[Pharmwaste] MU's Frederick vom Saal wants FDA to ban BPA, endocrine disruptors

DeBiasi, Deborah (DEQ) Deborah.DeBiasi at deq.virginia.gov
Wed Feb 1 17:22:19 EST 2012


http://www.columbiamissourian.com/stories/2012/01/31/mus-frederick-vom-s
aal-wants-fda-ban-bpa-endocrine-disruptors/


MU's Frederick vom Saal wants FDA to ban BPA, endocrine disruptors


Tuesday, January 31, 2012 | 6:00 a.m. CST; updated 8:05 p.m. CST,
Tuesday, January 31, 2012 

 

Frederick vom Saal, professor of biological sciences, poses for a
portrait in his laboratory in Lefevre Hall at MU on Nov. 13. Vom Saal
has researched the effects of industrial chemicals, such as bisphenol A,
which acts as an endocrine disruptor, that can enter the human body and
mimic hormones. Low levels of endocrine disruptors can be found in
household goods and the environment, but according to Vom Saal's
research, even small exposure to such chemicals can have drastic effects
on biological systems.   |  Nick Michael
<http://www.columbiamissourian.com/accounts/profiles/nmichael/>  

BY Simina Mistreanu
<http://www.columbiamissourian.com/accounts/profiles/Simina/>  

COLUMBIA - For the past 20 years, much of MU biology professor Frederick
vom Saal's research, thoughts and time have converged into one point:
trying to get endocrine disruptors - chemicals that interfere with the
hormone system and can cause obesity, infertility and cancer - out of
daily use.

He's accomplished the laboratory part, which resulted in dozens of
scientific papers outlining the negative effects of bisphenol-A, an
endocrine disruptor found in plastics.

How to minimize your exposure to BPA

________________________________

Several changes in shopping and eating habits can help minimize everyday
exposure to BPA:

*	Avoid water bottles and baby bottles that contain BPA and
instead choose BPA-free products, which are sold in several
supermarkets. 
*	Don't heat food in the microwave using plastic containers. 
*	Try to touch fewer cash register receipts. 
*	Avoid canned vegetables and canned soup; use fresh products
instead. 
*	Choose glass over cans for drinks. 

________________________________

Related Media

*	
<http://www.columbiamissourian.com/multimedia/document/2012/01/31/societ
y-toxicology-letter/> 

 
<http://www.columbiamissourian.com/multimedia/document/2012/01/31/societ
y-toxicology-letter/> 

 

*	
<http://www.columbiamissourian.com/multimedia/graphic/2012/01/31/timelin
e-road-convincing-fda-ban-bpa/> 

 
<http://www.columbiamissourian.com/multimedia/graphic/2012/01/31/timelin
e-road-convincing-fda-ban-bpa/> 

BPA is a chemical used to make plastic more durable. It is found in
plastic No. 3 and No. 7, which is used to make baby bottles among other
baby products. It is also used in the production of some food cans.
Frederick vom Saal, MU professor, has concerns about the effects of
long-term exposure to BPA, especially for fetuses and young children. 

*	
<http://www.columbiamissourian.com/multimedia/graphic/2012/01/27/effects
-bpa-cell-fetus/> 

 
<http://www.columbiamissourian.com/multimedia/graphic/2012/01/27/effects
-bpa-cell-fetus/> 

BPA is a chemical used to make plastic more durable. It is found in
plastic No. 3, as well as plastic No. 7, which is used to make baby
bottles among other baby products. It is also used in the production of
some food cans. MU professor Frederick vom Saal has concerns about the
effects of long-term exposure to BPA, especially for fetuses and young
children. 
<http://www.columbiamissourian.com/multimedia/document/2012/01/31/assess
ing-chemical-risk/> 

<http://www.columbiamissourian.com/multimedia/photo/2012/01/31/frederick
-vom-saal-trying-convince-us-authorities-restrict-use-endocrine-disrupto
rs/> 

 
<http://www.columbiamissourian.com/multimedia/photo/2012/01/31/frederick
-vom-saal-trying-convince-us-authorities-restrict-use-endocrine-disrupto
rs/> 

Frederick vom Saal, 67, a MU biology professor, poses in his laboratory
in Lefevre Hall at MU on Nov. 13. Vom Saal's research centers on the
effects of endocrine disruptors, found in commercial products such as
plastics, food cans and other household products, on the human hormone
system. He has completed his research and is now trying to convince U.S.
authorities to regulate the chemical and remove it from daily use.
Eleven states, Canada, China and the European Union have enacted
legislation prohibiting and restricting the use of endocrine disruptors
in commercial products. 

