New Directions Workshops Identifying Information Needs
for Risk Managers Series
Identifying Information Needs for
Risk Managers
Summary Report
for the Workshop Series
June 15-16,1999
Information Needs for Risk Management Decision Making
July 14-15,1999
Communication and Stakeholder Involvement in the
Risk Management Process
Preparedfor
Office of Science Policy
Office of Research and Development
U.S. Environmental Protection Agency
Washington, DC 20460
September 1, 1999
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New Directions Workshops — Identifying Information Needs
for Risk Managers Series
Workshop I:
Information Needs for
Risk Management Decision Making
Summary Report
Preparedfor
Office of Science Policy
Office of Research and Development
U.S. Environmental Protection Agency
Washington, DC 20460
September 1, 1999
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Executive Summary
The two workshops that comprised the ORD-sponsored series, Identifying Information
Needs for Risk Managers, held in June and July of 1999, provided opportunities for EPA
managers and staff to engage in a cross-agency dialogue on informing the risk management
decision-making process. The two workshops addressed four general topic areas.
• Risk management paradigms/models
• Information needs for risk managers
• Risk assessor-risk manager communication
• Stakeholder involvement in decision making
Workshop participants discussed these topics within two related contexts: (1) informing the
decision-making process by bringing all relevant information to bear on decisions, and (2)
identifying research opportunities to meet currently unaddressed or future information needs.
Risk Management Paradigms/Models
After reviewing and discussing several diagrammatic representations of the risk
management process, including models developed by the Presidential Commission on Risk
Assessment and Risk Management and ORD's National Risk Management Research Laboratory,
workshop participants indicated that a simple model could provide a useful, if not complete,
representation of the risk management process. The utility of such a model would be two-fold.
First, it would provide managers with a checklist of information sources and input points, and
would identify interactions between actors in the decision-making process. Second, a model
would help ORD identify what types of information/research/data are needed, where or from
whom to obtain this information, and at what points in the process such information would be
most useful to decision makers. To be realistic and useful, a model must also capture the
iterative nature of the risk management process and identify key communication pathways.
STATUS OF THIS REPORT
The objective of this workshop (or workshop series) was to bring together EPA scientists from
the regions, programs, and ORD labs and centers to discuss issues of common interest. The
focus of the meeting (or each meeting) was preliminary discussion among scientists and
managers from different parts of the Agency, each with their individual and office-specific
information and viewpoints.
As a result, it is important to understand that this report summarizes individual and program-
specific perspectives. References to pre-existing Aaencv information and policies should be
credited as such, but none of the individual workshop statements or summaries in this report
should be credited or cited as Agency information or policies. Rather, this report is developed
exclusively for internal EPA use and distribution as a record of the meeting for participants in
each meeting, and for EPA's use in planning future meetings and discussion. EPA staff will use
information from this report, as appropriate, to design and conduct workshops or other
activities for broader discussion both within EPA and with external participation, again as
appropriate.
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Information Needs
Panel discussions by senior EPA managers, case study presentations by agency staff, and
break-out and plenary discussions by workshop participants identified many types of non-risk-
assessment information that factor into decision making at EPA. Such information includes
technical feasibility and effective alternatives, the real transaction costs of a decision and
resource burdens on the agency, legal issues and statutory mandates, and equity/fairness, to name
just a few. In many cases, the risk manager is not an EPA official, but rather someone from a
state or local government, the business community, or the general public. The importance of
non-risk-assessment information is growing, as stakeholders become more involved in agency
decisions and EPA increases its use of non-regulatory approaches to risk mitigation. For the
program and regional offices, this means viewing risk assessment as but one of many factors
used to formulate a decision or communicate a concern. For ORD, the growing importance of
non-risk information points to a possible need for more social science research; it also suggests
that, increasingly, the users of ORD research may reside outside the agency.
Communication between Risk Assessors and Risk Managers
When risk assessment is part of the decision-making process, the quality of the decision
may hinge on how well the risk assessor and risk manager communicate. Workshop participants
noted the importance of early collaboration—planning and scoping and conceptual model
development were cited as means to effect early risk assessor-risk manager interaction. While
front-end communication between assessors and managers is important, sustained interaction is
essential. By establishing feedback loops and communication milestones throughout the
decision-making process, risk assessors and risk managers can clarify expectations, discuss
preliminary findings, and work together to solve problems in a manner that addresses both
science and policy issues.
A unified paradigm or model of the risk management process in general, and of
information needs in particular, would be useful in facilitating and enhancing communication
between risk assessors and risk managers. If both parties share a common understanding of the
process, they are more likely to agree on the expectations for each person's contribution to the
decision; assessors and managers would also better comprehend the information they receive
from one another, since the model would illustrate the context within which the information was
developed.
Stakeholder Involvement
Stakeholder involvement is becoming a regular way of doing business for EPA's
programs and regions, and must be included in any discussion of informing the agency's
decision-making process. Stakeholder involvement requires careful preparation, and is both time
consuming and resource intensive. However, decisions made with stakeholder input are not only
likely to be better decisions, but may be viewed more favorably by interested parties and be less
vulnerable to legal or other challenges. So long as EPA follows through with its commitments to
stakeholders, their continued involvement can over time build greater public trust in agency
decision making.
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For any particular decision, the appropriate role of stakeholders—be it exchanging
information, developing recommendations, or participating in joint decision making—should be
determined early on and sustained past the decision point through the evaluation stage. An
implication for the development of a risk management paradigm or model, then, is the need to
determine points in the risk management process where stakeholder interaction should take
place, given the nature of the particular risk issue and the extent/type of stakeholder involvement
being considered.
Conclusions
Workshop participants did not come to consensus on a preference for any particular
paradigm or model of the risk management process. However, it is clear that none of the current
models adequately addresses the many different information and communication issues discussed
at the workshops. Nor did participants identify specific potential research areas related to
paradigms, information needs, communication, or stakeholder involvement. Nevertheless, the
rich discussion of these issues, reflected in the body of this report, suggests that the area of
information needs is fertile ground for developing new risk management research topics.
Path Forward
While there are many important points made within the body of the report that deserve
additional attention, follow-up actions and a time line for next steps have not been finalized. The
intent over the next several months is to refine the salient elements of the two workshop
proceedings, possibly in a white paper, for further discussions with EPA's Program and Regional
Offices, and the Science Advisory Board. In addition, stakeholders may be consulted to gain
insights on the risk management process from outside of the Agency. Ultimately, an improved
process for making risk management decisions will be of importance not only to EPA, but also to
those involved hi human health and environmental decisions at the state, community, and tribal
levels.
This report was prepared for the Office of Science Policy, Office of Research and Development, U.S.
Environmental Protection Agency, by S. Cohen & Associates, Inc., 1355 Beverly Road, Suite 250, McLean, VA
22101, and Environmental Management Support, Inc., 8601 Georgia Avenue, Suite 500, Silver Spring, MD
20910, under contract number 68-D5-0132, work assignment III-8. For futher information, please contact
Gerardo Pascual at 202-564-2259.
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Table of Contents
Preface [[[ Page vi
1. Introduction
2. Panel Discussions [[[ Page 2
2.1 Media Program Office Information Needs ............................ Page 2
2.2 Cross-Media and Regional Office Information Needs .................. Page 10
3. Presentations [[[ Page 15
3.1 Evolution of the Risk-Management Paradigm ........................ Page 15
3.2 A Few Thoughts on Risk Analysis and Risk Management .............. Page 16
4. Paradigm Review and Development ....................................... Page 19
4.1 Evaluating the Paradigms, Part One ................................ Page 19
4.2 Case Study Presentations - Information Used to Inform Risk-Management Decisions
[[[ Page 26
4.3 Evaluating the Paradigms, Part Two ................................ Page 31
5. Wrap-Up Activities [[[ Page 37
5.1 Summary of Issues and Action Items ............................... Page 37
5.2 Preview of Next Workshop ....................................... Page 38
Appendices
Appendix A. List of Participants A-l
Appendix B. Agenda B-l
Appendix C. Guidance to Presenters C-l
Appendix D. Risk-Management Models D-l
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Preface
EPA's Office of Research and Development (ORD) is currently pursuing new approaches for
using science to address several topics of importance to the Agency. These topics represent new
directions for EPA in that they transcend the traditional media- or pollutant-based boundaries and
encompass a variety of disciplines and specialities. ORD wishes to link EPA staff interested in
these topics with the appropriate science staff hi ORD to identify areas for collaboration. To
accomplish this goal, ORD's Office of Science Policy (OSP) is hosting a series of New
Directions workshops between March 1999 and Spring 2000. The workshops will provide a
forum to present information and discuss current and future issues on new topics of interest.
There are four topic series being presented under the auspices of New Directions: risk
management, community assessment, reinvention, and regional science. Each topic series will
consist of three or four workshops designed to bring interested staff together to develop a set of
action items that will be completed over the course of the series.
The Risk Management workshops are designed to identify the types of information, such as
costs and benefits, technological feasibility, community values, and other non-risk assessment
information, that EPA managers need and use to inform their risk-management decisions. This
summary describes the first workshop, held June 15-16,1999 in Washington, DC; a second
workshop was held July 14-15 to discuss communication and stakeholder involvement in risk
management. A third meeting may be held, if deemed necessary. The desired outcome of the
series is a review and analysis of risk-management processes and information needs for use in the
development of a draft unified paradigm for organizing and providing information to risk
managers.
The first workshop, Developing Information Needs for Risk Management Decision-Making,
took the following approach to: (1) Obtain the perspectives of senior managers in the media
program offices, cross-media offices, and regional offices on the kinds of information they need
to make risk-management decisions; (2) Present work currently being done in ORD and
elsewhere on the information-needs aspects of the risk-management paradigm; (3) Examine case
studies that offer detailed descriptions of information used to make risk-management decisions;
and (4) Use break-out groups to review, evaluate, and recommend improvements to the current
draft paradigms/models for providing information to risk managers.
This report summarizes the information that was presented and exchanged during the
workshop. The organization of the report follows the agenda of the workshop. Approximately
65 senior EPA staff, representing EPA program offices, ORD, and several Regions, participated;
Appendix A provides a complete list of participants. The two-day workshop was designed to
maximize participant input and collaboration; Appendix B is a copy of the final agenda.
Appendix C provides the instructions to presenters, while Appendix D includes copies of the
models discussed. Finally, Appendix E gives transcriptions of flip charts and posters produced
during the breakout group discussions.
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1. Introduction
The New Directions initiative and the Risk Management series were introduced in a
presentation by Timothy Oppelt of EPA's Office of Research and Development (ORD). New
Directions workshops are intended to bring EPA scientists, analysts and managers together to
discuss how new approaches to environmental protection are being addressed across the Agency.
Workshop sponsors believe that these discussions will produce cross-agency linkages that will
strengthen science at EPA by fostering collaboration and coordination of scientific issues that
cross traditional program and media boundaries.
EPA's Office of Science Policy (OSP) has identified community assessment, regional
science, reinvention, and risk management as workshop series subject areas. While these four
areas may not cover all the new science directions that EPA is taking, they encompass a wide
range of cross-program and cross-media science issues that may serve as potential workshop
topics. Each series will be comprised of three to four topic-specific workshops.
With this particular workshop, ORD is seeking to understand how to improve the information
managers use to support risk-management efforts throughout the Agency. Current risk
management decision-making processes include analyzing information about technical
feasibility, performing cost-benefit analyses, and performing a variety of tasks to assess
community values. ORD seeks to define what further information a risk manager uses to inform
his or her risk-management decisions and to answer questions about how participants, such as
States and various stakeholders, fit into the risk-management process.
Environmental protection is moving in new directions. As science has significantly advanced
our understanding of single-source environmental hazards to humans and the environment,
attention is now turning to the complexities and uncertainties associated with the impact on
health and ecosystems that may result from exposure to multiple pollutants through multiple
pathways. Thus, an additional goal of this workshop was to evaluate the usefulness and
completeness of present risk-management models and to consider new models to work with
evolving questions, such as assessing the impacts of pollutants across different media.
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2. Panel Discussions
Presenters for the panel discussion segment of the workshop were guided by workshop
organizers to discuss the kinds of information needed to make risk-management decisions in
their particular program office, how that information is used, and what kinds of information
would improve their work. The workshop document Guidance to Presenters can be found in- -
Appendix C. Presenters were directed to address the following questions:
• What kinds of non-risk assessment information (e.g., economic; science, other than hazard
and exposure data; technological feasibility; environmental justice) does your program
consider when making a risk-management decision?
• How is such information factored into the decision-making process?
• How does your program obtain this information?
• Do statutory mandates encourage or limit the consideration of such information. If so, how?
• We are all familiar with the uncertainties inherent in risk assessment. What comparable
uncertainties on the risk-management side could be reduced if more information were
available to decision-makers?
• Under ideal circumstances, what information, beyond what is currently available to you,
would you consider valuable to inform your program's decisions?
The first panel discussed the information needs of the media program offices, while the
second examined the information needs of the cross-media and Regional offices. Panel
presentations and group discussions are summarized below.
2.1 Media Program Office Information Needs
2.1.1 QAOPS/OAR Risk-Management Information Needs (Sally Shaver - OAQPS/OAR)
Sally Shaver opened the panel discussions by summarizing the activities of the Office of Air
Quality Planning and Standards (OAQPS). According to its authorization, Clean Air Act (CAA)
Sections 109 and 112, EPA's air program was intended to be strictly based on risk. The Act
mandated that the Agency consider health and welfare alone in risk management decision-
making; costs were not to be considered. Before 1990, therefore, regulation of air toxics was
based on risk and the lack of widely accepted tools and data hindered early efforts. As a result, a
limited number of standards were promulgated. However, with the promulgation of the 1989
Benzene rule, OAQPS started to make progress. The Benzene rule set a strong precedent in
demonstrating how to set risk-based standards.
The basis of considerations for risk management changed with the 1990 CAA Amendments.
Under these Amendments, 188 stationary-source Hazardous Air Pollutants (HAPs) were listed
for regulation under technology-based Maximum Achievable Control Technology (MACT)
standards by 2002. During the Residual Risk Program phase, which will begin eight years after
MACT standards have been in place, the CAA Amendments encourage consideration of an
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"ample margin of safety" in risk management decision-making. This means that many factors
other than health risk, such as cost, impact on industry, and who is impacted by exposures, can
now be considered.
Currently, OAQPS has completed half of the work of setting MACT standards for the 188
stationary-source HAPS. In addition to the remaining HAPs, OAQPS is also evaluating the need
to regulate mercury from coal-fired utilities. The Office is studying the deposition of mercury to
waters covered in the Great Waters Program. Further, Urban Air Standards have been expanded
to include mobile sources and OAQPS is mandated to achieve a 75% reduction in the incidence
of cancer risk from these sources.
Under the MACT program, cost and other factors may be considered in risk determinations
with technology-based standards. Eight years after MACT promulgation, residual risk standards
are to be considered. OAQPS is designing an assessment for three more categories to determine
if there is a need to regulate. These three categories are:
• Linear carcinogens.
• Nonlinear carcinogens (i.e., one for which there may or may not be a safe exposure level) and
non-carcinogens.
• Ecological risk (which is being developed as an interagency effort).
The statutory mandates discussed above both limit and encourage the uses of non-risk
assessment information. The CAA Amendments mandate that OAQPS use the "ample margin of
safety" framework put in place before 1990. The "ample margin of safety" considers a balance of
health risk information with other considerations, such as economics, technical feasibility, and
population-related information. Non-risk assessment information considered by OAQPS during
the risk-management process includes:
• Technical feasibility - Can technology reasonably be expected to be a control mechanism?
• Cost - Are control costs reasonable in comparison with health benefits expected?
• Industry impacts and potential job losses - Will the regulated industry be damaged
economically by the regulations?
• Subpopulation impacts - Which populations are being exposed to HAPs and at what levels?
• What is the total number of people exposed to specific risk levels?
OAQPS obtains the information it uses for risk-management decisions from internal EPA
databases; State, regional, and Federal agency sources; industry (both voluntarily and during
compliance negotiations); and other stakeholders. OAQPS also conducts its own analyses.
Residual risk is considered in the "ample margin of safety" step of risk assessment. This allows
OAQPS to develop health standards that are more stringent to increase public health protection
balanced against other considerations and use ecological cost and effects information to justify
decisions.
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Uncertainties in performing risk management with regard to costs could be reduced by
having more information about costs and impacts, as well as by having current economic
information validated by further research and testing. In addition, more information is needed to
determine the true impact of regulations on industry. Uncertainties in health risk assessment
could be reduced further by obtaining better human health risk information and addressing the
quality control of the data. Although some data exist for carcinogens, non-carcinogens have not
been addressed rigorously. Uncertainty could also be reduced by better understanding the
contribution of sources to cumulative risks. EPA still does not have the tools to look at
cumulative risk from combined sources in air (known as "air soup") and the effects of multi-
media exposures.
OAQPS does not regulate indoor air; however, by regulating pollutants in outdoor air, indoor
air quality is improved, since indoor air is ventilated using outdoor air. Clean outdoor air and
properly ventilated buildings therefore help maintain good indoor air quality.
2.1.2 Pesticide Management Risk Assessment (Marcia Mulkey - OPP/OPPTS)
EPA's Office of Pesticide Programs (OPP) makes a high number of risk decisions in the
assessments it conducts each year as it evaluates new chemicals, new uses proposed for known
chemicals, and emergency registration uses. OPP also analyzes chemicals made before 1984.
Unlike some programs, OPP does not lack data. Information for risk management decision-
making comes from an in-house, robust and comprehensive chemical database, with some
database information supplied by formulators. OPP also has good chemical usage data.
OPP operates under the statutory authority of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). The Office also operates under the Food Quality Protection Act,
which is not a risk benefit statute. This statute directs that there be a "reasonable standard of no
harm" used in considerations and is used to decide when to regulate. In risk assessment decision-
making, the Food Quality Protection Act mandates that OPP aggregate all public exposure
sources and perform cumulative risk assessment for pesticides.
The kinds of enhanced or new data that would help OPP better perform pesticide risk-
management assessments include non-risk related data, such as stakeholder polling. Ideally, this
effort would define who the stakeholders are for a given effort, what their opinions are, and how
and at what levels the Agency should engage stakeholders in the risk-assessment process.
Additionally, OPP could benefit from more information about the real transaction costs of
performing Agency business in pesticide risk management. For example, OPP needs ways to
ascertain how much political involvement will be required in a given risk-assessment transaction.
Even in a costftenefit analysis, the risk assessor needs to understand the context of the issue,
including the influence of interest groups. To be successful, the Office needs to have a realistic
expectation of the resource commitment that will be required by political involvement. OPP
needs better political information and expertise, but the method of developing this kind of
information is not clear. One starting point might be research into the intensity of feelings about
pesticide issues.
OPP also needs to have information about other resource burdens associated with a given
risk-management decision. It would be useful to have information about total economic costs,
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including a true quantification of externalities. For exairiple, promulgating a complex rule means
that resources will be committed to explaining it for the following five years. A true cost
accounting would allow risk managers to evaluate whether these resource requirements are best
used to achieve a relatively small reduction in risk. Small gains may warrant the resource
commitment, but OPP must know the burdens to make conscious risk-management decisions.
Information about the results of risk-management decisions can be gathered through
enforcement data. However, those who write the standards and those with the ability to
implement and enforce them are not the same. This results in a lack of ownership of standards
enforcement once standards are promulgated. There should be a tight feedback loop to ensure
that EPA promotes coordination between regulators and enforcers.
The issue of marketplace fairness also factors into the risk management decision-making
process. Agency efforts can rapidly distort the marketplace, depending on the .impact of
regulations. OPP tries to maintain a level playing field among industries. Eco-justice is
essentially an issue of redressing past unfairness, endeavoring to be fair in the present, and
striving not to create future distortions. Further considerations factored into decision-making are
geographical and international fairness. It would be helpful to develop sources of information
about our stakeholders aside from that provided by Washington lobbyists, who can give a
distorted view. OPP has benefitted from communicating in other ways. For example, OPP has
successfully approached the fifteen research and development pesticide companies that make up
a large part of the regulated community, to explain Agency actions and to gather information.
Risk management requires a great deal of information to enable conscious decision-making and
the factors discussed above are as important as the hard science issues to the success of OPP.
Science information needs include better understanding of safety factors, such as the
limitations of extrapolating risk from laboratory animals to humans and the implications of
single-gender data. Data quality within OPP would benefit from more data about ecological
effects, such as population level impacts in ecosystems, and not simply human effects. To
calculate risk precisely, risk assessors need to know sensitivity endpoints in the ecosystem.
Group discussion focused on the effect of the mandate to reassess pesticides in food under a
tight time line. To address this mandate, OPP chose to address the worst situations first. Now,
OPP is considering the remaining substances, as well as cumulative effects, under a tight
deadline. This has a higher degree of difficulty than the Office's earlier efforts.
The cumulative risk process in OPP involves an evaluation of a cluster of pesticides that
operate across media. This is different from considering mixed sources, such as "air soup," which
is a mixture of sources operating within the same media. The SPC Cumulative Risk
Subcommittee is now assisting the Agency in addressing these types of issues.
2.1.3 Risk Management in OSW (Elizabeth Cotsworth - OSW/OSWER)
The risk-management issues faced by the Office of Solid Waste's (OSW) program are similar
to those encountered by the other programs presented above. The waste program uses risk
assessment to designate what portion of the waste stream should be dealt with as hazardous
waste. Kinds of risk-assessment information considered during these determinations include:
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• Legal
• Ecological
• Treatment factors or the effects of technology in the disposal process
• Cost
OSW first determines if there are other statutes and regulations that will address the waste in
question. If not, specific OSW risk-management considerations include the potential for future
changes in conditions, such as the failure of a landfill liner, cover, or managed systems. The
OSW risk-management process takes into account hydrological changes, with the overall goal of
using information to think through risk-management decisions consciously.
The implementation factors important to OSW are compliance and enforceability. Flexibility
in permitting does present difficulty for enforcers; in fact, in one case, a contingent management
approach was dropped due to this difficulty. However, OSW is still carefully using contingent
management approaches in some cases. OSW also takes into account State and Resource
Conservation and Recovery Act (RCRA) program implementation and enforcement input. OSW
endeavors to create simple scenarios for the States that can be implemented with the resources
actually available.
Potential vulnerability to legal challenges is a factor in OSW risk assessment. For example,
RCRA standards must be based on scientific studies to estimate toxicity. In risk management
decision-making, OSW endeavors to track changes to previous decisions so that these changes
can be defended and that any precedents that are set are done so consciously. Statutory mandates
are a limitation for OSW risk management because of the demands of deadlines. Time
limitations sometimes affect the gathering of information needed to inform risk management
decision-making.
In the areas of economics and technology, OSW is not mandated to look at cost in risk
assessment. However, cost is considered in cost-benefit analyses. In the Hazardous Waste
Combustion rule, cost-benefit factors are explicitly detailed. In cost-benefit analyses, OSW
considers small business impacts and evaluates the potential for plant closings. The effects of
treatment or technological factors are also considered in risk management decision-making. The
RCRA "land ban" section mandates that EPA think about using technology by constituent and
type of waste.
Group discussion centered on defining how OSW evaluates the impact of decisions and
transfers knowledge about its program in-house. While OSW has not created a diagram or
flowchart of the risk-management process it follows, risk managers work from anecdotal oral
histories and mentors teach new people. OSW has recently begun an effort to improve program
planning, scheduling, and documentation of risk-management decisions for future reference.
2.1.4 Information Needs for Risk Management Decision-Making (A Wetlands Manager's
Needs) (John Meagher - OWOW/OW)
Authorized by the Clean Water Act (CWA), the wetlands program is working with many of
the same risk factors that have been discussed above, including transaction costs. EPA's Office
of Wetlands, Oceans, and Watersheds (OWOW) is developing the science of wetland protection
and can help partners in the States and in industry who actually implement wetlands protection
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work. OWOW activities rest on the basic premise of watershed management, which changes the
program from previous end-of-pipe approaches to the present focus on non-point sources.
OWOW believes that the program must involve all stakeholders in integrating environmental
resources and diverse land uses in a manner that balances ecological, social, and economic needs.
OWOW uses many kinds of non-risk information to evaluate potential pollutant impacts. -
This includes defining what roles individual and collective wetlands play in the life of a
watershed and performing "environmental sociology." This refers to gathering information
regarding the overall ecological, social and economic goals of stakeholders. Other non-risk
considerations factored into decision-making include environmental justice, economic feasibility,
archaeology, historic and tribal sites, and local zoning ordinances.
Additionally, OWOW identifies and evaluates alternative sites and strategies for corrective
actions that can reduce environmental impacts. OWOW risk managers consider whether it is
economically feasible to move projects and evaluate engineering methods to minimize impacts.
Because wetlands damage can potentially be offset by creating a new environmental function
elsewhere, OWOW collects information to evaluate potential wetlands replacements.
OWOW considers economic feasibility by looking at methods that will increase the success
of restoration, such as aggregating restoration in a watershed using mitigation banking. To use
these kinds of compensatory tools, OWOW develops information about where to locate a created
wetland within a watershed; what types of restorations are priorities; and what performance
criteria are appropriate for the restoration site. OWOW also makes determinations, such as
feasibility analyses, to determine whether alternatives are economically and logistically possible.
Stakeholders bring information to the risk-management decision-making process at all
phases; participation is encouraged at every stage, from plan selection to iterative actions during
which data-gathering occurs, to monitoring, and finally to management for the long term.
Statutory mandates encourage the consideration of these kinds of non-risk information by
giving OWOW management tools and authority. The Clean Water Act (CWA), local ordinances
and financial incentives help to reduce or offset impacts. Section 404 of the CWA, for example,
states that no discharge of dredged or fill material can be permitted if a practicable alternative
exists that is less damaging to the aquatic environment, or if the Nation's waters would be
significantly degraded. Section 404 also calls for alternatives analyses to either avoid or
minimize impacts, or require compensation for unavoidable impacts. Such mandates can be
limiting, however. The Constitutional "takings" issue requires that the Government provide
compensation to private landowners before depriving them of the use of their land, which has
caused controversy with wetlands regulation. This presents a financial limitation on the
protection of privately held wetlands.
OWOW obtains risk-management data from EPA-intemal databases, the United States Dairy
Association, the United States Geographical Survey, State and local governments, and from
applicants to the regulatory program. Further kinds of information that would aid OWOW/OW in
making risk assessments include data about methods for predicting landscape development
trends, such as appropriate distances for setbacks; methods for implementing best management
practices; methods for determining width and kinds of buffer strips; and methods for restoring
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wetlands. OWOW is now using Geographic Information System data to make future projections
in these areas.
Information needs for performing Section 404 work include methods for evaluating and
rmnimizing the consequences of losing a given wetland, methods for developing alternatives to
proposed impacts, and methods for reducing the effects of wetland development on wildlife and
water quality, including migratory corridors and habitats. OWOW also needs data about healthy
wetlands to define the healthy ambient levels for reference wetlands in different climates. The
Office of Research and Development could provide research on the science of wetlands creation
and methods for reducing risk from flooding.
Group discussion focused on issues of stakeholder involvement and influence. Given the
desire of people to live throughout watersheds, how can OWOW regulate against such strong
stakeholder pressure? While pressures are strong, there is an increasing recognition of the value
of wetlands. Wetlands themselves can be a marketing tool, as they represent open space for those
who would like to live in such an area. OWOW is working on forming relationships with the
insurance industry, which has an economic interest hi mitigating potential flood damage, to
defend regulations. The head of the Federal Emergency Management Agency (FEMA) is also
taking a strong interest in the wetlands issue, since it makes sense from planning, ecological, and
cost perspectives for the Federal flood insurance program.
2.1.5 Risk Management in the Effluent Guidelines Program (Bill Anderson - OST/0W)
The Effluent Guidelines Program, established under the Clean Water Act, resembles the
MACT program described in Section 2.1.1. Mandates guiding this program require that risk
evaluations consider technology-based standards along with economically-achievable results.
Industries or point sources regulated under this program are required to meet numeric limits.
Technological controls and remedies are not specifically designated, and the regulated
community can meet the numbers required in their permits in the way that they choose.
The Office of Water's (OW) Office of Science and Technology (OST) collects a broad array
of data to inform risk-based decision-making, including engineering, economic and
environmental information. Engineering data include the ages of facilities; proposed process
changes; best pollutant removal or process changes; evolving control technologies; energy usage;
and other information from stakeholders. Pollution-prevention principles are also considered and
were, for example, built into the Pulp and Paper Rules co-authored by OST. Some data is
acquired through permit disclosures, but not all of it While OST can collect any data needed,
decisions are made under a tightly scheduled consent decree. Because of this, outreach to
stakeholders to provide voluntary data is becoming more critical.
The economic factors considered for risk management include data about facility closures
and the potential for facility shutdown, as well as the Agency's exposure to litigation. According
to economic guidelines specified by Executive Order, rulemaking must incorporate a full
environmental assessment that includes cost-benefit analysis. However, the fact that economic
information is not to be used as an explicit criterion for decision-making poses a challenge to the
risk-management process.
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The environmental data collected includes information about fish kills and water use
warnings, water quality standards for a given area, human health impacts such as cancer
incidence, and reductions in biological systematic effects. To limit uncertainty as much as
possible, more data are needed on assessing impacts on the functioning of biological systems.
As discussed above, statutory mandates encourage consideration of many factors in the-risk
management decision-making process. The Paperwork Reduction Act, however, restricts the
Division from getting data from regulated facilities with reasonable speed.
Group discussion explored the economic feasibility of attaining zero-percent discharge,
concluding that it would be very difficult to achieve with reasonable cost. Older limits are not
based in reality on zero-percent discharge, because at this time it is not technologically possible
to achieve this limit. Therefore, using the Best Available Control Standards (BACT) is most
likely to produce the best results. BACT engineering approaches have been integrated into
facilities and are near to achieving all possible pollution control at the end of the pipe. Internal
process changes, rather than end-of-pipe controls, are yielding more gains.
2.1.6 Information Needs for Risk Management Decision-Making - The Superfund Perspective
(David Cooper - OERR)
The pace of clean-ups performed at Superfund sites is increasing, reflecting gains from past
experience with Superfund site remediation. Remedial construction has been completed at 43
percent of Superfund National Priority List sites nationwide. Construction is underway at an
additional 33 percent of sites. Consequently, the EPA Office of Emergency and Remedial
Response (OERR) is beginning to focus on the end of the program, when only a relatively small
number of sites (40) will be listed annually. The sites that remain will likely be problematic, as
remediations that are more easily achieved have been completed.
Themes guiding the work of the Superfund program are: (1) to protect health and the
environment; (2) that every site is unique and requires a local focus; and (3) that responsible
parties pay. Information gathering driven by these considerations includes data about remediation
technologies and how best to enact technology transfer; information about functioning in local,
multi-jurisdictional, multi-stakeholder settings; communicating guidance to all parties; and data
about responsible parties needed to obtain funds for Superfund work.
The first statute authorizing Superfund activity has now expired and the program is now
operating under the National Contingency Plan of 1991. This plan does not require the cost-
benefit analysis mandated under the original statute. Economic information is considered in risk
management decision-making but does not necessarily drive decisions. The bulk of Superfund
activity is directed toward remedial investigations and feasibility studies. Treatment and
containment alternatives are considered, although treatment is preferred. These alternatives
sometimes run counter to cost-effectiveness considerations. Remedies are selected based on the
long-term effectiveness of clean-up, health protection, ability to minimize untreatable wastes, use
of innovative technologies if they are best, and the most costly aspect of remediation, the ability
to return groundwater to beneficial uses. Additionally, all standards promulgated by other
Agency offices, as well as State regulations, apply to Superfund activities.
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All this information is factored into the risk management decision-making framework, which
is evaluated against the following criteria:
• Threshold Criteria:
- Overall protection of human health and the environment
- Compliance with applicable or relevant and appropriate requirements
• Primary Balancing Criteria:
- Long-term effectiveness
- Reduction of toxicity, mobility and volume
- Short-term effectiveness
- Implementability
- Cost
• Modifying Criteria:
- State acceptance
- Community acceptance
Thus, risk management for Superfund is arriving at decisions that balance effectiveness with
Implementability, cost, and State and community acceptance.
Ideally, the following kinds of scientific data would help risk-management decision-making
and reduce uncertainties associated with this program. Studies of human health effects of special
populations, such as children, would be useful. The program would also benefit from a process of
validation to give decision-makers confidence in the data by answering questions about site
concentrations compared to ambient levels and the effectiveness of selected remedies. This, in
turn, would give feedback about the accuracy of risk-management decisions. Research relating to
the issue of cumulative risk is also necessary to fill data gaps. Other data needed include models
of contaminant fate and transport patterns within and across media, as well as the effects of
natural attenuation.
Economic data needs include information about the cost-effectiveness of various cleanup
technologies and strategies and quantification of the economic benefit of site clean-up. Future
concerns include the need for data about the long-term cost of pollutant containment, forecasting
of future land use and the ability to enforce institutional controls long-term. Surveys of
stakeholder opinions are also useful. Gathering this information will become even more of an
issue as the States take over management of Superfund sites.
Group discussion focused on clarifying the issue considering cost-effectiveness in risk
decision-making. The definition of cost-effectiveness under this program is somewhat nebulous,
since risk reduction is balanced with long-term clean-up and containment effectiveness. The risk
assessment and feasibility study process has been based on generic cost estimates of
technological remedy selection in the past. Now that there is an experience base from which to
draw, the program is moving toward using performance evaluations during the remedial design
phase.
2.2 Cross-Media and Regional Office Information Needs
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2.2.1 Needs for Risk Managers in the Reinvention Context (Jerry Phiben - OR)
Jerry Phiben of the Office of Reinvention (OR) opened the panel discussion by speaking to
the need for creating accessible and relevant information for those making risk-management
decisions outside of EPA. As EPA reinvents itself, EPA will need partners outside the Agency to
succeed with new challenges. These partners will come from communities and from industry.
The ability to address new problems means that the Agency will have to inform and guide
decisions in various places, and form what could be called "Partnerships for Progress." Decisions
will be made at the local, facility, and individual level.
The Agency will be dealing increasingly with non-point source problems. It will be important
to encourage community members to see themselves as partners in controlling non-point source
pollution by providing information that is accessible, understandable, usable and targeted to the
needs of the community. All information that Agency programs suggest for the use of
community members should pass the test of being understood by non-experts. Community
partners are able to understand uncertainty if it is properly explained.
In addition, Agency information should not be limited in scope by media, as community
concerns often cut across different media. Community concerns are united in that they are about
one place, not one medium. Health, quality of life, cost, and children's health will all be areas in
which accessible information for sound decision-making will be needed. One example of
consideration based on place exists in the "Eastward Ho" movement, which is a term used to sum
up the idea of focusing on redevelopment of older eastern cities instead of promoting new
development in the increasingly developed western United States.
To be effective in providing information to communities and influencing risk management
decision-making at this level, the Agency will have to develop more social science tools to
influence community opinion One example of this kind of tool already exists in the Community
Profiling Guide. Toward this end, the Science Advisory Board is adding non-economic, social
scientists to its members
During group discussion, participants asked about external feedback concerning the Agency's
reinvention initiative and the ability of EPA to lead communities by providing information.
There are indications that Congress thinks that it is a good idea for EPA to address the States in
the ways detailed above. EPA intends to lead through community influence, which requires the
Agency to understand community needs. By so doing, the Agency will assist the community in
defining its needs.
2.2.2 Risk Management in OPPT (Mary Ellen Weber - OPPT/OPPTS)
Risk management in the Office of Pollution Prevention and Toxics (OPPT) rests, in part, on
the premise that, given a choice, people will use safer chemicals. Risk managers, regulators,
scientists and engineers can be powerful risk managers because they make the decisions to
reduce or avoid use of harmful substances. The kinds of information needed to make good risk-
management decisions include data about "green chemistry" and how to apply "Design for the
Environment" principles to formulations and processes. EPA can play a vital role by making the
risk involved in business decisions explicit in the areas of:
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• Compliance
• The use of unregulated chemicals
• Multi-media impacts of chemical choices
• Worker health risks associated with chemical use choices
• Total cost accounting
• Cost, risk, and process and environmental performance of chemicals
Because of its oversight of an entire industry, EPA can bring groups together to capture the
economies of scale that make it economically feasible to test new technologies that can then be
promoted for use by smaller businesses. One example of this kind of effort exists in the "green
chemistry" engineering research done to find solutions to the problems presented by the use of
Perchloroethylene (PERC) in dry-cleaning. Liquid carbon dioxide has been identified as a less
harmful substitute that is a good catalyst and cleans clothes.
Uncertainty in risk management decision-making could be reduced through research into the
changes associated with hazardous effects at the molecular level. What, for example, makes a
substance toxic - does it metabolize in a way that is toxic? How does toxicity relate to a
substance being water soluble or persistent? Obtaining more information about safer chemistry
would allow OPPT to design more effective risk-management tools and rules. OPPT also
demonstrates that using Design for the Environment concepts is valuable to industry because it
can improve compliance rates, reduce worker risk, reduce costs, provide a competitive
advantage, and help companies avoid liability.
The mandates of the Toxic Substances Control Act (TSCA) allow the Agency to consider a
variety of risk-management options and factors. Business managers are the real risk managers.
EPA can inform and coerce, but, ultimately, the work is done outside the Agency. Successfully
partnering with industry stakeholders is effective if OPPT maintains a focus on small clients and
does not promise regulatory relief as part of the incentive to partner. As a partner, OPPT obtains
cost information, product and performance evaluation information, and defines liability issues
associated with the use of alternatives. The "Flexography Project" is one successful example of
partnering with industry. This project identified environmentally cleaner inks with equal
performance capability for use by printers. The printers involved in the project were small
businesses and could not have afforded experimentation individually. The project also produced
a readable, two-page case-study pamphlet based on Design for the Environment principles.
