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Congressional Testimony
ATSDR's Progress in Meeting Congressional Mandates

Statement of
James 0. Mason, M.D., Dr.P.H.
Administrator
Agency For Toxic Substances and Disease Registry

Before the
Committee on Energy and Commerce
Subcommittee on Oversight and Investigations
U.S. House of Representatives

June 20, 1988

Created by the original Superfund legislation of 1980, the Agency was directed by that statute to provide public health assistance and services in emergencies caused by release of hazardous substances, to conduct health assessments, to conduct periodic surveys and screening programs to determine relationships between exposure to hazardous substances and illness, to establish and maintain a registry of persons exposed to hazardous substances and a registry of serious diseases caused by such exposure, and to establish and maintain a comprehensive and publicly accessible inventory of literature, research, and studies on the health effects of hazardous substances.

In addition to these responsibilities, the Superfund Amendments and Reauthorization Act of 1986 (SARA) added significant new responsibilities that increased the number of required health assessments, expanded the toxicology databases and medical and health education activities, and required the preparation of a report to Congress on the nature and extent of childhood lead poisoning in the U.S.

The Agency has addressed these mandates in CERCLA and those added by SARA by developing 10 program areas. I will now discuss our accomplishments in meeting these mandates, giving emphasis to the SARA mandates.

HEALTH ASSESSMENTS

The ATSDR health assessment is the evaluation of data and information on the release of hazardous substances into the environment in order to: assess any current or future impact on public health, develop health advisories or other 'health recommendations, and identify studies or actions needed to evaluate and mitigate or prevent human health effects.

The Agency's health assessments serve two purposes. First, they contain our opinion as to the public health implications posed by individual sites. Each health assessment contains specific recommendations as to actions that we feel should be considered in protecting the public health. The health assessments reports are therefore useful to EPA and States in their management of health and environmental risks associated with individual sites. The Agency checks the outcome of its recommendations. We find that EPA accepts about 95% of our recommendations. It is important to recognize that ATSDR advises other agencies on health concerns, but we do not manage or remediate the health risks. That is the responsibility of regulatory agencies with that authority. The second purpose of a health assessment is to identify public health studies and actions that should be undertaken by ATSDR and other health agencies. Such actions on the part of ATSDR primarily include the issuance of an health advisory, pilot health studies, health surveillance, and epidemiological studies.

The Agency is required by SARA to complete, by December 10, 1988, a health assessment of all sites on, or proposed for inclusion on, the National Priorities List (NPL) as of October 17, 1986. In addition, a health assessment must be completed for all proposed sites within 1 year of the date when they are proposed for addition to the NPL. On October 17, 1986 there were 887 sites on the NPL. On January 20, 1987, EPA added 64 additional sites, the Update VI sites. This means ATSDR is mandated to conduct, by December 10, 1988, health assessments of 951 NPL sites. In fiscal year 1988 ATSDR entered into cooperative agreements with 11 States to perform health assessments within their borders. The states are Colorado, Florida, Iowa, Massachusetts, Michigan, Minnesota, New Hampshire, New Jersey, New York, South Carolina, and Wisconsin. To date, ATSDR has conducted health assessments of 359 NPL sites.

We are optimistic that, in conjunction with the States under cooperative agreements, we will be able to conduct health assessments for all 951 NPL sites prior to December 10, 1988. This will consist of reviewing the existing environmental data; interviewing knowledgeable parties such as EPA personnel, State and local health and environmental personnel, and the involved public; and conducting site inspections where indicated. We expect that sufficient data will exist for some sites adequate to allow us to make a determination regarding the potential for human exposure, the health implications, and possible health actions. For other sites, further health assessments will be necessary as better environmental and health-related data become available. It should also be mentioned that some sites counted as a single health assessment site actually require several distinct health assessments, since the information upon which we base our health assessment is sometimes developed around EPA operable units, and some sites have several such units.

The health assessments that ATSDR has conducted to date have already yielded some valuable information and insight. We have found that about 80% of the sites indicate a pathway, such as water or air, of potential exposure to hazardous substances. Further, about 10% of all sites present a pathway of potential exposure of sufficient concern to currently warrant a pilot health study. Our experience has also shown that the Remedial Investigation/ Feasibility Study data form an excellent basis upon which to conduct health assessments. For those site for which RI/FS data are not currently available, the ATSDR staff, working with EPA regional staffs, obtain the best information and data available for individual sites, and it is upon such summary data that we conduct health assessments in advance of obtaining the RI/FS data. Of course, as the RI/FS data become available, each site will be re-evaluated in terms of additional more in-length health assessment.

