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18 ELR 10132 | Environmental Law Reporter | copyright © 1988 | All rights reserved Health Effects of Hazardous Waste: The Expanding Functions of the Agency for Toxic Substances and Disease RegistryBarry L. JohnsonEditors' Summary: One of the most important participants in the Superfund scheme is the Agency for Toxic Substances and Disease Registry. Established in 1980 pursuant to CERCLA, the ATSDR evaluates the potential health problems caused by individual NPL sites and analyzes the health effects of numerous substances subject to Superfund cleanup. Dr. Johnson, Associate Administrator of the ATSDR, describes his agency's various functions, its plans for future activities, and how it is adapting traditional public health methods of disease prevention and control to meet the unique challenge posed by hazardous substances in the environment. Barry L. Johnson, Ph.D., is Associate Administrator of the Agency for Toxic Substances and Disease Registry, Public Health Service, U.S. Department of Health and Human Services, Atlanta, Georgia. Numerous hazardous chemical substances have entered the environment, principally through waste disposal and accidental spills, and remain there today. Many of these substances are toxic to laboratory animals, and some have caused adverse health effects in humans — primarily in workers, but, in some instances, in community residents as well. Effective programs to prevent adverse health effects are necessary to ensure that the chemical legacy left in the environment does not do ill to present and future generations. The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA),1 one of the most sweeping laws concerned with hazardous substances, created the Agency for Toxic Substances and Disease Registry (ATSDR), whose mission is to prevent or mitigate adverse human health effects and diminished quality of life resulting from environmental exposure to hazardous substances. The Superfund Amendment and Reauthorization Act of 1986 (SARA)2 greatly expanded the ATSDR's authorities and responsibilities, making the Agency a central participant in the Superfund process. Because much of its work is newly authorized, the ATSDR is unfamiliar to some environmental professionals. This Article describes the ATSDR's organization, statutorily required activities, overall plan, and future directions. In establishing the ATSDR in 1980, Congress created a nonregulatory, public health organization that would work closely with a regulatory agency, the Environmental Protection Agency (EPA), in dealing with the removal of hazardous substances from the environment and in responding to health concerns. This duality of federal agencies is akin to the pairing of the Occupational Safety and Health Administration, a regulatory agency, with the National Institute for Occupational Safety and Health (NIOSH), a nonregulatory public health organization. Congress created the ATSDR as an agency of the Public Health Service within the United States Department of Health and Human Services. The Department placed the ATSDR in Atlanta, Georgia, for the purpose of association with the Centers for Disease Control (CDC), which is another agency of the Public Health Service. Being located in Atlanta allows the ATSDR to draw from the administrative services, technical expertise, and public health experience of the CDC. The Agency works with the CDC, EPA, the National Institutes of Health (NIH), state agencies, universities, and private sector organizations. The ATSDR has members of its staff in each of the 10 EPA regional offices to coordinate and facilitate its programs and communicate with EPA's officials in the regions, state agencies, community groups, and individuals. The ATSDR is organized into three offices. The Office of the Associate Administrator (OAA) reports to the ATSDR's Administrator, Dr. James O. Mason, who is also the Director of the CDC. The OAA is responsible for the Agency's overall policies, planning, budget administration, personnel management, and coordination of intra-agency affairs, as well as for the Agency's research program. An Assistant Administrator for Science will be responsible for developing a five-year comprehensive plan of research to be supported by the ATSDR. This person will be the Agency's principal contact with its Board of Scientific Counselors, which is composed of 11 outside experts in the fields of environmental science, toxicology, epidemiology, medicine, and engineering. The Board, which was recently established, will advise the ATSDR on specific scientific issues and provide peer review of study designs and findings. The OAA also contains the Agency's Chief Medical Officer, who coordinates such activities as consultations to primary care physicians in their care of persons exposed to hazardous substances. Reporting to the OAA are two other offices, the Office of External Affairs (OEA) and