Good morning, I am Dr. Henry Falk, and I am the Assistant Administrator of the Agency for Toxic Substances and Disease Registry (ATSDR), a public health agency within the U.S. Department of Health and Human Services (HHS). I am accompanied by Sharon Campolucci, RN, MSN, Deputy Director of the ATSDR Division of Health Studies; she was coordinator of the medical testing program in Libby.

Senator Baucus, ATSDR is grateful for the interest and support given by you and other members of the Montana delegation since we began working in Libby in late 1999. As you know, we came to Libby in response to concerns expressed by yourself, community members, former vermiculite mine workers, and the health department. Over the last several years, we have worked very closely with the U.S. Environmental Protection Agency (EPA) to address these concerns. Without the support of all of you we would not be able to report today on the significant progress we have made in evaluating the public health issues in the Libby, Montana, area.

Congress created ATSDR in 1980 under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), or what is more commonly known as the Superfund legislation. CERCLA mandates of ATSDR a broad, national program of Superfund site health assessments, health investigations, surveillance and registries, applied research, emergency response, health education, and toxicological database development. Broadly speaking, ATSDR's responsibilities under Superfund, the Resource Conservation and Recovery Act (RCRA), and other federal statutes are to assess the effects of toxic substances on community populations and to recommend interventions to protect public health where they are needed. This may include medical screening and epidemiologic investigations of health effects of community populations exposed to hazardous substances; ATSDR undertook these activities in Libby. We also conduct investigations to measure human exposure to toxic substances released from waste sites or other sources of release. We conduct our work in close collaboration the U.S. Environmental Protection Agency (EPA), state health departments, local health agencies, and affected communities.

Since being called upon in November 1999, ATSDR has been actively involved with the citizens and public health and environmental officials to determine the extent of harm to humans from asbestos-contaminated vermiculite that was mined in Libby.

In the earliest days of our involvement in Libby, we developed a plan to help guide site-related public health activities. As we have shared with you in the past, this Public Health Response Plan identifies the areas of responsibilities for the conduct of our health-related activities. All stakeholders, including officials and the affected community, provided input throughout the process of both developing and implementing the Public Health Response Plan. The plan describes specific activities that are designed to prevent exposures and to mitigate or prevent adverse health effects. Key elements targeted in the plan were:

1) to provide community-based medical testing to determine the health status of exposed people;

2) to assess disease and illness trends to characterize the impact of the environmental exposure;

3) to provide a public health education program to assist residents in obtaining full and up-to-date information on asbestos-related risks and diseases; and

4) to collect and analyze medical and epidemiologic data to better characterize the nature and extent of asbestos-related disease in the community.

Following are updates on activities that resulted from this action plan.

Medical testing

From July to November 2000, ATSDR staff conducted medical tests on current and former residents of the northwest Montana town. Participants included 6,149 adults who lived, worked, or played in Libby for at least six months before December 31, 1990. Components of the testing included an in-depth questionnaire to build an exposure history for each of the participants, three x-ray views to identify changes in the lungs and lung lining that might be the result of asbestos exposure, and a spirometry test that measured air flow in and out of the lungs to measure lung function. Of those 5590 study participants 18 years of age and older who were eligible for x-ray testing, 18 percent (994) showed pleural abnormalities (chest wall scarring). According to data reported in the literature, the rates of pleural abnormalities in the United States among groups without known exposure to asbestos range from 0.2 to 2.3 percent.

Additional findings included:

! Forty-eight percent (159 of 328) of former W.R. Grace employees who participated in the medical testing had pleural abnormalities.

! Most participants reported multiple routes of exposure (household contact, occupational, recreational, and other) to the asbestos-contaminated vermiculite. For example, 24 percent of participants who reported six or more routes of exposure had pleural abnormalities.

! Five percent (6 of 122) of those participants who reported no apparent exposure had pleural abnormalities.

The second phase of initial medical testing was conducted between July and September 2001, and included 1,158 participants. Notification letters have been sent to these participants, and ATSDR is in the process of analyzing these new data and combining them with results from those tested in 2000. Once the analysis is completed, ATSDR will produce and make available to the community a final report combining results from both medical testing phases. The preliminary analysis of this combined data does not indicate any significant change in the prevalence of abnormalities when compared to data from the first phase of testing.

