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PLANNING AND SCOPING GUIDE:
WITH EMPHASIS ON CUMULATIVE RISK
ASSESSMENT
Internal Review Draft
(See note inside for instructions)
August 8, 2000
U.S. EPA Headquarters Library
Mail code 3201
1200 Pennsylvania Avenue NW
Washington DC 20460
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Request for Comments on the Draft Planning and Scoping Guide
August 8, 2000
EPA Reviewers,
Attached please find a draft copy of the document "Planning and Scoping Guide with v
Emphasis on Cumulative Risk". We are requesting comments on this version of the guide to
make sure the concepts are clear to those who have expressed an interest, before it is offered for
review bv the Steering Committee of the Science Policy Council (SPC). Your comments and
suggestions will be most helpful if they are received before the end of September.
Planning and scoping is a concept which emerged from the ecological risk assessment
guidelines. It was developed in the risk characterization workshops and the process is
recommended for risk assessment in the risk characterization handbook. This Guide clarifies the
1997 Guidance on Cumulative Risk Assessment, Part 1. Planning and Scoping". The SPC
sponsored three practica (1998-1999) to apply the concepts of planning and scoping to agency
case studies. From that series, participants recommended that we develop a handbook or guide to
describe the planning and scoping process.
For this version, we added information on stakeholders, clarified the problem formulation
discussion, and plan to add other examples from program offices to the workshop case studies.
We note that planning and scoping is not just for cumulative risk assessments. We maintained a
broad definition of cumulative risk, emphasizing that this term must be defined in the context of
the risk management problem, therefore, dialog with the risk manager and problem formulation
are vital initial steps in the process. We also note that planning and scoping is an iterative
process. The conceptual model can be revised and elaborated even after the assessment begins.
We are interested in your suggestions and comments on this draft. We call it a "Guide",
because the process is relatively new and the Agency is still gaining experience with it. We use
case studies to illustrate the process-Appendix B includes cases from the SPC-sponsored
workshops, and other appendices are still developing examples from program offices. In your
review of this document, please consider the following questions:
1. Does this guide clarify how the planning and scoping process is performed?
2. Is the relationship between the text and the case studies informative and does it clarify the
concepts from the original guidance?
3. Are there sections of this guide which need to be modified (expanded or eliminated)? If so.
how would you suggest it be modified?
4. Is there information which is missing or should be referenced? Please be specific.
U.S. EPA Headquarters Library
Mail code 3201
1200 Pennsylvania Avenue NW
Washington DC 20460
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If you have ideas about other documents, references, or case studies we should cite or
abstract, please contact us and provide details about how to obtain the document.
Thanks for your assistance,
Ed Bender
(202) 564-6483"
(MailStop8l03R)
02)
Rowe
564-6488
Nader Elkassabany
(202) 564-6769
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TABLE OF CONTENTS
INTRODUCTION II
1. THE NEED FOR PLANNING AND SCOPING OF COMPLEX RISK
ASSESSMENTS 1
1.1 Overview Statement 1
1.2. What is the purpose of the 1997 Guidance?
1
1.2.1 What does the 1997 Guidance require? 2
1.2.2 How has the Guidance been implemented within the Agency?
2
1.2.2 How does Planning and Scoping relate to other Agency
initiatives? 3
1.3 What is the first step of Planning and Scoping? 4
1.4 What value is added to environmental decision-making from the
planning and scoping process? What are the intrinsic limitations of
this process? 5
1.5 How much effort is involved in developing the planning and scoping
products (conceptual model, analysis plan)? 6
1.6 How does the terminology used in the 1997 Guidance relate to the
definitions currently used in cumulative, ecological, and human health
risk assessment? 6
2. THE PLANNING AND SCOPING PROCESS
9
2.1 Overview Statement
9
2.2 What is the purpose of the planning and scoping process? Why is it
necessary? 9
2.3 What are the Steps in Planning and Scoping for Cumulative
Risk Assessments?
10
2.4 How does planning and scoping affect the scientific integrity of the
risk assessment?
10
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3. DEFINING THE PROBLEM 12
3.1 Overview statement 12
3.2 What does "defining the problem" mean for planning and scoping?
12
3.3 What is the relationship between the risk management objectives, the
development of the risk assessment and the risk management options?
12
4. ROLES OF PARTICIPANTS IN THE PROCESS 14
4.1 Overview Statement 14
4.2 Who does planning and scoping? 14
4.2.1 What are the roles of the risk manager and the assessor in
planning and scoping? 15
4.2.2 What is the role of economists, engineers and the
stakeholder community in the risk assessment?
15
4.3 Who Are Stakeholders? 16
4.3.1 What Is the Purpose of Stakeholder Involvement in Planning
and Scoping? 16
4.3.2 What Do Stakeholders Provide? 17
4.3.3 What Is the Process for Selecting Stakeholders? 18
4.3.4 When Can Stakeholders Participate in Planning and Scoping?
'. 19
4.3.5 How Does the Spectrum of Stakeholder Issues Affect the
Planning and Scoping Exercise? 21
4.3.6 23
4.4 How Does FACA Apply to Planning and Scoping? 23
4.5 What Are the Best Ways for Communication with Citizens and Other
Interested Parties? 23
5. DEFINING THE SCOPE OF THE ASSESSMENT 25
5.1 Overview Statement 25
5.2 What is a cumulative risk matrix? 25
5.3 Why should options, technical or resource limitations, or approaches
that will not be included in the risk assessment be presented or
discussed? 26
5.4 Why are health and ecological risks considered in the same matrix?
26
5.5 How do you decide what is in the assessment and what is out? .... 27
II
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5.6 Is it necessary to establish a cause and effect relationship between a
stressor(s) and endpoints? 27
5.7 What is the difference between assessment endpoints and
measurement endpoints?
27
5.8 Does the risk problem represent a place-based or national risk?
28
6. THE PRODUCTS: CONCEPTUAL MODEL WITH NARRATIVE,
ANALYSIS PLAN 29
6.1 Overview Statement 29
6.2 What is a conceptual model and what is its utility?
29
6.2.1 Who develops and supports the conceptual model? .... 32
6.2.2 What are the rules for developing conceptual models? 32
6.2.3 How much detail is required for the conceptual model? 33
6.2.4 What tools are available for constructing the model? 33
6.2.5 What are the components of the narrative? 34
6.2.6 When do you know that you have achieved an acceptable level of
refinement of the conceptual model? 34
6.2.7 Are conceptual models and their narratives subject to peer
review? 34
6.3. How do you develop an analysis plan? 35
6.3.2 How much detail is required in the plan? 38
6.3.3 When should the plan be revisited? 39
7. CONCLUSION 40
8. References 41
APPENDIX A
CUMULATIVE RISK ASSESSMENT GUIDANCE
PLANNING AND SCOPING
43
APPENDIX B
WORKSHOP CASE STUDIES 67
B-l. The Reregistration of Pentachlorophenol: Case Study 68
III
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B-2 Chicago Cumulative Risk Initiative-Region V: Case Study 96
B-3. Cumulative Risk Index Analysis (CRIA) Method in Concentrated Animal
Feeding Operations (CAFO) In Region VI: Case Study 106
APPENDIX C
CUMULATIVE RISK GUIDANCE
PLANNING AND SCOPING WORKGROUP
120
Appendix D. Planning and Scoping for the National Air Toxics Assessment ... 123
Appendix E. Surface Impoundment Study - Technical Plan for Human Health and
Ecological Risk Assessment 124
Appendix F. Considerations for Integrating Health and Ecological Risk
Assessments
125
IV
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FOREWARD
This document is intended to supplement the "Guidance on Cumulative Risk
Assessment. Part one. Planning and Scoping," July 1997, and to be used by
EPA/non- EPA individuals who are interested in the application of planning and
scoping in cumulative risk assessment. It is NOT intended to provide guidance for
analyses of cumulative or other complex risk assessment; guidelines and specific
program guidance serves that function. Rather, this guide is intended to illustrate
the process and concepts established in the 1997 Guidance. It is an iterative
process for organizing what is considered within a complex risk assessment
(including those with cumulative risk aspects), illustrating the planned approach,
and explaining the rationale for what is included or excluded. This guide relies on
case studies and information collected at three meetings with EPA personnel, as
well as on Agency guidelines, program office guidance, and professional experience.
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INTRODUCTION
Based on EPA's experience with the four-step NAS risk assessment paradigm
(NAS, 1983), it has become clear that the additional step of planning and scoping at
the beginning of the risk assessment process will improve and better characterize
risk assessment product. The 1997 Guidance complements EPA's Risk
Characterization policy and guide (EPA, 1994; EPA, 2000). In addition, planning
and scoping provides a more integrated view of the risk assessment-risk
management process that involves the affected and interested parties in
environmental decision-making (NRC, 1996; Presidential Report on Risk
Assessment and Risk Management, 1997). This guide will help EPA managers and
risk assessors implement the requirements of the 1997 Guidance.
Key features of the 1997 Guidance on planning and scoping include a
dialogue among the risk assessor and risk manager, economists, engineers, and
other technical experts in planning and formulating the problem for the risk
assessment. It also provides details on the nature of the risk assessment planning
dialogue and activities that can shape the next generation of integrated risk
assessments from Programs and Regions.
Planning and scoping occurs before the risk assessment begins. It is the
phase when the purpose and context for the risk assessment is developed. Without
this preliminary step, the risk assessment may overlook information and key
participants that are critical to inform the risk management decision.
Planning and scoping is not limited to cumulative risk assessment-indeed
these concepts apply equally well to plan assessments of hazard, exposure,
environmental impact, or other risk assessments. In fact the scientific community
has not yet developed a consensus on the definition of cumulative risk assessment.
Within the Agency, several program offices are working on aspects of cumulative
risk which are discussed in detail in this guide and in case studies in the
appendices. Until a broad consensus is developed, we recommend that cumulative
risk assessment be defined as "risks considered in the aggregate", with the specifics
defined on a case by case basis according to the steps and concepts presented here.
Planning and scoping is a dialogue among experts, stakeholders, and decision-
makers that precedes the analysis and continues as needed through the risk
management decision.
U.S. EPA Headquarters Library
Mail code 3201
2 1200 Pennsylvania Avenue NW
Washington DC pai'-:.
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1. THE NEED FOR PLANNING AND SCOPING OF COMPLEX RISK
ASSESSMENTS
1.1 Overview Statement
Planning and scoping is a process that sets the stage for conducting a risk
assessment. This process begins with a dialogue between the risk assessor and risk
manager. The dialogue and problem formulation; first described in the Ecological
Risk Assessment Guidelines, was elaborated and highlighted in the Cumulative
Risk Assessment Guidance, Part 1. Planning and Scoping (1997) (hereafter referred
to as the 1997 Guidance). The dialogue between the risk manager and assessor
defines the risk management objective and the purpose for the risk assessment.
The assessor and manager work as a team to determine how to obtain technical
input, stakeholder comments, and develop a conceptual model and an analysis plan
for the risk assessment.
As the 1997 Guidance has been applied and discussed in the planning and
scoping workshops, we found that cumulative risk assessment can be improved by
using the planning and scoping process. The challenge is to determine how much
effort to invest.
This chapter provides some background and rationale for using planning and
scoping and the case studies show different approaches.
1.2. What is the purpose of the 1997 Guidance1!
EPA's practice of risk assessment is evolving from a focus on single
pollutants within a single medium towards integrated assessments involving
multiple pollutants in several media that may cause a variety of adverse effects on
humans, plants, animals, or on ecological systems and their processes and
functions.
The 1997 Guidance (see Appendix A)was intended to help EPA plan for
cumulative risk assessments and other integrated risk assessments (i.e., those
dealing with multiple stressors, sources, pathways, and endpoints of concern). It
directed all EPA offices to take into account the combined effects of multiple
environmental stressors in planning and scoping major risk assessments, and to
integrate multiple sources, effects, pathways, stressors, and populations where data
are available. The 1997 Guidance placed particular importance on opportunities for
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1 citizens and stakeholders to understand EPA's ongoing risk assessments and
2 become involved in the risk management decision-making process.
3 1.2.1 What does the 1997 Guidance require?
4 The 1997 Guidance directs each office and region to conduct planning and
5 scoping in major risk assessments, with special emphasis on cumulative risk and
6 the integration of multiple sources, effects, pathways, stressors, and populations.
7 For major assessments,the results of the planning and scoping process should be
General Steps in Planning and Scoping
Process
Define Risk
Management
Objective
Define purpose
for Risk
Assessment
Develop a
Cumulative
Risk Outline
Determine what
will or will not be
included in the
Risk
Assessment
i
r
Develop
hypotheses to
fink stressors to
assessment
endpoints
Conceptual
Mode! path of
stressors from
sources to
receptors/effects
Evaluate data
availability,
critical linkages,
schedule and
resource needs
Develop a plan
for the risk
assessment
(Analysis Plan)
8 described, including the risk management objective, problem formulation, the scope
9 of the assessment, key assumptions and elements to include, technical products (the
10 conceptual model and analysis plan), and participants.
11
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1.2.2 How has the Guidance been implemented within the Agency?
The Science Policy Council's (SPC) Cumulative Risk Working Group (CCRS)
(Appendix C), which prepared the 1997 Guidance, developed a series of workshops
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1 intended to introduce EPA scientists to the concepts of cumulative risk planning
2 and scoping. The practica were designed to offer guidance and training to EPA risk
3 assessors on cumulative risk and to bring EPA risk assessors and managers
4 together to gain experience applying the 1997 Guidance. The SPC sponsored
5 workshops to introduce the concepts of planning and scoping for cumulative risk
6 assessment. The first practicum was held in Washington, DC, on July 28-29, 1998,
7 and attracted 54 EPA scientists representing the breadth of EPA programs,
8 research, and several regions. The second practicum was held in Chicago, IL, on
9 November 12-13, 1998. More than 40 EPA, state, and Canadian scientists and risk
10 managers participated. More than 50 participants attended the final workshop in
11 the series, held in Washington, DC, on June 16-18, 1999. Separate summaries were
12 prepared for each of the first two practica and for the entire series (ref.).
13 Each practicum featured presentations and facilitated discussions in large
14 and small group settings. Drs. Mark Harwell and Jack Gentile, both of the
15 University of Miami's Rosentiel School of Marine and Atmospheric Science, lectured
16 and facilitated the development of the cumulative risk conceptual models and
17 analysis plans through case studies of actual risk assessments going on in the
18 Agency. The cases considered during the series were: Pentachlorophenol;
19 Cumulative Risk Index Analysis of a Concentrated Animal Feeding Operation; and
20 the Chicago Cumulative Risk Initiative. The attached case studies illustrate how
21 the 1997 Guidance was applied in each of these three instances (see Appendix B).
22 1.2.2 How does Planning and Scoping relate to other Agency
23 initiatives?
24
25 The 1997 Guidance on planning and scoping complements many of the
26 Agency's initiatives, because cumulative risk assessment covers a wide variety of
27 risk assessment issues including: the role of public involvement; sensitive
28 subpopulations, such as children; and the physical or temporal boundaries of the
29 assessment. Where possible, these issues should be integrated into planning and
30 scoping of major risk assessments. Even when cumulative risk is not involved,
31 planning and scoping is valuable for sorting issues, data, and contributors that
32 must be considered in the risk assessment. For example:
33 • Planning and scoping accommodates public input and understanding
34 by identifying experts and stakeholders and involving them in the
35 earliest stages of risk assessments (see Section 4).
36
As the scope is developed, risk assessors must consider the
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1 characteristics, of the population(s) at risk. These include individuals
2 or sensitive subgroups which due to their age, gender, disease history,
3 size or developmental stage, may be highly susceptible to risks from
4 stressors or groups (see Section 5).
5 • The development of hypothetical stressor-effects relationships and a
6 conceptual model provides a basis to evaluate data that are needed for
7 the assessment and how they may be integrated for the assessment
8 (see Section 6).
9 There are several other risk issues and concerns (e.g., environmental justice1)
10 that the 1997 Guidance could not address, at this time, but are recognized as
11 important in the risk assessment process. This broader set of issues and concerns
12 relates to social, economic, behavioral or psychological factors that may contribute
13 to adverse health effects. These stressors may include existing health conditions,
14 anxiety, nutritional status, crime, and congestion. The assessment of this broader
15 perspective.of risk is very difficult due to : a) major deficiencies in data to establish
16 plausible cause and effect relationships, b) ability to measure exposure to such
17 risks, c) understand their incidence and individual susceptibilities, d) availability of
18 methods for assessing such risks, and e) techniques or approaches to managing the
19 risk.
20 1.3 What is the first step of Planning and Scoping?
21
22 Planning and Scoping usually starts with a dialogue between the risk
23 assessor and risk manager (as shown in Figure 2 below from the Guidance). The
24 risk manager describes an objective for risk management (e.g., reducing childhood
25 cancers in agricultural worker families or reducing exposure of city residents to
26 lead). The manager also presents the expectations on timing and available
27 resources. The assessor defines potential cause and effect relationships (e.g.,
28 stressors and assessment endpoints to measure the effects). A basic problem is
29 defined, participants are identified (including the appropriate stakeholder groups),
30 and plans are prepared (conceptual model, analysis plan) for the integrated risk
31 assessment. Figure 2 shows that planning and scoping is part of the risk
32 management decision process, separate from the analysis phase of the assessment,
33 and there is extensive interaction among all parts of the process. Also, the risk
1 EPA has issued Interim Guidance for Investigating Title VI Administrative Complaints
Challenging Permits (Interim Guidance) which is under review by the Agency's Title VI
Implementation Advisory Committee.
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assessment is but one of the essential inputs to make an environmental decision.
Other inputs include stakeholder input (see Section 4), economic benefits/costs,
political science factors, social values and technology assessments. Section 2.3 gives
more specific details on steps in the planning and scoping process.
The basic tasks for the risk assessment planning dialogue (see p. 7 of the
1997 Guidance for additional discussion) are to:
Define the purpose for performing the risk assessment
• Define the scope of the risk assessment: what's in, what's out
Define hypotheses relating stressors to assessment endpoints
Document the problem formulation (technical approach): conceptual
model, analysis plan
Risk Assessment/ Management Decision
Needs.
Planning
and
\ ' •
ng
^-IWJtanN
Poli-Scicnce,
and Social Analysis
1.4 What value is added to
environmental decision-
making from the planning
and scoping process?
What are the intrinsic
limitations of this
process?
As discussed in the SPC Risk
Characterization Guide, "Planning
and scoping is an important first
step to insure that each risk
assessment has a clear purpose, a
defined scope, and logical approach.
These [attributes] provide a sound
foundation for judging the success
of the risk assessment and for an
effective risk characterization." Further, it formalizes a process that is already
used by the Agency's programs on an ad hoc basis, opens up the process (increases
transparency) to the public in a structured context, and allows a more clearly
defined method of feedback in the risk assessment through the use of the
conceptual model and analysis plan. The description of the assumptions and scope
of the risk assessment helps participants and stakeholders understand the initial
Figure 8. Stages in the Integrated Risk
Assessment Process
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assumptions and expectations about the risk analysis. Finally, planning and
scoping evaluates changes and characterizes the results of the assessment.
The intrinsic limitations of Planning and
Scoping are: a) it has the potential to become a
protracted process due to public involvement; b) the
process can be strongly influenced by the
knowledge and judgement of the participants; and
c) it may not work for short deadlines. However,
the extra time that may be required for planning
and scoping generally results in greater credibility
in the public's eye for the final decisions made.
The extra time that may be
required for planning and
scoping may be well
rewarded because it
generally results in greater
credibility in the public's
eye for the final decisions
made.
1.5 How much effort is involved in
developing the planning and scoping
products (conceptual model, analysis plan)?
The level of effort for developing planning and scoping products will vary
with the complexity of the problem, the number of participants, the risk
management objectives, and the experience of the participants. An experienced
team of participants, familiar with the problem and data that are available could
develop a conceptual model for human health risks within a week, while a complex
ecological assessment of a large watershed or regional ecosystem may require
several months of work and discussion with experts, stakeholders, and residents.
1.6 How does the terminology used in the 1997 Guidance relate to the
definitions currently used
in cumulative, ecological,
and human health risk
assessment?
The definition of
cumulative risk in the 1997
Guidance is the potential risk
presented by aggregating
specific multiple stressors.
However, the 1997 Guidance
intended that a definition of
cumulative risk be developed
on a case-by-case basis.
Concepts that Workshop Participants associated with Cumulative Risk
• integrated risk
• total environment
• relationship between risk assessors and risk managers
• multiple compounds, multiple sources, and multiple pathways
• risk over time
• "thinking outside the box"
• difficulties in obtaining good data
• complex interactions and relationships
• uncertainty, unknowns-how to deal with them
• total exposure-sources; similar mechanisms/modes of action of
chemicals
• expanding scope to include stakeholders; environmental justice issues
• developing systemic approach
• need framework for scoping and strategies to address overall risk
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1 Participants in the first two practica were encouraged to express their own
2 understanding of "cumulative risk assessment" (see textbox).
3 The variety of workshop participant responses demonstrates the essence of
4 the problem—everyone has a different initial understanding and emphasis, and
5 nearly everything can be considered. Cumulative risk might implies different
6 things at different times in different cases. To clarify the situation, a SPC
7 Cumulative Risk Subcommittee (CCRS) has recently drafted a set of working
8 definitions (see table below; selected examples are included). The underlying
9 premise of the definitions is that "All assessments, whether exposure assessments,
10 ecological assessments, aggregate assessments, or cumulative assessments, require specification
11 of the context in terms of agents or stressors being assessed, defining populations being
12 assessed, endpoints being assessed, and routes/pathways/sources being assessed, etc." (CCRS,
13 1999).
WORKING DEFINITIONS FOR CUMULATIVE, ECOLOGICAL AND HUMAN HEALTH RISKS
(CCRS, 1 999) These are draft definitions.
Aggregate exposure
Cumulative Risk (FQPA)
Aggregate exposure
assessment (FQPA)
Aggregate risk
Cumulative Risk*
(see below)
Cumulative risk assessment
The combined exposure of an individual or defined population to a specific agent or
stressor via relevant routes, pathways, and sources, e.g., chlorpyrifos exposure to
children via dietary /residential use.
Cumulative effects which are the sum of all effects from pesticide chemical residues
with the same mechanism of toxicity (e.g., the combination of all organophosphates and
carbamates and which inhibit acetylcholinesterase).
An analysis, characterization, and possibly quantification of exposure of an individual
or defined population to a specific agent or stressor via relevant routes, pathways, and
sources. The Food Quality Protection Act (FQPA) defines aggregate exposure
as all anticipated dietary exposures and all other exposures for a single
substance. In practice, this includes routes and pathways of exposure for
ingestion (food, drinking water, residential scenarios), inhalation (residential
pathway) and dermal (residential pathway). Cumulative exposure for FQPA
refers to all routes/pathways of exposure to two or more substances that
cause toxicity by a common mechanism of toxicity
(see Chlorpyrifos Risk Assessment).
The risk resulting from aggregate exposure to a single agent or stressor.
The combined risks from aggregate exposures to multiple agents or stressors.
Note: the term "cumulative risk" has two major facets. First, it must include multiple
agents or stressors. Second, the risks of the agents or stressors must be combined, not
just listed separately as might be done in a "multi-chemical" assessment -where risks
are listed separately
An analysis, characterization, and possibly quantification of the combined risks to
health or the environment from multiple agents or stressors.
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Total risk
Total risk assessment
Stressor
Population-based exposures
Receptors
The combined risks resulting from all agents or stressors.
An analysis, characterization, and possibly quantification of the combined risks to
health or the environment from all agents or stressors.
In human and ecological risk assessment the term is defined as a chemical, biological,
or physical agent (including radiation) that may produce an adverse effect for an
individual, population, sub-population, species, community, ecosystem or
environmental process.
Exposed populations is a human health term.
