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 

Scan this mobile 

code to learn more 

about the EPA OIG. 
 

 

Report Contributors: Benjamin Beeson 

Ming D. Chang 

 Dwayne E. Crawford 

 Bram Hass 

 Eric Lewis 

 Ryan Patterson 

 Rodney Rice 

 Johnny Ross 

Abbreviations 

ATSDR 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: 

fax: 

1-888-546-8740 

202-566-2599 

1200 Pennsylvania Avenue, NW 

Mailcode 2431T 

online: http://www.epa.gov/oig/hotline.htm Washington, DC 20460 
 

Planned Agency Corrective Actions

U.S. Environmental Protection Agency 13-P-0221 

April 17, 2013 Office of Inspector General 

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.gov/oig/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. 
 

 

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 

FROM: Arthur A. Elkins Jr. 

TO: See Below 

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 
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.carolyn@epa.gov; or Eric Lewis, Director, 

Special Reviews, at (202) 566-2664 or lewis.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 
 

 

 

 

 

 

 

 

 

 

 

 

Better Planning, Execution and Communication 13-P-0221 

Could Have Reduced the Delays in Completing a 

Toxicity Assessment of the Libby, Montana, Superfund Site 

Table of Contents 

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 
 

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. 

13-P-0221 1 
 

 

 

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. 

13-P-0221 2 
 

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 

13-P-0221 3 
 

 

 

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 

organizations—along with ORD/NCEA, NIOSH, and ATSDR—responsible 

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. 

13-P-0221 4 
 

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. 

13-P-0221 5 
 

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. 

13-P-0221 6 
 

 

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 

13-P-0221 7 
 

 

 

 

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. 

13-P-0221 8 
 

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 

13-P-0221 9 
 

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. 

13-P-0221 10 
 

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 

13-P-0221 11 
 

 

 

 

 

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. 

13-P-0221 12 
 

 

 

 

	 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. 

13-P-0221 13 
 

 

 

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 

13-P-0221 14 
 

 

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. 

13-P-0221 15 
 

 

 

 

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. 

13-P-0221 16 
 

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. 

13-P-0221 17 
 

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 1a, 

and disagreed with Recommendations 1b, 1c, 2a, 2b, 3a, 3b, 4 and 5. 

Recommendation 1a 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 1a, including a proposed action plan and 

completions dates, within 60 calendar days of the report issuance. 

However, Recommendations 1b, 1c, 2a, 2b, 3a, 3b, 4 and 5 remain unresolved, 

pending dispute-resolution actions. The dispute-resolution process starts 

immediately upon report issuance. 

13-P-0221 18 
 

 

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 assessment(s) 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 

13-P-0221 19 
 

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, 2013—First complete draft of revised toxicological 

review and comment disposition. 

 January 14, 2014—Revised draft to go to Interagency and Agency 

reviewers. 

 April 25, 2014—Revised draft to final clearance. 

 June 24, 2014—Post 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 

13-P-0221 20 
 

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. 

13-P-0221 21 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Status of Recommendations and 

Potential Monetary Benefits 

POTENTIAL MONETARY 

RECOMMENDATIONS BENEFITS (in $000s) 

Planned 

Rec. 

No. 

Page 

No. Subject Status1 Action Official 

Completion 

Date 

Claimed 

Amount 

Agreed-To 

Amount 

1 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. 

U

 U

Assistant Administrator 

for Solid Waste and 

Emergency Response, 

and Region 8 

Regional Administrator 

c. Distribute original and revised plans to 

stakeholders.

 U 

2 17 a. Establish a charter to define project roles and 

responsibilities for completing the remaining 

corrective actions under the Libby Action 

Plan. 

U Assistant Administrator 

for Solid Waste and 

Emergency Response, 

Assistant Administrator 

b. Determine whether the SAB or another 

organization will review the completed risk 

assessment.

 U for Research and 

Development, 

and Region 8 

Regional Administrator 

3 18 Direct the SAB to determine and report on whether: Deputy Administrator 

a. EPA has followed guidance sufficient to 

support the findings in the Libby toxicity 

assessment. 

U

b. Limitations exist in applying the cancer and 

noncancer values to the determination of 

U 

acceptable levels of exposure to asbestos in 

Libby.

4 18 Ensure that future contracts issued through 

interagency agreements are within the scope of 

those agreements.

 U Region 8 

Regional Administrator 

5 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 

U Assistant Administrator 

for Research and 

Development 

consequences.

O = 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. 

13-P-0221 22 

1 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Appendix A 

Name and Ranking of Studies Under 

the Agency’s Libby 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. 

13-P-0221 23 
 

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 sitespecific 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.http://www.epa.gov/oswer/riskassessment/ragsa/index.htm 

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. 

http://www.epa.gov/superfund/health/contaminants/asbestos/pdfs/framework_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 activitybased 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. http://www.epa.gov/oswer/riskassessment/ragsf/index.htm. 

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. 

http://www.epa.gov/oswer/riskassessment/rags3adt/index.htm 

This guidance provides methods for alternative approaches for the calculation of exposure 

and risk estimates based on statistical distributions rather than single point estimates. 

13-P-0221 24 
 

 

Appendix C 

Toxicity Assessment Guidance 

1.	 EPA. 1986b. Guidelines for mutagenicity risk assessment [EPA Report]. (EPA/630/R98/003). Washington, D.C. http://www.epa.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/cfm/recordisplay.cfm?deid=186068. 

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/cfm/recordisplay.cfm?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. 

http://www.epa.gov/raf/publications/useof-bda-healthrisk.htm. 

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. 

http://www.epa.gov/raf/publications/pdfs/REPRO51.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. 

http://www.epa.gov/raf/publications/benchmark-dose-doc-draft.htm. 

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. http://www.epa.gov/osa/spc/pdfs/rchandbk.pdf. 

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. 

http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?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) 

13-P-0221 26 
 

 

10. EPA. 2005a. Guidelines for carcinogen risk assessment. (EPA/630/P-03/001F). 

Washington, D.C. http://www.epa.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/cfm/recordisplay.cfm?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.htm. 

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. 

13-P-0221 27 
 

 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. 

13-P-0221 28 
 

` 

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 

ranking.” This 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. 

13-P-0221 31 
 

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. 

13-P-0221 32 
 

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. 

13-P-0221 33 
 

 

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 of Libby 

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. 

13-P-0221 34 
 

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. 

InterAgency 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. 

13-P-0221 35 
 

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. 

13-P-0221 36 
 

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. 

13-P-0221 37 
 

 

Recommendation Comments 

1a) 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 1a 

status is unresolved pending an action plan with completion dates (when determined) 

for the agreed-to recommendations. 

1b) 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 1b, even though 

they have agreed to keep stakeholders informed in Recommendation 1.a. Therefore, 

Recommendations 1b is unresolved with dispute actions pending. The dispute 

resolution process starts within 30 calendar days of the report issuance. 

1c) 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 

13-P-0221 38 
 

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 1c. 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 1c 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. 

13-P-0221 39 
 

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 exposureresponse 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.1 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. 

13-P-0221 41 
 

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. 

13-P-0221 42 
 

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 

13-P-0221 43 
 

 

 

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 assessment.” As 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. 

13-P-0221 44 
 

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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