Group discussion dealt with questions about information delivery and defining the scope of
"green chemistry" activity. One method OPPT uses to deliver information is to "train the
trainers," such as trade associations, ecological groups, and equipment suppliers, through
seminars. Participants suggested that EPA could stimulate the creation of a new small entity to
get this information to a wider audience than EPA can currently manage. In addition, to build
trust and communicate across sectors, OPPT endeavors to learn about critical industry issues.
These issues can relate to avoiding regulation, working with suppliers to giant industries, or other
topics of industry Interest.
Life-cycle assessment is incorporated into "green chemistry" as OPPT tries to generalize
about the effects from certain structures, not just specific compounds. OPPT does not endorse
partners in using "green chemistry" market labels, but partners receive a certificate. In addition,
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fonnulators, such as detergent manufacturers, who remove chemicals of concern from their
products can promote this in their marketing.
2.2.3 Information Needs for Risk Management Decision-Making- A Regional Office
Perspective. (Stan Laskowski - Region 3)
Current crosscutting issues in Region 3 include mountain top removal mining and valley fills,
urban sprawl and related transportation concerns, wetlands protection, and watershed/ coastal
concerns. Risk management decision-making plays a role in each of these areas. For example,
stakeholders in the area of sprawl include local and county planners, the Department of
Transportation, the States, and EPA. The Office of Surface Mining, the Fish and Wildlife
Service, the Army Corps of Engineers, the public, industry, and groups like the Natural
Resources Defense Council are stakeholders with regard to mountain top removal mining. EPA
can affect risk-management decisions through data dissemination to the stakeholders.
The kinds of information needed for risk management decision-making in Region III are data
correlating landscape and associated environments; assessments detailing cumulative effects;
data about the effect of multiple stresses on aquatic resources; real-time indicators to enhance
monitoring and other measurements; economic data; and information about social and
environmental justice considerations in the Region.
Useful data about landscape and environmental correlation would involve assessing forest
cover, impervious areas, slopes and other features, and aligning that with data about
environmental indicators, including water quality and songbird and aquatic life representations.
Region III is beginning to build a body of information that shows real correlations. For example,
having over 21 percent of a given landscape be made up of impervious surfaces means that the
area will have no brook trout. This is the kind of risk-management information Region III wants
to distribute to decision-makers.
Good risk-management information for cumulative effect assessments involves methods to
define geographic boundaries for use hi Environmental Impact Statements, and methods that will
enable solid future projections about land use impacts. It is necessary to know how to evaluate
impacts over time and define the capacity of a given area to withstand impacts.
For the effective management of watersheds, including coasts and estuaries, risk-
management information used for decision-making ideally will include methods that define how
much aquatic loss is due to various stresses, such as land use changes or over-fishing. In defining
the actual causes of the stresses, risk managers can target which stresses can be controlled, define
the costs and benefits associated with that control, and determine the chance of success of a given
control effort.
Information needed for good risk management decision-making in the area of cost and
environmental justice hi Region III is focused on the economics of coal mining and the
recreation industry. Region III needs site-specific data as well as macro, or interstate, economic
impact data. ORD has been a major supplier of information in this area.
2.2.4 EPA's Framework for Community-Based Environmental Protection (Border 2000
Projectt (Hal Zenick - NHEERL/ORD)
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The EPA document Framework for Community-Based Environmental Protection posits that
environmental protection is a process, not a program. Risk-management opportunities are
presented at all stages of the process. Gathering community information is critical to the process
and to fulfill this requirement EPA might consider putting together a community science team.
The border between the United States and Mexico presents special risk-management
challenges. EPA became concerned after community cancer rates and birth defects were found to
have occurred in disproportionate numbers. To factor needed information into the risk
management decision-making in this area, the National Health and Environmental Effects
Research Laboratory (NHEERL) used a priority setting or decision tree approach. The result is a
research plan to work with the community to define the problem or problems. The goal is not to
reach a consensus, but to approach one. The underlying principle is to work with stakeholders at
the beginning of the process to understand the possible scenarios that could explain their
concerns. EPA must be clear that existing science will not necessarily be able to demonstrate
causation unequivocally, and that it is a misrepresentation to say that it can do so.
The quality assurance performed for the purposes of project planning must be as rigorous as
that performed for actual project implementation. This is due to the threat of litigation and adds
an accountable expense. Community-based work is more successful if there is a planning group
with no more than eight to 10 members involved from the beginning of the process. Larger
groups may become unmanageable and impede progress. The effectiveness of public meetings is
limited due to their size, and media notices do not always work to inform the public. Ideally,
program managers must meet with small groups of people. Stakeholder relations in performing
community-based work are an ongoing challenge and Federal travel restrictions increase the
difficulty of scheduling face-to-face interactions.
Public health concerns are often overlooked in economic considerations, resulting in
underestimated costs. To be effective in community-based work, strong relationships with public
health agencies must be developed. The Agency must be able to refer people to the appropriate
resource to address their problems, rather than expecting the public to accept that the problem is
out of the Agency's scope.
While there is a tradeoff between achieving consensus and moving forward toward meeting
program goals, a program cannot give up on the notion of consensus. EPA should set quantitative
goals to measure its progress in consensus-building. Program managers must be sensitive to the
dual roles played by community representatives. They can appear to take seemingly
contradictory public and private postures when they are promoting community desires within the
risk-management framework.
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3. Presentations
3.1 Evolution of the Risk-Management Paradigm (Hugh McKinnon, ORD; Lee Mulkey,
ORD)
The current focus of EPA's Office of Research and Development (ORD), which was
reorganized in 1995, is to define how it can meet the research needs articulated in the Agency
through workshops such as this on risk management. It is necessary to define what ORD needs to
do to develop the risk-management paradigm or models needed for present and future work.
During the Agency's 20 years of performing risk assessments, risk-management considerations
have been added to the equation. Although historically these efforts have been risk or technology
driven, it is necessary to look more deeply at social and economic drivers. An article by Powers
and McCarthy, which appeared in the May 1,1998 issue of Environmental Science and
Technology, presents a comparative analysis of environmental and risk-assessment frameworks
(see Appendix D).
The National Research Council model is based on a repetitive analysis process leading to
decision-making and other risk-management activities. The Presidential/Congressional
Commission, in a study on risk assessment and risk management, produced a model that defines
risk, options, and evaluation steps. These models are useful but may be too simple for the kinds
of risk-management activity performed by EPA. EPA's Science Advisory Board is currently
working on a model of risk reduction options to be used as a process for making decisions. This
model is a follow-up to the SAB's Unfinished Business report.
A series of risk assessment and risk-management models are presented in the handouts
entitled Paradigm Puzzle Pieces and Risk-Management Models (see Appendix D). The first of
the paradigm "puzzle pieces" is the risk assessment or risk characterization phase. The definition
of a risk-management evaluation is an analysis of the sources of a potential or assessed risk, the
options for reducing the potential or assessed risk, and the availability, costs, and effectiveness of
the identified options.
Process representation is well understood. Process steps imply scientific activities.
Guidelines for the risk characterization process are in place and pending assessments are peer-
reviewed products usually characterized as input to decision-making. Uncertainties are
increasingly characterized as the ability to do so evolves. Reducing uncertainties sets new
priorities for science. Risk managers are increasingly trying to get quantitative data where
previously only qualitative data were available.
Risk management can be said to be the second piece in the paradigm puzzle. This is the point
at which uncertainties arise. It is the point at which the scientific data, engineering, cost, and
socially based factors, such as policy and legalities, merge. To resolve potential areas in which
information is not clear, the risk manager must consider all technical and scientific dimensions of
uncertainties. This will include process elaboration, defining scientific and technical steps,
defining what the risk-management product will be, characterizing uncertainties, and targeting
research to reduce uncertainty.
Components of an assessed or potential risk-management evaluation include defining the
who, what, and where of a potential risk. The timing of a risk must also be defined to answer
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questions about how the risk will change over time. An example of this exists in the use of
emission estimation techniques. A second component is identifying risk-management options.
These have increased in number as the Agency has matured. Considerations in this area involve
evaluations of effectiveness and cost. In addition, the Agency is considering ways in which the
knowledge derived from certain activities can be made commercially available to offset costs.
There are uncertainties in risk management that affect outcomes. As a next step, ORD is
going to conduct four pilots on four very different topics to test its model of risk management.
These topics will address areas involving air, water, and soil, such as the occurrence of arsenic in
drinking water and the Pfisteria problem.
Group discussion focused on identifying the reason for the difference in process flow
between risk assessment and risk management. A risk assessment is concerned with identifying
baseline risk. However, the management of a risk that is identified involves spending scarce
resources; the best use of those resources involves other considerations, including social and
economic factors, among others.
3.2 A Few Thoughts on Risk Analysis and Risk Management (M. Granger Morgan -
Carnegie Mellon University and EPA Science Advisory Board)
Quantified information in risk analysis and risk management must be used to reduce
uncertainties as much as possible. However, risk is a multi-attribute concept; people care about
more than just a measure of the number of deaths and injuries. Other things that matter include
equity, controllability, intergenerational effects and more. Risk managers must insist that risk
assessment include these multiple factors. Risk control strategies can be based on modifying
human activities, exposures, effects, and perceptions. These strategies can also be based on
mitigation or compensation options.
Different risks require different strategies. For example, different strategies are suitable for
managing risks associated with auto accident injury versus the risk of getting shot by a handgun.
Though both risks can be managed by using avoidance or exposure modification, different
strategies are used. In the auto accident example, strategies could involve changing speed limits
or training people in defensive driving. In the case of limiting or modifying exposure to control
the risk of being shot by a handgun, strategies could involve banning handguns and staying out
of high crime areas.
There are now more tools available to reduce uncertainty. There are two kinds of uncertainty:
uncertainty about the value of coefficients and uncertainty about basic component functions and
functional relationships. Qualitative descriptions are subjective and not adequate for risk
management. Meanings vary from individual to individual, according to context, and depending
on the knowledge level of the communicator. For example, in a Science Advisory Board survey
for EPA, measurements of listeners' understanding of the meaning of the word "likely" varied by
as much as four to five orders of magnitude. The probability associated with the word "likely"
and that associated with the word "unlikely" actually overlapped. Quantitative discussions can
mask differences in what is known about key components in a risk assessment and a lack of
clarity among expert opinions can be damaging. Therefore, risk managers should insist on at
least some quantification.
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In gathering information from and communicating about uncertainty with non-experts, using
the "mental model" will help risk managers to: (1) understand what people already know; (2)
determine what people need to know; and (3) develop actual messages. The mental model refers
to the fact that the very process of finding out what people think can inform them if information
gathering is not done carefully. The mental model advocates use of a validated, five-step,
interview-based approach. A summary of the five steps is as follows:
• Review scientific knowledge about the risk and summarize it in an influence diagram
• Conduct open-ended elicitation of people's beliefs about the risk using an interview protocol
shaped by the influence diagram
• Administer structured questionnaires to a larger set of people to determine belief prevalence
• Draft a risk communication message that is based on an assessment of what people need to
know to make informed decisions and addresses their current beliefs
• Iteratively test and refine successive versions of the risk communication before, during and
after people are given the message
Experts can analyze and characterize risks to establish risk-management priorities. They have
the knowledge to understand all factors involved and to explain the risk in terms that will
communicate the complexity of the issue in a way that is understandable to educated members of
the public. Representative groups of educated lay-people can be drafted to perform actual
ranking because ranking requires the application of social values. Ranking can be performed
using two different approaches, either through a holistic consideration of all aspects, or through
judgments based on the importance of individual attributes. This process should produce a
prioritization that is robust and a product that is useful in risk management decision-making.
To evaluate how risk-management programs are doing, Carnegie Mellon has developed a
survey hi which experts are asked to provide their evaluations of regulatory performance in their
area of expertise in response to structured questions and against provided attributes. Criteria air
pollution will be addressed first and wastewater next. A good regulatory system reflects the
following attributes.
• Adaptive - integrates new knowledge and transfers to new situations
• Democratic - all parties participatory and informed
• Efficient - timely, cost effective, can be measured, encourages innovation
• Equitable - stakeholders have standing, and costs and benefits are distributed fairly
• Scientifically sound - science used, research encouraged, and uncertainties grasped and
communicated
3.3 Day 1 Synopsis
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During the first day of the workshop EPA managers discussed the types of non-risk
assessment information they factor into their decisions. It was evident from these discussions
that information needs vary with individual program and regional activities, but that in nearly all
cases the risk assessment is but one factor of many that figures into the decision-making process.
The evolution of the risk management paradigm is ongoing, and in benefitting from many
inputs. These include recent work by the Presidential/Congressional Commission on Risk
Assessment and Risk Management and ORD's National Risk Management Research Laboratory.
Carnegie Mellon University and EPA's Science Advisory Board have also been conducting work
on risk management strategies that could factor into further development of a unified model or
paradigm.
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4. Paradigm Review and Development
4.1 Evaluating the Paradigms, Part One (Tim Oppelt - ORD)
Breakout groups were tasked with evaluating the models summarized in Section 3.1 in terms
of the model's usefulness and comprehensiveness for risk management decision-making: Using
evaluation approaches such as model-to-model comparison, sorting by information type, or
critiquing individual process steps, the groups were to evaluate the model's utility against the
information conveyed in the presentations summarized in Section 2. Breakout groups were asked
to determine whether and to what extent any or all of the models allow for the development of
and integration into a single risk management decision-making process. The groups were asked
to consider the question: Do the models capture the needed data and answer information needs
such as cumulative risk considerations?
Copies of the models which the breakout groups were asked to evaluate are provided in
Appendix D. Flip charts from the breakout sessions are transcribed in Appendix E. Breakout
group reports are summarized below.
4.1.1 Reports from the Break-Out Groups. Part One
Breakout Group 1
This breakout group was not monitored by a recorder. However, their report to the plenary
group is summarized.
Models are useful in that they can outline the general aspects of the risk-management process
and ensure that all parties are have the same understanding of the process. However, while they
must be sufficiently comprehensive to be useful, it is necessary to recognize that too many details
hamper the flexibility of the model needed to cover a variety of cases. While process steps are
similar across cases, problem definitions, decision makers, resource and data needs, and other
points will differ. Multi-media, multi-issue problems will require approaches different from thai
of a single contaminant on a site. In addition, EPA's motivation for performing a risk assessnien-
and making a risk-management decision will differ. In some cases, a decision is mandated by
statute, while in others, EPA is attempting to identify a problem that the Agency may have no
legal means of resolving.
Breakout Group 2
The group reviewed the descriptions of the decision-making frameworks provided to help
define a model to meet the needs of risk managers. Working from the models presented in
Appendix D, the group first addressed the Risk-Management Evaluation "Egg" model and then
included all the models in generalized remarks.
The critique of models centered on defining the parameters of the risk assessor and risk
manager roles, evaluating the comprehensiveness of the models, and documenting how decisions
are ultimately made. Overall, the models seemed clear with regard to human health effects
assessments, but the role of ecological assessment was not clear.
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With regard to task parameters, the models did not clearly designate which steps were to be
carried out by risk assessors and which were to be done by the risk manager. For example, in one
model, source characterization (which is essentially data gathering) is listed under risk
management. Group 2 stated that data collection is more correctly an aspect of risk assessment
and that the risk manager should focus the effort and set the questions.
The group discussed whether this was a management or a science issue and made the point
that risk-assessment decisions are not clear or separate from politics. This means that one job of
the risk manager is to understand all ramifications of decisions and to document the real basis of
the decisions that were made. A list of all the factors that should be documented includes social
and economic considerations, technical data and political issues. One benefit of this kind of
documentation is that it avoids the possibility of setting potentially dangerous precedents by
demonstrating, for example, that a given decision was made because of an exceptional
circumstance or that it was based on qualitative not quantitative data. Documentation of
decisions should detail:
• Program mandate
• Options considered
• Data considered and used
• Uncertainties
• Interactions with internal and external stakeholders
The communication pathway between the risk assessor, the risk manager, and the team as a
whole, was also not well defined. Project communication should ideally be structured as an
interactive process with regular points of communication designated. Role definitions and
communications pathways should be based on risk-assessment/risk-management process and
policy and should involve:
• Risk assessors/managers
• Team members
• Public
• Others with input to process
The correct audience for assessment information is those who make decisions at project sites.
Risk assessors feel that they must make decisions, but they can only be one-dimensional if they
are based solely on risk numbers. Models need to better define the boundaries and
communication pathways of the risk manager and the risk assessor. The endpoint of ih*j Icciaiive
process should be a well-defined exit strategy.
Group 2 also felt that opportunities to define monitoring were not well established in the
models. A process must be articulated to establish what is to be monitored, the types of
monitoring to be used, and how monitoring will be used to determine if the assessment has
achieved designated goals. Characterizing sources is a critical issue, because it entails an implied
policy. Answers to questions about what the issue really is, who is affected, and what are the
risk-management goals will affect the designation of resources. Public opinion, though
sometimes problematic with regard to science findings, does need to be taken into account on ail
models and the public should be involved in the review of preliminary findings. Some of the
models put this step further along in the process.
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Breakout Group 3
The models presented highlighted the processes and information needed to make risk-
management decisions and can be considered paradigms for risk management. The group first
identified situations in which the concept of one risk-management model might not work te meet
risk-management needs. Different ways of using risk management by the different Agency
programs may mean that it is not necessary or possible to have only one model. For example, the
needs of local community risk managers must be considered - their risk-management needs may
be different than those of EPA. Also, individual risk managers may not require all parts of a
model for all projects. There are some differences in the way risk assessments are handled by the
different offices within EPA, but ecological and human health risk assessments are performed
essentially the same way. It is necessary to determine if a comparable situation for risk
management exists.
Individual programs need to make different types of decisions using risk management. There
are two choices for decision-making frameworks:
• A taxonomy with a complicated system in which system parts are used for different types of
decisions
• A simple model for decision-making with a checklist of additional topics to consider
Considering decision-making in this way could lead either to a system of many models that
address specifics and includes some method for selecting the appropriate model, or a system with
one simple model that can be modified to account for specifics.
Models need to define the linkages between the sources of information (e.g., stakeholder
positions, environmental justice). The generation of risk-management options should have a
pattern. While there is "mystery" associated with risk management, there should be a way to
describe the process in common terms.
Risk assessment requires scientific and technical decision-making to be conducted in a
transparent and easily understood way. ORD uses a conceptual view of risk assessment and risk
management to make decisions and reduce uncertainty in risk assessment. There seems to be a
systematic approach to risk management, but it needs to be described. There may be parts of
decision-making that are not meant to be transparent for risk management, while it may be
appropriate for other parts to be transparent.
The group listed other sources of input to risk management in addition to risk assessment
such as:
• Attorneys
• Chemists
• Economists
• Ecologists
• Toxicologists
• Stakeholders
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• Social factors (minimal)
These inputs should be built into a model for risk management. It was pointed out that
including politics as an input to risk management might include too much flexibility in the
process and destroy any attempt to make the decision-making process transparent. Politics may
be better described as the willingness of the public to accept risks and be included as partof
stakeholder involvement.
ORD is one source of information for risk managers. Information regarding risk assessment
and social and economic considerations should also be gathered. A decision-making team for
national-level assessment implemented through regulations should include chemists, chemical
engineers, attorneys, economists, and hazard assessors. The team might include biologists,
lexicologists, and ecologists. Representatives from the community would not be appropriate for
this type of team.
Can risk assessment and risk management actually be part of a single risk-based decision
model? Where do risk reduction experts get involved hi the process? Risk characterization
informs risk management, but not risk-management evaluation and options because of the timing
of projects. Additionally, there is uncertainty in the decision-making process. Risk-management
decisions are not always simple "yes" or "no" decisions. Any inclusive model needs to account
for uncertainty, especially when addressing communities. Different offices have different factors
which must not or cannot be taken into account at different steps under different statutes. These
limitations should be communicated to the community to help make the process more transparent
and provide a better understanding of statutory constraints.
The group then developed a diagram designed to combine parts of existing models (see
Exhibit 1). The most important point illustrated is the interaction between risk assessment and
risk management.
The group completed the morning discussion with the following summary comments from
each group member. Comments regarding diagrams refer to the models given in Appendix D.
• Diagrams that focus on risk management are the easiest to understand. Sequential diagrams
may better reflect what EPA currently does with respect to risk management.
• A three-dimensional diagram might be better able to illustrate the process.
• The circular diagrams are preferable as they show inputs to the decision-making process from
different areas. Stakeholder involvement is critical.
• The circle within a circle diagram is a good representation, but there should be a way to show
the iterative process between risk assessment and risk management.
• Stakeholder input, stakeholder education, economics, and social concerns should have
increased emphasis in the decision-making model.
• Simple models are the best. Complicated models intimidate people.
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RA
RM
options
iterative
needs more development
States
Local
Stakeholders
RM decisions
Manager's
additions
Other fed
Statutory
Exhibit 1 - Breakout Group 3 Comprehensive Model
• Risk management is the primary reason EPA exists as an Agency.
Breakout Group 4
This group's discussion centered on the intended purposes of the five models presented in
Appendix D: the "olive cell" model, the "master card" or "egg" model, the National Research
Council model, the Science Advisory Board model, and the model created by the Presidential/
Congressional Commission on Risk Assessment and Risk Management.
As they reviewed the handout, the group suggested that the word "paradigm" not be used in
the future. Individuals presented a series of other observations. There was consensus that all the
models were useful; to some degree, all models described the relationship between risk
assessment and risk management. All models were seen as linear in nature. Several observations
were made that linearity may not be very useful, either for presenting information or for
representing how the risk-management process actually takes place. In reality, it was observed
that there is more action of an iterative and parallel nature. This continued to be a main aspect of
the group's critique of the models. In addition, the group wondered if one model could be
sufficiently versatile to handle the variety of environmental issues that might be addressed.
Group 4 noted that there should be an awareness of the possible statutory constraints of the
use of models. Also, the options listed in the models were viewed as sufficient in number, but
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lacking in any information on their relative strengths or weaknesses. In addition, options need to
be resource-based. And, with the exception of the 1996 NRC model, the models are deficient in
defining input into the various options. The group also felt it was important to highlight
continually the importance of stakeholder involvement, while making it clear that the nature and
involvement of stakeholders should vary from step to step.
The group discussed the various purposes of the models. They questioned how a model can
guide research or be used to educate the public. Again, doubt was expressed that a single model
could incorporate all approaches reflected in the five models examined. Members of the group
observed that a model is helpful in allowing users to pick and choose which elements might be
appropriate given their specific issues. Several purposes of the model were suggested:
• The model could serve as a guide to risk managers in program offices
• The model could be used within ORD to serve as a reminder of factors that may not be
obvious
The group also wondered whether the model should help ORD define research needs or
should ORD respond to the needs of the program offices using the model. The group proposed a
series of questions concerning the purpose of risk-management models:
• Is it (the model) useful for program and regional offices in conducting their work?
• If it is useful, is it useful to ORD hi assisting program and regional offices?
• Will the model indicate new types of research for ORD?
• Will the model be useful for public discourse (e.g., communicating risk-management
decisions to the public)?
• Will the model help influence the way risk management is conducted?
The group believed that the following conditions were applicable to responding to the above
questions:
• To respond affirmatively to the second and third questions, one needs to be able to respond
similarly to the first
• One can answer "yes" to the first question if the model is seen as a checklist
• One can also answer yes to the first question if the model is seen a guide to stakeholder
involvement
Discussion turned to whether the models were lacking in any area. One group member felt
that the models were not lacking in any particular aspect, but that their value in communicating
risk management to the regions should be recognized. Some felt that the models were lacking in
an evaluation stage, in terms of success or performance metrics. This was considered particularly
important, since showing tangible risk reduction benefits is a major part of the risk-management
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process, but also the most troublesome. The group observed that to produce risk-management
decisions, one must have results in mind.
The question was asked which models come closest to reality. Some thought the "master
card" model was more realistic than the Science Advisory Board model. The "master card"
model was also recognized because it highlights the interplay of science/economic/political
concerns. Another thought the "olive-cell" model was closer, but that the model should include a
feedback/evaluation loop. Earlier in the discussion, the group observed that the "olive cell"
model, when compared to the "master card" model, highlights risk assessment as a subset of risk
management. However, this model should include non-risk assessment factors that are equally
important. For example, the suggestion was made that the nucleus of the "olive cell" be replaced
with multiple "mitochondria" or "organelles," each denoting additional factors to be considered.
Following onto this idea was the suggestion that the model might be best rendered in hypertext,
with a basic first page showing the model structure and its associated "organelles." Hypertext
links could be provided to pages which describe in detail each of the components. Finally, the
group noted that the Presidential Commission model has all of the necessary elements; however,
the concept of iteration needs to be added.
The group also pondered the utility of the models to the programs. One discussion participant
felt that because economic/political considerations are most important to risk management, the
"master card" model is most useful. Observations included that this model was useful as an
explicit checklist, so perhaps only a checklist was necessary. Ultimately, the group concluded
that the model should be flexible enough to accommodate different environmental issues.
The group closed its discussion with the following cautionary question: "Are we being too
EPA-centric?"
In its report to the plenary session, Group 4 highlighted the following points:
• Superfund has developed a model surrogate in practice
• Focus should be placed on the iterative nature of the process
• An alternative to very complex diagrams is a checklist
• A good choice in models might be the 'olive-cell' with additional "organelles"
• Risk assessment is part of a broad risk-management process and does not exist for its own
sake
• Defining the problem is paramount
• Evaluation data are missing from some of the models but are very important
• Move towards simplicity: more complexity = less usefulness
• One solution is to add hypertext links to the sub-diagrams for each organelle
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The presentation concluded with the following observation: "The fact that this process
highlights the complexity of developing management options, while including contributing
factors such as laws and prior experience, also highlights research opportunities for ORD."
Plenary Group Discussion
The plenary group discussion after the morning breakout group presentations resulted in the
following points about the models:
• Exit strategies are not covered in circular diagrams and would be useful
• Checklists should be suggestive, not prescriptive, to maintain flexibility in application
• Stakeholder perspectives need to be kept in mind at all times, but they need not be intimately
involved at every step. The "average Joe's" opinion is contained in the laws in the first place.
That is our mandate.
• Linear diagrams are not really useful; we need models with iterative loops and which include
an exit strategy
• The "egg" diagram is useful in that it points out that risk assessment is part of the entire risk-
management process. This diagram also specifies problem definition.
• Inputs are not well characterized in any diagram and models are lacking in evaluation
functions
• Models lack a component of concern about residual pollution and cross-media concerns
• Models do not help us to define areas of research or include information about what has or
has not worked previously. Evaluation of results would be a good ORD area - maybe a focus
on anecdotal as well as theoretical research.
4.2 Case Study Presentations - Information Used to Inform Risk-Management Decisions
Case study presentations discussed the kinds of information used to make risk-management
decisions during particular projects. Case studies addressed the following questions:
• What kinds of non-risk assessment information (e.g. economic; science, other than hazard
and exposure data; technological feasibility; environmental justice) did your program
consider when making a risk-management decision?
• How did such information factor into the decision-making process?
• How did your program obtain this information?
• Did statutory mandates encourage or limit the consideration of such information? If so, how?
• What uncertainties on the risk-management side were dealt with?
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• What further information would have been valuable to inform your program's decisions?
Case studies and ensuing group discussions are summarized below.
4.2.1 Al/Mg Phosphide Case Study (Mark Hartman - OPP)
Phosphide gas is a fumigant, often used to kill mammals and insects infesting agricultural
facilities and other storage areas. The primary method of use is to seal a facility, activate the
phosphide gas, and then aerate the building. Phosphide is registered under FIFRA, which
requires a cost-benefit analysis. The objective of control is to ensure that pesticides do not
present unreasonable adverse effects (risks) to humans and the environment. Re-registration
involves data collection and risk assessors use this information as the basis for risk-management
decisions, which are called Registration Eligibility Decisions, or REDs.
Risk assessment factors considered include toxicology, exposure rates, Agency policies and
guidelines, and scientifically-derived risk estimates. Risks are determined for workers,
bystanders, and endangered species. In this assessment, risks were not estimated for dietary or
drinking water exposures. Non-risk assessment information considered included incident
information such as fatality incidents, economic benefits of avoiding pest damage by using
phosphide fumigants, and technological availability of alternative methods, such as use of methyl
bromide. The role of cost in alternative selection is not necessarily primary, but the weight given
it depends on the strength of other factors. Information comes from government agencies, the
National Pesticides and Toxics Network, and State databases. Uncertainties associated with risk
assessment include the duration of exposure versus toxic effects, the potential for exposure in
open air, and uncertainties associated with alternative analysis and technological feasibility.
Some information about alternative technologies exists; however, ORD research in this area
would be helpful.
An ideal set of information for risk management decision-making would include:
• Highly refined scientific information on exposure in the "real world"
• Clear understanding of the human-to-animal relationship
• Comprehensive incident reporting and analyses
• Verifiable damage estimates
• Reliable understanding of the effectiveness of alternatives to phosphide use
• Efficient lines of communication about alternative technologies
• Detailed economics profiles
4.2.2 OOP Chemical Removal and Replacement - Case Study for Stratospheric Ozone
(William Rhodes-OAR)
With the 1974 stratospheric ozone depletion announcement by Rowland and Molina, the
public began to stop buying Chlorofluorocarbon (CFC) containing products. Despite this action,
the measurable impacts of CFCs continued to increase. Motivated by a suit by the National
Resources Defense Council, EPA, under Administrator Lee Thomas, concluded that it needed to
act on this issue before all evidence was collected to avoid letting today's risks become
tomorrow's crisis.
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Risk assessment began and stratospheric impact studies and assessment and biological and
climatic effect research were performed beginning in 1974 and continuing the 1980s. Industry
reacted by stating that it was "innocent until proven guilty" and equating the rights of people
with the rights of chemicals. In 1978, the use of CFCs as a propellant was banned except in cases
in which no alternatives were possible and the product was considered essential.
Risk management took many forms during this initiative. EPA hired the Rand Corporation
for technology support. A source characterization of chemicals and sources with detailed reports
was performed. Control options such as alternative selection and replacement chemicals were
evaluated for their potential across industries, by control per chemical, and by considering end-
of-pipe versus alternative technology or treatment methods. Cost and benefit analyses were
performed. However, industry argued that the theorized depletions could not be happening and
posited that bans on CFCs would adversely affect worker safety and the economy of the nation.
Further scientific evidence and details about the effects of CFCs, such as the enlarging hole
in the ozone layer, led to an increase in control efforts on a multinational level. The result was
the 1986 Regulatory Impact Analysis. Ultimately, CFC control efforts were organized in a
multinational plan based on agreement reached in the Montreal Protocol. Industry continued to
resist, with the exception of the electronics and solvents industry. Through 1988 and 1989, EPA
research resulted in identifying viable process chemical substitutes that refuted industry's
assertion that no substitutes were available.
Risk management moved to a new level as a result of these available alternatives. The
chemical industry renewed research efforts. EPA continued to prove the cost and process
viability of substitutes. Most risk-management action in the 1990s involves further understanding
of human and biological system effects, research to find ways to lessen impacts through
prevention and adaptations, and continued research about rapid mitigation technologies.
Several principles emerged from this multi-phased and multinational effort. First, scientific
data gathering and risk management are best performed in an atmosphere of freedom that
promotes factual conclusions as opposed to political or qualitative conclusions. Politics works
best after the facts are known. Second, industry needs to be involved. While the interests of
industry are usually about short-term financial considerations, the attitudes and roles of industry
evolve during this process. While first objecting to the very fact that CFCs were suspected of
causing atmospheric harm, industry has now identified and switched over to safer substitutes
under the motivation of various drivers, such as public opinion and EPA research. Third, ORD
and program offices can benefit from working together in situations in which ORD allows
program offices to define their needs and then is able to meet those needs.
Group discussion focused on the issue of continuing CFC use in developing countries.
Because of the economics of CFC elimination and substitution in developing countries, the
Montreal Protocol built in a longer time frame for CFC reductions in poorer economies. The
phase-out has not been followed, but there is little official resistance. The primary problem is the
black market and the fact that China is not a signatory of the Protocol. Ongoing research includes
active study of the effects of alternatives, including potential future problems presented by the
CFC substitutes themselves.
4.2.3 Valley Wood Preserving Superrond Site (Patricia Erickson - ORD)
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The Valley Wood Preserving Superfund site was historically used as a wood pressure treating
facility. The site was brought to the attention of the California Department of Environmental
Quality (DEQ) by site, neighbors who complained of foul-looking ponded water at the site and
were concerned about effects on their water wells. The site was added to the Superfund list in
1989 and is in an area of mixed residential and agricultural use. Both California and Supeffiind
have certain standards to be used as starting points for determining the cleanup goals for the site.
This site presented a variety of challenges since it could be considered a model of how not to
construct and operate a pressure treating operation. The pole barn, where wood was dried, and
chemical storage tanks were located on the edge of the site, thus allowing spills to run off-site.
Paved areas were completed after preserving chemical had already inundated site soils. The site
had been cited for operating over five years without a permit from the local water quality
authority. California state authorities had worked with the facility and identified chromium in
site monitoring wells. Information gathering at this site was done more easily than at others
because it is a relatively small site. Consequently, the Record of Decision was signed quickly in
1991. Risk management decision-making at the site was performed according to the established
Superfund process, given in Section 2.1.6.
Characterization activity first involved a site assessment; chromium and arsenic
contamination was found at the surface, in subsurface soils, and in the ground water. The
decision was made to use an innovative, in situ groundwater treatment and to perform a reduction
in the mobility of water toxics. Long-term effects were an issue at this site because inorganics
cannot be transmuted. Cost was not a deciding factor in terms of comparative treatment costs,
unless it would be extremely high or if the levels of uncertainty associated with projected
expenditures were very high. State and community acceptance was easily attained due to
previous work performed and the desire of the community to have the site cleaned. Legal
considerations involved the difficulty of getting the perpetrator to pay. In this case, the
perpetrator indicated willingness to pay but threatened bankruptcy and had to be ordered by the
Court to act.
The establishment of soil cleanup standards was a technical issue that affected risk
management decision-making. Leaching standards assume high attenuation and the levels for
arsenic had to be established by considering direct contact versus background levels. The
groundwater had to be treated in concert with California's non-degradation policy and the
technology chosen was an innovative treatment technique.
4.2.4 Mid-Atlantic Integrated Assessment Case Study (Tom Demoss - Region 3)
The Mid-Atlantic Integrated Assessment (MAIA) is a development effort that will result in a
model ecosystem program for the Mid-Atlantic region, including all of Region 3 and parts of
Regions 2 and 4. Pennsylvania, Maryland, Delaware, Virginia and West Virginia, and the
District of Columbia are covered in their entirety. Parts of New Jersey, New York and North
Carolina are also covered. Because of dense population, proximity to Washington, DC, and
association with studies performed to assess the Chesapeake Bay, this program has a great deal
of data.
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Special care has been taken to design the software for the project so that the data presented
are usable by a variety of audiences. The resulting software is a very user-friendly program with
highly detailed assessable graphic presentations of assessment data. The graphics use color and
other design features to present data in the most accessible formats possible.
The MAIA mission is to provide integrated scientific knowledge to support the
environmental decision-making process for the Mid-Atlantic region. Goals in support of this
mission include:
• Develop acceptable and valid environmental indicators for natural resource protection
• Merge physical, chemical and socioeconomic data into dynamic and useful assessments
• Develop the best characterizations of environmental resources to data
• Have data influence and drive management decisions and influence public perception and
opinion
• Translate data to relative risk
Work on the MAIA has been performed in concert with ORD and stakeholders. Satellite
surveys are being utilized to characterize some areas, and field studies are being performed to
augment this data since this technology has limited accuracy with regard to wetlands. The reports
that will be available by 2001 include information on:
• Mid-Atlantic landscape atlas - a landscape cluster analysis where landscapes will be ranked
according to 33 criteria
• A report on the condition of Mid-Atlantic estuaries, which is being done through field data
collection
• Pesticides in Mid-Atlantic ground water
• State of the streams in highland areas using benthic index and onsite water data to quantify
water quality
• State of the forests
• State of agriculture
• Condition of biodiversity
The study will also result in an atlas detailing environmental stresses, loading to watersheds,
and other conditions, such as impervious areas, that have an effect on streams. Socioeconomic
considerations will also be given to answer questions about what drives the land use changes in
the areas assessed.
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The MAIA assessment framework is divided into levels - each level integrates and expands
on data from the previous level. Level one considers individual systems such as forests and
streams; level two explores the relationships within resource groups; and level three is concerned
with integration and associations between resource groups, such as streams and forests.
Group discussion following the case study presentation focused on the usability of th&MAIA
program by decision makers with varying degrees of expertise. How, for example, can the
program explain the problem of nitrates in water? MAIA can demonstrate the biological impacts
and then explain the causes. To validate usability, program designers will keep testing out ideas
with focus groups and State users. Short fact sheets are also a product of this effort, and program
staff is also working with other groups, such as the Bay Alliance, to provide information.
A participant suggested that one result of this effort might be an actual EPA-led project
demonstration, on a topic such as habitat restoration. This kind of high-profile, EPA-sponsored
activity might help the Agency gain support and trust out in the Regions.
4.3 Evaluating the Paradigms, Part Two
The afternoon breakout groups were instructed to look again at the models and the general
risk-management process with the addition of the four case studies presented. The groups
structured their work around the following questions:
• Did any case study describe a process or provide information different than the discussions
and conclusions drawn from the modeling presentations?
• Did EPA, industry, or someone else develop the risk-management options?
• Should EPA actively develop risk-management options?
• Can industry be forced to reduce the market for their product?
For example, in the stratospheric ozone case study presented, the risk management and risk-
assessment processes were reversed. Based on the potential for further damage caused by CFC
use, EPA made the decision to move forward with risk-management decisions and their
implementation, letting the risk assessments catch up.
