EH&S, Inc.

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ENVIRONMENTAL HEALTH
RISK ASSESSMENTS
SCIENCE OR VOODOO?

Ron Pearson, M.S., CIH
Environmental Health & Safety, Inc.
St. Paul MN
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The Nature of Risk
200 people die annually in U.S. from
electrocution (risk level 10-6 per year)
should I replace the wiring in my old
house?
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The Nature of Risk
7000 people die annually in U.S. from
falls in their homes
but ... most are over age 65, so should
the rest of us ignore this?
It's all about CHOICES
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Estimating Risk
Probabilities are fine until it happens to
me
Some of the uncertainty is due to
chance, some of it isn't
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Estimating Risk
Historical risks are easily understood -
e.g. car accidents
What kind of car do you drive?
Does it have airbags?
Do you drive fast?
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Comparing Risks
action annual risk uncertainty
all cancers 3 in 1,000 10%
pack-a-day 4 in 1,000 150%
smoker
mountain 6 in 10,000 50%
climber
car accident 24 in 10,000 10%
drinking MCL 6 in 1,000,000 1,000%
of chloroform
in water
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Comparing Risks
Human nature dictates that we tend to
worry more about risks that are severe
and abrupt, as opposed to something
that has some "probability" of occurring
down the road
Many say that we cant compare
unlike risks, but in fact, we do it all the
time
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The Costs of Risk Reduction
Location Risk Reduction Cost per
(geog.) means life saved
Indonesia Death Immunization $100
countries (infection)
U.S./ Cancer Pollution $1,000,000
other prevention
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Why do we need Risk
Assessment?
"Emerging" risks - e.g. hormonal
analogues
Shifts in perception
information overload - the "health studies"
results that we are bombarded with daily
ability to measure minute amounts of
substances
many traditionally severe health risks
(e.g. smallpox) are gone
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Environmental Health Risk
Assessment
health risk = the likelihood that an
adverse effect will occur to a person (or
group of persons) in a chemical
exposure situation
Usually, a higher exposure causes more
serious effects or makes them more
likely
At some low exposure level, the risks
become insignificant
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Estimates of Risk
Estimates of risk are needed to assist in
making decisions
Only in extreme cases will risks
estimates alone drive decision making
zero risk compels no action, while a
great risk may compel immediate action
IN REALITY, risk estimates lie
somewhere in between
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Environmental Health Risk
Assessments use two types of
Risk Estimates:
for carcinogens, the increased
probability of individuals' getting
cancer from a particular exposure
for other toxicants, a comparison of
expected exposure to an exposure that
is assumed to be insignificant
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Environmental Health Risk
Assessments use two types of
Risk Estimates
Why? Because they are most often used
in USEPA risk assessments
In general, effects on systems such as
the reproductive or immune system are
not scrutinized nearly as much as
carcinogenic effects
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What DONT risk assessments
estimate?
total number of people affected
relative incidence of an adverse effect in
populations known to be exposed with
those not exposed
the ratio of the expected risk with the
exposure to that expected without it
reduced life expectancy associated with
the effect
lost income potential, costs to society
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Uncertainties in Risk
Assessments
Dose Effect = relationship between the
amount of a chemical exposure and the
nature and/or severity of the toxic
effect
Data on toxic chemicals usually come
from:
laboratory experiments on animals NOT
epidemiology studies of humans
moreover, many are inferences based on
bacterial and/or human cells

