Bottled water information│BPA facts.

BY David Case | February 1, 2009 / Fast Company featured article.

The real story behind Bisphenol A

How a handful of consultants used Big Tobacco’s tactics to sow doubt about science and hold off regulation of BPA, a chemical in hundreds of products that could be harming an entire generation.

Surely you’ve heard about BPA by now. It’s everywhere. Some 7 billion pounds of it were produced in 2007. It’s in adhesives, dental fillings, and the linings of food and drink cans. It’s a building block for polycarbonate, a near-shatterproof plastic used in cell phones, computers, eyeglasses, drinking bottles, medical devices, and CDs and DVDs. It’s also in infant-formula cans and many clear plastic baby bottles. Studies have shown that it can leach into food and drink, especially when containers are heated or damaged. More than 90% of Americans have some in their bodies.

BPA is dangerous to human health. Or it is not. That’s according to two government reports in recent months that came to opposite conclusions. The National Toxicology Program (NTP), which is part of the National Institutes of Health, reported in September 2008 “some concern” that BPA harms the human brain and reproductive system, especially in babies and fetuses. Yet less than a month earlier, the U.S. Food and Drug Administration declared that “at current levels of exposure” BPA is safe. Even after the FDA’s own science board questioned the rigor of this analysis in late October, the agency didn’t change its position.

Let’s take a moment to ponder this absurd dichotomy. How could our nation’s health watchdogs reach such divergent conclusions? Are we being unnecessarily scared by the NTP? Or could the FDA be sugarcoating things? What exactly is going on?

We went on a journey to find out. What we learned was shocking. To some degree, the BPA controversy is a story about a scientific dispute. But even more, it’s about a battle to protect a multibillion-dollar market from regulation. In the United States, industrial chemicals are presumed safe until proven otherwise. As a result, the vast majority of the 80,000 chemicals registered to be used in products have never undergone a government safety review. Companies are left largely to police themselves.

Just five companies make BPA in the United States: Bayer, Dow, Hexion Specialty Chemicals, SABIC Innovative Plastics (formerly GE Plastics), and Sunoco. Together, they bring in more than $6 billion a year from the compound. Each of them referred questions about BPA’s safety to their Arlington, Virginia — based trade association, the American Chemistry Council. “Our view would be, Well, no, there isn’t anything to be concerned about,” says Steve Hentges, the council’s point person on BPA. “In a sense, you could have ‘some concern’ about just about anything.”

Of the more than 100 independently funded experiments on BPA, about 90% have found evidence of adverse health effects. On the other hand, every single industry-funded study ever conducted — 14 in all — has found no such effects.

It is the industry-funded studies that have held sway among regulators. This is thanks largely to a small group of “product defense” consultants — also funded by the chemical industry — who have worked to sow doubt about negative effects of BPA by using a playbook that borrows from the wars over tobacco, asbestos, and other public-health controversies. A secretive Beltway public-relations consultant. A government contractor funded by the industries it was hired to assess. A Harvard research center with a history of conflicts of interest. These have been the key actors in how the science of BPA has been interpreted by the government. And it is their work, as much as the science itself, that has stymied regulation.

Raging Hormones

There are a few facts about BPA that everyone agrees on. One is that people are constantly exposed to the compound. Babies — particularly those fed canned formula via polycarbonate bottles — are at the highest risk from BPA; their undeveloped digestive systems metabolize it poorly. It’s also undisputed that BPA mimics the female sex hormone estrogen, and that some synthetic estrogens can cause infertility and cancer.

What is in dispute is whether the tiny doses of BPA we’re exposed to are enough to trigger such hormonal effects. For decades, the assumption was that they didn’t. This was based on traditional toxicology, which holds that “the dose makes the poison.” In other words, a threshold exists below which a compound is harmless. This makes intuitive sense. Consider alcohol: The more you drink, the drunker you get; but if you drink just a little — below the threshold — you may not feel anything. In the 1970s and 1980s, government scientists used standard toxicology to test BPA. They concluded that, at doses far higher than those found in humans, it may cause organ failure, leukemia, and severe weight loss. Yet as BPA products have made their way into every part of our lives, biologists have discovered evidence that very low doses may have a completely different set of effects — on the endocrine system, which influences human development, metabolism, and behavior.

At first, these discoveries emerged by accident, when test tubes and petri dishes in laboratories were switched from glass to plastic. A group of Stanford researchers in 1993 found that breast-cancer cells it was studying reacted with a mysterious estrogen, which it traced to polycarbonate lab flasks. A few years later, Patricia Hunt, a geneticist at Case Western Reserve University, discovered abnormalities in the chromosomes of her lab mice. She eventually concluded that damaged polycarbonate cages were at fault.

In 1995, a developmental biologist named Frederick vom Saal stepped into the picture. A tenured professor at the University of Missouri — Columbia, with funding from the National Institutes of Health, vom Saal tested BPA to see how it interacted with samples of human blood. He found that, because it bypassed mechanisms that control the dose of hormones in the body, its estrogenic effects were magnified. “We said, ‘Wow, that’s bad. This stuff should be considered a lot more potent than it is,’ ” vom Saal recalls. He then fed small amounts of BPA — 25,000 times lower than the EPA’s toxic threshold — to pregnant mice. He discovered that the compound enlarged the prostates of the male offspring, signaling potentially serious developmental disorders. His study was published in 1997 in the peer-reviewed journal Environmental Health Perspectives.

In the years since, more than 100 experiments have shown BPA to cause permanent harm in lab animals at the low exposure levels found in humans. In 2000, Chandra Gupta, a biologist at the University of Pittsburgh, replicated vom Saal’s prostate study. Hunt, the geneticist, replicated under controlled conditions her findings of damage to mouse chromosomes. Others have found impacts on sperm production, testes development, and mammary-gland tissue, as well as behavioral disorders including hyperactivity, aggressiveness, and impaired learning. Most recently, scientists found a correlation (though it’s impossible to determine causation) between BPA levels and heart disease and diabetes in humans.

If these low-dose findings were counterintuitive to toxicologists, they made perfect sense to developmental biologists. After all, BPA is a synthetic hormone. Any physician knows that at small doses, most hormones are extremely powerful in stimulating their target organs, while at higher doses — above a certain threshold — they can paralyze these same organs. (Testosterone powers the male sex drive, for instance, but at high doses causes impotence.)

What’s more, BPA is hardly the only chemical to be identified as an “endocrine disrupter.” To date, more than 50 such compounds have been identified. Dioxins, PCBs, and DDT are some of the more infamous examples. Some cosmetics and soft plastic toys contain one or more phthalates — a group of chemicals that interfere with testosterone and have been shown to lead to infertility and cancer. But because BPA is used in so many common products and has shown effects at such low doses, Hunt says, it quickly became the “poster-child chemical for these endocrine disrupters.”

Rats in the Lab

As the evidence against BPA has mounted, some 29 studies have found the opposite: that the compound is safe. While these experiments have been fewer in number, many of them have the advantage of being far larger in sample size — and thus, their backers say, more statistically significant. Yet the largest of these studies also have another thing in common: They have been funded by BPA’s manufacturers. Sample size, of course, isn’t the only criterion for judging a study. There’s also methodology, lab procedures, and interpretation of data. And a close look at the big industry-funded studies indicates significant flaws.

One of the first such studies, paid for by the trade group Society of the Plastics Industry, was directed by Stuart Cagen of Shell Chemical Co.; another was conducted by John Ashby, at the AstraZeneca lab in the U.K. Both were attempts to replicate vom Saal’s experiment. Published in 1999, the Cagen and Ashby studies gave BPA a clean bill of health. Independent scientists, though, questioned the findings. In addition to testing BPA, Cagen and Ashby had tested the chemical DES as a “positive control” — a lab procedure to determine if a study is conducted properly. Although DES is known to harm mice, neither study found any effects from it. By the definition of a positive control, this indicates the experiments were flawed. (Cagen declined comment; Ashby has retired and could not be reached.)

The largest and most influential industry studies have been conducted by Rochelle Tyl of the Research Triangle Institute, a private lab in North Carolina. Tyl’s first BPA study, published in 2002 at a cost that Tyl puts at around $2 million (also funded by the Society of the Plastics Industry), examined three generations of rats and found no adverse effects at low doses. Yet here, too, there are questions of protocol. The study used a rat strain called the CD Sprague-Dawley, which has been shown to be insensitive to synthetic estrogens like BPA. (A Japanese study found that the CD Sprague-Dawley rat can withstand a dose of synthetic estrogen more than 100 times greater than what a female human can tolerate.) As of early 2007, of the 29 studies that have shown no harm due to BPA, 13 have used the CD Sprague-Dawley rat. Nonetheless, when the FDA declared BPA “safe” this fall, it relied almost exclusively on Tyl’s work — a shortcoming that the agency’s science board publicly criticized in October.

