The Natural Resources Defense Council brought suit last week against the FDA for allegedly failing to take timely action in response to its petition asking the agency to ban the chemical bisphenol A. NRDC v. Sebelius, D.C. Cir., No. 10-1142 (filed 6/29/2010).
NRDC is one of a number of advocacy groups who allege that this important chemical, used to make polycarbonate plastics in water bottles and epoxy resins used to line cans containing food, causes harmful health effects, particularly to infants and children, including early puberty, reproductive abnormalities.
However, both the scientific process and the public interest are better served by allowing the FDA to complete its ongoing review of the science surrounding the safety profile of BPA — at its own pace. Just this January, the U.S. Department of Health and Human Services and the FDA made it clear that BPA has not been proven to harm children or adults. EPA released its bisphenol A Action Plan in March 2010. Importantly, the agency clearly indicated that it does not intend to initiate regulatory action under TSCA at this time on the basis of human health concerns.
This observation is consistent with a draft assessment issued by FDA in 2008, and the scientific conclusions of many other government regulatory agencies around the world. In January 2010, the German Federal Institute for Risk Assessment (BfR, Bundesinstitut für Risikobewertung) wrote, “Following careful examination of all studies, in particular the studies in the low dose range of bisphenol A, BfR comes to the conclusion in its scientific assessment that the normal use of polycarbonate bottles does not lead to a health risk from bisphenol A for infants and small children. BfR is not alone in this assessment. The European Food Safety Authority (EFSA) and the U.S. Food and Drugs Administration (FDA) share this opinion. Japan, which has conducted its own studies on bisphenol A, does not see any need for a ban either.”
In January 2010, FDA Deputy Josh Sharfstein was quoted as noting the FDA does support the use of baby bottles with BPA because the benefits of sound infant nutrition currently outweigh the known risks from BPA. Nevertheless, and perhaps not surprisingly, the California Assembly passed legislation last week to ban the use of bisphenol A in children’s food and drink containers beginning in 2012. The bill passed by a vote of 43-31 vote. The Toxics-Free Babies and Toddlers Act (S.B. 797) moves to the state Senate for approval, since the Senate initially passed a different version early last month.
The bill provides that if the state Department of Toxic Substances Control begins to regulate the chemical through its “green chemistry’’ initiative, S.B. 797 would be repealed. In the meantime, the law would would limit the level of BPA in baby bottles, toddlers’ cups, and food and drinking containers. Infant formula manufacturers would have until July, 2012, to stop using BPA in the coatings used to line their metal containers.