Framework
for Environmental
Health Risk Management
The Presidential/Congressional
Commission on Risk Assessment
and Risk Management
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Framework
for Environmental
Health Risk Management
The Presidential/Congressional
Commission on Risk Assessment
and Risk Management
Final Report
Volume 1
1997
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The Presidential/Congressional
Commission on Risk Assessment
and Risk Management
Gilbert S. Omenn (Chairman), Dean, School of
Public Health and Community Medicine,
University of Washington, Seattle, WA
Alan C. Kessler (Vice-Chairman], Partner,
Buchanan Ingersoll, Philadelphia, PA
Norman T. Anderson, Director of Research,
American Lung Association of Maine,
Augusta, ME
Peter Y. Chiu, Senior Physician, Kaiser
Permanente, Milpitas, CA
John Doull, Professor, Department of
Pharmacology, Toxicology and Therapeutics,
Kansas University Medical Center,
Kansas City, KS
Bernard Goldstein, Director, Environmental and
Occupational Health Sciences Institute and
Chairman, Department of Environmental and
Community Medicine, UMDNJ-Robert Wood
Johnson Medical School, Piscataway, NJ
Joshua Lederberg, President Emeritus, Rockefeller
University, New York, NY
Sheila McGuire, President, Iowa Health Research
Institute, Boone, IA
David Rail, Former Director, National Institute of
Environmental Health Sciences; Director,
Environmental Defense Fund, Washington, DC
Virginia V Weldon, Senior Vice President for Public
Policy, Monsanto Company, St. Louis, MO
Staff
Gail Chamley, Executive Director
Sharon Newsome, Associate Director
Joanna Foellmer, Program Specialist and Designated Federal Official
Office: 529 14th Street, N.W, Suite 420
Washington, DC 20045
Tel. 202-233-9537
Fax: 202-233-9540
WWW: http://www.riskworld.com
All photos courtesy of Steve Delaney, U.S. EPA, unless otherwise credited.
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Preface
In the 1990 Clean Air Act Amendments, Congress mandated that a Commission on Ri-k
Assessment and Risk Management be formed to:
...make a full investigation oj the polity implications and appropriate uses of risk
asvssnu-nt and nsl; management in regulaforv pro^iams under various Federal laws
to prevent cancer and other chronic human health effects which max result from t-xp< MUC
to hazardous substances.
The Commission was assembled in May 1994 Our members included specialists in public
health, occupational and environmental health, medicine, pediatrics, toxicology, epidemiology,
engineering, law, and public policy. The members were appointed—six by Congress, three by
President Clinton, and one by the president of the National Academy of Sciences—from health
and environmental organizations, acadcmia, research institutes, a law firm, and industry. Mem-
bers also have experience in federal, state, and local governments. We held hearings across the
country to obtain input from interested and concerned parties. The information and insights
provided by these forums, as well as public comments on our June 1996 Draft Report, provided
valuable contributions to our deliberations, findings, and recommendations.
A clear need to modify the traditional approaches used to assess and reduce risks emerged as
a major theme from our deliberations. These approaches rely on a chemical-by-chemical. me-
dium-by-medium, risk-by-risk strategy. They tend to focus attention on refining assumption-
laden mathematical estimates of the small risks associated with exposures to individual chemicals,
rather than on the overall goal of reducing risk and improving health status
With this volume, which constitutes Volume 1 of our two-volume Final Report, the Commis-
sion introduces a unique Risk Management Framework to guide investments of valuable public-
sector and private-sector resources in researching, assessing, characterizing, and reducing risk.
We set forth principles for making good risk management decisions and for actively engaging
stakeholders in the process. Our Framework is intended to catalyze a new generation of risk-
based environmental and health protection. Building on current practices, it adds important new
dimensions to the risk management process.
The Commissions Framework defines a clear, six-stage process for risk management that tan
be scaled to the importance of a public health or environmental problem and that:
• Enables risk managers to address multiple relevant contaminants, sources, and pathways of
exposure, so that threats to public health and the environment can be evaluated more
comprehensively than is possible when only single chemicals in single environmental media
are addressed.
• Engages stakeholders as active partners so that different technical perspectives, public values
perceptions, and ethics are considered.
• Allows for incorporation of important new information that may emerge at any stage of the
risk management process.
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In response to public commenters on our June 1996 Draft Report, we decided to issue a two-
volume final report. The first volume focuses solely on our Risk Management Framework and its
implementation. This publication has been prepared for regulatory authorities and others who
may participate in the risk management process as risk managers or stakeholders. We have pro-
vided a glossary for those who seek more information and listed resource documents and organi-
zations at the end of this report. Volume 2, to be published in February 1997, addresses many
other issues related to health and environmental risk-based decisions, including recommenda-
tions for specific federal regulatory programs and agencies. The table of contents for Volume 2 is
provided in an appendix to this report.
The Commission gratefully acknowledges the valuable contributions made by the many people
who testified during our deliberations or provided written comments on our Draft Report. We
also acknowledge and appreciate the time and effort that regulatory agencies devoted to providing
us with needed information and resources. Finally, we acknowledge members and staff of the
Congress and leaders and staff of the Clinton Administration for the interest they have taken in
our findings and recommendations. We look forward to continuing to work with them to imple-
ment the recommendations.
Gilbert S. Omenn
Chair
NOTE: The Commissions June 1996 Draft Report, both volumes of our Final Report, and all
supplementary reports (listed in Appendix 6 of Volume 2) can be found on the Commissions
homepage at the Riskworld website: http://www.nskworld.com.
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Contents
Volume 1
Page
Preface j
The Commissions Risk Management Framework 1
Framework for Risk Management 3
Principles for Risk Management Decision-Making 4
Defining Problems and Putting Them in Context 7
Guidelines for Stakeholder Involvement 16
Analyzing Risks 23
Examining Options 29
Making a Decision 37
Taking Action 41
Evaluating Results 45
Implementing the Framework 49
Resources 55
Glossary 59
Appendix: Table of Contents for Volume 2 of the
Commissions Final Report 63
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The Commission's Risk
Management Framework
What Is Risk Management?
During the last 25 years, our nation has made
tremendous progress in improving the quality of
our environment and our workplaces, as well as
the safety of pharmaceutical drugs, food, and other
consumer products. Much of this progress has re-
lied, explicitly or implicitly, on a process called risk
management.
Risk management is the process of
identifying, evaluating, selecting, and
implementing actions to reduce risk to
human health and to ecosystems. The
goal of risk management is scientifically
sound, cost-effective, integrated actions
that reduce or prevent risks while tak-
ing into account social, cultural, ethical,
political, and legal considerations.
Our definition of risk management is broader
than the traditional definition, which is restricted
to the process of evaluating alternative regulatory ac-
tions and selecting among them. In recent years, the
scope and tools of risk management have broadened
considerably beyond regulatory actions taken by fed-
eral, state, and local government agencies, for two
reasons:
• Government risk managers now often consider
both regulatory and voluntary approaches to
reducing risk. This is particularly important as
our society is challenged to solve more complex
risk problems, especially those that cut across
environmental media, with limited resources.
• Increasingly, risk management is being
conducted outside of government arenas, by
individual citizens, local businesses, workers,
industries, farmers, and fishers. This
decentralization has resulted in part from the
growing recognition that decision-making is
improved by the involvement of those affected
by risk problems ("stakeholders").
What Is "Risk"?
Risk is defined as the probability that a substance or situation will produce harm
under specified conditions. Risk is a combination of two factors:
• The probability that an adverse event will occur (such as a specific disease
or type of injury).
• The consequences of the adverse event.
Risk encompasses impacts on public health and on the environment, and arises
from exposure and hazard. Risk does not exist if exposure to a harmful substance or
situation does not or will not occur. Hazard is determined by whether a particular
substance or situation has the potential to cause harmful effects.
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The Commission's Risk
Management Framework
Risks to human health can come from many
sources: industrial facilities, combustion
engines, and different media—air, water, or soil.
During the traditional risk management process,
decision-makers (typically government officials and
other risk managers) gather information about a situ-
ation that poses or may pose a risk to human health
and to ecological health. Air pollution, water pollu-
tion, workplace exposures, and the introduction of
new pharmaceutical or consumer products are ex-
amples of situations that could pose risks to health
or the environment. Risk managers use this informa-
tion they have gathered to consider the:
• Nature and magnitude of risks.
• Need for reducing or eliminating the risks.
• Effectiveness and costs of options for reducing
the risks.
In some cases, risk managers also consider the
economic, social, cultural, ethical, legal, and po-
litical implications associated with implementing
each option, as well as any worker health, com-
munity health, or ecological hazards the options
may cause. In other cases, laws or procedures
hinder risk managers from considering those
implications and impacts.
The Need for a More Comprehensive
Approach to Risk Management:
The Commission's Risk Management
Framework
In the environmental arena, statutes and legal pre-
cedents tend to dictate risk management approaches
that focus on one type of risk (e.g., cancers or birth
defects in humans) posed by a single chemical in a
single medium (air, water, or land). Conclusions about
risk are based almost exclusively on observations of
toxicity from high doses of the chemical in labora-
tory animals or in the workplace. While these ap-
proaches have contributed to tremendous progress
in reducing health, safety, and environmental risks in
recent decades, they are not adequate for addressing
the more complex risk problems we now face.
Creative, integrated strategies that address mul-
tiple environmental media and multiple sources of
risk are needed if we are to sustain and strengthen
the environmental improvements and risk reduction
our nation has attained over the last 25 years. To help
meet these needs, the Commission has developed a
systematic, comprehensive Risk Management Frame-
work, illustrated and summarized on page 3.
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Framework for Risk Management
The Commission's Framework is designed to help all types of risk managers—government
officials, private sector businesses, individual members of the public—make good risk
management decisions (see "Principles for Risk Management Decision-Making" on page 4). The
Framework has six stages:
Define the problem and put it in context.
Analyze the risks associated with the problem in context.
Examine options for addressing the risks.
Make decisions about which options to implement.
Take actions to implement the decisions.
Conduct an evaluation of the actions results.
The Framework is conducted:
• In collaboration with
stakeholders.
• Using iterations if new
information is developed that
changes the need for or nature of
risk management.
Problem/
Context
Engage
Stakeholders
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The Commission's Risk Management Framework
The Framework is general enough to work in a
wide variety of situations. The level of effort and re-
sources invested in using the Framework can be scaled
to the importance of the problem, potential severity
and economic impact of the risk, level of controversy
surrounding it, and resource constraints. The Frame-
work is primarily intended for risk decisions related
to setting standards, controlling pollution, protect-
ing health, and cleaning up the environment. It is use-
ful for addressing these types of decisions at a local
community level (e.g., siting an incinerator or clean-
ing up a hazardous waste site) or a national level (e.g.,
developing a national program for controlling motor
vehicle emissions). The Framework need not be in-
voked for risk situations that are routinely and expe-
ditiously managed—for example, by hazardous
Principles for Risk Management Decision-Making
A good risk management decision . . .
• Addresses a clearly articulated prob-
lem in its public health and ecologi-
cal context.
• Emerges from a decision-making pro-
cess that elicits the views of those af-
fected by the decision, so that
differing technical assessments, pub-
lic values, knowledge, and percep-
tions are considered.
• Is based on a careful analysis of the
weight of scientific evidence that sup-
ports conclusions about a problems
potential risks to human health and
the environment.
• Is made after examining a range of
regulatory and nonregulatory risk
management options.
• Reduces or eliminates risks in ways
that:
- Are based on the best available sci-
entific, economic, and other tech-
nical information.
- Account for their multisource, multime-
dia, multichemical, and multirisk
contexts.
- Are feasible, with benefits reasonably
related to their costs.
- Give priority to preventing risks, not
just controlling them.
- Use alternatives to command-and-con-
trol regulation, where applicable.
- Are sensitive to political, social, legal,
and cultural considerations.
- Include incentives for innovation,
evaluation, and research.
Can be implemented effectively, expedi-
tiously, flexibly, and with stakeholder sup-
port.
Can be shown to have a significant impact
on the risks of concern.
Can be revised and changed when signifi-
cant new information becomes available,
while avoiding "paralysis by analysis."
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Every stage of the framework relies on defining
risks in a broader context, involving
stakeholders, and repeating the process, or
part of it, when needed.
materials response teams, emergency room physi-
cians, firefighter rescue teams, and voluntary prod-
uct recalls.
Every stage of the Framework relies on three key
principles:
Broader contexts. Instead of evaluating single risks
associated with single chemicals in single environmen-
tal media, the Framework puts health and environmen-
tal problems in their larger, real-world contexts.
Evaluating problems in context involves evaluating dif-
ferent sources of a particular chemical or chemical ex-
posure, considering other chemicals that could affect a
particular risk or pose additional risks, assessing other
similar risks, and evaluating the extent to which differ-
ent Exposures contribute to a particular health effect of
concern. The goal of considenng problems in their con-
text is to clarify the impact that individual risk manage-
ment actions are likely to have on public health or the
environment and to help direct actions and resources
where they will do the most good.
Stakeholder participation Involvement ot
stakeholders—parties who are concerned about or
Advantages of the Commission's
Risk Management Framework
Traditionally, risk management has relied on command-and-control approaches that often require envi-
ronmental protection standards to be met using specific technologies. Risk management has generally fo-
cused on controlling single hazards in single environmental media. Many risk management failures can be
traced to not including stakeholders in decision-making at the earliest possible time and not considering
risks in their broader contexts. In contrast, the Commission's Risk Management Framework is intended to:
/ Provide an integrated, holistic approach to solving public health and environmental problems in
context.
/ Ensure that decisions about the use of risk assessment and economic analysis rely on the best scien-
tific evidence and are made in the context of risk management alternatives.
/ Emphasize the importance of collaboration, communication, and negotiation among stakeholders
so that public values can influence risk management strategies.
/ Produce risk management decisions that are more likely to be successful than decisions made with-
out adequate and early stakeholder involvement
/ Accommodate critical new information that may emerge at any stage of the process.
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The Commission's Risk Management Framework
affected by the risk management problem—is critical Iteration Valuable information or perspective
to making and successfully implementing sound, cost- may emerge during any stage of the risk management
effective, informed risk management decisions. For process. This Framework is designed so that parts of
this reason, the Framework encourages stakeholder it may be repeated, giving risk managers and stake-
involvement to the extent appropriate and feasible holders the flexibility to revisit early stages of the pro-
during all stages of the risk management process, cess when new findings made during later stages shed
"Establish a Process for Engaging Stakeholders" on sufficiently important light on earlier deliberations
page 15 discusses in depth the value of and ap- and decisions. ("The Importance of Iteration" on
proaches to involving stakeholders. page 47 provides more information.)
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Defining Problems and
Putting Them in Context
The problem/context stage is the most important
step in the Risk Management Framework. It involves:
1 Identifying and characterizing an environmental
health problem, or a potential problem, caused
by chemicals or other hazardous agents or
situations.
2 Putting the problem into its public health and
ecological context
3. Determining risk management goals.
4. Identifying risk managers with the authority or
responsibility to take the necessary actions.
5. Implementing a process for engaging
stakeholders.
These steps are all important, but may be con-
ducted in different orders, depending on the particu-
lar situation. For example, when a state or federal
regulatory agency is mandated to take the lead on a
problem, the steps often will proceed in the order
listed above, with the identity of the risk managers
already clear, since the state or federal agency will
have assumed that role from the start. On the other
hand, if the group or individual discovering the prob-
lem is not in a position to be the risk manager or to
characterize the problem, stakeholders might have to
engage in a collaborative stakeholder process to iden-
tify risk managers with the needed authority before
the other steps can take place. Each step in the prob-
lem/context stage of the risk management process is
described below.
1. Identify and Characterize the
Problem
An environmental or human health problem
may already be well recognized or may be a po-
tential problem. Ideally, potential problems will be
anticipated and addressed at a very early stage.
Problems may be identified through a range of in-
dicators, using such methods and events as:
• Emissions inventories; including the Toxic
Release Inventory
• Environmental monitoring; for example,
measuring concentrations of solvents that
pollute ground water.
• Biological monitoring; for example, measuring
children's blood lead levels or anemia.
A good risk management decision
addresses a clearly articulated
problem in its public health and
ecological context.
Toxicity testing in laboratory animals to help
identify chemicals that might pose risks to
humans or ecosystems.
Toxicity testing using sentinel species in the
environment to help identify the impacts of
pollution on ecosystems.