Receptor is often used in ecology to imply populations, individuals, or more complex
entities who are affected by stressors.
8
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1 2. THE PLANNING AND SCOPING PROCESS
2 2.1 Overview Statement
3 Planning and scoping provides a broad foundation for cumulative and other
4 risk assessment. It allows participants to define the problem that will be addressed
5 and document the rationale for what is included. The process is a "dialogue"
6 between risk assessors and risk managers with significant input from stakeholders.
7 The risk manager should explain why a risk assessment is needed and what
8 questions should be answered. Planning and scoping is an opportunity for the
9 concerns of policy-makers and stakeholders to surface and for determining
10 information needs and participants for planning the assessment. The planning and
11 scoping dialogue should also discuss resources and participant roles.
12 2.2 What is the purpose of the planning and scoping process? Why is it
13 necessary?
14
15 The planning and scoping process promotes discussions between risk
16 managers and risk assessors about the risk management objectives, their roles, and
17 needs for risk assessment. The 1997 Guidance provides principles that EPA
18 Programs and Regions can follow in the planning, scoping, and problem
19 formulation stages of their risk assessments. Additionally, it applies principles
20 from the Agency's March 1995 Policy for Risk Characterization by providing a clear,
21 transparent, reasonable, and consistent basis for conducting any assessment.
22 Regions and Program offices are strongly encouraged by the Guidance to undertake
23 a formal problem formulation exercise for all risk assessments. In that way,
24 planning and scoping ensures that risk assessment will reflect the principles of the
25 policy.
26 The planning and scoping process is necessary for complex risk assessments,
27 including cumulative risk assessments, because it promotes a better understanding
28 of risk manager expectations, assessment limitations, and establishes a common
29 purpose for performing the risk assessment. The process helps clarify what will
30 (and can) and what will not (and cannot) be included in the risk assessment. It also
31 identifies who needs to be involved (both from a technical and stakeholder
32 standpoint). Finally, it serves to describe how the risk assessment is expected to
33 proceed and to build consensus.
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1 2.3 What are the Steps in Planning and Scoping for Cumulative Risk
2 Assessments?
3 During Planning and Scoping, risk assessors, other technical experts such as
4 ecologists, toxicologists, economists, and engineers, and risk managers work
5 together as a team, informed by stakeholder input, to follow generally sequential
6 steps to:
7 1. Determine the overall purpose and risk management objectives for the risk
8 assessment;
9 2. Determine the scope, the problem statement, participants, and resources for
10 the assessment;
11 3. Develop a cumulative risk outline of the risk dimensions and technical
12 elements that may be evaluated in the assessment;
13 4. Formulate a technical approach including an analysis plan and a conceptual
14 model for conducting the assessment.
15 2.4 How does planning and scoping affect the scientific integrity of the risk
16 assessment?
17 The 1983 National Research Council (NRC) report has been interpreted by
18 some as recommending a separation between risk assessment and risk
19 management. A primary concern at that time, was that risk management might
20 unfairly influence the results or analysis of the assessment to support a particular
21 decision or outcome. The 1997 Guidance recognizes this concern, but it also
22 recognizes that risk assessments (and scientific information) but one of several
23 factors that inform the risk management decision. More recently, the NRC (1996)
24 has recommended dialogue and interaction between the risk assessor, risk
25 manager, and stakeholders throughout the risk assessment-risk management
26 process. In addition, the Agency has discussed the need for dialogue between risk
27 managers and assessors in the risk characterization process (EPA, expected 2000).
28 The development and analysis of the risk assessment should be guided by risk
29 management objectives, input from stakeholders, and other technical information;
30 however, risk assessments must represent unbiased and peer reviewed scientific
31 analysis to maintain scientific integrity.
32
33 A written record of the planning and scoping discussion frames decisions on
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1 the risk assessment, its scope and the aspects that will be assessed for the decision-
2 making process. This record may include lists of stakeholders, issues considered
3 and the rationale for including or excluding specific technical elements or data in
4 the cumulative risk assessment. Such information will help all participants
5 evaluate and understand how the Agency addressed the issues. It also
6 distinguishes between policy, science, and compromise positions. This record
7 provides a basis for developing the risk characterization in the assessment phase.
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i 3. DEFINING THE PROBLEM
2 3.1 Overview statement
3 There is a logical synergy between risk management and assessment. The
4 risk management problem stimulates the need to conduct the risk assessment. The
5 risk assessment informs the development of risk management options. The risk
6 assessment is guided by the risk management objectives and general nature of the
7 problem. The objectives and scope of the problem help define the participants.
8 Stakeholders also provide key information on concerns and social context. Problem
9 formulation is an iterative process within which the risk assessor develops
10 preliminary hypotheses about why adverse effects might occur or have occurred. It
11 provides the foundation for the assessment and sets the stage for planning how the
12 risk will be analyzed.
13 3.2 What does "defining the problem" mean for planning and scoping?
14
15 Problem formulation or "defining the problem" is a process for generating
16 and evaluating preliminary hypotheses about adverse human health or ecological
17 effects that have occurred or may occur. Risk assessment objectives are refined
18 early in problem formulation (See Figure 4, Section III of Appendix A). Sometimes
19 participants in the planning and scoping process define the problem; other times
20 the problem is defined prior to planning and scoping. Problem definition sets the
21 stage for an evaluation of the nature of the problem, a plan for analyzing data and
22 characterizing risk. The importance of problem formulation has been shown
23 repeatedly in the Agency's analysis of risk assessment case studies and in
24 interactions with senior EPA managers and regional risk assessors (EPA, 1994;
25 EPA, 2000-iiirisk characterization guide). Shortcomings reported from case studies
26 (EPA, 1998) consistently included 1) absence of clearly defined goals, 2) endpoints
27 that are ambiguous and difficult to measure, and 3) failure to identify important
28 risks. By following the planning and scoping process, the shortcomings cited above
29 should be avoided. For the CCRI case study, when the problem was defined, the
30 workshop participants discovered that the problem was focused on hazard and not
31 risk.
32 3.3 What is the relationship between the risk management objectives, the
33 development of the risk assessment and the risk management options?
34 Risk management objectives define the condition (i.e., public health and
35 ecological quality) that the public wants to protect and regulatory goals that risk
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1 assessors must consider. The risk management options are the means to achieve
2 the goals and objectives. The objectives are considered by risk assessors in the
3 problem formulation and the development of the risk assessment. The risk
4 assessment is used by risk managers to evaluate risk management options. In
5 some cases, managers may want to clarify or modify the options based upon further
6 data analyses and they may wish to determine how to achieve the risk management
7 goal(s). For example, risk management options for the CAFO case study (see
8 Appendix B) include general permit" conditions that limit contaminant releases or
9 specify control technologies. The risk management objectives for that case are to
10 protect existing water quality, groundwater purity, and public health and welfare.
11 The objectives consider legal requirements and authorities of,the Agency as well as
12 conditions which stakeholders value and want to preserve. The risk management
13 options also consider legal authorities, jurisdiction of the Agency and control
14 mechanisms that are available. In the CAFO case, the objectives were developed by
15 the risk assessor and risk manager with input from the farmer and affected parties
16 in the community.
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1 4, ROLES OF PARTICIPANTS IN THE PROCESS
2 4.1 Overview Statement
3 The planning and scoping process involves risk managers, risk assessors and
4 other technical participants. It also involves stakeholders (parties who are involved
5 or affected by environmental risks). Public participation in the planning stage
6 helps ensure that the risk assessment targets aspects of the environment impacted
7 by relevant human activities. Public participation leads to the incorporation of new
8 kinds of information in environmental decision-making and has shifted the model
9 for public participation from a paternalistic one where the government defines the
10 process and invites stakeholders to participate toward the consensual type in which
11 "every affected group participates" (Bear 1994).
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13 Most of the discussion in this section focuses on stakeholders participation in
14 the planning and scoping process It requires communication throughout the
15 process (Glicken, 1999). The nature and degree of stakeholder involvement varies
16 among different risk management decisions. The venue for participation is defined
17 by the risk manager. Early in the planning and scoping of the risk assessment,
18 decisions must be made about the participants such as: Who should participate?
19 What could they contribute? How can they be involved? Affected parties can
20 share their points of view about the risk and how it should be managed. Their
21 input is particularly helpful in determining what should be included in the
22 assessment, how they might be affected or exposed to the risk, and what additional
23 data or exposure scenarios should be developed. Interested parties often bring
24 special expertise to planning and scoping, including technical knowledge of
25 monitoring data or models of effects or exposure or practical knowledge on their
26 lifestyles, potential routes of exposure, or habits.
27 4.2 Who does planning and scoping?
28 The risk manager, risk assessor and technical staff of EPA (or a state)
29 initiate the process. They develop the list of participants based on the issues,
30 affected parties, and technical experience. Stakeholders (interested and affected
31 parties) may participate during any steps of planning and scoping depending upon
32 the nature of the problem, their interest, and ability to contribute. The risk
33 assessor and risk manager should establish some ground rules for participants and
34 describe the process that will be used to gather information.
35 4.2.1 What are the roles of the risk manager and the assessor in planning
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1 and scoping?
2 Risk managers define objectives, schedules, available resources, and approve
3 the analysis plan for the risk assessment. They must plan how they will solicit
4 public input, analyze it, and communicate with the stakeholders. Risk assessors
5 may facilitate the discussion of the scope and lead development of the conceptual
6 model and analysis plan. The assessor must include and evaluate stakeholder
7 data, identify data requirements, select models and default conditions, and explain
8 the rationale for these choices in comparison with other alternatives.
9 Members of the regulated community are relatively easy to engage; however,
10 public citizens may have difficulty participating in highly technical discussions or
11 in attending multiple meetings during the course of the planning and assessment
12 process (e.g. the PGP case study). In the CCRI case study, many stakeholders were
13 represented by one or more spokespersons and detailed information was posted on a
14 website by EPA that provided them with analytical tools to prepare maps of sources
15 and stressor concentrations monitored in their communities.
16 ' 4.2.2 What is the role of economists, engineers and the stakeholder
17 community in the risk assessment?
18 Economists evaluate costs and benefits, equities for stakeholders, and the
19 efficiency of risk management options. Engineers develop alternative approaches to
20 control, avoid, or mitigate sources of risk or protect against the effects of risks.
21 Stakeholders provide information on their concerns, values, and personal data on
22 risks. Stakeholders provide feedback on the relevance and clarity of the risk
23 management objective, scope for the assessment, conceptual model, and analysis
24 plan. Stakeholders may also provide details on the release of stressors from
25 • sources, behavior and exposure patterns, and concerns of the community.
26 In public meetings over concentrated animal feeding operations (CAFOs),
27 citizens expressed concerns about health effects from odors and decreases in
28 property values. Regional risk assessors were able to find some data on adverse
29 health effects from chronic odors and local zoning officials were included to begin an
30 analysis of the economic impact of CAFO sitings on property assessments and tax
31 revenues. The conceptual model also includes effects on quality of life which may
32 be considered in future assessments.
33 In CCRI, citizens participated in development of a cumulative risk outline
34 and recommended which stressors, sources, and human health effects should be
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given priority. Their concerns are reflected in the conceptual model.
For PCP, both health and ecological effects were developed in great detail.
OPP is considering ways to engage multiple stakeholders in planning and scoping.
For the National Air Toxics Assessment (Appendix D), other regulatory
agencies were consulted to plan the assessment and the analysis. Other
stakeholders were also invited to comment on the proposed urban air toxics strategy
(Appendix E).
4.3 Who Are Stakeholders?
Identified CAFO Stakeholders
Residents
CAFO Workers
Other Farmers (small farmers)
Owners and shareholders (corporate
farmers)
State/federal regulators
Environmental groups (local and national)
Trade associations
Academic/university/Ag cooperative
researchers
Elected officials
Non-Governmental Organizations
Regionally compiled list of interested parties
from previous interactions
Participants informing the
environmental decision-making
process include regulators, the
regulated community and the affected
and interested public (see examples
from the CCRI and CAFO case study).
Stakeholders may consist of 1) parties
and individuals who are affected by a
risk management decision, 2) parties
or individuals who are interested in
the management of a particular risk, 3)
members of the community who may
be affected financially, 4) stakeholders
who health may be at risk, and 5)
elected representatives of interested or affected parties. Common approaches to
involving stakeholders may include public hearings, citizen advisory committees
and task forces, alternative dispute resolution including mediation, policy dialogues
or negotiated settlements (e.g., regulatory negotiations), citizen juries and panels,
surveys, focused group discussions, interactive technology-based approaches or
combinations of deliberative methods (Appendix B, NEC, 1996).
4.3.1 What Is the Purpose of Stakeholder Involvement in Planning and
Scoping?
Stakeholders add both credibility and valuable information to environmental
decisions. Just as the scientific peer review is designed to assess the quality and
relevance of technical information so, in a parallel fashion, stakeholder involvement
provides a form of social peer review which enables interested parties to contribute
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1 information and review options in the conceptual model under development to
2 address an environmental concern (Ybsie and Herbst, 1998). By involving
3 stakeholders in the planning and scoping process they can add knowledge and gain
4 understanding about the rationale and plans for the risk analysis. Public
5 participation in planning and scoping allows the risk assessors and risk managers
6 to understand how the interested and affected parties perceive the risk, and
7 incorporate their perspectives and specialized knowledge into the process (NEC,
8 1996). Without this input, the conceptual model may overlook potential risks that
9 concern stakeholders.
10 4.3.2 What Do Stakeholders Provide?
i
11 Stakeholder input can focus the risk management goals, as in the case of the
12 Chicago Cumulative Risk Initiative (CCRI) where the risk assessment was initiated
13 at the behest of concerned citizens.
14 Stakeholders may provide technical expertise in hazard and exposure
15 assessment, technology, economic, social, political and legal areas. For example,
16 affected parties may help identify concerns and costs so they can be considered in
17 the problem assessment and the general deliberation process. With a clearer
18 statement of costs, benefits, uncertainties, and other implications available to the
19 assessor, experts, and stakeholders, a wider range of risk assessment options may
20 be characterized or developed, including some that may be more innovative, more
21 protective, voluntary, and more economical. In addition, exposed communities or
22 groups can often provide critical information on potential or actual exposure
23 scenarios, endpoints, or subpopulations that should be considered in the risk
24 assessment. They also provide invaluable insights into public values and
25 perceptions on the risk of concern, the preliminary remedial actions being
26 considered ,and public reception of those remedies.
27
28 To develop an accurate depiction of the risks and risk management options,
29 the conceptual model must reflect the risks dimensions; i.e., populations at risk
30 (human, ecological entities, landscape or geographic concerns), sources of stressors,
31 stressors, pathways of exposure, assessment endpoints, and time frames of
32 exposure. Stakeholders are needed along with all other participants to explore the
33 elements in the conceptual model. For a regulated chemical, for example, the
34 industry representative will usually have the most definitive information on its
35 chemical synthesis, production and use, which can more completely define the
36 sources of exposure. Exposed groups or individuals can confirm or more accurately
37 reflect the qualitative or quantitative aspects of the exposure pathways, including
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routes of exposure and the relevant time frames involved in the proposed model.
Stakeholders may suggest alternative methods of looking at the problem that may
allow more flexible approaches to remediation of the risks, the development of
additional conceptual models not originally considered, or novel, non-regulatory
solutions to a problem.,
4.3.3 What Is the Process for Selecting Stakeholders?
Identification of need: We recommend an initial brainstorming effort, using a
set of diagnostic questions, such as those provided here from the third Planning and
Scoping workshop (see textbox) the answers to these questions should allow
identification of the most relevant, affected and interested parties. While
determining the right mix of stakeholders to involve in a specific problem can be
challenging, the Agency has taken
steps to increase the opportunities and
quality of stakeholder participation
through its Stakeholder Involvement
Action Plan (EPA, 1999).
Diagnostic Questions for Stakeholders
Who are the "interested and affected parties"?
What approaches should be considered (focus groups,
etc)
What should be deliberated?
When?
How should participants be selected?
Should the program enlist outside help in establishing the
deliberative process?
What are the external constraints for deliberation?
(Budget, time, legal)
(Planning and Scoping Summary Report, 1999)
Value added: Due to the
limitations of time, resources, and
regulatory or legal requirements,
stakeholder input must be evaluated
in the context of value added. When
the manager and assessor determine
that stakeholder input is critical, there
should be an opportunity for involvement by the appropriate stakeholders based
upon the potential impact on their affected group(s), their experiences, and/or
expertise. It is important to advise the stakeholders when their input will be most
valuable, since there will be situations in which specific regulatory remedies are
required by law and stakeholder involvement would not affect the choice of remedy
but may affect the implementation schedule. The nature and number of
participants within each step in the decision making process, including planning
and scoping, should be clearly defined by the manager or assessor as well as the
methods for identifying and notifying the stakeholder representatives.
Each stakeholder contributing to the planning and scoping process should
come to the table with a willingness to define objectives and inform the process with
data, surveys, experiences or other information that might support their concerns
about the risk(s), mitigating circumstances, or impacts of various risk assessment
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1 approaches. While all parties should work to achieve consensus wherever possible,
2 it may not be possible in some instances. See a caution regarding consensus in
3 section 4.4.
4 Assurance of fairness: Stakeholders involved during the process should be
5 assured by the regulatory Agency(ies) that their input will be used in a fair and
6 open manner. The degree of input will differ from assessment to assessment for
7 various reasons including: differing complexities of each analysis, the resources
8 available for interaction, the risk mitigation options proposed and time limitations.
9 4.3.4 When Can Stakeholders Participate in Planning and Scoping?
10 Stakeholders may participate in the initial planning and scoping exercise,
11 the revision of the conceptual model, or at the peer review stage.
12 Initial Planning and Scoping: Depending on their expertise, stakeholders
13 may be able to contribute to the development of:
14 1) the overall purpose and general scope of the risk assessment;
15 2) the products needed by management for risk decision-making;
16 3) the approaches, including the risk dimensions and technical elements, that may
17 be evaluated in the assessment;
18 4) the relationships among potential assessment endpoints and risk management
19 options;
20 5) an analysis plan and conceptual model;
21 6) the resources (e.g., data or models) required or available;
22 7) the identity of other critical participants and their roles; and
23 8) the schedule to be followed (including provision for timely and adequate internal,
24 and independent, external peer review) (Guidance, 1997).
25 Revision of the conceptual model: Feedback throughout the planning and
26 scoping process is critical. Therefore, all participants and assessors should remain
27 flexible during any particular phase of risk assessment discussions, and recognize
28 the need to revisit previous assumptions in the conceptual model based on new
29 data or information.
30 Peer Review: The conceptual model must'be peer reviewed before major risk
31 assessments are completed. Qualified and active stakeholders should be expected
32 to be considered in the selection of the peer reviewers where appropriate. Selection
33 of the appropriate representatives should be a flexible process, since it requires a
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1 specific analysis of the needs for each individual risk management case and the
2 constituencies of the affected parties, which may change as the decision making
3 process evolves.
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1 4.3.5 How Does the Spectrum of Stakeholder Issues Affect the Planning and
2 Scoping Exercise?
3 Discussions among the three case workgroups highlight the case-specific
4 nature of each risk assessment and the need to be sensitive to the perceived or real
5 needs of the stakeholders in addressing the risk issues. The topics discussed and
6 the length of the discussion in each case was influenced by the experience of the
7 participants, the problem they faced, and the dynamics of the group.
8 In the pentachlorphenol (PCP) case study, originally it was believed that
9 stakeholder groups should be limited to PCP registrants, utility companies and the
10 Agency. However, the facilitated discussion expanded the list of stakeholders to
11 include international parties (Canada, Mexico/NAFTA), other agencies involved in
12 OSHA issues, the general public, Congress and environmental groups. Workers
13 (e.g., linemen, treatment), the public and environmental groups were not involved
14 on the PCP issues (although currently, the Pesticides Program is actively engaged
15 in examining mechanisms (e.g., putting Registration Eligibility Decisions on the
16 internet) to open up the process more fully). The workgroup noted that in
17 developing national criteria for a chemical, it is often difficult to define who the
18 stakeholders are or should be. The workgroup was also concerned that preliminary
19 dissemination of risk information may lead to erroneous conclusions on the part of
20 the public, resulting in adverse economic effects (i.e., raising some health concerns
21 may result in pesticide users prematurely rejecting a product).
22 The concentrated animal feeding operations (CAPO) case study included a
23 complex risk assessment involving many inputs and considerations. These
24 included CAFOs and their component operations, as well as other regional sources
25 such as agriculture, oil and gas exploration and production, roads and
26 transportation infrastructure, and domestic waste; multi-media (surface- and
27 groundwater and air), multiple pathways and routes of exposure (drinking water
28 and surface-water contamination from microbiological contamination; odors);
29 scientific disciplines (ecological, human health, social sciences/economics); and
30 statutory overlap (CWA, CAA, NEPA, FQPA, RCRA). It illustrates the challenge of
31 involving a wide range of stakeholders in a complex ecological and public welfare
32 issue (see stakeholder list in textbox under Section 4.3) where states are being
33 influenced by local economic considerations and need flexibility to make regulatory
34 or mitigation decisions.
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1 The Chicago Cumulative Risk Initiative (CCRI) case study is an example of a
2 stakeholder-initiated assessment. It illustrates the importance of stakeholder
3 concerns and demonstrates how stakeholder interests may diverge from EPA's
4 standard risk assessment approaches. The stakeholders2 were involved in
5 deliberations regarding the scope of the assessment, data needs and constraints,
6 "products" to be produced, and the project schedule. Consensus was achieved in
7 • Region 5's deliberations with stakeholders on the scope of the assessment to be
8 performed (see textbox). An important breakthrough occurred at the final
9 workshop. The breakout group recognized that the real objective of CCRI was
10 hazard assessment, not cumulative risk assessment. The project does not involve
11 assessment of "cumulative risks" but rather "cumulative hazard". CCRI is not a
12 true risk assessment, but rather a hazard mapping exercise showing the air quality
13 impact of point, area, and mobile sources (environmental loading) within the two-
14 county area. This realization helped them avoid spending unneccessary time and
15 expense on a risk assessment.
16 The type of information provided by non-scientists is different from that
17 provided by technical experts. This non-technical information enters the decision-
18 making process at a different point from scientific information, and informs the
19 decision in a different manner. It thus should not substitute for science, but
20 supplement or augment it. In an ecological risk assessment process, for example,
21 this non-technical information generally enters in the planning stage where a suite
22 of social values relative to the
23 environmental issues is elicited
24 from stakeholders. These values
25 are then converted to assessment
26 endpoints used by the scientists
27 to structure data collection and
28 analysis. The public thus
29 delineates the universe within
30 which the risk is defined.
EPA/Stakeholder Recommendations on Scope of the
Assessment for CCRI
Conduct a cumulative rather than comparative analysis
Focus specifically on children
Focus on sources rather than receptors
Concentrate on EPA-regulated sources
Use only existing data
Cover a broad two-county geographic area
Limit study to air pathway/medium
Do not tie health effects to causes
(Planning and Scoping Summary Report, 1999)
Stakeholders include 11 advocacy groups, represented by the Chicago Legal Clinic (CLC), state, county and city
governments, the Chicago Department of Health, the Chicago Department of the Environment (also representing industry
interests related to brownfields), EPA Region 5, Asthma Coalition, University of IL School of Public Health.
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4.3.6 What are the lessons learned from the case studies?
