[Pharmwaste] Labels often fail to list compounds that can disrupt biological development

DeBiasi,Deborah dldebiasi at deq.virginia.gov
Tue Nov 27 13:50:29 EST 2007


JOURNAL SENTINEL WATCHDOG REPORT <http://www.jsonline.com/index/index.aspx?id=102> 
Are your products safe? You can't tell. 
Labels often fail to list compounds that can disrupt biological development
srust at journalsentinel.com
Posted: Nov. 24, 2007
Take a look at your shoes, your shampoo, your carpet.
Your baby's bottles, even the dental sealants in your mouth.
These products contain chemicals that disrupt the natural way hormones work inside of you.
The chemicals known as endocrine disruptors are all over your house, your clothing, your car. 
The chemicals are even in you. 
They promise to make skin softer, clothes smell fresher and food keep longer. 
The problem is, neither the companies that make these products nor federal regulators are telling you that some of these substances may be dangerous. Many have been found to cause life-threatening illnesses in laboratory animals.
Chemical makers maintain that their products are safe. They point to government assurances and the millions of dollars they have spent on their own research as proof.
But a growing number of scientists are convinced the chemicals interfere with the body's reproductive, developmental and behavioral systems.
Hundreds of studies have shown that these compounds cause a host of problems in lab animals. They include cancers of the breast, brain and testicles; lowered sperm counts, early puberty, miscarriages and other defects of the reproductive system; diabetes; attention deficit disorder, asthma and autism - all of which have spiked in people in recent decades since many of these chemicals saturated the marketplace.
A Journal Sentinel investigation found that the government has failed to regulate these chemicals, despite repeated promises to do so. The regulatory effort has been marked by wasted time, wasted money and influence from chemical manufacturers.
The newspaper reviewed more than 250 scientific studies written over the past 20 years; examined thousands of pages of regulatory documents and industry correspondence; and interviewed more than 100 scientists, physicians, and industry and government officials. 
Among the findings:
* U.S. regulators promised a decade ago to screen more than 15,000 chemicals for their effects on the endocrine system. They've spent tens of millions of dollars on the testing program. As yet, not a single screen has been done. 
* Dozens of chemicals the government wants to screen first have already been tested over and over, even while thousands of untested chemicals are waiting to be screened.
* By the time the government gets around to doing the testing, chances are the results will be outdated and inconclusive. The government's proposed tests lack new, more sensitive measures that would identify dangerous chemicals that older screens could miss. 
* As the U.S. testing process remains grounded, hundreds of products have been banned in countries around the world. Children's products - including some baby toys and teething rings - outlawed as dangerous by the European Union, Japan and Canada, are available here without warning. 
* Lacking any regulation in the U.S., it's impossible for consumers to know which products are made with the dangerous compounds. Many companies don't list chemicals known to disrupt the endocrine system on product labels.
The government's efforts have been "an abject failure, a disaster," said Philip Landrigan, a pediatrician and chairman of the department of community and preventive medicine at Mount Sinai School of Medicine in New York.
Landrigan was at the White House ceremony in 1996 when President Clinton signed laws requiring the U.S. Environmental Protection Agency to screen chemicals for their effects on the endocrine system. 
Because the effects of endocrine disruptors may take years to reveal themselves, it is almost impossible to say that a particular chemical caused a certain disease. There also is a lot of uncertainty about how these chemicals work inside your body. So, scientists extrapolate. They can't test their theories on humans. Instead, they have to rely on animal studies and try to figure out the implications for people.
By mimicking or blocking the body's hormones, endocrine disruptors can trigger faulty messages that disrupt development. That makes them particularly dangerous to fetuses and young children, scientists say. These chemicals can be ingested, inhaled and absorbed through the skin.
Michael E. Mitchell, chief of pediatric urology at Children's Hospital of Wisconsin, has seen the consequences he attributes to these unregulated chemicals.
He has witnessed a dramatic spike in the number of genital birth defects in the last 30 years. And it breaks his heart, he said, to see the damage done to so many children who must undergo painful surgery to correct birth deformities.