To address criticisms of her first study, Tyl recently completed a follow-up, this time with funding from the American Chemistry Council. “It doesn’t matter who pays for my studies,” says Tyl, who denies there has been any industry influence over her experiments. “It offends the living bejesus out of me, that I’m going to alter a study design or a result.” The follow-up used mice instead of the CD Sprague-Dawley rat and also found no adverse effects from low-dose BPA. However, the study’s details indicate that the mice were fed a type of animal chow that has been shown to mask the effects of estrogens like BPA. Moreover, according to Tyl’s own data, the prostates in both her experimental and her control mice were enormous, suggesting that her study had, in fact, shown effects from BPA, or that there were significant flaws in her team’s lab practices.

Harvard to the Rescue

With two pools of warring studies, BPA regulation has hinged on scientific reviews that assess and pass judgment on the overall body of research. In April 2001, a select group of scientists received a letter emblazoned with the Harvard University crest inviting them to sit on the first such BPA panel. The Harvard Center for Risk Analysis (HCRA), a program under the Harvard School of Public Health, would assume “much of the technical writing responsibilities,” the letter explained. In exchange for attending three two-day meetings and reviewing drafts of the panel’s report, the scientists would be paid $12,000 apiece plus expenses. The letter noted that the Society of the Plastics Industry had commissioned the study and that the panel’s deliberations would be private. The letter concluded, “I assure you it will be a stimulating and productive experience.”

“I said, ‘Great! This is a Harvard center. They’re obviously an honorable bunch,’ ” recalls one accomplished biologist on the panel, who spoke on condition of anonymity. What he didn’t know at the time, he says, was that the center has a history of conflicts of interest. Under founder John D. Graham, a Harvard professor and later administrator of the Office of Information and Regulatory Affairs in the George W. Bush White House, the center had solicited funding from companies whose business might be affected by its research. HCRA’s donors have included more than 100 corporations, including BPA producers Dow, Shell, and Germany-based BASF, as well as industry associations such as the American Chemistry Council.

“In the past, HCRA has acted very much like a product-defense group,” says David Michaels, a Clinton-era Energy Department official and author of the book Doubt Is Their Product. “In a 2000 study, paid for by AT&T Wireless, HCRA justified letting motorists talk on their cell phones by arguing that the added productivity outweighs the cost of accidents. Three years later, in a Harvard-funded study, the same researchers found that not to be true.” A more recent example: In 2005, the center published a study concluding that “government advisories on fish consumption and mercury may do more harm than good”; the lead researcher didn’t disclose that most of the study’s $500,000 in funding was underwritten by the United States Tuna Foundation.

Back in October 1991, in a letter to Philip Morris (obtained through the archives of tobacco-industry files released during litigation and maintained by the University of California, San Francisco), Graham demonstrated how HCRA could recast opposition to regulation as concern for the greater good. In the D.C. debate on fuel-efficiency standards, he noted, “We have urged consideration of the safety risks associated with smaller vehicles.” The letter concluded with an appeal for money and an offer of assistance. In an internal memo, a Philip Morris executive noted, “Depending on the ‘vibes’ you guys get when you meet Graham, I would also be in favor of PM becoming a contributor to the center.”

When it came to its BPA review, the Harvard center held several meetings of its panel between summer 2001 and 2002. But then the report languished for two years, during which time dozens of studies were released that strengthened the case against BPA, including a human study that linked the compound to ovarian cysts (a cause of infertility). None of those findings made it into the final report. Instead, the review, published in the journal Human and Ecological Risk Assessment in 2004, focused on Tyl’s research and a few other industry studies that downplayed BPA’s health concerns. The review concluded that there is “no consistent affirmative evidence of low-dose BPA effects.”

Several members of the 12-person panel didn’t feel comfortable with the conclusions. Four removed their names from the study. One of those scientists, Marvin Meistrich, says, “I disagreed with the way the final report was prepared.” After the panel’s last meeting, the Harvard center selected additional studies to include in its review — “ones that tended to demonstrate no effects,” says Meistrich. One panel member who did sign the report, Claude Hughes, turned around and less than a year later published a paper with vom Saal in Environmental Health Perspectives (the NIH’s premier journal) that refuted the Harvard center’s conclusions.

In the end, HCRA paid even the scientists who pulled their names from the review. The published paper’s acknowledgments thank them by name for their “helpful comments and guidance.” That, in itself, is a score for BPA’s defenders: These scientists have rare specialties that would be vitally important if BPA were to wind up in court. A judge could rule that they had a conflict of interest. “It’s fairly commonplace for companies facing tort suits to corner the market on experts, making it more difficult for the plaintiff to hire witnesses,” says Peter Nordberg, a toxic-tort lawyer at Berger & Montague in Philadelphia.

Through a spokesperson, George Gray, the acting director of the Harvard center at the time, declined to comment on the study. (Shortly after the HCRA review appeared, President George W. Bush appointed him assistant administrator of the EPA.) For its part, the Harvard School of Public Health distances itself from the center’s controversial past. “HCRA is a much different place since John Graham left [in 2001],” says assistant dean Robin Herman. Graham says that industry-funded studies at the center have always been subject to “rigorous quality-control procedures.”

You might expect that a compromised review like this would wither away. Yet the opposite is true. The plastics industry still uses it as evidence that BPA is safe. Journalists and consumers who visit bisphenol-a.org, a site created by the American Chemistry Council, can see that none other than Harvard University has weighed in and pronounced BPA harmless.

For a Few Dollars More

In December 2005, another review of BPA began, this one spurred by the federal government, not industry. The National Institutes of Health had started the Center for the Evaluation of Risks to Human Reproduction (CERHR), an arm of the National Toxicology Program, in 1998 to study chemicals that might be contributing to alarming trends in the developmental health of Americans. Infertility and birth defects are up. Sperm counts are down. Girls reach puberty earlier. Breast cancer, prostate cancer, and neurobehavioral conditions such as attention-deficit disorder are mounting. Soon after the center’s inception, however, its operations were outsourced to a Beltway consultancy called Sciences International. For a fee of about $1 million a year, Sciences ran the evaluation of roughly 20 chemicals in an eight-year period.

On the surface, Sciences International appeared highly qualified for the task. Its president and founder was Dr. Elizabeth Anderson, a former government toxicologist who had helped establish the EPA. She conducted the EPA’s first studies on carcinogens and later spearheaded its Office of Health and Environmental Assessment. A 10-person firm, launched in 1993, Sciences had analyzed the toxicity of dozens of chemicals for the EPA, the FDA, and other government agencies.

Sciences had also built a robust practice helping corporations grapple with lawsuits and regulation. Among its clients were law firms, trade associations, and oil-, tobacco-, and chemical-industry giants. Until 2006, Sciences reported on its Web site that it had defended MTBE (a gasoline additive since banned in 25 states), TCE (an industrial solvent in drinking water found highly likely to cause childhood cancer and birth defects), and perchlorate (another toxin in drinking water that California has deemed “a serious threat to human health”). Tools of the trade included providing expert testimony in lawsuits and producing scientific papers for publication.

A 2005 investigation in Environmental Health Perspectives raised questions about the boundaries that Anderson and her firm were willing to cross in service of their clients. The journal focused on Sciences’ defense of the pesticide phosphine. In the late 1990s, the EPA proposed stricter standards for phosphine after several people died near fumigated warehouses. The tobacco industry determined that the restrictions would cost millions and turned to Sciences for help. Correspondence between Anderson and R.J. Reynolds, obtained from the UC San Francisco tobacco archives, reveals that Anderson lobbied her former colleagues at the EPA to reconsider. Then, with input from her clients, she drafted a report arguing for the old standards and offered to get it published in a peer-reviewed journal. “My experience is that consultant reports funded by those being regulated, and written expressly for the EPA, are easily and frequently ignored,” she wrote in a memo to Joel Seckar, a toxicologist at R.J. Reynolds. “Since I am currently editor-in-chief of the international journal Risk Analysis, perhaps the peer-review process could be expedited.” For this, “Sciences would need an additional $35,000 over and above the $50,000 provided by the original contract,” the letter concluded. When the EPA eventually decided not to change the exposure standard for phosphine, the agency cited the review by Sciences International as justification. (Risk Analysis‘s board — which included HCRA’s George Gray — later tightened its conflict-of-interest standards, after examining the Sciences-phospine episode, but allowed Anderson to remain editor. Anderson declined to talk with Fast Company about the matter.)

Among the first tasks in Sciences’ examination of BPA was to draft a review of previous studies. That draft would serve as a foundation for a panel of scientists who would judge the compound. According to biologist Pete Myers, chief scientist of the nonprofit Environmental Health Sciences, who analyzed the 330-page report, it shared flaws with the discredited Harvard review. “They contained similar biases, both giving undue weight to flawed industry studies and dismissing a wealth of research funded by the National Institutes of Health,” he says. In its own investigation, the Environmental Working Group, a D.C.-based consumer advocate, found that the Sciences draft failed to note which studies were industry funded and ignored details such as Tyl’s use of the estrogen-resistant CD Sprague-Dawley rat.

