U.S. Environmental Protection Agency's Approach to Risk Reduction
Through the Process of Comparative Risk Assessment
By
Vincent R. Nathan
AAAS/EPA Environmental Science & Engineering Fellow
Senior Scientist Staff
Health & Environmental Review Division
Office of Pollution Prevention & Toxics
U.S. Environmental Protection Agency
Washington, D.C.

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ABSTRACT
Comparative risk assessment, broadly defined, is the analysis and
comparison of a group of chemicals or issues on the basis of a set
of defined risk criteria. Most risk assessments, done in context
of environmental programs, have important comparative aspects.
Because of the large uncertainties inherent in any risk assessment,
conducting a risk assessment strictly to characterize the absolute
level of risk without a comparative component would not be prudent
economically or environmentally.	Furthermore, the U.S.
Environmental Protection Agency (USEPA) clearly espouses risk
assessment as the policy guide for risk reduction.
In 1987, the USEPA published a report titled "Unfinished Business."
This report supported comparative risk studies on a broader scale
than standard risk assessment underpinnings. The USEPA's
independent Science Advisory Board (SAB), in its' September, 1990
seminal report "Reducing Risk," suggested that USEPA target
available resources at the greatest risks to human health and the
environment. These two reports set the framework for the agency's
look at all environmental problems and thereby ranking the risks
which pose the greatest harm to human health and the environment.
The agency does, however, recognize that other forces play critical
roles in directing policy, including statutory mandates,
traditional cost-benefit considerations, environmental equity,
technological advances, public perceptions and public values.

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USEPA and other federal agencies, as well as industry, have been
focused, and in some cases mandated, on reducing environmental
risks. There are numerous complications and impediments to the
reduction process. This paper focuses on how the USEPA approaches
risk reduction through the process of comparative risk assessment.

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Acknowledgments
This draft report was prepared during the author's tenure as a
Fellow under the American Association for the Advancement of
Science (AAAS)/U.S. Environmental Protection Agency Fellowship
Program during the summer of 1993. The views expressed herein are
entirely the author's and do not represent official policy of
either the AAAS or USEPA. The report is subject to further review
and revision. Mention of trade names of commercial products does
not constitute endorsement or recommendation.
The author wishes to thank Roger Garrett, Ph.D., Harry Milman,
Ph.D. and the entire Senior Scientist Staff of the Health and
Environmental Review Division of the Office of Pollution Prevention
and Toxics of the USEPA for their assistance and support during the
course of this report.

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USEPA Acronyms
This report includes information obtained from interviews with
various officials in the following USEPA offices.
Office of Pollution Prevention & Toxics (OPPT)
Office of Policy, Planning & Evaluation (OPPE)
Office of Water (OW)
Office of Solid Waste & Emergency Response (OSW)
Office of Air & Radiation (OA&R)
Office of Prevention, Pesticides & Toxic Substances (OPPTS)
Office of Research & Development (ORD)
Science Advisory Board (SAB)

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Table of Contents
I.	Introduction
II.	Risk Reduction Activities at USEPA
III.	The Nature of Ranking
IV.	Legislation
A. The Delaney Clause
V.	Quantitative Risk Assessment
VI.	Conclusions
VII.	References

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I. Introduction
Comparative risk assessment, broadly defined, is the analysis and
comparison of a group of chemicals or other issues on the basis of
a set of defined risk criteria. Simply described, comparative risk
assessment is a procedure for ranking environmental problems by
their seriousness (relative risk) for the purpose of assigning
priorities (Cothern, 1992). It is useful to adopt specific
definitions for several other key terms. "Environmental risk" is
defined as the probability of occurrence of a particular adverse
effect on human health or the environment as a result of exposure
to an environmental hazard. An "environmental hazard" may be a
hazardous chemical in the environment, a natural hazard, or a
hazardous technology. "Environmental risk assessment" refers to
any formal or informal procedure used to produce a quantitative
estimate of environmental risk, while "environmental risk analysis"
(sometimes referred to as "environmental impact analysis") is
defined more broadly to include quantitative or qualitative
evaluation of all relevant attributes of environmental hazards,
risks, adverse effects, events and conditions that lead to or
modify adverse effects, and populations or environments that
influence or experience adverse effects.
The USEPA has set a policy goal for reducing human health and
ecological risks (USEPA, 1987, 1990, 1993). Broadly stated, the
methodology for achieving this goal is comparative risk assessment.
Ideally, the goal and the methodology both are what policy-makers