Disease surveillance; for example, observing
increases in the occurrence and severity of
asthma or noting regional differences in the
rates of a particular cancer or birth defect.
Epidemiologic studies; for example.
observations of workplace exposures and
particular disease rates.
Lack of compliance with local or national
standards to control contaminant concentrations
in air, water, soil, or food.
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Defining Problems and Putting Them in Context
A permit application or a violation of a standard
or permit le.g., facility siting, wastewater
discharge).
A bad odor, as in communities where gasoline
additives (oxygenated fuels) were used to reduce
carbon monoxide emissions from automobiles.
Community reaction, as may result when a
decision is made to build a municipal solid
waste incinerator in a neighborhood that was
not consulted about the decision.
Media or environmental activist reports that
arouse public concern about a risk based on
preliminary or incomplete information.
Potential problems may take some searching to identify.
Characterizing a problem involves investigating
what is causing the problem and who or what is
affected. For example, characterizing an environ-
mental problem could involve identifying which
pollutants or other stressors (such as sediment in
a stream) are causing the problem, determining the
sources of the pollutants or other stressors, and
then determining which human and/or ecological
populations are affected. While problem identifi-
cation may be performed by an individual stake-
holder (including the risk management authority),
problem characterization should be performed in
collaboration with other stakeholders. Here are
some questions to ask when characterizing a prob-
lem:
Hazard
• What is the problem? Why is it a problem? How
was it first recognized?
• What types of adverse effects might the problem
cause? Are they reversible?
• How imminently might the effects be
experienced? In other words, are the effects
likely to appear in the near future, later on in
life, or in future generations? How urgent is the
need for action? For example, a tank car
carrying flammable solvents that overturns in a
suburban neighborhood requires immediate
attention (and therefore does not require
implementation of this Framework); a municipal
solid waste incinerator operating normally in the
same neighborhood can be assessed more
deliberately.
• How do stakeholders perceive the hazard? Do
different groups of stakeholders have different
perceptions and concerns? For example, parents
of children at risk from exposure to an industrial
pollutant may feel quite differently about a
hazard than workers whose income depends on
the facility causing the problem. When these are
the same people—that is, the parents are also
the workers—perceptions of the hazard can be
quite complex.
Exposure
• Who may be exposed? Does the exposure pose
different risks to different groups? For example,
are the elderly, children, immunosuppressed
individuals, or certain ethnic groups at greater
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Children can experience higher
exposures to pesticides than adults
because they eat larger amounts of fruits
and vegetables for their sue.
risk than others due to age, medical, genetic, or
socioeconomic factors, diet, or activity patterns?
• What are all ot the relevant sources of exposure?
How much does each source contribute to the
problem?
• Are the exposures likely to be short term or long
term? What is their frequency?
Problem characterization may be iterative, requir-
ing several attempts at refinement as new informa-
tion is gathered. For example, stakeholders joining
the process may bring important information or in-
sights that could modify a characterization or sug-
gest additional lines of investigation. Early iterations
might focus on research and education, while later
iterations focus on specific pollution reduction
measures.
How the problem is characterized will have a tre-
mendous impact on the focus and likely outcome of
the risk management process. For example, a prob-
lem related to waste disposal capacity could be
characterized:
• By waste haulers as the result of inadequate
landfill space.
• By local government officials as inadequate
recycling of residential or industrial waste.
• By environmental advocates as too much waste
generation.
If a problem is characterized too narrowly or in-
correctly, risk managers and other stakeholders will
invest their resources in exploring and implementing
solutions that will be inadequate, less effective, or
more costly for reducing risk than they might have
been. Also, inappropriate solutions can produce un-
intended consequences. For example, tightening solid
waste disposal regulations can lead to an increase in
illegal dumping. In the ease of Superfund site clean-
ups, Resource Conservation and Recovery Act regu-
lations have engendered disposal methods that pose
even greater risks than the Superfund sites themselves.
Therefore, it is very important to consider the full
context of the problem, as described below, before
proceeding with other stages of the risk management
process.
2. Carefully Consider the Context
A full understanding ot the context of a risk prob-
lem is essential for effectively managing the risk. Yet
historically most risk management has occurred in
an artificially narrow context that considers just one
chemical, one environmental medium, and one risk
at a lime. Because this narrow context does not re-
flect the true complexities of risk situations, it results
in risk management decisions and actions that are less
effective than they could be. The Commissions Frame-
work expands the context of risk management by in-
cluding a step in the opening stage, described here,
to explicitly consider and define a comprehensive
context for a specific risk that is broadly reflective of
real-life risk situations. To do this, risk managers and
stakeholders must systematically consider several kev
dimensions of the risk's context:
Multisource context. Is the population exposed to
the same pollutant from other sources? For example, a
local community might be concerned about breath-
ing pollutants such as hydrocarbons and particles
released to the air from a nearby power plant, but it
might also be breathing hydrocarbons and particles
from motor vehicle exhaust, wood stoves, secondhand
tobacco smoke, or other sources. (See "The Multi-
\9
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Defining Problems and Putting Them in Context
Understanding the context of a risk
problem is essential for effectively
managing the risk.
source Context: Air Toxics" and "The Multisource
Context: Residual Risks from Petroleum Sources" on
pages 11 and 12 for elaboration.)
Multimedia context, h exposure to the pollutant
also occurring from other environmental media? In the
power plant example, the community members who
are concerned about breathing pollutants could also
be exposed to them from food, water, or soil. Other
sources of hydrocarbons could be food (such as
broiled meats) and soil (resulting from cumulative
contamination from decades of emissions from the
power plant, vehicles, and other sources). (See "The
The broad context of risks in this community include an
industrial facility, motor vehicles, lead paint, and contaminated
soil.
Multimedia Context: Residual Risks From Secondary
Lead Smelters" on page 12 for elaboration.)
Multichemical context. Do other pollutants from
the same sources pose additional risks to the population
of concern? Do the pollutants interact? Are their effects
cumulative? In the power plant example, other air
pollutants may pose risks for similar adverse effects
or may produce different effects when in combina-
tion than they do alone. For example, hydrocarbons
are usually attached to very small particles, which can
increase the risk of cancer from hydrocarbons alone
and which can interact with ozone and other air pol-
lutants to form smog.
Multirisk context. How great a risk does the prob-
lem pose compared to other similar risks that the com-
munity faces from environmental chemicals? For
example, the risks of respiratory disease associated
with exposure to power plant emissions might be
compared with the risks of diseases associated with
exposure to heavy metals from local municipal solid
waste incinerator emissions and the risk of neuro-
logical disorders resulting from exposure to a local
drinking water source that is contaminated with in-
dustrial solvents. ("The Multirisk Context: Ecologi-
cal Degradation" on page 13 provides an ecological
example.)
There may be even broader public health or eco-
logical contexts that local governments and public
health agencies have to confront and weigh against
chemical exposures—for example, a high incidence
of HIV or other infections, a low rate of childhood
vaccination, a high drug use and crime rate, or a high
rate of alcoholism and its contribution to liver dis-
ease, birth defects, and injuries from automobile
accidents.
In the power plant example, the initial problem
is defined as the health risks posed by air pollutants
emitted by a particular type of industrial facility in a
particular geographic area. The multisource context
would involve identifying other sources (e.g., other
types of industrial facilities, motor vehicles) that emit
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A problem's context can include
other chemicals and other
environmental media, and other
risks.
those same pollutants to the air in the same geographic
area. The multimedia context would involve identi-
fying other environmental media that serve as local
pathways of exposure to the same pollutants. The
multichemical context would involve comparing the
risks from those particular pollutants with the risks
associated with other important air pollutants from
the same source, such as sulfur oxides and nitrogen
oxides. Finally, the multinsk context could consider
risks posed by water contamination and solid wastes
in the area, and sometimes, other risks to public
health.
An initial problem might also be identified and
evaluated on the basis of a particular health effect
instead of on the basis of contaminant emissions. For
example, the increasing incidence and mortality rates
of asthma could be addressed. The reasons for the
increases are not known, but likely candidates include
sulfur oxides, smog, particles, and second-hand to-
bacco smoke.
The relevant contexts that are identified and char-
acterized after these considerations, and
the rationale for their identification,
should be incorporated into the risk
analysis (see "How Should Risks be
Analyzed?" on page 24).
The Multisource Context: Air Toxics
Under the 1990 Clean Air Act, EPA
is required to promulgate maximum
available control technology (MACT)
standards for major sources of haz-
ardous air pollution. MACT standards
reduce, but don't necessarily elimi-
nate, air pollutants from these
sources. For this reason, the Clean Air
Act requires EPA to assess the residual
risk caused by the air emissions that
will remain after MACT standards are
implemented.
Several types of industrial facilities thai emu
the hazardous air pollutants benzene. 1 .3-hutadi-
ene, formaldehyde, and acetaldehyde will require
MACT standards. A 1993 EPA study of the risks
associated with motor vehicle emissions of these
same pollutants provides an important context for
evaluating the residual risk from those facilities.
Motor vehicles contribute 60%. 94%, 33%. and 39%
of the nationwide total of benzene, 1,3-butadiene, form-
aldehyde, and acetaldehyde air pollution, respectively.
EPA estimated the cancer risk of these pollutants for the
years 1990, 2000, and 2010. For the 1990 estimate.
EPA assumed that 1990 automotive technology was in
place. For the 2000 and 2010 estimates. EPA assumed
that a number ol controls would be in place, including
those required by California's stringent emissions stan-
dards and a requirement that reformulated gasoline be
used by vehicles in all areas of the country that do not
attain the current national ambient air quality standard
for ozone.
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Defining Problems and Putting Them in Context
Benzene, formaldehyde, and acetaldehyde from
motor vehicles were each estimated to cause no more
than 30 additional cases of cancer nationwide per year
in any of the years evaluated, while 1,3-butadiene was
estimated to cause no more than 300. (At present there
are more than 500,000 new cases of cancer each year
in the United States.)
The fact that air toxics from industries properly
controlled under MACT standards are not likely to
be the major sources of cancer risk will be an impor-
tant context for EPA to consider when the residual
risks from industries are assessed and compared to
risks from other sources of cancer and respiratory
disease. This situation reinforces the need to view all
air pollution risk management activities in one con-
text. Both EPA and California have started to do just
that by developing integrated air toxics strategies.
The Multisource Context: Residual Risks From
Petroleum Sources
In July 1994, EPA promulgated a MACT standard
for petroleum refinery emissions. That standard was
based partly on EPAs finding that benzene in refinery
emissions poses a potential leukemia risk to exposed
populations. The standard will reduce, but not elimi-
nate, the benzene and other hazardous air pollutants
emitted by petroleum refineries.
Once the standard is implemented, a series of local
and regional risk assessments will be conducted to de-
termine whether the remaining benzene in emissions
from individual petroleum refineries may pose a leuke-
mia risk in their local area. At this stage it will be impor-
tant to consider other sources of benzene in air. In fact,
motor vehicle emissions are the largest single source of
airborne benzene in the United States. When assessing
the residual risk from benzene in refinery emissions in a
particular region, the benzene risk from refinery emis-
sions could be compared with the benzene risk from
mobile sources and any other important benzene emis-
sion sources in the area—including benzene in cigarette
smoke and from consumer products used at home. It
would be appropriate for stakeholders to identify who
has responsibility for controlling the other sources.
If the residual leukemia risk from refinery emis-
sions is significant compared to the leukemia risk
contributed by other sources, risk-reduction efforts
should focus on further reducing refinery emissions.
However, if the refinery risk proves insignificant, risk
reduction might better be directed at other sources.
The overall goal should be to direct risk manage-
ment resources where they will do the most good to
protect or improve the community's health.
A situation in which the multisource context was
ignored, with unfortunate results, arose in New Jersey.
Benzene is a contaminant found in the air and some-
times the groundwater near marine oil terminals. Ben-
zene levels were measured inside homes near a marine
oil terminal and, because the levels were believed to
be unsafe, residents were evacuated. In fact, the ben-
zene levels were well within the range found in homes
nowhere near any external source, but residents have
refused to return to their homes, property values have
decreased substantially, and a great deal of community
discord persists.
The Multimedia Context: Residual Risks from
Secondary Lead Smelters
EPA promulgated MACT standards for second-
ary lead smelters to reduce human exposure to ar-
senic, lead, and other pollutants in smelter
emissions. Assessing residual risk was difficult be-
cause few site-specific data were available on expo-
sure to smelter emissions. To compensate for this
data gap, EPA performed a screening risk assessment
that relied on many assumptions.
Arsenic. Arsenic causes skin disorders and can
increase lung cancer risk. EPAs screening assess-
ment indicated that residual arsenic emissions
100 meters from a smelter would be about one
hundred times the average air concentration of
arsenic in the United States and about one thou-
sand times the maximum exposure level that EPA
12,
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considers to pose negligible risk. An examination
of other major sources of arsenic exposure (prin-
cipally seafood consumption and smoking), how-
ever, indicates that smelter emissions actually
account for only one-tenth of exposure to arsenic
for people living 100 meters from the smelter.
Thus, the total exposure context raises a broader
risk management issue about what actions should
be taken to reduce exposure from all sources. The
first step should be to measure actual arsenic con-
centrations in air around the smelter to compare more
accurately the contributions of all sources of arsenic.
Lead. Exposure to lead can cause brain damage.
Children are particularly vulnerable. EPAs screening
risk assessment found that exposure to lead emissions
100 meters from a secondary lead smelter would be
about ten times greater than both the national ambi-
ent air quality standard for lead and the average con-
centration of lead in the United States. Although there
are many other sources of human exposure to lead,
an analysis of total exposure around the smelter shows
that the smelter itself is by far the primary contribu-
tor. Thus, in the case of lead the total exposure con-
text confirms that smelters should be the leading
target for risk reduction in those communities. Moni-
toring children's blood lead levels would be a good
first step to help guide risk management actions and
to evaluate their results.
The Multirisk Context: Ecological Degradation
Many problems not only have multiple sources
(the multisource and multimedia contexts), but
also are interdependent with other problems (the
multirisk context). For example, degradation of
watersheds typically is caused by a variety of
sources that may include specific industrial dis-
charges, urban and agricultural runoff, land-dis-
turbance activities such as logging and grazing,
diversion of water for domestic and agricultural
use. overfishmg. the introduction ot exotic spe-
cies, and deposition of air pollutants into water.
In such cases, risk managers mus/ consider the-f
problems in multisource and multirisk contexts in
order to develop effective solutions.
One example ol a problem requiring multirisk
analyses and multisource solutions is the decline
of salmon populations in the Columbia River Ba-
sin. According to Pdcf/k FisJu¥n?uin Vrcirhivlcv the
annual salmon and Mcelhead catch ranged between
25 and 44 million pounds ol fish in the early
1900s. By the 1940s, the range had declined to
between 13 and "50 million pounds due to over-
fishing, irrigation, and power dams. Since that
time, many believe that the salmon tisheries have
been further stressed by nuclear reactors that have
contributed radiation, heat, and chemicals to the
Hanford Reach of the Columbia River and by popu-
lation increases that have resulted in pollution from
sewage treatment plants, industrial discharges, and
runoff. In the tributaries, timber harvesting has in-
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Defining Problems and Putting Them in Context
creased sedimentation, water temperature, and
blockages of important spawning habitats. Salmon
populations have continued to decline.
The ecological consequences of this degrada-
tion are accompanied by other impacts. For ex-
ample, the decline in the salmon fisheries has
affected the diet, culture, and religious practices
of the Yakama Indian Nation. To successfully ad-
dress the Columbia River's degradation, risk man-
agers will need to consider multiple sources of
stress and complex risk management strategies.
Risk management goals should be
used to guide risk analyses.
3. Identify Risk Management Goals
The goals of risk management are varied. They may
be risk related, aiming to:
• Reduce or eliminate risks from exposure to
hazardous substances.
• Reduce the incidence of an adverse effect.
• Reduce the rate of habitat loss.
They may be economic, aiming to:
• Reduce the risk without causing job loss.
• Reduce the risk without reducing property
values.
They may involve public values, aiming to:
• Protect the most sensitive population.
• Protect children.
• Preserve a species from becoming extinct.
They may also be dictated by statute, policy, or
existing regulations.
Risk management goals should be used to guide the
next stage of the Framework—Analyzing Risks—but the
results of risk analysis may lead stakeholders and deci-
sion-makers to redefine those goals. It is important to
identify the goals early, so they may serve to guide the
rest of the decision-making process.
