http://www.jsonline.com/story/index.aspx?id=733566
Agency oversight panel out of money and, critics say, beholden to industry
Posted: March 29, 2008
Like many parents, New Berlin mom Becky Fisco figures that if the chemicals sprayed on crib mattresses could make her 5-month-old baby sick, government regulators would warn her about it.
“I just assume that these things are safe or they wouldn’t be allowed to be sold,” said Fisco as baby Natalie cooed in her stroller and 3-year-old Grant tumbled around the Betty Brinn Children’s Museum.
The Environmental Protection Agency is supposed to evaluate compounds in products such as flame retardants in mattresses and car seats to see if they are especially harmful to children.
But it doesn’t.
The EPA’s Voluntary Children’s Chemical Evaluation Program, which relies on companies to provide information about the dangers of the chemicals they produce, is all but dead.
Funding ran out last August.
Committees haven’t met in nearly a year.
Key members of the program can’t even say if it is still alive.
The EPA’s own advisory committee blasted the pilot program as severely flawed and has called for a total overhaul.
Still, EPA administrators call the program a priority and routinely cite it as proof that the government is answering concerns about kids being exposed to potentially dangerous household chemicals.
The Journal Sentinel reviewed all public correspondence of the little-known federal program, the backgrounds of program panel members and meeting attendance records. Among the findings:
• Some panels deciding on the safety of chemicals were disproportionately staffed with scientists who had financial ties to chemical makers.
• Industry scientists often downplayed the risks that their chemicals posed. In one case, scientists underestimated by nearly 40 times the amount of a certain chemical found in the blood of people tested for the compound – a substance suspected of interfering with behavior and brain development.
• When pressed for more information about the chemicals they made, companies often refused or ignored requests by the EPA.
• The EPA did not keep a budget for the program and couldn’t say how much was spent over the past eight years.
• The program’s Web site describing the dangers of chemicals to children is so riddled with jargon that even pediatricians specializing in environmental health say they can’t make sense of it.
The program has “failed in its goal of providing the public and pediatricians with timely, useful information,” said Jay Berkelhamer, then president of the American Academy of Pediatrics, in a letter to EPA administrator Stephen Johnson last year. “The EPA should consider terminating this pilot and replacing it with a mandatory program with stricter deadlines and a more transparent, accountable review system.”
Berkelhamer, an Atlanta pediatrician, said in an interview that nothing has changed his opinion since he wrote the letter. He called chemicals, including those routinely found in mattresses, car seats and other products used by children, “a tremendous health concern.”
“We need to be a lot more diligent,” he said.
Still, the American Chemistry Council, the industry trade group, praises the federal program as “scientifically rigorous, open, transparent, timely and useful.”
And EPA administrator Johnson, who declined interview requests for this story, repeatedly points to the program in public statements as proof that his agency is committed to protecting children.
Ward Penberthy, associate director of the EPA’s Chemical Control Division, acknowledged that the EPA program is not working as many had envisioned.
“Whenever you work on environmental issues that are complex and contentious, they take longer than you would ever hope,” Penberthy said. “Clearly we want to get this working faster and make improvements. Admittedly, this needs to be speeded up and streamlined.”
This comes as Johnson and the EPA’s political appointees are increasingly under fire from environmental groups and scientists – including the EPA’s own – for ignoring science and bowing to industry.
A letter written to Johnson last month by the union representing EPA scientists charges the administrator with ignoring the agency’s own principles of scientific integrity for the sake of political expediency.
Began in 1990s
The children’s chemical screening program was created in the late 1990s amid concerns about compounds such as those found in flame retardants and cleaning products after traces of them were detected in samplings of Americans’ blood, breast milk, breath and fat.
Chemicals used in flame retardants were among the first group of chemicals to be studied.
Flame retardants were developed to protect people from injuries and death caused from fire. But mounting evidence shows that these chemicals may be dangerous to children’s health, and particularly to the health of developing fetuses and infants.
A 2007 study conducted by the Maine Center for Disease Control and Prevention showed that exposure to these chemicals in utero affected learning behavior and motor skills in mice.
The EPA claims to be working with the chemical companies to provide more data that will allow the public to better understand the chemicals’ risks to children.
Just last week, however, the EPA reported that the consortium of U.S. companies that makes the chemical refused its request for more testing.
EPA officials admit that they are powerless to elicit more information from the companies about the chemicals.
“We can’t make them do anything,” Penberthy said.
The EPA has identified the chemical as a possible cancer-causing agent and one that potentially can interfere with brain development.
