United States
Environmental Protection
Agency
EPA Headquarters, East Building I Map Room 1153
1201 Constitution Avenue, NW I Washington, D.C. 20004
Office of Research and Development
Science To Achieve Results (STAR) Research Program
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Table of Contents
Agenda (presenter's name is linked to his or her presentation) v
Meeting Summary l
Abstracts and Presentations (listed in the same order as in the Agenda) 11
Welcome 12
Devon Payne-Sturges, Assistant Center Director for Human Health, NCER, EPA
Theme 1: Applying Cumulative Assessments to Inform Environmental Decision Making 14
Characterizing Cumulative Risk in EPA Criteria Pollutant Benefits Assessments: Moving Toward
a More Comprehensive Accounting of Population Risk 15
Neal Fann, Office of Air Quality Planning and Standards, EPA
The U.S. EPA Cumulative Risk Assessment Guidelines 19
Lawrence Martin, Risk Assessment Forum, Office of Science Advisor, EPA
Intramural CRA Research at EPA and a View on How It Relates to CRA Grants 22
Jonathan Levy, Professor, Boston University School of Public Health and STAR Grantee
Intramural CRA Research at EPA and a View on How It Relates to CRA Grants 26
Bradley D. Schultz, National Exposure Research Laboratory, EPA
Theme 2: Data Analysis Methods for Combining Stressors 31
Issues Related to Backward and Forward Translation of Toxicological and Epidemiological Studies
of Cumulative Risk Assessment 32
Deborah A. Cory-Slechta, Professor, Department of Environmental Medicine, University
of Rochester School of Medicine
Innovative Approaches to Qualitative Data Analysis 36
Madeleine Kangsen Scammell, Assistant Professor, Boston University School of
Public Health
Theme 3: CPBR; Community Partnerships 39
Theme 4: Grants Management 41
No abstracts or presentations were provided for this theme session.
Participants List 42
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Progress Review Meeting on Cumulative Risk Grants
May 14, 2012
EPA Headquarters, East Building, Map Room 1153
1201 Constitution Avenue, N.W.
Washington, DC 20004
Monday, May 14, 2012
Session Title
Speakers
Time
PART 1 - Open to EPA Staff and Webinar Access to EPA
MAP Room EPA EAST 1153
Welcome
Devon Payne-Sturges, Assistant Center Director
for Human Health, NCER
8:30 - 8:40 a.m.
Theme 1: Applying Cumulative Assessments to Inform Environmental Decision Making
Topic: Characterizing Cumulative Risk in EPA
Criteria Pollutant Benefits Assessments: Moving
Toward a More Comprehensive Accounting of
Population Risk
Neal Fann, Office of Air Quality Planning and
Standards, EPA
8:40-9:00 a.m.
Topic: The U.S. EPA Cumulative Risk Assessment
Guidelines
Lawrence Martin, Risk Assessment Forum, Office
of Science Advisor, EPA
9:00 - 9:10 a.m.
Topic: Integrating Chemical and Non-Chemical
Stressors in Cumulative Risk Assessment
(with copy of white paper)
Jonathan Levy, Professor, Boston University
School of Public Health and STAR Grantee
9:10 - 9:20 a.m.
Topic: Intramural CRA Research at EPA and a View
on How It Relates to CRA Grants
Bradley D. Schultz, National Exposure Research
Laboratory, EPA
9:20 - 9:30 a.m.
Discussion
All
9:30-10:00 a.m.
BREAK
10:00-10:15 a.m.
Theme II: Data Analysis Methods for Combining Stressors
Topic: Issues Related to Backward and Forward
Translation ofToxicological and Epidemiological
Studies of Cumulative Risk Assessment
Deborah A. Cory-Slechta, Professor, Department
of Environmental Medicine, University of Rochester
School of Medicine
10:15-10:30 a.m.
Topic: Innovative Approaches to Qualitative Data
Analysis
Madeleine Kangsen Scammell, Assistant
Professor, Boston University School of Public
Health
10:30-10:45 a.m.
Discussion
All
10:45-11:05 a.m.
Adjourn - End of Part 1
11:05 a.m.
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Part 2 - Grantees Only
EPA East Room 1117A
Theme III: CBPR; Community Partnerships
Community Engagement in Research Spectrum
Exercise. What Are the Challenges? What Are the
Opportunities?
Moderator: Tina Yuen, Association of Schools
of Public Health (ASPH) Fellow, NCER
11:10-11:20 a.m.
Reflections from the Exercise
Grantees and Their Community Partners
11:20-11:30 a.m.
Theme IV: Grants Management
Topic: Q& A with EPA Office of Grants and
Debarment
Jill Young, OGD, and La Shaun Phillips, OGD
11:30-12:00 p.m.
Working Lunch
Grantees ONLY
12:00-1:00 p.m.
Topic: Open Discussion
All
Adjourn for Social Stressors Workshop
1:00 p.m.
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Cumulative Risk Grants, Grantees Progress Review Meeting
Cumulative Risk Grants
Grantee Progress Review Meeting
EPA Headquarters, East Building
Room 1153 (Map Room)
1201 Constitution Avenue, NW
Washington, D.C. 20004
May 14, 2012
MEETING SUMMARY
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Cumulative Risk Grants, Grantees Progress Review Meeting
The Office of Research and Development's National Center for Environmental Research
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Cumulative Risk Grants, Grantees Progress Review Meeting
Welcome and Opening Remarks
Devon Payne-Sturges, National Center for Environmental Research (NCER), Office of Research and
Development (ORD), U.S. Environmental Protection Agency (EPA)
Dr. Payne-Sturges welcomed the meeting participants and said that the purpose of the meeting was to
share and discuss the progress of the grantees of the Science To Achieve Results (STAR) cumulative risk
grants. Assessing the reality of environmental impacts on human health is imperative. Over the years, the
EPA has tended to focus on the average person, one medium, one agent and/or one source of pollution;
however, to better reflect reality, steps need to be taken to understand the impacts of multiple sources,
multiple agents, multiple media and whole-community characteristics.
In 2009, the STAR program released a request for applications (RFA) for research that moves toward
better reflecting reality. Seven grants were awarded initially. In addition, during the past several years
there have been a number of efforts at the EPA to develop tools for cumulative risk assessment (CRA)
and to apply those tools.
Dr. Payne-Sturges expressed the need for expertise and knowledge across multiple disciplines. She also
commented that the terminology that is used makes a difference. She encouraged meeting participants to
question what the word "cumulative" means. Participants were asked to provide their responses by
writing them on the large pieces of paper supplied at the meeting.
THEME I: Applying Cumulative Assessments to Inform Environmental Decision-making
Characterizing Cumulative Risk in EPA Criteria Pollutant Benefits Assessments
Neal Fann, Office of Air and Radiation, EPA
Mr. Fann said that he would discuss the EPA's approach to estimating health impacts for Regulatory
Impact Assessments, and opportunities for improving that approach and characterizing cumulative criteria
pollutant risk.
There is a pyramid of effects that are related to air pollution. In the array of impacts associated with
exposure to air pollution, death is at the top of the pyramid and more transient effects, such as
inflammation, cardiac effects and so forth, populate the base of the pyramid. Although mortality is at the
top of the pyramid, accounting for a small portion of the air pollution impacts, it is associated with the
largest monetary cost.
To estimate the health impacts of air pollution, epidemiology data are inputted into health impact
mathematical functions. Software then maps environmental benefits and assigns a value to health impacts.
Mr. Fann adheres to this approach for each scenario and each pollutant. Multiple pollutants are not
handled with this approach. Estimates for the health impacts of air pollution use a baseline of no
environmental policy. The software then is used to examine the effect of various regulations and policies.
Frequently, particulate matter (PM) and ozone are examined. Other air pollutants are studied rarely
because they are more data intensive. When reporting PM and ozone impacts, the preference is to use
epidemiology studies that control for covariates.
Mr. Fann explained that there is a reduction in the risk of mortality with educational attainment. This is
relevant because PM mortality coefficients were stratified by educational attainment. Populations with
less than a grade 12 education level are at higher risk of mortality due to PM; however, their risk has been
dropping precipitously.
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Cumulative Risk Grants, Grantees Progress Review Meeting
Mr. Fann and colleagues characterized the overall percentage of deaths attributable to PM and ozone in
2005 as 6.1 percent. They now are moving their focus to a nonregulatory characterization of cumulative
risk. This will help inform decision-makers because they will be able to ascertain overall risk and
magnitude, as well as spatial distribution. For example, a study that identified populations that were
vulnerable to PM air pollution in Detroit, MI, found that focusing on a local area can generate superior
information concerning demographics and exposure. These data can better target changes that are
necessary to alter air pollution. Data types that can be used to determine populations that are susceptible
and vulnerable to air pollution include hospitalization, poverty, education and so forth.
There are many ways that the EPA could better account for cumulative risk, including informing air-
quality management strategies, as well as demographic, baseline health and baseline risk estimates;
broadly applying education-modified PM mortality risk coefficients; and assessing risk across a more
comprehensive array of pollutants (nitric oxide [NO], sulfur monoxide [SO], mercury [Hg], lead [Pb]).
For future risk assessments, temperature-pollutant and multipollutant interactions should be accounted
for, as well as the effects that are modified by other variables.