4. Identify Risk Managers
The risk manager is the person responsible for
managing the problem. Who the most appropriate
risk managers are in a particular situation will de-
pend on the problem's context. In some situations,
such as a regulatory context, it will be obvious to
all stakeholders that the responsible regulatory
agency should or must manage the problem. In
other cases, it may not be obvious, or different
stakeholders may have different opinions. If so, the
issue of who should be the risk manager or man-
agers must be resolved at this stage of the risk
management process. Often, risk management re-
sponsibilities can be shared, or evolve with chang-
ing circumstances. Sometimes, who the risk
manager should be will not become evident until
the risk management options are identified.
Many different types of people may be risk man-
agers, including:
Federal regulators
State regulators
Local regulators
Local businesses
Industries
Plant managers
Public health officials
Clinicians
Citizens
II
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Stakeholders are more likely to accept and
implement a risk management decision they
have helped to shape
5. Establish a Process for Engaging
Stakeholders
The appropriate numbers and types of stakehold-
ers depend on the situation.
A stakeholder is anyone who has a "stake" in a
risk management situation. Stakeholders typically
include groups that are affected or potentially affected
by the risk, the risk managers, and groups that will
be affected by any efforts to manage the source of the
risk. The overlap between "Engage Stakeholders" and
"Problem/Context" in the Framework hexagon on
page 3 is larger and darker than the other overlaps
because active stakeholder involvement at this par-
ticular stage is the most critical element of the deci-
sion-making process.
Who the stakeholders are depends entirely on the
situation:
• In the case of a contaminated site, stakeholders
would include those whose health, economic
well-being, and quality of life are currently
affected or would be affected by the cleanup and
the sites subsequent use. They would also
include those who are legally responsible for the
sites contamination and cleanup, those with
regulatory responsibility, and those who may
speak on behalf of ecological considerations or
future generations.
• In the case of an application for a pesticide
re registration, stakeholders would include the
pesticide manufacturer, owners of the farms
where the pesticide is used, laborers who apply
the pesticide, consumers who may be exposed to
pesticide residues in foods, scientists who seek
further pesticide research funding, trade
associations like the Grocery Manufacturers
Association, (hose who speak on behalf of
ecological considerations, and those with
regulatory responsibility.
• In the case of a substantial decline in the oyster
population in a bay because chemicals have been
carried into the bay from farms and roads,
stakeholders could include the people who
harvest the oysters, retailers, consumers, dairy
farmers, pesticide manufacturers, manufacturers
of automobile emissions control devices, local
communities, those who speak on behalf of
ecological considerations, and, ot course, those
with regulatory responsibility.
Questions that can help identify potential stake-
holders include:
• Who might be affected by the risk management
decision? (This includes not only groups that
already know or believe they are affected, but
also groups that may be affected but as yet do
not know this.)
• Who has information and expertise that might
be helpful?
• Who has been involved in similar risk situations
before?
• Who has expressed interest in being involved in
similar decisions before?
• Who might be reasonably angered if they are not
included?
15
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Defining Problems and Putting Them in Context
Guidelines for Stakeholder Involvement
• Regulatory agencies or other organizations considering stakeholder involvement
should be clear about the extent to which they are willing or able to respond to
stakeholder involvement before they undertake such efforts. If a decision is not
negotiable, don't waste stakeholders' time.
• The goals of stakeholder involvement should be clarified at the outset and
stakeholders should be involved early in the decision-making process. Don't make
saving money the sole criterion for success or expect stakeholder involvement to
end controversy.
• Stakeholder involvement efforts should attempt to engage all potentially affected
parties and solicit a diversity of perspectives. It may be necessary to provide
appropriate incentives to encourage stakeholder participation.
• Stakeholders must be willing to negotiate and should be flexible. They must be
prepared to listen to and learn from diverse viewpoints. Where possible, empower
stakeholders to make decisions, including providing them with the opportunity to
obtain technical assistance.
• Stakeholders should be given credit for their roles in a decision, and how
stakeholder input was used should be explained. If stakeholder suggestions were
not used, explain why.
• Stakeholder involvement should be made part of a regulatory agency's mission by:
- Creating an office that supports stakeholder processes.
- Seeking guidance from experts in stakeholder processes.
-Training risk managers to take part in stakeholder involvement efforts.
-Building on experiences of other agencies and on community partnerships.
-Emphasizing that stakeholder involvement is a learning process.
• The nature, extent, and complexity of stakeholder involvement should be
appropriate to the scope and impact of a decision and the potential of the decision
to generate controversy.
16,
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A good risk management decision emerges from a decision-
making process that elicits the views of those affected by the
decision, so that differing technical assessments, public
values, knowledge, and perceptions are considered.
Thus, stakeholders may include:
• Community groups.
• Representatives of different geographic regions.
• Representatives of different cultural, economic,
or ethnic groups.
• Local governments.
• Public health agencies.
• Businesses.
• Labor unions.
• Environmental advocacy organizations.
• Consumer rights organizations.
• Religious groups.
• Educational and research institutions.
• State and federal regulatory agencies.
• Trade associations.
Why Is Stakeholder Involvement
Important?
Experience increasingly shows that risk manage-
ment decisions that are made in collaboration with
stakeholders are more effective and more durable.
Stakeholders bring to the table important informa-
tion, knowledge, expertise, and insights for crafting
workable solutions. Stakeholders are more likely to
accept and implement a risk management decision
they have participated in shaping. According to a 1996
public opinion poll, 80% of U.S. citizens think that
the responsibility for controlling risks should be
shared by government, businesses, communities, and
individuals and that government at all levels should
involve citizens in health and environmental
protection.
Stakeholder collaboration is particularly impor-
tant for risk management because there are many
conflicting interpretations about the nature and
significance ot risks. Collaboration provides op-
portunities to bridge gaps in understanding, lan-
guage, values, and perceptions. It facilitates an
exchange of information and ideas that is essen-
tial for enabling all parties to make informed de-
cisions about reducing risks. Collaboration does
not require consensus, but it does require that all
parties listen to, consider, and respect each other's
opinions, ideas, and contributions.
•The Commission acknowledges concerns that the
costs and additional time needed to involve stake-
holders in risk management can be considerable.
However, risk management by government agencies
has generally been costly anyway, and investment in
stakeholder involvement can bring long-term savings,
especially when stakeholder involvement catalyzes
win-win solutions or when litigation becomes less
likely or less protracted. The U.S. Department of En-
ergy, the U.S. Department of Defense, and several
states have reported that including community stake-
holders in their decision-making process for clean-
ing up contaminated sites substantially reduced the
overall time and expense required.
How Can Stakeholders Be Engaged?
The Risk Management Framework promotes at
least some stakeholder participation at each stage ot
the risk management process. Every risk management
situation has a spectrum of interested and affected
parties who have different perspectives, concerns,
knowledge, and interests. Some parties are proactive
in seeking involvement. Others are not. In all cases,
however, risk managers should work to:
• Identify all stakeholder groups as early as
possible in the risk management process,
beginning with the problem/context stage.
• Determine the optimal process for stakeholder
involvement.
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Defining Problems and Putting Them in Context
Incentives for stakeholders to become involved might
be helpful in some cases. For example, some commu-
nity stakeholders have received child care and trans-
portation expenses or funding for technical reviews.
Some industry stakeholders could be attracted by the
potential for reduced reporting requirements or more
efficient permitting. Sometimes, industry stakeholders
cover the expenses of community stakeholders through
mechanisms such as community advisory groups.
Not all risk management decisions will benefit
from extensive stakeholder collaboration. The nature
and complexity of stakeholder involvement should
be consistent with the:
• Complexity, uncertainty, impact, and level of
controversy associated with the decision to be
made.
• Urgency with which the problem must be
addressed.
• Extent to which participants can have a genuine
influence on the decision. If the decision is really
not negotiable, stakeholders time should not be
wasted.
There are no hard-and-fast rules for stakeholder
involvement. Research on stakeholder involvement
3.0.0. f.~f.M
X-
••>.
Potential stakeholders include workers,
//" plant owners, and fishers.
Seven Benefits of Engaging
Stakeholders
1. Supports democratic decision-making.
2. Ensures that public values are considered.
3. Develops the understanding needed to
make better decisions.
4. Improves the knowledge base for
decision-making.
5. Can reduce the overall time and expense
involved in decision-making.
6. May improve the credibility of agencies
responsible for managing risks.
7. Should generate better accepted, more
readily implemented risk management
decisions.
18
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is in us early stages, so we are still learning what
works, what doesn't work, and why. Nonetheless,
a number of guidelines were developed on the ba-
sis of the experiences to date that practitioners
shared with the Commission, which seem basic to
effective stakeholder involvement Those guide-
lines are described in the box on page 16 ("Guide-
lines for Stakeholder Involvement").
Successfully Engaging Stakeholders: San
Francisco Bay/Delta Accord
Declaring "a major victory of consensus over con-
frontation" on December 14, 1994, California Gover-
nor Pete Wilson and Cabinet-level federal officials
announced the signing of an historic agreement to pro-
tect the San Francisco Bay/Delta estuary—the largest and
most productive estuary on the West Coast. Known as
the Bay/Delta Accord, the agreement was negotiated by
the leadership of the state's environmental, urban, and
agricultural interests. The accord broke decades of
gridlock on California w-ater policy issues by establish-
ing an integrated, ecosystem based approach to protect-
ing the estuary while providing more reliable supplies
to the states urban and agricultural water users.
The collaborative process that led to the accord
marked a sharp departure from the decision-making
approach traditionally used under the Clean Water Act
and Endangered Species Act. Rather than issuing pro-
posals developed by individual agency experts for for-
mal public comment and review, the agencies worked
together with environmental, urban, and agricultural
interests over two years to identify common goals and
mutually acceptable solutions. The final standards were
developed through an extensive peer-review process that
involved both local and national experts in estuarine
systems. This approach sharply reduced the number of
legal and scientific challenges that accompany most
major agency decisions, and has been hailed as a na-
tional model for solving environmental problems.
Building on the success of this collaborative process,
the state and federal agencies and interest groups have
continued to work together as part of the new CALFED
Bay/Delta Program to develop long-term ecosystem res-
toration goals In 1996. the agencies and interest groups
reached consensus on a S995 million bond measure that
will help finance the ecosystem restoration process and
other projects vital to the programs success. The bond
was passed by voters in November 199n
Insufficient Stakeholder Collaboration:
Granite City, Illinois
When stakeholders are not included early in the
decision-making process, they are more likely to
oppose the risk management decision and block
its implementation This has been happening in
Granite City. Illinois, since 1993, according to tes-
timony from Mayor Ronald Selph and Alderman
Craig Tarpoff. Heavily contaminated with lead by
a former smelter, much of the city was designated
by EPA as a Superfund site. Based on soil sample analy-
ses and a screening risk assessment model, EPA decided
to remove the contaminated soil around 1.200 homes
and businesses and haul it away.
Some believe that EPA made this decision with-
out adequately consulting the community City
officials believe that this remedy ignored a num-
ber of problems:
• The potential health risks associated with
recontarnination by fugitive dust from the waste
pile remaining at the smelter, which was not
going to be removed by EPA.
• The health risks posed by fugitive dust from
the trucking lot adjacent to the waste pile
(which was also not going to be removed by
EPA). This soil was contaminated with 50,000
parts per billion of lead.
• The common presence of lead-based paint in
the area, which a local study suggested was
the most important source of exposure to lead
for children.
• The fact that 95% of the children had blood lead
levels below 15 ug/dL.
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Defining Problems and Putting Them in Context
The industrial facility held responsible tor the
contamination did not respond to EPA's decision,
so the agency sued the facility. The city then filed
a petition in the suit because officials felt that nei-
ther EPA nor the responsible party represented the
best interests of the community. EPA began the
cleanup anyway, but was restrained by court or-
der. EPA retained an expert whose analysis sup-
ported the agency's choice of remedy and the city
retained an expert whose analysis concluded that
removing contaminated soil would be fruitless
unless the remaining sources of contamination-
house paint, the smelter waste pile, and the trucking
lot soil—were removed as well. Granite City residents
are left confused and caught in the middle—some
support the city and some support EPA. Property val-
ues have fallen. As of late 1996, the case remains
unresolved and is back in federal courts.
»• Local public health agencies can play an important role in the
execution of the Commission's Risk Management Framework. In
Boston, the Department of Public Health produces neighborhood
health reports, which individually describe the health status of 16
neighborhoods. The department asked residents what they thought
their priorities were, then set up forums for discussing those priorities
and pursuing ways to achieve public health goals. Each year the
department updates and expands the reports based on neighborhood
needs and priorities. }}
—Ngozi Oleru, Director,
Office of Environmental Health,
Boston Public Health Commission
20,
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Involving Stakeholders in Maine
Unsuccessful: An Automobile Inspection and Maintenance Program
A sophisticated emissions testing program for automobiles is considered by many to be
one of the most cost-effective strategies for reducing emissions of ozone precursors. In early
1993, Maine was the first state in the Northeast to propose adopting this control strategy.
This was Maine's first air pollution control plan that would require compliance by citizens
Maine had not required emissions testing previously, focusing instead on stationary sources
as the means by which it met its ozone control requirements.
Maine's Department of Environmental Protection conducted all the necessary adminis-
trative procedures to implement the program, but never adequately addressed many of the
questions and concerns the public raised about the program. In the end, public opposition
became so strong that the department was forced to abandon the program in 1994 after only
a few months of implementation.
Involving stakeholders would not have guaranteed success, but certainly would have
increased its chances. By involving stakeholders early, state regulatory officials could have
helped the public understand the legal requirements of the Clean Air Act and the public
health need for the control strategy, and officials could have better understood what issues
the state needed to resolve to gain public support.
Successful: A Transportation Policy That Considered Alternatives to
Highway Expansion
Several years ago, the state of Maine proposed to add lanes to the southern portion of the
Maine Turnpike because of significant increases in traffic volume. Citizen opposition was so
strong that a referendum was passed, placing a moratorium on turnpike expansion and
mandating that the state develop rules requiring the consideration of alternatives to any
proposed highway expansion project. Key stakeholders were identified, mobilized, and in-
vited to participate in a negotiated rulemaking, which set up regional, stakeholder-based
decision-making committees and criteria for considering alternatives. All agreed that pro-
jected traffic volumes did not warrant highway expansion at that time, although such pro-
posals could be considered in the future.
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Defining Problems and Putting Them in Context
The Important and Synergistic Roles of Regulatory and
Public Health Agencies in Identifying and Reducing
Environmental Health Risks
The effort to sustain our gams in public health and environmental health protection
will be most effective if regulatory and public health agencies work together. Regula-
tory and public health agencies have important and complementary roles to play in
setting policies for environmental health protection and risk management. Yet, in gen-
eral, these two communities do not interact sufficiently and the connections between
environmental exposures and public health are not well established.
The likely synergy between environmental and public health agencies is a reservoir
of untapped potential for environmental risk management. Many environmental pollu-
tion problems can be identified by their public health contexts. For example, construc-
tion of an asphalt batch plant was proposed in Boston. The residents of the urban
community in which it was to be constructed were found by public health officials to
have a relatively high incidence of asthma and cardiovascular disease. The public health
findings signaled a potential environmental health problem that could have been exac-
erbated by emissions from the asphalt plant. On that basis, construction of the plant
was opposed by citizens and by the public health agency, and a decision was made to
try to locate the plant elsewhere.
Environmental, public health, and social agencies can work together with commu-
nity activists to define problems and to develop and implement strategies to manage
environmental risks in the full context of poverty, poor schools, and inadequate hous-
ing. As our society works to reduce risks in an era of diminishing resources, it is vital
that environmental and public health agencies collaborate in deploying the tools of
public health—epidemiology, exposure assessment, surveillance, nutrition, genetics,
and behavior change—to identify and evaluate the most cost-effective ways to reduce
risks and improve public health in all segments of the population. The public health
community should accept the challenge to play an influential role in setting national,
state, and local priorities and in developing strategies to understand, manage, and pre-
vent environmental risk.
22
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Actions ?!<&=< Options
Decisions
Analyzing Risks
Why Is Risk Assessment Important?
To make an effective risk management decision,
risk managers and other stakeholders need to know
what potential harm a situation poses and how great
is the likelihood that people or the environment will
be harmed. Gathering and analyzing this information
is referred to as risk assessment.
The nature, extent, and focus of a risk assessment
should be guided by the risk management goals. The
results of a risk assessment—along with information
about public values, statutory requirements, court de-
cisions, equity considerations, benefits, and costs—
are used to decide whether and how to manage the
risks.