the Office of Health Assessment (OHA). The OEA is responsible for extramural plans (e.g., cooperative agreements with states and interagency agreements with other federal agencies), regional operations, exposure and disease registries, toxicological profiles, and the Agency's health education program. The OHA conducts the Agency's health assessments and health effects studies, and is responsible for the emergency response program. Current Programs and Activities CERCLA requires that the ATSDR undertake a number of specific activities.3 Because not all of these activities require the same level of effort, the resources associated with each program vary considerably. CERCLA § 104(i)(6) requires the ATSDR to conduct a health assessment of every site on or proposed for inclusion on the National Priorities List (NPL).4 A health assessment is a site-specific "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."5 An individual may also petition the ATSDR to conduct a health assessment for a release of a hazardous substance.6 In addition, § 3019 of the Resource Conservation and Recovery Act (RCRA) authorizes the ATSDR to conduct a health assessment of a RCRA facility if requested by EPA, a state, or an individual.7 Health assessments are based on Remedial Investigation/Feasibility Study (RI/FS) data furnished by EPA regional offices. These data usually include environmental data (what hazardous substances are present and in what concentrations), modelling forecasts (where and by what means the substances are likely to spread away from the site), numerical estimates of risk associated with hazardous substances identified for the site, data that characterize pathways of possible human exposure, and estimates of human populations at special risk of adverse health effects (e.g., children). When RI/FS data are not available, the ATSDR collects any site summary data obtainable from EPA and state and local health departments, and conducts a preliminary health assessment. In the case of a petition for a health assessment, some data come directly from the petitioner (e.g., health complaints or medical records), supplemented by other data obtained from EPA, and state and local agencies. After obtaining and evaluating the relevant data, the Agency prepares a health assessment report expressing its opinion about public health implications posed by the site and setting forth recommendations for public health actions to reduce human exposure to the substances of concern. These recommendations are used by EPA and states in their design of remedial actions to clean up a site. In instances of severe health threats, the ATSDR, EPA, and state authorities work expeditiously to effect health-based actions; for example, they might relocate people away from contaminated sites or provide an alternative supply of water.8 In one instance, the ATSDR worked with EPA and states in their relocation of persons from two small communities built over mine tailings. Some children in the communities were measured to have high levels of metals in their bodies. Follow-up health surveys showed that the children's levels decreased to acceptable amounts following relocation. In addition to advising EPA and states on the health implications of individual sites, we use health assessments for a second important purpose. During the course of performing a health assessment, the ATSDR reviews the site's data to ascertain when traditional public health practices should be mobilized as long-term follow-up procedures.9 We [18 ELR 10134] evaluate each site to identify those for which certain further activities are appropriate: human exposure assessments (collection of biological samples for measurement of chemical substances associated with exposure), development of an exposure registry (a list of the names of persons known or thought to have been exposed), health surveillance of citizens exposed from the site, or an epidemiological study. The ATSDR's health assessments often lead to meetings with concerned citizens. The Agency views this as an important form of health communication and public education. Whenever possible, the Agency actively involves citizen groupsin the planning of health surveys, exposure assessments, exposure registries, and other such activities. The result is better communication and understanding between citizens and government, though not always agreement. CERCLA requires the Agency to complete, before December 10, 1988, a health assessment of each site included or proposed for the NPL as of October 17, 1986 — a total of 887 sites.10 Each new site proposed to be added to the NPL must receive a health assessment within one year of its proposed inclusion on the NPL.11 Sixty-four sites were added to the NPL in January 1987. The ATSDR has completed health assessments of these sites within the one year statutory deadline. In 1988, the ATSDR must conduct health assessments of 951 NPL sites (this number