The U.S. EPA Cumulative Risk Assessment Guidelines
Lawrence Martin, Risk Assessment Forum, Office of the Science Advisor (OSA),EPA
The definition of CRA according to the CRA framework (2003), is "an analysis, characterization and
possible quantification of the combined risks to health or the environment from multiple agents or
stressors." The CRA panel and the EPA have been working for more than a decade on the complications
of CRA. A technical panel was formed following an Executive Order, and the panel was charged with
developing guidance for CRA. They developed a framework for CRA in 2003, and in 2010, the panel was
re-formed to further hone guidelines.
The re-formed CRA technical panel has four assignments: (1) prepare responses to the National Research
Council (NRC) recommendations in Science and Decisions, and in Phthalates and CRA for the Human
Health Colloquium (October 2010); (2) design and oversee the conduct of an environmental justice (EJ)
CRA project; (3) complete work on a compendium of lessons learned and best practices; and (4) prepare
guidelines for the conduct of CRA.
The preparation of guidelines will be the panel's most challenging task. The CRA panel has worked with
various researchers and EPA staff to identify case studies and white papers for use in developing the
guidelines. Key concepts for the guidelines include planning and scoping the assessment to constrain
focus, analysis and cost; combining chemical and nonchemical stressors; integrating human and
ecological risk; and informing decisions about sustainability initiating factors. The guidelines for CRA
will focus on integrated characterization of items such as public health data, mixtures toxicity, population
vulnerabilities, population illness, chemical concentrations and so forth. The guidelines were thus far five
chapters in length and were expected to be completed in 2013. The CRA lessons learned and current
practices were expected to be available within a month or two following this meeting.
The panel believes that CRA is not too complicated to handle quantitatively because available data may
support that approach, and new science is perpetually expanding what is possible.
Integrating Chemical and Nonchemical Stressors in Cumulative Risk Assessment
Jonathan Levy, Boston University
Dr. Levy said that he would focus on the white paper, "Integrating Chemical and Non-Chemical Stressors
in Cumulative Risk Assessment," prepared to support the development of CRA guidelines. This white
paper, which was distributed to meeting participants, focused on areas that were under discussion,
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Cumulative Risk Grants, Grantees Progress Review Meeting
including the incorporation of nonchemical stressors, explicit consideration of the exposure assessment
step, more direct recognition of the role of epidemiology, and the use of the Science and Decisions dose-
response approach.
The working definition of nonchemical stressors includes all stressors that have not been examined in
CRAs to date. The white paper was structured by examining each step of risk assessment (the
conventional four steps from the "EPA Red Book"), scoping to build a conceptual model, restricting the
number of stressors, and using a framework that is more risk management-based.
Hazard identification should be similar to the standard risk assessment process, with a few refinements.
These refinements include considering stressors that only act as modifiers, even in the absence of direct
effects for the outcome of interest, and using the effects- versus stressor-based orientation to narrow the
hazard identification process.
Four key dimensions of exposure assessment are discussed in the white paper. These four dimensions are:
(1) using mode of action/common adverse outcomes to determine the appropriate form of exposure
assessment; (2) using proxy variables for nonchemical stressors that cannot be ascertained directly;
(3) considering correlations among exposures for appropriate joint characterization; and (4) establishing
default assumptions in the absence of population-specific data.
For dose-response modeling, the white paper examines guidance for chemical mixtures. Chemical
mixture guidance is applicable to dose-response modeling in theory; however, the lack of quantitative
data for nonchemical stressors in some settings can be challenging. Additionally, chemical mixtures
guidance can be extended to nonchemical stressors if relevant dose metrics are available.
Toxicology can be used for risk assessments; however, there are limits because it is not possible to
incorporate many nonchemical stressors toxicologically. For example, there is no toxicological equivalent
for lacking access to health care. Using nonchemical stressors, however, can help researchers understand
the threshold versus non-threshold phenomenon. Diet, obesity and other factors can be captured in
physiologically based pharmacokinetic (PBPK) models to examine delivered doses or pharmacodynamic
outcomes.
Epidemiology is an important way forward for cumulative risk; it is rare, however, to have sufficient
epidemiologic data for a multistressor assessment. Combining epidemiology and toxicology can produce
a hybrid approach that could be viable to build a conceptual model.
Risk characterization was not covered extensively in the white paper. The white paper did reinforce,
however, that CRA is not equivalent to comparative risk assessment. Additionally, descriptions should
emphasize which stressors the EPA does and does not have authority over, and whether or not a risk-
management construct is used.
Some of the core recommendations of the white paper already are occurring with the research being
carried out from STAR grants. These recommendations include the formalization of planning and scoping
with expanded conceptual model development, the incorporation of common adverse outcome
orientation, elucidation of the mechanisms of action for nonchemical stressors via more primary research,
production of a nonchemical stressors exposure factors handbook, and development of case examples.
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Intramural CRA Research at the EPA and a View on How it Relates to CRA Grants
Brad Schultz, National Exposure Laboratory, EPA
Mr. Schultz summarized intramural EPA research, sustainable and healthy communities research, and the
potential coordination of research. One challenge is that decision-makers need information, but CRAs
have gaps. Some communities have limited resources and access to information. EPA-funded research is
intended to fill in these informational gaps.
The following EPA research programs were reorganized in fiscal year 2011: Air, Climate and Energy
(ACE); Safe and Sustainable Waters (SSWR); Chemical Safety for Sustainability (CSS); and Sustainable
and Healthy Communities (SHC). The human health risk assessment and homeland security research
programs did not undergo reorganization.
SHC research programs use stressor- and effects-based approaches. Community public-health research
includes asthma health effects research, CRA science, community public-health tools
(i.e., screening tools), health impact assessments (HIAs) and community case studies.
Needs and external drivers are related to tools and other research. According to Science and Decisions:
Advancing Risk Assessment (NRC 2009), "EPA should focus on development of guidelines and methods
for simplified analytic tools that could allow screening-level CRA and could provide tools for
communities and other stakeholders to use in conducting assessments."
One community public health tool is the Community-Focused Exposure and Risk Screening Tool
(C-FERST). This tool is a web-based community assessment tool that is geographic information system
(GIS) supported. It supports CRA and decision-making, and is user-driven. Community guidance
involves a community-cumulative assessment tool, a HIA roadmap, an EJ toolkit, Protocol for Assessing
Community Excellence in Environmental Health (PACE-EH) and a community action for a renewed
environment (CARE) roadmap. For self-directed use of C-FERST there is an alphabetical listing of issues
as well as stressor and health effects options. Another feature is the community data table. Issues are
broken into environmental community estimates, human exposure estimates (by zip code, county, state or
nation-wide) and human risk estimations for data. These categories have been consistent across many
issues.
The community assessment map in C-FERST can be broken down by census tract estimates and used to
separately consider categories of data. One example of how this has been implemented is in estimates of
the lifetime risk of lung cancer from radon exposure and smoking.
Discussion
A participant said that the presenters commented on issues related to partnerships for sustainable
communities (indicators, performance measures and so forth). She questioned whether partnerships
should explore the concept of education as a surrogate. Mr. Fann responded that in analyses, education
was found to modify the relationships among qualifier media, long-term exposures and risk of premature
death. He noted that education was a surrogate for an indicator that characterized access to health care,
proximity to roadways and so forth. To the extent that that information exists, it can be helpful in risk
assessments to characterize risk in subgroups differentially.
Jane Clougherty (University of Pittsburgh) asked about the distinction between the terms "susceptibility"
and "vulnerability" in the EPA framework. Mr. Fann responded that within the literature and the EPA,
there is no clear distinction between those two terms. "Susceptibility" often refers to individual
population characteristics, primarily health-based, that suggest that exposure to pollutants would result in
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Cumulative Risk Grants, Grantees Progress Review Meeting
an increased risk of an adverse health effect. "Vulnerability" is related more to a population exposure to
elevated pollutant levels and is less health-based. Dr. Levy agreed that there is not a clear distinction.
Mr. Martin commented that the panel will work to achieve clarity on this matter in the CRA guidelines.
THEME II: Data Analysis Methods for Combining Stressors
Issues Related to Backward and Forward Translation of Toxicological and Epidemiological Studies
of Cumulative Risk Assessment
Deborah A. Cory-Slechta, University of Rochester School of Medicine
Dr. Cory-Slechta said that most complex diseases and disorders arise from interactions of multiple risk
factors. These factors, some of which are protective, are unique to each individual and include stress,
smoking, exercise, deleterious genes and chemical exposures, among others. Most neurotoxicology
models, however, study toxicants in isolation and in healthy, young organisms. Chemical studies should
be improved so that they include all types of people and combine toxicants.
EPA guidance and CRA began in 1994, and STAR grants have begun to support this. The risk assessment
paradigm relies heavily on animal models and uses uncertainty factors to accommodate the differences
between animals and humans. This methodology is best used when corresponding human data exists.
STAR grants may be able to assist in overcoming these challenges.
The word "translation" has been used to suggest the importance of findings moving from the research
bench to the bedside. Human studies can benefit from animal models, but animal models also can be
refined further by incorporating human study data.
Stress is a component of cumulative risk. Stress can complicate epidemiological and toxicological studies
because there are different consequences of stress, depending upon the particular stress that is being
applied. Stress can cause resilience or psychopathology. The degree to which animal stress simulates
human stress is not entirely understood. In addition, gender differences are involved in the human stress
response. These gender differences can yield results that are exactly opposite for males versus females.