Considering the number of chemicals that developing fetuses are exposed to, "it's amazing that anyone turns out OK," he said. 
Anxiety is rising over the growing number of cancer cases and other diseases linked to these chemicals. But few answers are forthcoming.
"People should know what they're being exposed to and be given the option to choose alternatives," said Shanna Swan, director of the Center for Reproductive Epidemiology at the University of Rochester School of Medicine and Dentistry. "And that is not happening very fast."
EPA officials blame their lack of progress on the complexity of the undertaking.
"Clearly, we would have liked to have been a lot further along," said Elaine Francis, national program director of the EPA's endocrine disruptors research program. "But science tends to move at its own pace."
To find how pervasive these compounds are in everyday use, the Journal Sentinel asked Frederick vom Saal, an internationally known expert in endocrine disruption, to perform a chemical audit of the Greendale home of Dean and Ellen Lang Roder and their four children, ages 3 to 10.
As the University of Missouri biologist went through each room in the house, vom Saal found hundreds of reasons for the Roder family to worry - from the bathtub rubber duck to the plastic pipes that bring water into their home.
"Anything that goes in your child's mouth is a factor for you to be concerned about," vom Saal told Ellen Roder as he held one of her children's dolls. "Particularly, dolls made from a plastic called polyvinyl chloride that 10 years from now just won't exist. It will be looked at like cigarettes. It is that dangerous."
Industry scientists dispute that. 
"Science supports our side," said Marty Durbin, federal affairs managing director for the American Chemistry Council, the trade group representing the plastics industry.
They say there is no reason to fear the toys, baby bottles and other products containing the chemicals because none of their studies has proved that the chemicals cause harm to people. Chemists for the industry say you would have to consume 1,300 pounds of canned and bottled foods each day to notice any effects from the chemicals those products contain.
"I'm very comfortable with my kids and grandkids using these products, and that's really my bottom line," said James Lamb, an industry consultant and former EPA regulator. "And it is because I believe the industry has done the studies that need to be done and that they're interpreting them properly."
Lack of screening
There are roughly 100,000 chemicals on the market today. Yet, lacking a coordinated screening program, there is no way to know how many of these chemicals interfere with the human endocrine system.
The chemicals at issue are used as additives in plastics, fragrances, creams and as flame retardants. 
Some of the more controversial compounds include bisphenol A and certain phthalates.
Six billion pounds of bisphenol A, the raw material of polycarbonate plastic and epoxy resins, are produced each year in the United States.
Phthalates (pronounced "THAL-ates") are the chemicals that make plastic flexible and allow creams and personal-care products to hold their smell. U.S. chemical companies produce more than 2 billion pounds of these compounds a year. They are commonly found in nail polishes and hair sprays, shower curtains and even Halloween costumes.
For more than a decade, government agencies have said that several of these chemicals are safe at levels that people are exposed to every day.
Chemical makers have relied on these assurances as proof that their products are safe. They bolster these conclusions with millions of dollars of research and testing.
But the newspaper's review of 258 studies of bisphenol A, a common ingredient in baby bottles, reusable water bottles, eyeglass lenses and DVDs, shows otherwise. 
More than 80% of studies analyzed by the Journal Sentinel show that the chemical adversely affects animals, causing cancer and other diseases. 
Developing embryos exposed to endocrine disruptors through their mothers are most at risk, said Theo Colborn, a scientist trained at the University of Wisconsin-Madison whose book on the explosion of dangerous chemicals in the environment, titled "Our Stolen Future," stirred passionate calls for reform and regulation when it was published in 1996. 
"You need the right hormones in the right place at the right time sending out the right signals," Colborn said. "If that's fouled up prenatally, you're in trouble."
Colborn, like many of her colleagues, has changed the way she deals with these compounds, refusing to store her food in plastic or use certain creams and lotions that contain chemicals suspected of causing harm. 
Wildlife abnormalities
Scientists first suspected that endocrine disruptors were wreaking havoc decades ago when they began observing freakish abnormalities in wild animals, particularly along the Great Lakes with its legacy of industrial pollution. 