A further complication was that the panel of experts brought in to conduct the review itself — while all highly accomplished in their own specialties — included only one person with any experience in BPA research. Unfamiliar with the thousands of pages of literature, the panel was heavily dependent on the Sciences draft review, says Myers. In November 2007, the panel issued a weak warning on BPA: that the research merits “minimal concern” for most of the effects studied.

The fact that the National Toxicology Program eventually overruled the panel — strengthening the warning to “some concern” — has much to do with outrage in Congress over revelations that Sciences International had a significant conflict of interest. In February 2007, another investigation by the Environmental Working Group had revealed that Anthony Scialli, a top Sciences employee whose title was “principal investigator” under the 2005 CERHR contract, had coauthored a 2004 study on birth defects from chemicals with a toxicologist from Dow, a manufacturer of BPA. In response, Senator Barbara Boxer and Representative Henry Waxman, both of California, wrote letters upbraiding NIH brass and vowing to keep a close eye on the BPA panel. The NIH requested an explanation from Sciences, which denied that any conflicts had “impaired its judgment or objectivity.”

But Fast Company has learned that Sciences’ conflicts of interest went even deeper. The firm had passed its verdict on BPA, under oath, even before it began the government review. In 2003, Sciences provided expert testimony for the defense in a lawsuit over BPA. On an archived page of the firm’s Web site, the company bragged that, for a private client, it had acted as an expert witness “challenging the validity” of the science on BPA’s health risks. “The case was decided in favor of the defendants,” the site said. (Anderson, who sold Sciences for $5.1 million in 2001 and left for rival Exponent in 2006, confirmed by email that the testimony happened but declined to provide details. Herman Gibb, who took over as president of Sciences, says the staff working on the CERHR contract was not aware of the testimony.)

The NIH terminated the Sciences contract in April 2007, and the firm is now down to four employees. The Environmental Working Group has since reported that Sciences had client relationships with the makers of nearly every chemical it reviewed under the CERHR contract.

Echoes of Agent Orange

As the Sciences International scandal broke, John D. Dingell, Michigan congressman and then-chair of the House Committee on Energy and Commerce, launched an investigation into the product-defense industry. “I have grave concerns that science may be for sale at these consulting firms,” Dingell told Fast Company. “If supposedly reputable scientists are paid to cast doubt on valid scientific data that raise public-health concerns about everyday products, then the public’s health and safety are being endangered.”

“Science may be for sale at these consulting firms,” says Congressman Dingell. “If supposedly reputable scientists are paid to cast doubt on valid data, the public’s health and safety are being endangered.”

Dingell’s probe zeroed in on a 75-employee Beltway firm called the Weinberg Group (tagline: “Science minds over business matters”). The firm got started in the 1980s defending the carcinogenic defoliant Agent Orange. According to documents from the tobacco archives, founder Myron Weinberg was a major player in Philip Morris’s infamous “whitecoat” project, under which the company secretly paid dozens of PhDs to challenge the findings that secondhand smoke caused cancer. More recently, the firm has fought restrictions on drugs such as ephedra and Fen-phen — both since pulled from the market. On its site, it has noted that when the FDA proposed canceling an unspecified client’s drug, the Weinberg Group launched a lengthy appeal process that led “to 10 additional years of sales prior to the ultimate cancellation.”

An April 2003 marketing letter written by Weinberg vice president P. Terrence Gaffney provides insight into the services the firm offers. The letter offered DuPont help in defending PFOA, a component of Teflon that has been the subject of lawsuits and EPA enforcement costing the company more than $100 million. “Manufacturers must be the aggressors,” the letter urged. “We must implement a strategy at the outset which discourages government agencies, the plaintiff’s bar, and misguided environmental groups from pursuing this matter.” Specifically, Gaffney offered to facilitate “the publication of papers and articles dispelling the alleged … harm.” He promised, “We will harness, focus, and involve the scientific and intellectual capital of our company with one goal in mind — creating the outcome our client desires.”

According to Dingell’s investigation, Sunoco is among the manufacturers that hired the Weinberg Group to defend its BPA business. A spokesperson for Sunoco confirms the company hired Weinberg but says it was only to analyze BPA science. Weinberg also downplays its role. “The Weinberg Group certainly has been involved,” says spokesman John Kyte, managing director of PR giant Burson-Marsteller. “But critics want to attribute to the Weinberg Group this exorbitant influence and this cloak-and-dagger kind of thing. In the big picture, it’s not the reason the product is in widespread use.”

James Lamb, a lawyer and toxicologist, has been a prominent advocate for BPA’s safety, both as a Weinberg vice president and an independent contractor. In 1998, when BPA became a major issue at a scientific conference in Kyoto, Japan, Lamb led press conferences attacking vom Saal’s studies. In a 2001 press release publicizing Tyl’s study using the CD Sprague-Dawley rats, Lamb — identified only as a former NIH scientist, not a consultant to BPA manufacturers — declared that “the concerns raised by sketchy or incomplete data have now been conclusively addressed. The results indicate very clearly that there is no risk to human health from these low-dose exposures.”

The Weinberg Group also sponsors the journal Regulatory Toxicology and Pharmacology, which has published much of the industry-backed science on BPA. It published one of Cagen’s BPA studies, as well as the Ashby experiment that cast doubt on vom Saal’s prostate findings. George Gray, formerly of HCRA, is a regular contributor, and many of the studies the Harvard center sent to its expert panel were published here.

Reg Tox Pharm, as the journal is known, is published by the International Society of Regulatory Toxicology and Pharmacology. That may sound like a weighty organization, but its annual budget is about $50,000, according to its nonprofit tax return. The society was headed by its founder, C. Jelleff Carr, until he passed away in 2005 at age 94. It is now managed by his wife from her suburban Columbia, Maryland, home.

Every year, the society presents an International Achievement Award, for which “there are no specific criteria … however, international scientific developments in toxicology are of special interest,” according to the society’s Web site. The 2004 award went to Dr. Lester M. Crawford, who later was appointed FDA commissioner by President Bush but resigned after two months. The following year, he pleaded guilty to conflict-of-interest charges. In 2005, the award went to Jerome H. Heckman, general counsel to the Society of the Plastics Industry since 1954. And the 2006 honoree was Elizabeth Anderson of Sciences International.

Watchdogs and Canaries

Where the BPA saga goes from here is unclear.

The dueling government reports’ effect on business began rippling out as early as last April, when a draft version of the National Toxicology Program decision was made public. Outraged activists accused the chemical industry of poisoning infants for profit. Trial lawyers filed class-action suits against bottle manufacturers. Senator Charles Schumer of New York proposed banning the suspect baby bottles outright. Wal-Mart, Toys “R” Us, and CVS all announced plans to phase out polycarbonate bottles. Some companies, such as bottle maker Nalgene, have adopted BPA-free plastic. Yet most businesses stuck with BPA products — at least partly because they don’t have a good substitute. Nearly all of the 130 billion food and beverage cans made in the United States each year are still lined with a BPA resin, for example. There is an alternative called Oleoresin, but it’s more expensive, has a shorter shelf life, and can’t be used for acidic foods like tomatoes.

You might expect the government to start controlling the use of BPA, but the track record suggests otherwise. The United States has a long tradition of keeping harmful substances — lead, DDT, tobacco, PCBs — on the market for decades after scientists find adverse effects. The National Toxicology Program report citing “some concern” has no regulatory impact, and the FDA has repeatedly deemed BPA “safe,” even in the face of criticism. Senator Charles Grassley of Iowa, who has launched numerous investigations into the agency, contends, “The FDA has got to be a watchdog, not a business partner with industry.” (The agency owes a substantial portion of its budget to fees it collects from companies registering new products.) What’s more, the Milwaukee Journal Sentinel reported that the outside scientist supervising the FDA’s latest review, Martin Philbert of the University of Michigan Risk Science Center, failed to disclose a $5 million donation from a man named Charles Gelman — a retired medical-device executive and an opponent of BPA regulation.

The government is unlikely to start controlling the use of BPA. The United States has a long tradition of keeping harmful substances — lead, DDT, tobacco, PCBs — on the market for decades after scientists find adverse effects.

The EPA could theoretically step in, but that’s unlikely too. The agency “has no real program to regulate industrial chemicals, as a result of deep flaws in the 1976 Toxic Substances Control Act,” says Andy Igrejas, environmental-health campaign director for the Pew Charitable Trusts. Under the act, the EPA needs to show “substantial evidence” that a chemical is harmful, and must weigh the costs of restrictions against the economic benefits of keeping the chemical in commerce. That’s a byzantine chore and helps explain why the agency has managed to restrict only five chemicals in the law’s 33-year history. Under the 1996 Food Quality Protection Act, Congress ordered the agency to screen industrial chemicals to determine if they interfere with the endocrine system, a program that might have flagged BPA. Nine years after the 1999 deadline, the agency has yet to screen a single chemical.

