NRDC Citizen Petition Requests that FDA Prohibit All Use of Bisphenol A as a Food Additive

By Riëtte van Laack –

On October 21, 2008, the National Resource Defense Council (“NRDC”) petitioned FDA to issue a regulation to prohibit the use of Bisphenol A (“BPA”) as a food additive.

Currently, BPA is approved as a chemical for use in the production of polycarbonate polymers and epoxy-based enamels and coatings.  See, e.g., 21 C.F.R. §§ 175.300(b)(3)(viii), 177.1440, 177.1580,and 177.2280.  The safety assessments concerning the use of BPA date from the 1960s.  These safety evaluations focused on carcinogenicity and on genetic toxicity as an indicator of carcinogenicity.  However, recent research has raised concerns about the potential effects of BPA on the endocrine system. 

The release, in 2007, of two government sponsored reviews of BPA has resulted in a debate about the safety of residues of BPA in food contact substances.  Based on its review of existing data, the National Toxicology Program (“NTP”) concluded that there was “minimal concern” about the reproductive and developmental effects of BPA. In contrast, in the “Chapel Hill” report, a group of 38 experts raised serious concerns about the safety of BPA.  In August 2008, based on these reports, amendments thereto, and additional sources of information, FDA determined in its draft safety assessment that “an adequate margin of safety exists for BPA at current levels of exposure from food contact uses.” 

NRDC disagrees with FDA’s draft safety assessment, which NRDC claims relied on two-industry funded studies.  According to NRDC, “in light of the data suggesting that BPA is harmful to human health, and in response to well-founded concerns of experts in the field, FDA must prohibit BPA from use in food and food packaging [and] revoke all regulations permitting the use of any food additive that results in BPA becoming a component of food.”

NRDC’s petition was submitted shortly before a subcommittee of the FDA Science Board Advisory Committee released its review of FDA’s draft safety assessment.  The subcommittee also disagreed with FDA’s draft safety assessment and concluded that the margins of safety for BPA are inadequate.  However, the subcommittee indicated that “this does not mean that exposures are not acceptable.”  According to the subcommittee, the acceptability of exposures is a question of policy, and this decision lies with FDA. 

In response to the subcommittee review, FDA acknowledged in a statement the existence of “uncertainties” about BPA and that “additional research would be valuable.”  The Agency is “moving forward with [additional] research to address the potential low dose effects of [BPA].”  FDA’s statement also pointed to “the present consensus among regulatory agencies in the United States, Canada, Europe, and Japan . . . that current levels of exposure to BPA through food packaging do not pose an immediate health risk.”