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U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF INSPECTOR GENERAL
Better Planning, Execution
and Communication Could
Have Reduced the Delays in
Completing a Toxicity
Assessment of the Libby,
Montana, Superfund Site
Report No. 13-P-0221
April 17, 2013
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about the EPA OIG.
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Report Contributors: Benjamin Beeson
Ming D. Chang
Dwayne E. Crawford
Bram Hass
Eric Lewis
Ryan Patterson
Rodney Rice
Johnny Ross
Abbreviations
AT SDR
Agency for Toxic Substances and Disease Registry
CERCLA
Comprehensive Environmental Response, Compensation, and Liability Act
(Superfund)
EPA
U.S. Environmental Protection Agency
FAR
Federal Acquisition Regulations
FY
Fiscal Year
IRIS
Integrated Risk Information System
IUR
Inhalation Unit Risk
LAA
Libby Amphibole Asbestos
LAP
Libby Action Plan
LATAG
Libby Area Technical Assistance Group
NCEA
National Center for Environmental Assessment
NHEERL
National Health Effects and Environmental Research Laboratory
NIOSH
National Institute for Occupational Safety and Health
NTP
National Toxicology Program
OARM
Office of Administration and Resources Management
OIG
Office of Inspector General
ORD
Office of Research and Development
OSWER
Office of Solid Waste and Emergency Response
PCM
Phased Contract Microscopy
RfC
Reference Concentration
SAB
Science Advisory Board
SOW
Statement of Work
USGS
U.S. Geological Survey
Cover photo:
Exterior removal of contaminated soil from a residential area in
Libby, Montana. (EPA photo)
Hotline
To report fraud, waste, or abuse, contact us through one of the following methods:
email: OIG Hotline@epa.gov write: EPA Inspector General Hotline
phone: 1-888-546-8740 1200 Pennsylvania Avenue, NW
fax: 202-566-2599 Mailcode 2431T
online: http://www.epa.gov/oig/hotline.htm Washington, DC 20460
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. U.S. Environmental Protection Agency 13-P-0221
f % Office of Inspector General April 17,2013
v\l/^
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^ At a Glance
Why We Did This Review
We performed fieldwork to
determine why the EPA did not
meet planned corrective-action
milestones for completing a
comprehensive toxicity
assessment of asbestos
necessary to determine the
cleanup level for the Libby,
Montana, Superfund site. We
also determined whether EPA
informed appropriate officials
about the delays in a timely
manner. In 1999, EPA began
investigating local concerns
about asbestos contamination in
Libby. EPA designated the Libby
site a national priority in the
Superfund program in 2002; and
in December 2006, the EPA OIG
recommended that the EPA
perform a comprehensive toxicity
assessment of amphibole
asbestos to determine the safe
level for human exposure. EPA
submitted its Libby Action Plan in
2007 to address the OIG
recommendations. In June 2009,
the EPA Administrator declared a
public-health emergency in Libby
due to the number of deaths and
illnesses reported in the town.
This report addresses the
following EPA Goal or
Cross-Cutting Strategy:
Cleaning up communities
and advancing sustainable
development.
For further information, contact
our Office of Congressional and
Public Affairs at (202) 566-2391.
The full report is at:
www.epa.aov/oia/reports/2013/
20130417-13-P-0221.pdf
Better Planning, Execution and Communication Could
Have Reduced the Delays in Completing a Toxicity
Assessment of the Libby, Montana, Superfund Site
What We Found
U.S. Environmental Protection Agency (EPA) action officials did not complete
planned corrective actions under its Libby Action Plan in a timely manner. This
occurred because the scope of the work was larger than originally thought;
there was no established charter; and there were contracting delays,
competing priorities, unanticipated work, and poor communication with
stakeholders. Consequently, the Agency has twice revised its estimates for
completing actions in response to our December 2006 report.
The toxicity assessment is one of two components (an exposure assessment
being the other) that makes up the health risk assessment for determining
cleanup levels in Libby. In December 2011, EPA informed us that the health
risk assessment would be substantially delayed. As a result, the Agency's final
determinations that the completed and ongoing cleanup actions are sufficient to
address the health risks from site contamination have been delayed from 2 to 6
years, depending on the studies being performed. This is a significant concern,
considering that the EPA Administrator declared a public-health emergency at
the Libby site in 2009 and the Agency has spent over $400 million on cleanup.
Communications about delays in completing Libby Action Plan items, and the
reasons for those delays, were not always timely or clearly communicated to
stakeholders; and EPA officials failed to update the Agency's follow-up system
or notify the Office of Inspector General (OIG) about known delays until
planned corrective actions under the Libby Action Plan could not be met.
Recommendations
We recommend that EPA: (1) require action officials to disclose risks to
completing corrective-action plans, and update and distribute original and
revised plans to stakeholders; (2) establish a charter to define project roles and
responsibilities for completing remaining corrective actions under the Libby
Action Plan, and determine whether the Science Advisory Board (SAB) or
another organization will review the completed risk assessment; (3) direct the
SAB to determine whether EPA has followed guidance sufficiently to support
the findings in the toxicity assessment, and whether other possible limitations
exist when applying cancer and noncancer values to determine acceptable
levels of exposure to asbestos in Libby; (4) ensure that future contracts issued
through interagency agreements are within the scope of those agreements;
and (5) develop a priority list for pending and ongoing research work.
The Agency agreed with part of one recommendation and disagreed with other
recommendations. The recommendations are unresolved, pending estimated
completion dates or an action plan for the agreed-to recommendation, and
dispute-resolution actions for recommendations with no agreement.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
THE INSPECTOR GENERAL
April 17, 2013
MEMORANDUM
SUBJECT: Better Planning, Execution and Communication Could Have Reduced the Delays
in Completing a Toxicity Assessment of the Libby, Montana, Superfund Site
Report No. 13-P-0221
This is our report on the subject evaluation conducted by the Office of Inspector General (OIG)
of the U.S. Environmental Protection Agency (EPA). This report contains findings that describe
the problems the OIG has identified and corrective actions the OIG recommends. This report
represents the opinion of the OIG and does not necessarily represent the EPA position. This
report contains part of a recommendation that the Agency agreed with, but the Agency did not
provide estimated completion dates or an action plan. Therefore, this recommendation is
unresolved. The report also contains recommendations where the Agency and OIG disagreed.
These recommendations are also considered unresolved.
Action Required
In accordance with EPA Manual 2750, resolution should begin immediately upon issuance of the
report. We are requesting a meeting of action officials from the Office of Solid Waste and
Emergency Response, the Office of Research and Development, EPA Region 8, and the
Assistant Inspector General for the Office of Program Evaluation, to start the resolution process
and attempt to obtain resolution. If resolution is still not reached within 30 days, these action
officials are required to complete and submit a dispute-resolution request to the Chief Financial
Officer to continue the resolution process.
Please email your response to Carolyn Copper at copper.carolyn@epa.gov. The final response
should not contain data that you do not want to be released to the public. If your response
contains such data, you should identify the data for redaction or removal. We have no objections
FROM
Arthur A. Elkins Jr.
TO:
See Below
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to the further release of this report to the public. We will post this report to our website at
http://www.epa.gov/oig.
Should you have any questions, please contact Carolyn Copper, Assistant Inspector General for
Program Evaluation, at (202) 566-0829 or copper.carolvn@epa.gov; or Eric Lewis, Director,
Special Reviews, at (202) 566-2664 or 1 ewis.eric@epa.gov.
Addressees:
Bob Perciasepe, Deputy Administrator
Mathy Stanislaus, Assistant Administrator, Office of Solid Waste and Emergency Response
Lek Kadeli, Acting Assistant Administrator, Office of Research and Development
Howard Cantor, Acting Regional Administrator, Region 8
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Better Planning, Execution and Communication
Could Have Reduced the Delays in Completing a
Toxicity Assessment of the Libby, Montana, Superfund Site
13-P-0221
Table of C
Chapters
1 Introduction 1
Purpose 1
Background 1
Scope and Methodology 4
2 Improved Management Controls Needed to Ensure
Completion of Corrective Actions Under the Libby Action Plan 6
Original Project Milestones Were Overly Ambitious 7
No Charter Established 9
Contracting Issues Delayed Noncancer Assessment 9
Risk and Toxicity Assessment Guidance and Reviews 11
Competing Priorities and Unanticipated Work
Delayed Cancer Assessment 12
Communication of Plan Execution Could Be Improved 13
Other Issues 15
Conclusion 17
Recommendations 17
Agency Response to Draft Report and OIG Evaluation 18
Developments Since Issuing Our Draft Report 19
Status of Recommendations and Potential Monetary Benefits 22
Appendices
A Name and Ranking of Studies Under the Agency's
Libby Action Plan 23
B Risk Assessment Guidance 24
C Toxicity Assessment Guidance 25
D OIG Consolidated Responses to Agency's
Comments on Libby Draft Report 28
E Distribution 45
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Chapter 1
Introduction
Purpose
The U.S. Environmental Protection Agency (EPA), Office of Inspector
General (OIG), conducted this review as a follow-up to EPA OIG Report
No. 2007-P-00002, EPA Needs to Plan and Complete a Toxicity Assessment for
the Libby Asbestos Cleanup, December 5, 2006. Our objectives were to:
Conclude why the Agency did not meet planned corrective-action
milestones in response to the recommendations in the OIG's
December 2006 report.
Determine whether appropriate Agency officials were properly
informed of the breaches in these milestones for the purpose of updating
stakeholders (e.g., Congress; OIG; residents of Libby, Montana) in a
timely manner.
Background
The town of Libby is located in the northwest corner of Montana. EPA has been
working in Libby since 1999, when the Agency sent an emergency-response team
to investigate local concerns and news articles about asbestos-contaminated
vermiculite. In January 2000, due to citizen concerns, EPA started sampling and
analyzing lawn and garden products from Libby, which contained vermiculite.
In 2002, EPA began an emergency-response cleanup of Libby residential and
commercial properties, and that same year the Libby site was added to the
National Priorities List of Superfund sites. In June 2009, the EPA Administrator
declared a public-health emergency at the Libby site due to the number of deaths
and illnesses reported in the town.
The OIG's 2006 Report
We conducted our 2006 review in response to inquiries received from the two
U.S. senators from Montana, who requested information regarding cleanup
activities of asbestos material in Libby, Montana. Our December 2006 report
identified two significant issues critical to a successful cleanup in Libby. First,
EPA had not completed a toxicity assessment of amphibole asbestos to determine
the safe level for human exposure. Therefore, EPA could not be sure that the
Libby cleanup sufficiently reduced the risk that humans may become ill or, if ill
already, get worse. Second, EPA's public-information documents Living with
Vermiculite and Asbestos in Your Home were inconsistent about safety concerns.
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The OIG report included two recommendations to the Assistant Administrator for
the Office of Solid Waste and Emergency Response (OSWER) and the Regional
Administrator for EPA Region 8:
1. Fund and execute a comprehensive amphibole asbestos toxicity assessment
to determine (1) the effectiveness of the Libby removal actions, and (2)
whether more actions are necessary. The toxicity assessment should include
the effects of asbestos exposure on children. The EPA Science Advisory
Board (SAB) should review the toxicity assessment and report to the Office
of the Administrator and the Libby Community Advisory Group whether
the proposed toxicity assessment can sufficiently protect human health.
2. Review and correct any statements that cannot be supported in any
documentation mailed or made available to Libby residents regarding the
safety of living with or handling asbestos, until EPA confirms those facts
through a toxicity assessment.
Agency Response to the OIG's 2006 Report
By removing inconsistent documentation or communications provided to Libby
residents, the Agency satisfied recommendation 2 prior to issuance of the
December 2006 report.
To satisfy OIG recommendation 1, a meeting was held in January 2007 with EPA
and other federal scientists from the Agency for Toxic Substances and Disease
Registry (ATSDR) and the National Toxicology Program (NTP), to identify data
gaps that needed to be addressed to complete a toxicity assessment of the mixture
of fibrous amphibole minerals found in Libby (Libby amphibole). The group
developed a list of 12 studies needed to complete this assessment. These studies
are collectively referred to as the Libby Action Plan.
In April 2007, OSWER and EPA Region 8 provided the OIG with their specific
corrective actions under the Libby Action Plan. They committed to completing
the EPA Office of Research and Development's (ORD's) National Health Effects
and Environmental Research Laboratory (NHEERL) animal toxicity studies by
September 30, 2009; and to completing a baseline risk assessment, including a
comprehensive toxicity assessment, by September 30, 2010.
