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OFFICE OF INSPECTOR GENERAL
Catalyst for Improving the Environment
Quick Reaction Report
EPA Needs to Plan and Complete a
Toxicity Assessment for the Libby
Asbestos Cleanup
Report No. 2007-P-00002
December 5, 2006
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Abbreviations
AT SDR
Agency for Toxic Substances and Disease Registry
CAG
Community Advisory Group
EPA
U.S. Environmental Protection Agency
NCP
National Contingency Plan
NPL
National Priorities List
NTP
National Toxicology Program
OIG
Office of the Inspector General
OSWER
Office of Solid Waste and Emergency Response
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U.S. Environmental Protection Agency
Office of Inspector General
At a Glance
2007-P-00002
December 5, 2006
Catalyst for Improving the Environment
Why We Did This Review
At the request of both Montana
Senators, the Office of Inspector
General (OIG) initiated this review of
the U.S. Environmental Protection
Agency's (EPA's) efforts to clean up
amphibole asbestos contamination in
Libby, Montana. We are issuing this
quick action report to bring EPA
management's immediate attention to
significant, time-critical issues we
identified during our limited review.
Background
After 1999 media reports called
attention to Libby citizens' health
problems, EPA officials requested
that we review EPA's actions. Also
in 1999, EPA began a cleanup of
Libby asbestos contamination. In
January 2000, due to citizen
concerns, EPA started sampling and
analyzing lawn and garden products
that contained vermiculite. In
March 2001, we reported that EPA
had addressed asbestos contamination
at other sites, but failed to institute
regulations or other controls that
might have protected Libby's citizens
from the health effects of asbestos
contamination. In 2002, EPA began
an emergency response cleanup of
Libby residential and commercial
properties.
For further information, contact our
Office of Congressional and Public
Liaison at (202) 566-2391.
To view the full report,
click on the following link:
www.epa.qov/oiq/reports/2007/
20061205-2007-P-00002.pdf
EPA Needs to Plan and Complete A Toxicity
Assessment For the Libby Asbestos Cleanup
In our limited review, we identified the following significant issues that we
believe are critical to a successful cleanup in Libby, Montana.
• EPA has not completed a toxicity assessment of amphibole asbestos
necessary to determine the safe level for human exposure; therefore,
EPA cannot be sure that the Libby cleanup sufficiently reduces the risk
that humans may become ill or, if ill already, get worse.
• EPA's public information documents Living with Vermiculite and
Asbestos in Your Home are inconsistent about safety concerns.
We recommend EPA:
• 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 Board1 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.
• 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.
1 Congress established the EPA Science Advisory Board in 1978, in part, to review the guidelines governing the use of scientific and
technical information in regulatory decisions.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
INSPECTOR GENERAL
December 5, 2006
MEMORANDUM
SUBJECT: EPA Needs to Plan and Complete a Toxicity Assessment for the
Libby Asbestos Cleanup
Report No. 2007-P-00002
Deputy Administrator
Susan Parker Bodine
Assistant Administrator for Solid Waste and Emergency Response
Robbie Roberts
Region 8 Administrator
This report contains time-critical issues the Office of Inspector General (OIG) identified during
the limited work performed on this review, and proposes corrective actions. This report
represents the opinion of the OIG and does not necessarily represent the final position of the U.S.
Environmental Protection Agency (EPA). EPA managers will make final determinations on
matters in this report.
Action Required
Please provide a written response to this report within 30 calendar days. You should include a
corrective action plan for agreed upon actions, including milestone dates. We have no objections
to the further release of this report to the public. This report will be available at
http://www.epa.gov/oig.
You may contact me at (202) 566-0847 or roderick.bill@epa.gov. or Eileen McMahon at
(202) 566-2391, if you have any questions concerning this report.
TO:
Marcus Peacock
Sincerely,
-BttfTSTRoderick
Acting Inspector General
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Purpose
On August 22, 2006, the Office of Inspector General (OIG) initiated a project to review EPA's
efforts to clean up amphibole asbestos contamination in Libby, Montana (Region 8). The
impetus for the review was two congressional requests to evaluate whether potential problems
exist with the Libby asbestos National Priorities List (NPL) site cleanup. In our limited work to
date, we identified some issues, which we believe to be of imminent concern, and are presenting
them in this report.
The preliminary review objective was to determine whether the U.S. Environmental Protection
Agency's (EPA's) Office of Solid Waste and Emergency Response (OSWER) and Region 8
personnel developed and executed an effective cleanup based upon Federal requirements that
protect human health. However, once we determined that EPA had not followed its own
guidance regarding the conducting of a toxicity assessment, we felt it necessary to bring the issue
up for immediate attention and resolution because - as reported to EPA by the Agency for Toxic
Substances and Disease Registry (ATSDR) in their assessment on public health in Libby in 2003
- "people in the Libby area have elevated levels of disease, and death, associated with exposure
to asbestos."