Averaging these stress responses yields null results, even though males and females each had a strong but
polarized response. There are statistical limitations for evaluating interactions; a better methodology is
required for examining interactions with limited sample sizes.
Dr. Cory-Slechta emphasized that not all stress is detrimental. The stress response of resilience versus
vulnerability is dependent upon the conditions of the stressor. Less pronounced types of stressors can lead
to resilience later in individual's lifetime; however, more severe stressors can lead to pathophysiological
problems later in an individual's life. Additionally, stressors that are uncontrollable and unpredictable
lead to psychopathology, but those that are controllable and predictable can lead to a more resilient
phenotype.
Stress protocols for animal models most commonly utilize immobilization (restraint) stress, maternal
separation and intruder stress. Additional stressors that are utilized include chronic homotypical stress and
chronic variable stress. Dr. Cory-Slechta explained that restraint and maternal separation stresses yield
inconsistent results. Intruder stress better represents human responses to stress; however, it matches the
response better for males than females.
As biomarkers for stress, corticosterone and noradrenaline can be examined and compared in animals
exposed to unpredictable and uncontrollable stress versus predictable and controllable stress. Results
indicate that corticosterone normalization and increased noradrenaline define "stress."
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There are limitations to evaluating statistical interactions, and it is important to understand how these
limitations apply to risk factor interactions. One limitation is sample size; however, achieving the required
large sample size for statistical validation is not always feasible. A biostatistical approach is needed to
evaluate smaller sample sizes in human and animal studies. Such an approach should assess potential
interactions based on factors such as the co-occurrence of environmental chemical exposures and the
extent to which they share biological targets.
An example of why interaction effects are critical comes from a brain study that examined Pb exposure in
males versus females. In males, there was more of an effect of Pb exposure and stress history, and less of
a change in females. This is a striking gender difference, and if interaction effects are not separated by
gender, large differential factors can be overlooked.
Innovative Approaches to Qualitative Data Analysis
Madeleine Kangsen Scammell, Boston University School of Public Health
Dr. Scammell explained that there are two types of innovation for qualitative data analysis: (1) erasing the
distinction between quantitative and qualitative data analysis; and (2) suggesting analytical methods for
handling qualitative data. Dr. Scammell said that her presentation would introduce the study location and
methodology used in her work, convince attendees that working within a framework that distinguishes
two types of data is not helpful, provide a brief analysis of handling data using standard methods, and
introduce innovative analytic methods.
Dr. ScammeH's work occurred in the Sea of Chelsea near Boston, MA. There are oil tank storage areas
along the Chelsea Creek near locations where data were gathered. These areas are EJ regions based on
demographic information, not on environmental exposures. In addition to oil tanks, a liquid natural gas
tanker regularly enters the area. A census tract that was used for the study included four designated port
areas and one commercialized district.
Five hundred interviews were conducted with residents in the designated areas. There were 180 questions,
of both open and closed types. Interviewees provided a wide range of responses to the open-ended
questions. These responses were turned into data via a coding methodology. The code was applied to
certain aspects of these comments, such as a reference to being in an oil tank area or near to the natural
gas tanker. These codes then were entered into software, and the qualitative data analysis proceeded
hierarchically.
Themes were identified, followed by larger concepts. One theme indicated that three out of five
respondents had fears of disaster. This theme was uncovered by aggregating several codes. Instead of
determining the frequency of special answers, the actual reasons for people feeling the way that they did
were examined. At a higher level than theme, concepts, which show how themes are related, are used.
Concepts are better representations of environmental burdens and stress. Assigning codes to data,
followed by the identification of themes and concepts, is an appropriate way to characterize
environmental burden and is not unlike handling quantitative data.
Quantitative research usually is defined by numeric data, with measurements that are standard and
generalizable. Qualitative research, however, generally refers to non-numeric data that "increases depth of
understanding" and provides insight into thoughts, feelings, opinions and motives.
All research requires measurement, and when representing data with numbers, this measurement is
quantitative. In risk assessments, non-numeric representations are relied upon, and this can be achieved
by utilizing diagrams that exhibit spatial relationships and logic. It is incorrect to think that numbers are a
privileged representation of reality.
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As an example, Dr. Scammell discussed smoking. Smoking intensity and duration are measured by two
different measures: the number of cigarette packs that smokers consume per day (intensity) and years that
smokers have smoked (duration); both measures supply numeric data. Dr. Scammell analyzes these data
structurally and visually. The concepts of smoking intensity and duration are kept separate. By doing this,
the data can indicate the reasons for peoples' smoking style. Reliance on quantitative data would lose
some of this vital information.
Dr. Scammell concluded by saying that lattice mathematical structures can be used to delve into data and
interpret it. Data gathered by open- and close-ended questions can be used quantitatively to study
cumulative risk and make assessments.
Discussion
Mr. Fann requested that Dr. Scammell further explain the lattice mathematical diagram. Dr. Scammell
explained that the lattice structure compares smoking intensity to years. Smoking intensity has more to do
with health risk and duration; however, reducing data to just smoking intensity creates the loss of other
important data.
A participant questioned how Dr. Scammell proposed to distinguish between the two measures of
smoking intensity and duration. Dr. Scammell responded that a bigger question is how researchers can
decide what factors to examine in relation to others. The smoking data that she presented is driven by
what is already known; without that previous knowledge, however, it would be difficult to know where to
tease apart differences in data.
A participant asked about the resilience factor, how it can be expressed and what its mechanisms are.
Dr. Cory-Slechta gave an analogy. If children never experience disappointments in life, then they never
have any experience with that type of stress. This means that they will not do well in later life. If they
have severe stress, however, there can be a lifetime of negative consequences. It is difficult to look at the
human world via research because it is not ethical to formulate certain kinds of experiments. Resilience
(the ability to respond to stressors and stress challenges later in life) is addressed in a confusing manner in
the scientific literature. Many papers on the biomarkers of stress do not differentiate appropriately and
predictable, controlled stress (resiliency) versus uncontrollable, unpredictable stress. Until these
complications are resolved, it is difficult to identify reliable stress biomarkers. Cortisol is the best
example of a stress biomarker. The levels of Cortisol depend entirely upon a person's history. There is a
feedback loop regarding Cortisol levels, and that loop can be delayed depending on the types of stressors
to which a person has been exposed.
A participant commented that stress response is a learned phenomenon. People learn how to deal with
stress; for uncontrollable, unpredictable stress, however, there is not much to be done. Another participant
said that the capacity to overcome stress is a factor that speaks to EJ circumstances. She questioned if EJ
can become a component in risk assessment analysis. Dr. Cory-Slechta responded that she currently had a
grant to examine this. She said that this would be an animal study initially and would involve the
examination of historical data sets.
Dr. Payne-Sturges requested a comment on how stress can be examined from a community-wide
perspective. Dr. Scammell responded that currently the community level is considered an aggregate of
individuals that reflects the community experience of stress. Dr. Cory-Slechta said that she conducted a
cohort study in Rochester, NY, in which mothers came in every 6 months to have their childrens' blood
drawn. She said that mothers consistently commented that chemical risks and stressors were not a high
priority because they were more concerned with paying their health insurance or rent. Dr. Cory-Slechta
felt that this was indicative of the state of many communities.
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A participant commented that there is an analytical problem when community responses are mined. When
handling one community at a time, data can be skewed; it is important to examine several communities at
once. That is another possibility for analyses and requires analytical methodology to be broadened.
Dr. Scammell agreed that scale is a very important component of analyses. For her studies, she
commented that each census tract represents a different type of community.
A participant commented that to examine community stress, questionnaires are designed to ask about
community meetings that include EJ questions, racial questions and so forth. These questions could
indicate some shared community stresses.
Adjournment
Dr. Payne-Sturges, NCER, ORD, EPA
Dr. Payne-Sturges thanked the participants for attending and the speakers for their presentations. Grantees
continued the meeting in a closed session, followed by a social stressors workshop in the afternoon.
Dr. Payne-Sturges adjourned the meeting.
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Abstracts and Presentations
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Cumulative Risk Grants, Grantees Progress Review Meeting
Devon Payne-Sturges
Welcome
Devon Pavne-Sturees
Assistant Center Director for Human Health, NCER, EPA
Multiple aspects of the environment in which we live, learn, work and play impact our health. However, it
is the general practice of governmental agencies/policy makers responsible for protecting public health and
the environment to focus on one factor at a time, more specifically one environmental contaminant at a time.
For example, EPA traditionally has used the risk assessment paradigm to assess exposures and risks to single
chemicals. For many years, the environmental justice movement and local communities have advocated for
the consideration of multiple exposure and cumulative impacts in environmental policy and decisions.
Further, the social context/real word context in which exposures to environmental contaminants occur also
needs to be reflected in the science that supports EPA's decision-making, as emerging evidence demonstrates
that social and contextual factors may enhance the toxic effects of both single and multiple environmental
contaminant exposures. Such considerations require new models for assessing the toxicity of environmental
hazards, advanced methods for analyzing complex interactions between multiple stressors, and enhanced
access to community-level knowledge and resources. Under a 2009 RFA, the EPA STAR program awarded
7 grants to fund cumulative human health risk assessment research on how the combination of harmful factors
affect human health, including poor and underserved communities with extensive pollution problems.
