PART TWO

Dr. Peter Montague commenting on risk assessments in an artice "Questions to Ask About
Risk Assessment" for Rachel's Hazardous Waste News, a publication of the Environmental
Research Foundation said:

The calculated risk is expressed numerically as a probability. For example, in a hypothetical
case we might say--based upon some experimental animal data collected in various
laboratories over the years--that if, for 70 years, you drank two liters per day of Envirobubbly,
a popular bottled water containing 5 parts per billion (ppb) benzene, your lifetime risk of
getting cancer from that exposure would be 10-6, or one chance in a million. Another way to
phrase this is, if you exposed a million people to that level of contamination for a lifetime, you
would expect to kill one of them by a fatal cancer.

Now that you have a risk assessment in hand, you turn to public policy makers to decide that
this or that amount of risk is "acceptable". Someone decides that it is OK to kill one in 10
million citizens, or one in a million citizens or one in 100,000. Then the regulatory agencies
draw up regulations that allow the public to be exposed to bubbly water contaminated with 0.5
parts per billion (ppb) of benezene (or 5 ppb, or 50 ppb, depending on the political judgment
someone has made about what's an "acceptable" death rate from benezene in water supplies.
In short, the risk assessment becomes the basis for making public policy (p. 1).

In other words, the people who do risk assessments are generally working with vast gaps of
knowledge, which is another name for ignorance. This will always be true. With 500 to 1000
new chemicals entering commercial channels each year, we will never, ever have an adequate
base of information about the toxic potency of the chemicals we routinely expose our
neighbors to. We will continue to be ignorant about exposure levels. We can't measure
everything; we haven't the resources.

The negligible risk victims are known only as numbers, they have no name or face. No one
knows who they are.

We allow our regulatory officials to get away with killing large numbers of us because we
accept their rhetoric in which they claim not to kill us, but only to impose "risks" on us. And
because we accept many risks each day (such as driving our car), they argue we should
accept new, chemical risks without complaint. If we accept the substantial risk of driving an
automobile, how can we logically object to a tiny (one in a million) added risk from chemical
contamination of our food and water?

These offenders do not impose 'risks' upon a crowd; they deliberately execute individual
human beings in the name of profit...They actually kill people by their decisions, no merely
impose abstract 'risk'. And it is important to note that the informed consent of the victims is not
obtained, nor do the victims enjoy the Constitutional protections of due process. (p. 3)

But perhaps the most appealing aspect of risk assessment is that it is based on the underlying
assumption that chemicals are presumed innocent until proven guilty. If chemicals weren't
presumed innocent until proven guilt, we wouldn't need any risk assessments; as a matter of
public policy, we would require the users of chemicals to adopt closed-loop technologies,
systems designed to avoid all intentional releases. Government programs based on risk
assessment add major support to the view that chemicals are presumed innocent until proven
guilty--a bad presumption from a public health perspective. (p. 4)

the rights of citizens to enjoy a safe and healthy environment. Why should a young mother
accept any additional risk for her children even if some risk assessment says the
risk is negligible?

Quantitative risk assessment is not the only technique that can be used for assessing the risk
posed by a chemical . Chemical profiles could be gathered which would include much evidence
that a quantitative risk assessment could not give such as field studies and observations,
medical reports, worker complaints and observations who were exposed to the chemical in
question, records of groundwater contamination, and health surveys.

A chemical should be considered guilty until proven innocent. What precisely was the process
of deciding how many citizens it is permissible to kill?

We have to live with the consequences of the decision made by the regulatory agency.

Human elements are the exposure of infants, small children, the elderly, and people with
chronic illness such as asthma, emphysema, heart condition, Aids, and other preexisting
health conditions etc.

Elements that are ignored in a risk assessment are hazards of the entire chemical compound
including secret or proprietary ingredients (solvents, preservatives, emulsifiers, petroleum
distillates, etc.) alone and in combination with the revealed ingredients, metabolites,
degradation byproducts, and in the case of pesticides, carriers.

Additive, cumulative, and synergistic hazards of daily exposure to other toxic chemicals (e.g.
pesticides in foods, air contamination, water pollution) as well as the chemical
in question.

Effects that might have been noted if required tests had been completed or performed
adequately, or it tests not currently required (nerve damage, reproductive disorders,
developmental damage, immune system suppression, endocrine system damage) had been

All possible effects, including those not detected in laboratory tests (e.g., headaches, joint
pain, fatigue, emotional perturbation, and so forth) Rats can talk and tell you how they feel.

Actual exposures in various distinct situations

Exposure to the full compound and associated compounds (such as a carrier in case of a
pesticide, or a glue in the case of formaldehyde exposure due to installation of particle board)
including secret ingredients, contaminants, and metabolic and degradation byproducts.

Information on chemicals from the Agency for Toxic Substances and Disease Registry
(ATSDR), U.S. Public Health Service, Toxicology Profiles. Information includes extensive
bibliographies, discussion of the sources and uses of each chemical, the toxicology of each
chemical, gaps in the data, and a summary of international, national, and state regulations that
have been established to control human exposure to the chemical, a profile of the 100
chemicals found most often at superfund sites.

The health of your family is at stake.

Congress passed the  Clean Air Act in 1970 eighteen years later they had set regulations for
12 air pollutants out of the thousands that exist. These were sulfur dioxide, particulate matter
(soot), carbon monoxide, ozone, nitrogen oxides, lead, radionuclides, beryllium, mercury, vinyl
chloride, benzene, and arsenic.

EPA would not consider the risk to any individual but would only consider the total number of
people made sick or killed. They propose that one death per year from each kind of
regulated pollutant would be acceptable,

The EPA to decide how much of each pollutant was acceptable.

Acceptable lifetime risk of death from each pollutant would be one additional death for 10,000.
This means if you exposed 10,000 people to the legal amount of that pollutant, one of those
10,000 people would die. Since there are about 245 million Americans, it's Ok for each
regulated pollutant to kill 24, 500 people each year, (HWN,#95, p. 1) Almost everyone familiar
with EPA will agree that the agency cannot be trusted to make decisions consistently to protect
public health and safety. EPA's discretion should be limited.

