Our Stolen Futurea book by Theo Colborn, Dianne Dumanoski, and John Peterson Myers
 
 

 

 

California's legislature evaluates a bill that will protect infants' health ... and industry distorts the science.

The plastics industry is engaging in misrepresentations of current scientific understanding of the low-level effects of a molecule, bisphenol A, that is one of the biggest volume plastic materials in production in the world today. They have formed a lobbying coalition, NoAB319, to fight the bill, using misrepresentations of science to make their case.

In a nutshell, this is what they are doing:

They ignore all but a handful of scientific studies that have been done on bisphenol A, and focus their attention on one study, published in 1997, that was the first to test for low level effects of BPA. Over 100 studies by independent laboratories have been published since then, confirming low-dose effects laboratory experiments within the range to which most Americans are exposed.

Since that 1997 publication, industry has conducted several attempts to replicate that specific study and they have failed. They point to their failures as proof that the work can't be replicated. Yet it has been replicated by another independent laboratory, and the original lab has recently published an important extension of the original work. If you read industry's public statements, you would not know of these research findings.

Most important, the industry studies upon which they rest their case are clearly and fatally flawed in design and execution. Their failure to replicate is not proof of safety. Instead it is proof of incompetence, or fraud.

Once they conclude that the 1997 study is not valid, they use a 'safe level' estimate based on 1982 data to conclude that bisphenol A is safe at the levels that most people experience.

If the FDA and EPA were to accept the 1997 data, and the 100+ other studies that are consistent with it, the acceptable level of exposure to BPA would have to be reduced at least 2,000-fold. Many current uses would not be allowed.

The tactics being used to defend bisphenol A are similar to those used to defend tobacco.

 

During the 2006 legislative session, the California legislature is considering legislation, AB 319, to ban the use of phthalates and bisphenol A in products to be used by children under the age of 3.

 

Various polycarbonate bottles

A selection of bottles made out of polycarbonate

 

In addition, the bill would require manufacturers to use the least toxic alternative when replacing bisphenol-A and phthalates in their products and would prohibit manufacturers from replacing bisphenol-A and phthalates with certain carcinogens and reproductive toxicants.

A hearing of scientific witnesses is scheduled for 10 January 2006 in the Capitol.

 

Bisphenol A, used to make polycarbonate plastic and also to make resins that are used to line metal food cans and coat children's teeth, is strongly linked by laboratory studies to a wide range of adverse effects. These effects occur at levels to which most Americans are exposed. The effects include impaired reproductive function, altered reproductive tract development, altered behaviors, including elimination of male-female differences in some behaviors and reductions in maternal care, and causation of insulin resistance. More...

Phthalates are used as additives in many types of plastics and in cosmetics. Many animal experiments have clearly shown specific types of phthalates to be reproductive toxicants. Human studies now are finding similar effects in people, at levels that have been measured in 25% of American women. More...

While there are many studies from animals, there are very few from people. To prove with scientific certainty that bisphenol A or phthalates cause specific illnesses in people is a very difficult scientific challenge (see panel to right).

With overwhelming data from animals, repeatedly confirming adverse effects, and with replacements available, it makes no sense to take risks with the impacts of exposure, especially as they include effects with life-long, debilitating impacts.

 

Why is this difficult to prove in people?
Think about how long it took to prove that tobacco causes lung cancer. Two things were going on. First, the science is hard to do because it takes a long time and there are many variables. Second, tobacco companies were aggressively trying to distort scientific results. The same things are happening here.

Because the major concerns about both these compounds are the effects of exposure in the fetus and infant on adult health, --impacts which are readily and repeatedly shown in animals, where experiments are possible-- it is actually much more difficult than with tobacco to reach scientific certainty about the effects on people. It will require multiple studies that have direct measurements of exposure during early develpoment and then track health of the exposed people all the way into adulthood. Studies like this are just beginning to be published.

Nonetheless, a coalition of chemical manufacturers and plastic product companies, each with large economic interests in preventing any constraint on their ability to use these chemicals, has come together to form a lobbying group, NoAB319. Their website, www.NoAB319.org, contains grotesque distortions of current scientific understanding of bisphenol A and phthalates.

Here is what they say on www.NoAB319.org (7 January 2006), compared to what science now shows.

Industry statement
Scientific reality

Industry myth: "BPA has been safely used for more than 50 years to make polycarbonate plastic and epoxy resins, which are used to make countless safe and reliable consumer products. Government bodies worldwide have reviewed the scientific evidence and each supports the conclusion that BPA does not pose a risk to human health, including the health of children. For example, the U.S. Food and Drug Administration recently stated “based on all the evidence available at this time, FDA sees no reason to change its long-held position that current uses with food are safe.”

 

Fact: Many studies by independent scientists find effects on animals. With people, however, very few studies have been done, not even for the impacts predicted by the animal studies (with some exceptions). Hence for NOAB319 to claim "countless safe products " is a profound misrepresentation. They confuse ignorance... we haven't tested... with safety. That is especially dangerous because many of the adverse effects caused in animals by these chemicals are or resemble conditions that have become much more common in people during the last 30 years, the decades during which both phthalates and bisphenol A have come into widespread use.

