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The U.S. Public Health Service (PHS), the Department of Health and Human Services (HHS), and the Agency for Toxic Substances and Disease Registry (ATSDR or the Agency) convened a meeting of the Board of Scientific Counselors (BSC or the Board). The proceedings were held at the Westin Peachtree Plaza Hotel in Atlanta, Georgia on November 30-December 1, 2000. The following individuals were present to contribute to the discussion.
BSC MembersOpening Session. Dr. Melissa McDiarmid, a member of the Board, called the meeting to order at 8:48 a.m. on November 30, 2000. She presided over the meeting until the arrival of Dr. James Melius, the BSC Chair. She welcomed the attendees to the proceedings and opened the floor for introductions.
Review of the Minutes. Dr. McDiarmid entertained a motion to approve the minutes from the previous meeting. Dr. Harris recalled that several comments were made about the possibility of integrating the Office of Tribal Affairs (OTA) into the Office of the Assistant Administrator (OAA). She noted that these remarks were not reflected in the minutes. Dr. Robert Spengler, the BSC Executive Secretary, clarified that the discussion actually occurred during the May 2000 meeting of the Community and Tribal Subcommittee (CTS). Agreement was reached to reference the CTS discussion on this issue in the BSC minutes. Dr. Sorber moved to approve the minutes with the modification; Dr. Harris seconded the motion. There being no further changes or discussion, the May 4-5, 2000 BSC Meeting Minutes were unanimously approved with the revision as noted.
Review of Current Action Items Dr. Spengler provided a status report on the action items that were raised during the previous meeting.
ATSDR Updates. Dr. Henry Falk, the ATSDR Assistant Administrator, acknowledged that the majority of the Agency's time is spent on site activities. Over the course of one year, ATSDR can be involved in 500 to 1,000 sites. In response to the Board's previous request, he distributed detailed information on sites with a high level of public interest. The potential population, contaminants of concern, ATSDR's activities, and current status were described for each of the 18 sites. Over the past six months, Dr. Falk has been actively involved with 10-12 high priority sites by briefing Congress and meeting with community members. However, most of ATSDR's time has been spent in Libby, Montana. An update on the site is scheduled for the following day.
Dr. Falk turned to the budget and announced that ATSDR received $75 million for FY'01, which is $5 million increase from FY'00. On the one hand, the increase is positive because the budget for the EPA Superfund program remained steady. On the other hand, the increase does not adequately address ATSDR's needs due to earmarks of up to $6 million for Libby activities; up to $2 million for Great Lakes initiatives; up to $1 million for the Toms River cancer study; and $500,000 for the Alaska Native Subsistence Study. The new Alaska project was triggered by concerns of elevated PCB levels in basic food chain sources. ATSDR plans to produce a solid product in the hope that the study will be extended beyond the one-year funding period.
FY'01 marked the first time ATSDR had independent budget authority because the Agency never had an opportunity to directly make a case for funding. For example, ATSDR would propose its funding needs to EPA; EPA would present ATSDR's proposed budget to the Office of Management and Budgets (OMB); the President's budget would be proposed for EPA and ATSDR collectively; and EPA would allocate funds to ATSDR. The revised language "appropriates $75 million for salaries and expenses of ATSDR in a new separate account. The conferees believe this new account structure will provide higher visibility and better oversight of ATSDR." In the future, EPA will not serve as the conduit for the Agency's funding. Instead, ATSDR will propose its budgetary needs directly to OMB. ATSDR expects to see long-term benefits from the new appropriations process, but does not anticipate that its strong partnership with EPA will change. Most notably, the Agency will annually notify EPA of the budget it plans to propose.
In terms of planning efforts, ATSDR hopes that its broad-based research agenda will lead to an applied research program. However, several other initiatives also have the potential to contribute to the Agency's growth. First, delegated PHS authorities will provide an opportunity for ATSDR to be included in the PHS Act rather than solely operating under Superfund authority. Although ATSDR is a PHS agency, it has never been included in the PHS Act. The value of ATSDR's involvement and expertise in activities outside of Superfund have already been demonstrated, i.e., guidance on the issue of mercury in vaccines. Nevertheless, delegated PHS authorities will not detract from ATSDR's commitments and obligations to Superfund. Second, ATSDR is near the end of its most recent five-year strategic plan. A new planning process for the next five years was recently initiated. ATSDR will solicit the Board's input during the planning process.