The United States Constitution says no one may be deprived of life or liberty without 'due
process'. It's OK for each regulated pollutant to kill a few hundred people each year
without due process. No indictment, no trial, nothing.

However we have all had "risk assessment" used against us by industry and its supporters in
government. They focus the discussion on one aspect of "hazard", usually the potential to
cause cancer in humans. They simply don't discuss any other health consequences, and they
ignore non-human species entirely. Then they use a mathematical model to show how the
chemical will move through the environment. (The mathematical model itself may be based on
guesswork but it often seems convincing to local officials because its results are spit out by a
computer). They use these results to show how based on one or two studies of mice or guinea
pigs, the amount of chemical likely to reach the 'average person' will only cause "acceptable"
numbers of cancers. What is an "acceptable" number of cancers? What is the average person
a healthy white well-to-do male in the prime of life? Hazard assessment is complex because so
little is known about the effects of most chemicals.

The National Research Council concluded in a 1984 report that fewer than 2 percent of the
chemicals currently used for commercial purposes have been tested sufficiently for a complete
health hazard assessment to be made. Adequate information to support even a partial hazard
assessment is available for only 14 percent of the chemicals; for 70 percent, no information is
available. Moreover, these percentages refer only to human health hazards. In general
environmental hazards are even less well understood (p. 425)

Some chemicals degrade into other, more toxic chemicals, For example, in the environment,
trichloroethylene (TCE) may be transformed into vinyl chloride or  1.2-dichloroethylene,
substances that are 2.5 and 5 times more potent than the original solvent.

There may be more than one pathway of exposure.

It is difficult to assess the sensitivity of the people and the environment that will be exposed. A
person's health, age, and exposure to other chemicals (besides the one being assessed will
affect that person's sensitivity to a chemical. For example, a person with asthma responds
differently to air pollution than a person without asthma. A child may absorb more lead than an
adult because children have a higher metabolic rate and are more active, and because some
children eat dirt (pp. 421-422)

Mr. Reilly also thinks we need new information on health effects of chemicals. He says "Much
attention has focused on cancer, and the ability to assess the risk from carcinogens has
increased considerably in the past 10 years. Comparable progress needs to be made in
improving methods to assess other types of health and environmental effects. After all
exposure to some chemicals can affect people's reproductive, immune, and nervous systems
and can cause other problems as well. (p. 455)

Reilly, W., et al (1987) State of the Environment: A View
Toward the Nineties, Washington, D.C. Conservation Foundation

Chemicals were given the Constitutional protections that individuals enjoy--chemicals were
presumed innocent until proven guilty, and chemicals received the legal protections called
'due process'. To ban a new chemical, or curb its use, the burden of proof was on you (the
consumer) to line up the dead bodies and prove with legal certainty that a chemical had
damaged you. (Actually it was worse than that--you had to prove that many people had been
damaged; if only you were harmed individually, it was assumed to be your fault because you
were chemically sensitive--a freakish and unnatural condition, industry argued, often

The 5th amendment to the Constitution of the United States says, "No person shall
be...deprived of life, liberty or property without due process of law." Before the state can
execute you, you are supposed to have your day in court, to be judged for your crimes (if any)
by a jury of your peers. An execution without due process is a murder. Despite these important
protections in our Constitution, murder of innocent Americans is slowly but surely becoming
acceptable because of the increasing use of a technique called "risk assessment".

Risk assessment had its origins in the U.S. Food and Drug Administration's 1954 decision to
establish the first "tolerance" limits for chemical residues on food. In other words, FDA
sanctioned and legitimized certain amounts of poisons in our foods.

These amounts were referred to as "safe". When scientists learned more about these poisons,
many of them cancer producing, they realized that if any amount was allowed in
our food someone somewhere would be harmed. So following that realization, risk
assessments were used to predict how many people exposed to a particular poison in
acceptable amounts would be killed.  Usually one in a million  or one in ten
thousand is an acceptable risk.

The United States Environmental Protection Agency's Science Advisory Board recently said
that risk analyses "always will be imperfect tools" and "No matter how much the data and risk
assessment techniques are improved...EPA's judgment {based on risk assessment} will entail
a large measure of subjective judgment."Rachel's HWN #204

This inherent uncertainty in risk assessment means that clever people can manipulate data,
and can manipulate unspoken assumptions, to achieve any quantitative result they choose. In
fact, it is common for risk assessors to select the goal that their risk assessment is supposed
to o achieve (one in a million is a common goal), then to manipulate the data and assumptions
to come up with the "right" answer. The result is usually expressed as a single number and
such numbers look very precise and scientific even though they may be based only on
estimates or guesses , or may even have been fabricated. (Rachel's HWN #204

The basic goal of a risk assessment is to evaluate the potential consequences of a decision,
recognizing that much necessary information is not available and may never become
available. (Rachel's HWN #204

Mary O'Brien, who edited Journal of Pesticide Reform and served as a staff scientist for
Northwest Coalition for Alternatives to Pesticides in Portland, Oregon  has seen how risk
assessments have been used by the scientists working for polluters to justify the exposure of
people to toxic chemicals.

"Worker inhalation and absorption of workplace toxics is approved via risk assessment," she
says. "The spraying of pesticides on schoolgrounds, roadsides, over urban areas and forests,
and on the nation's food supply is dubbed acceptable via risk assessment. The degradation of
our drinking water supplies, aquifers, and air is approved via risk assessment."
Rachel's HWN #204

Many chemicals have been affecting the human immune system, reproductive system, and
nervous system.

Science April 3, 1992 p. 28

In the 1980s, human immune systems were first faced with the blatant destructive power of
AIDS. Now in the 1990s, humans-- and immunologists--are encountering dramatic increases in
yet another disturbing, though far more subtle problem: Environmental pollutants are having a
deleterious effect on immune systems. Indeed, everywhere these days doctors are
seeing increasingly severe cases of immune-related diseases.