Reviews by the US government of the safety of bisphenol A were last conducted in 1988 (revised in 1993) based on data from the early 1980s. Almost all of the relevant animal studies have been published since 2000. Hence government reviews are grotesquely out of date and not reliable.

     
Industry myth: "The sum of weak evidence does not make strong evidence. The most definitive studies have found no effects from low levels of BPA and comprehensive reviews of all of the evidence by government and scientific bodies worldwide support the conclusion that BPA is not a risk to human health at the very low levels at which humans are exposed. Consistent with this, products made from polycarbonate plastic and epoxy resins have a long and safe history dating back more than 50 years."  

Fact: An overwhelming number of studies conducted by independent laboratories report harmful effects of BPA at levels of exposure within the range to which many people in the US are exposed today.

Of the few that don't find effects, most of the were funded by companies and trade associations with economic interests in the outcome of the studies. Careful analysis shows that these studies had fatal flaws that misled the researchers. These flaws have been confirmed by an analysis of the US government agency responsible for assessing toxic substances.

     
Industry Myth: "Not only does BPA have low toxicity, but only minute traces of it may be detected in consumer products. It simply is not possible to encounter BPA from normal use of polycarbonate products at a level that could cause harm. In addition, BPA is excreted rapidly from the body (within a day) and it doesn't build up in tissues. Government bodies worldwide have reached the conclusion that BPA is not a risk to humans at very low levels."  

Fact: In April 2005, researchers from the University of Texas Medical Center demolished the notion that bisphenol A has low toxicity. They showed that BPA was just as powerful as estrogen and the potent drug diethylstrilbestrol at causing calcium influx into cells and prolactin secretion, and that this activity took place at 0.23 parts per trillion BPA. Calcium influx is a physiological event in cells that triggers a wide range of gene cascades that are linked to health conditions in people. Data from the CDC show that 95% of Americans have BPA in their tissue at levels higher than required for this effect.

The scientific error industry is making here is that they continue to regard BPA as a 'traditional' toxic substance. BPA doesn't kill outright, it alters gene expression, at levels far beneath the levels it is toxic in the traditional sense. And by alterning gene expression, it changes the course of development.

And while it is true that BPA is excreted, because BPA is used so widely, exposure is constant.

     
Myth: Scientists from the United States, Europe and Japan all have concluded after studying the data on BPA that typical human exposure does not pose any detectable risk of harm. In fact, human exposure levels are typically more than one million times lower than levels shown to cause no adverse effects in experiments involving multiple generations of laboratory animals.   Fact: The vast majority of over 130 scientific studies that have been published about low dose effects of BPA conclude just the opposite. The vast majority of published papers examining low dose effects have shown adverse impacts at levels well within the range of exposures experienced by most Americans. More than 90% of academic/government studies of the impacts of low doses of BPA have found adverse effects. None of 11 industry-sponsored studies have found effects. Only industry-funded scientists, lawyers and lobbyists cite the 11 industry-funded studies as evidence that BPA is completely safe.
     
Myth: High-quality repeat studies in independent laboratories have not been able to replicate these claims from small-scale studies in one laboratory by a single researcher. The weight of scientific evidence demonstrates that low levels of BPA do not adversely affect human reproductive and developmental health.  

Fact: The 'high-quality' studies this refers to were demonstrably flawed. When the first of these was finally published in the peer-reviewed literature, it even hid from readers one of the features of the study's original design, which had been described in a press release by the Society of Plastics Industries.

The 'small-scale studies' have now been repeated, including by another laboratory, with the results confirmed. And the original lab has published a dramatic follow-up, showing the microanatomy of how BPA causes its effect.

Most important, the prostate result is one of many health endpoints affected by low doses of bisphenol A. By focusing on this one publication, they are ignoring over one hundred other studies that are consistent with the prostate work, including on mammary gland tumors, chromosome abnormalities, brain structure and behavior and insulin resistance.

For a detailed analysis of the serious flaws of industries' published studies, follow this link.

 

Note about noAB319's "press room" ...

As of 7 January 2006, their press room contains 3 opinion pieces written by people with long associations with various industry efforts to distort science. The most extreme, fact-free of these is an op-ed by Steve Milloy, whose roots have been traced by public health scholars at the University of California, San Francisco back to the tobacco industry (through internal memos of the Philip Morris Co).

For some reason they have chosen to ignore a wide array of news stories in the mainstream press, most notably the Wall Street Journal, which have dealt honestly and fully with the science of bisphenol A and phthalates.

The Wall Street Journal's series on 'Toxic traces' explored both the science and the politics of a series of compounds, including bisphenol A, phthalates and perchlorate. This series was especially valuable for the dispassionate care it applied to dissecting industry efforts to distort scientific understanding of the health effects of low level exposures.

Follow these links (updated daily) for additional mainstream coverage of:

Phthalates

Bisphenol A

 

 
   
   

 

 

 

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