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Uncertainties in Risk
Assessments
Dr. Bruce Ames, (Ames salmonella
microsomal screening test developer),
stated repeatedly that he never
intended for his "tool" to be applied as it
is today
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Uncertainties in Risk
Assessments
both of these sources of data cause
problems because:
an animal or cell is not a human being
most animal toxicity data is short-
term
relatively high exposures are used
experimentally, to cause statistically
significant effects
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Uncertainties in Risk
Assessments
many species are
homogeneous
(purposely, to limit
variability in
response)
By contrast, humans
are diverse in their
response to
chemicals due to:
genetic make up
age
habits
occupation
health status
diet, etc.
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Uncertainties in Risk
Assessments
some argue that extrapolations from
animals to humans are more reliable
than epidemiology studies, due to:
small study populations (lack of
"statistical significance")
confounding variables
lack of exposure data
differences between study populations
and the population to be protected
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Uncertainties in Risk
Assessments
When no effect is seen in lab animals, is
there negligible risk to humans exposed
at such a level?
a 1% incidence of any disease would be
impossible to detect in a study of 25
animals, but would represent more than
2 million cases if the entire U.S.
population were exposed
HOW DO WE ANSWER THIS
QUESTION???
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Uncertainties in Risk
Assessments
In risk assessment, it is often assumed
that:
for cancer: there is no safe dose, and;
at low doses, the relationship between
dose-effect is directly proportional
(linear)
for other health effects: there is a safe
dose
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Public Perception and Public
Demands
The "vicious circle":
public perception ->
media reporting ->
congressional action ->
agency regulation in response to public
demands
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Public Perception and Public
Demands
Are we (in the U.S.) better off now than
before the "skyrocketing" industrial use
of chemicals?
Since 1940 - life expectancy has
increased nearly 15 years
Since 1970 - infant mortality has
decreased by 1/2
Since 1970 - heart disease has dropped
by nearly 1/3
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Public Perception and Public
Demands
Cancer deaths have increased...or have
they?
Many feel the this is due simply to:
smoking (increases lung, pharyngeal,
pancreatic and bladder cancer incidence)
sun exposure (malignant melanoma has
increased eight-fold)
the increase in life expectancy (you have to
die of something...)
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Where has this all brought us?
Many times, the science of
epidemiology simply confirms the
obvious - rarely has an epidemiological
study drawn attention to an agent that
was not already recognized by an astute
observer in the field (e.g. Fen-Phen)
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Where has this all brought us?
We fear carcinogens in our drinking
water ... but what about Milwaukee's
public water supply and an outbreak of
cryptosporidium? Would we better off
taking some of our money from the
former and spending it on the latter?
Asbestos: we won't even get into it ...
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Regulatory Reform
What agencies conduct health risk
assessments?
OSHA
EPA
FDA
USDA
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Regulatory Reform
1983 - the NAS published the "Red
Book" - "Risk Assessment in the Federal
Government: Managing the Process"
defined four steps of risk assessment,
but more importantly, discussed how to
separate the "science" from the "policy"
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Regulatory Reform
1987: EPA published "Unfinished
Business" - ranked items such as
pesticides in food and radon as higher
health risks than items such as
groundwater contaminants or
hazardous waste sites BUT...failed to
rank airborne lead as a high risk - again,
it was driven by
carcinogens....essentially we have no
scientific methods for comparing cancer
with non-cancer risks
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Regulatory Reform
1991 - Federal Focus, Inc. called for an
executive order (16 CRR 171),
essentially prohibiting the use of overly
conservative assumptions
Risk Assessment has been represented
by many as a "value free" process, when
in fact it is full of judgements
Risk Assessment and Risk Management
are, and should remain, separate
processes
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Regulatory Reform
Risk Assessment produces very precise
numbers of questionable accuracy
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Regulatory Reform
Federal Trend: legislators pursuing risk
assessment as means of telling us what
the "real" risks are, so we can spend our
money accordingly - represents another
easy answer for attacking what ails us -
after all, what politician in their right
mind would outright oppose legislation
that is supposedly "good for the
environment"?
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Regulatory Reform
State Trends: decreasing funding for
public health/environmental health
programs but increasing environmental
regulatory spending - in 1994 we spent
$4.09 per capita on the former and
$18.87 per capita on the latter
In the Republican party's "Contract
with America" a bill called the "Job
Creation and Wage Enhancement Act"
bolstered risk assessment and cost
benefit analyses requirements
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Cost-Benefit Analysis
A good example of cost-benefit analysis
and the fallacies that can be put forth:
OSHA's proposed IAQ rule estimated
that a facility manager would spend an
average of 15 minutes documenting
each complaint
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"Advancements" in the Science
of Environmental Health Risk
Assessment


ASTM RBCA - Risk Based Closure
Assessment methodology
many states have jumped on the
bandwagon for this approach to
screening UST sites, especially as state
funds have become more scarce
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ASTM RBCA - Risk Based Closure
Assessment methodology
uses a tiered approach
Tier I: "lookup tables"
Tiers 2 - 4: incorporate more site specific
values for:
ground water
soil types
specific information on receptors
Still, much of the conclusions depend
on mathematically modeled results -
"garbage in - garbage out" still applies
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Conclusion: Where do we go
from here?
Most environmental problems are
extremely complicated technically
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Conclusion: Where do we go
from here?
We live in the age of entitlement: we
want the government to provide us a
risk-free society, and we want it now!
We MUST decide how much minuscule
reductions in risk we are willing to pay
for
We MUST question our legislators
AND regulators motives and actions
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Conclusion: Where do we go
from here?
We live in the age of technology, and
science can solve all of our ills: modern
science has it's limitations, particularly
when it comes to the analysis of living
systems - it may never suffice in
accurately predicting health effects or
their potential from low level exposures
We MUST decide how much
uncertainty we are willing to tolerate
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Conclusion: Where do we go
from here?
We live in the age of the sound byte:
most of the public gets the lion's share
of this information from the media
We MUST improve communication of
these issues dramatically
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Conclusion: Where do we go
from here?
We live in the age of cancer paranoia:
most of the EPA's regulatory efforts
focus on cancer
We MUST shift the emphasis equally to
non-cancer endpoints
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"Security is mostly a superstition. It
does not exist in nature, nor do the
children of men as a whole experience
it. Avoidance of danger is no safer in
the long run than outright exposure.
Life is either a daring adventure, or
nothing."... Helen Keller
DON'T WORRY - BE HAPPY ...
Bobby McFerrin