From today's Washington Post:

The Food and Drug Administration ignored scientific evidence and used flawed methods when it determined that a chemical widely used in baby bottles and in the lining of cans is not harmful, a scientific advisory panel has found.

In a highly critical report to be released today, the panel of scientists from government and academia said the FDA did not take into consideration scores of studies that have linked bisphenol A (BPA) to prostate cancer, diabetes and other health problems in animals when it completed a draft risk assessment of the chemical last month. The panel said the FDA didn't use enough infant formula samples and didn't adequately account for variations among the samples.

Taking those studies into consideration, the panel concluded, the FDA's margin of safety is "inadequate." [Link]

Here are the key points from the report's summary, verbatim (emphasis mine):

• Bisphenol A is present in food contact applications resulting in dietary exposure of BPA to infants, children and adults. The Subcommittee agrees with the focus of the draft assessment on dietary exposures to children, because they are likely to have both greater exposures and susceptibility than adults as a function of food consumption patterns, metabolism, vulnerability of developing systems and other factors. Nevertheless, it is the opinion of the Subcommittee that the FDA assessment would be strengthened by considering cumulative exposures and differential risk in neonates.


• The draft FDA exposure assessment has important limitations including that it lacks an adequate number of infant formula samples and relies on mean values rather than accounting for the variability in samples.


• The draft FDA report does not articulate reasonable and appropriate scientific support for the criteria applied to select data for use in the assessment. Specifically, the Subcommittee does not agree that the large number of non-GLP studies should be excluded from use in the safety assessment.


• Consistent and credible criteria for study inclusion, recommended by the Subcommittee, would be to use those studies that are judged as “adequate” by CERHR in the FDA hazard, dose-response and safety assessment of BPA. In addition, 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 assessment.


• The Subcommittee finds that the assessment lacks an adequate characterization of uncertainties in its estimates of both exposure and effects.


• The weight-of-the-evidence, including studies identified by CERHR as adequate and having utility, provides scientific support for use of a point of departure substantially below (i.e., at least one or more orders of magnitude lower than) the 5 mg/kg bw/day level selected in the draft FDA assessment.


• Coupling together the available qualitative and quantitative information (including application of uncertainty factors) provides a sufficient scientific basis to conclude that the Margins of Safety defined by FDA as “adequate” are, in fact, inadequate.

The American Chemistry Council's Tiffany Harrington is also sounding more agreeable these days: "If the agency determines that existing margins of safety are insufficient in infant applications, our member companies that manufacture BPA will put processes in place to promptly phase out the use of materials containing BPA in baby bottles and infant formula packaging," she told the WP. In other words, if the FDA decides to enforce a partial ban on BPA, the chemical industry will actually comply with that ban, rather than staging a coup and declaring martial law. Good to know!

The Natural Resources Defense Council also commented on this report today, and they're spearheading a campaign to ban BPA from all food contact products, including food packaging. We reported on this effort last week.

Here's the full report. Clicking through to Scribd offers a bigger layout and sharing/embedding options - please pass this around!

Canada moved Saturday to formally ban BPA in infant bottles, after determining earlier this year that BPA should be classified as a toxic substance.

From the Toronto Globe & Mail:

None of the major infant formula makers has figured out a way to cut BPA seepage from their liquid formula cans, according to interviews with company officials, although the industry has begun working with can makers to review new packaging.

“We're looking at alternatives now and keeping [Health Canada] informed at every step of the way,” said Gail Wood, spokeswoman for Evansville, Ind.-based Mead Johnson, which sells several brands of infant formula in Canada. ... Ms. Wood said her company initially estimated that it would take five to seven years to find replacements, but she said “it's not going to be that long.”

Indeed. As the auto industry has so amply demonstrated over the last decade, industry reps are really not useful sources when it comes to discussing the level of hardship that might result from higher standards. We collected data on BPA in infant formula packaging last year, and as the inevitable shift occurs in Canada away from BPA-lined cans over the next few years it will be interesting to see if a company breaks out of the pack and begins distributing alternative cans in the U.S. too. With infant formula, a single brand breaking the silence on the issue could see a major market advantage before competitors were forced to fall in line.

We still see several questions for Canada, including:

• If BPA is banned in bottles, shouldn't it be banned in pacifiers and infant teethers, too?


• If BPA is banned in liquid formula cans, shouldn't it be banned in glass jars of semi-liquid baby food with lids coated with the same BPA-containing epoxy? It's in all of them. And are the BPA-containing lids of cardboard containers really acceptable, or should we go ahead and get those changed, too?


• If the period of primary concern is "up to 18 months," shouldn't this include sippy cups instead of just bottles? And what about exposure levels for pregnant women? Could warnings be an intermediate step for adult items?

We'll see over the next two months just how the ban shapes up, as the government writes the regulations and works towards finalizing them. The most interesting part of this story may then be how much adults should be exposed to BPA. From the Mail:

While Health Canada has concluded the chemical isn't a hazard to adults, that position has been undermined by research issued after the government began its assessment.

A study in the influential Journal of the American Medical Association last month linked bisphenol A to heart disease, diabetes, and liver abnormalities in adults. Earlier this month, a study from the University of Cincinnati found that BPA interferes with chemotherapy used to treat breast cancer, raising the possibility the chemical undermines the efficacy of cancer-fighting drugs.