by food industry interests have criticized the agency for using “surrogate” chemicals, such as formaldehyde and aspartame, an artificial sweetener, to support listing methanol as a likely human carcinogen. They also challenge the agency’s reliance on controversial studies suggesting a link between aspartame and increased incidence of lymphoma and leukemia.
EPA apparently used data involving the surrogate chemicals because they are related to methanol as metabolites. According to the Calorie Control Council, which represents companies that make low-calorie and reduced-fat foods, EPA’s review “reads like an aspartame report and not a methanol report.” Because aspartame’s safety has been studied for many years and the chemical additive has been approved for general use in more than 100 countries, the council argues that it should not be included in the methanol report.
The Juice Products Association, noting that “food is the primary source of human methanol exposure,” called on EPA to “state unequivocally that no health hazards have been associated with methanol in doses in the dietary range. Consumption of fruits, vegetables and fruit juices natural dietary sources of methanol should not be called into question by the absence of a clear statement on the issue.” While EPA says that “normal dietary exposure to aspartame . . . is unlikely to significantly increase blood methanol or formate levels,” the agency expresses concern about the lack of data on such levels in “sensitive populations,” such as those with a limited ability to break down alcohols or marginal folate tissue levels.
The council and Ajinomoto Corporate Services LLC, a leading aspartame manufacturer, both criticized the agency’s use of two European Ramazzini Foundation (ERF) aspartame rat feeding studies in the methanol review, claiming these studies “are inconsistent with the extensive database confirming aspartame’s safety” and “are without any scientific merit.” According to a news source, the ERF aspartame studies have been questioned by U.S. and European authorities, and the Food and Drug Administration concluded that it could not use the studies because ERF refused to share its slides with the agency. See InsideEPA.com, April 7, 2010.