The EPA – Completing the Trifecta

On the heels of yesterday’s post on the FDA failing to protect our public health and riddled with conflicts-of-interest, which followed last week’s rising tide of criticism of the CDC, the U.S. Environmental Protection Agency (EPA) joins the club.  It’s an official trifecta. 

From The Milwaukee Journal Sentinel:


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EPA drops ball on danger of chemicals to children

Agency oversight panel out of money and, critics say, beholden to industry

Posted: March 29, 2008

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

"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

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

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

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

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

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

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

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

"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. 

From the March 30, 2008 editions of the Milwaukee Journal Sentinel
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