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With the European Union and a Slew of New Studies Reaffirming the Safety of BPA, At What Point Will the Science Prevail?

Posted: 10/13/10 02:36 PM ET

Maybe the journalism consensus has it wrong.

A few weeks ago, a story flashed across my computer screen about bisphenol A, the plastic additive better known by its initialism BPA. European food safety scientists had been asked on an emergency basis to look into a study that it caused brain damage in rodents, and they were releasing their findings. Scary stuff, I anticipated.

I've heard a lot of talk about BPA from my environmentalist friends and in the media, almost none of it good. It's used in all kinds of things: electronics, DVDs, car dashboards, eyeglass lenses and polycarbonate plastics, from microwavable containers to infant sippy cups. It's added to epoxy resins to create dental sealants and to line metal cans to prevent spoilage and botulism. For most of its uses, there are no known substitutes.

It's a hidden killer, my activist friends tell me. I Googled "BPA" and "dangerous" and got 273,000 hits. The Los Angeles Times, Consumer Reports, Fast Company and innumerable other information sources cite "hundreds" of studies claiming it wreaks havoc with our hormonal system, causing neurological problems and breast cancers, autism, diabetes, ATD...you name it, if it's a common disease it's mentioned in some report or another as linked to BPA.

Surfing the web, I found an incendiary quote from an animal neurobiologist named Frederick vom Saal at the University of Missouri, who appears to have staked his entire career on the premise that BPA is harmful to humans. "The science is clear and the findings are not just scary, they are horrific," he says. "When you feed a baby out of a clear, hard plastic bottle, it's like giving the baby a birth control pill." That's not the way scientists usually talk. I gaze at my daughter drinking a Gatorade, and the label gradually morphs into a skull and cross bones.

So, I was a little shocked when this article came across the transom. It noted that scientists with the European Commission had looked at more than 800 studies on BPA and came away unimpressed by the clamor to ban it. They concluded that the research to date has "many shortcomings" and is generally not relevant to human health. What about brain cancer, the subject of a BPA study released earlier this year, which created such a stir in the media? The EFSA concluded there is no "convincing evidence" of BPA's neurobehavioral toxicity.

At first, that didn't make sense. This is the E.U. Aren't regulators guided by the precautionary principle, the "better safe than sorry" standard that leads to restrictions of chemicals all the times when there is even just a hint of a potential threat, even absent evidence of actual danger?

A blogger for The Atlantic, a nutritionist and professor at New York University, Marion Nestle, who hates BPA from what I can see from her writing, apparently read the same story and came away unmoved and a little ticked that those pesky scientists and regulators were challenging the consensus that BPA is the 'world's most dangerous commonly encountered substance'. "Aren't you reassured by this (e.g. the EFSA exculpation of BPA)," she sneered.

It didn't seem from what she wrote that she had even read the EFSA report, but I guess she has a point. After all, haven't Canada, France and Denmark all banned BPA in products used by children? Yes, they all did. But something doesn't seem right here either. I looked into the Health Canada review first. The chief scientist, and head of the study, Mark Richardson, said BPA's impact was "so low as to be totally inconsequential." He compared its estrogenic effects to tofu. It turns out that dozens of natural substances known as phytoestrogens, including soy products, nuts, seeds, berries, bourbon and even beer have the same effects on the human endocrine system as does BPA, and often with higher levels of exposure. (Uh oh, I hope no one recommends banning beer.)

All hell broke loose after Richardson made those comments. The Toronto Globe and Mail and some environmental NGOs helped fuel an attack on his independence and got him reassigned, even though he had no industry connections and has an impressive CV. A month later, the Health Canada report came out, sans Richardson, but it repeated all his key conclusions, albeit in less colorful language. It concluded: "Bisphenol A does not pose a risk to the general population, including adults, teenagers and children."

If there is no risk, why were restrictions slapped on infant baby bottles? Canada has the precautionary principle in effect, and its version of it requires regulators to issue restrictions even without evidence that kids are in danger. "[D]ecisions have to be made to meet society's expectations," Health Canada writes.

