Summary Report on
     Cumulative Risk Assessment Practicum No. 2
(Phase I: Planning and Conceptual Model Development)
                   Prepared by:

              Office of Science Policy
         Office of Research and Development
        U.S. Environmental Protection Agency
              Washington, DC 20460

                   June 8, 1999
                     Draft

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                Summary Report on
     Cumulative Risk Assessment Practicum No. 2
(Phase I: Planning and Conceptual Model Development)
                   Prepared by:

              Office of Science Policy
         Office of Research and Development
        U.S. Environmental Protection Agency
              Washington, DC 20460

                   June 8, 1999
                      Draft

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                            Table of Contents
Preface	3

1. Introduction  	5

2. Overview of the Planning and Scoping Process 	5

3. Conceptual Model Development	6
      3.1  Problem formulation	7
      3.2  Societal goals and scientific endpoints 	8
      3.3  Conceptual Model Development	9

4. Hypothetical Case Study  	10

5. Case Studies	14
      5.1    The Chicago Cumulative Risk Initiative 	14
      5.2    Wood Preservative (PCP/HDWP)  	15
      5.3    Cumulative Risk Index Analysis for Concentrated Animal Feeding
            Operations	18
6. Discussion and Next Steps	19

Appendix A. List of Participants	A-l

Appendix B. Practicum Agenda	B-l

Appendix C. Preliminary Case Study Materials  	C-l

Appendix D. Slides from Presentations	D-l

Appendix E. Hypothetical Model Exercise	E-l

Appendix F. Case Study Results from the Break Out Sessions  	F-l

Appendix G. Comments and Suggestions from Participants	G-l

Appendix  H. Draft Conceptual Model	H-l

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                                         Preface
        EPA's practice of risk assessment is evolving from a focus on single pollutants within a
 single medium towards integrated assessments involving suites of pollutants in several media that
 may cause a variety of adverse effects on humans, plants, and animals, and also may have effects
 on the processes and functions of ecological systems.

        In July 1997, Administrator Carol Browner issued the Cumulative Risk Assessment
 Guidance—Phase I Planning and Scoping, which set forth certain fundamental values to guide
 the U.S. Environmental Protection Agency's (EPA's) risk assessment and communication efforts.
 The Guidance 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 Guidance
 placed particular importance on the right-to-know opportunities for citizens and on enabling all
 stakeholders to understand EPA's ongoing risk assessments and become involved in the decision-
 making process.

        The Guidance defines "cumulative risk" as the aggregate ecologic or human health risk
 caused by the accumulation of risk from multiple stressors and pathways. The importance of
 planning and scoping for cumulative risk assessments cannot be over-emphasized. As part of this
 planning, risk assessors and risk managers are encouraged to define the dimensions of the
 assessment, including the characterization of the populations (human and ecological) at risk.
 These include individuals, sensitive subgroups (such as children, the elderly, or critical plant or
 animal species). The Guidance also acknowledges that a broader set of important issues relating
 to societal, economic, behavioral, and psychological stresses may contribute to adverse health
 effects. The present state of data and science do not permit a quantitative assessment of risk that
 encompasses these broader concerns, important though they are.

       The Guidance identifies a set of eight key aspects of the risk assessment that risk
 assessors, risk managers, technical experts, and stakeholders must determine during the planning
 and scoping phase of risk assessment. They are:

 1.      Overall purpose and general scope of the risk assessment;

 2.      Products needed by management for risk decisions;

 3.      Approaches and consideration of the dimensions and technical elements that need to be
       evaluated;

4.      Relationships among potential assessment endpoints and risk management options;

5.      Analysis plan and conceptual model;

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 6.     Resources (data, models, or other technical tools) required and available;

 7.     Identity of those involved and their roles; and

 8.     Schedule to be followed (including timely and adequate internal and external peer
        reviews).

        The "conceptual model" that emerges from the planning and scoping phase of the process
 is a description or diagram of the relationships among predicted responses of a population of
 concern and its stressors, including the environmental routes of exposure. The conceptual model
 also contains an analytical plan that documents how data will be used, how endpoints will be
 measured (directly or in surrogate), and what uncertainties exist.

        The Science Policy Council's (SPC's) Cumulative Risk Working Group1, in order to
 implement the Guidance, was directed to conduct a series of workshops intended to introduce the
 concepts of cumulative risk planning and  scoping throughout the Agency. The workshops, or
 practica,  are designed to offer guidance and training to EPA risk assessors on cumulative risk and
 to bring EPA risk assessors and managers together to exchange information and experience in
 implementing the Guidance. The first workshop was held in Washington, D.C. in July 1998.

        The second practicum was held in Chicago, EL, on November 12-13, 1998, and attracted
 more than 40 EPA, state, and Canadian scientists and risk managers. This practicum featured a
 mix of presentations and facilitated discussions in both large and small group settings. Drs.  Mark
 Harwell and Jack Gentile, both of the University of Miami's Rosentiel School of Marine and
 Atmospheric Science, lectured and facilitated the development of the cumulative risk conceptual
 models through case studies of actual risk assessments going on in the Agency.

        This report summarizes the highlights of this second practicum, including the information
 that was presented and exchanged and key themes that emerged from the discussions, which are
 highlighted  throughout the report. The report is organized following the Practicum agenda.
 Copies of the agenda, the case materials distributed to participants, a roster of attendees and
 conceptual models drafted as a result of the second practicum are included in appendices.
'Donald Barnes (OA/SAB)              Edward Ohanian (OW)
Ed Bender (ORD)                     Larry Reed (OERR)
Carole Braverman (Region 5)            Joe Reinert (OPPT)
Pat Cirone (Region 10)                 James Rowe (ORD)
Penny Fenner-Crisp (ORD)             Jeanette Wilste (ORD)
Michael Firestone (OPPTS)             Bill Wood (ORD)

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 1.  Introduction
 "Planning and Scoping for Cumulative Risk Assessments" occurs before the assessment begins.  It
 sets the stage for the questions that will be addressed through the analysis.

 When asked about their thoughts upon hearing the term "Cumulative Risk Assessment,"
 participants expressed the following ideas:
 -resources
 -integrated risk
 -total environment
 -relationship between risk assessors and risk
 managers
 -single vs multiple chemicals
 -multiple compounds, multiple pathways
 -difficulties in obtaining good data
 -skepticism as to how to get good answers
 -whole ecological system
 -everything but incremental risk
 -spectrum of kinds of assessments needed
 -overall risk
 -multiple risks
 -potential exposure
 -traditional and nontraditional, sources of
 risk
 -inclusive assessment
-complexity, challenges to decision making
-useful to public, how to integrate with site
specific risks
-complex interactions and relationships
-what people want
-uncertainty, unknowns-how to deal with
them
-total exposure-sources; similar
mechanism/mode of action of chemicals
-complex considerations, less than complete
data base but requiring decision; cradle to
grave; expanding scope to include
stakeholders—broad and complex  in nature
-developing systemic  approach
-need framework for scoping and  strategies
to address
2. Overview of the Planning and Scoping Process

       EPA's Guidance on Cumulative Risk Assessment: Phase I-Planning and Scoping draws
on the process and procedures described in the ecological risk assessment guidelines. Planning
and scoping begins with a dialogue between the risk manager and risk assessor to help define the
risk management needs for the assessment. For the long term, EPA's Risk Assessment Forum
(RAF) is developing a framework for cumulative risk assessment guidelines which will discuss
traditional approaches for performing risk assessments.

       This workshop addresses the preparations for the risk assessment, which involves
discussing what to include or exclude from the risk assessment through brainstorming, identifying
participants and contributors, and formulating stressor-response hypotheses. These principles are
applied to both hypothetical and real case studies. Definitions of cumulative risk are developed in
context on a case by case basis.

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       The planning and scoping guidance includes these basic steps: 1) problem formulation
dialogue (risk assessors, risk managers, stakeholders, economists, etc); 2) defining the purpose of
the risk assessment; and 3) developing a conceptual model. The conceptual model is a hypothesis
about the relationship between stressors (biological, chemical or physical promoters of some
effect) and endpoints (receptors). Human health assessors are still trying to determine if this is a
useful process.
 Definition of Cumulative Risk
 1. Who is affected or stressed?
 2. What are the stressors?
 3. What are the sources?
 4. What is the time frame for the
 risk(s)?
 5. What are the assessment
 endpoints?
                                             Questions and Discussion:

                                             Integrated vs Cumulative Risk? In this case,
                                             these terms are almost equivalent. The use of
                                             the term "dimension" in the Guidance may be
                                             confusing. (Some think it refers to spatial
                                             aspect like landscapes).

                                             Should stakeholders be in dialogue with risk
                                             assessors and risk managers? In the model
                                             derived from ecological guidelines, problem
                                             formulation occurs within EPA as a scientific
                                             task. There are internal discussions within
                                             EPA on this point. Some interpret the
                                             ecological guidelines to say this is a scientific
                                             endeavor. We are trying to find that boundary
between the risk assessment and this broader discussion.

       Cumulative risk assessment is neither generic nor consistent across the Agency.  On the
one hand^are site-specific Superfund and RCRA assessments, while, on the other hand, there are
air and water rules which set national standards. We cannot  resolve differences across programs
here.  Those issues will be addressed in cumulative risk guidelines and other projects.

       In the SPC guidance, we are trying to capture needs across the Agency while deferring to
offices for specifics.  The guidance encourages using other sources of help and input. At this time,
cumulative risk planning and scoping is a qualitative process, but it could become quantitative if
we choose to bring data to the discussion.  Planning and scoping provides a broad foundation for
cumulative risk assessment and allows users to develop a reasonable subset of decisions upon
which to move forward. This process provides benefits in many situations. The RAF will address
this issue in the future. It is necessary to break down the problem of cumulative risk into bite-
sized pieces. This process can be exceedingly difficult, but we need to listen to the questions
asked by risk managers and stakeholders and to frame our approach to address those questions.

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 3.  Conceptual Model Development

        Dr. Mark Harwell explained that the risk assessment process has evolved over the past
 twenty years. The basic structure of a risk assessment includes: hazard assessment, exposure
 assessment, and risk characterization as described by the National Research Council (NRC) in
 1983. Ruckelshaus incorporated this paradigm into Agency policy. The Agency also
 distinguished between risk assessment and risk management. Due to concern about risk managers
 "having a on thumb on scale" (Gorsuch era); the Agency kept a "bright line" that separated risk
 assessment from risk management so that risk assessments would not be biased by non-scientific
 factors.  This separation between risk assessment and risk management still is maintained in parts
 of the Agency.

        Since the  1980's, there has been more consideration to entwining risk assessment and risk
 management in documents, including the ecological risk guidelines, cumulative risk guidance, and
 recent National Academy of Science (NAS) recommendations on "Understanding Risk".  The
 Agency also has attempted to rank risks in its 1985 "unfinished business" project, and in the
 Science Advisory Board's (SAB) 1988 "reducing risk" project.  This project recommended that
 EPA elevate  ecological risk in addition to human health.  The process used by the Risk
 Assessment Forum to develop an ecological risk framework (1992, 1997) put together a structure
 to tackle more difficult problems while understanding many uncertainties still exist.

       The "Framework for Eco Risk Assessment" found that the Agency had concerns about
 multiple chemicals.  They said that the "Red Book" paradigm was insufficient to deal with
 ecosystems and the multiplicity of risks, and that EPA needed a more broadly defined paradigm.
 The framework also expanded from a focus on chemicals to stressors (agents of change).
 Stressors are any change leading to ecological effect (physical, chemical, biological stresses).
 Stressors also may include psychological and economic factors.

 3.1  Problem formulation

       The first stage in the process is problem formulation, in which the scope, spatial extent,
 goals, initial ideas on stressors, human activity,  and other issues are discussed. At present, the
 problem formulation phase is more developed for ecological risk assessment, but it has parallels in
 human health risk assessment. In fact, the terms "planning and scoping" and "problem
 formulation" mean much the same thing. A major output of the planning and scoping phase is a
 conceptual model  leading to the analysis phase (qualitative or quantitative in nature), which leads
 to development of an analysis plan. The analysis plan is a scientific planning activity which
 includes sensitivity and uncertainty analyses and conclusions about endpoints for the assessment.
 This type of preliminary thinking and dialogue is essential to promote adaptive management-a
flexible way of making decisions that also deals with uncertainties, which we have found valuable
in dealing with stakeholders.

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Human Health Risk Assessment
Hazard Identification
Exposure Assessment
Ecological Risk Assessment
Selection of end points
Characterization of ecosystems, communities,
and populations potentially at risk
        In ecological risk, any human action can affect an ecosystem. In problem formulation
 (planning and scoping) for ecological risk assessment, we distinguish significant from trivial
 actions (based both on societal concerns and ecological impacts). We define a parsimonious set
 or suite of health changes and identify those that really matter (in terms of Economic or societal
 consequences).  For the risk assessment,  we measure endpoints and surrogate measures. The
 conceptual model is a  graphical representation of these societal drivers, environmental stressors,
 and ecological effects. In planning and scoping for cumulative risks in the human health context,
 we follow the same problem formulation approach for systems at risk from similar stressors.

 3.2 Societal goals and scientific endpoints

        Goals for society are set by society and constrained by science.  The goal must be
 established first (e.g., restore everglades).  Science translates what that means (i.e, ecosystem
 attributes of importance). Endpoints are the bridge between society and science.  Measures are
 chosen as a scientific function to address a technical question. There needs to be a feedback loop
 to ensure that the technical question supports measuring attainment of the goal.  The NRC (1996)
 discussed the feedback loop as an analytic deliberation that is an iterative process.  The basic
 concept of this iterative process is what the Agency is struggling to adopt through the cumulative
 risk guidance. The current EPA Science Advisory Board (SAB) project on integrated risk also is
 working on this problem.

       Dr. Harwell described categories of ecological endpoints, noting that they were different
 for different ecosystems.  These ecological endpoints  increase in complexity from  endangered
 species and population survival to landscape-level endpoints.  A comparable set of endpoints for
 human health should be developed. There also is an interesting  set of interactions between
 ecological and human health concerns (e.g., vectors may have direct relevance to human disease;
 plants producing  cancer drugs). Some of these could be added to the cumulative risk guidance.

       Dr. Harwell presented a comparative ecological risk assessment from Tampa Bay, where
 the Port Authority compared  the potential impacts of a spill of two chemical mixtures (oils). He
 explained the endpoints of concern, critical habitats (including sea grass beds, mud flats, and
 marshes), and systems  at risk, to be assessed. The physical processes in fate and transport models
 for fuel oils were key elements in the study. Toxicity  tests were conducted on principal biota.
Risks were evaluated under scenarios for shipping the oil with selected sets of conditions for
comparing stressors. The audience found that the conceptual model was very helpful for defining
the scenarios and interpreting the data.

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 3.3 Conceptual Model Development

        Dr. Jack Gentile discussed principles and examples for developing conceptual models. A
 conceptual model is a spatially explicit graphical or text description of the candidate causal
 linkages among sources, stressors, receptors and endpoints describing the spectrum of potential
 risks.  He recommended the following steps for developing conceptual models:
   1. Define the goals and assessment context.
   2. Delineate scales and boundaries.
   3. Inventory land uses/activities.
   4. Describe potential stresses and sources.
   5. Identify contaminant release mechanisms.
   6. Describe exposure pathways.
   7. Identify health/ecological endpoints.
   8. Determine specific health/ecological endpoints..
   9. Determine specific health/ecological measures.
   10. Develop a suite of risk hypotheses.
   11. Rank relative importance of potential risks.
       Dr. Gentile also presented a General Conceptual Model Sequence, as follows:

 Societal Drivers=»System stress=>Stress regime/Exposure Pathways=>Disturbance/Stressor Co-
 occurrences with Receptors=»Primary/Secondary Effects=»Health/Ecological
 EndpointsHvIeasurements

       He described several examples to demonstrate some of the principles and methods listed
 above. Highlights are summarized here. (See the appendix for additional information). The first
 example is the Waquoit Bay Conceptual model. Dr. Gentile showed how the sources (drawn
 from human activities) might contribute to exposure. He also discussed how to aggregate kinds
 of stressors (toxics, nutrients, etc.), system stressors toward ecologic effects, and measurement
 assessment endpoints.  He noted that it helps to identify how various stressors affect the
 ecosystem and to prioritize stressors. One must choose how to partition out major stressors and
 determine whether and how are they acting independently or synergistically. For example, are
 major stressors acting cumulatively on an endpoint or across endpoints in interrelationships? He
 also recommended that each pathway be developed independently and then put back together in
 the context of the complete model.  Dr. Gentile showed another example that used an Impact
 Matrix for Green Bay, which involves looking at nutrient loading (stressors) vs impact criteria
 (human health, aesthetics). In this example, major gaps were determined with BPJ.

       Drs. Gentile and Harwell applied these processes to a set of water resource management
problems for South Florida which involved extensive interaction among governments and other
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 stakeholders. Initially, societal goals were developed in order to get stakeholders and scientists to
 discuss both the science of the problem and restoration options. Here, societal goals guided
 science efforts. A Governor's Commission was created, and the commission was effective in
 promoting cooperation between the groups. He described spatial boundaries of the risk
 assessment using ecological criteria, hydrological criteria, and physiological
 transcripts/designations (sawgrass, mangrove estuary,  etc).  (The conceptual model Dr. Gentile
 described is included in Appendix D).

        For the analysis phase for the Biscayne Bay model, hydrology was the major factor. In
 fact, hydrology was found to have impacted all 13 different models used in the study. To confirm
 this, the best relationship was selected, and a holistic model incorporating the  concerns for each
 endpoint was used.

        A member of the audience asked how to establish performance criteria for each stressor.
 Criteria for impact will be different across stressors. He was told that you can rank major
 stressors and dominant effects to be sure they are represented in the conceptual model.

        The discussion also highlighted an example of the development of RI/FS conceptual site
 models being developed for a Superfund site in a western state. The problem  in the example was
 mining waste that was distributed over many miles of a watershed and reservoir system. Mining
 waste was represented by a chemical-physical stressor  model.  Effects were both ecological and
 human health.  The basin was subdivided using geology, hydrology, and ecology into five sub-
 basins, a series of potential watershed segments. For each sub-basin the habitat and contaminant
 levels were graded. Inputs, release mechanisms, affected media, exposure routes, receptors and
 systems, effects, endpoints, and measures were estimated for each sub-basin.  Geography,
 topography and sediment movement were also evaluated for remediation options.  Based on
 contaminant levels, two segments were termed heavily polluted. Biota were characterized
 according to class  1 streams through generalized models.

       The conceptual model was constructed from the preliminary process models and the
 biological models.  Most important pathways were determined from the most likely exposures and
 endpoints of greatest concern. For humans, ingestion offish and inhalation of contaminants in
 domestic water supplies are being scrutinized as major  routes.  The chemical-physical process
 model links the stressors to both ecological concerns and human health concerns. The conceptual
 model also has helped identify key characteristics of remediation approaches.

 4. Hypothetical Case Study

       Dr. Harwell described a hypothetical case involving an industrialized and agricultural
watershed. The scenario (See Appendix E) involves a new hazardous waste incinerator which has
been proposed for this area.  The community was concerned about the cumulative risk associated
with this additional source of air emissions and solid waste. Dr. Harwell led the group through an
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 exercise using the planning and scoping guidance to define cumulative risk for each of the possible
 dimensions, narrow the possibilities to a parsimonious set, and develop a conceptual model.

 The group brainstormed ideas on risk dimensions. These are summarized below:

 o Sources:  Single sources, point sources, non-point sources; multi-sources: combination of those
 above

 o Stressors (by source category):
 - Agriculture—stressors-nutrients, pesticides, sedimentation, particulates
 - Petrochemicals-stressors—toxic organics, criteria air pollutants, toxic inorganics, hydrocarbons
 - Industrial— stressors— ammonia, S02, particulates, metals, temperature, economic =noise,
 odors, cultural, aesthetics, property values
 - Aquaculture  stressors—nutrients, pesticides and drugs, disease/pathogens, exotic species,
 odors, habitat alteration-wetland conversion, levee, hydrologic effects

 Urban Stressors— pesticides, nutrients, toxic organics, toxic inorganics, flooding (physical),
 mobile air emissions, habitat alteration, turbidity, PAHs, pathogens, exotic species,

 Societal: thermal increases, odor, noise, air pollutants, crowding

 Receptors:  (what's at risk?)
 (eco receptors usually talking about populations or higher not single species)
 Aquatic Habitat                           Human
 -fish                                      -women of child-bearing age
 -amphibians                              -worker populations
 -macrophytes                             -respiratorily sensitive
 -water fowl                               -subsistence fishers
 -macro invertebrates                       -swimmers
 -trophic structure (?)

