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FDA criticised over BPA assessment

By Jane Byrne , 03-Nov-2008

An advisory board to the US Food and Drug Administration (FDA) said that the agency ignored evidence that suggested bisphenol A (BPA) in baby bottles and formula cans could be damaging to children.

BPA is a chemical used in certain packaging materials such as polycarbonates for water bottles, drinks and baby food bottles. It is also used in epoxy resins for internal protective linings for canned goods and metal lids.

Concerns have arisen over the chemical since it has been found to migrate in small amounts into foods and beverages stored in the materials and some recent animal studies have indicated that high levels of BPA could be carcinogenic.

The full Science Board, which is made up of independent experts and advises the FDA commissioner on scientific and technical matters, voted unanimously last Friday to approve the recommendations made earlier in the week by its BPA subcommittee.

The subcommittee concluded that the margins of safety in the FDA draft assessment on BPA in regard to the risks of infant exposure to the chemical were “inadequate.”

The FDA’s assessments of the food packaging component had “important limitations,” said the report.

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.

Call for inclusion of studies

The review group criticized the FDA for dismissing several government and academic studies in its draft assessment on the basis of their not meeting the standard of ‘good laboratory practices.’

The panel said that several studies of effects of BPA on adult humans and animal species that were published after the draft assessment was finished should be considered for inclusion in the final FDA assessment on the chemical.

The current margin of safety in the US for the chemical is 5 mg/kg, but the subcommittee recommended lowering that level by one order of magnitude.

FDA welcomes input

Andrew von Eschenbach, FDA commissioner of food and drugs, said that the Science Board’s view was not a rebuke of the agency’s position but rather an affirmation of the FDA’s process; a process, which he claims, aims to identify information that will better inform the agency’s regulatory decision making.

“FDA asked for this report, asked for this critical analysis, and we will continue to do so. Input such as this, as well as information from a variety of sources like analyses conducted by other regulatory agencies, will be incorporated into our regulatory decision-making,” added Eschenbach.

Last week, the American Chemistry Council (ACC) said that it 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.