Risk assessment can be controversial, reflecting the
important role that both science and judgment play
in drawing conclusions about the likelihood of ef-
fects on human health and the environment. Often,
the controversy arises from what we don't know and
from what risk assessments can't tell us, because our
knowledge of human vulnerability and of environ-
mental impacts is incomplete, especially at the rela-
tively low levels of chemical exposure commonly
encountered in the general community.
How Should Risk Be Characterized?
Risk results from a combination of hazard and ex-
posure. Hazard is an intrinsic property of a substance
or situation: for example, benzene can cause leuke-
mia but not lung cancer; DDT can prevent eagles from
reproducing in the wild, but does not affect prairie
dogs; a rattlesnake bite can kill but a garter snake
bite does not. Exposure means contact between the
hazardous substance and a person, population, or eco-
system. The more exposure, the greater the risk. When
A good risk management decision is
based on a careful analysis of the
weight of scientific evidence that
supports conclusions about a
problem's potential risks to human
health and the environment.
there is no current or potential exposure, there is no
risk.
Risk assessment is performed by considering in-
trinsic hazards, the extent of exposure to the hazards.
and information about the relationship between ex-
posures and responses. Unfortunately, we seldom have
enough information to accurately determine hazards.
exposures, or exposure-response relationships, so risk
assessors must use a combination of scientific infor-
mation and their best judgment to characterize risks.
Making judgments about risk on the basis of scien-
tific information is called "evaluating the weight of
the evidence." For example, considerations involved
in analyzing the weight of the evidence associated with
identifying a hazard using toxicity studies in rodents
include the:
• Quality of the toxicity study.
• Appropriateness of the toxicity study methods.
• Consistency of results across studies.
• Biological plausibility of statistical associations.
• Similarity of results to responses and effects in
humans.
It is important that risk assessors respect the ob-
jective scientific basis of risks and procedures for
making inferences in the absence oi adequate data.
Risk assessors should provide risk managers and other
stakeholders with plausible conclusions about risk
-------
Analyzing Risks
Risk is determined by considering the
nature, likelihood, and severity of
adverse effects on human health or
the environment.
that can be made on the basis of the available infor-
mation, along with evaluations of the scientific weight
of evidence supporting those conclusions and descrip-
tions of major sources of uncertainty and alternative
views.
The outcome of a risk assessment is called a risk
characterization. Typically a risk characterization
should address the following:
• Considering the hazard and the exposure, what
is the nature and likelihood of the health risk?
• Which individuals or groups are at risk? Are
some people more likely to be at risk than
others?
• How severe are the anticipated adverse impacts
or effects?
Are the effects reversible7
What scientific evidence supports the
conclusions about risk? How strong is the
evidence?
What is uncertain about the nature or
magnitude of the risk?
What is the range of informed views about the
nature and probability of the risk?
How confident are the risk analysts about their
predictions of risk7
What other sources cause the same type of effects
or risks?
What contribution does the particular source make
to the overall risk of this kind of effect in the
How Should Risks Be Analyzed?
Clarify the factual and scientific basis of the risks posed by the problem, treating health and ecological risks both
qualitatively and quantitatively. Describe the nature of the adverse effects, their severity, and their reversibility or
prevemability. Identify who is at risk and when they are at risk, and explain the possibility of multiple effects.
Evaluate the weight of the scientific evidence and identify the primary sources of uncertainty. For ecological
risks, consider indirect effects on human health through disruption of the environment and possible effects on
future generations.
With input from the problem/context stage, put the spe-
cific risks posed by the problem into their multisource,
multimedia, multichemical, and multirisk contexts.
Identify stakeholder perceptions of the risks posed by
the problem.
Combine information on the scientific and contextual
aspects of the risks posed by the problem into a charac-
terization of the problems risks to human health or the
environment. Include descriptions of stakeholder per-
ceptions and any other social or cultural impacts of the
problem.
r 5
24
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V\V I.K k ^ulluk'nt animal data on many
subbianccs, however, drawing i_ondusions about
human risks from laboratory animals is uiucrtam
affected community? To the overall health of
the community7
• How is the risk distributed in relation to other
risks to the community?
• Does the risk have impacts besides those on health
or the environment, such as social or cultural
consequences?
The level of detail considered in a risk assessment and
included in a nsk chacterization should be commensurate
with the problems importance, expected health or envi-
ronmental impact, expected economic or social impact,
urgency, and level of controversy, as well as with the ex-
pected impact and cost of protective measures.
Risk characterizations should include sufficient infor-
mation to enable:
• Risk managers to make a useful risk management
decision.
• Stakeholders to understand the importance and
context of that decision.
Stakeholders' perception of a risk can vary sub-
stantially depending on such factors as the extent
to which they are directly affected, whether they
have voluntarily assumed the risk (as in choosing
not to wear a seatbelt) or had the risk imposed on
them (as in exposure to air pollutants), and
whether they are connected with the cause of the
risk. For this reason, the Commission recommends
that a risk assessment characterize the scientific
aspects of a risk and note its subjective, cultural,
and comparative dimensions (see "How Should
Risks Be Analyzed?" on page 24). While this ex-
pands risk assessment beyond its traditional, more
narrowly scientific scope, including these addi-
tional dimensions will help educate all stakehold-
ers about key factors affecting the perception of
risk. Such education is likely to reduce controversy
and litigation and to improve communication dur-
ing the risk management process
Risk characterizations must include
information that is useful for all
stakeholders.
Risk characterization should form a common ba-
sis for the understanding of a problem among stake-
holders. Stakeholder involvement within the Risk
Management Framework should enhance the integ-
rity of the risk assessment. Stakeholders play an im-
portant role in providing information that should be
used in risk assessments and in identifying specific
health and ecological concerns they would like to see
addressed. For example, community stakeholders
consulted at this stage can help identify groups with
high exposures so that appropriate exposure assess-
ments can be designed. Industry stakeholders can
provide important information about a substance's
toxicity and lifecycle.
The integrity of a risk assessment is best assured if
it is carried out or peer-reviewed independently, for
example, by scientists at regulatory agencies, univer-
sities, and research institutions. To relieve some of
the burden on regulatory agencies and other public
institutions, however, certification, auditing, and over-
sight programs should be considered, so that compa-
nies, industry organizations, and other organizations
or individuals can provide risk assessments that are
considered credible by all stakeholders. For example,
in order to place greater responsibility on the private
sector for cleaning up contaminated sites, the state of
Massachusetts has instituted a successful program for
certifying Licensed Site Professionals to oversee or per-
form site assessments or cleanups.
<25>
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Analyzing Risks
The Need for More Data
Lack of data is a major barrier to reliable risk as-
sessments.
We lack data on the hazards that chemicals and
other stressors pose, largely because of:
• The ethical barriers to deliberately exposing
humans.
• The limitations of tests in laboratory animals
and cell systems.
• The technical uncertainties involved in
extrapolating data from laboratory animals or
cell systems to humans.
• The difficulties associated with determining
differences in susceptibility among people.
• The expense involved in studying hazards.
As a result, many chemicals are never properly tested
at all.
We lack data on actual human and ecological ex-
posures to agents of concern, largely due to:
• The privacy issues involved in studying humans
directly.
• The substantial cost of the environmental
monitoring needed to gather the data.
Because of the difficulties involved in studying
chemical hazards and exposures, risk assessors can-
not always accurately determine the health risks of
an exposed population or the ecologic risks of an ex-
posed ecosystem, the contribution of each individual
source of exposure to the overall risk, or the success
of risk management actions in reducing the risk from
existing sources of exposure.
Ecological Risk Assessment and Risk Management
Human and ecological health are intimately connected. Ecosystems are crucial to human survival and well-
being. We depend on them for many things—including material goods (such as food, building materials, and
fiber) as well as recreation and spiritual sustenance. Many environmental problems, such as global climate
change and hormonally active contaminants, pose an
inseparable combination of health and ecological risks.
While many of our laws were intended to protect
simultaneously human and ecological health, ecologi-
cal risk assessment has long been eclipsed by human
health risk assessment. In recent years, however, we
have begun to recognize the importance of directly pro-
tecting ecosystems, rather than indirectly protecting
them through measures taken to improve human health.
As agencies gain experience in applying the ecological
risk assessment process, risk managers will become
better equipped to address important ecological prob-
lems—such as protecting biological diversity and habi-
tats, maintaining ecosystem health, and guiding sustainable development.
Although the techniques for ecological risk assessment differ somewhat from those of traditional human
health risk assessment, the Commission's Framework is designed to be flexible enough to accommodate both.
26,
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Assessing aggregate risks from
multiple exposures is an area in which
risk assessors and risk managers need
both methods and experience.
and cumulative exposure studies have been per-
formed. However, few other regulatory agencies con-
sider exposures or risks this comprehensively, and EPA
often does not do so because of resource or statutory
limitations. Failure to account for multiple and cu-
mulative exposures is one of the primary flaws of
current risk assessment and risk management.
To the greatest extent possible, EPA and other
regulatory agencies must work to develop and re-
fine techniques for comprehensive risk assessment
In addition to the work already being done by EPA.
a number of other efforts provide useful models.
One example of a technique for assessing aggre-
gate or cumulative risks from multiple pollutants
and multiple sources is the method lor regional
risk assessment of air pollution developed by the
Air and Waste Management Association. This
method was used in San Diego as part of
Risk assessment will be greatly improved if risk
assessors and other members of the scientific and risk
management communities can work to develop and
validate new toxicity tests in laboratory animals, in-
vestigate similarities and differences in laboratory
animals and humans, obtain data on exposures, and
develop and validate models to help fill toxicity and
exposure data gaps.
The Importance of Comprehensive,
Multimedia Risk Analysis
Risk assessment provides the scientific foundation
for risk management decision-making. Traditionally, nsk
assessments, like risk management, have largely focused
on assessing the risks of just one chemical in one me-
dium at a time. However, to achieve comprehensive,
multimedia risk management, risk managers will need
comprehensive, multimedia
risk assessments. Thus, to
improve risk management,
the risk assessment para-
digm must be expanded.
A number of EPA offices
conduct more comprehen-
sive risk assessments. Spe-
cifically, when establishing
a standard for exposure to
a chemical in drinking wa-
ter, EPA accounts for
nondrinking water sources
of exposure to that chemi-
cal. When considering
whether to reregister a pes-
ticide, EPA now considers
other sources of exposure
to that pesticide and to
similar pesticides. In addi-
tion, some total exposure Scientists must develop methods to assess multimedia, muhisource, multichemu:al risks
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Analyzing Risks
California's "hot spots" program, which examines
the potential lor cumulative pollution from mul-
tiple facilities to impact neighborhoods in a county.
The method generates a contour map of estimates
of the maximum cancer risks associated with in-
dustrial facilities throughout the county using me-
teorological data and information on contaminants,
emission rates, and risks from individual facilities.
The results can be used to:
Estimate the relative contribution of individual
industrial facilities to the overall regional risk
associated with industrial facilities.
Estimate the relative contribution industrial
facilities make to background risks.
Compare risks from industrial facilities to risks
associated with other sources of air pollution,
such as motor vehicles.
28
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Examining Options
This stage of the risk management process in-
volves identifying potential risk management op-
tions and evaluating their effectiveness, feasibility,
costs, benefits, unintended consequences, and cul-
tural or social impacts. This process can begin
whenever appropriate after defining the problem
and considering the context. It docs not have to
wait until the risk analysis is completed, although
a risk analysis often will provide important infor-
mation for identifying and evaluating risk
management options. In some cases, examining
risk management options may help refine a risk
analysis. Risk management goals may be redefined
after risk managers and stakeholders gain some ap-
preciation for what is feasible, what the costs and
benefits are, and what contribution reducing ex-
posures and risks can make toward improving hu-
man and ecological health.
Stakeholders can play an important role in all
facets of identifying and analyzing options. They
can help risk managers:
• Develop methods for identifying risk-
reduction options.
• Develop and analyze options.
• Evaluate the ability of each option to reduce
or eliminate risk, along with its feasibility,
costs, benefits, and legal, social, and cultural
impacts.
The two components of this stage of the Risk
Management Framework—identifying options and
analyzing options—are described below. Creativ-
ity, imagination, and openness are key to success
during this stage.
A good risk management decision is
made after examining a range of
regulatory and nonregulatory risk
management options.
Identify Options
There are many different regulatory and
nonregulatory approaches to reducing risk. These
include:
• Encouraging pollution prevention either by
reducing or eliminating the use of hazardous
agents or by improving technology to reduce the
likelihood that they will be released to the
environment.
• Limiting pollutant emissions by requiring
operating permits for industrial facilities.
incinerators, and wastewater treatment plants.
• Taxing industries on the basis of the pollutants
they release.
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Examining Options
These workers are discussing changes in processing that could
eliminate the use of some hazardous chemicals.
Enforcing compliance, as is done by EPA to
ensure cleanup at Superfund sites, by the
Department of Agriculture when foods are
found to be contaminated with
microorganisms, and by the Occupational
Safety and Health Administration when
workplace exposure limits are exceeded.
Recycling and encouraging the use of recycled
materials.
Educating/informing affected communities
about steps they can take to reduce their
risks, such as posting signs warning about
contaminated fish, showing workers which
workplace practices lead to fewer chemical
exposures, and encouraging people to reduce
the fat and increase the fruits and vegetables
in their diets.
Establishing market or other incentives for
voluntary behavior changes that will reduce
risk, such as allowing companies to trade
among themselves the amount of pollutants
they are permitted to release and requiring
facilities that emit pollutants to publicly
report the amounts they release.
• Removing the source of risk, such as cleaning
up a hazardous waste site, banning a pesticide
that prevents birds from reproducing, or
removing contaminated food from the
marketplace.
During this stage of the Framework, risk man-
agers and stakeholders consider which of these
and other types of options may be appropriate.
Sometimes only one of these options will seem
appropriate. However, a combination of options
often will be most effective for reducing risk. (The
box "Risk Management Methods" on page 31 pro-
vides more information on options.)
Analyze Options
Once potential options have been identified, the
effectiveness, feasibility, benefits, and costs of each
option must be assessed, along with their poten-
tial legal, social, cultural, and political implica-
tions, to provide input into selecting an option.
Key questions to ask include:
• What are the options expected benefits?
• What are the options expected costs?
• Who gains the benefits and who bears the
costs? What are the equity or environmental
justice implications?
• How feasible is the option, given the available
time and resources, as well as legal, political,
statutory, and technology limitations?
• Does the option increase certain risks while
reducing others?
30,
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Risk Management Methods
The number of options for reducing risks to human health and the environment has increased in
recent years, providing risk managers with greater flexibility and a wide suite of risk management
tools. Historically, risk reduction was most commonly achieved by command-and-control regula-
tions that dictated how to control pollution at the "end of the pipe" rather than reducing or prevent-
ing it in the first place. Regulatory requirements were then enforced through a system of permits.
penalties, and legal actions. This approach significantly reduced pollution, but may have reached a
point of diminishing returns—in other words, further improvement via this approach will likely be
very expensive for the additional benefit gained
For this reason, regulatory agencies have been exploring and implementing a number of regula-
tory and nonregulatory alternatives in recent years, including education, incentives, monitoring.
surveillance, and research:
Education/Information. Educational tools include right-to-know requirements such as EPAs
Toxics Release Inventory and California's Proposition 65. These laws require industry to publicly
and periodically disclose information about pollution and potentially hazardous products. Right-to-
know laws are based on the idea that public concern about pollution will encourage industry to
voluntarily reduce the use and release of pollutants and hazardous products.
Incentives. Voluntary risk reduction can be encouraged through a number oi mechanisms, in-
cluding market-based incentives, subsidies, alternative compliance, and consensus, mediation, and
dialogue projects. One example of market-based incentives is the use of tradable pollutant allow-
ances in combination with a cap on the amount of pollution released—such as sullur dioxide in
EPA's acid rain program. Alternative compliance projects include EPAs Project XL, which is experi-
menting with ways to give companies greater flexibility in how they reduce emissions or their re-
lated risks to or below target levels.
Monitoring. Monitoring can be a useful risk management tool, especially when a community is
skeptical about how effective a risk management option will be. Communities may be more willing
to accept an alternative to a traditional command-and-control program when monitoring data pro-
vide concrete evidence about its effectiveness.
Surveillance. Health surveillance is a valuable technique for observing the effects of pollution
and the expected positive impact of pollution reduction measures, especially in the workplace.