They were seeing female gulls nesting together, birds with twisted bills and frogs with severe deformities, including one with an eye growing inside its mouth. Elsewhere across the country, scientists reported finding male fish with sacks of eggs and alligators with withered penises.
In 1991, Colborn, then a zoologist working for the World Wildlife Fund, convened a conference of some of the country's leading wildlife biologists, toxicologists and endocrinologists at Wingspread Conference Center in Racine to discuss the emerging science. 
It was there that the term "endocrine disruptor" was coined. The 21 scientists signed a consensus statement, expressing concern about the dangers that these new chemicals posed and calling for them to be tested immediately.
Five years later, Colborn and two colleagues chronicled the bizarre spectacles of nature and their theories about the causes. 
The authors wondered that if the toxins in the environment could cause these effects in animals, what were they doing to people? Just as with lead and tobacco decades before, these chemicals are all around us, ravaging nature's delicate design, the authors said. 
Their book stirred controversy in the scientific community, and many dismissed the claims as "junk science" because there was no direct link between specific chemicals and illnesses in people.
Within days of the book's publication, the chemical industry's trade group issued an alert to its members, warning them to expect a swarm of calls about the book's claims. The memo predicted the fallout could be fierce.
It was. 
Later that year, Congress unanimously passed two laws ordering the EPA to begin screening and testing chemicals and pesticides for endocrine disrupting effects by 1999.
The EPA convened a committee of scientists from academia, the government and the chemical industry to lay the groundwork for testing these chemicals. They came up with a way to identify and test chemicals for the risks and get the information to the public.
In the beginning, there was a groundswell of enthusiasm. Then-EPA administrator Carol Browner said in 1998 that her agency would begin fast-tracking efforts to screen these compounds by the end of that year. 
"Some 15,000 chemicals used in thousands of common products, ranging from pesticides to plastics," would be screened, Browner said.
Officials identified the program as a top priority. Browner appointed the first panel of scientists to build a framework for how to screen the chemicals. She left the agency after the presidential election in 2000. 
More than $80 million later, the government program has yet to screen its first chemical.
That has left Browner, and others, concerned about the lack of any results.
"It doesn't take nine years," she said with a sigh. "You adjust as you go. You don't have to build a Cadillac when a Model T will do."
Promise unfulfilled
Frustrated at the lack of action, a consortium of environmental, patient advocacy and labor groups filed a federal lawsuit, prompting the EPA to promise that screening would begin by the end of 2003. 
But the agency repeatedly has missed its self-imposed deadlines as well as those set by law.
Agency administrators testified twice before Congress, first in August 2000 and again two years later, pledging that the screening would be in place soon. Three separate committees of academic and industry scientists, including the one Browner formed, have been appointed by the EPA to take up the issue. 
"A lot of bureaucratic foot-stomping and dust-raising," was the observation of Peter DeFur, a researcher at the Center for Environmental Studies at Virginia Commonwealth University who served on all three of the committees.
"To delay is to win on the part of the industrial community," DeFur said. 
Industry, he said, tried mightily to slow the effort. He was particularly critical of one test pushed by chemical makers that involved studying mature male rats to see the chemicals' effects on the development of the reproductive system.
"What does the old white rat have to do with development?" DeFur said. "By the time he gets to be mature, or even nearly mature, all the organs are developed."
Industry and other groups have flooded the EPA and the committees with research, said L. Earl Gray Jr., an EPA research biologist. 
The industry's lobbying efforts are led by the American Chemistry Council. The group has a $75 million budget and includes some of the biggest names in commerce - Dow Chemical Corp., Procter & Gamble Co. and DuPont.
Chemical makers have "in some sense learned that if you play on the uncertainty of danger, you're going to be able to stop regulatory action especially in an anti-regulatory era," said David Rosner, professor of history and public health at Columbia University. That's particularly true "in a time when so many of our regulatory agencies have been neutered politically and socially," he added. 
Durbin, of the trade group, denied any stall tactics.
"If it was our interest to delay things around here, we'd just sit on our hands and see whether or not EPA gets any funding," said Durbin, noting that the trade group frequently lobbies for increases in the EPA's budget. 