To carry out the list of 12 studies developed during the meeting held in
January 2007, a steering committee1 was established to develop a draft action
plan. The toxicity assessment, coupled with an exposure assessment, would
comprise the baseline risk assessment needed to support the Record of Decision
for the Libby site. Our review did not address the Agency's efforts related to
1 Members of this steering committee included representatives from NHEERL, the National Center for
Environmental Assessment (NCEA), OSWER, and EPA Region 8.
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completing the exposure assessment, because this assessment did not fall under
the scope of our review.
Libby Action Plan Studies, Responsibilities, and Milestones
Appendix A lists 12 studies that constitute the Libby Action Plan, the responsible
parties for conducting these studies, and the estimated milestone dates for their
completion. This appendix lists these studies in the order to be performed and
their relative priority for completing the Libby toxicity assessment. This order
was established by EPA and other federal scientists in January 2007.
Responsibility for carrying out the studies under the Libby Action Plan were
given to EPA's OSWER, ORD, and Region 8, with assistance to be provided by
the U.S. Geological Survey (USGS), the National Institute for Occupational
Safety and Health (NIOSH), and ATSDR. The Agency's April 2007 Libby Action
Plan called for all planned studies to be completed by the fourth quarter of fiscal
year (FY) 2009.
OSWER
OSWER's responsibilities involved developing the methodology for
estimating the risk of lung cancer and mesothelioma from inhalation exposure
to different forms of asbestos. OSWER was also responsible for oversight of
the Libby Action Plan and reporting progress made to internal and external
stakeholders, including:
Senior Agency officials (EPA Administrator, Assistant Administrators
for OSWER and ORD, and Region 8 Regional Administrator)
OIG
Congressional staff of Montana's U.S. senators
Libby residents
ORD
ORD/NCEA was responsible for conducting a cancer assessment specifically
for Libby amphibole for the Integrated Risk Information System (IRIS).
Responsibilities of the ORD/NHEERL included developing a dosimetry
model and simulation studies, conducting in vitro dissolution assays,
evaluating in vitro toxicity endpoints, conducting comparative toxicology in
mice and rats, and conducting inhalation toxicology studies in rats.
Region 8
EPA Region 8, with assistance from ORD/NCEA, was responsible for
developing the site-specific reference concentration (RfC) for the Libby
amphibole asbestos. The RfC applies to noncancer health effects and is the
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concentration of a substance that is likely to be without an appreciable risk of
adverse health effects over a lifetime. Region 8 was also one of the
organizationsalong with ORD/NCEA, NIOSH, and ATSDRresponsible
for developing epidemiological information from cohorts exposed to Libby
amphibole. The cohort used to develop the RfC was the Marysville, Ohio,
cohort. Workers in that cohort were exposed to the Libby amphibole. The
region was also responsible for verifying fiber-size distribution of Libby
amphibole and assisting ORD/NCEA, NIOSH, and ATSDR with developing
epidemiologic information from other cohorts exposed to Libby amphibole.
Scope and Methodology
We conducted our review from December 2010 through July 2012. Our
review was conducted in accordance with generally accepted government
auditing standards. Those standards require that we plan and perform the
review to provide a reasonable basis for its findings and conclusions. We
believe that the evidence obtained provides a reasonable basis for our findings
and conclusions based on our review objectives. To complete our work we:
Interviewed appropriate EPA personnel from OSWER, ORD/NCEA, the
Office of Administration and Resources Management (OARM), and
Region 8, who were involved with oversight and coordination of the
Agency's efforts under its Libby Action Plan.
Held briefings with senior managers from OSWER, ORD, SAB, and EPA
Region 8.
Interviewed U.S. Department of Transportation/Volpe Center2 personnel
involved with the contract award to the University of Cincinnati for Libby
noncancer studies.
Evaluated work performed by other government agencies assisting EPA
with the completion of tasks under its Libby Action Plan. These agencies
included the USGS, ATSDR, and the Volpe Center.
Obtained and reviewed the following documents to determine the
Agency's timeliness in meeting Libby Action Plan project milestones:
o Examples of monthly progress reports prepared by EPA and
submitted to the congressional staff of U.S. senators from
Montana.
2 The center is part of the U.S. Department of Transportation's Research and Innovative Technology Administration
and is an innovative, federal, fee-for-service organization. Its mission is to improve the nation's transportation
system. The center performs work for the U.S. Department of Transportation, as well as for other federal, state,
local, and international agencies and entities.
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o Annual progress reports on accomplishments under the Libby
Action Plan to determine whether the Agency was adequately
managing activities in order to meet established milestones.
o Peer-reviewer comments rendered about studies under the
Agency's Libby Action Plan to determine whether any concerns
were noted regarding the Agency's ability to complete study
milestones in a timely manner.
o Funding and budget information for implementing the 2007 Libby
Action Plan to determine whether there were any funding issues
that may have impeded progress under the plan.
o Contract award documents issued via interagency agreement for
studies related to the Marysville, Ohio, cohort and maintained by
OARM.
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Chapter 2
Improved Management Controls
Needed to Ensure Completion of Corrective
Actions Under the Libby Action Plan
EPA action officials did not complete planned corrective actions under its Libby
Action Plan in a timely manner. This occurred because:
EPA did not develop a charter that would have established a single
authority responsible for completing the milestones.
EPA took almost 2 years to issue a sole-source contract to support the
noncancer study.
EPA had other priorities that delayed completion of the cancer study.
EPA encountered unforeseen problems preparing dosing material for
animal studies; delays in government contracting; and revisions to
experimental designs, which have prevented the completion of the
remaining studies until 2015.
Agency action officials are ultimately responsible for establishing reasonable
timeframes for completing corrective actions, and for ensuring that corrective
actions are implemented. However, action officials in OSWER and Region 8 did
not ensure that corrective actions under their Libby Action Plan were monitored
and completed in accordance with initially planned milestones. As a result, the
Agency's efforts to complete Libby Action Plan studies in support of a
comprehensive amphibole asbestos toxicity assessment have been delayed
2 years for key cancer and noncancer studies, and 6 years for all other studies.
This is a significant concern considering that the EPA Administrator declared a
public-health emergency at the Libby site in 2009, and the Agency has spent over
$400 million of the funds obtained from the responsible party.
In addition, outside of OSWER, ORD and Region 8, no one was informed of the
reasons for the delays. EPA officials failed to update the Agency's follow-up
system or notify the Office of Inspector General (OIG) about known delays until
planned corrective actions under the Libby Action Plan could not be met.
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Original Project Milestones Were Overly Ambitious
EPA's Libby Action Plan called for all studies to be completed by the fourth
quarter of FY 2009. This included all individual project plans, peer reviews,
contract awards, and the completion of all tasks involving cancer and noncancer
assessments and animal studies. We found that the milestones established for
accomplishing these studies were ambitious, and there was a high risk of the
milestones not being completed on time. Consequently, since establishing
corrective actions under its April 2007 follow-up response, EPA has twice
revised these milestones.
Overly Ambitious Timetable
The original Libby Action Plan had an overly ambitious timetable and required
coordination and oversight to meet that timetable. In addition, there was intense
stakeholder interest. From the beginning, it appears that there was not sufficient
time built into the timetable to complete the individual tasks that comprised the
plan. OSWER and Region 8 managers told us that the Agency had significantly
underestimated the magnitude of effort that would be needed to achieve the
agreed-to corrective action. The Region 8 Libby on-scene coordinator, who
attended the Agency's planning meeting held in January 2007, stated that the
Libby Action Plan was "doomed to fail from the start," with respect to meeting
the original project milestones because:
EPA was trying to be responsive to external pressure when the Libby
Action Plan was first put together; and
EPA officials from OSWER and Region 8 had made promises to Montana
politicians and to the residents of Libby to come up with a baseline risk
assessment. This promise included a comprehensive toxicity assessment to
support a Record of Decision for ongoing cleanup activities at the Libby
Superfund site. EPA staff involved with developing the Libby Action Plan
tried to deliver on those promises.
OSWER managers stated that:
OSWER had never executed such a complex research project.
The initial milestone dates had to be extended due to the depth and breadth
of the studies that had to be performed.
Preparation of the Libby amphibole test material was essentially a
research project in itself, and was needed to provide a consistent dosing to
animals in terms of both the quantity of Libby amphibole and the character
of fibers provided.
Concerns over projected milestone dates were also noted during the initial peer
review of planned animal toxicity studies to be performed under the Libby Action
Plan. Proposed methods for conducting these animal toxicity studies were peer
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reviewed externally in May 2007 by experts from academia, ATSDR, the
National Institute of Environmental Health Sciences, and the Libby Area
Technical Assistance Group (LATAG).3 Peer reviewers stated that some animal
studies were overly ambitious and perhaps unattainable within the proposed time
frames.
Milestone Revisions
EPA revised its estimated milestones on two separate occasions after providing
the OIG its first plan in April 2007. In its April 2007 response, EPA estimated:
The completion of a baseline risk assessment, including a comprehensive
toxicity assessment by September 30, 2010.
The completion of NHEERL animal toxicity studies by
September 30, 2009.
However, in October 2009, OSWER informed the OIG that the estimated date
for completing the comprehensive toxicity assessment was revised from
September 30, 2010, to September 30, 2012; and from September 30, 2009, to
September 2015 for the NHEERL animal toxicity studies. At the time, OSWER
cited the following reasons for the delays:
Substantial analytical and statistical complexities associated with exposure
limits characterization using new activity-based sampling techniques.
Contracting delays for additional epidemiological work related to the
Marysville, Ohio, cohort that supports the development of the RfC for
Libby amphibole.
Unforeseen problems in preparing the dosing material for animal studies.
Delays in government contracting.
Revisions to experimental designs.
EPA provided its second estimates in December 2011 when the Assistant
Administrator for OSWER informed the OIG that the milestone date for the
completion of the health risk assessment would likely be delayed beyond the
September 30, 2012, date. The Assistant Administrator stated that the health risk
assessment relies upon two components: (1) a toxicological assessment of Libby
amphibole asbestos led by ORD and EPA Region 8, and (2) a site-specific
exposure assessment by EPA Region 8. According to the Assistant Administrator,
neither component was complete and both would entail significant effort in 2012.
The Assistant Administrator stated the schedules for completion remain highly
uncertain for both components.
3 The focus of the LATAG is to make certain that the cleanup of Libby amphibole contamination is comprehensive,
complete, and timely, resulting in the elimination of the Libby amphibole threat to human health and environment.
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No Charter Established
The accomplishment of the Agency's Libby Action Plan required a collaborative
effort. The Agency chose to use a group comprised of the Assistant
Administrators for OSWER and ORD, and the Regional Administrator for EPA
Region 8 to manage the project. EPA considered developing a charter but decided
against it. The project charter could have addressed the purpose, measurable
objectives, a high-level description of what is to be done, risks, summary
milestones, initial budgets, approvals required, and project manager authority and
responsibility.
OSWER, ORD, and Region 8 oversaw initial efforts under the Libby Action Plan,
discussed cross-coordination efforts within EPA, and approved funding.
However, each member was only responsible for the Libby Action Plan studies
assigned to them (see appendix A). No office had authority over the level of staff
participation from other EPA program offices. This management approach did not
have a single figure who had the authority to ensure project milestones were being
met, or who had the ability to delineate responsibilities, oversee funding, and
ensure proper channels of communications.
Contracting Issues Delayed Noncancer Assessment
The RfC Development study was ranked number one by the Agency for its
importance in completing the Libby toxicity assessment. EPA Region 8, with
assistance from ORD/NCEA, was responsible for carrying out the RfC
Development study. This study would develop a site-specific noncancer toxicity
value for Libby amphibole from the Marysville, Ohio, cohort. According to the
Agency's Libby Action Plan, all contracts were to be drafted by the third quarter
of FY 2007, or no later than June 2007. However, the sole-source contract for the
RfC Development study was not awarded until May 2009. Consequently, it took
almost 2 years from the time the sole-source contract should have been drafted
and when it was actually awarded.
Contract Award
The University of Cincinnati completed studies on the effects of Libby asbestos
on the Marysville, Ohio, workers in 1984. Because the university owned this data,
EPA Region 8 wanted to contract with the university to update, compile, and
provide the Marysville, Ohio, cohort data in a format that could be used for
developing the RfC in support of the Libby toxicity assessment.