Several key points can be extracted from the workshop case studies.
a) It is important to involve stakeholders in the planning and scoping process
very early, before a formalized conceptual model is developed.
b) Planning and scoping helps to organize thinking and to document the
process.
c) The conceptual model is a useful tool for communicating with interested
and affected parties and the general public (e.g., presenting information,
explaining analysis, and cause-effect hypothesis). It allows them to see risks
in context. The systematic thoroughness and rigor of model development
enables effective risk communication.
d) Explaining uncertainty to stakeholders is a problem that needs up-front
planning. There is a hesitancy to-reveal all that is known and not known
about chemicals and their risks, because it reveals uncertainties that can
lead to criticism and political ramifications. Yet, uncertainty is inevitable
since there will never be sufficient data to answer all questions.
e) The public should be involved in the cumulative risk assessment as early
as possible. They should be involved in helping make decisions necessary for
development of the conceptual model, and should be invited to participate
and provide feedback for revisions to the conceptual model, and at each step
in the deliberative process.
f) Careful analysis of the problem can focus the effort and clarify what type of
analysis is needed.
g) National assessment.
25 4.4 How Does FACA Apply to Planning and Scoping?
26 The Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2) prescribes
27 steps that federal agencies must take in order to receive consensus advice from two
28 or more individuals that are not employees of the federal government. The steps
29 include establishing a committee charter, maintaining records or minutes of the
30 meetings, public notice of the meetings and meetings must be open to anyone.
31 Planning and scoping sessions are exempt from FACA if they do not require
32 consensus. Further details on planning and scoping exercises involving peer review
33 of consensus products are referred to in Section 2.7.3 of the SPC Peer Review Guide.
34
35 4.5 What Are the Best Ways for Communication with Citizens and Other
36 Interested Parties?
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1 Initially, "face-to-face" meetings with, the participating stakeholders will be
2 necessary in firming up the problem to be resolved and its scope, and for drafting
3 the conceptual model, narrative and analysis plan. Subsequent consultations or
4 informational briefings may also be necessary, depending on the length or the
5 nature of the problem. If the stakeholders are contributing data, a schedule must
6 be developed with appropriate time for questions and interaction. Additional
7 meetings of contacts may be necessary if there are new data requirements,
8 modifications to the conceptual model and/or analysis plan. The nature of the
9 information that is shared will vary with the expertise and interest of the
10 stakeholder groups. This could be achieved through a workgroup meeting with
11 hardcopy products, or it may be sufficient to share the changes electronically (e.g.,
12 via email, webpage, "virtual work environments" or an interactive listserver) with
13 the opportunity for feedback and observation of the interim and final products. A
14 process manager may be needed who should recognize that public participation
15 will always involve problems, and that the problems will be specific to the
16 particular participatory process.
17 If the risk assessment examines a problem of sufficient economic, human
18 health, or environmental impact, an intranet website (and password) with
19 information on the conceptual model could be established for the specific
20 stakeholder workgroup. A website providing examples of "finished" conceptual
21 model products could be made available on the internet. The users (stakeholders)
22 may wish to compare the planning and scoping documents with the final decision.
23 The Agency must be prepared to reconcile any differences.
24 It is important to remember that science has a language all its own; non-
25 scientists do not know this language and can feel excluded by its use. However,
26 scientists often feel that the precision of information captured in scientific
27 terminology is lost in its translation to lay terms. Accomplished and trusted
28 translators between scientific and lay communities can help bridge this gap.
29 Communication between the risk manager and all stakeholders must be ongoing
30 throughout the risk assessment process (DeFur in press), and not occur just at the
31 beginning and the end. The nature of the communication will vary throughout the
32 process: some situations require a simple conveyance of information or findings;
33 other situations require a solicitation for input or dialogue surrounding a decision.
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5. DEFINING THE SCOPE OF THE ASSESSMENT
5.1 Overview Statement
The 1997 Guidance states "The scope of Agency risk assessments describes
the currently identifiable context of the environmental risk that will (or can) be
analyzed. It is defined according to
who or what is at risk of adverse
effects from identifiable sources and
st ressors through several routes of
exposure over varied time frames.. .
A review of possible risk dimensions..
The scope of Agency risk assessments
describes the currently identifiable context
of the environmental risk that will (or can)
be analyzed.
. done at the beginning of the
assessment can help to define its
scope and how the risks will be integrated... (T)his guidance is designed to help
risk managers and risk assessors plan and document the scope of risk assessments
and to consider appropriate participants (that is, technical, advisory or stakeholder)
or information to enrich the risk assessment" (EPA, 1997).
5.2 What is a cumulative risk matrix?
The cumulative risk matrix is an outline of risk dimensions and elements
that might apply to a complex risk assessment and is intended to help risk
managers, risk assessors, economists, engineers, and other experts discuss the
assessment's technical dimensions and specific elements. It can be used as both a
checklist to note how the risk assessment will be framed, and also for planning the
risk assessment with the risk manager and explaining the scope of the risk
assessment to the interested and affected parties. The possible dimensions of the
risk assessment are presented below. Details of the elements are presented in
pages 10-13, Section IV of the EPA guidance (Appendix A).
• Population: Who/What/ is at risk?
O Example-Hispanic toddlers or the process of nitrogen fixation
• Sources: What are the relevant sources of stressors?
O Example-Auto exhaust or exotic species
• Stressors: What are the stressors of concern?
O Example-Lead or overfishing
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• Pathways: Environmental Pathways and Routes of Exposure: What
are the relevant routes of exposure?
O Example- Drinking water or ingestion
• Endpoints: What are the assessment endpoints and their
measurement metric?
O Example-biodiversity and number of species
• Time Frames: What are the relevant time frames of exposure,
frequency, duration, intensity, and overlap of exposure intervals for a
stressor or mixtures of stressors?
O Example-one generation, chronic
Why should options, technical or resource limitations, or approaches that will
not be included in the risk assessment be presented or discussed?
It is important that the planning exercise be a balanced, transparent effort so
that the basis for the final environmental decisions (and the alternative options,
limitations, and approaches considered but not selected) are clearly understood
early in the process by the public and regulated community. Thus, the reasons to
limit the technical scope of the assessment must be stated explicitly and must
include details on limitations of resources, data, the impact of risk elements on the
risk estimate and methods available. In cases where an element of risk is likely to
be important but cannot be quantified due to lack of data, the assessor must
highlight this deficiency, using professional judgement or estimates(if possible) to
approximate the missing data. Judgements and approximations must be clearly
noted and explained to the relevant risk manager and/or relevant stakeholder
participants in the final risk characterization.
5.4 Why are health and ecological risks considered in the same matrix?
To achieve the goal of a comprehensive environmental risk assessment,
human health and ecological risks must be considered together. In terms of
mechanics, this may initially entail separate analyses with a combination of the
risks in the final phase of development. EPA has developed the "problem
formulation" process for ecological risk assessment, but not for human health risk
assessments. In effect, the "planning and scoping" process for developing conceptual
models and analysis plans for cumulative risk assessment is much the same as
problem formulation for ecological risk assessment. The conceptual models for
Pentachlorophenol, Concentrated Animal Feeding Operations, and the Chicago
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1 Cumulative Risk Initiative (Appendix B) illustrate the value in developing aspects
2 of human health effect models along with ecological effect models. However,
3 ultimate integration of the two models into an "environmental effects" conceptual
4 model awaits further work. Agency scientists are considering methods to fully
5 address the integration of human health and ecological risks for environmental
6 assessments.
7 Additional informaton will be added here referencing NCEA work.
8 5.5 How do you decide what is in the assessment and what is out?
9
10 In the first round, the risk matrix includes all options that were considered
11 for each dimension of the risk assessment (e.g., sources, stressors, effects,
12 pathways, etc). Next, a prioritization process should take place to define the initial
13 scope of the assessment including milestones for revisiting the issues as the
14 assessment proceeds and additional data or advisory input is received. The basis
15 for prioritization will vary among risk assessments but will include scientific,
16 technical or regulatory support for the selection of the sources, stressors,
17 environmental pathways, populations/receptors and endpoints of concern, as well as
18 other consideration such as economic resources, public pressures for action,
19 national and international trade issues, etc. For screening assessments, this may
20 be a relatively simple selection process. Priority should be given to those elements
21 that are supported by data most relevant to the risk management objective and the
22 hypothesized relationship between stressors and assessment endpoints.
23 5.6 Is it necessary to establish a cause and effect relationship between a
24 stressor(s) and endpoints?
25 No. Adequate information may not be available to establish a cause and
26 effect relationship between the stressor (s) and endpoints. The purpose of the
27 conceptual model is to provide a template for generating risk hypotheses while
28 providing explicit expressions of the basic assumptions and understanding of the
29 risk problem. Hopefully, by the time that the environmental risk assessment is
30 complete, the cause-effect relationship will be strengthened, confirmed, or in some
31 cases modified based on additional data or analyses.
32 5.7 What is the difference between assessment endpoints and measurement
133 endpoints?
27
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1 Assessment endpoints are functions or characteristics of a group or
2 population of people or organisms (such as reproduction, growth, and lack of
3 disease) that can be measured in relation to the intensity or concentration of a
4 stressor. For example, measurement endpoints are the specific indices to help
5 quantify and predict potential or real changes in the assessment endpoint.
6 Examples include measurements of chlorophyll used to estimate the photosynthetic
7 function of algae in a water body or acetylcholinesterase inhibition as an indicator
8 of certain types of neurotoxicity. See Section 6,2, 6.3 for additional details and
9 examples.
10 5.8 Does the risk problem represent a place-based or national risk?
11
12 Place-based (e.g. CCRI case study) versus national-based (e.g. PCP
13 reregistration case study) planning and scoping exercises will necessarily involve
14 different orientations and sets of requirements (including those for stakeholder
15 involvement) in constructing the conceptual model and analysis plan.
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If place-based:
- define the boundary of the problem area
- determine the relevant pollution sources
- identify the stressors of possible concern
- scope out the location of targets
- identify and inform relevant local/regional stakeholder groups,
citizens
If national-based:
- define general and specific subpopulations of concern within the
national boundaries; establish a clear rationale for their inclusion
- define the stressors and their sources
- identify sources or indicators of human health, ecological effects
(e.g., epidemiology data, USGS trend data)
- identify and inform the relevant national stakeholder groups
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6. THE PRODUCTS: CONCEPTUAL MODEL WITH
NARRATIVE, ANALYSIS PLAN
6.1 Overview Statement
Central to the 1997 Guidance is the conceptual model with its risk
hypothesis (es) and narrative and an analysis plan. The analysis plan is the
implementation strategy for performing the cumulative risk assessment.
Consistent use of the conceptual model approach should result in a consistent,
transparent process for planning assessments, communicating risks of concern, and
explaining risk management decisions.
11 6.2 What is a conceptual model and what is its utility?
12 The conceptual model is a visual representation relating:
13 1) sources of contaminants, physical, chemical, radiological, psychological
14 stressors, etc.;
15 2) to their potential or actual release;
16 3) through environmental media;
17 4) resulting in exposure via single or multiple routes;
18 5) to populations, subpopulations or groups of individuals (human health),
19 communities, and ecosystems;
20 6) resulting in adverse (or potential adverse) effects to human health or the
21 ecology as
22 7) measured by assessment endpoints (see textbox) such as carcinogenicity,
23 reproductive toxicity, population or species effect, alteration in species
24 diversity, keystone species or loss of habitat structure, etc.
25 The conceptual model should always be accompanied by a detailed narrative
26 explaining the rationale for the nature of the conceptual model developed.
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The simple diagram of a generic conceptual model given below illustrates the
application of the terms in the 1997 Guidance document. Sources are activities that
generate or release stressors. These may include industry, municipal waste and
wastewater treatment, solid waste disposal, transportation, agriculture, and
natural resource management. Stressors are chemical, physical, or biological
agents that cause an adverse effect. The stressors move from the source to the
receptors through pathways (e.g., air or surface water), where they may be
converted or metabolized in some way. Exposure occurs in similar ways for plants
and animals, although ecological entities, like communities and ecosystems, are
exposed in more complex ways. Receptors express the effects of the stressors,
usually in response to the dose or quantity of stressor they experience. Under
health endpoints, the generic model adds confounding factors that contribute to
how the effect is expressed. Quality of life issues are often concerns for siting or
expanding existing facilities or projects. Although they are beyond the normal
considerations of risk assessment guidelines, quality of life issues are of great
concern to people.
The narrative
shows the basic rationale
for pursuing particular
courses of action in a
cumulative risk
assessment. It provides a
record of decisions for
future reference during
risk analysis,
characterization, and
communication of the risk
management decision. It
is also valuable as a risk
communication tool both
internally within the
Agency and externally in
interactions with the
public. For peer review,
the conceptual model
provides a scientific or
technical work product
that includes:
Selected Measures ofEcoloeical Assessment Endooints
(Ecological Risk Assessment Guidelines. 1995)
Assessment endpoints and conceptual models help risk assessors
identify measurable attributes to quantify and predict change.
However, determining what measures to use to evaluate risk
hypotheses is... critical to the success of a risk assessment.
There are three categories of measures:
o Measures of effect are measurable changes in an
attribute of an assessment endpoint or its surrogate in response to
a stressor to which it is exposed.
o Measures of exposure(s) are measures of stressor
existence and movement in the environment and their contact or
co-occurrence with the assessment endpoint.
o Measures of ecosystem and receptor characteristics are
measures of ecosystem characteristics that influence the behavior
and location of entities selected as the assessment endpoint, the
distribution of a stressor, and life-history characteristics of the
assessment endpoint or its surrogate that may affect exposure or
response to the stressor." A table of measures for ecological and
human health assessment endpoints is presented below (excerpted
in part from text box 3-16, Eco-Risk Guidelines).
Measures of human health assessment endooints include:
o Toxicological responses (human and/or experimental
animal) including cancer rates or unique cancer types,
neurotoxicological changes including pathology and
neurofunctian, reproductive dysfunction, developmental toxtcity,
cardio-vascular insult, immunotoxicity, renal effects,
hepatotoxicity, others, etc.
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I
2
3
1) the scientific rationale for the selection of the stressor (s), source(s),
receptor(s) (exposed populations), exposure or environmental pathways,
assessment endpoints, and measurement endpoints;
4
5
2) the scientific, technical, economic, or sociologic basis for the construction of
the conceptual model; and,
6
3) the scientific implications of additional data gathering.
Figure . Generic Conceptual Model
Conceptual Model
with Examples of Possible Elements and Linkages
Sources \ Stressors
Biological
-Pathogens
-Exotic spp.
Physical
-Thermal
-Erosion/
sedimentation
-Habitat
alteration
Other
Nuisance,
Noise, Odor
'I Pathways/Exposure!
Routes
Endpoints
Ecological Endpoints
Habitat structure,
distribution, and
diversity
Condition of
Ecosystems
• Populations
•environmental
processes
Status of critical species
or species of special
Public Health
-Cancer, heart
disease
-Disease incidence
Sub-clinical effects
Confounding Factors
-Pysch. Condition
-Access health care
-Income, education
Quality of Life
The effect of the
stressor may be
inequities for the
community
infrastructure,
aesthetics, or recreation
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I 6.2.1 Who develops and supports the conceptual model?
2 The conceptual model is developed by risk assessors and other technical
3 experts such as ecologists, toxicologists, economists and engineers, working together
4 with risk managers as a team. Depending upon the nature and complexity of the
5 risk assessment, stakeholders will inform the development of the model to various
6 degrees, and may continue to play a part in the selection of elements and linkages
7 from the model which are included in the analysis (see Sections 4.3.2 and 4.3.4).
8 Ultimate responsibility for its development and support lies with senior
9 management in the Program Offices or Regions.
10 6.2.2 What are the rules for developing conceptual models?
11 The conceptual model must be developed within the context of the overall
12 purpose and general scope of the risk assessment (see Tasks 1, 2 , Section III of
13 guidance). Once that context is established, we recommend using an iterative
14 process to achieve the final structure of the conceptual model.
15 Developing a conceptual model is a four-step process.
16 1. Bring together appropriate technical, managerial and stakeholder
17 expertise and brain-storm the risk dimensions and technical elements of the
18 assessment (see Section IV of the 1997 Guidance), At this initial stage, it is
19 important not to exclude any options (see 5.3).
-i
20 2. Develop a cumulative risk outline of the elements for each dimensions:
21 sources; stressors; affected groups; entities, or populations; environmental
22 pathways and routes of exposure; relevant time frames, and assessment endpoints
23 (ecological, human health). Reflect in this outline the resources (e.g., data or
24 models) required or available.
25 3. Prioritize the dimensions and elements within this outline and include the
26 rationale (see Section 6.2.5 below on narrative) for excluding any elements.
27 4. Develop the linkages between all the dimensions of the outline and
28 construct a visual model3 to represent these relationships (graphic illustration).
ihis step is the technical approach (also called Problem Formulation in the Agency's Ecological Risk Assessment
Guidelines), a process in which the analysis plan and preliminary hypotheses about the relationship between stressors and
effects on receptors are developed in a conceptual model.
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The strength of these linkages should be clearly defined (e.g., thin versus thick
lines, etc) (see Section 6.2.4 for tools for constructing the models). The linkages
should represent hypotheses about the relationship between the stressors and the
assessment endpoints. If needed, hypertext links may be employed where
additional detailed modeling is required to fully describe the risk
dimensions/elements relationships to the endpoints.
6.2.3 How much detail is required for the conceptual model?
The conceptual model may be a simple diagram (e.g., for a screening level
risk assessment) or a complex, multi-level graphic representation of the sources,
stressors, exposed populations, or ecosystem elements of concern. The economic or
societal importance, complexity, and novelty of the risk, and the data and resources
available for the risk assessment will determine the degree of sophistication and
detail needed. Sufficient detail is required to clearly articulate the rationale for the
inclusion of major dimensions/elements of the conceptual model and to support the
peer review, of the scientific and technical bases for the model (see Section 6.2).
Depending on the case, and the area of interest of the risk assessor, risk manager,
and/or any stakeholder, a part of the conceptual model could be isolated and its
details further examined (see 6.2.6).
6.2.4 What tools are available for constructing the model?
For the bramstorming phase of the conceptual model, poster paper, Post-It®
notes, whiteboards, and writing implements (magic markers, pens) are used
to write down needed information, options, data available, data needs,
resource constraints, etc. No limit should be set on the ideas or information
until the group feels that all
bases have been sufficiently
covered. Then, criteria may be
developed to focus ideas and to
The outline (EPA 1997) can be used as a checklist
to frame the dimensions of the risk assessment, to
plan the risk assessment with the risk manager and
to explain its scope to the stakeholders.
sort and prioritize the different
bits of information in
preparation for developing a
cumulative risk outline. In
some cases, facilitation may be necessary.
For constructing the conceptual model, graphics capability is available in
Corel WordPerfect® (limited capability), Microsoft PowerPoint® or Lotus
Notes Freelance® . Other, more advanced graphics systems (e.g., Visio®) may
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1 be available from your information technology support personnel. The USDA
2 offers training in these graphics systems. Hypertext links to expand a
3 particular aspect of the conceptual model may be created using
4 WordPerfect®4. Figures in this report (Appendix NATA) were developed in
5 Microsoft PowerPoint® and imported to WordPerfect® as windows metafiles.
6 6.2.5 What are the components of the narrative?
7 The narrative is a written description of the conceptual model; i.e, 1) what
8 are the dimensions of the model [stressor (s), sources, receptors (exposed
9 populations), exposure or environmental pathways, assessment endpoints and
10 measurements of endpoints], and 2) what is the scientific, technical, economic, or
11 sociologic basis for the construction of the conceptual model. Examples of ecological
12 and human health narratives for pentachlorophenol (PCP) are presented in
13 Appendix B. The rationale for selecting assessment endpoints and where possible,
14 supporting data or information should be described.
15 6.2.6 When do you know that you have achieved an acceptable level of
16 refinement of the conceptual model?
17 The level of refinement for the conceptual model must be determined by the
18 group constructing it and involves a flexible, iterative process. When the risk
19 assessors, risk managers and stakeholders determine that the model includes the
20 risk factors of concern, the data and resources available to address the risk
21 assessment are described along with their limitations, and transparent, clear
22 hypotheses for determining the potential risks are acceptable to the participants,
23 the conceptual model should be considered "complete". Subsequent information
24 affecting the structure and assumptions of the conceptual model (feedback loop) or
25 peer review comments may require additional adjustments to the model. Thus,
26 while a model may be developed that is acceptable to the workgroup it should
27 always be viewed as a "work in progress".
28 6.2.7 Are conceptual models and their narratives subject to peer review?
29
30 In general, conceptual models are subject to peer review. The Peer Review
31 Guide (EPA, 1998) states "...that all major scientific and technical work products
4Go to the help function, select Create Reference, Create Online Jump, Create Hypertext Link.
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1 used in decision making..." are subject to peer review. Major scientific or technical
2 work products:
3 1) establish a significant precedent or application for a model or methodology,
4 2) address significant controversial issues,
5 3) focus on significant emerging issues,
6 4) have significant cross-Agency/inter-agency implications,
7
8 5) involve a significant investment of Agency resources,
9 6) consider an innovative approach for a previously defined
10 problem/process/methodology, or,
11 7) satisfy a statutory or other legal mandate.
12 When the risk manager determines that a model does not meet the criteria for a
13 major product, a rationale for its exclusion from peer review should be developed .
14 For example, one rationale might be that the conceptual model is for a routine,
15 narrow-impact environmental decision such as a screening-level site-specific risk
16 characterization or a screening-level chemical use-specific characterization in the
17 premanufacturing notice program for new chemicals under the Toxic Substance
18 Control Act (TSCA).
19 6.3. How do you develop an analysis plan?
20 The analysis plan is the final stage of planning and scoping before the risk
21 assessment. The analysis plan is based upon the analytical plan discussed in the
22 Ecological Risk Assessment Guidelines, Section 3.5. The analysis plan includes
23 pathways and relationships identified during planning and scoping that will be
24 pursued during the risk analysis phase. "... Those hypotheses considered more
25 likely to contribute to risk are targeted. The rationale for selecting and omitting
26 risk hypotheses is incorporated into the plan and includes discussion of data gaps
27 and uncertainties. It also may include a comparison between the level of confidence
28 needed for the management decision with that expected from alternative analyses
29 in order to determine data needs and evaluate which analytical approach is best.
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1 When new data are needed, the feasibility of obtaining them can be taken into
2 account...".
3 In situations where data are few and new data cannot be collected, it
4 may be possible to extrapolate from existing data. Extrapolation
5 allows the use of data collected from other locations or organisms
6 where similar problems exist... When extrapolating from data, it is
7 important to identify the source of the data, justify the extrapolation
8 method, and discuss recognized uncertainties.
9 A phased, or tiered, risk assessment approach... can facilitate
10 management decisions in cases involving minimal data sets. However,
11 where few data are available, recommendations for new data collection
12 should be part of the analysis plan. When new data are needed and
13 cannot be obtained, relationships that cannot be assessed are a source
14 of uncertainty and should be described in the analysis plan and later
15 discussed in risk characterization.
16 When determining what data to analyze and how to analyze them,
17 consider how these analyses may increase understanding and
18 confidence in the conclusions of the risk assessment and address risk
19 management questions. During selection, risk assessors may ask
20 questions such as:
21 o How relevant will the results be to the assessment endpoint(s) and
22 conceptual model(s)?
23 o Are there sufficient data of high quality to conduct the analyses with
24 confidence?
25 o How will the analyses help establish cause-and-effect relationships?
26 o How will results be presented to address manager's questions?
27 o Where are uncertainties likely to become a problem?
28 When direct measurement of assessment endpoint responses is not
29 possible, the selection of surrogates measures is necessary... The
30 analysis plan provides a synopsis of measures that will be used to
31 evaluate risk hypotheses. The plan is strongest when it contains
32 explicit statements for how measures were selected, what they are
33 intended to evaluate, and which analyses they support. Uncertainties
34 associated with selected measures and analyses and plans for
35 addressing them should be included in the plan when possible.
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1 6.3.1 What does the analysis plan look like?
2 The analysis plan can be a brief summary of what the key components of the risk
3 assessment are and how each component will be measured or calculated. Examples
4 of ecological and human health risk analysis plans that might be developed are
5 presented below.
6 A. Ecological Risk Analysis Plan
7 Risk management/regulatory goal: Viable, self-sustaining coho salmon population
8 that supports a subsistence and sport fishery.