Senator Frank Lautenberg of New Jersey has proposed an overhaul of the whole system. In May, he introduced the Kid-Safe Chemical Act of 2008, which would reverse the burden of proof on chemicals, requiring manufacturers to demonstrate their safety in order to keep them in commerce. The E.U. passed a similar law in 2006, as did Canada in 1999. (Canada has banned BPA in baby bottles.) Still, even if Lautenberg’s bill passes, the question remains whether it would be any less vulnerable to product-defense firms gaming the science.

In the meantime, consumers and concerned producers and retailers of BPA products are left with two options: Trust that the chemical industry has their best interests at heart, or take precautions. In its report, the NIH’s National Toxicology Program advised “concerned parents” to reduce their use of canned foods; use BPA-free baby bottles; and opt for glass, porcelain, or stainless-steel containers, particularly for hot foods and liquids. Independent scientists applauded, though many of them contend that the advice should have been even more strongly worded — and would have been, were the agency not constrained by the industry-funded science.

“The U.S. has this disjointed approach to chemicals management that doesn’t focus on the inherent hazard of the chemical,” says Joel Tickner, project director at the Center for Sustainable Production at the University of Massachusetts Lowell. BPA is far from the only modern-age substance whose effects we don’t fully understand, and isn’t the only product whose safety record has been twisted. In that way, perhaps, it may be the canary in the coal mine. And so the question looms: In our quest for progress — and profit — are we putting our future at risk?

David Case interviewed unlikely wind-power tycoon T. Boone Pickens in the June 2008 issue. He is an editor of the Global

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Bisphenol A (BPA): Use in Food Contact Application

Update on Bisphenol A (BPA) for Use in Food Contact Applications

January 2010; Updated March 30, 2012

• Overview
• Background
• FDA’s Current Perspective on BPA
• Additional Studies
• Public Comment and Next Steps for FDA’s Assessment of BPA
• Interim Public Health Recommendations
• The Regulatory Framework for BPA
• Collaboration with International Partners
• Original January 2010 update available in PDF (52KB).

Overview

Bisphenol A (BPA) is an industrial chemical that has been present in many hard plastic bottles and metal-based food and beverage cans since the 1960s.

Studies employing standardized toxicity tests have thus far supported the safety of current low levels of human exposure to BPA. However, on the basis of results from recent studies using novel approaches to test for subtle effects, both the National Toxicology Program at the National Institutes of Health and FDA have some concern about the potential effects of BPA on the brain, behavior, and prostate gland in fetuses, infants, and young children. In cooperation with the National Toxicology Program, FDA’s National Center for Toxicological Research is carrying out in-depth studies to answer key questions and clarify uncertainties about the risks of BPA.

In the interim:

• FDA is taking reasonable steps to reduce human exposure to BPA in the food supply. These steps include:
  • supporting the industry’s actions to stop producing BPA-containing baby bottles and infant feeding cups for the U.S. market;
  • facilitating the development of alternatives to BPA for the linings of infant formula cans; and
  • supporting efforts to replace BPA or minimize BPA levels in other food can linings.
• FDA is supporting a shift to a more robust regulatory framework for oversight of BPA.
• FDA is seeking further public comment and external input on the science surrounding BPA.

FDA is also supporting recommendations from the Department of Health and Human Services for infant feeding and food preparation to reduce exposure to BPA.

FDA is not recommending that families change the use of infant formula or foods, as the benefit of a stable source of good nutrition outweighs the potential risk from BPA exposure.

Background

BPA is an industrial chemical used to make a hard, clear plastic known as polycarbonate, which has been used in many consumer products, including reusable water bottles. BPA is also found in epoxy resins, which act as a protective lining on the inside of metal-based food and beverage cans. These uses of BPA are subject to premarket approval by FDA as indirect food additives or food contact substances. The original approvals were issued under FDA’s food additive regulations and date from the 1960s.

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.[1] However, results of recent studies using novel approaches and different endpoints describe BPA effects in laboratory animals at very low doses corresponding to some estimated human exposures.[2] Many of these new studies evaluated developmental or behavioral effects that are not typically assessed in standardized tests.

The National Toxicology Program Center for the Evaluation of Risks to Human Reproduction, part of the National Institutes of Health, completed a review of BPA in September 2008.[3] The National Toxicology Program uses five different terms to describe its level of concern about the different effects of chemicals: negligible concern, minimal concern, some concern, concern, and serious concern.[4]

In its report on BPA, the National Toxicology Program expressed “some concern for effects on the brain, behavior, and prostate gland in fetuses, infants, and children at current human exposures to bisphenol A.”[5] The Program also expressed “minimal concern for effects on the mammary gland and an earlier age for puberty for females in fetuses, infants, and children at current human exposures to bisphenol A” and “negligible concern” for other outcomes.[6]

The National Toxicology Program does not make regulatory recommendations. With respect to neurological and developmental outcomes of BPA, the Program stated that “additional research is needed to more fully assess the functional, long-term impacts of exposures to bisphenol A on the developing brain and behavior.”[7] The Program also stated:

Overall, the current literature cannot yet be fully interpreted for biological or experimental consistency or for relevance to human health. Part of the difficulty for evaluating consistency lies in reconciling findings of different studies that use different experimental designs and different specific behavioral tests to measure the same dimension of behavior.[8]

In August 2008, prior to the release of the final National Toxicology Program report, FDA released a document entitled Draft Assessment of Bisphenol A for Use in Food Contact Applications.[9] This draft assessment was then reviewed by a Subcommittee of FDA’s Science Board, which released its report at the end of October 2008.[10]

Since that time, the Center for Food Safety and Applied Nutrition (CFSAN) within FDA has reviewed additional studies of low-dose toxicity cited by the National Toxicology Program and the Science Board Subcommittee as well as other such studies that have become available. The Center then prepared a document entitled Bisphenol A (CAS RN. 80-05): Review of Low Dose Studies,dated August 31, 2009. In the fall of 2009, FDA’s Acting Chief Scientist asked five expert scientists from across the federal government to provide independent scientific evaluations of this document. In April 2010, FDA made the CFSAN documents available for public comment, and also made public the independent scientific evaluations.

FDA is continuing to consider the low dose toxicity studies of BPA as well as other recent peer-reviewed studies related to BPA. At this stage, FDA is explaining its current perspective on BPA, its support for further studies, its establishment of a public docket for its assessment of BPA use in food contact applications, its interim public health recommendations, its view of the appropriate regulatory framework for BPA use in food contact applications, and our collaborations with international partners.

FDA’s Current Perspective on BPA

At this interim stage, FDA shares the perspective of the National Toxicology Program that recent studies provide reason for some concern about the potential effects of BPA on the brain, behavior, and prostate gland of fetuses, infants and children. FDA also recognizes substantial uncertainties with respect to the overall interpretation of these studies and their potential implications for human health effects of BPA exposure. These uncertainties relate to issues such as the routes of exposure employed, the lack of consistency among some of the measured endpoints or results between studies, the relevance of some animal models to human health, differences in the metabolism (and detoxification) of and responses to BPA both at different ages and in different species, and limited or absent dose response information for some studies.

FDA is pursuing additional studies to address the uncertainties in the findings, seeking public input and input from other expert agencies, and supporting a shift to a more robust regulatory framework for oversight of BPA to be able to respond quickly, if necessary, to protect the public.

In addition, FDA is supporting reasonable steps to reduce human exposure to BPA, including actions by industry and recommendations to consumers on food preparation. At this time, FDA is not recommending that families change the use of infant formula or foods, as the benefit of a stable source of good nutrition outweighs the potential risk of BPA exposure.

Additional Studies

FDA supports additional studies, by both governmental and non-governmental entities, to provide additional information and address uncertainties about the safety of BPA.

FDA’s Studies. FDA’s CFSAN and FDA’s National Center for Toxicological Research has been and continues to pursue a set of studies on the exposure to dietary BPA and the safety of low doses of BPA, including assessment of the novel endpoints where concerns have been raised. These include studies pursued in collaboration with the National Toxicology Program and with support and input from the National Institute for Environmental Health Sciences.

Recent evaluation by the FDA’s CFSAN has:

• Determined that exposure to dietary BPA for infants, the population of most potential concern, is less than previously estimated. The initial FDA exposure estimates were 0.185 micrograms/kg-bw/day for adults and 2.42 micrograms/kg bw/day for infants. The new estimate of average dietary exposure, based on increased data collection, is 0.2-0.4 micrograms/kw-bw/day for infants and 0.1-0.2 micrograms/kg-bw/day for children and adults.

