The Dallas Morning News, August 3, 2007
Chemical in baby bottles may pose risk
Scientists, industry await U.S. report on health risk from BPA, made in Texas
Next week, a federally appointed panel of scientists is scheduled to finish its evaluation on the health risks of an industrial chemical, widely used in baby bottles, food cans and other consumer products, that many researchers believe poses risks to human reproduction and development.
But in a news briefing Thursday, a separate group of university and government scientists said they have reached their own conclusion – that there is ample reason to fear that the chemical is, in fact, causing adverse human health effects – including possible abnormal development of reproductive organs and predisposition to cancer.
The chemical in question, bisphenol A (BPA), the basic building block of polycarbonate plastic, also mimics the female hormone estrogen. An estimated 95 percent of Americans have it flowing through their bodies – and Texas is a major producer of the chemical.
Industry representatives insist that BPA, in its current use, does not pose a risk to human health. But experiments on lab rodents within the last decade have found that BPA decreases fertility in both sexes after adult exposure. It can also cause reproductive and behavioral problems when developing males and females are exposed to low doses in the womb.
Two years ago, the National Toxicology Program, part of the National Institutes of Health, set up the panel to review scientific studies on BPA and assess the risk the chemical poses to human reproduction.
Studies have shown that BPA can leach out of products – like plastic bottles and food can linings – and that the chemical is widespread in the environment, including in air and household dust. In one study on almost 400 Americans, the Centers for Disease Control and Prevention found BPA in urine samples in more than 95 percent of the subjects.
Scientists have reported that in tests on animals, BPA disrupted sperm production and caused problems in the male reproductive tract. Other studies suggested abnormal, possibly precancerous changes to the uterus, mammary tissue and prostate gland. Many of these changes showed up in adulthood after animals were exposed to BPA in the womb or as newborns. Other studies – mostly funded by the chemical industry – have claimed little or no effect of BPA.
And this week, Duke University researchers reported in the Proceedings of the National Academy of Sciences that exposure to prenatal BPA reprogrammed a gene, causing mice that were normally brown to develop yellow coats. Genetic reprogramming, a relatively new area of research, is thought to contribute to a variety of illnesses, including cancer.
There are already indications that the public is taking notice. Baby bottles and sippy cups made without BPA are on the market; a popular baby book has recommended buying products free of BPA; and Norway has proposed a ban on BPA.
Controversial review
The review process, which invites public comments, has stirred vehement controversy. Several university scientists have accused the government-appointed panel of favoring chemical industry studies that have found no harmful effects of BPA. This spring, the government terminated the contractor hired to prepare the initial summary of BPA studies for the review panel, because of the contractor‚s ties to the chemical industry.
A coalition of university and government scientists decided to put together its own review of BPA. Their findings, published recently in a scientific journal, were discussed in Thursday‘s conference call with news media.
„There is a very high level of concern that humans are being impacted by the levels of BPA that they are currently exposed to,“ said Fred vom Saal, a biologist at the University of Missouri-Columbia and lead author of the group‚s summary report.
During the news briefing, scientists discussed a published study on mice that found that exposure to BPA just after birth causes many of the problems that DES, a now-banned anti-miscarriage drug, causes in women. These include ovarian cysts, fibroids and precancerous growth later in life.
Another paper published this week included a prediction that humans may well be exposed to more than 10 times the daily dose of BPA deemed safe by the Environmental Protection Agency. The American Chemistry Council, an industry group, has found fault with both papers.
The federal government‘s review panel is scheduled to meet Monday through Wednesday to finalize its report. After the review panel reaches its conclusions, the National Toxicology Program will compile a final report. A strong indictment of BPA could force stronger regulations and affect the chemical industry.
„I can‚t say which way the panel will go,“ said John Vandenbergh, a member of the panel and an emeritus professor at North Carolina State University.
„Is the draft perfect?“ asked Steven Hentges, executive director of the Polycarbonate/BPA Global Group at the American Chemistry Council, an institute that represents the chemical industry. „Not yet, but it‘s better“ than an earlier version.
Dr. vom Saal said the panel‚s findings will come under intense scrutiny. „What I can tell you is if the panel totally ignores the criticism, all hell is going to break loose,“ he said.
Economically, the stakes are high.
Global production capacity for BPA is 8.2 billion pounds per year, according to chemical industry analysts. U.S. production capacity is estimated at 2.3 billion pounds – and half of that is in Texas plants owned by Dow, Bayer and Hexion Specialty Chemicals.