9 Assessment endpoints: Coho salmon breeding success, fry survival, and adult
10 return rates.
11 Measures of Effects:
12 - egg and fry response to low dissolved oxygen
13 - adult behavior in response to obstacles
14 - spawning behavior and egg survival with changes in sedimentation
15 - population data over time in relation to fish passage
16 Measures of Ecosystem and Receptor Characteristics:
17 - water temperature, water velocity, and physical obstructions
18 - abundance and distributions of suitable breeding substrate
19 - abundance and distribution of suitable food sources for fry
20 - feeding, resting, and breeding behavior
21 - natural reproduction, growth, and mortality rates
22 Measures of Exposure:
23 - number of hydroelectric dams and associated ease of fish passage
24 - toxic chemical concentrations in water, sediment, and fish tissue
25 - nutrient and dissolved oxygen levels in ambient waters
26 - riparian cover, sediment loading, and water temperature
27 What Can and Cannot be Done Based on Planning and Scoping
28 - pathways and relationships to be evaluated
29 - resource restraints
30 - milestones for completion of risk assessment
31 Methods for Conducting Risk Analysis
32 - quotients
33 - narrative discussions
34 - stressor-response curves with probabilities
35 Data Needs and Uncertainties
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B. Human Health Risk Analysis Plan
Risk management /regulatory goal: Protection of the general human population and
susceptible subpopulations to adverse effects from exposure to pesticide X under the
1996 Food Quality Protection Act (FQPA)
Assessment endpoints:
- human or animal health status of exposed versus unexposed
populations/cohorts/dose groups
Measures of Effects:
- general toxicological effects including subchronic, chronic, reproductive,
developmental, neurotoxicity, developmental neurotoxicity, immunotoxicity,
hepatotoxicity, pulmonary, cardio-vascular, etc.
- carcinogenicity
- mutagenicity
Measures of Exposure:
- monitoring of food, water, residential, occupational exposures, etc. (direct
or surrogate)
- monitoring of biological fluids or biomarkers (blood, urine, DNA or other
macromolecules)
What Can and Cannot be Done Based on Planning and Scoping
- pathways and relationships to be evaluated
- resource restraints
- milestones for completion of risk assessment
Methods for Conducting Risk Analysis
-RfD
- Margin of Exposures (MOEs)
- quantitative risk assessment with probabilities on dose-response or
exposure parameters
- quotients
- narrative discussions
Data Needs and Uncertainties
6.3.2 How much detail is required in the plan?
As in the conceptual model, the economic or societal importance, complexity,
data and resources available will determine the degree of sophistication and detail
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1 needed in the analysis plan. Key data gaps should be identified. It should also
2 include thoughts about how to fill the information needs in the near-term using •
3 existing information, in the mid-term by conducting tests with currently available
4 test methods to provide data on the agent(s) of interest, and over the long-term to
5 develop better, more realistic understandings of exposure and effects and more
6 realistic test methods to evaluate agents of concern.. The plan should explain how
7 measures were selected, what they are intended to evaluate, and which analyses
8 they support. Uncertainties associated with selected measures and analyses, and
9 plans for addressing them, should also be explicitly stated.
10 6.3.3 When should the plan be revisited?
11 The analysis plan should include (where feasible) milestones for completion
12 of the risk assessment. These milestones offer an opportunity to revisit the
13 analysis; to plan and modify it based upon new information (data generation); to
14 refine analyses of exposure and toxicity; to modify the conceptual model risk
15 hypothesis; or to compare public concerns with the projected risk management
16 options.
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1 7. CONCLUSION
2 The Planning and Scoping process is a vital step to coordinating the
3 assessment of risks for complex problems. The conceptvhas been applied to
4 ecological risk assessments, cumulative risk assessments, community based risk
5 assessments, and to the development of national standards for pesticides and the
6 manufacture of toxic chemicals. The process relies heavily on the dialogue between
7 the risk manager and the risk assessor and their experience and judgement about
8 the potential scope and stakeholders for the problem. The level of effort and the
9 effectiveness of the process and the risk management decision can be significantly
10 improved by their hard work in this first phase of the risk management decision
11 process. Risk assessments of this type are too complex and costly to be conducted
12 without a clear understanding of the risk management objectives, stakeholder
13 concerns and values, and consideration of the full range of stressors and effects.
14 This planning and scoping guide is intended to help organize that approach.
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8. References
2 Bear, D. 1994. Public Participation in Environmental Decisionmaking. American Bar
3 Association Standing Committee on Environmental Law Washington, DC
' 4 deFur, P. (editor) in press Ecological Risk Management (working title) Society for
5 Environmental Toxicology and Chemistry, Pensacola, FL (publication date 2000)
6 Finney, C. and R. E. Polk 1992. "Developing Stakeholder Understanding, Technical Capability,
7 and Responsibility: the New Bedford Harbor Superfund Forum" Environmental Impact
8 Assessment Review vol 15 p.517-541
9 Glicken, J. 1999. "Effective Public Involvement in Public Decisions" Science Communication
10 vol 2, no 3 p. 298-327
11 National Research Council. 1983. Risk Assessment in the Federal Government: Managing the
12 Process. National Academy Press, Washington, D.C.
13 National Research Council. 1994. Science and Judgement in Risk Assessment.
14 National Academy Press, Washington, D.C.
15 National Research Council. 1996. Understanding Risk: Informing Decisions in a
16 Democratic Society. Paul C. Stern and Harvey V. Fineberg, Editors.
17 National Academy Press, Washington, D.C.
18 The Presidential/Congressional Commission on Risk Assessment and Risk Management. 1997.
19 Volume 1. Framework for Environmental Health Risk Management. Washington, D.C.
20 United States Environmental Protection Agency. 1998. Guidelines for Ecological Risk
21 Assessment EPA/630/R-95/002F April 1998
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APPENDICES
A-F
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APPENDIX A
CUMULATIVE RISK ASSESSMENT GUIDANCE
PLANNING AND SCOPING
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MEMORANDUM
Dated July 3,1997
SUBJECT: Moving Toward More Comprehensive, Integrated,
And Cumulative Risk Assessments at EPA
TO:
Assistant Administrators
Regional Administrators
General Counsel
Associate Administrators
Inspector General
A major advance of the last few years has been steadily increasing attention on how to
assess environmental problems in all of their currently identifiable dimensions. To
explain what this means for the U.S. Environmental Protection Agency's (EPA) evolving
risk assessment and decision-making activities, we are providing guidance on Integrating
Environmental Risks in order to move us toward more comprehensive and integrated risk
assessments (that is, cumulative risk assessments). This guidance provides principles that
EPA Programs and Regions can follow in the planning, scoping and problem formulation
stages of their future risk assessments. This guidance will be updated as our
understanding and experience develops. The goal is a clear explanation of which aspects
of total environmental risk (for both human health and ecology) will and will not—and in
some cases due to gaps in our current knowledge cannot—be included in an Agency risk
assessment.
For most of its history, EPA risk assessment and decision-making have focused on
individual environmental contaminants. One by one, EPA has regulated and reduced
pollution from such agents as ozone, lead, particulate matter, chlordane, kepone, and
DDT, with risk assessments for these chemicals often focused on single endpoints,
pathways, or sources. By contrast, new risk emphases and methods allow EPA to move
toward cumulative risk by evaluating multiple stressors, endpoints, sources, pathways
and other factors. As a result, EPA assessments now often describe and, where possible,
quantify the risks of adverse health and ecological effects from multiple stressors. In
analyzing risks, EPA looks at sensitive subpopulations (1992 Exposure Assessment
Guidelines), including those characterized by age (such as the priorities established by
our October 1995 Policy on Evaluating Health Risks to Children) and by differences in
susceptibility which may relate to gender, ethnicity, or geographic origin.
There are integrated and cumulative risk issues, dimensions and concerns, however, that
this guidance cannot address, at this time. This broader set of concerns, recognized as
potentially important by many participants in the risk assessment process, relate to social,
economic, behavioral or psychological stressors that may also contribute to adverse
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health effects. These stressors may include—among other factors—existing health
condition, anxiety, nutritional status, crime, and congestion. Currently, assessment of
this broader perspective of risk is very difficult due to major deficiencies in: the data
establishing plausible cause and effect relationships; capability to measure exposure to
such risks, and to understand their incidence and individual susceptibilities; availability
of methods for assessing such risks; and techniques or approaches for their management.
In this guidance, therefore, EPA will focus initially on risk assessments that integrate
risks of adverse health and ecological effects from the narrower set of environmental
stressors noted above. For the longer term, the Agency is focusing research to improve
integrated risk assessments as well as stakeholder and scientific community outreach
efforts on the broader set of concerns.
In recent years, EPA's risk assessment emphasis has shifted increasingly to a more
broadly based approach characterized by greater consideration of multiple endpoints,
sources, pathways and routes of exposure; community-based decisionmaking; flexibility
in achieving goals; case-specific responses; a focus on all of the environmental media;
and significantly, holistic reduction of risk.. This more complex assessment involves
cumulative risk assessment. It is defined in each case according to who or what is at risk
of adverse effects—from identifiable sources and stressors—through several routes of
exposure over- varied time frames.
Key features of the guidance include a dialogue among the risk assessor and risk
manager, and economists, engineers, and other technical experts in planning and
formulating the problem for the risk assessment. It provides details on the nature of the
risk assessment planning dialogue and activities that, in the immediate future, should lead
to the next generation of integrated risk assessments from the Programs and Regions.
Deliberative planning discussions involving risk assessors, economists, managers, and
other technical advisors, with early and continued input from the public and other
stakeholders, are important components of this guidance. It is important that each
member of the team (that is^a risk assessor, economist, or risk manager), the public and
other stakeholders understands the nature of the problem and how the data would be used
in. the risk assessment and hi risk decision-making before the assessment is completed.
These discussions will ensure that the Risk Characterization principles of clarity,
transparency, reasonableness and consistency in our decision making are embraced in the
planning and scoping stages of the risk assessment. Activities that consider the broad
dimensions and cumulative aspects of risk will be required for all major risk assessments;
and, such integration should be considered for routine applications where appropriate.
The scope of these integrated assessments often will extend beyond the boundaries of
individual program offices—and even beyond the traditional statutory mandates for the
analysis of major environmental risks. Indeed, recent legislation on drinking water and
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pesticide food safety requires more comprehensive and integrated approaches to the
assessment and management of risk.
Already, integrated or cumulative risk approaches are being used in some cases by
Regions and Program Offices within the Agency. They range from assessments
addressing multiple pathways and multiple endpoints to place-based assessments
covering a wide range of stressors and endpoints. Several cumulative risk assessments
and problem formulation cases, discussed during the Agency's recent Colloquia on Risk
Characterization, illustrate the approach described in the attached guidance document.
This guidance will evolve as it augments the Agency's next generation of Risk
Characterization.
This approach needs to be used for all major risk assessments undertaken by Program
Offices and Regions. We challenge Agency risk assessors and managers to expand the
traditional scope of their assessments to help us better advise concerned and affected
citizens and stakeholders about the environmental risks they face and how these risks can
be addressed and managed.
Carol M. Browner
Administrator
Attachments
Fred Hansen
Deputy Administrator
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Guidance on
Cumulative Risk Assessment.
Part 1. Planning and Scoping
Science Policy Council
U.S. Environmental Protection Agency
Washington, DC 20460
June, 1997
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Cumulative Risk Assessment-Planning and Scoping
Section I. Introduction
The practice of risk assessment within the Environmental Protection Agency (EPA) is
evolving away from a focus on the potential of a single pollutant in one environmental
medium for causing cancer toward integrated assessments involving suites of pollutants in
several media that may cause a variety of adverse effects on humans, plants, animals, or
even effects on ecological systems and their processes and functions.
In recent years, EPA's risk assessment emphasis has shifted increasingly to a more
broadly based approach characterized by greater consideration of multiple endpoints,
sources, pathways and routes of exposure; community-based decisionmaking; flexibility
in achieving goals; case-specific responses; a focus on all of the environmental media; and
significantly, holistic reduction of risk (Table 1). This more complex assessment involves
cumulative risk assessment. It is defined in each case according to who or what is at risk
of adverse effects—from identifiable sources and stressors—through several routes of
exposure over varied time frames.
Table 1. Transition in EPA Risk Assessment Characteristics
Old
Single Endpoint
Single Source
Single Pathway
Single Route of Exposure
Central Decision-making
Command and Control
One-Size-Fits-All Response
Single Media-focused
Single Stressor Risk Reduction
New
Multiple Endpoints
Multiple Sources
Multiple Pathways
Multiple Routes of Exposure
Community-based Decision-making
Flexibility in Achieving Goals
Case-Specific Responses
Multi-media Focused
Holistic Reduction of Risk
This evolution has occurred at an uneven pace, propelled at times by the public and by
Congressional concern about environmental risks and their cumulative effects; and, it has
been restrained in some cases by statutory authority or limitations of technical knowledge,
data and resources.
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The scope of Agency risk assessments describes the currently identifiable context of the
environmental risk that will (or can) be analyzed. It is defined according to who or what
is at risk of adverse effects from identifiable sources and stressors through several routes
of exposure over varied time frames (see Section V, Risk Assessment Terminology). A
review of possible risk dimensions (shown in italics in the previous sentence) done at the
beginning of the assessment can help to define its scope and how the risks will be
integrated.
The term "cumulative risk assessment" covers a wide variety of risks. Currently, EPA
assessments describe and where possible quantify the risks of adverse health and
ecological effects from synthetic chemicals, radiation, and biological stressors. As part of
planning an integrated risk assessment, risk assessors must define dimensions of the
assessment, including the characteristics of the population at risk. These include
individuals or sensitive subgroups which may be highly susceptible to risks from stressors
or groups of stressors due to their age (for example, risks to infants and children), gender,
disease history, size, or developmental stage. There are other risk issues, dimensions and
concerns, however, that this guidance cannot address, at this time. This broader set of
concerns, recognized as potentially important by many participants in the risk assessment
process, relate to social, economic, behavioral or psychologi-cal stressors that may
contribute to adverse health effects. These stressors may include—among other
factors—existing health condition, anxiety, nutritional status, crime, and congestion.
Currently, assessment of this broader perspective of risk is very difficult due to major
deficiencies in: the data establishing plausible cause and effect relationships; capability to
measure exposure to such risks, and understand their incidence and individual
susceptibilities; availability of methods for assessing such risks; and techniques or
approaches to manage them.
On the important topic of special subpopulations, EPA and others are giving more
emphasis to the sensitivities of children and to gender-related differences in susceptibility
and exposure to environmental stressors. New legislation requires that the Agency expand
its historical approaches to determining human exposures and health impacts to improve
our understanding of gender-related differences. It is the goal of the Agency to address
gender-specific issues and use gender^and ageyifferentiated data, whenever it is
appropriate and available, in Agency risk assessments and risk management decisions.
Likewise, the Agency will pursue further research to provide this kind of information and
address relevant data gaps once they are identified.
In this guidance, therefore, EPA will focus initially on risk assessments that integrate risks
of adverse health and ecological effects from the narrower set of environmental stressors
noted above. For the longer term, the Agency is focusing on research to improve
integrated risk assessments as well as stakeholder and scientific community outreach
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efforts on the broader set of concerns. For example, pilot projects such as the Office of
Prevention, Pesticides and Toxic Substances Baltimore Project and the Office of Policy
Planning and Evaluation's Cumulative Exposure Project will likely lead to new ways to
incorporate qualitative factors, also mentioned above, into our integrated risk assessment
process.
Recommendations from the National Research Council's (NRC) "Understanding Risk:
Informing Decisions in a Democratic Society" and a report from the Commission on Risk
Assessment and Risk Management suggest that a variety of experts, including economists
and social scientists, and stakeholders must be involved throughout the environmental risk
assessment and risk management process. This guidance also recommends involving
experts and stakeholders in the planning and scoping of risk assessments. The Agency is
engaged in several activities that involve working with stakeholders. Experience from
these activities will provide the solid basis for engaging interested and affected parties in
risk assessment and risk management issues.
As it evolves, this guidance is designed to help risk managers and risk assessors plan and
document the scope of risk assessments and to consider appropriate participants (that is,
technical, advisory, or stakeholder) or information sources to enrich the risk assessment.
Additionally, it augments the Agency's March 1995 Policy for Risk Characterization by
providing a clear, transparent, reasonable, and consistent basis for any assessment.
Regions and Program offices are strongly encouraged to undertake a formal problem
formulation exercise for all risk assessments.
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Section II. Key Characteristics of a Process for Integrating Environmental Risks
Agency risk assessors and risk managers need to make judgments early in planning major
risk assessments regarding the purpose, scope, and technical approach (that is, the
conceptual model) by evaluating the full range of discernible human health and ecological
dimensions of risk (that is, stressors, sources, effects, exposed populations, pathways of
exposure, and time frames of risks). Agency managers need to place special emphasis on
cumulative risk (that is, the potential risks presented by multiple stressors in aggregate).
The specific elements of risk evaluated need to be determined as an explicit part of the
Planning and Scoping (PS) stage of each risk assessment. During PS, risk assessors, such
other technical experts as ecologists, toxicologists, economists and engineers, and risk
managers work together as a team, inform by stakeholder input, to determine:
1. the overall purpose and general scope of the risk assessment;
2, the products needed by management for risk decision-making;
3. the approaches, including a review of the risk dimensions and technical elements that
may be evaluated in the assessment (see sections III and IV);
4. the relationships among potential assessment end points and risk management options
and;
5. an analysis plan and a conceptual model;
6. the resources (for example, data or models) required or available;
7. the identity of those involved and their roles (for example, technical, legal, or stakeholder
advisors); and
8. the schedule to be followed (including provision for timely and adequate internal, and
independent, external peer review).
Due to the current state of the practice and limited data, the aggregation of risks may often
be based on a default assumption of additivity. The Agency will support research to
improve our understanding of cumulative risks and to develop methods to account for the
multiple elements of risks that affect humans, animals, plants and their environment. In
addition, the Science Policy Council will support workshops for risk assessors and
managers to discuss implementation opportunities and problems, and solutions.
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To aid those involved in developing this planning and scoping process (including risk
assessors, risk managers, ecologists, toxicologists, economists and other social scientists)
an outline has been developed (see Section IV of this guidance) listing six dimensions of
risk (that is, sources, stressors, pathways or routes, populations, endpoints and time
frames) and specific elements that will be considered for evaluation in major risk
assessments5. This outline of risk dimensions and elements is part of a systematic
approach in which risk managers and technical experts develop a specific, yet broadly-
based, conceptual plan for major risk assessments.
The conceptual model (mentioned above) is a description or diagram, of the relationship
between the predicted responses of a population (or entity of concern) and its stressors
laying out the environmental pathways and routes of exposure in the context of the
assessment. The analytical plan needs to show how data sources and information will be
used and integrated in the assessment and how measurement endpoints and uncertainties
are related to the assessment endpoints. Decisions on the purpose, scope and conceptual
plan must be summarized and attached to the final risk assessment. The conceptual plan
must be available for peer review before major risk assessments are completed.
3 Major assessments are defined here as those that require a Regulatory Impact Analysis
or external peer review.
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Section III. Implementation Tasks
Planning and scoping involves several steps that are described in this paper (see EPA
(1996) for a more complete discussion of the steps). The planning and scoping process
involves specific participants and processes. In the first step, a risk assessment dialogue
among the risk manager, risk assessors, economists, and other technical experts should
develop the broad dimensions and elements of the risk assessment, the management goals
for the assessment, a tentative budget and schedule, and an approach for conducting the .
risk assessment. The overall approach for integrated risk assessment and management is
shown in Figure 1. This figure shows that stakeholders (interested or affected parties)
need to be involved in the process. The NRC in "Understanding Risk: Informing
Decisions in a Democratic Society" and a draft report from the Commission on Risk
Risk Assessment/ Management Decision Proces
New Management Needs
Planning
and
Scoping
(Assessor-
Manager
Dialogue)
Risk Assessment
Risk
haracterization
Economic, Poli-Science,
and Social Analysis
figure 5 Stages in the integrated Risk Assessment Process
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Assessment and Risk Management recommend that stakeholders be involved throughout
the process. The Agency is engaged in several activities that involve stakeholders in risk
assessment and in the risk management decision process. Risk managers must decide on a
case by case basis when and how stakeholders can be involved..
Risk Assessment Planning Dialogue
Task 1. Define the purpose for performing the risk assessment. .
The risk manager must explain clearly why the assessment is being performed and what
questions need to be addressed. The manager must also advise the assessors, economists,
engineers, and other contributing experts on the planning team of any interested party,
affected party, or policy interests to be considered in the context of the risk issue. These
factors may influence the risk management options, management goals, key participants,
data sources, selection of assessment endpoints, or the schedule for the developing the
assessment. The manager and assessment planning team must discuss any regulatory basis
for the risk assessment and what kind of information is required to satisfy such
requirements.
Task 2. Define the scope of the risk assessment.
Initially, the risk assessor and manager (and the planning team) need to evaluate and
select the kind of risk information, exposure scenarios and assessment issues that need to
be covered. At this point, most EPA assessments focus on technical information related
to the sources, effects, populations and the routes of exposure. Reasons to limit the
technical scope of the assessment must be stated explicitly and must include details on
limitations on resources, data, the impact of risk elements on the risk estimate, and
methods available. In cases where an element of risk is likely to be important, but no
valid data are available, the assessor must highlight this deficiency or use judgement or
assumed values to approximate the missing data. Such judgements and approximations
must be noted clearly and explained to the manager in the risk characterization.
Task 3. Develop a Cumulative Risk Outline
Use the example outline (section IV, or other appropriate and documented outline of risk
dimensions and elements) to develop through brainstorming the specific elements that
may be relevant to each dimension of the risk. In practice, cumulative risk as a term must
be defined in each particular case in the context of the elements that will or will not (as
well as can or cannot) be included in the risk assessment. This is done through a planning
and scoping process that considers the following dimensions:
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A. Who, what or where is being affected or stressed?
B. What are the stressors?
C. What are the sources?
D. What are the environmental pathways and routes of exposure?
E. What are the relevant time frames?
F. What are the assessment endpoints?
For example, one could attempt to assess:
* cumulative acute and subchronic health risk to field workers' infants and toddlers in farm
communities to organophosphate pesticide exposure (that is, through respiratory dermal,
dietary and non-dietary ingestion) resulting from agricultural and residential uses in light
of the nutritional status of field worker families; or
* cumulative ecological risk to the survival and reproduction of populations of blue crabs or
sniped bass in the Chesapeake Bay resulting from water and air emissions from both
urban and agricultural sources. "
* cumulative risk under the Food Quality Protection Act may be defined using terms such
as aggregate exposure (that is, the exposure of consumers, manufacturers, applicators, and
other workers to pesticide chemical residues with common mechanisms of toxicity
through ingestion, skin or inhalation from occupational, dietary, and non-occupational
sources)6 or cumulative effects (that is, the sum of all effects from pesticide chemical
residues with the same mechanism of toxicity). ;
Participants and Process. The risk assessor and the risk manager need to review the outline
initially to identify elements that may be included. Once the possibilities (that is, the
elements of each dimension of the outline) have been identified through initial
brainstorming, the risk assessor should indicate who could assist with technical
information and how such information may affect the overall uncertainty of the
assessment. The risk manager and assessor must determine what elements will and will
not (or. can and cannot') be included in the risk assessment. Information gathered at this
stage is preliminary and may be modified during the analysis phase.
6 Actually, the language of FQPA excludes occupational exposure and
pesticide workers.
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Product. Ultimately, after iteration, this stage likely will produce a well-developed
outline of cumulative risk possibilities (that is, a combining of the elements under each
dimension) and document what is included and what is left out of the risk assessment,
with an explanation of the reasons for the
latter. The outline and rationale need to be available for risk characterization.
