Environmental Public Health
Outcomes Workshop Proceedings:
Research Triangle Park, North
Carolina, July 30-31, 2002
Environmental Protection Agency
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Office of Research and Development
EPA/625/R-03/001
www. epa.gov/ttbrnrmrl
Summary Report
Environmental Public Health Outcomes
Workshop Proceedings
Research Triangle Park, North Carolina
July 30-31,2002
August 26, 2002
U.S. Environmental Protection Agency
Office of Research and Development
26 W. Martin Luther King Drive
Cincinnati, Ohio 45268
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Notice:
The views expressed in these Proceedings are those of the individual authors and do not necessarily
reflect the views and policies of the U.S. Environmental Protection Agency (EPA). Scientists in
EPA's Office of Research and Development have prepared the EPA sections, and those sections
have been reviewed in accordance with EPA's peer and administrative review policies and approved
for presentation and publication. Mention of trade names or commercial products does not constitute
endorsement or recommendation for use.
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Acknowledgments:
The workshop on Environmental Public Health Outcomes was organized and planned by the
public health outcomes (PHO) workgroup of the USEPA which included: Alva Daniels, Aparna
Koppikar, Chris Saint, Cynthia Sonich-Mullin, Dan Petersen, Daniel Axelrad, Dennis Pagano,
Doug Steele, Ed Chu, Edward Washburn, Elaine Francis, Hal Zenick, Herman Gibb, Hugh
Mckinnon, Hugh Tilson, James Avery, Jerry Blancato, Kevin Teichman, Larry Cupitt, Lawrence
Martin, Pam Noyes, Patricia Murphy, Rebecca Calderon, Robert Chapman, Ross Highsmith,
Michael Wright and Valerie Zartarian. We appreciate the efforts of Science Application
International Corporation (SAIC), an EPA contractor, for technical and logistical assistance,
particularly the efforts of Virginia Hodge, Alina Martin and Lisa Kulujian. We would also like to
acknowledge the assistance of Treva Bunch for last minute details. We are particularly indebted to
the speakers at the workshop who gave their time and expertise to guide our program. Dr. Dan
Petersen (USEPA) managed the production of this document and can be contacted at
petersen.dan@epa.gov for further information.
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Table of Contents
Table of Contents i
List of Acronyms iv
Executive Summary ix
Section 1 Introduction 1-1
Section 2 Public Health Outcomes White Paper 2-1
2.1 Are the Approaches Proposed Reasonable and Realistic First Steps In
Initiating an Environmental Public Health Outcomes Research Program? 2-1
2.1.1 General Program Observations 2-1
2.1.2 Establishing Priorities 2-3
2.1.3 Potentially Applicable Approaches and First Steps 2-5
2.1.4 Potential Models for Program Development 2-7
2.2 Are There Other Areas/Activities To Consider In the Early Stages? 2-8
2.2.1 Forms of Measurement 2-8
2.2.2 Types of Indicators 2-10
2.2.3 Other Tools 2-10
2.2.4 Other Disciplines 2-11
2.2.5 Communication of Information 2-12
2.3 Are There Existing Data Sets/Resources That May Be Useful? 2-13
2.4 Are There Ongoing/Planned Activities Within Your
Organization/Agency That May Be Appropriate for Collaboration? 2-13
2.4.1 CDC 2-13
2.4.1.1 NCEH 2-14
2.4.1.2 NCHS 2-15
2.4.2 ATSDR 2-15
2.4.3 NIOSH 2-16
2.4.4 NCI 2-16
2.4.5 NIEHS 2-16
2.4.6 WHO 2-16
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Table of Contents (continued)
Section 3 State of the Environment Report Environmental Health Chapter 3-1
3.1 What Are the Challenges in Merging Environmental Monitoring Data
with Health Surveillance Data? 3-1
3.1.1 Data Availability 3-2
3.1.2 Data Collection Capacity 3-2
3.1.3 Data Compatibility 3-3
3.1.4 Database Communication 3-3
3.1.5 Data Access 3-3
3.1.6 Data and Interpretation Limitations 3-4
3.1.7 Program Framework/Asking the Right Questions 3-6
3.1.8 Common Terminology/Definitions 3-6
3.2 What Data Sets/Resources Exist that Can Inform the Linkages Between Health
Outcomes and Environmental Factors, to What Level Are the Data Applicable
(National, State, etc.), and What Are the Geographic, Temporal, and Demographic
Sampling Parameters? 3-6
3.3 What Are the Lessons Learned in Carrying Out These Programs? 3-7
3.3.1 Planning, Collaboration, and Innovation 3-7
3.3.2 Data Collection/Analysis 3-8
3.3.3 Use of Accepted Standards, Tools, and Systems 3-9
3.3.4 Information Technology 3-9
3.3.5 Informed Consent 3-9
3.3.6 Program Burden on Collaborators and Respondents 3-9
3.4 What Pilot Projects Could Be Done To Identify Opportunities To Improve
the Understanding of Environmental Public Health Outcomes? 3-10
Section 4 Other Feedback 4-1
4.1 General Observations 4-1
4.2 State vs. National Focus 4-1
4.2.1 Determining the Focus from the Data 4-2
4.2.2 Potential Need for Both a National and a State/Local Focus 4-2
4.2.3 Special State/Local Focus Considerations 4-2
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Table of Contents (continued)
4.3 Resources 4-3
Section 5 Establishing a Framework for an EPA Intramural/Extramural Public Health Outcomes
Research Program 5-1
5.1 General Framework Discussions 5-1
5.1.1 Research Initiative Focus 5-1
5.1.2 Planning Process and Relationship to GPRA Goals 5-1
5.1.3 Development of a Data Source List 5-2
5.1.4 Interagency Partnering and Collaboration 5-3
5.2 Next Steps for FY 2003 5-3
Appendix A Workshop Agendas A-l
Appendix B List of Attendees B-l
Appendix C List of Existing Data Sets/Resources C-l
in
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List of Acronyms
ABLES Adult Blood Lead Epidemiology and Surveillance
ADHD Attention deficit hyperactivity disorder
AFIP Armed Forces Institute of Pathology
ALS Amyotrophic lateral sclerosis
ATSDR Agency for Toxic Substances and Disease Registry
BRFSS Behavioral Risk Factor Surveillance System
CBLS Childhood Blood Lead Surveillance
CDC Centers for Disease Control and Prevention
CF£AD Consolidated Human Activities Database
CISNET Cancer Invention and Surveillance Modeling Network
CSTE Council of State and Territorial Epidemiologists
CTEPP Children's Total Exposure to Persistent Pesticides and Other Persistent Organic Pollutants
DALY Disability-adjusted life years
DHHS Department of Health and Human Services
DNA Deoxyribonucleic acid
DOE Department of Energy
EBD Environmental burden of disease
EIMS Environmental Information Management System
EMAP Environmental Monitoring and Assessment Program
EPA Environmental Protection Agency
IV
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List of Acronyms (continued)
EPHO Environmental public health outcome
EPO Epidemiology Program Office
FFPE Formalin-fixed, paraffin-embedded
FY Fiscal year
GIS Geographic information system
GPRA Government Performance and Results Act
HEDS Human Exposure Database System
HEI Health Effects Institute
HIV Human immunodeficiency virus
1KB Institutional review board
JHU Johns Hopkins University
MOU Memorandum of Understanding
NAACCR North American Association of Central Cancer Registries
NCBDDD National Center on Birth Defects and Developmental Disabilities (CDC)
NCRA National Cancer Registrars Association
NCCDPHP National Center for Chronic Disease Prevention and Health Promotion (CDC)
NCEH National Center for Environmental Health
NCER National Center for Environmental Research
NCHS National Center for Health Statistics
NCHSTP National Center for HIV, STD, and TB Prevention
NCI National Cancer Institute
NCID National Center for Infectious Diseases
v
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List of Acronyms (continued)
NEDSS National Electronic Disease Surveillance System
NERL National Environmental Research Laboratory
NHANES National Health and Nutrition Examination Survey
NHEERL National Health and Environmental Effects Research Laboratory
NHEXAS National Human Exposure Assessment Studies
NIH National Institutes of Health
NIEHS National Institute of Environmental Health Sciences
NIHS National Health Interview Survey
NIOSH National Institute for Occupational Safety and Health
NMMAPS National Morbidity, Mortality and Air Pollution Study
NNDSS National Notifiable Disease Surveillance System
NORA National Occupational Research Agenda
NPHSS National Public Health Surveillance System
NRMRL National Risk Management Research Laboratory
OEI Office of Environmental Information
OMB Office of Management and Budget
ORD Office of Research and Development
OSP Office of Science Policy
PM Particulate matter
RFA Request for Applications
SEER Surveillance, Epidemiology, and End Results
SENSOR Sentinel Event Notification System for Occupational Risks
SOER State of the Environment Report
VI
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List of Acronyms (continued)
STD Sexually transmitted disease
TB Tuberculosis
TMDL Total maximum daily load
USEPA United States Environmental Protection Agency
WHO World Health Organization
WTC World Trade Center
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Executive Summary
"It is also important that we hold ourselves accountable to the American public and report to them our
progress in reaching the goals we have set for ourselves. Therefore, I am directing the Agency to
prepare a State of the Environment Report... to describe the condition of critical environmental areas
and human health concerns."
This declaration by the USEPA administrator recognizes that for EPA to truly measure the
progress in achieving cleaner air, safer water, and better protected land resources, the Agency must go
beyond its historic reliance on process indicators (e.g., decreased emissions/discharges, increased
facilities in compliance) to measuring actual changes in ecological and human health outcomes.
Process indicators served the Agency and Nation well in the first 30 years of EPA's existence, during
which large gains were made in achieving cleaner air, safer water and reduction of land-based pollution
(e.g., waste sites, pesticides). However, to justify the costs associated with further incremental
improvements may require a more direct demonstration of the benefits to ecological and human health.
Whereas the Office of Research and Development's (ORD's) programs have traditionally focused on
research to better inform the Agency's risk assessments and risk management decisions, a program is
presently to be initiated that would assess the environmental public health outcomes (EPHO) of those
decisions and directly support the goals presented in the EPA Administrator's message.
In addition, EPA's EPHO initiative complements similar initiatives in the wider public health
arena. For example, as a result of the 2000 Pew Charitable Trust report, America's Environmental
Health Gap: Why the Country Needs a Nationwide Health Tracking Network, Congress is providing
appropriations in Fiscal Year (FY) 2002 and FY 2003 to the Centers for Disease Control and
Prevention (CDC) to begin bolstering America's ability to track and prevent health problems caused
by environmental conditions. Also, the CDC recently released the National Report on Human Exposure
to Environmental Chemicals (March 2001) that provided data on 27 pollutants present in the blood and
urine of a small sample of the U.S. population. Its intent is to continue to build this inventory over the
next several years.
To better define ORD's EPHO research agenda, a workshop was held July 30-31,2002 at EPA
facilities in Research Triangle Park, North Carolina. The intent of this workshop was to engage federal
and other organizations in a dialog that will assist ORD in developing a framework to guide this
research program, identifying potential near-term research areas and pursuing opportunities to
collaborate with other public health agencies and organizations. A total of 47 attendees met to discuss
aspects of near-term research planning that would involve broad collaborations between several federal
agencies in assessing environmental public health outcomes. Discussions on the first day focused on
topics emanating from the draft ORD Human Health Research Strategy' s Chapter three including: one;
are the approaches proposed reasonable and realistic first steps in initiating an EPHO Research
Program? two; are there other areas/activities to consider in the early stages? three; are there existing
data sets/resources that may be useful? and four; are there ongoing/planned activities within your
organization or agency that may be appropriate for collaboration?
Discussions during the second session centered on the Supporting Document for the
Human Health Chapter of the EPA's Draft State of the Environment Report (Final Draft). The
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panelists were also asked to consider the following questions in reading this background material
and in preparation for workshop discussions on these topics: one; what are the challenges in
merging environmental monitoring data with health surveillance data? two; what data
sets/resources exist that can inform the linkages between health outcomes and environmental
factors? three; what are the lessons learned in carrying out these programs? and four; what pilot
projects could be done to identify opportunities to improve the understanding of environmental
public health outcomes?
Workshop Response
Workshop participants agreed that the proposed EPA effort to measure public health
outcomes associated with environmental policies and regulations was worthwhile and that the
approach to link environmental monitoring data with health surveillance data seems logical.
Numerous suggestions for areas or activities to consider in the early stages of formulating and
implementing the proposed program were noted, including forms of measurement, types of
indicators, other tools, other disciplines, and communication of information. Participants also
agreed that it would be helpful to develop an interagency list of data sets, surveillance programs,
research efforts, models and other resources that are currently available. It was also determined
that a successful program in this area will have to build on EPA's strengths and existing activities
and be coordinated with on-going programs at other agencies.
Several possible challenges were noted to developing a program on public health
outcomes. These included whether the science is sufficiently developed, whether the necessary
data are available, and whether the proposed activities can be accomplished within a reasonable
time frame. The need to anticipate limitations to what can be accomplished, as well as the need
for a coordinated effort with other agencies and stakeholders, was also identified.
Next Steps
The workshop also identified several steps that could be followed in developing a program
on evaluating public health outcomes, including the following:
1. Create an inventory of data sources to determine what is currently
available, how they are structured, and how the data can be related:
2. Identify a known environmental hazard (e.g., methylmercury, ultraviolet
radiation) and conduct a pilot study by working through existing exposure
and effects data to determine data gaps and data needs:
3. Issue an RFA by the Extramural Program of EPA to develop research on
the area of public health outcomes. CDC has expressed interest in co-
funding such a solicitation: and
4. Attempt to provide EPA ad hoc participation in the review of RFAs from
other agencies (i.e., CDC, NCEH) related to evaluation of public health
outcomes
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Section 1
Introduction
"It is also important that we hold ourselves accountable to the American public and report to them
our progress in reaching the goals we have set for ourselves. Therefore, lam directing the Agency
to prepare a State of the Environment Report... to describe the condition of critical environmental
areas and human health concerns. "'
This declaration by Governor Christine Todd Whitman, the Administrator for the U.S. Environmental
Protection Agency (EPA), on November 13, 2001, recognizes that for EPA to truly measure the progress
in achieving cleaner air, safer water, and better protected land resources, the Agency must go beyond its
historic reliance on process indicators (e.g., decreased emissions/discharges, increased facilities in
compliance) to measuring actual changes in ecological and human health outcomes. Process indicators
served the Agency and Nation well in the first 30 years of EPA's existence, during which large gains were
made in achieving cleaner air, safer water and reduction of land-based pollution (e.g., waste sites,
pesticides). However, EPA must now show that the costs associated with further incremental improvements
can be balanced with demonstrated benefits in ecological and human health to justify continuation,
modification, and/or redirection. Whereas the Office of Research and Development's (ORD's) programs
have traditionally focused on research to better inform the Agency's risk assessments and risk management
decisions, a program is presently to be initiated that would assess the environmental public health outcomes
(EPHO) of those decisions and directly support the goals presented in the EPA Administrator's message.
EPA's EPHO initiative complements similar initiatives in the wider public health arena. For example, as
a result of the 2000 Pew Charitable Trust report, America's Environmental Health Gap: Why the Country
Needs a Nationwide Health Tracking Network, Congress is providing appropriations in Fiscal Year (FY)
2002 and FY 2003 to the Centers for Disease Control and Prevention (CDC) to begin bolstering America's
ability to track and prevent health problems caused by environmental conditions. Also, the CDC recently
released the National Report on Human Exposure to Environmental Chemicals (March 2001) that provided
data on 27 pollutants present in the blood and urine of a small sample of the U.S. population. Its intent is
to continue to build this inventory over the next several years.
