Integrating Public Health Into Superfund: What Has Been the Impact of the Agency for Toxic Substances and Disease Registry?

20 ELR 10013 | Environmental Law Reporter | copyright © 1990 | All rights reserved


Integrating Public Health Into Superfund: What Has Been the Impact of the Agency for Toxic Substances and Disease Registry?

Martin R. Siegel

Editors' Summary: One of Congress' major goals in amending the Comprehensive Environmental Response, Compensation, and Liability Act in 1986 was to better address the health threats posed by hazardous waste sites. Congress sought to add greater firepower to the role of the Agency for Toxic Substances and Disease Registry, a part of the Public Health Service. But more than three years after the amendments' passage, ATSDR remains an agency many have never heard of. Even environmental professionals are often confused about what it does and how it works.

In this Article, the author, a lawyer formerly on the ATSDR staff, outlines the Agency's organization, functions, and the current status of its work. He considers the Agency's impact on environmental litigation. Finally, he reviews areas where improvement is needed, and observes that reform may be possible as part of the upcoming reauthorization of CERCLA.

Mr. Siegel is a senior research scientist with the Pacific Northwest Laboratory. Previously, he was a Senior Attorney with the Office of the General Counsel, U.S. Department of Health and Human Services, responsible for legal issues related to the Agency for Toxic Substances and Disease Registry. He is a graduate of Temple University Law School, Johns Hopkins University School of Hygiene and Public Health, and the University of Pennsylvania. Funding for this work was provided by the U.S. Department of Energy under contract DE-AC06-76RLO 1830.

[20 ELR 10013]

With the passage of the Superfund Amendments and Reauthorization Act (SARA)1 in 1986, Congress showed increased interest in the relationship between hazardous waste sites and human health effects. Apparently dissatisfied with the previously limited role that had been played by the Agency for Toxic Substances and Disease Registry (ATSDR) in investigating toxic substances' health effects, in SARA Congress greatly expanded ATSDR's responsibilities. Congress amended § 104(i) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA)2 to require ATSDR to conduct health assessments at every site on, or proposed for inclusion on, the Environmental Protection Agency's (EPA's) National Priorities List (NPL); establish a priority list of hazardous substances found at CERCLA sites; produce toxicological profiles for each of the substances on this list; and undertake various research and health studies related to hazardous substances.

Three years after the passage of SARA, and with reauthorization of CERCLA due in 1991, this Article reviews ATSDR's progress in implementing its statutory responsibilities. It assesses ATSDR's activities to date and outlines issues which should be addressed as part of CERCLA reauthorization.

Background

CERCLA, as originally enacted in 1980, authorized ATSDR's formation as part of the U.S. Public Health Service, a component of the Department of Health and Human Services. However, ATSDR was not formally established until 1983, as a result of a lawsuit brought by the Environmental Defense Fund, the Chemical Manufacturers Association, and the American Petroleum Institute.3 Headquartered in Atlanta, Georgia, ATSDR works closely with its sister Public Health Service agency, the Centers for Disease Control (CDC). In fact, the Director and Deputy Director of CDC also serve as the Administrator and Deputy Administrator, respectively, of ATSDR. ATSDR's 1989 fiscal year budget was $ 44.5 million and it employed 175 people.

In addition to its CERCLA responsibilities, ATSDR is also authorized under the Resource Conservation and Recovery Act (RCRA) to conduct health assessments, at EPA's request, at landfills and surface impoundments.4 In addition, the Medical Waste Tracking Act of 1988, which added a new subchapter at the end of RCRA, requires that ATSDR prepare a report on the health effects of medical wastes.5

In creating ATSDR, CERCLA repeated a division of federal agency responsibility similar to that established under the Occupational Safety and Health Act (OSHA).6 OSHA created the Occupational Safety and Health Administration as a regulatory, risk management agency and the National Institute for Occupational Safety and Health as a public health research, risk analysis agency. Similarly, under CERCLA, EPA is the regulatory agency in the hazardous waste area and ATSDR is the public health non-regulatory agency.

In amending CERCLA in 1986, SARA laid out a very specific framework for many of ATSDR's health responsibilities. Generally, now ATSDR's activities fall into two broad categories: general health research and assessment of health impacts of hazardous substances, and health studies at specific hazardous waste sites to assess those [20 ELR 10014] specific sites. These general categories, however, are not mutually exclusive. For instance, ATSDR may conduct epidemiological or pilot studies at a particular hazardous waste site that provide both general knowledge about the relationship between exposure and health and specific knowledge about the health of individuals at that site.

ATSDR has encountered difficulties in implementing the SARA requirements. Even in the best of times, ATSDR would have faced an imposing task to meet the mandates of this newly amended CERCLA. At the time of SARA's passage, however, ATSDR was particularly ill-prepared to meet this challenge. At that time, ATSDR was a small agency with an annual budget of approximately $ 30 million and the equivalent of approximately 75 full-time employees, a large number of whom were detailed to other Public Health Service agencies.