 Endpoints (what should you worry about/minimal set)
 Ecological (aquatic)                       Human Health (go to specific Dose Response level)
 -biodiversity-community                         -cancer (bladder)
 richness, evenness                               -the array in the guidance
 -habitat quality-eco                              - respiratory
 -water quality-eco                               - (may want to go back and do attributable
                                                risk exercise; 4x increase in bladder cancer)
 -economic fish health-pop                        - capture endpoints people care about!!!!
 -critical species loss-pop
 -habitat species/seagrass-pop

-ephemeral wetland loss-landscape


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       It was noted that it is important to look at similarities and dissimilarities of eco and human
risk assessment. For example, .causation is always a problem in human health risk assessment and
this is a factor that differentiates human health from eco risk assessment.

       Dr. Gentile presented a hypothetical case example for cumulative risk which incorporated
both ecological and human risk concerns.  (See Appendix E).  After discussing the case example,
Dr. Gentile reviewed the six basic cumulative risk questions used to flesh out details on sources,
stressors, exposure pathways, single species routes, community/ecosystem routes, receptor
categories at risk, and human health and ecological endpoints that are incorporated into the
conceptual model. Based on the hypothetical case example, a preliminary conceptual model was
sketched out to illustrate the approach that could be taken.

Observations of the group
1.      Include quality of life as an endpoint.
2.      It is not a good idea to present complex models to uneducated stakeholders, but if you get
       them to help you build the model, you can get buy-in. You must get stakeholders
       involved.
3.      Important to work with stakeholders on endpoints of significance.
4.      Different parts of country will accept different levels of risk.
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       SOURCES
                              AGRICULTURE
   URBAN
      STRESSORS*
       ENDPOINTS*
                          FISH POP.
                          (SUSTAINABLE
                AQUACULTURE
                                      PETRO-1NDUSTRIAL
        AIR POLLUTANTS  HABITAT     TURBIDITY
        (S02/N02, PARTI-  I ALTERATION
        CULATES
                                   RESPIRATORY
CANCER
NEUROTOX.
QUALITY OF
   LIFE
        * It is critical to identify what are the mechanisms/causal relationships between stressors and endpoints.
Conceptual Model developed at the Practicum for the Hypothetical case.
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 5.  Case Studies

       On the second day of the workshop, Mark Harwell introduced the EPA case studies.
 They are:  1) the Chicago Cumulative Risk Initiative(CCRI), presented by Carole Braverman
 (Region V); 2) Wood Preservative (PCP/HDWP) , presented by Nader Elkassabany and Wanda
 Jakob (Office of Pesticide Programs): and 3) the Cumulative Risk Index Analysis for
 Concentrated Animal Feeding Operations (CAFO), presented by Gerald Carney (Region VI). The
 three cases represent a spectrum of cumulative risk problems in the broadest sense. They concern
 human health and ecological impacts, and involve place-based and national assessments.  All are
 multimedia and all are presently underway. Also, each has significant stakeholder involvement
 outside the Agency. The case materials for each study are provided in the Appendix.

       Practicum participants were divided into three break out groups to focus on the
 application of planning and scoping guidance for each of these cases.  Each group worked
 separately. Case presenters provided an introduction to the problem and facilitators led each
 group through the guidance.

       Each case study summary below is followed by the break out group's report. Comments
 and suggestions pertaining to each case study are shown in boxes.

 5.1    The Chicago Cumulative Risk Initiative

 The Scenario

       The Chicago Cumulative Risk Initiative (CCRI) is a multi-Office effort to measure and
 reduce the risks posed to residents of the Chicago metropolitan/Northwest Indiana areas by
 cumulative exposure and hazard. CCRI was initiated in response to  a Toxic Substances Control
 Act §21 Citizen's Petition from eleven 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
 §21 Petition to include information and planned action on multi-media sources of pollution. CCRI
 consists of four phases:

Phase I: Generating the environmental loading profile.
                           The Agency will establish  quantities and destination of toxics
                           released into the Chicago-area environment.
                           The Agency will analyze this data to approximate cumulative
                           environmental and human  exposure.
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Phase II:
Phase'
Phase IV:
The Results
               Convening a facilitated workshop to discuss loading profile data, risk assessment,
               and pollution prevention/remediation options.
                            The Agency will work with State/local regulators and community
                            groups (Stakeholders) to create a consensus on data interpretation,
                            calculation of the toxics hazard, and the general approach for
                            "cumulative"risk analysis.

               Performing "cumulative" risk assessment.
                            The Agency will act to develop the consensus procedure (from
                            Phase II) into a scientifically valid methodology for approximating
                            cumulative risk for residents of the Chicago metro area.

               Implementing Pollution Prevention/Remediation activities (e.g., initiating industry
               negotiations, public education campaigns).
                                                      CCRI Evaluation Comments

                                               •  Covered basic elements and the conceptual
                                                  model very effectively.

                                               •  Take environmental justice into account.

                                               •  Stakeholder involvement discussion was
                                                  limited.
        This break out group defined the
 problem, goals, stakeholders, stressors, sources,
 and endpoints, and presented a simplified flow
 diagram/conceptual model for the risk assess-
 ment. Ecological risk was separated from human
 health risk for later discussion. They concluded
 that the cumulative risk conceptual model is
 really a "living document" and should be subject
 to iterative changes and refinement by the stakeholders as the study progresses. The group started
 with sources and identified stressors (ozone, particulates, lead), defined the media (air, soil,
 water) and pathways (inhalation, contact, ingestion), and identified potential diseases and health
 impacts (such as eye irritation, asthma, neurological effects).  They developed similar but separate
 approaches for ecological risks. They developed measurement tools to recognize effect levels and
 monitor trends over time.

        The group reported that they benefitted from having participants who were very familiar
 with the case, the available data, and the risk assessment. Many of the group members felt that
 having a better understanding of environmental conditions in Cook and Lake Counties would help
 future permit decisions and communication with stakeholders. It also would help in framing
 societal goals within the region.

 5.2    Wood Preservative  (PCP/HDWP)

 The Scenario

       Pentachlorophenol (PCP) is used throughout North America as a wood preservative. PCP
is used primarily in the treatment of utility poles, and also is used to treat railroad crossties, wood
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pilings, fenceposts, and commercial/residential decks. PCP is teratogenic, fetotoxic, and
oncogenic, and has been banned from use on all non-wood applications since 1987. It is classified
as a "probable human carcinogen." The risk assessment is driven by PCP's Reregistration
Eligibility Decision Document, which is due in 1999, and will consider FIFRA, FQPA, Clean
Water Act, Clean Air Act, RCRA, and input from the North American Free Trade Agreement
(NAFTA).  Stakeholders include industry and trade associations, environmental groups, and the
public. Unlike the other cases discussed in the workshop, the PCP risk assessment does not
address a particular site-it is nationwide in scope.

       The hazard identification will examine all available data for acute toxicity, developmental
effects, chronic effects, carcinogenicity, and endocrine effects. Epidemiological studies and
pesticide incident data will be used as available. PCP is highly toxic to fish (acute and chronic),
moderately toxic to birds in acute oral doses, but is virtually nontoxic to birds in dietary doses.
Human exposure scenarios include occupational exposure (wood treatment workers; construction
workers). Primary pathways are dermal absorption, inhalation of treated dust and aerosol, and
ingestion (indirectly, from contaminated hands). Environmental exposure pathways under
consideration include emissions from utility poles and other treated lumber via air, soil, and water
routes. Uncertainties and remaining issues include the statutory overlaps, disposal of treated/
contaminated wood after service, limited emissions data, and a focus on individual risk.

The Results

       The group began with a presentation on highlights of the regulatory history, chemistry,
usage, hazard identification and human and  environmental exposure concerns, including the issue
of microcontaminants..  The group agreed to a process that involved identification of sources,
stressors, pathways and endpoints for a conceptual model, primarily focused on PCP and
microcontaminants.  A previous ranking exercise on human and environmental sources and
pathways, which was completed at the last practicum, was the basis for ranking the degree of
exposure (low, medium or high). The ranking relied on professional judgement.
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HUMAN
Occupational
Accidental (L)*
Occupational (H)*
Occupational (L)
Occupational (RCRA)
Children (L) (?)
(L)
(L)
Residential Occupational
(L)
ECOLOGICAL
Aquatic
Spill
Aquatic (L)
Soil (L)
Aquatic (H)
SOURCES
Manufacturing
Transport [of chemicals and logs]
Wood Preservative Facility
Utility Poles [localized]
Disposal of Treated Poles [consumer misuse]
i
1 Residential Uses (e.g., decks)
Soil (L) ! Fences
Aquatic
Soil/Water (H)
(L)
Pilings, Piers, Docks
Remedial Ground line Treatment
Farm buildings/Industrial buildings
*L=Low, H=High
                        Human Pathways/Routes of Exposure
SOURCE
Manufacturing
Transportation
Wood Preservative Facility
Utility Poles
Disposal of Treated Poles
Residential Uses/ subpopulation-children
Fences
Pilings, Piers, Docks
Remedial Ground line treatment
a. Occupational
b. Residential
Farm Buildings/Industrial Buildings
DERMAL
High

High
Low
Low (RCRA Issue)
Medium - children
Low
Low (N/A)

Low
High
Low
INHALATION
Low

Medium
Low
Low
Low
Low
Low

Low
Low
Low
INGESTION
Low

Low
Low
Low
Medium
Low
Low

Low
High
Low
                                       17

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        The group used a broad pathway design with major sources at top, followed by stressor
 sources, pathways and major habitats impacted (a Biscayne Bay model). Major habitats of
 concern were evaluated and a table of receptor habitats and endpoints affected by PCP and
 dioxins/furans was developed.  For example, for soils: earthworms, microbes and invertebrates
 were highlighted as potentially  affected endpoints.  The group also attempted to construct a
 rough conceptual model.  (Detailed notes from the breakout group are included in Appendix F).

        As follow-up to its discussion, the group developed an example of a draft human health
 PCP conceptual model. (See Appendix H).  Participants emphasized that the final conceptual
 model should be accompanied by a detailed narrative that describes the thought process and basis
 for the conceptual model  design.

 5.3  Cumulative Risk Index Analysis for Concentrated Animal Feeding Operations

 The Scenario

        Concentrated Animal Feed Operations (CAFOs) are a common and significant concern
 throughout Region 6. CAFOs are large (significantly so in terms of watershed areas) and produce
 enormous quantities of waste discharge into on-site lagoons. These lagoons and associated
 operations are permitted under  the Clean Water Act's National Pollutant Discharge Elimination
 System (NPDES) and require environmental impact reviews under the National Environmental
 Policy Act (NEPA). NEPA requires "cumulative" evaluations of the proposed threat. For some
 watersheds which are not meeting state-prescribed  standards, there may be Total Maximum Daily
 Load analyses and additional restrictions or penalties imposed. There is also public concern over
 the rapid expansion of CAFOs.  EPA needs to determine when a watershed reaches a significantly
 polluted or impacted state, but there currently is no method or approach for doing so. The risk
 evaluation was requested by Region 6's Enforcement Office due to the NEPA requirement
 inherent in the NPDES review for waste lagoons.

        Stakeholders include Region 6 program managers and staff (involved with NEPA
 enforcement, NPDES permits, watershed quality, groundwater,  surface water, risk assessors,
 RCRA, Superfund, and GIS experts), academics, industry (primarily swine production),  state
 regulators, EPA headquarters (NEPA, agriculture center), Department of Agriculture's Natural
 Resource Conservation Service, environmental groups, and residents.

       The cumulative/multimedia aspect to CAFOs include surface water contamination
 (ecological and human health), drinking water contamination from surface water and
 groundwater, microbiological/pathogen hazards from wastes, statutory overlap (CWA, CAA,
 NEPA, FQPA, RCRA), and multiple pathways and routes of exposure. In addition to the concern
 from waste lagoons, there is a significant public concern with odors.

       Region 6 developed a new approach based upon a mathematical algorithm that established
the potential for significant environmental risk (CRIA) for each CAFO.
                                          18

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                   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)
 The Results

        The case-study break out group developed lists for each dimension in the Cumulative Risk
 Guidance. They also developed separate lists for assessment and measurement endpoints. The
 initial discussions clarified the terms "stressor" and the "sources of stress" from a concentrated
 animal feeding operation. Several members of the group indicated that, in the states in which they
 worked, feedlots and suburban development were in direct conflict. One participant noted that
 feedlots were on the ballot of twenty states in recent elections.
                                                        CRI Evaluation Comments

                                                   CRIA approach to screening was very useful.

                                                   Helpful ideas for risk managers.  Needed
                                                   more time to explore the model and linkages.

                                                   Slow starting, but valuable. Need to clarify
                                                   dimensions and process for building the
                                                   models.

                                                   Although skeptical at first about the topic of
                                                   animal feedlots, it was an interesting and
                                                   important issue.
       The group identified several issues that
were unusual to this case study. For example,
the primary human concerns concerned quality
of life impacts (in terms of odor and nuisance)
from the facilities rather than health effects.
They also noted that cumulative effects from
multiple facilities within the same watershed also j
could be examined.  The group did not reach
agreement on how to develop a preliminary
conceptual model. They concluded, however,
that Region 6's CCRI tool appeared to be
valuable for screening site-specific decisions,
such as facility siting.

6. Discussion and Next Steps
 Meeting in plenary session, Practicum participants raised several issues and made several
 suggestions about how to improve Agency efforts for planning and scoping for cumulative risk
 assessment, and about future workshops on the subject, including the following:

 1.     Take things a step further in next practicum; Develop a framework for Cumulative Risk
       Assessment.
2.     Value in taking conceptual model further in development (more detail, reality check in
       process).
3.     Clarify the scope in terms of spatial extent of the problem to be addressed.
4.     I am optimistic after working through diagrams, at least possibility for future; need to
       identify important threats and problems with a transition away from programmatic to
       multi-media risk assessments.
5.     It is normal that we do not have a complete database. We need a method to zero in the
       most important decisions/risk.
                                            19

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Participants made several comments and raised a series of closing questions, including the
following:

- When and how should we engage stakeholders?
- Cumulative risk assessment should be used beforehand to organize thoughts and present to
public, get feedback from public and then revising conceptual model
- Endpoints will be highlighted by stakeholders
- Includes exposure, habits, activity patterns
- Stakeholder meetings should be held to introduce them to conceptual model approach; trade-
offs will be forced by such meetings; need to involve at some point; prioritize issues.
                                           20

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                        Appendix A. List of Participants
          Cumulative Risk Practicum Participants
               Chicago - November 12-13,1998
Elmer W. Akin
EPA/Region 4 (AFC-EPA/WD)
61 Forsyth Street, SW
Atlanta, GA 30303
(404) 562-8634

Edward Bender
EPA/ORD (8103R)
401 M Street, SW
Washington, DC 20460
(202) 564-6483

Carol Braverman
EPA/Region 5
77 West Jackson Blvd.
Chicago, IL 60604
(312)886-2910

John Connell
EPA/Region 5 (DT-J)
77 West Jackson Blvd.
Chicago, IL 60604
(312)886-6832

Arunas K. Draugelis
EPA/Region 5 (SR-6J)
77 West Jackson Blvd.
Chicago, IL 60604
(312) 353-1420

Priscilla Fonseca
EPA/Region 5 (OT-8J)
77 West Jackson Blvd.
Chicago, IL 60604
(312) 886-1334
Mike Beedle
EPA/Region 5 (DE-9J)
77 West Jackson Blvd.
Chicago, IL 60604
(312)353-7922

David Belluck
MPCA
520 Lafayette Road
Saint Paul, MN 55906
(612) 296-7874

Lisa Capron
EPA/Region 5 (DE-9J)
77 West Jackson Blvd.
Chicago, IL 60604
(312)886-0878

Harriet Croke
EPA/Region 5 (DRP-8J)
77 West Jackson Blvd.
Chicago, IL 60604
(312)353-4789

William Enriquez
EPA/Region 5 (DW-8J)
77 West Jackson Blvd.
Chicago, IL 60604
(312)886-1484

Jack Gentile
Center for Marine & Environmental
Analyses Rosenstiel School of Marine
and Atmospheric Science
University of Miami
4600 Rickenbacker Causeway
Miami, FL 33149-1098 USA
                                    A-l

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Mark Harwell
Center for Marine & Environmental
Analyses Rosenstiel School of Marine
and Atmospheric Science
University of Miami
4600 Rickenbacker Causeway
Miami, FL 33149-1098 USA

Margaret L. Jones
EPA/Region 5 (DT-8J)
77 West Jackson Blvd.
Chicago, IL 60604
(312)353-5790
Brenda Jones
EPA/Region 5 (SR-6J)
77 West Jackson Blvd.
Chicago, IL 60604
(312)886-7188
Lawrence Lehrman
EP A/Regie® 5 (MG-9 J)
77 West Jackson Blvd.
Chicago, IL 60604
(312)886-0836
Karen McCullagh
(PMRA)
Room E-735
Sir Charles Tupper Blvd.
2250 Riverside Drive, A.L. 6607E
Ottawa, Ontario, Canada Kl AOK9

William L. MacDowell
EPA/Region 5 (AE-17J)
77 West Jackson Blvd.
Chicago, IL 60604
(312)886-6798

Mario Mangino
EPA/Region 5 (DRP-8J)
77 West Jackson Blvd.
Chicago, IL 60604
(312)886-2589
Caje Rodrigues
(PMRA)
Room E-735
Sir Charles Tupper Blvd.
2250 Riverside Drive, A.L. 6607E
Ottawa, Ontario, Canada Kl AOK9

Marvin Hora
MPCA
520 Lafayette Road
Saint Paul, MN 55155
(931)296-7201

Chuck Maurice
EPA/Region 5 (DW-8J)
77 West Jackson Blvd.
Chicago, IL 60604
(312)886-6635
                                      A-2

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Daniel Mazur
EPA/Region 5 (DW-8J)
77 West Jackson Blvd.
Chicago, IL 60604
(312)353-7997

Patricia Morris
EPA/Region 5 (AR-18J)
77 West Jackson Blvd.
Chicago, IL 60604
(312)353-8656

Colleen Olsberg
EPA/Region 5 (DRP-8J)
77 West Jackson Blvd.
Chicago, IL 60604
(312)353-46-86

Amy Pelka
EPA/Region 5 (B-19J)
77 West Jackson Blvd.
Chicago, IL 60604
(312) 886-9858

Joseph C. Reinert
EPA/OPP (2129)
401 M Street, SW
Washington, DC 20460
(202)260-0512

James Rowe
EPA/ORD (8103R)
401 M Street, SW
Washington, DC 20460
(202) 564-6488

Meagan Smith
EPA/Region 5 (DW-8J)
77 West Jackson Blvd.
Chicago, IL 60604
(312)886-4446
Rosita Clarke-Moreno
EPA/Region 5 (SR-6J)
77 West Jackson Blvd.
Chicago, IL 60604
(312)886-7251

Amy Mysz
EPA/Region 5 (DRP-8J)
77 West Jackson Blvd.
Chicago, IL 60604-  •'
(312)886-0224

Michele Palmer
Department HHHS (ORHA)
105 W.Adams, 17th Floor
Chicago, IL 60604
(312)353-7800

Larry Reed
EPA/OERR(5201G)
401 M Street, SW
Washington, DC 20460
(703) 603-8960

George Bollweg
EPA/Region 5 (DW-8J)
77 West Jackson, Blvd.
Chicago, IL 60604
(312)353-5598

Margaret Sieffert
EPA/Region 5 (AE-17J)
77 West Jackson Blvd.
Chicago, IL 60604
(312)353-1151

Mary Beth Smuts
EPA/Region 1 (CPT)
JFK Federal Building
Boston, MA 02203
(617)565-3232
                                      A-3

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Maryann Suero
EPA/Region 5 (AR-18J)
77 West Jackson Blvd.
Chicago, IL 60604
(312)886-9077
Bilue Thomas
EPA/Region 2 (DEPP/MPB)
290 Broadway
New York, NY 10007
(212) 637-3768
Winona Victery
EPA/Region 9 (PMD-1)
75 Hawthorne Street
San Francisco, CA 94105
(415)744-0121

Amary White
EPA/Region 5 (T-13J)
77 West Jackson Blvd.
Chicago, IL 60604
(312)353-5878

Lucy Stanfield
EPA/Region V(B-19J)
77 West Jackson Blvd.
Chicago, IL 60604
(312)353-3440
Alan Walts
EPA/Region 5 (C-14J)
77 West Jackson Blvd.
Chicago, IL 60604
(312)353-8894

Howard Zar
EPA/Region 5 (B-19)
77 West Jackson Blvd.
Chicago, IL 60604
(312)886-1491
                                      A-4

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                           Appendix B. Practicum Agenda

                          Cumulative Risk Assessment Workshop
                    (Phase I: Planning and Conceptual Model Development)
                                 November 12-13, 1998
                                       Chicago, 111.
                                       Room 328
                                 77 West Jackson Boulevard

                                       Agenda

Purpose: Demonstrate the use of the Cumulative Risk Assessment Guidance (Planning and
Scoping) process and the Ecological Risk Assessment Guidelines principles for developing
cumulative risks from multiple sources over a range of spatial scales. Illustrate the feasibility of
the planning and problem formulation phases for identifying critical issues such as public values
and perceptions, defining sources of stress and potential assessment endpoints and indicators and
finally demonstrating the utility and value of conceptual models in the assessment and decision
making process.