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will need to know in setting priorities for risk reduction actions.
The reliability of the methodology is the focal point of
justifiable opposition to risk-based prioritization. Some
proponents (Bromley, 1992) argue that in relative risk ranking, and
in making risk comparisons, the uncertainties tend to cancel. That
logic, however, does not support the hard science approach to risk
decision-making.
USEPA Comparative Risk staff in the Office of Policy, Planning and
Evaluation (OPPE) defines risk-based priority-setting (comparative
risk) as a public process that helps participants (stakeholders)
decide which environmental problems are most serious and how best
to reduce risks. OPPE has outlined the identification and analysis
of the problems with 3 levels of risk assessment:
-	health risks,
-	ecological risks, and
-	quality of life risks.
Given the above outline, there are several conditions needed for
risk assessments. Known, or hypothetical, pathways linking the
risk and the potential effects; empirical data to confirm and
quantify the nature, probabilities, and related uncertainties with
respect to the pathway; and methodologies to integrate data into
the pathway. Table 1 lists management options for different toxic
chemical problems. The range of choices for action reflect
decisions that result from risk assessments. Table 1 also
highlights the no action option and the preventative option.

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Also pertinent to risk decisions are nuclear, chemical and
biological warfare materials and their threat to human life
survival. Furthermore, the USEPA does not monitor or regulate the
environmental impact of military operations. Though it is beyond
the scope of this paper, military environmental decisions impact
the budget and priority setting of the federal government. The
huge cleanup costs of these operations is considerably larger than
the operating budget of the USEPA.

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Table 1
Management Options for Different Toxic Chemical Problems
Range of Choices for Action
Problem
Preventive
Reactive
Research
No Action
PCB
Ban PCB
On-site
Health
In cases
contaminated
production
destruction
effects;
with low
ecosystem


develop
cones, or



substitutes
large




areas
Learning
Transporta
Catalytic
Study
Live with
Impairments
tion
converters;
effects of
problem
from Lead
planning;
smog alerts
lead on


ban leaded

biological


gasoline,

systems,


solders

develop




substitutes

Toxic waste
Incentives
engineering
Effects of
Let it
dumps
recycle
controls
leachates
leak

reclaim

on humans


reuse

and


reduce

ecosystems


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Minimata
Ban
Don't eat
Determine
Do
disease
mercury,
fish, close
causes;
nothing

limit
fishery,
levels,


effluents
compensate
metabolic



victims
conversions




diet


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II. Risk Reduction Activities at USEPA
The U.S. Congress (USC, 1992) has sent a clear message to the
Executive Branch that environmental decisions have to be
prioritized. Congress has suggested that risk ranking and cost-
benefit analyses be used as tools to set priorities. The irony in
this approach is that Congress believes that some questions are a
matter for the legal system and not the scientists and the USEPA is
aggressively seeking the "hard science" approach to risk decisions
USEPA, 1993) . Additionally, State and local governments will hold
Congress and the USEPA more accountable about obligating them to
spend their resources on Federal requirements Thus, the consensus
is that there are three themes that should be addressed by the
process of comparative risk assessment.
1)	Protect individuals at high risk.
2)	Enhance public participation.
3)	Address environmental equity.
Conversely, the limitations of risk assessments (Dwyer, 1990) are:
1)	In determining the social, cultural, or political
acceptability of a hazard.
2)	Addressing issues of equity.
3)	Indicating the magnitude of a problem if exposure or effects are
linked to special subpopulations or specific situations.