EPA has supported and been intimately involved in both of these efforts and will be a direct beneficiary.
It is recognized "up front" that much of the data needed to support EPA's EPHO effort (e.g., health
surveillance and human exposure monitoring) is collected by other agencies with which cross-agency
cooperation and collaboration will be essential. The challenge for ORD will be to conduct the
complementary research to establish the linkages between these exposure and health events. The
characterization of such relationships will be of great value in future environmental decision making for
two reasons. First, such characterizations will substantially enhance the scientific basis of environmental
policy making. Second, this characterization will increase EPA's accountability to the American public.
There are also a number of established research strategies and assessment approaches from other agencies
that may serve as useful models for developing the EPA research framework. Examples include the
Surveillance Strategic Plan developed by the National Institute for Occupational Safety and Health
(NIOSH), the surveillance research program at the National Cancer Institute (NCI), and global assessments
of environmental health outcomes conducted by the World Health Organization (WHO). CDC also leads
a number of initiatives of interest such as the National Health and Nutrition Examination Survey
(NHANES) that are national in scope and multi-purpose in design.
JText from Governor Whitman's memorandum to EPA Assistant and Regional Administrators,
dated November 13, 2001.
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To better define ORD's EPHO research agenda, a workshop was held July 30-31, 2002 at EPA facilities
in Research Triangle Park, North Carolina. The intent of this workshop was to engage federal and other
organizations in a dialog that will assist ORD in developing a framework to guide this research program,
identifying potential near-term research areas and pursuing opportunities to collaborate with other public
health agencies and organizations.
In anticipation of the workshop, ORD has produced an EPHO white paper as part of its overall Draft
Human Health Research Strategy, which outlines a conceptual research program and sets the stage for
future activities. ORD also had the lead in producing the human health chapter of EPA's Draft State of the
Environment Report (SOER), due to be released in the fall of 2002. These two documents provided much
of the basis for discussions at the workshop, and participants were asked to read both documents prior to
attending the workshop.
On the first day of the workshop, WHO presented its conceptual model for measuring environmental health
outcomes and the integrated framework it developed for research in this area. The approach developed by
WHO focuses on the environmental burden for disease (EBD) within a harmonized framework for
assessment, policy action, and evaluation. The presentation also identified current activities for global- and
geographically-focused assessments completed or ongoing, as well as future plans for coupling
environmental health assessments to cost-effectiveness of interventions. Through this effort, an extensive
list of risk factors has been developed that may be of interest to this EPA initiative.
The first workshop day also included two panel sessions, and each focused on one of these documents. A
subset of the participants was assigned to each panel, and specific questions were provided in advance to
facilitate discussions. Each panel session included presentations by the assigned panelists, followed by a
panel discussion and an open discussion. Included in one panel session was a workshop presentation that
provided background information to all participants on the purpose, scope, expectations, and status of the
SOER currently in preparation by EPA.
On the second-day of the workshop, a subset of participants gathered to review the suggestions,
recommendations, and other outcomes of the first-day presentations and discussions. This led to further
discussions on setting the overall research framework, as well as next steps for FY 2002 and FY 2003.
This report presents highlights and key points of discussions throughout the two-day EPHO workshop and
is organized as follows. Section two summarizes discussions according to the four charge questions
identified for the first panel discussion. Section three summarizes discussions according to the four charge
questions identified for the second panel discussion. Section four provides other types of feedback received
from workshop participants pertinent to the proposed research initiative. Section five presents key
highlights of the second-day workshop discussion pertaining to program framework and next steps. The
workshop agendas and the lists of workshop attendees are provided in Appendix A and B, respectively.
Appendix C provides a list of data resources identified in workshop discussions and presentations.
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Section 2
Panel One: Public Health Outcomes White Paper
In preparation for this workshop, panelists were asked to read excerpts from EPA/ORD's Draft Human
Health Research Strategy, specifically the Executive Summary, Introduction, and Chapter three (Research
to Enable Evaluation of Public Health Outcomes from Risk Management Actions}. The panelists were also
asked to consider the following questions while reading this background material in preparation for
workshop discussions on these topics:
1. Are the approaches proposed reasonable and realistic first steps in initiating an EPHO Research
Program?
2. Are there other areas/activities to consider in the early stages?
3. Are there existing data sets/resources that may be useful?
4. Are there ongoing/planned activities within your organization or agency that may be appropriate
for collaboration?
In their presentations, panelists provided information specific to these questions and/or provided illustrative
examples observed while conducting similar programs.
The following sections summarize the information presented in workshop sessions and discussions relevant
to the preceding questions.
2.1 Are the Approaches Proposed Reasonable and Realistic First Steps In Initiating an EPHO
Research Program?
Workshop participants agreed that the proposed EPA effort to measure the public health outcomes
associated with environmental policies and regulations is worthwhile and that the proposed approach—to
link environmental monitoring data with health surveillance data—is attractive. In association with this
overall comment, participants offered additional suggestions for EPA consideration in four areas; general
program observations, approaches for establishing priorities, potentially applicable approaches and first
steps, and potential models for program development. The following sections provide highlights of
workshop discussions in each of these areas. The challenges specifically associated with linking
environmental and health data are presented in Section 3.1.
2.1.1 General Program Observations
The general consensus that the proposed EPA program is worth pursuing was tempered with a number of
cautionary considerations. The concerns expressed generally focused on whether the science is sufficiently
developed, whether the necessary data are available, and whether the proposed activities can be
accomplished within the time period required. Workshop participants also noted the need to anticipate that
there will be limitations to what can be accomplished as well as the need for a coordinated effort with other
agencies/stakeholders. (NRMRL)
Workshop participants also noted that there are limitations to science and to risk assessment as well as
significant levels of complexity, uncertainty, and unknowns to be filled by research. Explaining to the
public the limitations of science in identifying risk factors, assessing risk, designing interventions, and
reducing risks can be difficult. Clusters of disease such as cancer may occur that are not statistical
anomalies, yet the cause may remain unknown despite the best scientific efforts. Also, currently available
techniques and data sets may be inadequate to detect improvements in overall public health as a
consequence of environmental policies and regulations. This does not necessarily mean that public health
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has not improved since the institution of pollution control regulations, rather that the improvement may not
be measurable with currently available tools. Clearly communicating these distinctions to the public will
be very important. (NRMRL, CDC/NCEH)
A related concern was that the background documents for this workshop make these very complex and
challenging issues seem achievable to those who are not knowledgeable in these scientific fields. Program
planners were cautioned about setting standards, goals, or expectations too high for what can be delivered
or implying that complex issues will be solved in a brief period of time. (CDC/NCEH, ATSDR) In
addition, workshop participants also acknowledged the difficulty of acquiring hard data that no one will
criticize or that prove correlations with diseases. (AFIP)
Framing the program into phases may be reasonable and helpful, but this may mislead critics and the public
regarding the linkage between individual phases. How individual projects are related to each other and to
the accomplishment of the program and each program phase will be important to communicate. (NIOSH)
Is the program intent to reinvent EPA or to add a new direction or definition to existing programs?
Reinvention would require the involvement of more disciplines, backgrounds, and interested/affected
stakeholders (e.g., state/local). (NIOSH)
Also noted was the importance of showing that this program is meaningful and has potential, because
environmental health is not yet considered a core health area. (WHO) NIOSH similarly noted the need to
make this program relevant to the public and to the decision makers rather than focus solely on EPA needs.
To do this may require reaching out to a broader audience (beyond those in this workshop) and recognizing
roles for professional organizations, academic centers, and industry. Of related importance is encouraging
academic collaborators to work with public health counterparts at the state/local levels on real-world
situations. (NIOSH)
Many of the EPHO mentioned in the reports reviewed for this workshop are not direct measures for
assessing impacts. More research may be necessary to determine specific exposure-outcome relationships
in order to make such determinations. (ATSDR)
Furthermore, developing an integrated, coordinated national EPHO research agenda will be challenging
because of the number of agencies involved in data collection and the overlap of common research interests
between agencies. A helpful step may be to identify the types of research that each agency, including EPA,
is most suited to conduct (NRMRL). This research initiative also depends on having the capacity to collect
the necessary data and the expertise to interpret the data, and fewer suitable data sets are available than
many would assume. (CDC/NCEH)
Also noted was the need to consider, for a successful program outcome, a range of indicators beyond just
human health. For example, there are environmental changes that cause adverse global effects but may not
cause disease directly (e.g., global warming from hydrocarbon emissions increases floods that kill people
in another country). Reasons to control such adverse environmental changes may have nothing to do with
disease. A potential program pitfall is to focus on public health outcomes as the only priority to the
exclusion of other programs that measure environmental influence. (AFIP)
This initiative could serve to strengthen implementation of risk management approaches, delay them, or
lead to the evaluation of things that individuals or organizations may not want evaluated. Programs may
be adversely affected if the proposed research is unable to measure/document health benefits from actions
the Agency has already taken. Thus, EPA must be prepared to address negative outcomes from the
proposed initiative. These could include:
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• Finding that the wrong thing is being regulated and being prepared to shift efforts in response to
such a finding, even if the proposed studies are not finished (Day-two Sum)
Inability to show that environmental exposures from certain discharges are causing adverse health
effects (or that eliminating such exposures reduces adverse health effects) may result in public
pressure to drop the controls/restrictions on such discharges, even though such controls/restrictions
are known to be desirable for other reasons or from other source information (NCEA, NRMRL,
AFIP, NERL)
Finding that a specific polluting situation is causing adverse health effects, resulting in criticisms
for delaying implementation of appropriate controls or restrictions in favor of completing the
research (NCEA, NRMRL AFIP, NERL)
Of particular concern is that this effort may be unable to show that the Agency's policies are successful
based on public health indicators. Such success may depend on the creation of a national system to track
diseases. Inherent to both the proposed program and a national tracking system are questions of which
diseases to select, which diseases are of most concern in managing different types of environmental
pollutants, and how individual indicators will be picked. (NIEHS)
Other general suggestions included the following:
• Different individuals may choose to live with different levels of risk (AFIP)
Better explanation is necessary in the EPA documents reviewed for this workshop regarding the
need to link exposures to public health outcomes (NIEHS)
• If emphasis is placed on recording and reporting raw data, trends both upward and downward will
be apparent, and increasing trends are not well received (NIOSH)
Plan so opportunities and expectations are realistic. (ASTHO)
2.1.2 Establishing Priorities
EPA queried participants and attendees for suggestions on how to establish priorities for the proposed
program and suggestions on recommended first steps in this effort. The background documents for this
workshop cast a broad net and participants suggested the need to winnow the ideas down to core elements
that are most important to achieving the desired goals. To do this, participants and attendees suggested that
EPA consider:
What end points are being protected or reduced (ATSDR)
How the information will provide value to better understanding and validation for risk-management
decision making (ATSDR)
• What can be achieved with available resources (ASTHO)
• Economic impact and the cost per life saved (ASTHO)
• What information would EPA like to have or needs to have several years from now, such as the
data necessary to support tracking or evaluation of success beyond what is currently available with
due consideration given to what data are practical to obtain (ASTHO)
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• Using burden of disease in the population as a means of selecting which issues to monitor
(CDC/NCHS)
What public health level(s) to address—case (assure appropriate treatment), contact (assure
contacts are treated), community (remove source of outbreaks), or program (monitor effectiveness
in real time) (ASTHO)
What EPA wants to meet or achieve, then steer efforts toward what is desired to be accomplished
and look at what already exists that can be converted to help. (WHO)
In addition, the environmental burden of disease (EBD) approach used by WHO in global assessments was
noted as one of many tools for prioritizing health problems and risk factors because it uses common health
units, compares various risk factors and diseases, and compares environmental health to other areas. This
approach can help to monitor progress, to provide a basis for evaluation, and to identify vulnerable
subpopulations, and can also serve as basis for calculating the cost-effectiveness of interventions. (WHO)
Workshop participants consistently emphasized that initial studies should be conducted in a manner that
will yield rapid results. One option was to begin with a contaminant, an existing data set, an exposure
scenario, or a health outcome, and to map out a program covering all three areas of interest—exposure,
environment, and health effects. (EPA, NCI, ATSDR) Going through such an exercise will help to identify
gaps in the data and in the methodology, and will help to clarify exactly what types of data are most useful.
For example, using particulate matter or arsenic data, describe the available data sets and how the risk
management programs would be evaluated. This in turn would generate a design of the evaluation system
and its required elements. (NIEHS) EPA human exposure researchers already use this approach; for
example, they start with a specific pesticide and use exposure models to identify the data needs. (NERL)
Workshop participants also suggested approaches that involved the anticipation of future research needs.
For example, consider what data are needed to evaluate the public health outcomes of newly implemented
interventions and those that are "in the works" but not yet implemented. Consider EPA's 10-year plan for
mercury and think about what data would need to be collected to identify changes in public health outcomes
over the years. Recent changes in pesticide registrations provide an additional opportunity to track
outcomes over the next few years. Baseline data for some interventions can be collected now, before the
effects of the interventions become widespread. (ASTHO)
Other suggestions for first steps to help define program approach and focus involved the use of a pilot
program (CDC/NCEH), a hypothetical example (NIEHS), or a hypothetical case study. Examples offered
for consideration included:
• Developing an example using a specific regulation or guidance that includes an environmental
control activity. "Scope out" the effort, and identify all possible measures in the three areas of
interest, (exposure, health effects, environment) considering their utility to the EPA program, to
the EPA Administrator goals, and the public good (as good stewards of federal dollars). (ATSDR)
Working backward from a given regulation or standard. (ATSDR)
Determining the interests of the public and relating program efforts to those areas; for cancer
surveillance, these include prevention, early detection, and quality of life. (NCI)
• Building an evaluation into new regulatory strategies or use the new regulatory strategies as
exercises if such an approach cannot be added into the current regulatory process. (ASTHO)
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• Identifying the best indicators for success in air or water or waste, then picking only two or three
core indicators and conducting the best possible analysis using those indicators. To do this, select
a suite of indicators or a specific disease focusing on high priority issues that will measure the
success of the program, and specifically consider a set of core tracking indicators where the
environment can in fact be measured. (ASTHO)
• Mining existing data sets to determine what additional data are needed and how such data should
or can be collected. (NERL)
Identifying regional issues or focuses (e.g., Great Lakes, large cities, specific chemicals) that are
important to community health and are of political interest. (ATSDR)
• Evaluating some specific exposure situations for suitability to this initiative. Examples include the
Libby asbestos mine that had specific health impacts and data available from extensive residential
health examinations. Such an example would need to consider both cancer and noncancer
outcomes. (NIEHS, ATSDR)
Assuming, for a hypothetical case study, that all the information desired can be obtained, then
determining what is really needed to carry out an actual study. (Day-two Sum)
Refer also to other sections of this report for related suggestions pertaining to pilot projects (Section 3.4),
other potentially applicable approaches (Section 2.1.3), and collaboration opportunities (Section 2.4).
