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Good afternoon, Mr. Chairman and members of the committee. My name is Dr. Henry Falk, Assistant Administrator of the Agency for Toxic Substances and Disease Registry (ATSDR). I am accompanied by Mr. Dennis Williams, Acting Assistant Secretary for Management and Budget in the Department of Health and Human Services.

As you well know, our testimony is a first for ATSDR. Prior to FY 2001, the appropriations for ATSDR were included in funding to the US Environmental Protection Agency (EPA). Last year this subcommittee recommended a separate account for ATSDR. We appreciate your highlighting the Agency's role and want to thank you for the opportunity to appear before you today. I assure you that this will not diminish in any way our close working relationship with EPA. I would also like to note our valued collaborative relations with the National Institute of Environmental Health Sciences, which follows us in the testimony this afternoon.

ATSDR is a public health agency. We evaluate health and environmental information to assist in remedial decision-making, answer the health questions of impacted community members, recommend preventive measures to protect public health, and we provide diagnosis/treatment information to local health care providers.

We work with challenging medical and health issues at sites such as Libby, Montana, and Vieques, Puerto Rico, and Fallon, Nevada (the latter in coordination the Centers for Disease Control and Prevention).

The volume of ATSDR's work at sites continues to be very heavy and is the major part of our workload. In fiscal year 2000 alone, ATSDR and our partners produced over l,500 health consultations, more than 100 public health assessments, and 32 exposure investigations. Also, ATSDR is now being asked to respond to a broader array of sites, including more and more non-NPL sites.

ATSDR's health consultations, public health assessments, and exposure investigations at sites are critical in assisting EPA and state officials with clean-up decisions, addressing community health concerns, and investigating possible increases in disease rates.

• Recently, for example, ATSDR provided environmental public health support to the District of Columbia Department of Health (DCDOH) and the US Army Corps of Engineers at the American University/Spring Valley site here in Washington, DC, where the US Army had conducted chemical warfare research and testing during World War I. Arsenic contamination has been found during environmental sampling, and ATSDR reviewed environmental sampling to determine potential human health effects and, in January 2001, conducted an exposure investigation using hair samples to measure arsenic and to ensure that children and staff at a university day care center were not adversely affected by arsenic-contaminated soil.

ATSDR's work with the District of Columbia Department of Health also provides a good example of how important public health considerations can be in evaluating the effects of property redevelopment. Certainly, attention to contaminants and health risks early on can save much anguish and reduce costs in the long term.

To supplement our own staff, ATSDR works in close collaboration with state and local health departments. ATSDR currently funds public health activities in 28 states through separate cooperative agreements that provide assistance to develop local capacity to conduct public health assessments, health education activities, and epidemiologic studies. In FY 2000, ATSDR provided nearly $10 million (including carryover funds) to cooperative agreement states; these funds supported approximately 125 environmental health professionals within the states.

As you know, Mr. Chairman, we have funded the New York State Health Department since the beginning of our program to conduct work such as the evaluation of chemical solvent contamination of wells in Union Springs/Auburn, New York.

ATSDR's work is not confined to individual site activities. We have a clear responsibility to assess the health effects of exposure to toxic substances, to provide the most up-to-date information available on the most hazardous substances, and to educate health care providers and citizens on how best to protect themselves from toxic exposures.

For example, the toxicological profiles ATSDR produces have become the standard reference for hazardous substances recognized by a broad array of professional organizations, such as the American College of Occupational and Environmental Medicine and the World Health Organization. Toxicological Profiles assemble key information for decision-making. For example, data on mercury was helpful as a reference to assist the US Public Health Service and others in decisions on the safety of childhood vaccines containing mercury preservative; information about DDT was helpful to the State Department in negotiating the Persistent Organic Pesticides (POPs) Treaty. And, most recently, the US Department of Defense requested copies of our new toxicological profile on uranium for use at a recent NATO meeting to discuss of the fate of NATO depleted uranium armaments.

