Update: 11/07 California recently passed a bill on phthalates, sponsored by Fiona Ma. Acronym Required has written a update on San Francisco's efforts to pass a phthalates bill called "Phthalates and Bisphenol A: Media and Politics"
Assembly Bill 319 Dies in Appropriations
The California Assembly Bill 319, sponsored by Wilma Chan, D-Oakland, would have banned some products intended for children under 3 years old that contained bisphenol A and some phthalates; di(2-ethylhexyl) phthalate (DEHP), dibutyl (DBP), and butylbenzyl (BBP). The bill was defeated yesterday by the appropriations committee. The bill addressed the use of the environmental endocrine disrupters bisphenol A and phthalates in products for young children: "toys, pacifiers, baby bottles and teethers".
AB 319 sought to limit some transitional phthalates that have been shown to be especially deleterious to normal development, especially sexual development. The chemicals are used primarily to make brittle plastic softer, pliable, and more suitable for uses like toys and medical equipment. The fact that these chemicals cause developmental changes is proven by research, including some done by ExonMobil Biomedical and the American Chemical Council's (ACC) studies for the EPA, although much of
the industry sponsored research counters alarming academic findings or supports the idea that BPA in low doses is insignificant to humans.
Bisphenol A is used in a wide variety of products. In 2003 about 6.3 billion pounds of bisphenol A was incorporated into products like tooth sealants, water bottles, glasses and plastic liners for cans.
It is now widely recognized that BPA can leach out of plastic during normal use and cause physiological changes. The most compelling evidence against bisphenol A shows deleterious estrogenic affects in the offspring of pregnant mice, for instance enlarged prostates, genital deformities and disrupted puberty. In addition, there are increased cancer rates in certain organs and cell lines, pancreatic changes that promote insulin resistance, pubescent mammary gland developmental changes, and altered to thyroid regulation.
A serendipitous finding in 2003 showed that bisphenol A can disrupt meiosis. Researchers at Case Western Reserve University were studying meiosis in mice that were housed in polycarbonate cages. The cages had mistakenly been cleaned with a highly alkaline detergent by some wayward lab denizen whereupon the polycarbonate cages began to melt. The scientists then observed that the chromosomes in 40% of the eggs were abnormal, a defect rate far and above the usual 2%. Because of this observation, the scientists designed experiments and found that the relatively unstable chemical bisphenol A was leaching out of the melted plastic and disrupting meiosis. Other scientists observed similar results in experiments when labware containing certain phenols was introduced.
The Campaign
Acronym Required wrote an article on bisphenol A last year called "Plastic Bottles- Protecting Your Baby, by the ACC." The article provides some background information on low level endocrine disruptors and on the advertising approaches of the chemical industry to counter health safety concerns about their products. For instance on www.babybottle.org, the American Chemistry Council [10/31/07 this site is now run by the Juvenile Products Manufacturers Association], has a section called "Ask The Doctor", in which they pose questions and answers that parents might have about plastic baby bottles that contain bisphenol A:
"you may hear stories that glass bottles get too hot or plastic bottles leak dangerous amounts of harmful chemicals into the formula. Rest assured, there are no facts to support these claims."
This fictional answer to a hypothetical question by the hypothetical doctor seeks to quash research results coming from labs around the world showing detrimental effects from bisphenol A. [Update: October 31, 2007): The site http://www.babybottle.org, which used to be sponsored by the The American Chemical Council, as described below, is now sponsored by the Juvenile Products Manufacturers Association, a collection of manufactures who lobby extensively along the same lines as the ACC. The site is no longer "garish pink and blue", as I wrote a couple of years ago, it's light green, pink and blue. In lieu of "Ask the Pediatrician", they have "Ask the Expert", and give the name and photo of an Ob/Gyn (not a pediatrician -- but still, she's taken the Hippocratic Oath, can understand science, but lobbies on behalf of manufacturers of plastic products, given 150 studies about the dangers of bisphenol A? Would you trust this person?]. She does not warn that your baby may "drop or throw" a glass bottle and endanger itself. Instead she says that "as a mother...[she] believe[s] mothers have more important things to worry about." She posts the same message (parents have other things to worry about) on numerous blogs. So from JPMA, the same message --buy plastic, it's safe, and the same affiliates; bisphenol and phthalate manufacturers, the American Chemical Association, stats.org-- with a more subtle, tasteful packaging]
A research group at the University of Missouri group has done a lot of the work with bisphenol A (BPA), and provides a list of 153 studies done with low-dose BPA. Of the 153 low dose studies, 128 studies funded by government showed effects of bisphenol A and 11 did not. The chemical corporations also funded studies. 12 of their studies did not show any effect, 0 did. The author provides additional reasons why some of these studies may have shown no result.