Of final note was a recommendation to avoid giving states complete discretion for setting priorities. A
NIOSH program developed in the 1980s was offered as an example for setting national priorities while
including mechanisms to address some state-specific aspects. This NIOSH program prescribed a list of
conditions to address, yet retained the option for states to submit alternative proposals. (NIOSH)
2.1.3 Potentially Applicable Approaches and First Steps
Workshop discussions addressed the use of both prospective and retrospective approaches. A prospective
approach requires the process to be thought out in advance in order to formulate hypotheses. (NERL)
However, retrospective approaches using existing data may still yield useful results. (ATSDR) Existing data
as well as dose/response and other models can help to develop retrospective and prospective questions to
get at the larger issue of "Can or do we affect public health?" (NERL)
Workshop participants also noted the importance of conducting hypothesis-driven studies, even if they are
retrospective. (NCEA) Such approaches would involve developing hypotheses for the end points then
looking for the environmental conditions that are thought to be contributing or to develop hypotheses of
linkages that must then be tested. (NERL)
Additional, more specific suggestions to consider in developing an approach to linking environmental and
public health data and measuring health outcomes included the following:
• Measure impacts and endpoints rather than compliance. (ATSDR)
• Choose one parameter from the WHO efforts and apply it in a manner that best fits the needs of
the United States. (WHO)
Select a few high-priority issues to measure success and determine the best indicators for success,
then pick a suite of indicators or a specific disease and look at what others are doing in that area.
For example, if asthma is a core indicator for air, look into what research is being conducted on
asthma and air quality. (ASTHO)
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Use a case control approach to study a high exposure area as compared to low exposure areas, such
as air pollution impacts in Los Angeles or another urban center vs. rural areas. (ASTHO)
• Focus on areas that appear to have moderately high or high rates of disease because these represent
greater opportunity to observe disease reduction than in areas that have only sporadic disease
occurrences. (NIEHS)
• Re-analyze specimens collected under previous studies for new parameters of interest. (ASTHO)
• Make the most of the data that already exist; start with what is available and try to make the data
better. (NCI)
Take advantage of relevant measurement opportunities that may occur such as the study of the
relationship between health effects and particulate matter (PM) exposure changes resulting from
short-term closure of a plant in Utah or applications of pollution controls on diesel engines in urban
areas. (HEI)
• Consider applicability of approach used by the Agency for Toxic Substances and Disease Registry
(ATSDR) to evaluate specific remediation activities (removal of lead-contaminated soil) and how
this was linked to findings that this intervention decreased blood lead levels in children in nearby
households.
Examine consequences of compliance and noncompliance as well as different levels of
noncompliance (grades of noncompliance) to see what the effects are and to look for gradation of
effects requiring adjustments for different areas. (ATSDR)
Involve public health officers to help identify specific local venues/situations for study. (NIOSH)
Integrate decision making with science and regulations by integrating the principles of surveillance,
risk management, and prevention and through more dialog among researchers, risk managers, and
policymakers. (NIOSH)
Acquire and use anecdotal information in addition to case-based surveillance data. (NIOSH,
ASTHO)
• Consider different levels of indicators such as core (what are practical nationwide), optional (not
applicable nationwide), and developmental (have promise but are not ready for implementation).
(ASTHO)
• Leverage the EPA asset of having significant amounts of exposure data rather than reinventing the
Agency because this will represent an enhancement or growth area. (NCI)
Host a conference with representatives from all states and identify several (perhaps five) good
venues to pursue. Both science and diplomacy must be considered since few venues may be
advantageous to program needs, which may have negative repercussions among the states not
selected to participate. (NCEA)
• Consider a two-track system involving data rich/poor areas as well as high/low problem areas.
(WHO)
2.1.4 Potential Models for Program Development
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There are a number of established research strategies and assessment approaches that might serve as models
for framework development. Participants also presented illustrative examples as guidance based on their
program experience. These include WHO's conceptual framework for EBD assessments, the NIOSH
Surveillance Strategic Plan, CDC prioritization efforts, and the framework for the NCI surveillance research
program.
In developing global EBD estimates, WHO is using disability-adjusted life years (DALYs) as a summary
measure of population health that spans both diseases and risk factors. Each DALY corresponds to 1 year
of healthy life lost. Disease burden is a calculation that considers incidence, mortality, and DALYs. WHO
noted that DALYs are a common metric, but the power of their use dissipates when focusing on smaller
geographic areas.
NIOSH offered the approach presented in its Surveillance Strategic Plan (available on the NIOSH website)
as a useful method for approaching these types of initiatives. Also suggested was applying other NIOSH
lessons learned to this process for environmental health evaluation. In developing surveillance programs,
NIOSH teamed with academia, federal/state authorities, labor, professional organizations, and academic
centers. NIOSH also brought in the insurance industry, which operates at the state level and is an important
data resource in the health arena.
In addition, NIOSH created partnerships to develop data resources such as the Sentinel Event Notification
System for Occupational Risks (SENSOR, which addresses occupational asthma and pesticides among
other factors), the Adult Blood Lead Epidemiology and Surveillance (ABLES), and occupational mortality.
CDC programs are establishing their priorities based on those defined by the Department of Health and
Human Services (DHHS) in Healthy People 2010 and the recommendations from the Pew Charitable Trust
report. In this effort, CDC is first arranging for state participation, in order to consider their priorities
before actually establishing or setting out CDC programs, for two reasons: (1) the states have specific
state/local priorities that need to be considered, and (2) CDC must consider whether these state/local
priorities may be national priorities as well.
As another example, setting priorities for each NHANES is a challenge because this is a multi-purpose
survey that considers nutrition, disease, and environment. To address this challenge, NHANES planners
conducted a significant amount of outreach to the professional community that uses the data collected and
held many stakeholder meetings to address priorities. (CDC/NCEH)
NCI has a national framework of cancer registries (SEER), yet the core of the work is through data linkage
and ecologic analyses. NCI also draws on modeling and analytical tools applied at many levels. Much of
what is accomplished is through a peer review program and grants. NCI also worked with the partners to
develop a national framework for cancer surveillance. This considered treatment of cancer, living with
cancer, and dying with cancer; primary, secondary, and tertiary prevention; and information/measurement
needs for describing the cancer burden by social, economic, racial/ethnic, and geographic subpopulations.
(NCI)
The mission of the National Institute of Environmental Health Sciences (NIEHS) is to reduce the burden
of environmentally-associated diseases, to define susceptibilities, and how these change over time. The
research encompasses the diseases mentioned in the EPA reports reviewed for this workshop including the
emerging diseases such as autism, Parkinson's disease, diabetes, and others that may be environmentally-
based. Basic and applied research is conducted in all of these areas extramurally and intramurally. Much
of the funding goes to various universities and for prevention/intervention programs.
Other frameworks to consider include the following:
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• ORD's development of better water quality indicators, which help state TMDL monitoring
programs, may be a good model of state-EPA cooperation.
Many remediation actions are accomplished by combined federal, state, and local efforts and might
serve as models of interagency, multilevel cooperation. (NIEHS, ATSDR)
2.2 Are There Other Areas/Activities To Consider In the Early Stages?
Workshop discussions presented numerous suggestions to EPA for other areas or activities to consider in
the early stages of formulating and implementing the proposed program. These suggestions involved five
general areas: forms of measurement, types of indicators, other tools, other disciplines, and communication
of information. The following sections address key points raised in workshop discussions in each of these
areas.
2.2.1 Forms of Measurement
EPA program planners were encouraged to think about existing and new forms of measurement to
understand the environmental contributions to exposure and health (ATSDR). Examples offered by
workshop participants included:
Identifying biomarkers or biologic measures of exposure that are easier to measure rather than
waiting for disease to become clinically apparent in order to measure disease endpoints (ASTHO)
• Use of the DALY metric or other existing summary measures of health to measure across diseases
and conditions (WHO)
Collection and evaluation of both rates of occurrence (frequency) and counts (number of
occurrences) (NCI)
• Finding positive as well as negative measures of performance (NIOSH)
Coupling assessments for risk factors to cost-effectiveness of interventions using the same
measurement units. (WHO)
Suggestions for environmental parameters to measure included the following (ATSDR):
• Releases, emissions, and storage
• Ecosystem impacts
• Contamination levels—air, water, food, soil
• Levels of compliance with standards and regulations
• Contaminant levels in workplace, home, school, day care—where people spend large amounts of
time
• Usability or sustainability of natural resources.
Suggestions for exposure parameters to measure included the following (ATSDR):
Level by pathway—air, water, food, soil.
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• Re-education and intervention monitoring.
• Biomarkers of exposure—150 contaminants are measurable, some biomarkers have been identified.
• Behavior and knowledge, including perceptions of exposure/risk and compliance behaviors.
• Exposure-dose relationship in humans, including body burdens and excretion.
Suggestions for human health parameters to measure included the following (ATSDR):
• Morbidity, mortality, incidence/prevalence
• Biomarkers of effect—early and late biomarkers of effect and reversibility
• Acute health effects—significant to communities and the general public
• Occupational disease or injury
• Contributions of nonenvironmental factors—lifestyle, demographics, genetics, etc.
• Behavior and knowledge—perceptions of health, knowledge of health outcomes/risks.
2.2.2 Types of Indicators
Environmental public health indicators need to be developed. An example is the initial core list of
indicators adopted by the Council of State and Territorial Epidemiologists (CSTE) in July 2001 (ASTHO).
This list includes environmental public health indicators needed to monitor the following:
• Air—indoor, outdoor
• Water—drinking and recreational
• Agents/sentinel events—chemicals (e.g., pesticides, metals), physical (e.g., ultraviolet radiation,
noise, disasters).
The core list also includes various types of environmental public health indicators such as:
Hazard—toxic releases from industries, etc.
• Exposure—levels in blood, urine, hair
Health effect—unusual occurrences of diseases such as asthma (many factors may contribute to
a decrease in mortality)
• Intervention.
Workshop participant recommendations also included the need to develop both additional indicators and
more precise indicators of human behavior (bottled water use, fish advisory compliance, etc.) as well as the
need to create action-oriented indicator(s) tied to a public health objective. (ATSDR, ASTHO)
2.2.3 Other Tools
Integrating national surveillance data systems or making existing data systems compatible was identified
as an important tool in many workshop discussions. Similar recommendations involved increasing the
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compatibility of state-level data systems with national systems, which would also help to give state/local
agencies an opportunity to participate in national surveillance activities and data policies. Some state
systems may already be undergoing upgrades to address recent bioterrorism concerns. (ASTHO)
Modeling was identified as another potentially useful tool. Before/after health outcome data can be used
in models to try to predict risks; the predictions can then be compared to the actual before/after information
to help validate the models. Once validated, the models can be used to predict the effect of environmental
policies and regulations on public health. (NERL) In cancer risk management, modeling has been used to
link screening, treatment, and prevention goals to mortality goals (NCI). Models, mathematical
calculations, and other tools can also be used to predict trends, then measure actual occurrences against
those trends. (NCI) Inverse modeling tools are available and may aid in working backward from an effect
to the source. (NERL) There may also be the need to develop models that show the entire exposure-effect
process. (NERL) In addition, research may be needed to back-up or validate the models, which has been
a past criticism of some efforts. (ATSDR)
Another important concern was to geocode the collected data and to either use or plan for the future use
of Geographic Information System (GIS) technology. This tool will help with risk communication,
especially in regional or national presentation of findings. GIS data layering capabilities are very useful,
but depend on the quality of data entered. (ATSDR)
Newly emerging technologies, such as genomics techniques, may aid in identifying susceptible populations
that were previously unrecognized, which may be a more appropriate level of consideration. (ASTHO)
These new genomic tools and other new technologies would serve in addition to (not instead of) traditional
mortality and morbidity data to better evaluate risk management programs. (NIEHS)
For example, toxicogenomics (which elucidates the genomic response of organisms exposed to
environmental toxicants), proteomics, and metabonomics have the potential to provide environmental
public health indicators in the form of biomarkers of early disease, exposure, and susceptibility.
Biomarkers of early stages of disease will enable earlier detection of health effects from pollutants. These
technologies may allow scientists to identify the cellular networks of response to environmental toxicants.
(NIEHS)
Other suggestions included the following:
• Identify what can be done with the data and tools that are currently available. Identify what tools
(modeling and otherwise) and data need to be developed (NERL)
Use probability/decision analysis tools to identify the likely influences on a desired outcome then
test these possibilities; many such tools already exist (NIEHS, NRMRL)
• Evaluate and develop, as needed, techniques for exposure-dose reconstruction noting that data
quality is very important to this effort (ATSDR)
Develop prevention-effectiveness assessment (cost-effectiveness) techniques; an example is the
collaboration between the Agency for Toxic Substances and Disease Registry (ATSDR) and EPA
for disinfection models (NCEA)
Recruit tissue donors to create tissue banks for future analysis for parameters that cannot be
measured with current techniques (ASTHO); the Army explored creating such a tissue bank, yet
cost was a significant factor in the decision not to pursue it. (AFIP)
2.2.4 Other Disciplines
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Economics, social science, and behavioral science were identified as additional disciplines that may be
important in developing and conducting the proposed program. Economists have different analytical tools
and insights that may be useful.
In addition, economic assessments are important because a key issue in any program such as this is the cost
associated with environmental regulations. (ASTHO) The economic costs may need to be merged with the
health aspects, for example, by assessing the money spent according to some easily identified metric; an
illustrative example involved a measure of state dollars spent per highway mile (one million dollars) to
enable comparisons of different program costs (e.g., $19 million for bioterrorism equals 19 miles of road
construction). Other economic evaluation considerations are the cost of intervention vs. health life years
gained or the cost for each life saved as part of a cost-benefit analysis. (WHO, ASTHO)
Social scientists and behavioral scientists also have potential contributions to make in linking exposure and
environmental contamination. Specific areas include the identification and assessment of behaviors that
lead or contribute to exposure and, subsequently, adverse health effects. Some of these may be age-related
or vary by age group, particularly for susceptible populations such as children.
In addition, measurements of social well-being are needed because behavioral aspects affect health (Day2
Sum). Since the risks in many communities result from cumulative stressors, application of a "quality of
life" approach also may be useful in developing an index of environmental stressors that could be applied
by any community. This type of information may also be more readily collected (e.g., through telephone
interviews rather than medical exams). (ASTHO)
2.2.5 Communication of Information
Numerous recommendations emphasized the importance of disseminating findings and communicating with
the public and stakeholders. These include:
• Communication of activities and findings to the public is important to overall program success.
(NCI, CDC)
Communication of reasons why certain locales or situations are selected for study, while others are
not, is important to maintaining cooperation of state/local agencies. (NCEA)
• Improvement of the dialog among researchers, risk managers, and policymakers to better integrate
science and decision making. (NIOSH)
Language-free communication tools can enhance and improve information dissemination to non-
English-speaking and illiterate persons. (NIOSH)
• Risk assessment and other aspects of this program may be difficult to explain to the public.
Information must be translated and communicated in terms the recipient audience can understand.
Risk communicators can assist in communicating and explaining these concepts to legislative
personnel and the general public. (NCI, CDC/NCEH)
Limitations of science in identifying risk factors, designing interventions, and reducing risks also
can be difficult to explain to nonscientists. The reasons for a health occurrence may be beyond
current scientific understanding, yet also may be known not to be a statistical anomaly.
(CDC/NCEH)
• Effective information dissemination is important for the information to be applied and used because
the information will not diffuse on its own. (NCI)
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Communicating information back to a community regarding studies conducted in its area (e.g.,
cancer cluster-type study) helps to involve the community in the effort and thereby garner its
support. (NCEA)
Conduct outreach to stakeholders as well as to collaborators and potential information sources.