Instead of using the Agency's contracting resources, Region 8 used an existing
interagency agreement with the U.S. Department of Transportation Volpe Center
to award the sole-source contract to the University of Cincinnati. However, we
believe that Region 8's use of the Libby cleanup interagency agreement to award
a contract to the University of Cincinnati exceeded the scope of work under the
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agreement between Region 8 and the Volpe Center. Region 8's interagency
agreement with the Volpe Center is site specific and the scope of work describes
authority for work to be done at Libby, Montana, and not at the University of
Cincinnati. The Region 8 Libby on-scene coordinator who made this decision
stated that the Volpe Center had assisted Region 8 with cleanup efforts at the
Libby asbestos site since 1999; and, at the time, he considered them better, faster,
and more innovative at contracting than EPA.
In a May 2009, Libby Action Plan meeting, EPA cited getting the sole-source
contract in place with the University of Cincinnati as a reason for the delay under
the RfC Development study. Managers with OSWER's Office of Superfund
Remediation and Technology Innovation also attributed the delay to the time it
took the Volpe Center to award the sole-source contract.
However, Volpe Center personnel stated that EPA did not readily know what the
Agency wanted in the contract with the University of Cincinnati. According to
Volpe Center personnel, the contract was originally estimated at $2.1 million and
included seven tasks. However, EPA could not decide whether all seven tasks
would be done by the university. When the contract was awarded, Region 8
decided that only two tasks would be completed at a cost of $410,000. Volpe
Center personnel described the following timeline for awarding the contract to
the University of Cincinnati:
Initial technical discussions began between EPA Region 8 and Volpe
Center technical staff in November 2007.
EPA provided a draft statement of work (SOW) to Volpe Center technical
staff around the December 2007/January 2008 timeframe.
Between January 2008 and April 2008, Volpe Center technical staff and
EPA worked cooperatively on refining the SOW, and in April 2008 the
SOW was finalized.
The Volpe Center's Acquisition Division received the purchase request
package, including the finalized SOW, in April 2008.
Once in the Acquisition Division, Acquisition staff, along with advice
from the legal advisor, worked on the justification required to support a
sole-source procurement.
The justification for a sole-source procurement was approved on
July 22, 2008. The solicitation was drafted, finalized, and issued on
October 29, 2008.
The contract was awarded to the University of Cincinnati on May 4, 2009.
We asked Volpe Center personnel how they kept the Agency informed about the
progress for awarding the contract, and whether there were any problems with
meeting deliverables. We were told that there were monthly meetings with the
University of Cincinnati, technical staff of the Volpe Center, and EPA Region 8.
Volpe Center personnel stated the milestones for deliverables were agreed to by
EPA Region 8 and the University of Cincinnati at the kick-off in May 2009.
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Volpe Center personnel could only recall one deliverable that needed to be
adjusted due to the volume of data encountered. In this instance, Volpe indicated
that EPA was informed and agreed to extend the deliverable schedule. Volpe
Center personnel said the final deliverable for tasks 1 and 2 were delivered to the
Agency in August 2010. These deliverables were used by EPA to develop an
exposure-response relationship RfC report for peer review.
Although the Region 8 on-scene coordinator claimed that the use of the Volpe
Center services through the interagency agreement would provide better, faster,
and more innovative contracting, this did not occur. Rather, the process took more
time than planned, and the EPA and the Volpe Center blamed each
other for the delays.
Risk and Toxicity Assessment Guidance and Reviews
The Agency's April 2007 response stated that it would complete a baseline risk
assessment, including a comprehensive toxicity assessment, in response to
recommendation 1 in our December 2006 report. This recommendation also
required EPA's SAB to review the Libby toxicity assessment. Since the final
site-specific assessments have not been developed, EPA will, at a minimum,
develop the risk assessment based on guidance listed in appendix B. EPA
developed the draft IRIS Toxicological Review of Libby Amphibole Asbestos in
support of a toxicity assessment based on the 14 guidance documents found
in appendix C.
We requested that the former SAB director, who put together a panel to review
EPA's work, provide the SAB's perspective on the quality of the toxicity
assessment. The former director stated that:
The SAB has not been charged to review the risk assessment when it is
completed.
The SAB has received charge questions from EPA to guide the focus of
the review of the draft IRIS Toxicological Review of Libby Amphibole
Asbestos. However, the SAB director stated that the SAB review will go
beyond the charge questions as they deem appropriate.
The SAB looks for the best experts with no conflicts of interests to
provide different scientific perspectives on a particular review.
Additionally, all reviewers of the draft IRIS Toxicological Review of Libby
Amphibole Asbestos document are from outside of EPA.
The SAB panel supports the selection of the Marysville, Ohio, cohort for
the noncancer assessment, although uncertainties exist with the small size
of the cohort to accurately represent the general population. However,
with regard to the Marysville cohort, the SAB has asked EPA to conduct
additional analyses, which include chest X-ray abnormalities other than
localized pleural thickening. In addition, the SAB has asked EPA to do
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analyses on more recent published cohorts (e.g., Minneapolis). This would
provide more scientific support for the calculated RfC.
The RfC risk is stated in terms of phased contract microscopy (PCM).4
For years the SAB has asked the Agency to be more transparent in
describing the rationale for choosing or excluding studies (i.e., selection
criteria) and the choice of statistical models that support the dose-response
assessment for cancer and noncancer health endpoints.
External reviewers should have all available information at their disposal
at the beginning of the review; this is necessary to verify the results of the
EPA analysis. However, EPA only provides the information upon request.
The Libby Action Plan states that the baseline risk assessment would include the
toxicity assessment. However, while the toxicity assessment will be reviewed by
the SAB, the overall risk assessment will not. EPA should determine whether the
SAB or another organization should review the risk assessment. That review
should be an assessment of the risk involved with not completing all the required
studies of the Libby Action Plan. EPA and the SAB should resolve issues relating
to developing specific guidance on study selection and dose-response model
selection to improve the toxicity assessment process. We also agree with the SAB
that external reviewers should receive all available documentation at the start of
their review. This will avoid delays and make the Agency's work transparent.
Competing Priorities and Unanticipated Work
Delayed Cancer Assessment
The Libby Amphibole Cancer Assessment study5 was conducted by EPA's
ORD/NCEA. According to milestones stated in the Libby Action Plan, this study
was supposed to be completed by the fourth quarter of FY 2009. Completion of
this study was ranked second in terms of importance by the Agency for
completing the Libby toxicity assessment. Although this study is now complete, it
was delayed due to ORD/NCEA competing priorities and to unanticipated work
that ORD/NCEA personnel realized was needed.
Competing Priorities
ORD/NCEA senior managers stated that:
Determining a cancer value for Libby asbestos was not their only
ongoing work priority at the time. ORD usually listed Libby asbestos,
perchloroethylene, and formaldehyde as the top three priority assessments.
4 The current IRIS value for asbestos states that unit risk is based on fiber counts made by PCM and should not be
applied directly to measurements made by other analytical techniques. Many environmental monitoring
measurements are reported in terms of fiber counts or mass as determined by transmission electron microscopy.
The correlation between PCM fiber counts and transmission electron microscopy mass measurements is very poor.
5 Appendix A, study 2.
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Depending on events, sometimes ORD had to put emphasis on one
chemical assessment over another; making a choice was difficult because
they were all high priorities with significant public health consequences.
In 2008, the former ORD/NCEA director decided that it was important to
complete the formaldehyde assessment in a timely fashion. Consequently,
in the fall of 2009, ORD/NCEA decided to focus on getting the
formaldehyde assessment completed and into the review/revision steps,
even if that meant some delay in the Libby cancer assessment.
Unanticipated Work and Other Priorities
NCEA personnel stated that assessment projects are scientifically complex and
milestone timelines are unpredictable, especially with regard to the time needed
to complete the base scientific work and to develop a draft to put into the first
formal review steps. Most of these large, complex projects and related
peer-review procedures take longer than originally forecast. For example:
Primary research took longer than anticipated because NCEA did not have
adequate published data. NCEA had to perform its own research on the
data provided by NIOSH.
To obtain the data, NIOSH and EPA entered into an interagency
agreement. However, the interagency agreement was delayed 6 months
until EPA and NIOSH attorneys agreed on privacy issues related to
individuals in the data.
NCEA researchers also obtained updated National Death Index6 data,
which was unplanned. This data also had privacy issues and added
6 to 8 months to the schedule.
No analysis was performed to determine whether the formaldehyde and Libby
assessments had equivalent concerns. For Libby, EPA reported deaths, illness, an
expensive clean-up, and continued asbestos exposure. EPA did not have similar
data on formaldehyde; therefore, we could not determine how EPA set it priorities
for determining which chemical assessment took precedence over the other.
Additionally, given the relative priority of the Libby Amphibole Cancer
Assessment study for completing the Libby toxicity assessment, the delays should
have been explicitly shared with stakeholders through the monthly status reports.
Communication of Plan Execution Could Be Improved
We found that communications regarding delays in completing the Libby Action
Plan items, and the reasons for those delays, were not always timely or clearly
communicated. After it was clear that delays were inevitable, EPA officials
responsible for completing the actions failed to explicitly update internal and
6 The National Death Index is provided by the Centers for Disease Control and Prevention and is a central
computerized index of death-record information on file in states' vital statistics offices.
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external stakeholders until the due dates had passed. Further, EPA officials
responsible for the actions failed to update the Agency's follow-up system or
notify the OIG about known delays until it was clear that planned corrective
actions under the Libby Action Plan could not be met.
Incomplete and Untimely Communication Within EPA
We reviewed documents, such as Gantt charts, which OSWER and Region 8 used
to brief senior Agency officials, including the EPA Administrator, about progress
on the Libby Action Plan. The Gantt charts had completion dates later than the
dates the Agency committed to in its April 2007 response to OIG. After
mid-January 2008, the Gantt charts no longer showed the dates the Agency
committed to for responding to OIG recommendations. Also, a May 2009
OSWER document used to brief the EPA Administrator did not address the
original planned milestones under the Libby Action Plan. These documents did
not discuss the delays or reasons why the delays occurred.
Also, OSWER staff responsible for tracking OSWER action on OIG
recommendations (audit follow-up personnel) had requested periodic updates
from appropriate officials, but it was not until September 2009 that audit
follow-up personnel learned of the delays. Moreover, the OIG was not formally
notified that the Agency had missed the planned milestone dates under the
Agency's Libby Action Plan until October 2009 (the first quarter of FY 2010),
even though the 12 tasks in the Libby Action Plan were to be completed by the
fourth quarter of FY 2009 (see appendix A).
Incomplete and Untimely Communication to Members of Congress
and Their Staff
During an April 5, 2007, congressional hearing on the Libby site, a U.S. senator
from Montana asked the OSWER Assistant Administrator to provide monthly
status reports on toxicity studies being conducted in response to the
recommendation in our December 2006 report. The OSWER Assistant
Administrator agreed and in June 2007, OSWER began submitting monthly
progress reports to the senator's office. Each progress report included a short
statement describing activity for Libby Action Plan studies.
Our review of the progress reports issued from June 2007 through June 2011
show no explicit description of the Agency's change in planned milestones for the
completion of the toxicity studies or the reason for the changes. For example, the
OSWER monthly updates to the senator's office for the noncancer study remained
unchanged from December 2007 through September 2009. This information was
incomplete, considering the Agency did not award the contract for the study to the
University of Cincinnati until May of 2009.
Managers with OSWER's Office of Superfund Remediation and Technology
Innovation acknowledged that their monthly progress reports to the senator did
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not explicitly mention delays to original corrective-action milestones. These
managers also provided briefing materials for the EPA Administrator to use to
brief the senator in March 2010. The briefing materials still included a timeline
indicating anticipated completion of the analytical studies supporting the
completion of the comprehensive toxicity assessment in 2010. Region 8 personnel
informed us that they agreed with the information OSWER provided to the
senator and his staff. However, the previous Region 8 administrator provided the
OIG with a schedule of undocumented meetings and discussions with the senator
during April and May 2010. While this document did show dates where Libby
issues were addressed, we could not determine that these discussions explicitly
addressed cause for delays.