________________________________

Endocrine disruptors are everywhere in the environment: in plastics,
food cans, clothing fabrics, furniture and household and beauty
products.

Now he's doing the communicator's part, trying to convince U.S.
authorities to regulate the chemicals.

In mid-September, vom Saal was among 20 scientists who met in a closed
session in St. Louis to discuss why, in the face of what they see as
mountainous evidence, U.S. regulatory agencies such as the Food and Drug
Administration don't ban endocrine-disrupting chemicals.

Vom Saal's work, and that of other scientists, has so far persuaded 11
states, Canada, China and the European Union to enact legislation
prohibiting or restricting endocrine disruptors. Now he's making further
attempts to crack a tougher nut: the U.S. regulatory system.

That's why Vom Saal, 67, spent most of the first week of October away
from his beloved laboratory mice. Instead, he knuckled down at the
computer in his office in Lefevre Hall, surrounded by figurine mice and
a drawing of a wide-eyed rodent. He had a paper to write.

Seen as a three-act play, vom Saal's pursuit is near the end of its
second act - influencing federal regulation on endocrine disruptors.

Getting to Act 3 might be up to the public.

"As a scientist I feel I have an obligation to identify when, in fact,
science and government policy are not consistent with each other," vom
Saal says. "And that's what I'm doing."

"We need to get together and talk"

Vom Saal's quest to get endocrine-disrupting chemicals out of daily use
began with a 1990 phone call from Theo Colborn.

He was preparing to leave for New York when Colborn, then leading the
toxics division of the World Wildlife Fund, called because she had just
read vom Saal's paper on the physiological changes of animals exposed to
low doses of estrogenic hormones. At the same time, Colborn was studying
how chemicals in the environment altered the physiology of animals.

But somehow, their studies were describing the same effects.

"Are you aware of this?" Colborn asked.

"No," vom Saal said.

"We need to get together and talk," she said.

They met in New York, and Colborn provided vom Saal with a 2-foot stack
of research papers on the chemicals in wildlife, posing the hypothesis
that the chemicals might be acting like hormones even in very small
doses - smaller than anyone would have thought.

Vom Saal took a few weeks to read the papers, then got back to Colborn.
"My God, this is astounding," he recalls telling her. "I think you are
onto something really important."

They called a meeting of scientists from different fields:
physiologists, wildlife biologists and epidemiologists. The specialists
talked over a weekend in Racine, Wis., and concluded that
endocrine-disrupting chemicals interfere with hormonal signals, altering
the physiology of animals.

A few years later, Colborn wrote a book called "Our Stolen Future" in
which she included the conclusions of the Wisconsin meeting. 

Now, two decades after the scientists met, the bibliography on endocrine
disrupting chemicals has increased by thousands of papers and so has the
list of chemicals identified as endocrine disruptors.

"It happened in the first experiment"

One disruptor, in particular, bisphenol-A, or BPA, has stirred public
interest.

Vom Saal has become nationally recognized as a leader opposing the
chemical, which is used to manufacture plastics and plastic linings - in
water bottles, baby bottles, food cans, soda cans, dental sealants and
cash register receipts, among others.

In 1976, BPA was included in a list of more than 60,000 chemicals deemed
safe by the Toxic Substances Control Act.

In the mid-1990s, vom Saal and his research partners, Wade Welshons, an
associate professor of veterinary biomedical sciences, and Susan Nagel,
an assistant professor of obstetrics and gynecology, did an experiment
to test whether proteins act as barriers to keep natural estrogens from
entering cells and thus having effects on organisms. They wanted to see
which chemicals can get around those protective proteins at extremely
low doses and act like hormones in the body.

They tried it with BPA at a dose 25,000 times lower than toxicologists
had studied before.

"And good grief, it happened in the first experiment," Welshons recalls.

The group repeated the experiment several times and got the same
results: BPA was an endocrine-disrupting chemical, acting like estrogen
at very low doses to enlarge the prostates and lower sperm counts in
laboratory mice. In 1997, they published their findings.

A few months later, when the MU professors were preparing the
publication of a second article on BPA, they received a visit from
someone at Dow Chemical Co., one of the leading BPA manufacturers.

Vom Saal has repeatedly described that visit in media interviews over
the years: The Dow Chemical representative allegedly asked the
scientists not to publish their paper unless approved by the Chemical
Manufacturers Association, offering MU instead a research budget for a
new study.

