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#839 -- Failure of Chemical Regulation, 26-Jan-2006


Rachel's Democracy & Health News #839

"Environment, health, jobs and justice--Who gets to decide?"

Thursday, January 26, 2006
www.rachel.org -- To make a secure donation, click here.

Featured stories in this issue...

In 2005 the Wheels Came Off the U.S. Chemical-Regulation System
  In 2005 the Wall Street Journal blew the whistle on the U.S. system
  for regulating chemicals, showing that it is based on scientific
  assumptions that are simply wrong, and that the system is allowing all
  of the nation's babies and children to be exposed to combinations of
  industrial poisons that no one even knows how to evaluate for safety.
New Report: Half of All Breast Cancers May Be Tied to Environment
  A review of 350 studies of breast cancer concludes that exposure to
  chemicals and radiation may be contributing to half of all new cases,
  or 106,000 breast cancers each year.
One Third of All Americans Are Endangered by Air Pollution
  If you are one of the ninety-six million Americans who are exposed
  to excessive fine-particle air pollution (from diesel engines, coal-
  fired power plants and automobiles) you might be forfeiting 14 years
  (or more) of your life, says a new study by U.S. Public Interest
  Research Group. The good news is, this pollution is absolutely
  preventable -- all it requires is the political will to toughen our
  standards and develop clean alternatives.
World Bank Says Climate Change and Pollution Are Killing Millions
  The World Bank says almost 20% of all ill health, worldwide, plus
  millions of deaths each year, are caused by global warming and by
  pollution. Furthermore, pollution is holding back economic
Philanthropy and Democracy: A View from the U.S.
  "Democracy is in crisis in the so-called advanced countries of the
  world and in the so-called developing countries. Here I will reflect
  mainly on the United States because I know it best. In other countries
  the issues of democracy will differ. In most cases with which I am
  familiar the differences will be matters of degree. But the
  obligations of the philanthropic sector are the same." -- Stephen


From: Rachel's Democracy & Health News #839, Jan. 26, 2006


By Peter Montague

[In this series we are describing the important events of 2005. --

The wheels came off the U.S. chemical regulatory system in a very
public way in 2005. The Wall Street Journal published a 4-part series
showing that the system is scientifically bankrupt because it is based
on assumptions that are simply wrong.

Despite these revelations, bureaucratic inertia allowed the system to
keep on trucking, but I suppose that's to be expected. Acknowledging
the harsh truth would be too devastating, personally, for the well-
intended, hard-working civil servants who have devoted their lives to
the proposition that a chemical regulatory system like ours could
somehow protect human health and the environment from the industrial
poisons that are intentionally discharged in multi-billion-ton
quantities year after year into the air, water, and soil that make
life possible.

Think of it -- 1800 brand-new chemicals gushing into commercial
channels each year, without the responsible parties being required to
provide any detailed health or safety testing data. Armed with minimal
(or no) health and safety data, the government then has a scant few
months in which to prove that one or another of these 1800 new
chemicals poses an "unreasonable risk" to human health or the
environment. If by some miracle the government feels is can meet that
scientific and legal burden and it orders the responsible party to
produce some safety-test results, the responsible party can go to
court to dispute the government's order. In court, even a modest-sized
corporation like Monsanto can field an army of junkyard-dog lawyers to
oppose the government; the government, for its part, has been shredded
and downsized by decades of tax cuts, so its legal staff is a gaggle
of relative pipsqueaks compared to any major chemical corporation's.

Given such a system, what are the chances that industrial poisons will
NOT be released into the environment in harmful quantities? Zero. The
system was designed to fail from the get-go in 1965. What's amazing is
that all of us have been able to convince ourselves for 40 years that
the U.S. chemical requlatory system is basically sound -- that if we
all just keep pretending it is working, somehow it will work.

"Oh, our emperor is a wearing a fine set of threads, isn't he? Yes,
yes, look at that golden raiment glinting in the sunlight.... [40-year
pause]... Oh my, isn't that his willy I'm seeing?"

Today, I doubt you could find a single federal scientist who actually
believes in his or her heart that the chemical regulatory system is
presently protecting the public adequately from unwanted assault by
industrial poisons. But of course they could never admit anything like
that in public -- for one thing, they'd be fired or sent to Siberia
(or Kansas) almost immediately.