Bisphenol A was studied early last century as a synthetic estrogen. Chemists later realized that molecules of BPA could be strung together to make polycarbonate, a form of plastic.
Conflict of interest
Since the late 1990s, there have been allegations that the chemical industry has distorted science to show that BPA poses no threat to human health. The allegations of bias have carried over to the government‘s current evaluation.
After the government terminated its contract with Sciences International Inc., an audit concluded that the studies that the contractor compiled for the review panel were largely appropriate and complete. But several scientists and environmental groups have complained that the contractor‚s work was biased and contained factual errors. Researchers have also complained that the panel includes no BPA researchers, a strategy the government says avoids preconceptions on the part of panel members.
Dr. Vandenbergh, a member of the government-appointed panel, said he spot-checked the initial summary with the original studies and found few errors. But Ana Soto, a biologist at Boston‘s Tufts University School of Medicine, charged that revisions to the panel‚s draft report, carried out after Sciences International was dropped, still favored the chemical industry.
Dr. Soto noted that 12 out of 17 industry-funded studies – about 70 percent – were deemed adequate for the panel‘s evaluation. But only 27 out of 89 non-industry-funded studies – about 30 percent – were deemed adequate. The Dallas Morning News confirmed Dr. Soto‚s numbers.
Dr. Hentges, of the American Chemistry Council, dismissed that criticism.
„Who did the study is not really the question“ he said. „It‘s the science, and the science stands on its own merits. She‚s comparing different study design and quality.“
In fact, study design and quality are another point of contention.
The Dallas Morning News confirmed – as several scientists noted in their public comments – that the review panel has so far retained a study, despite a failed „positive control“ – an internal check that scientists use to confirm whether an experiment worked as intended.
Despite the control‘s failure, the scientists, who were funded by the chemical industry, concluded that BPA did not harm the reproductive system.
The News also discovered factual inconsistencies in the portion of the panel‚s draft report dealing with BPA levels in human blood. For example, a table claiming to summarize BPA levels in human blood omitted data indicating some of the highest blood levels reported. Also, two studies that report BPA blood levels and that are openly available are not cited in the draft.
‘Misleading summary‚
The News pointed out these omissions to Wade Welshons, a BPA researcher at the University of Missouri, who said they were a serious oversight.
„It gives a very incorrect, misleading summary of the literature,“ he said. „The effect is that it dilutes the impact of actual measures of BPA in human blood.“
The final draft from the expert panel is expected to be released soon after next week‘s meeting. By SUE GOETINCK AMBROSE
NEWS RELEASE, May 4, 2007
Canada: Scarpaleggia calls on government to ban bisphenol A
Ottawa– The government should move to ban bisphenol A, a highly toxic chemical used in food and beverage containers, said Francis Scarpaleggia, Member of Parliament for Lac-Saint-Louis and chair of the Quebec Liberal Caucus. Based on the overwhelming scientific evidence that suggests bisphenol A is harmful to humans even in very low doses, Scarpaleggiawho is also a member of the House of Commons Standing Committee on Environment and Sustainable Developmenttoday introduced a private members bill to the House of Commons that calls on the government to regulate a ban of this toxic substance.
Derived from petroleum, bisphenol A is a key ingredient in polycarbonate, the translucent hard plastic used in water bottles and many baby bottles, including “sippy cups. It is also used to make the resins that line most food cans, dental sealants, microwaveable plastics, sports helmets, and CDs. Although scientists have known for years that bisphenol A leeches from these containers into food and beverages, the substance remains widely used throughout North America and Europe.
According to Scarpaleggia, “Bisphenol A acts in humans like the hormone estrogen. Numerous studies have linked it to lowered sperm counts, increased risk of infertility, breast and prostate cancer, neurological disorders, and obesity. Bisphenol A is so toxic it is one of 200 substances recently identified by Environment Canada as potentially dangerous to humans and most in need of further study.
Although industry representatives argue the science surrounding bisphenol As toxic effects is controversial, and that studies have shown the minute amounts of bisphenol A that leeches from food and beverage containers is harmless, Scarpaleggia said he remains highly sceptical of this so-called “scientific controversy.
“Over 90 per cent of the more than 150 independent and government-funded studies published in leading medical journals over the past decade say that bisphenol A is damaging to humans even at very low doses. Yet not a single one of the dozen major studies funded by the chemical industry has come up with that result, said Scarpaleggia.