November 12.1998

8:00         Registration

8:30         Welcome - David Ullrich, Regional Administrator (Acting)

             Introduction of the Cumulative Risk Assessment
             Theme - Ed Bender

                    - Participant introductions and expectations

                    - Highlights of the Cumulative Risk Assessment Guidance

9:30         Overview of Scoping/Planning Process     - Mark Harwell
             Conceptual Model Development    - Jack Gentile

             Broad overview of the risk planning process and experience of the outside
             experts. Include each step through the conceptual model.  The model presentation
             will highlight the principles and process for developing conceptual models,
             employ examples to illustrate the diversity of models, and discuss how conceptual
             models could  be used to engage  decision makers and stakeholders. Cumulative
             Risk Guidance and Ecological Risk Guidelines will also be compared.
                                         B-l

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 12:00-1:15    Lunch

 1:15          Introduction of Hypothetical Case Study and Practicum - Mark Harwell

              A single case study will be used to give participants an opportunity to apply the
              planning and scoping guidance and actually develop a conceptual model. The
              hypothetical case study reflects both non-chemical and chemical categories of
              stressors as well as both ecological and health concerns. Step through each part of
              the planning and scoping and problem formulation process."

 4:15          Recap

 4:30          Adjourn

 November 13.1998

 8:00-8:30     Introduction to EPA Case Studies and Instructions to Work
              Groups - Mark Harwell

 8:30          Adjourn to work groups
              Case Study Presentation (Leaders)
              Work groups will develop planning and scoping and develop
              conceptual models

              Case Study 1
              Chicago Cumulative Risk Initiative - Carole Braverman

              Case Study 2
              Wood Preservative (Pentachlorophenol) - Nader Elkassabany, Wanda     Jakob

              Case Study 3
              Cumulative Risk Index Analysis (CAFOs) - Gerald Carney

 12:00-1:15    Lunch

 1:15          Continue work in break outs

3:00          Report Out, Discussion and Next Steps - Ed Bender

4:00          Adjourn            (Debrief with Case Presenters)

                                          B-2

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Appendix C. Preliminary Case Study Materials
                   C-l

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     Cumulative Risk Assessment Practicum
               Case Study Draft
        Cumulative Risk Index Analysis
(Swine Concentrated Animal Feeding Operations)
                  Region VI
                                   Prepared for Practicum
                                   November 12-13, 1998

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CUMULATIVE  RISK INDEX ANALYSIS (CRIA)

 (Swine Concentrated Animal  Feeding Operations)
Introduction

Regulated, concentrated Animal  Feeding Operations  (CAFOs) are open
lots or  facilities  where  animals  have, been, are, or will be
stabled  or confined and fed or maintained for a total of at least
45 days  in any 12-month period, and the animal confinement areas
do not sustain crops,  vegetation,  forage growth, or post-harvest
residues in the normal growing season  (U.S.. EPA. 1997a, 40 CFR
122.23[b]).

Animal waste from these facilities can potentially contaminate
ground water,  surface  soils and water, and air.  Contamination
includes nitrogen and  phosphorus  compounds, organic, amines, fats,
and" sulf ides.   Environmental concerns include ecological, human
health,  and socio-economic  issues {i.e., eutrophication,
biological oxygen demand, E. coli, Pfisteria pisicida, and other
microbial contaminants, carbon dioxide, ammonia, and -nitrogen
oxide releases,  toxic  and nuisance odors, fish kills, nitrate
drinking water contamination,  particulate matter from trucking
operations,  and other  impacts). Region 6 has developed a
watershed based geographic  information system / cumulative risk
screening methodology  to  assist EPA regulators in environmental
assessment and permitting of CAFO facilities through the National
Environmental  Policy Act  (NEPA) and the Clean Water Act  (CWA) ..
The environmental assessment tool or CRIA  (Cumulative Risk Index
Analysis)  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  the Fish and Wildlife Service,
state environmental agencies with cultural resources concerns).
The analysis identifies thirty-four  (34) assessment parameters.
The CRIA considers  environmental  vulnerabilities and potential
effects  of individual  CAFO  projects by watershed subunits.  These
subunits.are called Hydrologic Unit Codes or HUCs.  A watershed
subunit  is created  by  merging  watershed area data and state
stream segment  information.  The  HUC becomes the methodology's
base analytical  unit.

The scope  or base area of analysis could be an entire $t*fe  •

-------
 few selected counties,  a circle drawn around the project site,  or
 a.watershed. 'The CRIA methodology does  not  just list various
 risk concerns for projects  but, applies  a  ranking criterion to
 each of the 34 environmental and  industry  operation concerns.
 This effectively rates the  parameters from desirable to less
 desirable compelling EPA regulators,  industry,  and others
 concerned with CAPO siting  and operations  to communicate
 regarding the industries potential impact  within a given
 watershed or larger drainage area.  The  watershed level of
 analysis is reasonable (ecologically  based and  not so
 geographically large that cause, and effect relationships among
 criteria are lost).   The level of analysis is also  consistent.
 Watersheds are a common denominator for  other programs,  agencies,
 the public.   A systematic CIS analysis sums  the % areas of
 projects within 11-digit HUCs and scores, the projects on a-. 1-5
 scale .based on a number of  location specific "vulnerability"
 criteria and industry imposed "impact"'criteria.  A list of the
 34 criteria is provided in  Table 1.   Specific 1-5 rankings are
 provided in Appendix A (the CRIA methodology is also found on the
 web at  http//www. epa.gov/xp/earthlr6/enxp4a. htm) .   Region 6 is
 currently using the  CRIA in NEPA for  evaluation of swine CAFOs in
 western Oklahoma.  The  CRIA results are  documented into a NEPA
 Statement of Findings for the Pig Improvement Company (U.S.EPA,
 i997b)  and an Environmental Assessment (EA) for  Vail,  Inc.  (U.S.
 EPA,  1998) .  Region  6  hav£ used CRIA results  to  communicate
 regulatory concerns,  consistently compare  CAFO  operations,  secure
 remediation agreements,  and gain assistance  from industry to
 conduct basic ecological research around CAFOs.   The research
 field tested the accuracy of CRIA evaluations for odor and
 wildlife ecology (U.S.EPA,  1997),  Region 6 has  performed CRIA
 analyses for over fifty swine CAFOs.  The Region plans to expand
 the methodology to cattle,  chicken, and  other animal agriculture
 operations throughout Texas, Oklahoma, Louisiana,  Arkansas,  and
 New Mexico.

 CRIA Methodology         :

 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;  and 3)  impacts  from known CAFO projects (water quality,
 vector/odor,  wildlife habitat)  specific  to each watershed
 subunit.   Table  l lists  these criteria for cumulative risk
 consideration.

 Cumulative risk  criteria  are summed using  a  mathematical
 algorithm.   Key  components  of the algorithm  are Area of known
 CAFO projects  (AI), Area  of the Watershed  Subunit (AWS), Degree
of Vulnerability (DV),  and  Degree of  Impact  (DI).

The CRIA  algorithm is as  follows:

      CRIA   =   ISA /  AWS]   (pv) (j>r)

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 where :
            f

      CRIA  =   Potential  for  significant  environmental risk

       A    =   Area  of  known  CAFO projects

       AWS  =   Area .of  watershed  subunit

       DV   =   Degree of  Vulnerability for  subunit  (e.g.,  ground
           water depth,  rainfall,  soil permeability,  populated
           areas) .

       DI   =   Degree of  Impact produced  by regulated CAFO
           projects within the watershed subunit  (e.g.,  animal
           population density, land application,  lagoon systems) .


The CRIA for swine CAFOs  is calculated for  each  facility in a
watershed subunit area.   Total areas  (A)  of known projects in a
watershed subunit are scored  from 1 to 4  based on the percentage
of the watershed area they represent.  Vulnerability and impact
factors  are identified, and criteria for  each were developed.
Each DV  and DI  criterion  is scored from 1 to 5.

The calculations involve:

     .1)    summing the areas for known projects (A) and
           determining what percent of a watershed subunit  is
           affected.  ( [EA  / AWS] X 100); these percentages  are
           scored on  a 1 to 4 scale [no project(s) =  0 score] .

     2)    summing the vulnerability and impact criteria scores,
           and calculating the average for DV and DI  respectively;

     3)   .multiplying the A score by the  average DV  score  by  the
           average DI score.

The maximum score possible in a watershed subunit  (HUC) is 100.
The summation factor  (£A) is cumulative for CAFOs in the
watershed subunit.  Maximum rank  for  [SAI / AWS] is  4,  maximum
for DV is  5, maximum score for DI is S.

      CRIA   =   [SAI  /  AWS]   (DV)    (DI)

                     [4]          (5)     (5)   =   100
Pig Improvement Company Cumulative Risk Evaluation Results

The Region 6 Cumulative Risk Index Analysis  (CRIA) was  used to
supplement the expanded EA's evaluation of the potent j nl  f«f

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significant, cumulative, environmental impacts from swine CAFOs,
The CRIA considered environmental vulnerabilities and potential
effects of -individual CAFOs by watershed subunits, called
Hydrologic Unit Codes, or HUCs.
                             Table 1
     Cumulative Risk Index Analysis (CRIA) List of Criteria
     WATERSHED SUBUNIT AREA ( AI / AWS )  CRITERION

     DEGREE of VULNERABILITY (DV)  CRITERIA
          Ground Water Probability
          Rainfall
          Surface Water Use
          Distance to Surface Water
          Population Around Facility
          Other Industries, Pollution Sources,  or
          Protected Lands." (Quadmapper Data)
          Wildlife Habitats
          Soil Permeability
           Ground Water Quality (Nitrate-Nitrite)
          Economic (Environmental  Justice)
          Minority (Environmental  Justice)
          Surface Water Quantity
          Water Quality (STORET Data)
          Other CAFO Facilities

     III.  DEGREE Of IMPACT  (DI)  CRITERIA
          Livestock Population Density
          Lagoon Loading Rate
          Treatment System  Liner
          Land Application  Technology
          Nitrogen Budget
          Storage Capacity
          Well Head Protection
          Employment
          Odor
       ^   Transportation
          Habitat Area Effected
          Density of CAFOs
          Proximity of CAFOs
          Phosphorus Budget
          Endangered and Threatened Species
          Cultural  Resources

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The. following  is a summary of the major  findings  and  conclusions
from the CRIA_- version 6.0 dated January  24,  1997  (Data  is
presented in Appendix A):

1)  The CAFOs  represent a very small percentage of  the  total
     surface area of each HOC .(i.e., from  0.17 to 2.95  percent).

2)  The lowest, individual vulnerability,  average score was 2.538
     and the highest was 3.077.

3)  The lowest individual impact average score was  1.75 and the
     highest was 2.812.

4)  The lowest HUC vulnerability score was 2.538  and  the  highest
     was 2.885.

5)  The lowest HUC impact score was 1.875 and the highest was
     2.398.

6)   HUC 11050002040, with only the PM1  site, had the lowest area
     effected  (0.17%), as well as the lowest vulnerability
     (2.538),  impact (1.875), and total  (4.759) scores.

7)   HUC 11050002050, with sites Cl, C2, C3, LI, L2,  L3,  L4 and
     Choate, had the highest area effected  (2.95%), as  well as
     the highest vulnerability (2.885),  impact (2.398), and total
     (6.918) scores.

8)   The HUC vulnerabilities for the CAFOs are generally  high in
     the areas of soil permeability, ground water quality,
     surface water use, and population.

9)   The HUC vulnerabilities for the CAFOs are generally  moderate
     to high in the areas of ground water probability,  water
     quality,  and wildlife habitats

10)  The HUC vulnerabilities for the CAFOs are generally  low to
     moderate  in the areas of rainfall,  distance  to surface
     water, and economics.

11)  The HUC vulnerabilities for the CAFOs are generally  very low
     in the areas of surface water quantity, other  industries,
     and minorities.     '

12)  The adverse impacts of the CAFOs are generally very  high in
     the area of proximity of facilities.

13)  The adverse impacts of the CAFOs are generally high  in the
     area of ground water well locations, density,  and  odor.

14)  The adverse j/Hact^ of f^ GAR?S are generally moderate to

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      high in the areas of habitat area effected,  employment,  arid
     ' livestock population density.
          '  *«
 15). The adverse impacts of the CAFOs are generally low to
      moderate in the areas of,  transportation,  land application
      technology,  and phosphorous budget.

 16}  The adverse impacts of the CAFOs are generally very low in
      the areas of lagoon loading rate,  treatment  system liner,
      nitrogen budget,  storage capacity,  endangered and threatened
      species, and cultural resources.                 .      -

 On the 0 to 100 scale,  the total scores  are very  low for all  five
 HUCs.  This result is primarily because  the area  portion of the
 equation scored a 1 (representing less than five  percent of the
 total surface acres in the HUC).   This score is considered
 reasonable and representative of the situation, since it is
 expected that in comparison to other HUCs in the  Region,  the  area
 component should score higher.   For example,  in HUCs with large
 concentrations of CAFOs,  the area portion of the  equation will
 score higher since it takes only 15 percent of  the HUC to be
 represented by CAFOs to score a 4.

 Even though the total scores for the'HUCs are relatively low, the
 individual scores for a specific criterion provide meaningful
 insight into potential impacts.   This is  also true for the
 variation of scores for all sites in a criterion.   Scores of  4
 and 5 are important considerations at one site  and multiple
 sites,  particularly when they relate to both vulnerability and
 impact criteria.   These scores  (i.e.,  ground water1 quality, soil
 permeability,  density of CAFOs,  proximity of CAFOs,  and ground
 water protection)  support the conclusions in the  expanded EA that
 potential ground water impacts  warrant monitoring.   Also,  high
 scores (e.g.,  odor and habitat  area effected) should be  verified
 through follow-up field work to improve the accuracy of the CRIA
 for future use.

 Discussion

 The Cumulative Risk Index Analysis is designed  to assess location
 specific environmental  vulnerabilities and CAFO industry imposed
 impacts to watersheds  in Region 6.   The CRIA was  applied to 18
 swine operations  owned  by the Pig Improvement Company.  The
 facilities are located  in a semi-arid, rolling  grassland area of
 western Oklahoma.   The  CRIA identified vulnerabilities of the
 landscape to  be permeable soils,  known nitrate  ground water
 contamination  in  the watershed,  and a relatively  high number of
 farm  operations in  close  proximity to one another.  The CRIA also
 identified the ecological concern of large acres  of habitat being
effected.   The CRIA evaluation  resulted  in EPA  working with the
facilities  to  mitigate  specific concerns  (i.e., protection of
playa lakes, construction of  dikes and berns to protect surface
water)  and  to  allow EPA to conduct ecological studies on the
facility  property to evaluate species diversity dn^ \Qity(yb£f

-------
presence of odors.
References:
1.   U.S. EPA, 1997a. 40  CFR  122.23 [b],  Concentrated.Animal
     Feeding Operations  (applicable  to State NPDES programs).
     revised July l, 1997. Office of the Federal Register
     National Archives and Records Administration, Washington,
     D.C.

2.   U.S. EPA, 1997b. Swick,  J.,  G.  Carney, S. Osowski.
     Cumulative Risk Index Analysis  (CRIA)  (Swine Concentrated
     Animal Feeding Operations).  Version 6.0, January 24.
     Enforcement Division, Region 6  Environmental Protection
     Agency, Dallas, TX 75202.

3.   U.S.EPA, 1997c. Swick, J. National  Pollutant Discharge
     Elimination System  (NPDES) Statement of Findings for a
     General Permit to the Pig Improvement Company (PIC) .
     February 13, 1997, Region 6  EPA,  Dallas, TX 75202.

4.   U.S. EPA, 1998. Swick, J. National  Pollutant Discharge
     Elimination System  (NPDES) Statement of Findings for a
     General Permit to the VAL Farms.  Inc.  February 13, 1997,
     Region 6 EPA, Dallas, TX 75202.

5.   U.S.EPA, 1997d. Osowski, S.  Swine confined Animal Feeding
     Operation Ecological Inventory  and  Odor Study. Publication
     No. 906-R-98-001, December 1997,  Region 6 Environmental
     Protection Agency, Dallas, TX 75202.
     Appendix A: CRIA Data for Pig  Improvement Company  (PIC)

              Cumulative Risk Index Analysis  (CRIA)

-------
     Appendix A:  CRIA Data for Pig Improvement Company (PIC)
      • f     *  '     *                                     ' •     •


               Cumulative Risk Index Analysis (CRIA)










                Appendix B: Facility and Area Maps




Cumulative Risk Index Analysis  (CRIA) for PIG Improvement

                          Company PIC)      .  .

