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assessments. The TRW has recently expanded its membership and
completed a transition in leadership. We welcome the new co-
chairs, Pat Van Leeuwen (312-886-4904) of Region 5 and Paul White
(202-260-2589) of the Office of Research and Development, who
have recently tak^n on the challenge of leadership for the TRW.
We believe that this transition is a good time to improve
communications among Regions and Headquarters to better conform
with the objectives of the Administrative Reform for lead.
I am attaching a draft issues plan for lead. In the spirit
of continuous improvement, the draft lead issues' plan proposes
several activities to provide for improved communications among
Regions and with Headquarters. One of the most significant of
these actions would be the formation of a policy group for lead
that should include senior managers from all Regions and
Headquarters. It is our intent to use the Policy Group to work
for clarity and consistency across the country in managing lead
sites.
Action
Please comme.it by May 31 to Larry Zaragoza on the draft lead
issues plan and on priorities for work identified in the plan.
Review of Site-Specific Lead Risk Assessments for Children in
Residential Areas
Background
Since the publication of the January 1994 Integrated
Exposure Uptake Biokinetic Model for Lead in Children (IEUBK:
version .99d), few lead risk assessments have been brought to the
attention of the TRW for their review during the planning stages.
We have seen some assessments later in the process, and the
review by the TRW has resulted in improvements in the application
of the IEUBK model. Earlier reviews are a much more efficient
use of resources. In the spirit of continuous improvement, it is
in our long-term interests to review our IEUBK risk assessments
for consistency with guidance and, if appropriate, modify our
guidance to promote continually improving,science.
Action: In order to promote consistency and address these
concerns, each Region should:
1) Sand all completed lead risk assessments which used the
IEUBK model to the TRW. A review will focus on consistency
with guidance.
2) Identify all IEUBK risk assessments that are either in
planning or underway.
3) Identify any application of the IEUBK that is expected to be
challenged or will set a precedent in IEUBK application.
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Thus, the TRW can be informed of the issues and provided an
opportunity to comment on the approach undertaken.
4) Send any draft Regional Guidance relating to lead to
Headquarters for review before release.
Materials requested above should be sent to Larry Zaragoza (703-
603-8867), the Headquarters member of the TRW.
Support for Adult Lead Risk Assessments
I am pleased to report that a number of adult lead risk
assessments are being referred to the TRW, which is developing
guidance on this issue. It is our belief that these reviews will
promote consistency and help ensure that information is shared
across Regions. To request consultation, contact Mark Maddaloni
(212-637-4315) of EPA' s Region 2, the head of the adult lead
subcommittee.
Feedback on the Process
Questions on policy or the overall approach outlined in this
memo should be directed to Larry G. Reed (703-603-8960), Deputy
Director, OERR. Questions specific to the application of risk
assessment in Superfund should be directed to David Bennett (703-
603-8759), Senior Process Manager for Risk.
cc: E. Laws
Attachment
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DRAFT LEAD ISSUES PLAN
Introduction
On October 2, Administrator Browner announced a series of Administrative Reforms to
improve the operations of the Superfund Program. Administrative Reform 2 is "Risk
Assessments Grounded in Reality". Lead was a visible pollutant before this Administrative
Reform. The effect of the latest round of Administrative Reforms will be to focus efforts to
develop and implement actions that improve the consistency and understanding of Superfund
Risk Assessments. The output for this administrative reform involves continued utilization of
the Lead Work Group (usually known as the Technical Review Workgroup [TRW]). The TRW
has been responsible for supporting the refinement of the model (Integrated Exposure Uptake
Biokinetic Model-IEUBK), which is used to assess the impact of environmental lead levels on
child blood levels. This document provides a plan for addressing the issues associated with
effective implementation of more effective use of the TRW and establishing clear
communication links in the reorganized OERR.