Bisphenol A is one of the highest-volume manufactured chemicals in the world. The Canadian Food Inspection Agency does not monitor canned good or bottled water to see how much bisphenol A is leeching, and Health Canada has only prescribed a provisional exposure standard, which it set in 1999, just as research was beginning to explore the damage bisphenol A causes to humans.
“Theres a mountain of data that suggests any exposure to bisphenol A is damaging to human health. The risks of using this toxic chemical far outweigh the benefits, and the government should act to regulate a ban of bisphenol A now.
The Globe and Mail, April 7, 2007
Bisphenol A: ‚Inherently toxic‘ chemical faces its future
Bisphenol A is ingested by practically everyone in Canada who eats canned foods or drinks from a can or hard plastic water bottles.
Now a controversy is raging over the safety of widespread public exposure to the chemical, which is known to act like a synthetic female sex hormone.
At the heart of the intense debate over bisphenol A is that it challenges the main tenet of modern toxicology, the idea that the dose makes the poison, a principle credited to the 15th-century Swiss alchemist Theophrastus Paracelsus.
Under this principle, a two-pack-a-day smoker is more at risk of cancer than a one-pack-a-day user, and the belief that rising doses make a substance more dangerous is the basis of all government regulations that seek to set safe exposures for harmful chemicals.
It seems obvious that a high dose of a poison would be more dangerous than a lower one, but bisphenol A is creating a stir because it doesn‚t follow this seemingly common-sense rule. Researchers say this oddity results from the fact that bisphenol A isn‘t a conventional harmful agent, such as cigarette smoke, but behaves in the unconventional way typical of hormones, where even vanishingly small exposures can be harmful.
This is why some environmentalists and scientists contend that bisphenol A, which leaches in trace amounts from food and beverage packaging, is among the scariest manufactured substances in use, an eerie modern version of the vaunted lead water pipes by which ancient Romans were unknowingly poisoned.
Extrapolating from the results of animal experiments, they suspect bisphenol A has its fingerprints all over the unexplained human health trends emerging in recent decades hinting at something going haywire with sex hormones, including the early onset of puberty, declining sperm counts, and the huge increase in breast and prostate cancer, among other ailments.
But manufacturers which include some of the world‚s biggest chemical companies insist bisphenol A is harmless and say those claiming otherwise have it wrong.
Derived from petroleum, bisphenol A is the chief ingredient in polycarbonate, the rigid, translucent hard plastic used in water bottles and many baby bottles. It‘s also used to make the resins that line most tin cans, dental sealants, car parts, microwaveable plastics, sports helmets and CDs.
Environment Canada and Health Canada last year selected it as one of 200 substances that a preliminary review deemed possibly dangerous and in need of thorough safety assessments. The 200 were culled as the most worrisome chemicals from among about 23,000 substances in use in the 1980s and grandfathered from detailed safety studies when Canada adopted its first modern pollution laws.
Government scientists classified bisphenol A as „inherently toxic,“ and companies making it will be challenged by the assessment to prove that continued use is safe.
The assessment is expected to begin next month and provide a glimpse into one of the biggest public-health and scientific controversies in the world.
Some researchers with close-up views of bisphenol A are so shocked by its ability to skew development in their laboratory animals, even at among the lowest doses ever used in experiments, they aren‚t waiting for the government to ban it. In their personal lives, they can‘t run away from products containing it fast enough. „I would love to see it banished off the face of the Earth,“ Dr. Patricia Hunt, a Washington State University geneticist, said.
She began ditching her bisphenol-A-containing products after discovering that mere traces of the chemical were able to scramble the eggs of her lab mice. In humans, similar damage would lead to miscarriages and birth defects, such as Down syndrome. „I thought, ‚Oh my God,‘|“ she said. „I‚m going to throw out every piece of plastic in my kitchen.“
Although it has been known, since a search for estrogenic drugs in the 1930s, to act like a sex hormone, bisphenol A has recently emerged as one extremely odd compound, perhaps the most unusual in widespread use. Research has found that it seems to turn modern toxicology on its head by being more dangerous at very low exposures than at high ones, a finding that is focusing attention on the possible health repercussions of the relatively small amounts leaching from consumer products.
Bisphenol A also has a bizarre pattern of research results, with the funding source of a study the best predictor of whether scientists find it harmful or safe. All major industry studies into bisphenol A‘s safety, and they number about a dozen, haven‚t found anything worrisome in low-dose exposures.
