The FDA's internal Science Board agreed with an independent advisory panel that the agency was wrong to base its assessment of BPA - which it declared safe for use in food packaging, including canned and jarred foods and infant formulas - on two studies funded by the American Plastics Council, dismissing more than 200 independent studies that concluded that BPA could be harmful in extremely small doses. This means that the FDA will "reopen" its case and do another review.

From the New York Times:

The F.D.A.’s draft risk assessment in August, finding the chemical safe as it is now used, stood out against a tide of recent scientific opinion. The National Toxicology Program, part of the Department of Health and Human Services, has said there was reason to be concerned that BPA, as the chemical is called, could harm the brain, behavior and the prostate gland in fetuses, infants and children. Canada added the chemical to its list of toxic substances this year and has said it will ban BPA from polycarbonate baby bottles.

In September, a study published in the Journal of the American Medical Association found that adults with high levels of BPA in their urine were more prone to heart and liver disease and diabetes.

More than 200 animal studies have linked ingesting minute amounts of the substance to a range of reproductive problems, brain damage, immune deficiencies, metabolic abnormalities, and behavioral oddities like hyperactivity, learning deficits and reduced maternal willingness to nurse offspring. [Link]

We'll keep you posted on where this goes.

We haven't been on the best of terms with Alicia Voorhies since we reported on the presence of bisphenol-A in Sassy products many (including us) had previously reported as BPA-free. At the time, we thought it would be unfair to point out that these items were on sale at Alicia's "BPA-free" shop, The Soft Landing, although several of our readers did, with much frustration. Alicia responded to the issue by posting about the issue on her store's blog without crediting the source of the information. Fair enough, I suppose.

Today's missive from the Soft Landing, entitled "Nuby Responds to Incorrect Materials Listing In ZRecs Guide," finds Alicia in top form. In it, Alicia scoops the universe by revealing that the ZRecs Guide contained "incorrect" information about the status of Nuby pacifiers and teethers in regards to PVC (not phthalates).

Here's what actually happened:

• In April 2008, we asked a top-level executive at Nuby the following via email in response to a BPA product spreadsheet he sent us: "Thank you for the spreadsheet. Can you also identify which, if any, of these products have phthalates or PVC in them?" He responded that none of their products contained phthalates, and that they had been phthalate-free for some time.


• In June, we contacted the company's customer service department, asking them the following: "I'm interested in learning which of your products (bottles, feeding, teethers, toys, pacifiers) do not contain BPA, PVC and/or phthalates. Do you have a list?" We received a list of BPA-free products in response, which made no mention of phthalates or PVC.


• On October 2, 2008, we launched the ZRecs Guide, which included listings for Nuby's teethers and pacifiers, rated as possibly containing PVC (with a rating of "low" or "medium" confidence, depending on the product) along with the following statement in each listing's notes: "Nuby has not responded to a ZRecs request for information regarding PVC content in their teethers."


• On November 6, 2008, we wrote this representative back: "Do you have an updated list? We're trying to confirm the accuracy of the information in our ZRecs Guide for Safer Children's Products. You can see the Nuby/Luv 'n Care listing here [link to all Nuby listings inserted]. Thanks for any help you can give in distributing accurate information to our readers." We received a new list, again lacking any PVC or phthalates information.


• Today, the top-level Nuby executive contacted us to inform us that a customer had alerted him to the statements, and told us that all Nuby products are PVC-free.

Jenni then spoke to the Nuby executive on the phone and explained how the ZRecs Guide works - that we categorize products based on chemicals they may contain, with our relative level of confidence displayed prominently in the listings; that we work from the information we are provided with, which we work very hard to get; and that we track more than 1,000 products by around 150 companies, so asking for the same information on three different occasions was about our limit. We explained that companies often avoid answering our direct questions, sometimes quite ingeniously, and that in the absence of clear company statements we err on the side of caution in our ratings to help parents avoid products that may contain chemicals.

In other words, there was nothing "incorrect" about the statements we had made - we had asked, repeatedly, for information, and in its absence we felt it our duty to warn consumers that the products might contain a substance some (but not all) wish to avoid, allowing them to make informed decisions based on the best information we could get.

