PRO
Office of Research and Development's Response to the
Board of Scientific Counselors Report on
Review of ORD's Human Health Research Program
(Final report received December 2009)
June 2010
BOSC Human Health Research Program Subcommittee:
James E. Klaunig (Chair), Indiana University
Henry Falk (Vice-Chair) — Centers for Disease Control and Prevention
Paul D. Blanc — University of California San Francisco
George P. Daston — The Procter & Gamble Company
David G. Hoel — Medical University of South Carolina
Donald Mattison - National Institutes of Health, NICHD
Edo Pellizzari — RTI International
Christopher J. Portier — National Institute of Environmental Health Sciences
Joel Schwartz — Harvard University School of Public Health
Submitted by:
Sally Perreault Damey, PhD
National Program Director for Human Health
Office of Research and Development
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
RESEARCH AND DEVELOPMENT
Gary S. Sayler, Ph.D
Chair, Board of Scientific Counselors
Center for Environmental Technology
The University of Tennessee
676 Dabney Hall
Knoxville, Tennessee 37996
Dear Dr. Sayler:
On January 13-15, 2009, the Human Health Research Program Subcommittee of
the Board of Scientific Counselors (BOSC) met in Research Triangle Park, North
Carolina to evaluate the Office of Research and Development's (ORD) Human Health
Research Program (HHRP). The Subcommittee presented a report of its findings and
recommendations to the Executive Committee of the BOSC on August 6, 2009, and the
Executive Committee, in turn, provided a final BOSC report to ORD on December 1,
2009. With this letter, I am pleased to enclose the Agency's response to the final BOSC
report of its review of the HHRP.
The Human Health Research Program greatly appreciates the insights, advice, and
recommendations offered by the BOSC. The attached document presents an overview of
specific recommendations made by the BOSC and provides ORD's response to each of
the recommendations and a timeline for action. It also includes a table that summarizes
each recommendation, the action to be taken, and the timing for completion of these
actions.
As you are aware, ORD conducts periodic reviews of its research programs at
intervals of 4 to 5 years. The purpose of these reviews is to evaluate research relevance,
quality, and performance. The reviews also focus on identifying how the scientific
community and our programmatic partners use ORD's scientific results to protect human
health and the environment. In addition to these formal reviews, ORD will be providing
a mid-cycle progress report to update the BOSC on progress made implementing the
actions described in this document. The timing for the HHRP mid-cycle progress report
will likely be in early 2012. In this context, we look forward to working with the BOSC
again.
Since
Ke
Deputy
for Science
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of
ORD's Human Health Research Program (final report received December 2009)
The U.S. Environmental Protection Agency's (EPA) Office of Research and Development
(ORD) relies on its Board of Scientific Counselors (BOSC) to conduct independent expert
reviews of its environmental research programs every four to five years. The Human Health
Research Program (HHRP) Subcommittee of the BOSC met in Research Triangle Park, NC on
January 13-15, 2009, and the BOSC Executive Committee provided a final report in December,
2009. The principal charge to the BOSC reviewers was to evaluate ORD's HHRP from a
program assessment framework relative to program relevance, structure, performance, quality,
leadership, communication, and outcomes. A second priority was to provide a summary
assessment and performance ranking for each of the four long-term goals identified with the
HHRP. A set of specific charge questions was used to guide the Subcommittee through the
review, producing a number of recommendations and observations with regard to the program.
The Subcommittee met by conference call in October, 2008, and December, 2008, and for a
face-to-face meeting in January, 2009, in Research Triangle Park, North Carolina. The face-to-
face meeting consisted of an in-depth review of all aspects of the Program. Sally Darney,
National Program Director for Human Health, presented an overview of the HHRP including its
broad strategy, history, general structure, goals and resources. Each of the Program's four long
term goals (LTG) was then introduced by a leader of the respective LTG who provided a more in
depth description of each goal and oriented the subcommittee to the respective poster session that
followed. Posters for each of the four sessions were arranged in sub-groups by topic area with an
overview poster. All posters employed a consistent format that was structured to present the
science questions, summarize general methods and approaches, integrate results for a large body
of work, and summarize the impact of that work for EPA partners and others who use it to guide
risk assessment and risk management decisions. Poster booklets were sent to the subcommittee
ahead of the review and included a written abstract of the poster and a list of key products
(original research papers and synthesis papers) associated with it. The Subcommittee also heard
from the key partners in the Agency's program offices and regions who rely on the information
and scientific expertise provided by the HHRP, as well as external users of HHRP products. The
Subcommittee began drafting its report at the face-to-face meeting. A draft report was reviewed
by the Subcommittee in February, 2009, and again in April, 2009.
Overall, there was consensus among the Subcommittee members that there has been a maturing
of the HHRP. The Program is much more integrated, and the level and quality of science has
improved. There is considerably more emphasis on human health and human health-related
issues, and there is movement toward more of a public health-themed program. The HHRP, as a
whole, appears to be robust and responsive to emerging issues. The scientific content is
excellent and, compared to previous reviews, is more integrated within each LTG and among the
LTGs as well. There appears to be good evidence for strong scientific productivity and a
formidable impact of the work produced by the Program overall. In general, the members found
the Program leadership to be excellent to outstanding from the senior level to the laboratory/field
study levels.
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of
ORD's Human Health Research Program (final report received December 2009)
The purpose of the following narrative is to respond to the specific recommendations made in the
Review of the Office of Research and Development's Human Health Research Program at the
US Environmental Protection Agency, received December 1, 2009.
UPDATE ON ORD PLANNING AND CONTEXT FOR HHRP RESPONSE:
ORD activities since the HHRP review in January 2009 are transforming the way ORD research
is being planned, organized and implemented. Specifically, ORD is placing significant emphasis
on an integrated transdisciplinary research paradigm in order to help solve important national
environmental problems. As a means to this end, ORD is developing a "pilot" or "vanguard"
program to integrate research around the broad problem of "Safer Products for a Sustainable
World" (SPSW). This activity incorporates a significant portion of the current HHRP themes.
This pilot program is directed at assuring the safety of chemicals, which is one of the EPA
Administrator's primary goals. SPSW will integrate exposure and toxicology research across
ORD, capturing those elements of HHRP and the Safe Pesticides/Safe Products Program that are
specific to chemical evaluation, and integrating these with ORD's Computational Toxicology
Program (NCCT), Endocrine Disrupters Program, Nanotechnology Program, and risk assessment
methods in the Human Health Risk Assessment (HHRA) Program.
Importantly, SPSW is being planned with partner engagement, including EPA Program Offices,
Regions and others from the start, with a concerted effort to engage their participation
throughout the process. Thus, we will engage appropriate partners in problem formulation,
prioritization of science questions, and development of research products that are useful and
timely to the Agency.
This new planning approach addresses many of the issues raised by the HHRP Subcommittee
related to research planning, outreach to partners and effective delivery of research products to
users. Indeed, comments and recommendations from the 2009 HHRP BOSC subcommittee were
consistent with the need for this new approach and have contributed substantially to our thinking.
Accordingly, recommendations related to HHRP will be addressed in the context of this broader
ORD process.
To date, the SPSW steering committee has organized several workshops that gathered
preliminary input from EPA program and regional partners and plans to solicit input from
outside partners (other agencies, industry) in the near future. Based on this input, there is
consensus that EPA needs to change current approaches for chemical screening and testing to be
far more efficient, effective and systematic. New approaches would address toxicity and
exposure of both new and existing chemicals according to the principles outlined in NRC's 2007
report "Toxicity Testing in the 21st Century." This involves concerted research to resolve
toxicity pathways using genomics and systems approaches to revolutionize toxicity testing.
Furthermore, principles of green chemistry and life cycle analysis are viewed as critical to the
new SPSW program in order for commerce to create sustainable products and processes.
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of
ORD's Human Health Research Program (final report received December 2009)
SPSW is expected to incorporate aspects of research underway in the current Human Health
Research Program, particularly as described in LTG-1 and LTG-2 which support this objective
and are responsive to EPA's Strategy for Toxicity Testing in the 21st Century report (2009).
Preliminary descriptions of these projects were included in the January 2009 BOSC review. As
part of SPSW planning, these projects (as well as new project proposals) will be reviewed by a
program planning group that includes ORD partners and will be prioritized according to criteria
that include responsiveness, relevance and innovation.
Since January, 2009, HHRP has completed many of the Annual Performance Goals outlined in
the 2006 HHRP MYP and continues to build capacity in exposure science, modeling and
computational toxicology prerequisite for the new SPSW program. Ongoing efforts in HHRP
and other ORD programs contributing to SPSW include development of common "mine-able"
databases on exposure and toxicity, verification of methods for using high throughput and high
content data, development of high throughput computational tools for toxicity testing and risk
prediction, and toxicity pathway analysis in risk assessment.
An essential underlying assumption is that this research program must inform how vulnerability,
according to exposure factors and inherent susceptibility, can be considered in risk assessment
and mitigation efforts to ensure protection of vulnerable groups such as children. Targeted
animal based testing and Mode of Action (MoA) research will be designed to meet existing
regulatory needs and to verify the extent to which the new toxicity pathway approaches predict
in vivo toxicity. Accordingly, the selection of chemicals for study and of models/tools for
development will continue to be made in close partnership with program office and regional
partners. This new program is being developed with the expectation that its products will
directly inform regulations, including those resulting from upcoming TSCA reform, and also
make significant strides to further the use of green chemistry and enhance sustainable product
development.
Of relevance to HHRP going forward, ORD plans to sustain a human environmental health
program designed to use information on chemical risk derived from SPSW and other ORD
programs to evaluate complex risks in real world community settings. While extending concepts
developed in the current 2006 MYP (LTG-2 on cumulative risk; LTG-3 on Susceptible
Populations and LTG-4 on Evaluating Risk Management Decisions), the program will be
integrated to align more specifically with the Administrator's goal of "Cleaning up our
communities" and the cross-cutting themes of: protecting susceptible populations, especially
children; working for environmentalism and environmental justice; and, building partnerships
with States, Tribes and community groups.
