On March 30, 2012, the U.S. Food and Drug Administration (“FDA”) denied a request to ban the chemical bisphenol-A, commonly known as BPA, from food and drink packaging materials. The request, made by the Natural Resources Defense Council (“NRDC”), sought for the FDA to ban the controversial substance, citing the potential for serious adverse health effects. The NDRC Petition, filed on October 28, 2008, may be accessed here. Ultimately, the FDA concluded that there is insufficient evidence to demonstrate that BPA is harmful when used in food contact materials. More information about the FDA’s efforts in response to the request may be found here.
The petition to ban BPA sought to prohibit the chemical for use in human food under 21 C.F.R. § 189.1 (2011). This provision allows the FDA, either on its own initiative or on behalf of an interested party, to add or remove materials to a list of prohibited substances that may not be used in human food. In order for the FDA to prohibit a substance under this regulation, the Agency must find that such a substance poses “a potential risk to the public health or [has] not been shown by adequate scientific data to be safe for use in human food.” 21 C.F.R. § 189.1(a) (2011). Further, in order to reach such a finding, any petition seeking this prohibitive action must include an “adequate scientific basis” showing the potential for harm. 21 C.F.R. § 189.1(c) (2011). In the present circumstances, the FDA decided to deny the NDRC’s Petition based on its finding that the scientific evidence was insufficient to show that the amount of BPA being ingested poses such risks.