It may be years before the full extent of the system's essentially-
total failure is acknowledged in Washington -- if ever -- but to
anyone who reads the Wall Street Journal carefully, the U.S. chemical
regulatory system now looks like a 40-year-old jalopy, rusted out,
gussied up every four years with a fresh paint job of promises, its
credibility sustained mainly by the "Ooohs and aaahs" of the chemical
corporation flaks who designed and built the system 40 years ago and
who are desperately hoping no one will notice that their baby is a
tangled heap of legal junk that has NEVER protected workers, moms, or
babies -- not to mention the fish, birds, beasts and vegetables that
most of us eat, and the water we drink.

What's odd is that the truth leaked out in 2005 not through the
nation's "newspaper of record," the New York Times (which continues to
oooh and aaah that the system will be ready to roll any day now -- all
that's needed is more research) but through the Wall Street Journal
(WSJ). This leads me to believe that the editors of the Journal must
have seen clouds of liability lawsuits on the horizon for their main
readers, the corporate elite, and they felt they simply had to raise a
warning flag by revealing a modicum of the truth.

The truth, it turns out, ain't pretty, when you get it in concentrated
bites -- like four long stories by a powerful WSJ writer named Peter

In a series that began in July, the WSJ told its readers that, "For
years... something about modern living has driven a steady rise of
certain maladies, from breast and prostate cancer to autism and
learning disabilities."

In the very next paragraph the WSJ said "one suspect that is drawing
intense scrutiny" from scientists is "the prevalence in the
environment of certain industrial chemicals at extremely low levels --
minute levels previously thought to be biologically insignificant."

The third paragraph contains this bomb shell: "An especially striking
finding: It appears that some substances may have effects at the very
lowest exposures that are absent at higher levels."

Striking indeed. The WSJ goes on to explain that this "especially
striking finding" runs contrary to the basic premise of the science of
toxicology which was established 500 years ago by the Swiss physician
(and alchemist and astrologer) Paracelsus: "The dose makes the

If the "dose makes the poison" then tiny doses should be assumed non-
poisonous, shouldn't they? The entire chemical regulation system is
built on that assumption (as is the science of toxicology) -- but it
now turns out that this assumption doesn't necessarily hold true. A
striking finding, indeed. More like a Richter-8 earthquake. As the WSJ
said, "the new science of low-dose exposure is challenging centuries
of accepted wisdom about toxic substances and rattling the foundation
of environmental law" -- because U.S. environmental laws are ALL based
on the assumption that tiny doses don't have any biological

To its great credit, the WSJ doesn't flinch and doesn't stop there. It
immediately asks the obvious question: "But what if it turned out that
common substances have essentially no safe exposure levels at all?"
And it immediately offers a hard-edged answer: "That was ultimately
what the U.S. Environmental Protection Agency concluded about lead
after studying its effects on children for decades."

So there's no safe dose of lead for children, EPA acknowledges, yet
U.S. industry is allowed to continue to use about 260,000 metric tons
of lead each year all of which eventually enters the environment and
gets into air, soil, water, and the food chain. That fact alone sums
up the effectiveness of the U.S. regulatory system.

But it gets worse. The WSJ immediately points out that "...scientists
have found that with some chemicals, traces as minute as mere parts
per trillion have biological effects. That's one-millionth of the
smallest traces even measurable three decades ago, when many of
today's environmental laws were written." No wonder our laws have
failed us -- they were based on false assumptions about the biological
effects of low doses of chemicals.

Having completely discredited the basis of the nation's environmental
protection laws, the WSJ goes on to lob another grenade into the
crowd: "Some chemical traces appear to have greater effects in
combination than singly, another challenge to traditional toxicology,
which tests things individually." Whatever remained of traditional
toxicology has now been blown to smithereens (more on this below).

Now the WSJ starts blasting away with some evidence to back up its
frontal assault on toxicology and the nation's failed structure of
environmental protection laws:

** "Tiny doses of bisphenol A, which is used in polycarbonate plastic
baby bottles and in resins that line food cans, have been found to
alter brain structure, neurochemistry, behavior, reproduction and
immune response in animals....