The medical community also looks to ATSDR for information on how best to diagnose and treat patients exposed to toxic substances. ATSDR has created a series of documents called Case Studies in Environmental Medicine to provide a resource for health care professionals, such as the Case Study on Lead.

In closing, I would like to mention several recent efforts. In 1998, ATSDR joined with the Association of Occupational and Environmental Clinics and EPA to develop the Pediatric Environmental Health Specialty Unit program. Health care providers specifically trained in both pediatrics and environmental medicine are available on a case-by-case basis to see children and their families, and to provide training and information on toxic substance exposures and childhood environmental health issues. The program is designed to reduce environmental health threats to children; improve access to expertise in pediatric environmental medicine; and strengthen public health prevention capacity.

ATSDR views itself as a service agency and relies heavily on basic research conducted by others. However, because our service areas (health and exposure) still have many uncertainties, we are constantly striving to improve the product we offer to communities exposed to toxic substances. ATSDR has developed a small, focused applied research agenda to guide its research activities and enhance the agency's ability to identify, evaluate, and intervene in toxic exposures and adverse health outcomes.

The agency also has begun to look at its responsibilities in the area of disease registries or surveillance or "health tracking." ATSDR is now at the point where we can begin addressing the "disease registry" part of our name and mission -- and begin assuming a key role in the development of systems for tracking environmental disease.

With the additional funds the President's budget recommends for ATSDR's use in FY 2002, we plan to undertake several new activities to initiate disease surveillance around Superfund sites. The goals of these activities will be:

• to develop and evaluate methods to measure and track high-priority diseases with potential links to environmental exposures, particularly those diseases of concern to communities around Superfund sites;
• to link health databases with environmental data; and
• to identify potential associations with environmental exposures.

Mr. Chairman, the public naturally becomes concerned when they see situations such as half of a class of third graders needing to bring asthma inhalers to school, or when persons compare notes about their first diagnosis of multiple sclerosis at a 20 year high school reunion, or when multiple parents within the same neighborhood watch their children suffer from brain tumors and other severe illnesses.

In communities near obvious sources of environmental contamination, such as Superfund sites, people understandably worry that somehow environmental pollution might be playing a role. Our job is to address those concerns -- which we do everyday all across the country. Though there is still much to learn and many concerns yet to be addressed, we want to assure the members of this committee that ATSDR will do its best to answer the questions people have, whether it is childhood leukemia in Fallon, Nevada, autism in Brick Township, New Jersey, multiple sclerosis in Wellington, Ohio, or lung cancer in Libby, Montana.

Mr. Chairman, this concludes my testimony. I want to again thank you for the opportunity to appear here today, and would be happy to answer any questions you or the committee members might have.

Good afternoon, Mr. Chairman and members of the committee. My name is Dr. Henry Falk, Assistant Administrator of the Agency for Toxic Substances and Disease Registry (ATSDR). I am accompanied by Mr. Dennis Williams, Acting Assistant Secretary for Management and Budget.

I am very pleased to provide you with information regarding the Agency for Toxic Substances and Disease Registry's (ATSDR) programs for Fiscal Year (FY) 2002 appropriations. As you well know, our testimony is a first for ATSDR. Prior to FY 2001, the appropriations for ATSDR were included in funding to the US Environmental Protection Agency (EPA). Last year this subcommittee recommended a separate account for ATSDR though I assure you that this will not diminish in any way our close working relationship with EPA. We appreciate your highlighting the Agency's role and want to thank you for the opportunity to appear before you today.

ATSDR is a federal agency created by Congress in 1980 by the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), or what is more commonly known as Superfund legislation. As such, ATSDR is the public health agency charged with determining the existence of human exposure to hazardous substances, assessing the nature and extent of health problems at Superfund sites, and advising the EPA and State environmental agencies on needed cleanup and other actions to protect the public's health. To accomplish this mandate, ATSDR received approximately $75 million in FY 2001.

ATSDR works in close collaboration with the EPA, other federal, state, local, and tribal governments, health care providers and affected communities. The agency has made a difference to all of these partners by evaluating health and environmental information to assist in remedial decision-making, answering the health questions of affected community members, recommending preventive measures to protect public health, and providing diagnosis/treatment information to local health care providers.