To clarify, in June 2012, we spoke with three staffers for the two senators from
Montana, who either (1) participated in meetings with the Agency involving
discussions with Libby; or (2) reviewed monthly progress reports from the
Agency on the status of Libby cleanup activities. The purpose of our inquiry was
to determine whether EPA informed the Montana senators or their staff about the
delay in meeting corrective-action milestones for completing a toxicity
assessment for Libby amphibole. The scope of our inquiry went from
June 2007, when OSWER began submitting monthly progress reports about
activities for the Libby Action Plan to the senators' offices, through June 2012.
We were told the following by the senators' staff:
Two staffers did not recall any discussions that explicitly pertained to
milestone delays or reasons for delays in completing the Libby toxicity
assessment. A third staffer vaguely remembered being told about
milestone delays in completing the toxicity assessment during informal
discussions regarding the overall cleanup effort at Libby.
None of the three staffers recalled ever being told the reasons for the
milestone delays in completing the Libby toxicity assessment.
All three staffers stated that discussions with the Agency mainly involved
what was happening with the overall cleanup effort at the Libby
Superfund site.
Other Issues
Current Status of Peer Reviews
The external review of the Agency's draft IRIS Toxicological Review of Libby
Amphibole Asbestos, on the results of the Libby Amphibole Cancer Assessment
study and the Libby Amphibole RfC Development study, were posted for public
comment on August 25, 2011. A public listening session was held October 6, 2011.
The public comment period closed October 24, 2011. On February 23, 2012, an
independent peer-review panel under the EPA SAB convened to review the
Agency's draft IRIS Toxicological Review of Libby Amphibole Asbestos. This effort
was necessary for the Agency to complete the toxicity assessment.
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We spoke with the former SAB director regarding the status of the SAB's
peer-review efforts. The director told us that in response to ORD's request, the
SAB staff office established an expert panel to conduct an independent peer
review of the Agency's draft IRIS Toxicological Review of Libby Amphibole
Asbestos. The review panel held a public meeting February 6-8, 2012, to discuss
its review comments in response to EPA's charge questions. The former director
also told us that on May 1 and May 8, the panel held two public teleconferences
to discuss the SAB's first draft report. In early December 2012, the former
director said the SAB panel held a public teleconference on July 25, 2012, to
discuss its revised draft report. The panel's report was considered by the chartered
SAB (Board) on September 25, 2012, via a public teleconference. The Board
tentatively approved the report, provided that revisions are made based on the
Board's comments. The SAB's final report was presented to EPA on
January 30, 2013.
Milestones for NHEERL and Epidemiology Studies Had to Be Revised
The Agency's Libby Action Plan also included NHEERL and NCEA/Region 8
epidemiology studies7 contributing to the development of the final Record of
Decision and the 5-year review requirements for the Libby Superfund site. We
noted that these studies have been delayed as well. For instance, the NHEERL In
Vitro Dissolution Assays studies were set back due to the delay in the preparation
of testing samples. We also noted that a project scope change caused by the
addition of the NHEERL fiber separation studies also contributed to the delay in
the initial completion date for these studies.
Contracting delays also prevented EPA from completing the NCEA/Region 8
Dosimetry Model Development and Simulation Studies and the Inhalation
Toxicology in Rats studies based on planned milestones. The Dosimetry Model
Development and Simulation Studies contract was awarded 3 years late, and the
Inhalation Toxicology in Rats contract was awarded 15 months late.
Based on revised estimates by OSWER, the NHEERL animal toxicity studies will
be 6 years late from the original baseline date. In its correspondence dated
October 2009, OSWER informed the OIG that the estimated date for completing
the NHEERL animal toxicity studies is now September 2015. OSWER's initial
estimate for completing the NHEERL animal toxicity studies was
September 2009. The Region 8/NCEA epidemiology studies are ongoing, and
several studies have been published already. These studies will continue for many
years to come, and will help to improve knowledge about the health effects of
asbestos exposure. However, OSWER's Interim Risk Methodology for
Quantification of Cancer Risk from Inhalation Exposure to Asbestos study8
was dropped due to an unfavorable peer review. The SAB identified significant
concerns with this model so EPA decided not to pursue it further.
7 Appendix A, studies 3, 5, 6, 7, 8, 9, 10, and 11.
8 Appendix A, study 12.
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Conclusion
EPA has taken steps to plan and implement a toxicity assessment for Libby
asbestos as we recommended in our 2006 report. We believe EPA could have
made better progress to complete its work through improved communication,
planning and execution of actions. EPA should have been clear and provided
complete information on the challenges it was experiencing in meeting
milestones. This could have allowed the Administrator, other senior EPA
officials, or congressional staff to provide needed focus, assistance, or
priority-setting direction. EPA should have issued a charter designating a project
manager to expedite the completion of the toxicity assessment, to manage
communication of action plan status within and outside EPA, and to keep
contracting matters on track.
EPA's lack of transparency and timely, full disclosure regarding its delays and
challenges in addressing the Libby Action Plan could reduce public confidence in
EPA's work and decision. As a result, residents affected by the Libby site
contamination may think that EPA did not act as urgently as possible to address
the significant human health and environmental risks present at the Libby site.
Recommendations
We recommend that the:
1. Assistant Administrator for Solid Waste and Emergency Response, and
Region 8 Regional Administrator, require action officials to:
a. Disclose significant risks to completing the Libby Action Plan.
b. Update the Libby Action Plan to reflect changes in milestone dates.
c. Distribute original and revised plans to stakeholders.
2. Assistant Administrator for Solid Waste and Emergency Response,
Assistant Administrator for Research and Development, and Region 8
Regional Administrator:
a. Establish a charter to define project roles and responsibilities for
completing the remaining corrective actions under the Libby
Action Plan.
b. Determine whether the SAB or another organization will review
the completed risk assessment.
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3. Deputy Administrator direct the SAB to determine and report on whether:
a. EPA has followed guidance sufficient to support the findings in the
Libby toxicity assessment.
b. Limitations exist in applying the cancer and noncancer values to
the determination of acceptable levels of exposure to asbestos in
Libby.
4. Region 8 Regional Administrator ensure that future contracts issued
through interagency agreements are within the scope of those agreements.
5. Assistant Administrator for Research and Development require the
development of a priority ranking list among the ongoing IRIS
assessments, and that the Assistant Administrator be informed of any
recommended changes in those priorities. The rankings should consider
human health consequences.
Agency Response to Draft Report and OIG Evaluation
The EPA stated that, in general, it had significant concerns about the OIG draft
report. The Agency also stated that our draft report primarily focused on EPA not
meeting the initial draft Libby Action Plan project timelines, but did not
acknowledge accomplishments or the fact that EPA's delay in meeting research
timelines did not impede the extensive cleanup activities that have occurred to
date. One of the objectives of our review was to determine how EPA had satisfied
a previous OIG recommendation to conduct and complete a toxicity assessment of
Libby asbestos. Our report does acknowledge the Agency's completion of its draft
IRIS Toxicological Review of Libby Amphibole Asbestos on the results of the
Agency's cancer and noncancer studies in support of its Libby toxicity
assessment. The OIG did not review Libby cleanup actions and our report makes
no representations about the Libby site cleanup efforts.
In response to our draft report, the Agency agreed with Recommendation la,
and disagreed with Recommendations lb, lc, 2a, 2b, 3a, 3b, 4 and 5.
Recommendation la remains unresolved until the Agency provides sufficient
information to determine whether the intent of this recommendation has been
satisfied. In accordance with EPA Manual 2750, and its instructions for
unresolved recommendations, the Agency is required to provide a written
response to Recommendation la, including a proposed action plan and
completions dates, within 60 calendar days of the report issuance.
However, Recommendations lb, lc, 2a, 2b, 3a, 3b, 4 and 5 remain unresolved,
pending dispute-resolution actions. The dispute-resolution process starts
immediately upon report issuance.
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We reviewed the Agency's comments and made changes to the report as needed.
Appendix D provides a condensed version of the Agency's comments and the
OIG's responses. The condensed version was necessary due to the voluminous
size of the Agency's comments concerning the draft report. We provide the
Agency's comments in their entirety as a stand-alone document separate from this
report. Comments are available at http://www.epa.gov/oig.
Developments Since Issuing Our Draft Report
Claimed Libby Action Plan Accomplishments
In response to our draft report, Agency officials stated that substantial and
significant progress has been achieved on important Libby Action Plan projects.
EPA has developed improved analytical methods, identified adverse
health effects from exposure to Libby amphibole asbestos, researched the
mechanisms of injury, and developed a better understanding of the
exposure response relationships in epidemiological studies.
Basic research conducted under the Libby Action Plan has resulted in 19
peer-reviewed publications.
The draft IRIS Toxicological Review of Libby Amphibole Asbestos was
made available to the public in August 2011. This toxicity assessment
provides a Libby amphibole asbestos-specific RfC to evaluate noncancer
health effects and an Inhalation Unit Risk (IUR) to assess the potential
cancer risk from exposure to Libby amphibole asbestos in the
environment.
According to EPA officials, together with site-exposure characterizations based
on activity-based sampling, the upcoming risk assessments) for the Libby
Superfund site will assess the risk to the Libby community from exposure to
Libby amphibole asbestos, and inform site risk-management decisions and future
site remedies.
The Agency also stated that the Libby cleanup has substantially reduced the
exposure levels of Libby citizens and that EPA's delay in meeting research
timelines did not impede the conduct of extensive cleanup activities that have
occurred to date.
The OIG did not substantiate these claims by the Agency.
The SAB's Final Report on the Agency's Toxicity Assessment
The SAB reviewed the Agency's toxicity assessment, and the Board presented its
final report to EPA on January 30, 2013. The SAB's report cited several areas that
need more consideration, and provided recommendations to further enhance the
clarity and strengthen the scientific basis for the conclusions presented. This
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included additional analysis using cohorts other than the Marysville, Ohio, cohort,
and to use different statistical sampling models. In response to the OIG draft
report, the Agency said the LATAG will review the overall risk assessment and
EPA will make the risk assessment available to the public. Review of the risk
assessment was not within the scope of our review.
On April 4, 2013, the director for ORD/NCEA in Washington, D.C.,
provided the OIG with developed milestones based on a review of the SAB's
January 30, 2013, report, and an examination of what work the ORD expects to
do in response to the SAB's recommendations. The director stated ORD/NCEA's
schedule includes some uncertainties that could result in additional modifications
to the schedule. Below we provide the director's verbatim response for the
estimated schedule and potential uncertainties:
Developed Milestones
September 30, 2013First complete draft of revised toxicological
review and comment disposition.
January 14, 2014Revised draft to go to Interagency and Agency
reviewers.
April 25, 2014Revised draft to final clearance.
June 24, 2014Post final toxicological review (current estimate of
when the final Libby Amphibole Asbestos Toxicity Review would
be released to the public, assuming unknown events).
Uncertainties
Estimating the timeline for further modeling work in response
to the SAB peer review
In their peer review report, the SAB agreed with many of the choices EPA
made on how to assess the toxicity and dose-response of Libby amphibole
asbestos. However, the SAB recommended that EPA conduct extensive
and innovative additional modeling and sensitivity analyses, which EPA
plans to do. These types of modeling and analyses are complex, and it is
difficult to predict exactly how long it will take to successfully complete
such modeling and analysis.
Potential for further peer review
At this point, EPA does not think that the revised IRIS assessment of LAA
will require additional peer review. The additional analysis being
conducted is directly responsive to specific SAB peer review
recommendations and will not need further peer review. The SAB agreed
that EPA should use the cohorts and endpoints used in the draft
assessment. After responding to the SAB recommendations, it is possible
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that EPA may decide that some portions of the work (e.g., new modeling
or analysis) needs further targeted peer review. If EPA makes such a
decision, this may add time to the projected timeline.
Clearance
Because of the very high profile nature of the Libby, Montana, site, and by
extension, the IRIS assessment of LAA, it is possible that additional effort
related to briefings and communication will be needed before releasing the
final assessment. EPA's projected schedule provided above allows for
2 months to complete formal review and final clearance, including all of
the requisite communications tasks and briefings. The timing of final
reviews and clearances are often variable with very high profile work, and
this step may take longer than projected.
Litigation
EPA could be required to respond to potential litigation related to Libby
amphibole asbestos. In the event this happens, EPA may need to devote
significant time to address issues which may extend the timeline.