Goal:
The goal of the meeting was to share and discuss progress of this ground-breaking research on cumulative
risks and methods for assessing the combined health impacts of multiple stressors.
Outcomes:
1. Shared knowledge about innovative approaches for data analysis methods for combining stressors.
2. Understanding the opportunities and barriers for applying cumulative assessments in environmental
decision-making.
3. Enhancing community engagement in research on cumulative risk.
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Cumulative Risk Grants, Grantees Progress Review Meeting
Impacts from releases into all media
from all sources
ivViltiple facilities
source
Average
person
What does
cumulative mean
to you?
This Morning's Agenda
Part 1 8:30AM - 11:05AM
Theme I: Applying Cumulative Assessments to Inform
Environmental Decision-making
Theme II: Data Analysis Methods for
Combining Stressors
Adjourn 11:05AM
1:00PM Workshop on Interactions between Social
Stressors and Environmental Hazards
PROGRESS REVIEW MEETING ON
CUMULATIVE RISK GRANTS
EPA Headquarters. East Building I Map Room 1153
1201 Constitution Avenue. NW I Washington, D.G. 20004
The Office of Research and Development's National Center for Environmental Research
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Theme 1
Applying Cumulative Assessments to Inform
Environmental Decision Making
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Cumulative Risk Grants, Grantees Progress Review Meeting
Neal Fann
Characterizing Cumulative Risk in EPA Criteria Pollutant Benefits Assessments:
Moving Toward a More Comprehensive Accounting of Population Risk
Neal Fann
U.S. Environmental Protection Agency,
Office of Air and Radiation
In this presentation, I will describe the U.S. Environmental Protection Agency's (USEPA) methods
for assessing the cumulative effect of population exposure to multiple criteria pollutants. The first portion
of my discussion will focus on the way in which USEPA assesses these impacts in a regulatory context,
with an emphasis on the recently promulgated Cross-State Air Pollution Rule. In particular, I will detail
the human health benefits assessment, the evaluation of welfare benefits and the Environmental Justice
assessment. Next, I will describe an Environmental Justice Assessment performed as part of a multi-
pollutant pilot project for Detroit (Fann et al., 2011). In that project, USEPA used a combination of
demographic, baseline health and exposure data to identify susceptible and vulnerable populations and
then evaluated the ability of alternate air quality management strategies to deliver air quality
improvements among these population sub-groups.
The Office of Research and Development's National Center for Environmental Research
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Cumulative Risk Grants, Grantees Progress Review Meeting
Characterizing Cumulative Risk iri
EPA Criteria Pollutant Benefits
Assessments
Moving toward a more comprehensive accounting of
population risk
Presentation to cumulative risk grantee progress
review meeting
May 14th, 2012
Overview
EPA's approach to estimating health impacts
for Regulatory Impact Assessments
Characterizing cumulative criteria pollutant
risk
Opportunities for improving our approach
A "Pyramid of Effects" from Air Pollution
MtagnitUde A ~90%ofthe
o impacts " monetized benefits
Thousands AjgAjil
Tens of
Thousands
Doctor visits.
Respiratory symptoms,
Asthma attacks
Proportion of population affected
Step One: Derive Health Impact Functions from
Epidemiology Literature
Epidemiology Study
Ln(y) = Ln(B) + B(PM)
Health impact function
Yo ¦
AY =Yo Pop
APM -
Pop - E
EPA Regulatory Analyses: Health Benefits of
2014 Cross-State Air Pollution Rule
Summary of health impacts Monetized health and welfare
avoided benefitsA
Health endpoint
Value
Endpoint
Value j
(billions of 2006$)
PM2 j-related mortality
(Pope et al. 2002)
13,000
(5,20021,000)
Hurran healths
PM25-related mortality
(Laden et al. 2006)
34,000
(18,00049,000)
Pope et al. 2002 PM25 and
Bell etal.2004 03 mortality
$120
($14$350)
Oj-related mortality
(Bell et al. 2004)
m
(| |42)
Levy et al. 2005 03 mo
mty
$280
($29$810)
Oj-related mortality
120
estimates
(Levy et al. 2005)
(90160)
Visibility
$3.6
PM25-related chronic bronchitis
8,700
(1,60016,000)
Total
PMj ^-related non-fatal heart
attacks
15,000
(5,60024,000)
Pope etal. 2002 PM25and
al. 2004 03 mortality estim
-sM
$120
($10$360)
PM,and O,-related
respiratory hospitalizations
2,900
(1,3004,300)
Laden et al. 2006 PM2 5 and
et al. 2005 03 mortal it/ est
titrates
$290
($26$850)
ficant figures
PM25 and Os-related emergency
department visits
9,900
(5,80014,000)
B Discounted at 3%
The Office of Research and Development's National Center for Environmental Research
BeftMAP
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Cumulative Risk Grants, Grantees Progress Review Meeting
Assessing Education-Modified PM25 Mortality
Risk in the 2014 Cross-State Rule
Percentage of deaths due to PM25 among
populations living in counties at greatest risk of Percentage of deaths due to PM among
air pollution* populations living in all other counties
t for the increased level of baseline risk experienced by those populations
Burden Assessments: Estimating the Risk
Attributable to Recent PM25 and Ozone Levels
Percentage of 03 and PM2 5 related deaths due
to 2005 air quality levels by county
Summary of National PM2 s & 03
impacts due to 2005 air quality
Excess mortalities
(adults)A
130,000 to 340,000
Percentage of all deaths
due to PM2.5 and 03B
6.1%
Impacts among Childre
ER visits for asthma
(age < 18)
Acute bronchitis
(age 8-12)
n
1 10,000
200,000
Exacerbation of
asthma (age 6-18)
2,500,000
Identifying Populations Susceptible and
Vulnerable to PM25 Air Pollution in Detroit
Populations
susceptible to
PM2S impacts
Asthma hospital visits
Populations
vulnerable to
PM2S impacts
Annual mean PM2.5
air quality levels
Populations
susceptible and
vulnerable to
PM2 s impacts
Analysts can consider
alternate variables to
identify susceptible and
vulnerability populations
Susceptibility;
Hospital Admissions
Mortality
Vulnerability
Annual mean PM25 levels
Educational attainment
Poverty
f
TW
'-v
Irrespective of variables
used, the multi-pollutant
risk-based approach
provides greatest
reductions in PM25
exposure
¦ik * ₯
&
Incorporating Local Scale Data in the Design and Evaluation of Air Quality P
licies, Risk/toa^is, 2011; in
DresTd Mln'mlZlnS lneqLBl"?' 10
Table II: Reduction in annual mean PM25 exposure per-person, according to air quality scenario and approach to identity ing
vulnerable & susceptible populations (ng/m3/person)A
How Might we Better Account for
Cumulative Risk?
Using available data and tools:
Inform air quality management strategies with
demographic, baseline health and baseline risk
estimates
More broadly apply education-modified PM25
mortality risk coefficients
Assess risk across a more comprehensive array of
pollutants (N02, S02, Hg, Pb)
Future assessments:
Account for temperature-pollutant and multi-pollutant
interactions
Account for effect modification by other variables
The Office of Research and Development's National Center for Environmental Research
17
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Cumulative Risk Grants, Grantees Progress Review Meeting
References
Abt Associates, Inc. Environmental Benefits and Mapping Program (Version 4.0), 2010.
Bethesda, MD.
Prepared for U.S. Environmental Protection Agency Office of Air Quality Planning and
Standards. Research Triangle Park, NC. Available on the Internet at
Fann N, Roman HR, Fulcher CF Gentile M,Wesson K, Hubbell BJ, Levy Jl. Maximizing Health
Benefits and Minimizing Inequality: Incorporating Local Scale Data in the Design and
Evaluation of Air Quality Policies. Risk Analysis; 2012a.
Fann N, Lamson A Wesson K, Risley DAnenberg SC, Hubbell BJ. Estimating the National
Public Health
Burden Associated with Exposure to Ambient PM2.5 and Ozone. Risk Analysis; 2012b.
Krewski D, Jerrett M, Burnett RT, Ma R Hughes E, Shi YTurner C, Pope CAThurston G, Calle
EE,Thunt MJ. Extended follow-up and spatial analysis of the American Cancer Society
study linking particulate air pollution and mortality. HEI Research Report, 140, 2009;
Health Effects Institute, Boston, MA.
Levy Jl, Greco SL Spengler JD.The Importance of Population Susceptibility for Air Pollution
Risk Assessment:A Case Study of Power Rants Near Washington, DC. Environmental
Health Perspectives, 2002 I 10(12): 12531260.
Wesson KH, Baker K, Nopmongcol U,Yarwood G, Sakulyanontvittaya T, Strum M.Thurman J,
Camalier L , Ensley DTimin B, Phillips S and FoxT."Comparing Models/Methods for
Estimating Multi-pollutant Rne-scale Air Quality Concentrations" in Air Pollution
Modeling and Application XX. Ed. By DG Steyn and ST Rao.
Wesson K, Fann N, Morris M, FoxT, Hubbell B.A Multi-Pollutant, Risk-based Approach to Air
Quality
Management: Case Study for Detroit.Atmospheric tollution Research, 2010 I: 296304.