EPAs has blessed this as the official technique for showing that industrial poisons rarely, if
ever, cause significant harm (in safe doses) To expose the swindle inherent in all risk
assessments, one merely needs to point out that little or nothing is known about the effects of
chemicals on the immune system, the reproductive system, and the nervous system. When
little or nothing is known, it is obviously impossible to show that any particular chemical
exposure is safe. Under these circumstances the only dose known to be safe is zero. Since
there will never be enough research to discover the ill effects of all individual chemicals now in
use, much less combinations of all chemicals now in use, risk assessment is
and always will be, a sham and deception HWN #318

The National Research Council's study of neurotoxins jolted the political system into a new
awareness of risk assessment. Senator Edward M. Kennedy (D-Mass.), sponsor of a bill called
the "Safety of Pesticides and Food Act", greeted the NRC report saying, "This report makes
clear how little we know about the health consequences of the thousands of toxic chemicals
that permeate our high-tech society. The most ominous finding is that current risk assessment
methods are not sensitive enough to detect real and avoidable risks lurking in our
environment," (1992)

The federal Centers for Disease Control in 1992 officially reduced the amount of lead that is
considered "acceptable" in children's blood, from 25 micrograms per deciliter to 10
micrograms per deciliter.

The New England Journal of Medicine reported October 29 (pps 1279 and 1308) that low
levels of lead in young children don't merely "delay neurobehavioral or motor development" but
actually produce "deficits in intelligence."

According to Rachel's HWN #318 At least three studies of children exposed to lead before the
age of 4 have now shown that the damage is measurable during school years, ages seven to
10. One study of well-to-do children in Boston showed that each increase of 10 micrograms of
lead per deciliter of blood at age 2 produced a six-point decrease in IQ at age 10. This held
true in the range of 0 to 25 micrograms per deciliter, which means that a child with 25
micrograms of lead in his or her blood at age 2 would lose 15 IQ points compared to what his
or her IQ would otherwise have been. Such a decrease might not debilitate a person who
started with a 125 IQ, but it would devastate a person at the lower end of the normal range of
intelligence. A person pushed from a 90 to a 75 IQ would face a lifetime of serious learning
disabilities, and expensive remedial help. (p.2)

The alternative approach, which was adopted at the Paris Ministerial Meeting in September in
which  13 European nations agreed to eliminate all discharges and emissions of chemicals that
are toxic, persistent and likely to bioaccumulate. (Belgium, Denmark, Finland, France,
Germany, Iceland, Ireland, the Netherlands, Norway, Portugal, Spain, Sweden, and the United
Kingdom. Do no harm 1992

Because they didn't know  the effects of these chemicals on the environment and how of much
of them the environment could stand  they would not chance it instead they assumed
that all chemicals could cause harm In sum zero discharge.

The IJC International Joint Commission (USA and Canada) which was established in 1909 by
the U.S. and Canada to oversee water quality in the Great Lakes

April 1992  IJC called for the US and Canada to define many chemicals as "persistent toxic
substances" and then eliminate them because, "We conclude that persistent toxic substances
are too dangerous to the biosphere and to humans to permit their release in any quantity To
adopt a "weight of evidence" approach not waiting for scientific certainty to be established but
taking action to protect against toxins  as soon as the weight of evidence indicates the need
for action. "Persistent chemicals be defined as those with a half-life in air, water, sediments, or
living things, of 8 weeks or longer (The half-life of a substance is the time it takes for half
of it to disappear).

Toxocological science has no way of analyzing multiple exposures, cumulative exposures,
cumulative damage, or multiplier effects known to occur between different chemicals.

For the past 3 or 4 years, evidence has been accumulating that many industrial chemicals
(including many common plastics, pesticides, and by products of combustion) mimic hormones.
These hormone minickers disrupt reproduction and development in humans and in many other
species of mammals, birds, and fish. A growing body of evidence also indicates
that these same chemicals may cause some of the most common and fastest-increasing
cancers: breast cancer in women, and cancers of the testicles and prostrate in men. The
American Chemical Society (ACS) recently affirmed the following phenomena:

Sperm count in men worldwide has dropped to 50% of what it was 50 years ago

The incidence of testicular cancer has tripled in some countries in the last 50 years and
prostrate cancer has doubled

Endometriosis--the growth outside the uterus of cells that normally line the uterus--which was
formerly a rare condition, now afflicts 5 million American womem, the ACS said

In 1960, a woman's chance of developing breast cancer during her lifetime was one in 20.
Today the chances are one in nine

Female common terns (seabirds) are sharing nests near a PCB-contaminated site in New
Bedford Harbor, Mass., an unnatural female-female pairing

Young male alligators in pesticide-contaminated lakes in Florida are growing up with penises
so small that they are "sexually incompetent".

In January 1994, the federal National Institute of Environmental Health Sciences (NIEHS)
convened a meeting of 300 scientists who presented papers on estrogens and estrogen
mimickers in the environment. Many of those scientists think there's probably a connection
between diminished sperm counts, increasing endometriosis, female-to-female pairing in birds,
sexally incompetent alligators, and breast cancer in women. The connection is poorly
understood, they say, but the common link is probably chemicals dumped into the environment
that mimic, or interfere with hormones.

Slowly, mainstream scientific thinking has been coming to grips with this accumulating bad
news. First, the American Chemical Society began to write about it. Then the National Institute
of Environmental Health Sciences (NIEHS), a division of the U.S. National Institutes of Health,
started writing about it. And this month the Journal of American Medical Association (JAMA)
broke the story for its readers: Estrogen and {chemical} agents that mimic it appears to be
more pervasive and problematic than ever suspected," JAMA said February 9th.

Estrogen is usually considered a female hormone, but males produce estrogen too, in small
amounts. In the developing fetus, in both humans and animals, a specific ratio of estrogen to
androgens (male hormones) must be maintained for proper sexual differentiation to occur, in
other words, for a male to become a male and a female to become a female--regardless of
species-- a certain balance of male and female hormones must be present in the mother
between the time of fertilization and the time of birth or hatching.

If the hormone balance is disturbed, the offspring will be born with two sets of partially
developed sex organs (intersex), or with a single set that is incompletely or improperly
developed. Diminished sperm count, or future cancer, may be set at this early stage.