Libby Versus the Formaldehyde Assessment
In November 2012, ORD personnel provided additional information regarding the
selection of the formaldehyde assessment work over Libby work. Specifically, in
September 2009, NCEA management requested that two scientists working on
both the Libby and formaldehyde assessments temporarily focus only on
completing the formaldehyde assessment so that staff could later focus on the
Libby assessment without distraction. During our exit conference, ORD agreed to
consider establishing a priority list of EPA projects with milestones that would
require senior management review if any changes occurred with the milestones.
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Status of Recommendations and
Potential Monetary Benefits
RECOMMENDATIONS
POTENTIAL MONETARY
BENEFITS (In $000s)
Rec.
No.
Page
No.
Subject
Status1
Planned
Completion
Action Official Date
Claimed
Amount
Ag reed-To
Amount
17 Require action officials to:
a. Disclose significant risks to completing the
Libby Action Plan.
b. Update the Libby Action Plan to reflect
changes in milestone dates.
c. Distribute original and revised plans to
stakeholders.
17 a. Establish a charter to define project roles and
responsibilities for completing the remaining
corrective actions under the Libby Action
Plan.
b. Determine whether the SAB or another
organization will review the completed risk
assessment.
18 Direct the SAB to determine and report on whether:
a. EPA has followed guidance sufficient to
support the findings in the Libby toxicity
assessment.
b. Limitations exist in applying the cancer and
noncancer values to the determination of
acceptable levels of exposure to asbestos in
Libby.
18 Ensure that future contracts issued through
interagency agreements are within the scope of
those agreements.
18 Require the development of a priority ranking list
among IRIS assessments, and ensure that the
Assistant Administrator be informed of any
recommended changes in those priorities. The
rankings should consider human health
consequences.
Assistant Administrator
for Solid Waste and
Emergency Response,
and Region 8
Regional Administrator
Assistant Administrator
for Solid Waste and
Emergency Response,
Assistant Administrator
for Research and
Development,
and Region 8
Regional Administrator
Deputy Administrator
Region 8
Regional Administrator
Assistant Administrator
for Research and
Development
1 0 = Recommendation is open with agreed-to corrective actions pending
C = Recommendation is resolved with all agreed-to actions completed.
U = Recommendation is unresolved with resolution efforts in progress.
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Appendix A
Name and Ranking of Studies Under
the Agency's Lib by Action Plan
(as of April 2007)
Name of Study
Responsible Party
Original Milestone
Date
1. Libby Amphibole Reference Concentration (RfC)
Development (noncancer)
Region 8/ NCEA
4th
Quarter -FY 2009
2. Libby Amphibole Cancer Assessment
ORD/NCEA
4th
Quarter -FY 2009
3. Preparation of Libby Testing Material
USGS
4th
Quarter -FY 2007
4. Fiber Size Distribution in Libby Vermiculite
Region 8
4th
Quarter -FY 2007
5. Dosimetry Model Development and Simulation
Studies
NHEERL*
4th
Quarter -FY 2009
6. In Vitro Dissolution Assays
NHEERL
2nd
Quarter -FY 2009
7. In Vitro Toxicity Endpoints
NHEERL
2nd
Quarter -FY 2009
8. Comparative Toxicology in Mice and Rats
NHEERL
4th
Quarter -FY 2009
9. Inhalation Toxicology in Rats
NHEERL
3rd
Quarter -FY 2009
10. New Epidemiologic Information from Libby Cohort
Region 8/NCEA
2nd
Quarter -FY 2009
11. Region 8/NCEA, New Epidemiologic Information
From Other Cohorts
Region 8/NCEA
3rd
Quarter -FY 2009
12. Interim Risk Methodology for Quantification of
Cancer Risk From Inhalation Exposure to Asbestos
OSWER
4th
Quarter -FY 2009
Source: EPA's April 2007 follow-up response.
* The National Health Effects and Environmental Research Laboratory (NHEERL) is located in
Research Triangle Park, North Carolina.
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Appendix B
Risk Assessment Guidance
The guidance documents listed below are general in nature. As the final site-specific risk
assessments have not yet been developed (awaiting final toxicity values and complete site-
specific exposure data), it is not possible at this time to determine exactly which additional
guidance documents may be eventually referenced.
1. EPA. 1989. Risk Assessment Guidance for Superfund, Human Health Evaluation
Manual, Part A. (EPA/540/1-89/002. Washington, D.C.: EPA, Office of Emergency and
Remedial Response.httD://www.eDa.gov/oswer/riskassessnient/ragsa/index.htni
The guidance for the development of a site-specific risk assessment. As stated in the
document: The policies and procedures set forth here are intended solely as guidance to EPA
and other government employee and contractors. This guidance does not constitute
rulemaking by the Agency... EPA may take action that is at variance with the policies and
procedures in this manual...."
2. EPA. 2008. Framework for investigating asbestos-contaminated superfund sites.
Washington, D.C.
httD://www.eDa.gov/suDerfund/health/contaniinants/asbestos/Ddfs/franiework asbestos
guidance.pdf.
This guidance provides the methods for the calculation of cancer risk from asbestos
exposure. This guidance also recommends methods for the statistical summary of activity-
based sampling data.
3. EPA. 2009a. Risk assessment guidance for superfund volume I: Human health
evaluation manual (Part F, supplemental guidance for inhalation risk assessment):
Final. (EPA/540/-R-070/002). Washington, D.C.: EPA, Office of Superfund Remediation
and Technology Innovation. httD://www.eDa.gov/oswer/riskassessnient/ragsf/index.htni.
This guidance is part of the overall risk assessment guidance for superfund giving more
specific recommendations regarding the assessment of risk and hazard from inhalation
exposures.
4. EPA. 2001b. Risk assessment guidance for superfund: Volume III part A, process for
conducting probabilistic risk assessment. (EPA 540-R-02-002). Washington, D.C.:
EPA, Office of Solid Waste and Emergency Response.
httD://www.eDa.gov/oswer/riskassessnient/rags3adt/index.htni
This guidance provides methods for alternative approaches for the calculation of exposure
and risk estimates based on statistical distributions rather than single point estimates.
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Appendix C
Toxicity Assessment Guidance
1. EPA. 1986b. Guidelines for mutagenicity risk assessment [EPA Report]. (EPA/630/R-
98/003). Washington, D.C. http://www.eDa.gov/iris/backgrd.html.
These guidelines informed the evaluation of available scientific information regarding the
potential mutagenicity of the Libby Amphibole asbestos fibers. (Section 4.4.2)
The evaluation of mutagenic potential primarily applies to the cancer assessment.
2. EPA. 1991a. Guidelines for developmental toxicity risk assessment [EPA Report].
(EPA/600/FR-91/001). Washington, D.C.: EPA, Risk Assessment Forum.
http://www.epa.gov/iris/backgrd.html.
Although there are no developmental data specific to the Libby Amphibole, the potential for
developmental effects is discussed in Section 4.7 addressing susceptible populations
(including life stages). These guidelines would apply to the general data on asbestos which
may address the potential for developmental effects.
3. EPA. 1994a. Interim policy for particle size and limit concentration issues in inhalation
toxicity studies [EPA Report]. Washington, D,C.: EPA, Office of Pesticide Products,
Health Effects Division. http://cfpub.epa.gov/ncea/cfni/recordisplav.cfni?deid=l 86068.
These are general guidelines for evaluating exposure conditions for animal inhalation studies
and were used in evaluating the studies in Appendix D of the Toxicological Review where
applicable.
4. EPA. 1994b. Methods for derivation of inhalation reference concentrations and
application of inhalation dosimetry. (EPA/600/8-90/066F). Research Triangle Park,
N.C.: EPA, Office of Research and Development, Office of Health and Environmental
Assessment, Environmental Criteria and Assessment Office.
http://cfpub.epa.gov/ncea/cfni/recordisplav.cfni?deid=71993.
This guidance was used in derivation of an RfC for the Libby Amphibole (Section 5.2), as it
provides the primary guidance for establishing reference concentrations under the IRIS
Program.
This guidance was used to calculate the exposure estimates for the occupational cohorts
which were the basis of both the RfC and IUR (Sections 5.2.3.1 and 5.4). {Although the
Guidance was written specifically for the RfC process, the 2005 EPA Cancer Guidelines
recommend the same procedures be employed in inhalation cancer assessments (see section
3.1.1.2 of the cancer guidelines, EPA, 2005)}
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5. EPA. 1995. The use of the benchmark dose approach in health risk assessment
[EPA Report]. (EPA/630/R-94/007). Washington, D.C.
httD://www.eDa.gov/raf/Dublications/useof-bda-healthrisk.htni.
Although this guidance is being updated (see EPA 2000a), this technical guidance provides
the foundation for the exposure-response modeling of the noncancer health effects observed
in the O.M. Scott cohort and used as the basis for the RfC.
The guidance also informed some of the decisions in the exposure-response modeling in
support of IUR derivation.
6. EPA. 1996. Guidelines for reproductive toxicity risk assessment [EPA Report].
(EPA/630/R-96/009). Washington, D.C.: EPA, Risk Assessment Forum.
httD://www.eDa.gov/raf/Dublications/Ddfs/REPRQ51.PDF.
Although there are no reproductive data specific to the Libby Amphibole, the potential for
reproductive effects is discussed in Section 4.7 addressing susceptible populations. These
guidelines would apply to the general data on asbestos, which may address the potential for
reproductive effects.
7. EPA. 2000a). Benchmark dose technical guidance document [external review draft].
(EPA/630/R-00/001). Washington, D.C.: EPA, Risk Assessment Forum.
httD://www.eDa.gov/raf/Dublications/benchniark-dose-doc-draft.htni.
This technical guidance was applied to the exposure-response modeling of the noncancer
health effects observed in the O.M.Scott cohort and used as the basis for the RfC.
(Sections 5.2.3-5.2.5)
The guidance also informed some of the decisions in the exposure-response modeling in
support of IUR derivation. (Sections 5.4.3-5.4.5)
8. EPA. 2000c. Science policy council handbook: Risk characterization. (EPA 100-B-00-
002). Washington, D.C.: EPA, Office of Research and Development, Office of Science
Policy. httD://www.eDa.gov/osa/sDc/pdfs/rchandbk.Ddf.
This general guidance document informed the scientific evaluations and decisions in both the
cancer and noncancer portions of the toxicological review.
9. EPA. 2002. A review of the reference dose and reference concentration processes.
(EPA/630/P-02/002F). Washington, D.C.
httD://cfDub.eDa.gov/ncea/cfni/recordisDlav.cfni?deid=51717.
This review provides a summary of current practices as well as recommendations for the
IRIS Program where setting reverence values, and informs the RfC derivation for Libby
Amphibole asbestos. (Section 5.2)
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10. EPA. 2005a. Guidelines for carcinogen risk assessment. (EPA/630/P-03/001F).
Washington, D.C. http://www.eDa.gov/cancerguidelines/.
The Cancer Guidelines were followed for all aspects of the Libby Amphibole asbestos cancer
assessment: hazard identification, discussion of Mode of Action, determination of
carcinogenicity (carcinogenic to humans), exposure-response modeling and IUR derivation
from the chosen exposure-response model(s). (Sections 4.4, 4.6 and 5.4)
11. EPA. 2005b. Supplemental guidance for assessing susceptibility from early-life exposure
to carcinogens. (EPA/630/R-03/003F). Washington, D.C.: EPA, Risk Assessment Forum.
http://www.epa.gov/cancerguidelines/guidelines-carcinogensupplement.htm.
The supplemental guidance was employed in Section 4.6.2, where the mode of action
information is reviewed to determine if the adjustment factors for early-life exposure should
be applied.
12. EPA. 2006b. A framework for assessing health risk of environmental exposures to
children. (EPA/600/R-05/093F). Washington, D.C.
http://cfpub.epa.gov/ncea/cfni/recordisplav.cfni?deid= 158363.
This guidance was applied in those sections which discuss the exposures to children
(Section 2.3 exposure potential, Section 4.7 susceptible populations).
13. EPA. 2006d. Science policy council handbook: Peer review, 3rd edition.
(EPA/100/B-06/002). Washington, D.C.: EPA, Science Policy Council.
http://www.epa.gov/OSA/spc/2peerrev.htni.
The external peer review of the Libby Amphibole Asbestos Toxicological Review is being
conducted by the EPA Science Advisory Board.