At the current level of personnel resources that have been allocated to ATSDR, it is highly unlikely that ATSDR will be able to conduct the necessary health assessment work in fiscal year 1989. We expect significant additional site specific data to become available in FY 1989 that will require extensive further health assessment work on many site in addition to that already conducted. Also, EPA expects to add 300 to 400 new sites to the National Priorities List during this period.

In addition to requiring an increased number of health assessments, SARA contains language that permits a licensed physician or any other individual to petition ATSDR for a health assessment at a site of concern. The Agency has received, to date, 30 such petitions. They have been submitted by a variety of petitioners individual citizens, community groups, attorneys, Senators, Congressmen, and local authorities. To date, we have rejected one petition because it concerns a potential future release of hazardous substance rather than a current release. The remaining petitioned health assessments are in various stages of implementation or decision making. Since few of the petitions are accompanied by supporting environmental and health data, ATSDR responds to each petition by attempting to develop as much background data as possible. This has resulted in each petitioned health assessment, not already an NPL site, equating to about 4 non-petitioned health assessments. Although petitioned health assessments are more resource intensive, the Agency feels they are an excellent device for individuals to have their health concerns addressed by government.

Another important outcome of health assessments is recommended public health actions. The Agency has currently underway 14 pilot health studies for the purpose of assessing human exposure to hazardous substances of concern around specific waste sites; 4 pilot health studies have been completed. The pilot health study is extremely valuable in terms of getting better data on what substances people are exposed to and at what levels. Additionally, the Agency, over the past 2 years, has issued two health advisories, which are statements to EPA that a site is of sufficient public health concern that immediate action should be taken to prevent human exposure to the substances in question. We have announced cooperative programs with States for them to conduct health studies of persons exposed to hazardous substances. The Agency expects to begin this new program in this fiscal year.

In the years prior to SARA, health assessments identified several sites for which epidemiological studies were begun. These were long-term studies of specific sites and populations of concern. Five of these studies have been completed in fiscal year 1987 and early 1988. (These completed studies are described in the Health Research part of the attachment.) In addition to these completed epidemiological studies, the following are ongoing: morbidity and mortality studies of workers (New Jersey and Missouri) exposed to dioxin, an investigation in Michigan (Battle Creek) of persons exposed to volatile organics in drinking water, a study of adverse reproductive effects in Louisiana (St. Gabriel), and a study of adverse reproductive effects in Massachusetts (Woburn). Additional epidemiological studies are being considered as the current round of health assessments is completed this year.

Regarding health surveillance, ATSDR is supporting several Statebased health surveillance programs. The states involved are California, Maine, Michigan, and Wisconsin for surveillance of chronic disease outcomes and Georgia, Iowa, Massachusetts, New York, New Jersey, and Washington for adverse reproductive outcomes. The Agency has no site specific health surveillance projects; we feel there is need to learn from the larger State-based programs before the attempt is made to initiate smaller, site-specific health surveillance projects.

With regard to the registry of persons exposed to hazardous substances, ATSDR is sponsoring a listing of Missouri residents exposed to dioxin, and a registry of workers exposed to betanaphthylamine, a human bladder carcinogen. Other sites will be considered upon the completion of a review of peer reviewers' comments concerning the exposure registry program.

The Committee asked for information concerning ATSDR's efforts at Federal facilities. There are 48 federal facilities on the current NPL. The Agency has completed health assessments of 2 of the 48; 13 sites are currently undergoing health assessments. An attachment lists these 15 federal sites for which there has been ATSDr activity. ATSDR has met and corresponded with officials of Department of Defense (DOD) to discuss DOD sites and support from DOD in ATSDR's conduct of health assessments.

TOXICOLOGICAL PROFILES

The ATSDR was mandated by SARA, in cooperation with EPA, to identify and rank by April 17, 1987, the 100 most hazardous substances found at Superfund sites. In addition, this list must be expanded by 100 substances by October 17, 1988, and by 25 substances annually thereafter. I am please to say that ATSDR and EPA released in the Federal Register of April 17, 1987, their list of 100 most hazardous substances. An attachment to my testimony contains that list. In addition, ATSDR and EPA are currently at work to prepare the next list of 100 ranked hazardous substances. We anticipate having the expanded list completed by the deadline of October 17, 1988.