Task 4. Problem Formulation (the Technical Approach)
Problem formulation is an iterative process within which the risk assessor develops
preliminary hypotheses about why adverse effects might occur or have occurred. It
provides the foundation for the assessment. The analytical plan is used in defining the
work required in the risk assessment and how the risks will be integrated.
Conceptual models are used to represent the predicted responses of populations to
stressors to which they are exposed. The model is developed by the risk assessor and may
include input from other experts (including stakeholders). The model needs to distinguish
between what is known or determined and what is assumed or based on default values.
Also, it needs to include a discussion of uncertainties in the formulation of the assessment.
In some cases, conceptual models will be submitted for peer review.
Players and Process. Although the development of a conceptual model is inherently a
technical process, the selection of assessment endpoints should use input from the
interested and affected parties either directly or by a summary of their opinions and
concerns. Assessment endpoints should also be discussed with economists.
Product. The principle outputs from this stage are assessment endpoints that are related to
the management objectives, the plan for analysis of the risk, and the conceptual model.
These final products are summarized in the description of the risk assessment dialogue
outcomes (the planning, scoping, and problem formulation tasks) required by this
guidance. The conceptual model has features of both a scientific hypothesis and of a work
plan. For a major assessment—for example, on dioxin, mercury, or pollutants with
controversial methodological or scoping issues—this model needs to be peer reviewed.
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Section IV. An Outline of Risk Dimensions and Elements
This outline is intended to help risk managers, risk assessors, economists, engineers and
other experts discuss the technical dimensions and specific elements that might apply to a
particular risk assessment. This outline can be used as a checklist to note how the risk
assessment will be framed in terms of the sources, stressors, pathways, population,
endpoints, and time frames. It can also be used to plan the risk assessment with the risk
manager and explain the scope of the risk assessment to the interested and affected parties.
The next step is the technical approach (also called Problem Formulation in the Agency's
draft Ecological Risk Assessment Guidelines), a process in which the analysis plan and
preliminary hypotheses about the relationship between stressors and effects on populations
are developed in a conceptual model. This model needs to be peer reviewed.
For the purposes of this outline, six dimensions are used: sources, stressors, pathways,
population, endpoints, and time frames. Each dimension is defined below by a question;
and, some of the most likely answers are listed as elements for the risk assessment.
Dimension A. Population
("Who /What/Where is at Risk?")
1. Humans
a. Individual
b. General population distribution or estimation of central tendency and high end
exposure
c. Population subgroups
(1) Highly exposed subgroup (for example, due to geographic area, age group, gender,
racial or ethnic group, or economic status)
(2) Highly sensitive subgroups (for example, asthmatics or other pre-existing
conditions, age, gender)
2. Ecological Entities
a. Groups of individuals
b. Populations
c. Multiple species
d. Habitats or ecosystems
3. Landscape or Geographic Concerns
a. Groundwater aquifers
b. Watersheds (that is, surface water bodies and their associated terrestrial ecosystems)
c. Airsheds
d. Regional ecosystems
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e. Recreational lands
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pimensjonJB. Sources
(What are the Relevant Sources of Stressors?)
1. Single source
a. point sources (for example, industrial or commercial discharge, superfund sites)
b. non-point sources (for example, automobiles, agriculture, consumer use releases)
c. natural sources (for example, flooding, hurricanes, earthquakes, forest fires)
2. Multi-sources (Combinations of those above)
Dimension C. Stressors
(What are the Stressors of Concern?)
1. Chemicals
a. Single chemical
b. Structurally related class of substances
(1) Individual substances (that is, only one is present at a time)
(2) Existing in a mixture
c. Structurally unrelated substances with similar mechanism of impact and/or same
target organ
(1) Individual substances
(2) Existing in a mixture
d. Mixtures (that is, dissimilar structures or dissimilar mechanisms)
2. Radiation
3. Microbiological or biological (these range from morbidity to ecosystem disruption)
4. Nutritional (for example, diet, fitness, or metabolic state)
5. Economic (for example, access to health care)
6. Psychological (for example, knowledge of living near uncertain risks)
7. Habitat Alteration (for example, urbanization, hydrologic modification, timber harvest)
8. Land-use changes (for example, agriculture to residential, public to private recreational
uses)
9. Global climate change
10. Natural Disasters (for example, floods, hurricanes, earthquakes, disease, pest invasions)
Dimension D. Pathways
(Environmental Pathways and Routes of Exposure. "What are the Relevant Exposures?")
1. Pathways (recognizing that one or more may be involved)
a. Air
b. Surface Water
c. Groundwater
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d. Soil
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e. Solid Waste
f. Food
g. Non-food consumer products, Pharmaceuticals
2. Routes of Human and single species exposures
a. Ingestion (both food and water)
b. Dermal (includes absorption and uptake by plants)
c. Inhalation (includes gaseous exchange)
d. Non-dietary ingestion (for example, "hand-to-mouth" behavior)
3. Routes of Exposure within communities and ecosystems
a. Direct Contact or ingestion (without accumulation)
b. Bipaccumulation
c. Biomagnification '
d. Vector transfers (for example, parasites, mosquitoes)
Dimension E. Endpoints
(What are the assessment endpoints?)
1. Human Health Effects (for example as based on animal studies, morbidity and disease
registries, laboratory and clinical studies, or epidemiological studies or data)
a. Carcinogenic
b. Neurotoxicologic
c. Reproductive dysfunction
d. Developmental
e, Cardio-vascular
f. Immunologic
g. Renal
h. Hepatic
I. Others
2. Ecological Effects
a. Population or Species
(1) Loss of fecundity
(2) Reduced rate of growth
(3) Acute or Chronic toxicity
(4) Change in biomass
b. Community
(1) Loss of species diversity
(2) Introduction of an exotic species
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(3) Loss of keystone species
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c. Ecosystem
(1) Loss of a function (for example, photosynthesis, mineral metabolism)
(2) Loss of habitat structure
(3) Loss of a functional group of organisms (for example, grazers, detritivores)
(4) Climate change (for example, sunlight, temperature change)
(5) Loss of landscape features (for example, migration corridors, home ranges)
Dimension F. Time frames
(What are the Relevant Time Frames: Frequency, Duration, Intensity and Overlap of Exposure
Intervals for a Stressor or Mixtures of Stressors)?
1. Acute
2. Subchronic
3. Chronic or effects with a long latency period
4. Intermittent
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Section V. Risk Assessment Terminology
This is a partial list of risk assessment terms that often associated with risk
assessment practice. The list is not exhaustive, but it does include terminology used in
this guidance and other terms that are closely related to the planning and scoping of risk
assessments.
Agent-Suter et ah (1994) suggested it as an alternative for the term stressor. It is considered to be
more neutral than stressor, and is used in EPA's Guidelines for Exposure Assessment.
Aggregate exposure - the sum of exposures to pesticide chemical residues with a common
mechanism of toxicity from multiple sources and multiple routes of exposure (Food
Quality Protection Act, 1996).
Analysis- The analytical phase of the risk assessment in which the potential for adverse effects
are calculated based on the hazard identification, dose-response assessment, and the
exposure assessment.
Assessment endpoint- functions or characteristics of a group or population of people or organisms
(such as reproduction, growth, and lack of disease) that can be measured in relation to the
intensity or concentration of a stressor.
Comparative Risk Assessment- A process that generally uses an expert judgement approach to
evaluate the relative magnitude of effects (relative risk) and set priorities among a wide
range of environmental problems (US EPA, 1993b). In some cases this may be done as a
preliminary risk assessment.
Cumulative Risk Assessment- involves the consideration of the aggregate ecologic or human
health risk to the target entity caused by the accumulation of risk from multiple stressors,
[multiple pathways, sources] (US EPA, 1995).
Cumulative effects- 1) the sum of all environmental effects resulting from cumulative impacts
(Liebowitz et al., 1992), and 2) the combination of effects from all pesticide chemical
residues which have a common mechanism of toxicity (Food Quality Protection Act,
1996).
Cumulative impacts—the sum of all individual impacts occurring over time and space, including
those of the foreseeable future (CEQ, 40 CFR Sect. 1508.7)
Conceptual model- a diagram or written description of the predicted key relationships between
. , the stressdr(s) and the assessment endpoint(s) for a risk assessment.
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Disturbance-(See physical stressor) any event or series of events that disrupts ecosystem,
community, or population structure and changes resources, substrate availability, or the
physical environment.
Environmental Impact Assessment- an assessment required by the National Environmental Policy
Act to evaluate fully potential environmental effects associated with proposed federal
actions.
Exposure-the contact or co-occurrence of a stressor with a receptor.
Integrated Risk Assessment- a process that combines risks from multiple sources, stressors, and
routes of exposure for humans, biota and ecological resources in one^assessment with a
defined point of focus (See also cumulative risk assessment).
Receptor-the entity which is exposed to the stressor.
Relative Risk Assessment- a process that involves estimating the risks associated with stressors or
management actions that often uses qualitative risk techniques.
Source- an entity or action that releases to the environment or imposes on the environment
chemical, biological, or physical stressor or stressors.
Stakeholder - a person, group of people, an organization (public or private), a business, or other
party that has an interest in terms of knowledge or jurisdiction or is affected in terms of
their health, property rights, or economy by an environmental risk (s).
Stressor- Any physical, chemical, or biological entity that can induce an adverse response.
Stress Regime- (1) a characterization of multiple exposures to stressors, (2) a synonym for
exposure, or (3) a series of interactions of exposures and effects resulting in secondary
effects. Because of its potential for confusion, the term is not used in guideline
documents.
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References
The Presidential/Congressional Commission on Risk Assessment and Risk Management. 1997.
Volume 1. Framework for Environmental Health Risk Management. Washington, D.C.
National Research Council. 1994. Science and Judgement in Risk Assessment. National
Academy Press, Washington, D.C.
National Research Council. 1983. Risk Assessment in the Federal Government: Managing the
Process. National Academy Press, Washington, D.C.
National Research Council. 1996. Understanding Risk: Informing Decisions in a Democratic
Society. Paul C. Stern and Harvey V. Fineberg, Editors. National Academy Press,
Washington, D.C.
United States Environmental Protection Agency. 1998. Guidelines for Ecological Risk
Assessment EPA/630/R-95/002F April 1998
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APPENDIX B
WORKSHOP CASE STUDIES:
1. The Reregistration of Pentachlorophenol
2. Chicago Cumulative Risk Initiative-Region V
3. Cumulative Risk Index Analysis (CRIA) Method in Concentrated Animal Feeding Operations
(CAFO) In Region VI
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B-l, The Reregistration of Pentachlorophenol: Case Study
1 The Situation
2
3 Pentachlorophenol (PCP), a heavy duty wood preservative, is an organic oil-borne
4 pesticide first registered in the United States in 1948 to prevent wood decay from fungal
5 and insect damage. PCP is formed by the high temperature chlorination of phenol, which
6 results in the formation of microcontaminants (dioxins, furans, and hexachlorobenzene) in
7 PCP.
8 In 1978, USEPA issued a Federal Register Notice initiating an administrative process to consider
9 whether pesticide registrations for wood preservative chemicals should be cancelled or
10 modified due to adverse toxicological effects noted in animal toxicity studies. The
11 Agency issued notices of "Rebuttable Presumption Against Registration" (RPAR) for PCP
12 based on teratogenicity and fetotoxicity findings. In addition, the Agency determined that
13 PCP use posed the risk of oncogenicity due to the presence of microcontaminants
14 (dioxins/furans/HCB). The Agency subsequently published Position Documents to
15 address comments made by stakeholders on the Federal Register Notice, The conclusion
16 . of the RPAR process in 1984 and final settlement agreements with registrants in 1986
17 restricted PCP uses and modified its terms and conditions of registration. The RPAR
18 process also resulted in cancellation in 1987 of certain non-wood preservative uses of PCP
19 as a herbicide, defoliant, mossicide, and mushroom house biocide. In 1993 uses of PCP
20 were terminated as a biocide in pulp and paper mills, oil wells, and cooling towers.
21 Currently, two U.S. manufacturers produce PCP, and approximately 100 wood treatment plants
22 apply the pesticide to wood. Treatment plants vary considerably in age and design. Utility
23 companies nationwide use 92.5% of all PCP-treated lumber for utility poles and cross
24 arms. Secondary uses include railroad crossties, wood pilings, fenceposts, and
25 6868commercial/residential structures, such as decks, fences, and walkways.
26 The Office of Pesticide Programs/ Antimicrobial Division (OPP/AD) is reassessing the potential
27 risks of PCP on human health and the environment. The reassessment is driven by a
28 FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act) requirement for a
29 Reregistration Eligibility Decision (RED) on heavy duty wood preservatives, due in 2001,
30 and will conform with the Food Quality Protection Act (FQPA). Although the
31 reregistration of PCP is regulated under FIFRA, PCP also is regulated under the Clean
32 Water Act, Clean Air Act, and Resource Conservation and Recovery Act.
33 Reregistration of PCP is unusual in that it requires risk assessment harmonization with Canada
34 under the North American Free Trade Agreement (NAFTA). Mexico is not an active
35 participant in this process, but EPA and Canada keep Mexico informed.
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1 Risk Assessment Planning and Scoping Dialogue:
2 Task one: Define the purpose for performing the risk assessment
3 The purpose of the risk assessment was already determined by the regulatory requirement to
4 produce a Reregistration Eligibility Decision (RED) document for heavy duty wood
5 preservatives. Participants of all three workshops accepted this regulatory purpose
6 without debate.
7 Task two: Define the scope of the risk assessment
8
9 Workshop participants accepted the decision to limit the reassessment process to PCP and address
10 the other two wood preservatives (CCA and creosote) separately. Due to the time limit,
11 participants of the third workshop decided to focus mainly on PCP and dioxins/furans, but
12 not to address hexachlorobenzene. The participants recommended that the risk assessment
13 for HCB separately and later synthesize the results with the PCP component.
14 Task three: Develop a cumulative risk outline
15 Ecological
16
17
18
19
20
21
22
23
24
25
26
27
,28
I
The participants of the first two workshops identified the components of six dimensions of
ecological risk that form the elements of a conceptual model for ecological effects (see the
sidebar ).
The participants considered treated wood and disposal as the most important sources of PCP
release into the environment. Utility poles are widely distributed even in residential
neighborhoods, and while a lot of used wood is incinerated, some is sold and even
acquired by unsuspecting homeowners. Facilities that treat wood were not considered a
major source because drip pads and recapture technologies are supposed to prevent release
to the environment. However, participants in the third workshop suspected that treatment
plants may be an important source of PCP to the environment during the drying process at
the plant and possibly due to runoff. OPP/AD does not account for misuse in risk
j assessment, but participants generally agreed that the conceptual model could encompass
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1 Using the dimensions of ecological risk
2 developed during the first two
3 workshops (see the sidebar), OPP/AD
4 had prepared a tentative PCP
5 conceptual model for ecological effects
6 [Figure 1 of Summary Report, EPA
7 (1998)]. The third workshop reviewed
8 that model and each component of the
9 six dimensions and recommended
10 several changes:
11 • Create one inclusive
12 ("generic") conceptual model
13 and create others as appropriate
14 to expand on and highlight
15 specific areas of focus.
16 • Consider changing the
17 emphasis for PCP (but not
18 necessarily PCP's
19 microcontaminants) from the
20 treated wood and disposal
21 sources to wood treatment at
22 the plant and disposal.
23 Participants suggested that
24 treated wood in use as utility
25 poles may not be a major
26 concern because PCP
27 metabolizes rapidly under
28 aerobic conditions and has a
29 short half-life and thus may not
30 migrate far from the pole.
31 • Describe miscellaneous sources
32 (does it mean decks, retaining
33 walls, garden borders?) and
34 whether they are important to
35 the ecology or human health.
36 * Add furans to the dioxin
37 stressor (i.e., dioxins/furans).
38 • Reexamine the pathways and highlight the critical pathways from the top of the
39 model to the bottom.
40 • Add ingestion or food chain as a pathway.
Ecological Conceptual Model Components
Sources
The six primary sources that may release
PCP into the environment are facilities where
PCP is manufactured, facilities where PCP is
used to treat wood, transportation of treated
wood, disposal of treated wood, treated wood
that is in use, and miscellaneous uses
Stressors
The stressors are PCP and its contaminants,
dioxin and hexachlorobenzene
Pathways
The air, soil, and water carry PCP from a
source to the environment
Exposed Populations
Two major categories of exposed populations
are terrestrial and aquatic. Examples of
terrestrial organisms that may be subject to
potential impacts from PCP might include
invertebrates in and on the soil, birds, small
mammals, and plants. Aquatic populations
may be subdivided into freshwater and
marine/estuarine organisms. Representative
aquatic organisms might include
invertebrates, fish, and plants. Fish-eating
birds also might be affected indirectly
Endpoints and Time Frames
The potential impacts may exist for
individual organisms, populations, and entire
ecosystems. Effects on individual organisms
(flora and fauna) may include direct toxicity
of varying time periods (acute, subacute, and
chronic), teratogenic effects, and effects on
reproduction and behavior. Population effects
may occur from lowered survival and
reduced reproduction. Ecosystem effects may
occur due to a decline in species diversity
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-/
1 • Add assessment endpoints and measures so the model can be used to develop
2 practical management goals.
3 OPP/AD agreed to revise their conceptual model for ecological effects based on the group's
4 recommendations and distribute it to workshop participants for comment after the third
5 workshop. The revised conceptual models are presented below along with a narrative
6 description.
7 Human Health
8 The third workshop began developing a conceptual model for human health. Participants
9 concurred that while one generic human health model is needed, it may be easier to
10 construct separate submodels for each stressor or source and then combine them to create
11 one comprehensive model. The participants also recognized that the generic conceptual
12 . models for ecological and human health should be comparable at some levels, such as
13 sources and stressors. When aggregating submodels to create a complete picture, it should
14 be possible to determine which components go together and which can be de-emphasized
15 or eliminated from the assessment.
16 The group agreed with a suggestion to use a materials-flow approach to try to identify potential
17 human exposures to a stressor from a source. The half-life in the environment and
18 potential of the chemical to bioaccumulate were also considered useful in identifying
19 relevant pathways of exposure.
20 The group briefly discussed several sources, such as PCP manufacturing, PCP transportation,
21 treatment of wood at the plant, transportation and handling of treated wood, wood in use,
22 remedial treatment (usually ground-line treatment of utility poles), and transportation and
23 disposal. The group decided to concentrate on one source only—wood treatment—and
24 one stressor—"clean" PCP (i.e., without microcontaminants)—due to the time limitation,
25 and complete a draft submodel for clean PCP (Figure 2 of Summary Report). They then
26 began a conceptual submodel for the dioxins and furans and acknowledged that the
27 Agency' s reassessment of dioxins and furans will affect OPP/AD's assessment.
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1 The participants generally agreed that the
2 sources should be the same for PCP,
3 dioxins/furans, and
4 hexachlorobenzene submodels. They
5 also indicated that the sources for
6 human health should be similar, if not
7 the same, as those identified for the
8 ecological conceptual model.
9
10 Participants concurred on several components
11 for the clean PCP conceptual
12 submodel using wood treatment at the
13 plant as the primary source of PCP
14 exposure to humans (see the sidebar).
15 While developing the PCP submodel, several
16 participants acknowledged the
17 importance of defining the terms used
18 in the models. For instance,
19 participants had to try to clarify
20 definitions for pathway and route and
21 found that ecological and human
22 health risk assessment guidelines use
23 some terms differently. They also
24 acknowledged that in their conceptual
25 models for human health they
26 reversed the order of the dimensions
27 listed in the guidance, putting the
28 stressor before the source.
29 Participants agreed that a clear rationale is
30 needed to explain why a component
31 may be eliminated from a model. For
32 instance, the indirect occupational
33 pathway and non-occupational visitors
34 to the treatment plant probably could
35 be eliminated from the clean PCP
36 submodel because their risks are so
37 minimal. Using professional
38 judgment, they expected that the oral
39 route for the direct occupational
Human Health Conceptual SubModel (PCP)
• Stressor
Clean PCP
• Source
Wood treatment at plant
• Pathways
Occupational, categorized as direct
occupational (mixers, loaders, etc) and
indirect occupational (office workers)
pathways; and non-occupational (e.g.,
neighbors and visitors) pathways
• Exposure Routes
Oral (hand to mouth), dermal, and inhalation.
Dermal and inhalation are the main routes for
the direct occupational pathway while oral
exposure through contamination on the hands
is a minor route. Oral, dermal, and inhalation
are relatively minor for the indirect
occupational pathway. For the non-
occupational pathway, inhalation is probably
more important than oral or dermal routes
• Potential Subpopulations (receptors)
Due to time limitations, participants chose to
focus only on the direct occupational
pathway and selected adults as the most
important subpopulation for this pathway.
They further subdivided adults into males
over age 16, females over age 16, and
pregnant females with fetus. They eventually
eliminated pregnant females because they are
not allowed to work directly with PCP, and
there are no known health endpoints directly
related to pregnant women. Thus, the most
important pathway flowed from direct
occupational exposure through mainly
dermal and inhalation exposure routes to
working-age adult males and females (over
16 years of age)
• Endpoints
Endocrine disruption, neurotoxicity, skin
irritation, cancer, chronic toxicity, and
mutagenicity
• Measures
Thyroid dysfunction as a measure of
72
endocrine disruption; nerve conduction, sleep
disorders, etc as measures of neurotoxicity;
liver tumors as a measure of cancer; and liver
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1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
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27
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29
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31
32
33
34
35
36
37
pathway probably represents a minor risk compared to dermal and inhalation, especially
since oral exposure (hand to mouth) is preceded by dermal exposure. Also, workers may
wear gloves and wash their hands before eating. Adults were selected because younger
people would not be allowed to work at the plant. Since data indicate that clean PCP does
not have reproductive, developmental, or immunological effects, these endpoints probably
could be eliminated from the clean PCP submodel. However, they may be relevant to
PCP's microcontarmnants.
Participants discussed eliminating non-occupational pathways (neighbors as well as visitors) from
the submodel on the basis that if workers are protected then little or no risk can be
expected to reach people in the neighborhoods. However, risk managers pointed out that
actually the neighborhoods might be at greater risk because controls, such as protective
clothing, available for workers are not generally used by residents in the neighborhoods.
Also, OSHA typically allows less stringent risk standards for workers than EPA allows for
residents.
Several participants recognized that while
duration and frequency of exposure are
important variables that influence
endpoints are relevant for ecology and
human health. They are best captured
in the text supporting the models rather
than in the models themselves. Most
participants preferred the terms short-
term and long-term rather than acute
and chronic.
Participants then attempted to identify the
major components of a dioxin/furan
microcontaminant submodel for PCP,
again using the wood treatment plant as
the source (see sidebar and Figure 3,
Summary Report).
Note that the lines drawn on the conceptual model
and the submodels represent only selected
linkages for illustrative purposes. A.
complete conceptual model would require
filling in all appropriate linkages, and the
arrows on the conceptual model ideally
would be drawn in various widths to
Human Health Conceptual Submodel
(Dioxins/Furans)
Stressor
Dioxins/furans
Source
Wood treatment plant
Pathways
Same as clean PCP submodel above
Exposure Routes
Oral, dermal, and inhalation. Participants
chose to follow the direct occupational
pathway and identified dermal as the
principal exposure route
Potential Subpopulations
Adults including males over age 16, females
over age 16, and pregnant females with fetus
Endpoints
Same as clean PCP submodel above but with
the addition of immunological endpoints, and
for pregnant females with fetuses,
reproductive and developmental endpoints.
Dioxins and furans are considered non-
mutagenic
Measures
Not addressed due to time limitations
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1 indicate the strength or importance of each linkage.
