Federal regulators today defended their assessment that a chemical widely used in plastic baby bottles and in food packaging is safe, even as the first major study of health effects in people linked it with possible risks for heart disease and diabetes.

“A margin of safety exists that is adequate to protect consumers, including infants and children, at the current levels of exposure,” Laura Tarantino, a senior Food and Drug Administration scientist, told an expert panel that has been asked for a second opinion on the agency’s assessment of bisphenol A or BPA.

However, a study released Tuesday by the Journal of the American Medical Association suggested a new concern about BPA. Because of the possible public health implications, the results “deserve scientific follow-up,” the study authors said. Using a health survey of nearly 1,500 adults, they found that those exposed to higher amounts of BPA were more likely to report having heart disease and diabetes.

But the study is preliminary, far from proof that the chemical caused the health problems. Two Dartmouth College analysts of medical research said it raises questions but provides no answers about whether the ubiquitous chemical is harmful.

FDA officials said they are not dismissing such findings, and conceded that further research is needed. “We recognize the need to resolve the concerning questions that have been raised,” said Tarantino. But the FDA is arguing that the studies with rats and mice it relied on for its assessment are more thorough than some of the human research that has raised doubts.

The JAMA article was released to coincide with the FDA scientific advisers’ hearing.

The Food and Drug Administration is considering the safety of bisphenol A at a meeting in Washington. New information could alter the FDA's preliminary conclusion that the agency is satisfied that current regulations are sufficient to protect the public.

(To listen to this report, click the Read More link below.)

A new study could change the debate over the safety of bisphenol A, a compound found in many plastics.

It suggests that there is an association between higher exposures to BPA and the development of heart disease and diabetes.

The study, appearing in this week's Journal of the American Medical Association, finds that adults with the highest levels of BPA in their urine were more than twice as likely to report having diabetes or heart disease — compared with adults with the lowest levels of the chemical in their urine.

Though it brings up new possible human health risks, the study, which is being discussed today at a meeting of the Food and Drug Administration's science advisory board, offers no conclusive answers. It does not prove a cause and effect between use of plastic food containers and the development of diabetes or heart disease.

"We don't have a lot of evidence in people about the effects of BPA. This is one of the first studies, and it finds something disturbing. It's suggesting there may be harm in adults, which we didn't really believe based on the animal studies," says David Schardt, a staff scientist with the Center for Science in the Public Interest.

A major study links a chemical used in many plastic products including baby bottles to human problems such as heart disease and diabetes, while U.S. regulators on Tuesday said they still believe it is safe.

The chemical bisphenol A, or BPA, is widely used in plastic food and beverage containers and in the coating of food cans.

Until now, environmental and consumer activists who have questioned the safety of BPA have relied on animal studies. But the study by British researchers in the Journal of the American Medical Association found that among 1,455 U.S. adults, those with the highest levels of BPA were more likely to have heart disease, diabetes and liver-enzyme abnormalities than those with the lowest levels.

U.S. Food and Drug Administration officials said they would review the new findings, which were not taken into consideration when the agency issued a draft conclusion in August that BPA is safe at current exposure levels.

"We have confidence in the data that we've looked at and the data that we're relying on to say that the margin of safety is adequate," FDA official Laura Tarantino told reporters at a meeting of experts advising the agency on its BPA conclusions.

"There are things you can do if you choose to reduce your level of bisphenol A," Tarantino said. "But we have not recommended that anyone change their habits or change their use of any of these products because right now we don't have the evidence in front of us to suggest that people need to."

The Food and Drug Administration this week reopens the debate over a chemical used in many plastic products -- including baby bottles -- amid mixed messages on its safety from the U.S. government.

An FDA panel of outside experts on Tuesday was set to review the agency's draft report issued last month saying that bisphenol A, or BPA, is safe. Critics argue the FDA has ignored strong evidence in animal studies that BPA is harmful.

Government toxicologists at the U.S. National Institutes of Health on September 3 reiterated their view that BPA presents "some concern" for harmful effects on development of the prostate and brain and for behavioral changes in fetuses, infants and children.

BPA is used to make polycarbonate plastic, a clear shatter-resistant material in products ranging from baby and water bottles to sports safety equipment and medical devices.

It also is used to make durable epoxy resins used as the coating in most food and beverage cans and in dental fillings.