SARA requires that ATSDR prepare a toxicological profile for each hazardous substance on the list of ranked substances. The profiles are to be developed at the rate of no fewer than 25 per year; the first 25 were due on October 17, 1987. Each profile is required by SARA to contain an examination, summary, and interpretation of available toxicological information and epidemiological evaluations on hazardous substances in order to ascertain the levels of significant human exposure; a determination of whether adequate information on the health effects of each substance is available or is in the process of being developed; and, where appropriate, an identification of toxicological testing needed to determine significant gaps in knowledge about a hazardous substance's toxicity and exposure levels of significance to human health.

The ATSDR has worked closely with EPA and agencies of the Public Health Service (CDC, NIEHS) to prepare, under contract, the first 25 profiles. An attachment lists the profiles prepared to date. In order to make the documents of high quality, the Agency has had each profile peer reviewed and made available to the public for review and comment. This has meant that the profiles were not available in final form on the deadline date of October 17, 1987. The Agency is currently preparing final revisions of the documents and will be releasing them in final form during July and August. The profiles have proven to be of great interest. During the public comment period we supplied over 37,000 copies to some 2,500 individual requestors.

The second set of 25 profiles will be prepared in the same manner as the first set. We expect to have them available for public review and comment by December 30, 1988. The final documents for the second set of 25 profiles will be completed during April to July 1989. We believe that allowing the extended time period for peer review and public review and comment for the second set of profiles is well merited in order to continue to achieve quality profiles of scientific merit. The Agency's experience has shown that the profiles improve in quality when adequate time is allowed for peer and public reviews. ATSDR expects to be able to complete 40 toxicological profiles and updates in fiscal year 1989.

SARA directs ATSDR, EPA, and the National Toxicology Program to evaluate data gaps for each hazardous substance that is the subject of a toxicological profile. Those gaps that represent significant data needs in terms of developing levels of exposure significant to human health must be filled by research that is to be initiated by ATSDR. The three federal groups are working to develop a decision framework to identify significant data gaps. How to implement the research program must the be determined.

CHILDHOOD LEAD POISONING

Section 118(f) of SARA requires ATSDR, in consultation with EPA, to prepare a report to Congress on the nature and extent of childhood lead poisoning in the United States. In order to prepare the report, ATSDR convened a federal ad hoc panel of eight agencies to advise on the report's preparation. The preparation of the study of childhood lead poisoning and the resulting report was performed by two consultants to ATSDR. The consultants and ATSDR had to acquire new data bearing on childhood lead poisoning, extend statistical estimation models, and conduct a lengthy analysis and two peer reviews of the findings. As a result, the Agency was unable to complete the report by the statutory deadline of March 1, 1987. The Agency's concern from the beginning has been to prepare a report of high scientific quality.

The report is currently in the final stages of clearance within the Department of Health and Human Services. We plan to present the report's findings and recommendations to the Committee to Coordinate Environmental Health and Related Programs of the Public Health Service for the purpose of coordinating a follow-up on the report's recommendations.

HEALTH EDUCATION

The Agency is responsible under SARA for assembling, developing as necessary, and distributing to the States, and, upon request, to medical colleges, physicians, and other health professionals, appropriate educational materials on the medical surveillance, screening, and methods of diagnosis and treatment of injury or disease related to exposure to hazardous substances. This is a new responsibility for ATSDR. We are working to complete an integrated program in health education that will be available later this fiscal year. However, we can report some important progress to date. In one effort, ATSDR is working with the Jefferson County, Kentucky, Emergency Response program to train 200 individuals to respond to emergency releases of hazardous substances. In a second project, ATSDR and the Federal Emergency Management Agency recently conducted a national teleconference on the health consequences of emergency releases of hazardous substances. We estimate that about 80,000 persons viewed the teleconference.