I'm getting a little nervous about this 'fulfilling societal expectations' thing. On the 100th anniversary of Darwin's birthday last summer, a Gallup poll showed that less than 40 percent of Americans believe in evolution. I look over at my daughter again, imagining her, in this brave new world where societies expectations about science are fulfilled, designing a diorama about evolution for science class, with Adam and Eve staring down a tyrex and a pack of velociraptors. And she'd get an "A." Maybe we should think twice about subjecting science issues to a popular vote.

What about France and Denmark? Here's where my daughter really came in handy; she speaks French. She translated some stories for me that we found on the web. Apparently, French scientists were (and are) steadfast against a ban voted into place by the French Parliament. "Canadian authorities banned BPA under public pressure and without any serious scientific study," said Minister of Health Roselyne Bachelot during an inquiry at the National Assembly. "The precautionary principle is a principle of reason and under no circumstances a principle of emotion," Bachelot concluded, noting, "It applies when there are no reliable studies. Here, there are reliable studies, which conclude, with current scientific data, that baby bottles containing this chemical compound are innocuous."

So French politicians did what politicians do in such situations and capitulated to outraged NGOs to 'fulfill societal expectations' by banning BPA in kids products, ignoring its own scientists' recommendations. Denmark restricted it too, reacting to a study published earlier this year that linked BPA to neurobiological problems in rodents. Those are the findings that prompted the E.U. to take up the issue again this summer in an emergency review. They assessed the new data and concluded -- how do I put this diplomatically -- that the study was lame.

What do U.S. authorities say about BPA? I consulted my consumer activist friends again. They're disconsolate. Last February, the Food and Drug Administration reviewed the data for the second time in two years. Everyone expected the agency to ban it, but it didn't change a thing, just ordered up more expensive studies, authorizing $30 million in stimulus funds. When asked directly if adults or children faced any genuine health dangers, Joshua Sharfstein, M.D., the FDA's principal deputy commissioner, minced no words: "If we thought it was unsafe, we would be taking strong regulatory action."

Although the FDA again refused to recommend that BPA be restricted, I've been told on the hush that the situation might change soon. The Obama inner circle hasn't yet been able to wrest control of the agency from all those career scientists, who apparently are in hock to industry. A few Congress people have proposed sidestepping the science to do what they think society apparently wants, which according to some NGOs is to ban that terrible chemical. They call their bill, "The BPA-Free Kids Act." Catchy and smart linking it to children.

I thought about what I had been finding, and was perplexed. Maybe all these scientists in the U.S. and Canada and Europe that have reviewed more than 800 studies and have concluded that BPA is safe are in the pay of industry? I read an article on this debate on the venerable Huffington Post by David Ropeik, a journalist who lectures at Harvard on risk issues. That's what he believes. In a recent post, he made it sound like this issue is a shoot out between what he called "industry experts [who] seem sure it is [safe], and environmental health experts [who] seem pretty sure it's not."

But that can't be right. If that were true, then every independent science advisory board in every major industrial country would be on the take. Yet not one has recommended that it be banned. The scientists (as distinguished from political boards) reviewing the BPA studies in North America, Europe, Australia, New Zealand and many countries in Asia have all concluded it's safe as used.

It seems that most scientists, at least among toxicologists, believe there's not much there there. A survey of 937 toxicologists by the non-partisan watchdog group STATS at George Mason University found only 9 percent rated BPA as a serious health risk, about one-third the number who thought sunlight was a danger.

The Milwaukee Journal Sentinel, which has won a bushel of awards for its reporting on BPA bestowed on it by organizations run by fellow journalists who have also written critically about BPA using the same sources that independent science boards find wanting, criticized the study, claiming that toxicologists were the wrong ones to talk to. Toxicologists generally embrace the maxim of the Renaissance scientist Paracelsus usually written as "the dose makes the poison." As a group, they're likely to be highly suspicious of the central claim of BPA ban proponents who endorse what the FDA calls the "novel hypothesis"-- that low doses of BPA can have more effect on the human endocrine system than high doses.

It's a controversial notion, but it's not without some possible validity We just need to figure out, using empirical and replicatable science, what those effects might be--in humans. The hypothesis does have some traction among some endocrinologists as well as some geneticists studying how hormone mediators, like BPA or soy or beer, can effect gene expression -- what's called an epigenetic effect. Of those who consider the notion plausible, I have found none, outside of vom Saal and a literal handful of others, who believe with real confidence that BPA is harmful to humans. Mostly they just have worries based on crude, small scale, rodent studies

To get to the bottom of this, I began reading over some of the hundreds of studies published over the past decade on BPA. They break down into two major categories that I think helps explain why the controversy is so contentious, even among scientists, and why journalists keep misreporting this issue.

