April 3, 2012

NRDC BPA Citizen Petition Denied Following Suit to Obtain Timely Answer

by Brian Malkin

Bisphenol_A.pngOn March 30, FDA denied the Natural Resources Defense Council, Inc.'s ("NRDC's") Citizen Petition to remove the chemical bisphenol A ("BPA") from food packaging and other products where it comes in contact with food. NRDC said that BPA may be found in a wide variety of the liners of metal food cans and hard plastic containers such as baby bottles.

As we previously reported here, on August 19, 2011, NRDC sued FDA for declaratory and injunctive relief for FDA to grant the citizen petition and issue a regulation prohibiting the use of BPA in food packaging. NRDC's original Citizen Petition was filed in October 2008 yet remained unanswered by more than 1000 days, as of the complaint filing date. According to NRDC's complaint, FDA should have responded to its type of petition within 90 days and had a maximum time of 180 days to respond. NRDC had asserted that FDA's failure to respond to NRDC's Petition prolonged its members from unwanted exposure to BPA in food packaging. FDA's failure to respond to the Petition, NRDC further claimed, denied NRDC from seeking judicial review, if necessary.

NRDC's latest suit on this Petition resulted in a Consent Judgment, where FDA agreed to issue a final decision to NRDC's Citizen Petition "on or before March 31, 2012" as the "settlement of all claims that were asserted, or could have been asserted . . . related to the allegations in the Complaint." NRDC was also awarded $10,500 as "attorney feed and costs arising out of this Action" in a Stipulation and Order that followed the Consent Judgment.

FDA's denial acknowledged that FDA takes NRDC's "concern seriously" where FDA is "continuing to review scientific data concerning the safety of BPA, including its food contact issues, as such data becomes available." At this time, however, FDA determined that NRDC's Petition "failed to provide sufficient data and information to persuade FDA to initiate rulemaking under 21 U.S.C. § 348(d) and (i) and 21 CFR 171.130 to revoke regulations permitting the use of BPA in food contact materials." FDA also denied NRDC's request to list BPA as a substance prohibited from use in human food.

FDA reviewed the studies in NRDC's Petition as well as additional information that has become available since the Petition was filed. FDA determined that the studies cited in NRDC's Petition had "limitations in their utility for assessing safety and exposures to BPA," which it discussed in more detail in its denial. On the one hand, FDA agreed with NRDC that:

[M]ost infants, children and adults, are exposed to low levels of BPA through their diet. These low levels of dietary exposure are due to residual BPA that can migrate from certain food packaging materials or other food-contact articles into food, and then be consumed in the diet.

On the other hand, FDA noted that humans quickly and efficiently metabolized BPA to its inactive form BPA-monoglucuronide, which is then excreted:

Consequently, the amount of the active BPA circulating internally in humans and the degree to which various potential targets of any toxicity (e.g., cells and organs) are exposed is predicted to be significantly lower than the amount ingested, and even lower -- much lower -- than seen after a similar exposure by typical non-oral routes (e.g., subcutaneous injections) used in many animal studies, including many of the studies cited in your petition.

... The findings of these pharmacokinetic studies, together with the negative findings of other studies reviewed in FDA's ongoing evaluation of BPA, confirm that FDA's current safety assessment identifying a no-observed adverse effect level (NOAEL) of 5 mg/kg bw/day and use of a 1000 fold safety factor is an appropriate safety level relevant to human dietary exposures and public health.

Dr. Sarah Janssen, senior scientist in the public health program at NRDC had this to say following FDA's decision:

BPA is a toxic chemical that has no place in our food supply. We believe FDA made the wrong call.

The agency has failed to protect our health and safety ­- in the face of scientific studies that continue to raise disturbing questions about the long-term effects of BPA exposures, especially in fetuses, babies and young children.

The FDA is out-of-step with scientific and medical research. This illustrates the need for a major overhaul of how the government protects us against dangerous chemicals.

FDA said that it will continue to assess BPA through ongoing research in its own laboratories and evaluation of studies performed elsewhere and will continue to make its review of these studies public. Interesting to note, as we reported here, some countries have already decided to ban BPA despite the World Health Organization's ("WHO's") assessment that any BPA ban would be premature. In November 2010 the European Union decided to ban BPA in baby bottles, and Canada has added BPA to a list of toxic substances.