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4)	Comparing highly divergent types of risks.
5)	Comparing the relative risks of different hazards, if the level
of uncertainty varies considerably, or if the underlying
mechanisms are so different as to rest on divergent or contrary
assumptions.
6)	For risk management uses, if the input data are insufficient or
highly controversial.
According to OPPE, of the 13 major laws regulated by the USEPA,
environmental problems can be roughly placed into 22 categories of
risks. The agency estimates that only 20% of its budget are spent
on pollutants that it considers to be of greatest risk to humans
and ecological systems. These categories are based on the risk
rankings from the Science Advisory Board (SAB) 1990 report.
The disparities between risk and funding in the USEPA budget result
from: 1) Congressional statutory mandates prioritize agency
programs largely on the basis of public perception; 2) the
administration makes funding decisions according to policy, not
science and 3) federal court orders force USEPA to allocate funds
on the basis of lawsuits successfully brought against the agency.
Table 2 lists USEPA*s 1993 funding according to risks. Under the
heading of "Other Risks," inactive and abandoned hazardous waste
sites spent 28% and point source discharges to surface waters spent
33% in 1992. Management and multimedia research and development
spent 12% in 1992 and estimated 15% in 1993. All of the above

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risks were either low or unranked by the USEPA experts.

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Table 2
USEPA FUNDING ACCORDING TO RISK
High Risk
Health
Risk
Ecol.
Risk
Public
Concern
% 1992
Budget
% 1993
Budget
Air
Pollutants
High
Medium
Medium
7.25
8.39
Pesticides
High
Medium
Med./Low
1.75
2. 10
Worker
Health
High

High
0. 15
0.16
Drinking
Water
High

Med./Low
1. 64
1.91
Indoor Air
High

Low
0.51
0. 58
Radon
High

Low
0.45
0.49
Depletion
of Ozone
Layer

High
High
0.43
0. 58
Destruction
of Wetlands

High
Med./Low
0.61
0.74
Global
Climate
Change

High
Med./Low
0.70
0.75

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High Risk
Health
Risk
ECOl.
Risk
Public
Concern
% 1992
Budget
% 1993
Budget
Pollution
of
Estuaries,
Oceans,
Coastal

Medium
Med./High
1.40
1.60
Nonpoint
Surface
Water Poll

High/Low
Med./Low
1.35
2.39
Source: Center for Resource Economics, May, 1993

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The USEPA's current pollution prevention paradigm, which started
about 1990, focuses on reduction. The agency uses and promotes
cooperative industry strategies to reduce risks. Two of the more
notable projects, within the agency, are the Design for the
Environment (DfE) Program's Cleaner Technologies Substitute
Assessment and the Environmental Assistance Division's 33/50
Program.
The DfE methodology is to identify use clusters for a product or
industry. A "use cluster" is a set of chemicals, processes, and
technologies that can substitute for one another in order to
perform a specific function. The use cluster is then ranked using
a USEPA system that incorporates factors such as human and
ecological risks, exposure, regulatory interest, and pollution
prevention opportunities. The intent of the scoring system is to
help prioritize and direct research into more environmentally
beneficial alternatives.
In 1991, the agency produced a Toxic Release Inventory, as required
under Superfund legislation (SARA, 1986). The agency then targeted
17 chemicals for reduction by 33 percent by the end of 1992, and at
least 50 percent reduction by 1995. The targeted compounds were
identified from recommendations submitted by USEPA program offices,
taking into account such criteria as health and ecological risk,
the likihood of exposure, technical or economic incentives, and
limitations of treatment. The 33/50 program essentially allows

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flexible and voluntary reduction of the 17 chemicals. The success
of the program will be on the retrospective evaluation of how
environmentally effective industry reduces these substances.
Other pollution prevention strategies at USEPA include research and
development programs in the Waste Minimization Branch and the Risk
Reduction Engineering Research Laboratory. The agency also has
developed a hazard ranking system for uncontrolled hazardous
substance releases (USEPA, 1988).
One of industry's strategies for risk reduction is called life-
cycle assessment (LCA). The Society for Environmental Toxicology
and Chemistry (SETAC) has developed an objective process to
evaluate the environmental burdens associated with a product,
process, or activity in the industrial sector. By identifying and
quantifying energy and material usage and environmental releases,
LCA assesses the impact of those energy and material releases on
the environment. The assessment includes the entire life cycle of
the product, process, or activity encompassing extracting and
processing raw materials; manufacturing, transportation, and
distribution; use/reuse/maintenance; recycling; and final disposal.
A complete life-cycle assessment, as developed by SETAC, consists
of the following separate, but interrelated components:
Life-Cycle Inventory
Life-Cycle Impact Analysis