On the one side you have university researchers who are hypothesis-driven: academicians who have organized studies asking targeted questions designed to challenge existing paradigms -- in this case, the belief that BPA is safe at very low exposure levels. Because it's easier and less costly, they almost administer BPA by injection directly into a rodent's gut, which is not the way humans ingest it, I'm fairly certain.


 
 
 

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tomteboda
03:27 AM on 10/15/2010
Thank you, Jon Entine, for this very comprehensive and clear summary of the state of research and reporting on BPA. As a chemist, I have been astounded to watch the great to-do made by the media over this in the face of hundreds of studies showing no harm at low doses and normal administration. I believe the true story to the excitement lies in a handful of environmental policy activists who would like nothing more than to see all types of polymers banned as "unnatural", an obsession that borders on a religion with them.

The American Chemical Society, made of chemists in academics, industry and government, has stated officially that there is no credible evidence that BPA is anything other than safe as it is used, and that the public health and economic risks to banning this product are considerable. BPA is the primary reason botulism is nearly unheard of these days.

Thank you again.
11:47 AM on 10/15/2010
The National Toxicology Program (NTP), an interagency program of the Department of Health and Human Services disagrees with you. Their review and conclusions in 2007 state that there is "some concern" about exposure to BPA, even at very low doses. The animal studies, while not conclusive, point to a number of problems at dosages similar to human exposure.

I'm not chemist, but I'm a parent. As I'm responsible for my children, I have to do what is in their best interest. It has nothing to do with activists, or a "green" religion.

It seems prudent to take the public health warnings seriously as there is a long history of industry and government acting slowly to remove dangerous products from the marketplace. DDT, mercury and lead were considered safe to handle not too long ago. Given the risks to reproductive health and a list of other possible impacts, I would rather be on the conservative side regarding exposure to BPA and phthalates. I'm glad that my representatives in the legislature are siding with me and taking a reasonable look at reducing our exposure to BPA.

Here is another good source of information about BPA studies:
http://www.niehs.nih.gov/news/media/questions/sya-bpa.cfm#ntp
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Jon Entine
12:51 PM on 10/15/2010
With all do respect, the NTP totally agrees with me. It's clear you're not familiar with NTP nomenclature or how risk assessment is done and haven't read the NTP report and the FDA report based on the NTP report. It declared that BPA posed "negligible" or "minimal" concern for most adults and "is not proven to harm children or adults." Although activist groups have charged that the FDA's evaluation protocol is inadequate or outdated, according to the report, "Studies employing standardized toxicity tests used globally for regulatory decision making thus far have supported the safety of current low levels of human exposure to BPA." The report said there was "some concern" "some concern" for pregnant women and infants but made it crystal clear that that "some concern" did not indicate that is was harmful, just that some "novel" studies on rodents indicated some problems. "Some concern" is NOT a danger sign according to the NTP or FDA--it means one thing: there is no danger, but let's keep researching. That's what scientists are doing....and EVERY robust study shows that it is not harmful. It's time to end this chemophobic hysteria. Let's focus energy and money on real problems and not continue to waste it on obsessions.
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oxjr
12:01 AM on 10/23/2010
Canada's decision was based upon the fact that BPA was discovered in 90% of the populations urine. That means it is not being broken down like it does in animal studies. That means there is a constant chronic exposure of a chemical that mimics estrogen. I know correlation doe not mean causation but with rising infertility rates, breast cancer rates, - especially in native groups who have even higher levels of BPA in their system - Canada chose to error on the side of caution. We can find a replacement that either doesn't stay in our system or is not bio-similar to a human hormone.
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Jon Entine
02:09 PM on 10/25/2010
Your post, and other posts, are not accurate..either about the politics or science. You have not read Health Canada's report. Its limited ban was required by law, because of PUBLIC CONCERN INDEPENDENT OF SCIENCE. Health Canada concluded BPA was not harmful. Here's what it wrote: "Our focus now is on the health of newborns and infants under 18 months. Science tells us that exposure levels are below those that could cause health effects. The current research tells us the general public need not be concerned. Bisphenol A does not pose a risk to the general population, including adults, teenagers and children. " Period. As for the suggestion that any decision was based on trace amounts found in urine (or blood as you state, erroneously, elsewhere) that's factually wrong....as is your claim that presence is urine demonstrates "chronic exposure." Time and again, the CDC has weighed in on this point, only to be ignored by the media. “In animal and human studies, bisphenol A is well absorbed orally,” the CDC notes (citing numerous studies) in its latest report on BPA, released in July 2010. “Finding a measurable amount of bisphenol A in the urine does not mean that the levels of bisphenol A cause an adverse health effect. … In humans, little free bisphenol A circulates after oral absorption due to the high degree of glucuronidation by the liver. The glucuronidated bisphenol A is excreted in the urine within 24 hours with no evidence of accumulation.”
11:54 PM on 10/14/2010
This article sure seems like an unwarranted pass for BPA.