-------
                                                        CUMULATIVE RISK INDEX ANALYSIS
                                                        DEGREE OF VULNERABILITY SCORES
                                                PIC USA, COCHINO RANCH LLC, AND MAJOR FARMS
                GWP
Rf
SWU
DSW
PAF    Ol
WH
SP
GWQ
EEI
MEJ      SWQ   WQ

a
a
CJ
i.i
U
U
L4
LS
L6
Kronswlcrb-f
Krarvseder n -f
PMI
PM2
PM3
PM4
CM I
CM2
CM 3
30.2%
0.0%
8.2%
1.7%
12.2%
34.2%
21.1%
2.8%
0.0%
0.0%
0.8%
0.8%
3.1%
n.o%
0.0%
0.0%
9.1%
2.8%
0.5%
5
1
3
1
4
5
5
2
1
1
1
1
2
1
1
t
3
2
I
30.75
30.75
30.75
30.75
30.75
30.75
30.75
30.75
30.75
30.75
30.7$
10.75
27.46
27.46
27.46
27,46
27.46
27.46
27.46
.3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
<50
<50
<30
50 - 576
>50 • 576
>SO - £76
>30-*76
>30 • £76
>50 - 576
>50-*76
S
5
5
5
S
3
S
5
S
S
5
5
4
4
4
4
4
4
4
26B3
2
7297
1261
1552
8031
5208
4762
7206
5991
4093
4093
11832
85J-;
12358
9665
11575
8934
10444
3







2
2
2
2







114
74
82
56
95
94
76
58
72
50
64
64
32
82
85
-2
144
95
100
S
4
5
3
5
5
4
1
4
3
4
4
2
5
5
4
5
5
5
0
0
0
0
0
0
0
0
0
a
0
0
0
0
a
0
0
0
0



















32.1%
32.1%
32,1V,
32.1%
32.1%
32.1%
32.1%
12.1%
2tV)%
26.7%
31.7%
31.7%
58.1%
49.7%
49.7%
49.7%
49.7%
49.7%
49.7%
3
3
3
3
3
3
3
3
2
2
3
3
3
4
4
4
4
4
4
<20%
22.9%
<20%
93.4%
<20%
<20%
<20%
86,3%
95.7%
104.0%
<2tt%
<20%
38.0%
21.4%
<20%
20.7%
<2fl%
23.6%
<20%
3
5
4
3
3
3
4
5
5
5
4
4
5
3
4
5
4
S
4
3.4
5.4
5.4
5.4
5.4
5.4
5.4
5.4
5.4
5.4
10.9
10.9
6.1
7.2
7.2
7.2
7.2
7.2
7.2













4
4
4
4
4
4
43.0%
43.8%
41.7%
22.8%
47,2%
44.1%
39.2%
28.8%
Ki.9%
16.7%
18.8%
18.8%
15.2%
11.6%
45.1%
36.0%
37.0%
33,8%
45.3%
3
3
2
1
3
3
2







3
2
2
2
3
11.8%
8.0%
9.8%
3.4%,
9.R%
10.8%
9.9%
8.9%
2.6%
1.3%
2.9%
2.9%
0.0%
9.3%
1.8%
6,154
0.7%
7.3%
4.8%








•










0.6
0.6
'0.6
0.6
a.
-------
                                                          CUMULATIVE RISK INDEX ANALYSIS
                                                              r SCREE OF IMPACT SCORES
                                                  PIC US A, CO  HINO RANCH LLC, AND MAJOR FARMS
Facility
LPD
LLR
TSL
LAT
                                          NB
SC   GWP
O
' HAE  DOC POC
                                                                                                                                    PB
ETCR Dl

Cl
C2
Cl
LI
L2
LI
L4
L5
L6
Kronseder b-f
Kronieder n-f
PMI
PMJ
PMJ
PM<
CM"
CM*
CM1

13.3
21.0
22.1
18.9
20.4
20.2
19.1
21.7
20.4
16.1
21.1
(5.3
25.7
20.7
21.7
15.1
25.7
19.9

1
J
3
2
3
3
2
3
3
2
]
2
4
3
3
2
4
2
$100%
$100%
SI 00%
now.
$100%
$100%
$100%
$100%
5100%
5100%
sion%
$100%
$100%
$100%
$100%
SI 00%
$100%
$100%
$100%



















$100%
$100%
$100%
$100%
£100%
$100%
$100%
$100%
$100%
$100%
$100%
$100%
$100%
$100%
$100%
$100%
$100%
510(1%
$100%



















T>3ha
T>3h«
T>3fir»
T>3hf»
T>3hr*
T>3hrs
T>3h«
T>3hr*
T>Shrs
T>Jhri
T>3hrs
T>3hr*
T>3ht§
T>3hr»
T>3hn
T>3hrs
T>3hra
T>3hrs
T>3hr«
3
3
3
3
3

J
J
3
3
3
J
3
J
3
3
3
3
3
strow
$100%
JUIOV.
sion%
$ma%
SlUtW.
sioov.
$100%
$100%
$100%
$100%
•5100%
$100%
$100%
$100%
$100%
•5100%
:|9Q
>90
>90
>90
>90
>90
>W
>90
>90
>90
>90
>90
>90
>90
>90
>90
>90
>90
>90
I



















-------
  Confined  Animal
 Feeding Operations
    rn Waterahad
    A? Mflfor Road
    A/Road   ..--.
         SreanVRlver
       ^Cbunty
       !  Water Body
       I  CAFO
A
    *r;'?.city
 Bi«a Catiur«( «ra from ibe
 1992 TJOER filet of Iha U.S.
 Buretu of Iho Ceani*.   .  ,'

 CAFOi 
-------
 Confined Animal
Feeding Operations
  r~"l  Watershed
  A/  Major Road
        Stream/Rlv«r
        County
        Water Body
        CAFOs
        City
    ficmju/ei ft/i fratn the
1991 TIGER fihx of tho U.S.
Bureau o( the Coniui.
CAFO« d«i» it (rorn
E£pr\rau>ch Sonritot. Inc
M»p Crertod: Aufuit  II,  1996

-------
  Cumulative Risk Assessment Practicum
             Case Study Draft
         Pentachlorophenol (PCP)
(A Heavy Duty Wood Preservative (HDWP))
                  OPP
                                Prepared for Practicum
                                November 12-13,1998

-------
                                                  July 08, 1998
                                  Cumulative Risk Assessment
                              Planning and Scoping Document For
                                   Pentachlorophenol (PCP)
                           A Heavy Duty Wood Preservative (HDWP)
  I.    Background
U.S. EPA's Office of Pesticide Programs (OPP), as required by the Federal Insecticide, Fungicide, and
Rodentieide Act (FIFRA), and amended by the Food Quality Protection Act (FQPA) of 1996, institutes
procedures for the registration and reregistration of pesticides.  OPP's Antimicrobials Division (AD)
has regulatory management over antimicrobial pesticides, including certain wood preservative
pesticides such as Pentachlorophenol (PCP). AD is currently responsible for generating Reregistration
Eligibility Decision documents (RED's) for three wood preservatives (PCP, Chromated Copper
Arsenicals (CCA), and Creosote). These documents will reassess the potential risks these chemicals
may have on human health and the environment.  All three RED's are slated for release in FY 1999.

Note that as part of the reassessment of the wood preservative chemicals NAFTA harmonization efforts
are underway between USEPA and Health Canada's Pest Management Regulatory Agency (PMRA).
Since late FY 1997, AD's science and regulatory managers have dedicated staff resources within the
division to accomplish the goal of preparing and issuing the PCP RED, AD formed a PCP RED Team
charged with generating the draft RED document by the end of FY 1998. Designated staff leads from
each science discipline, and regulatory managers prepared a "Workplan" which identified datagaps,
created a timeline for completion of the RED, and identified steps to be taken by each discipline in
order to expedite the work. Science staff from AD and PMRA are collaborating on data sharing and in
conducting joint data reviews hi compliance with NAFTA.

Since the PCP RED will be the first RED document to be issued by OPP's newly formed AD, the
division welcomes the opportunity to participate in the "Planning and Scoping" exercise for ORD's
Cumulative Risk Assessment Workshop.  Involvement will foster dialogue with other Agency program
offices and enable AD to develop a risk assessment process that is as comprehensive and valid as
possible.

II.    Regulatory History

       A.     Regulation Under FIFRA/FOPA

*      Pentachlorophenol (PCP) was first registered in the United States in 1948 as an active
       ingredient.

*      In 1978 USEPA issued a Federal Register Notice initiating an administrative process to
       consider whether pesticide registrations for  wood preservative chemicals should be cancelled or
       modified due to adverse  toxicological effects noted in animal toxicity studies. The Agency
       issued notices of "Rebuttable Presumption Against Registration" (RPAR) for  PCP based on
       teratogenicity and fetotoxicity findings. In addition, the Agency determined that PCP use
       posed  the risk of oncogenicity due to the presence of microcontaminants (dioxins/furans/HCB).
       The Agency subsequently published Position Documents to address comments made by

-------
        stakeholders on the Federal Register Notice.  The conclusion of the RPAR process in 1984 and
        final settlement agreements with stakeholders in 1986 restricted PCP uses and modified its
        terms and conditions of registration.

 *      Banned uses of PCP included treatments to wood used for food contact surfaces/containers, log
        homes, and structures housing livestock which are farrowing, brooding, and/or cribbing.

 *      The RPAR process also resulted in cancellation in 1987 of certain non-wood preservative uses
        of PCP as a herbicide, defoliant, mossicide, and mushroom house biecide.  In 1993 uses of
        PCP were terminated as a biocide in pulp and papermills, oil wells, and cooling towers.

 *      In August, 1996, the Food Quality Protection Act (FQPA) was passed. FIFRA, as amended by
        FQPA, now requires EPA to examine pesticide uses relative to the potential aggregate and
        cumulative exposures and risks for the general population and for sensitive subpopulations
        (children and infants).  Aggregate exposures/risks represent the multiple exposures/risks from
        uses of a single chemical (e.g., exposures/risks from the diet, drinking water,  or other
        sources).  Cumulative exposures/risks represent the multiple exposures/risks from uses of
        multiple chemicals sharing a presumed common mechanism of toxiciry. For wood
        preservatives such as PCP, the Agency must now address aggregate and cumulative exposures
        and risks.

        B.     Regulation Under Other Acts

PCP is also regulated under other Acts including:  Clean Water Act, Safe Drinking Water Act, Clean
Air Act, and Resource Conservation and Recovery Act. Attachment B outlines the major points of
regulation under these Acts.

HI.     PCP Use Profile

*       PCP is an organic chemical formed by the high temperature chlorination of phenol. These high
        temperatures result in the formation of microcontaminants (dioxins/furans/HCB).

*       PCP is an oil-borne pesticide first registered in the United States in 1948 as a preservative of
        wood (seasoned/unseasoned) to prevent decay from fungal organisms and insect damage. It is
        commercially available in various forms, including: as a solid crystalline block, soluble
        concentrate (solid/liquid), and ready-to-use (grease/liquid).

*       Vulcan Chemicals, division of Vulcan Materials Company, and KMG-Bemuth, Inc. are the
        primary producers of the PCP technical chemical for the Unites States and Canadian markets.
        These companies are considered the primary stakeholders.

*       PCP product labeling and  Label Use Information System (LUIS) Reports generated by
       OPP/BEAD were used  as primary sources to confirm PCP use patterns.

*      Meetings  with stakeholders on The Penta Task Force further clarified banned and current use
       practices and identified some minor specialty  use applications. (See Attachment A for an
       overview  of PCP use patterns.)

-------
*      Currently j 25 PCP products remain registered as wood preservatives in above and below
     .  ground wood protection treatments and for treating wood for aquatic/marine environments. All
       25 products are Restricted Use pesticides: 22 are End-Use Products for commercial use, and 3
       •are TechnicaTGrade Products for manufacturing use. (Health Canada's PMRA has regulatory
       purview over three (3) Technical Grade Products.' There are no End-Use Products registered
       in Canada.)

*      Utility poles and crossarms represent 92.5 % of all uses for PCP-treated lumber.  Secondary
       uses for PCP include the treatment of railroad crossties, wooden«pilings, fence posts, and
       lumber/timber used for the construction of commercial/residential structures (e.g., patios,
       decks, walkways, and fences).

*      There are various types of PCP wood preservation treatments including: pressure/noh-pressure
       treatments to seasoned and unseasoned wood, and remedial treatments to wood previously
       treated with PCP.  Commercial treatment of lumber, such as telephone poles, usually involves
       a pressure  treatment process hi which wood is pushed into long cylinders (retorts) that are
       pressurized in the presence of PCP. Non-pressure treatment processes also exist such as
       thermal treatment (wood soaked in hot/cold baths), dip treatment, and extended soaking of
       wood in open vats. Remedial treatments are primarily groundline wood surface treatments
       (brush-on,  sponge-on/swabbing, spraying, low pressure injection, or  bandage-wrap) to
       standing utility poles and other standing timbers to extend then* service life.
                                         f
 IV.   Hazards. Exposure and Risk Dimensions

       A.      Hazard Identification

       1.      Hazards - Human Health

The Agency and PMRA are examining the full range of data, submitted by the registrants) or available
in the scientific literature, for both the active ingredients and contaminants of concern. Such data
include: acute toxicity, developmental/reproductive effects, chronic effects, carcinogenicity, and
endocrine effects.  Also, if epidemiological studies or pesticide incident data are available for PCP, the
Agency will examine these as well.

As a summary, AD presents the following:

*      PCP has been associated with both acute and chronic (non cancer) adverse health effects,
       primarily related to liver toxicity.  Also, EPA's weight of evidence carcinogenicity
       classification for PCP is B2, probable human carcinogen. PCP is known to contain
       polychlorinated dibenzo(p)dioxins (PCDDs) and  polychlorinated dibenzofurans (PCDFs) as
       contaminants. The toxicity of PCDD/PCDF congeners are typically expressed, based on the
       comparison of their toxicity to the most toxic congener (2,3,7,8-tetrachlorinated
       dibenzo(p)dioxin; 2,3,7,8-TCDD), using Toxicity Equivalency Factors (TEFs). Toxic
       Equivalency values (TEQs) are calculated as the  sum of the products of individual congener
       concentrations and their respective TEF.  EPA has set regulatory limits on the concentrations of
       certain PCDD/PCDF congeners in PCP.

-------
 *       Available scientific literature confirms that PGP targets the liver, kidneys and central nervous
     .   system and has been linked to cancers {e.g., acute leukemias, lymphomas, and multiple
         myelomas). Data suggest PCP damages the nervous, immune, and reproductive systems
         (including elidocrine disruption)-. PCP is readily absorbed by lungs, skin, and stomach. While
         much of PCP is excreted in the urine, it does accumulate in tissues, particularly muscle, bone
         marrow and fat.                                                            ''  •

         2.     Hazards - Environmental

 The Agency and PMRA are examining the full range of data, submitted by the registrants) or available
 in the scientific literature, for both the active ingredients and contaminants of concern. Such data
 include:  acute toxicity, subacute effects, chronic effects, and endocrine effects.  Also, if pesticide
 incident data are available for PCP, the Agency will examine these as well.

 As a summary, AD presents the following:

 *      Available  scientific literature confirms that PCP bioaccumulates in mammalian and fish tissue
        and laboratory data indicate there is a very high toxicity of PCP .to fish on an acute and chronic
        basis.  Data submitted by the registrants to the Agency suggest that PCP is moderately to
        slightly toxic to avian species (mallards and bobwhite quail) on an acute oral basis. Subacute
        dietary tests indicate that it is practically nontoxic to avian species.   •

        3.     Hazards - Microcontaminants

 The hazards of the microcontaminants are an important part of the human and environmental hazards
 identification process. AD plans to utilize data compiled by the Office of Research and Development
 (ORD), the lead office for dioxin issues.  AD believes that there are likely more data available to
 identify human health hazards than to identify environmental hazards. Therefore, the environmental
 hazards identification process may be highly qualitative.

        B.     Exposure Scenarios

 Canada's PMRA will focus on all exposure aspects of PCP:   i.e., a "cradle-to-grave" approach which
 addresses manufacture, wood preservation, utility poles  in service, and removal/disposal of utility poles
 from service to disposal sites (e.g., landfills).  However, AD/OPP (because of overlapping Agency
 statutes) will focus its exposure assessments as follows:  (1) human exposure assessments will address
 occupational, or wood preservation, sites where the greatest human exposures are likely to occur; and
 (2) environmental  exposure assessments will focus on in-service,  treated utility poles, since these
 provide potentially for emissions of PCP and/or microcontaminants into the terrestrial and/or aquatic
 environments.

        1.      Exposures - Human Health

AD will examine application and post-application exposures for both occupational and residential
settings. AD's focus will be on occupational settings (primarily, wood treatment plants) where the
exposures for mixers, loaders, applicators as well as utility pole workers  must be evaluated. However,
AD plans to address aggregate and cumulative exposures since utility poles are found, and can receive

-------
 remedial grqundline treatments of PCP, in residential settings. Specifically, the following points should
 be noted:
                                                         f                               •.
 *      Human exposure assessments will focus primarily on workers handling PCP
        formulations and/or PCP-treated wood. Exposure levels and the dernial/inhalation
        routes of- exposure will be of primary concern. AD will assess exposures to primary
        handlers who mixAoad/apply concentrates to treat wood in treatment facilities.  The
        assessment on secondary handlers will include addressing utility pole installers and
        repair workers. -AD anticipates;that,the most significant potential exposures*wUkoccur
        at the wood treatment plants during pressure/non-pressure applications and post-
      .  application handling; followed by the exposure potential to utility workers engaged in
        pole installation and remedial groundline treatments to utility poles.
                                                                                    :
 *      Human exposure to PCP may occur in occupational settings or among the general
        population primarily via dermal and inhalation routes. Ingestion of PCP can also
        occur indirectly through hand-to-mouth transfer after dermal contact. Workers may be
        exposed through inhalation of PCP-contaminated air in the workplace or by dermal
        absorption during handling of the PCP formulations or PCP-treated materials.
        Virtually all workers exposed to airborne concentrations take up PCP through the lungs
        and skin.  Exposure may occur during mixing and loading of PCP into the tanks,
        loading and unloading the retort, and during maintenance operations. General
        population exposure may occur through dermal contact with PCP-treated products or
        contaminated soils, or ingestion of food, soil, or groundwater that has been
        contaminated from historical uses (i.e., uses now banned under the 1986 RPAR
        proceedings).  General population exposure (i.e.,  inhalation of contaminated indoor air
        or dermal contact with treated areas) may also occur among individuals residing in
        older buildings constructed of PCP-treated wood products.(i.e., log homes).

 *      In 1991, as an outcome of the Agency's RPAR proceedings,  USEPA required registrants of
        PGP-based technical source and end-use products to submit certain applicator exposure
        monitoring data.  These data requirements were designed to estimate the potential dermal and
        inhalation exposures associated with PCP wood preservative uses (i.e., occupational, at
        application, exposures). However, the  Agency did not require post-application exposure data
        since the occupational (at application) exposure scenarios are expected to be the scenarios with
        highest human exposure.

*       Following 1991, an industry consortium, headed by Vulcan Chemical, formed the Penta Task
        Force to address the Agency's reregistration requirements for human exposure data.  In  1993
        five human exposure studies submitted by the Task Force were deemed  unacceptable upon
        Agency review. These studies had been conducted to evaluate occupational and general
       population exposures/risks from existing and historical uses of PCP. However, these studies
       did not provide empirical human exposure  data which could be used by  the Agency.  Thus,
        limited human exposure monitoring data, which are acceptable for use in the reregistration
       assessment of all three wood preservative chemicals, are available.

*      Present efforts: (1) AD is working with contractor personnel to identify all potential
       application and post application use scenarios at occupational and residential settings.  For

-------
                                                                                             6
                                                                                  ' •*

        occupational scenarios, a data matrix table has been drafted of the potential levels of exposure
        associated" with certain typical work tasks. However, the residential use scenario component
        has not yet been drafted for incorporation into this table. Therefore, AD has not finalized how
        it will approach aggregate and cumulative exposures for residential scenarios; (2) information
        regarding AD's choice of occupational/residential use scenarios has been shared with PMRA's
        human exposure assessors.  PMRA will conduct a peer review of the completed draft version
      '  of the Agency's Human Exposure Science Chapter for the PCP RED in early FY 1999; and (3)
        recent dialogue with the Penta Task Force has yielded a commitment to conduct an
        occupational exposure study of treatment plant workers using air sampling pumps to estimate
        inhalation exposure, and biological monitoring techniques (urine analysis instead of dermal
        exposure dosimetry testing) to estimate the absorbed dose.   This worker exposure study will
        monitor all application and post-application work tasks associated with PCP wood treatments.
        However, this study is not likely to  be completed until FY 2000, after issuance of the PCP
        RED.      .                                  '

        2.      Exposures - Environmental

 For PCP, AD believes the primary routes of environmental exposure are water and soil via leaching
 from utility poles, railway ties, pilings, piers, docks, etc.  The most likely environmental compartment
 to be exposed to PCP is the aquatic.  AD will characterize risks using these environmental scenarios.
 AD will not examine environmental risks from the following scenarios becuase they are regulated
 under other statutes:  manufacture of PCP, use of PCP in wood preservation plants, and disposal of
 treated lumber in landfills or as hazardous waste.