** "Minute levels of phthalates, which are used in toys, building
materials, drug capsules, cosmetics and perfumes, have been
statistically linked to sperm damage in men and genital changes,
asthma and allergies in children. The U.S. Centers for Disease Control
and Prevention has detected comparable levels in Americans' urine....

** "A chemical used in munitions, called perchlorate, is known to
inhibit production of thyroid hormone, which children need for brain
development. The chemical has been detected in drinking-water supplies
in 35 states, as well as in fruits, vegetables and breast milk....

** "The weed killer atrazine has been linked to sexual malformations
in frogs that were exposed to water containing just 1/30th as much
atrazine as the EPA regards as safe in human drinking water....

** "Since the review panel met in 2000, scientists have published more
than 100 peer-reviewed articles reporting further low-dose effects in
living animals and in human cells.

The WSJ then goes on to give examples of chemicals that cause
biological effects at low doses but no such effects at high doses --
thus standing Paracelsus and the science of toxicology on their heads.
The mechanism seems to be that some hormone-disrupting chemicals at
low doses latch onto the "hormone receptor sites" on cells and trigger
unnatural biological responses, such as brain and reproductive system
abnormalities. At higher doses the same chemical overwhelms the
hormone-receptor system and the whole system shuts down, producing no
biological response at all.

The WSJ then gives an example of chemicals that, taken alone, produce
no biological response, but taken together add up to produce a
response: "Environmental chemicals don't exist in isolation. People
are exposed to many different ones in trace amounts. So scientists at
the University of London checked a mixture. They tested the hormonal
strength of a blend of 11 common chemicals that can mimic estrogen
[female sex hormone].

"Alone, each was very weak. But when scientists mixed low doses of all
11 in a solution with natural estrogen -- thus simulating the chemical
cocktail that's inside the human body today -- they found the hormonal
strength of natural estrogen was doubled. Such an effect inside the
body could disrupt hormonal action."

WSJ goes on to describe the response of U.S. Environmental Protection
Agency (EPA): "In 2000, a separate EPA-organized panel, after
reviewing 49 studies, said some hormonally active chemicals affect
animals at doses as low as the 'background levels' to which the
general human population is subject. The panel said the health
implications weren't clear but urged the EPA to revisit its regulatory
procedures to make sure such chemicals are tested in animals at
appropriately small doses.

"The EPA hesitated. It responded in 2002 that 'until there is an
improved scientific understanding of the low-dose hypothesis, EPA
believes that it would be premature to require routine testing of
substances for low-dose effects.'...

In other words, EPA's position is, "We don't even know enough to test
for these effects."

It must be obvious that as time has passed, our ignorance of chemicals
has grown, not diminished. We know that combinations of chemicals are
important. Each year, we add 1800 new chemicals into the mix and so we
know less and less about what's going on, year after year, because the
environment becomes ever so much more complicated. We are not making
scientific progress -- we are losing ground in the struggle to
understand what we are doing to ourselves and to all the other
creatures with whom we share the planet.

To summarize:

** Chemicals at low doses sometimes cause biological effects that are
not present when the same chemicals are present in high doses.

Obvious implication: Almost all chemical-safety testing done during
the past 40 years has been with high doses, on the erroneous
assumption that "the dose makes the poison." Therefore -- as a panel
of experts told the EPA -- testing needs to be done with low doses as
well as high doses. But EPA says we don't even know enough to begin
testing. In other words, much of the chemical testing completed during
the past 40 years needs to be re-done but the government hasn't a clue
about how to begin.

** Chemicals at levels that are biologically insignificant can combine
with other chemicals at levels that are biologically insignificant --
and, in so doing, can create biologically-significant combinations.

Obvious implication: Chemicals need to be tested in combinations, not
merely one at a time. But there aren't enough laboratories on earth to
test all the possibly-relevant combinations. There are 80,000
chemicals in current commercial use. Suppose we wanted to test only
1000 of them, and we wanted to test all possible combinations of 11
chemicals out of the 1000, How many test would be required?

The answer is 23,706,860,441,577,319,154,916,000 experiments.[1]
That's 23 million million million million safety tests. According to
WSJ, EPA is hoping to develop new techniques that would allow them to
do 15,000 safety tests in a year -- and at that rate they could test
all 11-chemical combinations of 1000 chemicals in only
1,580,457,400,000,000,000,000,000 years (1.5 million million million
million years).