(Day2 Sum)
2.3 Are There Existing Data Sets/Resources That May Be Useful?
Participants generally agreed that it would be helpful to develop an interagency list of data sets, surveillance
programs, research efforts, models, and other resources that are currently available. Many agencies are
involved in collecting data relevantto environmental health, therefore, identifying relevant studies that have
been conducted already might also be helpful. Data available from outside the federal government should
also be identified.
To start this process, Appendix C provides a tabular listing of the data sets and surveillance systems
mentioned in workshop discussions. Other potentially relevant information sources include:
• Lists of indicators, surveys of information sources, and data sets collected for preparation of the
SOER; additional data exist beyond what is actually being used in the report
Lists of indicators developed by the U.S. Forest Service, the Council of State and Territorial
Epidemiologists, and EPA programs (e .g., the Environmental Monitoring and Assessment Program,
or EMAP)
A national burden of disease study already prepared by the United States (WHO)
A round table hosted by WHO on how to address risk factors at a national level.
WHO also offered to share information on its process for assessing disease burden since the entire process
is not documented in a specific report.
2.4 Are There Ongoing/Planned Activities Within Your Organization/Agency That May Be
Appropriate for Collaboration?
EPA plans for this to be a leveraged program that builds on EPA's strengths and existing activities in
coordination with other agencies. Thus, panelists and workshop participants were invited to provide
information about ongoing/planned activities in their agencies/organizations that are potentially suited for
collaboration with EPA in the EPHO initiative. The following sections present highlights of ongoing and
planned activities and initiatives for CDC, ATSDR, NIOSH, NCI, NIEHS, and WHO not otherwise
presented in other sections of this report or Appendix C.
2.4.1 CDC
CDC historically has developed programs as they are funded, and these programs are typically disease- or
topic-specific. Now CDC programs have an increased interest in standardizing data and integrating existing
databases with each other and with new data. CDC also has significant interest in the evaluation/assessment
after a risk decision is made (e.g., intervention) regarding effects and the quality of data used.
(CDC/NCEH)
CDC is establishing surveillance systems for a number of diseases that are not currently tracked. CDC is
willing to discuss disease surveillance methods with interested parties.
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CDC is also working to improve exposure databases. The best exposure databases are for childhood lead.
Other CDC activities include:
• Funding up to 15 state/local pilot projects to identify and either improve or initiate surveillance
activities on possible environmentally-related diseases as well as to explore the environmental-
health linkage
• Creating an inventory of more than 120 existing CDC surveillance systems (see examples in
Appendix C)
• Working for 3 or more years with the CSTE focusing on health indicators, including some
environmental health indicators.
Two Request for Applications (RFAs) have already been issued for state/local pilot projects. One RFA
requires state health and environmental agencies to work together to evaluate existing databases, evaluate
existing legislation/regulations, and to develop/enhance data systems. States are classified into tiers based
on their capacities in these areas. In states with existing capacities, activities will also include actual linkage
projects and examine the feasibility/utility of EPHO indicators in the field. The other RFA will create two
or three centers of excellence geared toward schools of public health to bring academic and state programs
together to develop statistical algorithms and other approaches.
Specific groups in CDC are developing surveillance systems for new conditions such as autism, learning
disabilities, attention deficit hyperactivity disorder (ADHD), and Alzheimer's disease, among others, that
may have an environmental contribution. The Developmental Defects Center is looking at autism as an
"add on" to the Atlanta birth defects registry effort. CDC also has awarded grants to develop surveillance
systems for developmental disorders in other areas.
The following sections summarize ongoing and planned activities within CDC for the National Center for
Environmental Health (NCEH) and National Center for Health Statistics (NCHS).
2.4.1.1 NCEH
NCEH is the lead agency developing a nationwide health tracking network for diseases and exposures. This
will be an integrated system responsible for data collection, analysis, and dissemination of information. The
program goal is to develop and implement comprehensive programs in all 50 states, the District of
Columbia, U.S. territories, and tribal nations. (See Appendix C for further information.)
Another NCEH focus is on developing information to be used at the state and local levels, including
involvement in the CDC RFAs discussed previously. In addition, NCEH is interested in opportunities to
collaborate with NHANES and other national surveys.
CDC/NCEH is also currently involved in discussions with the EPA Office of Environmental Information
(OEI) on existing data usage and integration within the constraints of privacy/confidentiality agreements.
A small team is being developed (EPA network personnel and others) to look at such issues as how to mesh
specific electronic data systems. A Memorandum of Understanding (MOU) is being developed and may
provide an opportunity for additional collaboration.
2.4.1.2 NCHS
NCHS collects vital statistics data in partnership with states, and also collects data on health status, health
behaviors and the environment, the health system, and treatment and care. The NCHS mandate includes
health, environmental, and social aspects. NCHS conducts surveys that include household interviews and
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health care providers. NCHS is interested in having these data used as extensively as possible, and noted
that links of its data to other data sets are possible, provided confidentiality is protected.
NCHS is also the administrator of the National Health and Nutrition Examination Survey (NHANES).
NHANES is an ongoing study with great flexibility to add features that address specific questions of
collaborators. The NHANES survey content will change in 2005, and advance planning for this is
beginning in September 2002. Opportunities exist at this time to collaborate with NCHS on future survey
content and to determine if some of new desired data can be obtained through this survey.
NCHS offered to participate in discussions on use of its data as well as strategization on data access within
the confines of the applicable confidentiality agreements. NCHS also offered to collaborate on evaluating
the feasibility of proposed data needs and collection techniques and in developing proposals. In addition,
NCHS offered partnering opportunities to address the acquisition of geographic information and linkage
of geographic information to public health data without violating confidentiality standards.
NCHS also recommended that, when working with an ongoing survey, collaboration should begin in the
planning stage so the survey can be adapted to provide the desired data.
2.4.2 ATSDR
ATSDRhas expertise in exposure-dose reconstruction and in applications of GIS technology to this field.
Priority health conditions being addressed by ATSDR initiatives include:
Birth defects and reproductive disorders
• Cancer (selected anatomic sites)
• Immune function disorders
• Kidney dysfunction
Liver dysfunction
• Lung and respiratory diseases
Neurotoxic disorders.
ATSDR research focus areas for 2002 through 2010 include:
Exposure assessment
• Chemical mixtures
Susceptible populations
• Community and tribal concerns
Evaluation and surveillance of health effects
• Health promotion and intervention.
ATSDR is also working with neurologists and public health agencies to launch pilot surveillance systems
for degenerative neurological disorders (e.g., multiple sclerosis, amyotrophic lateral sclerosis, etc.) in four
or five states. This will involve the collection of data and assessment of trends.
2.4.3 NIOSH
NIOSH looks at the burden of occupational health and is expanding research at the national and state levels.
Ongoing or planned activities include state-based occupational disease surveillance programs (some in
place since 1980), and National Occupational Research Agenda (NORA) grant solicitations that leverage
NIOSH and partner resources. In collaborative ventures, NIOSH can provide technical assistance,
surveillance research expertise, and capacity building.
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2.4.4 NCI
Much of what NCI does is conducted through peer review programs and grants. For example, NCI is
building a surveillance infrastructure and assembling complex data sets through its Surveillance,
Epidemiology and End Results (SEER) program (see Appendix C). In addition, NCI has formed a
cooperative group of 17 grantees that are modeling the impact of cancer control interventions on cancer
incidence and mortality.
NCI is involved in a partnership via the National Coordinating Council on Cancer Surveillance. This
partnership meets voluntarily and includes representatives from the American Cancer Society, American
College of Surgeons, North American Association of Central Cancer Registries (NAACCR), CDC, NCI,
Armed Forces Institute of Pathology (AFIP), and the National Cancer Registrars Association (NCRA).
2.4.5 NIEHS
NIEHS is working with the National Research Council to develop a committee on emerging issues and data
on environmental contaminants. This effort intends to bring together persons in the field of genomics and
other emerging technologies with those affected by data coming from such new technologies. This
committee will consider technology implications and whether such technologies will support the
identification and use of biomarkers for disease or otherwise help with program evaluations.
2.4.6 WHO
The EBD assessment activities that WHO has currently underway include:
• Preparing global assessments for various environmental and other risk factors
Preparing guides for national and local assessments
• Supporting training in various countries
Coupling assessments to cost-effectiveness of interventions.
WHO also desires to develop partnerships to look for risk factors relevant to developed countries.
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Section 3
Panel 2: State of the Environment Report Environmental Health Chapter
In preparation for this workshop, panelists were asked to read the Supporting Document for the Human
Health Chapter of the State of the Environment Report (Final Draft). The panelists were also asked to
consider the following questions in reading this background material and in preparation for workshop
discussions on these topics:
1. What are the challenges in merging environmental monitoring data with health surveillance data?
2. What data sets/resources exist that can inform the linkages between health outcomes and
environmental factors?
3. What are the lessons learned in carrying out these programs?
4. What pilot projects could be done to identify opportunities to improve the understanding of
environmental public health outcomes?
In their presentations, panelists provided information specific to these questions and/or provided illustrative
examples from their experience in conducting similar programs.
The following sections summarize the information presented in workshop sessions and discussions relevant
to the preceding questions.
3.1 What Are the Challenges in Merging Environmental Monitoring Data with Health
Surveillance Data?
Workshop participants agreed that there are significant challenges to address in linking environmental
monitoring data with health surveillance data, yet this is achievable even given that basic research is still
needed in order to accomplish this goal. The challenges identified by workshop participants came from
their own program experience and were offered to EPA for consideration in developing its own program.
These challenges ranged from those specifically related to the scientific and practical aspects of data
collection and analysis to data access and overall program framework. All of the presenting agencies
expressed their desire to work with EPA in developing and implementing this program as it represents a
cross-cutting area of interest and offers the potential to help meet multiple program needs.
Challenges in data linkage identified during the workshop involved the following eight areas:
1. Data availability
2. Data collection capacity
3. Data compatibility
4. Database communication
5. Data access
6. Data and interpretation limitations
7. Overall framework to ask the right questions
8. Common terminology/definitions.
The following sections summarize key points raised in each of these eight areas.
3.1.1 Data Availability
Many federal agencies collect environmental and health data. Because there is little to no coordination
between agencies, agencies are often unaware of the past, current, or planned efforts of other agencies that
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may be useful to their own efforts. As a result, these workshop sessions generated much interest in inter-
agency collaboration as presented in Section 2.4.
Specific data availability challenges noted in the workshop include the following:
Health surveillance data are not as prevalent as many often believe or assume. While there are
some excellent registries of disease (NCI) and for blood lead, many gaps exist. (CDC/NCEH)
• Exposure data are believed to be even more difficult to obtain than health surveillance data and that
the availability of good exposure databases may be among the weakest links in attempting to relate
exposure to environmental disease (CDC/NCEH). Yet, many workshop participants also felt that
EPA has extensive exposure information that may be useful to this program and other agencies'
efforts. (WHO, NCI)
• Linking public health outcomes and environmental program results may prove difficult without an
existing national tracking system. (NIEHS)
Efforts may be hampered as a result of "under reporting" relevant data, either as a result of missing
data or from "under recognition" of the "problem" requiring reporting. (NIOSH)
• Much information may be available (via existing databases and indicator information) that
ultimately is not useful to the linkage effort. In developing global risk factors and health
assessments, WHO found that, rather than needing more data, it needed less and slightly different
data than what was initially collected.
In addition, any approach that relies on state data or state-level assistance with data collection will need the
buy-in of the state environmental and/or health agencies. (EPA) The ability of the states to assist in
proposed efforts will depend on federal agencies to provide the funding for program implementation, but
the potential also exists for there to be legislative hurdles or for resistance because of perceptions that there
may be no real need to change their current approaches. Benefits for states to consider in this situation
include the usefulness of acquiring locally-correlated data regarding specific health issues as well as to
showcase state involvement. (ASTHO) Furthermore, CDC meetings with state personnel indicate
significant enthusiasm and interest in the environmental agencies for integrating environmental and health
data.
Specific discussions of existing or planned data relevant to EPA efforts are addressed in Section 2.3,
Section 3.2, and in Appendix C.
3.1.2 Data Collection Capacity
Development of a program such as EPA envisions must consider both the capacity to collect the data
needed and the expertise to interpret the data. Current capacities for both data collection and evaluation may
be insufficient to meet current or future needs. (CDC/NCEH)
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3.1.3 Data Compatibility
The types of data collected and the manner of their collection reflect the data needs being addressed in the
particular study design/protocol, which can limit broader use or applicability of the collected data beyond
its intended purpose. For example, environmental data collected by regulatory programs is typically
collected from a facility or a geographic location while health data are usually collected from individuals.
As another example, most medical data are not collected from a surveillance perspective. (CDC/NCEH)
Also, environmental and health data sets often do not mesh well. As an example, if a specific geographic
area is being evaluated, environmental data may not reflect the health data for the same region. People
move in/out of the area and some health effects may not be seen for many years after the exposure.
Assuming that all people in that geographic area are exposed to a contaminant of interest or that all health
effects are counted can be misleading. (ATSDR)
In addition, data quality will vary even among the same study conducted in different years. For example,
the quality standards differ in each NHANES. More is learned during each NHANES about how to monitor
quality of data and those lessons learned are incorporated into subsequent efforts. This can result in the
need to repeat analyses to obtain data that meet the quality standard. (CDC/NCEH, CDC/NCHS)
3.1.4 Database Communication
EPA, CDC, and many federal and state health agencies are developing databases and data repositories
without accounting for the possible need for these different data repositories to communicate and share
information. These data repositories are often disease- or program-specific. Without such communication,
efforts to facilitate data sharing and exchange for multi-purpose data use are and will continue to be
hampered. CDC and EPA are both currently exploring how to address such issues as how to integrate
databases, how to standardize, and how to get existing systems to communicate as well as consideration
of joint future needs. (CDC/NCEH)
3.1.5 Data Access
A major challenge in accessing data, particularly health data, involves conflicts between right-to-know and
right-to-privacy. This directly affects the ability to construct a program with a mandate to issue information
to stakeholders while also maintaining the privacy of survey respondents. The nature of the commitments
to privacy made in confidentiality agreements for surveillance program participants can preclude the
reporting of certain types of information, which in turn limits the ability to link these data with other data
or to use the data for other, future purposes. As an example, geographic data may be collected in a health
survey but may not be able to be released. However, in the future it may be possible to acquire the relevant
geographic data from other registries, death certificates, or other sources. (CDC/NCEH, CDC/NCHS)
These disclosure and confidentiality issues may also affect the ability to use older data because the
agreements signed at the time of those surveys do not meet the standards in use today. As a result, some
of those data may not be reportable for current or future programs. (CDC/NCHS) In addition, current
requirements on confidentiality provisions may require specific, focused reasons for data use; broad, open-
ended agreements on future access and use may not be allowed.
Access to restricted and/or confidential data may be especially important when trying to link environmental
and public health data. Stewards of human health data bases must both provide a public health benefit and
protect public health information. Access to this information may require explicit permission of
participants. This can prevent the acquisition of pertinent data. (NCI)
One key concern raised by EPA was the need to find appropriate ways to access existing health data given
the associated confidentiality/protection requirements and that investigators are often reluctant to release
raw data to the EPA. (NHEERL) Workshop participants noted that third-party researchers (via grants) are
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often able to access and evaluate confidential/proprietary information that the federal government is unable
to easily do so.
Other data access concerns include:
Maintaining future access to samples collected
Privacy and proprietary issues for privately held data (e.g., insurance and pharmaceutical
companies) similar to those described previously.
