The US Food and Drug Administration (FDA, Washington, DC; www.fda.gov) published its long-awaited latest review of bisphenol A (BPA) on 15 January – for previous coverage see Plasteurope.com of 08.12.2009. For the first time, it expressed “some concern” about the health effects of the chemical used in polycarbonate production and in epoxy resin can liners. While stopping short of mandating any immediate action, the agency said it may explore options to regulate BPA under its Food Contact Notification Program of 2000. Current food contact regulations for the substance date from the 1960s.

FDA pledged to support manufacturers of baby bottles and infant feeding cups in finding BPA-free materials and to facilitate the development of alternatives for lining of infant formula cans as well as minimising BPA levels in other food can linings. For the interim, it warned that “no harmful changes” be made in food packaging or consumption.

Defending its previous unequivocal stance that BPA is safe, FDA said studies employing standardised toxicity tests up to now “have supported the safety of current low levels of human exposure." However, recent studies using “novel approaches to test for subtle effects” suggest there is “some concern about the potential effects of BPA on the brain behaviour and prostate gland in fetuses, infants and young children.”

Under a US government stimulus package, the National Toxicology Program at the National Institutes of Health (NIH, www.nih.gov) is currently spending USD 30m on a test of lower exposure levels and how these influence behaviour, obesity, diabetes, reproductive disorders, asthma, cardiovascular diseases and various cancers – see Plasteurope.com of 13.11.2009. FDA’s National Center for Toxicological Research also is carrying out in-depth studies on the risks of BPA. Other studies are in progress worldwide. Canada has labelled the substance a “toxic compound.”

While supporting “a shift to a more robust regulatory framework,” FDA said it will also seek “further public comment and external input on the science surrounding BPA." To this end, it plans to open a public docket containing toxicity studies and “other relevant material.” For a period of 60 days, comment on these as well as “regulatory options” will be invited. At the same time, the agency pointed to “substantial uncertainties” in tests generally, that it said could lead the results to be over-interpreted.

Reaction to the FDA’s report was divided along the usual “battle lines.” The American Chemistry Council (ACC, www.americanchemistry.com) and PlasticsEurope (www.plasticseurope.org) in identical statements pointed out that while the agency did not say that exposure to BPA in food contact products has been proven harmful to children or adults, simply that more research is needed, they feared that “some of the recommendations are likely to worry consumers and are not well-founded.”

The US National Research Center for Women and Families said the FDA is putting the responsibility for avoiding exposure on families and not on companies that make or use BPA, and also urged that the safety focus not be limited to children. The newspaper “Milwaukee Journal Sentinel”, whose “Watchdog” column has been at the forefront of critical reporting on BPA, again claimed that the industry is influencing the FDA’s findings. Consumer Union, non-profit publisher of the magazine “Consumer Reports”, said it missed restrictions on the presence of BPA in baby bottles and guidance to pregnant women.