We are familiar with this framework of engagement around health and science issues; create controversy about scientific research and hope that in the fray, your customers just shake their heads confusedly and continue their familiar buying habits, lulled by the sounds of soothing advertising. This controversy has the familiar tone of asbestos, tobacco, flame retardants and fossil fuel products, it also has some interesting unique features.
Of course one expects no less then ferocious opposition from and industry confronted with public health concerns about its products. We expect the industries (chemical and plastic in this case) to do their own research that proves the safety of their products and at the same time vehemently discount studies that happen to show detrimental effects of their chemicals. The chemical and plastics industries do not disappoint, especially when it comes to BPA.
An editorial in the San Francisco Chronicle authored by Lorenz Rhomberg, a former professor who is now a consultant to the American Plastics Council, gives us the opportunity to illustrate the point. The author blazes away at proposed bill AB 319 and the science behind it with a fusillade of adjectives and adverbs:
The bill is "bad public policy", that "triggers needless fear in parents...", "crusad[es] against the illusion of harm", "preys upon parents' legitimate concern[s]", and "raises needless fears". "In truth", he says, the bill "might harm health".
Industries tout the safety of their products and sometimes contort the evidence to suggest that if consumers don't use their products they're being irresponsible. On the other side of the bay, in response to an article in the Oakland Tribune about the AB 319, Steven Hentges, the Director of the Polycarbonate Business Unit of the American Plastics Council wrote in a letter to the editor:
"Instead of improving the health of children in California, AB 319 could eliminate many products that protect children's health now, including devices such as incubators, dialysis machines and blood oxygenators - as well as food from cans lined with a BPA-based resin to prevent contamination."
The American Plastics Council mounts an energetic and no holds barred deluge against the toxicity research. Rhomberg writes in the San Francisco Chronicle that the grounds for the bill are based on:
"a scientifically unorthodox hypothesis", an "unproven speculation", that "lack[s] scientific rigor" and "ignores sound science and years of research-based evidence". He reduces the science behind the bill to "insubstantial claims" and "unproven hypotheses".
In Oakland, the shouting points echo from the Oakland Tribune letter, in which Hentges states:
"AB 319..is based on insubstantial claims and unproven hypotheses that lack scientific rigor...on unproven and unsupported speculation built on fear not facts."
If it so happens that there are studies that show effects, which there are, Rhomberg dismisses them in his SF Chronicle letter as:
"studies of limited or no relevance", that have "weak and inconsistent evidence"; or that merely "purport" to show negative effects. The legislature, he says, has "no science based reason to consider AB 319."
He adds:
"government and scientific bodies worldwide have conducted comprehensive examinations of the evidence and nowhere -- not in Europe, Asia or the United States -- have products made from bisphenol-A been banned or restricted."
It's enough that it's not relevant, but the author also fails to mention that phthalates (including the 3 chemicals targeted by the
bill) are "banned or restricted by the European Union and at least 14 other nations" for childrens' products. Also several toy manufacturers voluntarily don't use phthalates -- since they are replaceable.
Hormone Disruption at Low Doses
The author of the San Francisco Chronicle editorial devotes so much space to his sputtering dismissals that the reader is left only to wonder what the "unorthodox hypothesis" is since he does not tell us. The theory he dismisses without identifying is based on a large collection of research that shows that certain chemicals, especially hormone effectors and estrogen mimicking compounds, effect physiology and development.