Third, ATSDR and the Centers for Disease Control and Prevention (CDC) are developing a shared vision for environmental health. Due to the interaction between ATSDR and CDC's National Center for Environmental Health (NCEH), a request for the two agencies to collectively create the vision was made by Dr. Jeffrey Koplan, the ATSDR Administrator and CDC Director. Despite the potential for overlap, gaps are expected to be filled in terms of an overarching ATSDR/NCEH environmental health program. A draft document will be submitted to Dr. Koplan in December 2000, but implementation of the vision is uncertain due to the upcoming change in Administration. Regardless of whether a new ATSDR Administrator/CDC Director is appointed, however, the collaborative effort on the shared vision has strengthened the partnership between the two agencies.
Fourth, ATSDR will be asked to submit transition plans to the new Administration. The Agency will use this opportunity to present new and innovative concepts. ATSDR's presentation on recent developments in Washington is scheduled for the following day. Fifth, the Pew Commission Report also proposes a transition plan to the new Administration. The political group has focused on tracking environmental diseases and is expected to make strong recommendations about the future of environmental health programs. This guidance will most likely have an impact on ATSDR and CDC.
For example, the Pew Commission drafted the following language for CDC appropriations: "The committee is interested in pursuing the development of a coordinated system among all of the States to identify and track diseases and conditions caused by exposures to environmental toxins, and asks that the Director prepare a plan to implement such a system, coordinated with existing efforts, for presentation at the fiscal year 2002 appropriations hearings." ATSDR and CDC are assisting Dr. Koplan in developing such an implementation plan. Dr. Falk explained that the current BSC meeting serves as an opportunity for ATSDR to begin obtaining guidance on these planning efforts.
The BSC inquired whether ATSDR's strategic plan will include components to eliminate health disparities. Dr. Falk responded that the strategic planning process is a new initiative and has only been discussed in general terms. However, he was extremely interested in defining specific goals in the strategic plan to eliminate health disparities. He also raised the possibility of the plan including a diversity component for ATSDR staff. He asked the Board to revisit the health disparity issue during the presentation of the strategic plan.
ATSDR Environmental Public Health Research Agenda 2002-2010. Dr. Spengler first recognized the significant contributions of persons who assisted in developing the research agenda over the past eighteen months, including the Research Agenda Subcommittee (RAS), OAA staff, the ATSDR Science Forum, as well as the Research Agenda Workgroup leaders and members. In addition to providing a general review of the research agenda, Dr. Spengler also described the public comments and outlined the implementation strategy.
Review of Agenda Development. In April 1999, ATSDR proposed the research agenda to the BSC and formed the RAS. Workshops were convened in November 1999 and January 2000 so the Agency could involve external partners and obtain input from stakeholders. On December 1, 1999, ATSDR submitted the draft research agenda to Dr. Koplan. In addition to obtaining external guidance, focus group sessions were also held with ATSDR scientists, staff and senior management. The research agenda underwent further development and was subsequently reviewed and revised. The draft document was then released for public comment from July through September 1, 2000.
Although ATSDR solicited advice after the draft research agenda was completed, guidance was also sought throughout the development phase. Input was received from Agency staff and senior management, the BSC, governmental partners, professional associations, universities, non-governmental organizations (NGOs), affected citizens, community groups, and Native American tribes. The external partners are identified in the draft research agenda, which was included in the Board's pre-meeting packets. ATSDR acknowledges that active involvement and guidance by external partners were critical in defining goals for the research agenda focus areas.