The breakout groups again prepared informal reports that were presented to the plenary group
and which answered the discussion questions. Notes from the breakout groups' work were
captured on flip charts, which are transcribed in Appendix E. Breakout group reports are
summarized below.
4.3.1 Reports from the Break-Out Groups. Part Two
Breakout Group 1
This breakout group was not monitored by a recorder. However, their report to the plenary
group is summarized.
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The risk-assessment process is well defined, while that of risk management is less
understood. The models developed to date all have applications, although the concrete steps
necessary for risk management are not necessarily clear. Uncertainties are a problem in risk
management, in that the data necessary to resolve them requires expenditure of considerable
resources. In reality, EPA often makes many decisions without the benefit of the time or
resources to follow all the steps in a complex model. Actions are decided along a continuum of
complexity, between a gut feeling of what is necessary to a full investigation at the level of the
Science Advisory Board, based on the problem at hand and the mechanism that triggered the risk
action in the first place. In some cases, the use of these full models may make decision-making
unnecessarily complex. Finally, the models do not necessarily account for the differences in risk
management of human health issues as opposed to ecological risks.
Breakout Group 2
Generalizing from the case studies presented, the group articulated that the type of risk
encountered in the assessment phase is the driver of the information needed to make risk-
management decisions. For example, risks that are acute versus chronic, or immediate versus
long-term, or limited in scope versus broad-based, require very different management tools. Risk
managers may prioritize based on the type and extent of the risk. This process is sometimes
called risk tiering.
The Valley Wood case study demonstrated the use of the Superfund model, which takes a
more iterative approach to risk management. Decisions about remedies, such as removal versus
in situ remediation, were made according to the nine Superfund criteria described in Section
4.2.3. Before beginning the risk assessment, management goals and public concerns were
identified, to the extent possible.
The types of information needed are also driven by the nature of the entity making risk-
management decisions. EPA, other Agencies, and public/individuals have different goals. This
means that communication between project teams and all stakeholders is very important. Any
model must work for decision-makers outside of EPA, as well as for Agency risk managers. The
use of several case studies linked with the models might be a good way to demonstrate use of the
model.
The models all need to take into account some methods of verification and validation of
decisions - did the risk-management decisions made achieve the Agency's intended goals? There
must be a process to connect outcomes to actions.
Breakout Group 2 summarized their afternoon work session in these points:
• It is necessary to identify management goals and public concerns
• The types of risk drive the type of information needed. Risk tiering may be necessary
• Identify the decision-maker
• Evaluate available technological alternatives
• Apply an iterative approach, e.g., the nine criteria of the Superfund program
• Include measures of success to evaluate whether the goals have been achieved
Breakout Group 3
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Breakout Group 3 structured its work around each individual case study.
Mid-Atlantic Integrated Assessment Case Study
MAIA involves more strategic thinking about risk management. This model could possibly
be used as a tool for the risk manager to identify areas for future work. The group felt tharlhe
model only focused on the water issue as an indicator of regional environmental status. A risk-
management model should include other media as well.
EPA Region 3 has spent significant resources on communicating risk to the community in an
attempt to gain acceptance of its risk-management decisions. The work done by Region 3 helps
prioritize risks and identify problems in a way stakeholders can understand.
CFC Presentation Case Study
The CFC presentation outlined a decision in which a detailed risk assessment was not
required to propose action. This may represent an anomaly, in which the limited risk assessment
suggested overwhelming benefits to taking immediate action. Waiting to collect more data could
have led to tragic results.
Valley Wood Superfund Site Case Study
The Superfund site example was a problem that had already occurred and EPA was trying to
mitigate the situation. The example was very structured and was requirement-oriented because of
the regulations governing the Superfund program. The site followed a linear process in risk
management decision-making, which might not be a model for all situations.
Phosphide Fumigants Case Study
Breakout Group 3 suggested that the risk-management model should not be prescriptive.
Instead, it should be iterative, flexible, and able to consider site-specific characteristics. An
encompassing risk-management model should consider the difficulties in balancing the cost-
benefit equation and the possibility of standardizing cost-benefit determinations across programs.
To improve the risk-management process, the group suggested that risk management should
be an open and iterative process providing for input from stakeholders, as well as communication
of risk-management options to stakeholders and decision-makers. Risk-management projects
might include an independent auditor to make an unbiased final decision as an alternative to
obtaining consensus from all stakeholders.
To improve information for risk management, the group suggested that transaction costs are
important and need to be considered as part of risk management. The risk-management process is
complicated and this workshop is an early step in describing the process, the range of risk-
management projects, and the possible decisions resulting from risk-management activities.
There is a need for an "institute" to provide information on risk management and fill in data gaps.
The existence of such an institute will help make the models discussed at this workshop viable
Breakout Group 4
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Group 4 began its discussion by outlining what it considered to be the benefits of well-done
case studies. Such studies:
• Document examples of successful and unsuccessful approaches/actions and
order/characterize examples
• Provide an historical perspective
• Provide a feel for the diversity of issues
• Can be used to create a model based on actual cases
The group suggested that, given these benefits, it might be useful to use a contractor to
perform ORD-directed research about how the process actually works in the program and
Regional offices.
The group used this as a launching point for its discussion centering around the relationship
between ORD and the program and Regional offices. A variety of aspects to this relationship
were addressed by the group, including issues of communication, timing of involvement, current
ORD contributions, possible new areas for contribution, and practical and theoretical
considerations.
The group noted that decision-making is often a matter of managing constraints. At times, it
is difficult to incorporate risk assessment into risk management during the decision-making
process. However, the uncertainty in risk assessment must be dealt with, particularly in terms of
uncertainty or safety factors. ORD may disagree with the risk-management approach taken by
the program offices. Hence, the program and regional offices may object to ORD involvement
and could feel a lack of trust. For instance, one reason program or regional offices might object
to ORD involvement is that the office has a history of last-minute interruptions to the decision-
making process on the basis of "new science." While this may be true, it may also be related to
the fact that ORD's contributions are coming to the table late in the process. This discussion
touched upon the broader issue of inter- vs. intra-agency involvement.
The group noted that programs want to keep decision-making within their purview, but that
ORD should provide technical support to that process. It was recognized that traditional support
is still needed, but that the Agency is dealing with more issues, such as stakeholder involvement,
and that ORD might have a role in helping the program offices address them. ORD's assistance
to the Superfund offices was discussed. ORD helps hi the evaluation of remedial options, but the
program retains the final choice. In part, this is because the program office takes the
responsibility for the decisions and performs the non-science aspects of the evaluation stages. In
practice, program offices often become mediator between our (ORD's) and their (industry's)
science. Thus, some sense of separation between the offices is necessary.
There was consensus that early involvement is the key to any possible value-added ORD
involvement. The group noted that early ORD involvement might result in new risk-management
options based on an understanding of a broader range of possible technologies.
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The group returned to a discussion of the models and considered items on the "checklist" or
in the "models" on which program offices need input and to which ORD might be able to
respond. Group discussion focused on the following questions: Are there areas of the models that
have gone unfilled? Can ORD provide research support to fill in the blanks? There was
agreement that ORD's resources of technical knowledge could help guide the development of
efficient/better regulatory guidance. This would require including ORD as part of the thinking
process; again, early involvement is the key. The focus of the discussion shifted to the concept of
incorporating prevention strategies in the options identification stage of risk management. It was
noted that prevention is not reflected in the models. The discussion of prevention was lengthy,
and the group considered it to be an area in which ORD could make a large contribution if
brought into the process early.
Other identified areas for ORD support were:
• Research on the multi-party bargaining process
• Development of tools to help evaluate cost and effectiveness issues and to determine what
risk-management strategies are appropriate in which cases
• Research on the identification of appropriate application of market-based regulatory
strategies
• Research on methods of communicating uncertainties
A number of theoretical observations were presented throughout the discussion. One way to
view risk management decision-making across the variety of individual applications is that in
each case one needs to deal with "constraint management." Risk managers navigate the
differences between a scientific community and a litigious society. The scientific community,
while often in disagreement, usually works "to narrow the bounds of what is true." On the other
hand, a litigious society works to widen the space between what is true and what is not, pushing
attention to the outer margins of this space. The group thought risk assessors took a reductionist
approach: they consider a range of inputs or factors which lead them to conclude a certain output.
Risk managers often attempt to include an inductive approach in their deliberations.
Group 4 maintained an awareness of outside implications for risk management and raised
concerns throughout the discussion. One concern was articulated as, "what is the real reason for
the risk-management decisions made?" This highlighted the fact that while ORD may look to
provide additional support, often the risk assessment and technical or scientific input must be
balanced with political or other unrecognized factors.
The group also considered that the practicability of increases in intra-agency participation
should be understood before attempting to implement new processes. Group 4 concluded that, as
an agency, EPA needs both to make the regulations and actions understandable to those involved,
and to understand them internally before releasing them to the public.
The report to the Plenary session stressed the following points and raised some important
questions:
Page 35
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• ORD could take steps to understand and flesh out the risk-management process. The office
could do this by:
- Developing more case studies of risk-management decisions.
- Working more closely with the program and regional offices in the decision-making
process.
• Where should ORD scientists in general be involved in the risk-management process?
• Pollution prevention is not adequately represented in the frameworks:
- The frameworks work well for large, well-recognized problems.
- They do not allow for looking at pollution prevention options as new management
processes are developed. Is this an area which should be handled by industry or should
ORD have a role in conducting applicable research?
• What are some newer, key areas in which ORD could contribute through research to the
present risk-management process:
- Cost and effectiveness issues.
- Evaluations of overall program effectiveness.
- Negotiation process.
- Communicating risk-management options.
- Market-based systems.
Page 36
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5. Wrap-Up Activities
5.1 Summary of Issues and Action Items (Hugh McKinnon - ORD)
Risk assessment was not the focus of this workshop intentionally, in order to allow the group
to focus on other influences on the risk-management process. The next step is to carry this
information into the evolving dialogue at ORD. Many of the comments heard in this workshop
are similar to what ORD has been hearing in stakeholder meetings for reinvention plans.
Feedback includes suggestions that ORD must do a better job in: (1) researching science and
technology issues, e.g., impacts to ecosystems; (2) defining the implications of scientific
research; and (3) effectively communicating these implications to risk managers. Information
must be presented simply so that all stakeholders can understand it and make informed decisions.
Any model or models developed should not be tightly prescriptive. Risk managers need
guidance, such as checklists, but any guidance should incorporate flexibility.
The risk-management process would benefit from having more guidance about how to
conduct a public process in ways that are fair, lawful, cost-effective, and fit community values.
ORD might want to consider adding expertise so that research can be most effective. The goal is
not to decrease science support but to add capacity to address social and economic issues at
greater depth.
Because risk management is an iterative process with many different points, two-dimensional
models have difficulty in portraying it correctly. Comprehensive models must be designed to
incorporate the iterative nature of risk management.
Several major themes emerged from the workshop:
• The information needed for risk management is risk-driven and project-specific.
• Roles of all project participants and stakeholders, especially the roles of risk manager and
risk assessor, need to be defined at project conception.
• Communication between the risk assessor and the risk manager during a project should be
iterative and ongoing.
• Risk-management models need to be flexible, simple, clear, and include problem
prioritization considerations.
• To provide comprehensive information to inform risk-management decisions, EPA needs to
improve the depth of the decision makers' understanding through intensified research on
science and technology issues.
• Information about innovative technologies that might be available must be communicated to
risk managers.
• It might be necessary to acquire additional expertise to gather information about social and
economic issues influencing risk management.
Page 37
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• There is a need to enhance communication paths both across EPA offices and among project
members.
Perhaps the most important finding from this workshop is that open communication
throughout the risk management decision-making process is key to its success.
5.2 Preview of Next 'Workshop
The Office-of Science Policy will sponsor a second workshop in the Risk Management series.
The next, to be held July 14-15,1999, will focus on communication and stakeholder involvement
in the risk-management process. The scope of the final workshop in the series, to be held late this
summer or in the Fall, is currently being defined. Organizers want this workshop to build in
some way on the concepts developed through previous workshops. Workshop participants are
invited to forward suggestions about the content of this final workshop.
The objectives of the July workshop on communication and stakeholder involvement in the
risk-management process are to discuss risk assessor and risk manager communications and how
this communication should inform the decision-making process. Additionally, stakeholder
involvement in decision-making will be explored. Finally, the extent to which current models of
the risk-management process accommodate risk assessor and risk manager communication and
stakeholder involvement will be discussed.
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APPENDICES
Pagel
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Appendix A. List of Participants
Washington, DC
June 15-16,1999
Bill Anderson
EPA OW/OST/EAD
401M Street, SW (4303)
Washington, DC 20460
tel. 202-260-5131
fax 202-260-7185
anderson.william@epa.gov
Dr. James K. Andreasen
EPA ORD/NCEA
401M Street, SW(8623D)
Washington, DC 20460
tel. 202-564-3293
fax 202-565-0076
andreasen.james@epa.gov
Andrew P. Avel
EPA ORD/NRMRL/ALD Pest.& Toxics
26 W. Martin Luther King Drive
MD-235
Cincinnati, OH 45268
tel. 513-569-7951
fax 513-569-7680
avel.andy@epa.gov
Ben Blaney
EPA ORD/NRMRL
26 W. Martin Luther King Drive
MD-235
Cincinnati, OH 45268
tel. 513-569-7852
fax 513-569-7680
blaney.ben@epa.gov
Kathryn Boyle
EPA OPPTS/OPP/SRRD/SRB
401MSt.,SW(7508C)
Washington, DC 20460
tel. 703-305-6304
fax 703-308-8005
boyle.kathryn@epa.gov
Phil Budig
EPAOPPTS/OPP/SRJRD
401 M Street, SW (7508C)
Washington, DC 20460
tel. 703-308-8029
fax 703-308-8041
budig.phil@epa.gov
Amy Caicedo
EPAOPPTS/OPP/SRRD
401 M Street, SW (7508C)
Washington, DC 20460
tel. 703-308-9399
fax 703-308-8041
caicedo.amy@epa.gov
Kathleen Conway
EPAOA/SAB
401 M Street, SW (1400)
Washington, DC 20460
tel. 202-260-2558
fax 202-260-7118
conway.kathleen@epa.gov
David Cooper
EPAOSWER/OERR
401 M Street, SW(5204G)
Washington, DC 20460
tel. 703-603-8763
fax 703-603-9100
cooper.david@epa.gov
Elizabeth Cotsworth (speaker)
EPA OSWER/OSW
401 M Street, SW(5301W)
Washington, DC 20460
tel. 703-308-8895
fax 703-308-0513
cotsworth.elizabeth@epa.gov
Kerry Dearfield
EPA OSP/ORD
401 M Street, SW(8104R)
-------
Washington, DC 20460
tel. 202-564-6486
fax 202-565-2925
dearfield.kerry@epa.gov
Tom Demoss
EPA Region 3, Environmental Science
Center (3ES01)
701 Mapes Road
Ft. Meade, MD 20755-5350
tel. 410-305-2739
fax 410-305-3095
emoss.tom@epa.gov
Karen Doerschug
EPA Design for the Environment
401 M Street, SW (7406)
Washington, DC 20460
tel. 202-260-0695
fax 202-260-0981
doerschug.karen@epa.gov
Patricia Erickson (speaker)
EPA ORD/NRMRL
26 W. Martin Luther King Drive
MD235
Cincinnati, OH 45268
tel. 513-569-7406
fax 513-569-7680
erickson.patricia@epa.gov
Robbi Farrell
EPA OPPT/OPP/Special Review &
Registration Branch
401 M Street, SW (7508C)
Washington DC 20460
tel. 202-308-8065
fax 202-260-1847
farrell.roberta@epa.gov
Jerry Filbin
EPAOA/OR
401 M Street, SW (2184)
Washington, DC 20460
tel. 202-260-8099
fax 202-260-7875
filbin.gerald@epa.gov
Demson Fuller
EPAOPPTS/OPP
401 M Street, SW (7508C)
Washington, DC 20460
tel. 703-308-8062
fax 703-308-7042
fuller.demson@epa.gov
Peter Grevatt
EPAOSWER
401 M Street, SW (5105)
Washington, DC 20460
tel. 202-260-3100
fax 202-401-1496
grevatt.peter@epa.gov
EdHanlon
EPA ORD/OSP
401MStreet,SW(8104R)
Washington, DC 20460
tel. 202-564-6761
fax 202-565-291 lhanlon.edward@epa.gov
Mark Hartman (speaker)
EPAOPPTS/OPP
401 M Street, SW (7508C)
Washington, DC 20460
tel. 703-308-0734
fax 703-308-7042
hartman.mark@epa.gov
Scott Hedges
EPANRMRL/ORD
401 M Street, SW(8301D)
Washington, DC 20460
tel. 202-564-3318
fax 202-565-0075
hedges.scott@epa.gov
Jonathan G. Herrmann
A-2
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EPAORD/NRMRL
26 W. Martin Luther King Drive
MD-235
Cincinnati, OH 45268
tel. 513-569-7839
fax 513-569-7680
hemnann.jonathan@epa.gov
Brian Hirsch
EPA OIA/OTCA
401 M Street, SW(2670R)
Washington, DC 20460
tel. 202-564-1138
fax 202-565-2411
hirsch.brian@epa.gov
Stephen C. James
EPA ORD/NRMRL
26 W. Martin Luther King Drive
MD-235
Cincinnati, OH 45268
tel. 513-569-7877
fax 513-569-7680
james.steve@epa.gov
JoanKarrie
EPA OPP/IRSD
401MSt.,SW(7502C)
Washington, DC 20460
tel. 703-305-5289
fax 703-305-5512
karrie.joan@epa.gov
Timothy Kropp
EPAOSWER
401 M Street, SW (5103)
Washington, DC 20460
tel. 202-260-1270
fax 202-401-1496
kropp.timothy@epa.gov
Arnold Kuzmack
EPAOW/OST
401 M Street, SW (4301)
Washington, DC 20460
tel. 202-260-5821
fax 202-260-5394
kuzmack.arnold@epa.gov
RashmiLal
EPACEIS
401 M Street, SW (2152)
Washington, DC 20460
tel. 202-260-3007
fax 202-260-4968
lal.rashmi@epa.gov
Stanley Laskowski (speaker)
EPA Region 3
1650 Arch Street
Philadelphia, PA 19106
tel. 215-814-2989
fax 215-814-2782 or
215-814-2783
laskowski.stanley@epa.gov
Robert Lee
EPAOPPTS/OPPT
401M Street, SW (7406)
Washington, DC 20460
tel. 202-260-1670
fax 202-260-0981
lee.robert@epa.gov
Kimberly Lowe
EPA OPPTS/OPP/SRRD/SRB
401 M Street, SW(7508C)
Washington, DC 20460
tel. 703-308-8059
fax 703-308-8041
lowe.kimberly@epamail.epa.gov
Alec McBride
EPA Office of Solid Waste
A-3
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401 M Street, SW(5307W)
Washington, DC 20460
tel. 703-308-0466
fax 703-308-0511
mcbride.alexander@epa.gov
Douglas McKinney
EPA IEMB/APPCD
MD-60
Research Triangle Park, NC 27711
tel. 919-541-3006
fax 919-541-5227
mcldnney.douglas@epa.gov
Hugh McKinnon (speaker)
Acting DAA for Science, EPA ORD
401 M Street, SW(8101R)
Washington, DC 20460
tel. 202-564-6620
fax 202-565-2910
mckinnon-HQ.hugh@epa.gov
John Meagher
EPA OW/OWOW
401 M Street, SW (4502F)
Washington, DC 20460
tel. 202-260-1917
fax 202-260-2356
meagher.john@epa.gov
Cletis Mixon
EPA OPPTS/OPP/SRRD
401M Street, SW(7508C)
Washington, DC 20460
tel. 703-308-8032
fax 703-308-8005
mixon.cletis@epa.gov
Dean Monos
EPA OPPTS/OPP/SRRD/RB3
401M Street, SW(7508C)
Washington, DC 20460
tel. 703-308-8074
fax 703-308-8005
monos.dean@epa.gov
M. Granger Morgan (speaker)
Carnegie Mellon University
Dept. of Engineering and Public Policy
Pittsburgh, PA 15213
tel. 412-268-2672
fax 412-268-3757
granger.morgan@andrew.cniu.edu
gm5d+@andrew.cmu.edu
Jeff Morris (speaker)
EPA ORD/OSP
401 M Street, SW(8104R)
Washington, DC 20460
tel. 202-564-6756
fax 202-565-2926
morris.jeff@epa.gov
Marcia Mulkey (speaker)
Director, EPA Office of Pesticide Programs
401 M Street, SW(7501C)
Washington, DC 20460
tel. 703-305-7090
fax 703-308-4776
mulkey.marcia@epa.gov
Lee Mulkey (speaker)
EPA ORD/NRMRL
26 W. Martin Luther King Drive (MC 235)
Cincinnati, OH 45268
tel. 513-569-7689
fax 513-569-7549
mulkey.lee@epa.gov
Gary Mullins
EPAOPPTS/OPP/FRR
401 M Street, SW (7508C)
Washington, DC 20460
tel. 703-308-8044
fax 703-308-8005
mullins.gary@epa.gov
Deirdre L. Murphy, Ph.D.
EPA OAR/OAQPS, Risk & Exposure Group
MD-13
Research Triangle Park, NC 27711
tel. 919-541-0729
fax 919-541-0237
murphy.deirdre@epa.gov
Dan Murray
A-4
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EPA ORD/NRMRL/TTSD
26 Martin Luther King Drive
MD-G75
Cincinnati, OH 45268
tel. 513-569-7522
fax 513-569-7585
murray.dan@epa.gov
Michael Nieves
EPA OPPTS/OPP/SRRD/RB1
401 M Street, SW (7510W)
Washington, DC 20460
tel. 703-308-6351
fax 703-308-7042
nieves.michael@epa.gov
Cynthia Nolt
EPAORD/NCERQA
401 M Street, SW(8723R)
Washington, DC 20460
tel. 202-260-9642
fax 202-260-1812
nolt.cynthia@epa.gov
Barry Nussbaum
EPA CEIS
401 M Street, SW (2152)
Washington, DC 20460
tel. 202-260-1493
fax 202-260-4968
nussbaum.barry@epa.gov
Dan Olson
EPA OW/Office of Ground Water and
Drinking Water
401M Street, SW (4607)
Washington, DC 20460
tel. 202-260-6269
fax 202-401-6135
olson.daniel@epa.gov
E. Timothy Oppelt (speaker)
EPA ORD/NRMRL
26 W. Martin Luther King Drive
MD-235
Cincinnati, OH 45268
tel. 513-569-7418
fax 513-569-7680
oppelt.tun@epa.gov
Phil Oshida
EPA OW/OWOW/Wetlands Division
401 M Street, SW (4502F)
Washington, DC 20460
tel. 202-260-6045
fax 202-260-2356
oshida.phil@epa.gov
Pasky Pascual
EPAORD
401 M Street, SW (8104R)
Washington, DC 20460
tel. 202-564-2259
fax 202-565-2911
pascual.pasky@epa.gov
Dorothy Patton
Director, EPA ORD/OSP
401 M Street, SW(8104R)
Washington, DC 20460
tel. 202-564-6705
fax 202-565-291 lpatton.dorothy@epa.gov
Dan Petersen
EPA ORD/NRMRL/TTSD
26 W. Martin Luther King Drive
MD-G75
Cincinnati, OH 45268
tel. 513-569-7896
fax 513-569-7585
petersen.dan@epa.gov
A-5
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Frank T. Princiotta
EPAIEMB/APPCD
MD-60
Research Triangle Park, NC 27711
tel. 919-541-2821
fax 919-541-5227
princiotta.frank@epa.gov
William Rhodes
EPAOAR/APPCD
86 T.W. Alexander Drive
MD-63
Research Triangle Park, NC 27711
tel. 919-541-4115
fax 919-541-7885
rhodes.bill@epa.gov
Kelly Rimer
EPA OAR/OAQPS
MD-13
Research Triangle Park, NC 27711
tel. 919-541-2962
fax 919-541-0840
rimer.kelly@epa.gov
Deanna Scher
EPAOPP/SRRD/RBI
401M Street, SW(7508C)
Washington, DC 20460
tel. 703-308-7043
fax 703-308-7042
scher.deanna@epa.gov
Anne Sergeant
EPA ORD/NCEA
401 M Street, SW (8623D)
Washington, DC 20460
tel. 202-564-3249
fax 202-565-0045
sergeant.anne@epa.gov
Victor B. Serveiss
EPA ORD/NCEA
401 M Street, SW (8623-D)
Washington, DC 20460
tel. 202-564-3251
fax 202-565-0078
serveiss.victor@epa.gov
Sally Shaver (speaker)
EPA OAR/OAQPS
MD-13
Research Triangle Park, NC 27711
tel. 919-541-5572
fax 919-541-0840
shaver.sally@epa.gov
Subhas K. Sikdar
EPA ORD/NRMRL/STD
26 W. Martin L. King Drive
MS-497
Cincinnati, OH 45268
tel. 513-569-7528
fax 513-569-7787
sikdar.subhas@epa.gov
Tom Veirs
EPA ORD/NCERQA
401M Street, SW(8722R)
Washington, DC 20460
tel. 202-564-6831
fax 202-565-2447
veirs.thomas@epa.gov
Mary Ellen Weber
EPA OPPTS/OPPT
401M Street, SW (7406)
Washington, DC 20460
tel. 202-260-0667
fax 202-260-0981
weber.maryellen@epa.gov
Linda Werrell
EPA OPPTS/OPP/SRRD/SRB
401 M Street, SW(7508C)
Washington, DC 20460
tel. 703-308-8033
fax 703-308-8041
werrell.luida@epa.gov
Jan Young
EPA OSW/EMRAD
401 M Street, SW (5307W)
Washington, DC 20460
tel. 703-308-1568
fax 703-308-0509
young.jan@epa.gov
A-6
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Hal Zenick (speaker)
EPA ORD/NHEERL
MD-51
Research Triangle Park, NC 27711
tel. 919-541-2283
fax 919-541-4324
zenick.hal@epa.gov
A-7
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Appendix B. Workshop Agenda
"Identifying Information Needs for Risk Managers" Workshop Series
Information Needs for Risk Management Decision-Making:
Toward a Risk-Management Information Model
June 15-16,1999
Washington Plaza Hotel, Washington, DC
Workshop Objectives
» To identify the types of information (non-risk assessment) that EPA managers need and use to
inform their risk-management decisions.
*• To conduct a review and analysis of risk-management processes and information needs, for
subsequent use in the development of a draft unified model for organizing and providing
information to risk managers.
Davl Information Needs, Paradigm Proposals
9:00-9:15 Introduction Tim Oppelt, ORD
9:15-11:30 Panel Discussion -Media Program Office Information Needs
" Sally Shaver, OAQPS/OAR
•• Marcia Mulkey, OPP/OPPTS
- Elizabeth Cotsworth, OSW/OSWER
10:15-10.30 BREAK
- John Meagher, OWOW/OW
•• Bill Anderson. OST/OW
•• David Cooper, OERR/OSWER
11:30-12:30 LUNCH
12:30-2:30 Panel Discussion -Cross-Media and Regional Office Information Needs
•• Jerry Phiben, OR
- Mary Ellen Weber, OPPT/OPPTS
» Stanley Laskowski, Region 3
»• Hal Zenick, NHEERL/ORD (Border 2000 project)
2:30-2:45 BREAK
2:45-3:25 Presentation-£vo/w//ow of the Risk-Management Paradigm Hugh McKinnon and
Lee Mulkey, ORD
3:25-3:45 Presentation-^ Few Thoughts on Risk Analysis
and Risk Management M. Granger Morgan,
Carnegie Mellon
University
3:45-4:15 Preparation for the Day 2 break-out groups Jeff Morris, ORD
B-l
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4:15-4:30 Synopsis of the Day 1 presentations & discussions
Day 2 Paradigm Review and Development
8:30-8:45 Day 1 Recap; Final Instructions for Break-out Groups
8:45-10.30 Break-Out Group Exercise-Evaluating the Paradigms
10:30-11:00 Reports from the Break-out Groups
11:00-2:00 Case Study Presentations-/n/br/nar/0n Used to Inform Risk
Management Decisions
Phosphide fumigants
ODP chemical removal and replacement
12:00-1:00 LUNCH
Valley Wood (Superfund)
Mid-Atlantic Integrated Assessment (MAIA) case
2:00-4:00 Break-Out Group Exercise-£va/waf/ng the Paradigms, Part II
4:00-4:30 Reports from the Break-out Groups
4:30-4:45 Wrap-Up Activities
• Summary of Issues
• Action Items
• Preview of Next Workshop
• ADJOURN
Lee Mulkey, ORD
Tim Oppelt, ORD
Mark Hartman, OPP
Bill Rhodes, ORD
Patricia Erickson, ORD
Tom Deraoss, Region 3
Hugh McKinnon, ORD
B-2
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Appendix C
Guidance to Presenters
A. Guidance for Media Program Office Presenters
EPA Workshop-//7fon7?atfo/7 Needs for Risk Management Decision Making
First workshop in the series, "Identifying Information Needs for Risk Managers"
June 15-16, Washington Plaza Hotel, Washington, DC
Panel Discussion: Media Program Office Information Needs
Guidance for Presenters
When June 15,1999, 9:15-11:30 a.m.
Where Washington Plaza Hotel, 10 Thomas Circle (14th Street and Massachusetts Ave, NW),
Washington, DC
Topic The kinds of information needed to make decisions in [your program office]
Length 15-20 minutes
Format Presentation followed by q&a/discussion. There will be a total of five presentations, with a
15-minute break following the second presentation.
Subject While we expect and encourage each presenter to address the topic from the
Matter unique perspectives of their particular program office, there are some key questions that we
would like each presentation to address.
» What kinds of information (e.g., economics, science other than hazard and exposure
data, technological feasibility, environmental justice) does your program consider
when making a decision, taking an action, or implementing a project?
» How is such information factored into the decision-making process?
» How does your program obtain this information?
» Do statutory mandates encourage or limit the consideration of such information. If so,
how?
» We are all familiar with the uncertainties inherent in risk assessment. What
comparable uncertainties could be reduced in your program's decision-making
process if more information were available to decision makers?
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•• Under ideal circumstances, what information, beyond what is currently available to
you, would you consider valuable to inform your program's decisions?
Materials If you would like to have materials photocopied for distribution at the workshop, please send
them by interoffice mail or email to Jeff Morris of OSP/ORD by May 28,1999.
Questions Please call Jeff Morris (202-564-6756) if you have any questions about your presentation,
or about other aspects of the workshop series.
Follow-Up Jeff will schedule a conference call with all presenters about a week before the workshop,
as a final check-in to answer questions and address any remaining issues.
B. Guidance to Cross-Media Office Presenters
EPA Workshop-/nfom7af/on Needs for Risk Management Decision Making
First workshop in the series, "Identifying Information Needs for Risk Managers"
June 15-16, Washington Plaza Hotel, Washington, DC
Panel Discussion: Cross-Media/Regional Office Information Needs
Guidance for Presenters
When June 15,1999, 12:30-2:30 p.m.
Where Washington Plaza Hotel, 10 Thomas Circle (14th Street and Massachusetts Ave, NW),
Washington, DC
Topic The kinds of information needed to make, implement, or otherwise address or consider risk
management decisions in [your office]
Length 15-20 minutes
Format Presentation followed by q&a/discussion. There will be a total of five presentations.
Subject While we expect and encourage each presenter to address the topic from the
Matter unique perspectives of their particular office, there are some key questions that we would like
each presentation to address.
» What kinds of non-risk assessment information (e.g., economics, science other than
hazard and exposure data, technological feasibility, environmental justice) does your
office consider when making, implementing, or addressing/ considering a risk
management decision?
» How is such information factored into the decision-making, implementation, or
consideration/evaluation process?
•• How does your office obtain this information?
C-2
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" Do statutory mandates encourage or limit the consideration of such information. If so,
how?
>• We are all familiar with the uncertainties inherent in risk assessment. What
comparable uncertainties on the risk management side could be reduced if more
information were available to decision makers?
» Under ideal circumstances, what information, beyond what is currently available to
you, would you consider valuable to inform your office's decisions?
Materials If you would like to have materials photocopied for distribution at the workshop, please send
them by interoffice mail or email to Jeff Morris of OSP/ORD by May 28,1999.
Questions Please call Jeff Morris (202-564-6756) if you have any questions about your presentation,
or about other aspects of the workshop series.
Follow-Up Jeff will schedule a conference call with all presenters about a week before the workshop,
as a final check-in to answer questions and address any remaining issues.
C-3
-------
Appendix D
Risk-Management Models
-------
Public
officials
Natural and
social sciences
Interested and
affected parties
Learning and feedback
I ^r
Analysis
deliberation
Decision
•«•
Analysis
deliberation
Problem
formulation
,=__=
Process
design
Option
selection
•
Information
gathering.
•
?^R#S8qtfaKie?ff steps irf arfaiysfs/denbefation ."CA -.'•' ".
*" t » A*™ «"» * • • " • ** *A«I ' { * f • '
3
Synthesis
====£>
From NR.C, 1996 Understanding Risk: Informing Decisions in a Democratic Society
-------
Define
problem
context
From Presidential/Congressional Commission on Risk Assessment and Risk Management, 1997,
Framework for Environmental Health Risk Management (Vol.1), and Risk Assessment
and Risk Management in Regulatory Decision-Making
-------
Risk Reduction Option Selection Methodology
From USEPA Science Advisory Board - Integrated Risk Project (Risk Reduction Options Subcommittee)
-------
RISK ASSESSMENT
RISK
MANAGEMENT
CHARACTERIZATION
RISK
MANAGEMENT
-------
Risk
Management/
Risk Assessment
Identification of Future Problem, Initiating
Event or
Public Policy Mandate
Paradigm
Risk Management
Dose-Response
Assessment
Define the Problem
Jf
Risk Assessment
\
Hazard
[Identification
Risk
Characterization j
Exposure
Assessment
Develop Compliance
Assurance Models and Methods
Define Risk Management
Objectives
Identify and Evaluate
Risk Management Options
Risk Management
Decision
Implement Option(s)
Develop Measures of
Environmental and
Public Health ^
Improvement
Monitor
bt Environmental
and Public Health
Improvement
• Public Health
Considerations
• Statutory and Legal
Consideration
• Social Factors
> Economic Factors
• Political
Considerations
Reduced Environmental
and/or
Public Health Risk
-------
Risk Management/Risk Assessment Paradigm
Identification of Future Problem, Initiating
Event or
Public Policy Mandate
Risk Ma rii ai gem en t [''.• \ .|: .'l-..->.
Source/Stressor
Characterization*
Dose-Response
Assessment
Hazard Risk
Identification Characterlzatlo
Resource Valuation *
Sustalnablllty *
Socloeconomlcs *
Risk Reduction
Goals Policy/Regulation
Land/Resource Use *
Prevention *
Influence
Control *
Remediation *
Rehabilitation *
Adaptation *
Development/
Demonstration *
Policy/Regulation
Systems Analysis *
Cost Analysis*
Cost/Benefit Analysis *
Risk/Benefit Analysis *
Socloeconomics *
Failure Analysis *
Risk Communication *
Technical Assistance *
Technology Transfer *
Training *
Technical Guidance *
Technology
Commercialization *
Performance
Verification *
-------
Comparison of commonalities and differences among frameworks
In spite of differing objectives, ages, nations of origin, and sponsoring agencies, a number of critical themes are common to all .
frameworks. Tabular entries provide summary descriptions of the stated development purpose and key conceptual innovation of
each framework. Agreements among frameworks suggest likely future changes in risk assessment and risk management
processes. Differences reveal temporal change? in attitude toward the measurement and management of risk.
Issue
Canadian National
U.S.Risk Standards Research
Commission Association Council
1937 1996 1996
UX Department
o( the Australia/
Environment New Zealand U.S. EPA He Netherlands
199S 1995 1992 . 1389
Framework's Risk Environmental Risk Risk Risk Risk analysis Risk reduction
prime management, decision characterization management- management
objective making decision
making
Assessment Explicitly Assessment Explicitly Assessment Explicitly Explicitly Implicitly
versus management- embedded in management- embedded in management- assessment- management-
management oriented management oriented management oriented oriented oriented
Decision
making
Decision- Decision- Decision- Implicitly
oriented, oriented, oriented, decision-
eommenteon identifies decision oriented,
principles and specific making used requires
techniques decision points for problem balance In
solving decision
making
Decision- Not decision- Decision-
oriented, oriented, oriented,
stresses decisions includes
a priori criteria deferred to risk specific
for decision management regulatory
making objectives
Stakeholder
input
Strong Weak Strong Implicit Strong Implicit Implicit
emphasis on emphasis on emphasis on emphasis on emphasis on 'emphasis on emphasis on
input use input use input use input use input use input use input use
Bole of science Necessary far
risk
management
decision-
making
Socioeconomic Viewed as
valuation useful in
decision
making
Uncertainty Prefers
analysis qualitative to
quantitative
methods
Necessary for Necessary for Necessary for Necessary for Necessary for Necessary for
risk estimation assessment. risk risk estimation risk estimation risk estimation
but insufficient management
alone decision
making
Excluded in
decision .
making
Requires
quantitative
methods
Used to Used in Notes need for Not included Costs used to
broaden risk decision cost-benefit select among
understanding making due to analysis. regulatory
resource limits options
Prefers both Stresses Requires Requires
qualitative and qualitative and qualitative and quantitative
quantitative quantitative quantitative methods
methods methods methods
Risk Should be Emphasizes
characterization both quantitative
qualitative and approaches
quantitative
Risk Important in Uses
prioritjiation risk qualitative da
management -minimus and
doowd/nus
ranking
Linear versus Iterative at all Iterative
iterative
stages
between
assessment
and
management
Should be Will be "Can be either
both partially qualitative
qualitative and qualitative due and/or
quantitative to information quantitative'
gaps
Implicit in risk Necessary but Core
management not always management
precise activity
completed
using criteria
Iterative at all • Iterative at all Iterative at all
stages stages stages
Emphasizes
quantitative
approaches
A derivative
property of
repeated
assessment
Iterative
between
assessment
and
management
Key innovation Includes social. Recognizes the Recognizes the Explicit use of Emphasizes Formalizes the
ethical, and
economic
values in risk over
analysis
primacy of analyb'c-
management deliberative
nature of
assessment risk-based
decision
making
the ihe problem
precautionary comparison of identification
principle in the risk to phase
face of • a priori
uncertainty decision
criteria
Requires
quantitative
methods
Emphasizes
quantitative
approaches
Completed by
comparing
risks to
standards
Unearwith
implicit
feedbacks
Specifically
states
numerical
management
standards
MAY1. IMS/ENVIRONMENTAL SCIENCE StTECHNOLOOY/N£WS«129 A
-------
Appendix E
Breakout Group Flip Chart Transcriptions
Breakout Group 1 AM
Key Points:
Think of as principles - not too much detail (such as guidance, not checklists) not too directive - examples
/cases
All models could work - there is variability however.
