NIH to Review Flawed Report on Impacts of BPA Exposure
After a steady drumbeat of criticism from EWG, Congressman Henry Waxman (D-CA), outside scientists and mainstream media, the National Institute’s of Health’s (NIH) National Toxicology Program (NTP) has agreed to launch a top-down investigation into the Center for the Evaluation of Risk to Human Reproduction’s (CERHR) flawed, industry-friendly report on the health impacts of the dangerous toxic chemical Bisphenol-A (BPA).
“ The decision by NIH to finally review the flawed process in which the CERHR panel ignored independent scientific research in favor of the chemical industry’s own studies regarding the impacts of BPA exposure on human health is welcome news,” said Dr. Anila Jacob, MD – Senior Scientist with EWG.
“The mountain of independent research showing risks from low levels of exposure to BPA must be seriously considered as the panel works toward it’s decision on what risks BPA has on human health,” added Dr. Jacob.
PLASTICS REPORT REVIEWED
Agency to scrutinize oft-criticized findings that chemical poses little risk
By MEG KISSINGER, CARY SPIVAK and SUSANNE RUST
Jan. 9, 2008
A controversial report on chemicals found in baby bottles and hundreds of other household products is under intense review by the National Toxicology Program after the agency was swamped with complaints that the authors were unduly influenced by the chemical industry.
John Bucher, head of the toxicology program, said Wednesday that the agency is giving unprecedented scrutiny to the work of a panel studying the effects of bisphenol A, a chemical used as a hardening agent for plastic. The panel had downplayed the risks of bisphenol A, finding some concern for fetuses and small children but that adults had almost nothing to worry about.
The chemical, commonly used as dental sealants, eyeglasses, CDs, DVDs and as lining in aluminum cans, was found in the urine of 93% of Americans tested. More than 6 billion pounds are produced each year in the United States.
The Journal Sentinel reported in December that the study, by a panel of 12 scientists appointed by the National Institute of Environment Sciences, gave more weight to industry-funded studies and more leeway to industry-funded researchers. The newspaper found that the panel missed dozens of studies publicly available that the newspaper found online using a medical research Internet search engine.
Scientists, many of whom have spent years studying bisphenol A and have found it to be harmful, also criticized the panel's report. These scientists have found that bisphenol A can cause breast cancer, testicular cancer, diabetes, hyperactivity, obesity, low sperm counts, miscarriage and a host of other reproductive failures in laboratory animals.
"In this case, there's been so much criticism raised," Bucher said.
The Journal Sentinel found that studies paid for by the chemical industry were much less likely to find damaging effects or disease. The newspaper's stories were widely circulated in the scientific community. Bucher said the newspaper's findings will be considered in the review, including criticism that the panel allowed a study to be translated by the American Plastics Council.
Bucher said the review would consider why the panel had rejected academic studies that found harm when looking at the effects of low doses of bisphenol A. The panel did not accept any studies that found an effect at low doses in its review of 742 studies.
Once the panel weeded out studies it believed had been done poorly, no studies remained that showed effects from low doses, panel chairman Robert Chapin said in an earlier interview.
"There's a lot of bad science out there," he said at the time.
Chapin could not be reached for comment Wednesday.
A growing number of scientists have found that bisphenol A causes harm to animals in low doses. And the National Academy of Science and the toxicology program itself have called for a radical reform in the way that government screens chemicals such as bisphenol A. But, so far, the government hasn't budged from its original formula.
Michael Shelby, director of the government agency that selected the panel to evaluate bisphenol A, said he welcomed the review.
"We want to get it right," he said. "That's the way science works is through scrutiny and through peer review." Shelby said he was not surprised at the extraordinary amount of criticism aimed at the report.
"It's a hot topic, and there's a considerable amount of literature," he said.
The federal government is soliciting public comment on the panel report until Jan. 25. After that, agency staff will review comments, criticism and any new research on bisphenol A. Then, the toxicology program will issue a report that will be subject to another round of public comment, and, ultimately, a scientific review in June.
Congress to investigate use of bisphenol A in formula cans
By SUSANNE RUST and CARY SPIVAK
Jan. 17, 2008
A congressional committee is launching an investigation into the use and safety of a chemical found in many children's and infant products, including the lining of liquid infant formula cans.