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- Life-Cycle Improvement Analysis
These three components make up an integrated approach that, when
combined with other appropriate information, can provide
information needed to maximize environment improvements.

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III. The Nature of Ranking
There are several ways risk can be ranked, or measured, in
quantitative terms. Expression of risk has to demonstrate that
the magnitude and probability of adverse conditions will occur in
a specific span of time. However, when assessing the overall
benefit of a proposed action, all the adverse conditions that may
arise throughout the life of the action must be integrated so that
the comparative aspect is clearly demonstrated. The lists or
rankings usually are based on risk-risk and cross-risk endpoints.
The quantifiable endpoints can be tiered. The tiered approach then
becomes the basis for the comparative risk analysis.
The most direct way of expressing risk is to put it as the
probability of an unacceptable condition arising and some kind of
loss being generated. Another way to express risk is in terms of
the probability of a release of say, toxic material involving costs
at a certain level measured in terms of loss of lives and damage to
property. To the general public, however, the central question is
whose life or what property is loss.
Large-scale technological systems have presented decisionmakers
with difficult problems in terms of justifying the levels of risk
that individuals and groups are exposed to during their lives.
Probability, and it's inherent uncertainty, sometimes make any
level of risk unacceptable. The power of the expert in determining
the ranking of a particular variable seems destined to be a cause

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for conflict between the various stakeholders in any decision.
Given the political climate and continued calls for public
participation in planning and evaluation, consensus may be
difficult to achieve.
Table 3 lists the composition of groups of ranking factors.

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Table 3
Composition of the Main Groups of Ranking Factors
Factor
Mature of Risk
Possible


Compositions of


Factors
Technical
Degree of physical
Structure

harm to people and
reliability,

environment
Societal risk,


Comparison to other


risks
Economic
Less than optimal
Supply and demand,

benefit from
Value of life,

financial outlay
Cost of Saving a


life,


Marginal cost of


saving a life,


Cost/benefit


analysis
Socio-Political
Public Opposition
Voluntary v.


Involuntary risks,


Response to public


comments,


Political climate,


Equity

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IV. Legislation
In 1981, President Reagan issued Executive Order 12291, ordering
regulatory agencies to prepare regulatory impact analyses (RIAs) on
all major regulations. Each RIA was to include the benefits and
costs of a proposed regulation's full range of effects and should
compare them with those of other regulatory and nonregulatory
approaches. The RIA also was to discuss fully the benefits and
costs that could not be quantified and assess the importance of
those that are quantified or monetized. When many benefits cannot
be monetized, or when law requires a specific regulatory objective,
cost-effectiveness analysis may be used to evaluate regulatory
alternatives. The goal of the executive order was to develop and
organize information on benefits, costs, and economic impacts so as
to clarify trade-offs among alternative regulatory options.
Specifically, the RIA was required to include:
1)	showing of the need for the proposed regulatory action;
2)	examining alternatives for the proposed action;
3)	quantifying benefits and costs and value them in monetary terms
(where feasible); and
4)	evaluating the findings on benefits, costs, and distributional
effects.
Since that time, the Congress and the Executive Branch have sparred
on the issue of risk-based budgeting. Currently, there are several
bills in Congress that mandate the use of comparative risk