Annual federal funding for the endocrine disruptor screening program peaked at $12.6 million in 2000 and has dropped by about one-third. 
Critics have charged that the White House has cut back on efforts to regulate a wide array of industries. DeFur, among others, felt that frustration while serving on the endocrine disruptor committees.
Clifford Gabriel, director of the EPA's Office of Science Coordination and Policy, countered that budgetary constraints have not hurt the progress.
Stephen L. Johnson, Browner's successor as head of the EPA, declined requests to be interviewed.
Whatever the reason, the committees met less frequently as time went by. 
By April 2006, 10 years after the congressional order to begin the screening, progress stalled altogether. 
Gerald LeBlanc, chairman of the committee charged with developing the screens, got a call from an EPA administrator, assuming that the two would be setting the committee's next meeting. Instead, LeBlanc was told the committee was being terminated.
"They were not going to allow me to take this job to completion," said LeBlanc, toxicology professor at North Carolina State University. 
Edward Orlando, a biology professor at Florida Atlantic University and a member of the last committee, said its abrupt dissolution came as a disappointment - not to mention a waste of public money. 
"How long will this take? Another five years? Another 10?" Orlando said.
The EPA's Francis said that LeBlanc's committee had a set term, and the agency felt it was more efficient to turn the work over to an advisory panel, where it remains today. But committee members say the effort was doomed for the past several years.
"Frankly, there was not enough political oomph behind it," said Gina Solomon, a member of the first EPA committee and senior scientist for the National Resources Defense Council.
Those with ties to industry say they, too, wish the process moved faster.
"Everyone is disappointed that you can't make quicker progress, but it does take time," said Thomas Osimitz, an industry consultant who sat on two of the three EPA committees. "It's frustrating, but, on the other hand, I don't know what could be quicker."
Outdated testing
By the time the government gets around to the tests, they likely will be of little value. Under the current model, government tests do not screen for the chemicals' effects at low doses. 
Instead, government researchers follow standard toxicology testing practices, feeding animals such as rats huge doses of the chemical. 
Then they record the damage to the animal, most often cancer, behavioral or reproductive failures. The researchers then test the rats at lower and lower doses until they no longer find those problems.
But bisphenol A and phthalates don't work that way, many scientists say. They can elicit different effects in animals at extremely low doses. 
Two groups of scientists, one from the National Academy of Science and the other from the National Toxicology Program, have called for a radical reform in the way that government screens these chemicals. But, so far, the government hasn't budged from its original formula. 
"The EPA is lumbering along trying to clumsily incorporate the science of a couple of decades ago," Solomon said. 
The list of chemicals scheduled to be screened is also being questioned.
The EPA will first screen 73 chemicals - all pesticides, none of the chemicals found in household products. The tests aren't set to happen until sometime next year.
EPA officials declined to say exactly when the screening would occur, explaining that the agency must finish its study of the tests before shipping them to another panel for review. But most of the pesticides have already been tested, and many have been established as endocrine disruptors.
Francis, of the EPA, says her agency chose to screen that relatively small batch of chemicals as a way to test the reliability of the process. But even scientists hired by the chemical industry question the value of screening chemicals that have been studied thoroughly. 
"Most of those on the list have already been tested, so why are we doing this?" asked Lamb, the toxicologist who works as a consultant to the chemistry council.
The EPA hopes to conclude the first round of tests by 2010, said Enesta Jones, an agency spokeswoman. Only then will the agency have an idea when the next group of chemicals will be screened. 
Buyer beware
For as slow as the process of screening chemicals has been in the U.S., concern about the safety of endocrine disruptors has caught on in Europe, Japan, South America, the Middle East, Mexico and even Fiji. 
Reports of declining sperm counts, birth defects and fertility problems have sparked widespread concern there. The European Union has banned 1,100 chemicals from cosmetics that are thought to cause cancer or reproductive harm.
"When we go to Europe, I breathe a sigh of relief because of all of the things I'm not exposed to over there," said Rochester's Swan, an epidemiologist and biostatistician. 
Earlier this year, the European Union passed a law that requires chemical companies to prove their products are safe before they are put on the market.