ATSDR is working to Alocalize@ the medical testing program B transitioning it to the state and local health departments with our ongoing technical and resource support.

Mortality review

In addition, after consultation with the National Institute for Occupational Safety and Health (NIOSH), CDC, we investigated an association between contaminated vermiculite and human health through a mortality review in which we compared death rates for residents of the Libby area with those in Montana, and the United States, for selected diseases that have been associated with asbestos. ATSDR staff reviewed death certificate data from 1979 to 1998 for the Libby community. The review focused on the underlying cause of death in Libby-area residents. We found that mortality from asbestosis in the Libby area was at least 40 to 60 times higher than expected. We also found that death from mesothelioma appeared to be elevated. This mortality review is continuing; additional data are being reviewed to support these early findings. We expect to release this mortality review by early July.

These two investigative tools B the medical testing and mortality review B clearly indicated a public health problem in Libby. Based on these findings, ATSDR recommended many follow-up activities, several of which already have been initiated.

! Working with a local pulmonary physician who treats referrals from the Libby area, ATSDR has conducted a focused review of patients with an asbestos related diagnosis and no known link to vermiculite mining. This review was conducted to address community concerns about environmental asbestos exposure outside the workplace. Final revisions for the report are now in progress and preliminary results will be released later this month.

! A computerized tomography (CT) scan study is nearly complete. This study was designed to evaluate the sensitivity of the medical screening tool (chest x-rays) and to help in planning possible future medical testing activities. All 353 scans have been completed and reviewed by expert CT radiologists, and letters providing individual scan findings have been sent to participants and their physicians. Analysis of these data for the study report is underway.

! Detailed planning and preparatory work has begun on the development of a registry to track former Libby-area miners and their household contacts. This focuses on the members of this community who were at greatest risk based on exposure levels and on the results of the medical testing program; a key source of registrants would be those who participated in the medical testing program. ATSDR sponsored a workshop in February to consult with and solicit advice from experts in pulmonology and asbestos-related disease to help guide the next steps for the Libby registry. The recommendations from this group will assist in addressing the concerns of the Libby community while also meeting ongoing surveillance needs and in the collection of valuable scientific data. In addition, the registry will help us stay in contact with all of the identified individuals and provide updated information on diagnosis and treatment options. The registry is intended to be a long-standing fixture that will not only be a repository of information about the registrants, but will also be a source of the latest information about treatments and other medical breakthroughs.

! ATSDR is working with the State to support localized planning to address future medical needs. Extended medical testing will need to continue in some form for many years. People who have tested positive will need to be followed to note any progression in the course of the disease. People who have tested negative to date, but who were substantively exposed, will also need periodic testing, but probably on a different schedule. Primary responsibility for the medical testing program will be transitioned to the State and local health department with ongoing technical and resource support from ATSDR.

! ATSDR worked in close cooperation with HHS Region VIII staff to help the community identify sources of assistance for medical care. In fact, HHS Deputy Secretary Claude Allen personally visited Libby last August and was instrumental in developing an HHS response. HHS now supports the Community Health Clinic (CHC) in Libby which provides primary health care services to people in the Libby area. ATSDR has also worked cooperatively with the Center for Asbestos Related Disease (CARD) in Libby. This facility, operated by St. John's Hospital, provides ongoing medical care for persons diagnosed with asbestos related medical conditions or those requiring further evaluation after undergoing initial medical testing.

! The Lincoln County Department of Environmental Health and the University of Montana in Missoula, in cooperation with ATSDR and the Montana Department of Public Health and Human Services, are organizing a research conference for later this month (June 24-26) to discuss current asbestos-related research and plan for future projects. Conference co-sponsors include EPA, the National Institute for Environmental Health Sciences, and the National Science Foundation.

! this June to facilitate development of the future research agenda related to the Libby site.