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assessment and require USEPA to promulgate and enforce regulations
that are effective in reducing risk, that are economically
efficient, and that are rational and equitable.
Section 123 of S.B. 171, which elevates the USEPA to cabinet level,
mandates economic and risk analysis. The Johnson amendment to the
bill requires, whenever a final regulation relating to human health
and safety or environment is promulgated, publication in the
Federal Register of the following:
-	An estimate ... of the risk to health and safety of individual
members of the public addressed by the regulation and its effect on
human health or the environment and the costs associated with
implementation of, and compliance with, the regulation;
-	A comparative analysis of the risk addressed by the regulation
relative to other risks to which the public is exposed;
-	Certification that the risk estimate and analysis are based on
scientific evaluation of the risk to health of individuals and to
human health and the environment, generally, and are supported by
the best available scientific data;
-	Certification that the regulation will substantially advance the
purpose of protecting human health or the environment against the
specified risk; and

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- Certification that the regulation will produce benefits to human
health or the environment that will justify the costs to the
Government and the public.
If the Secretary cannot make these certifications, then the
Secretary must report the fact and identify the reasons.
The requirements of section 123 differ somewhat from the
requirements of an RIA. The section does not require analysis of
regulatory alternatives, for example, although it does require
estimation of costs, benefits, and risks for the regulatory
strategy of choice. Neither does the section require calculation
of net benefits. Nevertheless, the Secretary is required to
certify that the costs of regulation are justified by the benefits.
The basis for justification is unclear, but it could be interpreted
to require at least a positive net benefit. Most significantly,
the proposed mandate would apply to all regulations promulgated by
USEPA, approximately 150 regulations annually, whereas currently
RIAs only are prepared for a handful of "major" rules.
A resolution of the Science Committee of the U.S. House of
Representatives, H.R. 1994, for the reauthorization of the USEPA
research and development funds states that within six months after
the date of enactment, the Administrator shall submit to the
Congress a report that identifies at least 10 environmental
research issues:

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-	Corresponding to the environmental hazards which the
Administrator estimates to be in the category of highest risk;
-	Regarding which there are, as determined by the Administrator,
significant scientific uncertainties with respect to the assessment
of such environmental risks; and
-	Issues with respect to which such uncertainties could be
significantly reduced through research.
The report indicated above shall include an assessment of the
research to be conducted, an identification of the significant
scientific uncertainties, and a list that identifies, in order of
priority, how such research should be conducted.

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A. The Delaney Clause
Because of the historical and legislative nature of risk at USEPA,
zero risk is not usually the goal. Nevertheless, the Delaney
Clause would appear to be the exception. Table 4 lists the
statutes and the USEPA program offices that regulate acceptable
cancer risks from exposure to toxic chemicals. Except for the
Delaney Clause, it appears risks greater than 10-4 are regulated
and risks less than 10-6 usually are not.

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Table 4
Risk Assessment and Management in
USEPA's Program Offices
Program
Office
Statute
Classi-
fication
Uses
CRAVE
Potency
Consider
Indiv.
Scenario
Consid
er
Size
of Exp
Pop.
Key
Risk
levels
OPTS
TIFRA
yes
yes
no
yes
10-4
10-5
Delaney
yes
yes
no
no
0
TSCA
no
yes
yes
yes*

OSW
CERCLA
no
yes
yes
no
10-4
10-7
RCRA
yes
yes
yes
no
10-4
10-6
OA&R
CAA
yes
yes
yes
yes
<10-4
<10-6
ODW
SDWA
yes
yes
no
no
<10-4
<10-6
OW
CWA
no
yes
no
no
10-5
10-7
* refers only to existing chemicals

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Source: Rosenthal, A., G.M. Gray & J.D. Graham (1992). Legislating
Acceptable Cancer Risk from Exposure to Toxic Chemicals. Ecology
Law Quarterly 19(2): 321.

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The Federal Food, Drug and Cosmetic Act (FFDCA) is the organic act
of the Food and Drug Administration (FDA) and regulates a variety
of areas which lie outside the realm of traditional environmental
protection. The sole exception is Section 308 of the Act, which
gives the USEPA authority to regulate pesticide tolerances.
Section 409 of the Act, the Delaney Clause, prohibits any pesticide
residue "if it is found ... to induce cancer when ingested by man
or animal, or if it is found, after tests which are appropriate
for the evaluation of the safety of food additives, to induce
cancer in man or animal." Under this rule, the USEPA has tried to
legitimize the use of quantitative risk assessment.
The risk dilemma the agency faces is the fact that older pesticides
that were not adequately tested were grandfathered under the
standard. Applying the strict mandates of Delaney would prevent
replacement of older high risk toxic compounds with less toxic
alternatives.
Table 5 shows a comparison of how the agency's provisions for new
and existing products are measured.