People can consume BPA when it leaches out of plastic into liquid such as baby formula, water or food inside a container.

Environmental and consumer safety groups say studies show the chemical can interfere with how the body absorbs the hormone estrogen, which is key to the development of young bodies.

The NIH's National Toxicology Program, or NTP, became the first U.S. government agency to embrace health concerns regarding BPA. It followed up this draft report with a final report this month reiterating the concerns.

The FDA said the meeting would focus on these worries.

Yale School of Medicine researchers reported today that the chemical bisphenol-A (BPA), a building block for polycarbonate plastics found in common household items, causes the loss of connections between brain cells. This synaptic loss may cause memory/learning impairments and depression, according to study results published in the Proceedings of the National Academy of Sciences (PNAS).

Unlike previous studies that looked at the effect of BPA on rodents, the team examined the effects in a primate model. They also used lower levels of the chemical than in past studies. “Our goal was to more closely mimic the slow and continuous conditions under which humans would normally be exposed to BPA,” said study author Csaba Leranth, M.D., professor in the Department of Obstetrics, Gynecology & Reproductive Sciences and in Neurobiology at Yale. “As a result, this study is more indicative than past research of how BPA may actually affect humans.”

Over a 28-day period, Leranth and his team gave each primate 50 micrograms/kg of BPA per day, adjusted for body weight, the amount considered safe for human consumption by the Environmental Protection Agency (EPA). The team also administered estradiol, the major form of hormonal estrogen that modulates nerve cell connections in the brain. Best known as one of the principal hormone products of the ovary, estrogen has also been shown in past studies to be synthesized in the brain, where it aids the development and function of the hippocampus and prefrontal cortex.

Much to my dismay, the governor of Minnesota vetoed a bill that would ban the use of Bisphenol-A in products sold in that state. Any parent living in Minnesota needs to get on the bandwagon and work with the politicians who fought in favor of the ban to see that it isn't a lost cause.

Leslye Adelman, Founder
Gentle Nurturing

Minnesota Gov. Tim Pawlenty (R) has vetoed a bill that would have banned the chemical bisphenol-A from products that come into contact with children.

Proponents of the ban claim the chemical causes reproductive harm in laboratory rats, but numerous scientific studies show no such adverse health effects if the chemical is somehow digested by humans.

Bisphenol-A Benefits

Bisphenol-A is an important component in plastic products because it provides desired texture and flexibility. It is a common component of baby bottles and other infant products, giving parents an alternative to glass items that might break and expose a child to harm from glass shards.

In addition to baby products, plastics now take the place of metals, paper, wood products, and other less safe and less durable materials for the packaging of grocery purchases and consumer goods. In the medical field, doctors and nurses no longer use glass syringes and bottles, instead using disposable plastic products that reduce infections, failures, and breakage.

A chemical used in plastic baby bottles is being driven off retailers' shelves not by regulators, but by advocacy groups, politicians and giant retailers.

How, exactly, did Wal-Mart become the new Food and Drug Administration?

The giant retailer, along with CVS and Toys 'R Us, announced recently that it plans to stop selling baby bottles containing the chemical bisphenol-A.

The question is, why? Bisphenol-A has been widely used since the 1950s. The Food and Drug Administration, as well as Japanese and European regulators, have no problems with it. Canada is about to ban it from baby bottles, but officials term the move purely precautionary.

To be sure, other scientists worry because animal studies have linked small doses of BPA to cancer and other health problems. But scientific debate isn't driving the baby bottle war; a hard-hitting push by activist groups, politicians and trial lawyers is.

As traditional media picked up the story in the spring, spooked retailers like Wal-Mart backed away from BPA, while companies that had done so earlier scored a PR coup that boosted their fortunes.

One could argue, as BPA opponents do, that the government is too slow to take action to protect health, so private action by consumers and companies is necessary. Or one could argue, as does Steve Hentges, a chemist and industry lobbyist that "the science can't compete with the emotion."

What's inarguable, though, is how rapidly markets can by reshaped today by an activist campaign that catches fire online. The Environmental Working Group and the authors of the book Our Stolen Future have used the Internet to sound alarms about bisphenol-A. The Bisphenol-A Free portal keeps a running tally of bad news reports. Bloggers at www.safemama.com and www.healthychild.org pound away at the chemical industry.