        3.      Environmental Fate Chemistry

 AD believes that environmental fate chemistry is a key component of both the human and
 environmental exposure (and risk) assessments for PCP and microcontaminants. For PCP AD has
 compiled pertinent data from the registrant and literature sources and believes that the fate and
 degradation of PCP are well understood (see Attachment C). However, for the microcontaminants AD
 will be  working with a contractor and ORD to determine if adequate environmental fate and emissions
 data can be compiled for dioxins and furans relative to the wood preservation sector.  Of particular
 interest are emissions from in-service utility poles; if inadequate emissions data exist, then AD plans to
 use modeling (see 4 below).

        4.     Exposures - Modeling
                              s
 Because of the apparent lack of monitoring and/or emissions data for PCP (and/or microcontaminants)
 for various use scenarios, but particularly for in-service utility poles, AD will utilize models, such as
 the fugaciry model, to estimate concentrations of PCP and/or microcontaminants in the environment.
 Fugacity models identify the percentage distribution of a chemical (e.g., PCP)  in various compartments
at equilibrium and the proportion of loss through advection and reaction from each compartment.  Such
models typically utilize three levels of estimates, but AD may also use other models that appear to be
appropriate. Also, AD  will need to work closely with ORD concerning any emissions estimates the
division may develop for the microcontaminants.

       C.     Risk Characterizations

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        1-     Human Risks            ....                        •
                *
     *
 For the Agency to conduct a thorough human risk characterization, data are needed on: (1) the
 toxicity/effects of the pesticide, (2) the pesticide's use patterns, and (3) human exposure scenarios.' To
 date, AD has compiled extensive information for (1) and (2), but is utilizing surrogate data for (3) as
 well as requiring an occupational exposure study of treatment plant workers. (However, this study is
 not likely to be completed until FY 2000.)

 As discussed .earlier, AD's focus will be on characterizing the occupational risks of PCP:  the risks
 (application) for mixers/loaders/applicators who prepare or apply PCP to wood and the risks (post-
 application) for workers handling treated wood products (e.g., utility pole installers, repair workers).

 However, with passage of FQPA in 1996, AD now must characterize the potential risks associated with
 non-occupational, or residential, use scenarios. For these AD is planning to assess the aggregate
 (dietary, drinking water, other) and cumulative risks for PCP that may be associated with-any
 residential use scenarios.1 Further,  we plan to assess the potential risks of PCP to sensitive
 subpopulations such as children and infants as well as any potential endocrine effects.

 For both the occupational and residential risk assessments AD will compare available toxicological
 hazard data, use pattern information, and exposure data. As an example, Margins of Exposure
 (MOE's) will be calculated for occupational workers to determine the potential risks of workers
 exposed to PCP under various occupational use patterns. Also, Because of PCP's carcinogenic
 potential, the cancer risks will be calculated using the Lifetime Average Daily Dose (LADD) and the
 Cancer Slope Factor.  For residential use patterns similar approaches may be taken also.

       2.     Environmental Risks

 Environmental risk assessments are required under FIFRA to estimate the likelihood or probability mat
 adverse effects (e.g., mortality to single species of organisms, reductions in populations of nontarget
 organisms due to acute, chronic and reproductive effects, or disruption in community and ecosystem
 level functions) will occur, are occurring, or have occurred on wildlife and aquatic organisms.  Data
 developed and submitted are used by the Agency for determining potential hazards to nontarget birds,
 wild mammals, fish, plants, and aquatic invertebrates.

 In an environmental risk assessment, toxicological hazard data and exposure data are compared using
 regulatory risk criteria. Typically the toxicological hazard data may consist of acute LD50 and LC50
 values, or chronic no-effect-levels (NOEL's) for  the most sensitive indicator species.  Exposure data
 normally consist of model-based Estimated Environmental Concentrations (EEC's) in important media
 of concern (i.e., water, soil, nontarget organism  food items) plus a profile of the nontarget organisms at
 risk. A Risk Quotient (RQ) is determined by dividing the exposure data (EEC) by the toxicology data
 (LD50, LC50, etc.).  A comparison is then made between the RQ and an Agency  Level of Concern
       1  Aggregate  risks:   risks associated with multiple  pathways
of  exposure for  a  single chemical;  cumulative  risks:    risks
associated  with  multiple pathways  of exposure  for multiple
chemicals that share  a  presumed common  mechanism  of  toxicity.

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                                  .                                                           8

 (LOG) to determine if there is a potential risk to nontarget organisms.
      %                                                                i
 For PCP, the primary routes of-exposure are water and soil via leaching from utility poles, railway
 ties, pilings, piers, docks, etc.. The most likely environmental compartment to be exposed to PCP is
 the aquatic.  Available scientific literature confirms that PCP bioaccumulates m mammalian and fish
 tissue and laboratory data indicates there is a very high toxicity of PCP to fish on an acute and chronic
 basis.  Data submitted by the registrants to the Agency suggest that PCP is moderately to slightly toxic
 to avian species (mallards and bobwhite quail) on an acute oral basis. Subacute dietary tests indicate
 that it is practically nontoxic to avian species.
        *
        3.     Risks from Microcontaminants

 Considering the lack of pertinent emissions data for dioxins/furans for the wood preserving industry
 sector,  AD's human and environmental risk characterizations for PCP microcontaminants is likely to be
 highly qualitative.  However, AD recognizes that the risks of the microcontaminants are an important
 part of the risk characterization process. AD plans to work closely with a contractor and ORD, the
 lead office for dioxih issues, in an'effort to develop human and environmental risk assessments.

        4.      Comparative Risk Analysis

 Upon completion of the human and environmental risk assessments, AD plans to follow similar steps
 for evaluating creosote and CCA, two alternative HDWPs, Once all three risk evaluations are finalized
 then AD will perform a comparative risk analysis of the three compounds (PCP, creosote, and CCA) to
 determine how the human and environmental risks* associated with similar use patterns, compare.

  V-    Assumptions. Uncertainties, and Limitations With Risk Characterizations

 AD recognizes a variety of assumptions, uncertainties, and limitations exist with the proposed human
 and environmental risk characterizations. Some of these are:

        A.     Human Risk Characterization

 *       It is assumed that the occupational exposure study sponsored by the Penta Task Force will
        provide risk assessors with valuable data needed for the human exposure risk assessment.
        Since these data will not be available until FY 2000, the human exposure assessment will need
        to rely on surrogate data and may fall  short of its goal to accurately determine exposure risks to
        workers.

 *       The acceptability of biomonitoring data over dermal  (passive dosimetry) monitoring data has
        been questioned.  Although the pharmacokinetics of PCP are well known, certain reservations
        remain  regarding test participant compliance in generating urine samples. Dermal monitoring
        was rejected as an option due to workers overheating while wearing the test garments (whole
        body dosimeters) in a pilot study.

*       The required worker exposure field study will not analyze air and urine samples for the PCP
        microcontaminants (dioxins/furans/HCB),  only for the presence of PCP and its metabolites.

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*       The default assumptions, based on surrogate data, used by the risk assessors might not reflect
     .   real-use conditions, thereby weakening human exposure risk characterizations.             :

*•       AD's assessment will not include evaluation of risk concerns for PCP uses "banned" under the
        RPAR proceedings (e.g., risks to occupants of log homes).

*       AD's assessment will not include estimations of potential human exposure risks from contact
        with PCP-treated wood used for minor specialty applications (e.g., uses in bridges, trusses,
        architectural restoration), only typical exposure scenarios will be evaluated.

*       AD will assume that any existing uses for PCP-treated lumber in groundline contact "interior"
        building components pose limited human exposure concerns since the 1986 RPAR settlement
        requires 2 coats of an appropriate sealant be used on all interior wood surfaces.

        B.      Environmental Risk Characterization

*       The Agency does not typically require data on small mammals and does not look at the effects
        on small mammalian wildlife (voles, mice, bats, etc.).  Data is extrapolated from the human
        toxicology rat studies to be utilized in determining effects on wildlife mammals. This area is of
        importance because small mammalian wildlife feed on terrestrial invertebrates (insects,
        earthworms, etc.) and/or plants that may have been exposed to the pesticide.  AD is uncertain
        what effects are occurring in the food chain.

*       Canada uses data regarding subchronic exposure of bats to treated timbers used for bridge
        trusses. Scientific literature documents the lethal effects on bats nesting on bridge trusses
        newly treated with PCP. The Agency will note this information in their RED, however no
        further studies will be requested to further investigate the potential hazards to this mammalian
        population.

*       The Agency will not be conducting any field studies on the effects of PCP on terrestrial
        invertebrates such as earthworms.  Canada and Europe do incorporate data collected in this
        area.

*       There is no consensus on reproducible laboratory testing to determine the levels of PCP leached
        from the wood.  To date the levels leached into the environment are  unknown.  This is true for
        PCP and its microcontaminants,-furans, dioxins, and HCB.

*       The environmental risk  characterization is focused on the effects on  individual organisms as
        opposed to populations of organisms.  AD's environmental risk assessment's weakness is that
        mesocosms and population effects are not assessed on a routine basis.

*       USEPA's  ORD will generate a final version of a Dioxin Source Inventory Report for release in
       late fall  of 1998.  It is assumed that this report will benefit risk assessors in making quantitative
       determininations of dioxin releases for use in the environmental  exposure assessments.

VI.    Stakeholder Input

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                                                                                         10

AD has actively involved stakeholder input in the human and exposure/risk characterization processes.
In addition, (1) the review of the HDWPs is a NAFTA project in which Canada and IjSEPA are
working closely together; and (2) AD will need to work closely with other Agency offices such as
ORD.  Stakeholders who are involved in the review process consist of: industry consortiums (e.g. PCP
Task Force), PCP chemical manufacturers, PCP end-use product manufacturers, end-users of PCP
products, and end-users of PCP-treated wood.

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                                   Attachment A: PCP Use Patterns
Banned Uses;
     ^
*       Log Homes

*       Chairs/Outdoor Furniture                 '    -
        (Bare Treated Wood)

*       Residential/Industrial/Commercial Interiors
        (General Use)

*       Farm Building Interiors (Direct Contact with Domestic/Livestock Animals which Crib(bite) or Lick the
        Wood.)

*       Farm Building Interiors (Direct Contact with Animal Farrowing or Brooding Facilities.)

*       Farm Structures/Containers for Storing Silage or Food. (Human Food/Animal Feed Contact.)

*       Cutting Boards/Countertops

Allowed Uses:

*       Utility Poles/Crossanns
        Crossties
        Single Pole Structures (Radio Towers)
        Bridges
        Trusses (Glue laminates e.g. Swimming Pool Trusses)
        Timbers
        Posts
        Pilings/Piers/Docks
        Lumber
        Fencing
        Porches
        Shingles
        Steps
        Architercural Restoration (Outdoor Tongue .& Groove Flooring)
        Patios/Decks/Walkways

*       Chairs/Outdoor Furniture
        (ONLY if 2 Coats Sealant Applied )

*       Residential/Industrial/Commercial Interiors
        (Laminated Beams or Groundline Contact Building Components.
        Both Uses Allowed if 2 Coats of Sealant Applied.)

*       Farm Building Interiors (Where Domestic/Livestock Animals DO NOT Crib(bite) or Lick the Wood.
        Groundline Contact Building Components Use Allowed if 2 Coats of Sealant Applied.)


Diminished Uses:       Joinery/Millworking (No Evidence of Treated Products being Marketed.)

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                            Attachment B: PCP Regulation Under Other Acts


 Regulation of PCP under the Clean Water and Safe Drinking Water Acts
      *-                               .                               *
 *    .   PCP is designated hazardous substance under the CWA (40 C.F.R. pt 116)..

 *       PCP is a designated toxic pollutant under the CWA and is subject to effluent limitations resulting from
        application of best available technology '(BAT) that is economically achievable. New source.emitting PCP
        also must meet stringent new source performance and pretreatment standards (40 C.F.R. §§ 401.15,
        403.55).
                                                                      «•••;'!. ''i
 *       EPA has set a contaminant level of 0.001 mg/L for PCP in drinking water; granular activated carbon is
        BAT for achieving compliance with this standard (40 C.FJEL §§ 14131 (3) (46), 141.50 (a) (15)).

•*       Under federal water quality guidance for the great lakes system, PCP is subject to acute- and chronic-based
        water quality criteria for the protection of aquatic life in ambient water (40 C.F.R. § 132.6).

 Regulation of PCP under the Clean Air Act

 *       PCP is designated Hazard Air Pollutant (HAP) under section 112 of the CAA. Major sources emitting PCP
        are subject to stringent Maximum Achievable Control Technology (MACT) emissions standards (42
        U.S.C. §§ 7412(b), (d)). PCP wood preserving sites are not a major source for purpose of the MACT
        standards.

 *       Units at major sources that manufacture PCP are subject to National Emission Standards for organic HAPs
        for the Synthetic Organic Chemical Manufacturing Industry (40 C.F.R. pt 63 subst F).

 *      . National emission standards apply to off-site Waste and Recovery Operation if, in part, the material being
        handled contains PCP (40 C.F.R. pL 63 subst. DD).

 Regulation of PCP under RCRA

 *       Certain PCP containing waste are listed as acutely hazardous (40 C.F.R. § 261.31).

 *       PCP wood preserving wastes are identified as toxic (40 C.F.R. pt 261 subst D)

 *       PCP wastes are prohibited from land disposal under EPA's land disposal regulations, unless universal
        treatment for such wastes are met (40 C.F.R. §§ 268.30,268.40).

 *       PCP is subject to groundwater assessment monitoring requirements applicable to municipal solid waste
        landfills and to owners/ operators of hazardous waste treatment/storage/disposal facilities (40 C.F.R. pts.
        258,264).

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                            Attachment C; Pentachlorophenot (PCP)                  .
                           Environmental Fate Studies and Assessment
                 •i                                                                •*.
Abiotic degradation of PCP

PCP does not hydrolyze in acidic, neutral or basic conditions and can therefore be a persistent molecule
.in abiotic aqueous conditions. It, however, photodecomposes under uv.light in water quickly with a half-
life of 3.5 hours at pH 7.3 and 100 hours at pH 3.3.  Some of the, identifiable degradates are:
tetrachlorocathecol, tetrachlororesorcinol, tetrachlorohydroquinone, chloranil, hydroxyquinones, 2,3
dichloromaleic acid which slowly decompose to carbon dioxide., chloride ion and other organic
fragments which are hard to identify. In the vapor phase^PCP is moderately stable with a
photodegradation half-life of about 37 days under simulated sunlight 2,3,5,6-tetrachlorphenol was
identified as a major photoproduct. PCP showed no photolytic breakdown tendency on soil surface •  .
(sandy loam soil) under dark conditions. However, in the presence of light, it is moderately stable with
an estimated half-life of about 3 8 days.

Biotic degradation of PCP

PCP metabolizes rapidly under aerobic aquatic conditions and has a half-life of less than five days.
Under anaerobic conditions, it metabolizes a little more slowly with a half-life of about 34 days. (These
results were obtained with blue sandy loam soil.) It is therefore not a persistent substance in natural
waters. Under dark but aerobic conditions, soil (sandy loam) metabolizes PCP slowly with a half-life of
63 days. Tri and tetrachlorophenols were identified as degradates. Adsorption/desorption studies on
four soils (Georgia sandy loam, Ohio Clay loam, California sandy loam and Nebraska Blue sandy loam)
showed that PCP binds moderately to strongly to the soils. KQC values revealed that PCP soil binding is
tight with Georgia, Ohio and Nebraska sands and moderately so with the California sand. Thus, PCP has
a great tendency to attach to the organic content of sediments (high KQC) and is found to bind more
strongly in acidic soils but is mobile in neutral to basic conditions. Based on these data it appears PCP
could be transported to surface waters and potentially could be found in drinking water.

Bioaccumulation studies

Bioaccumulation studies with bluegill sunfish revealed that when exposed to 2.5  ug/L PCP for 28 days,
the Bioconcentration Factors (BCF) were 190X, 740X and 490X for edible tissue, non-edible tissue and
whole body tissue, respectively. Depuration for the whole body was one day, and 98% is depurated
within fourteen days. No metabolites were found in these studies.

Leaching Studies

One study on three Southern pine poles soaked with PCP was  conducted. Poles were exposed to
different solutions: unbuffered water, buffered water at pH 5, 7 and 9, sea water, sea water in 0.1 ON
HC1, and 0.10N HC1. The average leach rate varied between 1.76x10-* to 6.33x10° mg PCP/kg
leachate/in2 surface area/day. Leaching peaks in one day for most of the solutions except the solution at
pH 9 for which leaching peaked in 3  days.

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Cumulative Risk Assessment Practicum
           Case Study Draft
  Chicago Cumulative Risk Initiative
         Region V and OPPT
                               Prepared for Practicum
                               November 12-13,1998

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                                       DRAFT


                 Summary of Purpose, Scope, and Technical Approach:
             Evaluating Cumulative Risks in the Chicago Metropolitan Area

1. INTRODUCTION
       The following is a summary of the overall purpose, general scope, and technical approach
for the study, "Evaluating Cumulative Risks in the Chicago Metropolitan Area" (the CCRI Phase
III risk assessment). The approach is a synthesis of the direction and information that was provided
during meetings with stakeholders (petitioners, EPA Region V senior managers, and other state, and
local government representatives) in December 1997 and April 1998. As such, this summary does
not reflect any one viewpoint, but attempts to balance various needs and concerns with products that
are technically feasible.  It also attempts to incorporate major concepts suggested by the Petitioners
                                                                j
in their strawman proposal and matrix, while following EPA's Cumulative Risk Assessment
Guidance on Phase I Planning and Scoping.

       The three major study components will be an overview of health indicators, a cumulative risk
evaluation for multiple point sources, and a description of other risk pathways. These will be
integrated to produce a comprehensive risk assessment that allows comparison of contributions
among sources and of risk levels among subareas of the study region. In October 1997, Argonne
National Laboratory  produced a Concept Paper in which various conceptual approaches for
cumulative risk assessment were evaluated. The approach outlined in this summary is essentially
the source/receptor hybrid model described in the Concept Paper. Within this approach, the majority
of effort will be placed on evaluating the contributions to exposure and risk within study areas from
multiple point sources of emissions to ambient ah* (Section 3.2 below).

       Cumulative risk means different things to different people.  A general definition is the total
health risk associated with multiple stressors from multiple sources. EPA risk assessments have
typically addressed the incremental risks (above background) of all chemicals emitted in significant
quantities from a single facility.  Although a total measure of cumulative carcinogenic or toxic risk
for all possible exposures is not currently possible, this study will provide a learning process for
evaluating some additional aspects of cumulative risk in the permitting process.  This summary
presents general direction; the specifics may change to reflect technical feasibility.  Where data
inadequacies prevent full development of the proposed scope, the scope will be limited.

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 2. GOALS
                                                                •                v,
       The overall puipose of this study is to refine and demonstrate methodologies for assessing
 children's  environmental  health risks  (both  carcinogenic and noncarcinogenic)  due  to  the
 accumulation of multiple stressors from multiple sources that impact a specific area.  A basis will
 be developed for comparing risks in study areas to reference areas or baseline levels.  Specific
 objectives are to:
    a. conduct a cumulative risk analysis that specifically addresses concerns of the Agency and
       Stakeholders, including identification of health-compromised subpopulations of children and
                                        .                  •.
       of locales with elevated hazard levels;
    h. illustrate implementation of the Administrator's Cumulative Risk Guidance;
    c. take the initial steps in developing the basis for transferring a cumulative risk methodology
       to other units in the Agency.

3. SCOPE
       This section describes the general scope of the assessment and provides an overview of the
technical approach that will be used. Research on health indicators (Section 3.1) will address the
goal of identifying sensitive subpopulations of children. The data produced from the cumulative risk
evaluation for multiple air sources (Sections 3.2) will quantify the risks from air contaminants in
specific areas, and the description of other risk pathways (Section 3.3) will help to identify other
sources of risk. All the above information will be utilized in the risk integration portion of the study
(Section 3.4)  to gain insight into reducing risks to children. The following list is a summary of
elements that apply to the entire cumulative risk study:
   - Risk dimensions: Multiple  health endpoints (health effects), multiple stressors, and multiple
       sources will be assessed.
   - Stressors: The scope will be restricted to environmental contaminants, with a focus on releases
       due to human activity. The assessment will include the chemicals that are most important,
       given the locales and sources, selected as the focus of study. The selection of chemicals will
       be constrained by data availability
   - Sources: The emphasis will be on EPA-regulated/permitted sources, with other important
       source categories added as needed to develop a more complete risk management perspective.
   - Geographic Area: The study region will cover Cook and Lake Counties. Within that area, two
       to four locales will be selected for more detailed study.
   - Population: The focus will be on children, from conception through age 17, with assessment
       of lifetime exposures where appropriate.  Particular attention will be given to risk evaluation
       for health-compromised children (e.g., asthmatic, lead poisoned, etc.) where possible.

