USES OF
RISK ASSESSMENT
Dr. John Moore
Environmental
Protection Agency
Risk Assessment Conference
March 18, 1985
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USES OF
RISK ASSESSMENT
Role off Risk Assessment in
Regulation
Statutory Requirements
EPA Practices: Current and Future
COMMENTS
(Introduction by Dr. Moore)
Dr. Goldstein has talked to you about the elements of
risk assessment, but not its use. That's »y job. In
particular, I mm going to describe:
• The general role of risk assessment in regula-
tion
• Statutory considerations that shape the use of
risk aasessaents
• Current EPA practices and future directions in
using risk assessment.
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RISK ASSESSMENT
COMMENTS
A* Dr. Goldstein pointed out, there are four basic
component* of a riak assessment, with the final atage
reaulting in a characterization of the riak. Thia
riak m»y be aaaociated with a particular aubatance or
perhapa the uae of that aubatance in a particular
aetting or through a specific route of exposure. It
ia theae elements which you omat deal with as you
proceed through the case study this Morning and con-
front that dreaded aubatance—"dinitrochickenwire" or
DNC.
But for those of us at EPA, riak aaaeaaaent and the
aasociated riak characterization are only the atart
of the process. Once we know the risks we have to
face the question, "So what are you gonna do about
it?" Thia statement—part question, part cry for
help—goea to the heart of what haa become known aa
riak Management.
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COMMENTS
RISK ASSESSMENT
RISK
MANAGEMENT
The flow diagram illustrates the framework in
which we consider risk: how to estimate it sod
In general, once the risk assessment procedure
hss resulted in some estimate of the potential
dangers associated with a specific situation, the
deciaion as to the appropriate course of action still
remains; a regulatory decision has to be made.
Risk assessment is a critical input in that
decision, but it is not the only one* Possible ways
of reducing those risks, or control options, must be
identified, and many non-risk related factors must be
evaluated.
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NON-RISK ANALYSES
/ Hufc
CfcoractartzaUon
economics
\ / Control
\ / OpUow
* ,X
Noo Rtok,
Awvycoa ~^:*"~*
statutory
legal considerations
social lacluis
Any particular decision nay include significant
economic, political, legal, and social considera-
tions. A* ve will aee later in more detail, some
statutes place greater emphasis on economic factors
then-others. This has the potential to lead to dif-
ferent results; the sane substance used in the same
way could be regulated differently under, different
statutes.
Many of the non-risk analyses provide informa-
tion on alternative control options. These options
suy vary significantly, again depending on such fac-
tors as the statute under which a aubatance is regu-
lated and technological feasibility.
At the same time, even though the ultimate regu-
latory decision may vary, the underlying initial risk
assessment should remain independent of the non-risk-
related considerations.
Ultimately, a riak manager must carefully weigh
all these factors and use his best judgment in making
what is often a difficult deciaion affecting millions
of citizens.
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COMMENTS
RISK ASSESSMENT
RISK MANAGEMENT
Using the results of Che initial risk assess-
ment, rick managers begin the process of evaluating
option*. This process has a nuaber of steps:
• The risk characterisation identifies problem
areas.
• Non-risk factors are evaluated and possible
control options are identified.
• Possible regulations are identified.
• The effects of those regulations on risk and
non-risk factors are estimated.
• A regulatory decision is made.
The process is continuous, requiring estimates of the
effects of alternative regulations on risk. For
example, banning the use of one pesticide may lead to
the use of another. Is the other substance more or
less risky? How vill the risks to society change?.
Answering these questions requires additional risk
assessment.
To illustrate how this framework works in prac-
tice, I'm going to look at a hypothetical pesticide
llv II
A.
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COMMENTS
PESTICIDE X
Risk characterization
• Absorbed through skin, causing
kidney damage
• Doses that can cause effect are
quite low
• Exposure can occur at four
possible points
The risk characterization of X ha* been com-
pleted and the result* are quite interesting.
First, our hazard identification indicates that
X can cause kidney damage when absorbed through the
akin. This finding is baaed on the type of animal
and epidemiological atudiea discussed by Dr.
Goldstein as part of the hazard identification
stage.
Second, the dose-response results ahow that the
peaticide can cause kidney damage even at low doses.
Hanoi. Things are getting very interesting here. Do
we have a problem?
Third, aa we will aee on the next alide, there
appear to be a number of potential waya in which
people could be exposed to the substance. In addi-
tion, the actual number of people exposed through
each route can vary.
Of course, I've given you only the briefest
outline of the risk assessment results. The risk
characterization melds together the hasard identifi-
cation, doae-reaponse, and exposure aspects of the
problem. A* pointed out by Dr. Goldstein, there are
many assumptions that must be made and many uncer-
tainties. In practice the riaks would be presented
numerically, in a manner much like you have in your
case on "Dinitrochickenwire." For our pesticide "X,"
the critical component is exposure.