includes the sites identified prior to October 1986 and those identified since January 1987). Of this number, the ATSDR has completed health assessments for 165. Of the remainder, the ATSDR estimates that approximately 185 health assessments will be conducted on sites for which RI/FS data will become available in 1988. Sites for which RI/FS data are not available will require preliminary assessments, based on site summary data obtained by ATSDR regional staff. The ATSDR has entered into cooperative agreements with 11 states to work with them to conduct health assessments of sites within their borders. The ATSDR also expects to conduct about 1200 health consultations (less detailed responses to requests for hazardous substances information) and a small number of health assessments of non-NPL sites. As stated previously, an individual can petition the ATSDR under CERCLA to conduct a health assessment of a site.12 This authority has not been widely recognized, but is becoming known to environmental organizations, citizen groups, and attorneys. In 1987, the ATSDR received approximately 50 citizen petitions. CERCLA gives the ATSDR discretion as to how and when to respond to a petition for a health assessment.13 Response to a petition for a health assessment will involve the petitioner first. An ATSDR representative will contact the petitioner personally to obtain details regarding the petition. For example, are any medical data or other health data available? The ATSDR will also contact EPA, state and local agencies, and private individuals (e.g., physicians) to get whatever data are available to characterize the site and public health conditions around the site. The data collected will be used to determine whether a health assessment is appropriate, and then as the basis for the health assessment and any public health actions. The ATSDR has promulgated interim procedures for responding to petitions for health assessments, including a list of factors that the ATSDR will use to determine whether to conduct a health assessment.14 Some substances at Superfund sites present a greater threat to the public health than do others. CERCLA § 104(i)(2) requires that the ATSDR and EPA jointly rank, in order of priority, those substances that appear most often at NPL sites and pose the greatest threat to public health.15 Three criteria are to be used in the ranking: overall toxicity of the substance (acute, subacute, and chronic toxicities), frequency of occurrence of the substance at NPL sites, and potential for human exposure to the substance. Together with EPA, we have derived an algorithm that includes all three criteria. The algorithm has produced a list of the 100 most hazardous substances.16 An additional 100 will be added in 1988 to this list; thereafter, 25 per year will be added. The Table on page 10138 contains the 100 most hazardous substances found at NPL sites. The listing of a chemical as a priority substance has two principal consequences. First, the ATSDR will develop a toxicological profile for the substance.17 Draft toxicological profiles for all substances in Group 1 of the Table were completed in 1987 and are being made available for public review and comment.18 Toxicological profiles for the [18 ELR 10135] substances in Group 2 will be developed in 1988. Second, the ATSDR (in consultation with EPA and other agencies and programs of the Public Health Service) will assess whether adequate information on the health effects of such substance is available. If adequate information is not available, a plan of research must be developed and initiated.19 CERCLA § 104(i)(3)20 directs the ATSDR to develop and maintain up-to-date toxicological profiles on the priority hazardous substances identified pursuant to § 104(i)(2). The profiles describe levels of exposure that are significant to human health, the resulting health effects, and the adequacy of the data available for determining exposure levels of significance. The ATSDR must prepare no fewer than 25 profiles each year for the next two years, and must complete profiles on the 100 new substances to be added this year to the priorities list within three years of their addition.21 Moreover, the statute directs that ATSDR revise and republish each profile no less often than every 3 years as a means of keeping it current.22 The profiles are to be made available to the public.23 In addition, toxicological profiles are to be used by the ATSDR, EPA, and the National Toxicology Program (NTP) of the Public Health Service to identify significant gaps in scientific knowledge.24 The ATSDR must assure a program of research to fill any such gaps. Programs of research are to be coordinated with the NTP and with programs of toxicological testing established under the Toxic Substances Control Act (TSCA)25 and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).26 CERCLA § 104(i)(5)(D) states that "it is the sense of the Congress" that