An unofficial title "Healthy People in Sustainable Communities" (HPSC) will be used in this
report to distinguish this community program component from SPSW. HPSC will continue to
create and refine the tools and models necessary for community-based participatory research and
actions, particularly for communities at risk and in support environmental justice objectives.
HPSC will be informed by, and responsive to, recommendations from the 2010 EPA symposium
"Strengthening Environmental Justice Research and Decision Making: A Symposium on the
Science of Disproportionate Environmental Health Impacts." It will also continue to support
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of
ORD's Human Health Research Program (final report received December 2009)
research to ensure children's health protection in the context of family, school and community
stressors (only some of which involve chemicals), including collaborations with the National
Children's Study. To further the goals of EPA's Report on the Environment and our ability to
track changes and trends in environmental public health, HPSC will also continue to identify and
interpret biomarkers of exposure and effect, as well as public health indicators of
environmentally-related diseases such as asthma, and will continue to investigate linkages
between environmental exposures before and after birth on children's health and disease.
HPSC will be planned and reviewed as described above with an emphasis on partner engagement
from the start, particularly the engagement of EPA Regions, Tribal groups, and EJ communities,
as well as with other agencies such as CDC, NIH/NIEHS, HUD and the Department of
Education, which work toward related broad goals.
In summary, HHRP is actively engaged in the ORD transformation towards integrated
transdisciplinary research and in alignment with the Administrator's goals for the Agency.
SPSW and its companion program, HPSC, have in common the goal of finding innovative
approaches for assessing and ultimately preventing environmental health risks.
RESPONSE TO RECOMMENDATIONS ON LTG 1
Recommendation 1: The BOSC recommends that, through close collaborations with the
Integrated Risk Information System (IRIS) staff, examples be developed in which the Mode of
Action (MoA) for a chemical actually changes or influences the quantitative risk estimates IRIS
makes for the chemical.
Response: In responding to this recommendation, it is necessary to point out that the objective
of MoA research in HHRP LTG 1 is not specifically linked with the IRIS assessments. The LTG
1 research focuses on broad science issues that relate to multiple chemicals. While we partner
with the National Center for Environmental Assessment (NCEA) on many projects, we typically
have not set out to fill specific needs for MoA for IRIS compounds, nor do we select chemicals
for study based on upcoming IRIS assessments. IRIS compound selection is more often made
for chemicals for which a large body of data already exists. On the other hand, HHRP research
contributes conceptually to health risk and assessments performed by NCEA and EPA Program
Offices.
For example, HHRA and HHRP scientists are partnering on a project driven by the NRC's
Framework for Risk Based Decision-Making. Collaboratively, we are refining PBPK models,
applying bioinformatics-based knowledge mining, and mode of action research to augment the
"Next Generation (Nex Gen) Risk Assessment Program." This effort is incorporating
information derived from HHRP and NCCT research into prototype assessments in order to
evaluate how new types of high throughput/high content data can augment, extend or replace
traditional health assessment data. Prototype assessments are mode of action driven, with a
minimum of two sentinel chemicals each: respiratory injury via inflammation (ozone and
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of
ORD's Human Health Research Program (final report received December 2009)
chlorine), endocrine disruption via cell signaling alterations (BPA, perchlorate and phthalates),
and cancer via genotoxicity (benzene and PAHs). These prototypes will incorporate both
chemical-specific data and modeling approaches developed by HHRP. Related to respiratory
damage, for example, a PBPK model for chlorine (described in poster HHRP BOSC poster 1-14)
is undergoing completion.
Also relevant to this recommendation, LTG 1 research on mode of action is designed to provide
well characterized examples addressing fundamental science issues that can be used to advance
Agency risk assessments by reducing dependence on default assumptions and their inherent
uncertainties. Such research may fill specific gaps in current EPA assessments in NCEA (IRIS
or Integrate Science Assessments/ISAs), but more typically has been undertaken in response to
specific EPA program office requests. HHRP research on conazole pesticides, directed at
addressing the issue of cancer vs. non-cancer modes of action, is designed for use by the Office
of Chemical Safety and Pollution Prevention (OCSPP) to harmonize its risk assessment
approaches. HHRP research on common modes of action of chemically-related triazide
pesticides, with atrazine as a central focus, continues to inform OCSPP registration activities for
atrazine and related pesticides. Mixtures research in LTG 2 has been used by OCSPP in its
cumulative risk assessments for a number of pesticide classes: carbamates, organophosphates
and currently pyrethroids, and has contributed to the development of models for cumulative risk
anticipated to be needed in the future as EPA places more emphasis on cumulative risk
assessment.
Action/Timeline: The NCEA "Next Gen" projects are ongoing. Integrated teams (HHRP,
NCCT and NCEA scientists and extramural grantees) are drafting prototype concepts for review
at upcoming workshops. A final report (NCEA product) for at least one prototype is expected in
late 2011. Future presentations to the BOSC we will more clearly explain how our research
products are used in risk assessments.
HHRP will participate in Science Advisory Panels culminating in OCSPP assessments of
Conazoles (2011) and Pyrethroids (2010).
Recommendation 2: The BOSC recommends more integration of the MoA science with the
quantitative risk assessment generated by the epidemiology studies.
Response: ORD appreciates this recommendation and the importance of linking toxicology and
exposure data with epidemiology and public health studies. Efforts are progressing toward the
new SPSW program described above, in which information on mode of action derived using in
vitro screens and computational tools will be used to predict toxicity and prioritize chemicals for
further testing and/or inform epidemiology studies based on both exposure and toxicity. The
validity of these predictions will be tested in a systematic manner using higher order systems or
whole animals in a highly targeted fashion. For chemicals or mixtures with unacceptably high
risks based on exposure and toxicity, further testing may be designed to better define modes and
mechanisms of action as needed to help design safer substitutes. Where feasible, results of
epidemiology studies conducted by EPA or others may be used to verify these predictions as
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of
ORD's Human Health Research Program (final report received December 2009)
well as inform new toxicology and exposure assessments. Also, research in HHRP - HPSC is
determining which public health indicators make it possible to track environmentally associated
diseases in exposed populations. This will enable EPA to better evaluate the accuracy of risk
predictions based on exposure and toxicity, as well as the effectiveness of its risk management
decisions (remediation efforts).
Action/Timeline: Linkages will be made between the chemicals program (SPSW) and
epidemiology and children's health studies to translate chemical/toxicology information into
public and community health applications. This effort will be ongoing.
Recommendation 3: Increased interactions (data sharing and research planning) among the
researchers in LTG 1 with those in LTGs 2 and 3 are recommended.
Response: We are addressing this recommendation on both fronts (data sharing and research
planning).
Actions for Data Sharing: Improved linkage in the exposure to health outcome continuum has
been an underlying goal of HHRP since its inception, but has been hampered by lack of methods
for linking different types of databases and information that has not previously been in a
searchable database. Accordingly, ORD is investing in software and protocols for data sharing.
The general goal is to build capacity for collaborations not only across LTGs and within SPSW,
but also across ORD programs, EPA offices and federal agencies. For example, data sharing is a
big component of the interagency Tox 21 collaboration among EPA, NIEHS, HHS and FDA.
With this investment, ORD will be able to take a systems approach to identifying, predicting and
preventing risks of chemicals.
Specifically, in 2009 and 2010, HHRP has allocated funds to NERL and NHEERL to develop,
populate and link exposure and toxicology databases and ensure that they can connect with
NCCT's ACTOR information highway. This linkage is essential for information generated in
the current HHRP LTG 1 on toxicology to be compatible with cumulative exposure information
generated in LTG 2 (supporting exploration of the exposure to effects continuum) and then to
translate the integrated information for research in community/real world settings (LTG 3).
Such translation will ultimately address susceptibility of populations, especially children, enable
apportionment of risk among chemical and non-chemical stressors, and provide the means by
which to evaluate the effectiveness of risk management decisions (LTG 4). NCER is also
making provision for increased data sharing among its grantees (LTG 2, 3 and 4) and providing
access to data generated from the grants program for EPA scientists and regulators to use.
Research Planning: As capacity is being built, research planning for SPSW and HPSC
components is being coordinated across ORD Labs and Centers. For example, ORD is currently
engaged in reviewing its portfolio of chemical-based research and building interdisciplinary
teams to address the most important problems in an integrated manner. HHRP is also partnering
with the National Children's Study where we see potential for long term impact in two
directions. First, we want to contribute the best exposure science and environmental
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of
ORD's Human Health Research Program (final report received December 2009)
epidemiology approaches to the NCS so that this ambitious national study will achieve its long
term objectives. Second, we want to ensure that EPA scientists maintain the capacity to access
and evaluate NCS data over the next 21 years in order to address key questions about
environmental impacts on children's growth and development. Related to this effort is HHRP
research that is developing practical tools for gathering exposure data for very young children, in
their homes and in child care settings, and make such data available to others, including
community and regional decision-makers.
Action/Timeline: Investments in database building are expected to continue in 2011 to facilitate
data sharing within and across ORD programs. The planning process being implemented for the
new chemicals program, SPSW, and for its companion program in HHRP, HFSC, will involve
transdisciplinary teams of scientists from ORD Labs and Centers as well as collaborating
scientists from EPA Programs and/or Regions/Tribes, communities and other Agencies who will
be involved in planning from the start and continue to participate in the design, implementation
and interpretation/use of the research results. This effort will be ongoing.