It is foolish to say that if we don't exactly know the effects of a chemical, then it must be safe. Unfortunately, we don't know everything about BPA as a single chemical. More importantly, we don't know how it affects us in combination with other chemicals. The BPA animal studies have shown negative effects at low doses.

I agree with the precautionary principle. If there is evidence to suggest that it's harmful, but we're not completely sure how, I'm going to look at the "harmful" part very carefully. The chemical industry isn't going to look out for me, are they?

Minnesota banned BPA in baby bottles and sippy cups last year in the 2009 Toxic Free Kids Act. Other states and cities are following suit. That's sensible, isn't it? Keeping the most vulnerable more free from exposure, just in case? See more data of concern here:

http://www.healthylegacy.org/background_toxic_bisphenol.cfm
and
http://www.sph.emory.edu/PEHSU/html/exposures/endocrine.htm
01:29 AM on 10/15/2010
I agree with you about keeping BPA out of infant products for the time being. While there is no real evidence for toxicity in adults, the results seem to be more questionable when it comes to infants. In that regard, I'd say that a temporary ban is not unwarranted until we know more. If it eventually appears to be harmless, then oh well. And if not, then we've done the right thing.
10:01 AM on 10/14/2010
Bravo! Finally a common-sense article on BPA. More power to companies who see this as a brilliant marketing opportunity (I loves me my organic, fair-trade, cage-free, and now BPA-free water bottle!) but as far as a regulatory ban on BPA goes, there is no solid science to back it up.

I'm also not inherently opposed to a temporary precautionary ban, except that the idea there would be to then investigate further and see if the ban is really necessary. Anyone actually think a government would reconsider and revist a ban? Yeah, me neither.
10:24 AM on 10/14/2010
I'm sure the same thing was said of lead, way back ".....there is no solid science to back it up". I suggest you, and anyone else reading this post, read The Secret History Of Lead http://www.thenation.com/article/secret-history-lead. Toxins are toxins. They are not meant for human consumption. If corporations had this in mind when developing products, rather than profit (driven by greed), there would surely be a lot less grief in this world, and the planet would be far better off. I again congratulate the Canadian government for taking the lead on this.

...and BTW, why is the Can. govt. announcement not worthy of a headline at HP? The potential ramifications of a similar stance by the U.S. government could have far reaching implications. Come on HP. Take the lead here....
03:30 PM on 10/14/2010
I haven't had time to read the lead article, so I can't comment directly on that, but BPA was not initially put into plastics despite knowledge of its health effects. It has been used in consumer plastics since at least the 1960's and appeared to be safe. The corporations used it beacuse it was safe and effective. If research were to show it to be unsafe (in the concentrations and type of exposure normally experienced by humans) then by all means pull it, but this hasn't happened yet.
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oxjr
11:47 PM on 10/22/2010
the ban is based upon the fact that BPA was found in 90 percent of Canadians urine and that means we are not metabolizing it like we once thought and BPA is a bio-identical chemical that mimics estrogen in the body. While we may not know the effects of this newly discovered base-line of BPA we do know what the longterm effects of low level estrogen can be.
09:27 AM on 10/14/2010
Guess what?! It's Official: Canada Declares Bisphenol A Toxic.