the costs of such research programs be borne by the manufacturers and processors of the hazardous substance in question.27 The administrative procedures to effect the intent of Congress are currently being developed by the ATSDR, EPA, and the NTP. The ATSDR provides consultation to federal agencies, state agencies, and individuals in instances of emergency release of hazardous substances.28 Examples include those transportation mishaps, fires, and naturally occurring disasters that lead to the release of toxic substances. The Agency provides consultation from physicians, toxicologists, epidemiologists, laboratory scientists, and others, and we advise on the public health and medical implications of the release. This includes advice to hospitals on how to manage exposure victims and consultation to physicians about possible medical consequences of specific toxic exposures. CERCLA § 104(i)(1)(A) mandates that the ATSDR, in cooperation with states, establish and maintain a national registry of persons exposed to toxic substances and a national registry of serious diseases and illnesses caused by toxic exposures.29 The Agency has not developed, to date, any national exposure registries, but has been funding select state-based registries of persons exposed to dioxin and beta-naphthylamine. A national exposure registry will be established in 1988. It will contain subregistries that are chemical specific, as well as some site-specific subregistries. The Agency will also evaluate how to develop disease registries, but that awaits further study. Childhood Lead Poisoning Report The ATSDR, in consultation with EPA, has completed a draft final report to Congress on the nature and extent of childhood lead poisoning. As required by CERCLA § 118(f),30 the report contains the following: (1) an estimate of the number of children, arrayed according to appropriate geographic area, exposed to environmental sources of lead at concentrations sufficient to cause adverse health effects; (2) an estimate of the total number of children exposed to environmental sources of lead arrayed according to source or source type; (3) a statement of the long-term consequences for public health of unabated exposures to environmental sources of lead; (4) methods and alternatives available for reducing exposures of children to environmental sources of lead; and (5) a scoring and evaluation of specific sites at which children are known to be exposed to environmental sources of lead due to releases, utilizing the Hazard Ranking System of the NPL. The ATSDR's responsibilities in developing toxicological profiles and conducting health assessments involve adding to the body of knowledge concerning the relationships between human exposure to hazardous substances and adverse health effects.31 The Agency sponsors or conducts research in the following eight areas: environmental epidemiology, health surveillance systems, toxicological testing, human exposure assessment, information dissemination, clinical toxicology, health education, and occupational health. Epidemiological research includes health studies of persons living near sites, health surveillance programs, and veterinary health surveillance. Toxicology studies address the toxicity of hazardous substances for which knowledge may be incomplete, especially with regard to mixtures of hazardous substances. The exposure assessment studies address how to measure human exposure to hazardous substances, including the use of biochemical and cellular markers of exposure. Clinical toxicology research addresses the development or improvement of biomedical methods and tests to assess the health effects of hazardous [18 ELR 10136] substances. Occupational health research, conducted in conjunction with NIOSH, addresses health implications for those who carry out site cleanups and emergency response actions. Health education research and information dissemination research are both addressing better ways to communicate health risk information to the public and to health officials. Training of Health Professionals CERCLA § 104(i)(14) directs the ATSDR to develop medical education materials concerned with the effects of toxic exposure.32 These materials, which will include material for training courses, are to be made available to medical educators, primary care physicians, and other health professionals. The Agency intends to work with medical associations, medical schools, schools of public health, and state agencies in the development and dissemination of the medical education materials. In addition, the ATSDR has begun a training course for local health emergency response providers on the health aspects of emergency releases of hazardous substances. The Agency, pursuant to CERCLA § 104(i)(1)(B), works closely with the NIH's National Library of Medicine (NLM) in that organization's development, maintenance, and dissemination of information concerning hazardous substances.33 