Background
The National Contingency Plan (NCP) governs the clean up of NPL sites. The NCP requires
EPA conduct a remedial investigation and a (baseline) risk assessment for all NPL sites. The
NCP designates ATSDR, a component of the Department of Health and Human Services, as the
responsible agency for performing public health assessments for NPL sites. The NCP also states
that the responsible agency shall keep the public informed about the cleanup progress.
On May 28, 2003, ATSDR released the final version of its report, Public Health Assessment for
the Libby NPL site, Operable Unit 4, Town of Libby and Affected Libby Valley Residential and
Commercial Properties. The report concluded in part, that the citizens of Libby were exposed to
hazardous levels of asbestos, and had elevated levels of disease and death from exposure to
asbestos. It also recommended, in part, that EPA conduct a toxicological investigation (toxicity
assessment) and epidemiology studies. (See more information about asbestos in Appendix A,
Background of Libby Asbestos.)
Toxicology. In their Public Health Assessment report, ATSDR defines toxicology as the study
of the harmful effects of chemicals on humans or animals.2 The National Toxicology Program
(NTP), a component of the Department of Health and Human Services, states that they generally
perform tests on rodents to determine the toxicity of substances.
Epidemiology. ATSDR's Public Health Assessment report also defines epidemiology as the
study of different factors that determine how often, in how many people, and in which people
2 This sentence, corrected in January 2007, originally stated the definition as "the study of the harmful effects of
chemicals on humans and animals."
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disease will occur. The NTP states that toxicology studies along with epidemiology studies are
the best means available for identifying potential human hazards.
Superfund cleanups go through two phases before they are considered complete: the emergency
response phase and the remedial action phase. While in the emergency response mode, the
emphasis is on removing "hot spots," or areas of high contamination. During the remedial action
mode of a Superfund cleanup, risk is established through a formal, step-by-step, scientific
process for quantifying health risks to humans called a risk assessment.
OSWER staff and EPA Region 8 personnel acknowledge the importance of the toxicity
assessment. Specifically, Region 8 defines the risk assessment as a formal step-by-step scientific
process for quantifying human health risks. Region 8's Human Health Risk Assessment
procedures for Libby asbestos identify the toxicity assessment as central to completing the risk
assessment.
Scope and Methodology
We conducted our review from August 22, 2006, to November 22, 2006. However, many of the
significant facts surfaced during a related OIG investigation, which began on March 9, 2006, and
is ongoing. We included this data in our review as well. We interviewed (or obtained responses
from) EPA's OSWER (senior officials and staff) and Region 8 personnel, and obtained
documents related to the issues dated from 1990 to 2006. We are issuing this quick action report
to bring to management's immediate attention significant issues we identified during our initial
review. Specifically, the objective of this quick action report is to ensure that EPA fully
considers the role of toxicology in the remaining clean up of asbestos contamination in Libby.
Preliminary Findings
EPA has neither planned nor completed a risk and toxicity assessment of the Libby amphibole
asbestos to determine the safe level of human exposure. Thus, EPA cannot be sure that the
ongoing Libby cleanup is sufficient to prevent humans from contracting asbestos-related
diseases. Also, EPA presented inconsistent positions on safety issues in two public information
documents. EPA issued Living with Vermiculite to Libby residents in October 2003; the other,
Asbestos in Your Home, is now on the EPA Internet Website.
Risk and Toxicity Assessments
EPA personnel stated that the Libby cleanup, which began in 1999, was limited to removing the
most visible and prevalent signs of danger to the community. We agree that it was appropriate to
conduct these initial cleanup actions, and they should continue. However, EPA has no way to
determine whether the initial removals sufficiently reduced the risk that Libby residents would
become ill or get sicker. EPA personnel informed us that this is the case because EPA had not
completed an amphibole asbestos risk assessment. A risk assessment includes:
• data collection (site, history, exposure potential, contaminant type and distribution),
• exposure assessment (how much and in what ways exposure can occur),
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• toxicity assessment (potential of the contaminants to cause harmful effects to
humans), and
• risk characterization (integrates previous steps to calculate risk to humans).
The key element of the risk assessment, which the Agency has not completed, is the toxicity
assessment. A toxicity assessment is necessary to determine the safe level of amphibole asbestos
exposure for humans.
OSWER Studies of Libby Asbestos
We have had extensive conversations and correspondence with OSWER officials regarding
EPA's nonperformance of a toxicity assessment of the Libby asbestos. OSWER officials
responded that a toxicity assessment was proposed but denied for two reasons: (1) EPA did not
approve the budget request and (2) OSWER believed that they could obtain the information they
needed to determine the toxicity of Libby asbestos based on other epidemiology studies
(completed and ongoing).