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       The following subsections provide additional information on the technical elements that
apply specifically to each task, including assumptions, constraints, implications, and^atalimitations.
    «                                               •         ..
3.1 Health Indicators (Task 1)                                    .
       The availability of data related to children's environmental health status will be investigated
for lead poisoning, asthma incidence, and cancer incidence and mortality.  If these .data permit
identification of locales with elevated rates, this information.will be one of the factors considered
in selecting  study areas.  Specific health conditions  which lead to increased  sensitivity  (or
susceptibility) to environmental pollutants among children may also be included if data are available.
For instance, data on prevalence of sickle cell anemia in children within various locales may be of
interest.  Where data related to  a particular issue are absent or lack geographic relevance, further
exploration of that issue will be precluded.

3.2 Cumulative Risk Evaluation for Multiple Emission Point Sources (Task 2)
       This effort will focus on evaluating the contributions to exposure and risk within the study
areas from multiple point sources of emissions to ambient air.  To provide a basis for comparing the
study areas to the rest of the Cook and Lake County area, screening-level estimates of ambient ah*
risks from major source categories and background will be developed for all Census tracts.  To
develop comprehensive ambient air risk estimates for the study areas, appropriate portions of the
detailed modeling and the screening level modeling results will be combined.. The task will have
three components:

       Task 2a: Exposure and risk from multiple EPA-regulated point sources within two or more
(up to  four) discrete study locales will be evaluated.  Possible factors for use in identifying an
additional study area or areas include: (a) high levels of toxic emissions, based on information from
the Environmental Loadings Profile or emissions databases; (b) high prevalence of one or more
health indicators; or (c) Agency/Stakeholder consensus recommendations.

       A subset of the most significant point sources affecting the study area will be selected for
detailed study.  Emissions from these point sources will be modeled to identify locations with
maximum risk from multiple contaminants of concern.  Cancer risks will be modeled for both child
and life-time receptors at these maximum risk locations.  (Life-time receptors would be modeled in
addition to child receptors because cancer risks are greater when longer-term exposures (i.e., 30
years) are assumed.).

       Both direct (inhalation) and significant indirect pathways of exposure will be included in the
risk assessment. Examples of indirect pathways which may be evaluated, if data indicate they are

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 significant pathways to children, include contact with soil, waiter, and sediments to which
 contaminants have been released through air deposition, and ingestion of contaminated produQe'br
 fish which may have accumulated contaminants released from the point sources.              _  ,-

        Task2b: Exposure and risk from area, mobile, and background sources that also affect the
 study locales  will be  evaluated,  but  in  less detail.  These risks will be combined with 'the
 contributions from modeled point-sources impacting locations within the -study areas. Similarly/
 screening-level estimates of both point- and area-source risks will be developed for Census tracts
 throughout the larger area of concern (i.e., Cook and Lake Counties). These analyses are likely to
 rely on modeling methods developed for the air'toxics portion of the EPA National Cumulative
 Exposure Project, but to use more recent and more detailed area-specific data.

        Task 2c: Estimates produced by the ambient air modeling efforts described above will be
 validated by comparison to ambient monitoring data and results of detailed studies, where available.
 An uncertainty analysis will also be conducted to evaluate the robustness of the findings.

 33 Description of Other Risk Pathways (Task 3)
        All parties involved in the scoping and planning process have agreed that focusing the '
 cumulative risk assessment on EPA-regulated and EPA-permitted sources is most appropriate. As
 a result, the most detailed portion of the cumulative risk evaluation will be the community-based
 assessment of multiple EPA-regulated (and permitted) air sources, plus other outdoor air sources
 (described in Section 32).  Since emissions from these sources may contribute only .a portion of the
 potential risks to a community, development of risk estimates for other sources and pathways will
 be addressed in this task.
                                                                                         »
       This evaluation will include both exposures from sources that are regulated by EPA and some
 that are outside the direct control of the Agency. Exposure pathways from regulated or permitted
 sources could include drinking water ingestion and soil ingestion at or near contaminated sites.
 Examples of exposures that result from lifestyle and behavioral circumstances of children include:
 ingestion of lead in paint and soil; ingestion of pesticides  hi the diet; mercury and PCB ingestion
 from fish consumption (especially subsistence fishing); and inhalation of environmental tobacco
 smoke, radon, and other indoor air pollutants. Whenever possible,  local (community-specific)
 exposure data will be used in the assessment. In other cases, regional or even national estimates will
 be used. While a comprehensive, community-based assessment of all exposures is beyond the scope
of this study, the attempt will be made to include pathways affecting the particular vulnerabilities
of children. Due to data and resource  limitations, portions of the assessment of additional sources
and personal exposures will be more descriptive than quantitative.

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                       Appendix D. Slides from Presentations

1.  Cumulative Risk Assessment Practicum Phase I Planning and Scoping
2.  Problem Formulation: Lessons from Ecological Risk Assessments
3.  Conceptual Model Development
                                        D-l

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   Cumulative Risk Assessment
            Practicum
Phase I: Planning and Scoping
      November 12-13,1998
         Chicago, Illinois
      (Introductory Slides)
      Sponsored by the
      Science Policy Council
                   Presenter
                   Edward S. Bender, Ph.D.
                   SPC Staff

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 Cumulative Risk Assessment Pracjicum

     Phase I: Planning i
  Cumulative Risk Work
  Don Barnes, OA
  Ed Bender, ORD
  Carole Bravennan, Reg V
  Pat Cirone, Reg X
  Penny Fenner-Crisp, OPPTS
  Michael Firestone, OPPTS
Lany Reed, OS WER
Joe Reinert, OP
James Rowe, ORD
JeanetteWiltse.OW
Bill Wood, NCEA
Ed Ohanian, OW
   Cumulative Risk Guidance
  Phase I Planning and Scoping
i Address aspects of CR within domain of
 EPA regulations
i Establish a framework to plan for
 integrated risk assessments
i Coordinate with Risk Characterization
 Policy and Guidance
i Complement/promote use ofgutdefa
                              111

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  Gumulative Risk Objective
            the Practicum
 •  Learn to apply the guidance on planning
   and scoping for cumulative risk assessment
 •  Develop a Plan and Conceptual models for
   Case Studies.
 •  Discuss and practice approaches.
 1  Identify CR needs and concerns for the
   assessors and managers.
J
e

Risk Assessment
A
   Risk Assessment/ Management Decision
             New Mnngcmenl Needs
  PUiming
  and
  Scoping

 (Auoxr-
 Muugcr
                 Economic, Poll-Science,
                   and Social Analysis
                 *-*           .--•*"'**
   Definition of Cumulative Risk

• "Risks from one or more stressors
  considered in aggregate"
• Each Assessment is case-specific
   • Who is affected or stressed?
   • What are the stressors?
   • What are the sources?
   • What are the pathways?
   • What is the time frame for the risk?
   • What are the assessment endpoints?

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 Planning and Scoping Quid,
  Plan for an Integrated
  Risk Assessment
  Relies on existing
  guidance and policy
  Encompass current
  practice, guidance, and
  policies.
Guiddbe».Ec«iik,&qx»»t,
 Ncorown., Repro.. Cwcer..
Pnynm Guidweeml Poficy
(RAGS. IcjiiUtioa. mUet)
Case Sudia illume
 «pplicalionofP&S Guidance
EPA Policy-Risk Ctanaerizatioii
 Peer Review. Models, etc.
    Planning and Scoping
o Identify the Purpose, Scope, a
  participants
o Develop a matrix of possibilities
• Define the actual risk matrix
o Determine assessment endpoints
© Conceptual Model
   Problem Formulatio:
Risk Assessor Risk M
1. Backgrauad Koovledgc
•.idle of the riit
b. critical endpoinb
' concems
4. Political concerns
S. Timing/Resomccs
6. Acceptable Levels of
.. 	 |i'tnt~~n

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        Purpose of Dialog
  Risk Manager should explain why a risk
 assessment is needed and what questions
 should be answered.
 Surface policy and stakeholder concerns to
 determine information needs and
 contributors for planning the assessment
 Discuss resources and participant roles.
  Define the Scope of the risk
            assessment
 Identify the exposure scenarios, information
 needs, and assessment issues to be
 evaluated.
 Set criteria for defining the technical scope.
 Note judgements for risk characterization.
  Define the Cumulative Risk
   Dimensions and Elements
Develop a set of possible elements for each
dimension (see Outline) with participants.
Rank these elements in terms of data
available, relevance to the RM goal, etc..
Revisit these rankings as new data become
available.

-------
Cumulative Risk Dimensions and
         Elements Provide
- Definition of cumulative risk for the
  particular assessment
• A record of what was considered, included
  and explicitly excluded from the analysis.
• The rationale for the these decisions.
  Cumulative Risk Dimensions
                          Pathways
       Problem Formulation
 Iterative process for RA to develop
 hypotheses about why adverse effects might
 occur or have occurred.
 Determine the assessment endpoints-
 characteristics valued by society, and
 related to the management objective(s).
 Leads to a conceptual model.

-------
       Conceptual Models
Show relationships between assessment
endpoints and stressors.
Reflects both scientific hypothesis and a
rationale for accumulating risks from
stressors affecting common receptors.

-------
          Problem Formulation:


              Lessons from
      Ecological Risk Assessments
         Mark A. Harwell and Jack Gentile
Harwell Gentile
tt Associate*, L.C.

-------
Framework for Ecological Risk Assessment
                                        (EPA 1992, 1997)
            Problem Formulation
                                       Acquire Data,
                                       Iterate Process
                                        and Monitor
                                          Results
Exposure
           Risk Characterization
 Harwell Gentile
 & Auociatei, L.C.

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            Problem Formulation
HarweU Gentile
Sc Associates, L.C.

-------
Relationship Between Societal Goals and Scientific Endpoints
           and Measures in Ecological Assessments
                                            (Gentile and Harwell 1996)
 Societal
Relevance
                     Scientific Relevance
 Harwell Gentile
 & Associates, L.C.

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                                        Learning and Feedback
 Public
 Officials
                                                                                  Implementation
                                      Options and
Formulation  Design
 Natural and
 Social Scientists
                                                  Decision
                                                                                  Deliberation
FIGURE 1-2. A schematic representation of the risk decision process.

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       CATEGORIES OF ECOLOGICAL ENDPOINTS
HUMAN HEALTH CONCERNS
   • vectors for exposure to humans of diseases or toxics

SPECIES-LEVEL ENDPOINTS

   societal importance
   • economic, aesthetic, recreational, nuisance, or endangered
        species

   ecological importance
     interactions between species
     habitat role
     ecological role
     trophic relationships
     functional relationships
     critical species

COMMUNITY-LEVEL ENDPOINTS
   • food-web structure
   • species diversity of ecosystems
   • biotic diversity of ecosystems

ECOSYSTEM-LEVEL ENDPOINTS
   • ecologically important processes
   • economically important processes
   • water quality
   • habitat quality

LANDSCAPE-LEVEL ENDPOINTS
   • mosaic of ecosystem types
   • corridors for migration
   • spatial and temporal patterns of habitat
   • feedbacks to regional- and global-scale physical systems

-------
     Ecological Endpoints for Freshwater Marsh
             Ecosystems of South Florida
species-level endpoints
   • Spartina spp. productivity
   • Muhly productivity
   • exotic species

community/ecosystem-level endpoints
    hydroperiod/water levels
    plant community structure
    upland succession
    biodiversity
    periphyton productivity
    water quality
     • nutrient/oligotrophic status
    feeding habitat for wading birds
  landscape-level endpoints
    mosaic— spatial (physical distribution across landscape)
    mosaic— temporal (physical distribution across time)
    connectivity of habitats (e.g., with sawgrass)
    habitat fragmentation
    substrate dynamics
    stress response:
     • storm frequency
     • frost frequency
     • fire frequency/intensity

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        Cumulative Risk Elements
 What are
                The Questions ?
   What are the relevant sources of stress?
   What are the stressors of concern?
   What are the relevant paths and routes of exposure?
   Who and what are at risk?
   What are the health assessment end points?
   What are the ecological assessment endpoints?
Harwell Gentile
& Associates, L.C.

-------
Tampa Bay Bathymetry
                         0     5
                     Manatee Kilometers

-------
             Tampa Bay Critical Habitats
   Seagrass
• Mangroves
H Salt Marsh
— Sand Beac

-------
-4 -4 tl'A. MM ^w^HJ <.n«lfi
                   MANGROVES &
                     RSH GRASSES
                                         PHYTOPUNKTON
                                          (MICRO-ALGAE)
                                                                                                                         Sea Ituul
                                                                                                                         Suulhein MuuMiIci
                                                                                                                         RedlUh
                                                                                                                         Snuuk
                                                                                                                         Tdrnuii
                MACJO ALGAE
                                                                                                                         Killlliili
                                                                                                                         Suul
                                                                                                                         Suo CattW.

-------
. ,••- .-»-. -. 1t A MM	 *
                                                     111
                  WIND
         CURRENTS        VERTICAL MOTION
                                                                I  I
                                                                •••• •••
         SLICK
DISPERSION
DISSOLUTION        SEDIMENTATION
     BIODEGRADATION        ENTRAPMENT        COALESCENCE        EVAPORATION
               Physical Processes in fate and Transport Models

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    l.O-i
    0.8—
CO

o
     0.
     0.2-
     0.0
                                                                I Callinectes (Blue crab)



                                                 Cyprlnodon varlegatus (<2-hr-old embryos)


                                       ' Cyprlnodon variegatus (Minnow)


                                   Cyprlnodon varlegatus (>4-hr-old embryos)


                                Ampelisca (Amphipod)
                                       Penaeus (Pink shrimp)
                        Argopecten (Bay scallop)
                    Cynoscion (16-hr post hatch larvae)
Cynoscion (Seatrout yolk sac larvae)
              Mysidopsls (Mysid shrimp)
          0
    50
100
                                                 I
          150         200

Concentration (ppb BTEX)
250
            Cumulative Distribution of Fuel OH #6, Water Soluble Fraction
                                      Acute  Toxlclty Data

-------
Shipping Navigation Channels to
  Port Manatee and Sensitive
  Environments in Tampa Bay

-------
• Oiled Sand Beaches
(Seagrass
| Mangroves
I Salt Marsh
| Impacted Seagrass
! Impacted Mangroves
 Impacted Salt Marsh
Impacted Shallow Water/Nursery Habitats (< 1/2 m)
          Adverse Condition Fuel OH #6 Spill

                                                            J

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                   Summary
       Define goals and objectives
       Establish spatial/temporal boundaries
       Identify sources, stressors, and pathways
       Define endpoints and measures
       Construct conceptual models
       Formulate stressor-response hypotheses
       Rank stressor-effects relationships
Harwell Gentile
& Associates, L.C.

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        CONCEPTUAL MODEL
           DEVELOPMENT
     JOHN H. GENTILE & MARK A. HARWELL
Harwell Gentile
& Associates, L.C.

-------
             Conceptual Models:
           Principles and Examples
             Principles and rules
             Format & structure
             Watershed/habitat examples

             RI/FS case study example
 Harwell Gentile
""^ ft Associate*, L.C.
.w~

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          Conceptual Model Definition
           A spatially explicit graphical or text
           description of the candidate causal
           linkages among sources, stressors,
           receptors and endpoints describing
             the spectrum of potential risks.
^, Harwell Gentile
W*. 81 Associates, L.C.

-------
Framework for Ecological Risk Assessment
                                                (EPA 1992, 1997)
             Problem Formulation
                 Exposure
             Risk Characterization

Acquire Data,
Iterate Process
 and Monitor
   Results
         Cpmmunicatinggpesujte;
 Harwell Gentile
 & Associates, L.C.

-------
              Problem Formulation
jk Harwell Gentile
.^SSB?Si. Sc Associates. L..C.

-------
     Driver-Stressor-Effects Linkages
Harwell Gentile
& Associates, L.C.

-------
      Conceptual Model Benefits
Provides explicit expression of the assumptions
and understanding of the system

Reduces the dimensionality of the problem

Tool for learning, communicating, and consensus
building

Describes explicitly the linkages among sources,
stress, and the ecological components at risk

Template for generating testable risk hypotheses
Harwell Gentile
. 8c Associates, L.C.
                                                A

-------
          Cumulative Risk Questions
  What are the relevant sources of stress?
  What are the stressors of concern?
  What are the relevant paths and routes of exposure?
  Who and what are at risk?
  What are the health assessment endpoints?
  What are the ecological assessment endpoints?
Harwell Gentile
&As«ociates,L.C.

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      Conceptual Model Development
    1. Define the goals and assessment context
    2. Delineate scales and boundaries
    3. Inventory land uses/activities
    4. Describe the potential stresses and sources
    5. Identify contaminant release mechanisms
Harwell Gentile
Sc A»»oct««es, L..C.

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      Conceptual Model Development
   6.  Describe exposure pathways
   7.  Identify stressor - receptor co-occurrences
   8.  Identify health/ecological endpoints
   9.  Determine specific health/ecological measures
   10. Develop a suite of risk hypotheses
   11. Rank relative importance of potential risks
 Harwell Gentile
*- & Associates, L.C.

-------
        General Conceptual Model Format

                      Societal Drivers
                      (Landscape Activities)
                             I
                       System Stress
                             i
               Stress Regime/Exposure Pathways
                             l
             Disturbance/Stressor Co-occurrences
                       with Receptors

                             1
                  Primary/Secondary Effects
                   (Proposed Causal Linkages)
                             I
                 Health/Ecological Endpoints

                             4
                       Measurements
Harwell Gentile
8c Associates, L.C.

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      Waquoit Bay Conceptual Model
            EPA Watershed Case Study
 Harwell Gentile
5. & Associates, L.C.

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                                                                   Water and
                                                            Sediment Nutrients
     Decree
    Struam Gravel
      Substrate
                                                                                      Estuarlne
                                                                                       Benthlc
                                                                                     Invertebrate
                                                                                     Community
    Eelgrass
     HabHat
                                               CommunltvJ «  c
 /Invertebrate v/PlpIng Plover/  /ShelMlsW /
/ Indices. IBI/A least Tern /    Fish
/Eelgrass Cover /
Abundance /;
                                               of Resdent   3

-------
Agriculture   Atmosphere  Residential Dev.      Industry
Marine Activities
                                                                                    Shoreline
                                                                                    Protection
                                                                                    and
                                                                                    Modification

-------
                                    Plant accretion  (since mid 1800's)
                                                                  Precipitation
                                                                       I
                                                                              Fertilizers
       Septic systems
                                                                               Denitrified! ion
                                   NH4+  adsorption
1.1
  Nitrogen  entering
      coastal bay
x I  Figure E-5.  Inputs and fate of nitrogen (mol N x 10* yr') entering the watershed and traveling toward Buttermilk Bay near Waquoit Buy. Additional
     sources not shown are precipitation directly onto surface waters and onto impervious surfaces that are washed into surface waters. (Reprinted from
     "Couplings of Watersheds and Coastal Waters: Sources and Consequences of Nutrient Enrichment in Waquoit Bay, Massachusetts," by Valiela et ul.,
| |  published in Estuaritt, December 1992, Vol. IS, No. 4, pp. 443-457, with permission from Estuaries. •Estuarhte Research Federation.)

-------
     South Florida/Everglades Case Study
.^_ Harwell Gentile
A""1*, * AuocUwi. UC.