In addition, ATSDR suffered a severe identity crisis in how it was perceived by other federal agencies, Congress, and the public, a condition that still persists, although to a lesser degree. A common misconception was that ATSDR was simply a component of CDC or EPA. Often, ATSDR found itself in direct competition with CDC for staff when CDC was under great pressure to expand to address the acquired immune deficiency syndrome (AIDS) epidemic, and the Reagan administration was striving to shrink the federal government.

To this day, ATSDR is limited by funding constraints. It depends heavily on EPA, which administers the CERCLA hazardous waste "Superfund," for endorsement of its funding requests. ATSDR must also have its annual appropriations initially approved by EPA. This requires ATSDR to justify its funding requests, and thereby its policy objectives, to an agency which itself is also competing for limited Superfund dollars. Accordingly, faced with limited staff and budgets and with these factors largely controlled by other agencies with competing demands, ATSDR has been understandably hindered in its efforts to meet its statutory mandates.

General Research

Under the general health research authority, CERCLA now establishes a framework of specific mandates, tied to deadlines, for ATSDR activities. ATSDR, with EPA, was required to compile a rank order list of 200 hazardous substances most often found at NPL sites and that pose the greatest risk to public health.7 This list will be updated with an additional 75 substances over the next three years.

ATSDR was next required to prepare toxicological profiles for each listed substance.8 The profiles describe the levels of exposure that are significant to human health, the resulting health effects, and the adequacy of data available for determining levels of significance. The profiles also provide an introductory statement, aimed at a lay audience, that summarizes current knowledge about the health effects of each substance and lists a bibliography of major studies on the substances and existing regulatory standards and guidances. SARA's rigorous schedule for the completion of these toxicological profiles was subsequently relaxed by Congress.9 ATSDR now plans to produce or revise approximately 40 toxicological profiles a year. ATSDR is currently finalizing the first 25 of these profiles and has issued and solicited public comment on the second set of 25 draft profiles.

Finally, ATSDR is required to "assure the initiation of a program of research" to fill the data gaps identified by the profiles.10 ATSDR has developed a proposed decision guide for identifying and prioritizing substance-specific data needs.11

CERCLA urges that industry bear the costs of conducting the research to fill these data gaps.12 Accordingly, to the extent possible, these research needs will be coordinated with EPA's programs under the Toxic Substances Control Act13 and the Federal Insecticide, Fungicide, and Rodenticide Act,14 both of which authorize EPA to require industry participation and funding of toxicological research. To date, however, administrative procedures for coordination and cost recovery under this authority have not been developed. Because of legal and administrative obstacles, ATSDR has not actively pursued this cost recovery option. But regardless of cost recovery, this research agenda, established by ATSDR with assistance from EPA and the National Toxicology Program, could potentially have a considerable influence on private and government toxicology research over the coming years.

Site-Specific Activity

SARA added a large number of site-specific, health-related activities to those limited responsibilities of ATSDR already contained in the original CERCLA.

Health Assessment Responsibilities

SARA ordered ATSDR to conduct a health assessment by December 10, 1988, for the 887 sites on or proposed for the NPL at time of passage of SARA in October 1986.15 In addition, ATSDR is required to complete a health assessment within one year for every new site proposed for inclusion on the NPL.16 For instance, by January 20, 1988, ATSDR was required to complete health assessments for the 64 sites EPA proposed in January 1987 to add to the NPL. Before 1986, ATSDR generally conducted health assessments only in response to requests from EPA. Under the amended CERCLA, this responsibility to conduct health assessments at all NPL sites became mandatory.

ATSDR defines a health assessment as "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 [20 ELR 10015] or other recommendations, and identify studies or actions needed to evaluate and mitigate or prevent human health effects."17 CERCLA § 104(i)(6)(G)18 specifies that health assessments are to assist in determining whether action should be taken to reduce human exposure to hazardous substances and in determining whether additional information on health risks at a site should be acquired by conducting health effects studies for the site.

Since approximately early 1988, all health assessments have been prepared following ATSDR's internal guidance entitled "Health Assessment Format, Guidelines and Methodology." This guidance outlines the scope, format, and information which should be included in all health assessments, and presents a detailed discussion on methodological approaches and data needs for health assessments. Surprisingly, however, while this guidance was relied upon by ATSDR in preparing most of the first 951 health assessments, it has not been made generally available to the public. Unlike ATSDR guidelines for the preparation of the toxicological profiles, the health assessment guidance has not been subject to public review and comment. ATSDR only recently submitted this health assessment guidance to its Board of Scientific Counselors for review.