All plants and animals are composed of cells--tiny bags of fluid that work cooperatively
together to carry out metabolism (extraction of energy from nutrients) to maintain life. The
human body is composed of roughly 50 trillion individual cells that all cooperate and
communicate with each other. Hormones are chemical messengers, essential to the body's
healthy cooperation and internal communication. Hormones are present at very low levels
(parts per billion or even parts per trillion), and often for only short periods of time, yet they
have very powerful, long-lasting effects on
growth, development, and metabolism.

The female hormone, estrogen, and chemicals that mimic estrogen, operate inside cells by
fitting themselves into "estrogen receptors" (proteins) the way a key fits into a lock. Once the
key is in the lock, the key-and-lock together can move into the nucleus of a cell and attach to
the DNA, releasing messenger RNA which then causes a cascade of changes in cells, tissues,
and organs throughout the body.

No, the story of estrogen mimickers is not simple. Some estrogen mimics fit into the lock wrong,
filling up the space that the "correct" key would have used, thus interfering with natural
estrogens; these are called estrogen antagonists. Some estrogen mimickers fit into the locks
that weren't even intended to have an estrogen fitten into them. The amount of natural
estrogen in the mother is usually much greater than the amount of estrogen mimickers.
However, most natural estrogens are bound up by sex-hormone-binding proteins in the
blood-stream, which are not able to bind estrogen mimickers. This increases the effective dose
of the mimickers. The many ways estrogen mimickers can cause problems are just now
beginning to be appreciated.

"The structural diversity of estrogen chemicals is enormous," says Johm A. McLachlan, chief of
the productive and developmental toxicology laboratory at NIEHS, according to

In other words, you cannot simply observe a molecule and tell, by its chemical structure,
whether it will act as an estrogen mimic or not.

"Compounds with widely different structure bind to estrogen receptors even though they bear
no obvious structural resemblance to estrogen", says John A. Katzenellenbogen,
professor of chemistry at University of Ilinois.

Examples of estrogen mimickers are DDT and its breakdown by-product DDE; Kepone;
dieldrin; dicofol; methozychlor; some PCB's; 3,9-dihydrooxybenzanthracene; and alkyl phenols
from penta-to-nonylphenol, as well as bisphenol-A (the building block of polycarbonate
plastics) which is used in many common detergents, toiletries, lubricants, and spermicides.
Many estrogen mimickers are persistent (they resist breaking down in the environment) and
highly soluble in fat (causing them to accumulate in the bodies of fish, birds, and mammals,
including humans). Many of them cross the placental barrier and pass from the mother to the
developing fetus.

It is not simple to distinguish estrogens from nonestrogens. "Historically, we think of the
receptor as a switch," turning in on or off the body's reactions. But it is not that simple, says
George M. Stancel, head of the department of pharmacology at University of Texas Medical
School. Estrogen-like chemicals can form "many molecular configurations" that can "act in
different ways," Stancel told JAMA. The same chemical can also act differently in different
tissues, Stancel said.

To complicate the picture further, some cells appear to have estrogen receptors on their
surface, rather than inside. So "even if compounds do not manage to get inside cells, they
may still be estrogenic," says Cheryl Watson, associate professor of biological chemistry at the
University of Texas Medical Branch at Galveston.

Finally, JAMA reported that estrogenic chemicals have a cumulative effect. David Feldman,
professor of medicine and endocrinology at Stanford University, says, "The cumulative effect
may be much greater than any individual molecule." Ana M. Sota at Tufts University combined
10 estrogen mimickers, each at one-tenth of the dose required to produce a minimal
response; she found that the combination produced an estrogenic response.

The last bit of information has far-reaching implications for the regulation of chemicals. For 50
years the U.S. has regulated chemicals one by one, conducting laboratory experiments on
animals, and by experimenting on workers. If rats or workers get sick, then a particular
chemical may be regulated to a level 10 times (or 100 times) lower than the lowest amount that
caused an observable effect.

If chemicals at low ('safe') levels combine to produce an effect, this means that chemicals will
have to be regulated in combination. "Testing mixtures is right on the mark" says George M.
Stancel, at University of Texas Medical School. Kenneth Olden, head of NIEHS, agrees. "We
cannot ignore this milieu we live in that has all these estrogens. We have polluted our
environment. It is polluted, Now we have to allocate resources to sort out the different effects
of agents and learn whether they are synergistic. Additive, inhibitory, or antagonistic. We don't
know, Olden says, meaning we must try to learn whether chemicals in various
combinations are weaker or stronger than each chemical alone,

Scientists can pretend that they can discern "safe" levels of hundreds of different chemicals,
all acting in combination. They can pretend that they can understand all the ill effects of
multiple hormone mimickers on each type of cell, each tissue and each organ at every stage of
development from conception to birth, through youth and puberty, and into maturity, in each of
the thousands of affected species. They can pretend to know these things, but they cannot
ever actually know them. They are just pretending.

Scientists can pretend, but in so doing they perform a great disservice, preventing
decision-makers from seeing what really needs to be done: we need to abandon the practice
of chemical-by-chemical regulation. We need to regulate whole classes of chemicals. And the
dangerous classes need to be phased out and banned. Zero discharge. Pollution prevention.
These are the keys to sustainability and survival. HWN #377

the insurmountable limits of science in determining chemical hazards; the environmental justice
problems that government officials create when they use risk assessment to prioritize
environmental problems; and the widespread destruction of the environment that is occurring
because of our single-minded reliance on risk assessment

Joseph V. Rodricks of Environ Corporation in a paperback book on the theory of risk
assessment entitled Calculated Risks "Toxicologists know a great deal about a few chemicals,
a little about many, and next to nothing about most," he says (p. 146) (1992)

As Roderick's book illustrates, the government often doesn't even know what toxic effects to
test for. It does not even mention chemicals that damage the endocrine system. The endocrine
system, in wildlife and humans, is a complex set of bodily organs and tissues whose activities
are coordinated by chemical messengers called hormones, which control growth, development
and behavior. Bears hibernate because of chemical signals from the endocrine system, and
women menstruate under control of their endocrine system. In the past decade, evidence has
accumulated that several dozen pesticides and other industrial chemicals mimic, or interfere
with, hormones and thus disrupt the endocrine system. in both wildlife and humans, it is the
reproductive system of unborn offspring that is most prone to disruption by hormone-like

For 20 years, risk assessors like Rodericks-well-meaning people inside and outside of
government have given the green light to exposing people and wildlife to thousands of
chemical compounds without understanding that some chemicals mimic, or interfere with,
hormones. The very risk assessments gave the answer "No problem" when in fact there were
significant problems.