Research. The Risk Management Framework will generate questions and identify gaps in knowl-
edge that must be addressed through research. Research agendas are an important output of risk
management processes and are sometimes required by statute, such as the periodic reassessment of
evidence underlying national ambient air quality standards required by the Clean Air Act EPAs
cooperative effort with scientists in universities, industries, and environmental groups to identify
and design appropriate research projects on hormonally active contaminants is another example of
research to inform risk management decision-making.
,31
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Examining Options
Recycling and encouraging the use of recycled
materials are nonregulatory options.
Expected Benefits/Effectiveness
It is important to determine what the specific in-
tended benefits will be because they will be evalu-
ated at a later stage in the Framework. The most
obvious benefit from risk management is risk reduc-
tion or elimination. This may take a number of forms,
including:
• Improved health, through reduced occurrence of
cancer, birth defects, asthma, or other diseases.
• Habitat protection.
• Increased biodiversity.
Other important potential benefits include savings
in health care costs, technology development, the
economic benefits of exporting new technologies, and
the employment opportunities that new technology
development and its application can bring. (Technol-
ogy development can also be considered a cost; see
"Expected Costs.")
Because it is often difficult to detect risk reduction
in the rates of disease, death, or habitat destruction, in-
direct methods of evaluating effectiveness and identify-
ing reductions in risk may be necessary. Indirect
indicators of risk reduction include reductions in:
• Pollution-generating activities, such as fewer
vehicle miles travelled.
• Contaminant emissions from their sources, for
example, at the site of a facility's wastewater
discharge point or in stack emissions.
• Contaminant concentrations in environmental
media, such as lower ozone, radon, or
paniculate levels in air; lower concentrations of
industrial solvents in ground water; or lower
concentrations of heavy metals in soil.
• Contaminant concentrations in other sources of
exposure, such as less mercury in swordfish,
fewer microorganisms in meat, or pesticide
residues on fruit that are below detectable levels.
• The occurrence of particular biological markers
of exposure or disease, such as chromium levels
in hair, lead levels in blood, or changes in the
components of the immune system.
All potential forms of risk reduction should be
examined, as well as any other benefits, such as
the identification or development of new technolo-
gies or approaches for controlling or reducing
risks. Indirect measures of risk reduction or elimi-
nation are not the real objectives, however; they
are only surrogates and are not always reliable.
Their validation is difficult. Whenever possible,
direct measures of risk reduction or elimination
should be used. When indirect measures are used,
the uncertainties surrounding their use should be
discussed. When the stakes are high, investment
in developing and validating direct measures
should be considered. The box "Measuring the Ef-
fectiveness of a Risk Management Action" on
page 47 provides more detail on the challenges of
measuring the effectiveness of actions to reduce risk.
Expected Costs
The costs of implementing an option may be mon-
etary and nonmonetary. Monetary costs include the
costs of:
• Technology development—researching and
developing new engineering processes or
equipment.
• Technology application—purchasing, installing,
operating, and maintaining equipment needed to
-------
Purchasing honied drinking w.iu-r instead ol
pumping and treating contaminated ground
water may he an option.
improve an industrial process or reduce
emissions.
• Training needed to use new technology, carry out
new procedures, or monitor effectiveness.
• Cleanup—hiring contractors and engineers to
implement a remedy at a contaminated site.
• Transportation and infrastructure—removing
hazardous materials and trucking them to a
disposal site and, sometimes, improving
roadways to accommodate the increase in heavy
vehicle traffic.
• Health care, such as that needed for workers
responsible for implementing an option that puts
them at risk.
• Diversion of investments, or opportunity costs-
such as having to spend money on
environmental controls instead of using those
resources to build a school or reduce taxes.
Nonmonetary costs include the costs of:
• Valued environmental assets lost, such as
recreation areas, endangered species, visual
range, open space, and wetlands.
• Flexibility and choice for consumers and
businesses lost because certain products,
practices, or processes are no longer available or
permitted.
• Decreased sense of well-being or security.
Both types of costs should be considered when
evaluating options. As with estimates of risks and
benefits, however, cost estimates are uncertain. It is
important to obtain independent and defensible cost
estimates to the extent possible. See the section "Link-
ing Risk and Economics" on page 36 for more per-
spective on evaluating costs.
Distribution of Benefits and Costs
Evaluations of costs and benefits have been criti-
cized because they are often blind to issues of envi-
ronmental equity and fail to make explicit who bears
the costs of a risk management decision and who gains
the benefits. For example:
• If a new policy is instituted that limits the
application of a widely used pesticide, the cost
of certain fruits and vegetables could increase
significantly. Should this occur, those who still
can afford to buy those fruits and vegetables may
benefit by enjoying reduced health risks from
pesticides. However, economists argue, others
who can no longer afford those fruits and
vegetables may suffer poorer nutrition and
increased cancer risk associated with eating too
few fruits and vegetables.
• In Boston, a freeway exit ramp was proposed to
make commuting more convenient for office
workers. However, because of its location, the
new ramp would have substantially increased
exposure to air pollutants experienced by
residents of Chinatown, a densely populated
neighborhood.
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Examining Options
As these examples illustrate, understanding and
evaluating potentially inequitable costs and benefits
is important for making risk management decisions.
Feasibility
The feasibility of an option can be constrained
by a variety of technological, legal, political, eco-
nomic, and other issues. When an option is exam-
ined, the feasibility of actually implementing it
should be an important evaluation criterion. For
example, the feasibility of implementing a tech-
nological option may be limited by the availabil-
ity of the technology or by its cost; implementing
administrative options such as setting up a recy-
cling program or providing incentives may be con-
strained by political or legal barriers. Regulated
parties often debate an option's feasibility; how-
ever, options that are technologically infeasible
today frequently can, through technology devel-
opment or policy change, become feasible in the
future.
Stakeholders and EPA Identify Risk Management Options
for the Pulp and Paper Industry
In 1990, EPA assembled a team of experts in air and water pollution to formulate integrated rules to
control water discharges and air emissions from the pulp, paper, and paperboard industry. A screening as-
sessment of 104 mills that use chlorine as the bleaching agent for paper had found dioxins and furans in the
mills' water discharge, sludge, and pulp at levels that have the potential to harm fish and wildlife and to
cause cancer and other health effects in humans.
Before deciding how best to reduce these discharges, EPA held meetings, conference calls, and a sympo-
sium to seek views and information from many stakeholders—including individual companies, an industry
association, consultants, vendors, labor unions, and environmental organizations. EPA shared its data and
thinking about various approaches with stakeholders be/ore publishing proposed rules in the Federal Register.
Even the preamble to the proposed limitations and standards was reviewed by stakeholders before being
published. In all, five public meetings were held before the proposed rule was published in 1993 and one
afterwards.
During the many discussions of control options, environmentalists pressed for a "totally chlorine-
free" option to eliminate the discharge of chlorinated pollutants. EPA proposed a technology option.
Industry asked EPA to consider a second option they considered more feasible. EPA assessed potential
compliance costs, effluent reduction benefits, economic and environmental impacts, management prac-
tices, recovery systems, and equipment availability. The agency then proposed both technology op-
tions as well as a voluntary incentives program to encourage and reward individual mills that implement
"totally chlorine-free" technologies. While not everyone is happy with the proposals, stakeholder
involvement improved the development of options.
34,
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Consideration ol health care costs may be an
important lauor in li.ilaiii.ini: costs and h<_'netu>
Potential Adverse Consequences
Analysis must consider whether an option
may cause any adverse consequences. One of
the most important is the potential for an op-
tion to increase one type of risk while reducing
the risk of concern:
• While reducing pollutant concentrations in
one environmental medium, the option
may increase pollutants in another
medium. For example, using aeration
reduces pollutants in drinking water by-
releasing them to the air. (Of course, if
exposure to air is considerably less than
exposure to drinking water, this tradeoff
may be worthwhile.)
• While reducing long-term health risks for
community members, an option may produce
short-term health risks and injury for workers,
as can happen during cleanup of sites
contaminated with hazardous chemical and
radioactive wastes.
• Banning one pesticide because it might cause
cancer may increase the use of another pesticide
that is known to cause birth defects or to harm
wildlife, or whose health effects are not known.
Thus, tradeoffs among different risks must be iden-
tified and considered.
Together with social and cultural
considerations and information on risks to
health and the environment, economic
analysis can provide important input to
risk management and regulatory policy
decisions.
Other adverse consequences may be cultural, ethi-
cal, political, social, or economic, such as:
• Economic impacts on a community, including
reduced property values or loss of jobs.
• Environmental justice issues, such as inequitable
distribution of costs and benefits as mentioned
above; disregard for a particular population
group's dietary needs, preferences, or nutritional
status; or giving priority to site cleanup efforts in
more affluent areas.
• Harming the social fabric of a town or tribe b\
relocating the people away from a highly
contaminated area.
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Examining Options
Linking Risk and Economics
In addition to considerations of risk, public val-
ues, and legal requirements, economic analysis can
play an important role in the Risk Management
Framework. For example, cost-effectiveness analy-
sis can help identify the least costly risk manage-
ment option for reaching a particular goal. And, by
clarifying who bears the costs and who gains the
benefits, economic analysis can help identity ineq-
uities.
Economic analysis has strengths and limitations,
and its role in regulatory decision-making is con-
troversial. Three common concerns are that:
• Economic analysis places too much emphasis
on assigning dollar values to aspects of health
and the environment that are difficult, if not
impossible, to quantify in monetary terms.
• Regulatory decisions about health and
environmental protection might be based
strictly on whether the estimated monetized,
quantifiable benefits outweigh the estimated
quantifiable costs.
• The results of economic analyses are often
conveyed in a manner that ignores assumptions
and uncertainties, giving the impression of far
greater precision than is generally possible or
appropriate.
Another problem is the inconsistency between the
way risk assessors estimate risks and what economists
need to know about risks in order to evaluate risk-
reduction alternatives.
Nevertheless, the tools of economic analysis, when
appropriately used, are legitimate and useful ways to
provide information for risk managers making deci-
sions that will affect health and the environment.
Economic analysis should not be used as the sole or
overriding determinant of those decisions, however.
Information about costs and benefits that cannot be
assigned monetary values also must be explicitly con-
sidered, along with information about risks and so-
cial and cultural concerns. Peer review should play a
critical role in evaluation of the quality of economic
analyses and the technical information underlying
them.
36,
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Making a Decision
Who Decides?
During this stage ol the Framework.
decision-makers review the information
gathered during the analyses of risks and
options to select the most appropriate
solution. When the risk problem falls
under the purview of a federal, state, or
local regulatory authority, the regulator}
agency makes the risk management de-
cision. Consumers, manufacturers, and
others responsible for wastes and pol-
lution also can make socially important
decisions to reduce or eliminate risks
A productive stakeholder involvement
process can generate important guidance
for decision-makers. Thus, decisions
may reflect negotiation and compromise,
so long as statutory requirements and
intent are met. In some cases, win-win
solutions are available that allow stakeholders with
divergent views to achieve their primary goals.
Involving stakeholders and incorporating their
recommendations where possible reorients the deci-
sion-making process from one dominated by regula-
tors to one that includes those who must live with
the consequences of the decision. This not only fos-
ters successful implementation, but can promote
greater trust in government institutions.
What Is the Best Decision?
In most risk management situations, decision-
makers will have a number of options from which
to choose. Which option is optimal depends on
the particular situation. Seven criteria, listed above
and discussed below, are fundamental character-
istics of any sound risk management decision.
These criteria echo the key themes that underlie
A good risk management decision reduces
or eliminates risks in ways that:
• Are based on the best available scientific, economic.
and other technical information.
• Account lor their muhisource. multimedia.
multichemical, and muhinsk contexts
• Are feasible, with beneliis reasonably related to their
costs.
• Give priority to preventing risks, not just controlling
them.
• Use alternatives to command-and-control regulation.
where applicable.
• Are sensitive to political, social, legal, and cultural
considerations.
• Include incentives lor innovation, evaluation, and
research.
the early stages of the Framework because the goal
of the earlier stages is to produce the most relevant
and useful information for sound risk management
decision-making.
• Base the decision on the best available
scientific, economic, and other technical
information.
Usually, the technical information that is available
on which to base a risk management decision is in-
complete. Decision-makers often must rely on:
• Predictions about human hazards that are based
on experiments in laboratory animals.
• Predictions about how much exposure occurs in
a lifetime based on few or no measurements of
the actual levels of exposure.
,37
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Making a Decision
• Predictions about the risks to entire
ecosystems that are based on observations in
only one or two species.
• Assumptions and models of exposure,
exposure-response relationships, and
estimates of the costs and benefits of different
options.
Because so many judgments must be made based
on limited information, it is critical that all reliable
information be considered. Risk assessors and econo-
mists are responsible for providing decision-makers
with the best technical information available or rea-
sonably attainable, including evaluations of the weight
of the evidence that supports different assumptions
and conclusions.
• Be sure the decision accounts for the
problem's multisource, multimedia,
multichemical, and multirisk contexts.
Considering a risk in isolation cannot provide de-
cision-makers or the public with any sense of how
important the risk is, compared with other risks, or
of the impact that reducing or eliminating it might
have on overall human and ecosystem health. Con-
sidering risks in context can help direct resources
toward the risk management actions that will do the
most good. As described in the "Problem/Context"
section earlier in this report, we need to move away
from our current one chemical/one environmental
medium/one risk approach toward developing a more
comprehensive and holistic appreciation for problems
and their contexts, so that meaningful, practicable
goals can be developed.
• Choose risk management options that are
feasible, with benefits reasonably related to
their costs.
Many risk management options may be infeasible
for social, political, cultural, legal, or economic rea-
sons (see the "Examining Options" section of this
report), or because they do not reduce risks to the
extent needed. For example, groundwater remediation
using pump-and-treat technology may be infeasible
because, for a variety of technical and hydrogeologic
reasons, it will not sufficiently reduce contaminant
concentrations in the ground water. Removing all the
soil from an entire valley that is heavily contaminated
with mining waste is infeasible. Expecting everyone
to stop driving automobiles is infeasible. On the other
hand, the costs of reducing acid rain by controlling
power plant emissions are considered justified by their
benefits—protecting streams and lakes and reducing
damage to automobile finishes and construction ma-
terials. Of course, the feasibility and cost-effective-
ness of an option may change in the future as
technology is improved or as society's values
change.
• Give priority to preventing risks, not just
controlling them.
If pollutants are not released into the environment,
exposure cannot occur. If exposure does not and will
not occur, risks will not result. Where feasible, pre-
venting contaminant releases is preferable to remov-
ing them or cleaning them up later. Preventing releases
can avoid the costs of remediation and health care.
Many industries have found that eliminating pollut-
ants can substantially reduce the cost of producing a
product.
• Use alternatives to command-and-control
regulation, where applicable.
Command-and-control risk management strat-
egies have significantly improved human health
and environmental protection. Alternative strate-
gies will enable even greater levels of protection
by encouraging industries, municipalities, and
other stakeholders to tailor remedies to reflect the
circumstances of individual sources and locations.
38
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The department has learned the power of having the public
involved in decision-making. For example, the citizens advisory
board at Fernald has dramatically changed the department s
cleanup strategy at that Ohio site. The results will be a far more
expeditious cleanup, with a savings of some $2 billion compared
with the cost of the departments original plans. By opening the
process to meaningful public input, the department is
empowered to make decisions it could never make unilaterally'
—Carol Henry,
Associate Deputy Assistant Secretary
for Science and Risk Policy,
U.S. Department of Energy
Encouraging flexibility can result in risk manage-
ment options that meet or exceed expectations and
that are cost-effective. Various alternatives to com-
mand-and-control strategies are described in the
"Examining Options" section of this report.
• Be sensitive to political, social, legal, and
cultural considerations.
The least costly risk management option is not
always the most desirable. An option is more likely
to be implemented successfully if it takes into ac-
count important cultural needs or social impacts
(see the discussion of stakeholder involvement in
the "Problem/Context" section of this report).
• Include incentives for innovation, evaluation,
and research.
Command-and-control risk management strat-
egies that specify technology that must be used or
actions that must be taken can fail to stimulate
better, cleaner, and more cost-effective approaches.
Without evaluation, the success (or failure) of a
risk management action and its unintended con-
sequences may not be determined (see the 'Evalu-
ating Results" section of this report). Incentives for
research are needed to generate knowledge about
hazards, exposures, options, and actions.