The health assessment guidance document also establishes what are called "screening values" for a large number of contaminants found in different environmental media. According to the guidance document, these screening values are intended "to provide a method for easy and rapid determination of contaminants that potentiallypose a health threat to people near a hazardous waste site." Specifically, the screening values "are used to determine if a chemical, which is found in a specific environmental medium, has the potential to cause adverse health effects in individuals who come into contact with the specific contaminated medium." ATSDR has developed both acute and chronic screening values for contaminants in water, soil, and air, and is developing values for contaminants found in food.

ATSDR compares these screening values with levels found at specific sites. When environmental concentrations of a chemical at a site are greater than the media-specific screening value, ATSDR advises that a more detailed assessment be made to determine the substance's actual health threat under realistic exposure conditions. In general, screening values were derived using existing standards and recommendations from EPA and other agencies.

ATSDR has used this general guidance to try to standardize the format of its health assessments. Generally, the health assessment will contain information describing the site location, on- and off-site contamination, physical hazards, the populations at risk near the site, and land use. The health assessment also describes the environmental pathways, human exposure pathways, and the public health implications of this information. Finally, the health assessment is supposed to include conclusions and recommendations about the public health implications of the site, including future data needs.

ATSDR also tries to standardize the conclusions found in the health assessments. It places sites in one of four categories, ranging from Category 1 (Urgent Public Health Concern) to Category 4 (No Identifiable Public Health Risk at the Present Time). ATSDR intends this characterization to assist in prioritizing future work at NPL sites.

ATSDR has now proposed a regulation outlining procedures for health assessments and health effects studies.19 The regulation, proposed in August 1988 and expected to be finalized shortly, specifies a procedure for submitting and processing petitions for health assessments, establishes a notice and comment period for health effects studies, outlines record-keeping requirements, and discusses ATSDR's responsibility for recovering the costs of its health assessments and health effects studies. The proposed regulation does not establish public comment periods for health assessments.

Only industry groups and trade associations submitted comments on the proposed regulation. In general, the commentors supported ATSDR's efforts in this area, although some said that ATSDR's definition of health effects studies to include registries and health surveillance programs was not authorized by CERCLA and would lead to efforts to recover the costs of these activities. The final regulation will probably contain few substantive changes from the proposed action.

Conceptual Models for Health Assessments

There are two different models that ATSDR could have adopted to guide the implementation of its health assessment responsibilities. These conceptual models differ primarily in terms of the timing of the health assessment and the potential impact on the EPA remediation process.

The first model emphasizes early identification of potential public health problems and intervention to address possible problems at a site. Under this model, resourceswould be directed toward fulfilling the CERCLA mandate to complete health assessments at all newly proposed NPL sites within one year.

The advantages of this model are that public health issues are addressed very early in the cleanup process, potential public health problems are identified so as to reduce health damage at a site, and public health data needs are identified before EPA's own data gathering at the site. This early intervention model also enables decisionmakers to prioritize a large number of sites, channeling resources to the sites which pose the most serious health risks. EPA's removal assessment program, where EPA determines whether a removal action is necessary at a site, demonstrates that meaningful decisionmaking regarding a site can indeed be made very early. The principal disadvantage of this model is that quite frequently there is very little site characterization information available this early, limiting the ability to make definitive judgments about the health risks posed by a site.

The second model for health assessments concentrates health assessment activity later in the CERCLA process, generally during or after the remedial investigation/feasibility study (RI/FS) stage. Under this model, minimum effort is directed to addressing the one-year statutory requirement for newly proposed sites, with the maximum amount [20 ELR 10016] of resources dedicated to a comprehensive review of RI/FS data when they become available. The advantages of this model are that it allows ATSDR to make its review and recommendations on the basis of more complete information, and it could help EPA select remedial alternatives and prioritize remedial actions across sites. The disadvantages are that it minimizes ATSDR's ability to influence EPA's data gathering at sites, reduces the possibility of meaningful early public health interventions, and is more resource-intensive because of its commitment to conduct full health assessments based on RI/FS data at all NPL sites, regardless of the magnitude of health risks posed by each site.

These models are not mutually exclusive. It is possible to incorporate elements of one model into the other model. However, the two models do demonstrate fundamentally different concepts about the role and implementation of the health assessment responsibilities of ATSDR. Under ideal circumstances, there would be no need to differentiate between these two models. Given sufficient resources, it would be possible for ATSDR to devote adequate attention to both the early health assessments and those conducted during or following the RI/FS. However, limited resources force ATSDR to focus its efforts in one area or the other.