14. International Labour Organization (ILO), World Health Organization (WHO). (2002).
International classification of radiographs of pneumoconioses. In (Rev. Ed. 2000 ed.,
Vol. 22). Geneva, Switzerland: International Labour Office.
This guidance document was cited in Section 5.2.2 where the noncancer health effects
providing the basis of the RfC are evaluated. As this WHO publication is the standard for
describing the noncancer health effects of asbestos exposures based on standard radiographs,
these guidelines were used in evaluating and describing the critical health effect on which the
RfC is based.
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Appendix D
OIG Consolidated Responses to
Agency's Comments on Libby Draft Report
The Agency provided extensive comments to the draft report in three separate documents. This
included main comments dated September 5, 2012 from the Assistant Administrators for
OSWER and ORD, and the Region 8 Administrator. Additional attachments included comments
rendered by the Agency's Deputy Chief of Staff on August 10, 2012, and the Agency's
NHEERL on or about September 5, 2012. We summarize and respond to those comments
below. We have organized them into the following topics: general comments, charter comments,
cancer study comments, noncancer study comments, communications comments, interagency
agreement comments, Science Advisory Board comments, NHEERL comments,
recommendation comments, and EPA Deputy Chief of Staff Comments. We provide these 3 sets
of comments in their entirety as a stand-alone document separate from this report at website
(http://www.epa.gov/oig).
General Comments.
Understanding Health Effects. EPA stated that the draft report did not acknowledge EPA's
major strides in improving the understanding of health effects of exposure to Libby asbestos.
OIG Response 1: The purpose of this review was to determine how EPA had satisfied
our previous recommendation to conduct and complete a toxicity assessment of Libby
asbestos. However, we have included information in our report provided by the
Agency in response to our draft report on progress made under the Libby Action Plan
projects.
Reducing Exposure Levels. EPA stated the draft report did not acknowledge that EPA had
substantially reduced exposure levels of Libby citizens through the cleanup efforts.
OIG Response 2: The purpose of this review was to determine how EPA had satisfied
our previous recommendation to conduct and complete a toxicity assessment of Libby
asbestos. The OIG did not review the effectiveness of the cleanup.
Delays Did Not Impede the Cleanup. EPA stated the draft report did not state that the delays in
meeting the research timelines did not impede the cleanup.
OIG Response 3: The draft report makes no inference that the delays in completing the
toxicity assessment delayed the cleanup. We did not review the cleanup, which is a
separate activity from the toxicity assessment.
Draft Report Focused Primarily On Meeting Draft Milestones. EPA stated that the draft
report focused primarily on EPA not meeting the initial draft Libby Action Plans milestones.
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OIG Response 4: We disagree that the draft report focused primarily on EPA not meeting
the LAP milestones. The focus of the findings and recommendations is on how EPA
established the milestones and why EPA experienced delays.
The OIG Acknowledges that the Draft Milestones Were Unachievable. EPA stated that the
OIG acknowledges that the milestones were unachievable.
OIG Response 5: We disagree that the draft report acknowledges the LAP milestones were
not achievable. The OIG reports that EPA personnel stated at the initiation of the OIG
review that EPA knew the LAP milestones were not achievable when EPA presented them
to stakeholders. Further, the milestones were the estimates that the action official agreed to.
In an April 2007 memorandum, EPA informed the OIG that:
The milestone for the completion of the baseline risk assessment including a
comprehensive toxicity assessment would be September 30, 2010.
The tentative date to complete the NHEERL animal studies was September 30,
2009.
In an attachment to the memorandum, EPA provided tentative completion dates
for each of the 12 individual studies supporting the toxicity assessment, which
ranges from the fourth quarter of FY 2007 to the fourth quarter of FY 2009.
EPA did not update the milestones until October 20, 2009. At that time, they informed the
OIG that the milestone to complete the baseline risk assessment including a comprehensive
toxicity assessment changed from September 30, 2010 to September 30, 2012. EPA also
informed the OIG that the baseline to complete the NHEERL animal studies changed from
September 30, 2009 to September 30, 2015.
The OIG Uses the Term "Toxicity Assessment" Incorrectly. EPA stated that despite the
detailed information they provided and the availability of numerous EPA program and guidance
documents, the term "toxicity assessment is used to convey three different meanings, only one of
which is correct. Further EPA stated that the OIG draft report in several places continues to
confuse an agent-specific toxicity assessment and a site-specific risk assessment.
OIG Response 6: We disagree. We reviewed each instance of the term toxicity assessment
in the draft report and all refer to the work EPA committed to perform to satisfy the report
recommendation or are statements made by EPA personnel. The term agent-specific toxicity
assessment is a term EPA uses in its comments to this report. It is not a term the OIG uses.
The OIG does not refer to the term site-specific risk assessment in the introduction or other
part of the report. Appendix A, Risk Assessment Guidance, provided by the Agency,
provides the only mention of a site-specific risk assessment. The Agency identified twelve
studies that comprise the toxicity assessment (see appendix A); however, the report is clear
that the work accomplished by EPA to date will only reflect two, the cancer and noncancer
studies due to EPA delays in completing all the toxicity work.
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EPA Milestones Should Not Be Used as Baselines. EPA states that it does not agree with the
OIG's interpretation that the draft timelines provided in April 2007 should be the baseline
against which the EPA's progress on LAP projects should be evaluated.
OIG Response 7: We disagree with the EPA interpretation that the report findings are
based primarily on EPA not meeting the LAP milestones. The original baselines show that
EPA experienced significant delays in completing the toxicity assessment. OSWER
informed the OIG that the estimated date for completing the comprehensive toxicity
assessment was revised from September 30, 2010 to September 30, 2012 (two year delay),
and September 2015 (initially September 2009 ) for the NHEERL animal toxicity studies
(6 year delay). However, the report findings are based upon the EPA management actions
that contributed to the delays.
Revisions Did Not Cause Delays. EPA stated that the action of revising the timelines did not
affect the execution of the LAP projects. The action of revising the timelines reflected - not
caused - project delays.
OIG Response 8: We agree that the sentence stating that is unnecessary and
confusing. Therefore, we are removing it from the report.
Title Page and Cover: EPA states the OIG's field investigation and review seems to have
addressed all projects under the Libby Action Plan (LAP). As such they recommend the title
reflect this is a report on the progress of all LAP projects, not just the toxicity assessment.
OIG Response 9: The title of the report accurately reflects progress made under the
Agency's Libby Action Plan. EPA characterization of the OIG review is incorrect.
The 12 LAP studies did comprise of the toxicity assessment. For example in her
April 2007 Congressional testimony the former OSWER assistant administrator
stated, ".. .the Agency has identified and is implementing a comprehensive program
of 12 studies to support the development of the Libby toxicity assessment. The
cancer and noncancer work are clearly listed as two of the studies. This is also
consistent with the information EPA provided to the OIG.
At A Glance and Chapter 1, Background: EPA states that the OIG draft report indicates the
concerns of the Libby community centered around "lawn and garden products from Libby." The
concerns of the citizens include potential exposures and environmental contamination from past
mine operations, waste materials used as fill in the community, use of expanded vermiculite in
buildings (e.g. homes, schools) for insulation and use of both waste materials and expanded
vermiculite as a soil amender. The Libby Superfund site is not focused only on contaminated
lawn and garden products.
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OIG Response 10: The EPA characterization of the report is not correct. The report
language is as follows: In 2000, due to citizen concerns, EPA started sampling and
analyzing lawn and garden products from Libby that contained vermiculite. The
report does not state that the concerns of Libby citizens centered on lawn and garden
products. Rather, it states the action EPA took.
LAP Projects. EPA states that the list of LAP projects provided to the OIG as shown in
Appendix A of the draft report are not in order of priority, and requests that the statement making
reference to the order of priority of these projects be removed for accuracy.
OIG Response 11: EPA personnel provided this information. More specifically, EPA's
documentation states the RfC development study was ranked number one by the
Agency relative to its priority for completing the Libby toxicity assessment; and,
completion of the Libby Amphibole cancer assessment study was ranked second in
terms of relative priority by the Agency for completing the Libby toxicity assessment.
EPA has not stated why the information is not correct or provided a new list arranged in
accordance with priority. EPA should provide justification for this change in the 60 day
comments to the final report. That justification should include the priority ranking of
the remaining studies.
Unclear Statement. EPA states the following statement is unclear "We were told by OSWER
managers that the derivation of the reference concentration (RfC) and inhalation unit risk (IUR)
for Libby amphibole asbestos were needed for completion of the site-specific risk assessment."
OIG Response 12: We disagree that the statement as written by EPA was in the draft
report. The closest report language to the EPA statement is as follows. "We were told
by OSWER managers that studies 1 and 2 were especially critical to completing the
toxicity assessment in response to OIG recommendation 1 based on their priority
rankingThis particular statement is supported by evidence gathered during our
evaluation.
The Libby Action Plan Coordinator Is Not Recognized. EPA states the OIG Draft Report
does not acknowledge the Libby Action Plan Coordinator, who had the primary responsibility
for coordination of the projects among the offices. As this was a key aspect of LAP
management, this information needs to be included.
OIG Response 13: The report addresses the responsibilities of OSWER, ORD and
Region 8 in carrying out the Libby Action Plan. As such, we spoke with the Action
Officials for OSWER, ORD and EPA Region 8 during meetings leading up to the
issuance of the draft.
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Personnel Not Interviewed. EPA stated that no NHEERL personnel were interviewed
during this field investigation including the first two LAP coordinators who were responsible
for planning and coordinating the overall NHEERL research effort. Nor were personnel in
ATSDR, the lead Agency for projects 10 and 11 contacted in the field investigation.
OIG Response 14: The OIG conducted an entrance conference with EPA to discuss the
review and to determine whom the OIG needs to interview. We saw no benefit to
interviewing these personnel. The purpose of the review was to determine EPA efforts in
developing and completing the toxicity assessment.
The Term "Listing" Has a Specific CERCLA Meaning. EPA states that "Listing "has a
specific meaning in the context of CERCLA and is used to refer to a site being added to the
National Priorities list. It is not appropriately used in the OIG report. EPA recommends the
reference to "listed" be removed.
OIG Response 15: The report is not a CERCLA document and the term "listed" is used
appropriately. The term is used several times and in no way conveys that the subject of
conversation refers to listing on the National Priorities List in the draft report. Where
necessary, we have used the term National Priority Listing in reference to Libby as a
Superfund site.
Specific Word Changes to Draft Report.
Page 3, line 44: strike "determining" replace with "conducting."
Page 4, line 2: Should read "... conducting inhalation toxicology studies in rats."
Page 4, line 7: Should read "site-specific reference concentration (RfC) for the Libby
amphibole asbestos.
Page 5 and 6, Scope and methodology: Add the following bullet "Briefings to senior
managers."
OIG Response 16: We agreed with each word change request. All changes are
reflected in the final report.
Charter Comments
No Charter Necessary to Complete Libby Work. A LAP Coordinator was appointed from
management of one of the participating offices and was responsible for cross-Agency
coordination of all of the individual projects within the LAP
OIG Response 17: Our report addresses the role and responsibilities of the Assistant
Administrator for OSWER and ORD, and the Region 8 Administrator whom,
according the Agency managers, served as the senior Agency officials ultimately
responsible for ensuring the completion of corrective actions under the LAP. In this
structure, each office was only responsible to itself.
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OIG Response 17 Continued
OSWER was responsible for oversight of the Libby Action Plan and
reporting progress made to internal and external stakeholders.
ORD's National Center for Environmental Assessment (NCEA) was
responsible for conducting a cancer assessment specifically for Libby
amphibole for the Integrated Risk Information System (IRIS).
EPA Region 8, with assistance from ORD/NCEA, was responsible for
developing the Libby reference concentration (RfC) for Libby amphibole.
However, our review revealed the Agency's efforts to carry out its Libby Action
Plan experienced significant delays with this management structure. OSWER
oversight was not sufficient or empowered to ensure that:
ORD and Region 8 estimates to complete the studies were reasonable.
ORD did not postpone Libby work to complete another assessment without
justification.
EPA and University of Cincinnati scientists began work on the non-cancer
study as soon as possible rather than spend 19 months issuing the contract.
Cancer Study Comments
Libby Should Not Be The Sole EPA Priority. EPA stated that it is incorrect that the
declaration of the public health emergency in Libby Montana should have made the
Toxicological Review of Libby Asbestos the sole priority toxicity assessment for EPA.