Recent research studies pursued by FDA’s National Center for Toxicological Research have[11-17]:

• Found evidence in rodent studies that the level of the active form of BPA passed from expectant mothers to their unborn offspring, following oral exposure, is so low it could not be measured. The study orally dosed pregnant rodents with 100-1000 times more BPA than people are exposed to through food, and could not detect the active form of BPA in the fetus 8 hours after the mother’s exposure.
• Demonstrated that oral BPA administration results in rapid metabolism of BPA to an inactive form. This results in much lower internal exposure of aglycone BPA (i.e., the active form) than what occurs from other routes of exposure such as injection. Primates of all ages were also found to effectively metabolize BPA to its inactive form and excrete it much more rapidly and efficiently than rodents, thus reducing concerns about results from some rodent studies using oral and, particularly, non-oral exposures which result in higher actual internal exposures of rodents than of primates, including humans, exposed to the same dose.
• Developed a physiologically based pharmacokinetic model which can be used to predict the level of internal exposure to the active and inactive forms of BPA. This model allows comparisons of internal exposure across different ages and routes of exposure (e.g., oral and intravenous routes). Based on the effects of metabolism, internal exposures to aglycone BPA following oral administration are predicted to be below 1% or less of the total BPA level administered.

The FDA’s National Center for Toxicological Research is continuing with additional studies, including:

• Rodent subchronic studies which are in progress to characterize potential effects, and, where observed, the dose-response relationship in the prostate and mammary glands for orally administered BPA. In addition, these studies will explore other issues including potential effects of BPA on metabolic changes and cardiovascular endpoints. These studies will include an in utero phase, mimic bottle feeding in neonates, and employ a dose range that will cover the low doses where effects have been previously reported in some animal studies, as well as higher doses where estrogenic effects have been measured in guideline oral studies. Results from this study are expected to be available to FDA to inform the agency’s decision making starting in 2012.

• Rodent behavioral/neuroanatomical pilot studies which are also already in progress as part of the sub-chronic study to characterize dose levels at which behavioral, neuroanatomical, neurochemical and hormonal endpoints may be affected by developmental exposure to BPA. These data are intended to evaluate possible effects of exposure to BPA during development that have been reported in some published studies on sexually dimorphic behavioral endpoints such as anxiety, as well as on standard developmental neurotoxicity tests. Results from these studies are expected to be available to FDA to inform the agency’s decision making starting in 2012.

Other Studies. Other studies on the safety of BPA are also underway. For example, the National Toxicology Program/Food and Drug Administration (NTP/FDA) will conduct a long-term toxicity study of BPA in rodents to assess a variety of endpoints including novel endpoints where concerns have been raised. NTP/FDA will collaborate with the National Institute of Environmental Health Sciences by providing animals and tissues to a consortium of researchers with interest in studying a variety of additional toxicological areas.

Public Comment and Next Steps for FDA’s Assessment of BPA

On April 5, 2010 the FDA opened a public docket (FDA-2010-N-0100) for comment on BPA. The docket contains the Center for Food Safety and Applied Nutrition’s review of the low dose toxicity studies and recently published studies, the five expert reviews, other relevant material, and public comments.

FDA will also continue to consult with other expert agencies in the federal government, including the National Institutes of Health (and National Toxicology Program), Environmental Protection Agency, Consumer Product Safety Commission, and the Centers for Disease Control and Prevention.

Based on this outside input and the results of new studies, FDA will update its assessment of BPA and will be prepared to take additional action if warranted. As the scientific field is evolving rapidly, FDA anticipates providing further updates on BPA to the public as significant new information becomes available.

Interim Public Health Recommendations

At this interim stage, FDA supports reasonable steps to reduce exposure of infants to BPA in the food supply. In addition, FDA will work with industry to support and evaluate manufacturing practices and alternative substances that could reduce exposure to other populations.

Infants. Infants are a potentially sensitive population for BPA because (1) their neurological and endocrine systems are developing; and (2) their hepatic system for detoxification and elimination of such substances as BPA may be immature.

• FDA is supporting the industry’s actions to stop producing BPA-containing bottles and infant feeding cups for the U.S. market. FDA understands that the major manufacturers of these products have stopped selling new BPA-containing bottles and infant feeding cups for the U.S. market. Glass and polypropylene bottles and plastic disposable “bag” liners have long been alternatives to polycarbonate nursing bottles.

• FDA is facilitating the development of alternatives to BPA for the linings of infant formula cans. FDA has already noted increased interest on the part of infant formula manufacturers to explore alternatives to BPA-containing can linings, and has received notifications for alternative packaging. The agency is supporting efforts to develop and use alternatives by (1) working with manufacturers regarding the regulatory status and safety of alternative liners; (2) giving technical assistance to those wishing to prepare applications for approval of alternatives; and (3) expeditiously reviewing any such new applications for alternatives. Because reliable can lining materials are a critical factor in ensuring the quality of heat processed liquid infant formula, safe replacement of such materials requires not only that they both be safe for food contact but also allow for processing that is fully functional in protecting the safety and quality of the infant formula itself.

The American Academy of Pediatrics and other health authorities recommend breastfeeding as the optimal nutrition for infants. Infant formula, including infant formula packaged in cans, is a safe and acceptable alternative that provides known nutritional benefits and prevents life-threatening nutritional deficiencies.

FDA is not recommending that families change the use of infant formula or foods, as the benefit of a stable source of good nutrition outweighs the potential risk of BPA exposure.

Other Advice. FDA is supporting recommendations by the Department of Health and Human Services for infant feeding and food preparation to reduce exposure to BPA.

The Regulatory Framework for BPA

Current BPA food contact uses were approved under food additive regulations issued more than 40 years ago. This regulatory structure limits the oversight and flexibility of FDA. Once a food additive is approved, any manufacturer of food or food packaging may use the food additive in accordance with the regulation. There is no requirement to notify FDA of that use. For example, today there exist hundreds of different formulations for BPA-containing epoxy linings, which have varying characteristics. As currently regulated, manufacturers are not required to disclose to FDA the existence or nature of these formulations. Furthermore, if FDA were to decide to revoke one or more approved uses, FDA would need to undertake what could be a lengthy process of rulemaking to accomplish this goal.

Since 2000, FDA has regulated new food contact substances through the Food Contact Notification Program. Under this program:

• FDA receives notification from each manufacturer of the basis for the safe use of a food contact substance, detailing the conditions of the substance’s use, allowing the agency and public to know how much is being used, and for what applications;
• FDA can work with individual manufacturers to minimize exposure if a potential or actual safety concern is identified after approval;
• FDA can require the submission of additional safety and exposure data from individual manufacturers to address a significant safety concern;
• FDA can require additional studies by individual manufacturers to address a significant safety concern; and
• If FDA were to reach a conclusion that revocation of one or more approved uses is justified, FDA could quickly protect the public by revoking the use through a notice published in the Federal Register.

Given concern about BPA, and the ongoing evaluation of and studies on its safety, FDA believes that the more modern framework is more robust and appropriate for oversight of BPA than the current one.

FDA will encourage manufacturers to voluntarily submit a food contact notification for their currently marketed uses of BPA-containing materials.

In addition, FDA will explore additional options to regulate BPA under the more modern framework.

Collaboration with International Partners

FDA will continue to participate in discussions with our international regulatory and public health counterparts who have also been engaged in assessing the safety of BPA.

For example, FDA has participated with Health Canada in encouraging industry efforts to refine their manufacturing methods for the production of infant formula can linings to minimize migration of BPA into the formula.

In addition, FDA actively supported and participated in the Expert Consultation on BPA convened by World Health Organization and the Food and Agriculture Organization of the United Nations on November 2-5, 2010, in Ottawa, Canada. Information about this expert consultation and the report of the meeting is available from the WHO web site .

[1]See, e.g., European Food Safety Authority. Toxicokinetics of Bisphenol A, Scientific Opinion of the Panel on Food additives, Flavourings, Processing aids and Materials in Contact with Food, Adopted 9 July 2008 , The EFSA Journal 2008.

[2]See, e.g. vom Saal FS, Akingbemi BT, Belcher SM et al. Chapel Hill bisphenol A expert panel consensus statement: integration of mechanisms, effects in animals and potential to impact human health at current levels of exposure, Reproductive Toxicology 2007;24:131-8.

[3]NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A, NIH Publication No. 08-5994, September 2008.

[4]Ibid, page 6.

[5]Ibid.

[6]Ibid.

[7]Ibid, page 20.

[8]Ibid.

[9]U.S. Food and Drug Administration, Draft Assessment of Bisphenol A for Use in Food Contact Applications, 14 August 2008.

[10]FDA Science Board Subcommittee on Bisphenol A. Scientific Peer-Review of the Draft Assessment of Bisphenol A for Use in Food Contact Applications, 31 October 2008.

[11]Doerge D.R., Twaddle N.C., Woodling K.A., Fisher J.W. Pharmacokinetics of bisphenol A in neonatal and adult rhesus monkeys, Toxicology and Applied Pharmacology 2010; 248: 1–11.