CONCLUDING COMMENTS

Mr. Chairman, the preceding comments describe the Agency's new responsibilities under the amended Superfund Act. As I mentioned in my introduction, there are other mandates that ATSDR has that carry over from the original act of 1980. These mandates focus on developing toxicological databases, developing exposure and disease registries, addressing occupational safety and health issues, conducting health research, responding to emergencies, and maintaining a list of areas closed to the public due to toxic contamination. I am prepared to discuss each of these responsibilities. These programs are described in an attachment to my written comments today.

In closing. Mr. Chairman, I bring to the Committee's attention that the Superfund Act as amended has lead to a strengthening of the requirement for peer review of ATSDR's studies and reports. Each of the reports prepared by the Agency or under its sponsorship has been peer reviewed consistent with the SARA directive. This has been useful. For example, a recent report prepared by an investigator under a cooperative agreement did not pass peer review. That prevents a deficient work of science from getting into the scientific literature. The Agency is fully committed to conducting high quality science. We have recently established a Board of Scientific Counselors for ATSDR and look forward to the Board's advice on matters of science.

I believe ATSDR has performed well during the first 2 years of the reauthorization of Superfund. It is true that we have not met all of our deadlines, but I feel that the quality of the Agency's products and the dedication of a comparatively new staff bode well for the future. I look forward to' your questions.

In instances of emergency response to releases of hazardous substances, primary responsibility for public health rests with local and State health authorities. However, CERCLA and SARA list strong mandates for ATSDR in addressing the health issues posed by the release of hazardous substances. As part of the ATSDR emergency response program, the Agency maintains a 24-hour emergency contact whereby an Emergency Response Coordinator is available within 10 minutes of receipt of the initial call, with the preliminary health assessment team available within 20 minutes. A response team consisting of a physician, a toxicologist, and a public health advisor is available for consultation by telephone or deployment to the scene of the chemical emergency, should that be necessary. The Agency responds to requests for help from EPA Regional Response Teams, the Coast Guard, States, and local health units. The number of requests for assistance average 1,100 per year.

HEALTH EFFECTS RESEARCH

The ATSDR is one of three agencies authorized to conduct or sponsor research under Superfund. (The other two agencies are EPA and NIEHS.) ATSDR focuses on applied research that tends to be interdisciplinary. Much of the health research program is conducted by way of interagency agreements with the Centers for Disease Control and with the National Institute of Environmental Health Sciences.

In fiscal year 1987 five environmental epidemiology studies were completed by State health departments under a cooperative agreement with the Center for Environmental Health and Injury Control, CDC. The five studies (and the salient findings) were: The Missouri Dioxin Health Effects Study (no confirmed evidence of adverse health effects in Missouri residents exposed in 1973 to dioxin); the Missouri Dioxin Reproductive Outcome Study (no statistically significant evidence of adverse reproductive outcomes in Missouri residents exposed to dioxin); the Greater New Bedford, Massachusetts PCB Health Effects Study (those residents with the greatest risk of PCB exposure through consuming fish from the New Bedford Bay generally had levels within the typical range of the U.S. population); the Arsenic Exposure Study at Commencement Bay, Tacoma, Washington (the potential for environmental exposures were directly correlated to the proximity of the smeltering operations and, although observed biological levels of arsenic were within reported norms, the highest levels tended to appear in children aged 0-6 years who had indications of dust and soil exposures); and Blood Lead Levels in Children in Silver Valley, Idaho (has become a prevention program in which personnel screen for lead levels in area children and design and implement intervention strategies to reduce lead exposure).

The ATSDR, through an interagency agreement with CDC, is supporting ongoing health surveillance studies in several States. These are surveillance systems for chronic and sentinel diseases; they attempt to establish how these events may be related to exposure to hazardous substances. The States involved are California, Maine, Michigan, and Wisconsin. Adverse reproductive outcomes are being studied in surveillance programs in Georgia, Iowa, Massachusetts, New York, New Jersey, and Washington. The aim of all these surveillance programs is to link health outcome data with environmental data, from which studies of relationships can be pursued.

Toxicological testing of Superfund-relevant substances is conducted by the National toxicology program (NTP) under support form ATSDR. During fiscal year 1987 and NTP completed various short-term and prechronic studies for 6 hazardous aqueous mixtures. Six chemicals have been nominated for additional testing in fiscal year 1988.