Dear Gentle Nurturing,

I have great news. Last month, we told you about two California state Senate bills that would ban toxic chemicals.

SB 1713 would ban BPA, a hormone disruptor, from baby bottles and sippy cups. SB 1313 would ban cancer-causing PFCs (Teflon chemicals) from food products. Both bills are sponsored by Environmental Working Group.

You took action, and it paid off.

Both bills have passed the Senate and all required Assembly committees. Now it's on to the full Assembly, where the fate of these bills will be decided in the coming weeks.

If Two Similar Studies Completely Disagree, Look at How the Funders Framed the Issue

Wal-Mart and Toys R Us announced this spring that they will stop selling plastic baby bottles, food containers and other products that contain a chemical that can leach into foods and beverages. Even low doses of the chemical (bisphenol A, or BPA) are linked to prostate and mammary-gland changes in laboratory animals that were exposed as fetuses and infants. The big retailers are responding to the fears of parents, and Congress is considering measures to ban the chemical.

But is there enough evidence of harmful health effects on humans? One of the eyebrow-raising statistics about the BPA studies is the stark divergence in results, depending on who funded them. More than 90 percent of the 100-plus government-funded studies performed by independent scientists found health effects from low doses of BPA, while none of the fewer than two dozen chemical-industry-funded studies did.

This striking difference in studies isn't unique to BPA. When a scientist is hired by a firm with a financial interest in the outcome, the likelihood that the result of that study will be favorable to that firm is dramatically increased. This close correlation between the results desired by a study's funders and those reported by the researchers is known in the scientific literature as the "funding effect."

When Assemblyman Mark Leno was challenging Sen. Carole Migden's bid for a second term this year, one aspect of their campaigns was what one might term chemical warfare.

No, they weren't lobbying canisters of poison gas at each other, although the contest did get a bit nasty at times. They were, however, both carrying bills that would, if enacted, ban the use of certain chemicals in consumer products – clearly appealing to the naturalist, chemical-phobic sensibilities of voters in ever-trendy San Francisco and Marin County.

Leno, who won the Democratic primary duel, wants to prohibit two types of chemical fire retardants from being applied to furniture and bedding, having declared at one point that "We're poisoning our nation one sofa at a time."

Migden, meanwhile, proposes that bisphenol A (BPA), an additive used in manufacturing plastic products, be barred from baby bottles and other children's food containers, emulating Canada's ban.

The bills, Leno's Assembly Bill 706 and Migden's Senate Bill 1713, are emblematic of the Legislature's penchant for regulatory decrees on consumer products, based on what? Conclusive scientific evidence of looming harm, pressure from folks who dislike something for some reason, or merely a headline-grabbing crusade?

Some call them "nanny bills." Whatever the name, they are proliferating, as Monday's passage of a measure to ban "trans fats" from restaurant foods (but not, oddly enough, from foods prepared at home) attests. An Assembly committee analysis of Leno's measure put the syndrome this way:

Chemicals used in baby bottles, toys and thousands of other household items are getting closer scrutiny from lawmakers amid concern they can cause developmental problems in children.

A House Energy and Commerce Subcommittee meets Tuesday to look at the government's handling of phthalates, a group of chemicals used to soften plastic; and bisphenol A, which is used to make shatterproof containers.

Both types of chemicals have been used for over 50 years, but recent analysis by government scientists has raised new concern about their effects on infants.

In April, U.S. toxicology experts said there is "some concern" about bisphenol due to animal experiments that linked the chemical to changes in hormones and the brain, early puberty and precancerous growths in the prostate and breast.

Most Americans have traces of the chemical in their bodies because it leaches out of water bottles and food-can lining.

In response to the report, Canadian health authorities said they would consider banning bisphenol and Wal-Mart said it planned to rid its baby bottle selection of the chemical by early 2009.

A suit has been filed against five baby bottle makers who use the chemical bisphenol A (BPA) in their products.

The suit, which was filed last week in U.S. District Court by four Ohio parents, claims that the companies knew that bisphenol A was correlated to certain health problems.  The plaintiffs are seeking unspecified damages.

The five companies named in the lawsuit are: Ohio-based Evenflo; Illinois-based Avent America Inc.; Missouri-based Handicraft Co.; Connecticut-based Playtex Products Inc.; and the Swiss company Gerber Novartis. 