Public Comments on Draft Agenda. ATSDR used several methods of dissemination to obtain public comments on the draft research agenda, including a Federal Register announcement, a web site posting, and presentations to the Council of State and Territorial Epidemiologists, the Research Directors' Forum, state partners, and citizens. Additionally, more than 300 draft documents were mailed to federal and state agencies; professional associations; environmental organizations; Asian, Hispanic and Native American groups; women, children and minority organizations; business and industry groups, and other organizations. Electronic versions of the research agenda were also sent to requests made via e-mail. ATSDR selected the most appropriate groups to receive the draft research agenda from its existing database of organizations. The Agency requested that the CTS Special Consultants (SCs) provide names for distribution as well. A full list of the partner agencies, organizations and constituents that submitted public comments on the research agenda were distributed to the Board in the pre-meeting packets.
After the public weighed in on the research agenda, ATSDR saw that the comments related to one of nine categories. The Agency then created a database to manage, analyze and respond to the comments. Under definitions, the public requested that ATSDR clarify certain terms in the research agenda, i.e., "hazardous," "toxic," "endocrine disrupting," "susceptibility," "vulnerability," and "exposure." Under exposure pathways, the public wanted to ensure that ATSDR assessed mixtures, completed pathways and take-home exposures. Under funding, the public expressed the need for ATSDR to support clinical investigators and multi-site studies in optimal settings where known exposures have occurred. Under health education, the public emphasized the need for ATSDR to improve physician education initiatives and increase public understanding about hazardous substances, exposures and health outcomes.
Under implementation, the public noted the importance of ensuring that communities and tribes are involved throughout the process. Although a suggestion was made to provide more details on the research agenda by holding additional workshops, ATSDR believes the best approach is to distribute a one-page summary for each proposed project. The summary will outline the scope, purpose and direction of the research. As each research project is developed and implemented, more details will be provided in the actual study protocol. Under partnerships, the public encouraged ATSDR to seek additional organizational interests and enhance existing collaborations. Under research methods, the public underscored the need to evaluate impacts, measure exposures whenever possible, and use community-based approaches.
Under susceptible populations, the public requested that multiple chemical sensitivity be included in outcomes and vulnerability factors be added, i.e., socioeconomic status and access to care issues. Under support for the agenda, the public commended ATSDR for including external input, addressing priorities, and undertaking a long-range project that was viewed as ambitious, critically needed, a major step, thoughtful and thorough. All of the "Public Comments and ATSDR Responses" were compiled in a handout and distributed in the Board's pre-meeting packets.
Implementation Strategy for the Agenda. Based on the Board's previous recommendation, ATSDR developed the implementation strategy for its research agenda by first reviewing the National Institute of Occupational Safety and Health (NIOSH) National Occupational Research Agenda (NORA). To implement NORA, NIOSH first formed three groups. First, partnership teams were established with 130 staff members and stakeholders to better define research needs, assist in leveraging resources, and develop white papers for each of NORA's 21 priority areas. Second, the NORA Liaison Committee was formed with 22 NGOs to review outreach opportunities, increase the recognition of NORA, and administer partnership rewards. Third, the Federal Liaison Committee was formed with 41 federal agency representatives to guide the implementation of NORA, conduct surveys of federal investments in NORA-related research, and leverage additional resources.
In terms of funding, resources for NORA increased from $15.4 million in 1996 to $61 million in 2000. Moreover, the Congressional appropriation increased from $0 in 1996 to $13 million in 2000. Overall, funding for NORA increased from 9% to 34% of the total NIOSH budget in a five-year period. Based on data from partner surveys, NIOSH determined that $15 million was spent in 1996 by other agencies for NORA-related research. Funding for NORA by other agencies increased to $33.4 million in 1998. Approximately one-half of the funding is allocated to extramural research.
In addition to reviewing NIOSH's approach of partnership teams and outside funding sources, ATSDR also examined NORA's performance measures. For example, progress was tracked by the amount of federal funding spent on NORA; funding for extramural and intramural research; as well as the number of federal funding partners, submitted and funded grants, scientific publications in peer-reviewed journals, and policy, technical or educational documents. After a thorough review of NORA, ATSDR designed an implementation strategy with four components to build upon its well-established research program and provide direction and guidance for existing activities.