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ROUTES OF EXPOSURE
Harvesting
Miiing and
applying
Specifically, people may be exposed at four
critical point*:
—when X is aanufactured
—when X is Mixed and applied to the field
—when the produce is harvested
—when the produce is eaten
Obviously( the next question is "What are the
levels at which people are exposed?"
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PESTICIDE X
Exposure assessment
• Chemical is rapidly destroyed
by sunlight
• Production process is totally
enclosed
• Minimal residues remain on food
• Extensive skin contact during
mixing and application
COMMENTS
Firat, the riak manager discover*, after care-
fully reading the risk assessment results, that the
chemical ia rapidly deatroyed by sunlight. Aa a
result, the level of exposure during picking ia prac-
tically zero. His initial assessment ia that no riak
management iaaue ia involved in a aignificant vay
during harvesting.
Second, he finds that expoaure during manu-
facture of the chemical is also kept to acceptably
low levela becauae the manufacturer uaea a totally
encloaed production process. For now, manufacture
does not seem to be a high-priority riak management
iaaue.
Third, the riak manager finda that even though
there are reaiduea of pesticide "X" on the fruit
after processing, the levela are extremely low and
appear to preaent no aignificant risks.
Fourth, however, he finda that expoaure during
mixing and application of the liquid peaticide ap-
proaches levela that may cauae kidney damage.
These findings point to an intereating aspect of
riak management. The risk management process usually
involves more than one deciaion becauae the degree of
risk often variea in the different phaaes of product
uae.
Our riak manager must now aak the queation "What
should we do about it?"
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COMMENTS
SO WHAT DO WE DO
ABOUT IT?
FIFRA mandate is to control
"Unreasonable Adverse Effect"
FIFRA Sec. 3(c)(5)(c)
"... taking into account the
economic, social and environmental
costs and benefits."
FIFRA Sec. 2(bb)
Our riak nanager, after aone discussion with EPA
counsel, has decided that pesticide X should be
regulated under the Federal Insecticide, Fungicide
and Rodenticide Act. Under that Act he must protect
the public health and environment from the "unreason-
able adverse effect" of pesticide X. However, the
Act also says that he should do so "taking into
account the economic, social and environmental costs
and benefits."
As you can aee, there are indeed nany "non-
risk"-related considerations for our risk manager.
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FIFRA CONTROL OPTIONS
• Restricted use
• Labeling requirements
• Cancellation of registration
• Lowering tolerance levels in
food crops
• Restrictions on impurities
• Formulation or application
restrictions
COMMENTS
The risk manager and his staff identify the
option* available to then for controlling the risks
fron X.
They could declare pesticide X as "restricted
use," which Beans that to use the chemical, a person
nust first have taken a course designed for pesticide
users. But our risk Manager doesn't like this ap-
proach becauae the applicators are already doing vhat
they're supposed to; he wouldn't reduce the rieks
through this action.
He also decides that he can't cancel the regi-
stration because without this pesticide a significant
part .of the apple crop would be lost. And as FIFRA
says, he is supposed to take into account the effect
of a potential regulation on production and prices of
agricultural commodities, retail food prices, and the
agricultural economy.
Neither the food tolerance level nor iapurities
pose any health risks.
Finally, our risk manager decides to examine
restrictions on the formulation and application of
pesticide X. There are a number of potential choices
here. He could require applicators to wear protec-
tive clothing, reduce the application rate, or limit
the time of application, to name a few.
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RISK ASSESSMENT
X RISK MANAGEMENT
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NON-RISK ANALYSES
Crop yields not significantly
affected
Minimal increase in pesticide
production costs
No substantial use of alternative,
more toxic, pesticides
COMMENTS
In making this final decision, Che risk manager
will also evaluate many of the non-risk factors dis-
cussed earlier. For example, by allowing a granular
form, crop yields are not significantly reduced and
the benefits from using the pesticide are not sub-
stantially altered. There may be some increase in
pesticide production costs but these are minimal.
Finally, it does not appear that other more toxic
pesticides would be substituted for pesticide "X"
after regulations'were enacted.
These results are fed back into the risk assess-
ment process to see how a possible regulation changes
the risk characterization.
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RISK MANAGEMENT
DECISION
Formulation Restriction
Deny use as a liquid and permit
use in granular form
Application Restrictions
Prohibit entry to field immediately
following treatment
Require interval between last
treatment and harvest
COMMENTS
There are, of course, many other actions avail-
able to the risk manager. In addition to the formu-
lation reatriction there are application and uae
reatrictiona auch as the one* presented here. He
could prohibit entry to the field immediately follow-
ing treatment or require an interval of time between
the laat treatment and harvest. Both of these ac-
tions would be taken to ensure breakdown.of the pest-
icide prior to harvest and consumption.
Of course, each of these alternatives would also
be analyzed on the basis of the non-risk factors
previously discussed, and the effect of these addi-
tional actions on the risk characterisation would be
estimated.
What if our risk manager discovered that pesti-
cide X is used in other production processes and may
be regulated under the Toxic Substances and Control
Act?
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