However, about 90 per cent of studies by independent researchers over the past decade, numbering about 150, have found adverse effects, ranging from enlarged prostates to abnormal breast tissue growth.
Bisphenol A has been used in increasing amounts since the 1950s in food and beverage containers because it doesn‘t impart a plastic-like taste, although traces leach out. Plastics that use it are often identified by an industry triangle symbol and the number seven.
Because it is one of the highest-volume manufactured chemicals in the world and used in so many consumer products, bisphenol A exposure in Canadians is likely to be pervasive.
Urine testing in the United States suggests that about 95 per cent of the population have been exposed, and Ottawa began a survey in March to see if a similar figure applies to Canadians, a reasonable prospect given that the same products are used in both countries. Testing elsewhere in the world has also found it present in human blood, as well as in placentas and fetal cord blood.
Manufacturers say that exposures are nothing to worry about, contending that the amounts getting into people from what they eat and drink aren‚t of any consequence.
„We know that human exposure to BPA is extraordinarily low, well below levels that have been shown to be safe,“ said Steven Hentges, spokesman for bisphenol A at the American Plastics Council, which comments on the health controversy over the chemical for four of the five North American manufacturers, GE Plastics, Sunoco Inc., Bayer AG, and Dow Chemical Co. The other producer is Hexion Specialty Chemicals.
He dismisses disease trends showing increasing numbers of hormonally linked ailments rising in tandem with bisphenol A use as „only a statistical association at best“ that in no way implicates the industry‘s product. „You could co-relate those same disease trends with TV watching or coffee drinking or anything you want,“ he said.
While some companies insist that bisphenol A is harmless, others are just as adamant that it‚s among the biggest health hazards to which Canadians are unwittingly and routinely exposed.
For Rick Smith, executive director of Environmental Defence, a Toronto group that tracks the exposure of Canadians to pollutants, bisphenol A is the worst substance among the 200 Ottawa suspects may be dangerous. „I think bisphenol A is top of my list, even though there are others that I hate a lot,“ he said.
The group is so convinced the evidence already shows bisphenol A is a health hazard, it doesn‘t want Ottawa to wait until the assessment is finished, which could take years, to ban it, particularly in food contact uses. In March, after U.S. environmental groups found the chemical leaching from plastic baby bottles and into canned food, Environmental Defence asked the federal government to end its use, a step that if taken would make Canada the first country in the world to do so.
„If getting this chemical out of those products isn‚t priority No.|1, I don‘t know what is,“ says Mr. Smith, who in his personal life isn‚t waiting for Ottawa to act. With his five-month-old son‘s health in mind, he rid his home of bisphenol-A-containing baby bottles as a safety precaution.
The contradictory findings on bisphenol A have produced a picayune scientific tit for tat between the industry and its critics on almost every aspect of each other‚s research. For instance, Mr. Hentges claims some academic studies are useless as predictors for human health effects because they used pumps to inject bisphenol A into animals, while human exposure is mainly oral through food.
But scientists counter that their work replicates better what occurs during fetal development, a time when most animals are uniquely sensitive to dangerous substances.
The industry says that when humans consume bisphenol A, most is converted in the gut into a form that isn‘t dangerous, although those worried about the substance say not all of it is dealt with in this way and diet is constantly replenishing exposures.
There are also disagreements over how potent a hormone mimic bisphenol A is. The industry calls it a weak estrogen because it is thousands of times less effective on some cell receptors. However, it is similar in strength on receptors on the surface of cells crucial for many biological functions.
Dr. vom Saal dismisses this controversy over the relative estrogenic strength of bisphenol A as mere hair splitting. „This is like saying, well Arnold Schwarzenegger is weak, relative to Superman,“ he said.
To date, international regulatory bodies, most recently the European Food Safety Authority in an assessment issued this year, have given the benefit of the doubt to the industry on these disputes.
Mr. Smith thinks the scientific debate over bisphenol A is part of a broad pattern that emerges whenever industries are threatened by new findings of harm from their products.
Similar disputes have occurred over smoking and cancer, the hazards of lead paint and global warming. But he said that waiting for all scientific disputes to be resolved could be disastrous, when human health is at stake.
„If we wait for absolute certainty, there is a very strong chance that a lot of people will be harmed.“
Already, there have been a small number of scientific papers linking exposures to human health outcomes, such as miscarriages (women with miscarriages were found to have three times higher levels of bisphenol A than other women) and ovarian dysfunction, although the industry disputes the findings.