Additional activities planned for next year

Now that cases have been identified through the various methods I have outlined (e.g., mortality review, case series review, and medical testing), other recommended activities include:

! epidemiologic studies to better evaluate the relationship of exposures and exposure pathways to disease;

! follow-up evaluation of individuals in the medical testing program who were referred for medical care to assure that this referral worked effectively; and

! a better determination of the clinical course and natural progression of pulmonary disease related to tremolite asbestos.

Other sites that received asbestos-contaminated vermiculite

Processing of vermiculite ore shipped from Libby has occurred at approximately 300 sites in 40 states over the last 50-90 years. These sites are being reviewed to consider the potential for health problems similar to those experienced by Libby-area residents and former mine workers. ATSDR staff have been working with EPA to determine if any of these sites pose a public health hazard. This review has included site visits to assess the extent of current or past operations, and to determine the extent of human exposure and possible pathways of exposure to the asbestos. One site that has already elicited considerable attention is the Western Mineral Products site in Minneapolis, Minnesota.

This Minnesota site was used for insulation products manufacturing from 1936 to 1989. The plant received vermiculite ore from Libby, Montana, and processed the ore into insulation, fireproofing material, and other vermiculite products. Under a cooperative agreement with ATSDR, the Minnesota Department of Health (MDH) conducted a health consultation to identify health concerns related to asbestos exposure from the site. Plant workers were exposed to levels of asbestos in excess of current occupational standards for much of the time the plant was in operation, and cases of asbestos-related disease have been reported in former workers. Additionally, approximately 100 properties around the former plant have been identified as contaminated with asbestos-containing wastes from the site. The EPA is in the process of removing asbestos-contaminated soil from these properties and adjoining alleys.

The extent of past and current exposures to asbestos is difficult to estimate at this time. Based on available information, past exposure to workers in the plant, residents who lived near the site and children who played on piles of vermiculite waste material may have been at risk for asbestos exposure. To address this concern, MDH initiated the Northeast Minneapolis Community Vermiculite Investigation (NMCVI), a population survey to identify and characterize asbestos exposure in a community cohort. This study involves a door-to-door interview and visual inspection of properties in the immediate vicinity of the Western Mineral Projects Plant in Minneapolis, as well as a telephone interview of former residents in the target area and other individuals who may have had exposure to vermiculite. This investigation will determine the size and demographics of the population at risk. The EPA, Minnesota Pollution Control Agency, and MDH will continue to investigate and clean up the site and surrounding community.

ATSDR staff have developed a protocol for use by the state health departments to review vital statistics and cancer registry data to determine if there might be a health impact in any affected community that warrants further investigation. During FY 2001, ATSDR developed cooperative agreements with six states (Utah, Colorado, Massachusetts, California, Louisiana, and Wisconsin) to conduct health statistics reviews around sites that received asbestos contaminated vermiculite from Libby and to determine whether there is an excess of asbestos related disease. Later this summer, other states will have an opportunity to apply for support of similar health-related activities; we anticipate supporting up to four additional states. In addition, ATSDR has awarded funds to conduct evaluation of mesothelioma cases in three states (New York, New Jersey and Wisconsin). This surveillance process enables states to use their cancer registry data to identify all mesothelioma cases and then look backward to see if the disease in any portion of the cases could be associated with asbestos exposure from contaminated vermiculite or vermiculite insulation from Libby. ATSDR staff also is working with health officials in Montana to review mesothelioma cases in that state.

I would like to reiterate that ATSDR shares your concerns about the situation in Libby B both the environmental contamination and the health concerns. While we have done a great deal of work in Libby, much remains to be done. To summarize, our primary goals for this coming year are:

1) implement the registry of former workers and family contacts;

2) establish the medical testing program on a long-term basis by transitioning primary responsibility to State and local health departments, with technical and resource support from ATSDR;

3) conduct epidemiologic studies to formally investigate the links between the various environmental exposures and the development of disease;

4) provide data on potential health effects in other states that had vermiculite processing centers that led to harmful exposures; and

5) pilot mesothelioma surveillance activities, in coordination with NIOSH.

With your continued support, ATSDR stands prepared to continue the important work we have begun and do whatever we can to help the Montana and Libby community, and any other sites that may be identified with similar problems.

Mr. Chairman, this concludes my testimony; I would be happy to respond to any questions you may have.