It's important to note that Rhomberg does not argue that phthalates and bisphenol-A are safe. While the Plastics and Chemical organizations push their products, they are not arguing that they are safe either. Rather they contend that the levels that are currently condoned by regulatory agencies are AS safe as people hope they are.
The Environmental Protection Agency (EPA) has toxicity research data from studies conducted in the early 1980's. The bisphenol-A experiments test a dose as low as 50mg/kg/day, as sketched out here on the EPA site. They determined a "lowest observable adverse affects level" (LOEAL), that in the case of bisphenol A happens to be the lowest dose they tested. They adjusted for an "uncertainty factor" of 1000 in a seemingly random way:
"The UF of 1000 includes 10 for uncertainty in the extrapolation of dose levels for animals to humans, 10 for uncertainty in the threshold for sensitive humans, and 10 for uncertainty in the effects of duration on toxicity when extrapolating for subchronic to chronic exposure".
In this way the "safe" dose was determined to be 50ug/kg/day. Researchers have since shown that at this dose there can be toxic affects. Low-dose chemicals became a concern in the mid- 1980's when scientists started noticing abnormalities in wildlife native to the Great Lakes region that corresponded with an increased volume of industrial pollutants. As research accumulated scientists observed that certain chemicals, especially phthalates, and estrogen mimicking chemicals acted potently as hormones and caused developmental aberrations at very small doses. As far back is 2000 Science journal reported that the NIEHS's National Toxicology Program had confirmed the low dose affects of bisphenol A based on their survey of 37 papers (October 2000 Vol. 290. no. 5492, pp. 695 - 697). At the time that panel was unclear as to the affects on human health. Then as of now, the concern about the low dose hormone disruptors is that regulatory agencies mandate a reference level for
bisphenol A and other chemicals that is not actually safe. Now though, as the plastics and chemistry industries continue devoting money and energy to dissuading us from looking at the research, more and more research shows negative health affects.
Low Dose Research Bodes Ill for Plastics?
The comments of plastics lobbyists ring false in the face of research. As well, since there are alternatives to bisphenol A (BPA) and phthalates that manufacturers can use to make plastic. So their reasoning that chemical and toy companies use that state economics would be harmed -- compared to the deleterious health effects on children, is unconvincing.
The chemical di(2-ethylhexyl)phthalate (DEHP) is used to soften plastic and make polyvinyl chloride (PVC) used for medical devices, toys, plumbing and other products. In 2002 the Food and Drug Administration (FDA) released a warning about the phthalate DEHP in PVC. DEHP can leach into the solutions and while adults are not immune from the hormone disruption of phthalates, children and babies, like neonates in intensive care, are
especially susceptible. Nevertheless, at a hearing last year about AB 319, one toxicologist for the American Toy Industry asserted:
"phthalates used in children's products are safe. It's not the kind of thing that should be legislated..." The real hazard, he continued; "is children putting toy parts in their mouths, falling down stairs or getting poisoned under the kitchen sink."
However there are DEHP alternatives. For PVC medical products, for instance Sustainable Hospitals and No Harm list medical products that are DEHP free. Similarly plastic toys and teethers are available that don't have phthalates.
But industries would rather argue senselessly, than change their manufacturing to spare babies of the effects of toxins. If the chemical companies would us alternative sources, this Toy industry toxicologist would be off the hook. He would be freed from the job of plying compelling testimony to captive legislators and writers on deadline. He could cease the hogwash about why we should let our children teeth on plastic toys containing phthalates -- because otherwise they will just as easily crawl under the kitchen sink and gulp down furniture polish.
Why are they making such a fuss over AB 319? If there are health issues as problematic as babies with structural abnormalities or increased cancer risk, why wouldn't a manufacturers switch out the suspected chemicals? Some companies go so far as to label products "phthalate free" that actually contain phthalates. Why?