This is an insurmountable shortcoming of all risk assessments. If there are effects from
chemicals that scientists have not suspected and studied, those effects will be ignored in a risk
assessment. Furthermore, because it costs roughly $400,000 to $1,000,000 to study a
chemical even crudely, major harm must be demonstrated before study commences.
Therefore the risk assessment method of setting "safe" standards always requires that harm
must be done to wildlife and humans before study begins.

When good data are not available, risk assessments are put together from "science policy
choices" (a fancy name for informed guesses), assumptions, and speculation.

This is a key point. Rodericks (p. 178) says, for example, that in most cases the relationship
between dose and response at low levels of exposure is not known. (In other words, nobody
knows how sick your child will get from eating small amounts of several poisons every day).
There are usually several "scientifically plausible models" that could describe the
dose-response relationship, Roderick says, and "scientists cannot be sure which is correct.'
Moreover, the different models "yield sometimes substantially different pictures of the risk for
the same exposure" he says. And, "if a risk assessment is to be completed, a science policy
choice must be made before the model can be used...several similar choices having to do with
other uncertainties are needed to complete most risk assessments," Roderick says. In other
words guesswork is central to every risk assessment.

Interestingly, Rodericks does not elaborate on the "several similar choices" that go into every
risk assessment--perhaps because to do so would reveal that risk assessment is not the
scientific enterprise it appears to be, but it is in fact largely a political exercise. Rodericks does
say that "To base risk assessment and risk management decisions upon such uncertain
scientific knowledge is bad public policy." (p. 227). Unfortunately, the answer is not to reduce
our reliance upon risk assessment but to do more studies, as if more studies eliminate all the
important uncertainties in our scientific knowledge of the effects of chemicals on humans
and ecosystems. Dream on.

From the viewpoint of someone eager to dump exotic new chemicals into the ecosystem, this is
the real beauty of risk assessment; no matter how flimsy the base of information, every risk
assessment still gives the same satisfyingly numerical answer. Furthermore the answer you
get is completely dependent upon the "science policy choices" that you made, yet the final
result appears to be entirely objective and impartial. A political choice swaddled in
scientific trappings.

Back to our recently-discovered ignorance about hormone disrupting chemicals. In testimony
before Congress last October, Richard Wiles of the Environmental Working Group in
Washington D.C., showed that we now put 220 million pounds of endocrine-disrupting
pesticidal chemicals directly onto and into our food supply each year. The pesticide found
most often on fruits and vegetables is endosulfan and it is an endocrne-disrupter. Analysis of
data from the Food and Drug Administration's (FDA) routine food monitoring program revealed
endosulfan on 21 of 22 samples (95%) of fruits and vegetables heavily consumed by infants
and children, Wiles testified. Wiles testimony in Health Effects of 'Estrongenic Pesticides;
Hearing Before the Subcommittee on Energy, Commerce, and Environment of the {House}
Committee on Energy and Commerce, October 21, 1993 Serial No, 103-87, pp. 29-37
U.S Government Printing Office, Washington, D.C.

At the same hearing, Dr. Earl Gray, a section chief in U.S, EPA's Health Effects Research
Laboratory reported his latest findings on a fungicide called Vinclozolin--a pesticide currently
in use with EPA's approval. "Vinclozolin, when administered to a pregnant rat, demasculinizes
the male fetuses in a manner identical to the anti-androgenic drug flutamide and in effect
these effects are so obvious that all of the males look like females at birth." Dr. Gray testified.
He went on to say, "In the rats in vivo (in other words, in studies of living animals) this chemical
blocks development of the fetal male rat reproductive system so that they have undescended
testicles, they develop a vaginal pouch like a female, the penis fails to develop normally, and
they retain nipples which male rats do not normally do."

Congressman Henry Waxman (D-Ca.) asked Gray, "Do you think that Vinclozolin could have
the same kinds of hormonal effects on humans?" Gray answered, "I think that is quite possible,
and likely." Gray testimony in Health Effects 123- 126

Earlier in the hearing, Dr. Theo Colborn, an expert on endocrine-disrupting chemicals, made
the point that a single dose of some chemicals can disturb a baby's normal sexual
development. She said, "Nor is it comforting for a woman to realize that it takes only one very
low dose, it is called a hit, of an endocrine-disrupting chemical during one of the many critical
stages of embryonic development during her pregnancy to change the course of sexual
development of her baby." Colborn testimony in Health Effects p.38

So long as we use risk assessment as our chief guide for allowing chemical exposures, we can
expect an unending series of unpleasant surprises as today's 'safe' dose is discovered
tomorrow to be unsafe.

At the hearing last October, Congressman Waxman asked EPA's Dr. Lynn Goldman how long
it would take before Vinclozolin would be removed from the American food supply. Note the rich
fudge of risk assessor's language in Dr. Goldman's reponse. "Well, the decision could involve
a number of considerations, What we are going to be concerned about is the issue of not only
the inherent risk of the pesticide, but also the science that tells us about the exposures that
might be expected given the various uses that are allowed under the label, and so that there
could be a variety of actions that are taken ranging from, as you suggested, perhaps not even
allowing the registration to only allowing the registration on certain uses that are safe, to
allowing all of the uses that are currently allowed if we are very certain that we have no
exposures that would cause harm to those who might come in contact with it, so the
decision--this piece of information is one piece of the scientific data that needs to be examined
to make a good decision about this compound, but obviously a very important piece. (p. 127)  
Goldman testimony in Health Effects.

Stephen Breyer, Breaking the Vicious Circle, subtitled Toward Effective Risk Regulation (1993)
Cambridge, Mass:Harvard University Press.