The executive explained that he had never heard of PVC (rather than phthalates specifically) being a concern among parents, so he had thought that stating that their products were phthalate-free was "the same as" saying they were PVC-free. Jenni explained that PVC can in fact be made without phthalates, and discussed some of our readers' concerns about the environmental impact of PVC with him.

The conversation ended amicably, with us agreeing to update the information this weekend and with the executive welcoming us to call on him again when we next update our Nuby product information. He also stated that he or one of his representatives would now look through the Guide and let us know if there was any other information in need of updating, as Nuby's extensive product line can be confusing.

We will continue to update and enhance the ZRecs Guide in good faith and with malice towards none. If you prefer Alicia's style, you can find her blog here.

I mentioned something in passing in our plastics conference call yesterday that I figured I'd better follow up on.

At ZRecs we have always maintained - both to concerned consumers and to companies making unsubstantiated claims about the safety of their products - that our goal as consumers and as a society should be to reduce our overall exposure levels to many chemicals, knowing that we will never completely eliminate them, at least not within our lifetimes. The production, use, and waste cycle of these products ensures that chemicals like these are present not only in a huge array of products, but in our environment as well. It is quite likely, for example, that there is some (very small) amount of BPA in your tap water.

Another example, and one most people aren't yet aware of, is paper products. The one I mentioned specifically on the call was toilet paper.

As it turns out (post-call research on my part) the source of BPA in toilet paper appears not to be that it is added deliberately to the product, but that a lot of toilet paper is made from post-consumer sources that include lots of recycled thermal printing paper (credit card receipts). Dresden University did a study examining BPA turning up in wastewater streams and traced it back to toilet paper as the culprit. We first learned about this study here and here.

Environmental regulators consider sources like this disconcerting because endocrine-disrupting chemicals like BPA and phthalates can wreak havoc on marine ecosystems. Ultimately, it's sources like these that are the reason you probably have BPA (at extremely low concentrations) in your tap water, too.

The same thing goes for other kinds of recycled paper, too. When we add up all of the sources we now know of, BPA can be found at smaller levels, and less clear exposure levels, than the children's products we have been talking about for some time. These products include:

• Credit card receipts


• Recycled cardboard pizza boxes and paper


• Beer and wine (vats are lined with a BPA-containing resin)


• Rubbermaid polycarbonate-lined baking tins used by Subway


• Soda cans and food cans


• Baby food jars (lids) and formula packaging (metal cans, glass jar lids, and paper packaging foil seals)


• Many non-polycarbonate plastics (including the color-changing plastics used by Sassy and others), in addition to PC

Consumer advocates and reporters like us often avoid raising topics like this for a few, closely-related reasons:

1. Consumers often have difficulty managing their feelings about a given chemical, and think in terms of eliminating individual ones rather than chipping away at the overall chemical load of known harmful substances.


2. We believe not all sources are created equal. BPA is found in many of these products at extremely low levels. Most of these also expose us to BPA in far less obvious ways, if at all, and more research is needed on the dose/effect relationship of different levels of BPA and other endocrine disruptors.


3. We don't want people to feel powerless, or like the changes they make don't make a difference, because, to the best of our understanding of an emerging area of scientific scrutiny, they do make a big difference.

That said, we consider toilet paper to be a specific source of concern, for reasons a polite blogger should probably avoid getting into. Suffice to say that exposure is certain and frequent.

I also mentioned on the call that I don't believe there is currently enough scientific data to warrant fears about melamine tableware, or about chemicals leaching from #1, #2, and #5 plastics. A few isolated studies and alerts have come out on each of these but we believe a lot more rigorous data collection is needed before calling for any changes to regulation or to consumer habits. We may post more specifically about this if there is interest, or wait until we see more data and do so then.

I also discussed how our ability to test for these chemicals at lower and lower levels is steadily advancing, and that the scientific and regulatory community is going to face some challenging questions regarding what constitute acceptable levels of different chemicals. We'll write about that again in a future post.

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!