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Cumulative Risk Grants, Grantees Progress Review Meeting
Lawrence Martin
The U.S. EPA Cumulative Risk Assessment Guidelines
Lawrence Martin, Risk Assessment Forum, Office of Science Advisor, EPA
The EPA Framework for Cumulative Risk Assessment (CRA) was published in 2003. In the
intervening years, the EPA CRA Technical Panel has sponsored three workshops, a dozen white papers,
and prepared an interim "lessons learned" document. Concurrently, the EPA's Office of Research and
Development and the program offices have developed methods to advance discrete dimensions of CRA.
The CRA Technical Panel expects to complete a draft of the CRA Guidelines for review in 2013. Writing
teams are being assembled and are integrating the knowledge from across the agency and from the expert
authored topical papers. This presentation will provide an overview of the draft outline for the CRA
Guidelines, and highlight key issues defining the project. Topics include addressing vulnerable and
susceptible populations, integrating chemical and non-chemical stressors, how to organize the boundaries
of a CRA, integrating human health and ecological information, and how CRA can be used to inform
sustainability analysis.
The Office of Research and Development's National Center for Environmental Research
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Cumulative Risk Grants, Grantees Progress Review Meeting
e m
The US EPA Cumulative Risk
Assessment Guidelines
Cumulative Risk Assessment An
analysis, characterization, and
possible quantification of the
combined risks to health or the
environment from multiple agents
or stressors. (CRA Framework,
2003)
Lawrence Martin
EPA Office of Science Advisor
Risk Assessment Forum Staff
United States Environmental Protec
tion Agency
Technical Panel on Cumulative Risk
Assessment
CRA Panel Re-formed July 2010
Co-Chairs
Gino Scarano OCSPP/OPPT
Linda Teuschler ORD/NCEA
Sub-panels
Environmental Justice
Integrating Chemical and Non-Chemical Stressors
Current Practices and Lessons Learned
2
United Slates Environmental Protection Agency
Cumulative Risk Assessment Technical
Panel
Assignments
Prepare responses to the NRC recommendations
in Science and Decisions, and in Phthalates and
CRA for the Human Health Colloquium (October,
2010);
Design and oversee the conduct of an
environmental justice CRA project (CCAT);
Complete work on a compendium of lessons
learned and best practices; &
Prepare guidelines for the conduct of CRA.
United States Env
i r o n m e n t a I
tection Agency
CRA EPA Foundation Documents
Framework for Cumulative Risk Assessment (2003)
Concepts, Methods and Data Sources for Cumulative
Health Risk Assessment of Multiple Chemicals, Exposures
and Effects: A Resource Document (ORD/NCEA, 2007)
CRA Lessons Learned - narrative built upon 7 White
Papers and 12 case studies. (Est. July, 2012)
White Papers (2012)
How much information is enough?
Use of CRA by Program Offices & Regions
Integrating Chemical and Non-Chemical Stressors
CRA Current Practices
Piannning, Scoping and Problem Formulation
Sustainability
Communication
United Stat
P r o t e c t i
Agency
Some Key CRA Concepts for the
Guidelines
Planning and scoping the assessment to
constrain focus, analysis, and cost
Combining Chemical and Non-Chemical
stressors
Integrating Human + Ecological Risk
Informing Decisions about Sustainability
Initiating Factors
5
United States Environmental Protection Agency
perceived elevated rates
S\of miscarriages,
multiple industrial
facilities and disposal
areas, community near
highway and airport; .
Population
public health data
Source,
lultiple-
population l
subgroup v'
Integrated
population
high blood lead
toxicity
high levels of
diesel exhaust: lung
pesticides in egg
The Office of Research and Development's National Center for Environmental Research
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Cumulative Risk Grants, Grantees Progress Review Meeting
The Outline
Five
Chapters
/
-
JPfc
\ L
( : -
"ar1-
)l
j"* 11
1
1
States
E n v i r o
n m e n t
a 1 P r o
e c t i o n
1 IS * J *-3-
1 1 1 ' i
CRA Technical Panel Timeline
Chicago
CRA
Charge 1997 2005
CRA 2011 CRA 2012
Workshop Workshop
CRA
Framework
Published
2003
United States Environmental
CRA
Lessons Drafl CRA
Learned & Guidelines
Current 2013
Practices
2012
Protection Agency
The Five Chapters
Ch. 1- Intro and Approach to Develop Guidelines
Ch. 2 - Conceptual Principles of CRA Phases (2003
Framework)
Planning & Scoping, Problem Formulation, Risk Analysis,
Risk Characterization
Ch. 3 - Using the 2003 Framework and Moving
Forward
Ch. 4 - Risk Communication
Ch. 5 - Resources/Data for CRA
£
United States Environmental Protection Agei
is.
? if.
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Cumulative Risk Grants, Grantees Progress Review Meeting
Jonathan Levy
Intramural CRA Research at EPA and a View on How It Relates to CRA Grants
Jonathan Levy1 and Jane E. Clougherty2
Professor, Boston University School of Public Health and STAR Grantee;
2Assistant Professor, University of Pittsburgh
In a white paper titled "Integrating Chemical and Non-Chemical Stressors in Cumulative Risk
Assessment," we focused on strategies for inclusion of non-chemical stressors in human health
cumulative risk assessment. We began by discussing the planning and scoping phase of the analysis,
building on previously proposed frameworks to delineate the contexts in which non-chemical stressors
should and should not be included in cumulative risk assessments, as well as strategies for their inclusion.
We then considered the hazard identification step, as an initial qualitative determination of the stressors
under consideration in the analysis. We discussed available databases and metrics that could allow for
characterization of exposure to non-chemical stressors, considering theoretical ideal parameters as well as
proxy measures or default assumptions that could be used in the absence of detailed population-specific
data. For dose-response modeling, we presented strategies that could be used for either epidemiological or
toxicological evidence, with a broad-based discussion regarding similarities and differences from the
chemical mixtures problem. We briefly addressed risk characterization as a step that synthesizes evidence
across outcomes from a stressor-based cumulative risk assessment, or appropriately contextualizes the
findings from an effects-based cumulative risk assessment. We concluded by identifying significant data
and methodological gaps that could be addressed by targeted research.
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Cumulative Risk Grants, Grantees Progress Review Meeting
Overview
White paper prepared to support
development of cumulative risk assessment
guidelines
Co-authors: Jane Clougherty, Peter deFur
Coordinated by Scientific Consulting Croup
(Steve Gibb)
Presented at Workshop on Integrating Non-
Chemical and Chemical Stressors in
Cumulative Risk Assessments (November
201 1)
Background/framing
Focus of white paper on dimensions that had
not been extensively addressed previously
Incorporation of non-chemical stressors
Explicit consideration of exposure assessment step
(for both chemical and non-chemical stressors)
More direct recognition of the role of epidemiology
Use of the Science and Decisions "Chapter 5" dose-
response approach
Working definition
Non-chemical stressor:
Any exposure in the physical or social environment
that can impact human health through pathways
other than those chemical media and pathways
traditionally included in health risk assessment
Examples: Lack of health care, personal activities,
natural phenomena, biological pathogens,
psychosocial stress, noise, heat, income, ecosystem
services, etc., etc., etc.
Planning and scoping
White paper builds on foundation in 2003
EPA Framework, Menzie 2007, Science and
Decisions
Key steps
Build a conceptual model (effects-based vs.
stressor-based vs. receptor-based/community-
based)
Restrict the number of stressors under study using
risk management framework (if relevant), formal
hazard identification process, insight from
screening assessment
Hazard identification
Similar to standard risk assessment process
with a few proposed refinements
Consider stressors that only act as
exposure/dose/effect modifiers even in the
absence of direct effects for the outcome of interest
Example: Piperonyl butoxide and pyrethroids
Example: Calcium and lead
Use effects-based vs. stressor-based orientation to
narrow the hazard id process
Mbeting on Cumulative Risk G
Integrating chemical and
non-chemical stressors in
cumulative risk assessment
Jonathan Levy, Sc.D.
PRQFfflsoR OF Environmental health
Boston University School of Public Health
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Cumulative Risk Grants, Grantees Progress Review Meeting
Exposure assessment
Four key dimensions discussed
t. Using mode of action/common adverse outcomes
to determine appropriate form of exposure
assessment
2 Using proxy variables for non-chemical stressors
that cannot be directly ascertained
3. Considering correlations among exposures for
appropriate joint characterization
4 Establishing default assumptions in the absence
of population-specific data
Using toxicology
Many non-chemical stressors cannot be
feasibly incorporated toxicologically,
although animal models of stress are being
utilized regularly
Non-chemical stressors can inform the choice
among Science and Decisions conceptual
models, or can be captured in PBPK models to
examine delivered doses or
pharmacodynamic outcomes
Combining toxicology and
epidemiology
Hybrid approach could be viable
Use limited epidemiology to determine appropriate
conceptual model for toxicological data
Use toxicological studies to establish dose
equivalence between a chemical and non-chemical
stressor, to re-interpret epidemiology
Example: Toluene and alcohol
Combine evidence from both in special
circumstances where adverse outcomes were
comparable and vulnerability characteristics can be
aligned
Dose-response modeling
Can chemical mixtures guidance be used?