OSWER Epidemiology Work. As evidence that they did not ignore Libby asbestos toxicity
assessment work, OSWER officials cited EPA's funding, for several years, a number of efforts
to assess hazard and risk. Those efforts included various epidemiological studies, and the
updating of the Integrated Risk and Information System for cancer and non-cancer endpoints.
However, that work does not include ATSDR defined toxicology (animal) studies. In addition,
OSWER staff, as distinguished from OSWER officials, stated that:
• The work ongoing and planned was not sufficient to determine the toxicity of the Libby
asbestos.
• A toxicity assessment could take up to 2 years and should include assessing the effects of
amphibole asbestos exposure on children.
Benefits of Toxicology and Epidemiology. Toxicology and epidemiology are not the same
although they share the same goal of determining the hazardous effect of a substance on humans.
Toxicology specifically determines the harmful effects on humans through animal testing.
Epidemiology attempts to forecast how often a person gets sick, who gets sick, and how many
people get sick. The NTP suggests that together, toxicology and epidemiology are the best
means available for identifying potential human hazards. ATSDR agrees with the NTP
suggestion that the studies together would be protective of human health. In their Public Health
Assessment report, ATSDR:
• Concluded that Libby residents could still be exposed to hazardous levels of asbestos, and
that these levels could be especially hazardous to sensitive populations (adults previously
exposed or who smoked, and young children).
• Recommended that EPA conduct a toxicity assessment to help determine whether the
chemical makeup and fiber size found in Libby pose additional risks.
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In addition, an ATSDR official stated the epidemiology studies alone could not reliably provide
this information due to the uncertainty associated with determining the level and duration of
Libby asbestos exposure in individuals who are tested.
Therefore, we do not agree that OSWER can characterize epidemiology work as toxicology
work, or that epidemiology work alone is sufficient to protect human health. We do agree that
the epidemiology work is a key component in protecting human health in Libby, and that work
should continue.
OSWER Guidance. OSWER has not ruled out performing a toxicity assessment in the future;
however, they stated that in the guidance they prefer to use, a toxicity assessment was not
necessary. Specifically, OSWER cited EPA's March 2005 Guidelines for Carcinogen Risk
Assessment.
"When human data of high quality and adequate statistical power are available,
they are generally preferable over animal data and should be given greater weight
in hazard characterization and dose-response assessment, although both can be
used."
Additionally, OSWER cited EPA's December 2002 A Review of the Reference Dose and
Reference Concentration Process:
"Adequate human data are the most relevant for assessing risks to humans. When
sufficient human data are available to describe the exposure-response relationship
for an adverse outcome(s) that is judged to be the most sensitive effect(s),
reference values should be based on human data."
Neither document is official policy for EPA personnel. Specifically:
• Guidelines for Carcinogen Risk Assessment does not establish any substantive rules and
has no binding effect on EPA and any regulated entity.
• A Review of the Reference Dose and Reference Concentration Process is a review, not
guidance, but makes recommendations that users should consider.
We agree that human studies would provide better data; however, ATSDR recognized that, for
ethical reasons, personnel could not perform toxicity tests on humans. Further, the documents do
not discourage the use of animal studies; rather, they state their importance and how researchers
can use animal data with, or instead of, human data. Specifically:
• Guidelines for Carcinogen Risk Assessment states that epidemiologic (human) studies
that show elevated cancer risk that correspond to findings in animal studies strengthen the
evidence of human carcinogenity. The document also states that actual exposure
measurements are not available for many retrospective (past events) epidemiology
studies, which could lead to misclassifications (individuals placed in the incorrect
exposure group). That in turn could reduce the reliability of the epidemiology study.
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• A Review of the Reference Dose and Reference Concentration Process states that when
sufficient human data are not available, users must employ animal studies. However, it
would be advantageous to compare the animal data with human data even if the human
data is not quantifiable to determine whether toxicity occurs in the same organs and the
nature of the effect is similar.
Communication with Libby Residents
Region 8 personnel stated that because EPA does not know the toxicity of amphibole asbestos,
EPA cannot substantiate the accuracy of any communication with Libby residents that says that
the removal process eliminated the danger of contracting asbestos-related diseases. Region 8
recently changed the leadership managing the Libby removal process. The new Remedial
Program Manager stated that he has not reviewed all the communications that his predecessor
had with Libby residents.
Living with Vermicuiite
In Living with Vermicuiite, EPA recommended that Libby homeowners not disturb asbestos
because no guidelines exist on what is or is not safe. However, the document then states that
homeowners would have little risk of exposure if they handle asbestos to clean up an undefined
small release of asbestos. We believe this recommendation is inconsistent with the uncertainty
of the dangerous levels of exposure. Potentially, Libby homeowners could expose themselves to
dangerous levels of amphibole asbestos if they interpret the document to mean that no significant
risks exist.
