FDA Announces it Will Not Ban BPA
The saga surrounding BPA continues. After much ado, the U.S. Food and Drug Administration (FDA) has announced that it will not ban bisphenol A (BPA). Today the FDA denied in its entirety a citizen petition requesting that the FDA prohibit BPA has a substance for use in human food.
What is BPA?
BPA is a controversial chemical used in production of polycarbonate polymers and epoxy-based enamels and coatings. It is “an industrial chemical that has been present in many hard plastic bottles and metal based food and beverage cans since the 1960s.” An overview on BPA provided by the FDA can be found here. While past research on BPA indicated that the chemical is safe, more recent research has raised concerns relating to potential effect of BPA on the endocrine system. For instance, the “Chapel Hill” report indicated that there could be some safety concerns related to use of BPA.
The uses of BPA as a food contact chemical were approved through food additive policies prior to the enactment of FDAs food additive regulations and notification processes for food contact substances in place today. As an approved food additive, BPA can be used by any food manufacturer without prior notification to the FDA.
Background: NRDCS BPA Battle
In August of 2008, the FDA released a draft safety assessment stating that “an adequate margin of safety exists for BPA at current levels of exposure from food contact uses.” Disagreeing with the FDA, the Natural Resources Defense Council (NRDC) filed a citizen petition in October of 2008 requesting that the FDA take action and banning BPA as a food additive. In January 2010, the FDA seemed to change its course when it issued its “Update on Bisphenol A for Use in Food Contact Applications,” stating that it has “some concern about the potential effects of BPA on the brain, behavior, and prostate gland in fetuses, infants, and young children.”
Eventually, the FDA responded to NRDC with a form letter, stating that it lacked the resources to make a decision on the citizen petition. NRDC then petitioned the Court of Appeals for the District of Columbia Circuit to direct the FDA to render a decision. In June of 2011, the D.C. Circuit issued a ruling that it lacked exclusive jurisdiction and that the claim should be raised in district court. Persistently, NRDC filed a complaint in district court asking that the FDA be compelled to substantively respond to NRDCs petition by a specified date. Finally, in December of 2011, the FDA came to an agreement with NRDC and committed to issuing a decision on the NRDC petition by March 31, 2012.
In rejecting NRDCs citizen petition in its entirety, the FDA stated that it “takes this concern seriously” but that NRDCs petition “was not sufficient to persuade FDA, at this time, to initiate rulemaking to prohibit the use of BPA in human food and food packaging.” The FDA indicated that scientific studies done on the effects of BPA in small animals cannot be applied to humans. The FDA also indicated that the sample sizes for the studies used in support of the petition may not be large enough to draw conclusive results. However, FDA has emphasized that it will continue to examine the safety of BPA and expects to issue a new update on the safety issues surrounding BPA within the next year. According to FDAs denial, the agency “is performing, monitoring, and reviewing new studies and data as they become available.”
NRDC has not announced whether or not it will take further action. Fuerst Ittleman will continue to monitor this matter and further agency announcements related to the status of BPA. For more information about the regulation of food additives and food contact substances, please contact us at firstname.lastname@example.org or (305) 350-5690.