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Table 5
Comparison of TSCA and FIFRA Provisions
New Products
TSCA
FIFRA
New Chemical
Substances
Must be submitted
for review 90 days
before manufacture*
New active
ingredients cannot
be sold unless
registered by USEPA
New manufacturers
of existing
products, new
product
formulations, new
use of product
Not covered unless
there is
significant new use
rule
Must receive
registration
Test data
No data required
before submission
Extensive data
required to
register a new
active ingredient

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Exemptions
R&D, test
Experimental use

marketing, others
permits, emergency

by rule if no
uses, and state

unreasonable risk
registrations for

is found
special local needs


allow for partial


exemptions from the


full registration


process
Existing Products
Data gaps
Can require testing
Can require data to

through rulemaking:
reregister or

USEPA must show
maintain

need for data
registration of


existing


pesticides,


registration can be


suspended if data


are nor supplied
Control of
Through rulemaking
Administrative
unreasonable risks

proceeding to


cancel or suspend


registrations
* Manufacturer can commence production unless USEPA acts within the
review period.

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V. Quantitative Risk Assessment
Necessarily, one has to review quantitative risk assessment (QRA)
to commence the process of comparative risk assessment. The
framework for QRA was developed by the National Academy of Sciences
(NAS, 1983). That report identified one of the most perplexing
areas of QRA, environmental data. The validity of the data, lack
of adequate data, use of existing data, and data extrapolation
sometimes limit interpretation of findings and subsequent policy
formulation. Table 6 lists the availability of toxicity data on
chemicals based on a comparison of pesticides and toxic substances.
USEPA risk assessment research is focused on improving the science
and the knowledge base necessary for reducing the uncertainty
associated with risk assessments. USEPA's Risk Assessment Forum is
responsible for the agency-wide coordination of risk assessments.
The Forum is responsible for analysis of data, developing
consensus, and providing guidance to agency scientists and
managers.
One of the most important factors in risk assessments is the
comparison of cancer endpoints to noncancer endpoints. These
endpoints of concern are human subchronic ( i.e., neurological,
developmental, etc.), ecologic, and multiple exposures (e.g.,
mixtures).
Silbergeld (1993) listed some compelling limitations both

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conceptual and practical to QRA. The conceptual limitations are:
1)	QRA supports an almost exclusive focus on one health outcome,
cancer, and by inference one set of environmental hazards,
carcinogens;
2)	The methods for noncarcinogens follow the same quantitative
methodology and are biologically nonspecific for target organ
systems;
3)	QRA methods have become more inflexible as default assumptions
have become inference rules;
4)	Data needs are great; to satisfy the models, to reduce
uncertainty (decrease variance), and to escape the default
assumptions;
5)	It has not been possible to validate QRA through epidemiological
research. One notable exception has been dioxin, see Goldman
(1991);
6)	QRA cannot handle complex mixtures; and
7)	QRA does not distinguish between preventable (potential) and
reducible (actual) risks.
The practical limitations are:
1)	The data needs for resolving uncertainty are very great, leaving
the decision-maker with a conundrum of choice between making
decisions with a high degree of uncertainty or refusing to decide
(abdicating decision-making until further scientific research);
2)	QRA is not fully accepted as a policy tool by the public; and
3)	QRA does not provide a method for comparing risks on a practical
basis. The "infinite risk" paradox of such assessments tends to

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distort comparisons at the extremes.
Table 6
Availability of Toxicity Data on Chemicals

Estimated % with prescribed test for:

Category
Acute
Bubchron
Chronic
Reprod
Mutage
%

Toxic
ic
Toxicity
uctive
nicity
having

ity
Toxicity

or

no




Develo

toxici




pmenta

ty




1

data
Pesticides
59
51
23
34
28
38
&
49-70
41-62
15-32
25-44
20-38
28-49
their






Formulatio






ns






TSCA
20
10
4
6
9
78
>1 mil.
15-25
7-14
3-7
3-9
6-13
73-84
lb/yr






TSCA
22
8
3
4
10
76
<1 mil.
15-29
5-13
2-6
2-7
5-15
69-83
lb/yr







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Unknown or
15
7
3
7
8
82
Inaccessib
9-21
3-11
0-6
3-12
4-13
76-89
le






Source: National Academy of Sciences, "Toxicity Testing: Strategies
to Determine Needs and Priorities," Washington, D.C. (1984).

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VI. Conclusions
The USEPA and Congress are grappling with the issue of determining
the risk(s) of environmental pollution. The policy trend is toward
pollution reduction, rather than pollution prevention. The system
of comparative risk assessment, which prioritizes risks, is neither
new nor well-defined. Ranking is a critical step that can help to
set priorities when selecting chemicals for chronic bioassay or
mechanistic studies, for epidemiologic studies, and regulatory
policy. Other methods used for risk reduction include quantitative
risk assessment, health risk assessment, life cycle assessment,
substitute assessment, and other qualitative methods. Ranking
systems used by various organizations include; use cluster scoring
system, ecological controlling system, critical materials register,
enviro-accounting system, chemical candidates for sunsetting, and
several other priority systems.
Despite considerable regulatory efforts, the majority of chemicals
in commerce have grossly inadequate data to characterize potential
chronic hazards (Table 6) . There is a lack of appropriate
regulatory strategies to determine reasonable risks. The Toxic
Substances Control Act, promulgated to address such an issue, has
not been adequately enforced. It appears the dilemma the agency
faces is to again reorganize its structure. Single-media, single-
chemical focus of USEPA regulations and related science has
received significant challenge from external environmental

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interests, the USEPA Science Advisory Board, special science
advisory panels and Congressional leaders. The credibility of
USEPA science has been challenged, both the scientific quality and
its relationship to program office regulatory decisions. The USEPA
wants a "hard science" approach and the Congress virtually demands
ambiguous regulatory processes for political reasons. Thus, the
absence of valid information on any component seriously impairs the
agency's ability to assess accurately public health risk. The
absence of data on human exposure and dose has serious implications
for regulatory policies designed to protect public health.
Therefore, one of the most perplexing areas of any risk assessment
is reliable environmental data. The validity of the data, adequacy
of data, use of existing data, and data extrapolation sometime
limit interpretation of findings and subsequent policy formulation.
From earlier quantitative risk assessments, and in comparative risk
estimates, a major point of uncertainty is the comparison of cancer
endpoints to noncancer endpoints, such as neurological,
developmental, ecologic, and multiple exposures (e.g., mixtures).
Even with sufficient data the regulation of existing chemicals will
be difficult because of the inevitable uncertainties in
characterizing overall risks and the high economic stakes
associated with commercially important substances, such as
pesticides. The agency will continue to face rather difficult
tradeoffs between the need to adequately assess and control risks
and the desire to avoid delays in the introduction of beneficial
chemicals and technologies.

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The independent Science Advisory Board, in its' September, 1990
seminal report "Reducing Risk," suggested USEPA target available
resources, within statutory limits, at the greatest risks to human
health and the environment. The following items were recommended:
-	Target environmental protection efforts to opportunities for the
greatest risk reduction,
-	Give as much importance to reducing ecological risk as to
reducing human health risk,
-	Improve data and methodologies that support the assessment,
comparison, and reduction of different environmental risks,
Reflect risk-based priorities in strategic planning and
budgeting,
-	Along with the nation as a whole, make greater use of all the
tools available to reduce risk,
-	Emphasize pollution prevention as the preferred option for
reducing risk,
-	Integrate environmental considerations into the broader aspects
of public policy in the same way economic concerns are integrated,
- Improve public understanding of environmental risks and train a

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professional workforce to help reduce them,
- Develop improved analytical methods to value natural resources
and to account for long-term environmental effects in economic
analyses.
Risk communication is also deeply rooted in the complexity of
comparing risks. Risk data is summarily described as error or
range of uncertainty. The public perceives uncertainty as an
unknown phenomenon rather than the statistical level of confidence.
Science would surely be enhanced with efforts in the area of
communicating risk data. Scientists have an opportunity to better
describe the drawbacks of publishing point estimates with their
inherent uncertainties.