What Happens If There Isn't
Enough Information To Make a
Decision?
Decision-makers must balance the value of obtain-
ing additional information against the need for a de-
cision, however uncertain. Sometimes a decision must
be made under the precautionary principle. Every
effort should be made to avoid "paralysis by analysis"
where the need for additional information is used as
an excuse to avoid or postpone decision-making.
When sufficient information is available to make a
risk management decision or when additional infor-
mation or analysis would not contribute significantly
to the quality of the decision, the decision should not
be postponed. "Value-of-information" techniques can
be used to provide perspective on the next steps to
be taken.
-------
Making a Decision
Making Decisions: Steel Industry
The Clean Air Act Amendments of 1990 required EPA to cut toxic air pollution from iron and steel plant
coke ovens. Coke ovens produce the material used in blast furnaces to convert iron ore to iron Coke oven
air emissions were already regulated by the Occupational Safety and Health Administration and states, and
by EPA under the hazardous substance notification requirements of Superfund. The issue of how best to
reduce coke oven emissions was contentious
and had been deadlocked for 20 years.
To break this logjam, EPA initiated a nego-
tiated rulemaking process with extensive
stakeholder involvement. Over two years, the
Agency met with representatives of industry
and industry associations, labor unions, states,
and environmental groups in workshops and
informal and formal meetings. Negotiators
worked with stakeholders to develop a regu-
lation that all parties could support. By mak-
ing concessions in one area in exchange for
others in other areas, the parties resolved such
major issues as what emissions data would be
used, monitoring methods, numerical emis-
sion limits, costs and economics, and work
practices. They also identified and discussed
emission sources, enforcement and implemen-
tation needs, future research, and integrating
the proposed regulation with EPA's new per-
mitting system.
The process successfully involved stake-
holders in making decisions that had dragged
out for decades. The resulting regulation re-
duces hazardous air pollution by 1,500 tons
per year.
40
-------
Taking Action
Traditionally, implementation has been driven by
regulatory agencies' requirements. Businesses and
municipalities are generally the implementers. How-
ever, the chances of success are significantly improved
when other stakeholders also play key roles. Depend-
ing on the situation, action-takers may include:
• Public health agencies
• Other public agencies
• Community groups
• Citizens
• Businesses
• Industries
• Unions/workers
• Technical experts
These groups can help:
• Develop and implement a
plan for taking action.
• Explain to affected
communities what decision
was made and why and what
actions will be taken.
• Monitor progress.
The box "Examples of Risk
Management Actions" on page 42
provides specific examples of risk
management activities that stake-
holders can perform or assist.
Involving stakeholders in the
decision-making process, as set
forth in this Framework, not only
produces a better risk management decision, but also
lays a foundation for stakeholder involvement m
implementation. Involved stakeholders are more
likely to understand and support the decision and to
ha\'e developed the relationships, knowledge, com-
munication channels, and administrative mechanisms
to work together on implementing the decision.
A good risk management decision
can be implemented effectively,
expeditiously, flexibly, and with
stakeholder support.
This worker is cleaning up a Superfund site.
41
-------
Taking Action
Examples of Risk Management Actions
Public health agencies educating different cultural, ethnic, and socioeconomic groups about
practices to modify or avoid, such as smoking, alcohol consumption, high-fat diets, eating parts
of contaminated fish that concentrate pollutants, and chemical or radiation hazards in the home.
Municipalities working to reduce nonpoint sources of pollution, such as runoff from highways,
by preventing erosion; upgrading drinking water, sewage, and municipal solid waste treatment
facilities; or instituting recycling programs.
Community groups working with local businesses and industries to monitor the success of their
risk-reduction activities.
Citizens recycling, purchasing products that use recycled materials, or complying with automo-
bile emissions testing.
Businesses no longer selling products that can harm the environment; disposing of wastes safely;
or working with employees to anticipate and reduce worksite safety and health risks.
Industries reducing or eliminating
emissions or discharges to ambient
air, workplace air, and bodies of wa-
ter by upgrading air pollution con-
trol technology, upgrading
wastewater treatment, and improving
manufacturing processes (such as de-
veloping a closed-system approach,
recycling wastes, or substituting less
hazardous materials).
.
Unions working with industries to
identify less hazardous workplace
practices and processes; educating
workers about practices that reduce
hazardous exposures in the work-
place and hazardous emissions to the
environment, such as proper waste
disposal; or helping employers moni-
tor the success of risk-reduction activities.
Technical experts providing technical assistance to local agencies, community groups, busi-
nesses, and unions to help implement risk-reducing actions.
"42,
-------
Taking Action: San Francisco Bay
The San Francisco Bay is vulnerable to many sources of pollution. In 1978, the Association of
Bay Area Governments developed a regional environmental management plan to control pollution
in the bay. The plan was prepared through an extensive collaborative process that involved a broad
spectrum of stakeholders—federal, state, and local regulatory agencies; business, labor, and envi-
ronmental groups; ethnic minorities; and city and county governments. During the decision-mak-
ing process, stakeholders raised important issues about federal-state-local relationships, the social
and economic impact of land-use controls, and the extent of air-quality improvement likely to be
obtained.
Stakeholders who were involved in analyzing problems and solutions and in making decisions
supported the final plan and its implementation. And while some aspects of the plan might have
been developed and implemented without the help of stakeholders, most of the actions were imple-
mented more expeditiously as a direct result of stakeholder involvement.
Many actions recommended by the plan were implemented by public agencies, businesses, in-
dustries, and private citizens. For example:
• A state implementation plan for regional air quality resulted in designation under the federal
Clean Air Act as an attainment area for ozone in 1995.
• Almost all the industrial and municipal
wastewater treatment facilities have
been upgraded.
• Erosion-control measures to reduce
nonpoint-source pollution have been in
place for many years.
• A council of water-supply agencies was
formed and has engaged in cooperative
efforts, such as developing a regional
drought-response strategy.
• Hazardous-material spill response teams
have become available at the city and
county levels.
• Technical assistance was provided to
local agencies to initiate recycling
programs.
The plan has served as a blueprint for en-
vironmental management activities in the bay
area.
J^'p^ -A-.-......, L,
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/*tt >-*/
0 10 "ILES
-------
-------
Evaluating Results
A good risk management decision
can be shown to have a significant
impact on the risks of concern.
Why Evaluate?
At this stage of risk management.
decision-makers and other stakeholders
review what risk management actions
have been implemented and how effective
they have been. Evaluating effectiveness
involves monitoring and measuring, as
well as comparing the actual benefits and
costs to estimates made in the decision-
making stage. The effectiveness of the pro-
cess leading to implementation should
also be evaluated at this stage.
Evaluation provides important informa-
tion about:
• Whether the actions were successful,
whether they accomplished what was
intended, and whether the predicted
benefits and costs were accurate.
• Whether any modifications are needed to the
risk management plan to improve success.
• Whether any critical information gaps hindered
success.
• Whether any new information has emerged that
indicates a decision or a stage of the
Framework should be revisited.
• Whether the Framework process was effective
and how stakeholder involvement contributed
to the outcome.
Monitoring health indices can be one method ol evaluating whether risk
management has been successful.
• What lessons can be learned to guide future risk
management decisions or to improve the
decision-making process.
Tools for evaluation include environmental and
health monitoring, research, disease surveillance,
analyses of costs and benefits, and discussions with
stakeholders.
Evaluation is critical to accountability and to en-
sure wise use of scarce resources. Too often, past risk
management actions have had little or no evaluation
or follow-up after implementation, even when evalu-
ation was mandated.
-------
Evaluating Results
A good risk management decision
can be revised and changed when
significant new information becomes
available, while avoiding "paralysis
by analysis."
Planning for Evaluation
Plans for evaluation should be built into the over-
all implementation plan to specify when evaluation
will be conducted, who will conduct it, and what will
be evaluated. In most situations, periodic evaluation
will be important. The focus of evaluation may shift
with the stage of implementation, because it often may
take some time before the full impact of risk reduc-
tion can be measured. Evaluation might first focus
more on progress and success in implementing the
risk management plan. Later evaluations may focus
on the success of the risk management actions in re-
ducing risk.
In the past, evaluation, when conducted, has been
performed by the regulatory authority itself. As with
Evaluating Results: Integrating Regulatory
Activities at the State Level
Environmental agencies in Massachusetts, New York, and New Jersey have made significant efforts to
integrate their regulatory activities and to incorporate pollution prevention into these activities. Massachu-
setts has adopted a single, integrated inspection to assess a facility's compliance with environmental statutes,
instead of conducting separate medium-specific inspections. New York is using a facility-management strat-
egy in which a team directed by a state-employed facility manager is assigned to targeted plants to coordi-
nate medium-specific environmental programs. New Jersey is testing the use of a single, integrated permit
for industrial facilities instead of separate permits for releases of pollution to each environmental medium.
On behalf of Congress, the General Accounting Office (GAO) evalu-
ated the states' experiences with integrated programs, primarily through
interviews. The evaluation is considered preliminary because the data
needed to fully evaluate the states' experiences are not yet available.
GAO reported that Massachusetts and New York believe that their
integrated approaches have been sufficiently successful to implement
them statewide. Permits have only recently been issued as part of New
Jersey's program. Industry officials in those states believe that the inte-
grated approaches are beneficial to the environment, achieve regula-
tory efficiencies, and reduce costs. However, the states noted that
obtaining funding from EPA and meeting EPAs medium-specific report-
ing requirements were difficult and burdensome. In response, EPA pro-
posed a new grant program designed to provide states with easier access
to funding for multimedia programs and to facilitate easier reporting of
multimedia activities. Such a program would encourage other states to
integrate environmental management.
-------
Measuring the Effectiveness of a Risk Management Action
Few actions to reduce health or ecosystem risks lend themselves easily to measurement and validation
For example, it is dillicult to observe changes in cancer risk because it can take many years tor a tumor to
develop after exposure occurs. Some other effects are easier to observe because they can appear soon after
exposure—such as birth defects, anemia from lead, and asthma from sulfur oxides in the air Relationships
between action and effect often are detectable only when the action causes a sizable change in how much ol
a pollutant (or other stressor) populations are exposed to, or when the health effect of interest is easy to
recognize because it is rare and distinctive (such as the unusual type of liver tumor caused by breathing vinyl
chloride in the workplace).
One difficulty in measuring effectiveness is that most'environmental health risks are low compared with
the risks of such directly countable effects as occupational injuries, motor-vehicle collisions, infant mortality,
total cancer rates, and total birth defect rates. For example, suppose that a particular exposure is expected to
cause no more than one additional case of cancer per year in a population ol 10.000 and action is taken to
reduce exposure to a level anticipated to cause, at most, one additional case of cancer per year in one million
people (corresponding to one extra case per 100 years in that population of 10,000V With or without this
action, cancer still will be the cause of death in 24% of the population. No health study or surveillance
activity can measure the very small decrease in cancer incidence that would occur at the lower exposure
level. Instead, risk managers must rely on indirect measures that indicate cancer incidence may decrease-
such as decreased emissions, decreased exposure, and possibly decreases in biological markers of exposure
or effects.
Progress is needed in several areas if we are to improve our ability to implement and measure the effec-
tiveness of public health interventions. Specifically, we need to:
Link studies of exposure and studies of adverse health or ecological outcomes.
Determine regional differences in disease prevalence and disease incidence trends and risk (actors.
Develop good baseline and surveillance information about incidence rates of diseases specifically
linked to environmental causes.
• Identify the most important environmental causes of diseases.
other stages of the risk management process, evaluation
will benefit if stakeholders are involved, helping to:
• Establish criteria for evaluation, including the
definition of "success."
• Assure the credibility of the evaluation and the
evaluators.
• Determine whether an action was successful.
• Identify what lessons can be learned.
• Identify information gaps.
Determine whether cost and benefit estimates
made when evaluating the risk management
options were reasonable.
The Importance of Iteration
New information may emerge during evaluation
that is of sufficient importance to indicate that parts
of the Framework should be repeated. For example,
revisiting a decision might be needed if a more effec-
-------
Evaluating Results
live risk management option or a less costly option
of equal effectiveness is developed. Public comment,
negotiation, information-gathering, research, or analy-
sis of risks and options could clarify or redefine the
problem, change the focus to a different problem, or
identify other risks in a broader context. In such cases,
the risk management process will not be sequential,
but rather flexible and iterative as important new
information, ideas, and perspectives come to light.
The Commissions Risk Management Framework pro-
vides that flexibility.
While an iterative process is important for incor-
porating new information, it should not become an
excuse for taking no action. Decisions must be made,
even when information is imperfect.
Evaluating Results: Reducing the Use of Leaded Gasoline
Leaded
sInto any
(labeled
>Ilneonly"
TOTAL SALE
One of best documented evalua-
tions of the impact of a risk manage-
ment action on pollutant emission
levels concerns leaded gasoline. The
burning of gasoline was the single
largest source (90%) of lead in the
atmosphere beginning in the 1920s.
Significantly less of the lead moni-
tored in the air today comes from
gasoline because EPA phased out the
use of lead in gasoline. In 1984, the
average lead content of gasoline was
0.44 grams per gallon; in 1991-1992,
it was less than 0.0003 grams per gal-
lon. EPA estimated that before the
regulations to control lead in gasoline
were in place, the total amount of lead released to the air from motor vehicles was about 95 metric tons in
1979. After the controls were in place, only 2 metric tons were emitted from motor vehicles in 1989, with
less than 35% of the lead in air attributable to gasoline. Today, the emission of lead from motor vehicles
should be nearly zero, as required by the 1990 Clean Air Act.
L
PRICES BEING
CHARGED FOR
GASOLINE
DO NOT EXCEED
ti/IAYIMIIM
0: 0 1
LITERS
48
-------
Implementing the Framework
Recommendations to Congress and
Executive Branch Agencies
Most environmental problems affect more than one
environmental medium and involve exposures to
mixtures of chemicals. The Commission's Risk Man-
agement Framework is designed to address these com-
plex, real-world issues. Yet, environmental agencies
may encounter legal and administrative hurdles when
implementing the Framework because most environ-
mental statutes, agency programs, and Congressional
committees and subcommittees focus on managing
individual pollutants in single environmental media.
Current procedures also limit stakeholder involve-
ment in decision-making and the ability of agencies
to consider the larger context when addressing health
and environmental problems. In short, the programs,
regulations, and procedures developed under current
statutes often preclude an integrated approach. The
Commission makes six recommendations, described
below, to overcome these impediments.
ReccHnrnendation 1: Congress should coordinate
the activities of committees and subcommittees
with overlapping or related jurisdictional
responsibilities for environmental issues, starting
with joint oversight hearings.
Many different Congressional committees and sub-
committees have overlapping and conflicting respon-
sibilities for sources of and solutions to pollution. For
example, the Transportation and Infrastructure Com-
mittee and the Commerce Committee in the House
of Representatives both oversee EPAs implementation
of Superfund and the Safe Drinking Water Act. In the
Senate, the Agriculture Committee has jurisdiction
over pesticides, while the Environment and Public
FRIDAY, JUNE 14, 1996
New System of Assessing Health Risks Is Urged
By GINA KOLATA
In a draft report that is winning
praise from environmentalists and
the chemical industry, a Federal
commission recommended yester-
day that the system of assessing and
regulating health hazards from envi-
ronmental pollutants and other
sources, like food additives, be over-
hauled.
The 10-member Commission on
"we have a Clean Water Act that
regulates a whoie list of chemicals in
the water, but we don't ask about
exposures" to that chemical from
other sources.
From the very beginning, risk as-
sessments should include all inter-
ested panics, from citizens to those
who work with or near the chemicals
to enmonmentalists to industry, the
commission said.
praised the report as "a significant
contribution and a major advance,"
but Mr. Roe said he wished the group
had addressed the question of incen-
tives. For example, he said, how can
industry be coaxed to provide the
information on chemicals that is
needed for risk assessment?
"A constant theme is that there is
a body of information we need to
know but don't know," he said. "We
As this receni article from The New York Times shows, the public is keenly aware of the need for improved approaches to
controlling health risks. ©1996 The New York Times Company. Reprinted by permission.
49
-------
Implementing the Framework
Works Committee oversees other toxic substances.
These competing responsibilities make it difficult to
implement integrated strategies. We recognize the
practical and political constraints that make coordi-
nation difficult.
Joint Congressional hearings could:
• Help put problems into public health or
ecological context.