The central data file at the NLM is called the Hazardous Substances Data Bank; the Bank is subject to full peer review and now contains information on about 4200 substances. The NLM has made this data bank accessible to remote users by way of a computer network, called TOXNET. Use of a personal computer and a telephone modem permits access to TOXNET and auxiliary data files. The TOXNET system is currently used by federal government agencies, some state and local government agencies, private industry, and universities. Workers who respond to emergency releases of hazardous substances, or who clean up sites, or who care for persons exposed to toxic substances must not have their own health and safety compromised in the conduct of their work. The ATSDR funds projects at NIOSH in that agency's research on protecting hazardous waste workers and emergency responders. In particular, the ATSDR has funded research at NIOSH on personal protective equipment appropriate for use by clean-up workers and emergency responders. In addition, health assessments and emergency responses for exposed workers (cleanup workers and others at designated Superfund sites) are routinely conducted in conjunction with NIOSH. The Agency, to fulfill its mandate in CERCLA § 104(i)(1)(c), works with the National Governors Association to prepare and update a list of areas within the states that are closed or restricted to public access due to toxic contamination.34 The list includes approximately 2500 sites and is available to the public. Overall Plan and Future Directions The ATSDR believes that traditional public health experience accrued in the prevention of infectious diseases has important relevance to the prevention of adverse health effects caused by environmental factors such as hazardous substances. There are five traditional elements of disease prevention. They are: (1) identification of morbidity and mortality patterns; (2) evaluation of causes of morbidity and mortality; (3) control of identified causes of morbidity and mortality; (4) dissemination of information on how to prevent or mitigate the adverse health outcome; and (5) maintenance of an infrastructure to develop and conduct programs to prevent adverse health effects. These elements form the foundation that any governmental public health program will need in order to respond to individuals' concerns and to control adverse health effects from hazardous substances. The ATSDR's present efforts and future plans are built on this foundation, although the unique problems posed by hazardous substances dictate that certain traditional techniques of identification, evaluation, control, and communication be modified. Identification of morbidity and mortality patterns, the first element,can be accomplished in part by traditional means of disease surveillance, including reporting by physicians and state and local health agencies. Voluntary reporting systems for infectious diseases and some chronic diseases are well established. Environmental (and occupational) health in the United States, however, lacks a comprehensive surveillance system that is specific to environmental exposure to hazardous substances. It is doubtful that any reporting system that is specific only to hazardous substances is achievable. There are too many confounding factors other than hazardous substances that could produce chronic disease or acute illness. What is needed is a multi-faceted surveillance system. One component would be a traditional, but comprehensive, surveillance system for chronic diseases generally. The system would include cancer data, adverse reproductive outcome data, and other indicators of morbidity and mortality. This kind of surveillance could be linked periodically to environmental exposure data, either from actual measurements or from models. The product of this linkage would be the identification of adverse health effects possibly attributable to hazardous substances. A second component would identify adverse health effects due to acute exposure to hazardous substances. This component, comprised of such methods as health surveillance and epidemiologic research, would be specific to persons who were exposed as a result of emergency releases of toxic substances. Ideally, the data would indicate actual levels of exposure. In addition, exposure registries will provide an excellent mechanism for identifying adverse health effects from hazardous substances. Another element of identification, the ATSDR believes, is quantitative risk assessment. We foresee the use of quantitative [18 ELR 10137] risk assessment as a means of pointing surveillance systems toward possible adverse health effects in human populations. If an estimate of excess risk is found to be particularly high for a given chemical, responsible public health actions would be to reduce human exposures and implement a health surveillance system specific to that substance. The ATSDR also recommends