RESPONSE TO RECOMMENDATIONS ON LTG 2
Recommendation 1: The BOSC recommends that the Human Health Research MYP include a
concerted educational outreach effort to the program offices, regional offices, and states
regarding the use of sophisticated models and new knowledge developed through its research.
Response: This important recommendation is being implemented in several ways.
1. Inclusion of users in tools/model development. Sophisticated models and information need
to be developed with the end user in mind. Inclusion of the user and the developer from the start
ensures that the final model can be readily transferred to the user(s). To address issues outlined
in the Food Quality Protection Act, and other drivers for assessing cumulative risks of chemicals,
ORD has collaborated with OCHPP/OPP for over ten year to design, develop and evaluate our
Stochastic Human Exposure Dose Simulation (SHEDS) modeling system and companion
Exposure Related Dose Estimating Model (ERDEM), along with other generic PBPK models.
These models have been used to generate the science and data supporting a variety of FQPA risk
assessments including the organophosphate, carbamate and pyrethroid risk assessments. The
new science and knowledge gained from each risk assessment has been used to design the future
research and improve how the models characterize and address the key variables influencing
variability and uncertainty. The future SPSW will build off these programs. The users will be
fully integrated in all phases of the collaborative research planning, implementation and
application activities to ensure that the final model will be readily transferred to the user(s).
2. Providing web-based, user friendly interfaces ORD is developing, refining and
distributing its models and databases through ORD and Agency web-based, user friendly,
interfaces. In addition to ORD's SHEDS, ERDEM and PBPK models discussed above, a new
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of
ORD's Human Health Research Program (final report received December 2009)
major HHRP effort, the Community-Focused Exposure and Risk Screening Tool (C-FERST), is
being designed, refined and field-tested in close collaboration with several Regions, states, and
communities. This tool provides access to state of the art exposure and risk characterizations for
communities to use to understand the key stressors influencing their health, including primary
routes and pathways of exposure and to design site specific plans for reducing exposures to
chemical stressors. By providing a suite of simple, yet robust tools that incorporate innovative,
high quality science into a user-friendly, web-accessible interface, C-FERST enables
communities to evaluate the cumulative impacts of multiple stressors, prioritize environmental
issues, identify communities at risk, and assess impacts of risk management actions. It employs
user-friendly Google-Maps interfaces with a range of problem formulation and modeling
capabilities, including online training materials. ORD is making a concerted effort to
demonstrate these tools at national workshops and meetings. For example, the C-FERST tool
was demonstrated at a Superfund Basic Sciences meeting in December 2009, and at an ORD-
sponsored workshop in March on "Strengthening Environmental Justice Research and Decision
Making." C-FERST was also featured at an ORD-Regional Science Workshop on cumulative,
community-based risk assessment (July 2009, Chicago), at the 2010 Regional Applied Research
Effort (RARE)/Community Action for a Renewed Environment (CARE) project officers training
course, and the 2010 Tribal Science Forum.
Action/Timeline: Collaborative research to enhance ORD's SFIEDS and companion dose
models will focus on linking these tools to support rapid risk assessments and for characterizing
variability and uncertainty. C-FERST continues to be evaluated and enhanced. Over the next
few years, emphasis will be placed on enhancing exposure science, evaluating the tool in
selected communities, and developing the capabilities to translate the science for community
actions. The C-FERST prototype is being field tested internally in 2010 with expected public
release in 2011. Additional collaborations with OCSPP on developing publicly-accessible GIS-
based exposure models are also moving forward in 2010-2012.
Recommendation 2: The BOSC recommends that goals or guidelines be defined that describe
the threshold of acceptable accuracy for source-to-dose-to-health models and methods used in
making assessments. Further characterization of the uncertainty of models, similar to that
described in the source-to-dose paper by Ozkaynak et a/., is highly endorsed.
Response: EPA conducts a wide variety of assessments, ranging from very sophisticated
chemical-specific risk assessments to less robust assessments for site specific decisions. ORD
researchers have incorporated sophisticated methods and approaches in the development of
ORD's SFIEDS and dose models (as noted above) for characterizing variability and uncertainty.
Future ORD exposure and dose modeling research will continue to employ state-of-the-science
techniques for further characterization of uncertainty. As noted by the BOSC, the acceptability
of the models and data used by the multiple Program Offices and Regions for their assessments
varies greatly based on regulatory mandate and/or the criteria established by the Agency Office
for their decision-making processes.
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of
ORD's Human Health Research Program (final report received December 2009)
This BOSC recommendation will be considered in the design of the new ORD SPSW, which
incorporates a focus on improving the relevance of assessment methods. As SPSW
systematically conducts research to support "Intelligent Testing," while factoring in the inherent
properties of chemicals, the program will integrate available knowledge and databases to
produce the next generation of science and tools (including data attributes) needed to support
Agency assessments.
Action/Timeline: In addition to intramural projects, such as the one referenced above, an NCER
RFA on this topic will be yielding new relevant models in 2010-11. As we develop the SPSW
pilot, ORD researchers will continue to collaborate with program office scientists in the design
and implementation of research that develops better ways to characterize variability and
uncertainty in models used to support Agency decisions.
Recommendation 3: As part of future BOSC reviews and as an accountability goal, the BOSC
recommends that evidence (in summary narrative form) be provided on the use of completed
research products in cumulative risk assessments.
Response: ORD considers this recommendation as being important for all program reviews.
Specific to HHRP, tools (e.g., SHEDS, ERDEM) developed for aggregate and cumulative risk
assessments are being applied by the Program Offices and Regions to address regulatory
decisions. As an example, ORD's MoA information and exposure models are being integrated
and applied in the Agency's anticipated cumulative risk assessment of the pyrethroid insecticides
in 2011. Numerous documents citing the ORD research continue to be referenced in the various
Science Advisory Panel meetings supporting this landmark assessment. In this case, the primary
research is designed to develop the fundamental science supporting future cumulative risk
assessments, using the pyrethroids as a case study. As such, the documentation of the science in
the open literature is as important as the documentation of how the ORD tools are being used to
support the risk assessment.
Moving forward, ORD is developing methods to better track usage of its products in risk
assessments and other actions. To do this effectively, it will be particularly important to consider
that many regulations only cite review articles. We will need to evaluate the references cited in
the reviews in order to locate our primary research products and document their importance. We
anticipate that the increased emphasis on engaging partners and users in SPSW and HPSC
program planning, along with maintaining that engagement throughout the life of the program,
will not only increase the usefulness of our research products but also facilitate tracking.
Furthermore, ORD is considering developing a centralized tracking system. This would help
identify all ORD products that contribute to Agency cumulative risk assessments regardless of
which program generated them, and even when program structures change.
Action/Timeline: For future program reviews, specific examples in HHRP will be captured not
only in the posters for work done within the evaluation period (as in the 2009 review), but also
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of
ORD's Human Health Research Program (final report received December 2009)
for research products from previous evaluation periods. This is necessary because HHRP, as a
"core" program, develops models and solutions over time, not necessarily to meet a regulatory
deadline, and these models may be used in more than one risk assessment. Furthermore, we
agree that this information should be synthesized in a summary table that clearly links the
program goals, outputs and usage by risk assessors. Analyses of dockets done for the 2009
HHRP BOSC showed that we need to capture information over longer periods of time since it
can take years before a research product or model actually is used in a risk assessment and that
risk assessment is finalized, peer reviewed and released to the public. Nevertheless we will also
attempt to show interim steps, such as inclusion of ORD data/models/products in interim stages
of a risk assessment or health assessment document.
Recommendation 4: The BOSC recommends the continuation of the general framework for
planning, with the inclusion of greater planning efforts and knowledge sharing among LTG 1,
LTG 2, and LTG 3, and with other Agencies.
Response: We anticipate the current structure (4 LTGs) will be replaced by goals developed for
the SPSW and HPSC programs. These programs will be implemented by scientists working on
interdisciplinary teams. This strategy will address this BOSC recommendation by linking
exposure, health, risk assessment and risk mitigation components within a project. We also plan
to engage partners from other Agencies, as appropriate, to achieve the goals of the overall
program and component projects.
Action/Timeline: Ongoing. With respect to inclusion of other Agencies, planning for the
integrated SPSW program already involves partners from NIH, NIEHS and CDC, as well as
industry. Partnerships will be expanded to include parties interested in green chemistry and
sustainability. Planning to better integrate HHRP research in cumulative community risk,
children's health and EJ already includes NIH, NIEHS, CDC and HUD, and will be expanded to
include other agencies, especially as the newly reconfigured President's Taskforce on Children's
Health and Injury Prevention evolves its national children's health agenda.. To this end, we have
established close ties with the new director of the Office of Children's Health Protection, Dr.
Peter Grevatt, who also serves as an advisor to Administrator Jackson on children's health issues.
Involvement of our partners will be documented in the next review by including collaborating
scientists in the posters and presentations.
Recommendation 5: The BOSC recommends that researchers who have extensive experience
in "non- chemical stressors" be included in the overall plan for community-based research.
Response: ORD recognizes the need to include social scientists in our programs. The EPA
Science Advisory Board has also made this recommendation, and ORD has incorporated this
need into its intramural workforce planning efforts. HHRP NCER grants provide an excellent
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of
ORD's Human Health Research Program (final report received December 2009)
means of integrating social science expertise into the program. New efforts include an NCER
solicitation, released in 2009, focusing on the question of how to incorporate the influence of
non-chemical stressors into community-based research and risk assessment. An announcement
of these grants is imminent. NCER's Tribal Grants program, funded under HHRP, also makes
major contributions to our understanding of the importance of non-chemical stressors. Each
Tribal grant includes social science expertise to capture cultural, social and economic factors in
tribal communities, as well as exposures that may impact health. In 2010, NCER communicated
the results of this program broadly through a webinar series and by placing fact sheets on the
web. A new solicitation for Tribal Grants is planned for 2011, with similar emphasis on non-
chemical stressors. Furthermore, a new solicitation (for 2010 release) on how school
environments, defined broadly, impact student and teacher performance is also expected to
involve social scientists (as well as educators) in competitive grant applications. Finally, the new
round of Children's Centers, co-funded with NIEHS, includes social science expertise, as have
previous Centers in this successful program.