For its pilot program, the EPA identified 23 chemicals of the more than 80,000 on the market and asked the companies that make those compounds to provide information about their potential effects on children.
Instead of regulating the chemical companies, the EPA invited them to interpret and present data to a panel of scientists on the risks and exposures of chemicals they made. The approach was hailed by chemical company lobbyists as “breathtakingly significant.”
Leaders in government and industry touted their partnership as a novel way to engage the chemical industry to take responsibility for the safety of its products without the costly and time-consuming chore of government regulation.
The format was simple. Companies were to present data about their chemicals’ toxic properties and likely exposure to a panel of scientists. That panel would then determine if the chemical was safe to use around children. If not enough was known, the EPA would ask the company to provide more information.
“I think industry might have felt that, yeah, let’s rise to this challenge,” said Lynn Goldman, former head of the EPA’s Office of Prevention, Pesticides, and Toxic Substances. “That will give us the ability to develop the tools, give us the flexibility in how it’s done. . . . It could be a benefit to be a leader, to be innovative.”
Not everyone was so enthusiastic.
“Industry has a terrible track record of providing toxicological information,” said Jerome Paulson, a physician and professor at George Washington University who served on the committee to establish the program’s rules. “If they are so interested in providing this information, why haven’t they?”
Some are suspicious
Because the EPA leaves the review of chemicals to the chemical makers, the very framework of the program has invited suspicion.
Scientists on the panels were chosen by Toxicology Excellence for Risk Assessment, a private, nonprofit company paid roughly $2.5 million by the EPA to manage the program. The company has a number of contracts with the federal government to serve as an intermediary between government and industry. It also works directly for industry on a number of other projects.
Jacqueline Patterson, who works for the toxicology company that organized the meetings, said her firm went to great lengths to avoid conflicts of interests with the scientists it selected for the panels.
“Because we are a neutral, nonprofit organization, conflict of interest discussions are very serious to us,” Patterson said. “We will not seat an expert who owns any stock, or has any other financial dealings in the sponsor companies.”
But the Journal Sentinel review found that some panels were staffed with scientists who had financial ties to the chemical industry. For instance, eight of the 10 members of the panel studying a chemical found in gasoline and paints were either employed by chemical companies, worked for firms that had consulting contracts with chemical makers or received research funding from the chemical industry.
Patterson defended her company’s choice of scientists. Her company evaluated each panelist “carefully and determined they have no financial conflict of interest, nor extreme bias that would interfere with their objectivity,” she said.
“Fulfilling our . . . mission to protect public health depends on our ability to be neutral,” Patterson said.
There are other gaps in the program’s transparency.
Program managers do not account for how they spend public money. The EPA does not maintain a separate budget for the program. And the EPA’s public information officers were unable to say how much it spends, despite repeated requests by the Journal Sentinel.
Because the company that manages the program is not a direct contractor for the government, no one at the company is obligated to provide any information.
Cooperation not required
The voluntary nature of the program has proved to be a problem with enforcing safety, children’s health advocates say. Although the EPA can request more information about a chemical from the compound makers, companies are not required to answer. And many don’t.
“The EPA has no hammer,” said Melanie Marty, chairwoman of the EPA’s Children’s Health Protection Advisory Committee.
Even as the program was being established, critics complained about a lack of accountability. More needs to be done to let the public know about the meetings, they said.
Because the EPA doesn’t have direct control over the program, meetings are not announced in the Federal Register, the government’s official calendar scrutinized by policy-makers and watchdog groups.
“If you are going to try to assure people that you have enough information to protect kids, you’d better have a transparent process and let people comment,” Marty said.
Nothing is done when chemical companies refuse to answer questions about the chemicals that they make.
In one case, the EPA asked 12 chemical companies for tests to assess the safety of benzene, a chemical used in gasoline that is known to cause leukemia, anemia and bone marrow disease. The EPA wanted information about how the chemical could affect the developing brain and reproductive system. The chemical companies, including BP Amoco, Dow Chemical Co. and ExxonMobil Chemical Co., said they disagreed with the government’s opinion that more information was needed, and refused to provide the answers.
In the case of xylenes, a chemical found in gasoline, paint varnish, shellac and cigarette smoke, the companies simply did not reply when the EPA requested further testing.
“What I think happened is that, as time went by, the participants began to feel that they had the most to gain by the program doing as little as possible, because there wasn’t going to be a regulatory requirement,” said Goldman, the former EPA official.
Progress has been excruciatingly slow, Marty said. Of the 23 chemicals in the pilot, just 12 have been partially evaluated. Three were never even considered for review.