In expanding ATSDR's health responsibilities in 1986, Congress appears to have expressed a clear preference for the first model of early involvement for the health assessment program. The conference committee for SARA dropped the House of Representatives' definition of a health assessment that required that each assessment contain a specific determination of the potential individual and population health risks posed by individual facilities in favor of the more general Senate definition now found in the law.20 Implicitly, Congress was expressing a desire for early intervention by ATSDR even though complete information may not be available and definitive determinations may be impossible to make. Similarly, CERCLA § 104(i)(6)(D) states that "[w]here a health assessment is done at a site on the National Priorities List, the Administrator of ATSDR shall complete such assessment promptly and, to the extent practicable, before the completion of the remedial investigation and feasibility study at the facility concerned."21 Statements on the Senate and House floors in support of the SARA conference report supported this approach. Sen. Robert Stafford (R-Vt.) stated that in preparing health assessments, ATSDR "should accumulate as much information as possible within the mandated timeframes, issue the … assessment, and then update as necessary."22 Rep. Norman Mineta (D-Calif.) stated that the "guiding principle" for ATSDR in preparing health assessments should be to "aggressively gather as much information as is reasonably available in the mandated timeframes, issue the … assessment on schedule, and then update or revise as necessary."23

Implementation by ATSDR

The requirement that ATSDR conduct health assessments for all sites within one year of the date they are nominated to the NPL posed a dilemma for ATSDR officials. Prior to SARA, ATSDR had conducted health assessments at the request of EPA during or following the RI/FS, the point at which the most complete site characterization information is available. However, an RI/FS is rarely, if ever, initiated within one year of the date a site is proposed for the NPL. Normally, a site's nomination to the NPL is based on little more than EPA's preliminary assessment/site investigation, which frequently does not include detailed information on environmental pathways and potential human exposures.

Accordingly, soon after the passage of SARA, ATSDR was required to make an implicit decision concerning which of the two conceptual models to follow in implementing its health assessment responsibilities. During 1986 and 1987, ATSDR generally viewed the two alternatives as mutually exclusive, and ATSDR chose to conduct most of its health assessments after RI/FS data were available.

However, this approach changed as ATSDR faced its first statutory deadline for health assessments on January 20, 1988. One year before, EPA had proposed to add 64 new sites to the NPL. Pursuant to its policy to defer the conduct of health assessments until the RI/FS stage, ATSDR had made the implicit decision to miss this deadline and, by implication, the one-year requirement for all newly proposed sites.

In December 1987 and early January 1988, ATSDR's approach to the timing of health assessments shifted. ATSDR decided to meet all health assessment-related statutory deadlines, including not only the one-year requirement for newly proposed sites, but also the December 10, 1988, deadline for the 887 NPL sites existing at the time of SARA's passage in October 1986.

To do so, however, ATSDR created the concept of the "preliminary" health assessment to identify those health assessments completed before the RI/FS data were available. Under this approach, ATSDR claimed to meet both its January 20, 1988 (for the 64 new sites) and December 10, 1988 (for the remaining 887 NPL sites) deadlines by preparing many draft "preliminary" health assessments. Of the 951 sites requiring assessments, 504 involved "preliminary" assessments, while 282 were "full" assessments. Another 165 had been prepared prior to October 1986. Many of the health assessments — both preliminary and full — for the 951 sites were in draft form at the deadlines. While CERCLA requires that the health assessments be "completed" by the specified dates, ATSDR maintains that these drafts satisfy the statutory requirements. By mid-1989, many of these draft health assessments still had not been finalized. In addition, many of the pre-SARA health assessments do not satisfy either the statute's or ATSDR's definition of a health assessment.

Of the 951 health assessments, 207 were prepared by 11 states under cooperative agreement with ATSDR. Subsequently, another five states entered into cooperative agreements to prepare health assessments for sites within their states.

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While ATSDR instituted the practice of issuing "preliminary" health assessments, most resources continue to be dedicated to preparing "full" assessments. In fact, ATSDR currently remains committed to conducting a "full" health assessment for every NPL site, even if the "preliminary" health assessment indicated little cause for public health concern,24 though this policy may shift in the future.25 ATSDR has since failed to meet a deadline of June 24, 1989, for EPA's June 1988 update of sites on the NPL.26

Petitioned Health Assessments

Under CERCLA, individuals can now petition ATSDR to conduct health assessments for sites where they have been exposed to hazardous substances.27 In November 1987, ATSDR published procedures for individuals submitting petitions for health assessments.28 As of June 1989, ATSDR had received 49 petitions for health assessments. It rejected one of these petitions, and completed health assessments for five.29 However, the five health assessments completed in response to petitions were for sites on or proposed for the NPL for which ATSDR was otherwise required to prepare health assessments. While it accepted the remaining petitions, as of June 1989, ATSDR had not completed health assessments for these other sites. In some cases, the assessments remain incomplete two years after the receipt and acceptance of the petition.

Health Effects Studies

The amended CERCLA identifies several types of health effects studies that ATSDR can perform. These include pilot studies (which usually involve the gathering of biological samples from residents near hazardous waste sites to determine possible exposure to hazardous substances), epidemiological studies, health surveillance programs, and registries. Since 1986, ATSDR has supported approximately 30 pilot and epidemiological studies. Generally, the epidemiological studies are performed by CDC with ATSDR's financial support, while the pilot studies frequently are conducted in cooperation with the relevant states. ATSDR funds two worker-based registries being compiled by the National Institute for Occupational Safety and Health, but has not established any general population registries. In addition, ATSDR has not established any site-specific health surveillance programs.30

As with health assessments, the cost of the health effects studies is recoverable from potentially responsible parties. With EPA's help, ATSDR is pursuing cost recovery action for several of these studies.