-------
South Florida Regional Environments
• Urban
D Open Water
• Cypress Swamp
Q Grassland and Agriculture
• Upland Hardwood Forest
I Coastal Saltmarsh
H Freshwater Marsh
• Mangrove Swamp
• Pinelands
• Shrub Swamp
H Exotic Plants
H Mixed Hardwood Swamp
£3 Dry Prairie

-------
       Defining Spatial Boundaries:
         Conceptual Model Landscape Units
Harwell Gentile

-------
• Sawgrass-Slough-Tree Island
• Fresh water-Cypress Swamp
• Marl Forming Wet Prairie
• Mangrove Estuary
V Coral Reef Tract
   Coastal/Estuarine System
   Rockiand Pine
• Lake Okeechobee
   Pine Flatwoods
• Wet Prairie
   Dry Prairie
                                                                    yne Bay

-------
     Biscayne Bay Conceptual Model
Harwell Gentile
& Associates, L.C.

-------
                       Biscayne Bay Conceptual Model
                                                  LAND & WATER
                                                       USE
HARVESTING
  VESTING &\ /  PHYSICAL
POACHING  / V  DAMAGE
                             SUSPENDED
                             SEDIMENTS
NTAMINANTSJ (ALTERED SALINITYI  ( NUTRIENTS
                                        BNCREASED
                                         ALGAL
                                                                             INCREASED
                                                                              ALGAL
                            SEAGRASS
                             SCARS A
                             SPONGE
                            REMOVAL
              MANATEE
               INJURY
                         ALTERED
                        SEAGRASS
                       COMMUNITY
                       DISTRIBUTION,
                       GROWTH, AND
                       PRODUCTIVITY
                                                      ALTERED
                                                   HARD-BOTTOM
                                                    COMMUNITY
                                                   DISTRIBUTION,
                                                   GROWTH, AND
                                                      ODUCTIVITY
                              REDUCED
                               WATER
                              QUALITY
 CHANGES
 IN FAUNAL
COMMUNITY
                                                 SEAGRASS
                                                COMMUNITIES
                                                                   HARD-BOTTOM
                                                                   COMMUNTTIES
                              MOBILE
                              MACRO-
                             ERTEBRAT
         RARE&
       ENDANGERED
         SPECIES
          LANDSCAPE
          STRUCTURE

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         Decision Support Methods
     Best Professional Judgement (BPJ)

     Delphi Method (Linstoneand Turoff, 1975)

     Analytical Hierarchy Process (Saaty, 1990)

     Fuzzy Set Theory (Zadeh, 1965, Harris et al. 1994)

     Vital Issues Process (Engi and Glicken, 1995)

     EPA/SAB Integrated Risk Project
Harwell Gentile
& Associates, L.C.

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                    Summary
       Define goals and objectives
       Establish spatial/temporal boundaries
       Identify sources, stressors, and pathways
       Define receptors, endpoints and measures
       Construct conceptual models
       Formulate stressor-response hypotheses
       Rank stressor-effects relationships
Harwell Gentile
& Associates, L.C.

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       RI/FS Conceptual Site Models
             Chemical Stressor Model
             Physical Stressor Model
            Human Health Effects Model
Harwell Gentile
& Associates, L.C.

-------
       RI/FS Conceptual Model Format

                         Inputs
                          i
          Release Mechanisms (Primary /Secondary)
                          i
             Affected Media/Secondary Sources
                          i
                    Exposure Routes
               Receptors and Systems @ Risk
            Primary/Secondary Health/Ecological Effects
                           I
                Health/ Ecological Endpoints
                           i
                        Measures
Harwell Gentile
& Associates, L.C.

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      RI/FS Site Boundaries, Sources,
                and Stressors
             Geography and Topography
        Definine Spatially Explicit Sub-basins
        Source and Stressor Characterization
Harwell Gentile
& Associates, L.C.

-------
                       SEGMENT 3,
                        Gorge Gulch >
                                                                                  SEGMENT 1
                                                                        Ownership not mapf
                                                                        Drimarily USFS land.
                                                                                33
                                    O'Neill Gulch
                                                 SEGMENT 2
                       SEGMENT 4
       LEGEND
   • Floodplain Tailings
  •  MF&G Water Quality Stations
  •  Producers

  D  Non Producers
  •  Cities
'SEGMENT 5
— •» —Segments
Land Status

I • • • I  BUM
II II I  Forest Service

      Private

-------

-------
 RI/FS Ecological Conceptual Site Models
             Chemical Process Model
             Physical Process Model
Harwell Gentile
& Associates, L.C.

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Inputs
  Primary
Source wes
Primary Release        Secondary    T
  Mechanisms    | Release Mechanlsmp
     Affected
    Media and
Secondary Sources
Exposure
 Routes
Receptors     I   Geographic
              I    Linkages
                                                                                                                    Riverine
                                                                                                                  Fish

                                                                                                                  Benlhlc
                                                                                                                  Invertebrates
                                                                                                                  Birds

                                                                                                                  Perfphytron
                                                                              Contact, Ingestlon
                                                   Chemical
                                                   Process
                                                                         Surface
                                                                        Water and
                                                                        Suspended
                                                                          Solids
                    Surface Water
                       Erosion
                                                              Contact, uptake
                                                                                                                    Riparian

                                                                                                                  Plants

                                                                                                                  Soil
                                                                                                                  microbes

                                                                                                                  Soil
                                                                                                                  Invertebrates

                                                                                                                  Wildlife
                                                                             Contact, uptake
                                                                              Contact, Ingestlon


                                                                              Inhalation
                                                                                           Contact, uptake
                                                                                           Contact, Ingestlon
                Porcess
                Wastes
                                                                                                     Invertebrates
                                                                                                     Wildlife
                                                                                                               Preliminary Process Model

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                                Primary
                                Stressora
                                                                                                                                  Fish Community
                                                                                                                                     Structure/
                                                                                                                                     Function
                              Altered Stream
                                Hydrology
                                                             Altered Stream
                                                             Morphology
                                                                                                    Riverine
                                                                                                  Rsh

                                                                                                  Benthte
                                                                                                  Invertebrates
                                                                                                  Birds
                                                                                                  Periphylron
                                                              Decreased pool habitat
                                                              Decreased run habitat
                                                              Decreased riffle habitat
                                                              Decreased cover
                                                              Destabilized banks
                                                              Barriers to migration
                                                                                                                                 Riverine Invertebrate
                                                                                                                                 Community Structure
                                                                                                                                      Function
                                                                                                                                 Spawning Habitat
  Mine/Mill
 Structures
                                                                                                                                 Overwintering Hablte
                                                                                                    Riparian
                                                                                                   Plants
                                                                                                   Soil
                                                                                                   microbes
Other Process
   Wastes
                                                                                                                                  Riverine Migratory
                                                                                                                                       Routes
                                                                                                                                Diversity of*§tructure
                                                                                                                                  and Composition
  Vegetation
 Management
                                                             Altered Terrestrial
                                                             Habitat
                                                                mosaic
                                                             Loss ol connectivity
                                                             Loss of wildlife habitat
                                                             Loss ol soil structure/
                                                                function

                                                             Changed species
                                                                composition
                                                                                                                                    Riparian and
                                                                                                                                   Upland Migratory
                                                                                                                                      Corridors
                                                                                                                                  Son and Sediment
                                                                                                                                 Quality and Function
Waterborne Log
Transport (past)
  Upland
Plants
Soil
microbes
Invertebrates
Wildlife
Removal of
 Soil and
 Sediment
 Roads and
  Railroads
                                                                                                                                  Landscape Mosaic
                                                                                                                                 Forest Community
                                                                                                                                     Structure/
                                                                                                                                      Function
    Stream
Channelization
                              Decreased Soil
                                Productivity
Housing and
   Urban
Development
                                                                                                                                   Selected Species
                                                               Increased Export

                                                                Sediments
                                                                Nutrients
                                Increased
                               Nutrients to
                                 Stream
                                                                                                                                      See Issues
                                                                                                                                       Statement
                                                                                                                    Physical Stressors CSM

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    RI/FS Health Effects Conceptual Model
  Harwell Gentile
"" -". & Associate^ L.C.

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Inputs
  Primary
Source "types
Primary Release   I    Secondary    T
  Mechanisms    | Release Mechanlsmp
    Affected
   Media and
Secondary Sources
                                                                                       Exposure
                                                                                        Routes
Receptors       Geographic
             |    Linkages
p
eclpltatlon
                                                                                                      Preliminary Process Model

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    Affected
    Media and
Secondary Sources
     Surface
      Water
Pathways
                         Inhalation
                         Ingestion
                       (Water/Food)
                         Contact
                         (Dermal)
Receptors
                                          —n Adults
                                                 Mine
                                               Workers
                                                Children
                                                Infants
Endpoints
                                        Carcinogenic


                                        Neurotoxicity

                                        Reproduction


                                        Developmental


                                        Cardio-vascular

                                        Immunologic


                                        Renal


                                        Hepatic


                                        Others
Measures
                                                                       Human Health Effects

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                      Summary
         Define goals and objectives
         Establish spatial/temporal boundaries
         Identify sources, stressors, and pathways
         Define endpoints and measures
         Construct conceptual models
         Formulate stressor-response hypotheses
         Rank stressor-effects relationships
  Harwell Gentile
^2*!^. & Associates, L.C.

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Appendix E. Hypothetical Model Exercise
                 E-l

-------
             HYPOTHETICAL CASE EXAMPLE FOR CUMULATIVE RISK
The Scenario

The area of concern is a regional environment consisting of the lower reaches of a major river
system, its associated floodplain, wetland, and estuarine ecological systems, a highly engineered
water management system, and a nearby urban population of 1 million people.  The river system
drains a large area with extensive agricultural production; agricultural runoff adds significantly to
the river's already high load of suspended solids and turbidity. The river has very high levels of
nutrients, but because of the high turbidity (which lowers primary productivity) eutrophication does
not occur until the water reaches the estuary.  The river also receives high levels of pesticides and
organic chemicals from non-point agricultural sources, point source discharges from a fertilizer
plant, and an extensive petrochemical industry with a variety of discharges.  Alongside the river is
a levee built for flood control, and beyond that artificial levee is a floodplain with a natural ridge
some distance beyond. In between the two levees are natural wetlands, which are being rapidly
converted to open water systems because of the interference with the natural sedimentation
processes   historically associated with floods. Further, some wetlands have been converted to
agricultural use and others have been converted to aquaculture (oysters and catfish ponds).  The
remaining wetlands and croplands provide important habitat for migratory birds because the area is
located on a major flyway.  Near the mouth of the river is an urban area, which contributes
significant discharges from storm water, municipal waste treatment facilities, and surface runoff.
The river opens into a delta at the estuary. Offshore is a growing hypoxic area, resulting from the
eutrophication of the estuarine waters because  of excessive nutrient inputs, high secondary
productivity, and consequent depletion of dissolved oxygen.

The human populations of the area include workers in the agricultural and chemical industries, who
have high exposures to pesticides and toxic chemicals; a general urban population with a  high
incidence of bladder cancer (4 times the national  rate); and a sensitive population of asthmatics,
elderly, etc. exposed to high levels of particulates. Other ecological and/or human health issues
include high lead levels in sediments; bioconcentration of chemicals in fish and in fish-eating birds.

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                                           NATURA
                 AGRICULTURE
  AGRICULTURE
                                 FLOODPLAIN
                                                     AQUACULTURE
         INDUSTRIAL
                         PETROCHEMICAL
                            INDUSTRY
01-7/98

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            Cumulative Risk Questions
    What are the relevant sources of
    What are the stressors of concern?
    What are the relevant paths and routes of exposure?
    Who and what are at risk?
    What are the health assessment endpoints?
    What are the ecological assessment endpoints?
A. Harwell Gentile
S^i. & Associates, L.C.

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        Cumulative Risk Elements
 What are
                TheQwstons?
   What are the relevant sources of stress?

   What are the stressors of concern?

   What are the relevant paths and routes of exposure?

   Who and what are at risk?

   What are the heatth assessment endpoints?

   What are the ecological assessment endpohts?
What an
                  Sources?
   Single Source
    • point sources: industrial discharges, waste sites
    • non-point sources: automobtes, agriculture
    • natural sources: floods,hurricanes, fires


   Multi-sources
    • combinations of those above

       Cumulative Risk Elements
What are
Stem?
      Chemical
        • toxic metals and orgarics
        • nutrients

      Physical
        • liabtet alteration, floods, fires
        • climate: precipitation, temperature, etc.

           Steal
             gens, dsease
             •/invasive species

      Societal
        • economic
        • psychological

-------
        Cumulative Risk Elements
 What are
                Air
                Surface water
                Groindwater
                Sols/sediments
                Sold waste
                Food
                Non-food products
       Cumulative Risk Bemefits
 What an
    Ingestion - food and water

    Dermal - absorption and active uptake

    Inhalation - includes gaseous exchange

    Non-dietary Ingestion - hand-to-mouth behavior

       Cumulative Risk Elements
What are
    Direct contact or ingestjon without accumulation

    Bioaccumulation

    Biomagnifl cation

    Vector transfer - parasites, pathogens, eta

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       Cumulative Risk Elements
 What are
 Human
  • Individuals
  • General Population distribution or estimation of central
                   tendency and high end exposure
  • Population subgroups: highly exposed subgroup (e.g.,
                     age* gender) and highly
                     sensitive subgroups (e.g., age
                     gender, pre-existing conditions)
What an
         R«*fferCtf«oriMQRWc?
           Ecological
             Individuals
             Populations
             Communities
             Ecosystems/Habiats

           Landscapes/Regions
             Watersheds
             Regional scale ecosystems
       Cumulative Risk Elements
What are
               Carcinogenic
               Neifotoxicdogcal
               Reproductive Dysfunction
               Developmental
               Cardie-vascular
               Immunologc
               Renal
               Hepatic
               Others

-------
        Cumulative Risk Elements
What ire
            EoofaQtoilBndlpoMfc?
Species:   growth, survival, reproduction, habiat role

Population: long-term growth, sustainability. resliency, etc

Community: biotic and species dversly, richness,
           trophic structure, etc.

Ecosystem: structure, function, services, water quality,
           habitat quality etc.

Landscape: habitat mosaic, connectivity, spatial-temporal
           habitat patterns

-------
Appendix F.  Case Study Results from the Break Out Sessions
(Brainstorming, lists of dimensions, ranking and priorities and preliminary linkages and
conceptual models)
 I.CCRI

 Presenter: Carole Braverman, Region V
 Facilitator: Mark Harwell, University of Miami
                                          F-l

-------
Chicago Cumulative Risk Initiative Case Study-November 12, 13, 1998
(Transcription from Hand-Written Notes on Charts, not in any particular order)
At Risk Populations-Human Health
General Population
Children (pre-school)
Elderly
Pregnant females
Asthmatics
Immuno-Suppressed
                       Exposure population
                       Industrial workers
                       Proximity to point sources
                       Economic&Cultural > subpopulation
                       Children
                       Smokers
                       2nd Hand smoke pop.
Sickle Cell Anemics/Genetic predisposition  Confined populations
Economics/Cultural: subpopulations
Stressors (air)

Particulates
Bio-Aerosols Lead
Ozone
PAHs
Toxic Organics
Benzene
Metals
NOx and SOx
Odor
Mercury, PCBs, Dioxin

Cadmium
Chromium
Noise/vibration
Other Toxics
Flammables/Explosives
Endocrine Disrupters
Pesticides
Pathway Breakout
                             Dioxins
      Eco-Receptors
      (Fish)
      Biomagnification


      Human Receptor
      Deposition
      (aquatic)
      Absorb particles

Inhale           Deposition on Soil
                       Dermal contact
                                        Inges
                            ion
                                    F-2

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CCRI
Goals and Objectives

1. Understand environmental conditions of Cook and Lake County (Air quality
current focus) better

2. Use understanding as basis for:
      -(future) permitting decisions
      - communication with stakeholders

3. Determining societal goals in region

4. Determining if multiple contaminant sources are in COMPLIANCE (to result in
healthy environment)

SPATIAL/TEMPORAL Boundaries

1. Political boundary: Cook Co. (IL) and Lake Co. (IN)

Endpoints: Human Health

Cancer—
     Childhood leukemia
     Lung cancer
     Breast Cancer
     Other Cancers

Non-cancer—
     Asthma          Developmental
     COPD           Cardio-Vascular
     Birth Defects     Acute Effects
     Neurological Reproductive Disorders
     Immunological    Behavioral Effects
                                   F-3

-------
Human Health and Ecological Risk Assessment
SOURCES (Air)
      - Steel Mills
      - Oil Refineries
      - Incinerators
      -WWTP
      - Mfg. Plants
      - Small Point Sources
      - Recycling (Metals)
      - Indoor Air
      - Background sources
      - Asbestos
      - Land mgt. burning
      - Landfills
      - Chemical Plants
      - Power Generation Plants
      - Airports
      - Mobile
      - Pesticides (lawn/golf pest control)
      - Lake Michigan
Endpoint - Eco
      Lake (Aquatic)
UrbanHabitat    AG
            Tall grass
            Prairie
                                                    Migratory birds
Species     carp



Community

Ecosystem


Landscape
            Dunes      Forest Preserves
Neotropical  Earner blue      Amphibians
Birds       butterfly         Deer
                            Tree health
                             Maintain biodiversity
            Decomposition     Air filtering
            Processes
                                    F-4

-------
 SOURCES
 Steel mills
 Mfg. plants
 Small point sources
 Indoor air
 Mobile
 Incinerators
 Agriculture
 STRESSQRS

 Toxics:

 organics
 Pesticides
 PCB/Dioxin
 PAH
 Benzene
 Endocrine Disrupters

 Inorganics:
 Metals: Pb, Hg, Cr, Cd
 Particulates
 Noise
 Odor
 Ozone/NOx/SOx
 (Pathways presented below)

 Sources               Stressors

 Incinerators	End. Disrupters
ENDPQINTS

Human:

Cancer: leukemia, lung, breast,
Other
Respiratory :COPD, asthma
Dev./Reprod./Birth Defects
Neuro./Behav.
Cardio-Vascular
Immune

Eco:

Neotropical Birds
Tree Health
Biodiversity
Deer
                       Endpoints
Agriculture	
Incinerators.
Mfg. plants	

Indoor air	

Mobile	

Agriculture	
.Odor
                                   F-5

-------
Sources
Steel mills
Incinerators
Mfg. plants
Agriculture
                       Stressors
                       Participates
                        Pesticides
Endpoints

(Human)
Cancer
Dev./Reprod./BD
Neuro/Behav.
Immune
Incincerators
Indoor air
Mobile
                       PAH
Mfg. plants ....................... PCB/Dioxin_
                                              Cancer
                                              Neuro/Behav
                                              Immune
Steel mills
Mfg. plants
Indoor air
                       -Metals
                                              ECO
Mfg. plants
Small pt sources
Mobile
                       .Ozone/NOx/SOx.
Tree Health
Biodiversity
                        Noise
                                              Neotropical birds
                                              Tree health
                                              Biodiversity
                                              Deer
                                    F-6

-------
Pentachlorophenol-Assigned Participants
Presenter: Nader Elkassabany and Wanda Jacobs, Office Pesticide Programs
Facilitator: Jack Gentile, University of Miami

B.  Pentachlorophenol

Presentation of case on PCP

Milestones
used only for wood preservation, 1987

Working with PMRA-NAFTA
Doing work sharing with work plan dividing up tasks
Eco, human health etc. So won't duplicate work

Regulated under other laws

STAKEHOLDERS are industry, trade assoc., public, environmental groups

? Ho w do you mediate differences—No set formula (Karen Me); senior management and public
ultimate determiners; strong impetus to agree based on NAFTA

Chemistry
Usage~25 products registered for use
Hazard ID
-B2 carcinogen
-microcontaminants important; used TEFs and TEQs used to set criteria
Environmental Hazards
-limited eco effects; relying on ORD and contractor support—will be qualitative assessments
Human Exposure Scenarios
Human Exposure Pathways
Environ. Exp Pathway
Issues/Uncertainties

? Any indication of unintentional dietary exposure (beddding shavings used in hog farms);
swine showed PCP residues (Karen Me)--Wanda-some people using railroad ties for gardening;
Should be considered in conceptual model development? Canada requiring accountability for
bedding source-not sure how big problem; no requirement for putting wood into RCRA site in
Canada, and the US

Process for breakout group—id sources, stressors, pathways, endpoints; start inclusively could
go outside PCP; broaden conceptual model to include microcontaminants (perhaps 2nd model)

                                        F-7

-------
Do PCP and if time do microcontaminants

What about alternative—creosote, CCA-looking at relative risk assess.; may more relevant to
look across agents to evaluate relative toxicity; be careful not to eliminate less toxic material;

What are expectations? Jack
Tutorial, how to apply
PCP with contaminants (Karen's preference)

CR Risk Elements—the Questions

Potential Sources-PCP and microcontaminants
(Karen—looking at overall contribution to dioxin contamination in environment)

-wood treatment plants
-manufacturing
-disposal: landfill sites/recycled-re-dimensioned/incineration
-in-use/service: utility poles(soil), marine dock pilings (aquatic), residential (decks/outdoor
only),
residential (indoor)

Stressors

-PCP
-furans/dioxins (lump because can evaluate with TEFs
-hexachlorobenzenes (HCB)
(stressors must be in contact with receptors)

Pathways of exposure~eco and human health

? Is psychological legitimate stressor (stress)-yes; relates to contaminants; could put on human
side; however, not part of US thinking at this time but is in Canada-will put in as endpoint.