2 A complete conceptual model and submodels for PCP would show differing levels of depth and detail
3 that the reader could view as desired. At the most aggregated level, the conceptual model would
4 show only the most important items and linkages. The level of detail would increase with
5 subsequent diagrams. That way, a nonscientific audience could visualize the essence of the
6 problem without getting lost in a highly detailed diagram, and a technical audience could view
7 the more detailed diagrams and locate all plausible linkages and feedback loops.
8 A revised conceptual model for PCP and the contaminants is presented below along with a
9 narrative description. A combined eco/human health conceptual model has not been
10 completed at this time but is under study.
11 Task 4:Formulate the technical approach of the risk assessment
12 Participants in the third workshop outlined a human health risk analysis plan for PCP using
13 instructions provided for the workshop.
14
15 Risk Management/Regulatory Goals
16 • Protect general and susceptible subpopulations
17 • Distinguish between occupational and non-occupational exposure pathways in the
18 context of reassessment for reregistration
19 • Determine who the stakeholders are and when to involve them
20 • Evaluate resource needs
21 * Compile available data
22 • Identify key uncertainties that require the use of default assumptions
23 • Identify possible regulatory and remedial options for mitigating exposure
24 Assessment Endpoints (exposed populations)
25 Who is at risk—occupational and non-occupational populations and subpopulations based on age,
26 gender, and reproductive status (dioxins/furans)
27 Measures of Effect (examples)
28 • Cancer—liver tumor indicators
29 • Liver toxicity—incidence data
30 • Neurotoxicity—nerve conduction/sleep disorders
31 Measures of Exposure (examples)
32 • Pest Handlers Exposure Database (PHED) and chemical-specific data for
33 occupational exposures
34 • No ambient data are available for air and water
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1 • Biomonitoring
2 What Can and Cannot be Done Based on Planning and Scoping
3 Need more analysis (e.g., completed conceptual models and data analysis) before can identify
4 management options
5 Methods for Conducting Risk Analysis
6 • RfD
7 • Margin of exposure
8 • Quantitative risk assessment with probabilities on dose response and exposure
9 parameters
10 • Narrative discussions
11 Data Needs and Uncertainties
12 • Exposure data
13 • Toxicity data
14 Stakeholder Involvement
15 Dr. Lauren Zeise of the California Environmental Protection Agency led participants of the PCP
16 group in the third workshop in applying the lessons from the National Research Council's
17 Understanding Risk: Informing Decisions in a Democratic Society. She posed six questions
IS that risk assessment planners should consider during planning and scoping:
19 • Who are the interested and affected parties (stakeholders)?
20 Participants identified a wide variety of stakeholders: trade associations for manufacturers and
21 users (e.g., American Wood Preservatives Institute AWPI, American Wood Preservatives
22 Association AWPA, Chemical Manufacturer Association CMA); PCP manufacturers,
23 utility companies and others, such as workers (linemen, treatment), Penta Task Force
24 (registrants), NAFTA (Canada as co-regulator, Mexico as affected party), other EPA
25 offices (e.g., ORD, OAR, OW, OSW, OPPT), EPA regional offices, other agencies
26 regarding OSHA issues, public, Congress, and environmental groups such as National
27 Coalition Against Misuse of Pesticides (NCAMP).
28 • What should be deliberated? When?
29 The group indicated that what is deliberated should depend on the stakeholder group. OPP/AD has
30 established regulatory negotiation procedures for deliberating with industry and is
31 considering broadening stakeholder involvement in this process.
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1
2
3 Several participants suggested meeting early with stakeholders to scope the risk assessment and to
4 decide what should and should not be in the assessment. Secondary and tertiary exposures
5 of concern, impact on resources, and data needs to address management options also may
6 be discussed at this time. Intra-Agency deliberations may be required on disposal issues
7 and on contaminant issues, such as dioxin, which EPA's Office of Research and Develop-
8 ment is currently assessing. Most participants agreed that public involvement should be
9 limited to appropriate assessment endpoints and that regulatory negotiations should not be
10 conducted in public forums. However, one person suggested that OPP/AD discuss the
11 entire conceptual model, not just the endpoints with the public.
12 During the intermediate stages of the reassessment process, OPP/AD could distribute a draft of the
13 science chapter of the RED and meet with all stakeholders to make mid-course corrections.
14 OPP/AD usually hold meetings with industry to describe data gaps, the approach to the
15 risk assessment, and assessment endpoints before the draft RED is completed. OPP/AD
16 also hold meetings on the draft RED with NCAMP. A final meeting with various
17 stakeholder groups may be helpful to discuss the findings and avoid surprising anyone.
18 OPP/AD cautioned that when preliminary findings are widely distributed before the risk assess-
19 ment is complete, people may misinterpret EPA's intentions. This occurred when OPP/AD
20 put the preliminary risk assessment for organophosphate (OP) pesticides on the Internet in
21 a pilot program requested by the registrant. On the basis of this preliminary assessment,
22 which raised some health concerns, several OP users stopped buying OP products for fear
23 EPA would soon ban their use.
24 • What approaches might be taken in interacting with stakeholders during
25 deliberation? (Focus groups, etc.)
26 Participants suggested.that meetings would fulfill most needs. However, the Internet could also be
27 used to distribute information to the general public if costs allow. The current practice of
28 involving the public is through EPA's Science Advisory Board and Scientific Advisory
29 Panels. Dozens of meetings generally occur during the long pesticide registration process.
30 Most of them occur only with the registrants, but a few involve the public (e.g., NCAMP).
31 Although OPP/AD has not decided when and how to share information with the public,
32 OPP/AD has no plans to open the reregistration meetings with registrants to the public,
33 mainly due to insufficient resources.
34 • How should participants be selected?
35 Participants acknowledged that some stakeholders, such as workers, environmental groups, and the
36 public, have not been directly involved in the regulatory process for PCP. Participants
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1 recognized that public stakeholders for the PCP risk assessment are difficult to define
2 because there is no specific site to point to.
3 • Should the program enlist outside help in establishing the deliberative process?
4 Since a formal regulatory process is already established, participants questioned the value of
5 outside facilitation and saw no need for it in the development of the RED.
6 * What is the external constraints for deliberation (budget, time, legal)?
7 Participants acknowledged budget, time, and legal constraints as applicable to the pesticide
8 reregistration process.
9 Lessons Learned
10 Participants discussed briefly what they had learned from this case study. Their remarks are
11 summarized below:
12 • Ecological and human health assessment planning can be harmonized conceptually,
13 but a common vocabulary will be needed.
14 • Both top-down and bottom-up approaches to developing conceptual models are
15 useful—there is no wrong method.
16 • Explaining uncertainty to stakeholders is a problem that needs up-front planning.
17 There is a hesitancy to reveal all that is known and not known about chemicals and
18 their risks because it reveals uncertainties that can lead to criticism and political
19 ramifications. Yet, uncertainty is inevitable since some questions will have no
20 answers.
21 • The interplay between risk assessors and risk managers was valuable. For instance,
22 it provided insight into the potential PCP risks to workers versus neighbors.
23 • Planning and scoping for cumulative risk has proven to be very valuable. Risk
24 assessors and risk managers already perform the components of planning and
25 scoping but generally in an unorganized protracted way. Early planning and
26 scoping help organize everyone's thinking and results in a smoother and better
27 quality assessment than is possible without it.
28 • Planning and scoping offers a good opportunity to identify problem scenarios early
29 and the potential risk management options to address them. It also offers an
30 opportunity to determine if data exist to compare management options and to
31 develop contingency plans for potential risks.
32 • There are a lot more questions than answers, which is why an iterative planning and
33 scoping approach involving many different but knowledgeable people are valuable
34 for developing a good conceptual model.
35 • Planning and scoping is not risk assessment.
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1
2
3
4
5
6
7
The utility and the time involved in planning and scoping need to be presented
honestly to risk managers. Purporting that planning and scoping will be quick and
easy is likely to be counterproductive; it is a lot more work than people assume.
However, it ultimately saves time by explicitly organizing an assessment that would
have to be done at least implicitly anyway. Also, documenting the planning and
scoping leads to clearer thinking and greater credibility, and it captures the thinking
for others (stakeholders, risk managers, and next generation risk assessors).
8
9
10
11
DRAFT NARRATIVE FOR THE ECOLOGICAL CONCEPTUAL MODELS FOR
PENTACHLOROPHENOL (PCP) AND ITS CONTAMINANTS
12 Context of Conceptual Model Development
13 The Antimicrobials Division (AD), Office of Pesticide Programs (OPP), U.S. Environmental
14 Protection Agency (USEPA) is in the process of developing the Reregistration Eligibility
15 Decision (RED) documents for the Heavy Duty Wood Preservatives, (HDWP) including
16 Pentachlorophenol (PCP)7. In conjunction with the Science Policy Council's Cumulative
17 Risk Working Group, AD scientists have undertaken the development of conceptual
18 models for PCP. The purpose of conceptual model development is to describe the
19 relationships among predicted responses of a population of concern and its stressors,
20 including the environmental routes of exposure. The conceptual model also describes
21 endpoints of concern and how they will be measured. This approach (of developing
22 . conceptual models) is intended to assist in the process of cumulative risk assessment,
23 cumulative risk being defined as "the potential risks presented by multiple stressors in the
24 aggregate." During model development, key questions are addressed: who is affected or
25 stressed?; what are the stressors?; what are the sources?; what is the time frames for the
7AI1 pesticides sold or distributed in the United States must be registered by EPA, based on scientific
studies showing that they can be used without posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which were first registered before November 1,
1984, be reregistered to ensure that they meet today's more stringent standards. When a pesticide is eligible for
reregistration, EPA explains the basis for its decision in a Reregistration Eligibility Decision (RED) document
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1 risks? ; what are the assessment endpoints? For now, the Agency intends to focus on
2 assessments that integrate risks of adverse human health and ecological effects where
3 possible. A separate conceptual model and narrative for the human health effects of PCP
4 are included and may be integrated in the future with the ecological effects model.
5 Stressors
6 Pentachlorophenol is an organic pesticide which was used in the past for a number of applications.
7 Its use today is limited to the preservation of wood, but it is widely used in the treatment of
8 utility poles and pilings in the United States. During the manufacture of PCP several types
9 of contaminants are formed, specifically dioxins, furans, and hexachlorobenzene.
10 Considerable progress has been made toward the production of "pure" PCP; however,
11 complete removal of contaminants is not economically feasible at this tune. Therefore, for
12 the purposes of assessing cumulative risks associated with PCP, and based on data showing
13 that PCP and its contaminants have different inherent toxicities and chemical
14 characteristics, separate submodels for the dioxin/furan and hexachlorobenzene
15 contaminants were constructed.
16 Although some data are available on these chemicals, we do not have sufficient information to
17 estimate levels of environmental contamination via the leaching of these
18 rmcrocontaminants from treated wood.
19 Sources
20 The group identified five primary sources, related to wood preservation, from which PCP may be
21 released into the environment. These included: facilities where PCP is manufactured;
22 facilities where PCP is used to treat wood, and; the actual treated wood (during
23 transportation, during the in-use period, and after the in-use period [disposal]). They
24 agreed that the actual treated wood (during the in-use period) is the most significant source
25 for environmental exposure. While the other sources were considered valid, there were
26 reasons for not considering them as the focus of the model8. It was felt that a description
Manufacture of PCP, use of PCP in wood treatment, disposal of treated wood and transport all represent potential
sources of environmental exposure. However, treated wood (in-use) was chosen as the focus of these models, for the
following reasons:
* The first three sources {manufacture, treatment, and disposal) fall outside the scope of the Agency's regulatory
authority;
• The last source (transport of treated wood), while considered a source for potential exposure, is insignificant
when compared with actual in-use treated wood.
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1 of a conceptual model using treated wood (in-use) would be representative of a worst-case
2 scenario for environmental exposure to PCP and its contaminants. Treated utility poles and
3 pilings represent the most significant reservoir of treated wood in the United States.
4 Media/Pathways
5 There are three potential environmental pathways by which PCP and its contaminants may travel
6 from the sources to the environment: air, soil, and water. The most important pathways for
7 PCP transport, in regard to potential exposure of terrestrial and aquatic ecosystems, are
8 through soil and water. This is because significant exposure offish and wildlife
9 populations is most likely to occur via ingestion or direct contact with soil and water, as
10 opposed to inhalation.
11 Volatilization and deposition were not considered as significant environmental pathways. There
12 are little or no data to account for the amount or levels of volatilized PCP nor the potential
13 adverse impact it may have on the surrounding environment. Without sufficient data, it is
14 difficult to justify the importance of volatilized PCP.
15 Exposed Populations
16 The model breaks out exposed populations into two major categories, terrestrial and aquatic. As
17 indicated, aquatic populations may also be subdivided into freshwater vs. marine/estuarine,
18 and terrestrial populations into subterrestrial (below ground) vs. terrestrial (above ground).
19 Terrestrial organisms subject to potential impact from PCP exposure might include soil and
20 ground-dwelling invertebrates, birds, reptiles, small mammals, and plants. Representative
21 aquatic organisms could include aquatic invertebrates (such as shellfish and shrimp), fish,
22 amphibians, and aquatic plants. In addition to the organisms subject to direct exposure,
23 other organisms (e.g., fish-eating birds) may be exposed to PCP indirectly (secondary
24 effects).
25 In addition to breaking out the potentially exposed populations, subpopulations, and target
26 organisms, the ecological effects conceptual model illustrates that effects may occur at
27 different levels of organization. That is, exposure to PCP or its contaminants may cause
28 effects at the individual level, the population level, or the ecosystem level.
29 Assessment Endpoints
30 The next area of the ecological effects conceptual model relates to potential impacts or changes in
31 the ecosystem. These assessment endpoints are ecological system attributes that, if
32 changed, would indicate a change in the health of the system. The universe of potential
33 endpoints is large. However, all of them fit under one of the three "levels of organization"
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1 categories: effects on individual organisms, effects on populations, or effects on
2 ecosystems
3 Endpoints identified with the two latter categories are very limited, and include species diversity
4 (at the population level) and effects on the landscape ecology (at the ecosystem level).
5 Endpoints identified on individual organisms are numerous, and include direct toxicity
6 (acute, subacute, and chronic), teratogenic effects, and effects on reproduction,
7 development, and behavior, among others.
8 We have listed all the potential endpoints and measurements that could be explored, however, it
9 should not be implied that as an Agency we test and measure for these effective endpoints.
10 The Agency's current focus is to concentrate on acute and chronic impacts of pesticides on
11 the environment. This exercise provides what the "universe" has to offer and to make one
12 aware of potential areas of concern.
13
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1 Measurement Endpoints
2 There are one or more measures corresponding to each of the endpoints presented in the
3 conceptual models. These measures represent indicators for the endpoints identified above.
4 For example, evidence of behavioral disorders (measure) may indicate adverse impact in
5 the area of neurotoxicity (endpoint). Other measures and their corresponding endpoints
6 include: mortality (for acute toxicity); growth reduction (for chronic toxicity); reduced
7 fecundity or fertility (for reproductive toxicity); and thyroid dysfunctions (for endocrine
8 disruption). These measures were selected because they are relatively reliable indicators of
9 the affected endpoints, and because methods have been developed to assess endpoint
10 impacts using these measures.
11 As discussed above, considerable progress has been made toward the production of "pure" PCP;
12 however, complete removal of contaminants is not economically feasible at this time.
13 Therefore, for the purposes of assessing cumulative risks associated with PCP, and based
14 on data showing that PCP and its contaminants have different inherent toxicities and
15 chemical characteristics, separate submodels for the dioxin/furan and hexachlorobenzene
16 contaminants were constructed. An integrated model with PCP and its contaminants was
17 also developed. These models are presented below.
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i DRAFT NARRATIVE FOR THE HUMAN HEALTH CONCEPTUAL MODELS FOR
2 PENTACHLOROPHENOL (PCP) AND ITS CONTAMINANTS
3 Context of Pentachlorophenol (PCP) Human Health Conceptual Model Development
4 The Antimicrobials Division (AD), Office of Pesticide Programs (OPP), U.S. Environmental
5 Protection Agency (USEPA), is currently developing the Reregistration Eligibility
6 Decision for pentachlorophenol, a heavy-duty wood preservative (HDWP). The purpose of
7 the RED document is to ensure that currently registered uses of pentachlorophenol are
8 supported by adequate science data and risk assessments that reflect current USEPA policy
9 for regulation of pesticide chemicals. In conjunction with the Science Policy Council's
10 Cumulative Risk Working Group, AD scientists have undertaken development of
11 conceptual models for pentachlorophenol. The purpose of conceptual model development
12 is to describe the relationships among predicted responses of a population of concern and
13 its stressors, including the environmental routes of exposure. The conceptual model also
14 describes endpoints of concern and how they will be measured. This approach (of
15 developing conceptual models) is intended to assist in the process of cumulative risk
16 assessment, defined as "the potential risks presented by multiple stressors in aggregate."
17 During model development, key questions are addressed, such as who is affected or
18 stressed (receptors), what are the stressors (physical, chemical, biological or psychological
19 agents), what are the sources, the time frame of the risks, and the assessment endpoints.
20 For now, the Agency intends to focus on separate assessments of adverse human health and
21 ecological effects. A separate conceptual model and narrative for the ecological effects of
22 pentachlorophenol have also been developed by AD. This model may, in the future, be
23 integrated with the ecological conceptual models.
24 Stressors
25 Pentachlorophenol is an organic oil-borne pesticide used in the past for a wide variety of
26 applications (including herbicidal), but which is currently under restricted use status for
27 preservation of wood only. During manufacture of pentachlorophenol, dioxin and furan
28 contaminants as well as hexachlorobenzene are formed as the result of the high
29 temperature chlorination of phenol. Although considerable progress has been made
30 towards reduction of these contaminants within manufactured pentachlorophenol, they
31 cannot be completely eliminated. The wood preservation industry has argued that
32 complete elimination of PCP contaminants would represent a costly option and may
33 present an undue economic burden. However, there are efforts being undertaken to
34 determine if the contaminants can be eliminated completely from manufacture of PCP. At
35 present, because this goal has not been achieved, separate sub-models for the
36 dioxin/furan and hexachlorobenzene contaminants were constructed for purposes of
37 assessing cumulative risk from exposure to pentachlorophenol. A further reason for
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1 developing sub-models for the contaminants of pentachlorophenol was based on the
2 distinct toxicities resulting from exposure to the contaminants as opposed to
3 pentachlorophenol alone. A human health model which integrates the contaminants with
4 pentachlorophenol is anticipated at some point in the future.
5 In order to construct the conceptual model for pentachlorophenol and the contaminants, sources of
6 pentachlorophenol had to be identified. In conjunction with the EPA's Planning and
7 Scoping Working Group, workshops were held to aid in development of these models.
8 Perhaps this could be stated initially for both ecological and health models? Five sources of
9 pentachlorophenol which could result in environmental exposure as related to wood
10 preservation were identified. These sources included manufacture of pentachlorophenol
11 itself; transport of pentachlorophenol to the wood treatment plant; treatment of wood with
12 pentachlorophenol; use of the treated wood; and eventual disposal of the treated wood
13 once its useful life has expired. Manufacture of pentachlorophenol and disposal of
14 pentachlorophenol treated wood were identified as outside the scope of regulation for the
15 Office of Pesticide Programs. These aspects of pentachlorophenol regulation, while
16 recognized as relevant to the cumulative risks from pentachlorophenol exposure, are under
17 the regulatory authority of other offices within EPA,|The use of wood treated with
18 pentachlorophenol does not present a significant source of exposure as most of the
19 pentachlorophenol remains within the treated wood. Further, use sites for treated wood are
20 restricted mainly to utility poles, further lowering the potential for exposure. Thus, the
21 treatment of wood with pentachlorophenol was felt to offer the greatest potential for
22 exposure to this chemical out of all of the identified sources. In the treatment of wood,
23 there are several opportunities for exposure to pentachlorophenol that do not occur from
24 the other sources that are within EPA's regulatory authority. Personnel treating wood with
25 pentachlorophenol will come into contact with the technical material when preparing wood
26 for pressure treatment, and may also contact the chemical when cleaning equipment used
27 for pressure treatment, or when handling freshly treated wood. Persons living within the
28 vicinity of the wood treatment facility or those visiting the facility may also come into
29 contact with pentachlorophenol through dermal or inhalation contact. These types of
30 scenarios do not exist for the other sources of exposure to pentachlorophenol; therefore, in
31 relation to the other sources of exposure, treatment of wood with pentachlorophenol was
32 felt to be one of te most significant sources for exposure. Thus, it was felt that description
33 of a conceptual model using wood treatment (hi a plant and which represents a key
34 exposure pathway) would be representative of the other potential sources of exposure to
35 both pentachlorophenol and the contaminants.
36 The conceptual model for "clean" pentachlorophenol focuses upon the use of pentachlorophenol in
37 the wood preservation process. Within the realm of wood preservation, there are various
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types of treatments that can be performed with PCP. Commercial treatment of lumber,
such as utility poles, usually involves a pressure treatment process in which a quantity of
wood is subjected to treatment with PCP within a long metal cylinder (or retort).
Treatment times can vary based upon the type of wood being treated, but the process is an
enclosed one. After treatment, the treated wood is withdrawn from the retort and then
mechanically placed on a drying pad made of concrete to collect any residual chemical that
may leak from the freshly treated wood. Non-pressure treatment of wood also exists, such
as dipping or extended soaking of wood in open vats. For remedial ground line treatment
of existing utility poles, brushing, swabbing, spraying, bandage wrap, or low pressure
injection techniques are employed. In each case of treatment, appropriate precautions are
specified with regard to the required protective equipment and clothing. However, as can
be seen, the types of treatments just described can result in or provide opportunities for
significant exposure to both PCP and the contaminants.
14 Pathways
15 Pathways for exposure to PCP during treatment of wood can be either occupational (workers
16 within the treatment plant who actually handle treated wood and/or PCP) or non -
17 occupational ( visitors to the plant as well as persons living in proximity to the plant).
18 Within the occupational pathway, direct exposure can occur (such as to workers handling
19 treated wood ) as well as indirect exposure (workers not handling treated wood but who
20 may be exposed to PCP by virtue of their job being.located within the treatment plant, i.e.,
21 administrative workers). Persons living within proximity to the plant as well as visitors to
22 the plant are considered to have an indirect, but not necessarily lower, exposure to PCP,
23 through volatilization of PCP or contamination of soil and water surrounding the treatment
24 plant.
25 Routes of Exposure
26 Dermal and inhalation routes of exposure are considered significant routes for human exposure to
27 PCP in the wood treatment plant setting. Oral exposure through hand-to-mouth transfer
28 can also occur but is not considered as significant in the wood treatment setting. Oral
29 exposure may become more significant for other sources of PCP, such as use of treated
30 lumber in residential settings, especially for infants and children who accidentally ingest
31 soil surrounding treated wood.
32 For occupational pathways, both the dermal and inhalation routes are considered significant, while
33 for non-occupational pathways (visitors and those living in proximity to wood treatment
34 plants), the inhalation route would be most significant as a route of exposure. Within the
35 occupational setting, adults are the only subpopulation of concern, as children under 16 are
36 not expected to be employed in the wood treatment industry. The adult subpopulation
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1
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includes both males over 16 years of age as well as females (pregnant and non -pregnant).
For the non -occupational pathway, both adults and children have the potential for
exposure.
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1 Assessment Endpoints
2 Human health "effects" are equivalent to ecological endpoints. There are several endpoints of
3 concern resulting from exposure to PCP. The conceptual model identified several
4 endpoints of concern, including cancer (represented by liver tumors which have been
5 observed from animal studies of "clean" PCP), chronic toxicity (liver effects),
6 neurotoxcity, endocrine disruption (specifically, disruption of thyroid function), skin
7 irritation, and mutagenicity. For both occupational and non -occupational pathways, all of
8 these endpoints were felt to apply, with emphasis on the endocrine disruption endpoint as
9 applied to pregnant females in both the occupational and non -occupational setting. The
10 developmental and reproductive toxicity of PCP was not listed as an endpoint, as studies
11 have shown that "clean" PCP is not selectively toxic to the developing organism. In
12 contrast, the dioxin/furan contaminants have been shown to have selective toxicity for the
13 developing organism.