• Encourage EPA and other agencies to use their
discretionary authority to implement the
Commission's Risk Management Framework and
comprehensive risk assessment reforms.
• Reinforce integrated approaches to reducing
risks in industrial sectors and geographic areas.
• Evaluate experimental alternatives to command-
and-control regulations.
For example, the Agriculture Committee and the
Resources Committee in the House could stimulate
coordinated approaches to integrating chemical and
microbial risk assessment and benefit-cost practices
throughout the U.S. Department of Agriculture. They
could also promote the use of the Commissions Risk
Management Framework by the Natural Resources
Conservation Service in addressing erosion and wa-
ter pollution from agricultural lands. Other commit-
tees should look at industrial sectors, such as iron
and steel mills or oil refineries, to address sector-spe-
cific pollution and manufacturing processes on a
multimedia basis.
Some committees address the environmental sta-
tus of geographic areas, such as the House Resources
Committees jurisdiction over parks, wild and scenic
rivers, and national forests, but no committee is
charged with responsibility for the status of urban
pollution or of watersheds. In the House, joint hear-
ings involving the Resources Committee, the Agricul-
ture Committee, and the Transportation and Infra-
structure Committee, which has jurisdiction over the
Clean Water Act, could better address the myriad
stresses on a watershed. Similarly, the House Com-
merce Committee and the Transportation and Infra-
structure Committee could hold joint hearings to
encourage the use of the Commissions Risk Manage-
ment Framework to comprehensively deal with
Superfund sites.
Recommendation 2: The regulatory agencies
should fully use their existing discretionary
authority to propose and implement actions that
address the most significant sources of total
exposure to hazards under review.
Many agencies have improved their risk assessment
practices, used risk assessment in more programs, and
begun to engage stakeholders in decision-making
processes. In many cases, adoption of the
Commissions Risk Management Framework by fed-
eral, state, and local agencies will not require changes
in statutes so much as changes in the decision-mak-
ing process to identify all the sources that account
for total exposure and estimate the risks attributable
to each source.
California's air toxics program provides a good
model of an integrated regulatory strategy that is be-
ing achieved administratively. Rather than first assess-
ing risks from individual sources, that program
estimates the overall risk attributable to a particular
chemical. Upon deciding that the risk is sufficiently
high to warrant action, the program examines all iden-
tified stationary, mobile, and area sources of the
chemicals to determine the most cost-effective reduc-
tions in emissions and exposure. The EPA has
launched a similar cumulative exposure approach for
hazardous air pollutants (see below).
-------
••As a Commissioner, I saw far too many cases where extreme
attention was placed at an industrial facility on ensuring that
every last molecule of a toxic substance was kept out of the air,
only to have that same substance ignored as it poured through
the floor drain into the groundwater .... Taking a look at whole
facilities, at the whole mix of pollutants, at whole watersheds, is
fundamental. ^
—Daniel Greenbaum,
President of the Health Effects Institute
Former Commissioner for
Environmental Protection, State of Massachusetts
Recommendation 3: The regulatory agencies
should fully use their existing discretionary
authority to expand stakeholder involvement in
the development and implementation of solutions
to environmental problems.
Successful integrated approaches depend on trust
among agencies and stakeholders. Public notice and
comment procedures are inadequate for building the
level of trust and cooperation necessary for integrated
approaches. Stakeholder involvement processes such
as those used in the Common Sense Initiative and
Project XL are a good beginning. As the participants
have learned, however, unexpected difficulties—such
as disagreements about the composition of stake-
holder groups and problems arriving at consensus-
have slowed the completion of projects. We believe
that implementation of our "Guidelines for Stake-
holder Involvement" (see page 16) can increase pros-
pects for productive stakeholder involvement. Agency
adoption of the Commissions Framework for Risk
Management can provide a consistent approach to risk
management decision-making.
Recommendation 4: Congress should reinforce
implementation of the Commission's Risk
Management Framework legislatively, statute-
by-statute.
For several years, Congress has considered bills
that would prescribe government-wide risk assess-
ment and economic analysis practices and make them
judicially enforceable. Also, an "organic act" has been
proposed that would integrate the operations of EPA's
program offices. However, the 104th Congress found.
common ground for bipartisan action by reauthoriz-
ing specific statutes instead. For example, the Safe
Drinking Water Act and the Food Quality Protection
Act were modified in ways that provide flexible di-
rection to consider risks, costs, benefits, population
subgroups, and public values in decision-making. The
1996 Safe Drinking Water Act includes important
provisions on the roles of risk assessment and eco-
nomic analysis in setting standards and priorities for
regulation without dictating the specific steps in the
analysis or requiring one to outweigh another. It is a
good example of how statutes can be modified to pro-
mote more flexible risk management strategies. Con-
gress should consider legislative changes that:
• Address geographic areas such as urban areas and water-
sheds. Under the Clean Air Act Amendments of 1990.
EPA is developing an integrated urban air toxics strat-
egy that considers different types of pollutants and
multiple sources of pollutants together, so that risk
management actions in urban areas can address air
pollution in context. In the case of watersheds, EPA
already is working with states and localities to de-
velop ecological risk assessments and integrated ap-
proaches to pollution problems. The Clean Water Act
should be amended to establish a comprehensive, in-
tegrated watershed management approach.
• Mandate authority for EPA to consider sou/res of signifi-
cant indoor air pollution when evaluating the risks at-
tributable to multiple sources of air pollution. EPA should
collaborate with other agencies to reduce significant risk
-------
Implementing the Framework
indoor air i-.v/wsuivs. Numerous studies have
shown that the concentrations of many contami-
nants in air are higher in homes than outdoors.
\Yhile outdoor air pollution is extensively regu-
lated, problems in offices, public buildings, and
homes remain relatively unrecognized and unad-
dressed. Efforts by the EPA, Consumer Product
Safety Commission (CPSO, and Occupational
Safety and Health Administration (OSHA) to regu-
late indoor air have been thwarted by lack of statu-
tory authority and by lack of agreement on the
nature of the problems and the solutions. EPAs
regulatory authority appears to be limited to out-
door air. OSHA is responsible for industrial envi-
ronments. CPSC has authority over products, such
as carpets and insulating materials. A coordinated
approach by EPA, OSHA, and CPSC will not emerge
without a mandate from Congress and cooperation
from stakeholders.
Increase flexibility for meeting environmental protec-
tion goah. Integrated approaches to compliance can
provide greater cost-effectiveness and increased
flexibility for facilities that go beyond current lev-
els of environmental protection. EPA is currently
experimenting with such approaches in its Com-
mon Sense Initiative and Project XL programs.
However, EPA and participants must still meet the
original regulatory requirements, even when more
effective solutions are being implemented. For these
projects to succeed, EPA needs the legal authority
to provide flexibility in deciding how the regulated
community can improve its environmental perfor-
mance. Congress should explicitly authorize EPA
and state agencies to enter into compliance agree-
ments that waive certain current regulatory require-
ments if alternative controls can credibly achieve
equal or, whenever feasible, greater environmental
protection.
Recommendation 5: The Council on
Environmental Quality (CEQ) should consider
issuing guidance or regulations for implementing
additional provisions of the existing National
Environmental Policy Act (NEPA).
The National Environmental Policy Act offers some
opportunities for implementing the Framework. Instead
of aiming to protect specific places, activities, or envi-
ronmental media, as do most environmental statutes,
NEPA seeks to balance a broad range of environmental
factors with "other essential considerations of national
policy." The act states that its policies and goals are
supplementary to those in agencies' existing statu-
tory authorizations. NEPA regulations, which were
issued in 1978, focused on procedural provisions to
ensure that decisions about federal actions are made
only after the environmental consequences of the ac-
tions are fully considered and that the public ben-
efits of the actions outweigh their environmental costs.
These regulations are generally consistent with the
focus of the Framework.
In addition to procedural requirements, NEPA es-
tablished six objectives for all federal programs: respon-
sibility for the future; environmental equity; beneficial
use; historical, cultural, and biological diversity and in-
dividual liberty, widespread prosperity; and manage-
ment for quality and conservation. The act requires all
federal agencies to use a "systematic, interdisciplinary
approach" to planning and decision-making that incor-
porates the "natural and social sciences and the envi-
ronmental design arts." An analysis by the Environmental
Law Institute concluded that these provisions have not
been implemented. Agencies could use these objectives
to approach problems in the integrated, contextual man-
ner envisioned in the Commission's Risk Management
Framework. CEQ should work with other executive of-
fices and the relevant federal agencies to craft guidance
for implementing these NEPA provisions.
52
-------
Recommendation 6: State and load regulatory
and public health agencies should use the Risk
Management Framework, as many already do to
some extent, to address watershed, airshed,
community, worksite, and indoor and outdoor
environmental problems using an integrated,
multimedia process with stakeholders.
We have given several examples of state and local
actions that have been taken to address problems in
a broad context with stakeholder involvement, such
as California's toxics air program and efforts in Mas-
sachusetts, New York, and New Jersey to integrate
regulatory actions. As in other areas oi government
endeavor, states and localites engaged in successful
integrated risk management projects can serve as cata-
lysts for federal initiatives. However, state and local
agencies often rely on federal models of regulation.
As a result, they, too, focus primarily on single pol-
lutants in single environmental media and on com-
mand-and-control approaches to regulation. State and
local agencies should increase their ability both ad-
ministratively and legislatively to implement the
Commissions Risk Management Framework.
Looking Ahead
The Commission's Risk Management Frame-
work is not a panacea. It can require substantial
time to implement and, in some cases, it might
lengthen, not shorten, the risk management pro-
cess. The ability to implement the Framework will
undoubtedly improve over time as more experi-
ence is gamed with its various aspects and as more
relevant information becomes available. For ex-
ample, more experience with and guidance for in-
cluding stakeholders is needed. Both agencies and
stakeholders need training to better understand
and discuss health and environmental risk issues.
Agencies and academic institutions must cooper-
ate to generate more and better exposure and tox-
icily data and methods lor assessing multiple and
cumulative risk>
As illustrated in this report, >ome aspei.t> ol the
Framework—such as stakeholder involvement and
multimedia analysis—already are in use to some ex-
tent. However, no risk management effort to date has
employed all aspects ol the Framework. Many of the
questions and concerns associated with implement-
ing the Framework will be clarified as it is applied
and evaluated. However, gaining experience with the
Framework can best be achieved if Congress and the
Administration work together to overcome the statu-
tory and administrative barriers described above.
In using this Framework, risk scientists and deu-
sion-makers will be embarking on an important new
era in risk management designed to make wise use of
limited risk management resources. As described
throughout this report, the Framework's advantages
include:
• Use of an integrated, holistic approach to make
risk management more efficient and effective
compared with the traditional chemical-by-
chemical, medium-by-medium approach to
characterizing individual risks.
• Identification and targeting of the most
important sources of risk by putting individual
problems into larger public health and
environmental contexts and addressing multiple
and cumulative risks.
• Emphasis on collaboration, communication, and
negotiation in an open and inclusive process
among stakeholders so that public values can
inform and influence the shaping of risk
management strategies. Stakeholder involvement
can help generate decisions that are more
pragmatic and more readily implemented than
decisions that are made without considering the
diversity of interests, knowledge, and technical
expertise represented among stakeholders.
.53
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Implementing the Framework
Capacity for iteration. As with the scientific
The Commission envisions the Framework to be
process itself, at any stage of the Framework, the far more useful and effective than traditional regula-
discovery of critical new information can change
conclusions and decisions and lead to
reformulation and revaluation of the problem at
hand.
tory approaches to solving common multimedia risk
problems.
54
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Resources
The following reports and organizations can provide additional information on
the conduct and application of risk assessment, risk management, and risk-based
decision-making.
Reports
Albert, R.E. 1994. Carcinogen risk assessment in the U.S.
Environmental Protection Agency. Critical Reviews in
Toxicology 24:74-85
American Industrial Health Council (A1HC) 1993
Ecological Risk Assessment: Sound Science Makes Good
Business Sense. Washington, DC
Arrow, K.J., Cropper, M.L., Eads, G.C., Hahn, R.W, Lave,
L.B., Noll, R.G., Portney, PR., Russell, M, Schmalensee. R.,
Smith, V.K., and Stavins, R.N. 1996. Benefit-Cost Analysis
in Environmental, Health, and Safety Regulation A
Statement of Principles. Sponsored by the Annapolis
Center, the American Enterprise Institute, and Resources
for the Future. Washington, DC
Association of Bay Area Governments (ABAC). 1978.
Environmental Management Plan for the San Francisco Bay
Area. Berkeley, CA
Burke, T.A., Shalauta, N.M., and Tran, N.L. 1995
Strengthening the role of public health in environmental
policy. Policy Studies Journal 23:76-84
Carnegie Commission on Science, Technology, and
Government. 1993. Risk and the Environment. Improving
Regulatory Decision-Making. New York, NY
Chess, C, Salomone, K.L., Hance, B.J., and Saville, A.
1995. Results of a national symposium on risk
communication: Next steps for government agencies. Risk
Analysis 15:115-125
Council for Excellence in Government. 1996. National
Public Opinion Survey. Prepared by Peter Hart and Robert
Teeter, Inc. Washington, DC
Faustman, E.M. and Omenn, G.S. 1995. Risk Assessment.
Chapter 4. In: C.D. Klaassen, ed. Casarett and Doull's
Toxicology. The Basic Science of Poisons. Fifth Edition.
McGraw-Hill: New York, pp. 75-88
Goldman, L.R. 199:>. Environmental risk assessment and
national policy: Keeping the process fair, effective, and
affordable. University of Cincinnati Law Review 63:1533-
1551
Health Effects Institute (HEIV 1996. The Potential Health
Effects of Oxygenates Added to Gasoline: A Review of the
Current Literature. A Special Report. Cambridge, MA
Goldstein, B.D. 1996 Risk assessment as an indicator for
decision making. In: Risks, Costs, and Lives Saved: Getting
Better Results from Regulation, ed Oxford University
Press. New York, NY
Ikeda, M. 1988. Multiple exposure to chemicals.
Regulatory Toxicolology and Pharmacology 8:414-421
Jasanoff, S. 1996. The dilemma of environmental
democracy. Issues in Science and Technology. Fall:63-70
Lave, L.B., Ennever, EK., Rosenkranz, H.S., and Omenn,
G.S. 1988 Information value of the rodent bioassay.
Nature 336:631-633
McGinnis, J.M. and Foege, WH. 1993. Actual causes of
death in the United States. Journal of the American
Medical Association 270:2207-2212
Morgan, M.G., Fischoff, B., Bostrom, A., Lave, L., and
Atman, C.J. 1992. Communicating risk to the public.
Environmental Science and Technology 26:2048-2056
National Academy of Public Administration (NAPA1. 1995.
Setting Priorities, Getting Results: A New Direction for
EPA. Washington, DC
National Commission on the Environment. 1992.
Choosing a Sustainable Future. World Wildlife Federation
Washington, DC
National Research Council (NRO. 1983. Risk Assessment
in the Federal Government: Managing the Process.
National Academy Press. Washington, DC
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Resources
National Research Council (NRC). 1988. Complex
Mixtures. National Academy Press. Washington. DC
National Research Council (NRC). 1989. Improving Risk
Communication. National Academy Press. Washington,
DC
National Research Council (NRC). 1993. Pesticides in the
Diets of Infants and Children. National Academy Press.
Washington, DC
National Research Council (NRC). 1994. Building
Consensus Through Risk Assessment. National Academy-
Press. Washington, DC
National Research Council (NRC). 1994. Science and
Judgment in Risk Assessment. National Academy Press.
Washington, DC
National Research Council (NRC). 1996. Understanding
Risk. Informing Decisions in a Democratic Society.
National Academy Press. Washington, DC
North, D.W, Selker, FK., and Guardmo, T. 1992.
Estimating the Value of Research: An Illustrative
Calculation for Ingested Inorganic Arsenic. Decision Focus
Inc. Report. Mountain View, CA
Office of Technology Assessment (OTA). 1995. Gauging
Control Technology and Regulatory Impact in
Occupational Safety and Health—An Appraisal of OSHAs
Analytic Approach. OTA-ENV635. Washington, DC
Omenn, G.S. 1996. Putting environmental risks in a public-
health context. Public Health Reports 111:514-516
Omenn, G.S. and Faustman, E. 1997. Risk assessment, risk
communication, and risk management In: R. Detels,
W Holland,]. McEwen, and G.S. Omenn, eds.
Oxford Textbook of Public Health. Third Edition.