In March, the first U.S. class action lawsuit alleging harm from bisphenol A was launched, against five makers of baby bottles. It was filed in Los Angeles shortly after a U.S. environmental group found the hormone mimic leaching from the bottles when they are heated, something many parents do to formula or milk.
Coincidentally, one big industry player is getting out of the bisphenol A business. This year, GE announced it wanted to sell its plastic business, but the company says the sale has nothing to do with the health controversy.
Peter O‚Toole, a spokesman, said the plastics business isn‘t growing as rapidly as other GE operations and „doesn‚t seem to be fitting in the current business model.“ He classifies any litigation risks with bisphenol A as „speculation. There have been risk assessments done on bisphenol A and there has never been evidence shown that it‘s harmful to human beings,“ he said.
Dr. vom Saal, for his part, expects that companies associated with bisphenol A will be the next tobacco industry, mired in expensive health litigation in U.S. courts. „This is a train wreck that is absolutely coming,“ he said.
But Mr. Hentges dismisses views that bisphenol A is about to be derailed. „He has some very unusual views,“ he said of Dr. vom Saal. MARTIN MITTELSTAEDT
San Francisco Chronicle, November 19, 2006
San Francisco prepares to ban certain chemicals in products for toys
Widely used chemicals with suspected links to cancer and developmental problems in humans are present in common baby products like the yellow rubber ducky, bath books and clear plastic bottles, a Chronicle analysis confirmed.
The toxic chemicals, which are used to harden or soften plastics, can leach out each time a baby sucks on a favorite doll or gnaws on a cool teething ring, scientists say.
Starting Dec. 1, a first-in-the-nation ban goes into effect in San Francisco, prohibiting the sale, distribution and manufacture of baby products containing any level of bisphenol A and certain levels of phthalates.
The law, modeled on a European Union ban that started this year, reflects emerging concerns by environmental health scientists over the buildup of industrial chemicals in humans, particularly young children. Especially under scrutiny are chemicals that mimic estrogen, possibly disrupting the hormonal system and altering the normal workings of genes.
Yet the trouble is that no one knows for sure how many baby products contain the chemicals. Stores, many of which are still unaware of the pending ban, will be unable to decide what to take off the shelves because manufacturers aren‚t required to disclose what chemicals go into a product. For that reason, The Chronicle set out to test several common baby toys and found that most of them — even ones labeled „safe, non-toxic“ — contained the chemicals.
Toymakers and companies affected by the ban have sued to block enforcement of the San Francisco law, saying their products have been used safely for decades. A January hearing is scheduled. If the courts uphold the measure, most companies say they‘ll comply with the ban even though they believe it‚s unnecessary.
„The U.S. government has always felt that what‘s in the marketplace is perfectly safe for the consumer,“ said Jeff Holzman, CEO of New York-based Goldberger Doll Manufacturing Co., who found out from The Chronicle that his company‚s Fuzzy Fleece Doll would be banned under the San Francisco law.
„Be that as it may, if there‘s a question, all the products that we make will be made without phthalates by 2007,“ he said.
The U.S. Environmental Protection Agency admits that its own guidelines — called reference doses — for safe human exposure to the chemicals are decades old and don‚t take into account the new research. The EPA is actively reassessing the health risks of three types of phthalates but is not reassessing bisphenol A, agency spokeswoman Suzanne Ackerman said.
The Food and Drug Administration, which controls chemicals that may touch food, and Consumer Product Safety Commission, which is responsible for toy safety, haven‘t limited the chemicals in baby products for years. Representatives say they have no plans to impose new restrictions.
Chemical-makers say that‚s appropriate.
„We believe at very low levels of exposure, there is no concern,“ said Marian Stanley, a spokeswoman for the four U.S. phthalate-makers.
Low doses of bisphenol A are also not a health risk, said Steve Hentges, a spokesman for the five major U.S. companies that make that chemical. „In every case, the weight of evidence supports the conclusion that bisphenol A is not a risk to human health at the extremely low levels to which people might be exposed,“ he said.
Many scientists who study the materials disagree and point to hundreds of scientific studies they say show why bans such as San Francisco‘s are needed.
It‚s not the first time San Francisco has led the way in instituting a chemical ban. A decade ago, its leaders voted to eliminate the most toxic pesticides from city property. That sort of action is needed to cut exposure to harmful chemicals, said Dr. Richard Jackson, a UC Berkeley professor who for a decade headed the Center for Environmental Health at the U.S. Centers for Disease Control and Prevention.