-runoff onto surface water
- ground water
- soil,
- air (volatilization)
-dietary
-treated wood

Routes of exposure
-ingestion

                                          F-8

-------
 -contact
 -inhalation

 Review of approaches from yesterday/RI/FS model—1)Aggregate in how stressors move
 through environment together (process approach), 2) Waquoit Bay approach-sources at top,
 stressors at bottom, then stressor-driven analysis
                                                                          *

 Biscayne Bay model—little simpler approach; major sources at top, stressors sources,
 pathways, major habitats impacted (freshwater stream communities, etc.); develop broad
 pathways and put in detail; suggest to build simply but capture major issues; look in more detail
 later on

 Need to flesh major habitats of concern and then pick the endpoints

 Major Receptor Habitats/classes impacted
 -terrestrial community/soils (unsure if available in plants—may be thru air deposition)
 -streams/waterbody
 -estuarine
 -marine
 -human: 1) occupational: workers in plant, utility pole workers, handlers,
         2) residential (adults, children)

 (Conceptual models are accompanied by extensive text—Jack)

 Receptor Habitats:                Endpoints:
                     PCP            Dioxin/Furans           HCB

 Terrestrial:    Floral diversity             NA                 NA
              -acute effect

 Soils:         Earthworms               Birds (earthworms)
              Microbes                  Mammals(voles,
              Invertebrate community     moles)
                                        Raptors (subreceptor)
                                        Habitat quality

Freshwater:    Fish community           Fish/fishing
              Invertebrates               Mammals (mink, otters)
                                        Raptors(birds, waterfowl)
                                        Water quality

Marine:       Benthic invert. Cornm.      Same

                                          F-9

-------
              Fish/bottom feeders          Shellfish
              plants

Occupational: Teratogenicity
              Cancer, renal, stress
              Genotoxicity, subchronic

Residential:   developmental
              neurotoxicity

Next step rough out conceptual model using Biscayne Baymodel (flip charts)

Manufacturing    Water treatment. Transportation Disposal Poles  Pilings  Residential


              PCP         Dioxins/Furans             HCB


terrestrial           Soils         freshwater     marine  occupational residential

(Flora diversity)
passerine birdsearthworm pop

voles

hawks

(see hand written graphic)

Might be useful to look at receptor hits for manufacturing; do ranking of sources to receptors-
Jack

Manufacturing

terrestrial (runoff)
marine (effluent/spill, air deposition?)
occupational (inhalation, ingestion, dermal)
residential (stack emissions)
fresh water (effluent/spill, runoff)
soils (runoff, leaching)

Wood treatment

                                          F-10

-------
contaminated soils (runoff)
fresh water (runoff/effluent)
marine (runofFeffluent)--geographic (east coast primarily)
occupational (dermal, ingestion, inhalation?)
Transportation (tanker truck on road)

soils
fresh water
occupational

Disposal (landfills)

soils
fresh water

Poles

soils
occupational
residential

Pilings

marine

Miscellaneous (wood/homes)~replaces residential

residential
Ranking exercise for human pathways and environmental pathways/routes of exposure was
performed at the first practicum and was used in this exercise (see tables at the end of
discussion). Ranked for each source not across sources.
Environmental Pathways/routes of exposure
                                         F-ll

-------
(Secondary routes were identified to wildlife but didn't identify links to human life (in analysis)
2 hooks)

Process for breakout group-identify sources, stressors, pathways, endpoints; start inclusively
could go outside PCP; broaden conceptual model to include microcontaminants (perhaps 2nd
model). The group agreed to focus first on PCP and if time do microcontaminants.

What about alternatives—creosote, CCA—looking at relative risk assess.; may more relevant to
look across agents to evaluate relative toxicity; be careful not to eliminate less toxic material;

The expectations were that this case would serve as a tutorial on how to apply the guidance to
the risk assessment of this case.

Cumulative Risk Elements-the Questions

Potential Sources-PCP and microcontaminants.
(Karen—looking at overall contribution to dioxin contamination in environment)

-wood treatment plants
-manufacturing
-disposal: landfill sites/recycled-redimensioned/incineration
-in-use/service: utility poles(soil), marine dock pilings (aquatic), residential (decks/outdoor
only),
residential (indoor)

Stressors

-PCP
-furans/dioxins (lump because can evaluate with TEFs
-hexachlorobenzenes (HCB)
(stressors must be in contact with receptors)

Pathways of exposure—eco and human health

? Is psychological legitimate stressor (stress)--yes; relates to contaminants; could put on human
side; however, not part of US thinking at this time but is in Canada-will put in as endpt.

-runoff onto surface water
- ground water
- soil,
- air (volatilization)
-dietary

                                         F-12

-------
 -treated wood

 Routes of exposure
 -ingestion
 -contact
 -inhalation

 Review of approaches from yesterday/RI/FS model-1)Aggregate in how stressors move
 through environment together (process approach), 2) Waquoit Bay approach—sources at top,
 stressors at bottom, then stressor-driven analysis

 Biscayne Bay model-little simpler approach; major sources at top, stressors sources,
 pathways, major habitats impacted (freshwater stream communities, etc.); develop broad
 pathways and put in detail; suggest to build simply but capture major issues; look in more detail
 later on

 Need to flesh major habitats of concern and then pick the Endpoints

 Major Receptor Habitats/classes  impacted
 -terrestrial community/soils (unsure if available in plants—may be thru air deposition)
 -streams/waterbody
 -estuarine
 -marine
 -human: 1) occupational: workers in plant, utility pole workers, handlers,
         2) residential (adults, children)

 (Conceptual models are accompanied by extensive text—Jack)

 Receptor Habitats:                Endpoints:
                    PCP            Dioxin/Furans           HCB

 Terrestrial:    Floral  diversity             NA                 NA
              -acute effect

 Soils:         Earthworms                Birds (earthworms)
              Microbes                   Mammals(voles,
              Invertebrate community      moles)
                                         Raptors (subreceptor)
                                         Habitat quality

Freshwater:    Fish community             Fish/fishing
              Invertebrates                Mammals (mink, otters)

                                         F-13

-------
                                         Raptors(birds, waterfowl)
                                         Water quality

Marine:       Benthic invert. Comm.      Same
              Fish/bottom feeders         Shellfish
              plants

Occupational: Teratogenicity
              Cancer, renal, stress
              Genotoxicity, subchronic

Residential:   developmental
              neurotoxicity

Next step rough out conceptual model using Biscayne Bay model (flip charts)

Manufacturing    H20 trait. Transportation Disposal Poles  Pilings  Residential


              PCP         Dioxins/Furans              HCB


terrestrial           Soils         freshwater     marine  occupational residential

(Flora diversity)
passerine birdsearthworm pop

voles

hawks
Might be useful to look at receptor hits for manufacturing; do ranking of sources to receptors-
Jack

Manufacturing

terrestrial (runoff)
marine (effluent/spill, air deposition?)
occupational (inhalation, ingestion, dermal)
residential (stack emissions)
fresh water (effluent/spill, runoff)

                                          F-14

-------
soils (runoff, leaching)

Wood treatment

contaminated soils (runoff)
fresh water (runoff/effluent)
marine (runoff/effluent)~geographic (east coast primarily)
occupational (dermal, ingestion, inhalation?)

Transportation (tanker truck on road)

soils
fresh water
occupational

Disposal (landfills)

soils
fresh water

Poles

soils
occupational
residential

Pilings
marine
Miscellaneous (wood/homes)~replaces residential
residential
Ranking exercise (human pathways)

Management Goal: Review HDWPs in sequential order; then do comparative risk analysis.
       > Review wood preservatives as a class
       > Assess each class individually
       > Revisit each class as a group/cumulative risk/comparative risk

Planning Process: Use pentachlorophenol as a model/template.

To Build a Matrix:

                                         F-15

-------
      Point/Non-point?
      Health/Ecological?
      Pathways: human/eco?
HUMAN
Occupational
Accidental (L)*
Occupational (H)*
Occupational (L)
Occupational (RCRA)
Children (L) (?)
(L)
(L)
Residential Occupational
(L)
ECOLOGICAL
Aquatic
Spill
Aquatic (L)
Soil (L)
Aquatic (H)

Soil (L)
Aquatic
Soil/Water (H)
(L)
SOURCES
Manufacturing
Transport [of chemicals and logs]
Wood Preservative Facility
Utility Poles [localized]
Disposal of Treated Poles [consumer misuse]
Residential Uses (e.g., decks)
Fences
Pilings, Piers, Docks
Remedial Ground line Treatment
Farm buildings/Industrial buildings
*L=Low, HHHigh

Action: Enhance dialog between OP/AD and ORD: e.e., exposure pathways and toxicology.
Need to assume "partners" are providing appropriate information.

Air Emissions: Gene Grumpier from Kelly Rienert at workshop.
Pathways
                        Human Pathways/Routes of Exposure
SOURCE
Manufacturing
Transportation
Wood Preservative Facility
Utility Poles
Disposal of Treated Poles
DERMAL
High

High
Low
Low (RCRA Issue)
INHALATION
Low

Medium
Low
Low
INGESTION
Low

Low
Low
Low
                                      F-16

-------
Residential Uses/ subpopulation-children
Peaces
Pilings, Piers, Docks
Remedial Ground line treatment
a. Occupational
b. Residential
Farm Buildings/Industrial Buildings
Medium - children
Low
Low (N/A)

Low
High
Low
Low
Low
Low

Low
Low
Low
Medium
Low
Low

Low
High
Low
Human Health Endpoints
> Liver
> Carcinogenicity
> Immunotoxicity
> Endocrine Disruption
> Kidney
> Neurotoxicity
> Developmental Toxicity (Teratogenicity)
                    Environmental Pathways/Routes of Exposure
SOURCE
Manufacturing
Transportation - Parked
Wood Preservative Facility
Utility Poles
Disposal of Treated Poles
Residential Uses/ subpopulation-children
Fences
Pilings, Piers, Docks
Remedial Ground line treatment
DERMAL
Low?

Low
Low
Low (RCRA Issue)
Low
Low
Low

INHALATION
Low?

Low
Medium?
Low
Low
Medium?
Medium

INGESTION
High

Low
Medium?
Low
Low
Medium?
High

                                      F-17

-------
a. Occupational
b. Residential
Farm Buildings/Industrial Buildings
Low
Low
Low
Medium
Medium
Low
Low
Low
Low
Environmental Endpoints
A. Aquatic Organisms
>Fish
> Invertebrates
> Aquatic Plants
B. Terrestrial Organisms
>Bird
> Mammals
> Invertebrates- need receptor for
analysis/
scoping
Mortality
/
/
S

/
/

Reproduction
/
/



/

      F-18

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III. Concentrated Animal Feeding Operations
Presenter: Gerald Carney, Region VI, Dallas, TX
Facilitator: Larry Reed, Superfund, Ed Bender, OSP, Washington, DC

Preliminary comments and questions on scope and background
Needed to clarify that the Cumulative Risk Index Analysis was a screening process, which used
GIS data, being applied to a Concentrated Animal Feeding Operation,
Initially there was some confusion over the sources within a CAFO
The terminology of stressor needed a bit of clarification.
There were human health, quality of life and human welfare issues associated with CAFOs
watershed impact seems like good approach
what is cum risk aspect- either an addition of stressors to a watershed or siting of multiple
facilities.
odor and disease were main human effects; can capture as economic loss as well as risk.

List of factors for each dimension of the CAFO project

Assessment End points
-Sustainable natural grassland prairie ....
-biodiversity (richness, evenness)
Plant Communities
Wildlife communities
Sport and recreational fish and their habitats
Maintain a designated stream use for the water shed or stream segment
Habitats which may contain endangered species

Stressors
Turbidity
Nitrate-nitrogen (ammonia)
Nitrite-nitrogen
Phosphorus (phosphate)
Sulfur (hydrogen sulfide, sulfides)

Aerosol chemicals
Noise
Dust, particulates
Odor (also considered as an effect)
Pathogens
Attractive nuisance to waterfowl
Pesticides
Drugs and  antibiotics
Waste feed

                                         F-19

-------
 Manure
 Road Deterioration/construction and maintenance
 Water quantity (groundwater withdrawal, water table draw down)
 Increased traffic
 Higher taxes
 Sources

 One or more CAFOs within a watershed
 -lagoon
 -barns
 -land application system
 -trucks

 Other sources within the watershed which contribute similar stressors
 -Expansion of other farms
 -Urban areas looking for growth and higher land use
 -Federal facilities
 -Industry-particularly oil and petroleum exploration in Texas setting.
 -Septic tanks and drain fields
 -POTWs

 Measurement end points

 1. Fish, invertebrates, aquatic community
 -water quality measurements
 -water borne pathogens
 -algal populations, abundance and diversity, photosynthetic indices....
 -endocrine disrupters

 2. Terrestrial ecosystem (prairie)
 -number of birds vs. control areas (literature for screening
 -endangered species, other special species (presence, absence, abundance)

 3. Human health
 -incidence of disease, self-reported
 -medical survey data (screening)
 -complaints to local and state doctors and health service, police, firm and rescue
-could address EJ health (Indian reservations for example)

Effects

                                          F-20

-------
Siltation
Loss of water clarity
Anoxia
Odors causing anxiety and stress
land-use changes
algal blooms-eutrophication of lentic waters
aesthetics
met-hemoglobanemia from nitrites in water supply
headaches, dizziness, nausea
fish flesh tainting
Inability to urban/suburbanize (residential development fbre'cftfsed)
Fish effects of silt
Traffic accidents
Spills of materials
Water quality damage
Road deterioration
Habitat fragmentation due to new and wider roads
Wetlands dry up
Disease to humans and domestic and wild animals.
       The group focused on nutrients and toxic effects on the watershed, habitat degradation
and loss for the uplands, and nuisance (e.g., odor, flies, and increased traffic) and land-use
commitments as effects of concern to humans. The group was not aware of any studies on
human disease or other human health effects related to these CAFOs. Several people noted that
this is the kind of issue that sparks a lot of public interest and concern, but that most federal
agencies and state agencies are powerless to address.  Region VI is using the NPDES permit
process to set some conditions on these facilities, however, this discussion shows that it is far
more that can and should be considered than the traditional limitations placed on sewage
treatment facilities.

       The group also discussed how this might be used to communicate the nature of the
problem and the issues of greatest concern to the public.  The process of planning and scoping
was very helpful to open up the thinking of the participants and share experiences they had
about related problems and approaches. The group found that several stressors caused multiple
effects, e.g., ammonia as a nutrient for algae and being toxic to fish.

       The group put together a preliminary diagram of the dimensions of the risk assessment,
but the linkages were not completed.
                                         F-21

-------
       The role of stakeholders in the screening process was unclear. In some instances, this
type of analysis was prompted by public requests for assistance or review.
                                         F-22

-------
Appendix G.  Comments and Suggestions from Participants

Comments on Chicago Colloquium

Most useful:

1. Outline of conceptual model and planning and scoping.  Practice in the breakout sessions.

2. Seeing this from the ecological standpoint and a human health perspective.

3. Breakout session case studies to flesh out the guidance and conceptual models.

4. The examples presented on the first day and the working experience in the break-out session
were the most useful.

5. The format was excellent, concepts, hypothetical case and the real case study. Good balance
between into. Lectures, walk-through, and break out exercises.

6. Glad the discussion was not limited to existing data.

7. The advance materials were very helpful background. They articulated the main themes of
human health and ecological risk assessments and the problems of merging them into a
cumulative risk assessment.


Aspects to change:

1. Seems like first day could be done more quickly, get to the discussion of the hypothetical
earlier, let the detailed diagram be shown later, at least to some extent.

2. I would not change any aspect, but I probably would add to them when holding future
practicums.

3. The connection to cumulative risk was unclear and the presentations were almost too basic.

4. The hypothetical needed more basic facts and foundation regarding the proposed action site.

5. Add an analytical component to address conceptual models and rankings.

6.  Offer more ideas on how to merge ecological and human health risks into one cumulative
risk assessment.  Explain the differences.
                                          G-l

-------
7. Some examples of human health risk assessment would be useful.

8. Make more tune for the case study evaluation.

9. Separate ecological risk and health risk to avoid confusion about the terau'nology. Once
people have gone through the process it would be easier to join the disciplines.

Recommendations to strengthen the discussions and practicum:

1. Move to hypothetical earlier in presentation.

2. Add information on tools for diagram drawing and GIS

3. Add expert on human health and examples of human health cumulative risk assessment to
the introduction.

4. From a regulatory point of view, the practicum needs to strengthen the areas where no data
are available to determine potential exposure. Next what happens when the model is complete-
how is it converted to a numerical model.

5. Need to look more at  how it applies to regulatory program and sites.

6. Need to go beyond scoping/planning/conceptual models.


7. Unclear how ranking  individual stressors fits into true cumulative perspective.

8. Take environmental justice into account. Continue to emphasize stakeholder (interested and
affected parties) involvement at the problem formulation stage.

9. Make more time to explain and work with the conceptual models (the breakout sessions
helped). Perhaps have software that could draw a conceptual model.

10. More discussion of stressor-endpoint ranking exercise.  Demonstrate software for producing
conceptual models.

11. Add extra day for to  flesh out and apply the model in the case studies.

12. Identify issues up-front: 1) program level use of the exercises and 2) spatial scope for the
analysis.

13. Make the handout maps and charts clearer.

                                         G-2

-------
Case Studies

1. The case study was useful in serving as an example of developing a conceptual model as well
it is of direct interest since re-evaluation of PCP is currently in progress.

2. Not sure that cumulative risk assessment is the correct term for what we did.

3. Look at cumulative risk and compare what drives risk (i.e., scientific methods) with
community pressures and politics and economics.

4. CCRI is a good example of a case that has intense public interest

5. Discriminate between incremental and aggregate cumulative risk.
                                         G-3

-------
Appendix H. Draft Conceptual Model
               H-l

-------
                    PCP Human Health Conceptual Model
Sources
Pathways
                        Dermal Exposur
                         .:..-• . -;.. ... f.fc" •;-.. ;..,-;- JL •-
                                                 (—esidential-")
       (--Occupatiorfcl
Exposed
Populations
Adults
Non-
pregnant
Adults
-Pregnant
Fetus
Adults
Non-
pregnant
Adults
-Pregnant
Fetus
Toxicity
Endpoints
 Occupat/Residential
 Nonpregnant
 -Acute Toxicity (high)
 -Subchronic/chronic
 -reprod. & genotox
 -endocrine disruption
 -stress(high?)
                                              1
                Occupat/Residentia
                Pregnant
                Same endpoints as
                non-pregnant, plus
                -developmental tox.
                 and neurotoxicity
 Children
 -neonates
 -child
^ -juvenile
                 Children
                 -Reproductive
                 -Developmental Tox
                 incld. Neurotox.
                 -Endocrine Disrupt.

-------