Lead is a key pollutant for the Superfund program for two reasons. First, the
information on the adverse health effects associated with lead exposure is more extensive than
for other environmental contaminants. As a result of our improved understanding of lead
relative to other chemicals, EPA has developed the EEUBK to assess the relative contributions of
lead exposure to blood lead levels in children. This approach allows for the relative
contributions of all environmental sources of lead to be assessed (e.g., paint, soil lead, house
dust). Second,
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to obtain a common understanding of the objectives to be obtained and ideas of both Regional
and Headquarters members of the TRW. At this point, this draft document has been circulated to
members of the TRW and others. We are seeking additional comment before revising this draft.
This document should serve as a vehicle to develop some agreement on the issues of key
importance. Such a compilation of responsibilities, activities, and priorities has not been
prepared for lead in the past. As a first effort, this plan we intend to use this plan to improve
communications and the efficiency of program activities on lead.
Lead Technical Review Workgroup (TRW)
The Lead TRW provides sites specific assistance in the application of the IEUBK,
undertakes tasks to improve the IEUBK, and issues associated with the assessment of lead risks
at Superfund sites. The TRW is composed of lead health specialists from EPA Headquarters and
Regional Offices. In addition to providing advice on a number of sites that are being evaluated
with the IEUBK, the TRW produced the guidance manual for the application of the IEUBK. as
well as the model refinements to better prepare the model for site specific application at
Superfund sites. A primary function of the TRW is to promote good science. A listing of
specific projects that are scheduled for the workgroup is provided in Appendix A.
The current membership of the TRW is included as part of Table 1. This composition of
the TRW has served the program well. It provides representation from EPA Regional Offices,
ORD and OPPTS.
In addition to sharing information on program directions on lead assessmen* rfforts, the
other program office representatives have helped to build better working relationships with the
Superfund Program. This structure helps to promote more efficient communication on lead
program activities across the Agency as well as sharing scientific and technical information that
might not otherwise be shared as efficiently.
Policy Group
One of the suggestions made at this year's OERR Strategic Planning Retreat was that we
should have a policy group to discuss lead related issues and to promote consistency in the lead
policy issues. The approach that this group would take would be similar to the approach taken by
the Large Area Lead Mining Sites group, which has had periodic meeting to discuss key lead
policy issues. The support of this group would also provide a resource for access on lead
assessment approaches that should promote consistency. Finally, because the Policy Group
would be briefed on various lead activities, the support of the Policy Group for continued
dedication of staff to support the Technical Review Workgroup and other activities would be
sought.
The membership of this group will be composed of Regional Managers. The group may
be chaired by the OERR Director/Deputy Director and support will be provided by OERR and
Regional staff.
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April, 1996
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Headquarters Coordination Group
The Headquarters coordination group would be responsible for the coordination of
information generated by the Technical Review Workgroup and the Policy Group. In addition,
this group would track and share information that is generated by the other groups that perform
lead related work that are identified in this plan. This will help to ensure that information
provided by the Regions will be available to all Regions to better understand the effectiveness of
National lead policies. Moreover, this group will also seek to ensure that Headquarters requests
for information on lead will be coordinated and not duplicated. In order to achieve this objective,
a network of lead contacts will be established that will include at least one staff from each
Regional Center and Regional Contacts for lead issues (again, at least one from each region).
Work with Regional Coordinators
Given the challenges in Superfund Reauthorization, interests from Congress, and others,
we often find it necessary to seek information on lead. In order to avoid duplicate requests,
information on lead sites will normally be centralized and coordinated according to the
responsibilities outlined in Table 1. This will help to promote a more efficient use of
headquarters staff and reduce repeated requests from EPA Regions for site specific information.
Finally, this will provide a known source where information on lead sites has been centralized.
Requests for Information on Lead to Support Reauthorization
Given that much of the information outlined in this plan will address how the Superfund
program assesses lead and requires ready access to the information outlined in this plan,
information in this area will be coordinated through the headquarters lead contacts, as identified
in Table 1. This work would also include continuing support for the Three City Lead Study and
outreach with the Community Involvement and Outreach Center (e.g., Kim Fletcher).