Providing environmental public health services often is very challenging. ATSDR staff must balance the disciplines of science and effective human interaction at sites and in situations that can be very complex. From new medical issues at sites such as Libby, Montana, to very evident community concerns and broad policy aspects at sites such as Vieques, Puerto Rico, the challenges and solutions are rarely clear-cut.

The volume of ATSDR's work at sites continues to be very heavy and is the major part of our workload. In fiscal year 2000 alone, ATSDR and our partners produced 1,569 health consultations, 108 public health assessments, and 32 exposure investigations. For just those sites evaluated last year, ATSDR estimates that more than 4 million people lived in close enough proximity to be concerned about potential exposures. In addition, ATSDR is now being asked to respond to a broader array of sites. As always, ATSDR addresses issues at National Priorities List (NPL) sites listed under Superfund; however, we also find ourselves addressing more and more non-NPL sites. In 1996, a majority of the sites at which we worked were NPL sites; last fiscal year the majority were non-NPL sites, including responses to petitions from citizens.

Emerging health threats: Asbestos in Libby, Montana

Activities in Libby, Montana, provide a very good example of a current site where ATSDR's work is making a difference. The situation in Libby offers a dramatic example of past exposure resulting in serious disease. In 1999, reports from Libby documented cases of non-occupational asbestos-related pulmonary impairment among family members of former vermiculite mine employees as well as others in the community with no connection to the mining operations. They were suffering from three potentially fatal diseases: asbestosis, mesothelioma, and lung cancer related to their asbestos exposure. Finding non-occupational asbestos-related pulmonary disease is extremely unusual and suggests that dangerous levels of asbestos exposure have occurred within the Libby community. Given the latency period for mesothelioma of 40 years, the health care community could be seeing the effects of exposure to vermiculite from Libby for an entire generation.

Beginning in late 1999, ATSDR's activities in Libby have included: community outreach, close coordination with the EPA regional office on environmental sampling activities, broad ranging communications, education programs for health care providers, and collaboration with area health and social service agencies to provide long-term support systems for concerned local residents.

In 2000, ATSDR conducted a medical testing program to assess the public health implications of past human exposure to tremolite asbestos in Libby. We originally anticipated screening about 3,000 people -- but over the course of our medical testing program more than 6,100 Libby-area residents and former mine workers were screened. They all answered an extensive questionnaire about their possible exposures and received both chest x-rays and pulmonary function tests.

ATSDR recently reported a preliminary analysis of the medical testing results from the first 1,078 participants, or 18% of the total number of participants in the medical testing program. These results showed a very high percentage of individuals reporting contact with the contaminated vermiculite, and evidence of health impacts, particularly in the form of thickening and scarring of the outer pleural lining of the lung. Because this is an interim report based upon preliminary data, interpretations of the information need to remain cautious. Although the final percentages, based on data for the whole group, may change there is certainly cause for concern in the preliminary data -- particularly in cases where health effects have been found in those with no occupational association with the mine.

The findings of illness in participants with large, previously recognized exposures is consistent with clinical reports by Libby area physicians. ATSDR's information is too preliminary to predict the final risk estimates for participants with lower exposure potential, such as participants with vermiculite insulation in their residences, those with infrequent past contact with vermiculite, or those who resided in the community but had no apparent exposure to vermiculite. However, based on what already has been found, public officials and medical care providers are advised to plan accordingly for the long-term evaluation of participants exposed to vermiculite and for the care of those who may develop severe illness. ATSDR has already begun planning for an exposure registry of vermiculite-exposed individuals to assist in the long-term follow up and care of those at risk for severe illness.

ATSDR will soon complete the evaluation of the Libby medical screening program and will work with local, state, and federal health care providers to address health issues that are identified. ATSDR also is planning to conduct additional medical testing for people who are eligible to participate but who, for one reason or another, were unable to participate in the medical testing last year.