OIG Response 18: We disagree that the report states that Libby should be the sole
EPA priority. The OIG does not state that the declaration of the public health
emergency required EPA to make Libby the top priority. Rather, the OIG found
that the Agency could not provide criteria to make one assessment a priority over
the other. Specifically, EPA data acknowledges death and illness due to exposure to
Libby asbestos, over $400 million spent on the cleanup, Libby asbestos is in
millions of American homes, and EPA's only issuance of a public health
emergency as reasons to make Libby a priority. At the time of the review,
responsible EPA personnel could not provide similar reasons for other assessments.
Therefore, we recommended that the Assistant Administrator for Research and
Development develop a priority list for pending and ongoing research, not to make
Libby the sole priority. During our exit conference, an ORD official stated ORD
would consider establishing a priority list of EPA projects with milestones that
would require senior management review of any changes in the milestones. We
believe it is consistent with EPA's mission to clearly factor in human health risks
when deciding on priorities.
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Competing Demands Not the Sole Reason for Delays in the Cancer Study. EPA disagrees
with any implied finding that the delay in completing the Toxicological Review ofLibby
Amphibole Asbestos was due solely to competing demands.
OIG Response 19: We disagree that the report makes that statement. The report
clearly states that competing priorities and unplanned work caused delays in
completing the cancer study. The specific details of each as provided by EPA
personnel are included in the report. However, we have changed the wording from
unplanned work to unanticipated work.
Noncancer Study Comments
Contracting Issues Did Not Delay the Noncancer Study. EPA stated that it did take action
to try to expedite contracting procedures by choosing to use an existing contract mechanism
through the Volpe Center.
OIG Response 20: EPA's response does not reflect the Agency's Interagency
Policy and Procedures Compendium, which states that the agreement must be for-an
independent and distinct project. The scope of work listed in the agreement was for
the Volpe Center to perform site-specific clean-up work at the Libby site, not to
develop a noncancer value with the University of Cincinnati. Further, EPA's
response does not recognize that the Volpe Center provided no technical work in
developing the noncancer value. Specifically, the EPA staff member-who chose the
Volpe Center believed that the Volpe Center was better at contracting and was faster
and more innovative than EPA in getting contracts done. EPA's response also does
not account for the fact that performing pass through acquisitions, as defined by the
Volpe center, was against Volpe Center Policy. The Volpe Center stated that their
work on the interagency agreement must be technical in nature but the statement of
work states that Volpe would facilitate communication between EPA and University
of Cincinnati scientists. In our opinion, facilitating communication is not a technical
role in developing a noncancer toxicity value.
Communications Comments
EPA Communications with the Senate. EPA states the OIG should reconsider their
statements that EPA communications to the Senate were "misleading."
OIG Response 21: We concur. We have made changes to the report, as
appropriate. Specifically, the report now states that reports provided to the
senators were incomplete rather than misleading.
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EPA Provided Information to Internal and External Stakeholders. EPA has briefed
community stakeholders on LAP project status and timelines across the course of the
projects. Although EPA did not contrast the timelines to the draft timelines provided in the
Agency's response to the OIG (April 2007), community stakeholders had the best available
current project status and timelines well before September 2009.
OIG Response 22: The report does not dispute that EPA provided information to
stakeholders. The report does show that the information provided was not always
complete and in the case of the LAP, the information was incomplete.
InterAgencv Agreement Comments
The Volpe Center Did Not Perform a Pass Through Acquisition for EPA. EPA did not
use Volpe as a pass-through vehicle for contracting. Volpe Center provides EPA with
technical assistance in Superfund site cleanup to include site assessment and remedy
selection.
OIG Response 23: We disagree. The EPA comment does not reflect that:
EPA staff admitted they used the Volpe Center for contracting support to
avoid using EPA contracting.
The Volpe Center performed no technical work in developing the
noncancer value.
The agreement must be for an independent and distinct project.
We believe Region 8's use of the Libby Clean-up IAG to award a contract to the
University of Cincinnati exceeded the scope of work under the agreement between
Region 8 and the Volpe Center. Region 8's interagency agreement with the Volpe
Center is site specific and the scope of work describes authority for work to be done at
Libby, Montana, and not at the University of Cincinnati in Ohio.
EPA and Volpe Do Not Fault Each Other for the Delays. EPA disagrees with the OIG
statement "Rather, EPA and the Volpe Center fault each other for the delays."
OIG Response 24: The draft report statement is accurate. EPA and the
Department of Transportation Volpe Center personnel provided contrary opinions
as to who was at fault for the delay in issuing the contact awarded for the
noncancer assessment study under the Libby Action Plan. EPA personnel faulted
the Volpe Center for delays in completing the noncancer study. In turn, the Volpe
Center responded that EPA did not know what tasks it wanted to complete under
the contract and that contributed to the delays.
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Science Advisory Board Comments
The Role of the SAB. EPA stated there are critical flaws in the findings and recommendations
of the OIG Draft Report with respect to external peer review and the role of the EPA SAB. This
issue has been independently addressed by the Office of the Administrator. The EPA Deputy
Chief of Staff responded for the Office of Administrator stating that the SAB review is still
ongoing and, therefore, it is not appropriate to include SAB review comments in the OIG report.
OIG Response 25: In response to the EPA Deputy Chief of Staff comments
regarding this issue, we note that the statements made by the SAB Staff Director
are in response to questions posed by the OIG and are not taken from the SAB
draft report. However, the SAB's final report is public. The SAB's report cited
several areas that need more consideration, and provided recommendations to
further enhance the clarity and strengthen the scientific basis for the conclusions
presented in the draft toxicity assessment. Also note that the OIG report does not
recommend that the SAB direct EPA actions. The EPA has turned to the SAB for
scientific review of its risk assessments. It does not appear constructive for EPA
to engage expert SAB panels but deny the panel information they believe is
necessary to do their jobs effectively. Resolution of the issues could reduce the
limitations associated with SAB reviews of future EPA risk assessments.
Additionally, resolution of these issues could improve public confidence in EPA
risk assessments.
NHEERL Comments
EPA Was Responsive to Reviewer Comments. The OIG does not acknowledge that EPA
was responsive to the reviewer comments and EPA revised the project plans accordingly.
OIG Response 26: Our review objectives were to determine why the Agency did not
meet planned corrective action milestones in response to the recommendations in the
OIG's December 2006 report. EPA provided documentation to the OIG in October
2009 stating that the laboratory studies are expected to be completed in 2012;
however, EPA anticipated that an additional two to three years was necessary to
assess results, develop technical summary reports, and have the reports peer reviewed.
The report does not infer that EPA was non-responsive.
Delays in Government Contracting on the NHEERL Studies. EPA states that the OIG
should acknowledge that although true, these contracting delays (delays is government
contracting) were not the critical factor to delays in the NHEERL research projects. The
unforeseen technical difficulties in producing adequate quantities of test material were the
rate limiting factor.
OIG Response 27: The OIG did not rate the factors limiting the completion of the
NHEERL studies. However, EPA cannot ignore certain factors that cause delays.
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Fiber Separation Studies. EPA states the need for fiber separation studies only resulted in
minor project delays (a few months).
OIG Response 28: The report does not attempt to post the time caused by each
delay. Rather, it lists the causes of the delay as stated by EPA.
Dosimetry Delays. EPA states that the dosimetry contract was delayed because it was
initially developed as a desired sole source contract. It was eventually awarded based on
open competition.
OIG Response 29: As the report states, EPA informed the OIG that multiple
actions contributed to the delays the cumulative effect being a 6 year delay. The
OIG did not attempt to rank the amount of delay attributed to each action.
However, EPA cannot state that the contracting delay was not consequential. EPA
could not conduct the tests without the proper material. It also could not conduct
the tests without having the contract in place.
NHEERL Delays EPA states although the completion of all animal toxicity studies is
projected for 2015, this date reflects completion of all laboratory studies as well as
completion of all project reports and publications. The OIG report should acknowledge that
many of the subject studies have been completed and that results have published in peer
reviewed scientific journal demonstrating significant progress.
OIG Response 30: The draft report lists the delays and causes of the delays EPA
presented in completing the NHEERL studies. Specifically, in October 2009 EPA
informed the OIG that the time frame for these studies have been extended due to
unforeseen problems in preparing the dosing material for animals studies, delays
in government contracting, and revisions to the experimental designs. While EPA
states that many of the studies have been done or will be completed in 2012, EPA
also states that assessing the results would take another two to three years.
Therefore, EPA established a new completion date of September 2015 versus
September 2009 (6 years). Further, the report correctly states the studies are
6 years late based upon the information EPA provided. While it is good to know
that EPA is making progress it does not change the fact that stakeholders will have
to wait 6 years before the information can be used.
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Recommendation Comments
la) Assistant Administrator for Solid Waste and Emergency Response and Region 8
Regional Administrator require action officials to: Disclose significant risks to completing
the Libby Action Plan.
EPA Response: Concur
When and if, EPA is aware of factors that have the potential to affect the current project
milestones, this information will be shared with stakeholders.
OIG Response 31: The OIG acknowledges the Agency's concurrence. In response to
our draft report, Agency officials stated when, and if, EPA is aware of factors that have
the potential to affect the current project milestones, this information will be shared
with stakeholders. However, the Agency has not provided an action plan with the
mechanism for contacting the stakeholders and specifying how soon after the delays
are known that the stakeholders would be informed. Therefore, Recommendation la
status is unresolved pending an action plan with completion dates (when determined)
for the agreed-to recommendations.
lb) Assistant Administrator for Solid Waste and Emergency Response and Region 8
Regional Administrator require action officials to: Update the Libby Action Plan to
reflect changes in milestone dates.
EPA Response: Nonconcur.
Alternative text: "OIG finds that the LAP coordinator maintains a current timeline for all
LAP activities conducted across the Agency and that senior management from ORD,
OSWER, and Region 8 is regularly updated of LAP project status."
OIG Response 32: The Agency disagreed with Recommendation lb, even though
they have agreed to keep stakeholders informed in Recommendation l.a. Therefore,
Recommendations lb is unresolved with dispute actions pending. The dispute
resolution process starts within 30 calendar days of the report issuance.
lc) Assistant Administrator for Solid Waste and Emergency Response and Region 8
Regional Administrator require action officials to: Distribute original and revised plans
to stakeholders.
EPA Response: Nonconcur
EPA believes it has kept stakeholders informed. Specifically, EPA stated it has provided
monthly status reports to Congress, addressed LAP status in Senate testimony, attended
regular meetings with interested Senate staff, responded to all requests for information on
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LAP projects, and has briefed community stakeholders on LAP project status and timelines
across the course of the projects.
Alternative Remedy: EPA will continue to provide updates of schedules to stakeholders as
the progress on the LAP continues. In future updates, EPA will provide clear information on
schedule changes to the current project milestones of LAP projects.
OIG Response 33: The Agency disagreed with Recommendation lc. However, we do
concur that the Agency has provided information to stakeholders although our report
does not fully support that complete information has always been provided. Therefore,
Recommendations lc is unresolved with dispute actions pending.
2a) Assistant Administrator for Solid Waste and Emergency Response, Assistant
Administrator for Research and Development, and Region 8 Regional Administrator:
Establish a charter to define project roles and responsibilities for completing the remaining
corrective actions under the Libby Action Plan.
EPA Response: Nonconcur
The OIG Draft Report does not support a finding that the current tri-chair structure with a
LAP Coordinator is ineffective.
Alternative Remedy: No corrective action needed. EPA does not believe establishing a
formal charter is necessary to address the OIG's concern with respect to communicating
project milestones.
OIG Response 34: The Agency disagreed with Recommendation 2a. We disagree that
the purpose of the charter is to communicate project milestones. The purpose of the
recommendation is to help EPA improve its management of the completion of the
remaining LAP studies. The report shows that OSWER, ORD, and Region 8 oversaw
initial efforts under the Libby Action Plan, discussed cross-coordination efforts within
EPA, and approved funding. However, each member was only responsible for the
Libby Action Plan studies assigned to them and no office has the authority to oversee
the actions of all offices. Therefore, a single entity did not have the authority to review
the causes for the delays and to offer remedies. As a result, EPA distributed the LAP
to stakeholders with the knowledge that the milestones were not achievable,
contracting issues delayed the development of the noncancer value, an interagency
agreement was used to avoid EPA contracting personnel, competing priorities and
unanticipated work delayed development of the cancer value, and communications
with stakeholders could be improved. Therefore, Recommendation 2a is unresolved
with dispute actions pending.