[12]Doerge D.R., Twaddle N.C., Vanlandingham M., Fisher J.W. Pharmacokinetics of Bisphenol A in neonatal and adult CD-1 mice: Inter-species comparisons with Sprague-Dawley rats and rhesus monkeys, Toxicology Letters 2011; 207: 298– 305.

[13]Doerge D.R., Twaddle N.C., Vanlandingham M., Brown R.P., Fisher J.W. Distribution of bisphenol A into tissues of adult, neonatal, and fetal Sprague–Dawley rats, Toxicology and Applied Pharmacology 2011; 255: 261–270.

[14]Doerge D.R., Vanlandingham M., Twaddle N.C., Delclos K.B. Lactational transfer of bisphenol A in Sprague–Dawley rats, Toxicology Letters 2010; 199: 372–376.

[15]Twaddle N.C., Churchwell M.I., Vanlandingham M., Doerge D.R. Quantification of deuterated bisphenol A in serum, tissues, and excreta from adult Sprague Dawley rats using liquid chromatography with tandem mass spectrometry, Rapid Communications in Mass Spectrometry 2010; 24: 3011–3020.

[16]Doerge D.R., Twaddle N.C., Vanlandingham M., Fisher J.W. Pharmacokinetics of bisphenol A in neonatal and adult Sprague-Dawley rats, Toxicology and Applied Pharmacology 2010; 247: 158–165.

[17]Fisher J.W., Twaddle N.C., Vanlandingham M., Doerge D.R. Pharmacokinetic Modeling: Prediction and Evaluation of Route Dependent Dosimetry of Bisphenol A in Monkeys with Extrapolation to Humans, Toxicology and Applied Pharmacology 2011; 257; 122-136.

Bisphenol A (BPA) Action plan summary

• What chemical is addressed in the Action Plan?
• Why is EPA concerned about this chemical?
• What action is EPA taking?

What chemical is addressed in the action plan?

This action plan addresses EPA’s review of Bisphenol A (BPA), CASRN 80-05-7.

Why is EPA concerned about this chemical?

BPA is a high production volume (HPV) chemical widely used in manufacturing polycarbonate plastics and epoxy resins used in nearly every industry. Humans appear to be exposed primarily through food packaging manufactured using BPA, although those products account for less than 5 percent of the BPA used in this country. Food packaging is under the jurisdiction of the Food and Drug Administration (FDA), not EPA. FDA recently explained the steps it is taking to address BPA. Releases of BPA to the environment exceed 1 million pounds per year.

Because BPA is a reproductive, developmental, and systemic toxicant in animal studies and is weakly estrogenic, there are questions about its potential impact particularly on children’s health and the environment. Studies employing standardized toxicity tests used globally for regulatory decision-making indicate that the levels of BPA in humans and the environment are below levels of potential concern for adverse effects. However, results of some recent studies using novel low-dose approaches and examining different endpoints describe subtle effects in laboratory animals at very low concentrations. Some of these low-dose studies are potentially of concern for the environment because the concentration levels identified with effects are similar to some current environmental levels to which sensitive aquatic organisms may be exposed.

Regulatory authorities around the world reviewing these low-dose studies have generally concluded that they are insufficient for use in risk assessment because of a variety of flaws in some of the study designs, scientific uncertainty concerning the relevance to health of the reported effects, and the inability of other researchers to reproduce the effects in standardized studies. However, since the low-dose studies do raise questions and concerns, some authorities have taken action to protect sensitive populations, particularly infants and young children. For example, while acknowledging that science indicates exposure levels are below potential health effects levels, Canada is taking steps to ban BPA in baby bottles as a precautionary measure. On January 15, 2010, the U.S. Department of Health and Human Services (HHS) provided interim recommendations on how parents and families can reduce exposures to BPA while additional studies are underway.

What action is EPA taking?

Based on EPA’s screening-level review of hazard and exposure information, including the uncertainties surrounding the low-dose studies, EPA’s action plan called for EPA to:

1. Consider initiating rulemaking under section 5(b)(4) of the Toxic Substances Control Act (TSCA) to identify BPA on the Concern List as a substance that may present an unreasonable risk of injury to the environment on the basis of its potential for long-term adverse effects on growth, reproduction and development in aquatic species at concentrations similar to those found in the environment. A notice of proposed rulemaking is currently pending interagency review at the Office of Management and Budget (OMB).

1. Consider initiating rulemaking under section 4(a) of TSCA to develop data with respect to environmental effects relevant to a further determination that BPA either does or does not present an unreasonable risk of injury to the environment. This may include testing or monitoring data in the vicinity of landfills, manufacturing facilities, or similar locations to determine the potential for BPA to enter the environment, including surface water, ground water, and drinking water, at levels of potential concern particularly for environmental organisms, pregnant women, and children. EPA released this advance notice of proposed rulemaking (ANPRM)(PDF) (13 pp. 266 kb, About PDF) on July 26, 2011. Read more about the ANPRM on environmental testing of BPA.

1. Initiate collaborative alternatives assessment activities under its Design for the Environment (DfE) program to encourage reductions in BPA releases and exposures. One of these activities, initiated in April 2010, will address thermal paper coatings used in such applications as cash register receipts, a use where preferable alternatives to BPA may be readily available. This DfE environmental and health assessment is expected to be completed in the latter half of 2011. Additionally, EPA intends to initiate alternatives analyses for BPA used in foundry castings since foundries are accountable for large releases of BPA as reported under the Toxic Release Inventory (TRI), and for BPA-based materials lining water and waste water pipes since this application may have a potential for human and environmental exposure.
   • July 31, 2012 – Through its DfE program, EPA has released for comment the draft alternatives assessment “Bisphenol A (BPA) Alternatives in Thermal Paper” (PDF) (492 pp., 6.1 mb.) About PDF). Read more about the BPA alternative partnership. The draft report is available for comment until October 1, 2012.

EPA does not intend to initiate regulatory action under TSCA at this time on the basis of risks to human health. EPA remains committed to protecting human health and will continue to consult and coordinate closely with FDA, the Centers for Disease Control and Prevention (CDC), and the National Institute of Environmental Health Sciences (NIEHS) to better determine and evaluate the potential health consequences of BPA. The results of this assessment work will factor significantly in any future EPA decisions to address potential risks to human health resulting from uses within EPA’s jurisdiction.

As part of the Agency’s efforts to address BPA, EPA also intends to evaluate the potential for disproportionate impact on children and other sub-populations through exposure from TSCA uses.

Download the complete Bisphenol A (BPA) Action Plan (PDF), (22 pp., 202 KB, About PDF)

Access the public comment docket for the Bisphenol A (BPA) Action Plan (Docket ID EPA-HQ-OPPT-2010-0348) on Regulations.gov.

Access the American Chemistry Council’s request for correction of the BPA Action Plan and the EPA responses to that request.

Access information on the Design for the Environment (DfE) BPA Alternatives In Thermal Paper Partnership.

Track the progress of the TSCA section 4 test rule development activity on the EPA’s Rulemaking Gateway.

Access information on the Environmental Testing of Bisphenol A.

Access the public comment docket for the Testing of Bisphenol A Advance Notice of Proposed Rulemaking (Docket ID EPA-HQ-OPPT-2010-0812) at regulations.gov.

Bisphenol A

Bisphenol A
IUPAC name 4,4′-(propane-2,2-diyl)diphenol
Other names BPA, p,p’-isopropylidenebisphenol, 2,2-bis(4-hydroxyphenyl)propane.
Identifiers
CAS number	80-05-7
PubChem	6623
ChemSpider	6371
UNII	MLT3645I99
EC number	201-245-8
UN number	2430
DrugBank	DB06973
KEGG	C13624
ChEBI	CHEBI:33216
ChEMBL	CHEMBL418971
RTECS number	SL6300000
Jmol-3D images	Image 1 Image 2
Properties
Molecular formula	C15H16O2
Molar mass	228.29 g mol−1
Appearance	White solid
Density	1.20 g/cm³
Melting point	158-159 °C, 431-432 K, 316-318 °F
Boiling point	220 °C, 493 K, 428 °F (4 mmHg)
Solubility in water	120–300 ppm (21.5 °C)
Hazards
R-phrases	R36 R37 R38 R43
S-phrases	S24 S26 S37
NFPA 704	0 3 0
Flash point	227 °C (441 °F)
Related compounds
Related compounds	phenols Bisphenol S
(verify) (what is: /?) Except where noted otherwise, data are given for materials in their standard state (at 25 °C, 100 kPa)
Infobox references

Bisphenol A (BPA) is an organic compound with the chemical formula (CH₃)₂C(C₆H₄OH)₂. It is a colorless solid that is soluble in organic solvents, but poorly soluble in water. Having two phenol functional groups, it is used to make polycarbonate polymers and epoxy resins, along with other materials used to make plastics. Bisphenol A has a vapor pressure of 5*10^-6 Pa.^[1]