Impact of ATSDR Activities on the Superfund Program

A central question that Congress hoped to address through SARA was to what extent hazardous waste sites present a risk to public health. So far, though, based upon ATSDR's work, it is difficult to answer this question in anything other than general terms. ATSDR estimates that about 80 percent of all NPL sites have a pathway of potential human exposure to hazardous substances and that 10 percent of all NPL sites present a pathway of potential exposure of sufficient concern to warrant further health study.31 While ATSDR has characterized health risks posed by individual sites, it has not yet compiled and analyzed this information on a national basis. There is also no information available about the number of health advisories issued by ATSDR, although ATSDR has recommended emergency action at several sites. In addition, ATSDR does not have any published guidelines or internal guidance for the issuance of health advisories for specific sites.

With the passage of SARA, many observers felt that ATSDR health studies, especially health assessments, would have a dramatic impact on EPA site remediation decisions, toxic tort litigation, and community and government awareness of public health risks associated with hazardous waste sites. They expected that these health assessments and other ATSDR activities would guide data gathering and review of remedial options, as well as provide citizens with valuable information. To a large extent, however, ATSDR has not yet fulfilled these expectations.

The magnitude of the statutory mandate, staff and other resource limitations, competing program responsibilities, and its conceptual approach to conducting health assessments have combined to limit ATSDR's ability to effectively address many of the more complex Superfund sites, especially federal facilities. For instance, the document that ATSDR considers to constitute the health assessment for the Rocky Flats, Colorado, Department of Energy site is simply an evaluation of a proposed test burn of an incinerator at the facility.32 This document does not appear to satisfy the statutory requirement of addressing the public health risks posed by the entire site or the need for further health studies. Similarly, in finalizing a health assessment for Rocky Mountain Arsenal, an Army facility outside Denver, Colorado, ATSDR chose not to respond to detailed comments from the Army, U.S. Department of Justice, and Colorado.33 ATSDR also failed to meet the statutory deadline for preparing health assessments for the Energy Department's site in Hanford, Washington. While it is possible that these particular health assessments and [20 ELR 10018] efforts may not be representative of ATSDR's health assessment program as a whole, they are indicative of ATSDR's handling of several high profile, controversial sites where major public health questions have been raised. In general, under its current approach for conducting health assessments, ATSDR is likely to have minimal impact on NPL sites.

EPA has made efforts to integrate ATSDR's site-specific health studies into its Superfund remediation program. For instance, EPA's guidance to its remediation project managers includes a discussion of interaction with ATSDR.34 EPA and ATSDR hold regular mid-level manager meetings to discuss issues of mutual concern. However, a number of EPA officials, both in its headquarters and in its regional offices, in private interviews in which they requested not to be identified, have expressed dissatisfaction with ATSDR. While some of this dissatisfaction might result from "turf" and other interagency disputes, it is also rooted in more substantive issues. For instance, several EPA officials noted that many of the health assessments are not timely and lack substance. Some EPA officials said they feel there is a lack of responsiveness by ATSDR. Also, there continues to be general confusion about the differences between and the respective roles of ATSDR's health assessments and EPA's risk assessments.

A number of EPA representatives appear to have the general attitude that, while EPA must integrate ATSDR into its Superfund program, ATSDR's role should be minimized. They say that the health assessments are of little practical value to EPA and that they risk upsetting the course of EPA-determined remediation decisions at specific sites. In general, many in EPA feel that the health assessments, especially late in the Superfund process, offer little new substantive knowledge and have minimal impact on EPA decisionmaking.

This ambivalence on the part of EPA toward ATSDR is perhaps best demonstrated by EPA's recent management review of the Superfund program.35 That review, while recognizing the need for stronger cooperation between EPA and ATSDR, nonetheless directed each EPA regional office to conduct an "environmental and public health assessment at each NPL site." These assessments will probably be similar to the removal assessments that EPA has previously used to determine whether a removal action is necessary at a site. This action is intended to advance EPA's new stated goal of addressing the worst sites and worst problems first, with a heavy emphasis on public health. This directive, however, does not acknowledge a role for ATSDR in this effort or recognize that the type of public health assessment anticipated is the type which ATSDR is already mandated to conduct. Apparently, this directive was included in the management review without consulting ATSDR. Accordingly, this new directive may represent either EPA's ignorance of ATSDR's intended role or an implicit acknowledgement that ATSDR's health assessments are not currently serving EPA's needs. EPA's implementation plan for its management review does acknowledge a need for a systematic review of the health consequences of sites, and says EPA will ask ATSDR to prepare a report on this subject by March 1990.

