ENVIRONMENTAL AND HEALTH GROUPS ARE PUSHING TO RESTRICT THE USE
OF PHTHALATES - COMPOUNDS USED IN COSMETICS, TOYS AND MEDICAL
DEVICES

By David Kohn, Newsday, March 4, 2003

They have become ubiquitous: a group of little-known chemicals used
in everything from nail polish to skin moisturizers to toys to shower
curtains to time-release capsules to vinyl flooring. They soften
plastic and dissolve fragrance into perfume. They are the new car
smell in new cars.

But are they safe? Some researchers say there is evidence that the
chemicals can cause birth defects and damage the male reproductive
system. Several environmental and health groups are pushing to
restrict the compounds' use in cosmetics, toys and medical devices.

The chemicals in question are a family of versatile substances known
as phthalates, widely used for the past 50 years. U.S. manufacturers
produce around a billion pounds a year.

"Rubber boots, swimming pool liners, traffic cones, insulation on
electrical wiring - anything you see that's plastic, it's likely that
it contains phthalates. They're everywhere," says Mike Shelby,
director of the Center for the Evaluation of Risks to Human
Reproduction at the National Institute of Environmental Health
Services. The Center has spent the past 18 months studying phthalate
risks.

Scientists have long known that relatively large doses of some
phthalates (pronounced "tha-lates") can lead to health problems,
including cancer. But researchers have begun to suspect that lower
levels may also have negative effects. And new research suggests that
humans are being exposed to higher levels of phthalates than
previously realized.

"This is on everybody's radar now," says Boston University
environmental epidemiologist Richard Clapp. "We may not have seen the
fire yet, but there's an awful lot of smoke."

According to toxicologist Paul Foster of the National Institute of
Environmental Health Sciences, researchers are finding that smaller
doses than previously realized can cause harm. His recent work on how
the chemicals affect the development of the rat reproductive system
suggests that fetuses in the first trimester are particularly
vulnerable.

The lowest level that produced adverse effects in the rats was 100
milligrams a day per kilogram of body weight. This is about 500 times
more than what a 2001 study by the national Centers for Disease
Control and Prevention found in the general human population. Many
toxicologists prefer the level to be 1,000 times higher than a level
that produces adverse effects. "When you're dealing with things that
cause birth defects," Foster says, "you like to have a nice cushion."
Foster also notes that he examined only one compound, dibutyl
phthalate (DBP). Along with one other compound, Di 2-ethylhexyl
phthalate (DEHP), DBP is considered to be the most toxic phthalate.

"I don't think anyone needs to panic," he says. "But I don't feel
really comfortable with young women who are being exposed to two or
three different phthalates."

Industry groups counter that phthalate-containing products pose no
danger to humans. "Exposure in humans is well below levels that have
shown no effects in animals," says Gerald McEwen, vice president for
science at the Cosmetic, Toiletry, and Fragrance Association, based in
Washington, D.C. "The data shows that these [levels of] chemicals are
safe."

Most phthalate researchers say the jury is still out on phthalate
risks - particularly their threat to developing fetuses and children.

Dozens of animal studies have shown that phthalates can disrupt the
endocrine system, inhibiting male hormones and causing male
infertility and birth defects. But animal studies alone do not provide
enough proof, says Marian Stanley, manager of the American Chemistry
Council's Phthalate Esters Panel, which presents the industry's side
in the debate. "Nobody's been able to reliably link any harmful
effects to humans," she says.

The reason, says Shelby of the Center for the Evaluation of Risks to
Human Reproduction, is that research on humans barely exists.
"Industry says there is no human evidence, and that's true," says
Shelby. "But the absence of evidence doesn't mean there's no effect.
In this case, it means that no one's studied it."

As concern over phthalates grows, more scientists are doing research
on humans. A study published last year in Environmental Health
Perspectives, the official journal of the National Institute of
Environmental Health Sciences, found that a group of men with DNA-
damaged sperm also had higher levels of diethyl phthalate (DEP) -
regarded as one of the less toxic phthalates. "The data suggests there
may be an association between phthalates and problems with semen. It's
intriguing," says the study's leader, Professor Russ Hauser of the
Harvard School of Public Health.

U.S. regulators have already restricted some phthalate use. Earlier
this year, the Food and Drug Administration recommended that when
performing procedures on male babies and boys, as well as women
pregnant with boys, hospitals avoid using IV bags, blood bags and
tubing made with DEHP. The compound, which makes the devices pliable,
can leach from the plastic. The FDA also asked, but didn't require,
manufacturers to label DEHP-containing medical devices so hospitals
could more easily avoid them.

Much of the recent debate has focused on the chemicals' presence in
cosmetics. A 2001 study by the CDC found widespread phthalate
exposure, including higher than average levels of some phthalates in
the urine of women of childbearing age. Some women exceeded the EPA's
safety standard, a finding that scientists say are enough of a concern
to warrant further study. A follow-up CDC study in January reported
similar results.