Information Management Issues
In order to improve information that is maintained with known quality (sources of
information and accuracy and precision are characterized), lead related information management
issues will be coordinated through this group. Types of information that will be sought shall
include: sites where the IEUBK has been used (and the version of the IEUBK), cleanup levels,
cost of cleanup, satisfaction of the community with the outcome and other information that is
deemed important to assessing progress with lead related assessments and associated cleanups.
This work will be coordinated with Jim Konz, who is preparing the electronic reporting
requirements for risk information, and others. Larry Zaragoza will provide the lead for this
activity.
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Management Support
Lead issues are clearly a high visibility activity for OERR, and management support will
be key to success. David Bennett, the Process Manager for Risk will be a resource to help secure
resources for lead related issues (e.g., contractor support). In order to ensure communications in
critical areas, regular communications will take place with the Process Manager for Risk on key
activities in any leaJ area and the OERR Director. There will also be quarterly meetings that will
address all areas of lead work. Larry Zaragoza will serve as the overall coordinator for lead
related activities and he will be responsible for communicating with the different levels of
management on the items outlined above.
Coordination with Other Federal Agencies
ATSDR
ATSDR coordination will be facilitated through the Mid-Level Managers' Workgroup
and the Senior-Level Managers' Workgroup. This group will work directly with the
Headquarters Coordination Group.
Centers for Disease Control (C*^)
The CDC is responsible for a variety of public health issues including national lead
survey work. They also have established standards for sampling blood lead and conducting
epidemiological studies that are relevant to the interpretation of health data for Superfund sites.
Their review and comment is sought when appropriate.
Other Federal Agencies
Other Federal Agencies (e.g., Department of Energy, Department of Defense, Housing
and Urban Development) also have interests in lead risk assessment and the implementation of
policies. Promoting consistency requires outreach and exchange of information.
Representation on the Title X Workgroup for OPPTS
Larry Zaragoza will continue OERR representation in the Title X Workgroup efforts,
which includes an economic analysis that will support the upcoming OPPTS rulemaking under
Title X. Given Congressional interest in Superfund and its relationship to other programs, this
effort is important to both OPPTS and OERR.
rage 4
April, 1996
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Table 1. Contacts for Lead Activities
Activity
Participants
Technical Review
Workgroup
Region II (Mark Maddaloni)
Region HI (Roy Smith)
Region V (Pat Van Leeuwen, Co-chair)
Region VIII (Susan Griffin and Chris Weis)
Headquarters:
ORD (Harlal Choudnury/Cinn; Rob Elias and Allan
Marcus/RTP; and Paul White/DC, Co-Chair)
OPPTS (Karen Hogan)
OSWER/OERR (Larry Zaragoza/Barbara Davis)
Policy Group
Steve Luftig
Staff Support: Larry Zaragoza
Headquarters Coordination
Group
Chair, Larry Zaragoza
Lisa Askari
Other Federal Agency
Coordination
Steve Luftig/Larry Reed/Elaine Davies/David Bennett
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Aprii, 1996
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Appendix A: Listing of Lead Projects of the Technical Review Workgroup
April, 1^96
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LEAD TECHNICAL REVIEW WO
R.KGROUP Ongoing Lead Projects
Title
Activity
Chair(s)
Members
•Site-Specific Support
Support reviews of site specific lead risk
assessments.
Pat Van Leeuwen, Mark
Maddaloni
Entire workgroup
Validation Work
1) Compare measured blood lead levels in
children with IEUBK model results.
2) Check computer code for consistency
with documentation and correct
computations.
Karen Hogan
Paul White, Allan Marcus, Barbara Davis
Independent Verification
Oversee independent review of the computer
code for the IEUBK.
Karen Hogan, Lai <-y Zarago7.a
Rob Hlias, Susan Griffin
V alidation Workshop
Schedule and hold a workshop on lead model
validation in the fall of 1996
Harlal Choudhury, Larry
Zaragoza
Barbara Davis, Karen Hogan, Paul White,
Allan Marcus, Roy Smith. Rob Elias
Structure Papa-
Publish a paper that describes the structure of
the IEUBK model. •
Paul White
Pat Van Leewuen, Barbara Davis, Mark
Maddaloni
Adult Lead Number
Develop guidance for assessment of adult
lead risks using a subgroup.