Decision made without a process - need to recognize.
Problem definition is different for different cases - different users - issues (geographic, chemical,
technical, watersheds, regions, states)
Model/s put forward need to be sensitive to definitions - get everyone on the same page.
Driver/s for starting the process (legislative, public, data)
Components in the right egg need expansion and then integration into those eggs.
In many instances programs are doing the left-bottom egg but bringing it together would be useful
Like the idea of a circular diagram with an exit point.
A light framework (too detailed, too general - need a middle ground)
Do RA - Determining acceptable risks using RFCs (range) (decision process)
How much data do you need to support a concern and action about a risk?
What is the trigger/criteria for doing something (recognize that there is a trigger - different implications
for different programs)
Decision-makers will be different (local/state) individuals
Coming out of single chemical single site to a more multi-media, multi-issue problem
Go to situations that are not mandated (RAs) to doing RAs because it is a good thing
How do we handle the issue of eco-risks
Iterative (parallel nature of RA/RM) overpowering impacts
Stakeholder leverage $$ implications
Integrating all components is complex
Awareness of larger community / stakeholders
We think we know best how to do it - engagement means change in direction
Gathering data for evaluation
Insurance industry risk reduction
E-l
-------
Breakout Group 1 PM
RA is well defined: RM is not as well understood.
Exception is dealing with cumulative risk
All models can work in light of what we heard Day One.
• Superfund guidance does not look that different
• Right side of 3-egg diagram is not neat and clear - we do bottom left at OAQPS.
Process looks like a lot of processes - need to move toward the concrete.
Uncertainty is a predicament - all models seem to need a high amount of data.
We make many decisions without all of the complexity (gut-intuitive - SAB)
Need a way to screen
Models set up to deal with traditional problems.
Many of the models are data driven
We know the guts of what we wanted to do - become too prescriptive, characterize, etc.
Variety of process can be used
Framework with a light touch - suggestions - process police
Some want concrete - some want bigger picture
Too restrictive - no flex
Need a way to make suggestions with some detail
Give examples and guidance helpful insights
Think of as principles
Circular diagram speaks - iterative approach, tiered approach
Stairway diagram says we can stop - go- take and evaluate
Important to consider case-by-case
Make mention of defining the problem
Define problem - what does that mean? Have a broad definition / policy.
Scoping exercise to understand the problem
Drivers: Public input, monitored data, mandated directive.
What is the scale - chemical, geography. Regions can then invest $ in largest environmental problems
There are a bunch of clients
Problem ranking - how important is it - need to set priorities
Need to blow-up the components in the right egg
Appealing to do the left side even though most or all offices do.
SUMMARY
Preliminary Issue: Risk Assessment
Determining acceptable risks (1x10-6?)
Generating sufficient data
Risk actions are triggered by different groups (e.g., PO/RO using different criteria)
Increasing variety of risk management decision-makers
Moving from single issues (chemicals) and sites to multi-media, multiple issue problems
Non-mandated RA / RM options.
Human Health vs. Eco-risks
Iterative parallel nature for RA/RM options -overpowering impacts
Stakeholder leverage/$$ implications
RM paradigm - complex system with multiple component analysis
E-2
-------
Larger group of stakeholders - non-traditional groups such as insurance and banking
EPA knows best no longer acceptable
Breakout Group 2 AM
Up-front communication between RM and RAs.
Identify roles of RM and RA
Could be narrow or broad definition of what a RM is.
Might be situation dependent
Depends on the people involved
There should routine interaction as frequently as needed between the RA and the RM.
Characterizing "the source" is a critical issue.
policy
diversion of resources
opportunity cost
Consider:
Incorporation public input
situational - review of draft, public meetings
resource dependent
how to get fairly involved
Should also be required in risk-management decisions:
clarity
consistency
transparency
reasonableness
E-3
-------
Consider the various other inputs to the risk-management decision
Documentation issues:
How decision made
How justified
Who is the reader
Consider FOIA
Characterizing uncertainties
What options review and how
Superfund is a good model
SUMMARY
ID Roles and communicate up-front
Risk assessors/managers
Team members
Public
Other with input to process
RA/RM process and policy
Document Decision - Show how we got there including:
Program mandate
options considered
data considered and used
uncertainties
Interactions with interested stakeholders - internal and external
Breakout Group 2 PM
Type of risk drives information needs, e.g.:
acute or chronic
immediate or delayed
short or long-term
voluntary or involuntary
buy-in or behavioral changes
scope/extent
Tiering based on type/extent of risk (information needs listed above)
Iterative approach, e.g., Superfund model
removal vs. remedial - 9 criteria
Before beginning RA ID management goals, public concerns (to the extent possible)
Alternatives
Type of decision also drives information needs:
- Programs vs. projects
-Scale
- Scope/nature or outcome
- Immediacy of actions
Who is making the decisions?
-EPA
- Other agency
E-4
-------
- Public/ individuals
Communication becomes more important
Verification / validation of decisions - did they achieve goals?
What tools will you use for management action?
EPA
Other agency
Voluntary compliance
Measure of success
- How will you know when you get there?
- Connect outcomes to actions
SUMMARY:
ID management goals and public concerns.
Type of risk drives info. Needs tiering
Who is the decision-maker?
What tools alternatives?
Iterative approach, e.g. SPFD 9
Measures of success validation, goal achieved?
Breakout Group 3 AM
Common Elements
Full Set
Exemptions for User
Generic
Checklists for Specifics
Identify Multidisciplines
Sources of Options
Stakeholder Interactions
Similarities for Various Uses
Mystery in Risk Management
Risk Assessment not only input to Risk Management
Economics
Engineering Limitations
Politics (will of people)
Stakeholders
Implementation
Transaction Costs
Legal/Regulations
Defining Options
Risk-Assessment Contributions
Attorney
Chemists
Economists
E-5
-------
Ecologists
Toxicologists
Stakeholders
Social factors (minimal)
Risk Assessment and Risk Management both part of decision
More overlap
Maybe one process
(Exhibit 1 graphic)
Feedback
Risk Assessment -» Risk-Management Options -+ Risk Assessment -» Risk-Management Decisions
Mulkey Eggs
- Important Feedback Loops
- Focus on Risk Management
Agency's Prime Reason for being is Risk Management
- Add more input factors
Sequential Process (2)
- Simplicity
- Overview
- Needs structure behind it
- Stakeholder Important in All
- Education
- Input (e.g., social, economic)
Value in Identifying factors for Consideration
Cannot Totally Demystify
Risk Assessment not only input to Risk Management
Breakout Group 3 PM
Case Studies
- Across the board
- Did we see differences in info/processes in models discussed this AM?
- MAIA - strategic thinking vs. RM could ED areas for future RA and decisions
- MAIA - Risk characterization and tools - not necessary RA to take action
- Continue to characterize to verify actions or adjust RM
- Clarify use of surrogates
Did we see the RA/RM iterative process?
- In Ozone and pesticide with integration of regulations
Superfund Case Study was more linear RA _ RM.
Use of case studies and affect on controls in the absences of animal studies.
Source of RM options - role of individual or EPA?
Risk communication as a tool to get support for risk management
Communication with stakeholders as a strategic tool -
- Role of stakeholders and neutral party "jury"
Reinforcements from this morning
- Flexibility
E-6
-------
- Iterative process
Where do we go from here?
Clarify factors that should be considered and how to value each.
Open and iterative process with input from stakeholders and communication with those developing risk-
management options.
Risk-management option developers communicate with decision-makers.
Transaction costs not often taken into account - part of reality of process
It will be awhile until Agency gets to "the process" for decision-making
- Diverse set of risk managers
- Many different players
What would a risk management decision-making institute deliver if it existed?
"People like color" T. DeMoss, 1999
E-7
-------
Breakout Group 4 AM
• All relate RA and RM
• All are useful
• All are linear
• Linearity may not be so useful for presenting information
• Statutory constraints on use of models
• Some are useful for certain cases; fitting models/options to cases is complex; need more support
• Options need to be resource -based
• Models are deficient in defining input into various options (except NRC model)
• NAS model contains information exchange
• Highlight iterative vs. linear process (e.g., a shaded box to note iteration)
• Also highlight continual stakeholder input, but: nature and involvement of stakeholder should vary at
particular steps
• Olive-cell chart vs. master-card chart highlights risk assessment as a subset of risk management, but,
should include non-RA factors as equally important
for example: multiple 'mitochondria' for cell rather than a nucleus
• Suggestion: don't use the word "paradigm." How will the (paradigm - for the lack of a better term) be
used? To guide research? To educate the public?
• Options identification merits its own subset
• There is doubt that a single model can incorporate all approaches
• Reaction to above: The model is helpful to allow users to pick and choose which elements help
• Re: Purpose of the model
1. A guide to risk managers hi program offices
2. To be used within ORD - to serve as a reminder of factors that may not obviously spring to mind
• A variety of diagrams exist with limited utility; but, should model define research, or, should ORD
respond to program offices' needs who use the model
• PURPOSE: Questions:
1. Is it useful for program and regional offices in conducting their work?
2. If it is useful, is it useful to ORD in assisting program and regional offices?
3. Will the model indicate new types of research for ORD?
4. Will the model be useful for public discourse?
5. Will the model help influence the way risk management is conducted?
E-8
-------
Answers:
1. You cannot have #'s 2 and 3 without also having #1
2. Yes to #1 - Model serves as a checklist
3. Yes to #1 - For example, the need for stakeholder/community involvement
Question: Are there elements in the/a model that have been ignored?
Answer: No, but model can be useful to communicate risk management to regions
Models are lacking in an evaluation stage (success or performance metrics)
Question: Which models come close to reality?
Master-card model is more realistic/nuanced than the Science Advisory Board model
Answer: Olive-cell model is closer, but add feed-back/evaluation loop
Need to formalize risk-management thinking
The olive-cell model is OK but there is a need to simplify at a broad level
The master-card model is good because it highlights the interplay of science/economic/political
concerns
A suggestion: remove arrows and put things in organelles
Reaction to above: The arrows show flow
The Presidential Commission model has all of the necessary elements; it just needs to add iteration
Question: What is the utility of the models to the program?
Answer: Economic/political is the most important - the master-card model is most useful
Answer: As explicit checklist
Then, just have a checklist
The model should be flexible to accommodate different environmental issues
Breakout Group 4 PM
• Case Studies
• Document examples of successful and unsuccessful approaches/actions, order/categorize examples
• Provide a historical perspective
• Use actual cases to create the model
• Provide a feel for te diversity of issues
• Suggestion: Use a contractor to:
• Pick relevant issues
• communicate with program offices
• Decision-making is a matter of managing constraints
• There is difficulty in incorporating risk assessment into risk management during decision-making
• Uncertainty in risk assessment must be dealt with (uncertainty/safety factors)
• Program and regional offices can object to ORD involvement - trust issue
• ORD may disagree with program or regional office
• Inter- vs. intra-agency involvement
• Programs want to keep decision-making within the program, ORD provides technical support
• Traditional support is still needed, but now there are more issues to deal with:
• Do program offices need further information or support from ORD/technical staff? (stakeholder
involvement, etc.)
• Items on the "checklist" or model(s) that program offices need input on, or that are missing altogether?
That ORD can provide?
• Guidance on a process/options - be part of the thinking process in areas that ORD has knowledge
E-9
-------
• Especially if ORD participates early in the process
• Focus on prevention options as a solution to a problem - not reflected in the models
• Think more broadly about what risk management means: Views:
Approach processes thinking preventively up front
vs.
Establishing risk before approaching risk management
• Industry is focused on profits vs. preventing problems:
• Low-cost drives decisions
• Regulation drives more responsible actions
• Risk assessment is a reductionist approach (what we saw this afternoon)
• Cost-effectiveness
• Communication
• Research on the 'bargaining' process is needed (in red ink)
• 'Outliers' can play a big part - how do you deal with that (Extremists)
• Market-based approaches (Emissions trading)
• Other strategies for risk management; when are the different strategies appropriate (advantages and
disadvantages of each strategy)
• Uncertainty surrounding decisions - communication of that
SUMMARY
• What are some next steps that ORD could take to understand and flesh out the risk-management
process?
• More case studies of risk-management decisions
• Working more closely with the program and regional offices in decision-making process (e.g., reg.
support)
• Where should ORD scientists in general be involved in the risk-management process?
• P2 (prevention) is not adequately represented in the frameworks:
• The frameworks work well for large, well-recognized problems
• They do not allow for looking at P2 (prevention) options as new management processes are being
developed; Industry should handle?? ORD?
• What are some key (newer) areas where ORD could contribute through research to the present risk-
management processes:
• Cost and effectiveness issues
• Evaluation of program's overall effectiveness
• Negotiation process
• Communicating risk-management options, etc.
• Market-based systems
E-10
-------
Appendix F. Hand-Outs
-------
Information Needs for Risk Management Decision Making
The Superfund Perspective
David Cooper, Senior Manager for Risk
Office of Emergency and Remedial Response
June 15, 1999
-------
MAJOR SUPERFUND THEMES
Protect Public Health and the Environment
Identify sites where releases of hazardous substances occurred or
might occur and pose a threat to human health and the environment
Every Site is Unique
An analysis needs to be done for each site to determine the
appropriate action
Responsible Parties Pay for Cleanup Actions
Introduces liability issues
-------
Superfund: A Complex Environmental Program
* Addresses emergency removals and long-term remedial action
* Complex Network of Laws, Regulations, Guidance
* Requires Coordination with Governments, Public, Responsible
Parties
* Addresses Multiple Chemicals, Media, and Pathways
* Resource Intensive
* Multi-disciplinary
-------
Remedial Investigation/Feasibility Study
• Nature and extent of contamination
• Health and environmental risks
• Range of cleanup alternatives
• Analysis of alternatives
-------
Standards for Superfund Risk Management Decisions
The Nine Criteria
Threshold Criteria
1. Overall protection of human health and the environment
2. Compliance with Applicable or Relevant and Appropriate
Requirements (ARARs)
Primary Balancing Criteria
3. Long-term effectiveness
4. Reduction of toxicity, mobility, and volume
5. Short-term effectiveness
6. Implementability
7. Cost
Modifying Criteria
8. State acceptance
9. Community acceptance
-------
Rules of Thumb for Superfund Remedy Selection
'•'Program Goals
The remedy will:
• protect human health and the environment
• maintain protection over time
• minimize untreated waste
'•'Program Expectations
Appropriate remedial alternatives will:
• use treatment to address principle threats, wherever practicable
• use engineering controls for low long-term threat
• use combination of methods to protect human health and the
environment
• use institutional controls to supplement engineering controls to
prevent or limit exposures
• use innovative technology (if better, cost efficient, less adverse risks)
• return usable groundwaters to beneficial uses
-------
CERCLA (Section 121) Remedy Selection Requirements
1. Protect human health and the environment
2. Comply with federal and state ARARs
3. Use permanent solutions and alternative treatment technologies to the maximum extent practicable
4. Cost effective
5. Satisfy a preference for treatment, or explain why not
6. Include State and community participation
-------
Sources of Uncertainty in Risk Management
• Confidence in the Data
• Level of health protection, risk reduction
• Degree of stakeholder acceptance
• Economic impacts,
• Implementation, efficacy of remedy
-------
Other Valuable Information
Efficacy and Limitations of Alternative Remedies
Natural attenuation
Fate and transport of persistent contaminants
Future Land Uses
Realistic, reliable predictions
Enforceability and longevity of institutional controls
Children's Health
Early life exposures
Toxic effects
Accuracy of Risk Assessments
Are the methods "overprotective" or unrealistic?
Are some important risk factors overlooked?
-------
Conclusion
Superfund risk management decisions are grounded in-
* CERCLA's principle requirements
* The nine criteria for evaluating remedial alternatives
* Superfund Program's goals and expectations (40CFR300.430(a)(1)(i,iii))
Superfund decisions could benefit from-
* Reliable future land use information
* More data on cost-effective technologies for reducing risk
* Cross-agency discussions
10
-------
Identify, Generate, Analyze, Transfer
Information
Case Study for Stratospheric Ozone
For Use Only Within EPA
William J. Rhodes
U.S. Environmental Protection Agency
Air Pollution Prevention and Control Division
National Risk Management Research Laboratory'
June 16,1999
(information contributions from Richard Zepp, NERL and Jennifer Ormezavaleta, NHEERL)
-------
Announcement
1974 Rowland and Molina
Science: 1974 to early 1980s
stratospheric impact and assessment
biological and climatic effects research
including UV
NAS conclusion
Industry
Outcry: innocent until proven guilty
Identify rights of people with rights of chemicals
-------
Public & Risk Management
CFCs in aerosols
1978 ban CFCs as propellant
Exemptions: no alternative & product is
essential
Canada, Sweden, and Norway join U.S.
Problem solved?
Dialog
NAS and industry took opposite sides
1980- Alliance for Responsible CFC Policy
EPA issues notice to regulate
Industry objects
Executive Office rules out regulations
-------
Science
CFCs increase for other reasons
1982 Rowland et al. announcement
1984 British Antarctic Survey
EPA Administrator denounces as scare tactic
1985 Vienna Convention
1985 EPA sued by NRDC
1985 New evaluation of CFCs
Is there a problem?
EPA
New Administrator, Lee Thomas:
may need to act in near term to "avoid letting
today's risk become tomorrow's crisis"
-------
Risk Management (RM)
If a problem, what do we do?
OAP- Rand Corp for technology support
Source Characterization
chemicals and sources
detailed reports
"Control" Options
potential evaluated across industry
control per chemical
end of pipe versus alternative
technology/prevention
estimates of cost and benefits
1986 Regulatory Impact Analysis
International concerns and negotiations
-------
Science
Simultaneously study potential effects
SAB raises importance
Remember 1982 Rowland et al.
Industry
"Theorized depletion" could not be happening
Economy of Nation and worker safety
Early EPA conclusion (not unanimous)
Need to start "controls" before science is
complete
consequences of inaction
OAP evaluates RM options
difficulty of controlling widespread and
variety of sources
-------
• RM
Traditional approach
Most ODS uses, traditional seemed impractical
Consider:
replacement chemicals
alternative technologies
• Conclusion
Start small:
reductions in CFCs
flexibility for science and risk management
Confluence:
ozone hole
threat of UVb increases
promise of limited solutions
1987 Montreal Protocol
-------
TO THIS POINT,
ALL ACTIONS LEAD TO
FIRST AGREEMENT
BEYOND LIMITED
AEROSOLS 1978
-------
Approach for RM
Workshop (1987, GAP letid)
multi-nation, multi-organizational
privately industry had one chemical
industry saw no further need for research
industry/academia: Federal Gov't/EPA should
fund development of long-term solutions
in case science indicates the need
Simultaneous Actions
Some industry proactive
electronics/cleaning/solvents industry
saw opportunity
Key in cleaning: Mil Specs
Large chemical companies stop research
Halons and methyl bromide
-------
Chemical Industry Position
No solutions available
No controls are feasible
Wait and see
Approach for RM
ORD and OAP agreement on electronics cleaning
ORD and OAP agree on new chemicals
insurance policy
stimulate industry
show potential
counter industry claims
-------
ORD Chemical Data
Competitive cooperative agreements
synthesized and determined properties of new
chemical classes
Data: chemical, physical, and thermodynamic
properties
ORD defines and evaluates data
some potential
refrigeration uses, halons
Simultaneous Actions
ORD shows possibility
Science shows problem looks serious
minimal data
-------
Approach for RM
1988 Foam industries
1989 Aerosol replacements identified
28 categories detail on non-CFC
formulations: HCs, DME
alternative dispensing devices
availability, effectiveness,
descriptions, formulations, uses
7 categories reformulate to reduce
1989 Destruction of CFCs/halons
1989 ORD/OAP work with MACS
unbiased evaluation of recycling
technology
S&A protocols, impurities, age/condition
of system
compare to specs; effectiveness of cleanup
systems
establish agreement on voluntary criteria
-------
AT THIS POINT,
ORD DEMONSTRATED
THE NEED FOR AND THE
AVAILABILITY OF
SOLUTIONS
-------
• RM Approach
1990 Clean Air Act Amendments
SNAP Policy established
technical support to evaluate any
alternatives
continues today, but diminishing expertise
• Simultaneous Actions
1990 London agreement
ORD larger quantities of new chemicals
results promising
expand data
Chemical industry reinitiates R&D
1991 using ORD results, new chemicals pursued
alternative technologies are commercialized
solutions outpace science and regulations
economic advantages: better, safer, more
reliable
$ profits available
-------
Science
UV and cataracts from Effects Lab
Early 1990s Brewer UV
shows changes due to ozone not aerosols
sunburn and DNA effects identified
Enhanced UVb estimated
Eruptions of volcanoes
Health
Terrestrial
Marine phytoplankton 92-94
Importance of dissolved organic matter
Troposphere
Interactions of most of above
RM
1991 Aerosols manual to convert from CFCs
supply, product reformulation, equipment
conversion, safety
-------
FINAL ACTION
1992 Copenhagen
Industry continues to offer some ODS substitutes
MOST ACTIVITY AFTER THIS WAS AND IS TO
UNDERSTAND EFFECTS, TO LESSEN IMPACT
THROUGH PREVENTION/ADAPTATION, AND TO
CONTINUE MORE RAPID MITIGATION
-------
Risk Management
Some replacements high GWP
Benefits of near-term ozone outweighed long-
term Global Change
Need to find replacements for Global Change
Industry not concerned about Global Climate
Change
1993 Surplus CFCs/halons
estimate bank
transformation process
market for reformed chemicals
evaluation of transformation technologies
Utilize ORD expertise on Navy CFC-114
computer modeling of cooling systems and
alternative chemicals
-------
Science
UV on crops 94-97
Impacts of UVb on coral 94 and continuing
UV and risk of infectious disease (workshop) 95
Risk Management
Navy selects ORD new chemical
savings of over $300 million and large source
of CFCs
Avoidance of DoD resistance was a prime factor
-------
Science
UVb on amphibians 95
UV effects on immune system 97
Risk Management
HFC concerns
tested MACs for
HFC-134a impurity problems 94
new chemicals 96/97
human exposure to refrigerants 98/99
fastest growing GHGs
alternative technology in refrigeration
Program Office support in future
-------
Lessons Learned
Science and Risk Management freedom
Politics works best after facts are known
Industry usually has short-term financial
interests
Industry needs to be at the table
ORD and Program Office really need to work
together
ORD needs to understand Program Office needs
Program Office needs to let ORD have some
freedom
Will only happen with familiarity building trust
-------
ymation Needs
on Making
John Meagher
"A Wetlands Manager's Needs"
-------
. ..1
Clean Water Act
Objective (Sec. 101 (a))
;.;,tprestore and maintain the
chemical, physical, and biological
'"• '"""" '"' ' '• v'"' •''"*" * '' ^ v •• " *"• '"' • ' '" "'" ^^ '•" ' '' '"' ' '
integrity of the Nation's waters" ;
/, . • t ^^ . '*^ •• ' .' .* . L
V-Hji'/i..\;
&
-------
Watershed Management
mm*
ISE
• • * *
Involve all stakeholders in integrating
environmental resources and diverse land
• ,"•''-".' ' . •. •
uses in a manner that balances ecological,
social, and economic needs.
-------
u]#*i>»^»**^ •
mpact Evaluation
— What roles do the individual and collective
wetlancjs play in the watershed?
H What are the overall ecological, social, and
economic goals of stakeholders?
'""**.•* . 'i ~f S ^^ ' 'i *, ' '. «• ' », * e
A) Identify the alternative sites/strategies or
corrective actions that can reduce
environmental impacts. ;
B) Are the alternatives economically and
logistically feasible?
-------
formation Needs
Management tools available to
avoid/reduce/offset impacts:
'."'•* ' AI . . r
• Clean Water Apt .
• Local Ordinances
• Financial Incentives
••'•' V ':'•'• ''' ' ' . . ',•. • ' ' ' ' •
Information Needs for Risk Management
v Methods for predicting landscape development
(alternative futures) .;.--.
• Methods for determining appropriate setback
.distances
• Methods for implementing Best Management
Practices '• ••;•' '• • . • ' ''-: : :- . _••
• Methods for determining width and kinds of buffer
strips V " ''.•.'" . -''•: ••" • ' \
Method$ for restoring wetlands
-------
Lt--.".
Clean Water Act
SECTION 404
iASIC PREMISE
- .•'••' . ' "
No discharge of dredged or fill material can
* ' • i * ^^^ * i " ^^ >, * . *
be perrnitted if a practicable alternative
exists that is less damaging to the aquatic
environment or if the Nation's waters would
be,significan.tly degraded
-------
", l~
\:ifr
Clean Water Act
401 :
.Provides mechanism to protect water
';..•. • ". . ' . ' • . ' > ', ' ••.
quality^including wetland quality/condition,
• through aquatic life criteria and beneficial
' l A . i •!
•'uses,-''.'"'" • .-' . . " . :
-------
CWA Section 404
_ ^ ( ^ ,
'
A^jSids impacts ;
2)Minimize"Impacts • : • .
,•,/:'.•'.,;.,•;."•-*.. '-' .r . . • - , , . .'• * »
' -' %;"' ''.'.-.''•• .- ' •- - "• ' '. ; '.;,.
3):Q6rnpensate for uriavoiqable i
f. t < ^ • , i ,* • -1 • •,!'...«,• » • . . ^ - . •; i • , I-
,Sl?!i$%!S^
-------
CWA Section
Information Needs for Evaj'
r- Methods for evaluating and minimizing the
:,ponsequenpes of losing this wetlancJ
^Methods for developing alternatives, to proposed
S 1 , I " * ' ' * r r ,' i « ^^ " V ' ', ' •
,jmpacts ;\ . ,;•- , "• }. ...-'. .;•;•". __, • '•/ "•• •.
-r Methods for reducing effects pn wildjife and vyater
.^quality, inciuding inigratpry cbrridqrs and habitats
••'^vMethodsiorTeducing risks-from flooding
1 .. •'.'.•' • •. ** ' ,. •,..•' ^^ .
,~:pther cpn'sideratipns; environmental justipe,.
V econpmidfeasibility, hjstoric/tribal,.sites, local:
',-:zoning; ',:';,-.- -"':' -,. ".".'• '• ; -/." '/': ' ..-
-------
A Section 404
, .^. *.<..t-» ;.
^.,. ,*
.t
Information needs to determine
lensatory mitigation:
tp-Jpcate restoration in. the watershed
^ What types of restoration are priorities
1 ..',•,'', . ., ' • ' ' • ' .
!T- What performance criteria are appropriate
.for the restoration site
'i*'*.''' '(t"i.1 *. '.r*'
T- Management strategy to determine
1 . - t • ' ' •• . •. ' '
^environmental benefits of in-kind, on-site vs.
off-sitei but-of-kind restoratio.n ;
-------
;..", !»*«»?-—••'
GPRA Goal
• «" . » • • .
1) Annual net gain of 100,000 acres per
. • §.* < •• i • i. • • • ._ _ • • ,. .y/ • •,..-• ' ., . • I
t Year by 20005 ;;
1* in ^- ^, \... i^' a- • • * . •, in . . \.• ,11 * • ,i.
2) Enhanced role of restoration beyond
•.''.»' '• '-'*,',. "* • • ' ' • •" * '• •» ' '•
:i0n;
-------
VALLEY WOOD PRESERVING Turlock, California
OPERATIONS & ENVIRONS
- Pressure treated wood using chromated copper
arsenate.
- Operated from 1973 to 1979.
Partially paved; overlies sandy soil and shallow aquifer.
- Neighbors include residences, duck farm, and vineyard
with domestic wells.
ENFORCEMENT HISTORY
Operated ~5 years without permit from local water
quality authority.
Neighbors complained in 1979. Chromium in soil (3100
mg/kg) and ponded water (67 mg/L) on site.
- August 1979: Water authority ordered cleanup.
November 1979: chromium detected in monitoring well
on site at 8 ppm (MCL=0.05). County revoked use permit.
-------
SUPERFUND STATUS
Site added to National Priorities List (NPL) March 1989,
Record of Decision signed September 1991.
Medium
Soil,
surface
Soil,
subsurface
Ground
water
Contaminant
Cr(VI)
As
Cr(VI)
As
Cr(VI)
As
Risk
Current
use in risk
range;
future 1Q-4
to 10-2
Current
HNS;
future
HMO; 10 3
Max. Cone.
30 mg/kg
140 mg/kg
68 mg/kg
232 mg/kg
28 mg/L
2.35 rng/L
Cleanup
4 mg/kg
2 mg/kg
5 Mg/L
5 Mg/L
0.05 mg/L
0.016
mg/L
-------
SUPERFUND DECISION-MAKING PROCESS
Threshold criteria
1. Overall protection of human health and environment
2. Applicable or relevant and appropriate requirements
Primary balancing criteria
3. Long-term effectiveness
4. Reduction of toxicity, mobility, or volume
5. Short-term effectiveness
6. ImplementabJIity
7. Cost
Modifying criteria
8. State acceptance
9. Community acceptance
-------
RM DECISION-MAKING ISSUES: TECHNICAL
Soil cleanup standards
• Leaching standards assume 100x attenuation
• Two leach tests: CalWET and TCLP
• Arsenic
• level for direct contact vs background
Groundwater
• Treatment with non-degradation policy
• Innovative treatment technology
-------
SITE-SPECIFIC LEACH FACTOR
Time
1984-85
1988-89
1991-93
LF, As
83
830
10000
LF, Cr(VI)
4.7
8.6
11
-------
RM DECISION-MAKING ISSUES: LEGAL
• Prior to NPL listing, responsible party delayed most
response actions.
• PRP claimed financial straits.
• Costs and cost-recovery (PRP-lead).
• Administrative order on consent vs. unilateral order.
-------
RM DECISION-MAKING ISSUES: REGULATORY/ADMIN
Three active regulators-US. EPA, California DTSC,
Central Valley Regional Water Quality Control Board.
NPL requires compliance with ARARs or waiver.
Modifying criteria are state and public acceptance.
-------
EPA WORKSHOP
INFORMATION NEEDS FOR RISK MANAGEMENT DECISION MAKING
A REGIONAL OFFICE PERSPECTIVE
Stanley L. Laskowski
Environmental Services
Division Director, Region III
-------
SOME CURRENT ISSUES IN REGION III
(1) URBAN SPRAWL
(2) MOUNTAIN TOP REMOVAL/VALLEY FELLS
(3) TRANSPORTATION-NEPA/TEA 21
(4) WETLANDS
(5) WATERSHEDS/COASTAL
-------
ENVIRONMENTAL PROBLEMS HAVE MANY RISK
MANAGEMENT DECISION MAKERS
EXAMPLES
(1) SPRAWL/TRANSPORTATION
LOCAL/COUNTY PLANNERS - MPOs, ETC.
DOT/FHWA
STATE DOT/STATE ENVIRONMENTAL OFFICES
NGOs
EPA
(2) MOUNTAIN TOP REMOVAL/VALLEY FILLS
OSM
STATES - ENVIRONMENTAL; ECONOMICS/COMMERCE; DNR
FWLS
COE
PUBLIC
INDUSTRY
NGOs
-------
SOME GENERIC NEEDS FOR RISK MANAGEMENT
(1) LANDSCAPE-ENVIRONMENT CORRELATIONS
(2) CUMULATIVE EFFECTS ASSESSMENT
(3) MULTIPLE STRESSORS ON AQUATIC RESOURCES
(4) REAL TIME INDICATORS
(5) SOCIAL/ECONOMIC/ENVIRONMENTAL JUSTICE
-------
LANDSCAPE - ENVIRONMENT CORRELATIONS
(SPRAWL; MTR/VF; TEA 21)
(A) CORRELATE
LANDSCAPE (e.g., FOREST COVER; IMPERVIOUS AREAS; SLOPE)
AND
ENVIRONMENTAL INDICATORS (e.g., WATER QUALITY;
SONGBIRDS; AQUATIC LIFE)
(B) DEVELOP BREAKPOINTSflTHRESHOLDS
-------
CUMULATIVE EFFECTS ASSESSMENT
(SPRAWL; MTR/VF; TEA-21; NEPA)
HOW TO DEFINE GEOGRAPHIC BOUNDARIES
HOW TO EVALUATE OVER TIME
WHAT IS CAPACITY TO WITHSTAND IMPACT (RESILIENCY)
-------
MULTIPLE STRESSORS ON AQUATIC RESOURCES
(WATERSHED MANAGEMENT; COASTAL/ESTUARIES)
HOW MUCH AQUATIC LOSS IS DUE TO VARIOUS STRESSORS - e.g.,
WETLANDS LOSS
OVER FISHING
LANDUSE CHANGES
WHICH STRESSORS COULD BE CONTROLLED
COST-BENEFIT
CHANCE OF SUCCESS
-------
REAL TIME INDICATORS
(BEACHES; WATER SUPPLY)
BACTERIAL-OCEANS
DRINKING WATER - CRYPTO SPORTOIUM
-------
SQCIAL/ECQNOMIC/ENVIRONMENTAL JUSTICE
(MTR/VF; TEA 21)
ECONOMICS OF COAL MINING
• SITE SPECIFIC
• MACRO - INTERSTATE
ENVIRONMENTAL JUSTICE - DEFINE ENVIRONMENTAL JUSTICE STUDY
AREA
-------
New Directions Workshops — Identifying Information Needs
for Risk Managers Series ^^
Workshop II:
Communication and Stakeholder Involvement
in the Risk Management Process
Summary Report
Preparedfor
Office of Science Policy
Office of Research and Development
U.S. Environmental Protection Agency
Washington, DC 20460
September 1, 1999
-------
Risk Management Communication and Stakeholder Involvement
Table of Contents
Preface Page ii
1.0 Introduction Page 1
2.0 Communication Between the Risk Assessor
and the Risk Manager Page 2
2.1 Perspectives on Internal Communication Page 2
2.2 Planning and Scoping for Risk Managers and Assessors Page 6
2.3 Case Study Presentations - Communication Issues Page 7
2.4 Risk-Management Information Models Page 9
2.5 Risk Assessor - Risk Manager Collaboration
on Five Watershed Assessments Page 14
2.6 Day 1 Wrap-Up Page 15
3.0 Stakeholder Involvement Page 18
3.1 Introduction Page 18
3.2 Opportunities for Stakeholder Input Page 19
3.3 Stakeholder Involvement in the Rodenticide Cluster Case Page 21
3.4 Breakout Exercise - Stakeholder Involvement: Consideration in the Risk-
Management Models Page 22
3.5 Considerations in using FACA Committees Page 28
3.6 The Federal Facilities Cleanup Case Page 29
3.7 Day 2 Wrap-Up Page 30
4.0 Wrap-Up Activities Page 32
4.1 Summary of Issues and Action Items Page 32
4.2 Workshop Evaluation Page 32
Appendices
Appendix A. List of Participants
Appendix B. Agenda
Appendix C. Risk-Management Models
Appendix D. Breakout Group Flip Charts and Posters
Appendix E. Hand-Outs
This report was prepared for the Office of Science Policy, Office of Research and Development, U.S. Environmental
Protection Agency, by S. Cohen & Associates, Inc., 1355 Beverly Road, Suite 250, McLean, VA 22101, and
Environmental Management Support, Inc., 8601 Georgia Avenue, Suite 500, Silver Spring, MD 20910, under
contract number 68-D5-0132, work assignment III-8. For further information, please contact Gerardo Pascual at 202-
564-2259.
Pagei
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Risk Management Communication and Stakeholder Involvement
Preface
The U.S. Environmental Protection Agency's (EPA) Office of Research and
Development (ORD) is currently pursuing new approaches for using science to address several
topics of importance to the Agency. These topics represent new directions for the EPA in that
they transcend the traditional media- or pollutant-based boundaries and encompass a variety of
disciplines and specialities. ORD wishes to link EPA staff interested in these topics with the
appropriate science staff in ORD to identify areas for collaboration. To accomplish this goal,
ORD's Office of Science Policy (OSP) is hosting a series of New Directions workshops between
March 1999 and Spring 2000. The workshops will provide a forum to present information and
discuss current and future issues on new topics of interest. There are four topic series being
presented under the auspices of New Directions: risk management, community assessment,
reinvention, and regional science. Each topic series will consist of workshops designed to bring
interested staff together to develop a set of action items that will be completed over the course of
the series.
The Risk Management workshops are designed to identify the types of information, such
as costs and benefits, technological feasibility, community values, and other non-risk assessment
information, that EPA managers need and use to inform their risk-management decisions. The
first workshop, held June 15-16,1999 in Washington, D.C., dealt with developing information
needs for risk management decision-making. This summary describes the second workshop, held
July 14-15,1999, which discussed communication and stakeholder involvement in risk
management. A third workshop may be held, perhaps in conjunction with the third workshop of
the Community Assessment Series. The desired outcome of the series is a review and analysis of
risk-management processes and information needs for use in the development of a draft unified
paradigm for organizing and providing information to risk managers.