One issue may be that if this bill had passed, it would put the science behind it more squarely in the public arena by acknowledging that the results low-dose toxins are a legitimate public policy concern. Since the bisphenol A data calls into question methodology data for determining safe levels of many chemicals, and especially those that are hormone effectors, questions may arise about many more chemicals that are currently thrown into our bodies and environment by the grace of outdated toxicity data.
What The American Plastics Council's Studies Show About Plastics
Rhomberg hones in on studies that show that bisphenol A is safe. He notes that "...an independent panel of scientific experts organized by the Harvard Center for Risk Analysis..." As it turns out he's an author of that study, which was funded (PDF) by the American Plastics Council.
That study reviewed the results of 19 studies published as of April 2002. The authors summarized their results in "Weight of The Evidence Evaluation of Low-Dose Reproductive and Developmental Effects of Bisphenol A". The study is quite selective since at that time there were closer to 40 studies showing effects from low dose bisphenol-A (F.S. vom Saall and C. Hughes: "An Extensive New Literature Concerning Low-Dose Effects of Bisphenol A Shows the Need for a New Risk Assessment"; Environmental Health Perspectives, Aug. 2005).
Their conclusions are largely based on the consistency of the data across studies. Many of the studies were done in mice or rats; the typical lab animal. But the HCRA study downplayed these studies because the species was not "closer to humans". They also downplayed results based on "what is known about the underlying biological basis for a toxic response in test animals and the biology of humans.". For instance they discounted ideas that it might not only act via the estrogen receptor, an idea that is now confirmed. In the end "...the panel found that there is no consistent affirmative evidence of low-dose BPA effects for any endpoint."
Obviously it's suspect that the long delayed study only surveyed a handful of available papers and parsed the studies to discount any positive result. Three of the original authors quit the group and the 4th left and wrote a review article arguing the findings of the group based on 115 studies. The results were initially more controversial then they are now. However now, as nine years ago, its still difficult for the casual observer to discern which results are real.
Teaching the Controversy
The controversy initially fell into two camps. Those who observed low-dose toxicity, especially the group at the University of Missouri who published the first low-dose bisphenol A study, and industry studies. Industry studies were published that panned the low-dose research. The low-dose research panned the industry research. The controversy quickly became esoteric and revolved around disputed methodologies for weighing fetal mice prostates, choices of animal strain used for research, type of feed and the phytoestrogen content of that feed, statistical analysis of the data, and positive controls.
For instance the National Toxicity Center criticized industry sponsored studies that used diethylstilbestrol DES as a positive control. In one study the positive control failed to show an estrogenic affect in the mice along with the BPA samples, but the authors still used the results to discount a previous study that showed an effect for BPA. Taking this result into account, future industry studies simply used no positive control -- which is not an science acceptable methodology.
This controversy is kept alive even as more data comes to light. A study published in November of 2005 by Proctor and Gamble does a statistical analysis of the first study published in 1997 and two opposing studies. But now there are literally thousands of studies that study bisphenol A and over one hundred dealing with low-dose exposures. The American Plastics Council seeks to convince us that all this research is faulty. Rhomberg calls the bill "unnecessary", "unsupportable" and "counterproductive". Hopefully, as more people become aware of the research, they'll recognize the false assurances for what they are.
The website of the University of Missouri authors' book summarizes the industry's arguments against the bisphenol A research here, with a table that compares the "industry statement" to the "scientific reality". Even with a nod to legitimate discrepancies, they have a point.
The dead bill was supported by organizations like the Sierra Club of California, Breast Cancer Fund, Clean Water Action, and California Safe Schools. It was opposed by organizations like Big Time Toys, California Grocers Association, Legoland California, Cap Candy and Funrise Toys. The legislator who wrote the bill expects that the issue will re-emerge.
-------New January 26th:
A reader says that there is a growing concern about bisphenol A in Israel. We found this news: On January 22nd the Health Ministry warned parents to throw away baby bottles that were over a year old or scratched, and to throw away plastic teething rings that were worn. According to the article the move was based on growing research about bisphenol A including a study from Japan showing that heating baby bottles releases BPA into formula.