Risk assessment has 4 parts, says Mr. Breyer (p. 9): (1) identifying the potential hazard (i.e.,
defining the toxicity of the substance in question); (2) drawing a dose/response curve (i.e.,
deciding how much of a substance will cause how much damage); (3) estimating the amount of
human exposure; and (4) categorizing the result (i.e., putting it all together to state the
probability of a certain kind of damage).

Mr. Breyer says 2 of these 4 steps are particularly difficult: "In carrying out these activities,
particularly in making dose/response and exposure estimates, regulators often find that they
simply lack critically important scientific or empirical data: they do not know how many
Americans inhale how much benzene at gasoline stations; they do not know the extent to which
the biology of a rat or mouse resembles, or differs from, that of a human being. In such
instances, they will often make a "default assumption"--a formalized guess--designed to fill the
gap and to permit the regulator to continue the analysis." {We note that Mr. Breyer is in
complete agreement here with the risk expert we quoted last week, Joseph V. Rodericks; what
Mr. Breyer calls "default assumptions," Mr. Roderick called "science policy choices" but they
are the same thing--informed guesses) Guesses to fill data gaps are not science. They are
political judgments.

Having established that risk assessment is a highly political, not a scientific, enterprise, and is
subject to pressures from "the public's demands"

"These uncertainties, knowledge gaps, default assumptions, guesses and communications
difficulties, all embodied in the technical regulatory process, spell trouble--Such a system, in
respect to small risks, and with assumptions of varying reasonableness, can produce random
results." (p. 48)

"The very fact that the many assumptions required by uncertainties are not clearly derivable
from science can make them a lightning rod for contending political forces. Regulatory bodies,
after all, are politically responsive institutions, with boards, commissioners, or administrators
appointed by the President, confirmed by the Senate, written about by the press, and from
time to time, summoned by Congressional committees to give public testimony... Their
agendas, within limits, respond to the public's demands. Their choice of default assumptions,
to a degree, can respond to the desire of the President, Congress, Congressional staffs,
interest groups, or the agencies themselves to appear especially careful to err on the safe
side, or, alternatively, to show sensitivity to economic costs." (p. 49)  HWN#394

Simple declare some risks too small to worry about de minimus risks

When risk assessment is used to establish environmental priorities, the effect is to decide
which problems will be ignore, which destructive behaviors will be tolerated.

People exposed to pesticides and industrical chemicals don't matter much and that nuclear
power is safe.

The EPA is making risk decisions that affect air, water, soil

Defuse public concerns at the local level by touting the scientific basis of the risk assessment.

Chemicals that seemed safe in the past are now recognized as dangerous. Chemicals that
seem safe today are often recognized as dangerous tomorrow, and that will alwys be the case.
Furthermore, science has no way to judge the consequences of exposure to many pollutants

People are aware of increased birth defects, developmental disorders, cancer, and other
illnesses associated with pesticides, and with strange chemicals leaking from superfund sites.
Men today produce half the sperm their grandfathers did, most likely as a result of exposure to
"acceptable" levels of unnatural industrial chemicals. It is rational to be concerned about such

So called experts will decide what is important and what is safe. Risk assessment is not a
scientific enterprise but a political process.

Who expects people living near a Superfund site to sit by while the risk experts tell them their
problem is insignificant compared to global warming, or that society is better served by
spending its money, say subsidizing nuclear power. We are paying the price to our health and
environment from the same people who created the major environmental mess in the first
place. Are we going to allow them to make more bad decisions based on a faulty risk
assessment? Certain problems will be ignored question of synergism and certain destructive
practices will be tolerated.

Policy of the EPA if they don't have a risk assessment for it they just ignore it.

Risk assessment is one way of making decisions. Risk assessment has been described as a
fours-step process. Step 1: Hazard identification. This step is supposed to estimate chemical
damage from acute (single dose), subchronic (a few doses), or chronic exposures for each
possible toxic endpoint. Toxic "endpoints" include cancer, damage to organs (liver, kidney,
heart, etc.), developmental disorders, damage to the immune system, central nervous system,
reproductive system, and genes. Because organisms (whether hamsters or people) react
differently at different stages of development, particularly while in the womb, dozens of
'endpoints' must be considered. In actual practice, most endpoints are simply ignored.

Step 2: Dose-response assessment means determining what damage, and to which bodily
systems, will occur as the dose of a chemical increases. Most people are familiar with the
concept of dose-response; think of the effects from drinking one, two, or three glasses of wine.
In general, greater dose leads to greater effect. Usually assessing dose-response for a
chemical requires estimating (extrapolating) from data about laboratory animals, who have
been given high doses, to effects in humans who typically receive low doses from
environmental exposures. There are many different ways of "extrapolating" from high-dose
animals data down to low-dose human estimates.

Step 3: Exposure assessment. Exposure assessment tries, or should try, to determine how
much of a chemical is absorbs from all sources. Example: if the chemical is a pesticide,
exposures might occur through food, water, air, and perhaps even skin, through home and
occupational uses. (In practice, many sources of exposure are usually ignored)

Step 4: Risk Characterization. Ideally, risk characterization takes information from hazard
assessment, dose-response assessment, and exposure assessment, then adds information
about characteristics of the affected population--How old are they? Are they generally
malnourished? Overweight?--and combines it all together to determine an estimate of hazard
(called risk), (In practice, the characteristics of a particular population are usually ignored and
averages are used instead.) Hazard (called risk) is expressed as a probability of a particular
kind of harm to a specified group of people during a stated period of time. For example, a
typical estimate of 'risk' might be expressed this way: a particular group of people is expected
to endure one additional cancer for every 100,000 people, over and above the normal risk of
cancer, as a result of chronic exposure to some toxic chemical in their drinking water during
their lifetimes of 70 years.

Despite the NAS's idealistic description of risk assessment, the process is deeply flawed and
subject to abuse.. EHW #470

Risk assessment is inherently misleading: In actual fact there are no agreed-upon ways for
assessing nervous system damage, immune system damage, or damage to the genes.
Furthermore, science has no way to evaluate the effects of exposure to several chemicals
simultaneously. Because everyone in the real world is exposed to multiple chemicals
simultaneously, risk assessment is never describing the real world, yet almost always pretends
to describe the real world. Risk assessment pretends to determine "safe" levels of exposure to
poisons, but in actual fact it cannot do any such thing. Therefore risk assessment provides
false assurance of safety while allowing damage to occur. It is therefore inherently misleading.