At this rate, pediatrician Berkelhamer said, it will take “literally centuries” to get through data on the hundreds of chemicals that children are exposed to each day.
Flawed science
Some of the scientific findings that the companies presented were seriously flawed, records show.
In its own review, the company managing the program for the EPA found that the maker of chemicals used in flame retardants underestimated the concentrations of the chemicals in people’s blood by a factor of nearly 40.
Such an assessment greatly underestimated the risks the chemicals posed to children’s health.
Chemtura, formerly known as Great Lake Chemical Co., quit making those chemicals in 2004 and stopped answering the EPA’s questions.
“Chemtura has no further comments to make about these substances,” said Debra Durbin, director of communications for the company.
Penberthy of the EPA said his agency had no way to compel Chemtura to provide information once the company stopped production of the chemicals.”That’s a pretty good rationale to drop out of the program,” Penberthy said.
The chemicals are now banned from production in the U.S. and Europe.
But children are still exposed to those chemicals in thousands of products produced before the ban, including upholstery, carpeting and clothing.
In another case, Chemtura and two other companies – Albemarle Corp. and Ameribrom Inc. – used a peculiar group of subjects to determine the risks to children of a particular flame retardant commonly known as decaBDE.
Instead of using children, the companies used blood tests from 12 adult men living in Illinois in the 1980s. Children’s systems are potentially more sensitive and vulnerable to certain chemicals than adults’.
Further complicating the matter, the use of this chemical is much more widespread today than it was 20 years ago. Therefore, 12 adult men living in Illinois are hardly representative of the entire country, critics say.
“The claim that this chemical does not pose risk is totally unsupported,” said Ruthann Rudel, a scientist for the environmental group Silent Spring Institute who sat on the panel that considered the safety of the flame retardant chemical. The panel found a number of problems with the report prepared by a consortium of the companies on the safety of the chemical. The panel raised several questions, none of which has been answered, she said.
Neither Albermarle nor Ameribrom responded to the newspaper’s requests for interviews.
Other studies based their results on questionable assumptions or unrealistic conditions, a review of the panel remarks shows.
The trouble with acetone
In the case of acetone, a chemical found in nail polish removers, the chemical maker suggested that normal use of the product included being in a 700 cubic-foot room – about twice the size of the average bathroom – in which there was an open window with a window fan sucking out the fumes. Research shows that acetone, when inhaled in high concentrations, can potentially lead to birth defects and liver and brain damage. So proper ventilation is important.
Sarah Cassada, a Milwaukee day care director and the mother of two, says she knows that the chemicals in nail polish remover are dangerous if used without proper ventilation. But she confesses that she often caves in to the demands of her 5-year-old, Isabelle, to polish her nails.
“My daughter is obsessed with nail polish,” said Cassada, 31, of Oconomowoc. “She’s a real girly girl.”
Parents need more specific information about the dangers of chemicals and how to properly use them, said Berkelhamer, the former pediatrician association president.
What little information there is tends to be written in scientific jargon that is difficult for mothers like Cassada or anyone to understand, said Berkelhamer.
The EPA’s “Web site is not organized in a manner that is useful to pediatricians or families,” Berkelhamer said in his comments filed with the EPA last year. “Information is not presented in a format or language that is easily understood by the layperson or non-scientist, but makes heavy use of jargon, acronyms, and scientific terminology.”
Information left out
The Web site does not list information as basic as common sources for the chemicals, which would allow parents to determine how the chemicals might be getting into their child’s body, the comments point out.
Even the EPA’s own advisers are sharply critical of the program.
Marty, the EPA advisory committee chairwoman, says the program “is just not working.” Her committee has criticized the program for not being thorough enough in gathering information about the safety of chemicals and for taking too long.
“The elephant in the living room is the fact that this program is going painfully slowly,” she said.
Goldman, the EPA administrator who helped develop the program 10 years ago, said she used to get upset at how flaccid and floundering the program had become. But she found that it didn’t do any good.
“I went through my grief over that program a long time ago,” she said.
Penberthy, who oversees the program now, said the program has had some success.
“I think we’re very impressed by the amount of work and details that sponsor companies have put into it,” Penberthy said. “We hope we can get to the point where we can do it more rapidly. We will be making changes soon that will likely do that.”
Until they do, parents such as Fisco and Cassada say they just have to hope that the chemicals that their children are exposed to aren’t hurting them.
“I know I probably should pay more attention to stuff like that,” Fisco said.