3.1.6 Data and Interpretation Limitations
Workshop participants identified a number of limitations with regard to the data needed to form linkages
and the ability to identify linkages through the interpretation of such data. These include:
Reasonable expectations need to be set regarding what current data analysis tools can and cannot
measure. Current tools may not be able to measure a health or biological effect, but that does not
make the effect nonexistent. Conversely, the need also exists to remain cognizant of the limitations
of the data and the science. Concentrated outbreaks of disease, such as cancer clusters, may occur,
but current methods may be unable to ascertain the common factor. (HEI, CDC/NCEH, AFIP)
Environmental measurements may not correlate with health effects in a specific geographic area
for many reasons, including latency in appearance of the health effect after exposure, movement
of exposed populations out of the area, movement of unexposed populations into the area, etc.
(ATSDR)
• Back-calculation of exposure from environmental contamination data is the common, though not
preferred, approach. (WHO)
Monitoring data may show exposure, but may not always show health impacts. (WHO)
Many public health outcomes do not result solely from exposure. For example, development of
cancer involves more than just exposure and depends also on the failure of multiple repair,
homeostatic, and immune defense systems. Thus, the exposure damage may not result in cancer
for many years until another disease compromises the immune, defense, or repair systems that were
otherwise preventing the cancer from occurring. (AFIP)
Data can be interpreted in different ways and at different levels of stringency, resulting in different
conclusions. (AFIP)
• Most public health surveillance is conducted locally regardless of purpose (e.g., health,
environmental, enforcement) and the data are collected for a specific point in time. (ASTHO)
Establishing EBD requires having an indicator for exposure assessment at the population level and
the evidence must be applicable to the targeted study population. (WHO)
• Calculation of EBD requires a very strong database to show the relationship between exposure and
disease, a strong evidence base to show the relationship between risk factor and disease, and
knowledge of the exposure-response relationship. (WHO)
• Exposure distribution in the population needs to be in same format as the exposure-response
relationship. (WHO)
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• Basis for intervention may be difficult to establish for purposes of regulations as it may not be
possible to base interventions only on safe exposure value. Focusing only on health outcomes
without evaluating interventions and regulatory response may result in insufficient information for
policymaking. (WHO)
In addition, there are also a number of nonenvironmental components that contribute to exposure and health
outcomes including age, genetic predisposition, racial genetic inheritance, economic status, demographics,
and behavior/lifestyle. (ATSDR)
Significant challenges were also noted for the following types of data analysis:
Inferring annual or long-term exposure from one-day activity patterns. (NERL)
Making linkages that elucidate causal relationships. (NERL)
Proving that the agent of interest is the cause of disease. (AFIP)
Working backward from an effect to find the source unless a unique, discrete event or a well-
defined source are involved; working forward from a source through exposure to effect is easier,
but the source may be only one of many factors contributing to the observed effect. (NERL)
Developing one method to evaluate both short- and long-term outcomes and to enable comparisons.
(AFIP)
• Finding a common basis to address cancer and noncancer diseases because of the significant
differences in their nature and development. (AFIP)
Accounting for contributing factors beyond just mortality, such as reduced consumption of
contaminated fish. (ASTHO)
• Extrapolating exposure response data across species (e.g., rats to human). (CDC/NCEH)
Other challenges in data analysis include the consideration of different types of risks (e.g., cumulative and
aggregate risks), multiple chemical exposures and resulting effects on organ systems, and susceptible
populations. Some differences in health effects found in other programs indicate the potential for multiple
contributing factors. An example cited was the difference in blood lead levels between African Americans
and Caucasian Americans that seems to involve more than just the age of their homes. (CDC/NCEH)
In addition, the proposed efforts will be addressing multi-variable situations without simultaneous controls.
As a result, it will be difficult to obtain hard data that no one will criticize; criticisms may involve adequacy
of survey design, statistics, and DALY parameter selection, among others. (AFIP)
3.1.7 Program Framework/Asking the Right Questions
The program framework needs to set the focus of the effort through the following specific questions: (1)
what do we want to know, and (2) why the data should or need to be linked. Setting specific goals for
linking any type of data is very important in order to avoid spending effort on linking data just because it
is possible to do so. (CDC/NCEH)
Another program framework question is whether to focus on making linkages or to focus on hypothesis-
driven testing of these linkages. In addition, the SOER framework represents a transition from traditional
data-driven approaches (e.g., "we can answer this") to a question-driven approach ("what would we like
to be able to answer"), so it may also be necessary to identify a primary set of questions to address. Many
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workshop participants noted that hypothesis- or question-driven testing may be much more productive than
attempting to identify all of the linkages through more traditional framework approaches.
In addition, decisions must be made to determine whether the sampling design will involve a national effort
or state-level efforts that are then aggregated nationally. This also requires consideration of the capacity
of the state resources to support this. (NHEERL) More detailed discussions on a national vs. state and
resource/capacity considerations are found in Sections 4.3 and 4.7, respectively.
Furthermore, workshop participants also suggested that one aspect of any framework is whether the public
will see the proposed effort as an appropriate use of its tax dollars. (Day2 Sum)
3.1.8 Common Terminology/Definitions
Many workshop participants noted the need to have a common set of terminology and definitions of terms
as these differ among different agencies and between health and environmental programs and disciplines.
For example, the definitions of exposure and use of exposure terms may be different for WHO, CDC, and
EPA. This affects how problems and abatement of risk are conceptualized as well as the comparability and
use of data. (NIOSH) An exposure terminology workgroup organized by WHO examined many glossaries
of exposure and health terms, and used this information to develop a short list of terminology to use in its
efforts; this resource is available on the Internet. (NERL)
In addition, autism, ADHD, and other related disorders are on the increase and may have environmental
linkages. There is a need for common definitions of these disorders as well. CDC activities discussed in
Section 2.4 may yield some results in this area.
3.2 What Data Sets/Resources Exist that Can Inform the Linkages Between Health
Outcomes and Environmental Factors, to What Level Are the Data Applicable
(National, State, etc.), and What Are the Geographic, Temporal, and Demographic
Sampling Parameters?
Many data sets and resources exist at both the national and state levels that can assist in linking
environmental factors to health outcomes. The range of data encompass:
• One-time and ongoing health surveillance or other data acquisition efforts
• Cross-cutting demographics or over-sampling of specific subpopulations (e.g., age, gender, race,
socioeconomic)
Multiple topic areas such as health, mortality, disease, vital statistics, behavior, exposure,
environmental contamination, environmental effects, and burden of disease
• Tissue banks that may serve as surrogates of exposure
• Hard copy data, electronic data, and samples (e.g., tissue, body fluids, environmental).
Appendix C provides a table listing all of the data sets and resources mentioned during the workshop.
3.3 What Are the Lessons Learned in Carrying Out These Programs?
The general consensus of workshop participants was that EPA should move forward and attempt to develop
the desired linkages and performance measures, regardless of the concerns regarding the challenges in
linking health and environmental data and the potential absence of necessary data or measurement tools.
This was a key lesson learned from across many programs—move forward with the effort, describe the
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limitations, and recognize that linking the data will be more difficult than anticipated and will take time to
accomplish.
More specific lessons learned identified during the workshop involved the following six areas:
1. Planning, collaboration, and innovation
2. Data collection/analysis
3. Use of accepted standards, tools, and systems
4. Information technology
5. Informed consent
6. Program burden on collaborators and respondents.
The following sections summarize key points raised in each of these six areas.
3.3.1 Planning, Collaboration, and Innovation
Workshop participants generally agreed that planning, collaboration, and innovation are essential to
conducting a successful program. Specific lessons learned in these areas included:
• Involve stakeholders in the planning process and throughout the effort. (CDC/NCEH)
• Develop partnerships.
• Talk to candidate collaborators (agencies, organizations) regarding program needs and how they
might be accommodated. Explain in detail how the desired data will be used. (CDC/NCHS)
Be open to new ideas. (CDC/NCEH)
Be prepared for the process to take time since lots of planning is necessary for effective
implementation. (CDC/NCEH)
• Disseminate information, which is the product of interest. (CDC/NCEH)
With regard to the design of a program or survey, workshop participants offered a number of lessons
learned from their program experiences, including:
Set criteria for completeness, timeliness, and quality as well as data transmission. (CDC/NCEH,
NCI)
• Remodeling an existing system to meet new needs can be more difficult than developing a new
system. (CDC/NCEH)
A "staged approach" often works best. (CDC/NCEH)
Keep efforts focused on the environmental public health framework, yet also remain aware
throughout all activities that environmental health is part of a bigger picture. (CDC/NCEH)
• Design data collection to serve multiple purposes. (CDC/NCEH)
• Planning in advance for the data needed is easier than incorporating these needs later in the
process. (CDC/NCHS, CDC/NCEH)
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• Planning and design efforts need to continuously consider the intended usage of the data
(CDC/NCEH). Avoid collecting data for the sake of having the data and conducting study after
study without the results making a difference. (NRMRL, NCEA)
• Be prepared to use the data that exist even if those data are not perfect, complete, or do not entirely
accomplish or address what is really wanted or needed. (ASTHO)
Use of children in surveys or other studies may require special considerations, such as:
»• Children cannot provide the volume of specimen that adults can provide, which limits the
number of analyses.
*• There may be age-related issues in sample collection; for example, urine samples are not
usually collected from children under age six. (CDC/NCEH)
»• Interviews/surveys may require completion by parent.
Low budgets will not support the performance of complicated procedures. (CDC/NCEH)
Organizational separation of program activities can impede desirable program coordination as well
as fragment data collection, analysis, and dissemination efforts. (CDC/NCEH)
• Collaborate with statisticians to properly design the data collection effort. (CDC/NCHS)
3.3.2 Data Collection/Analysis
Workshop discussions noted the following lessons learned pertaining to the collection and analysis of
linkage data and the linkage process:
There is a difference between statistical proof and medical evidence. The same data can be
interpreted in different ways and at different levels of stringency, which may result in difficulties
in making convincing scientific arguments. (AFIP)
Older samples may not be useful for the analysis of fat-soluble materials or for other chemical
analyses because aging will have affected the matrix. (AFIP)
• Different sample collection/preparation techniques and materials used by pathologists (either over
time or by different pathologists) may influence results of interest or their comparability,
particularly with regard to use of older samples. (AFIP)
• Consider a broad range of impacts and avoid looking solely at cancer outcomes, which has been
a criticism of similar efforts in the past. (NIEHS)
Find pragmatic ways to integrate or correlate the data available, such as issue by issue. WHO
efforts obtained large amounts of data but at first were unable to correlate them due to differences
that were ultimately minor aspects.
Tailor exposure factors to each risk factor to match the exposure-response relationship. A different
approach will be needed for each risk factor. (WHO)
3.3.3 Use of Accepted Standards, Tools, and Systems
CDC/NCEH recommended the use of existing national data and information system standards formed by
those who develop national standards to develop efficient, integrated, and interoperable surveillance
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systems. This garners broader acceptance and may be a more efficient, cost-effective approach than
separately developing such standards. Additional workshop commentary expanded this to the use of
broadly accepted and applied data analysis tools and information systems as well.
3.3.4 Information Technology
Use of state-of-the-art information technology was strongly recommended as was the need to design
surveillance programs in consideration of future potential GIS applications. Acquiring latitude/longitude
data at the same time as other data are collected, even if there are no current plans for GIS application, was
noted as being easier to accomplish than having to recreate this information from other sources at a future
date. (CDC/NCEH)
3.3.5 Informed Consent
A recurring lesson learned was the need to address future sample use in participant consent agreements.
Of specific note was to design the informed consent agreements to anticipate future needs or uses for the
samples/data collected so that additional approvals or obligations to report results of future studies to the
previous participants are not required when archived specimens or data have been used (CDC/NCEH and
CDC/NCHS). For example the informed consent for NHANES participants indicates that samples and data
collected may be analyzed in the future but is not specific as to what this might be. As a result, CDC has
"banked" many tissue samples collected under NHANES. This option is not available in all cases as the
current trend by institutional review boards (IRBs) is toward more restricted, rather than broad, consent.
For example, starting this year, the Army requires specific permission to be obtained when there is an
interest in analyzing a stored sample for another purpose (AFIP).
3.3.6 Program Burden on Collaborators and Respondents
A general cautionary note was raised throughout many workshop sessions regarding the potential for new
programs, such as this one, to increase the burden on the limited resources of potential collaborators as well
as the potential to affect response rates. Specific lessons learned in this area supporting this cautionary note
included the following:
To avoid adding burden on the limited resources of the health care sector or state/local government,
work with existing data in its current form rather than requesting currently reported data be re-
reported in a slightly different format (i.e., avoid asking the same data sources for variations of the
same data). (CDC/NCEH)
• Individual respondents (from the general public) are often willing to provide substantial amounts
of data if they have bought-in to the program, but this willingness to assist will dwindle if the time
required to provide these data becomes or appears burdensome. (CDC/NCHS, CDC/NCEH)
3.4 What Pilot Projects Could Be Done To Identify Opportunities To Improve the
Understanding of Environmental Public Health Outcomes?
Throughout workshop presentations and discussions, workshop participants offered a number of
suggestions for pilot projects. These include:
• Attempt to link existing U.S. data on exposure, exposure risk, and disease, which appear to be
extensive, and evaluate these data by risk factor and by disease. This approach may backfire or
the data may fail to match up, yet such an effort enables the limitations of the data and the science
to be identified and described. (WHO)
Apply water-ecology indicator efforts as a model for this effort. The Office of Water developed
indicators of water quality other than concentration in water body, which gave the states more
flexibility in meeting TMDLs. Participants also referenced the EMAP efforts as another model.
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Internal resources already exist to support this such as a chart on developing monitoring based on
questions. (NHEERL)
• Have a small team examine some specific scenarios and see how the linkage might work.
(CDC/NCEH)
• Consider doing an exercise that, if EPA had ideal health and exposure data, how would one go
about linking exposure to public health outcome? Consider using PM or arsenic data for such an
exercise. Describe the data sets that already exist, and describe how someone would evaluate this
for the risk management programs. Such an exercise could help to design the framework and its
components as well as determining whether the appropriate focus is local or national. (NIEHS)
• Tap into airport expansion projects, since some modeling is already being done for these projects.
(NHEERL)
Compare areas in compliance with the National Ambient Air Quality Standards to areas that are
not in compliance. (Day2 Sum)
• Further examine the link between respiratory effects and motor vehicle use in Atlanta during the
Olympic games. (Day2 Sum)
Consider building on a CDC pilot project in Atlanta (along with some CDC grants) to develop
surveillance systems for developmental disorders. (CDC/NCEH)
• Consider pesticides as a topic to set up for tracking changes over next few years. Provisional
approvals for pesticides exist but new regulations will be taking effect in the next few years and
are anticipated to have large scale impacts. Such an approach would enable creation of a baseline
at this time and the ability to track changes resulting from the implementation of new regulations.
(ASTHO)
• Evaluate the link between lead levels and learning disabilities in low socioeconomic status areas.
(Day2 Sum)
Consider conducting a community NHANES that would use mobile units to more easily study one
community or one area of the country. (CDC/NCHS)
• Attempt to tie CDC-developed environmental health indicators into EPA indicator projects to
determine whether there is an association between environmental exposures and disease and
whether interventions can have an effect. (CDC/NCEH)
• Attempt to link air emissions data to NHANES data.
• Consider continuing or building upon air pollutant and health studies completed in support of the
PM air regulations.