Vom Saal and Welshons refused and reported the visit as inappropriate
and potentially illegal in a letter to the FDA, the MU chancellor and
the media. Dow Chemical's spokesman has repeatedly explained that the
incident was just an "enormous misunderstanding."

Hundreds of studies have since linked BPA to obesity, diabetes, breast
and prostate cancer, ADHD and abnormal development of genitals, but the
chemical industry has fought back with studies that showed that BPA had
no negative effects or that there wasn't enough exposure to unleash
those effects.

Vom Saal was interviewed and quoted by news media including The New York
Times and PBS' "Frontline."

But BPA was still on the market and still deemed safe by the U.S.
government.

"The regulatory community is locked in traditional mid-20th century"

In 2008, a National Toxicology Program report expressed "some concern"
regarding BPA's negative effects.

But then, in the same year, the FDA said the chemical was completely
safe - a conclusion later rejected by scientists on the FDA's review
board.

In January 2010, the FDA released a new statement, saying that BPA is of
"some concern" for infants and children. Then, in September, vom Saal's
team got a $1 million grant from the National Institute of Environmental
Health Sciences for further research.

Meanwhile, states have been passing legislation to ban BPA in feeding
products for children, such as baby bottles and sipping cups, with
California becoming the 11th state to do so at the beginning of October.
Similar legislation was adopted by the European Commission, and last
year Canada became the first country to declare BPA as a toxic substance
altogether.

All of these slow, steady steps built up to a case for regulations and
then suddenly collapsed before the most powerful authority in the field:
the FDA.

"We've gotten to a point where there's a huge amount of understanding
within the scientific community," vom Saal says. "However, the
regulatory community is locked in traditional mid-20th century, 1940s to
1960s' science and is saying, 'We don't know how to evaluate these new
studies, so we're going to continue to call all these chemicals safe.'"

Asked why the FDA doesn't ban endocrine-disrupting chemicals, a
spokeswoman said the FDA is considering the potential for harmful
effects on the endocrine system caused by very low exposures to some
substances.

"FDA considers the available high quality scientific information from
all sources (e.g. published literature, FDA research, manufacturer's
studies), as well as the structure of the molecule and what is known
about similar substances," spokeswoman Morgan Liscinsky wrote in an
email.

"He is work, that is what he does"

Why are endocrine disruptors important to understand? Because they
interfere with that magical process in which a single cell becomes an
organism. Depending on the hormonal signals the cell receives in
different stages of cellular division, it can become a nerve cell, a
skin cell, a muscle cell, a fat cell or a bone cell.

Wanting to understand this process was what got vom Saal started.

"I have always been fascinated with how is it that we develop the way we
are and what are the causes of the differences between people," he says.
"How do you start off with twins and have those twins become more and
more different throughout life?"

Those were the types of questions vom Saal encountered as an
undergraduate student at New York University in the 1960s. The biology
classes he took then got him interested in development. Right after
graduation, he enrolled in the Peace Corps and left his hometown of New
York for Africa. He taught biology in a secondary school in Somalia
until a military coup started in 1969 and Americans were expelled from
the country. He ended his service in Kenya.

The malnourished children he saw in Africa triggered his interest in
early nutrition and development factors that affect the way people end
up functioning later in life.

After Africa, he flew to Paris, where he spent another two years
teaching biology. Upon his return to the U.S., he enrolled at Rutgers
University in New Jersey, where he received his master's and doctoral
degrees. Since then he has been researching and teaching the ways
hormones influence development.

Vom Saal came to MU in 1979, where he is a curators' professor of
biology and teaches reproductive endocrinology. He lives in Columbia
with his wife, Kathi. They have a daughter, Jillian.

"He is work, that is what he does," says Annette Hormann, a doctoral
candidate who works with vom Saal. As a mentor, he focuses on his
students' successes. He picks up whether they understand a particular
issue, and if they don't, he explains it using metaphors - whether it's
science or the ups and downs of pursuing a Ph.D., which he compares to a
couple of magnets of the same pole, rejecting one another.

Vom Saal's work is driven by curiosity but also by a wish shared among
scientists: that their work might make people healthier.

"That's a huge part of it," he says.

He sees modern science as concentrating too much on treating diseases
instead of getting to the root of what causes the disease and stopping
it before it manifests.

Can the gradual removal of chemicals from the environment and people's
everyday lives lead to a world with fewer diseases? To an extent, vom
Saal believes it's possible. Then there are people's lifestyle choices.

"I'm certainly aware that what we're doing isn't 100 percent of the
answer," he says. "But it clearly is a contributor to arriving at an
answer of what is going on that Americans are becoming horrifyingly
obese and at an alarmingly rapid rate. And, you know, we think we've got
some of the answers to that."