Under resource development, ATSDR will expand its budget through ongoing research with three initiatives. First, the Substance-Specific Applied Research Program will continue to collaborate with industry and EPA to test the toxicity of various chemicals. Memoranda of Understanding (MOU) with private-sector volunteers will be maintained to address priority data needs at little or no expense to the Agency. Grants will continue to be supported for the Great Lakes Human Health Effects Research Program, the Minority Health Professions Foundation, and the Chemical Mixtures Research Program. Second, the Priority Health Conditions Research Program will continue studies for birth defects and reproductive disorders, cancer in selected anatomic sites, immune function and neurotoxic disorders, kidney and liver dysfunction, as well as lung and respiratory diseases.
Third, the knowledge base for disease surveillance activities will be strengthened with continued efforts on the multiple sclerosis pilot project, hazardous substances emergency events, the hazardous waste workers program, exposure subregistry cohorts, and the Great Lakes exposed cohorts. To expand its existing research programs, ATSDR will propose additional initiatives in 2001, including PHS authorities; the incorporation of a research component into state cooperative agreements; the development of interagency agreements for additional research; and a Fellows Program. In 2002, ATSDR will continue to develop resources by preparing research budget initiatives and requesting applications for extramural funding in aggregate exposure assessment, genetic markers of exposure or outcome, disease registry, and priority health conditions. The Agency pointed out that the 2001 and 2002 time-lines are not concrete due to funding uncertainties.
Under outreach and collaboration, ATSDR will strengthen existing networks and leverage additional resources to address research priorities. ATSDR is currently compiling a list of agencies and partners for each project or focus area of the research agenda. To better coordinate these activities, the Agency will continue to network with federal and state partners under a federal liaison committee. ATSDR is proposing to use the existing Research Director's Forum for this effort. The membership of this group includes senior scientists and managers from ATSDR, NIOSH, NCEH, EPA, the National Institute of Environmental Health Sciences (NIEHS), and the Food and Drug Administration. The purpose of the Forum will be to collaborate on common priority areas that are shared by the respective agencies.
To assist in this enormous undertaking, workgroups may be established to address specific research areas, such as exposure assessment. For example, the General Accounting Office recently recommended that HHS and EPA jointly develop a long-term strategy to assess and measure exposures in humans. The Forum has already discussed mechanisms to collaboratively respond to the recommendation. For other outreach initiatives, ATSDR will continue to conduct regional meetings with partners and states that have cooperative agreements. ATSDR will also convene workshops to develop projects and review the progress of research activities. Collaborations will be strengthened with federal partners that request applications for research within the ATSDR research agenda focus areas. The Agency will continue its commitment to involve communities and tribes in public reports, workshops, site-specific projects, and community-based approaches. ATSDR will seek guidance from the CTS in this effort.
Under monitoring and evaluation, ATSDR will assess the progress of the research agenda. The divisions will manage the respective research projects; the Office of the Associate Administrator for Science will monitor the progress of the overall research agenda, assist in planning and development activities, and serve as a liaison to the BSC and CTS. ATSDR has already started to create an inventory for ongoing and completed research projects. The database will eventually be linked to the Agency's web site. Other performance measures include annual progress reports and workshops with partners and constituents to identify priorities. ATSDR proposes to monitor its progress by reviewing the portion of the budget spent on intramural research, extramural research, and research agenda focus areas. Currently, 10%-12% of ATSDR's total budget is spent on research. The number of scientific papers, other publications, and submitted and funded grants will be tracked as well. ATSDR plans to periodically update the BSC, CTS and other groups on input received from all the evaluation sources.
Under operational issues, ATSDR drafted an organizational relationship chart as an example of how it can obtain guidance and facilitate the research agenda. The BSC and CTS would continue to make recommendations to the Agency. The Research Directors' Forum would assist in coordinating interagency activities. The ATSDR Divisions would manage the research programs through intramural and extramural projects, interagency agreements, partner initiatives, or requests for applications. The ATSDR Science Forum would assist in monitoring the research agenda by holding workshops. During its discussion of the research agenda, Dr. Spengler asked the BSC to specifically point out any changes that are needed. If the document meets with the members' approval, ATSDR looks forward to the Board's formal endorsement of the research agenda.