The issues in Libby have raised concern about other areas with vermiculite exposure. ATSDR and EPA are working together to evaluate more than 350 sites around the United States where asbestos-contaminated vermiculite was shipped and/or processed. In general, most of these sites will have posed significantly lower exposure risks than Libby, but we need to identify those with potential health impacts.

Site evaluations provide critical health information and services

ATSDR provides environmental public health services to concerned individuals and communities around the country. For example, we address issues:

• in urban areas like the former landfill located near Philadelphia that was associated with residents' concerns about cancer and asthma;
  
  
• at federal facilities like Pease Air Force Base in New Hampshire, the Fernald nuclear facility in Ohio, and Kelly Air Force Base in Texas;
  
  
• for children and families in Illinois, Michigan, Ohio, and recently in New York, who talk with staff in our Pediatric Environmental Health Specialty Units because they are concerned about exposure to mercury caused by the replacement of outdated gas regulators in their homes;
  
  
• on behalf of women who may have decreased bone density or earlier onset of menopause due to their occupational exposure to lead; and
  
  
• that may have a long-term impact on the public health and health care systems like ATSDR's work in Libby, and coordination with Centers for Disease Control and Prevention (CDC) on the response to a childhood leukemia cluster in Fallon, Nevada.

ATSDR's health consultations, public health assessments and exposure investigations at sites are critical in assisting EPA and state officials with cleanup decisions, addressing community health concerns, and investigating possible increases in disease rates. For example you may have heard about a site we've worked on here in the District.

• Recently, ATSDR provided environmental public health support to the District of Columbia Department of Health (DCDOH) and the US Army Corps of Engineers at the American University/Spring Valley site in Washington, DC The American University and Spring Valley community have been built and developed in an area where the US Army had conducted chemical warfare research and testing during World War I. Unexploded ordnance and evidence of past weapons research activities began to surface and varying health complaints were reported (including odors and skin and eye irritation). Arsenic contamination also has been found during environmental sampling. ATSDR reviewed environmental sampling to determine potential human health effects, and, in January 2001, conducted an exposure investigation to ensure that children and staff at a university day care center were not adversely affected by arsenic-contaminated soil. Fortunately, analysis of hair samples from children and staff at the day care center found no elevated exposure to arsenic. ATSDR continues to work with DCDOH, the EPA, and the US Army Corps of Engineers to ensure that past activities pose neither a present nor a future public health threat.

ATSDR's work with the District of Columbia Department of Health provides a good example of how important public health considerations can be in evaluating the effects of property redevelopment. Certainly, attention to contaminants and health risks early on can save much anguish and reduce costs in the long term.

As a small agency, the workload we have at sites like Libby or the American University site in DC would be impossible for ATSDR staff alone. To supplement our own staff, ATSDR works in close collaboration with state and local health departments. ATSDR has been funding environmental public health activities in states since 1987. ATSDR currently funds public health activities in 28 states through separate cooperative agreements that provide assistance to conduct public health assessments, health education activities, and epidemiologic studies. In FY 2000, ATSDR provided nearly $10 million (including carryover funds) to cooperative agreement states; these funds supported approximately 123 environmental health professionals within the states.

I'd like to give you several examples of the work state health departments have done that might be familiar to you.

• ATSDR is working with the New York State Department of Health (NYS DOH) to determine possible health effects of chemical solvents found in wells in Union Springs/Auburn, New York. In the late 1980s, low levels of the solvents were found in public water systems during routine water monitoring. ATSDR and NYS DOH worked with the EPA to conduct a site assessment to trace the source and extent of the contamination. Between September and December 2000, 58 wells around Union Springs were sampled; 18 wells were found to be contaminated. Sampling was accelerated and, to date, 230 wells have been sampled in a 10.5-mile swath between Union Springs and Auburn, potentially impacting approximately 1100 people. Of the wells sampled since September, 85 are contaminated with at least trace levels of volatile organic compounds. Information was provided to residents about the community-wide water sampling activities, chemicals that were found, and ways to reduce or eliminate exposure to the substances found in their water. This emphasizes the advisory role that ATSDR and health departments regularly undertake to prevent significant exposure to contaminants of concern.
  