OK, this is ridiculous. But suppose EPA wanted to test something more
realistic, like all 3-chemical combinations of only 1000 chemicals.
It's still impossible -- it would require testing 166 million
combinations and, at 15,000 tests per year, it would take 11,000 years
to complete. So we're never going to be able to test chemicals in
combinations in any thorough way -- even though the scientific
literature is full of statements saying "We need to test chemicals in
combination and we're working on it." Such statements are just eye
wash, perhaps intended to keep us believing that the current chemical
regulatory system can work if we just keep pretending that it can.

[To be continued]


[1] The formula for combinations like these is n!/(r!*(n-r)!) where
n is the total number of chemicals, r is the number of chemicals in
each subcollection and n! means "n factorial" -- see any basic
introduction to statistics or probability.

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From: Oakland (Calif.) Tribune, Jan. 24, 2006


Analysis of 350 studies finds half of cases are unrelated to genetic
risk or lifestyle choices

By Douglas Fischer

As many as half of all new breast cancers may be foisted upon women by
pollutants in the environment, triggered by such items as bisphenol-A
lining tin cans or radiation from early mammograms, according to a
review of recent science by two breast cancer groups.

Their report, "State of the Evidence," released Tuesday [Jan. 24],
buttresses what many researchers increasingly suspect: that repeated
low doses -- particularly in early childhood -- to chemicals normally
considered harmless can have a profound effect.

It also suggests that, for half of the 211,240 woman diagnosed with
breast cancer in 2005, lifestyle choices and genetics played no role.

"You just can't blame it on lifestyle factors, like when you have
children, or if you have children," said Nancy Evans, health science
consultant for the Breast Cancer Fund and the report's principle

"Half the cases are not explained by genetics or the so-called 'known
risk factors." There's something else going on."

The report, by the San Francisco-based groups Breast Cancer Fund and
Breast Cancer Action, analyzed the findings of more than 350
experimental, epidemiologic and ecological studies assessing breast

Breast cancer rates have climbed steadily in the United States and
other industrialized countries since the 1940s. In the U.S., for
instance, one in seven women will be diagnosed with breast cancer in
her lifetime, almost triple the rate in the 1960s.

Researchers believe less than one in 10 cases occur in women born with
a genetic predisposition for the disease. Instead, the report says,
recent science makes very clear the cancer arises from a multitude of
factors, from slight genetic mutations to altered hormone production
to even radiation.

For instance, the report cited a study from Tufts University that
found that exposing pregnant mice to extremely low levels of
bisphenol-A altered the development of the mammary gland in their
offspring at puberty.

And that alteration makes the gland more susceptible to breast cancer,
Evans said.

Bisphenol-A, originally developed as a synthetic hormone in the 1930s,
today is used as an additive to make plastic shatterproof and to
extend the shelf-life of canned goods. Nearly 6 billion pounds are
produced annually.

Industry has long maintained there is no evidence repeated low doses
of compounds such as bisphenol-A can have such deleterious effects. A
legislative effort to ban some of these chemicals from children's toys
failed last week after industry scientists argued there was no cause
for concern.

"A lot of work has been done on those issues," said Lorenz Romberg, a
former U.S. Environmental Protection Agency scientist who now works as
a consultant and testified before the Legislature on behalf of the
chemical industry last month. "When you look at this body of evidence
in total, we didn't find any evidence that there is a marked,
repeatable-across-laboratories effect that has any clear scientific

But the report, Evans said, makes clear there is no one culprit for
rising breast cancer rates. What happens, for instance, when
bisphenol-A or any several estrogen-like synthetic compounds on the
market gets combined with the harm from a few low-dose X-rays?

No one knows, but new research from the National Academy of Sciences
suggests there is no safe radiation dose: The lowest possible dose
still increases cancer risk. Yet the American Cancer Society still
recommends women over age 40 have a mammogram, despite evidence such
procedures are not effective until women are 50 years old.

"We have to have a replacement for mammography. It's so aggressively
promoted, especially for young women," Evans said.

But does the chance of early detection outweigh the risks?

"I'm not saying they should or shouldn't," Evans said. "They need to
be aware of the risk. An additional 10 years of radiation is not

The report, "State of the Evidence," can be found here. Contact
Douglas Fischer at dfischer@angnewspapers.com.