Suggestions and opportunities for collaboration regarding ongoing projects are presented in Section 2.4.
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Section 4
Other Feedback
The wide-ranging discussions in each workshop session included numerous examples and suggestions from
other program experiences potentially relevant to the planned EPA efforts, but did not fit the specific
questions used to focus the two panels on Day 1 as discussed in Sections 2 and 3. The general, overall
comment expressed by many participants was the need to move forward using the information currently
available while identifying the additional data necessary to achieve the goals expressed in the background
documents reviewed for this workshop.
The additional feedback from workshop participants encompassed general observations on exposure
assessment and public health frameworks, considerations of state vs. national focus, and resources. The
following sections summarize key points raised in each of these four areas.
4.1 General Observations
Several program frameworks, focused on different aspects of exposure, were described during workshop
sessions based on different global, federal, and state/local agency approaches and program focuses. These
include:
• An environmental public health tracking framework involves a hazard that leads to exposure,
which in turn leads to a health effect. Intervention can occur at any of these three steps to have an
impact on environmental health (e.g., to change health effects). (CDC/NCEH)
• Central to ORD's public health paradigm is exposure, which is defined as the contact between a
contaminant/stressor and a person as a result of that person's activities in the community. This
paradigm involves the linkage of health and environmental data. Sound science across the
paradigm (from source data to health effects data) is important in deciding whether an action needs
to be taken, what action should be taken, and whether the action taken succeeded in addressing the
issue. (NERL)
Exposure is contact between a human and a contaminant at a specific concentration for a specific
period of time. This involves a time period over which exposure and concentration (time of
contact), personal exposure, and level of exposure (concentration) are integrated, as well as
knowledge of how and when a person was exposed. (NERL)
Also offered for consideration was a general vision statement that effective environmental public health
surveillance has data driving prevention practices. (NIOSH)
4.2 State vs. National Focus
Much discussion in each workshop session considered whether a national or state/local focus was most
appropriate. This focus is an important decision that affects planning and implementation efforts as well
as the desired outcome. The discussions encompassed the use ofthe data to determine which focus is best,
the potential need for and benefits of having both a national and a state/local focus, and special
considerations regarding a state/local focus. The following sections highlight key discussion points in each
of these areas.
4.2.1 Determining the Focus from the Data
One suggestion was to determine the focus by collecting and analyzing the necessary data because the
resulting measurements in themselves may determine whether a summary measure or national estimate may
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be generated. A related suggestion was to attempt to describe those things that are important to measure,
which may be an index (composite of many factors) or a specific value, and to determine whether state/local
data must be aggregated to obtain a national summary number. (NCI)
The determination of a national vs. a state/local approach involves consideration of different purposes and
methods. At the state/local level, a key purpose is to link immediate control efforts and program
evaluations using real-time data on all cases with surveillance linked to control activities. At the national
level, a key purpose is to monitor national trends, detect emerging problems, and demonstrate the need for
resources; the methods used include aggregation of state/local data and national sample surveys. A related
factor to consider is the ability to gather local data to help answer a national question. If this is not possible,
then only a national focus on data collection may be possible. (ASTHO)
Another factor affecting selection of the program focus is what information the EPA needs for policy
making. WHO assessments involved a global focus, yet individual countries are focusing these assessments
on their needs by developing their own severity weights and DALY calculations. Individual countries are
developing disease severity weights that are different from those used by WHO and are rethinking the
specific parameters that flow into the DALY calculation in order to address country-specific needs.
4.2.2 Potential Need for Both a National and a State/Local Focus
Many workshop participants expressed the belief that both national and state/local data need to be collected.
One reason cited was that the public often wants both a national and a state/local emphasis. For example,
a criticism of an Hispanic-focused NHANES was that no national data were collected at the same time as
the specific data were collected. (CDC/NCHS).
The ideal approach is to derive national measures from an aggregate of local data. Collecting such data at
the state/local level is often impractical unless the information is obtained by telephone survey or from
death/birth certificates. A key issue is that the sample size to get meaningful results at the state level may
be about the same size as that needed for statistically valid national-level assessments. (ASTHO)
In addition, local vital statistics information and national statistics are both critical for comparative
purposes. Such information enables states to determine their relative ranking (i.e., high or low) compared
to a national average or to determine how good or bad their situation may be. National data are critical for
these types of comparisons and can also help in allocating resources to areas with greatest need. (ASTHO)
Also suggested for consideration was the development of a sampling design that allows national inferences
and enables the states to buy into the process. (NHEERL)
4.2.3 Special State/Local Focus Considerations
A number of experiences to date indicate that examination of local-level data may be more useful than a
national-level emphasis. One example involved blood lead studies that found blood levels in specific
housing areas to be much different than the national average. (CDC/NCEH) Another example is
understanding of location conditions that link to environmental health effects, such as the decreased driving
in Atlanta during the Olympics that led to decreases in emergency room visits for respiratory conditions
such as asthma. (CDC/NCEH) Breaking down information into different geographic or socioeconomic
regions helps to focus public health programs, yet the potential also exists to identify problems of local
concern that do not warrant national-level investigation. (CDC/NCEH, NRMRL)
Extremes are often the most interesting and most useful data. Broad studies such as national surveys help
to identify overall trends but often miss the extremes. As a result, they may have a limited ability to reveal
the results of EPA policies and interventions. Data of a more local nature may be necessary to make such
determinations. Studies that capture anomalies and what causes them (such as local areas with extremes)
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may have greater value in assessing the impact of regulations than national averages, particularly in areas
such as biomarkers. (NERL, ASTHO)
Political considerations may also favor inclusion of some state/local focus. Congressionally funded
programs often must be able to address state/local issues of interest to the public and not just national
issues. (ASTHO)
4.3 Resources
EPA has an advantage over many other agencies in that EPA funds both intramural and extramural
research. EPA also has both research and regulation in same agency, which is not the case in the federal
health arena. (NIOSH) Yet a challenge facing any federal initiative is the Office of Management and
Budget (OMB) responsibility for limiting the public cost and burden for collecting information.
(CDC/NCHS)
Thus, EPA will need consider ways to support and maintain the data acquisition and interpretation effort,
data archives, and the resources (human capital) needed at the national, state, and local levels. Local
capacity will be important to success. However, the manpower to acquire and assess the information may
not be available to support the needs of the proposed program because agencies are downsizing, budgets
are being redirected toward other national priorities such as bioterrorism, there is currently little exposure
assessment capacity at state/local level, experienced personnel are retiring, and few programs exist to retrain
environmental health officers in areas pertinent to the proposed program efforts. (NIOSH, ORD)
In addition, the public health data system is more tenuous than may be understood. Some data sources are
declining, the support for current data coding activities is dwindling as budgets are cut, and the capacity
for new initiatives may not be in place. For example, some states no longer code certain vital statistics data
on death certificates that have proven useful in the public health area. (ASTHO)
Other suggestions offered for consideration included:
Developing surveillance capacity with government and academic buy-in along with supportive
information systems to maintain all the data. (NIOSH)
• Integrating with what is already available at the local level and building on that to expand capacity.
(ASTHO)
Avoiding the premature inference that funding and positions are available for this effort; otherwise,
the academic community may respond to this perceived need by training people for positions that
may not exist. (NHEERL)
Following CDC approach of funding state laboratories to increase their abilities to link up health
systems within the states. (CDC/NCEH)
There will also be challenges in focusing the investigative community on measuring health impacts.
Integrating public health concepts into EPA research programs and the scientific community will take time.
The scientific community may not be positioned to be responsive to the study of opportunistic events (e.g.,
acute chemical releases, industrial plant shutdowns) as they occur. For example, few responses were
received for a recent RFA addressing the health impact of regulations in the context of looking at national
databases. Some consideration may need to be given to pre-qualify teams of investigators to address such
opportunistic events. (HEI)
Other resource-related observations include the following:
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States may need funds to restructure their databases to meet EPA data needs. (ASTHO)
A significant number of histological slides exist with researchers and diagnosticians for many
diseases, but availability to support this effort may depend on access restrictions. (ASTHO)
Specimens might be obtained by enlisting local physicians to participate in defining a national
survey and then participate in it. A challenge may be to convince them of the utility of this
information for more than just the research interest. (ASTHO)
Consider recruiting individuals to create tissue banks that may be used in the future to look for
biomarkers. (ASTHO)
Universities and clinics already participating in federally-funded grants and other extramural
research programs may be potential sources for reporting public health or other pertinent
information not already being collected in the funded research efforts. Consider how such programs
could be leveraged or restructured to acquire the additional information of interest. (ASTHO)
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Section 5
Establishing a Framework for an EPA Intramural/Extramural
Public Health Outcomes Research Program
A final workshop session involved wrap-up discussions pertaining to the general framework for proceeding
in developing a public health outcomes research program and specific first steps to pursue in government
FY 2003. The following sections present highlights of these wrap-up discussions.
5.1 General Framework Discussion
The general framework discussions considered the appropriate focus for the research initiative, the overall
planning process and its relationship to Government Performance and Results Act (GPRA) goals, factors
to consider in developing a data source list, and interagency partnering and collaboration as presented in
the following sections.
5.1.1 Research Initiative Focus
Participants noted that many of the workshop discussions in the first day raised questions among the health-
oriented agencies about the intent of the EPA program as presented in the background information. One
perception was the potential for EPA to become more involved in the public health arena in a manner that
complements activities of the other public health agencies.
EPA is faced with a new need to measure health and ecological improvements as a result of agency
programs/actions, which requires defining the health and ecological benefit. This also involves moving the
Agency towards a system that measures success more on outcome and end results rather than measures such
as the number of permits issued. Thus, the proposed EPA effort is different from the efforts in other
agencies, which are tied to meeting specific human health goals and measuring progress toward those goals.
Much public health research and surveillance is underway at other agencies. A suggested approach was to
define areas in which EPA can lead and areas in which EPA can be supportive. For example, EPA should
focus on developing the underlying science relevant to the public health outcomes initiative rather than
conducting public health surveillance and developing such infrastructure in every state.
Similarly, discussions addressed the differences in focus between what ORD is tasked to accomplish and
what efforts are more appropriate to other portions of the Agency. For example, an ORD focus is on
research issues such as the demonstration of concepts, descriptions of limitations/uncertainties, compilation
of federal agency data, issuing RFAs, and similar efforts.
There may be issues or activities relevant to this initiative, such as state/local and private sector
involvement or data access, that need to be identified to other EPA organizations to accomplish.
Many participants also favored the development of a framework that included economists, social scientists,
and behavioral scientists for the analytical tools and insights they can contribute.
5.1.2 Planning Process and Relationship to GPRA Goals
There was much discussion on whether to keep this effort under Agency GPRA goal 8.2 or to place it under
multiple Agency GPRA goals. Specific considerations in these discussions included the following:
• Some elements may be more appropriately addressed under other goals
• Spreading this effort across all goals may dilute ownership of the goal and its accomplishment
• Having a "home" for this effort provides the opportunity to validate specific hypotheses.
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All participants noted the cross-cutting nature of the public health outcomes initiative. Much of the
research to develop sensitive biomarkers (underlying this initiative) is under the GPRA goals for human
health (Agency GPRA goal 8.2), while much of the impetus for ecological side is under GPRA goal 8.1.
The focus of this initiative is on the public health outcomes, but the public health and ecological aspects
do have to be linked.
As a result of this cross-cutting nature, activities may need to be incorporated across all of the EPA multi-
year plans as they come up for revision, as is done for other cross-cutting research areas such as susceptible
populations and children's health. Consideration is also being given to developing a separate multi-year
plan for this effort, but the question remained as to whether support can be obtained for this initiative in
its own right. This research initiative may initially be part of an existing multi-year plan because of funding
issues, and, over time, the initiative may develop sufficient impetus to become a separate multi-year plan.
Since this is a core effort applicable to many EPA programs, numerous suggestions were presented for
contacting the program/regional offices to explain the proposed plans and how these initiatives will be
useful, to garner program/regional office support, and to build a constituency among the multiple
beneficiaries within the Agency. For example, biomarkers are of interest to many programs/regional offices
within EPA. Other suggestions included contacting the program/regional offices for their suggestions on
pilot projects or to develop proposals for such efforts to obtain program/regional office input.
5.1.3 Development of a Data Source List
A potential first step for this initiative would be to develop an interagency compendium of data sources and
surveillance systems. Such a compendium will support further determinations of what can be accomplished
with the information already available and whether modeling or other tools, data sets, or data collection are
necessary.
Such an effort can begin with the compilation of information sources identified during this workshop and
documented in this report. This can be expanded through the following additional efforts:
A list of databases put together by Ken Sexton within EPA during the last 10 years
Data sources identified during SOER preparation but not used in the SOER
Compliance programs represent a possible data source and opportunities for study
Relevant publications (sources of data and how to make the data linkages) such as those from
WHO
• WHO discussion group that transmits information on relevant topics, which is open to involvement
by others (see WHO website for more information).
Also for consideration is a question as to whether state data can be aggregated to get the types of answers
EPA needs, or whether other ongoing surveys may support EPA data collection needs. For example,
NHANES may not be designed to answer some of EPA's questions and therefore may not be a relevant
information source to pursue.
5.1.4 Interagency Partnering and Collaboration
Other health agencies are already moving forward with their initiatives and RFAs. These may represent
particularly relevant opportunities for collaboration and EPA participation. For example, Dr. Zenick
(NHEERL) and Dr. Qualters (CDC/NCEH) discussed a CDC RFA that is to undergo peer review in late
summer/early fall of this year, and whether EPA could be involved as an ad hoc participant.
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Another suggestion was to find ways to continue the dialog begun in this workshop with other agencies.
A particular area of interest was to discuss with NIOSH its occupational program experiences that might
make a proof of concept project more achievable. Given limited funding in future fiscal years for this
initiative, cost-effective efforts may also include followups with CDC and ATSDR for relevant data and
program initiatives.
A similar suggestion was to pursue other, more formal interagency arrangements. For example, an MOU
currently under development between EPA and DHHS (OEI and CDC) will look at the linkage of existing
data sets, particularly, whether information can be taken from the National Exposure Report databases to
meet their needs. Such an MOU provides an opportunity to create a related interagency work group, which
might serve as a venue to address privacy concerns regarding data sharing.
Few of the other agencies have an intramural research program. Thus, the ability to become involved with
EPA to jointly meet different program needs may be attractive to those agencies because many of their
efforts mesh well with the EPA public health outcomes initiative.
Similarly, EPA will not do much public health surveillance, but may be able to accomplish a lot in
partnership with the agencies that do collect such information. Therefore, understanding their surveillance
programs is important to identify areas that EPA can feed into the existing processes such as models,
biomarkers, etc., as well as new concepts to include in their surveillance programs. In return, EPA can offer
its statistical capability to these other agencies. EPA has conducted a significant amount of statistical work
in combining data and interpreting what the results do or do not indicate/support.
Other suggestions included:
Keep the panelist group from this workshop together as an advisory committee
Learn more about ongoing surveillance and surveys such as NHANES to better understand how
to effectively partner on such efforts to conduct the research
• Enter into Inter-Agency Agreements to fund third-party access to the health data that EPA needs
• A useful model may be how the Department of Energy (DOE) funds other agencies (e.g.,
CDC/NCEH, NIOSH) to conduct health monitoring useful to DOE programs.