„We don‘t want dry-cleaning solvents in our livers, lead in our brains or perchlorate in our thyroids. We certainly don‚t want endocrine disrupters in breast milk and umbilical cord blood. We need to be ratcheting down these levels in people by reducing the loading of these chemicals in the environment,‘‚ Jackson said.
The Intergovernmental Forum on Chemical Safety, a group based at the World Health Organization, recommended in September prevention of exposure to known hazards from chemicals already detected in some toys.
“Protections for children from chemicals in toys are weak at best and dysfunctional at worst,‘‚ said Joel Tickner, a professor of environmental health at the University of Massachusetts Lowell. He has served as a consultant to the forum and on national panels that advise the U.S. government on chemicals in the environment.
„Consumers would be astonished if they knew that federal laws regulating chemicals in children‘s toys all require balancing the benefits of protecting children with the costs to industry of implementing safer alternatives,“ he said.
The tests
It‚s often impossible for parents to tell if the teething ring or baby rattle they hand their children contains bisphenol A or phthalates. The Chronicle purchased 16 children‘s products and sent them to the STAT Analysis Corp. laboratory in Chicago, one of the few commercial labs that test for these chemicals.
The city‚s ordinance bans the manufacture, distribution or sale of items intended for children younger than 3 if they contain any level of bisphenol A. Six different forms of phthalates are covered by the ban, which sets the maximum phthalate level at 0.1 percent of the chemical makeup of any part of the product. Three of those phthalates are banned only in items intended for kids younger than 3, but the law doesn‘t include age limits for products that contain three other phthalates — DEHP, DBP and BBP.
Some items exceeded the city‚s phthalate limits:
— Little Remedies Little Teethers, a Prestige Brands product sold with an oral pain-relief gel, contained one phthalate at nearly five times the limit.
— The face of Goldberger‘s Fuzzy Fleece Baby doll contained one form of phthalate at nearly twice the limit.
— A rubber ducky sold at a Walgreens store contained a carcinogenic form of phthalate, DEHP, at levels 13 times higher than allowed under San Francisco‚s pending ordinance. A second form of phthalate was found three times above the limit.
These products were found to contain bisphenol A and would be banned in the city:
— The ring on a Baby Einstein rattle made by the Disney Co.
— A Fun Ice Soothing Ring teether made by Munchkin Inc.
— The plastic covers on two of Random House‘s waterproof books — „Elmo Wants a Bath“ and Dr. Seuss‚ „One Fish Two Fish Red Fish Blue Fish.“ The books also contain levels of phthalates below San Francisco‘s limit.
— A Walgreen-brand baby bottle decorated with colorful fish.
— The face of the Goldberger doll.
— The body of a My Little Pony toy contained both bisphenol A and one form of phthalate that measured three times the city‚s limit. The toy wouldn‘t fall under the San Francisco ban, however, because it‚s marketed for ages 3 and up. It didn‘t contain high enough levels of the other three phthalates to be subject to the ban.
The method used by STAT to test for bisphenol A wasn‚t sensitive enough to detect the chemical in three polycarbonate clear plastic baby bottles made by Philips Avent, Gerber and Playtex and one clear plastic Gerber cup. Experts from the American Plastics Council, however, say that polycarbonate plastic can‘t be made without bisphenol A. Those items would be banned under the San Francisco law.
The lab didn‚t detect the chemicals in three other products chosen by The Chronicle:
— A Baby Einstein caterpillar teething ring.
— A no-spill cup made by Nuby/Luv n‘ care.
— The plastic mouth cover of a Disney pacifier.
Most companies whose items were found to contain phthalates or bisphenol A learned about the pending San Francisco ban through interviews with The Chronicle.
Among them was Walgreen Co., which has since begun to examine ways to comply with the ban. Officials at the company‚s Illinois headquarters said the chain is asking its vendors to identify products that do not comply with the San Francisco law.
Representatives for Prestige Brands in Irvington, N.Y., said the company would remove the teether with phthalates from San Francisco shelves and is working on finding an alternative.
After Random House officials learned of the test results on their baby bath books, they made plans to conduct their own tests. The company pledged to stop shipping books to San Francisco if it finds the products would violate the pending ban.
When notified of the chemicals in its products, Hasbro spokesman Gary Serby responded in an e-mail: „Hasbro does not agree with the science behind the ordinance, but will comply as of Dec. 1.“
Nidia Tatalovich, a Disney representative, said all of the company‘s products meet state and federal compliance guidelines. She said that her company would examine the San Francisco law.