“We believe that the current safety margin needs to be higher. We have concluded that it is better to be safe than sorry,” Mr. Clement told a news conference yesterday in Ottawa, announcing the decision as “precautionary action.”

BRAVO CANADA!!! To all who are concerned about their health, and the future health of their children, this is great news.

http://www.treehugger.com/files/2008/04/health-minister-canada-bans-bpa.php
03:43 AM on 10/14/2010
OK --I'm confused- as usual! Son just had a baby-to be cautious, no bottles made with BPA--everything else I am not going to worry to much.
I would,however, like to see a huge reduction in all plastic use.
01:28 AM on 10/14/2010
The evidence of human health risks from BPA is a bit on the weak side, but evidence of environmental impact is significant and confirmed.

BPA has a profound effect on the reproductive systems of fish and other aquatic animals in contaminated freshwater, and it interferes with the nitrogen fixation of an ecologically important bacterium which colonizes the root nodules of members of the alfalfa and clover families.

BPA should be regulated as an environmental pollutant rather than as a hazardous substance.
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06:20 AM on 10/14/2010
EPA has looked at that and just doesn't agree. It's weak to nonexistent. Check the studies. International agencies agree as well. The word "chemical" is not a dirty word. If a chemical proves to be a danger, then restrictions are appropriate. But fear alone is not a justification for regulating.
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oxjr
11:27 PM on 10/22/2010
Um I am not an expert but I think the reason Canada changed its policy on BPA had to do with the finding of BPA in the bloodstream of 90 percent of all Canadians - that is a scary number for what is very similar to an estrogen molecule. Native communities have disturbingly high levels of BPA (possibly due to the higher levels of processed food consumption). and growing infertility (yes I know co is not cause) My point is that BPA is not just entering my body and being metabolized - there is a constant baseline of this chemical in my body at all times.
I don't want man-boobs. If my canned pineapple is a bit tinny tasting while they figure this out - I am OK with that.
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Jon Entine
07:03 PM on 10/13/2010
Actually, I'm NOT paid by the American Enterprise Institute. I'm a visiting fellow. I get no money from AEI except for "piece work" on human genetics. Science literacy is my a passion, and II abhor the disinformation on this topic.

BTW, no scholar at AEI has his work reviewed before publication. I never have in 8 years of my affiliation. My work is available at my website www.jonentine.com. I am non-partisan (I'm a registered Democrat, voted for Obama, still support him). I've never met anyone from Exxon/Mobil or from the oil industry.

The French and Danish "governments" are not "outrage." Check articles. The bans in both cases were instituted legislatively over opposition byindependent science review boards. The EFSA--which is made up of scientists and not legislators--reviewed 800 studies, and the Stump study in particular. It's lousy science. Period. The EFSA has NO vested interested to reach that conclusion. The fact that the legislatures in two countries refuse to take heed of scientific studies is no different than President Bush ignoring the science on stem cells. It's anti-science.

As your using the techniques of the tobacco wars, you're correct, that's exactly what's happening...by those who want BPA banned absent what's even close to a scientific consensus. We can't let minority, anti-science views drive debate. That's creationism.
As a liberal Democrat, I abhor such irrationalism driving policy.
04:41 PM on 10/13/2010
Mr. Entine neglects to mention that he is paid by the American Enterprise Institute, a "think tank" that many say has been funded by the petrochemical industry, and whose other staff have been spinning against climate change science as well.

This is pertinent because Exxon Mobil, which has funded AEI, doesn't want to lose its market for cumene, a chemical used as feedstock for making BPA.

Entine also forgot to mention that the governments of France and Denmark were outraged by the EFSA announcement, and that the German government is warning consumers to avoid BPA.

The chemical industry has spent millions on spinning doubt in their messaging in response to the growing number of scientific studies linking harm from this synthetic sex hormone.

US food manufacturers have announced they are shifting as fast as they are able from BPA in their food can linings. BPA manufacturer Sunoco refuses to sell BPA to manufacturers whose products will expose children.

Mr. Entine is deploying the age old technique honed in the tobacco wars - cast doubt on the science and confuse people. Meanwile, as they delay the inevitable banning of this chemical, more and more people - especially children - are suffering from the health effects.