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VII. REFERENCES
Bromley, D.W. and K. Segerson (1992). The Social Response to
Environmental Risk: Policy Formulation in an Age of Uncertainty.
Kluwer Academic Publishers, Boston.
Chicken, J.C. and M. Hayns (1992). The Risk Ranking Technique in
Decision Making. Long Range Planning 25: 125-26.
Dwyer, J.P. (1990). Limits of Environmental Risk Assessment.
J. Energy Eng.-ASCE 116(3): 231
Finkel, A.M. (1991). Risk Reduction Policy. Environment 33: 2-4.
Gilroy, J.M. (1993). Environmental Risk, Environmental Values, and
Political Choices: Beyond Efficiency Trade-Offs in Public Policy
Analysis. Westview Press, Boulder, CO.
Glaze, W.H. (1989) . Risk Reduction. Environmental Science &
Technology 23: 371.
Goldman (1991). N. Engl. J. Med. 324:1811.
Hart, R.W. and A. Turturro (1988). Risk Assessment and Management
Models in Development. Biol. Environ. Sci. 1(1): 71-8.

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National Academy of Sciences (1983). Risk Assessment in the
Federal Government: Managing the Process. National Research
Council, Washington, D.C.
Peto, R. (1985). Epidemiological Reservations About Risk
Assessment, in A.D. Woodhead, C.J. Shellabarger, V. Pond, and A.
Hollaender (eds.). Assessment of Risk from Low-Level Exposure to
Radiation and Chemicals. Plenum Press, New York.
Roberts, L. (1990). Counting on Science at EPA. Science 249:616-
618.
Shapiro, M. (1990). Toxic Substances Policy. In "Public Policies
for Environmental Protection," P.R.Portney (ed). Resources for the
Future, Washington, D.C.
Silbergeld, E.K. (1993). Revising the Risk Assessment Paradigm:
Limits on the Quantitative Ranking of Environmental Problems. In
"Comparative Environmental Risk Assessment,11 C. Richard Cothern,
Ed. Lewis Publ, Ann Arbor, MI.
Society for Environmental Toxicology & Chemistry. (1991). Technical
Framework for Life Cycle Assessments, January, 1991, pp. 1-11.
Superfund Amendments and Reauthorization Act of 1986 (SARA) . Publ.
L. No. 99-499, 100 Stat. 1613.

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U.S. Congress (1992). The Environmental Risk Reduction Act:
Hearing Before the Committee on Environment and Public Works, U.S.
Senate, 102nd Congress, 2nd Session, September 18, 1992,
Washington, D.C.
U.S. Environmental Protection Agency (1987). Unfinished Business:
Comparative Assessment of Environmental Problems. Office of
Policy, Planning and Evaluation, USEPA, Washington, D.C.
U.S. Environmental Protection Agency (1988). Hazard Ranking System
(HRS) for Uncontrolled Hazardous Substance Releases : Appendix A of
the National Oil and Hazardous Substances Contingency Plan. 40 CFR
Part 300. Fed. Reg. 53(247): 51962-51981.
U.S. Environmental Protection Agency (1990). Reducing Risks:
Setting Priorities and Strategies for Environmental Protection.
Science Advisory Board, USEPA, Washington, D.C.
U.S. Environmental Protection Agency (1993). EPA Organization for
Environmental Research: The Third Decade. Office of Research and
Development, USEPA, Washington, D.C.
Whyte, A.V.T. and I. Burton (1980). Environmental Risk Assessment.
Published on Behalf of the Scientific Committee on Problems of the
Environment (SCOPE) of the International Council of Scientific
Unions (ICSU). J. Wiley & Sons, N.Y.

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