"It's called a paradigm shift"

This is not the first case of a long path to regulation.

Dioxins, toxic byproducts of various industrial processes, have avoided
regulation for more than two decades, despite about 5,000 papers
highlighting their negative effects.

With endocrine disruptors, the problem is that decision-makers in
chemical risk assessment were trained in toxicology before the concept
of endocrine disruption was coined 20 years ago, vom Saal says. He
compares this to a patient with an endocrine problem seeing a foot
doctor instead of an endocrinologist.

Risk assessors are usually trained in evaluating chemicals that cause
DNA mutations and not in evaluating the way hormones modify gene
activity without mutating the genes. "It's an entirely different field
of science," vom Saal says.

And the foot doctor doesn't allow endocrinologists to examine the
patient.

In March 2011, eight scientific societies representing about 40,000
researchers and clinicians published a common letter, asking the FDA and
the Environmental Protection Agency to include them in the risk
assessment process for endocrine disruptors.

"One of the problems they have is they look at some of the science and
don't know how to interpret it because it's not done using the
traditional toxicology testing paradigm," Patricia Hunt, a professor in
the Washington State University School of Molecular Biosciences, said 
according to the university's website
<http://wsunews.wsu.edu/pages/publications.asp?Action=Detail&Publication
ID=24785> . "We need geneticists, we need developmental and reproductive
biologists, and we need the clinical people on board to actually help
interpret and evaluate some of the science."

The Society of Toxicology, which is currently involved in risk
assessment for chemicals, replied in a letter published in the
Washington Post, with a message that vom Saal summed up as: "We're the
experts, leave us alone."

It's not an atypical response whenever new scientific revelations
emerge.

"It's called a paradigm shift," vom Saal says, "(Causing) extreme pain
that people within a field experience when their beloved beliefs, their
cherished assumptions about how the world works are challenged."

A "revolving door"

Some of the scientists who attended the St. Louis conference in
September began collaborating on a common paper that would summarize
discussions and conclusions and propose new regulations on endocrine
disruptors, a paper that could speed up their unfolding scientific
revolution.

One of the things that needs to change, vom Saal says, is the heart of
the regulatory system. Its structure and its members are not organized
to recognize new scientific discoveries.

"We need to move beyond attacking one chemical at a time through
specific legislation," vom Saal says. "We're trying to move so that the
process of assessing risk of all chemicals is changed because there are
a hundred thousand chemicals in commerce. You can't rely on (state)
legislation independently regulating each of them. That's just not going
to work.

"We need a regulatory system that is set up to accurately assess risk
associated with chemicals and a regulatory system that works for the
public and not for the few corporations that manufacture the chemicals."

Vom Saal says regulatory structures in many countries incorporate a
"revolving door," which brings people in and out along with influence
from the industry. When members of the FDA assess chemical risks in this
country, they usually rely entirely on studies delivered by the chemical
industry itself.

In the documentary "Tapped," which examines the bottled water industry,
there is a sequence from a U.S. Senate hearing on BPA in 2008.
Massachusetts Sen. John Kerry asks FDA official Norris Alderson to
describe what kind of studies the FDA bases its decision when it is
telling the public that BPA is safe.

"Did you ask for studies from independent sources?" the senator asked.

"We don't normally ask for independent sources," Alderson answered.

"Then you don't protect the American people," Kerry responded.

"Running off into the sunset"

Roughly 2 billion pounds of BPA are sold every year in the U.S. for
about a dollar a pound to be used in plastic products. Profits by BPA
producers and customers who go on to use it in manufacturing add up to a
$10 billion-a-year industry, according to Welshons' calculations.

"Ten billion dollars a year is about $25 million a day or a million
dollars an hour," Welshons says, doing the math. "So it means that for
every hour that regulation of BPA is delayed, the industry is making a
million dollars."

The biggest BPA producers in the United States are SABIC Innovative
Plastics, Dow Chemical, Bayer MaterialScience, Momentive and Sunoco
Chemicals, according to Nexant Inc., a consulting company based in San
Francisco.

Welshons has a theory for why roughly all industry-funded studies found
no harmful effects or exposure to BPA.

There's no high-up, conspiratorial authority. Instead, "it's hundreds of
middle managers who are making these decisions within the company. They
ask for information and some lab will say, 'We have found low-dose
effects of BPA.' And another (lab) may say, 'Oh, we've done that, we
can't find a thing.' Where are they going to give the money?"