the surveillance of individuals' concerns about their exposure to hazardous substances. We believe that the use of our health assessments (particularly those in response to petitions) will provide an important means to hear community concerns and to identify potential adverse health effects before traditional reporting systems do. Evaluation of causes of morbidity and mortality patterns is the second element in effective disease prevention. When adverse health effects are identified, a comprehensive effort must be made to determine their cause. For hazardous substances, this means a critical examination of medical and scientific data that relate exposure to the substance and health effects. This examination takes the form of the ATSDR's epidemiological investigations and toxicological studies. Individuals' concerns are evaluated through health surveillance, exposure registries, and exposure evaluations. The actual control, or prevention, of causes of morbidity and mortality from exposure to hazardous substances constitutes the third element of disease prevention. There are both primary and secondary means of control. The primary means of control is through reduction of exposure to the substances of concern. Statutes such as TSCA, FIFRA, and RCRA that regulate the use and disposal of substances constitute one layer of control. For hazardous substances released unintentionally, the chief control technique is the remediation of sites. Secondary means of control include health surveillance to identify and treat potential problems and, we believe, petitions for health assessments, in that individual citizen's concerns may serve as a form of informal health surveillance. The fourth element in successful disease prevention is the dissemination of information. For hazardous substances, this means information on the toxicity, human health effects, and prevention measures associated with specific hazardous substances. The American public is poorly informed about hazardous substances. An effective dissemination program should help improve the public's knowledge about hazardous substances. The ATSDR believes that there are multiple audiences for information on hazardous substances. They include state agencies, local health agencies, private industry, environmental groups, academic institutions, medical and health professional societies, health care providers, and individuals. Obviously not all audiences would necessarily receive the same material. The Agency believes that three principal dissemination strategies should be available to the various audiences. First, the National Library of Medicine's TOXNET system, which contains comprehensive toxicological information, will be made available to a wider audience through expanded computer networking.35 Further, the Hazardous Substances Data Bank of TOXNET will be made available on compact disk for users who do not want to use a computer network. The second dissemination strategy will consist of a health education program. It will have two components. One component will be to develop medical and health information (from the ATSDR toxicological profiles) on hazardous substances and to make it available to medical educators, primary care physicians, and other health care providers. This distribution will be coordinated with national, state, and local medical societies. The second component will consist of health education materials developed for presentation and distribution to health educators, public schools, and the public. The third dissemination strategy will consist of communications built around exposure registries. One purpose of an exposure registry is to permit communication with registrants. The ATSDR plans to use its national registry system for sending contemporary scientific and medical information to registrants who could use it to manage their own health concerns regarding hazardous substances.36 Identification, evaluation, control, and dissemination of information will not prove effective in preventing morbidity and mortality unless the fifth element, an infrastructure, exists to support them. And, conversely, an infrastructure that lacks any of the four elements will fail as a prevention effort. Creation of the ATSDR filled an important gap in the infrastructure because before 1980 there was no centralized collection, analysis, and publication of information on the special problems associated with human exposure to hazardous substances. Filling this gap is important, since individual practitioners and some local and state health agencies may lack the expertise, data base, and other necessary resources to understand and deal effectively with these problems. Experience in investigating the potential health effects of hazardous substances has led the ATSDR to identify current research needs and future directions for research. In the area of environmental epidemiology, research is needed to improve upon traditional