Action/Timeline: The NCER grants described above will greatly expand ORD research in this
direction. Results will be published over the next three to five years. ORD will continue to
address this need in all its programs.
Recommendation 6: As a future goal, the BOSC recommends more engagement of the regional
offices in planning and identifying areas in which they need tools, methods, and data from ORD.
Response: ORD's transformation includes the goal of more effective partnerships with States
and Tribes, in alignment with the Administrator's priorities. ORD AA, Dr. Paul Anastas,
charged all National Program Directors with improving our engagement with, and
responsiveness to, Regional and Tribal needs. ORD's Office of Science Policy (OSP) is placing
increased emphasis on collaborative research with Regional partners through better coordination
of the RARE program. HHRP is now capturing RARE products in its tracking and
communication of accomplishments, and working to incorporate results into future planning to
address "next steps."
ORD participated in a recent meeting of Regional Risk assessors who provided input into an
upcoming (fall 2010) ORD-Regional Science Workshop on children's risk assessment, which
will include definition of future research needs. An ORD-Regional Science workshop on
Cumulative Community Based Risk Assessment, held in July, 2009, has built ongoing
connections between HHRP's community based program and regional science and tribal
programs. HHRP includes regional and OSP scientists on our Research Coordinating Team, and
the NPD is working closely with OSP to further this goal at its fall retreat.
As detailed under recommendation #1 above, C-FERST is a good example of collaborative
research with our regional partners. Developed with place-based input from users, this tool will
serve as a communications vehicle to disseminate innovative, high quality science on exposure
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of
ORD's Human Health Research Program (final report received December 2009)
and risk to the regional, state, tribal and community partners for use in evaluating the cumulative
impacts of multiple stressors.
Action/Timeline: A report from the 2009 Cumulative Risk Workshop, a 2010 HHRP APM
product, will provide a synthesis of the workshop presentations and recommendations to inform
future planning for this program. Actions ORD leaders can take to ensure regular
communication and coordination with Regions will be discussed at the ORD/OSP 2010 fall
retreat, for implementation in 2011.
Recommendation 7: The BOSC suggests an added influx of resources into developing the
science in cumulative risk assessments, if such assessments are to be effective in a reasonable
timeframe.
Response: ORD agrees that improvements in cumulative risk assessment methods are needed,
and that this should be a priority for HHRP. In 2009, ORD sponsored a highly successful
workshop with the Regions on this topic. In 2009-10, HHRP re-directed significant resources to
build capacity in, and advance the science of, cumulative risk assessments. Resources are
supporting ongoing efforts to build and link exposure databases with toxicity databases, extend
exposure models to address complex exposures (e.g. SHEDs multi-media), and link exposure
information obtained from multiple sources into a user-friendly tool for community use (C-
FERST: Community-Focused Exposure and Risk Screening Tool). Extramural funding is
providing better methods and models for cumulative risk assessment, with increased
consideration of the extent to which non-chemical stressors impact responses to chemical
stressors. A 2009 NCER RFA on this topic will fund a series of grants to be announced in 2010.
Action/Timeline: Direction of significant resources to this end is providing tools for cumulative
risk assessments. A report of the ORD-Regional Workshop to be published in 2010 will
summarize how new tools can be brought to bear on cumulative risk assessments at the
community level.
RESPONSE TO RECOMMENDATIONS ON LTG 3
Recommendation 1: The BOSC recommends developing a more fully elucidated conceptual
framework for vulnerability and susceptibility.
Response: ORD agrees that a more fully elucidated conceptual framework for vulnerability and
susceptibility would be helpful for future program planning and to prioritize research. The
SPSW conceptual framework under development includes susceptibility from biological
perspectives, i.e. inherent factors that impact response to toxicants such as gender,
developmental stage, genetics, pre-existing disease, metabolism (e.g. child specific absorption-
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of
ORD's Human Health Research Program (final report received December 2009)
distribution-metabolism-elimination that can result in different vulnerability to a given level or
type of ambient exposure). In turn, the HPSC program conceptual framework under
development places emphasis on vulnerable populations based on where people live and how
they behave (e.g. child-specific exposure factors based on behaviors of children at different
ages). This concept will include consideration of social and economic factors that can impact
vulnerability by, for example, determining where people live and how close they are to industrial
or mobile sources of pollution, or by placing people at greater risk of adverse health impacts due
to lack of adequate medical care, poor general health, or excessive stress associated with poverty
and social injustice. The conceptual framework will include recognition that biological
susceptibility at the individual level, as considered in toxicology studies, underlies the broader
definition of vulnerability at the population level, as considered in community-based and
epidemiology studies. Thus, a fully elucidated conceptual framework for vulnerability and
susceptibility would be expected to be important for both SPSW and HPSC. The two programs
will inform each other in this regard, and the framework will be applicable to other ORD
programs.
Action/Timeline: In response to this recommendation and outputs of the Spring 2010
Symposium on Environmental Justice mentioned previously, ORD will build capacity in
community-based participatory research and environmental justice awareness. These activities
are necessary as the foundation for a more fully elucidated framework for vulnerability and
susceptibility for articulation in SPSW and HPSC planning.
Recommendation 2: The BOSC recommends redressing a program imbalance within the life-
stage arm of LTG 3, such that the strengths of the childhood susceptibility research thrust are
matched with an expanded research program addressing the elderly, as well as potential
subgroups across the entire age range.
Response: While research on environmental impacts on Children's Health remains a critical
element of the research program, we understand the importance of considering health impacts of
the environment at all stages of the lifecycle. HHRP is leveraging efforts with the Air Program
dealing with exposures to PM and air toxics and the resulting health impacts for aging people.
As shown in posters 09 and 10, EPA has established a cross-ORD research program to address
the susceptibility of older adults. By 2030, the number of older persons is expected to double to
more than 70 million. EPA has previously launched an Aging Initiative, and ORD's research
feeds directly into this as part of a broader focus on Community Health. For example, we have
published handbooks on community-based UV radiation risk education, targeted to both children
and older adults and senior citizens. One aspect of the initiative is the program "Age Healthier,
Breathe Easier," and we are directing research to better inform this program. Clinical and animal
studies currently underway are looking at the effect of air pollution on older individuals.
In addition to direct research on aging, epidemiological studies are focusing on pollutant effects
on conditions that become more prevalent in an aging population, such as diabetes, metabolic
disease, atherosclerosis and subclinical cardiac disease. We are also studying whether
intervention strategies focused on the elderly could reduce their susceptibility to pollution. For
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of
ORD's Human Health Research Program (final report received December 2009)
example, a current study is expected to lead to an advisory on nutrition that could reduce
cardiovascular injury from air pollutants.
Action/Timeline: Consistent with budgetary availability, ORD is addressing certain issues
relevant to susceptibility of other life stages, particularly for older persons, and for people with
chronic diseases associated with both pollution and aging. Engagement in community-based
participatory research in the Children's Centers, Tribal grants program, and projects with
Regions should provide opportunities to address other life-stages which may present stage-
specific vulnerabilities.
Recommendation 3: Rethinking the approach to asthma as a target condition so that it is not
simply approached as a surrogate of childhood susceptibility to new disease onset, but rather
considered across the entire age range and considered also in terms of vulnerability in pre-
existing disease, is recommended.
Response: We agree with the recommendation to re-evaluate the approach to asthma research.
To that end, ORD is convening an Asthma Research Workshop on October 7l 2010. This
workshop will be focused on two themes: Asthma and Community Health, and Asthma and
Global Health. The goal is to provide information on the path forward to establish a research
framework that can be used by a cross-Agency writing group to update the ORD Asthma
Research Strategy.
As recommended, current and future research is expanding the focus of asthma to other parts of
the age range. For example, ORD is currently performing controlled exposure studies on older
asthmatics. Studies are focusing not only on respiratory outcomes but also on cardiovascular
injury caused by exposure to inhaled particles, to understand whether older asthmatics are at
increased risk to endothelial injury and accelerated coagulation. At the other extreme, ORD
researchers are studying developmental origins of disease and whether in utero exposure to
pollutants will result in increased risk of developing asthma.
As recommended, research in asthma as a pre-existing disease that confers vulnerability is being
initiated. ORD scientists have initiated studies to understand the role of severity of asthma
disease in conferring susceptibility to pollutants. As part of this research, we are integrating with
the SPSW program and conducting research to determine whether toxicity pathways are
perturbed by pollutants in different ways (e.g., different gene expression or micro RNA profiles)
in individuals with different asthma severity. Furthermore, research proposed in the new round
of Children's Centers will address fundamental questions about the interactions among
biological allergens and ozone in the etiology and progression of asthma, and about controlling
asthma symptoms by dietary intervention.
Action/Timeline: The studies and workshop described above will provide results and reports in
2011 that will inform research planning for 2012. Asthma research in the Children's Centers
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of
ORD's Human Health Research Program (final report received December 2009)
will occur over the next five years.
Recommendation 4: In addressing preexisting conditions, the BOSC recommends the program
consider expansion beyond asthma to encompass other airway disease (in particular chronic
obstructive pulmonary disease [COPD]) and, beyond lung diseases, consider other classes of
disease such as neurological and endocrine disorders.