Mark Maddaloni
Pat Van Ixeuwen, Paul White, Allan
Marcus, Rob Elias, Roy Smith, Susan
Griffin, Harlal Choudhury, Barbara Davis
Sampling Guidance
Management of a subgroup and contractor
effort that develops sampling guidance for
lead sites.
Susan Griffin
Chris Weis, Karen Hogan, Mark
Maddaloni, Paul White, Roy Smith, Rob
F.lias, Harlal Choudhury, Barbara Davis,
Pat Van 1-eeuwen
Research Planning
Develop a research plan for lead
Chris Wets, Rob Elias
Karen Hogan, Mark Maddaloni, Bruce
Means, Paul White, Allan Marcus,,Harlal
Choudhury, Barbara Davis
Title X
Track and coordinate TRW issues with Title
X (urban lead concerns with OPPTS/HUD)
Karen Hogan
Paul White, Larry,Zaragoza
P;igc 7
April. 1496
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NEW ISSUES (Issues may require a short sheet, technical memorandum, or coordination
efforts):
1. Criteria for Removal Action
Given the differences in the approaches that have been used to conduct removals, what
health-based criteria should be used in risk assessments that employ the IEUBK
to support time critical and non-time critical removals.
2. Blood Lead Studies
How should blood lead studies be used in assessing lead exposures at sites (e.g.,
comparison of IEUBK model results with results of blood lead studies, adjusting input values in
IEUBK Model, etc.) What is acceptable data from a blood lead study; criteria.
3. Uncertainty in Lead Risk Assessments
How should uncertainty in results of either the IEUBK or the Adult model be
characterized. Should the output be a single number, a matrix, what?
4. The individual GSD
Should site-specific GSDs be used instead of Model defaults (the Manual gives cautions).
What methods should be used to develop the GSD?
5. Soil to Dust Coefficient
/
When are the IEUBK model defaults inappropriate; what data is needed to justify a
change in the default value; what methodology(ies) should be used to develop soil to dust
concentration ratios?
6. PB STAT
Can the PB STAT computer program be used to provide useful comparison data? Should
it be there or not?
7 IEUBK Model, v. 0.99e
Region 8 has sponsored development of version 0.99e, which includes a batch mode for
operation. The workgroup should address the question of the distribution/use of this
version, especially given that other enhancements have been recommended as a result of
the Independent Validation and Verification Effort.
8. Other Enhancements to 0.99d
A number of other enhancements to the IEUBK Model are expected to be desired by
users; these are not yet under development (e.g., improving code, development of a
Windows version).
9. Sampling Manual Short Sheets
RPMs are asking for sampling protocols, e.g., dust sampling. Given the differences that
alternative methods can produce and the desire to have consistency with other Federal
Page 8
April, 1996
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agency activities, how do we become consistent? Is consistency important here?
Will it help/restrict our validation exercises?
10. Trespasser Scenarios
Review of the trespasser exposure scenario. How/when should the trespasser scenario be
used in lead risk assessments? What are the appropriate exposure duration and exposure
frequency.
11. Home Gardening Scenario
Evaluation of home garden exposure assumptions. Values recommended in the Manual
may need adjustment. Some commercial programs have values for transfer of lead in
soil/water to vegetables, meat, milk!!
12. Attributable Risk
Attributable risk-different interpretations and estimations. Are we consistent in our
definitions and use of attributable risk?
13. Bioavailibility Data
Review of bioavailablity data. Should we provide recommendations for changes in
the IEUBK Model based on species and/or matrix effects. Are there limitations ? What
data is needed? When are defaults appropriate7
14. Leaded Paint
Should there be some guidance on use of lead paint data in CERCLA risk assessments?
Does it diff~" for interior paint/exterior paint? OSWER Directive warrants clarification,
especially given the experience working with the 1994 OSWER Lead Directive.
Page 9
April, 1996
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