Oxford University Press. Oxford, UK, pp. 969-986
Organization for Economic Cooperation and Development
(OECD). 1996. Environmental Performance Reviews:
United States. Paris, France
Presidents Council on Sustainable Development (PCSD).
1996. Sustainable America. A New Consensus for
Prosperity, Opportunity, and a Healthy Environment for
the Future. Washington, DC
Richards, M. 1993. Siting Industrial Facilities. Lessons
from the Social Science Literature. Presented at the Fifth
Annual International Conference of the Society for the
Advancement of Socio-Economics. Environmental
Decision-Making. New York City. March 26-28
Ruckelshaus, WD. 1995. Stopping the pendulum The
Environmental Forum. Nov./Dec., pp. 25-29
Slovic, P 1987. Perception of risk. Science 236:280-285
U.S. Department of Energy (DOE). 1995. Risks and the
Risk Debate: Searching for Common Ground. Office of
Environmental Management. Washington, DC
U.S. Environmental Protection Agency (EPA). 1987. The
Total Exposure Assessment Methodology (TEAM) Study.
Summary and Analysis. EPA/600/6-87/002a. Office of Acid
Deposition, Environmental Monitoring and Quality
Assurance. Washington, DC
U.S. Environmental Protection Agency (EPA). 1987.
Unfinished Business: A Comparative Assessment of
Environmental Problems. Office of Policy Analysis.
Washington, DC
U.S. Environmental Protection Agency (EPA). 1990.
Reducing Risk: Setting Priorities and Strategies lor
Environmental Protection. Science Advisory Board. SAB-
EC-90-0021. Washington, DC
U.S. Environmental Protection Agency (EPA). 1992.
Guidelines for Exposure Assessment. Federal Register
57(May 29):22888-22938
U.S. Environmental Protection Agency (EPA). 1992.
Framework for Ecological Risk Assessment. EPA/630/R-92/
001. Risk Assessment Forum. Washington, DC
U.S. Environmental Protection Agency (EPA). 1992.
Safeguarding the Future: Credible Science, Credible
Decisions. Report of the Expert Panel on the Role of
Science at EPA. EPA/600/9-91/050. Washington, DC
U.S. Environmental Protection Agency (EPA) 1993. Motor
Vehicle-Related Air Toxics Study. Ann Arbor, Ml
U.S. Environmental Protection Agency (EPA). 1993. A
Review of Ecological Assessment Case Studies from a Risk
Assessment Perspective. Risk Assessment Forum. EPA630-
R-92-005. Washington, DC
U.S. Environmental Protection Agency (EPA). 1995.
Guidance for Risk Characterization. Science Policy
Council. Washington, DC
U.S. Environmental Protection Agency (EPA). 1996.
Proposed Guidelines for Carcinogen Risk Assessment. EPA/
600/P-92/003C. Office of Research and Development.
Washington, DC
56,
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U.S. General Accounting Office (GAO). 1996. Peer Review.
EPAs Implementation Remains Uneven. GAO/RCED-96-
236. Resources, Community, and Economic Development
Division. Washington, DC
Organizations
U.S. EPA Center lor Environmental Research Information
(CER1) Publications
26 West Martin Luther King Drive
Cincinnati, OH 45268
Phone Number: 513-569-7562
• Distributes brochures, reports, handbooks, newsletters,
and manuals based on the scientific and technical
environmental information produced by EPA
U.S. EPA Public information Center (PIC)
401 M Street. SW
Washington, DC 20460
Phone Number: 202-260-2080 or 202-260-7751
• Distributes a wide variety of general, nontechnical
information about EPA and its programs
USDA-ARS-HRS/MOB
Agriculture Resource Service
Human Resource Division
1400 Independence Avenue, SW
Stop 0308
Washington, DC 20250-0308
Phone Number: 202-720-6539
(or see your local directory for your local or county
extension agent)
• Provides education in wastewater and other
environmental subjects for local officials and residents.
International City/County Management Association
777 North Capitol Street, NE, Suite 500
Washington, DC 20002
Phone Number: 202-289-4262
• Provides information and training for local governments
on a variety of issues. Sets up peer matches for people to
learn from one another.
Northeast Center for Comparative Risk
Vermont Law School
P.O. Box 96
Chelsea Street
South Royalton, VT 05068
Phone Number: 802-763-8303
or
Western Center for Comparative Risk
5398 Manhattan Circle
Boulder, CO 80303
Phone Number 303-494-6393
• Both work with EPA to help states and cities use
comparative risk analysis. Can provide small communities
with publications on comparing environmental risks.
National Association of Towns and Townships
1522 K Street, NW
Washington, DC 20005
Phone Number: 202-624-3550
• Offers educational services, technical assistance
programs, and public policy support to local governments.
National Environmental Training Center
West Virginia University
P.O. Box 6064
Morgantown. YVV 26506
Phone Number: 800-624-8301
• Develops training materials on water, wastewater. and
solid waste issues.
Small Towns Environment Program
The Rensselaerville Institute
Rensselaemlle, NY 12147
Phone Number: 518-797-3783
• Helps small towns solve water and wastewater problems.
Provides tools for local action, self-help approaches to
design and construction, nonbureaucratic low-interest
loans, and technical support.
Solid Waste Association of North America
PO. Box 7219
Silver Spring, MD 20907
Phone Number: 301-585-2898
• Works to improve solid waste management sen-ices to
the public and industry via training, education, technical
assistance, and technology transfer. Also maintains
information on local government issues as they relate to
solid and hazardous waste management.
Control Technology Center (CTC) Hotline
Phone Number: 919-541-0800
• Provides technical support and information on air
pollution emissions and control technology.
Emissions Measurement Technical Information Center
Phone Number: 919-541-1060
• Provides information on air emissions testing methods
and federal testing and monitoring requirements.
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Resources
Air Risk Hotline
Phone Number: 919-541-0888
• Provides information on aspects of air risk.
National Response Center
Phone Number: 800-424-8802
• Receives notification of oil, hazardous chemical,
biological, and radiological releases, and passes them on to
a federal on-scene coordinator, who coordinates cleanup
efforts.
Resource Conservation and Recover)' Act (RCRA)/
Superfund/Emergency Planning and Community Right-to-
Know Act (EPCRA) Hotline
Phone Number: 800-424-9346 or 800-535-0202
or 703-412-9810
• Provides general assistance and information on solid and
hazardous waste management and on EPCRA.
Pollution Prevention Information Clearinghouse
Phone Number: 202-260-1023
• Provides technical, policy, programmatic, legislative, and
financial information about reducing industrial pollutants.
Clean Lakes Clearinghouse
Phone Number: 800-726-5253
• Provides information on lake and watershed restoration,
protection, and management.
Safe Drinking Water Hotline
Phone Number: 800-426-4791
• Assists public water systems and the public with their
understanding of the regulations and programs developed
in response to the Safe Drinking Water Act Amendments of
1986 Und is presumably updating information for the
reauthorized act).
Wetlands Information Hotline
Phone Number: 800-832-7828
• Responds to requests for information about the value and
functions of wetlands and options for their protection.
Inform, Inc.
120 Wall Street
New York, NY 10005
Phone Number: 212-361-2400
• Provides reports on practical solutions for problems in
municipal solid waste, chemical hazards, air quality, and
alternative vehicle fuels.
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Glossary
affected parties... Individuals and organizations acted upon by chemicals, radiation, or mi-
crobes in the environment or influenced favorably or adversely by pro-
posed risk management actions and decisions
alternative compliance... ...A policy which allows facilities to choose among methods for achieving
emission-reduction or risk-reduction specifications instead of command-
and-control regulations that specify standards and how to meet them. An
example of alternative compliance is the use of a theoretical bubble over a
facility to cap the amount of pollution emitted while allowing the company
to choose whe're and how within the facility it gets to or stays below the
cap.
attainment area ... ... A geographical area, such as a city, state, or regional airshed, that is meeting
EPA clean air standards.
benefit-cost analysis (BCA) An economic method for assessing the benefits and costs of achieving alter-
native health-based standards with dillerent levels of health protection.
collaborative stakeholder involvement Engaging interested and affected parties in the substantive work of risk
management, through all 6 stages of the Commission's Framework
command-and-control regulations Specific requirements prescribing how to comply with specific standards
defining acceptable levels of pollution.
Common Sense Initiative A current EPA initiative that convenes teams of stakeholders in six major
industrial sectors— automobile manufacturing, computers and electron-
ics, iron and steel, metal finishing, petroleum refining, and printing—to
find comprehensive and feasible strategies to reduce pollution.
contaminants Chemicals, microorganisms, or radiation found in air, soil, water, or food
that are not normally constituents of these environmental media.
context Here refers to public health and ecological assessment of the contribution
of any particular environmental hazard to health, safety, or the environ-
ment.
cost-effectiveness analysis (CEA) An economic method to identify the least costly way to achieve a particular
health protection goal.
cumulative Enlarging or increasing by successive addition.
disease incidence The rate of new occurrences of a disease.
exposure-response relationship The relationship between exposure level and the incidence of adverse ef-
fects.
ecological risk assessment A process used to estimate the likelihood of adverse effects on plants or
animals from exposure to stressors, such as chemicals or the draining of
wetlands. The process includes problem formulation, characterization of
exposure, characterization of ecological effects, and risk characterization.
economic analysis An analysis in monetary values of the costs and benefits of various actions
to protect health or the environment.
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Glossary
end of the pipe ... Relying on technologies, such as scrubbers on smokestacks and catalytic
converters on vehicle tailpipes, to reduce emissions of pollutants after they
have formed.
environmental justice .. ...Concern about the disproportionate occurrence of pollution and potential
pollution-related health effects affecting low-income, cultural, and ethnic
populations and lesser cleanup efforts in their communities.
epidemiology The core public health science, investigating the causes and risk factors of
disease and injury in populations and the potential to reduce such disease
burdens.
equity Just, fair, and impartial treatment of all people and population groups, in-
cluding low-income, cultural, and ethnic populations potentially more af-
fected by pollution.
exposure assessment Determination of the sources, environmental transport and modification,
and fate of pollutants and contaminants, including the conditions under
which people or other target species, could be exposed and the doses that
could result in adverse effects.
exposure pathway The path from sources of pollutants via air, soil, water, or food to reach
people and other potentially affected species or settings.
hazard A source of possible damage or injury.
interdependence Mutual dependence.
iterative process Replication of a series of actions to produce successively better results, or to
accommodate new and different critical information or scientific inferences.
life cycle Tracking a product through all stages of its development, from extraction of
luel for power to production, use, and disposal.
maximum available control technology (MACT) The emission standard for sources of air pollution requiring the maximum
reduction of hazardous air pollutant emisssions, taking cost and feasibility
into account. Under section 112 of the Clean Air Act Amendments of 1990,
the MACT must not be less than the average emission level achieved by
controls on the best performing 12% of existing sources, by category of
industrial and utility sources.
multimedia approach A process for considering several environmental media, such as air, water,
and land, together, rather than in isolation.
multiple risks Risks from several sources or many agents.
options Choices of actions.
peer review Evaluation of the accuracy or validity of technical data, observations, and
interpretation by qualified experts in an organized group process.
precautionary principle Decisions about the best ways to manage or reduce risks that reflect a pref-
erence for avoiding unnecessary health risks instead of unnecessary eco-
nomic expenditures when information about potential risks is incomplete.
60,
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Project XL .. ... An EPA initiative to give MS of 1996) six Companies ilntel. Anheuser Buseh.
HADCO, Merck, AT&T Microelectronics, and 3M ' and two government
agencies (California's South Coast Air Quality Management District and the
Minnesota Pollution Control Agency) the flexibility to develop comprehen-
sive strategies as alternatives to multiple current regulatory requirements to
exceed compliance and increase overall environmental benefits
public health context The incidence, prevalence, and seventy of diseases in communities and popu-
lations and the factors that account for such problems that can be reduced
or prevented, including smoking, alcohol consumption, poor diet, motor
vehicle accidents, infections, chemical exposures, and other common vol-
untary and involuntary exposures or activities.
public health approach ... Focuses on effective and feasible risk management actions at the commu-
nity level to reduce exposures and risks, with priority given to reducing
exposures with the biggest impacts in terms of the number of people af-
fected and severity of effect.
residual risk . The health risk remaining after risk reduction actions are implemented, such
as risks associated with sources of air pollution that remain alter the imple-
mentation of maximum achievable control technology.
risk .. The probability of a specific outcome, generally adverse, given a particular
set of conditions.
risk assessment An organized process used to describe and estimate the likelihood of ad-
verse health outcomes from environmental exposures to chemicals. The four
steps are hazard identification, dose-response assessment, exposure assess-
ment, and risk characterization.
risk characterization . The process of organizing, evaluating, and communicating information about
the nature, strength of evidence, and likelihood of adverse health or ecologi-
cal effects from particular exposures.
risk management The process of analyzing, selecting, implementing, and evaluating actions to
reduce risk.
screening risk assessment A risk assessment performed using few data and many assumptions to iden-
tify exposures that should be evaluated more carefully for their potential
risks.
toxicity The adverse effects of chemicals on living organisms.
value of information Value-of-information techniques provide an analytic framework for decid-
ing whether it is better to make a decision now based on an inherently un-
certain risk assessment as to collect additional information first and then
decide.
weight of the scientific evidence Considerations involved in assessing the interpretation of published infor-
mation about toxicity—quality of testing methods, size and power of the
study design, consistency of results across studies, and biological plausibil-
ity of exposure-response relationships and statistical associations.
61
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62,
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Appendix
Table of Contents for Volume 2 of
the Commission's Final Report
Executive Summary
1. Introduction
2. Framework for Environmental Health Risk Management
3. Risk Management and Regulatory Decision-Making
Communicating and Comparing Risks
Identifying Risk Communication Needs
Communicating About Risk by Comparing
Different Kinds of Risk
Need for a Common Metric
Comparative Risk Analysis for Risk Management
Priority-Setting
Risk-Based Priorities and Resource Allocation
Strategies for Managing Risk
Risk Management Options: Alternatives to
Command and Control
Bright Lines and Regulatory Standards for Risk
Management
Judicial Review of Regulatory Decisions to Manage Risk
Premature Interruption of the Administrative
Process
The Nature and Extent of Judicial Review
Standard for Judicial Review
Alternatives to Increased Judicial Review
4. Uses and Limitations of Risk Assessment for Risk
Management Decision-Making
Toxicity Assessment
Using Rodent Tests to Predict Human Cancer Risk
Evaluating Chemical Mixtures
Exposure Assessment
Design of Exposure Assessments to Meet Risk
Management Goals
Using Realistic Exposure Scenarios
Identifying High-Risk Populations
Ecological Risk Assessment
Environmental Hazards Other Than Chemicals
s from Radiation Hazards
Risks from Microorganisms
Risk Characterization
, Effective Risk Characterization to Support
Decision-Making
Characterizing the Uncertainty Associated with
Risk Estimates
Value of Obtaining Additional Information
5. Uses and Limitations ot Economic Analysis for Risk
Management Decision-Making
Benefit-Cost and Cost-Effectiveness Analysis
Useful Roles in Regulatory Decision-Making
Distributions of Costs and Benefits
Uncertainty and Inconsistency in Economic Analysis
Characterizing the Uncertainty Associated with
Cost and Benefit Estimates
Inconsistencies in Monetary Valuation of Benefits
Linking Risk Assessment and Economic Analysis
6 The Role of Peer Review in Regulator)- Decision-Making
Improving the Quality of Regulatory Decisions
The Conduct and Effectiveness of Peer Review
Evaluating the Use of Peer Review and of Scientific and
Economic Analysis in Regulatory Decision-Making
7. Recommendations for Specific Regulatory Agencies and
Programs
Environmental Protection Agency
Office of Air and Radiation
Superfund
Office of Prevention, Pesticides and Toxic
Substances
Office of Water
Occupational Safety and Health Administration
Food and Drug Administration
Department of Agriculture
Department of Energy
Department of Defense
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Contents of Volume 2
References A.5 Individuals who provided comments on the
Glossary Commission's June 1996 Draft Report
Appendices A.6 Abstracts of Reports Prepared at (he Invitation of the
Commission
A.I Biographies ol Commission Members
A.7 Federal Agency Risk Assessment and Risk
A.2 Mandate ot the Commission ..
Management Practices
A. 3 Comments on Science and judgment in Risk Assessment
A.4 Individuals and Organizations Who Presented
Testimony at Commission Meetings
64,
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