Response: As recommended, we have commenced studies on respiratory diseases beyond
asthma. These mechanistic studies are focused on airway inflammatory pathways that may
underlie many respiratory diseases. Animal models and human clinical studies are looking at
how pollutants can interact with viruses and other pathogens to impact host defense, and thereby
cause increased bronchitis. Epidemiological studies, such as those studying the impact of
wildfires on health outcomes, have considered hospital admissions and emergency room visits
for respiratory diseases as a whole, as well as individual diseases (asthma, COPD etc). As part
of these studies, admissions for other classes of disease, particularly cardiovascular disease, are
being tracked.
New studies focusing on individuals with other disease classes, e.g., diabetes, metabolic
syndrome, overt and sub-clinical cardiac disease, have been initiated. As part of this effort, new
animal models of different diseases are being established.
Action/Timeline: New studies are addressing this recommendation as detailed above.
Recommendation 5: The BOSC recommends better integration of LTG 3 across the other
LTGs, in particular with LTG 2 in terms of cumulative exposure.
Response: ORD agrees with this recommendation, which will be addressed in SPSW and HPSC
research programs. SPSW will transform how the Agency identifies and manages chemical
risks, particularly to mixtures that are encountered in "real world" settings. An important
element of SPSW is to improve our understanding of inherent biological susceptibility to
chemicals and contaminants. Specifically, toxicity pathway research will help determine who is
likely to be susceptible, e.g., people with a defect in genes/proteins involved in a pathway.
Conversely, the models used for toxicity pathways research will need to incorporate
susceptibility, e.g., by using cells reflecting a disease or lifestage, and will need to be validated to
ensure that they are applicable for susceptible/vulnerable groups.
SPSW research will elaborate linkages between contaminant exposures (including mixtures) and
the initiation and exacerbation of disease, while considering inherent factors that impact personal
susceptibility. A major focus on the Virtual Embryo project in SPSW, for example, will define
exposures that alter developmental pathways predictive of abnormal fetal and childhood
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of
ORD's Human Health Research Program (final report received December 2009)
development, and that can be confirmed in animal models. Together with improved exposure
data and exposure factor information for young children, this information will help in the design
of epidemiology studies and will be used to develop public health guidance for the public.
A recent ORD workshop (spring 2010) provided guidance for the National Children's Study on
the best metrics to use for linking: air pollution/allergens and asthma; pesticides and abnormal
neurological development; and endocrine disrupters and altered reproductive development.
Experts in exposure science, toxicology and epidemiology were convened for this purpose, and
their discussions resulted in a report that has been provided to the NCS and its advisory groups.
The Children's Centers also provide fundamental exposure and toxicology data that inform
community-based programs, as will be summarized at a workshop planned for October, 2010
(Children's Health Month) by ORD in partnership with NIEHS, EPA's Office of Children's
Health Protection and EPA/ATSDR's Pediatric Environmental Specialty Health Units. This
workshop is designed to foster translation of children's health research to clinical practice and
public health policies.
Action/Timeline: As described above, current and future planning will include the need to
articulate linkages between ORD's integrated chemicals program (SPSW) with research in the
companion program (SDSC) that will focus on populations in community settings, where
numerous chemical and non-chemical stressors interact to impact public health. Workshop
reports that summarize "lessons learned" will be published in 2011.
Recommendation 6: The BOSC recommends using successful intra-agency collaborations with
the National Institute of Environmental Health Sciences (NIEHS) and the Centers for Disease
Control and Prevention (CDC) in regard to childhood asthma as a model to address other
vulnerable subpopulations. For example, collaboration with the National Institute on Aging
(NIA) can address the potential susceptibility of the elderly to selected environmental exposures,
such as those linked to neurodegenerative disease.
Response: ORD agrees that it is critical to reach out to a broad range of partners. This
recommendation will be addressed as ORD seeks more effective partnerships with NIEHS and
CDC related to public health tracking and integration of exposure indicators into longitudinal
health studies dealing with aging groups. ORD envisions increased interactions with new
partners relevant to community public health, such as The National Partnership for Action to End
Health Disparities, and the Federal Collaborative for Health Disparities Research. See also
response to recommendation #2 in LTG 3.
Action/Timeline: ORD will reach out to a broader range of partners and participate in inter-
agency workgroups and taskforces with common goals.
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of
ORD's Human Health Research Program (final report received December 2009)
RESPONSE TO RECOMMENDATIONS ON LTG 4
Recommendation 1: The BOSC recommends improving interaction and linkage with other
federal agencies and state agencies.
Response: ORD agrees with the need for improved interactions and linkages with other federal
and state agencies. Efforts in this direction are inherent in the new planning process. To this
end, ORD is participating in efforts directed by OCHP to support re-invigoration of the
Interagency Taskforce on Children's Health (anticipated in 2010) and the President's Taskforce
on Obesity. These taskforces address children's health holistically, considering the many ways
by which the environment may impact health. The possibility that in utero exposure to endocrine
disrupters and other contaminants may contribute to childhood obesity by modifying metabolism
was raised as an emerging issue at an international meeting planned by ORD, in partnership with
NIEHS, FDA, CDC and international partners (December 2009). New approaches in exposure
science, developmental biology, epidemiology and public health tracking are needed to evaluate
if this risk is real. Thus, linkages with other Agencies concerned with the obesity epidemic and
other diseases, such as asthma, are clearly needed to advance a national health agenda. ORD's
community-based research will no doubt benefit from a recent agreement between HUD and
EPA directed at healthy and sustainable communities. ORD is participating with CDC in public
health tracking efforts and in projects designed to help CDC interpret biomonitoring data, such
as that obtained through NHANES. A new grants program related to school environments has
been developed with input from the Department of Education.
Action/Timeline: ORD is strengthening and expanding partnerships with other agencies,
particularly Nffl (NICHD, NIEHS), CDC and HUD.
Recommendation 2: Developing a means to capture and preserve institutional memory to
improve long-term assessment of programs is recommended
Response: This is a challenge. ORD is working to centralize and track how its products are
being used to impact Agency decisions. How and whether those decisions produce the effect
desired and actually improve indicators of human health and environmental quality remains
difficult. The goal of HHRP LTG-4 has been to have evaluation of risk management decisions
incorporated into each of the media-specific areas. "Accountability" has a reasonably strong
foothold in the Air program, with contributions from an NCER RFA on this topic and results of
the New Haven accountability project in HHRP. The HHRP Water accountability project has
broken new ground with the development of salivary antibodies as indicators of recent water-
borne disease. New projects specific to this goal are not planned at this time.
Action/Timeline: HHRP model projects have demonstrated the feasibility of accountability
research in Air and Water. Tools developed may be useful in new community-based programs
and showcase communities.
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of
ORD's Human Health Research Program (final report received December 2009)
Recommendation 3: The BOSC suggests making the ROE more prominent and influential in
the Agency.
Response: ORD agrees that this is an important goal. HHRP provides primary input for the
health chapter of ROE. ROE is web-based and updated with new data on 85 indicators as
captured quarterly by NCEA. A recent user analysis report, prepared for OMB, showed that the
2008 pdf was downloaded 9,024 times from December 2008 through March 2010, with about
29% of users being from the Federal government. The report was widely used beyond the
Federal government, being distributed as follows: State government, 6%; local government, 5%;
individuals, 13%; foreign, 14%; academia, 9%; non-profit, 5%; tribal governments, 12%; and
schools, 1%. This analysis provides baseline information from which future influence can be
measured. The SAB advises ORD on the ROE. A new edition is planned for 2012.
Action/Timeline: Indicators from the ROE are being incorporated into indices to assess the
effects of environmental quality on human health and well being, and into tools to identify
communities at risk to support risk management decisions by EPA Regions. The ROE is widely
consulted as a source of critical data in these actions, rather than simply a snapshot of America.
Recommendation 4: The BOSC recommends expanding the use of health databases used to
evaluate improvements in human health related to improvements in the environment, remaining
cautious in interpreting these types of ecological analyses.
Response: ORD agrees with this recommendation, although, in practice, access to health data is
limited in the US today. In the New Haven project, available health outcome data was less
useful than the air pollution data for detecting impacts of changes in national air pollution
standards, coupled with local actions taken to reduce air pollution (Lobdell et al. EHP,
submitted). ORD is piloting the use of restricted data from the census and from NHANES
(CDC) in developing census block level assessments of exposure to priority contaminants.
These estimates can serve to inform community level risk and as benchmarks for measuring the
success of risk management actions. New techniques, including using exploratory
epidemiological simulations (Baxter, JESEE 20, 2010; Lobdell et al., submitted) permit the
estimation of changes in exposure levels (resulting from risk management actions) to bring about
specified levels of changes in health outcomes. HHRP is working with CDC to support efforts to
link health databases, and also to develop and link exposure databases. HHRP is also funding
extramural research on the development and use of public health indicators. A synthesis of
research from a previous RFA on this topic is being prepared, and a series of new grants on this
topic will be announced in 2010.
Action/Timeline: Increased effort is being directed towards the use of health databases and
public health indicators in order to evaluate the Agency's risk management decisions. Final
products of HHRP LTG-4 accountability projects are being published in 2010-11, along with
reports from a recent NCER RFA on public health indicators. A series of new grants on public
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of
ORD's Human Health Research Program (final report received December 2009)
health indicators is being announced in 2010.
Recommendation 5: The BOSC recommends expanding the use of direct estimates of the
health implications of environmental interventions by calculating burden of disease or similar
appropriate measures of risk.
Response: ORD agrees with this recommendation, contingent on adopting a broader definition
of health, akin to the WHO, that would allow for more broadly defined indicators of community
health to be considered in the burden of environmental risk. The narrow definition of health as
absence of disease restricts estimates of the burden of disease to physiological health outcomes.
The difficulty of doing this has been acknowledged in the NRC report (2008) on Evaluating
Research Efficiency in the U.S. EPA.