ATSDR's Impact on Litigation

There are several types of litigation which may be related to specific Superfund sites: EPA-initiated litigation directed against potentially responsible parties (PRPs), citizen suits against EPA or the ATSDR to require these agencies to take specific actions, and private toxic tort litigation usually involving residents living near a hazardous waste site who are seeking damages for actual or perceived health problems or dimunition of property values.

ATSDR activities generally have had minimal impact on litigation in all of these areas. While attorneys constituted a significant percentage of the requestors for toxicological profiles and of the petitioners for health assessments, to date these studies have not greatly affected litigation.

ATSDR health studies, especially health assessments, could play a major role in assisting EPA in establishing "an imminent and substantial endangerment to the public health or welfare" posed by an actual or potential release of hazardous substances, the prerequisite for EPA action under CERCLA § 106. In a limited number of individual cases, ATSDR health opinions have been used to help meet this requirement. However, many in EPA and the Department of Justice fear that ATSDR's studies may undercut their efforts to make a showing in court of imminent and substantial endangerment. While the impact to date appears to have been slight, it is safe to assume that as both EPA and PRPs become more knowledgeable about the existence of ATSDR site-specific studies, and as these studies become more numerous in the future, their impact likely will grow. It is likely that these PRPs will make increasing use of ATSDR health assessments, especially when EPA's statement of risk does not match ATSDR's conclusions contained in a health assessment.

To date, no citizen suits under CERCLa have been filed against ATSDR to perform its nondiscretionary duties.36 The only nondiscretionary duties currently required of ATSDR are the updating of the list of substances found at NPL sites, the production of toxicological profiles, and the conduct of health assessments at sites within one year of their proposed inclusion on the NPL. With its failure to meet its health assessment deadline for some of the NPL sites, ATSDR's vulnerability to possible citizen suits in this area will increase.

It also seems that ATSDR health studies have had minimal impact on private toxic tort or other citizen-initiated litigation. Only two reported federal district court cases deal directly with ATSDR health studies, Neighborhood Toxic Cleanup Emergency v. Reilly37 and In Re Paoli Railroad Yard PCB Litigation,38 and only the Paoli case directly addressed the substance of ATSDR's health activities at the specific site. While it is likely that ATSDR studies have played some role in federal cases that were not reported or in state litigation, it still appears that overall ATSDR has had minimal impact in this area.

In the Neighborhood Toxic case, a citizen suit against [20 ELR 10019] EPA, the court dismissed the lawsuit for lack of jurisdiction when the citizens' group alleged that an EPA Record of Decision was deficient. The lawsuit alleged that ATSDR received insufficient information upon which to determine whether the remediation at the landfill posed a significant risk to public health. In the Paoli case, the only reported federal toxic tort case involving ATSDR, the court relied heavily on an ATSDR pilot study of local residents and ATSDR's toxicological profile on PCBs to base its dismissal of personal injury claims brought by local residents.

In addition, it appears that ATSDR has been specifically referred to in only two settlements for NPL sites and federal facility agreements for federal sites on the NPL.39

To date, the expectations that ATSDR activities would greatly aid the work of plaintiffs in private toxic tort litigation have not materialized. The ATSDR toxicological profiles are just beginning to have wide distribution, but they deal only with general information about substances and do not have direct application to specific sites. The petitioned health assessment program generally has been moribund to date. As ATSDR activity increases and its work becomes better known, its impact on litigation will likely increase. However, contrary to fears of industry groups, many of ATSDR's site-specific health studies, by finding an apparent lack of adverse health effects, are likely to benefit potentially responsible parties as much as they aid residents at hazardous waste sites.

Issues for CERCLA Reauthorization

Despite the expanded responsibilities given by SARA, ATSDR's work generally has not attracted a great deal of attention or scrutiny. It is still common to encounter many Superfund professionals, including those on Capitol Hill, and in EPA and the legal community, who are not aware of ATSDR's existence. Many in ATSDR's parent agency, the Department of Health and Human Services, are largely unaware of its existence. While this ignorance is unacceptable, it certainly is understandable. EPA, with its much larger Superfund responsibilities, budget, and staff, as well as its controversial implementation of CERCLA, has attracted most of the attention. ATSDR largely has escaped the attention to which EPA has been subjected. To date, ATSDR has not been the subject of any General Accounting Office, Office of Technology Assessment, or Inspector General's report, though a General Accounting Office investigation was recently begun. There has been no detailed congressional committee oversight of ATSDR.

However, as the time for Superfund reauthorization approaches in 1991, the work and role of ATSDR in the Superfund process should not be ignored. Several issues should be addressed as part of a comprehensive review of ATSDR's role. Many of these issues can be resolved through means other than legislative changes, but should be part of the overall dialogue.