5.2 Next Steps for FY 2003
First steps identified for government FY 2003 as a result of framework discussion included the following:
• Create an inventory of data sources (exposure, health effects, etc.)—look at what is currently
available, how the data/database is structured, and how the data can be related.
Identify and conduct a pilot study. Convene a small group to identify several possible situations
that might be amenable to this approach/analysis. Consider also approaching the program/regional
offices to see whether they have any case study suggestions to examine in prototypes. Candidate
projects offered for consideration included:
*• Identify a focus for an example study (e.g., an exposure worked backward, a chemical, a
geographic area) and work that example through with existing information to determine
where the real data gaps and data needs are. Suggestions included:
5O
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•v- Mercury—has known health effects and data are available; ecological programs
just as interested/concerned as are air, water, waste, pollution prevention, regional,
and program offices as well as United Nations programs; might create a demand
for public health outcome efforts.
•v* Ultraviolet light—has no direct regulatory program; indirect issue through
breakdown of ozone layer with UV exposure as an endpoint of concern;
interventions are different than in other EPA programs; multiple potential health
effects beyond just skin cancer (e.g., cataracts).
•v" Extend or draw on EPA air program studies conducted in establishing the air
regulations.
»• Attempt to merge health or NCHS mortality data with air monitoring data.
»• Consider making the hypothesis-driven National Morbidity, Mortality and Air Pollution
Study (NMMAPS) study permanent, as was done with NHANES.
*• Conduct a brainstorming session to consider what is needed for retrospective and
prospective studies. Use the output of this session to identify candidate projects, define the
data needed, and find topics where data are available. Set criteria to focus the potential
options on feasible ones (e.g., have readily accessible).
»• Identify geographic opportunities that are prospective. Identify what EPA wants out of
those and what might be done.
*• Identify pivotal studies recognized by program/regional offices as important and excellent
science to use as models for additional efforts. This could quickly obtain program/regional
interest, respect, and buy-in.
Issue EPA RFA by the National Center for Environmental Research (NCER) in October to January
time frame (preferably October) with consideration of the following:
»• Build in the idea of combining exposure and health data now to see if it can be done, and
draw on statisticians to look at the challenges in linking such data.
*• Pursue short studies, perhaps 2 years in length and focused on statistical analysis with no
new data collection.
»• Combining the data and statistical evaluations may enable funding from different sources
to be combined.
*• Consider 1- to 2-year funding for another group consisting of existing grantees that are
collecting data for a different purpose that is also useful to this initiative; however, past
experience indicates the potential for significant barriers to modifying or supplementing
an existing effort.
»• Consider drawing on the recently completed particulate matter RFA that combines EPA
and other agency health data.
*• Circulate first draft of proposed RFA to this workgroup as well as the program/regions that
were invited but unable to attend this workshop.
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*• One RFA rather than several, separate, smaller RFAs (e.g., one on air data and one on
statistics) is preferable.
Follow up with CDC/NCEH for EPA ad hoc participation on the review panel for their RFA
involving efforts of interest to this initiative. Also follow up on opportunities to collaborate with
CDC initiatives involving the creation of centers of excellence, and accessing data from states with
the necessary infrastructure to link health outcomes and benefits.
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Appendix A
Workshop Agendas
Workshop on Environmental Public Health Outcomes
Research Triangle Park, North Carolina
Day 1 Agenda - July 30, 2002
08:00 - 08:30 am Registration
08:30 - 08:40 am Welcome - William Farland, Ph.D., USEPA ORD
08:40 - 09:00 am Introductions and Charge - Hal Zenick, Ph.D., USEPA ORD/NHEERL and
Hugh McKinnon, M.D., USEPA ORD/NRMRL
09:00 - 09:30am International Perspective - Annette Pruess, Ph.D., World Health Organization
9:30 - 9:40 am Break
9:40 - 12:00 pm Panel 1: Public Health Outcome White Paper.
Each participant will respond to the charge questions (~20 minutes) followed by
panel and then open discussion.
Facilitator: Edward Washburn, USEPA ORD/OSP
Mike McGeehin, Ph.D., M.S.P.H., National Center for Environmental
Health, Centers for Disease Control and Prevention
Robert Spengler, Sc.D., Agency for Toxic Substances and Disease
Registry
John Sestito, J.D., M.S., National Institute for Occupational Safety and Health
Brenda Edwards, Ph.D., National Cancer Institute, Division of Cancer
Prevention and Control
Henry Anderson, M.D., Wisconsin Division of Public Health,
Association of State and Territorial Health Officers
David Brown, M.P.H, National Institute of Environmental Health
Sciences
12:00-1:00 pm Lunch
A-l
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1:00-3:00 pm Panel 2: SOER Environmental Health Chapter.
This session includes brief overviews of the topic, each participant then
responding to the charge questions (15-20 minutes) followed by panel and then
open discussion.
Facilitator: Herman Gibb, USEPA ORD/NCEA
SOER Introduction - Peter Preuss, Ph.D., USEPA ORD/NCER
Judith Qualters, Ph.D., National Center for Environmental Health, Centers
for Disease Control and Prevention
William Fishbein, M.D., Ph.D., Armed Forces Institute of Pathology
Vicki Burt, Sc.M., R.N., National Center for Health Statistics, Centers
for Disease Control and Prevention
Larry Cupitt, Ph.D., USEPA ORD/NERL
3:00-3:15pm Break
3:15-5:00 pm Resume
5:00pm Adjourn
Day 2 Agenda - July 31, 2002
(Participants include the EPA workgroup and some of the Day 1 Panelists.)
8:30 am Reports from Session Chairs from Day 1- Edward Washburn, USEPA ORD/OSP, and
Herman Gibb, USEPA ORD/NCEA
9:50 am Break
10:00 am Establishing a Framework for an EPA Intramural/Extramural Public Health
Outcomes Research Program
Discuss potential design options for the Framework which will provide EPA and
collaborating organizations with a mutually beneficial Public Health Outcomes
Framework. The Framework will build on existing interagency capacity and infrastructure
to provide the structure for an intramural/extramural research program.
Principal Objectives: Discuss potential design options for the Framework which will
provide the foundation for building capacity to assess the Public Health Outcomes of EPA
risk management activities. Examples of potential benefits include: efficiencies and cost
savings; additional support and justification for current health monitoring programs; data
comparison studies; data for improved modeling analyses; and multi-media analyses.
Explore potential opportunities for collaboration and integration which could be
incorporated into a Public Health Outcomes Framework.
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11:30 am Final Comments - Hal Zenick, Ph.D., USEPA ORD/NHEERL and Hugh McKinnon,
M.D., USEPA ORD/NRMRL
Meeting adjourns for outside guests
11:45 am Public Health Outcomes Workgroup Meeting
• Working Lunch
• Discussion of Next Steps
1:00 pm Meeting Adjourns
A-3
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Appendix B
List of Attendees
DAY 1 ATTENDEES
Henry Anderson, M.D.
Chief Medical Officer
Wisconsin Division of Public Health
1 West Wilson Street, Room 150
Madison, WI 53702
Phone: 608-266-1253
E-mail: anderha@dhfs. state.wi .us
Will Boyes
US EPA NHEERL/NTD
MD-74B
RTP,NC 27711
Phone: 919-541-7538
E-mail: boyes.william@epa.gov
David Brown, MPH
Staff Assistant to the Director
National Institute of Environmental Health
Sciences
111 Alexander Drive, Building 101
RTP,NC 27709
Phone: 919-541-5111
E-mail: brown4@niehs.nih.gov
Vicki Burt, Sc.M., R.N.
Chief, Planning Branch, Division of Health
Examination Statistics
National Center for Health Statistics, Centers for
Disease Control and Prevention
6525 Belcrest Road, Room 1000
Hyattsville, MD 20782
Phone: 301-458-4127
E-mail: VLB2@cdc.gov
Robert Chapman, M.D., MPH
US EPA NCEA
National Center for Environmental Assessment
(Mail Drop B243-01)
RTP,NC 27711
Phone: 919-541-4492
E-mail: chapman.robert@epa.gov
EdChu
US EPA
Ariel Rios Building, 1200 Pennsylvania Avenue,
NW
Washington, DC 20460
Phone: 202-564-2196
E-mail: chu.ed@epa.gov
Larry Cupitt, Ph.D.
Associate Director for Health
US EPA ORD NERL
D305-01, USEPA Mailroom
RTP,NC 27711
Phone: 919-541-0349
E-mail: cupitt.larry@epa.gov
Allen Dearry, Ph.D.
Chief, Chemical Exposure and Molecular
Biology Branch
Division of Extramural Research and Training,
National Institute of Environmental Health
Sciences, National Institutes of Health
79 T.W. Alexander Drive (P.O. Box 12233)
RTP,NC 27709
Phone: 919-541-4943
E-mail: dearry@niehs.nih.gov
Mike Devito
USEPA
MD-74
RTP,NC 27711
Phone: 919-541-0061
E-mail: devito.mike@epa.gov
Shelly Eberly
US EPA, OAQPS, EMAD
C339-02
RTP,NC 27711
Phone: 919-541-4128
E-mail: eberly.shelly@epa.gov
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Brenda K. Edwards, Ph.D.
Associate Director, Surveillance Research
Program
National Cancer Institute, Division of Cancer
Control and Population Sciences
Room 5029, MSC 8315, 6116 Executive Blvd.
Bethesda, MD 20892-8315
Phone: 301-496-8506
E-mail: be2w@nih.org
William Farland, Ph.D.
Acting Deputy Assistant Administrator for
Science
US EPA ORD
8101R, Ariel Rios Building, 1200 Pennsylvania
Avenue, NW
Washington, DC 20460
Phone: 202-564-6620
E-mail: farland.william@epa.gov
William N. Fishbein, M.D., Ph.D.
Armed Forces Institute of Pathology
Department of Environmental & Toxicology
Pathology
Washington, DC 20306-6000
Phone: 202-782-2728
E-mail: fishbein@afip.osd.mil
Elaine Francis
US EPA NCER
8701R, Ariel Rios Building, 1200 Pennsylvania
Avenue, NW
Washington, DC 20460
Phone: 202-564-6789
E-mail: francis.elaine@epa.gov
Herman Gibb
US EPA NCEA
860ID, Ariel Rios Building, 1200 Pennsylvania
Avenue, NW
Washington, DC 20460
Phone: 202-564-3334
E-mail: gibb.herman@epa.gov
92, USEPA Mailroom
RTP,NC 27711
Phone: 919-541-0015
E-mail: gilmour.ian@epa.gov
Kim Gotwals
Senior Policy Analyst
SAIC
10 Osborne Place
Durham, NC 27705
Phone: 919-401-4643
E-mail: kimberly.b.gotwals@saic.com
Ross Highsmith
US EPA NERL
D305-01, USEPA Mailroom
RTP,NC 27711
Phone: 919-541-7828
E-mail: highsmith.ross@epa.gov
Virginia Hodge
SAIC
11251 Roger Bacon Drive
Reston,VA 20190
Phone: 703-318-4621
E-mail: virginia.e.hodge@saic.com
Robert Kavlock
Director, RTD
US EPA NHEERL
MD-71
RTP,NC 27711
Phone: 919-541-2771
E-mail: kavlock.robert@epa.gov
Robert MacPhail
Chief, Neurobehavioral Toxicology Branch
US EPA NHEERL
86 TW Alexander Drive
RTP,NC 27711
Phone: 919-541-7833
E-mail: macphail.robert@epa.gov
Ian Gilmour
US EPA ETD
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Alina Martin
Conference Coordinator
SAIC
11251 Roger Bacon Drive
Reston,VA 20190
Phone: 703-318-4678
E-mail: martinali@saic.com
Mike McGeehin, Ph.D., MSPH
Director, Division of Environmental Hazards and
Health Effects
National Center for Environmental Health,
Centers for Disease Control and Prevention
Mailstop E-19
Atlanta, GA 30333
Phone: 404-498-1300
E-mail: mam7@cdc.gov
Hugh McKinnon, MD
Associate Director for Health
US EPA NRMRL
MS 225, 26 West Martin Luther King Drive
Cincinnati, OH 45268
Phone: 513-569-7689
E-mail: mckinnon.hugh@epa.gov
Pauline Mendola, Ph.D.
Epidemiologist
US EPA NHEERL
MD-58A
RTP,NC 27711
Phone: 919-966-6953
E-mail: mendola.pauline@epa.gov
Adele C. Monroe, DVM, MSPH
Senior Technical Writer
Science Applications International Corporation
4122 Pecan Drive
Stem,NC 27581
Phone: 919-693-8409
E-mail: amonroe@gracegift.net
National Center for Environmental Assessment
(MS-272), 2890 Woodbridge Avenue
Edison, NJ 08837
Phone: 732-906-6830
E-mail: murphy.patricia@epa.gov
Lucas Neas, Sc.D.
Epidemiology and Biomarkers Branch
US EPA NHEERL
MD-58A, USEPA Mailroom
RTP,NC 27711
Phone: 919-966-9961
E-mail: neas.lucas@epa.gov
Pamela Noyes
US EPA ORD OSP
Office of Science Policy, Office of Research and
Development (8104R), Ronald Reagan Building,
1300 Pennsylvania Ave., NW
Washington, DC 20460
Phone: 202-564-8297
E-mail: noyes.pamela@epa.gov
Robert O'Keefe
Health Effects Institute
Charlestown Navy Yard, 120 Second Avenue
Boston, MA 01219
Phone: 617-886-9330
E-mail: ROKeefe@healtheffects.org
Russell Owen
US EPA NHEERL
MD-68
RTP,NC 27711
Phone: 919-541-1141
E-mail: owen.russell@epa.gov
Dan Petersen
US EPA ORD NRMRL
MS G75, 26 West Martin Luther King Drive
Cincinnati, OH 45268
Phone: 513-569-7831
E-mail: petersen.dan@epa.gov
Patricia Murphy, Ph.D., M.P.H.
US EPA NCEA
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Julian Preston
US EPA NHEERL
68, USEPA Mailroom
RTP,NC 27711
Phone: 919-541-0276
E-mail: preston.julian@epa.gov
Peter Preuss, Ph.D.
Office Director
US EPA ORD NCER
8701R, Ariel Rios Building, 1200 Pennsylvania
Avenue, NW
Washington, DC 20460
Phone: 202-564-6825
E-mail: preuss.peter@epa.gov
Dr. Annette Pruess
Protection of the Human Environment (PHE),
World Health Organization
20, Avenue Appia
CH-1211 Geneva 27, Switzerland
Phone: (Oil) 41 22 791 3584
E-mail: pruessa@who.int
Judith R. Quakers, Ph.D.
Acting Chief, Environmental Health Tracking
Branch
Division of Environmental Hazards and Health
Effects, National Center for Environmental
Health / Centers for Disease Control and
Prevention
Mailstop E-19
Atlanta, GA 30333
Phone: 404-498-1815
E-mail: jxql@cdc.gov
Larry Reed
NIEHS (on detail from EPA)
P.O. Box 12233 (EC-27)
RTP,NC 27709-2233
Phone: 919-316-4622
E-mail: reedl@niehs.nih.gov
8723R, Ariel Rios Building, 1200 Pennsylvania
Avenue, NW
Washington, DC 20460
Phone: 202-564-6909
E-mail: saint.chris@epa.gov
John P. Sestito, J.D., M.S.