Related to this concept, new efforts are being directed at developing an "environmental quality
index" that will incorporate a wide range of both environmental and health indicators into a user-
friendly tool. This tool could be used to measure risks of exposures and other stressors to human
health and well being, and to measure benefits of Agency actions for environmental quality and
public health.
Action/Timeline: NCER RFAs on Accountability and on Non-Chemical Stressors will provide
data and models for population-based assessment of environmental burden of disease, and better
attribution of chemical vs. non-chemical determinants of disease for ecological analyses. In
addition, ORD's Ecological Services Research Program is exploring the use of metrics of human
well-being and broad indicators of population health.
Recommendation 6: The BOSC recommends incorporating additional case studies into LTG 4
and attempting to extrapolate from existing case studies to other examples.
Response: Case studies to evaluate community-based cumulative risk to assess community
exposure and health risk are being pursued as part of the program that was once under LTG 2.
OW is interested in pursuing further applications of the research on indicators of exposure and
effects of waterborne pathogens, in particular to recreational waters. Lessons learned in New
Haven about the use of hybrid air quality modeling as a surrogate for exposure measures, using
emissions profiles in conjunction with meteorological and monitoring data, can be extended to
other communities.
Action/Timeline: Case studies are underway as collaborations between ORD and the Agency's
Community Action for a Renewed Environment (CARE) and EJ Showcase programs.
Additional case studies are expected to be forthcoming from a new series of grants on public
health indicators (see previous), new Children's Centers funded in 2010, and a new RFA for
Tribal grants in 2011.
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of
ORD's Human Health Research Program (final report received December 2009)
RESPONSE TO RECOMMENDATIONS FOR THE OVERALL PROGRAM
Recommendation 1: The BOSC recommends that the partner survey be improved so that it is
informative, or it should be abandoned.
Response: We agree that the partner survey needs improvement. Therefore, the previous format
of partner surveys has been abandoned and we are piloting a different mechanism for obtaining
partner feedback.
Action/Timeline: The revised approach is being piloted with the Drinking Water Research
program and is expected to be complete by February, 2011.
Recommendation 2: The BOSC recommends an increase in the expertise and integration of
epidemiology and biostatistics throughout the LTGs.
Response: ORD agrees that expertise in, and integration of, epidemiology and biostatistics is
needed throughout HHRP. SPSW efforts are building capacity in database linkages and
computational toxicology that will enable higher level analyses and foster predictive toxicology
that will inform future epidemiology studies. We can acquire necessary expertise through
careful workforce planning and through increased partnerships with other Agencies, such as
CDC and NIH, with whom we can leverage our public health efforts.
Action/Timeline: ORD will put a priority on gaining expertise in epidemiology and biostatistics
through combined efforts in workforce planning, extramural research funding, and partnering
with other Agencies.
Recommendation 3: The BOSC recommends a reevaluation and reassessment of LTG
groupings, with the goal of increasing communication within and among the various LTGs and
decreasing silos.
Response: The integrated SPSW program, as described in the introduction to this report, is
predicated on the importance of combining expertise in exposure science, toxicology,
computational toxicology, risk assessment and risk management, in order to holistically manage
and prevent risks of chemicals. The companion HPSC program will be developed to translate
SPSW information into community and public health contexts which, in turn, will inform needs
for future research in SPSW. These two new programs will eliminate disciplinary silos.
Action/Timeline: This recommendation is being addressed through ORD's integrated
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of
ORD's Human Health Research Program (final report received December 2009)
transdisciplinary research planning process.
Recommendation 4: Development of a systematic process of prioritization and selection for
determining which agents will be prioritized will create needed transparency and is
recommended.
Response: ORD agrees. As stated above, SPSW will conduct targeted animal-based testing and
Mode of Action (MoA) research designed to fill existing regulatory needs and to verify the
extent to which the new toxicity pathway approaches predict in vivo toxicity. Accordingly, the
selection of chemicals for study and of models/tools for development will continue to be made in
close partnership with Program and Regional partners. This new program is being developed
with the expectation that its products will directly inform regulations, including those resulting
from upcoming TSCA reform, and also make significant strides to further the use of green
chemistry and enhance sustainable product development.
Action/Timeline: The SPSW will use a systematic and transparent process for selecting
problems and chemicals for study.
Recommendation 5: The BOSC recommends that a communication plan be implemented with
the intent to disseminate the impact of Program research throughout the Agency, clients, and the
general public.
Response: ORD's integrated transdisciplinary research principles will be used in planning
SPSW and HPSC, including the development and use of a communication plan as recommended
here.
Action/Timeline: Ongoing under the SPSW and HPSC planning and implementation actions.
Recommendation 6: The BOSC recommends that the HHRP explore more opportunities to
collaborate with other Agencies and with academia to strengthen the program, save resources,
and leverage external expertise.
Response: ORD's integrated transdisciplinary research principles will be used in planning
SPSW and HPSC, including engagement of relevant partners throughout the planning,
implementation and application of research. This includes collaborating with other Agencies and
academia to strengthen the program, save resources, and leverage external expertise.
Consideration is being given to special hiring authorities that enable outside experts to
participate in planning and research. ORD is strengthening its extramural STAR grants program
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of
ORD's Human Health Research Program (final report received December 2009)
to this end.
Action/Timeline: ORD is exploring opportunities to collaborate with other agencies and with
academia to strengthen the program, save resources, and leverage external expertise. Also,
increased emphasis on community-based participatory research will increase partnerships with
community groups, States and Tribes.
Recommendation 7: The BOSC recommends that susceptibility factors examined in children's
health be expanded to all life stages and across all LTGs.
Response: ORD agrees. As detailed previously, ORD is incorporating biological susceptibility
factors into SPSW, which addresses toxicity pathways relevant to all life stages, and other
susceptibility factors into HPSC which considers the response of populations to complex
exposures and environments encountered at the community level.
Action/Timeline: ORD will incorporate susceptibility factors such as those examined in
children's health into SWSP and HFSC research addressing all life stages. Ongoing
RESPONSE TO RECOMMENDATIONS FOR THE REVIEW PROCESS
Recommendation 1: There appears to be a good scientific impact of the Program, but the
bibliometric analysis is difficult to interpret and understand, especially with the co-mingling of
intramural and extramural publications. The BOSC recommends that this analysis be modified
and improved or discontinued.
Response: We recognize that many of the BOSC subcommittees have found the bibliometric
analyses difficult to interpret. Although we believe that such analyses may still have utility for
some of the programs, we are no longer measuring high impact and highly cited publications for
its research programs. We are exploring more appropriate measures, methods and tools to
replace the former bibliometric measures. ORD is awaiting OMB direction on performance
evaluation, and will continue working with the interagency Science of Science Policy committee,
along with the National Academies, to find more appropriate measures for research.
Action/Timeline: ORD anticipates having new measures by June, 2011.
Recommendation 2: The Subcommittee members found it challenging to navigate the Program
evaluation materials, not only in terms of quantity but in how the material was presented. The
BOSC recommends adding one poster at the beginning of each session that highlights all work
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of
ORD's Human Health Research Program (final report received December 2009)
done to date under each LTG to enhance each poster session. Inclusion of posters presented at
national scientific meetings during the previous two years, or an abstract book detailing such
posters, also would be helpful to the reviewers.
Response: Since this review, ORD has revised the BOSC Program Review process by focusing
the charge questions and the materials provided for the reviews. For future reviews, ORD will
be making the linkage between the materials provided and the charge questions more explicit.
This organization of materials should help the BOSC put the material in context to improve
understanding and use during the review.
The poster sessions primarily demonstrate the breadth of the research program and are generally
focused at a higher level than individual research projects. While keeping the focus of the BOSC
reviews at the programmatic level, ORD will consider these recommendations and others in
order to provide the BOSC a better understanding of specific research projects and their outputs
in future reviews.
Action/Timeline: ORD will implement these changes for future BOSC reviews.
Recommendation 3: Additionally, the Subcommittee would have benefitted from hearing about
more specific partner interactions. The BOSC recommends that in future reviews, program
partners and clients be included in the review, and that they justify how they use program
products. One suggestion is to include partner testimonials in the poster sessions so that there
can be more interaction between Subcommittee members and partners and clients.
Response: ORD interprets this recommendation as a request for more detailed information
regarding interactions with partners than what is typically given during partner testimonial
sessions. Because of the limitations and feasibility of having many partner and clients present at
the meeting, the poster session is meant to fill this role by demonstrating client use of ORD
research and outcomes, and collaborations with other Programs, Regions, or non-Agency
scientists.
In future reviews, ORD will try to more fully demonstrate how the research products and
information are being used by the partners in future program reviews.
Action/Timeline: ORD will implement this change for future BOSC reviews.
24
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of ORD's Human Health Research
Program (final report received December 2009)
Table 1. Summary of the BOSC's Recommendations and ORD's Response and Proposed Actions Associated with
Review of the Human Health Research Program
Recommendation
ORD Response
ORD Actions (Timing)
LTG 1 Recommendations
Through close collaborations with the staff at
IRIS, examples should be developed in which the
MOA for a chemical actually changes or
influences the quantitative risk estimates IRIS
makes for the chemical.
The objective of MOA research in HHRP
LTG 1 is not specifically linked with the IRIS
assessments. HHRP contributes data and
models to Agency risk assessments conducted
in OCSPP, OW, OAR and NCEA. HHRP is
also partnering with NCEA on "Next Gen"
risk assessments responsive to the NRC
"Science and Decisions: Advancing Risk
Assessment"
Integrated teams (HHRP, NCCT
and NCEA scientists and
extramural grantees) are drafting
prototype concepts for review at
upcoming workshops. A final
report (NCEA product) for at least
one prototype is expected in late
2011. In future reviews we will
more clearly explain how our
research products are used in risk
assessments.