14 Measurements of Endpoints
15 For the endpoints of concern, specific measures are used to characterize the relative significance of
16 each endpoint. In contrast to other conceptual models, data for pentachlorophenol was
17 available to define the effect(s) associated with each endpoint of concern. Liver tumors
18 were selected for the endpoint of cancer as it is known that the liver is a target organ of
19 pentachloro-phenol toxicity, and chronic studies have demonstrated the occurrence of liver
20 tumors after administration of pentachlorophenol. Other types of tumorigenic responses
21 are not observed to any significant degree after chronic exposure to pentachlorophenol
22 Liver tumors would also be expected to a part of the sub-model for the contaminants of
23 pentachlorophenol as data for the dioxins/furans and hexachlorobenzene also demonstrate
24 liver carcinogenicity. Several reports from the scientific literature also suggest effects such
25 as nerve conduction abnormalities as well as sleep disorders from exposure to
26 pentachlorophenol either occupationally or experimentally; definitive studies are still
27 necessary in order to better characterize the endpoint of neurotoxicity. Pentachlorophenol
28 is a known disrupter of endocrine function, specifically thyroid homeostasis. Studies have
29 demonstrated a potent effect of pentachlorophenol on decreasing the levels of thyroxine
30 and triiodothyronine. Pentachlorophenol is also a known irritant, and from dermal
31 exposure this measure would be expected to adequately characterize the endpoint of skin
32 irritation. Metabolites of pentachlorophenol, particularly the tetrahydroquinone
33 metabolites have been shown to be potent mutagens, which may also contribute to the
34 carcinogenic response.
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1 Possible next steps:
2 LA composite human health affects model illustrating all the stressors, is anticipated at some
3 point.
4 2. A composite ecological-human health effects model is a long-term goal but requires bridging
5 efforts between the two disciplines prior to its development.
6 3, A more complete analysis plan is appropriate.
7 4. Study of the potential for PCP/contaminants volatilization.
8 5. Application of the planning and scoping paradigm to additional REDs on a wider basis is under
9 study.
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B-2 Chicago Cumulative Risk Initiative-Region V: Case Study
The Situation
The Chicago Cumulative Risk Initiative (CCRI) is a multi-office effort to measure and reduce the
risks posed by cumulative exposure and hazard to residents of the Chicago metropolitan
and northwestern Indiana areas. CCRI was initiated in response to a Toxic Substances
Control Act §21 Citizen's Petition from 11 Chicago-area community advocacy groups. The
petition focused upon the regulatory gap in the Clean Air Act that allowed industrial air
permits to be approved on a site by site (rather than cumulative) basis. The advocacy
groups' purpose in submitting the petition was to convince the Agency to implement
activities that would measure and mitigate the cumulative risks faced by area residents.
CCRI's focus has expanded beyond the limited, sector- and media-specific concerns (e.g.,
incinerator siting) originally expressed in the petition to include information and planned
action on multimedia sources of pollution. CCRI is a multi-phased process. This case study
focuses on the cumulative assessment phase. Implementation of pollution prevention or
other hazard reduction activities is planned as the ultimate outcome.
CCRI is being conducted outside the scope of a traditional regulatory construct and the assessment
phase is both a hazard assessment and mapping exercise designed to provide information
for problem prioritization and better decision-making. Objectives of the two-county
screening study are to: (1) better understand environmental conditions in Cook and Lake
counties by examining the air quality impact of point, area and mobile sources; (2) foster
dialogue with stakeholders; (3) develop a transferable methodology that can be used in
other urban areas; and (4) inform enforcement targeting and pollution prevention
strategies. At the request of the citizens' groups, the project includes a special focus on
children. The project also is a pilot for the Region in the collection and use of a limited
number of environmental health susceptibility indicators (e.g., blood lead, asthma, etc.).
Improved access to and understanding of health data is a regional management objective.
27 Stakeholder Involvement
28 At the third workshop, Dr. Lauren Zeise of the California Environmental Protection Agency was
29 invited to lead a discussion on applying the lessons from the National Research Council's
30 1996 report, Understanding Risk: Informing Decisions in a Democratic Society. In her
31 remarks, she posed six questions that risk assessment planners should consider during
32 planning and scoping:
33 • Who are the "interested and affected parties (stakeholders)?
34 CCRI was initiated in response to a TSCA §21 Citizen's Petition from 11 Chicago-area
35 community advocacy groups, represented by the Chicago Legal Clinic(CLC). To date,
36 stakeholder involvement in the process has been limited to the parties involved in the
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petition process. In addition to these
groups, workshop participants noted
that other stakeholders should be
involved in the process. (See sidebar).
The most conspicuous omission is
representation from permitted facilities
and industries. However, case presenter
Carole Braverman, Region 5, noted that
industry interests were represented by
the City of Chicago's Department of
the Environment, which is very
interested in promoting industrial
development as part of its overall
brownfields strategy.
Stakeholder Considerations
Interested and Affected Parties Currently
Involved
• 11 advocacy groups, represented by
Chicago Legal Clinic (CLC)
• State, County and City governments
•, Chicago Department of Health
• Chicago Department of the Environment
(also represents industry interests)
• EPA Region 5 (Chicago and Indiana
teams, OPPT, OAQPS, OAR, etc.)
• Asthma Coalition
• University of IL School of Public Health
Other Interested and Affected Parties that
Should be Involved
* Permitted facilities and Industries
• Workers and Unions
• Chambers of Commerce
• Residents not represented by 11 advocacy
groups
• Groups representing schools/children
• Commuters and tourists
• What should be deliberated? When?
Because the CCRJ case was initiated in
response to a petition filed by
stakeholders, their involvement in the
process has been a central focus
throughout the process, and workshop
participants agreed that stakeholders
should continue to be involved in
deliberations on an ongoing basis, as
the process unfolds. Braverman explained that the stakeholder groups have been involved
in deliberations regarding the scope of the assessment, data needs and constraints,
"products" to be produced, and project schedule and timing issues.
Deliberations with stakeholders allowed EPA and the interested and affected parties to make a
number of key decisions defining the scope of the proposed assessment:
• Conduct a cumulative rather than comparative analysis
• Focus specifically on children
• Focus on sources rather than receptors
• Concentrate on EPA-regulated sources
• Cover a broad two-county geographic area rather than smaller geographic
subareas
• Limit study to air pathway/medium
• Do not link health effects to causes.
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1 Workshop participants agreed that stakeholders also should be involved in future discussions
2 relating to development of a strategy and action plan based on data findings, peer review,
3 and future involvement of additional stakeholder groups. They also suggested that EPA
4 present to the stakeholder groups the two assessment goals articulated by the workshop
5 group. (See discussion of "Defining the Risk Assessment Purpose" below).
6 • What approaches should be considered (focus groups, etc.)?
7 Region five currently works closely with the Chicago Legal Clinic, as representative of the 11
8 citizens' advocacy groups. The group listed the communications approaches currently used
9 to promote stakeholder involvement and suggested additional approaches, as follows:
10 • Periodic meetings with CLC
11 • Meetings with all 11 individual groups when there is something major to discuss.
12 • CLC Newsletter
13 • Future Web site
14 • Technical training of citizens (through EPA contractor, Argonne National
15 Laboratory)
16 • How should participants be selected?
17 Participants are the TSCA §21 petitioners. EPA solicited involvement by state, county, and local
18 governments. Bring in representation of appropriate permitted facilities and industries,
19 once data are analyzed and affected parties can be identified.
20 • Should the program enlist outside help in establishing the deliberative process?
21 Braverman said Region 5 briefly engaged the services of an outside party to facilitate the
22 deliberative process, but found this did not work well. She pointed out the importance of
23 understanding the difference between a mediator and a facilitator, as the two roles are very
24 different. However, outside help will be enlisted for the external peer review process.
25 • What are the external constraints for deliberation? (Budget, time, legal)
26 Braverman stated that all parties are interested in getting something done in a reasonable amount
27 of time. The deliberative process also is subject to legal and ethical constraints (regarding
28 data sharing). Participants noted that budgetary limitations sometimes can help focus
29 efforts.
30 CCRI was initiated in response to stakeholder concerns, and their involvement has been an integral
31 part of the project from the beginning. Participants in the third workshop acknowledged
32 the importance of stakeholder input and often sought information from the case presenter
33 on stakeholder interests and positions, which they carefully considered and factored into
34 their discussions at numerous points in the planning and scoping dialogue process.
35 Risk Assessment Planning and Scoping Dialogue:
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1 Participants in the three CCRI case study workshops defined the problem, goals, stakeholders,
2 stressors, sources and endpoints, sketched out a conceptual model of the risk assessment,
3 and developed a preliminary analytical plan. The discussion during the three sessions
4 ranged over a broad list of stressors, sources, and endpoints that are beyond the scope of
5 the actual project. The process was an iterative one: While participants in each subsequent
6 workshop considered, revised and refined, and expanded upon the work completed by
7 previous groups, they did. not consider themselves bound to prior decisions.
8 The first workshop group concentrated on identifying the elements of a conceptual model and
9 developed tools to measure effect level and monitor trends over time. The second
10 workshop developed a list of sources, stressors, and endpoints and drafted first-order draft
11 models of human health and ecological risk. By the third workshop, the idea of preparing a
12 conceptual model for ecological risk was discarded because ecological concerns were not
13 raised by petitioners. Participants in the third workshop refined the human health
14 conceptual model and concentrated on the four tasks associated with the planning and
15 scoping dialogue.
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Task one: Define the purpose for performing
the risk assessment
Goals of the CCRI Assessment
Goal 1: To develop the data upon which to
base a strategic plan to improve air quality
in the two-county area by effectively
targeting emission reduction activities.
To develop the data upon which to
develop a strategic plan to improve public
health by effectively targeting intervention
activities.
While the focus of discussion during the first
workshop was on developing the
elements of a conceptual model for
CCRI, participants hi the second and
third workshops spent considerable
time defining the objectives of the
study, in addition to revising and
expanding upon the conceptual model.
They clarified stakeholder and EPA
objectives of the two-county screening study, as follows:
• Better understand environmental conditions in Cook and Lake counties by examining the air
quality impact of point, area, and mobile sources;
• Foster dialogue with stakeholders;
• Develop a transferable methodology that can be used in other urban areas; and
• Inform enforcement targeting and pollution prevention strategies.
The third workshop accepted the stakeholder and EPA objectives articulated by the previous
group, although these did not provide clearly defined risk assessment purposes. After
drafting a conceptual model, the group revisited this issue as a necessary prelude to
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development of a risk assessment technical approach. Participants observed that
stakeholder groups and EPA each had their own set of objectives—some of which seemed
to overlap and others that appeared to conflict—but they had not articulated distinct
common goals upon which to base the
analysis.
EPA/Stakeholder Decisions Regarding
Scope of the Assessment
• Conduct a cumulative rather than
comparative analysis
• Focus specifically on children
• Focus on sources rather than receptors
• Concentrate on EPA-regulated sources
• Use only existing data
• Cover a broad two-county geographic area
rather than smaller geographic subareas.
• Limit study to air pathway/medium.
• Do not tie health effects to causes.
After considerable discussion of EPA and
stakeholder interests and concerns, the
workshop group was able to define two
distinct common goals for the project,
as shown above. The "breakthrough"
occurred when the group recognized
that the real objective of CCRI is
hazard assessment, not cumulative risk
assessment The project does not
involve assessment of "cumulative
risks," but rather "cumulative hazard."
CCRI is not a true risk assessment, but rather a hazard mapping exercise showing the air
quality impact of point, area, and mobile sources (environmental loading) within the two-
county area.
Task two: Define the scope of the risk assessment
Participants at all three workshops discussed some of the six dimensions of the planning and scoping
process:
• Who, what, or where is being affected or stressed?
What are the stressors?
• What are the sources?
• What are the environmental pathways and routes of exposure?
What are the relevant time frames?
• What are the assessment endpoints?
.The first workshop started with sources and identified stressors (ozone, particulates, lead), defined
the media (air, soil, water) and pathways (inhalation, dermal contact, and ingestion), and
identified potential diseases and health impacts (such as eye irritation, asthma, neurological
effects). The second workshop group revised and expanded the list of sources, stressors,
and endpoints drafted by the previous group and drafted first order models of human health
and ecological risk.
The third workshop group used the work of previous groups as a starting point to outline the
elements of a human health conceptual model. At the suggestion of facilitator Don Barnes,
the group decided to develop a broad conceptual model showing multimedia sources of
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1 pollution that goes well beyond the limited, sector- and media-specific concerns (e.g.,
2 incinerator siting) addressed in the §21 petition and beyond the specific goals of the
3 assessment. The inclusive model provides a broad framework that can be used to make
4 judgements about "what's in and what's out" of the risk assessment based on specific goals
5 and to illustrate the rationales for these decisions.
6 Task three: Develop a cumulative risk outline
7 The group slightly revised and expanded upon the dimensions of risk specified in the Guidance to
8 design a conceptual model with eight elements in the following hierarchy:
9 Activity->Sources-*Stressors-*-Pathways->Media->-Route-*Population-«-Health Effects
10 Measures/ Biomarkers (See conceptual model).
11 Activities
12 The group identified several "activity" categories, and then identified related sources of pollution.
13 Activities included: industrial, residential, transportation, commercial, and agricultural.
14 They noted that agriculture was a minor activity in this two-county urban area.
15 Sources
16 Sources included in the conceptual model are incinerators (a focus of the original §21 petition),
17 industries, mobile sources, indoor air, and "background/other," a category that participants
18 defined as inclusive of all other sources of environmental pollution.
19 Stressors
20 Stressors include particulate matter (PM); dioxin; heavy metals; VOCs and benzene; O3
21 Nox and Sox; noise; and odor.
22 Pathways
23 Participants had difficulty agreeing on the definitions for "pathways" and "routes of exposure."
24 They decided to add another dimension, "media," to provide a bridge between the two.
25 Pathways included in the conceptual model are outdoor air, indoor air, water, and soil.
26 Media
27 In the CCRI conceptual model, Stressors travel through pathways to various media, which
28 participants identified as soil, outdoor air, indoor air, water, and fish.
29 Route
30 Routes of exposure from these media to receptors include inhalation (from indoor air, outdoor air,
31 and soil), dermal contact (from water and soil), and ingestion (from soil, water, and fish).
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1 Populations
2 Potentially affected populations were identified as: children, infants, adolescents, adults,
3 pregnant women, elderly, and immuno-compromised populations. At the request of petitioners, the
4 project will focus on children.
5 Health Effects Measures/Biomarkers
6 Petitioners expressed an interest in looking at blood lead levels, asthma, and childhood leukemia
7 as measures of health effects. Participants also identified several other potential
8 measures/biomarkers, including DNA adducts, chronic obstructive pulmonary disease
9 (COPD), and endocrine disrupters residing in adipose tissues. In the conceptual model,
10 these measures are tied to specific populations, but the model does not attempt to address
11 causality, nor are observed effects/biomarkers tied to specific sources or exposures.
12 The group noted that the model cannot connect emissions to effects because exposure is not
13 addressed. This is not problematic because the objective is to enable GIS mapping of
14 emissions.
15 Due to the press of time, workshop participants did not fill in every detail showing linkages
16 between the various levels of the model. They acknowledged the need to show these
17 linkages, but moved on to discuss the risk assessment scope and development of an
18 analytical plan. A complete conceptual model would require filling in all the appropriate
19 linkages, and the arrows on the conceptual model ideally would be drawn in various widths
20 to indicate the strength or importance of each linkage.
21 A complete conceptual model for CCRI would show differing levels of depth and detail that the
22 reader could view as desired, so that at the most aggregated level, the conceptual model
23 would show only the most important items and linkages, and the level of detail would
24 increase with subsequent diagrams. That way, a non-scientist audience could visualize the
25 essence of the problem without getting lost in a highly detailed diagram, and a technical
26 audience would be able to local all the plausible linkages and feedbacks.
27 Case presenter Carole Braverman reviewed a number of decisions outlining the scope of the
28 proposed assessment that were made by consensus in Region 5's deliberations with
29 stakeholders. She noted that Region 5 decided to include information on indoor air as well
30 as outdoor air pathways/media in order to provide risk information "in context." The
31 decision to include indoor air hi the analysis is a source of disagreement and concern
32 among stakeholders.
33 Task 4:Formulate the technical approach of the risk assessment
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In addition to development of a conceptual model, participants in the third workshop were tasked
with preparing an analytical plan that flows from the conceptual model.
Conceptual Model
Most of the time the third group devoted to this task was spent on developing the conceptual
model (see Figure 1). Once the cumulative risk outline was completed (see Task 2)
building the conceptual model proceeded quickly through iterative and free-flowing
discussion among the group. Participants agreed that the conceptual model, once
developed, is extremely valuable—not only for formulating the approach for the
assessment, but as a communications tool to ensure that all participants (within EPA as
well as outside stakeholders) understand the scope of the issues.
Analytical Plan
The conceptual model and the analytical plan are the two products from planning and scoping
process. Together, they provide the basis for risk assessment. The analytical plan provides
the rationale for limiting the scope of the risk assessment, since it is not possible to address
everything in the conceptual model. It is the next level of "filter"—transparent rationale.
This is the place where feasibility and data availability are considered and factored in. The
analytical plan describes the tools to be used, and explains how, and why the analysis will
be conducted in a certain way. It discusses measures, surrogates, and rationale. It should
discuss data limitations and uncertainties.
After drafting a broad and inclusive CCRI conceptual model, workshop participants developed
"functional" conceptual submodels to address each of the overall assessment goals, given
data availability and limitations. They noted that developing a broad-based inclusive model
from which to draw submodels provided a "tool" that Region 5 could use to communicate
risks "in context" to interested and affected parties and to the public at-large. Each
functional submodel is a subset of the broad-based, inclusive CCRI model modified to fit
the scope of the proposed assessment, and each addresses one of the two overall assessment
goals.
Goal 1: To develop the data
upon which to base a
strategic plan to
improve air quality in
the two-county area by
effectively targeting
emission reduction
activities.
"FunctionaT'Conceptual Submodel: Uses CCRI Conceptual
model from"top/down" to focus on source emissions
and to map distribution of pollution in subareas.
Elements: Activity-*Sources-»-Stressors-»>Pathways (Outdoor
and Indoor Air only) -*Media (Outdoor and Indoor Air
only)-^Route (Inhalation only).
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Goal 2: To develop the data
upon -which to develop
a strategic plan to
improve public health
by effectively targeting
intervention activities.
"Functional"Conceptual Submodel: Uses CCRI conceptual
model from "bottom/up" to look at public health issues,
i.e., health effects on various sub-populations, without
tying effects to causes or to specific sources.
Elements: Populations (Children)«-Health Effects Measures/
Biomarkers.
Participants emphasized that the conceptual submodel for Goal 1 focuses on outdoor and indoor
air pathways and the inhalation route—not because other pathways are not important, but
because of the objectives agreed upon by EPA and the stakeholder groups. Similarly, the
conceptual submodel developed to address the public health objective in Goal 2 is limited
to addressing effects on children and infants because stakeholder petitioners asked EPA to
focus on children.
Data Availability and Limitations .,
Case Presenter Carole Braverman discussed the elements of a Region 5 matrix providing an
overview of existing databases, showing data type, year, sectors covered, sources and areas
covered, chemicals covered for the two counties, and comments on each database. The
group used this information to define data sources and outputs and determine the products
that will be produced under the project (See sidebar below).
Data Sources and Outputs
The basic output for the project are GIS maps by neighborhood. Maps will show ambient
concentrations based on monitoring data for Ozone, HAPs, and Criteria Pollutants; and
modeled from EPA's Cumulative Expose Project (CEP). They will show Toxicity
Weighted Emissions, calculated using OPPT toxicity weighting from the Environmental
Indicators Model, as follows:
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For Cancer Endpoints
Amount u x IURi)
where:
i
j
Amount^
IUR,
Data Sources for Emissions
= chemical /
facility./
total emissions of chemical / from facility/
inhalation unit risk for chemical i
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TRI (Toxic Release Inventory)
-includes 121 air toxics
-self-reported and generally estimates
RAPIDS (Regional Air Pollutant Inventory Development System)
- includes HAPS, PBTs, and
Criteria Pollutants
- county level estimates
allocated to census tracts based
on population.
Planned CCRI Project Products
Baseline measures for different
geographical areas.
For Goal 1 (Emissions)
• Ambient Concentrations (monitoring
and modeling
• Toxicity Weighted Emissions
• Emissions of Respiratory Concern
and Lead
• Facility Density
For Goal 2 (Public Health^
• Biomarkers (Blood lead)
• Disease (asthma, COPD, childhood
leukemia)
Data Sources for ToxicitvJ\Leights
•OPPT
-toxicity weights
• CEP Benchmarks
- modeled for 111 air toxics
r
Data sources and outputs for Goal 2 (Public
Health) include:
Health Indicators
- Blood lead
- Hospital admissions
-Asthma
- Chronic obstructive pulmonary disease (COPD)
- Childhood leukemia
Exposure/Susceptibility Indicators
-Age of Housing
- Household Income
- Proportion of children, elderly residents
- Ethnic distributions
- Population changes since 1990 Census
Lessons Learned
• Developing a broad-based inclusive model from which to draw functional submodels provided a
"tool" that Region 5 could use to communicate risks "in context" to interested and affected
parties and to the public at-large.
• The major hurdle in defining the purposes of the assessment was in acknowledging that risk
assessment was not the objective. Once they did so, they were able to define distinct
common goals for the assessment.
* Chicago "Cumulative Risk" Initiative may be a misnomer. The project addresses cumulative
hazard rather than cumulative risk. It does not address risk or exposure to specific groups
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1 nor tie causes to effects. CCRI will not involve a true risk assessment; but rather a hazard
2 • assessment mapping exercise.
3 • The four tasks in the planning and scoping dialogue may not always be accomplished in the
4 order specified in the Guidance. The process is an iterative one. In this case, participants
5 completed the cumulative risk outline and drafted a conceptual model before determining
6 assessment goals. They then developed working models—subsets of the broad and
7 inclusive CCRI conceptual model—to address each.of the assessment goals.
8 B-3. Cumulative Risk Index Analysis (CRIA) Method in Concentrated Animal Feeding Operations
9 (CAFO) In Region VI: Case Study
10 The Situation
11 Concentrated Animal Feeding Operations (CAFOs) are a common and significant concern
12 throughout Region 6. CAFOs are large (often occupying a quarter square mile—significant
13 in terms of watershed areas) and produce enormous quantities of waste discharge into on-
14 site lagoons. These lagoons and associated operations are permitted under the Clean Water
15 Act's National Pollutant Discharge Elimination System (NPDES) and require
16 environmental impact reviews under the National Environmental Policy Act (NEPA).
17 NEPA requires "cumulative" evaluations of the proposed threat. For some watersheds that
18 are not meeting state-prescribed standards, there may be Total Maximum Daily Load
19 analyses and additional restrictions or penalties imposed. General statewide permits under
20 which many CAFOs operate expired in 1998, and Region 6 needs to consider if there is a
21 threshold above which cumulative impacts from CAFOs and other regional sources
22 (agriculture, oil and gas exploration, roads and transportation infrastructures, and domestic
23 waste) may cumulatively exceed the permitted pollution levels. The risk evaluation was
24 requested by Region 6's Compliance Office to meet the NEPA requirement to review
25 waste lagoons for NPDES permits. In addition, there is public concern over the rapid
26 expansion of CAFOs.