The second workshop, Communication and Stakeholder Involvement in the Risk-
Management Process, had the following objectives: (1) to obtain the perspectives of risk
assessors and risk managers on how they communicate during the risk management decision-
making process and to discuss how a unified model for providing information could enhance
such communication, and (2) to discuss how stakeholder input can add value to the decision-
STATUS OF THIS REPORT
The objective of this workshop (or workshop series) was to bring together EPA scientists from the
regions, programs, and ORD labs and centers to discuss issues of common interest. The focus of
the meeting (or each meeting) was preliminary discussion among scientists and managers from
different parts of the Agency, each with their individual and office-specific information and
viewpoints.
As a result, it is important to understand that this report summarizes individual and program-
specific perspectives. References to pre-existing Agency information and policies should be
credited as such, but none of the individual, workshop statements or summaries in this report
should be credited or cited as Agency information or policies. Rather, this report is developed
exclusively for internal EPA use and distribution as a record of the meeting for participants in each
meeting, and for EPA's use in planning future meetings and discussion. EPA staff will use
information from this report, as appropriate, to design and conduct workshops or other activities
for broader discussion both within EPA and with external participation, again as appropriate.
Page ii
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Risk Management Communication and Stakeholder Involvement
making process and how such input could be incorporated into a unified risk-management
information model.
This report summarizes the information that was presented and exchanged during the
workshop. The organization of the report follows the agenda of the workshop. Approximately 35
EPA staff, representing EPA program offices, ORD, and several EPA Regional offices,
participated; Appendix A provides a complete list of participants. The two-day workshop was
designed to maximize participant input and collaboration; Appendix B is a copy of the final
agenda. Appendix C includes copies of the models discussed. Finally, Appendix D gives
transcriptions of flip charts and posters produced during the workshop's breakout group
discussions.
Page iii
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Risk Management Communication and Stakeholder Involvement
1.0 Introduction
The New Directions initiative and the Risk Management series were introduced in a
presentation by Hugh McKinnon, of the U.S. Environmental Protection Agency (EPA) Office of
Research and Development (ORD), National Risk Management Research Laboratory (NRMRL).
The mission of NRMRL is to enable, assist, and support Agency decision-making. This series is
intended to raise the visibility of the risk-management process within the Agency to the same
level as risk assessment. By conducting this series of workshops, EPA's Office of Science Policy
(OSP), also within ORD, hopes to be a catalyst for discussions and follow-up actions for
decision-making. OSP is uniquely qualified for this position since it works with all the program
offices within the Agency. OSP seeks to determine information needs and research needs and
provides suggestions on how ORD can support the Regional and program offices in the risk-
management process. Research needs identified by the workshops in the series will be
incorporated into research planning. This work is particularly important at this time, as the
Government Performance Review Act (GPRA) spurs the Agency to pay particular attention to
the outcome and effectiveness of its decisions.
The first workshop in the Risk Management series was held June 15-16,1999, and
addressed information needs for risk management. Proposals for several risk-management
paradigms were examined to determine how better to frame the process. Participants at the
workshop found that risk management is not a uniform process across the Agency. EPA's role as
a decision-maker is often dependent on differences in the enabling legislation for the various
EPA regulatory and research programs. Risk assessment plays a strong role in risk management
decision-making; however, many additional factors are considered in making decisions. These
factors include: transaction costs and research burdens associated with decisions, issues of
fairness, enforceability of decisions, economic considerations, and technological feasibility.
The risk assessment-risk management process, and indeed the decision-making process as
a whole, is usually not linear. Instead, decisions must often be made at times when EPA lacks a
complete understanding of risks and other factors. Participants hi the workshop series will
continue to examine a variety of proposals for risk-management frameworks. The strengths of
each will be combined into a consensus framework, to the extent possible, that is case-dependent,
flexible, and simple.
Perhaps the most important finding of the first workshop was that open communication
throughout the risk management decision-making process is key to its success. As a result, this
second workshop examines communication between the risk manager and risk assessor, as well
as between the risk manager and stakeholders.
Pagel
-------
Risk Management Communication and Stakeholder Involvement
2.0 Communication Between the Risk Assessor
and the Risk Manager
The first day of the workshop focused on communication between the risk assessor and
the risk manager. Through presentations and breakout sessions, participants sought to identify
the issues particular to both positions and how the risk assessor and risk manager can most
effectively work together throughout the risk-management process.
2.1 Perspectives on Internal Communication
2.1.1 The Role of Risk Assessment in the Risk-Management Process (Plenary Discussion)
Risk assessment plays a very important role in the risk-management process. However,
decision-making does not hinge on the risk assessment alone. Whereas the risk assessment serves
to define the problem, the risk-management decision itself also requires consideration of other
factors, such as economics. Because of the technical nature of the risk assessment, it is often
falsely assumed to be more complicated than it is. In addition, since risk assessments depend on
the quality of the data input, as well as the level of conservativeness in such inputs, some risk
managers are distrustful of risk assessments. Rather than accepting a good, low-cost solution
based on risk alone, a risk manager may assume that the solution is not sufficiently protective
because of its low cost. Finally, risk assessments are not always definitive, but often require the
judgment of the risk manager in making a decision.
Some in EPA are currently considering whether risk-assessment information needs
should be considered separately from other information used in the risk-management process.
While separation may not be feasible, it is important to remember that risk assessment is only
one factor in the risk-management process. Risk assessment is often the focus of attention,
because it is the part of the risk-management process that is based on scientific data. Many
people trust such information more than other subjective considerations. Because of this, a
quantitative basis for decisions may be sought even if a decision has been based on other factors.
Risk data obtained through the risk-assessment process are also important, because all of
EPA's enabling legislation, with two exceptions, requires the improvement of health as a primary
basis for decision-making. Only the Toxic Substances Control Act (TSCA) and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) require EPA to consider cost in its
decision-making process. Decision making based on health alone places risk assessment at the
center of the decision, although the reality of decision making at EPA is that other factors are
also important.
2.1.2 Communication between the Risk Assessor and Risk Manager (Plenary Discussion)
Participants were asked to consider communication between risk assessors and risk
managers in their own offices and comment based on the following questions:
In your program, how do risk assessors and risk managers communicate
throughout the decision-making process?
Page 2
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Risk Management Communication and Stakeholder Involvement
• At what points in the process do they communicate?
• What kinds of critical information are elicited from this communication?
• Do communication breakdowns occur? If so, why? If not, how are they avoided?
In many cases, communication between risk managers and risk assessors works well if
the risk assessor is included on the risk-management team from the beginning. Continuity and
trust among staff members makes decision-making at the staff level more successful. However,
when decisions are raised to a higher management level, political considerations and second-
guessing of staff decisions can pose a problem. One factor that impedes good communication
between the risk assessor and the risk manager is time pressures. Time constraints placed on the
risk assessor can make complex work and responsiveness difficult and may cause an increased
reliance on contractors. Likewise, a risk manager can also be under time constraints, such as
statutory mandates or political pressures. These issues may be unfamiliar to the risk assessor.
In an office with few risk assessors and many competing priorities, a risk manager may
find difficulty gaining the attention of the risk assessor. As a result, the risk manager may be
forced to work directly with a contractor, even though he or she may lack the technical
background necessary to properly oversee the work. This appears to be a particular problem for
smaller sites; risk assessors are generally assigned to work on larger, more problematic sites,
leaving the risk managers for smaller sites to take on more of the technical, risk assessment work
themselves. As a consequence, risk managers for the smaller sites are left with less time to
concentrate on the other aspects of risk management.
The best risk-management outcomes occur when the risk assessor and risk manager can
work together from the beginning of a project before stakeholders enter the process. The risk
manager uses the expertise of the risk assessor to create and evaluate different risk scenarios,
rather than Involving the risk assessor only at the point of examining data. This can help focus
the work of the risk manager on those risks that seem potentially significant and the risk assessor
can obtain an idea of the mitigating factors that may make one potential risk factor more or less
important than another. By an early examination of the existence of useable data and the analysis
of detection limits, the risk assessor can help the risk manager design the entire site investigation.
2.1.3 Criteria for Successful Communication (Plenary Discussion)
Participants discussed a number of criteria for the success or breakdown of
communication between the risk manager and risk assessor. (See Appendix D for a transcription
of the flip chart prepared during the plenary session.) In general, it is vital to consider risk
assessment as one of many drivers for risk management, but one that attracts much attention. In
order to make and then explain or defend a decision, the risk manager must have a full
understanding of the risk assessment. In order to ensure that the risk assessment addresses the
problems and issues faced by the risk manager, it is vital that the risk assessor understand the
context in which the risk manager is working.
Page 3
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Risk Management Communication and Stakeholder Involvement
The risk assessor and risk manager must come together at the beginning of the risk-
management process to discuss the goals of the process as well as any time constraints, either in
the form of statutory requirements or workload. Doing so will increase trust and commitment
among team members. Risk assessors must know the context of their work and understand that,
although a risk assessment might ideally continue until a problem is solved, this is not possible
under the time lines set by statute. In addition, through an awareness of the time frame and
budget for an assessment or decision, the risk assessor will be able to describe the potential limits
on data collection and analysis. These limits may serve either to focus the assessment or to
indicate its likelihood of success. By an early discussion of the problem and its context, the team
can anticipate criticisms of the risk assessment and understand what stakeholders will be looking
for from the assessment. This early involvement must be considered, however, as an addition to
the risk assessor's already heavy workload.
Specific goals of a project should be discussed. For example, the goal may be to clean up
the site, but what pollutant levels would be considered 'clean'? How much uncertainty is
acceptable? How conservative should the risk estimate be? Risk managers must understand that
the amount of money devoted to a risk assessment will determine the level of data which can be
obtained and therefore the level of uncertainty associated with the analysis. Communication
throughout the process allows for refocusing of resources on identified concerns, either those
with a technical basis, as identified by the risk assessor, or those with a non-technical basis, as
identified by the risk manager.
It is important for scientists to be without bias and not to use inputs deliberately that
would make the outcome of an assessment support a pre-determined decision. While a risk
assessor should be aware of the context of his or her work, it is important to separate political
influences from risk assessment outcomes. Some participants felt that because the outcome of a
risk assessment depends on the data entered at the beginning, there exists the potential for risk
managers to make a decision and then ask the risk assessor to use the data or levels of uncertainty
that support the decision. Doing so could create mistrust between the risk assessor, who wishes
to protect public health based on the risk assessment, and the risk manager, who must also
consider other factors. Not only is this a potential conflict within EPA, it is also a concern among
Congress and lobbyists, which often accuse EPA of using risk assessment to support already-
existing decisions.
Although the risk manager should not attempt to fit the risk assessment to his or her
decision, it is also important for the risk manager to know as soon as possible the direction the
assessment is taking. This will allow the risk manager to begin to consider the challenges that
will be associated with a particular decision. For this reason, it is helpful for the risk manager to
have an estimate of the risk assessment before it is completed. Screening out some sources or
pollutants early in the risk assessment stage can focus the assessment and allow it to be truly
helpful for the decision which must be made. Consideration of different scenarios is done for
more complex, larger-scale risk assessments, in which data are not collected for each source and
assessments are based on estimates and hypothetical scenarios.
Determining the type of data to use in a risk assessment will affect the outcome. The use
of defaults or estimates tends to result in a more conservative risk estimate than the use of site-
Page 4
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Risk Management Communication and Stakeholder Involvement
specific data. Risk managers are reluctant to accept a risk assessment that shows that less cleanup
is necessary than the risk manager believes is acceptable, based on cleanup levels that were set
using estimates rather than site-specific data. On the other hand, the risk assessor, as a scientist,
believes that the truth is found only in the data. However, risk managers
sometimes find risk assessments based on assumptions that are too conservative for a process in
which decisions must be made based, at least in part, on subjective considerations.
2.1.4 A Regional Perspective on Risk Management (Bill Murray - Region 8)
Two cases from the Region 8 Superfund program were presented. The first involved the
Summitville gold mine in Colorado. The mine had been operating cyanide leaching technology
without a discharge permit. The firm then went bankrupt. Meanwhile, rainfall levels had been
underestimated and leachate run-off flowed towards the river. In 1994, the site was registered on
the National Priorities List (NPL) and was stabilized so outflows did not occur. EPA did not
include toxicologists on the initial risk-management team and a risk assessment was not
performed before $85 million was spent on remedial work. A human-health risk assessment was
then attempted and previously gathered data were found to be useless. The ecological risk
assessment was also delayed. As a result, the community downstream of the site lost respect for
EPA.
The second case was at the Murray lead smelter in Utah. Arsenic and lead in soil and
water were of concern and this site was proposed for listing on the NPL. The following nine
criteria for risk management at Superfund sites were considered:
• Threshold Criteria:
Overall protection of human health and the environment
Compliance with applicable or relevant and appropriate requirements
• Primary Balancing Criteria:
Long-term effectiveness
Reduction of toxicity, mobility and volume
Short-term effectiveness
Implementability
Cost
• Modifying Criteria:
State acceptance
Community acceptance
The site team was established early and included both the risk assessor and risk manager.
The community was also involved from the beginning and was shown a conceptual model of the
process and the site. A stakeholder working group was established to develop alternatives for
future land use. A toxicologist was available at all public meetings to explain technical issues. At
this time, remedial action is underway. However, the Utah Department of Environmental Quality
is not pleased with the management decision, wishing the Federal government to pay for the
most extensive cleanup possible, despite the fact that the risk levels do not support such action.
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The importance of involving the risk assessor at the beginning of the risk-management
process has been emphasized. However, the risk assessor should also be involved during the
post-decision review process, which for many programs is required after five years. During this
review, EPA evaluates the effectiveness of the decision. The same considerations that applied
during the initial decision-making process remain important during the review process.
One aspect of communication is trust in the objectivity of a risk assessor. In Regional and
program offices with few risk assessors, generation of the risk numbers may depend on one
person rather than a team. Since the risk assessment process takes place in the public eye and is
not separated from the risk-management process, the potential for bias exists. A risk assessor
often spends time at a problem site and may have his or her own opinion on the correct solution.
The style of analysis chosen, the uncertainties accepted, the level of conservativeness, and the
use of estimates or site-specific data are choices made by the risk assessor that can affect the
outcome of the risk assessment. These choices are based on the professional judgment of the risk
assessor; this judgment must be trusted by the risk manager as well as by stakeholders. The risk
manager must then interpret the resulting risk numbers and make a decision. It has been
suggested that risk assessments undergo peer review to build confidence in the assessment.
The risk assessor looks to the data to determine risks. While the risk assessor might wish
to base a decision solely on objective data, this is not always possible for the risk manager. For
example, stakeholders desiring the most extensive cleanup that can be had may be in conflict
with the needs of other stakeholders, who feel that the incremental risk reduction may not be
worth the resources that must be expended. At other times, what might be a good solution from
the perspective of risk may not be acceptable to stakeholders. In an example from the Murray
lead smelter case and others, some stakeholders would not accept a solution as "safe," even
though the technical risk assessment showed that it was.
In summary, a risk manager must consider issues of cost, public perception and
acceptance, and legal limitations, as well as risk, in making a decision. In some cases, these
considerations may take precedence over risk, especially in situations in which science is not yet
capable of providing a risk estimate devoid of great uncertainty.
2.2 Planning and Scoping for Risk Managers and Assessors (Ed Bender - ORD/OSP)
The risk manager uses risk assessment to guide the risk management decision-making
process, from problem formulation to analysis to risk characterization. Planning and scoping for
both the risk-management and risk-assessment processes ensure that the risk assessment work is
relevant to the decision that must be made. During planning and scoping of the risk assessment,
technical issues such as the presence of risk drivers should be addressed, but other factors related
to the context of the decision, including economics, legal questions, and social analysis, should
also be discussed. Stakeholder input may not directly affect the risk assessment itself, but it does
influence the risk-management decision. Because the purpose of the risk assessment is to inform
that decision, stakeholders do have an indirect relationship with the risk assessment.
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Existing guidance on cumulative risk and ecological risk assessments focuses on planning
and scoping and can be used for risk assessments supporting risk-management decisions. Other
EPA workshops on cumulative risk have divided the planning and scoping process into the
following five steps:
• Discuss why the assessment is needed. It is important for both the risk manager
and risk assessor to understand the problem that requires a solution or a decision.
The risk-management objective serves to orient the discussion about the risk
assessment.
• Define the scope of the effort. Not only should the team brainstorm to determine
the stressors and other technical factors to be addressed in the risk assessment, but
the team should also discuss the particular remedial options that the risk manager
is considering. How much of what type of data is required to decide among these
options? How much budget or management support is available for the
assessment?
• Determine the context (what factors will be included/excluded?). The context of a
problem will give an idea of which risk-management options will be politically
acceptable, and how much difficulty will be encountered if a particular option is
selected.
• Develop a conceptual model. This model should show the relationship between
the stressor/pollutant and the endpoint of concern, tracking it through the
environment to the receptor. This step involves brainstorming, screening out
factors of less concern, and understanding what type of data are available for each
stressor.
• Formulate the problem and analysis plan for the assessment. The analysis plan
links planning and scoping to the assessment itself. It serves to highlight priorities
for the risk assessment, so that it informs the decision that has to be made by the
risk manager. The consequences of missing data should be discussed, as well as
potential sources of surrogate data outside the Agency.
The process outlined above is not linear but allows for brainstorming about different
scenarios. It also provides the flexibility necessary to decrease the focus on one factor and move
on to another, if necessary. Some factors simply will not be considered because of legal, cost, or
political constraints, so time and resources should not be wasted on them. Finally, it is important
to document the decision-making process so that those evaluating a decision later will understand
how it was made. Doing so assists senior management in addressing questions about the decision
and facilitates future evaluation.
2.3 Case Study Presentations - Communication Issues
2.3.1 Pownal Tannery Superfund Site (Leslie McVickar - Office of Solid Waste and
Emergency Response)
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In 1998, EPA listed the Pownal Tannery in North Pownal, Vermont as a Superfund site.
While a human health risk screening (performed in support of an ongoing non-time critical
removal action) did not exceed the level of concern typically used to place a site on the NPL,
other information unrelated to the risk assessment weighed heavily in the decision to act The
Emergency Cost Evaluation Analysis protocol was used, which provided more flexibility than
the Superfund criteria. Contaminant threats included metals, semi-volatile organic compounds,
and dioxin in ground water, soil, sludge, and building materials. While data showed that the site
had not adversely affected the nearest residential wells, continued migration of contaminated
ground water could present a future threat to human health. Using very conservative
assumptions, EPA's human health risk screening indicated low risks to the most at-risk groups,
including adolescent trespassers returning to the site daily and future adult employees.
During this case, data were not necessarily available for all factors that might be
considered risks. In fact, some risks were simply not quantifiable, such as the physical risk from
the building itself and releases from flooding or fires. Because of this, the risk manager sought to
make the known risks conservative enough so as to provide protection from the non-quantifiable
risks. By making conservative assumptions, lower levels of known contaminant risks were
increased. The risk manager sought to make a decision based on a common-sense analysis of
various scenarios as opposed to relying simply on risks demonstrated by the data. The risk
manager worked with the risk assessor to ensure that the conservative assumptions remained
valid. In addition, the risk assessor supported the risk manager in evaluating the technical aspects
of the contractor's work and in identifying factors and applicable regulations to communicate to
the contractor.
2.3.2 Phosphide Fumieants (Mark Hartman - OPP)
Within the Office of Pesticide Programs (OPP), the risk manager is considered the leader
of a team working towards a regulatory decision. It is necessary to coordinate interdependent
efforts of the team (such as the results of those examining exposures from different media), fulfill
information needs and data requirements, maintain the project schedule, set priorities, communi-
cate with management, and develop a mitigation strategy. The risk assessor works with the risk
manager to enhance his or her understanding of risk and other science issues, while the risk
manager communicates policy issues to the risk assessor. Communication begins at the team
kick off meeting and continues through the development of the risk assessment, the development
of the mitigation strategies, and the regulatory decisions.
EPA is required by FIFRA to reregister pesticides, including aluminum and magnesium
phosphide, that were originally registered before November 1,1984 to ensure that they meet
today's more stringent safety standards. Registration of a pesticide is a scientific, legal, and
administrative process through which EPA examines the ingredients of the pesticide; the
particular site or crop on which it is to be used; the amount, frequency, and timing of its use; and
storage and disposal practices. EPA assesses a wide variety of potential human health and
environmental effects associated with product use.
The reregistration process for aluminum and magnesium phosphide began with several
potential problem areas. The risk manager in charge was about to leave EPA and the risk assessor
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was newly hired. Other turnover of key players increased the pressure to complete the product
review while removing some of the expertise to do so. In addition, the industry stakeholders were
smaller companies who were not familiar with the applicable regulations and had no experience
with the process. Finally, EPA was attempting to use a new approach utilizing greater
stakeholder involvement in the process.
The risk-management team responsible for this project sought to ensure its success. The
team accepted the fact that they had to flatten their learning curve by working together and
strategizing with many minds to determine a successful approach. They also recognized the
importance of educating industry. By maintaining open, honest, consistent, and two-way
communication, the team was successful in its efforts. While a natural dichotomy exists between
the risk assessor and risk manager, as it exists between science and policy, it is vital that the two
work together as a team.
Without successful communication, the team might have failed to meet its milestones. It
would have been faced with reworking its assessments, since the science provided by the risk
assessor would not have matched the needs of the risk manager. The team would not have been
able to inform its management of project progress correctly. Ultimately, these problems would
have led to a poor decision.
2.4 Risk-Management Information Models (Hugh McKinnon - ORD)
Risk assessment guidance has existed since 1983, when the first guideline from the
National Academy of Sciences was published. The process follows these four steps: (1)
identification of a hazard; (2) assessment of the dose-response relationship; (3) assessment of
exposure; and (4) characterization of risk. A similar framework for risk management has been
developed. A model developed by the National Research Council in 1996 follows an iterative
process with analysis and feedback throughout. Other groups, including ORD, have also created
models depicting the process (see Appendix C). These models attempt to show the types of
information needed to reduce uncertainty in the risk-management process. The models tend to
lack an evaluation component, which will become increasingly necessary as the Agency attempts
to demonstrate its GPRA goals.
The data needs identified in the risk-management model cover a wide range of areas,
many of which are outside of EPA's traditional expertise. ORD is considering building up social
science expertise, such as economists, to provide support to program offices. ORD is also
undertaking a series of pilot programs to examine risk-management options and predict
effectiveness and cost for four areas: (1) endocrine disrupters; (2) fine participate matter; (3)
arsenic in drinking water; and (4) Pfisteria.
2.4.1 Breakout Exercise - Communication During Planning and Scoping
Participants were divided into three groups for this exercise. Each group was asked to
discuss the risk management/risk assessment communication process and develop a set of
principles for what should be done or avoided, from the perspective of communication, to aid the
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process. Summaries of each group's work are presented below; transcripts of flip charts prepared
during the sessions are given in Appendix D.
Breakout Group 1
Group 1 first differentiated between external and internal risk-management
communications. Communication with stakeholders is considered external, while the dialogue
between the risk assessor and risk manager is an internal process. Group discussion examined
three aspects of this internal communication process:
• Defining risk-management project roles and qualifications
• Creating project teams
• Using documentation to ensure risk-management communications
To create a structure to ensure successful communication during the risk assessment, the
role and qualifications of the risk assessor should be defined during initial project planning. For
example, risk assessors may be trained as toxicologists, statisticians, or those with other areas of
expertise. Their view and interpretation of information will likewise vary based on their
educational background. Risk managers must understand the limitations or qualifications of the
risk assessor to be able to use and present assessment information credibly.
The risk assessor must know the full context of risk-management decisions and
understand that the role of the risk manager includes attending to socioeconomic considerations
as well as to scientific data. The risk assessor must be kept involved in the process as decisions
are made. The risk assessor can provide clarification of assessment details, support the
interpretation of information for decision-making, and help refocus the effort if necessary.
Currently within EPA, however, risk assessors are not available for additional input
during risk management decision-making, because project resources are reassigned to the next
risk assessment. One way to ensure that project resources are available for the duration of
decision-making is to create permanent project teams. Permanent project teams would support a
feeling of project ownership and would provide continuity and clear accountability. Training
programs should be structured so that, at a minimum, risk assessors and risk managers are trained
together. If possible, all risk-management project team members could train together to ensure
that methods are defined, roles understood, and the many kinds of information that are factored
into a risk-management decision are communicated.
A second step to ensure good communications between the risk assessor and the risk
manager is to identify areas hi which the information needed by a project's risk assessor and risk
manager overlap. The focus should be on what information both need to know and what
information must be documented for use by future risk managers and others, such as new
employees, who will be trained to work on projects.
A formal documentation process, which describes the rationale behind risk-management
decisions, is needed to capture lessons learned during project work, provide a solid basis for
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defending risk-management decisions, and record the existence of special circumstances which
were used in the decision-making process, thus minimizing the possibility of the decision being
considered a precedent.
Decision trees offer one form of graphic documentation that can be used both to structure
and to record project choices. Additionally, decision trees clearly present the uncertainties
contained within the decision-making process. Because decision trees are not widely used in risk
management at this time, cultural change must be initiated within the Agency.
Since many risk assessments must be made within short time frames, any documentation
process created should be supported administratively and be easy to implement. Existing Agency
formats could be used and adapted for this purpose. All documentation should work toward
clarifying project issues, since one of the major goals of communication is ensuring that all those
involved understand the issues in the same way.
A method of ensuring the accuracy of communication between the risk assessor and the
risk manager is to build feedback loops, or communication milestones, into the process.
Communications should involve a follow-up step in which receipt of any information is
confirmed. After the information is used, the communication process should involve some kind
of debriefing step in which the risk assessor and risk manager can evaluate if their actions
worked toward furthering project goals.
Breakout Group 2
The group began by laying out the decision-making process as a whole. It includes the
following steps:
Identifying the problem
Planning and scoping
Analyzing factors
Considering management options and transaction costs
Making the decision
Evaluating the decision
Transaction costs include the potential loss of political capital resulting from a decision; a
particular solution may be achievable in the case at hand, but the overall effect on the entire
program may be detrimental.
Preliminary and detailed planning and scoping is an iterative process. It includes
bounding what will and will not be accomplished, based on legal, statutory, resource,
stakeholder, and other concerns. A clear explanation of what will not be accomplished is
important, not only for maintaining trust with stakeholders but also for highlighting potential
gaps that might be addressed by others. Finally, creation of a conceptual model during scoping
will help the risk-management team plan the rest of the process.
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The group then considered factors in the process, such as the risk assessment for a health
or ecological exposure; prioritization of risk; selection of endpoints; identification of
management goals for the entire EPA program and for the specific case under consideration; the
cost effectiveness of the decision (whether a remedy or regulation); stakeholder involvement;
technical feasibility; political feasibility; legal issues; State acceptance; and risk-management
options.
The group attempted to place each factor into the process, but concluded that most factors
required different levels of consideration at many points throughout the process. This demonstra-
ted the iterative nature of the process. For example, stakeholder involvement is important in all
parts of the process in order to make it transparent. However, there are points in the process at
which each type of stakeholder can best be involved. Not all stakeholders have the scientific
background to contribute to the more technical aspects of the discussion, but should be involved
in making decisions based on science.
The group then considered communication aspects involved with these factors. It was
decided that communication needs are similar for all factors; therefore, the group chose to
consider risk assessment in particular. The group identified who was involved in the assessment,
when they should be involved, and what their involvement should be.
Risk assessors, as stated throughout the workshop, must be involved in the process and
communicate with the risk manager. This should occur "early and often," depending on the level
of the risk assessment, the resources available, the level of trust, and organization policy. An
important role of the risk assessor is to educate the risk manager. Participants felt that the
Agency currently hires young, non-technical people and expects them to perform the job of risk
management without training. New hires should receive an initial orientation to familiarize them
with the work of all the different parts of EPA. They should be connected with those who have
more experience within the Agency. Stakeholders must also be involved in the process from the
beginning, but their level of involvement depends on the stages of the process, among other
factors.
Breakout Group 3
This group focused on developing a sample process as well. They determined that it is
important to build the team early, identify stakeholders, provide basic information on the issues,
and define the goals for both the risk-assessment and risk-management processes. In addition,
applicable regulations, legal requirements, and potential obstacles to the process, both technical
and political, must be identified early. They emphasized that all members of the team must
understand the complexity of the process.
A regional representative provided information on how the process actually looks to those
involved. The framework of the process appears simpler in application than the discussions make
it seem. Also, in practice, there is a greater awareness of an overall schedule of projects and the
teams responsible for them. It is important to remember that the risk-management process does
not represent the first involvement with a site, but rather occurs after significant and useful
preliminary work has been done, often by a site assessment team.
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An important consequence of this prior work is the existence of available and potentially
useful data. In many cases, these data contribute to how the risk manager sets priorities and
directs the initial stages of the process.
The usefulness of existing data to aid in the creation of a conceptual model and identify
preliminary options must be balanced with the need for a risk assessment to be completed before
determining remedial options. In trying to navigate this tension, the group discussed both the
uses of a conceptual model and the values of iteration. The conceptual model was seen in one
sense as helping team members understand the process beyond their individual perspectives.
However, most were wary of a model that would define the process too strictly before the data
were received from the risk assessors.
In practice, this problem is solved by maintaining communication and interaction within
the steps of the process. Therefore, risk assessors do not simply receive assignments and return
with a final result. Rather, there is a system of review of interim deliverables, which creates a
forum for the risk manager to inform the risk assessors of changing priorities and to negotiate
additional data needs. The iterative process provides a mechanism to revisit assumptions based
on new data, such as new exposure scenarios. In this sense, the conceptual model serves both as
an early framework and as a tool to manage the products of the iterative process.
Once the goals of the process are set, the risk assessor can work with the risk manager to
determine the amount and quality of data necessary to meet those goals. In addition, the
resources necessary to obtain and analyze the data must be estimated. When the scope of the
effort is known, team members can set up a schedule for the risk assessment and review process.
Review throughout the risk-assessment process is important so that the risk manager can
anticipate the outcome and the assessment can be focused on the most important aspects of a
problem. The risk manager can identify potential scenarios and a preliminary risk analysis can be
performed. Such screening should be done before completing a full risk assessment on factors
that are not important. Flexibility must be built into the process to address changing needs
identified during the preliminary stages of the assessment.
Plenary Discussion
During the plenary discussion following the breakout groups, the point was raised that
potential exists for conflict between the engineer and the risk assessor. Engineers do not see the
value in assessing risk in cases in which the best available technology is already being used.
However, risk assessment hi such cases can point out potential problems requiring an
engineering solution. Risk can be considered hi conjunction with technical limitations in the
following four ways: (1) if there is a low risk and control technology exists, it should be used if
cost effective; (2) if there is a low risk and no technology exists, nothing needs to be done; (3) if
there is a high risk but technology does not exist, it should be developed; and (4) if there is a high
risk and technology exists, it should be used.
The group agreed on several factors involved hi enhancing communication between the
risk assessor and risk manager. The first is assembling the entire team, including the risk
assessor, early and setting project goalsr perhaps using a conceptual model to ensure that all
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understand their roles in the context of the project. Initial scoping and planning must address
identifying key stakeholders, legal requirements, project time line, and data-quality requirements.
Continuous communication is necessary throughout the process. Risk assessors should provide
preliminary findings to the risk manager so that priorities for the risk assessment might be
refined as necessary. This will also allow the risk manager to define potential options and begin
to evaluate them.
2.4.2 Technical Innovation Support (Deanna Crumbling - TIO)
The EPA Technology Innovation Office (TIO) works to move innovations for the
characterization and remediation of hazardous waste streams into common practice, particularly
hi the Superfund and Resource Conservation and Recovery Act (RCRA) programs. Of particular
interest to the risk manager is Field Analytical Technology, which is becoming easier to use and
may be able to provide data in support of risk assessment. The technology should be combined
with planning methods to increase its efficiency, hi a process called Technical Project Planning.
While this process requires more resources at the beginning, the end result is more likely to be
acceptable. Less resources for redoing work that was unnecessary means cost savings over the
long run. TIO has created a training program for Superfund remedial project managers and their
management, although modules will be created.for use at the staff level. The 4 '/2-day course
covers project strategy and Field Analytical Technology.
A software system, called Spatial Analysis and Decision Assistance, has been created by
the University of Tennessee and is in the beta-testing phase. Once data are entered, the system
plots boundary maps and determines uncertainties for different risk levels. The system can assist
investigators in identifying sample locations that will be most helpful hi reducing uncertainties.
The program will be available through the Internet. TIO seeks input from EPA staff on potential
applications of the software and other modules it should include.
Workshop participants pointed out that there is a misperception within Agency
management as to which systems and protocols are usable. They suggested that TIO meet wilh
staff throughout the Agency program offices to address obstacles to the use of new techr.chry.
TIO should focus its outreach on mid- to upper-level management rather than on staff members,
who are interested in the tools but not permitted to use them.
2.5 Risk Assessor - Risk Manager Collaboration on Five Watershed Assessments (Victor
Serveiss - ORD)
Risk management through a watershed approach requires merging environmental science
and ecological risk assessment with public policy. A variety of factors enter into decision-
making, including social and cultural factors, legal mandates, political considerations,
economics, historical precedence, and ecological risk. Watershed assessments were conducted at
five demonstration sites around the country (Waquoit Bay, Massachusetts; Clinch Valley,
Virginia; Middle Platte River, Nebraska; Mid-Snake River, Idaho; and Big Darby Creek, Ohio).
Risk-assessment and risk-management teams were created for each site. Risk-assessment teams
included universities and research centers in the region, contractors, EPA Headquarters and
Regional offices, and other Federal agencies. Risk-management teams included some of the same
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research centers, non-profit environmental groups, farmers, and local, State, and Federal
government entities.
Risk-management goals for watersheds are not as clear as those addressing only health
concerns. For example, reduction of certain pollutants can be traced directly to increased cancer
incidence in a. population, while the effects of pollution in a watershed are less obvious.
Traditional risk assessments are not appropriate for determining effects on a watershed. Instead,
cumulative risk assessments are required in order to examine multiple stressors. For example, to
understand the effects of a mine on a watershed, the risk assessment must consider a variety of
stressors, including sediments, excess nutrients, and chemicals. Because cumulative risk
assessment is a complex process, it is important for the risk assessor to work with the risk
manager to determine from the start what resources and budget would be required to obtain
meaningful results.
The process for risk management for geographical settings should begin with a clear goal
and definition of the scope of the risk assessment. A conceptual model of the process, outlining
ecological effects and measurements, should be developed. Such a model might flow from
identifying the source, stressor, response, and finally a measurable change. Such models are
powerful communication tools, in that they illustrate the link between human activities and
ecological effects. They facilitate understanding multiple stressors, pathways, and the watershed
approach. However, it is important to maintain flexibility as multiple issues arise and the focus of
the effort changes.
In the case of watersheds, the current regulatory authority of EPA is not necessarily clear.
Therefore, the result of the cumulative risk assessment may not be a regulatory decision by EPA.
Instead, EPA will seek to point the problem out to those who can take action, including State and
local authorities as well as other stakeholders. In these cases, the role of the EPA risk manager
might be to simplify the technical aspects of the assessment for the stakeholder audience and
provide suggestions of risk-management options. It is particularly necessary, then, for those
stakeholders to understand what will, and what will not, result from the risk assessment
In the case of watersheds, and other times in which EPA does not have clear regulatory
authority, it is the stakeholders who are the true "risk managers" because it is they who can take
action. For example, in the case of non-point source pollution from farm runoff, EPA can
identify the problem and provide suggestions for best-management practices. However, it is the
fanners themselves who, in the absence of regulations, must decide to implement them. It
becomes part of EPA's job to help these "risk managers" understand the situation and address it.
2.6 Day 1 Wrap-Up
At the end of the first day, workshop participants were asked to consider key points they
would wish to convey to the EPA Administrator regarding the Agency's focus on
communication in the risk-management process. The most important of these points is that
communication between the risk assessor and the risk manager must occur early, often, and
continue throughout the process. Other participant perspectives include:
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• Sufficient risk-assessment capability, in the form of staff and money, to provide
quality information to the risk manager in a useful format does not currently exist
at EPA.
• Early interaction between the risk assessor and risk manager is necessary and
must be institutionalized so that the connection remains strong throughout the
process.
• Communication between the risk assessor and risk manager does not simply
involve keeping each informed during the process, but rather clarifying
information and actually working together to solve a problem in a scientifically-
and politically-acceptable method.
• New, junior-level employees are expected to enter the risk-management process
without first receiving any form of guidance, orientation, or explanation of the
resources available at the Agency or the benefit of others' experience. An
orientation or training session is necessary so that all members of the team begin
the risk-management process with the same understanding.
• The risk manager and risk assessor must both be educated in all aspects of the
risk-management process so that they can understand the information they receive
from one another.
• Different stages of the risk-management process should be documented, making it
easier for newcomers to the team to understand what has occurred and also to help
explain decisions to management or to those who might question them.
• No single person can know everything about risk management. Cross-disciplinary
understanding is necessary, perhaps through mutual education.
• It is necessary to have a general plan or model for risk management, which creates
a system that all parties agree to and lays out the expectations for all team
members.
• At this time, in some programs risk managers and risk assessors are evaluated
differently, which gives them different perspectives of success. For example, a
risk-management decision may be made that does not involve action, such as
deciding that the level of risk for a particular problem is not sufficient to warrant
remediation. On the other hand, a risk assessor will receive credit for registering a
chemical, but not for sending a chemical back for further development without
registering it, although this is also a valuable action.