HHRP will participate in Science
Advisory Panels culminating in
OCSPP assessments of Conazoles
(2011) and Pyrethroids (2010).
More integration of the MOA science with the
quantitative risk assessment generated by the
epidemiology studies is needed.
ORD appreciates this recommendation and
the importance of linking toxicology and
exposure data with epidemiology and public
health studies. Efforts are progressing
towards the new SPSW program described
above in which information on mode of
action derived using in vitro screens and
computational tools will be used to predict
toxicity and prioritize chemicals for further
Linkages will be made between the
chemicals program (SPSW) and
epidemiology and children's health
studies to translate
chemical/toxicology information
into public and community health
applications.
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of ORD's Human Health Research
Program (final report received December 2009)
Recommendation
ORD Response
ORD Actions (Timing)
testing and/or inform epidemiology studies
based on both exposure and toxicity. Where
feasible, results of epidemiology studies
conducted by EPA or others may be used to
verify these predictions as well as inform new
toxicology and exposure assessments.
Increased interactions (data sharing and research
planning) among the researchers in LTG 1 with
those in LTG 2 and LTG 3 are recommended.
We are addressing this recommendation on
both fronts (data sharing and research
planning).
Investments in database building
(2010-11) will facilitate data
sharing within and across ORD
programs. The planning for SPSW
and HPSC, will involve
transdisciplinary teams of scientists
from ORD Labs and Centers as
well as collaborating scientists
from EPA Programs and/or
Regions/Tribes, communities and
other agencies who will be
involved in planning from the start
and continue to participate in the
design, implementation and
interpretation/use of the research
results.
LTG 2 Recommendations
The MYP should include a concerted educational
outreach effort to the program offices, regional
offices, and states regarding the use of
sophisticated models and new knowledge
developed through its research.
As detailed above the program is including
users in tools and models development, and
providing web-based, user friendly interfaces
with instructions. ORD is demonstrating
these tools for program offices, regional
groups and at a variety of national meetings
The C-FERST prototype is being
field tested internally in 2010 with
expected public release in 2011.
Additional collaborations with
OCSPP on developing publically-
accessible GIS-based exposure
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of ORD's Human Health Research
Program (final report received December 2009)
Recommendation
ORD Response
ORD Actions (Timing)
and workshops.
models are also moving forward in
2010-2012. Future emphasis will
be on using these in community
based projects.
Goals or guidelines should be defined that
describe the threshold of acceptable accuracy for
source-to-dose-to-health models and methods
used in making assessments. Further
characterization of the uncertainty of models
similar to that described in the source-to-dose
paper by Ozkaynak, et al., is highly endorsed.
ORD researchers have incorporated
sophisticated methods and approaches in the
development of ORD's SFtEDS and dose
models (as noted above) for characterizing
variability and uncertainty. Future ORD
exposure and dose modeling research will
continue to employ state-of-the-science
techniques for further characterization of
uncertainty. As noted by the BOSC, the
acceptability of the models and data used by
the multiple Program Offices and Regions for
their assessments various greatly based on
regulatory mandate and/or the criteria
established by the Agency office for their
decision-making processes.
Intramural and STAR grantee
projects are yielding relevant
models in 2010-11 timeframe. As
we develop the SPSW pilot, ORD
researchers will continue to
collaborate with program office
scientists in the design and
implementation of research that
develops better ways to
characterize variability and
uncertainty in models used to
support Agency decisions.
As part of future BOSC reviews and as an
accountability goal, evidence (in summary
narrative form) should be provided on the use of
completed research products in cumulative risk
assessments.
ORD considers this recommendation as being
important for all program reviews. For
FfflRP, numerous documents citing the ORD
research continue to be documented in
Science Advisory Panel meetings supporting
the landmark pyrethroids cumulative risk
assessment.
For future program reviews,
specific examples in FtHRP will be
captured not only in the posters for
work done within the evaluation
period (as in the 2009 review) but
also for research products from
previous evaluation periods
because it can take many years for
the Agency to complete a risk
assessment.
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of ORD's Human Health Research
Program (final report received December 2009)
Recommendation
ORD Response
ORD Actions (Timing)
The general framework for planning should be
continued, with the inclusion of greater planning
efforts and knowledge sharing among LTG 1,
LTG 2, and LTG 3, and with other agencies.
We anticipate the current structure (4 LTGs)
will be replaced by goals developed for the
SPSW and HPSC programs. These programs
will be implemented by scientists working on
interdisciplinary teams. This strategy will
address this BOSC recommendation by
linking exposure, health, risk assessment and
risk mitigation components within a project.
We also plan to engage partners from other
agencies as appropriate to the goals of the
overall program and component projects.
Future programs will link exposure
and toxicology research with
epidemiology and
public/community health research.
Researchers who have extensive experience in
"non-chemical stressors" should be included in
the overall plan for community-based research.
Agreed. NCER grants in chemical/non-
chemical stressors, Tribal grants and the
Children's Centers program are/will
incorporate researchers with expertise in
social science and economics.
The influence of non-chemical
stressors on health impacts of
chemicals will receive significantly
more emphasis in HHRP funded
NCER grants over the next 3-5
years. Intramural workforce
planning in ORD will also address
this need.
As a future goal, there should be more
engagement of the regional offices in planning
and identifying areas in which they need tools,
methods, and data from ORD.
Agreed
In response to Dr. Anastas's
challenges in the path forward,
ORD will increase engagement of
regional offices to address this
recommendation.
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of ORD's Human Health Research
Program (final report received December 2009)
Recommendation
ORD Response
ORD Actions (Timing)
There should be an added influx of resources into
developing the science in cumulative risk
assessments if such assessments are to be
effective in a reasonable timeframe.
Agreed
Direction of significant resources
to this end is providing tools for
cumulative risk assessments. A
report of the ORD-Regional
Workshop to be published in 2010
will summarize how new tools can
be brought to bear upon cumulative
risk assessments at the community
level.
LTG 3 Recommendations
A more fully elucidated conceptual framework
for vulnerability and susceptibility should be
developed.
Agreed, as discussed above.
In response to this recommendation
and outputs of the spring 2010
Symposium on Environmental
Justice mentioned previously, ORD
will build capacity in community-
based participatory research and
environmental justice awareness
needed to build and address a more
fully elucidated framework for
vulnerability and susceptibility for
articulation in SPSW and HPSC
planning.
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of ORD's Human Health Research
Program (final report received December 2009)
Recommendation
ORD Response
ORD Actions (Timing)
Program imbalance within the life-stage arm of
LTG 3 should be redressed such that the
strengths of the childhood susceptibility research
thrust are matched with an expanded research
program addressing the elderly as well as
potential subgroups across the entire age range.
While research on environmental impacts on
Children's Health remains a critical element
of the research program, we understand the
importance of considering health impacts of
the environment at all stages of the lifecycle.
We are leveraging research with the Air
program and maintaining an emphasis on
aging.
Ongoing efforts in aging, and new
community-based and Tribal
research will help us address the
current imbalance despite lack of
new resources, and without
decreasing our commitment to
children's health.
Rethinking the approach to asthma as a target
condition so that it is not simply approached as a
surrogate of childhood susceptibility to new
disease onset, but rather considered across the
entire age range and considered also in terms of
vulnerability in pre-existing disease, is
recommended.
As recommended, current and future research
is expanding the focus of asthma to other
parts of the age range including studies with
older asthmatics. Studies on cardiovascular
injury caused by exposure to inhaled
particles, will shed light on why older
asthmatics are at increased risk to endothelial
injury and accelerated coagulation. At the
other extreme, ORD researchers are studying
developmental origins of disease and whether
in utero exposure results to pollutants will
result in increased risk of development of
asthma.
An asthma workshop in fall of
2010 will address this
recommendation by defining future
research needs and priorities for
ORD within a new research
framework.
In addressing preexisting conditions, the program
should consider expansion beyond asthma to
encompass other airway disease (in particular
COPD) and, beyond lung diseases, consider other
classes of disease such as neurological and
endocrine disorders.
Agreed. Mechanistic studies (both in house
and in the Children's Centers) are focused on
airway inflammatory pathways that may
underline respiratory diseases, and host-
pathogen interactions in the etiology of
bronchitis. Others are integrating stressors
(e.g. wildfires) with multiple outcomes
(asthma, COPD, cardio vascular).
New and ongoing studies are
addressing this recommendation.
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of ORD's Human Health Research
Program (final report received December 2009)
Recommendation
ORD Response
ORD Actions (Timing)
Better integration of LTG3 across LTGs is
recommended, in particular with LTG 2 in terms
of cumulative exposure.
ORD agrees with this recommendation which
will be addressed in SPSW and HPSC
research programs.
Current and future planning will
include the need to articulate
linkages between ORD's integrated
chemicals program (SPSW) and
research in the companion program
(SDSC) that will focus on
populations in community settings
where numerous chemical and non-
chemical stressors interact to
impact public health. Workshop
reports that summarize "lessons
learned" will be published in 2011.
Successful intra-agency collaborations with the
NIEHS and the CDC in regard to childhood
asthma should be used as a model to address
other vulnerable subpopulations, for example,
collaboration with the National Institute on
Aging to address the potential susceptibility of
the elderly to selected environmental exposures,
such as those linked to neurodegenerative
disease.
ORD agrees that it is critical to reach out to a
broad range of partners. ORD is seeking
more effective partnerships with NIEHS and
CDC related to public health tracking and
integration of exposure indicators into
longitudinal health studies dealing with aging
groups. Other include The National
Partnership for Action to end Health
Disparities and the Federal Collaborative for
Health Disparities Research. See also
response to recommendation #2 in LTG 3.
ORD will reach out to a broader
range of partners and participate in
Inter-Agency workgroups and
taskforces with common goals.