Organizational Independence

ATSDR currently is closely tied to CDC, both formally and informally. The question remains whether ATSDR is best served with its Administrator and Deputy Administrator also serving, respectively, as CDC's Director and Deputy Director and with CDC staff providing much of ATSDR's administrative support. Essentially three approaches could be implemented to address this issue. First, the status quo can be maintained. Second, ATSDR could be abolished, with its statutory responsibilities and mandates transferred to CDC or some other existing agency. And third, efforts could be made to make ATSDR in reality a completely separate agency from CDC.

The current situation clearly is untenable. There is continuing confusion within ATSDR and CDC about the respective roles of staff for both agencies. In theory, the health objectives of CERCLA may be best served by simply abolishing ATSDR and transferring its mandates and responsibilities to CDC. CDC already conducts a large number of the health effects studies for ATSDR and provides administrative support for the agency. This measure would eliminate the need for duplicative administrative and support staff, which would be necessary if ATSDR were made completely independent, and would likely provide other efficiencies in operation. It would also eliminate the need for numerous agreements and arrangements between the two agencies, along with the attendant paper work and red tape.

In reality, it is unlikely that Congress will choose to abolish ATSDR, if for no other reason than to avoid the perception of weakening its position in the area of environmental legislation. In that case, a completely independent ATSDR would be an improvement over the current situation.

Financial Independence

Currently, ATSDR's funding requests must go through EPA. Even under the best of circumstances, this creates the possibility that legitimate institutional rivalries can affect ATSDR's budget request. Accordingly, the need for an independent funding mechanism for ATSDR should be explored.

Congress could directly appropriate Superfund money to ATSDR and thereby eliminate the requirement that ATSDR seek its funding through EPA. This would give ATSDR more authority and responsibility to defend its budget requests, both within the administration and to Congress. Congress, of course, would have to weigh the merits of ATSDR's requests with other Superfund needs when making such appropriation decisions.

Health Assessment Philosophy

ATSDR's continued emphasis on "full" health assessments after the RI/FS stage over the "preliminary" health assessments earlier in the process has clearly affected its ability to adequately address many of the NPL sites, especially complex sites like federal facilities. Congress should consider whether it is satisfied with this. In addition, Congress should consider expanding the role of states in conducting health assessments and other health studies.

[20 ELR 10020]

EPA-ATSDR Programmatic Interaction

There is ongoing confusion concerning the role that ATSDR plays in the EPA's Superfund removal and remedial programs. ATSDR's health-related activities have the potential both to add to the knowledge base about specific sites and to streamline the remediation process in a cost-effective manner. In addition, the work of ATSDR, with its toxicological profiles and health assessments, potentially duplicates activities carried out by EPA.

Mandating Health Activities

Under the current law for site-specific activities, ATSDR is mandated only to conduct health assessments. Its other site-specific studies, such as registries, are not mandated. ATSDR has performed over 1000 health assessments, yet has not established a single general population-based registry. Congress should consider mandating these types of studies.

Basic Research

As currently written, CERCLA divides toxicology research among ATSDR, EPA, and the National Institute for Environmental Health Sciences (NIEHS). Congress should consider whether this current scheme, with its possibility for overlap and lack of coordination, is the most efficient means of accomplishing the basic toxicology research objective. ATSDR is not the best suited to oversee and coordinate such a potentially complex area of toxicological research. Other agencies, such as EPA or NIEHS, which already have in place such research programs and the administrative structures to manage such programs, may be better prepared to act upon the research needs and priorities identified by ATSDR.

Support for ATSDR Activities

Congress has greatly expanded the responsibilities of ATSDR, but the administration and Congress generally have been reluctant to provide sufficient financial and personnel support to adequately address both ATSDR's mandated and discretionary duties. ATSDR has yet to be appropriated the amounts authorized by SARA in 1986. Congress should be wary of adding new mandates in this area without assurances that new resources will accompany the new responsibilities.

Conclusion

The passage of SARA signaled a renewed awareness and interest in the relationship between environmental degradation and public health. ATSDR was mandated a formidable, but generally achievable, task of breaking ground in this area. This is especially true for its health assessment program.

ATSDR has had a number of successes. Its toxicological profiles generally have been well received and could contribute to the streamlining of the RI/FS process. In many instances, its health assessments and health effects studies have been of assistance to EPA, the states, and the public. But for a number of reasons, some not fully within its control, ATSDR has not lived up to its initial promise. The building of a new agency, resource limitations, and interagency rivalries have all contributed to ATSDR's inability to fully address many of its responsibilities.

1. Pub. L. No. 99-499, 100 Stat. 1613 (1986).

2. Pub. L. No. 96-510, 94 Stat. 2767 (1980). CERCLA and SARA are codified together at 42 U.S.C. §§ 9601-9675, ELR STAT. CERCLA 001-075.

3. Environmental Defense Fund, Inc. v. Heckler, 13 ELR 20630 (D.D.C. May 27, 1983).

4. 42 U.S.C. § 6939a, ELR STAT. RCRA 024-025.