Michigan Democrats Rep. John Dingell, chairman of the committee on Energy and Commerce, and Rep. Bart Stupak, who chairs a subcommittee, on Thursday sent letters to seven major manufacturers of infant formula, including Nestle USA and Abbott, demanding answers about the companies' use and knowledge of the chemical bisphenol A.
"There is concern in the scientific community that this chemical, bisphenol A, may be harmful both to adults and children," Dingell said in a statement. "It would seem obvious that we would try to protect babies and infants from chemicals that may be considered dangerous to adults."
The pair also fired off a letter to the Food and Drug Administration, requiring the agency's commissioner to show the scientific support for its position on the chemical's safety.
The FDA in November reiterated its stance that bisphenol A is safe for infants and adults, saying it saw "no reason at this time to ban or otherwise restrict uses now authorized."
"Our primary goal is to protect infants from a potentially harmful chemical," Stupak said in a statement. "Our investigation intends to examine how the FDA determined this chemical to be safe for use in infant formula."
Trade group reassures
Officials from the International Formula Council, the trade group representing the nation's largest formula makers, stressed in an interview Thursday evening that formula is safe.
"Parents using infant formula should not be alarmed," said Marisa Salcines, the trade group's spokeswoman. "No changes in infant feeding practices are recommended."
However, Salcines and Haley Stevens, the council's scientific affairs coordinator, left the door open for changes in packaging infant formula if it is later proven that dangerous levels of bisphenol A are leaching into the product.
"It's a controversial issue . . . at this time there is not a scientific consensus," Stevens said. "The jury is still out."
Studies have shown that bisphenol A causes breast cancer, testicular cancer, diabetes and hyperactivity in laboratory animals. Two government panels, including one that has come under fire as being biased in favor of chemical-makers, have warned that bisphenol A might be dangerous to developing fetuses and children younger than 3.
Bisphenol A, or BPA, was developed in 1891 as a synthetic estrogen but came into widespread use in the 1950s when scientists realized it could be used to make polycarbonate plastic and some epoxy resins to line food and beverage cans. More than 6 billion pounds of BPA is produced annually in the U.S., for use in a wide array of products, including dental sealants and baby bottles.
The chemical has been found in the urine of 93% of Americans tested.
The congressional investigation was sparked by the growing volume of scientific research and a rash of media attention to the issue of hormone-mimicking chemicals, including bisphenol A and phthalates.
"There appears to be at least circumstantial evidence suggesting that BPA can be harmful to adults," said Rep. Al Wynn (D-Md.), the chairman of the subcommittee on environment and hazardous materials, in the statement announcing the investigation. "On its face, it seems unwise to expose infants to such a potentially dangerous substance."
Researchers find risks
The move by the congressmen comes on the heels of a controversial National Toxicology Program panel that downplayed the risks of bisphenol A. That report is now undergoing an extraordinary review by the toxicology program.
In December, the Journal Sentinel reported that the panel gave more weight to industry-funded studies and more leeway to industry-funded researchers. The newspaper also found that the panel missed dozens of studies publicly available that the Journal Sentinel found online using a medical research Internet search engine. The newspaper also found an overwhelming majority of independent scientific research determined that bisphenol A causes harm to lab animals.
Steven G. Hentges, executive director of the American Chemistry Council's Polycarbonate/BPA Global Group, said that the amounts of bisphenol A that may leach into formula do not pose any danger to people. He said the FDA and regulators in Europe agree with that position.
BISPHENOL A MOST HARMFUL TO INFANTS, STUDY SAYS
by MARTIN MITTELSTAEDT
January 11, 2008 at 3:58 AM EST
A new U.S. study on the plastic compound bisphenol A indicates that the chemical may be far more dangerous for young children than for adults.
The finding has been submitted to Health Canada for its current safety review of BPA, and bolsters the case for limiting bisphenol A exposure in infants, who lack the capacity that adults have to detoxify it.
Bisphenol A is used in polycarbonate baby bottles and the epoxy linings of cans, including those for almost all types of infant formula. Because BPA can mimic estrogen, many researchers suspect it is a factor in health trends linked to sex hormone imbalances, such as prostate and breast cancer.
In the new study, researchers found that neonatal mice exposed to trace amounts of bisphenol A, either orally or through injection, ended up with similar amounts of the chemical in their blood because they do not have high amounts of the liver enzyme that breaks it down into an inactive form.