BPA is a chemical that is used in the production of polycarbonate (PC) plastic and many types of resins. It can be found in products we use everyday, such as baby and water bottles, other food and beverage packaging, sports equipment, medical devices, CDs, and household electronics.

Bisphenol A has become controversial because it mimics estrogen and thus could induce hormonal responses.

According to one scientific study, possibly dangerous levels of BPA can leak into the liquid when the baby bottles are heated. The lawsuit associates BPA with conditions such as early puberty and possible autism.

One by One, They Are Losing Their Innocence

A good thing about the price of oil being up: Plastics will become less economically desirable. Because convenient as they are, they are certainly losing their innocence, one by one.

Following Canada's lead, California will most likely be the first state in the nation to pass a law banning Bisphenol-A (BPA) from use in toys or childcare products, including baby bottles. It is found in hard polycarbonate (#7) plastics. Last year the state similarly banned toys that are made with soft plastics (#3) that contain phthalates.

At least our children will ingest less of these chemicals found to be already present in most Americans' bloodstreams and which have been shown to be possible players in many and varied health problems, including hyperactivity, cancer, and hormonal/reproductive anomalies. It is thought that there is a greater danger for children because the amounts ingested are in a higher proportion to body weight, and also because early exposure increases the risk of health problems later in life.

As a reaction to the public's worries about BPA, the basis of polycarbonate plastic--which is found in reusable water bottles and a resin that lines food cans--some companies (e.g. Nalgene) have already removed this chemical from their products. Some Tupperware products and the 5 gallon water bottles in which we get water delivered are also made of polycarbonate, previously believed to be very stable and safe.

Studies Have Shown BPA Plastics Can Leech Out, Cause Medical Problems

Two Chicago aldermen are leading a charge for a citywide ban a chemical linked to hormonal defects from plastics found in baby products.

Bisphenol-A, or BPA for short, is an organic compound that has been used as a component in polycarbonate plastics for more than 50 years. Baby bottles are among the items in which they have been used.

In a test last year, a coalition of American and Canadian environmental groups tested six of the most popular brands of bottles and found that when they were exposed to high heat -- a condition that simulates normal wear and tear and washing -- the chemical was released into the milk or formula inside.

Some public health experts say bisphenol-A puts babies at risk for health problems, including reproductive and developmental defects, and down the road maybe even breast or prostate cancer. The chemical mimics estrogen and can disrupt the endocrine system.

Aldermen Edward Burke (14th) and Manny Flores (1st) have proposed an ordinance which would ban baby products containing BPA plastics.

Note from Gentle Nurturing: The South African government has come under sharp criticism for its recent mass deportation of Zimbabwean immigrants. Despite this grievous development, the South Africa seems to be leading the world--along with Canada--in caring for its babies by calling for a ban on Bisphenol A. Our hearts go out to those who cannot live in peace in their homeland, but we are thankful for things like the concern for toxicity in baby bottles.

Why can’t the government take care of the other issues that effect the babies as well?

The Cancer Association of South Africa has called upon the government to ban baby bottles made from polycarbonate. It says these bottles contain the industrial chemical, Bisphenol A, which is a carcinogen…

It’s released 55 times more into hot water -- such as when a bottle is heated, for example.

CANSA’s dramatic call was made earlier today in Cape Town, ahead of World Environment Day tomorrow.

More hazardous-ingredient oversight the ultimate goal

Do you think that Canadians have the right to know what is in the products they buy? The beds that we sleep on, the cleaners that we scrub with, the toys our children play with?

Democrats in the U.S. Senate are proposing a bill to ban the chemical bisphenol A from plastic products made for infants and young children.

The measure, introduced by Sen. Charles E. Schumer, D-N.Y., would also require the Centers for Disease Control and Prevention to study the health risks of the chemical to children and adults.

"There have been enough warning signs about the dangers of this chemical that we cannot wait to act," Schumer said in a statement. "If there is any serious risk at all posed by this chemical, it is simply unacceptable to allow Americans, especially vulnerable infants, to come into contact with it."

The U.S. House Energy and Commerce Committee is investigating allegations that the U.S. Food and Drug Administration based its positive safety rating of the chemical on studies funded by the chemical industry, The Washington Post reported Wednesday.

Bisphenol A, or BPA, is found in water bottles, food containers, baby bottles, some dental fillings and the coatings for the inside of cans containing foods, Schumer said.