Applicable in theory, though the lack of quantitative
data for non-chemical stressors in some settings
could be challenging
Phthalates report approach for chemical mixtures
can be extended to non-chemical stressors if
relevant dose metrics are available
"Sufficient similarity" might need a broad-based
redefinition, potentially using common adverse
outcomes rather than mode of action as an organizing
principle
Using epidemiology
Sufficient epidemiology for a multi-stressor
assessment will be rare
When it exists, diagnostic questions include:
Are dose-response functions based on multivariate
models, or can significant confounding be ruled
out?
Has effect modification been examined?
Do the vulnerability attributes of the study
population align with those of the cumulative risk
assessment?
Is there a clear conceptual model that would inform
the interpretation of sociodemographic variables as
non-chemical stressors?
Risk characterization
Cumulative risk assessment should not be
equated with comparative risk assessment
Descriptions should emphasize which stressors
EPA does and does not have authority over,
whether or not a risk management construct is
used
QALYs/DALYs/other weights can be used to
integrate across health outcomes in a stressor-
based assessment, but should be used with
caution
Qualitative information should be presented on
comparable footing as quantitative findings
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Cumulative Risk Grants, Grantees Progress Review Meeting
Recommendations
Planning and scoping should be formalized with
an expanded conceptual model development
Common adverse outcome orientation would be
appropriate to incorporate
Need more primary research to elucidate
mechanisms of action for non-chemical
stressors
Non-chemical stressor Exposure Factors
Handbook would be warranted
Case examples should be developed
The Office of Research and Development's National Center for Environmental Research
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Cumulative Risk Grants, Grantees Progress Review Meeting
Bradley D. Schultz
Intramural CRA Research at EPA and a View on How It Relates to CRA Grants
Bradley D. Schultz
National Exposure Research Laboratory, EPA
The EPA is working to advance cumulative risk assessment (CRA) through intramural and extramural
research programs, ongoing development of CRA Guidelines, and other activities. The objectives are to
improve health and well-being in the United States and reduce health disparities, using high-quality
science and fostering economically informed decisions. The goal of this presentation is to describe
intramural EPA research efforts and how they complement activities inside and outside EPA as well as
the EPA CRA Guidelines under development. CRA in the new EPA research structure will be
summarized, as well as a November 2011 workshop on integrating chemical and non-chemical stressors
in CRA and plans for a follow-up autumn 2012 workshop. The presentation will assess some
accomplishments to date as well as remaining scientific and implementation challenges.
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Cumulative Risk Grants, Grantees Progress Review Meeting
Intramural CRA research at EPA
and a view on how it relates to
CRA grants
Brad Schultz
with contributions from Valerie Zartarian, Andrew Geller, & Shannon O'Shea
Office of Research and Development, National Exposure Research Laboratory
Progress Review Meeting on Cumulative Risk Grants | May 14, 2012 | Washington, DC
Outline
Summary of intramural EPA research
Sustainable & Healthy Communities research
Community Public Health tools & CRA
Potential coordination of research
Common Challenge:
Decision-makers need information, but...
CRA science has many gaps
CRA implementation is difficult
Some communities have limited resources
o limited access to info, as well as disproportionate impacts
EPA-funded research is intended to...
Fill information gaps
Improve communities' access to CRA science
Be coordinated
EPA Research Programs
Program Office
Research program 4-
Air &
Radiation
Water
Solid Waste
and
Emergency
Response
Pesticides/
Pollution
Prevention
& Toxics
Other
offices (OEJ,
OCHP, etc.)
Air, Climate & Energy
*
Safe & Sustainable Waters
*
*
Chemical Safety for
Sustainability
*
Sustainable & Healthy
Communities
'
'
'
'
Human Health Risk Assessment
*
*
*
*
Homeland Security
*
Some primary linkages are shown above, although there are considerable cross-linkages
EPA Regional offices also
support community work
O
G
Sustainable & Healthy
Communities (SHC) research
CRA stressor-based approaches
Housing and infrastructure
Transportation
Land use
Waste and materials
Ecosystem services, etc.
CRA effects-based approaches
Community Public Health component of SHC
Many linkages
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Cumulative Risk Grants, Grantees Progress Review Meeting
Community Public Health
Asthma health effect research
environmental factors
* clinical, epi, exposure, etc.
CRA science
* exposure, effects, combining non-chemical stressors
animal studies, clinical, epi
Community Public Health Tools
~ Community-FERST, Tribal-FERST
Health Impact Assessments (EPA-related part)
Community case studies
Needs & External Drivers
Science & Decisions: Advancing Risk
Assessment (2009)
"EPA should focus on development of guidelines and
methods for simplified analytic tools that could allow
screening-level cumulative risk assessment and could
provide tools for communities and other stakeholders to
use in conducting assessments." (pp. 10, 236)
NAPA, NEJAC reports
EPA Administrator priorities
EPA Sustainable & Healthy Communities research program
Community Public Health Tools
Community-Focused Exposure and Risk
Screening Tool (C-FERST)/Tribal-FERST
* GIS and Web-based community assessment support tool
Support CRA and decision-making
User-driven or following community guidance
For more information visit: http://www.epa.aov/heasd/c-ferst
Self-directed use of C-FERST
Alphabetical listing of issues
o including individual chemicals
o to meet current user needs
Stressor option
Health effects option
Community Guidance
CARE Roadmap ~
PACE-EH
ttj!
EJ Toolkit
HIA roadmap
Community-Cumulative Assessment Tool
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Cumulative Risk Grants, Grantees Progress Review Meeting
Community Data Table (Summa
immmsm
NATA 2005
' Tonics Non-Canctr Respiralcry Risk' 1.2
NATA 2005
Source-outcome
Paradigm & E \
Implied Indicators
Ambient concentrations
Human exposure estimates
Biomarker estimates
Risks/Health outcomes
- Cancer, asthma, early neurotoxicity effects,
etc.
Radon and Smoking CRA Example
C-FERST provides
Web-based means for using roadmaps
Structure for stressor & effects-based RA
Geographically-specific screening-level estimates (a default)
Can peer review components in advance
Gives credibility to risk assessment when risk management
options are discussed
Facilitates stakeholder involvement
Web-based tool allows linkage to risk management options
Much work remains
But structure for consistency in research
The Office of Research and Development's National Center for Environmental Research
Predicted probability ot ever-smoking, by counly
Intended as illustrative results only. From
Chahine, et al (2011), "Modeling Joint Exposures
and Health Outcomes for Cumulative Risk
Assessment: The Case of Radon and Smoking" Int
J of Environ Sci and PubI Health.
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Cumulative Risk Grants, Grantees Progress Review Meeting
Conclusions
Need for CRA science & implementation
EPA addressing guidelines & screening-
level approaches recommendations in S&D
CPH tools (C-FERST) provide a structure
and platform to implement these goals
CRA grants results eagerly awaited
Great potential for coordination &
collaboration (in multiple areas)
Thank you!
Questions?
The Office of Research and Development's National Center for Environmental Research
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Theme 2
Data Analysis Methods for Combining Stressors
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Cumulative Risk Grants, Grantees Progress Review Meeting
Deborah A. Cory-Slechta
Issues Related to Backward and Forward Translation of Toxicological and
Epidemiological Studies of Cumulative Risk Assessment
Deborah A. Cory-Slechta
Professor, Department of Environmental Medicine, University of
Rochester School of Medicine
Toxicological studies have the potential to assist in hypotheses and experimental designs of related
epidemiological studies, and epidemiological study outcomes can provide information critical to further
refinement of animal models. However, several issues currently attenuate the extent to which
toxicological and epidemiological studies can inform and advance each other. In the case of "stress" as a
component of cumulative risk, there is the acute need to recognize in both toxicological and
epidemiological studies that stress can have both positive and negative consequences, leading, for
example, to either resilience or further behavioral pathology. Although grounded in the scientific
literature that includes underlying mechanisms and pathways, it would be extremely useful for
toxicological studies to develop stress protocols that better simulate human and environmental conditions.
Both toxicological and epidemiological studies can benefit from better methods for evaluating interaction
effects, a particular problem when human sample sizes are limited. Finally, based on toxicological study
outcomes, separation of effects by gender in human studies is critical.
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Cumulative Risk Grants, Grantees Progress Review Meeting
Issues Related to Backward and
Forward Translation of lexicological
and Epidemiologic^ Studies of
Cumulative Risk Assessment
Deborah A. CojySlechta
Department of Environmental Medicine
University of Rochester Medical School
Rochester NY 14642
Most Complex Diseases and Disorders
Arise from Interactions of Multiple Risk
Factors
Protective Genes
S,
Developmental Risks
Stress*
Smoking
Intercurrent disease """
Socioeconomic Status
Exercise -
HEALTHY ¦
Deleterious Genes
/
Cumulative Effects
Nutrition/Diet/Obesity
AGING
DISEASED
Risk Factors that are Unique to Each
Individual
in Contrast, Most Neurotoxicology Models Study
Toxicants as Risk Factors in Isolation
Chemical Exposure
Study of one chemical in-isolation in a healthy young organism, maybe
examining e.g., gender
There is a critical need to develop animal models and design epidemiological
studies that better simulate human conditions and to include interactions of risk
factors
EPA and Cumulative Risk
Assessment
EPA guidance on cumulative risk assessment
began as early as 1994
As we all know, the STAR program has
begun to support such initiatives:
o EPA-G2009-STAR-E1: Developing Statistical and Other
Analytical Techniques for Cumulative Risk Assessments
o EPA-G2009-STAR-E2: Evaluating the Interaction of
Nonchemical and Chemical Stressors
The Risk Assessment Paradigm
Relies heavily on data from animal models where
human data is not available
o Establishment of LOAELs or NOAELs and setting
benchmark doses
o Use of 'uncertainty (safety) factors' to accommodate
differences between humans and animal models.