BPA is controversial because it exerts detectable hormone-like properties, raising concerns about its presence in consumer products and foods contained in such products. Starting in 2008, several governments questioned its safety, prompting some retailers to withdraw polycarbonate products. A 2010 report from the United States Food and Drug Administration (FDA) raised further concerns regarding exposure to fetuses, infants, and young children.^[2] In September 2010, Canada became the first country to declare BPA a toxic substance.^[3][4] The European Union, Canada, and recently the United States have banned BPA use in baby bottles.^[5][6]

Production:

World production capacity of this compound was 1 million tons in the 80s,^[7] and more than 2.2 million tons in 2009.^[8] In 2003, U.S. consumption was 856,000 tons, 72% of which was used to make polycarbonate plastic and 21% going into epoxy resins.^[9] In the U.S., less than 5% of the BPA produced is used in food contact applications,^[10] but remains in the canned food industry and printing applications such as sales receipts.^[11][12]

Bisphenol A was first synthesized by the Russian chemist A.P. Dianin in 1891.^[13][14] This compound is synthesized by the condensation of acetone (hence the suffix A in the name)^[15] with two equivalents of phenol. The reaction is catalyzed by a strong acid, such as hydrochloric acid (HCl) or a sulfonated polystyrene resin. Industrially, a large excess of phenol is used to ensure full condensation; the product mixture of the cumene process (acetone and phenol) may also be used as starting material:^[7]

A large number of ketones undergo analogous condensation reactions. Commercial production of BPA requires distillation – either extraction of BPA from many resinous byproducts under high vacuum, or solvent-based extraction using additional phenol followed by distillation.^[7]

Use:

Bisphenol A is used primarily to make plastics, and products using bisphenol A-based plastics have been in commercial use since 1957.^[16] At least 3.6 million tonnes (8 billion pounds) of BPA are used by manufacturers yearly.^[17] It is a key monomer in production of epoxy resins^[18][19] and in the most common form of polycarbonate plastic.^[7][20][21] Bisphenol A and phosgene react to give polycarbonate under biphasic conditions; the hydrochloric acid is scavenged with aqueous base:

Diphenyl carbonate may be used in place of phosgene. Phenol is eliminated instead of hydrochloric acid. This transesterification process avoids the toxicity and handling of phosgene.^[22]

Polycarbonate plastic, which is clear and nearly shatter-proof, is used to make a variety of common products including baby and water bottles, sports equipment, medical and dental devices, dental fillings and sealants, CDs and DVDs, household electronics, and eyeglass lenses.^[7] BPA is also used in the synthesis of polysulfones and polyether ketones, as an antioxidant in some plasticizers, and as a polymerization inhibitor in PVC. Epoxy resins containing bisphenol A are used as coatings on the inside of almost all food and beverage cans,^[23] however, due to BPA health concerns, in Japan epoxy coating was mostly replaced by PET film.^[24]

Bisphenol A is also a precursor to the flame retardant tetrabromobisphenol A, and formerly was used as a fungicide.^[25] Bisphenol A is a preferred color developer in carbonless copy paper and thermal paper,^[26] with the most common public exposure coming from some^[27] thermal point of sale receipt paper.^[28][29] BPA-based products are also used in foundry castings and for lining water pipes.^[10]

Identification in plastics:

Some flexible type 3 plastics may leak bisphenol A

Some type 7 plastics may leak bisphenol A

There are seven classes of plastics used in packaging applications. Currently there are no BPA labeling requirements for plastics.

“In general, plastics that are marked with recycle codes 1, 2, 4, 5, and 6 are very unlikely to contain BPA. Some, but not all, plastics that are marked with recycle codes 3 or 7 may be made with BPA.”^[30]

Type 7 is the catch-all “other” class, and some type 7 plastics, such as polycarbonate (sometimes identified with the letters “PC” near the recycling symbol) and epoxy resins, are made from bisphenol A monomer.^[7][31]

Type 3 (PVC) also may contain bisphenol A as an antioxidant in plasticizers.^[7] This refers to “flexible PVC”, but not for rigids such as pipe, windows, and siding.

History:

Bisphenol A was discovered in 1891 by Russian chemist Aleksandr Dianin. In the early 1930s the British chemist Charles Edward Dodds recognized BPA as an artificial estrogen.^[32] During that time BPA had two initial uses. The first use of BPA was to enhance the growth of cattle and poultry. The second use of BPA in the mid 1930s was as an estrogen replacement for women. BPA was only briefly used as an estrogen replacement and was replaced by diethylstilbestrol (DES).^[33] Based on research by chemists at Bayer and General Electric, BPA has been used since the 1950s to harden polycarbonate plastics and make epoxy resin, and in the lining of food and beverage containers.^[34][35] The first evidence of the estrogenicity of bisphenol A came from experiments on rats conducted in the 1930s,^[36][37] but it was not until 1997 that adverse effects of low-dose exposure on laboratory animals were first proposed (hormesis).^[23] Modern studies began finding possible connections to health issues caused by exposure to BPA during pregnancy and during development. See Government and industry response. Research is ongoing and the debate continues as to whether BPA should be banned or not, and to what extent, all over the world. In 2010 Canada’s department of the environment declared BPA to be a “toxic substance”.^[38]

Health effects:

Bisphenol A is a weak endocrine disruptor, which can mimic estrogen and may lead to negative health effects.^{[39][40][41][42]} Early developmental stages appear to be the period of greatest sensitivity to its effects,^[43] and some studies have linked prenatal exposure to later physical and neurological difficulties. Regulatory bodies have determined safety levels for humans, but those safety levels are currently being questioned or are under review as a result of new scientific studies.^[44][45] A 2011 study that investigated the number of chemicals pregnant women are exposed to in the U.S. found BPA in 96% of women.^[46]

In 2009, The Endocrine Society released a statement citing the adverse effects of endocrine-disrupting chemicals, and the controversy surrounding BPA.^[47]

In 2011, the chief scientist of the United Kingdom’s Food Standards Agency commented on a study on dietary exposure of adult humans to BPA performed by the EPA,^[48] saying, “This corroborates other independent studies and adds to the evidence that BPA is rapidly absorbed, detoxified, and eliminated from humans – therefore is not a health concern.”^[49] In the study 20 subjects were tested for BPA every hour for twenty-four hours while consuming three meals consisting of canned food.^[48]

In 2012 a paper was written in response to this study, however, criticizing the study as lacking data and having flawed assumptions.^[50]

Overall, empirical evidence supporting the negative health effects of BPA varies significantly across studies. Opinions vary greatly about the health effects of BPA. Some studies conclude that BPA poses no health risks while others state that BPA causes a number of adverse health effects. In general, the European’s Scientific Committee on Food, the EUs European Chemicals Bureau, the European Food Safety Authority, and the US Food and Drug Administration have concluded that current levels of BPA present no risk to the general population. However, experts in the field of endocrine disruptors have stated that the entire population may suffer adverse health effects from current BPA levels.^[51] Experts advise readers of scientific studies to consider who conducted the study, what their affiliations are, and what the purpose of the study was.

Expert panel conclusions:

In 2006, the US Government sponsored an assessment of the scientific literature on BPA. 38 opponents of bisphenol A gathered in Chapel Hill, North Carolina to review several hundred studies on BPA, many conducted by members of the group. At the end of the meeting, the group issued the Chapel Hill Consensus Statement, which stated “BPA at concentrations found in the human body is associated with organizational changes in the prostate, breast, testis, mammary glands, body size, brain structure and chemistry, and behavior of laboratory animals.”^[52]

The Chapel Hill Consensus Statement claimed that average levels in people are above those that cause harm to many animals in laboratory experiments. They noted that while BPA is not persistent in the environment or in humans, biomonitoring surveys indicate that exposure is continuous, however, which is problematic because acute animal exposure studies are used to estimate daily human exposure to BPA, and no studies that had examined BPA pharmacokinetics in animal models had followed continuous low-level exposures. They added that measurement of BPA levels in serum and other body fluids suggests the possibilities that BPA intake is much higher than accounted for, and/or that BPA can bioaccumulate in some conditions (such as pregnancy).^[53] A 2011 study, the first to examine BPA in a continuous low-level exposure throughout the day, did find an increased absorption and accumulation of BPA in the blood of mice.^[54]

In 2007 studies indicating harm reported a variety of deleterious effects in rodent offspring exposed in the uterus: abnormal weight gain, insulin resistance, prostate cancer, and excessive mammary gland development.^[55]

A panel convened by the U.S. National Institutes of Health in 2007 noted that many of the studies referenced by the Chapel Hill group had methodological problems. This panel could not rule out “some concern” about BPA’s effects on fetal and infant brain development and behavior.^[9] The concern over the effect of BPA on infants was also heightened by the fact that infants and children are estimated to have the highest daily intake of BPA.^[56] A 2008 report by the U.S. National Toxicology Program (NTP) later agreed with the panel, expressing “some concern for effects on the brain, behavior, and prostate gland in fetuses, infants, and children at current human exposures to bisphenol A,” and “minimal concern for effects on the mammary gland and an earlier age for puberty for females in fetuses, infants, and children at current human exposures to bisphenol A.” The NTP had “negligible concern that exposure of pregnant women to bisphenol A will result in fetal or neonatal mortality, birth defects, or reduced birth weight and growth in their offspring.”^[57]

External links:

Look up bisphenol a in Wiktionary, the free dictionary.