• The risk-assessment process should be used to support the evaluation of risk-
management options. For example, the risk manager should be able to discuss
"what-if' scenarios with the risk assessor from an early point in the process to
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screen out factors of low importance and understand which risk-management
options would have the greatest benefit.
• Flexibility must be built into the process. The iterative nature of risk management
means that new information will be added, as the process progresses, both on the
risk-assessment and decision-making levels.
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3.0 Stakeholder Involvement
3.1 Introduction (Hugh McKinnon - ORD)
EPA's Stakeholder Involvement Action Plan, published December 1,1998, outlines
actions EPA intends to take in order to increase opportunities for, and the quality of, stakeholder
involvement inits regulatory and non-regulatory programs. This Plan is available on EPA's web
site at http://www.epa.gov/stakeholders/siapl298.htni. EPA is continuing to consider
improvements to its process of including stakeholders in the Agency's activities. Several
opportunities to examine such issues exist, including the EPA-wide Community Involvement
Conference, scheduled for August 1999 in San Francisco.
The second day of the risk-management workshop examined communication with
stakeholders during the risk-management process. Participants were asked to consider issues
involved with stakeholder communication at EPA (see flip chart transcription in Appendix D).
Their comments are summarized below:
• EPA staff may be involved in negotiations with stakeholders and across offices
and believe that agreement has been reached. However, the project fails when
stakeholders then contact EPA upper-level management directly, who then change
the agreement without ever considering, or possibly even being aware of, the
negotiations that were occurring. This puts the authority of the staff to conduct
such negotiations into question and seriously harms staff morale. EPA staff feel
that they lack the authority to negotiate, and, when they do so, they are not
supported by their management
• Communication during negotiation must involve more than simply having each
participant share their preconceived ideas. Communication requires an effort to
understand the issues of concern to each participant and to understand that
compromise is required.
• Stakeholders must be brought together in an organized fashion, knowing which
issues are available for negotiation and which are not. Stakeholders sometimes
presume that all points of view will be accommodated, which is not possible.
When such stakeholders find that their input was not reflected in the final
decision, the communication process may have built more opposition than
consensus.
• It is important to establish rapport with stakeholders. EPA risk managers should
understand their issues of concern, including those on which they can negotiate
and those which are fixed. All stakeholders, including those who are less vocal,
should be considered. Discussions should be limited so that vested interests and
those unrelated to the question at hand do not take over the process.
• EPA must make a conscious effort to involve the affected stakeholders
themselves, and not simply then* representatives. For example, industry trade
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association staff may not really understand the issues faced-by their members at
the facility level. The members themselves may be interested in some of the
solutions proposed by EPA, which may have been automatically rejected by the
association staff.
• Projects requiring stakeholder involvement do not always have a specific problem
to be addressed by EPA. Instead, EPA could be working to help local groups help
themselves. For example, in the Recycling Superfund Sites Initiative, EPA is
facilitating projects to determine the use of remediated Superfund sites for future
uses.
• Stakeholder involvement must be maintained throughout the process. At the same
time, it should be meaningful rather than done simply because it is required.
Active involvement of stakeholders requires more than simply mailing
announcements or placing notices in the newspaper.
• The public must be assisted in understanding technical issues. Many problems
arise because members of the public are frustrated during discussions because
they do not have an understanding of what is possible. When they do not
understand, the public often believes that EPA is hiding information and will
therefore oppose the Agency's work. EPA representatives at public meetings must
be able to communicate the technical information clearly to avoid misplaced
anger resulting from ignorance. Technical assistance grants also help local
organizations understand the technical issues so that they can participate in a
meaningful way.
3.2 Opportunities for Stakeholder Input (Deborah Dalton - Office of Policy and Reinvention)
Stakeholder involvement is mandated by several regulations and Executive Orders. There
are several categories of stakeholders: (1) parties who directly implement the rule; (2) Stale, £n.d
local co-regulators; (3) parties necessary to implement certain provisions of the rule; and (4}
parties who can block implementation of the rule.
Those who design stakeholder involvement should, above all, be clear about what role the
stakeholders will play in the process. It is important to specify whether they will be participating
in the actual decision-making or limited to providing input to inform a decision made by EPA.
Misunderstanding in this respect can result in stakeholders feeling betrayed that their input was
not used. EPA management must also understand the role of stakeholders in a particular
situation.
Three types of stakeholder roles exist. The first is information exchange, in which
opinions, generally of individual stakeholders rather than their representatives or associations,
are solicited. The second is using stakeholders to provide recommendations in an effort to reach
consensus. However, EPA is not committed to implementing these recommendations. The third
is joint decision-making, in which EPA and outside parties negotiate a rule or enforcement
settlement.
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Including the correct stakeholders is important. The risk manager should consider
potential stakeholders with respect to the knowledge and constituency they bring to the process.
Is it necessary that they participate hi reaching an agreement? Who will support or oppose the
risk-management options under consideration? Known parties to the process should be asked for
suggestions.
Stakeholders can be found in many forms. Members of the general public can be
stakeholders, but they are often difficult to involve because they are not organized. Associations
can provide a useful starting place for locating stakeholders for a particular issue. However, it is
important to know the range of membership in a particular association. For example, in some -
cases it might be useful to involve industry representatives from both large and small companies
rather than simply one association staff person. In addition, associations may send their outside
counsel to a negotiating session, rather than someone actually involved in the' industry. This
counsel may have the agendas of other related clients in mind and will most likely not have the
same understanding of the technical capabilities of the industry as an actual company
representative.
During a negotiation session, stakeholder representatives often form caucuses of allied
interests. The actual negotiation takes place in between meetings and during breaks; discussions
at the table serve to ratify what has been decided during the caucuses. The decisions of the
representatives may be called into question by their constituents if they feel that they were not
consulted. For this reason, it is important to extend involvement, if only at the level of
notification, to members of the public and the media. In addition, representatives must be
reminded and encouraged to undertake the same sort of communication process with their
constituents as EPA does, although this does not always occur.
To ensure that all participants have the same understanding of what is happening in the
decision-making process, brief summaries of all meetings should be prepared and provided to all
participating and other interested parties. Summaries, rather than transcripts, should be used.
When every word of a negotiation is recorded, it may be more difficult to obtain the
compromises necessary for negotiation. It is important for participants to be able to express their
ideas and positions without concern that they will be held to their suggestions. Protocols and
ground rules should be set in advance. They should cover the process of negotiation itself, but
should also extend to the conduct of stakeholders outside the meeting place. For example,
stakeholders should agree on what they will tell the public and the media about the ongoing
negotiations before an agreement is reached.
In summary, stakeholder involvement requires careful preparation. It is important to
include the correct parties and determine the scope and schedule of the proceedings. Stakeholders
should be given lead time to prepare their participation and coordinate their schedules and
budgets with EPA. Unprepared stakeholders, who have not had an opportunity to formulate their
position and points of negotiation, will reject all options automatically. Eight specific
recommendations for success have been identified in a document entitled Best Practices for
Government Agencies - Guidelines for Using Collaborative Agreement-Seeking Processes,
published by the Society of Professionals in Dispute Resolution and listed below:
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• An agency should first consider whether a collaborative agreement-seeking
approach is appropriate.
• Stakeholders should be supportive of the process and willing and able to
participate.
• Agency leaders should support the process and ensure sufficient resources to
convene the process.
• An assessment should precede a collaborative agreement-seeking process.
• Ground rules should be mutually agreed upon by all participants.
• The sponsoring agency should ensure the facilitator's neutrality and
accountability to all participants.
• The agency and participants should plan for implementation of the agreement
from the beginning.
• Policies governing these processes should not be overly prescriptive.
3.3 Stakeholder Involvement in the Rodenticide Cluster Case (Michael McDavit - OPP)
EPA OPP decided to mitigate the potential for poisoning from pesticides included in the
rodenticide cluster. The first phase of this project involved determining short-term mitigation
measures; during the second phase EPA created a stakeholder workgroup to examine long-term
solutions.
The workgroup consists of public interest groups, including a group involved with
environmental justice concerns, as well as large and small industry stakeholders. The first two
meetings of the workgroup were spent on acquainting stakeholders with one another, both
professionally and personally. Members were educated on relevant issues, including the context
for the workgroup as well as the problem. Only later did the workgroup begin examining
mitigation options. EPA staff emphasized that the workgroup was involved in the process to
generate an action plan rather than to argue over predetermined ideas. In this case, EPA was not
seeking agreement from stakeholders for a decision or comments on a proposed policy but rather
the creation of the decision itself.
A variety of lessons were learned regarding stakeholder communication. Stakeholder
workgroups allow for a better understanding of the problem at hand and the risks. They allow for
continued analysis and serve to educate the Agency, the public, and the stakeholders themselves.
They provide a way to better incorporate public values into decision-making. Involvement in a
workgroup is a way of making the process transparent and showing the evolution of a decision.
This activity is extremely resource-intensive; however, agreement is more likely to occur without
challenges and will more successfully withstand challenges that do arise.
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One of the challenges with such a workgroup is to find the correct balance. For example,
some stakeholders have more resources to devote to the work than others. Some, particularly
public interest groups, use volunteer support and do not have the same experience of
participating in this type of activity as an industry stakeholder might. In addition, these
stakeholders may only be inclined to remain involved when they feel that their concerns are
being addressed, although they may not have the same negotiation ability as an industry
representative. It is important to ensure that no stakeholder feels that they are simply there so that
EPA can say that they participated, when in reality their concerns were not even heard. Quality
facilitation is necessary to maintain a balance in the workgroup by addressing bias, encouraging
all who attend to participate fully, and asking participants to be open to all points of view. While
it is important to be inclusive, involving members of the general public who do not have a
constituency may present a problem. Experts in the field may be listened to by stakeholders, but
general members of the public with uninformed issues are more likely to be ignored.
In this particular case, OPP found that the workgroup participants were accustomed to
interacting in a more adversarial context. It was important for the workgroup facilitator to
cultivate a non-adversarial tone to the workgroup and remind participants, particularly industry,
that the process was meant to be cooperative. Likewise, it was necessary for EPA staff to allow
the group to work rather than pushing for a predetermined solution, providing an atmosphere in
which creative problem-solving could occur.
Before convening such a workgroup, it is necessary to set a concrete goal or mission,
although the goal may change as the group works. The mission will help the group know when to
end the process and will help to target discussion. This may be more important than agreeing on
the actual problem. For example, in this case, industry's view of the problem of potential
poisoning differed considerably from that of the environmental justice group. However, as long
as a solution could be found to make poisoning less likely, it was not important to agree on the
problem. It is also important that the expectations of the mission be realistic.
Sustained, sincere commitment of senior management to the workgroup is important.
While the actual work can be accomplished by staff, a senior manager should attend the first
meeting to show that the workgroup has support and that the staff have been delegated authority
to lead. In addition, management should make it clear that difficulties must be addressed within
the workgroup and that bypassing the group to reach upper management will not result in
concessions. Participants should also be encouraged to bring all their ideas to the workgroup
rather than seek EPA staff outside of scheduled meetings, as this undermines the collective work
of the group. EPA's position in such a workgroup is balanced between acting as a facilitator and
as a representative in its own right.
3.4 Breakout Exercise - Stakeholder Involvement: Consideration in the Risk-Management
Models
Workshop participants were divided into three groups and asked to develop
recommendations for applying the principles of stakeholder involvement discussed above to the
risk-management process (identifying, planning and scoping, analyzing, making a decision, and
evaluating the decision).
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Breakout Group 1
The stakeholder communication process must be made a priority at the outset of a project;
risk managers must plan for communication flow from the beginning. One of the first steps is to
identify stakeholders, including those with a specific stake in the risk assessment, as well as in
the risk-management process. This effort often reveals unexpected parties and concerns that will
need to be addressed. In the Pownal Tannery Superfund Site case study, the following groups
were revealed to be stakeholders in the project.
Residents, identified through a door-to-door canvass
Local fire-fighting authorities
Town officials
Children illegally trespassing on the site
Local development commission
State historical protection agency
Local watershed group associated with an onsite dam
Land owners
Groups that wanted technical assistance
State environmental official
Those who paid for project work
Stakeholders who are not at the table initially can intrude on the process later and cause
delays. Although this cannot be prevented, the impact of late intrusion on the process can be
minimized. Stakeholder representatives who are present must communicate effectively with the
groups they represent so that there are no surprise reactions late in the process. Effective
communication can be accomplished through updates, phone calls, fact sheets and use of other
communication methods. Project managers cannot assume that officials truly represent
constituent opinions, so use of several communication avenues is a method of ensuring receipt of
the desired information.
The role of stakeholders must be decided early in the process, as well as the points at
which they will have an impact on decision-making. Stakeholders may simply be asked to
provide input; in other cases, stakeholders will be asked to reach consensus about a decision.
While stakeholder involvement is necessary throughout the process, the role of the stakeholder
may change at various points. At some points, stakeholder involvement may be limited to
keeping them informed. At others, stakeholder opinions may be solicited. Assigning substantive,
specific tasks to stakeholders is one way to avoid confusion from participation by members
whose reason for involvement is unclear. After decisions have been made, it is important to
follow-up with stakeholders to let them know how their input influenced the risk-management
process.
Accurately identifying local stakeholders early in the process also minimizes the impact
of the involvement of national representatives. The agenda of local and national stakeholders can
vary. Local representatives are directly accountable to the constituencies they represent and may
have a greater motivation to achieve progress toward defined goals.
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Each stakeholder in a process should be made aware of the concerns and goals of the
other stakeholders in the process. All should be aware of the dimension of the effort in which
they are engaged and be given an accurate assessment of the achievements that are expected and
realistically possible. Risk managers can determine whether stakeholders are most productively
addressed separately or collectively.
Good project documentation is useful to inform those joining the process late as well as
explaining the decision in the event of challenge. Anticipating stakeholder stances is one way to
gauge the type of documentation needed.
Risk managers might have to devise ways to ensure that stakeholder representation is
balanced and communication is not one-sided. For example, funding may haye to be found to
remove obstacles to allow meetings to be attended by volunteer representatives. Grants may be
necessary for some stakeholders to hire technical assistance to help them interpret technical risk
assessment data.
The group summarized its discussion with the following list of requirements for
establishing balanced stakeholder participation:
• With local projects, identify local stakeholders
• Develop incentives for participation and help to remove obstacles to participation
• Communicate all stakeholders' roles and boundaries of influence
• Encourage commitment to the process by asking for stakeholders to commit
resources
• Cross-educate stakeholders about the goals of all others
• Follow-up on commitments and project decisions and outcomes
Breakout Group 2
Planning and scoping is one of the most essential parts of the process and the one thai
will affect the entire effort. It begins with the convening process, which involves deterciinbg, ±.t
appropriate stakeholders, locating them, and motivating them to participate. This must occur well
in advance of any action, to ensure that stakeholders have an opportunity to prepare their
positions and to obtain resources. Local stakeholders can be found in community clinics,
churches, libraries, and other places where people go for social interaction and information, such
as community newspapers. Outreach to individual stakeholders is important to encourage
attendance at stakeholder meetings and should extend beyond announcements on the Internet or
hi the newspaper. Parties who have been identified should be asked for suggestions about others
to include, based on who their partners are as well as then- adversaries with regard to the issue.
Local newspaper morgues can be searched on a particular locality or company and those who are
used as sources for quotes might be appropriate stakeholder representatives. Environmental
Impact Statements for other projects in the area or dockets for similar rules can be examined to
locate potential stakeholders. Chambers of commerce and local bar associations may have
members who would be stakeholders.
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The scope of the project must be determined; it is better to embark on a limited project
that will be completed instead of a larger one that will never have the resources to begin. While
EPA should clarify its goals, it is also necessary to ask stakeholders to identify the issues that
they believe are relevant. Unanticipated issues may affect who should be included, either -
expanding or contracting the pool of stakeholders. Contracting the number of stakeholders is as
important as including all who should be included. If EPA is not intending to address the issues
most important to a particular stakeholder, that stakeholder will lose motivation to participate
and may feel that his or her time has been wasted. This could lead to difficulties with future
efforts.
During planning and scoping, the time frame that corresponds to EPA's needs, whether
statutory or budgetary, should be explained. In addition, involved parties should be asked for
their opinion on a reasonable time frame. EPA must ensure that it has been realistic in the time
and resources the Agency wishes to devote and that potential stakeholders are also willing to
devote sufficient time to ensure that the objective can be accomplished. EPA should also explain
the level of commitment that is expected from stakeholders, for example, whether the Agency
expects stakeholders simply to provide comments or to follow the process through to the end.
Stakeholders should have an expectation of the number, type, and location of all anticipated
meetings. Knowing the issues of importance to particular stakeholders will help EPA understand
their potential level of commitment. An initial meeting where the goal is to observe interaction
and test certain ideas may help EPA to determine these issues.
Once stakeholders have been located, it is important to motivate them to participate and
establish trust. For example, meeting summaries can be distributed to stakeholders even if they
did not attend, or EPA can contact the stakeholder and tell them about the meeting. Stakeholders
should be shown that issues of concern to them will be addressed. They must know that they do
have the ability to influence the outcome and that they will be provided with the tools to
participate, such as technical assistance or reimbursement of the cost associated with attendance.
Stakeholder involvement should not be lost because people are intimidated by the technical
content of the issue. Disparity in technical expertise among stakeholders must be addressed. EPA
should attempt to identify a person associated with a stakeholder group who has the necessary
expertise or else provide other methods of technical assistance. For example, grants may enable a
group to hire an expert to interpret technical materials for them.
During the planning process, it is also necessary to plan for evaluation. A means of
evaluation should be planned and communicated to stakeholders, then tracked throughout the
process. If the evaluation hinges on availability of resources in the future, this fact should be
emphasized so that stakeholders feel that EPA staff are accountable. It is also possible that
someone other than EPA, such as a stakeholder group, could conduct the evaluation.
Stakeholder participation continues in the analysis stage of the risk-management process.
At this point, it is important for stakeholders and EPA to know regulatory restrictions that may
exist. EPA may be restricted from releasing certain data or from accepting a particular risk-
management option, for example. The analysis process must be well documented, and include
the issues and factors considered, sources of data, assumptions, and calculations in a format that
is readable and readily available. A trusted, independent technical expert can help a stakeholder
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group determine the validity of an analysis, enabling useful comment on the analysis itself and
not simply the decision made. Peer review of the analysis will also help establish its validity.
Rather than wait until all information has been collected and published in final report format for
a long-term analysis, EPA should release progress reports periodically to allay any concerns that
the Agency is taking action out of the public eye.
During the decision stage, EPA should clarify once again the level of influence the
stakeholder groups will have on a particular decision, beyond the information they have
provided. The person or entity who will make the final decision should be explicitly stated.
Issues of contention should be outlined, as well as alternatives, particularly when no consensus
has been reached. For those who have not been involved in the earlier part of the process, EPA
should summarize the factors it considered in reaching a decision. If personnel turnover has
occurred, EPA should reintroduce its project team and emphasize that the approach has not
changed. Since many outside EPA are not familiar with Agency protocols, the general
rulemaking process should be summarized.
Although EPA staff often try to adopt a neutral role in the negotiations and act as
facilitator, it is important to remember that EPA is not a neutral party. The Agency has its own
responsibilities and mandates based on statutes, as well as paths it cannot take. Therefore, it is
necessary to have a non-EPA person run the negotiation process, if possible. EPA should also
clearly state the flexibility of the decision. For example, is the decision final and not subject to
change, or will it be revisited within a certain period of time? Will its implementation be phased?
Will new information or factors be considered later? Is there a mechanism for evaluation?
During the evaluation stage, EPA must show the outcome of its decision and the
effectiveness of the action taken. At this time, EPA must remind its stakeholders of the goals
which were to be accomplished. Feedback should be sought from the stakeholders who were
involved. The evaluation mechanism established during planning and scoping should be
implemented, emphasizing trust and the accountability of the Agency. Technical assistance
should be provided to stakeholders to evaluate the results. Finally, applicable and usable items
should be continually placed in the docket for evaluation by stakeholders.
Breakout Group 3
The group began with a discussion of initiating events in the decision-making processes.
Initiating events include established regulatory processes, permitting applications, internal policy
review, and new public issues (such as atmospheric ozone). The nature of the initiating event
itself will provide information on the scope of the process, facilitate the identification of
stakeholders, and may suggest suitable approaches for their involvement. In many cases,
stakeholders will agree that a particular issue is a problem and agree to work on it if EPA's
response or decision will affect them materially. New environmental problems require EPA's
awareness of events beyond its established practices, and appropriate stakeholders may be harder
to identify. In all cases, the problem should not be stated immediately for stakeholders; instead,
stakeholders should be asked to provide their own definition of the problem. In this way, EPA
may gain new perspectives on the issue that the Agency had not considered previously.
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The group proceeded to address the planning and scoping step of the decision-making
process. Both useful approaches and typical obstacles were identified. Planning and scoping is an
initial step completed internally at EPA in advance of planning and scoping with stakeholders, at
which point a plan for stakeholder involvement throughout the process is developed. The plan
can be kept flexible throughout the process by inserting a mechanism for stakeholder feedback.
It is necessary to be open and consistent with potential stakeholders with regard to their
place in the process, whether it be as a provider of information while EPA makes the decision or
as a joint decision-maker. If a stakeholder is to be included at one step in the process, then they
should be included throughout. However, the type and level of involvement can and should vary
from step to step.
During the process, stakeholders may attempt to increase their share in the process. In
such cases, the chairperson must be willing to intervene. Therefore, it is important that the
chairperson be regarded by all parties as sufficiently objective (i.e., not directly in the EPA
chain-of-command). The regular reevaluation of the mission statement can be a way of dealing
with changing roles within the process. Also, the group noted that proper information gathering
at the outset will produce better role identification for stakeholders.
Given all of the emphasis placed on stakeholder involvement, it is important to recognize
potential problems. Greater stakeholder involvement in the decision-making process does
translate into better reception at the end of the process. However, it does mean that stakeholders'
expectations also increase, as they feel justified in expecting some return for their contributions
to the process. In response, it was suggested that a written document explaining the decision and
the issues surrounding each point of view should be developed. This document could serve as a
record of the process. In addition, an effort should be made to insure that the public understands
the risk tradeoffs involved in the Agency decision-making. EPA should explain at the outset of
the process what the risk numbers mean with regard to human health.
With good planning, stakeholder involvement can be very useful in decision-making. It is
in EPA's best interest to seek out stakeholders, encourage their involvement, and, when possible,
create schedules which increase rather than decrease the likelihood of involvement. If particular
stakeholders can be identified, but it is not possible for them to be fully involved in the process,
it is worthwhile to identify sub-issues that are important to those stakeholders and work to
include them at some level.
The implications for stakeholder involvement are amplified during the analysis step and it
is therefore especially important to be creative in reaching out to stakeholders. Industry often has
the fewest obstacles to its involvement, due to its general ability to draw upon financial,
technical, and personnel resources not usually available to non-profits, the public, or other
interest groups. Several ideas were proposed, including the posting of data and information on
the web. The guiding principle was to increase the number of people with access to existing data
in order to increase the number of analyses considered in the decision-making process.
It is often necessary to level stakeholder influence, so that industry input does not
outweigh the input of other groups. Grant money can enable other stakeholders to conduct their
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own analyses, although EPA technical assistance grants cannot be used for this purpose. Instead,
other groups and industry can be encouraged to provide funds.
Summary
During the plenary session, participants identified the most important aspects of
stakeholder communication. First, it is necessary to facilitate their involvement early in the
process. An understanding of the initiating event for the action to be undertaken can guide the
level of stakeholder involvement. Examples of initiating events include mandates by statute,
problems which EPA has the authority to research but not regulate, or the identification of an
entirely new issue. The style of involvement can range from simply providing information to
consensus-building to joint decision-making. The role of the stakeholders can be different
throughout the process. Finally, the decision-making process for each action should be
documented to show all aspects that were considered.
3.5 Considerations in using FACA Committees (Deborah Dalton, Jasmine Chapman - OGC)
The Federal Advisory Committee Act (FACA) provides requirements for groups of non-
Federal stakeholders that are established by the Federal government for the purpose of providing
advice or recommendations to the Federal government. Such groups require many of the same
public-involvement activities already recommended for stakeholder groups. They also bring a
level of commitment from EPA management and committee members beyond the simple
exchange of information to establishing promises and commitments. However, they also require
a charter and significant resources. In fact, an Executive Order mandated that FACA committees
be reduced by one-third and that spending on each be reduced by five percent. EPA staff can
form groups that provide the benefits of a FACA group without incurring the costs.
The EPA Office of General Counsel (OGC) discussed the definition of a FACA
committee. A FACA group includes non-government personnel and has a cohesive
organizational structure. If that cohesive structure is a result of EPA effort, and the group renders
specific advice or recommendations, FACA applies. If the organizational structure of the group
is not a result of Agency effort, but the group is subject to strict Agency management and
control, FACA applies if the controlled group renders specific advice or recommendations.
Groups that are convened by an EPA contractor, whose members are chosen by the contractor,
and EPA performs no work related to the group, are not covered under FACA. In general, the
groups can move along a continuum, from acting less like a FACA group to more like a FACA
group, depending on the means of establishing the group, selecting the group members, directing
or controlling the group's work, utilizing the group, and receiving advice from the group.
FACA groups are required to obtain a charter, maintain a balanced membership, hold
open meetings, allow the public to speak, announce meetings in the Federal Register, keep
minutes or summaries, and make committee documents available for public inspection.
Because the margin for interpretation of EPA involvement can be quite fine, it is best to
mitigate potential challenges by following the public participation requirements under FACA.
The public should be involved in the meetings of the group. Documents related to the group
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should be circulated to all attendees during meetings, including any members of the public in
attendance. All options suggested should be published, even if not accepted. Group meetings
should be held in places which are accessible to the public. Balance is important and all view
points should be represented and heard; those who are excluded will be the ones to challenge
decisions later.
More information on FACA can be found at the following Internet websites: http://
policyworks.gov/org/main/mc or http://policyworks.gOV/F ACA_Townhall.
3.6 The Federal Facilities Cleanup Case (Marsha Minter - OSWER)
The Federal Facilities Environmental Restoration and Reuse Dialogue Committee
(FFERDC) was a FACA group that convened between 1992 and 1996. It was made up of fifty
members of the public and organizational representatives who met to develop consensu-policy
recommendations aimed at improving the environmental cleanup and restoration process at
Federal facilities. The group was chaired by Administrator Browner and provided a forum to
discuss recommendations and build a consensus for solutions. The group provided interim
recommendations to improve public information and set priorities based on available resources.
The group's final report, entitled Consensus Principles and Recommendations for Improving
Federal Facilities, included fourteen principles to provide a basis for making Federal facility
cleanup decisions, as well as monitoring and facilitating stakeholder involvement associated with
cleanup operations. Citizen Advisory Boards are outgrowths of the FFERDC group
recommendations.
Principle Number 9 is particularly relevant to risk assessment. It states that "risk to
human health and the environment is an important and well-established factor that should
continue to be a primary consideration in Federal facility cleanup decision-making, including
setting environmental cleanup priorities and milestones." Risk assessments should consider
communities of color and iovt income, particularly susceptible sub-populations, populations
exposed to multiple hazards, and workers in particular. While fiscal constraints do not justify
failing to take actions to protect human health and the environment, they may result in the need
to set priorities about what cleanup actions can occur in any given year.
Many lessons were learned from this FACA group experience. First, it is important to
know which stakeholders should be included and to do so from the beginning of the process. In
this case, tribes and environmental justice groups were not included when FFERDC first
convened. When it was discovered that they should have been involved, some parts of the
process had to be repeated. Second, it is important that communication extend beyond public
relations-style outreach to two-way communication with all stakeholders. It is important to
include stakeholders who will be critical and hear their views. Many methods are available to
distribute information beyond the Federal Register or the newspaper; different avenues should be
used to ensure that all members of the community are reached. Membership in a stakeholder
group should minor the diverse interests within the community. Encouraging various
stakeholders to work together creates a partnership, which better identifies common interests and
results in better decision-making by EPA.
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Risk Management Communication and Stakeholder Involvement
When groups involving the public are convened, EPA should be prepared to handle the
anger of citizens. For example, when the Department of Defense began involving the public in
the cleanup of defense sites, complaints which had been festering over time flooded stakeholder
meetings, including the loss of jobs from base closures to past contamination which was not
disclosed.
It is important to include groups without the resources to participate fully by engaging in
activities to build this capacity in the communities. Technical Assistance Grants are one method
of doing this through the Superfund program. Research grants and technical outreach services
can be used as well. These methods are designed to assist communities in hiring technical
advisors to interpret scientific documents, not to conduct their own research.
3.7 Day2Wrap-Up
At the end of the second day, workshop participants were again asked to consider key
points they would wish to convey to the EPA Administrator. This time, the focus was on
facilitating stakeholder communication throughout the risk-management process. Participant
statements are given below:
• Early planning for stakeholder involvement is essential. Stakeholders must be
identified early in the process and then* participation scheduled from the
beginning. They should also be notified well in advance of the beginning of the
process so that they can prepare both then* responses to issues and their own
budget and resources. Their involvement should continue throughout the process,
even if their roles change.
• Both the stakeholders and the Agency itself must be clear on the role of
stakeholders in a given situation; it is important to acknowledge that consensus is
not always sought or possible.
• Resources and effort for stakeholder involvement must be committed at the
beginning of the process; early efforts will drive success at the end.
• If a stakeholder attempts to circumvent the negotiating process by contacting
senior management at EPA, they should be sent back to work through the process
rather than given concessions outside of it.
• EPA staff must be given the authority to negotiate and make decisions; when
given, those negotiations and decisions must be supported by senior management.
• EPA staff must have access to the training, time, and resources, including
qualified, neutral facilitators, necessary for meaningful stakeholder involvement.
For example, a facilitation services contract is available through OSWER.
• The Agency must follow through on its commitments. For example, if an
evaluation step has been promised during the decision-making promise, the
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Risk Management Communication and Stakeholder Involvement
evaluation must be completed and the results made available to stakeholders in a
useable format.
• Both EPA and the stakeholders must recognize that change and compromise are
necessary to solve problems. While stakeholder issues will be considered, not all
parties will obtain the outcome of their choice.
• Funding for technical assistance should be given to stakeholder groups, such as
environmental or citizen groups, when necessary to ensure that their participation
is meaningful. Sources of such funds should be listed. (One of the EPA Regions
has published a document listing technical assistance grants available for its
programs. The EPA Stakeholder Action Plan states that EPA should determine
gaps in these grants and establish similar funding mechanisms in programs
lacking them.)
• When a decision has been reached, stakeholders should be informed as to how
their input was used and their issues considered. The factors that weighed in oh
the final decision should be identified and explained.
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Risk Management Communication and Stakeholder Involvement
4.0 Wrap-Up Activities
4.1 Summary of Issues and Action Items (Hugh McKinnon - ORD)
As a possible next step, workshop organizers may present the key points identified by
participants regarding risk manager - risk assessor and EPA - stakeholder communication issues
to the EPA Administrator and to the Science Advisory Board. A potential third workshop may be
held in conjunction with the third workshop in the Community Assessment series. Workshop
participants were encouraged to continue to network with their colleagues throughout EPA to
share lessons learned regarding these issues. In particular, it is important to improve the
dissemination of information from Headquarters to the Regions, and to address perceived rifts
between the staff and management within EPA. These issues provide potential themes for
subsequent workshops.
4.2 Workshop Evaluation
Ten evaluation forms were returned from workshop participants. Copies of the completed
evaluation forms are included in this report as Appendix E. Selected responses to each of three
questions are summarized below:
What aspects of the meeting did you find most useful?
• The presentation on opportunities for stakeholder involvement, FACA, and phosphides
(similar comment made by several participants). The stakeholder discussion on Day 2
seemed to produce the most valuable set of recommendations for addressing the
involvement of these parties in the process, especially in the breakout sessions.
• Breakouts provided great information (similar comment made by several participants)
• Most of the discussions were very useful and to the point. The agenda and meeting were
well focused and the speakers were good.
• Bringing together people from different parts of the Agency, who ended up providing a
lot of useful information to each other, particularly from senior to junior staff (similar
comment made by several participants)
• Useful, needed meeting topic
• Active participation and discussion by attendees
• Regional participation, as well as national programs
• Use of actual case studies
• Discussions of risk manager - risk assessor communication
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Risk Management Communication and Stakeholder Involvement
What aspects of the meeting were least useful?
• Would have liked more complete information on forming and implementing stakeholder
groups.
• Perspectives on risk assessor - risk manager communication raised no new issues; the
session could have been shorter.
• FACA discussion (similar comment made by several participants). However, it is an
important topic for those not already familiar with it.
• Most people already seemed to have a good understanding of communication during the
planning and scoping phase.
• Breakout sessions were redundant after plenary discussions or presentations.
• Many registered participants did not attend, so attendance was small. Attendance was
skewed heavily toward OPP and OSWER, which were well represented, while the Office
of Water (OW) was not represented.
Please indicate specific recommendations you might have to strengthen the discussions/
practicum in the future?
• A presentation specifically about OPP's Reregistration Eligibility Decision (RED)
stakeholder involvement.
• Follow up with the program and division offices on the issues raised and how the results
will be used within EPA programs, including Superfund and water and air programs.
• Develop some internal EPA suggestions to improve risk manager - risk assessor
communication.
• Include more case studies.
• Have presentations on enforcement and legal aspects of the stakeholder process.
• Seek broader and greater participation and wider representation across the Agency for
presentations and case studies. Continue to encourage the attendance of the Regions so
that Headquarters thinking is not isolated and removed from the needs and constraints of
those working in the field. Send reminders to registered participants to ensure attendance.
• More detailed advance planning, including definition of the scope and purpose of the
meetings, and closer work of organizers with conveners/facilitators/presenters.
• Informal gathering is important; encourage people to plan ahead to share dinner on the
evening of the first day.
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Risk Management Communication and Stakeholder Involvement
• Clear explanation of tasks given to breakout groups (this was done better on Day
2).
• Continue with sessions on topics similar to F AC A that are important for EPA.
staff to understand, but which they don't often encounter.
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Risk Management Communication and Stakeholder Involvement
APPENDIX A
List of Participants
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Risk Management Communication and Stakeholder Involvement
Appendix A. List of Participants
Washington, D.C.
July 14-15,1999
Ed Bender (speaker)
EPAORD/OSP
401 M Street, SW(8104R)
Washington, D.C. 20460
tel. 202-564-6483
fax 202-565-2925
bender.ed@epa.gov
Ben Blaney
EPAORD
26 W. Martin Luther King Drive
MD-235
Cincinnati, OH 45268
tel. 513-569-7852
fax 513-569-7680
blaney.ben@epa.gov
Darlene Boerlage
EPA ORD/OSP
401 M Street, SW(8104R)
Washington, D.C. 20460
tel. 202-564-6639
fax 202-565-2916
boerlage.darlene@epa.gov
John Bowser
EPA OPPTS/OPPT/Chemical Control
Division
401 M Street SW (7405)
Washington, D.C. 20460
tel. 202-260-1771
fax 202-260-8168
bowser.john@epa.gov
Kathryn Boyle
EPA OPPTS/OPP/SRRD/SRB
401 M Street, SW (7508C)
Washington, D.C. 20460
tel. 703-305-6304
fax 703-308-8005
boyle.kathryn@epa.gov
EPA OPPT/OPP/SRRD/SRB
401 M Street, SW(7508C)
Washington, D.C. 20460
tel. 703-308-9399
fax 703-308-8041
caicedo.amy@epa.gov
Jasmine Chapman (speaker)
EPA OGC
401 M Street, SW (2322)
Washington, D.C. 20460
tel. 202-260-0548
fax 202-260-8392
chapman.jasmine@epa.gov
Deana Crumbling (ad hoc speaker)
EPA Technology Innovation Office
401 M Street, SW(5102G)
Washington, D.C. 20460
tel. 703-603-0643
fax 703-603-9135
crumbling.deana@epa.gov
Barbara Cunningham
EPA OPPT/Office of Program Management
and Evaluation
401 M Street, SW (7401)
Washington, D.C. 20460
tel. 202-260-1761
fax 202-2601764
cunningham.barbara@epa.gov
Deborah Dalton (speaker)
EPA OPPE
401 M Street, SW (2136)
Washington, D.C. 20460
tel. 202-260-5495
fax 202-260-5478
dalton.deborah@epa.gov
Amy Caicedo
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Risk Management Communication and Stakeholder Involvement
Kerry Deal-field
EPA OSP/ORD
401MStreet,SW(8104R)
Washington, D.C. 20460
tel. 202-564-6486
fax 202-565-2925
dearfield.kerry@epa.gov
Dennis Deziel (speaker)
EPA OPPTS/OPP
401 M Street, SW (7508C)
Washington, D.C. 20460
deziel.dennis@epa.gov
Jim Goodyear
EPA OPPTS/OPP/Environmental Fate and
Effects Division
401M Street, SW(7507C)
Washington, D.C. 20460
tel. 703-305-7726
fax 703-305-6309
goodyear.jim@epa.gov
Mark Hartman (speaker)
EPA OPPTS/OPP
401M Street, SW(7508C)
Washington, D.C. 20460
tel. 703-308-0734
fax 703-308-7042
hartman.mark@epa.gov
Scott Hedges
EPA ORD/NRMRL
401 M Street, SW(8301D)
Washington, D.C. 20460
tel. 202-564-3318
fax 202-565-0075
hedges.scott@epa.gov
Maria Hendriksson
EPA Design for the Environment Program
401 M Street, SW (7406)
Washington, D.C. 20460
tel. 202-260-8301
fax 202-260-0981
hendriksson.marla@epa.gov
Anne Kim
EPA OPPTS/OPPT/Risk Assessment Div.