Is best served when corresponding data are
available from human studies and animal models
o This possibility can be significantly enhanced by the
scientific translation of findings from toxicological
studies into human studies, and from human studies to
the further refinement of animal models.
Research Translation:
It Works Both Ways
The word translation has been narrowly used to suggest
the import of findings from animal models to humans
(bench to bedside).
o However, human study designs can benefit from findings in animal
models including mechanistic insights
o Similarly, animal models can be further refined by incorporating
outcomes from human studies
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Cumulative Risk Grants, Grantees Progress Review Meeting
Stress as a Component of
Cumulative Risk
Issues that complicate integration of
epidemiological and toxicological studies
*» Different consequences of different stress
~ Resilience vs. psychopathology
s How well do animal stress protocols simulate
human stress?
The critical role of gender differences
§ Statistical limitations of evaluating interactions
The constant limitation of sample sizes
Not All Stress is Detrimental:
Resilience vs. Vulnerability
A /
B.
/
\ | inoculation | /
w
i
Stress has always been difficult to define. It has also become increasingly clear that
the consequences of stress exposure are dependent upon the conditions of the
stressor and can have either beneficial or adverse consequences.
Not Ail Stress is Detrimental:
Resilience vs. Vulnerability
Environmental challenge
Uncontrollable
Unpredictable
Schematic illustrating the proposed restriction of the term 'stress'to stimuli that
are perceived as uncontrollable, unpredictable and life threatening, whereas those
events that are 'controllable and predictable' tend to lead to resiliency phenotypes
Stress Protocols for Animal Models: How
Well do they Simulate Human Stress?
Most Common:
a Immobilization (restraint) stress
i Maternal separation
a Intruder stress
Other Approaches:
m Chronic homotypical stress
| Chronic variable stress
Corticosterone Normalization and
Increased Noradrenaline Define 'Stress
Koolhaas et al.. 2011
Limitations of Evaluating Statistical
Interactions
An important source of our understanding of which non-
chemical stressors may influence the toxicity of an
environmental chemical comes through assessment of
interactions
o Since assessment of interactions in human studies typically requires
large sample sizes that are not feasible, new biostatistical
approaches for evaluating interactions that do no depend upon very
large sample sizes are critically needed,
o Both human and animal studies can employ an approach of
assessing potential interactions based on factors such as co-
occurrence of the factor with the environmental chemical exposure
and the extent to which they share biological targets.
The Office of Research and Development's National Center for Environmental Research
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Cumulative Risk Grants, Grantees Progress Review Meeting
Gender: An Example of Why
Interaction Effects are Critical
0 PPm O 50 ppm E3150 ppm
Frontal Cortex Nucleus Accumbens Striatum
mi in
i °-8
i::
n
, fit
Group
The Office of Research and Development's National Center for Environmental Research
35
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Cumulative Risk Grants, Grantees Progress Review Meeting
Madeleine Kangsen Scammell
Innovative Approaches to Qualitative Data Analysis
Madeleine Kangsen Scammell
Assistant Professor, Boston University School of Public Health
No abstract provided.
The Office of Research and Development's National Center for Environmental Research
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Cumulative Risk Grants, Grantees Progress Review Meeting
ChelseaSTAR
SCIENCE TO ACHIEVE RESULTS V
Innovative Approaches to
Qualitative Data Analysis
Madeleine Kangsen Scammell, D.Sc.
David Ozonoff, MD, MPH
Chelsea Collaborative
Boston University School of Public Health
Department of Environmental Health
Objectives
1) introduce study location and data collection methods, with a
brief example of the type of data we want to understand
2) convince you that working within a framework that
introduces a distinction between qualitative and quantitative
data is not helpful
3) provide an even briefer example of the analysis of our data
using "standard" methods
4) introduce our "innovative" analytic methods
And probably...
5) conclude with many questions left unanswered
77. I have asked about the environment,
odors, noises and access to the water. Do you
have any environmental concerns, problems,
or things you have thought about that you
would like to mention before we move to the
next set of questions?
Natural gas boats that come in. LNG tanker. If you listen to all the experts, they
tell you nothing bad will happen, but that's all lies. Some people say if one of
those goes, there won't be Admirals Hill. Also the airport and airplanes
contribute to pollution. New windows from MassPort let in draft. (ID 100)
I think it's not great that the LNG tankers are this close to the city. I think it's
crazy. It doesn't seem to be a safe thing. (ID 101)
I think about the salt pile and the poor people who live close to it. I think about
the oil tanks and the possibility of explosion. I think about an airplane losing
power and crashing into my house. (ID 132)
No big concerns but I'm grateful that the FBI will be in Chelsea. (ID 163) No
comment. (ID 501)
Here there are too many people in Chelsea who smoke, and this smoke does
more damage to those who don't smoke than to those who do. (ID 505)
E* yen 50 £ro|ea IJnts Code Farm* loots ffiraow
jS Msna
i^SwreliF
J All Sour
' 3 ! >**!
Find Mm Omt
.
In defense of this, this is die first time I've heard this because you know in Lynn, we b
really been involved with this. You had Rep. Peterson and the Marblehead Board of H
overseeing the thing. They can't be trusted? Couldn't they determine whether it wa
mrate study or not?
kh
Queries
Good question.
Models
lhey aren t so sophisticated
MODERATOR
The Office of Research and Development's National Center for Environmental Research
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Cumulative Risk Grants, Grantees Progress Review Meeting
Qualitative Data Analysis: codes ~ concepts
Concepts
Themes
Codes
Data
quantitative v. qualitative research
Quantitative: numeric data, usually
measurements that are standard and
generalizable
Qualitative: non-numeric data that "increases
depth of understanding" and provides insight
into thoughts, feelings, opinions, motives
Michael Quinn Patton (2002) Qualitative Research & Evaluation Methods
3rd edition Sage.
Lattice
> 1 pk
lyr
>2pk
(n=4)
The Office of Research and Development's National Center for Environmental Research
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Theme 3
CPBR; Community Partnerships
-------
Cumulative Risk Grants, Grantees Progress Review Meeting
All of the cumulative risk grantee projects were required to provide a community-based participatory
research (CBPR) plan, which outlined the level of community involvement in the development of and the
execution of the projects. Community participation enables the identification of variables that might
otherwise be missed, and their involvement is critical to obtaining community knowledge and
understanding complex cumulative exposures. The research projects also had to be cognizant of how
engaging in the research project would be able to enhance the capacity of the community and to provide
resources for their participation. Community participation is a crucial component of the cumulative risk
research program.
During the progress review meeting, a separate session was held to allow the grantees time to reflect
and discuss community involvement as it pertains to their project. A community engagement exercise
was developed and presented. A community engagement spectrum was shared as depicted below. At the
far left, "Expert-Driven" research projects incorporate community as participants primarily with very little
control or influence over the project. "Consultation" involves the community after the research issues
have been determined. "Cooperation" is where communities are engaged in an advisory role, but they
have no authority to make decisions. "Participatory" describes equally shared decision-making power
over the project. This is seen as the ideal CBPR partnership. "Community-Driven" is the complete
opposite of "Expert-Driven" in that "Community-Driven" privileges the community's authority over that
of academic partners with very little outside involvement. Grantees, both academic and community
partners if both were present, were asked to decide amongst themselves where they fell along this
continuum. Signs were posted along a wall of the different boxes. Each grantee team was asked to stand
along the wall next to or between signs that best defined where their project fell within this continuum.
Figure 1: Spectrum of Community Engagement in Research
Expert-driven
Very little community
involvement;
research done on
communities
Consultation
Communities become
Involved after experts ,
"^^predetermine issues
Cooperation
Ongoing advisory,
community input
Participatory
Relatively equal decision
making; partnership
Community
-driven
Process privileges
the community's
authority; very
little outside
involvement
Most of the grantee teams were clumped together around "Cooperation" and "Participatory." Very
few groups were standing along "Consultation" or at either ends of the spectrum. In the discussion, most
everyone voiced agreement that future RFAs and review processes should allow for flexibility in the
community involvement requirements. Definitions and attributes of community partnerships should be
less prescriptive and allow for variations in the manifestations of partnerships, acknowledging that not all
productive partnerships may fall within a rigid conceptualization. Additionally, the grantees commented
that not all communities and academic partners are at the same level for establishing partnerships at the
beginning of a grant. They urged NCER to support and adopt funding models that would allow for
partnerships to develop and communities to organize around topics of interest either through an elongated
grant cycle or multiple grant phases.
The Office of Research and Development's National Center for Environmental Research
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Theme 4
Grants Management
No abstracts or presentations were provided for this theme session.