Reliance on risk assessment harms democracy: Because risk assessment is a mathematical
technique, most people cannot understand, or participate in it, risk assessments. Therefore,
reliance on risk assessments for decision-making harms democracy because most people are
excluded from the process.

Demand that risk assessment be replaced by a better way to make decisions in which we can

NEPA National Environmental Policy Act of 1969, a federal law. NEPA requires that before
certain decisions can be made, all reasonable alternatives must be examined, If this approach
is taken, then the public can get involved in describing and discussing all reasonable
alternatives. In such a process, all views can be aired. Cultural  values, historical perspectives,
and local concerns can all be brought into the decision, along with issues of technology, costs
and benefits. People can look at all the alternatives and can decide which one they prefer.
The process of thinking about alternatives is healthy for a community--it helps people visualize
the future that they want for themselves and their children. Risk assessment suppresses such
decisions. Hawaii and Oregon made their own decisions-they stopped sludge.

No risk is acceptable if it is avoidable: When people are examining a full range of alternatives,
they have an opportunity to apply the principle that, "No risk is acceptable if it is avoidable."
However, when people are merely doing a risk assessment, this principle cannot come into
play. A risk assessment never reaches the conclusion that a risk is avoidable because risk
assessment never asks whether a particular risk can be avoided. That is simply not
a question that risk assessments ask.

Example:  A city decides to dispose of its sludge by applying it to land. They give it to a local
farmer telling him it is a fertilizer that will be beneficial to his crops providing the necessary
nutrients at no cost to him. A risk assessment made by the EPA says the risk is negligible
because only one in 10,000 people will be harmed by the organic chemicals found there.
Because the harm is so small to the people living nearby the land application is deemed
"acceptable" This is a typical use of a risk assessment to justify a decision that was made by
EPA. Often such a decision is announced after the fact, and the damage is done before the
people even are aware of it.

When people make a choice they want to balance the disadvantages and the advantages, the
costs and the benefits. Risk assessment merely assesses the costs (risks) of one proposal
and asks whether those "costs" are "acceptable", or not. But people in the real world don't just
want to know whether the "costs" are acceptable--they also want to know whether the
"benefits" are sufficiently desirable. Assessing all the alternatives will allow people to discuss
benefits as well as costs.

Risk assessment of one or a few choices is unethical: The environment is being harmed and
needs to be protected. Therefore, ethical considerations require us to try to harm the
environment as little as possible. Risk assessment does not ask the question, "What is the
least harm we can do?" Instead, risk assessment asks "Will the damage we are going to do be
acceptable?" To provide an ethical framework for decision-making, we need to ask, "Which
alternative will bring sufficient benefits and minimize damage to the earth?" If a decision has
not been made by examining all available alternatives and them selecting the least-damaging
alternative, the decision is not an ethical one.

It only evaluates some of the risks.

Two researchers from Oak Ridge National Laboratory (ORNL), Curtis Travis and Sheri Hester,
have just published a new study of chemical contamination of planet Earth and have confirmed
what many people already knew: The entire surface is polluted. What separates Travis and
Hester from other U.S. government researchers before them is their stated belief that all this
pollution is taking its toll on human health. "We maintain that ambient (normal, everyday0
levels of pollution have risen to the point where human health is being affected on a global
scale."  Furthermore, they conclude that planet-wide contamination seems certain to increase
because U. S. EPA does not even try to prevent the spread of low levels of chemicals through
air, water, and soil. EPA's regulatory programs have other goals.

EPA's regulatory programs are aimed at protecting the most-exposed individual. EPA therefore
picks a spot where they believe the greatest exposure will occur, then EPA establishes the
concentrations (in parts per million) that they believe the individual can "safely" receive during
a lifetime of exposure. They define "safe" as "an exposure" that will kill no more than one in
every million individuals so exposed. EPA then figures out, as best they can, how much dilution
will occur from the point of release to the place where the most-exposed individual resides.
Based on these goals (and assumptions about dilution), EPA then issues a permit for a
particular polluter to release a certain amount of mercury ( or radiioactivity, or other toxin) into
air or water continously. Since the allowable release is set to protect the maximally-exposed
individual, EPA assumes all is well, never considering the buildup from many "safe"

One could raise doubts about many aspects of this approach to pollution control, but the
ORNL researchers highlighted only one key problem: continuous releases of mercury (or
radioactivity, or other toxin), although they may protect the most-exposed individual, do
nevertheless allow toxic materials to enter the environment continuously. Toxics
released from thousands, or perhaps millions, of differnt sources add up. Additional "adding
up" occurs in the food chain. A low concentration of mercury in water turns into a slightly
higher concentration in plants living in that water, an even higher concentration in animals
eating those plants, and so on up the food chain. You may start off with a small dose in air or
water, but large predators at the top of the food chain (big fish, big birds, wolves, humans,
bear, etc.) get a large dose.

Once they are released into the environment, chemicals seek out the environmental medium
(air, water, soil, or living things) in which they are most soluble. Trichloroethylene (TCE) and
Benzene are most soluble in air, so they tend to be found in air. DDT and PCBs are most
soluble in the fatty tissue of living things, so they tend to move into the food chain and
concentrate in living things.

Transport through the atmosphere is the main way that chemicals spread around the globe;
even fat-soluble chemicals initially move via the atmosphere, then they enter food chains and
concentrate in animals (including humans). So most pollutants travel via the atmosphere, but
food is the main source of pollutants for humans. Travis and Hester focus on PCBs, dioxins,
benzene, mercury, and lead, showing how "ambient" (normal, everyday background) levels of
these contaminants are high enough to make people sick. They make the point worth
emphasizing--that they chose these chemicals because data exists for these chemicals. For
the vast majority of chemicals we dump into the air and water routinely via incinerators,
landfills, and intentional releases from factory pipes and stacks, no data exists on how much is
dumped, where it goes, or what effects it may be having. EPA has spent twenty years not
gathering the relevant

PCBs. Although Congress banned them in 1976 and EPA banned them in 1977, an estimated
900 tons of PCBs cycle through U.S. atmosphere each year. Somewhere between 60% and
90% of PCBs entering the Great Lakes come from the atmosphere, according to Travis and
Hester. The average PCB concentration in breast milk in the U.S. is 89 micrograms per
kilogram. They calculate that the background level of PCBs in the U.S. food supply creates a
cancer risk of 110 per million (using EPA's method of calculating cancer risks). That is to say,
among every group of one-million U.S. citizens (and there are 245 such groups in our
population of 245 million people), 110 individuals can be expected to get cancer from normal,
background PCB exposures.