27 The cumulative-risk considerations include multi sources (CAFOs and their component operations
28 as well as other regional sources such as agriculture, oil and gas exploration, roads and
29 transportation infrastructures, and domestic waste), multimedia (surface water, ground
30 water, and air), multiple pathways and routes of exposure (drinking water and surface
31 water contamination from microbiological contamination, and odors), scientific disciplines
32 (ecological, human health, social sciences/economics), and statutory overlap (CWA, CAA,
33 NEPA, FQPA, RCRA).
34 There was no method or approach to determine when a watershed reaches a significantly polluted
35 state. Region six developed Cumulative Risk Index Analysis (CRIA), a novel approach
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based upon a mathematical algorithm that established the potential for significant
environmental risk for each CAFO. Cumulative risks are identified through evaluation of:
1) Areas of regulated and unregulated CAFOs; 2) environmental vulnerabilities (e.g.,
ground water depth or soil permeability); and 3) impacts from known CAFO projects
(water quality, vector/odor, wildlife habitats) specific to each water shed subunit.
Watershed Unit Subarea
CRIA = (Total Affected Area -*• Watershed area)<
(scale of 1-4)
Degree of Vulnerability
(scale of 1-5)
Degree of Impact
(scale of 1-5)
CRIA facilitates communication of technical and regulatory data upon which better agency
decisions can be made. The CRIA is designed to better understand the effectiveness and
results of CAFO controls. The tool is not intended to be used alone but in concert with
other environmental program perspectives and data (i.e., endangered species and fish and
wildlife service, state environmental agencies with cultural resources' concerns)
Risk Assessment Planning and Scoping Dialogue:
14 Task one: Define the purpose for performing the risk assessment
15 It is important to recognize the difference between state and federal goals and objectives. States
16 may be more influenced by local economic considerations. However, recent
17 administrations are providing more flexibility to states in deciding regulatory or mitigatory
18 decisions, which adds a new dimension to decision making and cumulative risk
19 considerations.
20 After considerable discussion, the participants in the third workshop stated their risk management
21 objectives for region VI as:
22 1) develop new general permits for CAFOs in the state of Oklahoma
23 2) identify the point where cumulative impacts go beyond the level of the current permit
24 Task two: Define the scove of the risk assessment
25 The participants succeeded in defining management objectives with a geographic dimension and
26 rationale after spending considerable time debating the merits of adopting a broad or
27 narrow geographic scope (the temporal dimension did not arise). Region 6's Case
28 Presenter explained that waste lagoons are generally regulated on the basis of nitrogen/
29 nitrate concentrations, while ignoring phosphate. However, Region 6 (at least) may be
30 leaning toward regulating phosphate instead. There is a tradeoff between avoiding a
31 discharge to the atmosphere (the basis of limiting nitrogen) and avoiding a phosphorous
32 buildup hi the soil. There is also a water quality dimension: phosphate runoff to streams
33 and lakes or percolation of nitrogen to groundwater. How much excess phosphate or
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1 nitrogen might result in human health consequences is not yet known. Also, the total
2 amount of nitrogen being released from all sources (not just CAFOs) is unknown.
3 The Oklahoma panhandle alone may process 4.5 million hogs per year, in addition to ongoing beef
4 ranching, dairy production, and crop production. Virtually all the water comes from the
5 groundwater, and most is used for agriculture (cattle and crops; now hog production).
6 CAFOs use groundwater for irrigation and to dilute hog manure for fertilizing grasslands
7 and rangelands for grazing cattle. The area's natural system was probably a grassland
8 prairie with some riparian vegetation. It is on a major flyway for migratory birds. The
9 natural ecology depends on playa lakes. Concern has been raised that CAFO waste lagoons
10 will send greenhouse gases to the atmosphere, perhaps with far-reaching consequences.
11 These waste lagoons are constructed to be extremely large, so as to avoid the need to plan
12 for future sludge disposal (capacity is judged to be 10-15 years).
13 General NPDES discharge permits are issued statewide. Participants in the third group considered
14 several alternatives to define the geographic scope of the assessment: One was to look at
15 only two counties in the Oklahoma panhandle for permit renewals; another was to consider
16 the nationwide perspective of risks anywhere in the country; a third was to focus locally
17 but identify considerations (almost as "asides") that would apply in other areas. The
18 narrowest perspective would focus on a single CAFO. Region six preferred an assessment
19 to address all five states. The group initially preferred an assessment that .would address
20 nationwide perspective, but recognized that the decision maker may not want to consider
21 issues unrelated to his or her own risk management goal or to expend resources without
22 direct benefit. Ultimately, the group decided to focus the risk assessment on the watersheds
23 affected by CAFOs in a single county in the Oklahoma panhandle as the basis to develop a
24 risk assessment for all CAFOs in Oklahoma.
25 Task three: Develov a cumulative risk outline
26 Participants in the CAFO breakout groups at three workshops spent considerable time discussing
27 the six dimensions of the planning and scoping process.
28 The focus of the workgroup was on: .
29 • Who, what, or where is being affected or stressed?
30 • What are the stressors?
31 • What are the sources?
32 • What are the environmental pathways and routes of exposure?
33 • What are the relevant time frames?
34 • What are the assessment endpoints?
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Region 6's CRIA materials used the term "criteria" within its algorithm to identify components
(see sidebar and Attachment 1). While these criteria were defined for and relevant for the
CRIA model, they are not structured according to
the hierarchy of sources-*-
stressors-»-pathways^-assessment endpoints-*-
measurement endpoints recommended in the
Guidance.
Participants in the third workshop addressed all six
dimensions of the planning and scoping process.
The third group's lists of stressors, pathways, at-
risk components, and endpoints built upon the
progress made by the first two groups, but went
beyond both to a considerable degree. However,
the third group was advised by the facilitator to
ignore "measurement endpoints" (which require
data) and instead consider "at risk components" to
assist in conceptualizing the linkages between
stressors and endpoints so that they would not be
distracted by issues related to data availability.
Stressors
A "stressor" is "any physical, chemical, or biological
change that is affecting a system." The group
recognized that a complete list of stressors must
include those associated with non-CAFO sources
as well as second-order stressors, but due to the
time constraints limited themselves to CAFO-
related stressors.
All three workshop sessions addressed human health and
ecological stressors. Throughout the workshops,
there was considerable discussion on what consti-
tutes a "stressor," and whether stressors should be
aggregated or disaggregated. By the third session,
the facilitator advised the participants that it
depends on the stressor's relationship to regulatory
or pathway considerations. For example, if hog-
nursery barns have the same permit conditions as
CRIA Model "Criteria"
Groundwater probability
Rainfall
Surface water use
Distance to surface water
Population around facility
Other industries/sources
[existence]
Wildlife habitat [proximity]
Soil permeability
Groundwater quality [nitrate/
nitrite]
Economics [Environmental
Justice]
Minorities [Existence and
proximity]
Surface water quantity
Surface water quality
Other CAFOs
Livestock population density
Lagoon loading rate
Treatment system liner
Land application technology
Nitrogen budget
Storage capacity [lagoon]
Wellhead protection
[existence]
Employment
Odor
Transportation
Habitat area affected
Density of CAFOs
Proximity of CAFOs
Phosphorous budget
Endangered and threatened
species
Cultural resources
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1 finishing barns, is it necessary to distinguish the two? Ultimately, participants concluded
2 that they should have the greatest degree of disaggregation that can be handled, and
3 information can be re-aggregated later. "Associated chemical substances" became the
4 aggregated stressor for several specific stressors treated individually by the first two
5 workshops.
6 Sources
7 Region 6's Case Presenter discussed the various operations going on within a CAFO, each
8 contributing its own source of pollution (land application of diluted hog manure over very
9 large areas as fertilizer; hog barns; waste lagoons; truck washing and local transportation).
10 However, the Region considers land application as the primary concern and in the interests
11 of time, the participants discussed the other sources only in passing. Similarly, non-CAFO
12 sources (agriculture, oil and gas exploration, roads and transportation, and domestic waste)
13 were recognized by the Region and workshop participants as contributing to the regional
14 cumulative risk, but time did not permit their consideration.
15 Pathways
16 All three workshops had difficulty with defining "pathways" and "routes of exposure." Some of
17 the confusion stemmed from the different way these terms are used by ecological and
18 human health specialists and some arose from consideration of non-traditional sources
19 ("odor") and endpoints ("property value"). Traditionally, human-health specialists define
20 "inhalation," "ingestion," and "dermal absorption" as the pathways, but these do not apply
21 as well to ecological endpoints. In some cases, sources, pathways, and endpoints became
22 confused ("sediment" can be a source and an endpoint, and "sedimentation" is a stressor).
23 In the end, participants constructively redefined pathways to include concepts of
24 importance.
25 Receptors
26 Participants in the third workshop session opted not to consider "measurement endpoints" because
27 they could not adequately address data availability. As an alternative, the facilitator in the
28 third workshop session suggested that the group consider "at-risk components" to assist in
29 conceptualizing the linkages between stressors and endpoints without being distracted by
30 data availability. Here we will use the term receptors, which is already in wide use for
31 health risk assessments. Receptors are the entities (individuals, populations, species,
32 communities, and ecosystems) exposed to stressors. The participants defined three
33 categories of receptors—human health, ecological, and economic system—for the CAFO
34 risk assessment
35 Endooints
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1 An "assessment endpoint" is a human health or ecological system attribute that, if changed, would
2 indicate a change in the health of that system. Endpoints depend on scale of system as well
3 as societal values. Endpoints should be measurable, but not necessarily directly (they may
4 have surrogate measures). The purpose of endpoints is to focus attention on the effects of
5 stressors on attributes of societal importance (such as an endangered species) or system
6 significance (a keystone species) in the ecological system. Human health "effects" are
7 equivalent to ecological endpoints; ecological "effects" are changes in endpoint conditions.
8 These effects are expressions of risks that need to be managed.
9 Ecological Endpoints
10 Participants considered the ecological systems at risk from the stressors already identified.
11 Participants defined three ecological systems, with specific endpoints for each:
12 (a) Condition of aquatic ecosystem — a generic endpoint because there are no
13 specific components of concern either to stakeholders or to environment.
14 (b) Condition of terrestrial/wetlands ecosystems
15 • Population of migratory birds (area is on the Central
16 Flyway)
17 • Wetland community structure
18 • Rangeland community structure
19 • Habitat mosaic (including fragmentation)
20 (c) Condition of threatened/endangered species: Whooping crane (the only
21 listed species)
22 The group recognized that planners normally would get experts to define system components and
23 functions, but the size and makeup of the groups usually did not permit this in the
24 workshops. Also, groundwater and atmospheric communities are not normally considered
25 "ecosystems" — they are more pathways or avenues of exposure.
26 Human Health and Other Societal Endpoints Related to the receptors
27 The second workshop identified infants, minorities, farm workers, and other residents as human
28 health endpoints. The third workshop's participants listed specific diseases or health affects
29 as "endpoints," but added "societal" endpoints as well. There was some discussion of how
30 some of these endpoints could be measured, but the discussions generally concluded by
31 assuming that some quantification would be possible, without going into details.
32 Task 4:Formulate the technical approach of the risk assessment
33 Participants succeeded in formulating the problem and developing a conceptual model. During the
34 introduction to the third workshop (and in the pre-registration materials), participants were
35 instructed that, in addition to development of a conceptual model, one major product of
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1 their sessions should be the "analytical plan" that flows from the conceptual model.
2 Together, they provide the basis for risk assessment
3 Conceptual Model
4 Most of the time the third group devoted to this task was spent on developing the conceptual
5 model with linkages among the stressors, pathways, at-risk components, and endpoints (see
6 Figure 1). Note that the lines drawn on the conceptual model shown in Figure 1 represent
7 only selected linkages that the workshop groups worked on for illustrative purposes. While
8 the overall conceptual model elements are shown, a complete conceptual model would
9 require filling in all the appropriate linkages, and the model would also be expanded to
10 include other drivers beyond CAFOs. The arrows on the conceptual model ideally would
11 be drawn in various widths to indicate the strength or importance of each linkage. The
12 rationale for the model is described below.
13 A complete conceptual model for CAFOs would show differing levels of depth and detail that the
14 reader could view as desired, so that at the most aggregated level, the conceptual model
15 would show only the most important items and linkages, and the level of detail would
16 increase with subsequent diagrams. That way, a non scientist audience could visualize the
17 essence of the problem without getting lost in a highly detailed diagram, and a technical
18 audience would be able to locate all the plausible linkages and feedbacks.
19
20 Analysis Plan
21 The analysis plan provides the rationale for limiting the scope of the risk assessment, since it is
22 not possible to address everything in the conceptual model. It is the next level of
23 "filter"—transparent rationale. This is the place where feasibility and data availability are
24 considered and factored in. The analysis plan describes the tools to be used, and explains
25 how, and why the analysis will be conducted in a certain way. It discusses measures,
26 surrogates, and rationale. It should discuss data limitations in data and uncertainties.
27 Under NEPA, permit applicants should be required to prepare and submit their own
28 Environmental Impact Analysis (EIA), which requires them to do their own planning and
29 scoping. This may be a significant departure from the way EPA does business, since
30 programs and regions generally do not do EIA/EIS for permits.
31 Stakeholder Involvement
32 Stakeholders include Region 6 program managers and staff (involved with NEPA enforcement,
33 NPDES permits, watershed quality, groundwater, surface water, risk assessors, RCRA,
34 Superfund, and GIS experts), academics, industry (primarily swine production but also
35 beef producers who may have a future stake), state and county regulators, EPA
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1 headquarters (NEPA, agriculture sector), Department of Agriculture's Natural Resource
2 Conservation Service, national and local environmental groups, and community residents.
3 At the third workshop, Dr. Lauren Zeise of the California Environmental Protection Agency was
4 invited to lead a discussion on applying the lessons from the National Research Council's
5 Understanding Risk: Informing Decisions in a Democratic Society. In her remarks, she
6 posed seven questions that risk assessment planners should consider during planning and
7 scoping. Due to limited time, participants concentrated on two of Dr. Zeise's questions, 1)
8 who the stakeholders were and 2) how to engage them. The group recognized the value of
9 stakeholder involvement in the preparation of the conceptual model, and identified several
10 , ideas for expanding stakeholder involvement in process:
11 • Sharing the conceptual model with local residents and stakeholders (may need to
12 engage disadvantaged groups)
13 • Holding scoping meetings with plans and then follow up to the public comments
14 • Providing training opportunities for citizens to follow the project over the long-
15 * term
16 • Developing interactive communications tools based on the conceptual model
17 Lessons Learned
18 • The workshops permitted participants to identify the structure and linkages of all
19 the components in the systems. Participants realized that doing the Conceptual
20 Model was the key to the Guidance.
21 • Participants succeeded in developing a conceptual model which identified specific
22 public health endpoints that are ignored in the Region 6 CRIA. Region 6's case
23 presenter indicated that the Region probably will go back and add them.
24 • Initial public concern with CAFOs was over odor. Ironically, an odor is not
25 considered to be a health risk.
26 • Originally, the workshops focused on ecological risk and new terminology. Debate
27 over terminology and brainstorming sessions were necessary to reach a consensus.
28 • The Cumulative Risk Assessment planning process cannot be prescriptive.
29 • Consideration of "measurement endpoints" during formulation of the conceptual
30 model (before the Analysis Plan) may unduly restrict the model because of
31 concerns over data availability.
32 • EPA needs to overcome a cultural bias within the agency, that risk assessment is an
33 internal function. Stakeholder engagement is essential at the beginning.
34 • The intent of NEPA is to include all stakeholders in the scoping process.
35
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1 Conceptual Model Development
2 The Concentrated Animal Feeding Operations (CAFO) Model represents input and
3 deliberation of three sessions of EPA assessors and analysts. The model was developed to
4 include the major elements of each dimension. The relationships flow from the sources
5 that produce categories of stressors through a set of pathways to affect receptors. The
6 effects are expressed as a series of endpoints for ecological, health or economic system
7 (quality of life) effects. The frame of reference for this model is a watershed in the
8 panhandle of Oklahoma.
9 Sources The CAFO is the primary source of stressors that are considered in this model.
10 Also within the watershed some of the same stressors may be contributed by
11 existing sources which may include: Agriculture (primarily livestock and row
12 crops); oil and gas exploration; roads and vehicular traffic; and domestic waste
13 treatment facilities (both private and public). Existing sources form a background
14 for the type of stressors that the CAFO may add to the watershed. The solid
15 - vertical line has been used to show common linkages between elements within a
16 dimension.
17 Stressors The list of stressors represents some aggregation. Stressors were aggregated with
18 consideration to their pathways and routes of exposure to particular receptors, and
19 common endpoints of concern. The element for nutrients includes phosphate,
20 ammonia, and water soluble nitrogen compounds that may be released from the
21 land application or discharge. Note that the linkage to the air/aerosol pathway is
22 represented by a doited line to indicate the group considered it to be insignificant.
23 Air/aerosols are primarily volatile organic compounds released from lagoons or the
24 barns directly to the air. Associated chemicals include antibiotics, pesticides, and
25 nutritional supplements released from land application or surface water discharge.
26 Erosion and sediments include stressors which are physical particles from land
27 application, infrastructure, and transportation of supplies, animals, and wastes at the
28 CAFO, Habitat alteration includes stressors such as soil compaction, construction
29 of the facility, fragmentation of habitat, and changes in vegetation. Groundwater
30 loss reflects the net consumption of water by the facility. The odor is an obvious
31 public concern along with noise from the facility and traffic to and from the site.
32 Nitrate distinguishes stressors such as nitrite that are special concerns for
33 groundwater. Methane and GHG are stressors associated with the odor that are
34 known to have health consequences as well. They are separated to tract the health
35 endpoint. Pathogens are shown as stressors for surface and ground water pathways.
36 CAFO workers are most likely to be exposed by inhalation and direct contact, but .
37 that is not shown in the conceptual model. Pests, including mosquitoes, rats, and
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flies, may carry disease beyond the facility by a terrestrial route. They also
contribute to the nuisance factor of the facility.
Environmental
Pathways:
Receptors
Assessment
Endpoints
The pathways are key elements of the routes of exposure to the receptors.
The four elements shown aggregate the processes of transport,
transformation, decomposition, accumulation, and transfer which may
occur. The linkages to receptors represent best judgement of the group
about those that most likely significant. Surface water in Oklahoma is
intermittent and generally does not serve as a drinking water supply. The
strongest linkages are to ecological receptors, especially aquatic and wetland
ecosystems. Air/aerosols are linked to human health receptors. The
hypothesized linkage between the stressor nutrients and this pathway would
be linked to all ecological receptors. It is not shown, because it was
considered to be insignificant. Terrestrial/habitat alteration integrates the
principal changes to the structure of the watershed and the habitats it
provides. Presumably, this area is already used for grazing or row crops
and human health is not significantly by this stressor. There is an important
link between the terrestrial and habitat alteration stressors and
socioeconomic receptors.
As discussed with the workshops, receptors are the entities that are exposed
to the stressors. These entities express the effects (endpoints). There are
three groups of elements: ecological; human health and socioeconomic.
The aquatic, terrestrial, and wetland's ecosystems are considered
interrelated and most of the linkages apply to all three. For human health,
infants are a special group because of concern about nitrite in private
drinking water wells and the possibility of methemiglobanemia. The other
elements (sensitive populations, CAFO workers, other off-site residents and
minorities) are likely to have the same linkages.
The elements under this dimension of the model are highly aggregated.
They relate directly to concerns and values that the stakeholders and risk
manager may hold. They may also relate directly to risk management
objectives. In most cases, these are not directly measurable endpoints (also
called measurement endpoints). Again, there are three groups: ecological,
human health, and societal. The ecological endpoints highlight significant
aspects of each ecosystem and the whooping crane as a possible threatened
and endangered species which may occur in these watersheds. Health
endpoints are clustered as three diseases and dermatitis and the special
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concern for methemiglobanemia. This cluster also includes asthma. It is
linked to four receptors. Note that cancer is not among the elements. The
last two clusters are societal endpoints which transcend traditional human
health. In the diagram, three receptors (sensitive populations, other
residents, and minorities) are linked to these clusters. CAFO workers are
excluded because they have an economic interest in the CAFO.
Psychological condition of the surrounding community is an endpoint which
interacts with elements in both clusters. Odor, noise, pathogens, pests and
habitat change are of particular interest for analyzing and ameliorating this
endpoint for a CAFO watershed.
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1 Next Steps:These are activities that Region 6 may consider pursuing in the future in order to apply
2 planning and scoping to their CAFO general permitting program. This framework should
3 complement their own CRIA analysis.
4 The conceptual model:
5 1. Refine the details of the linkages for key stressors (nutrients, air/aerosols, habitat alteration,
6 odor and methane).
7 2. Clarify the problem of habitat fragmentation/alteration for ecological effects.
8 3. Add details for the ecological receptors below the ecosystem level.
9 4. Discuss the interaction and overlap between the human health receptors, add nursing and
10 pregnant women. Reexamine methiglobanemia.
11 5. Look for typical data and measurements to address each endpoint.
12 6. Share and discuss the model with stakeholders.
13 The analysis plan:
14 1. Identify data requirements and sources.
15 2. Set priorities for missing pieces.
16 3. Formulate hypotheses for the linkages within the model.
17 4. Develop a crosswalk with the CRIA and general permit process.
18 5. Establish a generic schedule.
19 Implementation:
20 1. Incorporate planning and scoping into a strategy for dealing with CAFOs.
21 2. Discuss with regional and program managers.
22 3. Share the revised program with other federal agencies and stakeholders.
23 4. Test on specific sites.
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1 5. Evaluate and improve.
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APPENDIX C
CUMULATIVE RISK GUIDANCE
PLANNING AND SCOPING WORKGROUP
AND OTHER KEY PARTICIPANTS
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1 1997 Guidance Workgroup
2 Donald Barnes (OA/SAB)
3 Ed Bender (ORD)
4 Carole Braverman (Region 5)
5 Pat Cirone (Region 10)
6 Penny Fenner-Crisp (OPP)
7 Michael Firestone (OPPTS)
8 Edward Ohaniau (OW)
9 Mary McCarthy-O'Reilly (ORD)
10 Larry Reed (OERR)
11 Joe Reinert (OP)
12 James Rowe (ORD)
13 Bill Wood (ORD)
14 Practicum Organizers and Case Presenters
15 Donald Barnes (OA/SAB)
16 Ed Bender (ORD)
17 Carole Braverman (Region 5)
18 Penny Fenner-Crisp (OPP)
19 Michael Firestone (OPPTS)
20 Mary McCarthy-O'Reilly (ORD)
21 Larry Reed (OERR)
22 Joe Reinert (OP)
23 James Rowe (ORD)
24 Bill Wood (ORD)
25 Vic Serveiss (ORD)- Big Darby
26 Nader Elkassabany, Wanda Jakob, Al Vaughn (OPP)- Pentachlorophenol
27 Carole Braverman, George Bollweg (Reg 5)- Chicago Cumulative Risk Initiative
28 Gerald Carney, Joseph Swick (Region 6) - CRIA for Concentrated Animal Feeding
29 Operations
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1 Council Cumulative Risk Subcommittee
2 Michael Shapiro (OSWER) Co-Chair
3 Penelope Fenner-Crisp (OPP) Co-Chair
4 Steven Galson (OPPTS)
5 Donald Barnes (OA)
6 Sally Shaver, Deirdre Murphy (OAR)
7 Michael Callahan (ORD)
8 William Muszynski, Roland Hemmett (Reg 2)
9 Michael Firestone (OCHP)
10 Peter Grevatt (OSWER)
11 Tudor Davies (OW)
12 Joe Reinert (OP)
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1 Appendix D. Planning and Scoping for the National Air Toxics Assessment
2 Paper under preparation
3
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1 Appendix E. Surface Impoundment Study - Technical Plan for Human Health and
2 Ecological Risk Assessment
Under preparation and Review by OSWER..
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1 Appendix F. Considerations for Integrating Health and Ecological Risk Assessments-
2 References and Status Report
3 Under preparation....
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