-------
Cumulative Risk Grants, Grantees Progress Review Meeting
U.S. EPA Progress Review Meeting on Cumulative
Risk Grants
May 14, 2012
EPA Headquarters, East Building, Map Room 1153
1201 Constitution Avenue, NW
Washington, D.C. 20004
Participants List
Lynn Berndt-Weis
Senior Evaluator
Health Canada
Department of Existing Substances Risk Assessment
269 Laurier Avenue, West
Ottawa, ON K1A 0K9
Canada
Ashley Bubna
Association of Schools of Public Health/
EPA Fellow
U.S. Environmental Protection Agency
Office of Research and Development
National Center for Environmental Research
Ariel Rios Building (8723P)
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Stan Buzzelle
U.S. Environmental Protection Agency
Office of Environmental Justice
1200 Pennsylvania Ave, NW
Washington, DC 20460
Rich Callan
U.S. Environmental Protection Agency
Office of Research and Development
National Center for Environmental Research
Ariel Rios Building (8723P)
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Jessie Carr
Research Analyst
University of Pittsburgh Graduate School of Public
Health
Department of Environmental and Occupational
Health
Bridgeside Point I
100 Technology Drive, Suite 350
Pittsburgh, PA 15219
Krista Christensen
U.S. Environmental Protection Agency
Office of Research and Development
National Center for Environmental Assessment
Ariel Rios Building (8623P)
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Jane Clougherty
Assistant Professor
University of Pittsburgh
Department of Environmental Occupational Health
100 Technology Drive, Room 350
Pittsburgh, PA 15209
Gelena Constantine
EJ Coordinator
U.S. Environmental Protection Agency
Office of Research and Development
Office of Science Policy
Ariel Rios Building (8104R)
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Deborah Cory-Slechta
Professor
University of Rochester School of Medicine
Department of Environmental Medicine
601 Elmwood Ave, Box EHSC
Rochester, NY 14642
Sally Darney
U.S. Environmental Protection Agency
Office of Research and Development
National Exposure Research Laboratory
109 TW Alexander Drive (E205-09)
Research Triangle Park, NC 27711
The Office of Research and Development's National Center for Environmental Research
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Cumulative Risk Grants, Grantees Progress Review Meeting
Amanda Evans
Association of Schools of Public Health
U.S. Environmental Protection Agency
26 W Martin Luther King Drive (MS-A110)
Cincinnati, OH 45268
Neal Fann
U.S. Environmental Protection Agency
Office of Air and Radiation
109 TW Alexander Drive (C539-07)
Research Triangle Park, NC 27711
Robert French
NorthStar Learning Centers
53 Linden Street
New Bedford, MA 02740
Mike Galbraith
Permits Branch (5303P)
Program Implementation/Information Division
Office of Resource Conservation and Recovery
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Jane Gallagher
U.S. Environmental Protection Agency
Office of Research and Development
109 TW Alexander Drive (MD 58C)
Research Triangle Park, NC 27711
Amelia Geggel
Industrial Economics
2067 Massachusetts Avenue
Cambridge, MA 02140
Molly Greenberg
Environmental Programs Assistant
Ironbound Community Corporation
Environmental Justice Department
317 Elm Street
Newark, NJ 07105
Diane Hcnshcl
Biologist
U.S. Environmental Protection Agency
Office of the Science Advisor
Risk Assessment Forum
1200 Pennsylvania Avenue (MC8105R)
Washington, DC 20460
Marion Hoyer
Environmental Scientist
Office of Transportation and Air Quality
U.S. Environmental Protection Agency
2000 Traverwood Drive
Ann Arbor, MI 48105
Vito Ilacqua
2777 Crystal Dr
Arlington, VA 22202
Maria Jimenez
Research Associate
University of Texas School of Public Health
Epidemiology Department
1200 Hermann Pressler, RAS-W638
Houston, TX 77030
Toshia King
Environmental Protection Specialist
OSWER/ORCR
U.S. Environmental Protection Agency
1200 Pennsylvania Ave., S.W.
Washington, DC 20460
Robert Laumbach
University of Medicine and Dentistry of New Jersey
Robert Wood Johnson Medical School
Department of Environmental and Occupational
Medicine
EOHSI Room 204
170 Frelinghuysen Road
Piscataway, NJ 07206
Jonathan Levy
Professor
Boston University School of Public Health
Department of Environmental Health
715 Albany Street, T4W
Boston, MA 02118
Stephen Linder
Professor
The University of Texas Health Science Center at
Houston
School of Public Health
1200 Herman Pressler Street, E-1023
Houston, TX 77030
Nica Louie
U.S. Environmental Protection Agency
Office of Research and Development
National Center for Environmental Research
Ariel Rios Building (8723P)
1200 Pennsylvania Avenue, NW
Washington, DC 20460
The Office of Research and Development's National Center for Environmental Research
-------
Cumulative Risk Grants, Grantees Progress Review Meeting
Richard Lukasik
Contractor
U.S. Environmental Protection Agency
Office of Research and Development
National Center for Environmental Research
2777 Crystal Drive
Arlington, VA 22202
Elizabeth Margosches
Statistician
U.S. Environmental Protection Agency
Office of Prevention, Pesticides, and Toxic
Substances
Office of Pollution Prevention and Toxics
Ariel Rios Building (7403M)
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Cynthia McOliver
Environmental Health Scientist
U.S. Environmental Protection Agency
Office of Research and Development
National Center for Environmental Research
Ariel Rios Building (8723P)
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Rafael Medina
STAR Project Coordinator
Chelsea Collaborative
318 Broadway
Chelsea, MA 02150
Lisa Melnyk
US EPA
26 W. Martin Luther King Drive
Cincinnati, OH 45268
April Nowak
U.S. Environmental Protection Agency - Region 8
1595 Wynkoop Street (8ENF-PJ)
Denver, CO 80202
Onyemaechi Nweke
U.S. Environmental Protection Agency
Office of Enforcement and Compliance Assurance
Office of Environmental Justice
Ariel Rios Building (2201A)
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Devon Payne-Sturges
Assistant Center Director
U.S. Environmental Protection Agency
Office of Research and Development
National Center for Environmental Research
Ariel Rios Building (8723P)
1200 Pennsylvania Avenue, NW
Washington, DC 20460
James Quackenboss
Research Scientist
U.S. Environmental Protection Agency
Office of Research and Development
National Exposure Research Laboratory
944 E Harmon Avenue
Las Vegas, NV 89119
Madeleine Kangsen Scammell
Assistant Professor
Boston University School of Public Health
Department of Environmental Health
715 Albany Street, T4W
Boston, MA 02150
Louis Scarano
U.S. Environmental Protection Agency - Region 1
11 Technology Drive
North Chelmsford, MA 01863
Brad Schultz
Research Environmental Scientist
U.S. Environmental Protection Agency
Office of Research and Development
National Exposure Research Laboratory
109 TW Alexander Drive (E205-02)
Research Triangle Park, NC 27711
Linda Sheldon
Associate Director for Health
U.S. Environmental Protection Agency
Office of Research and Development
National Exposure Research Laboratory
109 TW Alexander Drive (D305-01)
Research Triangle Park, NC 27711
Peggy Shepard
Executive Director
West Harlem Environmental Action, Inc.
1854 Amsterdam Avenue
New York, NY 10032
Jon Sobus
U.S. Environmental Protection Agency
Exposure Measurements and Analysis Branch
Human Exposure and Atmospheric Sciences Division
109 T.W. Alexander Drive
Research Triangle Park, NC 27711
The Office of Research and Development's National Center for Environmental Research
-------
Cumulative Risk Grants, Grantees Progress Review Meeting
Jovanna Garcia Soto
Lead Organizer
Chelsea Collaborative
Department of Green Space
318 Broadway
Chelsea, MA 02150
Elaine Symanski
University of Texas School of Public Health
Department of Epidemiology, Human Genetics, and
Environmental Sciences
1200 Herman Pressler, RAS E643
Houston, TX 77030
Kent Thomas
U.S. Environmental Protection Agency
Office of Research and Development
National Exposure Research Laboratory
109 TW Alexander Drive (E205-04)
Research Triangle Park, NC 27711
Nicolle Tulve
U.S. Environmental Protection Agency
Office of Research and Development
National Exposure Research Laboratory
109 TW Alexander Drive (E205-04)
Research Triangle Park, NC 27711
Tracy Wright
U.S. Environmental Protection Agency
Office of Prevention, Pesticides, and Toxic
Substances
Office of Pollution Prevention and Toxics
Ariel Rios Building (7403M)
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Jill Young
Branch Chief
U.S. Environmental Protection Agency
Office of Administration and Resources Management
Office of Grants and Debarment
Ariel Rios Building (3903R)
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Tina Yuen
Association of Schools of Public Health/
EPA Fellow
U.S. Environmental Protection Agency
Office of Research and Development
National Center for Environmental Research
Ariel Rios Building (8723P)
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Contractor Support
Mary Allen
Conference Planner
The Scientific Consulting Group, Inc.
656 Quince Orchard Road, Suite 210
Gaithersburg, MD 20878
Erinn Howard
Senior Science Writer
The Scientific Consulting Group, Inc.
656 Quince Orchard Road, Suite 210
Gaithersburg, MD 20878
Michael Schultz
Project Manager
The Scientific Consulting Group, Inc.
656 Quince Orchard Road, Suite 210
Gaithersburg, MD 20878
Michelle Watson
Senior Conference Manager
The Scientific Consulting Group, Inc.
656 Quince Orchard Road, Suite 210
Gaithersburg, MD 20878
The Office of Research and Development's National Center for Environmental Research
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