The phthalates found in largest quantities were DBP and DEP , which
tend to be used in cosmetics and perfumes. The EPA's "reference
dose" - an estimate of the maximum daily exposure that is unlikely to
cause adverse health effects - for DEP and DBP is 0.1 milligram per
kilogram of body weight per day (a kilogram is 2.2 pounds). The
agency, which set those levels over a decade ago, says it is now
revising them.

Researchers surmised that the elevated levels of DBP and DEP could be
caused by women's use of beauty care products.

"There's cause for concern," says researcher John Brock, who oversaw
the CDC study. "We have broad exposure to phthalates in the
population. We have animal studies that show risk. So we really need
to know where these exposures are coming from."

In response to the finding of elevated levels in women of
childbearing age, a coalition of three environmental groups decided
last year to analyze phthalate levels in cosmetics. They tested 72
name-brand cosmetics - everything from shampoo to perfume to deodorant
- and found phthalates in 52.

"We never found the word 'phthalate.' We read thousands of labels,"
says Charlotte Brody, director of Health Care Without Harm in
Washington, D.C., one of the groups. Federal labeling laws do not
require phthalates to appear on ingredient lists of many cosmetics and
other products; they are usually part of the "fragrance," which is
considered a trade secret, and so may be omitted from labels.

"Millions of women are being exposed to multiple phthalates," says
Jane Houlihan, director of research at the Environmental Working
Group, another coalition partner. "And they have no way of even
knowing what products contain phthalates."

Pediatrician Lynn Goldman, for one, would like to know. Her 6-year-
old daughter loves nail polish, and also bites her nails.

"I have no idea what is in those products," says Goldman, a professor
of environmental health at Johns Hopkins University and former
Environmental Protection Agency official who was in charge of
regulating toxic chemicals during the Clinton administration.

Hair and nail salon workers "are breathing nail lacquers and hair
sprays day in and day out," she said.

But the FDA says phthalate-containing beauty products are safe. In
November, the Cosmetics Ingredient Review panel (CIR), an industry-
funded safety panel that advises the FDA, reviewed existing scientific
data and found that phthalates in cosmetics pose no risk. The FDA
agreed.

"The consensus between the CIR and the FDA was that phthalates are
safe in cosmetics," said FDA spokeswoman Veronica Castro.

Several cosmetics companies, including Aveda, have stopped using
phthalates in new products. Recently, the European Union decided to
phase out DEHP and DBP from use in cosmetics. The chemical industry
argues that the move was not based on science, but on irrational fear
and incomplete evidence.

Noting that some cosmetics are made without phthalates, Brody wonders
why manufacturers don't simply replace the controversial compounds
with other chemicals. McEwen says the answer comes down to logic: "Why
should we change from something that is absolutely safe? That doesn't
make sense."

Phthalate opponents say that even without ironclad proof that low
levels cause harm in humans, there is enough data to warrant a ban.
Animal studies must be considered, they say, particularly given the
difficulty of doing phthalate studies in humans.

"It's very hard to study in people, and very hard to find problems
even when they exist," says Goldman. "If a kid grows up and has
fertility problems, are you going to know how much nail polish his
mother used during pregnancy? We need to use the animal data."

The debate extends beyond cosmetics. Many soft plastic toys are made
with diisononyl phthalate (DINP), which studies show causes liver
damage in animals. Some environmental groups say the chemical, which
makes up as much of 40 percent of some plastic playthings, can leach
out at risky levels, particularly when kids suck on toys. Responding
to a combination of research and pressure, some countries have
restricted phthalates in toys. The EU has banned DINP in toys for kids
3 and under, while Japan has announced a plan to get rid of DEHP and
DINP in toys for kids 6 and under. In 1998, U.S. toy manufacturers
voluntarily agreed to stop using phthalates in pacifiers and rattlers.
But environmental groups say many other toys still contain DINP.

Recently, the U.S. Consumer Product Safety Commission completed a
four-year study, concluding that toys with DINP were not a health
risk. While agreeing that DINP could be toxic, the commission said
children sucked on toys an average of 1.9 minutes per day, and would
have to suck for 39 minutes to ingest risky levels.

But environmental and consumer groups criticize the ruling. "The CPSC
is erring on the side of exposing kids to a toxic chemical," said Andy
Igrejas of the nonprofit, nonpartisan National Environmental Trust,
which wants DINP banned from all 5-and-under playthings.

For some, the disputes over specific types of products miss the
point. "It's wrong that we're asking about phthalates just in
cosmetics or toys. People are getting phthalates from multiple
sources," says Dr. Ted Schettler, science director for the Science and
Environmental Health Network.

Some researchers believe that phthalates can migrate from packaging
into food, especially fatty items like cheese and meat. An ongoing
study by the Silent Spring Institute is looking at air and house dust
in 120 Massachusetts houses and has found "significant concentrations"
of phthalates, including DEHP and DBP. The study has been submitted
for publication in a leading journal.

"That suggests we should consider inhalation as a pathway," says
toxicologist Ruthann Rudel, who led the study.

One senior government researcher, who requested anonymity, said that
because phthalates are part of so many products, no one has a clear
picture of how and where humans are being exposed. He notes that the
CDC study looked for only seven compounds; there are, he says, dozens
used in commercial products.

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Copyright 2003, Newsday, Inc.