Discussion. The deliberations on the research agenda are as follows: The BSC fully supported the excellent content and focus areas of the research agenda. ATSDR was commended for seeking and including input from a diverse group of external sources, particularly communities and tribes. For example, the CTS planned to recommend that ATSDR use the SCs and other community groups in identifying pilot sites for the research agenda projects. However, the BSC realized that the research agenda projects will need to be prioritized due to budgetary constraints.
One comment was that some of the objectives and approaches are basic research projects which are outside the scope of ATSDR. Many educational initiatives are targeted to communities, but projects to strengthen the capacity of ATSDR staff in evaluating community concerns are lacking. The Board recommended that a behavioral and social science component be prominently incorporated into the actual research agenda projects rather than added as an isolated activity. The BSC acknowledged that behavioral and social science research has been a difficult area for federal agencies to actively explore and fund. Due to this data gap, a strong recommendation was made for ATSDR to share the outcomes of the behavioral and social science component with other federal agencies, particularly EPA.
ATSDR made some follow-up comments based on the discussion of the research agenda review. The proposed projects represent intramural and extramural research. Some projects will be conducted as intramural activities or be collaborative efforts with other agencies. The overarching goal is to fill important data gaps on the toxic effects of chemicals and address the Agency's ongoing list of priority data needs.
ATSDR realizes that basic research is different than its traditional role in applied research. However, this involvement has already proven to be useful with the development of an animal model that was later applied at the Anniston, Alabama site. ATSDR and NIEHS were able to use the model to project body burdens potentially caused by contamination at the site. The Agency's updated toxicological profile on methylene chloride was recently published and was used in a basic research project as well. A model was developed in which data were extrapolated from inhalation studies and applied to oral risk factors. As a result, ATSDR was able to generate health guidance values.
With respect to the behavioral and social science component, the improvement of community interaction is not included as a formal research project, but is of significant interest to ATSDR. In addition to applying science in communities, the Agency will also assess environmental justice (EJ) issues and risk factors, such as diet, behavior, and access to medical care. The research agenda will provide an opportunity for ATSDR to place more emphasis on risk factors and better examine communities. The Agency has already met with federal agencies to discuss the behavioral and social science component of the research agenda. ATSDR committed to engaging EPA in this collaborative effort.
The Board turned to the public comments and noted that very few of the remarks related to items being omitted from the research agenda. This result is most likely due to ATSDR's innovative approach of continually obtaining broad input during the development phase. The BSC supported ATSDR's strategy of distributing one-page summaries for each research project.
With respect to the implementation strategy, the Board pointed out that the performance measures proposed by the Agency are bureaucratic or administrative components which do not show actual outcomes in the field. Recommendations were made for ATSDR to select other measures that will truly indicate success and evaluate the performance measures against specific targets or benchmarks. For example, the number of scientific papers published in 1999 can be used as a baseline to compare with the number of papers published in future years. With this strategy, ATSDR will be able to more effectively quantify its progress on the research agenda. Additional performance measures were also suggested for the Agency's consideration, i.e., leveraged funds on research through partner organizations, the timely completion of projects, and adherence to commitments.
The BSC noted that one of the primary reasons for NORA's success was the continued involvement of NIOSH staff and outside stakeholders throughout the implementation of intramural and extramural projects. A recommendation was made for ATSDR to follow NIOSH's example. Efforts should be made to ensure that the Agency's partners and constituents actively participate in initiatives and are aware of the strong emphasis being placed on the research agenda. During the implementation phase, ATSDR should also make efforts to raise awareness, increase involvement and generate outside interest in the research agenda. The Agency can again apply lessons from NORA by naming the research agenda and awarding the efforts of partners.
For outreach and collaborative efforts, the BSC advised ATSDR to partner with agencies that have additional resources or expertise, particularly EPA and NIEHS. For example, ATSDR could incorporate cohorts into the NIEHS prospective children's study and use this support to implement activities at the community level. The BSC inquired about the Agency's plans to use existing studies to evaluate outcomes in the general population, such as the NIEHS cohort study or the National Health And Nutrition Examination Surveys (NHANES). The Board requested that the Research Directors' Forum give consideration to these issues.