Shannon Jenest, spokeswoman for Philips Avent, which makes polycarbonate baby bottles, said, „We‚re working through the details right now. We‘re very concerned with those standards and will make sure that we adhere to those guidelines.“
Munchkin, the company whose teething ring contained bisphenol A, didn‚t respond to repeated queries.
In the past three weeks, groups representing the chemical manufacturers, toymakers, retailers and San Francisco‘s toy stores, Citikids and Ambassador Toys, filed two separate lawsuits, arguing that the city doesn‚t have the authority to pass such a ban.
Some of the same trade groups — the California Retailers Association, the California Grocers Association, the Juvenile Products Manufacturers Association and the American Chemistry Council — successfully fought a bill this year in the state Legislature that would have enacted a ban similar to San Francisco‘s. The city agreed to delay enforcement of its ordinance until a Jan. 8 hearing at which the companies will seek a preliminary injunction. A hearing date hasn‚t been set for the second lawsuit, which was filed Thursday.
Yet even without an injunction, there are no penalties for companies that violate the ban. City leaders said they wanted to make sure all companies knew about the ban before issuing fines or taking other actions.
The San Francisco ordinance is certain to cause concern among parents who may not have been aware of the European ban or studies on chemicals commonly found in child products.
Mary Brune, a technical writer from Alameda, said she first started paying attention to the issue when she was nursing her baby last year and read about chemicals in breast milk. With two friends, she founded Making Our Milk Safe, or MOMS.
She scans Web sites to find toys made without plastics and tells friends about baby bottles made from glass, polyethylene, propylene and other materials considered safe. She stores food in glass. Last month she passed out leaflets near Albany‘s Target store, urging company officials to remove polyvinyl chloride (PVC) toys from their shelves.
„It‚s impossible to keep plastic toys out of children‘s mouth. They chew on things,“ Brune said. „So we as parents rely on the manufacturers of products to ensure their safety. If consumers demand safer products and businesses demand safer products from their suppliers, we‚ll be able to get these toxic products off our shelves.“
The health effects
Scientists simply don‘t know how low or high levels of phthalates or bisphenol A will cause health problems in babies if they suck on a bottle or handle a doll containing those substances.
Studies on the chemicals are largely conducted with high-dose and low-dose experiments on animals, which over time help scientists determine the level of chemicals that may pose unacceptable risks.
Those sorts of strictly controlled animal experiments are what first showed that the pesticide chlordane could cause cancer and that industrial pollutants like dioxin could cause birth defects. Such studies were also cited when California named one phthalate a carcinogen in 1988 and two others as reproductive toxicants in 2005.
There is a dearth of long-term, epidemiological studies on children exposed to phthalates and bisphenol A. So scientists from groups like the American Chemistry Council say the fact that the chemicals are found in human bodies doesn‚t necessarily mean they cause health problems.
Yet scientists who study phthalates and bisphenol A say there is enough evidence to implicate some forms of the chemicals now.
New evidence about how bisphenol A affects lab animals and how it can leach out of items such as plastic bottles came out of 1999 research by Koji Arizono at Japan‘s Kumamoto University.
Arizono found that a used polycarbonate baby bottle can leach out bisphenol A at daily levels that damaged the brain and reproductive systems in lab animals. If a 9-pound baby drinks about a quart of liquid from the bottle a day, it can ingest 4 micrograms of bisphenol A.
„We‚re showing that amount is in the zone of danger, based on the animal studies,‘‚ said University of Missouri researcher Frederick vom Saal, who said that the doses that have hurt lab animals were very close to what a baby would get from a baby bottle.
Vom Saal found that 148 published bisphenol A studies, all financed by government bodies, reported significant health effects, including altering the function of organs and reproductive systems in male and female animals.
That compares with 27 studies that found no evidence of harm. Thirteen of those studies were financed by chemical corporations.
Last year, researchers at the Tufts University School of Medicine exposed pregnant lab rodents to levels of bisphenol A 2,000 times lower than the EPA‘s 18-year-old safety guideline, which the agency admits is outdated. That old guideline suggests it would be safe, for example, for a 9-pound baby to swallow about 200 milligrams (or 200,000 micrograms) of the chemical a day.
But rodents given just a very small fraction of that amount showed changes in mammary glands. In humans, such changes are associated with a higher risk of breast cancer. Other researchers showed that exposure of newborn rats to bisphenol A causes early stages of prostate cancer.
