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FDA shifts bisphenol A position, backs food packing phase out

By Rory Harrington, 18-Jan-2010

Related topics: Safety & Regulation

The US FDA has admitted it has “some concerns” over the health risks from bisphenol A (BPA) as it backed efforts to phase out use of the chemical in food packaging and called for heightened regulatory scrutiny.

The Food and Drug Administration also said it was carrying out in-depth research in a bid to “answer key questions and clarify uncertainties about the risks of BPA”.

But the agency stressed these were preliminary steps and said it was important that “no harmful changes be made in food packaging or consumption that could jeopardise food safety...”. The agency unveiled its shift in position on the controversial chemical on Friday, some sevens months after announcing it would review its previous stance, reached in 2008, that the chemical posed no risk to human health.

The FDA said it backed guidelines issued by the US Department of Health and Human Services (HSS) on how parents could limit their children’s exposure to the chemical. BPA is a chemical used in the manufacture of polycarbonate baby bottles, sippy cups and in the epoxy resin liners of food cans.

But Bill Corr, of the HSS, said: "BPA has not been found or been proven to harm either children or adults but because children ... in the early stages of development are exposed to BPA the data that we're getting deserves a much closer look.”

FDA’s new position

The FDA said it was now concerned about the potential effects of BPA on the brain, behaviour and prostate glands in foetuses, infants and young children after evaluating the results of a number of recent studies. But the body added that “substantial uncertainties with respect to the overall interpretation of these studies and their potential implications for human health” meant more in-depth research was necessary.

In the meantime, the agency said it would support “reasonable steps” to cut human exposure, particularly of infants, to BPA in the food supply. It also backed industry efforts to stop production of BPA-containing infant bottles and cups in the US market – as it highlighted the availability of glass and polypropylene bottles and disposable plastic bag liners.

The FDA said it would help in the development of alternatives to BPA for the linings of infant formula cans and support attempts to replace or minimise BPA levels in other food can linings.

It vowed to work with manufacturers on the regulatory status and safety of BPA alternatives, as well as giving technical assistance on how to prepare applications. The agency also agreed to prioritise evaluation of these submissions.

“Because reliable can lining materials are a critical factor in ensuring the quality of heat processed liquid infant formula, safe replacement of such materials requires not only that they both be safe for food contact but also allow for processing that is fully functional in protecting the safety and quality of the infant formula itself”, said an FDA statement.

It cautioned consumers against no longer using infant formula or food as “the benefits of a stable source of good nutrition outweighs the potential risk of BPA exposure”. It added that infant formula, including that from packaged cans, is a “safe and acceptable alternative” to breast milk.

Regulatory framework limits FDA scrutiny

The agency declared that the current regulations governing BPA, issued more than 40 years ago, limits its “oversight and flexibility” of the substance. It said that once a food additive such as BPA is approved, any manufacturer of food packaging can use it in accordance with the regulation without having to tell the FDA. The agency said under the current laws, producers of the hundreds of different formulations for BPA epoxy linings have no obligation to disclose the “existence or nature of these formulations”. The process to stop use of any one of these is also difficult and time-consuming, it said.

It said that since 2000, it had regulated new food contact substances through the Food Contact Notification Program. Under this scheme, the FDA receives applications from each manufacturer which includes details such as substance quantities and proposed applications. The agency can then make a series of follow-up inquiries and require further information and studies before making a decision.

“Given concern about BPA, and the ongoing evaluation of studies on its safety, FDA believes that the more modern framework is more robust and appropriate for oversight of BPA than the current one,” said the FDA.

The agency called on manufacturers of BPA-containing food packaging to voluntarily submit their products currently on the market to the food contact notification procedure. Additional options to boost BPA regulation under the modern framework will also be explored, said the FDA, without giving details.

Next steps

A 60-day consultation exercise is to be launched as the FDA said it would open a “public docket” on the issue. The agency said it would also consult with expert bodies both in the US and abroad – including its regulatory counterparts in Europe and Canada.