Asbestos in Your Home
Asbestos in Your Home, a document on the EPA Internet Website, was a product of a workshop
with the American Lung Association and the Consumer Product Safety Commission. It provides
information similar to that found in Living with Vermicuiite. In this document, EPA defines a
small release of asbestos to be no larger than a homeowner's hand. Contrary to the EPA
position, the American Lung Association warns that the homeowner should not attempt to
remove or repair any level of asbestos. EPA does not address the difference in opinion with the
American Lung Association so homeowners could make a fully informed decision regarding
handling asbestos.
Developments
EPA Region 8 personnel have begun to address concerns with the Libby cleanup and EPA's
communications with Libby residents, as evidenced in the minutes of the August and September
2006 Community Advisory Group (CAG) meetings, posted on EPA's Website. Specifically,
EPA personnel responded that new information, from toxicity assessment, might indicate that
Libby homes may not be as safe as EPA thought and that EPA may have to do additional
cleanup. EPA personnel agreed to participate in a panel to redraft Living with Vermicuiite
because an audience member stated that the document promoted a lackadaisical attitude toward
the asbestos contamination. Additionally, the Acting Deputy Director for the Office of
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Superfund Remediation and Technology Innovation and Region 8 personnel stated that EPA had
removed the Living with Vermiculite document from the EPA Website on October 11, 2006, as a
result of consultations with the CAG, and EPA is reviewing the Asbestos in Your Home
document. We believe the actions of OSWER and Region 8 personnel, coupled with our
recommendations, will help to ensure a swift and effective cleanup.
Recommendations
1. We recommend that EPA fund and execute a comprehensive amphibole asbestos toxicity
assessment to determine (1) the effectiveness of the Libby removal actions, and (2) to
determine whether more actions are necessary. The toxicity assessment should include
the effects of asbestos exposure on children. The EPA Science Advisory Board 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. We recommend that EPA 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.
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Appendix A
Background of Libby Asbestos
ATSDR is tracking the human health effects of Libby asbestos in 28 locations throughout the
country that received over 80 percent of the Libby vermiculite. In What is Asbestos?, ATSDR
makes the following statements regarding vermiculite and asbestos contamination in Libby
Montana.
Vermiculite Production. Zonolite Mountain in Libby produced vermiculite for more
than 65 years (until 1990). The mine itself is approximately 6 miles from the town. A
transfer facility was located approximately 3 miles from Libby. From the transfer facility,
vermiculite was loaded on trains or trucks. Two expansion ("popping") facilities operated
at different times within the town; these plants heated vermiculite to approximately 600
degrees Fahrenheit to expand the crystals. One of these facilities was next to a baseball
field, which was readily accessible to the community's children.
Types of Asbestos. There are two general types of asbestos, amphibole and chrysotile.
Some studies show that amphibole fibers stay in the lungs longer than chrysotile. This
tendency may account for their increased toxicity (harmfulness to the body). Regulatory
agencies such as EPA and the Occupational Safety and Health Administration recognize
six asbestos minerals: chrysotile, a serpentine mineral with long and flexible fibers; and
five amphibole (with relatively brittle crystalline fibers) minerals, actinolite asbestos,
tremolite asbestos, anthophyllite asbestos, crocidolite asbestos, and amosite asbestos.
Libby Asbestos. Vermiculite is usually free of asbestos. However, the vermiculite ore
taken from a mining operation in Libby contained asbestiform (asbestos-like) amphibole
minerals, including the regulated forms tremolite and actinolite. The vermiculite also
contains winchite, richterite, and ferroedenite asbestos, which the U.S. does not currently
regulate. Research has linked all of these forms to asbestos related diseases.
Asbestos Risk Factors. The heating process released asbestos fibers from the
vermiculite ore into the air. Inhalation of asbestos fibers suspended in air can result in
lung diseases such as asbestosis, mesothelioma, and lung cancer. The risk of developing
any of these diseases depends on many factors, including the type of fiber, the level and
duration of exposure, and the smoking history of the exposed individual.
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Appendix B
Distribution
Office of the Administrator
Assistant Administrator for Solid Waste and Emergency Response
Deputy Assistant Administrator for Solid Waste and Emergency Response
Audit Followup Coordinator, Office of Solid Waste and Emergency Response
Administrator, Region 8
Deputy Administrator, Region 8
Audit Followup Coordinator, Region 8
Agency Followup Official (the CFO)
Agency Followup Coordinator
Associate Administrator for Congressional and Intergovernmental Relations
Associate Administrator for Public Affairs
General Counsel
Acting Inspector General
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