epidemiological methods when applied to the study of health effects from hazardous substances. In particular, analyses of clusters of morbidity and mortality and prospective studies (i.e., long-term evaluations of the same persons) that utilize validated methods of measuring exposure to hazardous substances are needed. Also needed are reference data on normal levels of hazardous substances in human populations. In exposure assessment, improved methods must be developed and validated to characterize human exposure to hazardous substances. This includes laboratory methods as well as epidemiological methods. Laboratory methods need to assess new knowledge from molecular biology as to its potential to characterize human exposure. Toxicology research needs to address complex mixtures and combinations of hazardous substances. Risk assessment also needs to be improved. Given the importance of quantitative risk assessment in setting priorities for environmental and health decisions, it is important that research must be conducted to make it as useful and accurate a science as possible. Of particular importance is the greater use of pharmacokinetics data in risk assessment. Pharmacokinetics is the study of the body's uptake, distribution, and elimination of chemical substances, a better understanding of which will enhance comparisons between laboratory animals and [18 ELR 10138] humans. Finally, research to arrive at improved surveillance methods and more effective health education techniques is on the Agency's agenda. The ATSDR, through fulfilling its various CERCLA mandates, is addressing the threat of human exposure to hazardous substances by adopting and refining traditional public health techniques that have proven successful in battles against infectious disease. Our research programs and public health activities are all designed to serve one goal — to protect the public from potential harm caused by chemical substances in our environment. The ATSDR/EPA List of the 100 Most Hazardous Superfund Substances The following list contains the 100 most hazardous substances found at NPL sites. The four groups are listed in descending order of priority. The ATSDR and EPA decided that the data were insufficient to rank the chemicals within each group; therefore, they are listed alphabetically.
2. Pub. L. No. 99-499, 100 Stat. 1613, Pub. L. No. 99-563, § 11(c)(1), 100 Stat. 3177 (1986). CERCLA and SARA are codified together at 42 U.S.C. § 9601-9675, ELR STAT. 44005-44081. For an analysis of the 1986 Amendments, see Atkeson et al., An Annotated Legislative History of the Superfund Amendments and Reauthorization Act of 1986 (SARA), 16 ELR 10360 (1986). 3. See generally CERCLA § 104(i), 42 U.S.C. § 9604(i), ELR STAT. 44017-44021. 4. 42 U.S.C. § 9604(i)(6)(A), ELR STAT. 44018. 5. 52 Fed. Reg. 45019 (Nov. 24, 1987) (notice of interim procedures for requesting health assessments). 6. See CERCLA § 104(i)(6)(B), 42 U.S.C. § 9604(i)(6)(B), ELR STAT. 44018-44019. 7. 42 U.S.C. § 6939a, ELR STAT. RCRA 024-025. 8. CERCLA § 104(i)(11) states: If a health assessment or other study carried out under this subsection contains a finding that the exposure concerned presents a significant risk to human health, the President shall take such steps as may be necessary to reduce such exposure and eliminate or substantially mitigate the significant risk to human health. Such steps may include the use of any authority under this chapter, including, but not limited to — (A) provision of alternative water supplies, and (B) permanent or temporary relocation of individuals. In any case in which information is insufficient, in the judgment of the Administrator of ATSDR or the President to determine a significant human exposure level with respect to a hazardous substance, the President may take such steps as may be necessary to reduce the exposure of any person to such hazardous substance to such level as the President deems necessary to protect human health. 42 U.S.C. § 9604(i)(11), ELR STAT. 44020. The ATSDR has not yet articulated uniform standards for determining when there is a "significant risk to human health"; such decisions are presently made on a case-by-case basis. 9. CERCLA § 104(i) states in relevant part: (7)(A) Whenever in the judgment of the Administrator of ATSDR it is appropriate on the basis of the results of a health assessment, the Administrator of ATSDR shall conduct a pilot study of health effects for selected groups of exposed individuals in order to determine the desirability of conducting full scale epidemiological or other health studies of the entire exposed population. (B) Whenever in the judgment of the Administrator of ATSDR it is appropriate on the basis of the results of such pilot study or other study or health assessment, the Administrator of ATSDR shall conduct such full scale epidemiological or other health studies as may be necessary to determine the health effects on the population