ATSDR made some follow-up remarks based on the discussion of the implementation strategy. Progress reports and annual reports will be used to measure outcomes and identify lessons learned, but additional suggestions from the Board are welcome. The Agency agreed with the BSC about the need to closely collaborate with NIEHS and EPA. For example, ATSDR can use the agencies' existing basic research projects to implement newer approaches in the field. ATSDR also concurred with the Board's suggestion to become involved with the NIEHS prospective children's study. The Agency is already engaged in this effort and is represented on the Children's Environmental Health Task Force.
Another collaborative effort in this area is support for ATSDR's pediatric environmental health speciality units by the EPA/NIEHS Children's Centers of Excellence. These links are being strengthened to coordinate clinical and basic research issues. ATSDR hopes that joint funding between the two activities can be explored in the future. In terms of benchmarks, the Agency has not yet established specific targets for the research agenda. However, the performance measures will be able to determine whether ATSDR's ongoing direction is appropriate.
To address the general population, the Agency is closely collaborating with the NCEH laboratory to develop an environmental report card. The purpose of this activity is to evaluate blood and urine samples from NHANES on an annual basis. The goal is to produce a general population sample every four years that can be used in geographic regions among different age groups. ATSDR will attempt to use data from the project to improve the development of reference ranges.
Dr. Melius entertained a motion for the Board to formally endorse the research agenda with ATSDR placing special emphasis in three areas whenever possible. First, a behavioral and social science component should be prominently incorporated throughout the implementation of the actual research agenda projects. Second, collaborations should be strengthened with other federal agencies that have more resources and expertise in basic research. These activities would be relevant to ATSDR's research agenda, but should be conducted under the leadership of other federal agencies. ATSDR would be more involved in applied research projects. Third, the CTS and community groups should actively participate in selecting pilot sites to implement the research agenda projects. Dr. Claudio moved to endorse the research agenda; Dr. White seconded the motion. There being no further discussion, the ATSDR Environmental Public Health Research Agenda for 2002-2010 was unanimously endorsed by the BSC with the three special conditions as noted.
Action Item: The Executive Secretary to propose names for the research agenda during the next BSC meeting.
Before the floor was opened to the next presenter, Dr. Falk presented a letter from Dr. Koplan, a plaque and a certificate to Dr. Claudio in recognition for her service on the Board. The members applauded Dr. Claudio for her valuable input during her tenure on the BSC.
PHS Authorities. Ms. Georgi Jones, Director of the ATSDR Office of Policy and External Affairs, explained that the Agency currently operates under the Comprehensive Environmental Response Compensation and Liability Act (CERCLA) of 1980 and the Superfund Amendment and Reauthorization Act (SARA) of 1986. CERCLA was established to compensate victims who were exposed to environmental contaminants at sites, but physicians testified that the relationship between exposure and disease could not be determined. As a result, ATSDR was formed to conduct research to fill this data gap. With the expansion of its mandate by SARA in 1986, the Agency was given the authority to conduct site-specific activities, such as public health assessments and consultations, medical monitoring programs, and surveillance projects. ATSDR's mandate was also broadened to identify the 275 most hazardous substances, create toxicological profiles for each substance, develop a research agenda, and educate health professionals.
ATSDR's data and expertise are now being sought for activities outside of the Superfund authority, such as bioterrorism, pesticide use, and international studies. To address this dilemma, the Agency has asked the HHS Secretary to request that authorities under the PHS Act be delegated to ATSDR. The authorities would allow ATSDR to conduct research and investigations; cooperate at international, federal and state levels; provide project grants for preventive health services; and participate in interdepartmental activities. ATSDR is expecting to receive final questions from OMB within the next week. The request would then be forwarded to the HHS Secretary for signature.
Dr. Falk emphasized that the new authorities will not affect ATSDR's existing budget and personnel for Superfund activities. However, the request will allow the Agency to be involved with other initiatives. For example, CDC's funding for the bioterrorism initiative does not address chemical releases due to terrorist activities, but ATSDR's expertise could be used to fill this data need. Under the international cooperation authority, ATSDR's toxicological profiles, case studies and other data can be provided to developing countries to increase the knowledge base about toxic substances and hazardous wastes.