"It's a bunch of choices - a very diffuse thing like the protection of
the public versus something very specific, protection of corporate
income stream - and what choices are they going to make?" Welshons says.
"If they're loyal employees, of course, they're going to make the wrong
choice."

Vom Saal says chemical companies "have no incentive to care. It's not
going to cost them any money. They're going to bail out and take their
millions and go running off into the sunset before the end of their
world occurs."

Public pressure could lead to regulation changes

And who is there to save the world in vom Saal's intricate chemical
drama?

In short, the U.S. public and risk assessors in other countries.

Vom Saal and his colleagues plan to publish a paper with conclusions
from the St. Louis conference and then take pieces of it to distribute
in Congress and to the regulatory agencies. But also, most critically,
they plan to take it to the public through the news media.

Parts of the paper will be sent abroad, where vom Saal thinks they are
more likely to have an impact on regulatory systems. Canada and the
European Union have already introduced legislation on BPA. Changes in
other countries can put pressure on the U.S. to follow.

The European Union passed legislation that requires, starting in
December 2010, testing and classifying chemicals before they can be put
into products.

"We have no law like that in the United States," vom Saal says. "We are
literally like a Third World country in terms of our chemical regulatory
system, compared to the Europeans. And with this Congress, there's no
hope of getting a European-style approach."

He continues: "I mean, most people think that the chemicals in the
plastic you're using or in the clothes you're wearing or in the fabrics
on the couch you're sitting on - that they've been tested for whether
they're harmful or not. And the answer is no, they haven't. There's no
law that requires that. And that's crazy."

Vom Saal and his colleagues hope to convince the American public of the
need to regulate endocrine disrupting chemicals. Public pressure could
persuade Congress to make changes.

Public pressure could also influence corporations "in the middle,"
Welshons says, referring to the manufacturers that buy BPA to use in
baby bottles or cans. Welshons thinks that if the public stops buying
those products, manufacturers will change what they put into them
immediately.

In the past few years, after Canada took the lead in banning BPA,
Walmart promised to stop selling products containing the chemical.
Playtex launched a line of BPA-free baby bottles. Nalgene, a brand of
reusable water bottles, announced it would stop making bottles that
contained BPA. In Columbia, Clover's Natural Market got rid of BPA water
bottles and baby products.

A scientist's responsibility

To Welshons, vom Saal is a guy with "pathetic math skills, fantastic
animal development skills." It's an interesting description, vom Saal
says after he stops laughing, especially because he used to teach
statistics. The two scientists have known each other for 25 years and
have learned to have fun together, sometimes by making fun of each
other.

Outside the office, vom Saal sometimes plays guitar in his folk band and
flies his airplane.

Welshons, who is married with children to Susan Nagel, thinks that what
sets him and vom Saal apart as a research team is that they have a set
of scientific controls and an openness to accept results that contradict
their hypotheses.

And then there's the work outside the laboratory - talking to the media,
going to conferences, testifying at hearings in the Senate - to which
vom Saal has dedicated big chunks of his time. He refers to Albert
Einstein when he talks about a scientist's responsibility to get out in
the world and support his findings if they involve world safety or
public health issues.

"As I said, paradigm shifts are painful and never quick. But they're
inevitable," vom Saal says. "The regulatory system cannot ignore the
reality of science, particularly when you have literally tens of
thousands of scientists saying to them, 'You can't keep doing this.'
They cannot keep doing that and get away with it forever."

It would take new laws and the changing of the chemical regulatory
system. It would take the public understanding what changes are needed
and providing legislators in Congress with a mandate to do that. It
would maybe take different people from the ones who are now in the
regulatory structures.

"So am I optimistic that in the long run there will be a change? Yes,
it's inevitable," vom Saal says. "And the longer it takes for that to
happen, the more people will be harmed by these chemicals. That's the
sad part."

 

 

 

 

Deborah L. DeBiasi
Email:   Deborah.DeBiasi at deq.virginia.gov
WEB site address:  www.deq.virginia.gov <http://www.deq.virginia.gov/> 
Virginia Department of Environmental Quality
Office of Water Permit and Compliance Assistance Programs
Industrial Pretreatment/Whole Effluent Toxicity (WET) Program
PPCPs, EDCs, and Microconstituents 
www.deq.virginia.gov/vpdes/microconstituents.html

4th National DEA Drug Collection 04/28/12, 10-2 pm 
Go to www.dea.gov for site locations

Mail:          P.O. Box 1105, Richmond, VA  23218
Location:  629 E. Main Street, Richmond, VA  23219
PH:         804-698-4028      FAX:      804-698-4032

 

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