401 M Street, SW (7403)
Washington, D.C. 20460
tel. 202-260-1273
fax 202-260-1236
kim.anne@epa.gov
Michael McDavit (speaker)
EPA OPPTS/OPP
401 M Street, SW(7508C)
Washington, D.C. 20460
tel. 703-308-0325
fax 703-308-8005
mcdavit.michael@epa.gov
Julia McGinn-Rodriguez
EPA OPPT/Economics Exposure and
Technology Division
401 M Street SW (7406)
Washington D.C. 20460
el. 202-260-1157
fax 202-260-0816
cginn-rodriguez.julia@epa.gov
Hugh McKinnon (speaker)
Associate Director for Health
EPA ORD/NRMRL
26 Martin Luther King Drive (MS-225)
Cincinnati, OH 45268
tel. 513-569-7689
fax 513-569-7549
mckinnon.hugh@epa.gov
Leslie McVickar (speaker)
EPA Region 1
John F. Kennedy Federal Building
One Congress Street
Boston, MA 02203-0001
tel. 617-918-1374
fax 617-565-3660
mcvickar.leslie@epa.gov
A-2
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Risk Management Communication and Stakeholder Involvement
Ossi Meyn
EPAOPPTS/RAD/ECAB
401M Street, SW (7403)
Washington, D.C. 20460
tel. 202-260-1264
fax 202-260-1236
meyn.ossi@epa.gov
Jayne Michaud
EPAOERR/OSWER
401M Street, SW(5204G)
Washington, D.C. 20460
tel. 703-603-8847
fax 703-603-9104
michaud.jayne@epa.gov
Marsha Minter (speaker)
EPAOSWER
401 M Street, SW (5106)
Washington, D.C. 20460
tel. 202-260-6626
fax 202-260-3527
minter.marsha@epa.gov
Jeff Morris (speaker)
EPAOSP/ORD
401 M Street, SW(8104R)
Washington, D.C. 20460
tel. 202-564-6756
fax 202-565-2926
morris.jeff@epa.gov
C. Bill Murray (speaker)
EPA Region 8
Office of Ecosystems Protection and
Remediation
999 18th Street (8EPR-PS), Ste. 500
Denver, CO 80202-2466
tel. 303-312-6401
fax 303-312-6339
murray.bill@epa.gov
Larry Newsome
EPA OPPTS/OPPT/Risk Assessment Div.
401 M Street, SW (7403)
Washington, D.C. 20460
tel. 202-260-1262
fax 202-260-1236
newsome.larry@epa.gov
Pasky Pascual
EPAORD
401 M Street, SW(8104R)
Washington, D.C. 20460
tel. 202-564-2259
fax 202-565-2911
pascual.pasky@epa.gov
Dorothy Patton
Director, EPA OSP/ORD
401MStreet,SW(8104R)
Washington, D.C. 20460
tel. 202-564-6705
fax 202-565-291 lpatton.dorothy@epa.gov
Heidi Paulsen
EPA OPPTS/OPP/CBEP
401 M Street, SW (7506C)
Washington, D.C. 20460
tel. 703-305-5251
fax703-308-3259paulsen.heidi@epa.gov
Dan Petersen
EPA ORD/NRMRL/TTSD
26 W. Martin Luther King Drive (G-75)
Cincinnati, OH 45268
tel. 513-569-7831
fax. 513-569-7585
petersen.dan@epa.gov
Loan Phan, J.D.
EPA Office of Pesticide Programs
OPPTS/OPP/SRRD/SRB
401 M Street, S.W. (7508C)
Washington, D.C. 20460
tel. 703-308-8008
fax 703-308-8041
phan.loan@epa.gov
A-3
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Risk Management Communication and Stakeholder Involvement
Vivian Prunier
EPAOPPT/OPP/FEAD
401 M Street, SW(7506C)
Washington, D.C. 20460
tel. 703-308-9341
fax 703-305-5884
prunier.vivian@epa.gov
Kelly Rimer
EPA OAR/OAQPS
MD-13
Research Triangle Park, NC 27711
tel. 919-541-2962
fax 919-541-0840
rimer.kelly@epa.gov
James Rowe
EPA OSP/ORD
401 M Street, SW(8104R)
Washington, D.C. 20460
tel. 202-564-6488
fax 202-565-2925
rowe.james@epa.gov
Daljit Sawhney
EPA OPPTS
401M Street, SW (7403)
Washington, D.C. 20460
tel. 202-260-0289
fax 202-260-1216
sawhney.dalj it@epa.gov
Karen R. Seeh
EPA Design for the Environment (DfE)
Program
401 M Street, SW (7406)
East Tower Room 312
Washington, D.C. 20460
tel. 202-260-1714
fax 202-260-0981
seeh.karen@epa.gov
Victor B.Serveiss
EPAORD/NCEA
401 M Street, S.W. (8623D)
Washington, D.C. 20460
tel. 202-564-3251
fax 202-565-0078
serveiss. victor@epa. gov
Sarah Smith
EPA OPPT/Economics Exposure and
Technology Division
401 M Street SW (7406)
Washington D.C. 20460
tel. 202-260-1547
fax 202-260-0816
mith.sarah@epa.gov
Cindy Stroup
EPA OPPT/Economics Exposure and
Technology Division
401 M Street SW (7406)
Washington D.C. 20460
el. 202-260-3889
fax 202-260-0816
troup.cindy@epa.gov
Paula Williams
EPA Region 5, Enforcement and
Compliance Assurance Branch, Waste,
Pesticides, and Toxics
77 W. Jackson Blvd (DE-9J)
Chicago, IL 60604
tel. 312-353-1243
fax 312-353-4342
williams.paula@epa.gov
Jan Young
EPAOSW/EMRAD
401 M Street, SW(5307W)
Washington, D.C. 20460
tel. 703-308-1568
fax 703-308-0509
young.jan@epa.gov
A-4
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Risk Management Communication and Stakeholder Involvement
APPENDIX B
Agenda
-------
Risk Management Communication and Stakeholder Involvement
Appendix B. Agenda
"Identifying Information Needs for Risk Managers" Workshop Series
Communication and Stakeholder Involvement in the Risk Management Process
July 14-15,1999
Radisson Barcelo Hotel, Washington, DC
Workshop Objectives
» To discuss risk assessor-risk manager communication, and how this communication
does/should inform the decision-making process.
» To discuss stakeholder involvement, and how this involvement does/should inform the
decision-making process.
» To identify the extent to which the current models of the risk management process
accommodate risk assessor-risk manager communication and stakeholder involvement.
Workshop Chair Hugh McKinnon, Associate Laboratory Director for Health, National Risk
Management Research Laboratory, ORD
Davl Communication Between the Risk Assessor and the Risk Manager
8:30-9:00 Introduction, brief review of the June workshop Hugh McKinnon, ORD
9:00-10:00 Plenary Discussion-Perspectives on Communication between
Risk Assessors and Risk Managers Hugh McKinnon, ORD
10:00-10:30 Presentation -Regional Perspective on Risk Assessor-
Risk Manager Communication Bill Murray, Region 8
10:30-10:45 BREAK
10:45-11:15 Presentation-Introduction to Planning and Scoping Ed Bender, ORD
11:15-12:30 Case Study Presentations-Communication Issues
Pownal Tannery Superfund Site Leslie McVickar, Reg.
1
Phosphide Fumigants Mark Hartman, OPP
12:30-1:00 LUNCH
1:00-1:30 Presentation -Risk Management Information Models Hugh McKinnon, ORD
1:30-2:30 Break-Out Exercise-Communication during
Planning and Scoping Jeff Morris, ORD
2:30-2:45 BREAK
2:45-3:30 Reports from the break-out groups
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Risk Management Communication and Stakeholder Involvement
Appendix C
Risk-Management Models
-------
Public
officials
Natural and
social sciences
Interested and
affected parties
«••"
,.-"*"'
...'•'
Problem
formulation
i A
II ,,!' , , ..--.,.
I feE®^Ew!^B^'.PJL9Xf'.3y
1 *
b Analysis ^
^ deliberation *"
/-•- f
Process Option
design selection
.
-l^W
1 ^
ori^chajiaesfg
^ II
'••.
,,.,
**••<
Information
gathering'
•
^:Sequerj'ce*of steps inf arialysjs/de.Iibefation •v-'--./".
If
^
Analysis
deliberation
*"*v
Synthesis
I-*.
w"
From NRC, 1996 Understanding Risk: Informing Decisions in a Democratic Society
-------
Define
problem
context
From Presidential/Congressional Commission on Risk Assessment and Risk Management, 1997,
Framework for Environmental Health Risk Management (Vol.1), and Risk Assessment
and Risk Management in Regulatory Decision-Making
-------
Risk Reduction Option Selection Methodology
From USEPA Science Advisory Board - Integrated Risk Project (Risk Reduction Options Subcommittee)
-------
RISK ASSESSMENT
RISK
MANAGEMENT
CHARACTERIZATION
RISK
MANAGEMENT
-------
Risk
Management/
Risk Assessment
Paradigm
Identification of Future Problem, Initiating
Event or
Public Policy Mandate
Risk Management
Define the Problem
Dose-Response
Assessment
Risk Assessment
\
Hazard Risk
[Identification Characterization!
Exposure
Assessment
Develop Compliance
Assurance Models and Methods
Develop Measures of
Environmental and
Public Health ^
Improvement
Define Risk Management
Objectives
Identify and Evaluate
Risk Management Options
Risk Management,
Decision
Implement Option(s)
Monitor
fe. Environmental
and Public Health
Improvement
• Public Health
Considerations
• Statutory and Legal
Consideration
• Social Factors
• Economic Factors
• Political
Considerations
Reduced Environmental
and/or
Public Health Risk
-------
Risk Management/Risk Assessment Paradigm
Identification of Future Problem, Initiating
Event or
Public Policy Mandate
Source/Stressor
Characterization*
Risk Management
Risk Assessment
Hazard
Identification Characterlzatlo
Enylronhiental
Public Health
mprovement
Resource Valuation *
Sustalnablllty *
Socloeconomlcs *
Risk Reduction
Goals policy/Regulation
Land/Resource Use *
Prevention *
Influence
Control *
Remediation *
Rehabilitation *
Adaptation *
Development/
Demonstration *
Policy/Regulation
Systems Analysis *
Cost Analysis *
Cost/Benefit Analysis *
Risk/Benefit Analysis *
Socioeconomics *
Failure Analysis *
Risk Communication *
Technical Assistance *
Technology Transfer *
Training *
Technical Guidance *
Technology
Commercialization *
Performance
Verification *
-------
Comparison of commonalities and differences among frameworks
In spite of differing objectives, ages, nations of origin, and sponsoring agencies, a number of critical themes are common to all
frameworks. Tabular entries provide summary descriptions of the stated development purpose and key conceptual innovation of
each fcamework. Agreements among frameworks suggest likely future changes in risk assessment and risk management
processes. Differences reveal temporal change? in attitude toward the measurement and management of risk.
Issue
Canadian National
U.S. Risk Standards Research
Commission Association Council
1997 1996 1996
U.K. Department
of the Australia/
Environment New Zealand U.S.EPA The Netherlands
1995 1995 1992 1939
Framework's Risk
prime management
objective
Assessment Explicitly
versus management-
management oriented
Decision Decision-
making oriented,
comments on
principles and
techniques
Stakeholder Strong
input emphasis on
input use
Role of science Necessary for
risk
management
decision
making
Socioeconomic Viewed as
valuation useful in
decision
making
Uncertainty Prefers
analysis qualitative to
quantitative
methods
Environmental Risk Risk Risk Risk analysis Risk reduction
decision characterization management management
making decision
making
Assessment Explicitly Assessment Explicitly Explicitly Implicitly
embedded in management- embedded in management- assessment- management-
management oriented management oriented oriented oriented
Decision- Decision-
oriented, oriented,
identifies decision
specific making used
decision points for problem
solving
Implicitly
decision-
oriented,
requires
balance in
decision
making
Weak
emphasis on
input use
Necessary for
risk estimation
Excluded in
decision
making
Strong
emphasis on
input use
Necessary for
assessment,
but Insufficient
alone
Used to
broaden risk
understanding
Implicit
emphasis on
input use
Necessary for
risk
management
decision
making
Used in
decision
making due to
resource limits
Requires
quantitative
methods
Prefers both
qualitative and
quantitative
methods
Stresses
qualitative and
quantitative
methods
Decision- Not decision- Decision-
oriented, oriented, oriented,
stresses decisions includes
a priori criteria deferred to risk specific
for decision management regulatory
making objectives
Strong Implicit Implicit
emphasis on emphasis on emphasis on
input use input use input use
Necessary for Necessary for Necessary for
risk estimation risk estimation risk estimation
Notes need for Not included Costs used to
cost-benefit select among
analysis. regulatory
options
Requires Requires Requires
qualitative and quantitative quantitative
quantitative methods methods
methods
Risk Should be Emphasizes
characterization both quantitative
qualitative and approaches
quantitative
Should be Will be "Can be either
both partially qualitative
qualitative and qualitative due and/or
quantitative to information quantitative
gaps
Risk Important in Uses Implicit in risk Necessary but Core
prioritization risk . qualitative da management not always management
management -/rtf/i/mus and precise activity
da maxlmus completed
ranking using criteria
Emphasizes
quantitative
approaches
A derivative
property of
repeated
assessment
Linear versus Iterative at all Iterative
iterative stages
Iterative at all Iterative at all Iterative at all Iterative
between stages stages stages between •
assessment assessment
and and
management management
Key innovation Includes social. Recognizes the Recognizes the Explicit use of Emphasizes Formalizes the
ethical, and
economic
values in risk over
analysis assessment
primacy of analytic-
management deliberative
nature of
risk-based
decision
making
the the problem
precautionary comparison of identification
principle in the risk to phase
face of a priori
uncertainty decision
criteria
Emphasizes
quantitative
approaches
Completed by
comparing
risks to
standards
Linear with
implicit
feedbacks
Specifically
states
numerical
management
standards
MAY 1. 1938 / ENVIRONMENTAL SCIENCE & TECHNOLOGY/ NEWS • 229 A
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Risk Management Communication and Stakeholder Involvement
APPENDIX D
Breakout Group Flip Charts and Posters
-------
Risk Management Communication and Stakeholder Involvement
Appendix D. Breakout Group Flip Chart Transcriptions
Day 1 Introduction Summary
Perspectives on Internal Communications
Communication
• why it works well
- continuity
-trust
- early risk assessment involvement
• reasons for breakdown
- workload; getting, holding attention of risk assessors
- lack of RA training for managers
Why it works:
1.) "What if scenarios developed by assessors and managers.
2.) Commitment to time frames e.g. statutory deadlines
3.) Extent to which assessor can give interim back-of-the-envelop estimates
4.) Flexibility
Why it doesn't:
Manager's discomfort with RA
Importance of Risk Assessment
- decision making metric - science based
- value of discussion of preliminary findings?
-"what if scenario for complex RA, closer to decision point
Assessors' Perspective
- common understanding of expectations
- ideally, information-gathering process is continuous
- therefore, communication between assessor and manager needs to be ongoing
- legal importance/implication of risk numbers
- in SF, early assessor involvement is important
- breakdown can occur - when risk # used to justify policy
- understanding different perspectives of managers and assessors
- issue of using science to justify predetermined decision
- pressure to not collect data that may reduce uncertainty
D-l
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Risk Management Communication and Stakeholder Involvement
Breakout Group 1 Day 1
How to ensure good RM/RA communication to better inform the RM decision making process.
- focus on overlap of RA and RM jobs
- define who is the RA and their qualifications
- ensure that RA is qualified (has expertise)
- ensure that "successors" are well trained/equipped and informed to take over
responsibility (pass on institutional knowledge), document, formalize, keep historical
record; establish formal process and record consensus and rationale
- decision tree
- identify areas of uncertainty
- create a process that works for your group; get consensus to adopt it
- create a work plan
- ensure that info is clear, esp in planning and scoping
* Communication = Clarification"1
- communication must be reflective of needs and expectations and milestones
- feedback loop built into tasks required and used to evaluate if work was done and if
results occur
- debrief after completion (review what worked, etc)
- permanent teams
- clear roles of players, understand perspectives (science, policy, legal, socioeconomic)
brought by each player
- keep the team together throughout the process until decision is made
- be up-front and realistic about possible factors that might influence decision and
recognize which issues are in assessment and management side
- training for RA and RM together
- roles and responsibilities
- key considerations in decision process
- pragmatic exercises/case studies/ "what if scenarios
- recognize that communication works on 2 levels
-internal
- external (stakeholders)
Breakout Group 2 Day 1
Process
1.) Identify problem/whatever charged to address
2.) Planning & Scoping
- bounding what you can do
*legal, statutory, resources, stakeholder concerns
- explicitly understand what not doing
*see if others can do other pieces
- plan how to proceed (conceptual model if can do it)
3.) Analyze factors
4.) Mgt. Options/transaction costs
D-2
-------
Risk Management Communication and Stakeholder Involvement
5.) Evaluate decision
Factors (pieces of the process)
1.) Risk Assessment (health, eco, exposure)
- planning & scoping
2.) Management goals for waste program
- mgt. goals for specific case
3.) Cost effectiveness
4.) Technical feasibility
5.) Political feasibility
6.) Community acceptance (stakeholder acceptance includes community, State, etc.)
7.) Legal issues
8.) State acceptance
Risk Assessment:
Who: -risk assessors (depends on driving problem thru the whole process-all the planning and
scoping health and eco.)
-Assessors of other factors- risk manager
- Stakeholders
When: - early and often, but depends on level of assessment, number of resources you have,
level of trust of organizations9 policy
What: - educating risk managers
- Cancer vs. Non-cancer
Breakout Group 3 Day 1
Process with Principles
- Planning and Scoping
1.) Assemble team and get basic info.; define RM goal - 1st RM and RA have
varying goals; ID regs, legal requirements, tech, policy
2.) Conceptual model - soundly based
3.) Topics
- data quality
- schedule for RA and reviews
4.) Additional data needs determined and data provided
- flexibility
- RA report back to RM as new data available
Analysis - RA
- communication between RM and RA during process
- provide preliminary findings - who needs to review - R|EPA, Fed.parties, stakeholders
- RM dec. - analysis frames options
- RA provides numbers for different scenarios
* If you do a good job planning and scoping, full RA may not be needed
D-3
-------
Risk Management Communication and Stakeholder Involvement
Plenary Summary following Day 1 Breakout Groups
Features/Characteristics/Activities Enhancing Risk Assessor/Risk Manager Communication
1.) Team assembles early
2.) Goals set early; conceptual model
3.) Topics
- assessor/managers/key stakeholders
- legal requirements
- time line
- data quality requirements
4.) Residual data needs to be evaluated/identified early
5.) Continuous communication
Risk Analysis
- data needs
- interim deliverables/preliminary findings
- refine priorities depending upon communication among parties/stakeholders
Risk Management
- defines potential options and evaluates
Day 2 Introduction Summary
STAKEHOLDER INVOLVEMENT
What has worked: What hasn't:
- clarifying what issues are on/off the table - politics can short-circuit the process
- direct interaction with community = greater when staff do not have authority to
understanding speak for EPA
- identify - who, their positions & est. support - posturing
- clearly articulate what you want from them
- objectivity
- find the right stakeholders
- ask for alternatives as well as criticisms
keep process moving forward
- community interviews (S.F. has formal process)
- recycling S.F. sites initiatives
- follow up- maintaining contact so they know their
input has value
- technical assistance grants getting community up to
speed on technical issues important to communicate
availability
Breakout Group 1 Day 2
D-4
-------
Risk Management Communication and Stakeholder Involvement
• Establish stakeholder participation as priority up-front, but accept unpredictability.
(e.g. stakeholder late-comers; politics)
• ID stakeholders & involve early
- focus on locals
- develop incentives/tools (e.g. TAG)
- clarify role early
- decide when to involve
- encourage commitment by asking investment of resources
- educate re: diff. perspectives
• Process
- focus on problem-solving, not problems
- focus on process, not outcome
- acknowledge uncertainties/assumptions
- follow through to closure
• Handle stakeholder involvement
- identify all stakeholders
* think broadly
* outreach/communication
- involve them early
* educate them about each other's position
- prepare for the worst
* can't avoid politics
* fully document rationale for the process
- decide role of stakeholders
* individual versus group involvement
- determine at what points during the process to involve stakeholders
- be sure involvement is substantive
- not the usual suspects
- reduce/avoid gamesmanship
- focus on local citizens (community advisory panels)
- look for local continuity
- encourage resource investment by stakeholders to ensure participation
- seek other incentives/tools for stakeholder participation
- seek early agreement/commitment to the process, not to any predetermined
outcome
- accept the fact that the process is unpredictable
- focus stakeholders on problem solving, not the problem
- build trust by acknowledging uncertainties/assumptions up-front
- follow through to closure
Breakout Group 2 Day 2
D-5
-------
Risk Management Communication and Stakeholder Involvement
Planning and Scoping
• Right People (who, how to find, how to motivate)
* CoC, Bar Assn.
•"technical expertise, previous gov't analysis & contact points
•"announcements, places where people go
* clinics, churches, libraries, ask parties, networking, meetings, editorial pages
* establish trust, summaries, technical assistance
• Find out what are issues
• Schedule-level of commitment
- what is process - motivate
•"issues they care about
•"influence outcome
*pay ??? - budget, mechanism
Analysis
• FIFRA- DER by FOIA only; Dockets
• Analysis is well documented
• Data available for inspection:
•"Assumptions, Sources, Calculations
* Readable!
* Accessible - Web, repository
* Progress Reports
* Independent Technical Assistance
* Layout issues we are analyzing and factors considered
* Issues in contention
Decisions
• Clarify how much power/influence over decision
• Who is making decision
• Issues of contention- alternative
• Summarize process to date
* who, what, etc.
* remind people what it took to get there
• Neutral person run meetings
*maybe not EPA - establish
• FLEXIBILITY -
* final or revisit or phase
• Realistic, Implementable
Evaluation & Accountability
• Evaluate effectiveness of dec.
• What are you trying to do!
- before - at beginning
• Feedback with contact persons
• Build in a revisit testing program
• Track promises
• Technical assistance to stakeholders for monitors
• Data availability - docket, net, repository
D-6
-------
Risk Management Communication and Stakeholder Involvement
Planning and Scoping
Convening Process
1.) Issues
- ask stakeholders
- match issues/goods to resources/time
2.) People
-Who
"interest
*expertise
* balance
- Locate People
'"churches/libraries
* networks
* announcements
- motivate
"Issues
*power
*resources - tech support, money
3.) Process
- clarify roles
- explain reg: context
- influence over outcome
- ultimate decision maker
4.) Analysis
- clarify issues & factors to be discussed
- document
*clear
* readily accessible
* timely (progress reports)
* assumptions
* calculations
* sources of data
- independent tech experts
5.) Decisions
- review roles/process
- review progress to date
- stay FLEXIBLE
- be realistic
"clear statement of desired outcome
*no commitment you can't implement
*engage stakeholders in implementation/assessment
"accountability
- neutral person to run meeting
6.) Evaluation
- process begins at decision making phase
* clear statement of desired outcome
D-7
-------
Risk Management Communication and Stakeholder Involvement
*plan for evaluation
- data to be collected
- who does it
- who is responsible for project
- track all commitments
- tech assistance if needed
- data/analysis readily available (progress reports)
Breakout Group 3 Day 2
Iterate!!!!!!!!!
Same people throughout (base group)
Different types of involvement
• Building stakeholder trust
- explain level of involvement up. front
- explain how Agency will make decisions up front
- provide Feedback
- along the way
- in evaluation
• How to deal with getting effective involvement from SH groups
• How to deal with hidden agendas
• "Best" approach to SH involvement in analysis phase
Group 3 Summary
• Early facilitator involvement
• Consider the Initiating Event
- mandate EPA activity
- new issue
* process Mure or "new" env. problem
- impacts who stakeholders are and how involved
• Each EPA activity requires diff. stakeholder involvement - design matrix
Plenary Summary Following Day 2 Breakout Groups
Planning and Scoping
Facilitation early
Initiating event - Awareness of how it occurred imparts how to involve stakeholders
- mandated
- "build it and they will come" (watershed assessments)
- new issue identified
Information - gathering style
ID appropriate role for stakeholder throughout the process
D-8
-------
Risk Management Communication and Stakeholder Involvement
Summary
- Early involvement of facilitator
- Consider the initiating event
"mandate
*new issues (process failure, "new" environmental problem - how do you recognize this
IE??)
- Decision Matrix
D-9
-------
Appendix E. Hand-Outs
-------
Case Study:
Stakeholder Involvement
in the Rodenticide
Cluster RED
Special Review and Reregistration Division
Office of Pesticide Programs
-------
Background: Rodenticide Cluster REP
Rodenticide Cluster RED indirectly Addresses:
- Warfarin;
- Difethialone;
- Vitamin D-3;
Registrations of new rodenticide active
ingredients to be used in residential settings...and
other places that children may frequent."
-------
Background: Rodenticide Cluster RED
The Agency concluded that rodenticides as
currently used pose a significant risk of
accidental exposure to humans, particularly
children, household pets, and non-target animals.
RED uses data collected by the American
Association of Poison Control Centers (AAPCC)
for 1995 and 1996
- 1995 data: 17,187 human exposures
14,900 children <6 exposures
- 1996 data: 17,601 human exposures
13,362 children <6 exposures
-------
Background: Rodenticide Cluster RED
A two-phased approach was implemented by
the Agency to address risk concerns
PHASE 1: Short-Term Risk Mitigation:
- Indicator Dye and Bittering Agent;
- Improved Labeling Requirements;
- Restricted-Use Classification for tracking
Powders;
- Restricted-Use Classification for Field
Products;
- Change in % A.I. for Field Uses of
Chlorophacinone and Diphacinone;
-------
Background; Rodenticide Cluster RED
PHASE 2: Long-Term Risk Mitigation:
"The Agency will form a stakeholder group
and hold a series of meetings to discuss
means of significantly reducing exposures
to children."
-------
Implementing the Stakeholder Process
First RED to use stakeholder process;
General Guidance: Convene a stakeholder
group consisting of members from industry,
states, CDC, CPSC, AAPCC, rodent-control
experts, members of environmental
community, and medical community.
- Convene meetings no later than 90-days from
issuance of the RED;
- Conclude process no later than 9-months from
issuance of the RED;
-------
Implementing the Stakeholder Process
"Expert Panel'* convened: The Rodenticide
Stakeholder Workgroup
Established as a workgroup to the Pesticide
Program Dialogue Committee (PPDC);
27-member workgroup (see attached members
list);
Workgroup Assembled: Aug. 1998 - Feb. 1999
First Meeting: March 30, 1999
-------
The Rodenticide Stakeholder Workgroup
Meeting #1: March 30,1999
Focus: Introductions, workgroup mission,
RED background, problem definition
Meeting #2: June 9-10,1999
Focus: Rodenticide background, continued
problem definition, solution discussion begins
Meeting #3: July 14, 1999
Focus: Options discussion, continued solution
dialogue
-------
The Rodenticide Stakeholder Workgroup
Generative Process - Workgroup continues to
define problem and look for appropriate
solutions.
Last formal meeting of the Workgroup expected
in October 1999;
Rodenticide Cluster RED expected to be
amended Fall 1999; implemented beginning in
2000;
-------
Rodenticide Stakeholder Process:
Lessons-Learned
Better understanding of the problem and risk
- allows for continued analysis;
- educating and informing the Agency and the
public;
Increased transparency.
Better incorporates public values into decision-
making.
-------
Rodenticide Stakeholder Process:
Lessons-Learned
Resource implications are ENORMOUS
Difficult to find Workgroup balance.
-------
Stakeholder Challenges
Cteate atmosphere where creative problem-
solving can occur.
Expectations need to be realistic.
Need sustained, sincere commitment from senior
management.
-------
REVISED 7-9-99
MISSION STATEMENT
FOR THE
RODENTICIDE STAKEHOLDER WORKGROUP
MISSION:
The Rodenticide Stakeholder Workgroup (RSW) will advise the U.S.
Environmental Protection Agency, through the Pesticide Program Dialogue
Committee (PPDC), regarding potential measures to preclude or reduce the
occurrence of unintentional exposures of young children to rodenticides in and
around residences.
CONSIDERATIONS:
After considering information on exposure cases involving rodenticides and children (<6
years of age) in the home environment, the RSW will consider potential measures to preclude or
reduce their occurrence. For the purposes of this workgroup, the home environment is defined as
places in and around residences. The definition excludes all other registered use sites for rodent
control chemicals, including crop and livestock protection, golf course, and commercial
institutions.
The final recommendation(s) for precluding or minimizing unintentional exposures
involving young children shall be mindful of the following factors:
public health benefits of rodenticides
• avoiding the creation or aggravation of other human health "hazards"
• recognizing the equity of those who bear the cost and regulatory burden
• considering the overall economy and efficacy
-------
RODENTICIDE STAKEHOLDER WORKGROUP MEETING
Sheraton Crystal City Hotel
1800 Jefferson Davis Highway
Arlington, Virginia
March 30,1999
AGENDA
8:30 AM Registration
9:00 AM Welcome/Opening Remarks
9:15 AM Introduction of Workgroup Members
10:00 AM Discussion: Workgroup Process
Facilitator & Chair Duties
PPDC Charter and FACA
Ground Rules
10:30 AM BREAK
10:45 AM Presentation: Rodenticides Overview
11:00 AM Presentation: Children Incident Data
11:30 AM Discussion: Workgroup Mission Statement
12:00 PM LUNCH
1:00 PM Discussion: Exploration of Regulatory Options
to Minimize Rodenticide Exposure to Children
2:30 PM BREAK
2:45 PM Discussion: Options (cont.)
4:00 PM Public Comment Period
4:30 PM Defining Next Meeting Agenda
5:00 PM ADJOURNMENT
Susan Hazen, Acting
Deputy Director
Office of Pesticide Programs
Linda Werrell, Facilitator
Dennis Deziel
Jerry Blondell
Linda Werrell
Lois Rossi, Chair
Lois Rossi
Linda Werrell
Lois Rossi
-------
Lois Rossi, Chair
Kim Blindaiier, CDC
Steve Kellner, CSMA
Bobby Corrigan, RMC Consulting
Rodenticide Registrants
Task Force (RRTF)1
Rodenticide Stakeholder Workgroup II
National Rural Electric Cooperative Association Conference Center
4301 Wilson Blvd, Arlington, Virginia - 703-907-5500
(Metro Orange Line, 1 block from Ballston Metro)
June 9-10,1999
Preliminary Agenda
DAY 1: FRAMING THE ISSUE
JUNE 9.1999.9am - 3pm
8:30 Registration
9:00 Welcome/Opening Remarks
9:15 Rodenticide Benefits: Public Health
9:45 Rodenticide Benefits: Property Integrity
10:00 RRTF: Rodenticide Use Analysis
10:30 BREAK
10:45 Anatomy of a Rodenticide Exposure
• Comparative Toxicity of Rodenticides
• Poison Control Center Role
• Emergency Room Perspective
• Further Incident Analysis
12:15 Public Comment Period
12:30 LUNCH
1:30 Sub-Group Results: Review of State
Incident Data
2:00 RRTF: Incident Data Presented
in the Context of the Toxicity, Exposure,
and Risk of Rodenticide
2:30 Public Comment Period
2:45 Closing Remarks
3:00 Offsite Tour -Washington, DC
John Redden, EPA
Rose Ann Soloway, AAPCC
Joseph Wright, M.D.
Jerry Blondell, EPA
Linda Werrell, facilitator
Bob Wulrhorst, ASPCRO
Tony Schatz, Recldtt & Colman
Rick Kingston, Prosar Intematonal
Poison Center
Linda Werrell, facilitator
Lois Rossi
Mark Greenleaf, DC Department of Health
1 RRTF represents major manufacturers and formulators of home-use rodenticide products. Companies represented
are: Bell Labs, Inc., California Department of Food and Agriculture (CDFAX Consolidated Nutrition, Hacco, Inc., Liana Tech,
FM Resources., Reckin & Colman, Wilco Distributors, Zeneca Ag Products.
Page 1 of 2
-------
DAY 2: FINDING A SOLUTION
JUNE 10.1999.9am - 3pm
8:30 Registration
9:00 Consumer Labeling Initiative
9:15 Overview of Pesticide Education
and Outreach Programs
• Federal Perspective
• Federal Perspective
• Local Perspective
• State Perspective
• Industry Perspective
• Non-Government Organization Perspective
10:30 Revisit Workgroup Mission Statement
10:45 BREAK
11:00 Current Risk Mitigation Approaches for Rodenticides
• Bittering Agents
• Bait Stations, PR Notice 94-7
• Integrated Pest Management (IPM)
11:45 Public Comment Period
12:00 LUNCH
1:00 Workgroup Discussion: Rodenticide Use,
Toxitity, Incidents, and Options
• Overview of Options Paper
• Workgroup Brainstorm: Other Options
2:30 Public Comment Period
2:45 Setting Agenda for July 14th Meeting/
Closing Remarks
3:00 ADJOURNMENT
Amy Breedlove, EPA/OPP, Office of Field
and External Affairs Division (FEAD)
Claire Gesalman, EPA/OPP/FEAD
JohnImpson,USDA,
Mark Greenleaf, Washington DC/DOH
Gerry Miller, CDFA
Bob Rosenberg, NPCA
Lea Johnston, MaryPIRG
Linda Werrell
Gary Witmer, USDA/APHIS
Bill Jacobs, EPA
John Antonacci, City of Chicago
Linda Werrell, Facilitator
Lois Rossi
Dennis Deziel, EPA
Lois Rossi
Linda Werrell
Lois Rossi
Page 2 of 2
-------
Rodenticide Stakeholder Workgroup ffl
Ramada Inn Plaza Hotel, 901 N. Fairfax St,
Alexandria, Virginia (Tel 703-683-6000)
July 14,1999
Agenda
July 14. 1999. 9 am - 4 pm
8:30 Registration
9:00 Welcome/Opening Remarks
9:15 Discussion: Review Suggested Solutions
from June 10 Meeting
10:30 Break
10:45 Discussion: Other Potential Solutions
11:15 Discussion: Preliminary Evaluation of Solutions
11:45 Public Comment Period
12:00 LUNCH
1:00 Discussion: Evaluate Potential Solutions
Mission Statement "Considerations"
Implementation Issues and Concerns
2:00 Discussion: Monitoring Performance and Results
2:30 Discussion: Finalize Recommendation(s)
3:00 Break
3:15 Next Steps
3:45 Public Comment Period
4:00 ADJOURNMENT
Lois Rossi, Chair
Workgroup Members
Dennis Deziel
Linda Werrell, Facilitator
Linda Werrell
Michael McDavit
Linda Werrell
Linda Werrell
Lois Rossi
Linda Werrell
-------
RODENTICIDE STAKEHOLDER WORKGROUP « of s«/»s
vvEPA
Name
(alternate)
Lois Rossi,
Rodenticide
Worgroup
Chairperson
Mary Beth
Arnett
(Bamett
Lawrence)
Suzanne Barone
Jefferson
Biakeddy
JohnAntonaoci
(Terry Howard)
Robert Conigan
Martha Farkas
(Christine
Norman)
Mary Ellen Fise
Ron Grant
Mark Greenleaf
(Alvin Harris)
Stakeholder
Category
Federal Government
Pesticide Regulation
General Public
Federal Government
Consumer Product
Regulation
Tribal Government;
Pesticide Regulation
City Gov. - Health &
Sanitation
General Public
Canada Government
Consumer Group
Industry - Pesticide
Registrant
City Gov. - Health &
Sanitation
Affiliation
USEPA, Office of Pesticide
Programs
U.S. Consumer Product Safety
Commission, Division of
Health Sciences
Navajo Nation, Environmental
Protection Agency
City of Chicago Department of
Streets and Sanitation, Bureau
of Rodent Control
Pest Management Regulatory
Agency, Health Canada
Consumer Federation of
America
PM Resources, Inc.
District of Columbia
Department of Health
Address
Director, Special Review &
Reregistration Division, (MC7508C),
401 M Street, SW, Washington, DC
20460
3619 S. Berryfield Lane, Appleton,
Wisconsin 549 15
Room 600
4330 East-West Highway
Bethesda, MD 20814
Pesticide Program, PO Box 339,
Window Rock, Arizona 86515
Bureau of Rodent Control, Room 3-B,
510 N. Teshigo Ct., Chicago, Illinois
60610
5 1 14 Turner Road, Richmond, Indiana
47374
2250 Riverside Dr., Ottawa, Canada,
K1AOK9
1424 16th Street, NW, Suite 604,
Washington, DC 20036
13001 St. Charles Rock Rd.,
Bridgeton, MO 63044
Department of Health, EHA,
Pesticide Programs, 2100 MLK Ave.,
Washington, DC 20020
Phone/fax/E-mai!
(703)308-8000; 800S (fax)
Rossi LoiSiSleDaitiait epa goV
(920) 830-8535; 920-727-7519 (fax)
ArnettMB(S>3ol com
301-504-0477, ext. 1196; -0079
sbaronc(d}cpsc,gov
(520) 871-7810; 7818 (fax)
(312)744-6465; 0131 (fax);
ssOOO? l,ci.chi.il.us
(765) 939-2829 (phone/fax)
RCorr22(S!aol.com
(613) 736-3772; 3770 (fax)
mfarkas<3h>mra-arla.hc-sc.ec.ca
(410) 296-4290;4291 (fax);
merf(0>home.com
(3 14) 394-7489; 981 l(fax);
(202) 645-6080; 6102 (temp, fax)
inprccnlelSlcvbcrdudc.com (temp)
Page 1
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RODENTICIDE STAKEHOLDER WORKGROUP
vvEPA
Lebelie Hicks
John Impson
(Shirley Wager-
Page)
Bill Jacobs
Lea Johnston
Steve Kellner
Edward
Marshall
(Kelly Rahn)
Eileen Mpyer
(Earle Borman)
Michael
McDavit
Gerald H. Miller
(Robert
Roberson, Jr.)