Strategic Planning Activities. Mr. Scott McIntyre and Mr. Dave Romola of KPMG Consulting are supporting ATSDR in developing a comprehensive five-year strategic plan that will provide a framework for the overall vision and establish critical measures to monitor progress. Since the new strategic plan must be completed by October 2001, the Agency plans to seek additional guidance from the Board during the next meeting. The strategic assessment is being conducted so that ATSDR can obtain a better understanding of and effectively function in its current state; gain insight into its vision, mission and goals; and provide key input for the design, development and deployment of all resources. A baseline analysis is currently being conducted. Future directions will be determined by interviews with ATSDR senior management, staff and stakeholders.
KPMG's approach to the Agency's strategic planning process was to create a balance between process and a useful product. Emphasis was placed on executing rather than creating the plan. A strong focus was also placed on long-term organizational improvements and results to permanently change the decision-making process throughout the Agency. The strategic plan will identify and implement business best practices among industry, federal agencies and the private sector. Compliance with federal mandates will be supported as well, particularly the Government Performance and Results Act. By law, federal agencies are required to develop strategic plans, prepare annual plans that detail performance goals, and report on actual performance.
Strategic plans should include a comprehensive mission statement that outlines the major functions, operations, general goals and objectives of an agency. Resources, technologies and processes used to achieve the general goals and objectives should be described as well. External factors that may impact on an agency reaching these goals and objectives should also be identified. KPMG's methodology in developing the ATSDR strategic plan is structured in four stages. First, the current state assessment is in progress. KPMG met with ATSDR's existing executive team to determine the current vision, mission, goals and management philosophy. Barriers to planning and implementing the strategic plan will be identified and specific methods to gather information will be established. ATSDR's ability to change will be assessed during this phase.
Second, the external strategic assessment is in progress. KPMG will identify and assess external industry trends; evaluate industry and federal strategic and business plans for best or emerging practices; gather evaluations from customers and stakeholders; and establish and conduct external focus groups for specific evaluations. Third, the internal strategic assessment will be conducted at a later date. ATSDR employees will be interviewed about the current strategy, planning initiatives, procedures and policy perceptions. The results of the interviews will be assessed and presented to the Senior Executive Management (SEM) and Steering Committees. An analysis will be developed that conveys ATSDR's current situation. KPMG will then meet with the Steering Committee to develop future planning actions and create a case for change to assist the new strategy development.
Fourth, strategy development will be conducted at a later date. KPMG will facilitate workshops to better refine the planning, development and implementation of the strategic plan. Input from the external strategic assessment will be evaluated in terms of the overall strategic plan. KPMG will then create a draft strategic plan and develop strategic metrics to measure performance. After the strategic plan is implemented, the metrics will be reviewed with the Steering Committee and revised as necessary. All four phases of the development methodology will be completed by June 2001. Based on its experience in designing strategic plans for other federal agencies, KPMG believes ATSDR will truly benefit from the planning and implementation components. The overall result will be to promote the health and well-being of the Agency.
Discussion. The deliberations on the five-year strategic plan are as follow. The Board strongly recommended that ATSDR and KPMG identify and meet with external stakeholders at the beginning of the process. In this effort, a suggestion was made for the CTS to serve as a focus group during the external strategic assessment phase. The Board explained that the CTS is formally charged with providing input from the perspective of communities and tribes. Additionally, the SCs will be able to offer valuable guidance on cultural aspects that should be included in the strategic plan.
With all due respect to KPMG's expertise in developing strategic plans for other federal agencies, the BSC noted that the CTS is a completely different mechanism than other government advisory groups. The CTS must be actively engaged during the development and planning processes to ensure that the strategic plan is successfully implemented in the field. The SCs were offended by the overall result "to promote the health and well-being of ATSDR" because the focus of this goal should be on communities.
KPMG thanked the Board for clarifying the role of the CTS and mentioned that employees in the ATSDR regional offices will be asked to provide a list of external points of contact. The list will then be reviewed by SEM, the Steering Committee and EPA to ensure that no professional associations or other key stakeholders were omitted. KPMG mentioned that the overall result is not intended to exclude communities and tribes. ATSDR confirmed that both the BSC and CTS will be actively involved in the development of the strategic plan. The Agency reiterated that the strategic plan is a new initiative; only one meeting has been held with the SEM. Overall, ATSDR commended KPMG for the amount of thought and preparation that has gone into the plan to date. The Agency was confident that valuable outcomes will be generated by the five-year strategic plan.