Assistant Director for Surveillance
Division of Surveillance, Hazard Evaluations and
Field Studies, National Institute for Occupational
Safety and Health
Centers for Disease Control and Prevention, 4676
Columbia Parkway, Mailstop R-12
Cincinnati, OH 45226
Phone: 513-841-4208
E-mail: jsestito@cdc.gov
Mary Shaffran
USEPA
1200 Pennsylvania Avenue, MC 2812 A
Washington, DC 20460
Phone: 202-564-6668
E-mail: shaffran.mary@epa.gov
Debbie Smegal
US EPA OEI
1301 Constitution Ave, NW, 2842T
Washington, DC 20460
Phone: 202-566-0644
E-mail: smegal.deborah@epa.gov
Robert F. Spengler, Sc.D.
Associate Administrator for Science
Agency for Toxic Substances and
Registry
37 Executive Park Drive, Room #3720
Atlanta, GA 30329
Phone: 404-498-0003
E-mail: rys2@cdc.gov
Disease
Chris Saint
US EPA NCER
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Hugh Tilson Hal Zenick, Ph.D.
US EPA NHEERL Associate Director for Health
B305-02, USEPA Mailroom US EPA NHEERL
RTP,NC 27711 MDB105-01
Phone: 919-541-4607 RTP, NC 27711
E-mail: tilson.hugh@epa.gov Phone: 919-541-2283
E-mail: zenick.hal@epa.gov
John Vandenberg, Ph.D.
Acting Director, Human Studies Division
US EPA NHEERL
MD-58, USEPA Mailroom
RTP,NC 27711
Phone: 919-966-6209
E-mail: vandenberg.john@epa.gov
Edward Washburn
Goal 8 Research Coordination Team Leader
US EPA ORD OSP
8104R, Ariel Rios Building, 1200 Pennsylvania
Avenue, NW
Washington, DC 20460
Phone: 202-564-1134
E-mail: washburn.edward@epa.gov
Valerie Zartarian
US EPA ORD NERL
Office of Research and Development, National
Exposure Research Laboratory, 12201 Sunrise
Valley Drive, 555 National Center
Reston,VA 20192
Phone: 703-648-5538
E-mail: zartarian.valerie@epa.gov
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DAY 2 ATTENDEES
Vicki Burt, Sc.M., R.N.
Chief, Planning Branch, Division of Health
Examination Statistics
National Center for Health Statistics, Centers for
Disease Control and Prevention
6525 Belcrest Road, Room 1000
Hyattsville, MD 20782
Phone: 301-458-4127
E-mail: VLB2@cdc.gov
Robert Chapman, M.D., MPH
US EPA NCEA
National Center for Environmental Assessment
(Mail Drop B243-01)
RTP,NC 27711
Phone: 919-541-4492
E-mail: chapman.robert@epa.gov
Larry Cupitt, Ph.D.
Associate Director for Health
US EPA ORD NERL
D305-01, USEPA Mailroom
RTP,NC 27711
Phone: 919-541-0349
E-mail: cupitt.larry@epa.gov
Elaine Francis
US EPA NCER
8701R, Ariel Rios Building, 1200 Pennsylvania
Avenue, NW
Washington, DC 20460
Phone: 202-564-6789
E-mail: francis.elaine@epa.gov
Herman Gibb
US EPA NCEA
860ID, Ariel Rios Building, 1200 Pennsylvania
Avenue, NW
Washington, DC 20460
Phone: 202-564-3334
E-mail: gibb.herman@epa.gov
Senior Policy Analyst
SAIC
10 Osborne Place
Durham, NC 27705
Phone: 919-401-4643
E-mail: kimberly.b.gotwals@saic.com
Ross Highsmith
US EPA NERL
D305-01, USEPA Mailroom
RTP,NC 27711
Phone: 919-541-7828
E-mail: highsmith.ross@epa.gov
Virginia Hodge
SAIC
11251 Roger Bacon Drive
Reston,VA 20190
Phone: 703-318-4621
E-mail: virginia.e.hodge@saic.com
Hugh McKinnon, MD
Associate Director for Health
US EPA NRMRL
MS 225, 26 West Martin Luther King Drive
Cincinnati, OH 45268
Phone: 513-569-7689
E-mail: mckinnon.hugh@epa.gov
Adele C. Monroe, DVM, MSPH
Senior Technical Writer
Science Applications International Corporation
4122 Pecan Drive
Stem,NC 27581
Phone: 919-693-8409
E-mail: amonroe@gracegift.net
Patricia Murphy, Ph.D., M.P.H.
US EPA NCEA
National Center for Environmental Assessment
(MS-272), 2890 Woodbridge Avenue
Edison, NJ 08837
Phone: 732-906-6830
E-mail: murphy.patricia@epa.gov
Kim Gotwals
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Lucas Neas, Sc.D.
Epidemiology and Biomarkers Branch
US EPA NHEERL
MD-58A, USEPA Mailroom
RTP,NC 27711
Phone: 919-966-9961
E-mail: neas.lucas@epa.gov
Dan Petersen
US EPA ORD NRMRL
MS G75, 26 West Martin Luther King Drive
Cincinnati, OH 45268
Phone: 513-569-7831
E-mail: petersen.dan@epa.gov
Dr. Annette Pruess
Protection of the Human Environment (PHE),
World Health Organization
20, Avenue Appia
CH-1211 Geneva 27, Switzerland
Phone:(QU) 41 22 191 3584
E-mail: pruessa@who.int
Larry Reed
NIEHS (on detail from EPA)
P.O. Box 12233 (EC-27)
RTP,NC 27709-2233
Phone: 919-316-4622
E-mail: reedl@niehs.nih.gov
Chris Saint
US EPA NCER
8723R, Ariel Rios Building, 1200 Pennsylvania
Avenue, NW
Washington, DC 20460
Phone: 202-564-6909
E-mail: saint.chris@epa.gov
Robert F. Spengler, Sc.D.
Associate Administrator for Science
Agency for Toxic Substances and Disease
Registry
37 Executive Park Drive, Room #3720
Atlanta, GA 30329
Phone: 404-498-0003
E-mail: rys2@cdc.gov
RTP,NC 27711
Phone: 919-541-4607
E-mail: tilson.hugh@epa.gov
Edward Washburn
Goal 8 Research Coordination Team Leader
US EPA ORD OSP
8104R, Ariel Rios Building, 1200 Pennsylvania
Avenue, NW
Washington, DC 20460
Phone: 202-564-1134
E-mail: washburn.edward@epa.gov
Valerie Zartarian
US EPA ORD NERL
Office of Research and Development, National
Exposure Research Laboratory, 12201 Sunrise
Valley Drive, 555 National Center
Reston,VA 20192
Phone: 703-648-5538
E-mail: zartarian.valerie@epa.gov
Hal Zenick, Ph.D.
Associate Director for Health
US EPA NHEERL
MDB105-01
RTP,NC 27711
Phone: 919-541-2283
E-mail: zenick.hal@epa.gov
Hugh Tilson
US EPA NHEERL
B305-02, USEPA Mailroom
B-7
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Appendix C
List of Existing Data Sets/Resources
Data Set or Surveillance Study
Agent Orange (Vietnam) tissue
repository
Arsenic tissue repository
Breast Explant (+ tissue) repository
Gulf War (Kuwait) tissue repository
Mutagen, cell culture repository
Prisoner of War tissue repository
(1941 to present)
Tissue Reactions to Drugs Registry
Children's Cohort Study
Degenerative Neurological Disorder
Surveillance
Exposure and disease registries
(various), including World Trade
Center (WTC) and Libby, MT mine
Genetic Susceptibility Report
Hazardous Substance Release/Health
Effects Database (HazDat)
Hazardous Substances Emergency
Events and Surveillance System
Health tracking and exposure studies
Poison Control Center Data
Brief Description
• 4,000 formalin-fixed, paraffin-embedded
(FFPE) biopsies
• 50 frozen biopsies
• 170 cases inorganic Arsenic toxicity FFPE
blocks and slides
• 35 rodents; frozen tissue for speciation
• 1,600 matched exposed and control placentas,
cord blood, plasma, urine
275 cases
• 8,000 FFPE biopsies
• 3,000 frozen blood, serum specimens
• 500 frozen fibroblast preps
• suspect DNA repair defects
18,000 FFPE specimens from 12,000 cases
>12,000 cases, FFPE
longitudinal cohort
• neurodegenerative diseases (MS, ALS, etc.)
• launching in 4-5 states
• working with neurologists and public health
agencies to gather data and assess trends
• community cohort registries; some still in
development
• many follow individuals for subsequent health
problems
• WTC includes air toxics, >100,000 people
• Libby, MT addresses asbestos
looking for genes to be evaluated in NHANES
• site-specific information system
• release of hazardous substances from
Superfund sites or emergency events
• effects of hazardous substances on the health
of human populations
tracks hazardous substance releases, injuries,
health issues in 20 or so states
RFA closed July 2002
studying acute health effects w/ NCEH
Agency
AFIP
AFIP
AFIP
AFIP
AFIP
AFIP
AFIP
ATSDR,
CDC,
EPA, NIH
ATSDR
ATSDR
ATSDR w/
NCHS
ATSDR
ATSDR
ATSDR
ATSDR
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Data Set or Surveillance Study
States Cooperative Agreements
Program
Toxicological profiles
Inventory of existing CDC
surveillance systems
National Electronic Disease
Surveillance System (NEDSS)
National Public Health Surveillance
System (NPHSS)
Nationwide Health Tracking Network
National Notifiable Disease
Surveillance System (NNDSS)
Metropolitan Atlanta Developmental
Disabilities Surveillance Program
U.S. Birth Defects Surveillance
National Program of Cancer
Registries
Autistic Surveillance Program
Childhood Blood Lead Surveillance
(CBLS)
National Report on Human Exposure
to Environmental Chemicals
Core Reports (various topic)
Brief Description
30 states, potential mechanism for getting
resources to states for assessments/studies
>160 published on CD as a searchable database
and includes 5 interaction profiles for common
chemical groupings
• over 120 surveillance systems
• some at state level; updating 1998 inventory
data architecture that uses national data and
information system standards for development
of integrated surveillance systems at the state
and local levels
• overarching framework to classify all public
health surveillance efforts
• provides a single point to access PH
surveillance data
• integrated system for data tracking, collection,
analysis, and dissemination
• includes noninfectious diseases and health
effects from environment and exposure
• to cover all 50 states, DC, US territories, and
tribal nations
• states collect and forward to CDC standard,
case-level data without identifiers
• includes recommended list of conditions for
surveillance
birth defects surveillance data since 1967
cooperative agreements with 18 states to
address major problems that hinder the
surveillance of birth defects and the use of data
for prevention and intervention programs
helps states and territories improve cancer
registries, meet standards for data quality,
establish computerized reporting and data
processing systems for registries, etc.
just beginning
supports state blood lead surveillance programs
on the basis of blood lead tests from public and
private clinical laboratories
updated annually
• address various health topics
• upcoming supplements include Healthy
People 2010 and Children With Special Needs
Agency
ATSDR
ATSDR
CDC
CDC
CDC
CDCw/
NCEH lead
CDC EPO
CDC
NCBDDD
CDC
NCBDDD
CDC
NCCDPHP
CDC
NCEH
CDC
NCEH
CDC
NCEH
CDC
NCHS
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Data Set or Surveillance Study
National Health and Nutrition
Examination Survey (NHANES)
National Health Care Surveys
National Health Interview Survey
(NHIS)
National Vital Statistics System and
Atlas of United States Mortality
HIV/AIDS Reporting System
Foodborne Diseases Active
Surveillance Network (FoodNet)
National West Nile Virus
Surveillance System
Behavioral Risk Factor Surveillance
System (BRFSS)
Adult Blood Lead Epidemiology and
Surveillance (ABLES)
Sentinel Event Notification System
for Occupational Risks (SENSOR)
Agriculture Health Study (AHS)
Harvard Six Cities Study
Brief Description
• cross-sectional survey with longitudinal
ability
• estimates prevalence/distribution of health
conditions and related risk factors in the
population; not designed for regional
estimates
• oversamples selected groups
• collects/analyzes >300 biological and
environmental samples
• includes 5,000 persons and 15 geographic
locations each year
series of surveys on inpatient, ambulatory, and
long-term patient care
• annual
• personal interviews of 40,000 households and
100,000 persons
• uses computer-assisted interviews
• complete reporting on births and deaths along
with detailed geographic and demographic
information
• generates Atlas with national, regional, and
local analyses
U.S. AIDS and HIV case reports, including data
by state, metropolitan statistical area, mode of
exposure to HIV, and demographic traits
active surveillance for foodborne diseases and
related epidemiologic studies
• 49 states, five cities, and the District of
Columbia
• wild birds, sentinel chicken flocks, human
cases, veterinary cases, and mosquito
surveillance
state-based activity to help gather human
behavior and knowledge data
state-based surveillance program of laboratory-
reported adult blood lead levels
• build and maintain occupational illness and
injury surveillance capacity within state health
departments
• includes pesticides, occupational asthma
identifying exposure factors for pesticide
application to relate practices to exposures as
measured in urine/blood
evaluates influence of particulate matter on
human health and mortality
Agency
CDC
NCHS
CDC
NCHS
CDC
NCHS
CDC
NCHS
CDC
NCHSTP
CDC
NCID
CDC
NCID
CDCw/
ATSDR
CDCw/
NIOSH
CDCw/
NIOSH
EPA
EPA
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Data Set or Surveillance Study
National Human Exposure
Assessment Studies (NHEXAS)
National Morbidity, Mortality and Air
Pollution Study (NMMAPS)
Particulate Matter Panel Studies
State of the Environment Report
Children's Total Exposure to
Persistent Pesticides and Other
Persistent Organic Pollutants
(CTEPP)
Consolidated Human Activities
Database (CHAD)
Human Exposure Database System
(HEDS)
Cancer Intervention and Surveillance
Modeling Network (CISNET)
Surveillance, Epidemiology, and End
Results (SEER)
American College of Surgeons and
other health-related organizations
Pharmaceutical and insurance
companies
National Toxicology Program
Occupational mortality data
Analytical data from private
laboratories
Brief Description
• environmental and biological samples plus
activity patterns
• includes EPA Region 5, Arizona, Maryland
• available on-line
• addresses 90 cities
• links daily mortality data by cause and with
air pollution information
• various studies of particulate matter exposure
and health effects
• includes Baltimore, Fresno, and RTP; to be
available on-line soon
health, exposure, and environmental data in
background documents as well as data and
reports identified but not used
addresses 260 children; measures activities and
exposures at day care centers and at home
• data sets from actual exposure
• master access to human activity databases in a
consistent format
• some national, some local data
• web accessible
• >875,000 records
web-accessible repository of data sets,
documents, and metadata relating to human
exposure studies; directly linked to EPA EIMS
modeling impact of cancer control interventions
on incidence and mortality
• assembles complex data sets on cancer
incidence and survival data from 1 1
population-based cancer registries and three
supplemental registries
• covers approximately 14 percent of the U.S.
population
have collected health data
variable quality, nonstandard, proprietary health
data
testing program for carcinogenicity and other
outcomes
web-accessible counts and rates of death in the
United States (1960-1994)
• well water, radon, and other analyses
• data may lack specific source location
Agency
EPA
EPAw/
HEI, JHU,
Harvard
EPA
EPA
EPAORD
NERL
EPAORD
NERL
EPAORD
NERL
NCI
NCI
NCI has
used data
NCI has
used data
NIEHS
NIOSH w/
CDC
States
Note: the information presented in this table is drawn from workshop presentations and discussions.
Therefore, the descriptions may not be complete.
C-4
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