The U.S. has no such protocol, known as the precautionary principle, and the chemical industry has argued against it.
"The problem with the precautionary principle is that you have a moving target," said Tim Shestek, a chemistry council lobbyist. "You need to prove that something is safe - safe is never really defined by anybody."
Lacking testing or regulation by the U.S. government, it falls to consumers to watch out for themselves. 
Buyers must know the names of specific chemicals - such as dibutyl phthalate and diethyl phthalate - if they want to find out if a bottle of nail polish or a jar of hand lotion contains endocrine disruptors.
Even then, if the chemical is not considered a key ingredient, the company is not required to include it on the label.
There is nothing listed on a bottle of Chanel Precision Energising Radiance Lotion, for example, to let you know that it contains at least six chemicals that have been linked in laboratory studies to cancer in animals. Nor can you know by looking at the label for Avon's Anew Ultimate Skin Transforming Cream that it contains chemicals linked to cancer and endocrine disruption, according to a review by the nonprofit Environmental Working Group.
A spokeswoman for Chanel declined comment, and officials from Avon Products Inc. referred questions to the Cosmetic, Toiletry and Fragrance Association, which dismissed the claims as unfounded. 
Consumer groups
Consumer interest groups are trying to answer some of the questions that the government is not. The Campaign for Safe Cosmetics, a coalition of groups concerned with women's health, labor, consumer rights and the environment, offers a Web site run by the Environmental Working Group that enables shoppers to check the safety of cosmetics and personal-care products. The site identifies more than 450 products that are banned as dangerous in other countries but are widely available here.
As consumers learn more about these chemicals, more firms are taking steps to remove them from product lines.
Cosmetics giant Revlon Inc., for example, stopped using phthalates 15 years ago. A company spokeswoman said its products, including those sold in the U.S., comply with the stricter rules of the European governments. 
Other companies following similar policies include the L'Oreal Group, Hasbro Inc. and McDonald's Corp. In 1998, the fast-food giant stopped using phthalates in its Happy Meal toys designed for children age 3 and younger.
Retailers, including Target Corp. and Whole Foods Market Inc., have removed items and are looking at ways to eliminate products that contain some endocrine disruptors. 
"We are committed to reducing PVC in our products and packaging," said Susan Kahn, a vice president at Target, referring to polyvinyl chloride, the plastic that contains phthalates and is found in shower curtains, children's toys and packaging materials. 
Some companies, such as Born Free LLC, a Florida-based baby bottle-maker, are promoting goods that do not contain bisphenol A. Ron Vigdor, Born Free president, said his small company is experiencing rapid sales growth. 
Most consumers remain unaware of the potential dangers they are bringing into their homes, said Jane Adams, a neurotoxicologist at the University of Massachusetts. 
"Most of the population would not be well-informed and necessarily know what steps to take," Adams said. 
Roder, the Greendale mother who volunteered to have her house checked for endocrine disruptors, is grateful for the information she got.
Since the audit, Roder filled a garbage bin full of items that she'll no longer use - waxed paper, plastic wrap, old plastic cups, toys and containers.
She says her husband teases her for whacking bugs with shoes now, refusing to use bug spray. Instead of giving in to anxiety, Roder says her newfound awareness has brought peace of mind.
"It made me feel safe," she said.
But few people have the luxury of knowing what in their house is safe because few products contain any labeling of these compounds. Even the government scientists charged with alerting the public to the chemicals' dangers say information is sorely lacking.
"The real problem is that we don't know where all the different phthalates are coming from in our environment," said Gray, the EPA biologist whose lab has examined effects of endocrine disruptors for two decades. "I can't tell them what products to specifically avoid. The information isn't there."

Deborah L. DeBiasi
Email:   dldebiasi at deq.virginia.gov
WEB site address:  www.deq.virginia.gov
Virginia Department of Environmental Quality
Office of Water Permit Programs
Industrial Pretreatment/Toxics Management Program
Mail:          P.O. Box 1105, Richmond, VA  23218 (NEW!)
Location:  629 E. Main Street, Richmond, VA  23219
PH:         804-698-4028
FAX:      804-698-4032

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