Young rodents don't fully develop the capacity to make the enzyme until they are weaned, a trait they share with humans. By contrast, adult rodents fed BPA have been found to rapidly clear it from their bodies using the enzymes.
Similar experiments are not done on babies for ethical reasons, but given the similarity of biological processes among mammals, many scientists consider the results applicable to humans.
The research study is expected to be issued next week by the peer reviewed journal Reproductive Toxicology.
The finding is "extremely scary," said Dr. Frederick vom Saal, a professor in the biological sciences department of the University of Missouri, and a member of the team that conducted the study.
Dr. vom Saal is a leading authority on BPA, and he contended that formula and polycarbonate baby bottles expose children to worrisome amounts of the synthetic estrogen. "You are significantly dosing your baby with bisphenol A every day and every time the baby is consuming food," he said.
Health Canada said in a statement to The Globe and Mail yesterday that "it is too early for us to state whether we have a concern or not with infant formula or baby bottles which contain BPA."
But two major formula makers - Nestle Canada and Mead Johnson Nutritionals - dismissed the concerns.
"Health Canada, as well as other international authorities such as the U.S. Food and Drug Administration, have approved the use of BPA in food packaging," Nestle Canada said in an e-mail statement.
"The preponderance of valid scientific literature right now upholds the position that BPA and the levels found in the food chain of humans is absolutely safe," said Gail Wood, spokeswoman for Evansville, Ind., based Mead Johnson. She also discounted the significance for humans of research on mice.
Based on a preliminary risk assessment in 2006, Health Canada said that bisphenol A was a chemical for which it had a "predisposition to conclude toxic." It is expected to issue a formal evaluation by May.
The study also contradicts a major contention on the safety of bisphenol A advanced by chemical manufacturers. Many of the nearly 200 studies finding severe health effects from bisphenol A exposure have been done by injecting young or pregnant rodents with the chemical.
The American Chemistry Council, an Arlington, Va., trade group for major BPA manufacturers, has argued that injection study results aren't applicable to humans because people are thought to have most of their exposures from oral sources, such as food, subject to rapid metabolizing by liver enzymes. Delivering BPA by injection bypasses this detoxification process and may cause health effects that wouldn't occur by ingesting the chemical, according to the industry's view.
However, the new research indicates that both oral and injection approaches are equally valid for experiments during fetal and neonatal development.
Health Canada said it hasn't yet decided whether to accept or reject the industry's position on the dosing controversy.
The council did not respond to a request for comment on the new research.
CONGRESS PROBES BABY FORMULA PACKAGING
By MATTHEW PERRONE
January 17, 2008, 7:06PM ET
House Democrats are investigating whether a chemical used to package baby formulas poses a risk to infants, despite assurances by U.S. regulators that it is safe for kids and adults.
Reps. John Dingell and Bart Stupak sent letters Thursday to seven companies that make baby formulations, questioning whether they use bisphenol A in the lining of their cans and bottles. The companies include Hain Celestial Group, Nestle USA, Abbott Laboratories and Wyeth.
The chemical at issue has been used to package foods for over 50 years, but consumer advocates said last year that trace amounts that leak into food could be dangerous to babies.
Concerns about the chemical caused Canadian retailers to remove bottled water and other plastic containers from store shelves last month.
FDA is reviewing the safety of the chemical but said last November it "sees no reason at this time to ban or otherwise restrict its use."
In a letter to FDA, Dingell and Stupak, both Michigan Democrats, ask commissioner Andrew von Eschenbach to explain how the agency determined bisphenal's safety.
"At best, the scientific community has concerns about the safety of bisphenol A," said Stupak, in a statement. "Our primary goal is to protect infants from a potentially harmful chemical."
An expert panel of researchers assembled by the National Institutes of Health said last August that the chemical's "impact on human health is a concern, and more research is clearly needed."
Additional research is a good idea, according to a trade group for baby formula makers, but they stressed Thursday that regulators in the U.S. and Europe believe the amounts found in food products are not dangerous.
"Parents using infant formula should not be alarmed because the bisphenol used in infant formulas and other food packaging exists in trace amounts," said Marisa Salcines, spokeswoman for the International Formula Council. "No change in infant feeding practices are necessary at this time."
A spokesman for Wyeth said Thursday the company does not use the chemical to package any of its baby formula products. Calls placed to other companies Thursday evening were not immediately returned.