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of ORD's Human Health Research
Program (final report received December 2009)
Recommendation
ORD Response
ORD Actions (Timing)
LTG 4 Recommendations
Interaction and linkage with other federal
agencies and state agencies should be improved.
Agree. Interaction with CDC for
Environmental Public Health tracking,
indicators, and health impact assessments are
critical elements for making the linkages
necessary in the accountability framework. In
addition, interaction with NIEHS Partners in
Environmental Public Health affords
opportunities to work with communities
implementing risk management actions.
Further interaction is also necessary within
the Agency, specifically with the Regions and
Enforcement offices that work with states and
communities on implementation and need to
directly assess outcomes of the broad range of
risk management decisions.
ORD is strengthening and
expanding partnerships with other
agencies, particularly NIH
(NICHD, NIEHS), CDC, and
HUD. E.g., MOU signed with
CDC; connections made with
NIEHS PEPH.
A means to capture and preserve institutional
memory to improve long-term assessment of
programs should be developed.
This is a challenge. The goal of HHRP has
been to have evaluation of risk management
decisions incorporated into each of the media-
specific areas. "Accountability" has a
reasonably strong foothold in Air and in some
parts of Water.
HHRP model projects have
demonstrated the feasibility of
accountability research in Air and
Water. Tools developed may be
useful in new community based
programs and showcase
communities.
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of ORD's Human Health Research
Program (final report received December 2009)
Recommendation
ORD Response
ORD Actions (Timing)
The ROE should be made more prominent and
influential in the Agency.
HHRP provides primary input for the health
chapter of ROE. ROE is web-based and
updated with new data on 85 indicators as
captured quarterly by NCEA.
Indicators from the ROE are being
incorporated into indices to assess
the effects of environmental quality
on human health and well being
and into tools to identify
communities at risk to support risk
management decisions by EPA's
Regions. With these, ROE is
widely consulted as a source of
critical data, rather than simply a
snapshot of America. Decisions
about ROE's future enhancements
will be made at Agency level.
The use of health databases used to evaluate
improvements in human health related to
improvements in the environment should be
expanded, remaining cautious in interpreting
these types of ecological analyses.
Agree, although access to health databases
remains a challenge. ORD is piloting the use
of restricted data from census and NHANES
in developing census block level assessments
of exposure to priority contaminants. These
estimates can serve to inform community
level risk and as benchmarks of the success of
risk management actions. New techniques,
including using exploratory epidemiological
simulations (Baxter, JESEE 20, 2010;
Lobdell, et al, submitted) permit the
estimation of changes in exposure levels
(resulting from risk management actions) to
bring about specified level of changes in
health outcomes.
Increased effort is being directed
towards the use of health databases
and public health indicators in
order to evaluate the Agency's risk
management decisions. Final
products of HHRP LTG-4
accountability projects are being
published in 2010-11 along with
reports from a recent NCER RFA
on public health indicators. A
series of new grants on public
health indicators is being
announced in 2010.
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of ORD's Human Health Research
Program (final report received December 2009)
Recommendation
ORD Response
ORD Actions (Timing)
The use of direct estimates of the health
implications of environmental interventions
should be expanded by calculating burden of
disease or similar appropriate measures of risk.
Agree with this recommendation, contingent
on adopting a broader definition of health,
akin to the WHO, that would allow for more
broadly defined indicators of community
health to be considered in the burden of
environmental risk. The narrow definition of
health as absence of disease restricts
estimates of the burden of disease to
physiological health outcomes. The
difficulty of doing this has been
acknowledged in the NRC report (2008) on
Evaluating Research Efficiency in the US
EPA.
NCER RF As on Accountability
and on Non-chemical Stressors will
provide data and models for
population-based assessment of
environmental burden of disease
and better attribution of chemical
vs. non-chemical determinants of
disease for ecological analyses. In
addition, ORD's Ecological
Services Research Program is
exploring the use of metrics of
human well-being and broad
indicators of population health.
Additional case studies should be incorporated
into the LTG and the program should attempt to
extrapolate from existing case studies to other
examples.
Case studies to evaluate community-based
cumulative risk based on community
exposure and health risk are being pursued as
part of the program that was once under LTG
2. OW is interested in pursuing further
applications of the research on indicators of
exposure and effects of waterborne
pathogens, in particular to recreational waters.
Lessons learned in New Haven about the use
of hybrid air quality modeling as a surrogate
for exposure measures, using emissions
profiles in conjunction with meteorological
and monitoring data, can be extended to other
communities.
Case studies are underway as
collaborations between ORD and
the Agency's Community Action
for a Renewed Environment
(CARE) and EJ Showcase
programs. Additional case studies
are expected to be forthcoming
from a new series of grants on
public health indicators (see
previous), new Children's Centers
funded in 2010, and a new RFA for
Tribal grants in 2011.
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of ORD's Human Health Research
Program (final report received December 2009)
Recommendation
ORD Response
ORD Actions (Timing)
Overall Program Recommendations
The partner survey should be improved so that it
is informative, or it should be abandoned.
The previous format of partner surveys has
been abandoned. ORD is piloting a different
mechanism for obtaining partner feedback.
The revised approach is being
piloted with the Drinking Water
Research program and is expected
to be complete by February 2011.
An increase in the expertise and integration of
epidemiology and biostatistics throughout the
LTGs is recommended.
SPSW efforts are building capacity in
database linkages and computational
toxicology that will enable higher level
analyses and foster predictive toxicology that
will inform future epidemiology studies.
ORD will put a priority on gaining
expertise in epidemiology and
biostatistics through combined
efforts in workforce planning,
extramural research funding, and
partnering with other Agencies.
A reevaluation and reassessment of LTG
groupings is recommended, with the goal of
increasing communication within and among the
various LTGs and decreasing silos.
The integrated SPSW program, as described
in the introduction to this report, is predicated
upon the importance of combining expertise
in exposure science, toxicology,
computational toxicology, risk assessment
and risk management in order to holistically
manage and prevent risks of chemicals. The
companion HPSC program will be developed
to translate SPSW information into
community and public health contexts which,
in turn, will inform needs for future research
in SPSW. These two new programs will
eliminate disciplinary silos.
This recommendation is being
addressed through ORD's
integrated transdisciplinary
research planning process.
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of ORD's Human Health Research
Program (final report received December 2009)
Recommendation
ORD Response
ORD Actions (Timing)
Development of a systematic process of
prioritization and selection for determining which
agents will be prioritized will create needed
transparency and is recommended.
SPSW will conduct targeted animal-based
testing and Mode of Action (MO A) research
designed to fill existing regulatory needs and
to verify the extent to which the new toxicity
pathway approaches predict in vivo toxicity.
Accordingly, the selection of chemicals for
study and of models/tools for development
will continue to be made in close partnership
with program office and regional partners.
The SPSW will use a systematic
and transparent process for
selecting problems and chemicals
for study.
A communication plan should be implemented
with the intent to disseminate the impact of
program research throughout the Agency, clients,
and the general public.
Agreed. ORD's integrated transdisciplinary
research principles will be used in planning
SPSW and HPSC and as such will include the
development and use of a communication
plan as recommended here.
ORD's integrated transdisciplinary
research planning will include a
strategic communication plan.
The HHRP should explore more opportunities to
collaborate with other agencies and with
academia to strengthen the program, save
resources, and leverage external expertise.
Agreed. ORD's integrated transdisciplinary
research planning process for SPSW and
HPSC will include engagement of relevant
partners throughout the planning,
implementation and application of research.
SPSW is reaching out to academia,
other agencies and industry as
described above. HPSW is also
reaching out to community groups,
States, Tribes and Regions.
Susceptibility factors examined in children's
health should be expanded to all life stages and
across all LTGs.
Agreed, recognizing budget priorities. ORD is
incorporating biological susceptibility factors
into SPSW which addresses toxicity
pathways relevant to all life stages, and other
susceptibility factors into HPSC which
considers the response of populations to
complex exposures and environments
encountered at the community level.
ORD will incorporate susceptibility
factors such as those examined in
children's health into SWSP and
HPSC research addressing all life
stages.
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March 2010 ORD Response to the Board of Scientific Counselors Report on Review of ORD's Human Health Research
Program (final report received December 2009)
Recommendation
ORD Response
ORD Actions (Timing)
Review Process Recommendations
The bibliometric analysis is difficult to interpret
and understand, especially with the co-mingling
of intramural and extramural publications. This
analysis should be modified and improved or
discontinued.
ORD is no longer measuring high impact and
highlighted cited publications for all of its
research programs. We are exploring more
appropriate measures, methods and tools to
replace the former bibliometric measures.
ORD anticipates having new
measures by June 2011.
The Subcommittee members found it challenging
to navigate the program evaluation materials, not
only in terms of quantity but in how the material
was presented. The Subcommittee recommends
adding one poster at the beginning of each
session that highlights all work done to date
under each LTG to enhance each poster session.
Inclusion of posters presented at national
scientific meetings during the previous 2 years,
or an abstract book detailing such posters, also
would be helpful to the reviewers.
For future reviews, ORD will be making the
linkage between the materials provided and
the charge questions more explicit.
ORD will consider the other
recommendations in order to provide the
BOSC a better understanding of specific
research projects and their outputs in future
reviews.
ORD will implement these changes
for future BOSC reviews.
The Subcommittee would have benefitted from
hearing about more specific partner interactions.
The Subcommittee recommends that in future
reviews, program partners and clients be included
in the review, and that they justify how they use
program products. A suggestion by the
Subcommittee is to include partner testimonials
in the poster sessions so that there can be more
interaction between Subcommittee members and
partners and clients.
In future reviews, ORD will try to more fully
demonstrate how the research products and
information are being used by the partners in
future program reviews.
ORD will implement this change
for future BOSC reviews.
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