  
• Another incident involving water contamination occurred in Plaistow, New Hampshire. The Beede Waste Oil site processed waste oil between 1926 and 1991. Releases of oil and solvents from unlined lagoons and drums has resulted in groundwater and soil contamination, as well as water and sediment contamination. Nearby residential drinking water wells were contaminated with volatile organic compounds (VOCs), which were causing a public health hazard; and soil on the site was contaminated with polychlorinated biphenyls (PCBs). Working within its cooperative agreement with ATSDR, the New Hampshire Department of Health and Human Services (NH DHHS) assessed the site. The Public Health Assessment was a factor in EPA's decision to place the site on the National Priorities List in December 1996. ATSDR, the NH DHHS, and EPA worked together to address public health and environmental issues. Alternative water supplies have been provided to residents, and drinking water wells are regularly tested to ensure safety. Further testing was conducted in the area and findings included: residential yards around the site were found to have no PCB contamination at levels of health concern; VOCs tested in indoor air in nearby homes were found to be below comparison levels; and steps were taken to limit consumption of fish and edible plants from Kelly Brook which was contaminated with PCBs. Work at this site is still underway. Currently the NH DHHS is working with the EPA to assess human risk associated with site clean up.

The link between exposure and illness

ATSDR's work is not confined to individual site activities. We have a clear responsibility to assess the health effects of exposure to toxic substances, to provide the most up-to-date information available on the most hazardous substances, and to educate health care providers and citizens on how best to protect themselves from toxic exposures.

ATSDR's epidemiologic work has gone a long way in furthering our understanding of what health effects may result from toxic exposures. We are proud of our accomplishments in addressing a key mandate -- learning more about the association between exposure to toxic substances and adverse health effects and the prevention of illness at Superfund sites. As presented in other Congressional testimonies, ATSDR's health studies have revealed an increased risk of birth defects, certain cancers, respiratory illness, neurologic disease and other health conditions in populations living near hazardous waste sites.

The toxicological profiles ATSDR produces have become the standard reference for hazardous substances recognized by a broad array of professional organizations, such as the American College of Occupational and Environmental Medicine and the World Health Organization. Toxicological Profiles assemble key information for decision-making. For example, data on mercury was helpful as a reference to assist the US Public Health Service and others in decisions on the safety of childhood vaccines containing mercury preservative; information about DDT was helpful to the State Department in negotiating the Persistent Organic Pesticides (Pops) Treaty. And, most recently, the US Department of Defense requested copies of our new toxicological profile on uranium for use at a recent NATO meeting to discuss of the fate of NATO depleted uranium armaments.

The medical community also looks to ATSDR for information on how best to diagnose and treat their patients exposed to toxic substances. In 1989, ATSDR began creating a series of documents called Case Studies in Environmental Medicine to provide a resource for health care professionals. The Case Study on Lead is routinely used by pediatricians as the standard for treating childhood lead poisoning. Similarly, our case study entitled, "Taking an Exposure History," is a mainstay of ATSDR's health professionals education activities and is regularly used in medical residency programs and nursing schools across the country.

ATSDR's work spans from the largest communities to the smallest citizens -- as evidenced by work in children's health and specifically at the Pediatric Environmental Health Specialty Units (PEHSUs). In 1998, ATSDR joined with the Association of Occupational and Environmental Clinics (AOEC) to develop the PEHSU program. The PEHSUs are also supported by the EPA. The program serves as a national resource for pediatricians, other health care providers, and communities. The program is designed to reduce environmental health threats to children; improve access to expertise in pediatric environmental medicine; and strengthen public health prevention capacity.

The key focus areas of the units are medical education and training, clinical consultation, and clinical specialty referral for children who may have been exposed to hazardous substances in the environment. For example, the PEHSU at Harborview Medical Center in Seattle, one of the first units established, receives about 2,000 calls a month. Callers' concerns cover the gamut of toxic substances exposure, and have included the consumption of well water contaminated with pesticides, elemental mercury exposures, and solvent exposures from painting a child's bedroom. Health care providers specifically trained in both pediatrics and environmental medicine are available on a case-by-case basis to see children and their families, and to provide training and information on toxic substance exposures and childhood environmental health issues. In several cities the PEHSUs are affiliated with poison control centers which are resources for parents whose children have been exposed to toxic substances.