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2b) Assistant Administrator for Solid Waste and Emergency Response, Assistant
Administrator for Research and Development, and Region 8 Regional Administrator:
Determine whether the SAB or another organization will review the completed risk
assessment.
EPA Response: Nonconcur
An additional peer review is unnecessary and would delay final remedy selection and
finalization of the Record of Decision for the Libby Superfund site. Site-specific risk
assessments represent the application of EPA policies and guidance. They are released for
public comment but do not undergo a separate expert peer review since any influential
scientific information on which they rely has already undergone peer review. As the Libby
amphibole asbestos toxicity assessment is currently being reviewed by the SAB and the
Libby site-specific risk assessment will be based on the peer-reviewed toxicity values, it is
unclear what would be accomplished by a second SAB review.
Alternative Remedy: No corrective action needed.
OIG Response 35: The Agency disagreed with Recommendation 2b. However,
the Agency proposed action is responsive to the recommendation as the Agency
has committed to have the LATAG review and comment on the risk assessment.
Therefore, Recommendation 2b is unresolved with dispute actions pending.
3a) Deputy Administrator Direct the SAB to determine and report on whether EPA has
followed guidance sufficient to support the findings in the Libby toxicity assessment.
EPA Response: Nonconcur
The SAB is currently conducting an independent scientific peer review of the External
Review draft of the Toxicological Review of Libby Amphibole Asbestos. The SAB conducts
its peer review in the context of EPA guidelines on risk assessment along with their own
expert knowledge of the characteristics of asbestos, toxicity assessment, and exposure-
response analysis done for purposes of cancer and non-cancer risk evaluation. The questions
posed by EPA to the SAB are presented in the public "charge" to the Board. That charge
includes specific questions on the key issues in the assessment and makes explicit reference
to EPA guidances, such as the Guidelines for Carcinogen Risk Assessment (U.S. EPA, 2005)
and to EPA's Draft Benchmark Dose Technical Guidance (EPA, 2000).
The OIG provides no rationale as to why an additional or different peer review of the
Toxicity Assessment by the SAB is needed. The SAB is anticipating making their final
recommendations to the EPA Administrator in December, 2012. EPA does not agree that any
additional review of the Toxicity Assessment is needed from the SAB.
Alternative Remedy: No corrective action needed. EPA's position is that an additional
review by the SAB is neither warranted nor necessary.
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OIG Response 36: The Agency disagreed with Recommendation 3a. We note that the
recommendation does not require the SAB to perform an additional review. The
recommendation requires the SAB to comment on whether EPA followed sufficient
guidance to support the findings in the Libby toxicity assessment. The Agency
disagreed but stated that the information would be in the final SAB report regardless of
the OIG recommendation. Further, despite its disagreement, the Agency's proposed
action is responsive to the recommendation. Therefore, Recommendation 3a is
unresolved with dispute actions pending.
3b) Deputy Administrator direct the SAB to determine and report on whether limitations
exist in applying the cancer and noncancer values to the determination of acceptable levels
of exposure to asbestos in Libby.
EPA Response: Nonconcur
EPA is unclear what the OIG intends with the specific wording in the draft Recommendation
3b.
If the OIG intends that the SAB should provide advice on limitations of the Toxicological
Review or difficulties in its application; that issue is already being addressed per the specific
charge questions given to the SAB for their review of the Toxicological Review of Libby
amphibole asbestos. Response D.l provides details of these questions with respect to the
SAB's assessment of the "uncertainties and limitations" of the results of the toxicological
review.
Alternative Remedy: No corrective action needed. The SAB has already reviewed the
toxicity assessment and was asked by the Agency to identify "uncertainties and limitations."
The toxicity assessment does not set "acceptable levels" for specific sites.
OIG Response 37: The Agency disagreed with Recommendation 3b despite the EPA
Deputy Chief of Staff stating that the requested information would be in the final SAB
report. Therefore, Recommendation 3b is unresolved with dispute actions pending.
4) Region 8 Regional Administrator ensure that future contracts issued through
interagency agreements are within the scope of those agreements.
EPA Response: Nonconcur
Region 8 adheres to the Federal Acquisition Regulations (FAR) with regard to Interagency
Agreements (IAs). As such, Region 8 has ensured that work assignments issued through IAs
are within the scope of those agreements and will continue to do so. The EPA disagrees with
the OIG finding that the contract work was outside of the scope of the IA.
Alternative Remedy: No corrective action needed. Region 8 adheres to the FAR with regard
to IAs.
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OIG Response 38: The Agency disagreed with Recommendation 4. In response to the
OIG finding, Region 8 officials stated they adhered to the Federal Acquisition
Regulations (FAR) as authority for using the Volpe Center interagency agreement to
award the contract to the University of Cincinnati. The Agency did not adhere to FAR
Subpart 17.5, "Interagency Agreements Under the Economy Act." The Economy Act
applies when specific statutory authority does not exist. The report indicates that the
Agency use of the Libby Clean-up IAG to award a contract to the University of
Cincinnati exceeded the scope of work under the agreement between Region 8 and the
Volpe Center. The Agency also does not cite compliance with any particular FAR
requirement that would override the Compendium and the interagency agreement terms.
Therefore, this recommendation is unresolved with dispute actions pending.
5) Assistant Administrator for Research and Development develop a priority list for
pending and ongoing research.
EPA Response: Nonconcur
EPA strongly disagrees with any OIG findings or implications that other toxicity assessments
being conducted by ORD were not of equally high public health consequence. The OIG did
not evaluate the public health impacts of any of the other Toxicological Assessments being
conducted by EPA. They did not, for example, evaluate the public health significance of
completing assessments of the toxicity of formaldehyde, trichloroethylene (TCE), or
perchloroethylene (PERC). TCE and PERC are constituents of concern at over 700 sites on
the National Priorities List, and formaldehyde is a chemical with very widespread exposure
in both indoor and outdoor air. All of these assessments were nominated and selected per the
IRIS process described above.
Alternative Remedy: No corrective action needed. EPA believes the existing prioritization
approach used by ORD/ National Center for Environmental Assessment (NCEA) is
appropriate and adequate. In November 2012, EPA reconsidered this response. EPA provided
additional information for the selection of formaldehyde work over Libby work and
requested a change to the recommendation to require the Assistant Administrator for ORD to
review priority ranking among the ongoing IRIS assessments and that he be informed of any
recommended changes in those relative priorities.
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OIG Response 39: The Agency disagreed with Recommendation 5. We disagree
that the report states that other assessments were not of an equally high public health
consequence. Rather, EPA could not tell the OIG what the existing prioritization
approach was and how EPA made the determination to complete other work instead
of the Libby cancer study. Specifically, EPA made the management decision to
complete formaldehyde work, which resulted in some delay in completing the Libby
cancer study. We requested that EPA provide the rationale for this decision given
the noted health implications of the Libby cancer study. During the review, EPA
responded that the NCEA Director made the decision to complete the formaldehyde
assessment even if that meant some delays in the Libby cancer assessment. In these
comments, EPA states that the OIG did not evaluate the public health impacts of any
of the other Toxicological Assessments being conducted by EPA. However, this
concerns the EPA rationale for a decision that it had already made. Given that EPA
could not provide a health based rationale, we recommended that EPA develop a
process to determine priority in completing assessments. Therefore,
Recommendation 5 is unresolved with dispute actions pending.
Deputy Chief of Staff Comments
That OIG recommended that the Deputy Administrator direct the Science Advisory Board (SAB)
to determine whether:
a. EPA has followed guidance sufficient to support the findings in the toxicity
assessment; and
b. Limitations exist in applying the cancer and noncancer values to the determination of
safe levels in Libby.
1. Review Comment: We do not concur with the recommendation. The recommendation is not
warranted because the SAB is in the process of completing a peer review of ORD's Draft
Toxicological Review of Libby Amphibole Asbestos. The SAB review report will address
strengths and limitations of ORD's draft assessment for the derivation on noncancer and cancer
toxicity values.
OIG Response 40: Although EPA does not agree with our Recommendations (3a and
3b), the action specified through information to be addressed in the SAB report meets the
intent of the recommendation. These Recommendations requires the SAB to comment on
whether EPA followed sufficient guidance to support the findings in the Libby toxicity
assessment; and, whether limitations exist in applying the cancer and non-cancer values
to the determination of safe levels in Libby. Therefore, Recommendation 3a and 3b
remain unresolved pending dispute resolution actions.
2. Review Comment: The OIG draft report includes certain statements made by the SAB Staff
Office Director concerning some preliminary SAB review comments on the Draft Toxicological
Review of Libby Amphibole Asbestos. The SAB review is still ongoing and, therefore, it is not
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appropriate to include SAB review comments in the OIG report. The SAB review report is
expected to be completed in October 2012. We strongly recommend deletion of the 4th, 5th, and
6th bullets on p. 13 of the draft report.
OIG Response 41: The statements made by the former SAB Director are in response to
questions posed by the OIG and are not taken from the SAB draft report. However, the SAB's
final report is public. The SAB's report cited several areas that need more consideration, and
provided recommendations to further enhance the clarity and strengthen the scientific basis
for the conclusions presented in the draft toxicity assessment. Therefore, we find no
justification to delete the text.
3. Review Comment: The first bullet on page 14 referring to the former SAB Director's
statement about availability of information and data for SAB review is not specific to the Libby
Asbestos toxicity assessment and should be deleted. This is a general statement about SAB
experience in reviewing many EPA technical documents over the years. With regard to the
ongoing SAB review of Libby Asbestos toxicity assessment, the SAB panel has requested
additional data to verify the results of EPA analysis, and the Agency has been very responsive to
the SAB request.
OIG Response 42: The OIG does not ignore systemic weakness observed (EPA does not
provide all data to the SAB) when reviewing a specific topic such as the SAB review of the
toxicity assessment. The issue affects all assessments the SAB performs for EPA as
evidenced by the Deputy Chief of Staff who states, "This is a general statement about SAB
experience in reviewing many EPA technical documents over the years." The former SAB
Director stated that EPA did not provide all the data available on the toxicity assessment
without a specific request from them.
4. Review Comment: The OIG report states on page 14 (third paragraph) the "EPA and the
SAB should resolve issues relating to developing specific guidance on study selection and dose
response selection to improve the toxicity assessmentAs an external advisory body, the SAB
provides review comments and makes recommendations through written reports. The SAB
reports are advisory in nature, and the SAB has no(t) the authority to direct the agency or
negotiate with the agency regarding the SAB recommendations. Should SAB make specific
recommendations on this issue in its report, it is incumbent upon the agency to decide how to
implement the recommendations.
OIG Response 43: The report makes no such recommendation, as the OIG is aware that
the SAB has no authority to direct EPA actions. However, the EPA has turned to the SAB
for scientific review of its risk assessments. It does not appear constructive for EPA to
engage expert SAB panels but deny the panel information they believe is necessary to do
their jobs effectively. This is an insufficient response to address such a serious issue.
Resolution of the issues could reduce the limitations associated with SAB reviews of
future EPA risk assessments. Additionally, resolution of these issues could improve public
confidence in EPA risk assessments.
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Appendix E
Distribution
Office of the Administrator
Deputy Administrator
Assistant Administrator, Office of Solid Waste and Emergency Response
Assistant Administrator, Office of Research and Development
Regional Administrator, Region 8
Agency Follow-Up Official (CFO)
Agency Follow-Up Coordinator
General Counsel
Associate Administrator for Congressional and Intergovernmental Relations
Associate Administrator for External Affairs and Environmental Education
Principal Deputy Assistant Administrator, Office of Solid Waste and Emergency Response
Deputy Assistant Administrator, Office of Research and Development
Deputy Regional Administrator, Region 8
Director, Washington Division, National Center for Environmental Assessment,
Office of Research and Development
Director, Office of Superfund Remediation and Technology Innovation, Office of Solid Waste
and Emergency Response
Public Affairs Officer, Region 8
Audit Follow-Up Coordinator, Office of the Administrator
Audit Follow-Up Coordinator, Office of Solid Waste and Emergency Response
Audit Follow-Up Coordinator, Office of Research and Development
Audit Follow-Up Coordinator, Region 8
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