Testifying before the state Legislature this year on the failed bill, one of the EPA‚s top phthalate researchers, Earl Gray, said studies on pregnant rodents found in their male offspring such effects as disrupted testosterone production and low sperm counts, malformation of sexual organs, and disruption of the endocrine system.
There‘s no reason to believe that the same effects wouldn‚t be the same in humans as well, Gray said.
And last year, for the first time, scientists showed that pregnant women who had higher concentrations of some phthalates in their urine were more likely to later give birth to sons with genitals that showed changes similar to those seen in exposed rodents.
It appeared that human infants, like rodents, were less completely masculinized. Some of the changes, including incompletely descended testes, were similar to those included in the “phthalate syndrome„ seen in lab rodents that received high doses of phthalates, University of Rochester researchers found. Later in the lab animals‘ lives, those genital changes were associated with lower sperm count, decreased fertility and, in some, testicular tumors.
The Consumer Product Safety Commission, which works closely with industry, has developed a voluntary agreement to eliminate the phthalate DEHP in some baby products.
In 1983, the commission determined that substantial exposure to DEHP could put children at risk of cancer. The agency didn‚t issue a regulation, but instead reached an agreement with the Toy Industry Association to keep DEHP out of pacifiers, rattles and teethers. The agreement leaves unregulated all other toys that babies put in their mouths.
When advised that Chronicle tests found that all the polyvinyl chloride toys contained DEHP, including a teether, Scott Wolfson, a spokesman for the commission, promised that his agency would look into it.
Nevertheless, Wolfson said his agency believes that consumer products that contain low levels of phthalates are not a danger to children. His agency doesn‘t conduct its own tests on toys but follows up when other organizations share test results, he said.
“We have a saying: ‚The dose makes the poison.‘ We are not seeing a high dose of phthalates coming out of a product and into the body of a child.“
METHODOLOGY
The Chronicle decided to find out what popular toys and child care items sold in San Francisco contained chemicals that would be banned under a new city ordinance effective Dec. 1.
Chronicle environment writer Jane Kay purchased a random selection of 16 plastic baby items, including a toy doll and a horse, a rubber ducky, books, teethers and baby bottles.
The Chronicle sent the box of products to STAT Analysis Corp.‚s laboratory in Chicago, one of the few labs that can test for bisphenol A and six forms of phthalates.
The Chronicle identified parts of the toys and baby items that should be tested by the lab. Lab workers cut the items apart and weighed the pieces before adding them into a solvent of methylene chloride. After several hours, lab workers used the solution to quantify the amount of bisphenol A and phthalates in the products.
The method used to detect bisphenol A wouldn‘t be expected to find the chemical at low levels. Yet the lab, using gas chromatography and mass spectrometry, found both bisphenol A and phthalates in many of the products.
To see photos of the testing process, go to www.sfgate.com.
Phthalates
Uses: Softens polyvinyl chloride products such as toys, raincoats, shower curtains and medical tubing. Found in upholstery, detergents, oils and cosmetics.
Health effects: Lab animal studies show some phthalates interfere with hormonal systems, disrupt testosterone production and cause malformed sex organs. The DEHP form is a carcinogen and a reproductive toxicant. Phthalates shed or leach from products.
Regulation: The San Francisco law prohibits the manufacture, sale or distribution of toys and child care products if they contain the phthalates DEHP, DBP or BBP in levels higher than 0.1 percent. Products for children younger than 3 are banned if they contain DINP, DIDP or DnOP in levels exceeding 0.1 percent.
Production: Made by BASF Corp., Eastman Chemical Co., ExxonMobil Chemical Co. and Ferro Corp.
Bisphenol A
Uses: Acts as building block in hard, clear polycarbonate plastic baby bottles, water bottles and containers. Found in liners inside food and drink cans, electronic equipment and spray-on flame retardants.
Health effects: Lab animal studies show that at low levels, bisphenol A can alter the function of the thyroid gland, brain, pancreas and prostate gland. It leaches out of products under normal use. It is found in humans, especially in placental and fetal tissue.
Regulation: San Francisco law prohibits manufacture, sale or distribution of a toy or child care article intended for use by a child younger than 3 if it contains bisphenol A.
Production: Made by Dow Chemical, Bayer, General Electric Plastics, Sunoco Chemicals and Hexion Specialty Chemicals.
Jane Kay, Chronicle Environment Writer