Dioxins. Background dioxin levels in the American people are lower than PCB levels, but
dioxins are more potent carcinogens, than PCBs. The "background" cancer risk from
dioxins, according to Travis and Hester, is 210 per million.

Benezene. The background cancer risk from routine exposure to benezene in the U.S. is 100
per million (or one in 10,000)

Lead. Travis and Hester report that lead is affecting between 3 and 4 million U.S, children
adversely (chiefly impaired cognitive development--stunted mental growth) because of "our
mismanagement and heavy use of this toxic material." An additional 400,000 fetuses in the
U.S. are probably harmed by lead each before they are born, Travis and Hester report.

Travis and Hester calculated the background cancer risk from 11 chemicals, using data from
the USDA (which samples the U.S. food supply for chemicals occasionally) and using EPA's
method of calculating cancer risks. They conclude that these 11 chemicals create a
background risk of 1000 in a million, or one in a thousand. And of course this does not
consider consequences besides cancer. It omits consideration of respiratory problems,
reproductive and developmental illnesses, nervous system disorders, damage to the immune
system, the increasing occurrence of multiple chemical sensitivity and much more. HWN 234

Travis and Hester's cancer analysis is based on a tiny part of the full picture. They say, "The
true extent of human exposure to environmental pollution has never been quantified. For
example, the (EPA) human adipose (fatty) tissue survey has identified only a very small
fraction of the chemical mass found in human adipose tissue." In other words, no data exist for
the vast majority of chemical exposures that are occuring routinely. EPA has studiously
avoided gathering the data.

As for solving this problem, don't look to EPA. Travis and Hester say, "The only way to diminish
global cycling of contaminants is to decrease production of pollutants or to destroy pollutants
before they are released into the environment--At present, the most commonly used method to
destroy pollutants is incineration, However, emissions from incinerator stacks tend to release
pollutants into the atmosphere."

Travis, C.C. & Hester, S.T. (May, 1991). Global chemical pollution, Environmental Science and
Technology, Vol. 25, No. 5 pp. 814-819

Global pollution by toxic chemicals is increasing. Chemical contamination now contributes to
the following kinds of problems: global warming, ozone depletion, acid rain, rising cancer rates,
increasing asthma, the widespread poisoning of our children by lead, escalating rates of
Parkinson's disease, and of Lou Gehrig's disease, growing infertility among American men and
women in their prime reproductive years, the contamination of breast milk, a new disease
called "multiple chemical sensitivity," and more. Yet current approaches to regulation do not
incorporate ways of dealing with the continued spread of chemicals world wide.

Together these small sources add up to a big hazard, yet none of them individually presents a
large enough hazard to officially notice.

Toxic use reduction is not reducing the concentration of toxics. If you have one pound of toxins
mixed with one pound of water and you add another pound of water, you have cut the
concentration of toxins, but you have done nothing to protect the environment. It is the total
quantity of toxins entering the environment that is important, not the concentration. So toxins
use reduction will seek to reduce the total mass (amount) of toxins entering the environment,
regardless of concentration (We note that EPA permits issued to polluters describe the
allowable levels of pollution as a particular concentration. This reflects the EPA's desire to
protect the most exposed individual not the general environment. Those permits are a key part
of the EPA approach that has allowed the global pollution problem to get entirely
our of hand).

EPA has managed to define most environmental problems in terms of risk assessment--a
mathematical procedure based on so many half-baked assumptions that it allows an
accomplished risk assessor to reach any conclusion he or she sets out to reach. Since EPA
now defines "pollution" largely in terms of risk as revealed through risk assessments, it seems
only logical that the agency will soon start to define "pollution prevention" in terms of reduced
risks as revealed by risk assessments. EPA will not have made a single measurement of an
actual decline in the amount of any dangerous chemical entering the environment (which is the
only true measure of toxics use reduction)  HWN #235 1991

In the case of dioxins, over the years EPA's risk assessment  has assumed that airborne dioxin
only enters humans through  their lungs. Dioxin that falls to the ground and is then  
incorporated into the food chain and eaten has always been ignored in EPA's risk assessment.

Consider all routes of exposure to dioxin not merely via the lungs. It is well known that dioxins
accumulate in the food chain, and the meat, milk and fish are the major sources of
dioxin exposure for humans.

USEPA, Estimating Exposure to Dioxin-like Compounds
(EPA/600/6-88/005B Workshop Review Draft Aug 1992

Mary OBrien, Risk Assessment in the Northern Rockies
May 12, 1993 HWN may 12, 1993

Toxics risk assessors act as if they know what damage a toxic chemical does, and  as if they
can, on the basis of this knowledge, determine some safe or "insignificant" level of exposure to
the toxic. But of course they don't know this. They may know what kind of chronic damage or
birth defects a single chemical causes in a genetically pure line of healthy laboratory rats.
They generally have no information on whether it causes immune suppression, endocrine
disruption, or nerve damage in infants; or chronic damage in people who
already are damaged in some way.

Toxics risk assessors focus on one chemical at a time. When I recently asked the Director of
the National Institutes for Environmental Health Sciences about the possibility of switching the
focus of the National Technology Program from testing a handful of individual chemicals for
cancer a year to looking at types of mixtures of chemicals faced by people living near multiple
industries or incinerators or hazardous waste dumps, he indicated that studying mixtures of
chemicals is "too hard". The problem is that we and wildlife are exposed to mixtures of
chemicals and indeed are born with them, our mothers having passed on many to us.