• Fate of bisphenol a during treatment with the litter-decomposing fungi Stropharia rugosoannulata and Stropharia coronilla. Chemosphere. 2011;83(3):226–32. doi:10.1016/j.chemosphere.2010.12.094. PMID 21295326.
• Plastic Not Fantastic with Bisphenol A (www.scientificamerican.com)
• US FDA statement on bisphenol A from 2008
• Why Public Health Agencies Cannot Depend on Good Laboratory Practices as a Criterion for Selecting Data: The Case of Bisphenol A. Environmental Health Perspectives. March 2009;117(3):309–315. doi:10.1289/ehp.0800173. PMID 19337501. PMC 2661896.
• EHP Collection: Bisphenol A
• Hazard in a bottle Attempt to regulate BPA in California defeated (from The Economist)
• How to Protect Your Baby from BPA (Bisphenol A)
• Alternatives to BPA containers not easy for U.S. foodmakers to find Layton, Lyndsey. 23 February 2010. Washington Post
• ChemSub Online : Bisphenol A.
• Is It Time to End Concerns over the Estrogenic Effects of Bisphenol A?
• • This page was last modified on 4 August 2012 at 22:33.
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    Wikipedia® is a registered trademark of the Wikimedia Foundation, Inc., a non-profit organization.

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“Richard Branson – Water crisis – How do we save the water?”

WHOLE WORLD Water seeks to prove that economic, social, and environmental progress are not mutually exclusive. Developed to end the global water and sanitation crisis, WHOLE WORLD Water works to engage the hospitality and tourism industry to filter, bottle, and sell its own water, and contribute 10% of the proceeds to the WHOLE WORLD Water Fund. 100% of the proceeds will go directly to clean and safe water initiatives worldwide.
We believe that everyone should have access to clean and safe water. Visit Sir Richard Branson

www.wholeworldwater.co

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“Richard Branson – Water crisis – How do we save the water?”

WHOLE WORLD Water seeks to prove that economic, social, and environmental progress are not mutually exclusive. Developed to end the global water and sanitation crisis, WHOLE WORLD Water works to engage the hospitality and tourism industry to filter, bottle, and sell its own water, and contribute 10% of the proceeds to the WHOLE WORLD Water Fund. 100% of the proceeds will go directly to clean and safe water initiatives worldwide.
We believe that everyone should have access to clean and safe water. Visit Sir Richard Branson

www.wholeworldwater.co

Top of page

“Richard Branson – Water crisis – How do we save the water?”

WHOLE WORLD Water seeks to prove that economic, social, and environmental progress are not mutually exclusive. Developed to end the global water and sanitation crisis, WHOLE WORLD Water works to engage the hospitality and tourism industry to filter, bottle, and sell its own water, and contribute 10% of the proceeds to the WHOLE WORLD Water Fund. 100% of the proceeds will go directly to clean and safe water initiatives worldwide.
We believe that everyone should have access to clean and safe water. Visit Sir Richard Branson

www.wholeworldwater.co

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“You Get More Toxic Exposure From Taking A Shower Than From
Drinking The Same Water.”

This article is courtesy of Citizens Concerned About Chloramine (CCAC), a nonprofit organization based in the San Francisco Bay Area, California.

…. Summary statement from a recent study at a major U.S. University and as reported in Science News, vol. 130.

Diagram adapted from the Weekly Newsmagazine of Science, SCIENCE NEWS.Chemistry VOL 130 no. 12 Pages 177-192

In a new study, researcher Julian Andelman, of the University of Pittsburgh Graduate School of Public Health, the National Academy of Sciences has shown that volatile chemicals present in many municipal drinking water supplies are especially toxic to people when they are exposed to them when bathing or showering. “. . .the major health threat posed by these water pollutants is far more likely to be from their inhalation as air pollutants in the home, according to preliminary data from a study Andelman and his colleagues have just reported.”

“In the past, he says, inhalation exposure to water pollutants has largely been ignored.” His data indicates that hot showers can liberate between 50 to 80 percent of the dissolved chemicals into the air. Emissions from hot baths are half as high. “(One reason, explains Andelman, is that because water droplets dispersed by a shower head have a larger surface-to volume ratio than water streaming into a bath, more of the volatiles can vaporize out).”

It is interesting to note that chloramine actually exists in three forms: monochloramine, dichloramine, and trichloramine. The three forms constantly and rapidly shift from one form to another. “The different volatilities of the chloramines result in substantial differences in the rates of release from water: di- and tri-chloramine are released ~3 and 300 times faster than monochloramine, respectively.” (See page 3 of Chemicals in Drinking Water: Chloramine (PDF, 178 KB), by Scottish Centre for Infection and Environmental Health. Alternate source: click here.) These chemicals vaporize easily out of the water that is heated and aerosolized. All three forms are respiratory irritants, with trichloramine being the most toxic.

Andelman points out that.. . “Although showering can be an intense source of residential exposure to water pollutants, . . . it is far from the only important source. Andelman notes that only about 5 of the 50 to 70 gallons of water used daily by the average American goes for showers. Much of the rest is used by dishwashing and laundering. “

“Though actual doses will depend on many factors–especially the level of water contamination–the study does offer clues for limiting exposure. Cold showers can reduce the vaporization of dissolved volatile chemicals by 50 percent, Andelman says. And short showers help, since each doubling in shower time quadruples the dose from accumulating gases. Finally, to limit the spread of released gases into the rest of the home, he suggests closing the bathroom door while bathing and exhausting the room air outdoors.

“Science News, Vol. 130 no. 12, pgs. 177-192, cited by CCAC in this report.

More information about your drinking water

EPA strongly encourages people to learn more about their drinking water. Your water bill or telephone book’s government listings are a good starting point for local information. Water systems have several different choices when it comes to disinfection. To find out if chloramines are used in your community, contact your local water system.

EPA requires all community water systems to prepare an annual consumer confidence report (CCR) (sometimes called a water quality report) for their customers. The CCR lists the level of contaminants that have been detected over a certain period of time and shows how these levels compare with EPA’s drinking water regulations. Some water suppliers have posted their annual reports on EPA’s Website. If you have not received this annual report, and it is not posted on EPA’s Website, you may request it by calling your water system.

• Consumer Confidence Reports Web site
• Find out if your water systems has their CCR listed online

More information about chloramines and disinfection byproducts

More information about health effects and drinking water disinfection from EPA is available in the following locations:

• EPA’s Integrated Risk Information System (IRIS) Web site.
  IRIS includes updated information up to 2005 for the oral and carcinogenicity assessments for chloramine (assessment found under heading monochloramine).
• Drinking Water Health Criteria Document for Chloramines, (155pp, 2M, About PDF)
  Health and Ecological Criteria Division, Office of Science and Technology, Office of Water, EPA, 1994. [Note: This document is currently being revised]
• Stage 1 Rule page has further information on exposure and occurrence and summarizes of health information used to set the current chloramine standard.
• Stage 2 Rule Web site has further information on disinfection practices and explains risk-risk tradeoffs associated with disinfection byproducts and pathogen control.

2007 Version of Chloramines Q&A’s

EPA has updated the previous version of the Chloramines Q&A’s in order to better communicate complex issues to a wider audience. EPA expects to continue to review and possiblyupdate the Q&A’s on a periodic basis or as new information becomes available

• 2007 Version of Chloramines Q&A’s PDF. (7pp, 236K)

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“Richard Branson – Water crisis – How do we save the water?”

WHOLE WORLD Water seeks to prove that economic, social, and environmental progress are not mutually exclusive. Developed to end the global water and sanitation crisis, WHOLE WORLD Water works to engage the hospitality and tourism industry to filter, bottle, and sell its own water, and contribute 10% of the proceeds to the WHOLE WORLD Water Fund. 100% of the proceeds will go directly to clean and safe water initiatives worldwide.
We believe that everyone should have access to clean and safe water. Visit Sir Richard Branson

www.wholeworldwater.co

Top of page

WHOLE WORLD Water seeks to prove that economic, social, and environmental progress are not mutually exclusive. Developed to end the global water and sanitation crisis, WHOLE WORLD Water works to engage the hospitality and tourism industry to filter, bottle, and sell its own water, and contribute 10% of the proceeds to the WHOLE WORLD Water Fund. 100% of the proceeds will go directly to clean and safe water initiatives worldwide.
We believe that everyone should have access to clean and safe water. Visit Sir Richard Branson

www.wholeworldwater.co

Top of page