BrendaLee
Richardson
State Gov. -
Pesticide Regulation
Federal Gov. -
Education
Federal Gov. -
Pesticide Regulation
Environmental Group
Industry - Pesticide
Registrants
Industry - Pesticide
Registrant
Industry - Pesticide
Registrant
Federal Gov. -
Pesticide Regulation
State Gov. - Pesticide
Registrant
Environmental Justice
FIFRA Issues, Research and
Evaluation Group (SFIREG)
US Dept. of Agriculture -
Cooperative State Research,
Education and Extension
Service
USEPA - Office of Pesticide
Programs
Maryland Public Interest
Research Group (MaryPIRG)
Chemical Specialities
Manufacturers Association
Lipha Tech, Inc.
Reckitt & Colman, Inc.
USEPA - Office of Pesticide
Programs
California DepL of Food and
Agriculture
Women Like Us
Maine Dept. of Agriculture; &
State, Board of Pesticides Control, 28
State House Station, Augusta, Maine
04333-0028
Health, Environmental & Pesticide
Safety, Ag Box 2220, 901 D Street,
SW (#330), Washington, DC 20250-
2220
Registration Division, Insecticide and
Rodenticide Branch (MC 7505C), 401
M Street, SW Washington, DC 20460
3121 St. Paul Street, Suite 26,
Baltimore, MD 2 12 18
19 13 Eye Street, NW
Washington, DC 20006
3600 West Elm Street,
Milwaukee, WI 53209
1800 Valley Raod, Wayne NJ 07474
Special Review & Reregistration
Division, Reregistration Branch III
(MC 7S08C), 401 M Street, SW,
Washington, DC 20460
Plant Health and Pest Prevention
Services, Integrated Pest Control
Branch, 1220 N. Street, Room A-357,
Sacramento, CA 95814
3008 24* Place, SE, Washington, DC
20020
(207) 287-2731;
7548 (fax);
Lebelle.Hicks(3>staie.me.uB
(202) 401-4201;
6156 (fax);
iimDSon^reeusda.ROv
(703) 305-6406;
bill.iacobsfJTJcDa.eov
(410) 467-0439; 366-2051 (fax);
lea90Sfr3>aol.coin
(202) 872-81 10/X3036; 8114 (fax),
skellnerlfiicsma.org
(4 14) 35 1-1476; 1847 (fax);
edmarsUaHreckilt.cpm
(703) 308-0325; 8005 (fax);
micuael.mcdavit(?/>,epa.pov
(916) 654-0768; 653-2403 (fax)
GmilleriStedfa.ca. eov
(202) 678-1978;
889-1917 (fax);
Page 2
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RODENTICIDE STAKEHOLDER WORKGROUP
vvEPA
Bob Rosenberg
Carol Rubin
(Kim Blindauer)
Rose Ann G.
Soloway
Cisse Spragins,
PhD
(Jean Fugate)
Joseph Wright,
MD
Bob Wulfhorst
(Carl Falco)
Industry - Pesticide
Applicator
Federal Gov. -Public
Health
Medical Community
Industry- Pesticde
Registrant
Medical Community -
Emergency Pediatrics
State Gov. - Pesticide
Regulation
National Pest Control
Association & PPDC
US Dept. of Health & Human
Services - Centers for Disease
Control & Prevention
Associate Director,
American Association of
Poison Control Centers
Agent for Bell Laboratories,
Inc./Rockwell Labs.
Children's National Medical
Center
Association of Structural Pest
Control Regulatory Officials
(ASPCRO)
8 100 Oak Street,
Dunn Loring, VA 22027
Nat. Center for Env. Health,
Health Studies Branch, Mail Stop F-
46, 4770 Buford Highway, NE,
Atlanta, GA 3034 1-3724
3201 New Mexico Avenue, NW, Suite
310, Washington, DC 20016
1117 Marquette Avenue, Suite 2402,
Minneapolis, MN SS403
Dept. of Emergency Medicine, 111
Michigan Avenue, NW, Washington,
DC 200 10
Ohio Dept. of Agriculture Pesticide
Regulation, 899S East Main Street,
Bldg. 1, Reynoldsburg, OH 43068-
3399
(703) 573-8330; 41 16 (fax);
rrosenbere(3toestworld.ore
(770) 488-7350; -7557 (fax)
chrl (3jcdc.gov
(202) 362-7217; -8377 (fax)
raG(fi)poison.or£
(612) 339-4933; 4943 (fax);
csDraeinsi2lrockwelllabs.com
(202) 884-4177;
3573 (fax);
iwricht(KJ)cnmc.orc
(614) 728-6383; 4235 (fax);
wuliliorstffT'.odant.acri.Gtate.oh.us
Page 3
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Planning and Scoping for Risk
Managers and Assessors
Ed Bender
Science Policy Council Staff
July 14, 1999
Risk Assessment/ Management Decision Procej
New Management Needs
Risk Assessment
Planning
and
Scoping
Problem
Formul
(Assessor-
Manager
Dialogue)
Risk
haracterization
Economic, Poll-Science,
and Social Analysis
-------
Cumulative Risk Guidance
Planning and Scoping Steps
1. Discuss why the assessment is needed
2. Define the scope of effort
3. Determine context (What's in/out?)
4. Develop a conceptual mode!
5. Formulate the problem and Analysis
Plan for the Assessment
Problem Formulatio]
Dialog I
IB
Risk Assessor
1 . Background Knowledge
a. scale of the risk
b. critical endpoints
2. Available/appropriate
data (where?)
3. CR Matrix
RiskM
5. Potential RM options j gJBSSii
Cf«L»J»VlAl/ijM!£
oiciKenoiucrs
(.Values
^.
w
|y?:
anager
1. Why is RA needed?
2. Risk Managem't goals
3. Policy concerns
4. Political concerns
5. Timing/Resources
6. Acceptable Levels of
Utl\i1«l I.J11IIJ, f
7. Potential RM options
prnrv~>mist'S
1. Benefits
2. Tradeoffs
3. Rjvj OLHIUII
xJa.
Conceptual Model
-------
Dimensions of the Models
Sources
CAFO
Oil &Gas Explor.
Agriculture (grazing,
crops)
Domestic Waste
Road/infrastructure
Strcssors
Nutrients (N,P,K)
Sulfur compounds
Pesticides
Pesticides
Dust, odor, noise
Ammonia, turbidity
Sediment
Toxic chemicals
Endpoints
Diseases
Algal blooms
Loss of vegetation
Methemoglobinemia
wetland creation/loss
water quality
waterfowl abundance
Fish/wildlife tox.
Anxiety, outrage....
Conceptual Models
Show relationships between assessment
endpoints and stressors.
Reflects both scientific hypothesis and a
rationale for accumulating risks from
stressors affecting common receptors.
-------
Watershed Preliminary Conceptual Model
(CAFO Stressor Categories)
Sources
Application) >„•
Oiljixplor.
Product.*'"
_ . .
Agriculture
•»' •>••
'crops) .--J
Domestic
Waste,'
j; >i"li-:. - ' •
Sewage
Stressors
'Traffic '
Watershed Preliminary Conceptual Model
(All Source Contributions)
Sources
Stressors
-------
Human Health Preliminary Conceptual
Model
Population/
Receptors
Effects
Assessment
Endpoints
Ecological Preliminary Conceptual Model
Population/
Receptors
Effects
Assessment
Endpoints
-------
Analysis Plan
Links Planning and Scoping to Assessment
Identifies critical relationships to evaluate
Discuss consequences of missing data
Describe analysis process
Relate results to risk manager questions
Discuss recognized uncertainties
Messages from Cumrisk^
Workshops 1fll
Planning and Scoping and Conceptual
Models are important steps, especially for
geographically based risk assessments.
Early discussions with the risk manager are
essential.
More work is needed to reconcile health and
ecological risks for cumulative assessments.
-------
Clinch Valley
Risk Assessors • Risk Managers
^TetraTech ^USFWS
TVA * TNC
USDA NRCS
farmers
-------
Middle Platte River
5400 sq mi - Nebraska
migratory waterfowl
Stressors
hydrologic change, sediments
Effects
wetland loss, channel change
Scientific
Approach
landscape ecology approach
Mgt
Decisions
water withdraw^
NPS pollution
-------
Middle Piaffe
Risk Assessors
^Queens University
Cadmus
EPA Region 7
EPA ORD NCEA
Risk Managers
EPA Region 7
NE Natural
Resource Districts
Whooping Crane
Trust
USDA NRCS
farmers
-------
Mid-Snake River
Site
8600 sq mi - Idaho
anadromous & cold water fish
Stressors
Effects
sediments, hydrologic change
fish, macrophyte/algal growth
Scientific
Approach
sediment sampling study
Decisions
TMDL regulation,
dam licensing
-------
Big Darby Creek
sq mi - Ohio
water quality, species diversity
Stressors
Effects
sedimenfsTnutrients, channel
fish & macroinvertebrates
Scientific
Approach
indices of ecological integrity
to evaluate effects
BMPs, future land use
Decisions
K
Q
-------
Planning
Establish a management
goal
- organizational goals
-laws
-surveys
-public meetings
Agree on focus, scope
and complexity
-------
Elements of a Conceptual Model
Measurable
Change
-------
Conceptual Models
a powerful communication tool
Illustrate link from human activities to
ecological effects
Help understand multiple stressors,
pathways and the watershed approach
Show different perspectives
Provide insight and info for decision making
-------
Improvements - Waquoit Bay
o
Expand data set, improve model, fund more
Explaining preliminary findings
Modified planned presentation
Ul
o>
CD
ro
cs
-------
Watershed Eco-Risk Assessment
Lots of RA-RM Interactions - Teams
Management goal for watershed
Scope of assessment
Understanding the problem and causes
Improving the analysis
Estimating chnages associated with actions
Communicating the findings
LD
ID
Ul
N)
Ul
00
to
C9
cs
-------
Spatial Analysis and Decision Assistance Software Home Page
http://www.sis.utk.edu/cis/sac
THE UNIVERSITY OF
TENNESSEE, KNOXVILLE
Spatial Analysis and Decisicn Assistance
Home Page
Spatial Analysis and Decision Assistance (SADA) is free software that
incorporates tools from various fields into an environmental assessment
problem solving environment. These tools include integrated modules for
visualization, geospatial analysis, statistical analysis, human health risk
assessment, cost/benefit analysis, sampling design, and decision analysis. The
modules in SADA can be used independently or collectively to address site
specific concerns when characterizing a contaminated site and when
designing remedial action.
SADA was designed to simplify and streamline several of the environmental
characterization processes and to integrate the information in order to
facilitate decisions about a particular site in a quick and cost effective
manner. SADA is applicable for anyone who needs to look at data within a
spatial context, such as:
•Statisticians
* Risk Assessors
•CIS Users
•Project Managers
•Stakeholders
SADA output has been very effective in communicating site conditions to
non-technical stakeholders as well. Click on any of the topics at left to view
more detailed information in each area.
SADA was funded by the DOE and developed by the University of
Tennessee in collaboration with Oak Ridge National Laboratory (ORNL).
C Spatial Analysis and Decision Assistance Copyright 1996 University of Tennessee Research Corporation
All Rights Reserved
O SADA Home Page Copyright 1998 University of Tennessee. Research Corporation. All Rights Reserved
Main Pagel Visualization! Data ExploralionI Gtpspatial | Risk Assessment
Saniplingl Beta Release! Email Comments I Traininc
Decision I Cost/Beneful Secondary
Tech Support
You are visitor I
FastCounter by UnkExchanqe
since Marco
lof 1
7/15/997:14.
-------
jpatial Analysis and Decision Assistance Software Risk Assessment
http://www.sis.utk.edu/cis/sada/risk_assessment.htn
THE UNIVERSITY OF
TENNESSEE, KNOXVILLE
Spatial Analysis and Decisicn Assistance
Risk Assessment
SADA provides a full human health risk assessment module and associated
databases. The risk models follow the EPA's Risk Assessment Guidance for
Superfund(RAGS) and can be customized to fit site specific exposure
conditions. The following landuse scenarios and exposure pathways are
available for both radionuclides and nonradionuclides to calculate risk and
data screening levels.
Landuse Scenarios
Residential
Industrial
Agricultural
Recreational
Excavation
Exposure Pathways
Ingestion
Inhalation
Dermal contact
External (radionuclides)
Food consumption
Combined Exposure-
Risk results can be produced in standard tabular format or graphically.
Graphical Results
£'»" Ac 227 Sample Locations
Boxed data' indicates exceedance
of screening value.
1 of 2
7/15/99 7:17 A
-------
Spatial Analysis and Decision Assistance Software Risk Assessment
http://www.sis.utk.edu/cis/sada/risk assessment!
Risk due to exposure to entire area
O Spatial Analysis and Decision Assistance Copyright 1996 University of Tennessee Research Corporation. All Rights Res
O SADA Home Page Copyright 1998 University of Tennessee Research Corporation. All Rights Reserved.
Main Pagel Visualization! Data Exploration! Gcospalial I Risk Asysmcnlj Decision I Cosl/Bencfill Secondary Sampling!
Release! Email Comments I Trainingl Tedi Support
2 of 2
-------
Communications Issues
-------
OPP Process
Risk Manager
Development of Mitigation Measures
Regulatory Products
Interactions w/ External Entities
Team Concept
RM leads the team
RAs lead assessment teams
Communication is Key
-------
Key Aspects of Communication
Coordination of Interdependent Efforts
Ex.) Drinking water exposure; %CT
Fulfillment of Information Needs
Ex.) Data requirements; Media interactions
Maintaining Schedules
-------
Key Aspects of Communication
Setting Priorities
Informing Management
Enhance Understanding of Risks
Development of Mitigation Strategies
-------
When to Communicate??
In short: Always
Team Kickoff Meeting
Development of Assessments
Development of Mitigation Strategies
Regulatory Decisions
-------
Phosphine Case: Phase 1 "Uh Oh"
Out w/ the old in w/ the new
Got to get it out!
Industry needs a clue!
A novel approach
A journey instead of a trip
-------
Phase 2: Making It Work
Working together to flatten the learning curve
Pulling together many minds to strategize
Educating the industry
A successful path forward
-------
"The Price Not Paid"
Failure to meet milestones
Rework and more rework
Misinformed, unhappy management:(
Incomplete assessments
> Poor decisions
•*t •',;!-.. v'
>
^r
-------
RA<->RM Communication
The key to success is:
open
honest
consistent
two-way
COMMUNICATION
-------
Case Study: Pownal Tannery Superfund Site
Issue
In 1998 EPA listed the Pownal Tannery in North Pownal, Vermont, as a Superfimd site.
While a human health risk screening, done for the site in support of an ongoing non-time critical
removal action (NTCRA), did not exceed the level of concern typically used to place a site on
Superfund's National Priorities List (NPL), other (non-risk assessment) information weighed
heavily in the decision to perform the NTCRA and list the site.
Site Description
The Pownal Tannery site is located between Route 346 and the Hoosic River in the Village of
North Pownal, in Bennington County, Vermont. The site was a former hide tanning and
finishing facility owned by the Pownal Tanning Company, Inc. It has been inactive since 1988
when the company declared bankruptcy. The site consists of three contamination sources: the
tannery building complex, a lagoon system, and the tannery's sludge landfill. In total, the
Pownal Tannery site encompasses approximately 28 acres.
From approximately 1937 until 1962, untreated tanning process wastewater was directly
discharged into the Hoosic River. A lagoon system comprising six lagoons, was constructed in
several stages between 1962 and 1971 to receive the tannery's wastewater. In 1982, a state-
permitted, lined landfill was constructed on site to receive sludge dredged from a portion of the
lagoons. The tannery landfill is situated on a parcel of land across from the Hoosic River and
southeast of the tannery building complex. In 1987, two-thirds of the landfill was covered and
closed The remaining portion remains uncovered.
The area is a rural and residential community with approximately 3,SOO residents Many
residents live in rented trailers. The nearest residences are approximately 200 feet from the site
and rely upon groundwater from private wells for their water supply. While some site related
contaminants have been detected in residential wells in the past, current sampling data indicates
that safe drinking water standards are not being exceeded.
Threats and Contaminants
• The groundwater, soil, lagoon/landfill sludge, and building materials are contaminated
primarily with metals, semi-VOCs, and dioxin
• Metals, semi-VOCs, and dioxin have been found in site soil/sludge and on building materials
at levels that pose an unacceptable direct contact threat.
• Surface water and sediments'associated with the Hoosic River are contaminated with several
metals, with some exceeding federal benchmark criteria indicating a potential adverse impact
to aquatic organisms.
• Access to the site is largely unrestricted.
-------
• While sampling data indicate that the site has not adversely affected the nearest residential
wells, continued migration of contaminated groundwater could present a future human health
threat.
>sessment
EPA completed a human health risk screening of the site in 1998. Using very conservative
assumptions, the assessment indicated low (< 1 x 10"4) risks to the most at-risk groups
(adolescent trespassers returning daily to the site, future adult employee). See Separate
attachment.
EPA did not conducted an ecological assessment of the site.
Potential risks due to building/landfill condition and location of site to the river (see attached
map).
leanup Approach
— The site is being addressed in two stages: initial actions and a long-term remedial phase
«'hich will address contamination at the entire site. Following an initial EPA site evaluation in
93, a time-critical removal action was taken in 1993 and 1994 to remove 13,000 pounds of
contaminated material left behind in drums and tanks within the tannery buildings. Additionally,
-'•& access restrictions were put in place but were subsequently compromised by trespassers
is action mitigated the immediate threats to the community.
Between 1995 and 1998, EPA completed an additional preliminary investigation of the
urce areas at the site, which included the collection of samples at the lagoons, the landfill and
tannery building. In December of 1998, EPA released a proposed plan to the public to address
intamination at the buildings and the landfill. This proposal includes decontamination and
molition of tannery buildings, removal of contaminated soil/sludge under tannery buildings to
the on-site landfill, capping the landfill and repairing the leachate collection system at the
idfill. A final Action Memorandum, documenting this decision was released in March 1999
id the cleanup has begun and will continue for approximately one year. Contamination of the
eroundwater, lagoons, surface water, and sediment of the Hoosic river will be addressed during
i upcoming Remedial Investigation and Feasibility Study (RI/FS), which is also scheduled to
_ jgin in the spring of 1999 Through both of these upcoming actions, site access restrictions will
UT addressed.
environmental Progress
The initial actions to remove liquid and bulk hazardous materials remaining in the tannery
lildings reduced the potential for accidental exposure to hazardous wastes at the site. The
upcoming non-time critical removal measures to completely address building contamination and
close the landfill will address potential exposures to two of the three source areas at the former
nnery.
-------
POWNAL TANNERY
HUMAN HEALTH RISK SCREENING
PURPOSE
To determine whether the contaminants identified at the site pose a current and/or
future potential risk to people in the absence of a cleanup, and if an action needs to
be taken to protect the public.
LAND USE ASSUMPTIONS
Current: Tannery activities closed. Site is known to be utilized by local
trespassers.
Future: Continued trespassing and resumed industrial activities.
CONTAMINANTS OF CONCERN
16 Semi-Volatile Organic Compounds (SVOCs), dioxin, and metals.
EXPOSURES
Current: Adolescent trespasser to contaminated building surfaces and
soil/sludge in building basements via ingestion and dermal conts"
(direct contact).
Future: Same as current exposure with the addition of exposure to a future
adult employee at the building through ingestion and dermal contact.
RISKS
There is an unacceptable current and future cancer risk to adolescent
trespassers that may come into direct contact with contaminants on building
surfaces and to soil and sludge under the building.
There is an unacceptable future cancer risk to an adult future employee that
may come into direct contact with contaminants on building surfaces and to soil
and sludge under the building.
-------
Summary of Primary Contaminants of Concern.
Maximum Concentrations Detected
Tannery Building Complex
arsenic (mg/kg)
antimony (mg/kg)
barium (mg/kg)
cadmium (mg/kg)
chromium (mg/kg)
lead (mg/kg)
manganese (mg/kg)
nickel (mg/kg)
vanadium (mg/kg)
benzo(a)anthracene (ug/kg)
benzo(a)pyrene (ug/kg)
benzo(b)fluoranthene (ug/kg)
benzo(k)fluoranthene (ug/kg)
indeno(l,2,3-cd)pyrene (ug/kg)
pentachlorophenol (ug/kg)
dioxin (ng/kg)
Soils/Sludge
63 parts per million
232
8,270
33
126,000
1,380
2,140
606
1,640
56,000 parts per billion
63,000
74,000
45,000
22,000
33,000
459 parts per trillion
Landfill
arsenic (mg/kg)
cadmium (mg/kg)
chromium (mg/kg)
lead (mg/kg)
manganese (mg/kg)
mercury (mg/kg)
zinc (mg/kg)
pentachlorophenol (mg/kg)
2,4,5-trichlorophenol"
4-methylphenol (mg/kg)
phenol (mg/kg)
2-butanone (ug/kg)
dioxin (ug/kg )
sludge
10
76
18,900
975
3,640
39
171
100
51
500
200
740
7
Runoff Sediments
9 parts pe-
NA
60
22
3,110
.11
620
NS
NS
NS
NS
NS parts per billion
NA
-------
V-.X. APPROXIMATE EXTENT
' OF 100-YEAR FLOODPLAlN
CROUNDVATER MONITORING WELL
VATEI
EXISTING TREELIKE
FENCE
UNIMPROVED ROAD
RAILROAD
POTENTIAL WETLAND
(BASED ON MIE ECOLOGICAL
EVALUATIONS
APPROXIMATE BOUNDARY OP LAGOON
I «.L LOCATION* »»t '0 K COMSIKKI
2 H.AM it uci to ic uicn rot KSICH
1 JCt KfCKCNCC KCtlOH Of tt/C* Kl>ml
ran lASC n^f SOVjRCCS
LAGOON SYSTEM
POWNAL TANNERY SITE
TETRA TECH NUS, INC.
NORTH POWNAL VERMONT
-------
NORTH
POWNAL
BRIDGE
PROPOSED AREAS TO BE
EXCAVATED
»= RAILROAD
TREELINE
PROPOSED AREAS
TO BE DECONTAMINATED
PROPOSED AREAS
TO BE DEMOLISHED
PROPOSED EQUIPMENT AND
POTENTIAL
~~SLOPE SHORING
SUPPLY STAGING AREA
POWNAL
TANNERY
SITE IMPLEMENTATION LAYOUT - ALTERNATIVE B-
POWNAL' TANNERY SITE
TRA TECH NUS, INC.
39 Joniph RM4 MmlnqtM. MA 01887
NORTH POWNAL. VERMON1
iuiiiiiA. SKJVH 01 ria 1-4.
«.U l«ev.U«« I" ft* '0 * DCCfllTMIHATtB
-------
:m-
LEGENJQ
UNIMPROVED ROAD
TREEL1NE
FENCE
BERM
LEACHATE COI LECTION MANHOL
TO HOOSIC RIVER
(APPRDX. 700 TT
LEACHATE COLLECTION SYSTEM
LEACHATE COLLECTION PIPING
LEACHATE COLLECTION TANK
WATER
GRAVEL ROAD
GROUNDWATER MONITORING WELL
APPROXIMATE AREA
TO BE CAPPED
TO HOOSIC RIVER
SITE IMPLEMENTATION LAYOUT - ALTERNATIVE LF-2
lAUli. ,
t M.L lOCAHOlt MIC '0 tC
M it MU to ic uuo ft* KIICH
j ut Krtncxcc SCCIIONS or ct«A
rex IAIC »tf sources.
vtLL 1-13 "AX MCTCXCKCft
II IT HtC
POWNALy TANNERY SITI
NORTH POWNAU VERMONT
-------
SLUDGE LANDFILL AREA
O
Former
Tannery
Building
- Saeorfntarmfttent Stream/Dlfecfott of How
Tcoas t%| Ctat&KScfiSng 1 I Residence
Grass H f>rtsa BuJdhg ~ ~ 'Jnpaved Road
Bridge -}-j- fla«rt»d Tracta ZZI f**^1 Roari
F«oca . '^-Staam/OrtcaonotHoar W WaOand
F«ocaGata J L gjope (fldcs kxficata downhffl) @ Water
SITE SKETCH
POWNAL TANNERY
POWNAL, VERMONT
Rgurel
-------
Merging Science with Policy
thru 5 Watershed Assessments
ro
LD
UD
LO
Environmental
Science
(risk assessors)
Public Policy
(risk managers)
U)
CO
H-»
01
3
CD
ro
cs
-------
social factors
cultural factors
political considerations B^ MAKING
legal mandates « DECISION
economics
historical precedence
ecological risk
-------
Merging
Watershed
approach
Ecological risk
assessment
UJ
o
CD
CD
-J
I
2
fO
cs
-------
Applying the Ecological Risk
Assessment Approach
Ecological risk assessment framework
Apply principles to real world problems
Five demonstration sites were selected
-------
Watershed Assessments
(3
00
01
CD
LD
CD
Waquoit
Bay, MA
NJ
CO
-------
Waquoit Bay
20 sq mi estuary - MA
scenic, recreation, fishing
Stressors
nitrogen & toxins
algal growth -> SAV -> fish
Effects
Scientific
Approach
N loading model &
ecological effects model
septic tanks or WWTP
Decisions
-------
Waquoit Bay Participants
Risk Assessment Team
Boston University
University of Connecticut
Waquoit Bay National Estuarine Research Res
EPA ORDNCEA staff
K>
ID
to
VO
Ul
M
Ul
CO
ID
CO
A
CD
Risk Managers |
Waquoit Bay National Estuarine Research Res 5
> Cape Cod Commission
». Association for the Preservation of Cape Cod
^MADEP.F&W.CZM I
*- Towns of Mashpee & Falmouth
C9
CO
IO
CO
-------
Clinch & Powell River
Stressors
2900 sq mi- VA freshwater
fish, mussel species diversity
sediments & toxins
Effects
fish & mussel species
Scientific
Approach
GIS to compare land use with
fish & mussel data
Decisions
-------
Messages (cont.)
The scope of a complex risk assessment
should be determined by risk management
goals and risk priorities.
Conceptual models clarify priorities for data
collection, assessment, and RM decisions.
Stakeholder input (regulated, affected or
interested parties) should be early, but
process is needs more guidance.
Planning and Scoping Outputs
for Cases
A list of stressors, sources, and assessment
endpoints for each case showing what is in
and what is out with rationale
Conceptual model and text on hypothesized
linkages between stressors and effects
An analysis plan for the assessment.
-------
EPA Trainex Content Cover
wysiwyg://rbottom.9/http://trainex.org/content.l
Training-Exchange provides a range of training
information to EPA, other federal agency, state, tribal, and
local staff involved in hazardous waste management and
remediation. The site includes training schedules for
hundreds of deliveries of more than 65 classes.
Training Coordinators, On-Scene Coordinators (OSCs),
Remedial Project Managers (RPMs), Permit Writers,
Corrective Action Managers, Site Assessment Managers
(SAMs), Enforcement staff, Community Involvement
Coordinators (CICs), State Program Managers, and others
will find training courses and information directly targeted to
their needs.
EPA HOMEPAGE I TRAINING-EXCHANGE HOME
Privacy and Security Notice
Email: pachon.carios@epa gov
Training Exchange Homepage
Last Modified: 07/06/99 11:00:57
URL http://trainexo«j/contenthtm
lofl
-------
FEDERAL ADVISORY COMMITTEE ACT
DISCUSSION SCENARIOS
SCENARIOS INVOLVING WHETHER TO CHARTER A COMMITTEE
1. Management officials of the EPA program office are planning a public meeting to review a
strawman of the "dimethyl-chickenwire" rule. Notice of the public meeting has been published in
the Federal Register and specific interested parties have also been personally invited by EPA to
attend the meeting. EPA's agenda for the meeting will include presentations by the EPA of the
strawman, and presentations by various known interest groups on their views. A period of open
public comment will be held before the meeting is concluded.
Is this meeting subject to FACA?
What precautions should be taken to protect the integrity of the Agency's process?
2. Management officials of the EPA program office were so pleased with the range of responses
at the public meeting discussed above that they have decided to conduct a series of three "round-
table" discussions with the most active parties who spoke at the public meeting. EPA's agenda
for the round-table meetings includes presentation of a revised strawman rule and presentations
by the various interest groups on their views with regard to the revised strawman. While the
meeting is primarily by invitation and a table will be set up to seat the Agency and interest
groups, no one will be turned away who shows up. The agenda will allow time for members of
the audience to speak The stated purpose of the meetings is to obtain facts and to exchange
information with the parties. The roundtables will be held in three different locations. The agenda
for each of the round-tables will be the same in each city. The invited attendees will be from the
same interest sectors but not necessarily the same individuals or organizations.
Are these meetings subject to FACA?
What precautions should be taken to protect the integrity of the Agency's process?
3. Management officials of the EPA program office were pleased with the results of the round-
table meetings. Further development of the strawman rule rests on exploring technical options in
more detail with the interested parties. EPA has decided to hold three more round-table meetings,
each focusing on a different technical issue with the goal of fleshing out the options more
thoroughly. Most of the invited attendees will be the same at each meeting. Notice of the
meetings will be published in the Federal Register. There will be a plenary session with several
smaller breakout sessions for more interactive discussion. EPA's agenda will include time for
-1-
-------
the audience to speak at the end of the round-table session. While the stated goal of the sessions
is to obtain facts, generate a list of options and exchange information, the Agency does not want
to discourage the parties from narrowing down the options; however the Agency does not intend
nor expect the group to reach a consensus.
Are these meetings subject to FACA?
What precautions should be taken to protect the integrity of the Agency's process?
4. Management officials of the EPA program office have tasked a facilitation and meeting
support contractor to obtain input from outside stakeholders on the implementation of the
"dimethyl chickenwire" emissions rule. The contractor will identify appropriate stakeholders to
be members of a group that will meet several times to review the Agency's program
implementation. EPA will give the contractor a list of groups who have been involved in the past
on the issue of dimethyl chickenwire who might be appropriate group members. The contractor
and the group members, with input from EPA, will jointly draft meeting agendas and will jointly
decide on information to be gathered and discussions to be held. The meetings of the group will
be open to the public and EPA will announce the meeting schedule in the Federal Register. EPA
will attend all of the meetings of the group and will sit at the table and be an active participant in
the discussions.
Is this group subject to FACA?
What precautions should be taken to protect the integrity of the results of the discussions
for EPA's use?
SCENARIOS INVOLVING CLOSING OF MEETINGS AND
PROTECTION OF DOCUMENTS
The following scenarios assume that EPA has chartered a FACA committee to negotiate the
emissions standards for "dimethylchickenwire".
5 Three members of different interest sectors of the FACA Committee to Negotiate Dimethyl-
chickenwire Emissions agree among themselves to meet over lunch to discuss golf scores,
vacation plans and the issues to be addressed at the next plenary meeting of the Committee.
Is this meeting subject to the meeting notice and openness provisions of FACA?
-2-
-------
6 The industry members of the Committee to Negotiate Dimethylchickenwire Emissions decide
to hold a caucus meeting to discuss their responses to the emissions control options discussed at
the last plenary meeting.
fs this meeting subject lo the meeting notice and openness provisions of FACA?
7 The state, environmental and EPA representatives on the Committee to Negotiate Dimethyl-
chickenwire Emissions decide to hold a joint meeting independent of direction from the
Committee to draft a strawman options paper to be presented at the next plenary meeting of the
Committee.
Is this meeting subject to the meeting notice and openness provisions of FACA?
8 The Committee to Negotiate Dimethyl-chickenwire Emissions appoints a workgroup to draft a
strawman options paper to be presented at the next plenary meeting of the Committee.
Is a meeting of this workgroup subject to the meeting notice and openness provisions of
FACA?
9. During the plenary meeting of the Committee to Negotiate Dimethyl-chickenwire Emissions, a
break LS called for so that various interest groups can caucus with their members and constituents.
Must these caucus meetings be subject to the meeting openness provisions of FACA?
10. During the plenary meeting of the Committee to Negotiate Dimethyl-chickenwire Emissions,
the Committee decides to break into workgroups. Each workgroup is tasked with a different
subject to gather more information and to construct a list of options and recommendations.
According to the Committee's protocols, the workgroups are made up of both Committee
members and other subject matter specialists.
Must these workgroup meetings be open to the public?
-3-
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11 The Committee to Negotiate Dimethyl-chickenwire Emissions has drafted up a very sensitive
recommendations paper which will be discussed at the next committee meeting. There is
considerable concern that to make this document public before the Committee has finished its
deliberations would hurt the economic standing of the regulated industry.
Can the Committee close this meeting to the public?
12. The Committee to Negotiate Dimethyl-chickenwire Emissions needs to review certain
confidential business information in order to begin work on its recommendations. This
information is best presented in a meeting of the Committee members so that'the members can
ask questions and challenge assumptions together.
Can the Committee close this meeting to the public?
13. Members of the Committee would like to present information to the Committee on the
technology developments and costing information relating to emerging technology. Some of this
information is likely to be confidential business information.
How should the information be presented?
Does the presentation and consideration of this information create an antitrust concern?
14. The Committee to Negotiate Dimethyl-chickenwire Emissions has almost completed its work
on its recommendations to the Agency. An outside party has sent a letter to the facilitator
requesting a copy of the latest document.
Can the Committee deny the request for the previously unreleased draft document?
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15 The Agency has presented a draft rule to the Committee for its consideration. The draft rule
has not been released outside of the Agency and the Committee has not received the document in
plenary session. The facilitator has received a request for a copy of the draft document sent to the
Committee members by a person who is not a member of the Committee.
Can the Committee deny the request for this document? Can the Agency deny the request
for this document?
SCENARIOS INVOLVING COMMUNITY ADVISORY GROUPS
OR RESTORATION ADVISORY BOARDS
17. Our town, USA has a Superfund site that involves emissions of dimethyl chickenwire.
Citizens and elected officials in the community have separately approached the EPA regional
office regarding the interest of the community in taking a more active role in expressing their
opinions to EPA regarding how the site should be dealt with. The EPA Community Involvement
Coordinator has met with a number of these groups and has suggested that they form a
Community Advisory Group that would be a primary contact group for EPA in the community
regarding exchange of information, data and opinions regarding the site. A local minister has
taken the lead in forming the group which has members from local neighborhood associations,
the Chamber of Commerce, a local environmental group and some concerned individuals. EPA
officials are often invited to attend and observe or speak at the CAG meetings.
Is this group subject to FACA?
Do any of the following situations change this?
What if the group applied for and received a Technical Assistance Grant (TAG) from
EPA?
What if the Regional office provided the assistance of a facilitator on contract to EPA to
facilitate meetings of the CAG?
What if the group reviews the RI/FS and makes a consensus recommendation on the
remedy to EPA?
Do the meetings of the CAG have to be open meetings, announced in advance?
Does the CAG membership have to be balanced9
18 A primary manufacturer of dimethyl chickenwire, Bob's Chemicals, is interested in making
an application to EPA for consideration in Project XL. The project would involve changes in the
manufacturing process for dimethyl chickenwire that would require some flexibility in
compliance measures under the dimethyl chickenwire emissions rule. In order to present a
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successful project proposal, Bob's Chemicals must design and initiate a significant and effective
stakeholder involvement process in the community surrounding its facility. The EPA regional
office offers some advice on whom to contact in the community and gives the company some
background documents on design of effective stakeholder involvement programs. Bob's
Chemicals follows EPA's advice and contacts community members and eventually forms a
Community Advisory Panel to participate in design of the Project XL Project Agreement.
Is this group subject to FACA°
SCENARIO INVOLVING PUBLIC INVOLVEMENT IN SETTLEMENT
OF AN ENFORCEMENT CASE
The following scenario involves a Superfund enforcement settlement action.
16. The EPA has assembled a group of Potentially Responsible Parties (PRPs), local citizens and
state and local officials to discuss contamination and risk studies at a local Superfund site in
preparation for settlement negotiations. The initial goal of the group is to identify data gaps that
must be addressed to begin negotiations on the remedy. After identifying the issues and data
gaps, the group progressed to form a coordinating council to develop the scope of the Remedial
Investigation/Feasibility Study (RIFS), and then to supervise the completion of the studies. Once
the studies are completed the coordinating council will make recommendation on the remedy to
be incorporated into a consent decree.
Is this coordinating council subject to FACA?
What precautions should be taken to protect the integrity of the Agency's decision making
process?
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FACA QUESTION TREE
0.1 Does Collection of Individuals
Include Non-Government Personnel?
Yes J No
FACA does
not apply
0.2 Do Individuals Have A Cohesive Organizational Stnirmra?
Yes-
•No
FACA does
not apply
0.3 Is That Cohesive Organizational
Structure A Result of Aeencv
Vp- .
O.4A POIS Grc
mo Render Soecific
Advice or Recommendations?
YrT
FACA
applies
I
FACA does
not apply
Effort?
0.4B Is Grouo Subiect to Strict
Aeencv Management or Control?
FACA does
not apply
Yes-
O.S Does Controlled Group Render
Soecific Advice orRecommendations?
-No
FACA
applies
FACA does
not apply
24
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The term ADVISORY COMMITTEE means
any committee, board, commission, council, conference, panel, task
force, or other similar group, or any subcommittee or other subgroup thereof
(hereafter in this paragraph referred to as "committee") which is —
(A) established by statute or reorganization plan,
or (B) established or utilized by the President
or (C) established or utilized by one or more agencies,
in the interest of obtaining
advice or recommendations
for the President or one or more agencies or officers
of the Federal Government,
EXCEPT THAT such term excludes
W the Advisory Commiirion on Intcrgaveramcaul Relations,
\V' *»e Coounuiion on Govenuncnt Procurement,
and (iii) any committee which is composed WHOLLY of FULL-TIME
officers or employees of the Federal Government.
FEDERAL ADVISORY COMMITTEE ACT, 5 U.S.C. App. S 3(2}
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