5. RCRA § 11009, 42 U.S.C. § 6992h, ELR STAT. RCRA 050. For more on the ATSDR's functions, see generally Johnson, Health Effects of Hazardous Waste: The Expanding Functions of the Agency for Toxic Substances and Disease Registry, 18 ELR 10132 (1988).

6. 29 U.S.C. §§ 651-678.

7. 42 U.S.C. § 9604(i)(2), ELR STAT. CERCLA 018; see also 52 Fed. Reg. 12866 (Apr. 17, 1987); 53 Fed. Reg. 41280 (Oct. 20, 1988).

8. 42 U.S.C. § 9604(i)(3), ELR STAT. CERCLA 018.

9. Department of Housing and Urban Development, Independent Agencies Appropriations Act of 1989, Pub. L. No. 100-104, 102 Stat. 1023.

10. 42 U.S.C. § 9604(i)(5), ELR STAT. CERCLA 018.

11. 54 Fed. Reg. 37618 (Sept. 11, 1989).

12. CERCLA § 104(i)(5)(D), 42 U.S.C. § 9604(i)(5)(D), ELR STAT. CERCLA 019.

13. 15 U.S.C. §§ 2601-2654, ELR STAT. TSCA 001-046.

14. 7 U.S.C. §§ 136-136y, ELR STAT. FIFRA 001-029.

15. CERCLA § 104(i)(6)(A), 42 U.S.C. § 9604(i)(6)(A), ELR STAT. CERCLA 019.

16. Id.

17. 53 Fed. Reg. 32259 (Aug. 24, 1988) (to be codified at 42 C.F.R. § 90).

18. 42 U.S.C. § 9604(i)(6)(G), ELR STAT. CERCLA 020.

19. See supra note 17.

20. H. REP. NO. 962, 99th Cong., 2d Sess. 210, 212 (1986).

21. 42 U.S.C. § 9604(i)(6)(D), ELR STAT. CERCLA 019.

22. 132 CONG. REC. S14897 (daily ed. Oct. 3, 1986) (statement of Sen. Stafford).

23. 132 CONG. REC. H9598 (daily ed. Oct. 8, 1986) (statement of Rep. Mineta).

24. Statement of James O. Mason, Administrator, ATSDR, Before the Committee on Energy and Commerce, Subcommittee on Oversight and Investigations, U.S. House of Representatives (June 20, 1988).

25. Letter from Walter R. Dowdle, Acting Administrator, ATSDR, to Rep. Richard A. Gephardt (June 16, 1989) (response to inquiries from Reps. Gephardt and Synar).

26. Id.

27. CERCLA § 104(i)(6)(B), 42 U.S.C. § 9604(i)(6)(B), ELR STAT. CERCLA 019.

28. 52 Fed. Reg. 45018 (Nov. 24, 1987).

29. Letter from Walter R. Dowdle, supra note 25. But see Johnson, Health Effects of Hazardous Waste: The Expanding Functions of the Agency for Toxic Substances and Disease Registry, 18 ELR 10132 (1988) (observing that as of early 1988, ATSDR had already received approximately 50 petitions for health assessments). See also ATSDR, Annual Report for FY 1988 (May 1989) (ATSDR had received 17 petitions for health assessments during fiscal year 1988 and had completed 8 petitioned health assessments).

30. Letter from Walter R. Dowdle, supra note 25.

31. ATSDR, ATSDR Biennial Report to Congress (1989) (Vol. I).

32. Memorandum from Steven Von Allmen to the Record (Oct. 18, 1988) (establishment of health assessment equivalency for Rocky Flats NPL Site).

33. ATSDR, Preliminary Health Assessment for Rocky Mountain Arsenal (1988). ATSDR has followed up this preliminary health assessment with a health consultation for a portion of the site. See ATSDR, Final Health Consultation, Rocky Mountain Arsenal Basin F, July 5, 1989.

34. EPA, Guidance for Conducting Remedial Investigations and Feasibility Studies Under CERCLA, OSWER Directive 9355.3-01 (draft, Mar. 1988); see also EPA, Superfund Public Health Evaluation Manual, OSWER Directive 9285.4-1 (Oct. 1986).

35. EPA, A MANAGEMENT REVIEW OF THE SUPERFUND PROGRAM (1989).

36. CERCLA § 310, 42 U.S.C. § 9659, ELR STAT. CERCLA 067.

37. 19 ELR 21165 (D.N.J. July 5, 1989).

38. 406 F. Supp. 358, 19 ELR 20265 (E.D. Pa. 1988).

39. See Hanford Federal Facility Agreement and Consent Order (agreement among EPA, the Department of Energy, and the State of Washington Department of Ecology) (May 15, 1989). In addition, ATSDR roles have been included in draft versions of settlement agreements regarding Rocky Mountain Arsenal.


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