exposed to hazardous substances from a release or threatened release. If a significant excess of disease in a population is identified, the letter of transmittal of such study shall include an assessment of other risk factors, other than a release, that may, in the judgment of the peer review group, be associated with such disease, if such risk factors were not taken into account in the design or conduct of the study. (8) In any case in which the results of a health assessment indicate a potential significant risk to human health, the Administrator of ATSDR shall consider whether the establishment of a registry of exposed persons would contribute to accomplishing the purposes of this subsection, taking into account circumstances bearing on the usefulness of such a registry, including the seriousness or unique character of identified diseases or the likelihood of population migration from the affected area. (9) Where the Administrator of ATSDR has determined that there is a significant increased risk of adverse health effects in humans from exposure to hazardous substances based on the results of a health assessment conducted under paragraph (6), an epidemiologic study conducted under paragraph (7), or an exposure registry that has been established under paragraph (8), and the Administrator of ATSDR has determined that such exposure is the result of a release from a facility, the Administrator of ATSDR shall initiate a health surveillance program for such population. This program shall include but not be limited to — (A) periodic medical testing where appropriate of population subgroups to screen for diseases for which the population or subgroup is at significant increased risk; and (B) a mechanism to refer for treatment those individuals within such population who are screened positive for such diseases. 42 U.S.C. § 9604(i)(7)-(9), ELR STAT. 44019-44020. These determinations — when an epidemiologic study is appropriate, when there is a potential significant risk to human health requiring an exposure registry, or when there is a significant increased risk of adverse health effects that requires health surveillance — are made on a case-by-case basis, like those decisions discussed at supra note 8. 10. See CERCLA § 104(i)(6)(A), 42 U.S.C. § 9604(i)(6)(A), ELR STAT. 44018. 11. Id. 12. See supra note 6 and accompanying text. 13. CERCLA § 104(i)(6)(B) states: (B) The Administrator of ATSDR may perform health assessments for releases or facilities where individual persons or licensed physicians provide information that individuals have been exposed to a hazardous substance, for which the probable source of such exposure is a release. In addition to other methods (formal or informal) of providing such information, such individual persons or licensed physicians may submit a petition to the Administrator of ATSDR providing such information and requesting a health assessment. If such a petition is submitted and the Administrator of ATSDR does not initiate a health assessment, the Administrator of ATSDR shall provide a written explanation of why a health assessment is not appropriate. 42 U.S.C. § 9604(i)(6)(B), ELR STAT. 44018-44019. 14. See 52 Fed. Reg. 45018-19 (Nov. 24, 1987). The notice of interim procedures states in part: In determining whether to conduct a health assessment in response to a public request, ATSDR will consider, among other factors: (1) The location, concentration, and toxicity of the hazardous substances; (2) the potential for human exposure; (3) the recommendations and findings of other governmental agencies; and (4) other ATSDR priorities, such as its statutory mandate to conduct health assessments at all sites on, or proposed for inclusion on, the National Priority List. 15. 42 U.S.C. § 9604(i)(2), ELR STAT. 44017. 16. The chemicals are published at 52 Fed. Reg. 12869 (Apr. 17, 1987). 17. See infra notes 20 through 22 and accompanying text. 18. 52 Fed. Reg. 38340 (Oct. 15, 1987). 19. See infra notes 24 through 27 and accompanying text. 20. 42 U.S.C. § 9604(i)(3), ELR STAT. 44017-44018. 21. See CERCLA § 104(i)(3), 42 U.S.C. § 9604(i)(3), ELR STAT. 44018. 22. Id. 23. Id. 24. See CERCLA § 104(i)(5), 42 U.S.C. § 9604(i)(5), ELR STAT. 44018. 25. 15 U.S.C. §§ 2601-2654, ELR STAT. TSCA 001-046. 26. 7 U.S.C. §§ 136-136y, ELR STAT. FIFRA 001-029. 27. 42 U.S.C. § 9604(i)(5)(D), ELR STAT. 44018. 28. See CERCLA § 104(i)(1)(D), 42 U.S.C. § 9604(i)(1)(D), ELR STAT. 44017. 29. 42 U.S.C. § 9604(i)(1)(A), ELR STAT. 44017. 30. 42 U.S.C. § 9618(f), ELR STAT. 44046. 31. See supra notes 4 through 27 and accompanying text. 32. 42 U.S.C. § 9604(i)(14), ELR STAT. 44020. 33. 42 U.S.C. § 9604(i)(1)(B), ELR STAT. 44017. 34. 42 U.S.C. § 9604(i)(1)(C), ELR STAT. 44017. 35. See supra note 33 and accompanying text. 36. Registrants may also request in writing information compiled on their exposure. 18 ELR 10132 | Environmental Law Reporter | copyright © 1988 | All rights reserved |