The ability to measure human exposure to hazardous substances is critical to proper understanding of health implications. The Agency supports research to develop new methods, or refine existing methods, that can be used in human exposure assessment. In cooperation with the CDC, ATSDR is supporting research on measurement of volatile organics, dioxins, and select inorganics. The ATSDR and CDC are examining the list of 100 most hazardous substances to ascertain those for which biological methods to measure exposure are lacking and should be developed by research. Financial support is also being given to the NHANES-III project being conducted by the National Center for Health Statistics, CDC. This project will analyze the presence of select hazardous substances in a statistical random sample of 1,000 people.

The Agency entered into a cooperative agreement with the National Research Council, National Academy of Sciences, to determine the state of knowledge concerning: (1) mechanisms of neurotoxic action, (2) new methods of determining human exposure to airborne toxic substances, (3) new ways of improving the process of communicating health risk, and (4) the efficacy of using domestic animals and wildlife as sentinels of human disease from exposure to hazardous substances. The ATSDR will use this information to determine new programs or revise existing programs.

LITERATURE INVENTORY/DISSEMINATION

The ATSDR has approached the mandate to establish and maintain an information base on hazardous substances by working closely with the National Library of Medicine (NLM). The Agency has sponsored major enhancements to the NLM database on hazardous substances and has supported the increased use of the database by States and local health departments. The center piece of the NLM system is the Hazardous Substances Data Bank, which now contains toxicological, medical, safety, and other information on about 4,100 individual chemicals.

EXPOSURE AND DISEASE REGISTRIES

The CERCLA of 1980 requires ATSDR, in cooperation with States, to establish and maintain a national registry of serious diseases and illnesses and a national registry of persons exposed to toxic substances. SARA further states that in any case in which the results of a health assessment indicate a potential significant risk to human health, the establishment of a registry of exposed persons should be considered.

The ATSDR has supported a State of Missouri registry of persons exposed to dioxin and a State of Pennsylvania registry of workers exposed to a human bladder carcinogen, beta-naphthylamine. In addition, a proposal to develop a national registry of persons exposed to select hazardous substances has been developed and reviewed at five public meetings, including a scientific peer review meeting. The Agency anticipates starting a selective registry of persons exposed to select hazardous substances in fiscal year 1988. For the disease registry mandate, ATSDR will consult with experts in the field to ascertain whether such a registry is possible, given the current difficulty in causally associating exposure to hazardous substances to specific disease outcomes.

HEALTH AND SAFETY OF WORKERS

The ATSDR health and safety of workers' program is designed to contribute to the protection of workers who are involved in emergency response to releases of hazardous substances or are involved in work at waste sites. Emergency response workers include fire and police personnel, cleanup workers, and hospital emergency room personnel. The Agency also sponsors studies of workers exposed to hazardous substances of relevance to persons exposed to the same substances in non-occupational settings. ATSDR is currently sponsoring epidemiological studies and a surveillance project (number 3 below) in the area of worker health and safety. All the projects are administered by CDC's National Institute for Occupational Safety and Health (NIOSH). The individual projects consist of: (1) a mortality study of workers exposed occupationally to dioxin (due for completion in December 1988), (2) a dioxin morbidity study of workers exposed occupationally to dioxin (due for completion in 1990), and (3) an ongoing State-based event notification system that will develop sentinel health indicators of diseases of relevance to workers at Superfund sites.

LISTING OF AREAS CLOSED TO THE PUBLIC

The ATSDR is required by CERCLA of 1980 to establish and maintain a complete listing of areas closed to the public or otherwise restricted in use because of toxic substance contamination. To meet this mandate, the Agency entered into a cooperative agreement with the National Governors Association to prepare the listing. The first list was released in 1984, a second in 1987, and a third will be available in September 1988.

ATSDR TOXICOLOGICAL PROFILES - First set of 25

Aldrin/Dieldrin

Arsenic

Benzene

Benzo(a)anthracene

Benzo(a)pyrene

Benzo(b) fluoranthene

Beryllium

Cadmium

Chloroform

Chromium

Chrysene

Cyanide

Dibenzo(a,h)anthracene

1, 4-Dichlorobenzene

Di (2-ethylhexyl)phthalate

Heptachlor/Heptachlor epoxide

Lead

Methylene chloride

Nickel

N-Nitrosodiphenylamine

Polychlorinated biphenyls (PCBs)

2,3,7,8-TCDD

Tetrachloroethylene

Trichloroethylene

Vinyl chloride

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