By Meg Kissinger and Susanne Rust
MILWAUKEE — An international consortium of industry, academic and government scientists has rejected as incomplete and unreliable the U.S. Food and Drug Administration's case that a chemical found in food containers and other household products is safe.
The group, which met last month in Germany, is working to release a consensus statement in the next few weeks. The meeting was closed to the public, but McClatchy Newspapers has interviewed many scientists who attended the meeting and has seen several working versions of their agreement.
The group raises questions about the two studies the FDA has used as its foundation to declare that bisphenol A is safe in food and beverage containers. It calls for a much broader look at the chemical than the FDA has given.
Speakers at the conference included Rochelle Tyl, the author of the two studies that are being used as the FDA's bench marks. Both of Tyl's studies were paid for by the American Chemistry Council, a trade association for BPA makers.
According to scientists at the meeting, Tyl conceded that there were errors and inconsistencies in the 2008 report that the FDA used as the foundation for its findings.
"It is becoming undeniable that BPA is dangerous," said Laura Vandenberg, a developmental biologist at Tufts University, one of 58 scientists from around the world invited to the conference in Germany. "The FDA's standard for safety is reasonable certainty. It is no longer reasonable to say that BPA is safe."
The group's conclusions also call into question the European Food Safety Authority's assessment of BPA. The authority, which also relies on Tyl's studies, sets policy for all countries in the European Union.
The scientists' consensus statement will contradict claims by industry spokesmen who have been citing the FDA and European assessments as proof that BPA is safe.
Tyl told McClatchy in an e-mail that her studies do not claim that BPA is safe. Her studies were not designed to cover all aspects of the chemical's effects. They simply show no effects to the reproductive system of rats and mice that were exposed to the chemical at low doses, she said.
She has previously acknowledged inconsistencies in her data, particularly the age of some animals that were examined in the 2008 study for effects on the prostate.
While Tyl answered several questions by e-mail, she declined to be interviewed.
John Vandenbergh, a biologist at North Carolina State University who attended the conference in Germany, said the FDA risks losing credibility by relying on such flimsy evidence.
"We desperately need good judgment at the FDA," Vandenbergh said. "For years, they did a superb job looking out for food safety. I hate to see something like this jeopardize all that."
The conference, held in late March, was called to reassess the safety of BPA for German regulators. But the agreements that were forged there are being closely watched by those worldwide with a stake in the future of the chemical, including BPA-makers, regulators and advocates who consider the chemical to be dangerous.
The group agreed that Tyl's studies were too limited in their scope to be considered bench marks.
The group found that Tyl's studies failed to consider serious dangers posed by BPA. They include effects on behavior and the development of the brain and prostate. Those problems were identified in a National Toxicology Program report published last year. FDA administrators promise to address those issues more thoroughly now.
Despite concerns raised by other regulatory agencies, the FDA declared BPA to be safe last August. It cited Tyl's two studies, which were released in 2001 and 2008. Several BPA experts and health advocates protested the ruling, saying that the agency was too quick to ignore hundreds of other studies that found the chemical caused harm. The agency's Science Board agreed and recommended that the FDA reopen its assessment of the chemical.
Laura Tarantino, director of the FDA's Office of Food Additive Safety, said Tyl's studies followed proper protocol. But she acknowledged some uncertainties about whether Tyl's studies addressed all concerns about the chemical. Neither Tarantino nor any FDA scientists were invited to the meeting.
Tarantino said her agency would now look at other studies that raise concerns about BPA.
BPA, developed more than 100 years ago as a synthetic estrogen, is used in thousands of household products to make hard, clear plastic for things such as baby bottles and food containers. It also is used in many dental sealants and to line most food and beverage cans. The chemical has been found in the urine of 93 percent of Americans tested.
Tests conducted last year by McClatchy found that toxic levels of the chemical leached from 10 different product containers when heated, including those marked "microwave safe." Although the levels that leached from the containers were low, McClatchy identified several peer-reviewed studies that found health risks in laboratory animals at similar levels.
Scientists began studying the chemical more than 10 years ago after laboratory animals were found to be developing health problems suspected of being caused by their polycarbonate cages. These problems included heart disease, obesity, diabetes, some forms of cancers and reproductive failures.
Recent studies have linked the chemical to heart disease and diabetes. It has been found to interfere with chemotherapy for breast cancer patients. Concern is especially keen for its effects on fetuses and newborns, whose development are most affected by exposure to the chemical.
Canada declared BPA to be a toxin and has banned its use in baby bottles. Earlier this year, the six major baby bottle makers promised to stop using BPA. Sunoco, one of five BPA makers, now requires companies buying its BPA to sign a promise that they will not use it to make products for children under age 3.
The government is expanding its look at the chemical, and last month the National Institute of Environmental Health Sciences announced it was investing $5 million in BPA research. Last month, bills were introduced in both houses of Congress to ban BPA from all food and beverage containers.
The German conference did not reject Tyl's studies but had questions regarding her methodology and accuracy.
In the past seven months, Tyl has given three different accounts of the ages of the animals that she used to study BPA's effects on prostate size. Scientists who attended the conference in Germany say that the discrepancies are significant because prostate size varies greatly depending on age. A larger than normal prostate could indicate cell change caused by BPA.
Tyl said in her 2008 paper that the animals were younger than 14 weeks, or around 3 months old. Critics questioned this at an FDA hearing in September. They noted that Tyl's data showed the mice to have abnormally large prostates for animals that were 3 months old. They said that could indicate that either the animals were diseased or that a lab technician had bungled the data.
Tyl said then that the paper erred. The animals were 6 months old, she said. FDA administrators were at the hearing, but there is no record of the discrepancy on the FDA's Web site, which lists the studies for the public to review.
Last month in Germany, when questioned again, Tyl said the paper was wrong. The animals actually were 5 months old.
Vandenbergh, the BPA expert from North Carolina State, said the discrepancies "significantly weaken" Tyl's 2008 study.
"I wouldn't use it as a benchmark study," Vandenbergh said.
Scientists who attended the conference said they also were concerned about a fire that broke out in Tyl's North Carolina laboratory that was never reported to the FDA.
The fire occurred on Aug. 25, 2001, about a year after her first paper had been written and some three years before work began on the second study.
Eighteen polycarbonate cages, made with BPA, burned in the fire. Scientists at the conference say the lingering effects of the fire may have compromised future experiments. The chemical could have gotten into the heating ducts or the feed, exposing the animals to much higher doses than reported in the study.
Tyl's company, RTI International, investigated the fire — which appeared to be arson. An independent firm analyzed the lab and reported that it had been sufficiently cleaned. The group declared that the animals were not compromised and that Tyl's lab "was, and continues to be, an excellent facility."
But scientists at the conference, when told of the fire by McClatchy, said they would not trust that assessment. BPA is a sensitive chemical that acts at extremely low levels, and the group that analyzed the lab did not test for the chemical at those levels, they said.
Vandenbergh, of North Carolina State, who examined the reports on the fire and the laboratory's investigation for McClatchy, said he would have conducted the experiments at a different lab.
"In hindsight, this is too important of an issue to leave open these questions," Vandenbergh said.