Bisphenol risks highlighted by FDA subcommittee

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By Michael Stones, 30-Oct-2008

Fresh doubts about the safety of bisphenol A, found in baby bottles and some food packaging, have been raised by the Science Board sub committee of the Food and Drug Administration (FDA).

A review described the FDA margins of safety with regard to the risks of infant exposure to bisphenol A as “inadequate.”

The committee’s report concluded: “Coupling together the available qualitative and quantitative information….provides a sufficient scientific basis to conclude that the Margins of Safety defined by FDA as adequate are, in fact, inadequate.”

“Important limitations”

The FDA’s assessments of BPA had “important limitations,” said the subcommittee’s report published this week and due to be considered by the agency on Friday 31 October.

The assessment procedure “…lacks an adequate number of infant formula samples and relies on mean values rather than accounting for the variability in samples,” it said. Also, the assessment would be strengthened by considering the effects of cumulative exposures and differential risks in infants.

Responding to the report, the agency acknowledged that it “…raises important questions regarding the draft safety assessment.” FDA also agreed that additional research would be valuable due to uncertainties raised in some studies relating to the potential effects of low dose exposure to bisphenol A.

The FDA is already moving forward with planned research to address the potential low dose effects of bisphenol A, and we will carefully evaluate the findings of these studies,” it said.

Polycarbonate plastic

But parents who, as a precaution, wish to use alternatives for their bottle-fed babies can use glass and other substitutes for polycarbonate plastic bottles, said the agency. They should avoid heating formula in polycarbonate plastic bottles; and consult their pediatrician about switching to powdered infant formula.

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Meanwhile, the Grocery Manufacturers Association defended the FDA’s assessment procedure. “While we are currently evaluating the subcommittee’s report, we are confident that the risk-analysis approach utilized by the FDA and a host of regulatory agencies around the world to evaluate the risk associated with BPA exposure is scientifically sound,” said Robert Brackett, Grocery Manufacturers Association’s senior vice president.

The sub committee is an advisory group only and its latest report is the first step in a multi-step review process, he added. “We support FDA’s advice to consumers that there is no need to change their purchasing or eating patterns and that food and beverages using packages that contain BPA are safe to consume.”

The American Chemistry Council said: “ACC and the companies that manufacture BPA are committed to protecting public health and safety, especially when it comes to children. We respect the FDA’s oversight and assessment process and the value of new data and scientific viewpoints.”

The council pledged to promptly phase out the use of materials containing BPA in baby bottles and infant formula packaging if FDA determines that current safety margins are insufficient for children.

It also urged the agency to complete its evaluation of the input from the science board and other sources as quickly as possible.



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