Applied research and surveillance are key to future protection

ATSDR views itself as a service agency and relies heavily on basic research conducted by others. However, because our service areas (health and exposure) still have many uncertainties, we are constantly striving to improve the product we offer to communities exposed to toxic substances. As a result, we have developed a small, focused applied research agenda to improve our services. ATSDR has developed an applied research agenda for FY's 2002-2010, to guide its research activities and enhance the agency's ability to identify, evaluate, and intervene in toxic exposures and adverse health outcomes. The research agenda was approved by the ATSDR Board of Scientific Counselors in December 2000. The ATSDR applied research agenda is well positioned to address the agency's mission and mandates, strategic plan, and requirements for the Government Performance and Results Act (GPRA). In addition, ATSDR is working closely with the National Institute for Environmental Health Sciences at the National Institutes of Health, CDC, and other agencies in coordinating research agendas and identifying important areas for collaborative research.

ATSDR will work closely with federal partners and other constituents to maximize a collaborative focus on specific areas of research which are of high importance and of common interest. ATSDR has identified five focus areas for research: exposure assessment, chemical mixtures, communities and American Indian/Alaska Native tribes, evaluation and surveillance of health effects, and health promotion and intervention. Research will help answer essential public health questions asked by communities across the country, such as: have I been exposed or harmed?; can the hazardous substances cause adverse health outcomes?; and what can I do to improve my health? For thousands of waste sites and other environmental exposures, these health questions must be addressed.

ATSDR has made significant progress in developing registries of individuals exposed to specific substances and tracking them over time to assess their health status and provide updated information to those exposed. As noted, such an effort will undoubtedly be important in Libby, Montana. The agency also has begun to look at its responsibilities in the area of disease registries or surveillance (or "health tracking" as referred to by the Pew Commission). We are evaluating an appropriate set of activities in coordination with CDC. ATSDR is now at the point where we can begin addressing the "disease registry" part of our name -- and begin assuming a leadership role in the development of systems for tracking environmental disease.

With the additional funds the President's budget recommends for ATSDR's use in FY 2002, we plan to undertake several new activities to initiate disease surveillance around Superfund sites. We plan to look at high-priority environmental diseases to determine their potential association with exposures from Superfund sites. The goals of these activities will eventually lead to:

• development and evaluation of methods to measure and track high-priority diseases with potential links to environmental exposures, including the establishment of operational case definitions, through demonstration projects and pilot programs in selected communities and geographic areas;
  
  
• collaboration with existing health surveillance systems to link health databases at the state or local level with other environmental databases and geographic information systems (GIS); and
  
  
• understanding of the basic epidemiology of high-priority diseases (prevalence and distribution within the population) and the identification of potential associations with known environmental exposures.

Time has shown the wisdom of the Superfund legislation. Hundreds of communities are searching for health answers. They are real people with real concerns, particularly about children's health. Mr. Chairman, the public naturally becomes concerned when they see situations such as half of a class of third graders needing to bring asthma inhalers to school, or when persons compare notes about their first diagnosis of multiple sclerosis at a 20 year high school reunion, or when multiple parents within the same neighborhood watch their children suffer from brain tumors and other severe illnesses.

In communities near obvious sources of environmental contamination, people understandably worry that somehow environmental pollution might be playing a role. Our job is to address those concerns -- which we do everyday all across the country. Though there is still much to learn and many concerns yet to be addressed, we want to assure the members of this committee that ATSDR will do its best to answer the questions people have whether its childhood leukemia in Fallon, Nevada, autism in Brick Township, New Jersey, or multiple sclerosis in Wellington, Ohio.

Mr. Chairman, this concludes my testimony. I want to again thank you for the opportunity to appear here today, and would be happy to answer any questions you or the committee members might have.

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