Exposure Investigations (EIs) and Biomarker Studies. Dr. Robert Johnson, of the EI and Consultations Branch, conveyed that several limitations were previously noted about PHAs. In particular, the National Academy of Sciences stated in 1991 that "virtually no information about actual exposure to the public is derived from personal sampling, direct measurement of exposure of individuals or total exposure assessment modeling." To address this deficiency, ATSDR developed EIs in 1994 to better characterize past, current and possible future human exposures to hazardous substances in the environment. An EI is a limited and focused public health action that should not be misinterpreted as a health study. EIs cannot be generalized to other populations or used as a research tool. ATSDR only conducts EIs in communities with suspected exposure. The Agency has never used comparison or control groups in implementing the activity. The advantage of this approach is that an EI can be completed in days or weeks versus months or years.
The objectives of an EI are to enhance the PHA process and determine whether exposure is occurring. An EI can be conducted as a free-standing activity or in conjunction with other ATSDR public health initiatives, such as assessments, educational programs or health studies. The Agency has established a continuum to demonstrate the relationship between environmental contamination and clinical disease. First, the source of contamination is identified. Second, the method for transporting contamination through the environment is examined. Third, a target dose evaluation is conducted to determine total human exposure, internal doses, biologically effective doses, and early biological effects. Fourth, the altered structure or function is analyzed. Fifth, clinical diseases develop.
For purposes of an EI, ATSDR gathers, analyzes and interprets data to address three components of the continuum. For environmental transport, environmental samples of soil, water, air or dust are collected at indoor, outdoor or other locations where individuals may come into contact with contaminants at hazardous levels. For total human exposure, biological markers of urine or blood are gathered and evaluated to document current exposure to a contaminant. In some instances, ATSDR has been able to use biomarkers to demonstrate past exposure. For internal dose, an exposure-dose reconstruction analysis is conducted to estimate contaminant levels from past or future exposures. These projections are based on environmental sampling data and computer models of air and water.
ATSDR will conduct an EI based on four criteria: whether an exposed population can be identified; if data gaps will affect the ability to identify the existence of a public health hazard; whether data gaps can be addressed by an EI; and the impact of EI results on public health decision-making. Dr. Johnson presented three tables to illustrate ATSDR's EI activities over the past two years. Of the 24 EIs conducted with environmental data, only 125 "above background" samples were collected from 664 chemicals found at sites. Of the 31 EIs conducted with biological data, 70 out of 1,445 persons were found to be elevated above a reference range based on various chemical groupings. Out of 45 EIs, 12 filled data gaps for PHAs or health consultations; 14 led to health education activities; 4 led to health studies; and 10 resulted in other follow-up activities. Dr. Johnson pointed out that the tables reflect an extremely broad view of ATSDR's EI activities. He encouraged the attendees to contact the Branch for additional details.
Dr. Ken Orloff of the Branch described some lessons ATSDR learned from conducting EIs during the 1995-2000 time period. On the pro side, environmental sampling can project past or future exposures in some circumstances, such as groundwater contamination. These models can then be used to develop a retrospective risk assessment. The data can also play a significant role in regulatory actions. For example, a remedial action is automatically triggered if drinking water standards exceed the maximum contaminant level that has been established. For biological sampling, a direct and unequivocal measure of exposure is generated. Uncertainty is not an issue in the risk assessment process because samples are taken directly from the body.
On the con side, environmental sampling data do not directly lead to an exposure dose. Instead, assumptions must be made about an individual's intake of air, water or soil as well as the frequency and length of exposure. These estimations are associated with a considerable amount of uncertainty that ultimately impacts the risk assessment. For biological sampling, the body burden of a chemical oftentimes cannot be correlated with a health effect. Additionally, biological sampling cannot identify the source of exposure. Only recent exposures can be detected since many metals and inorganic materials quickly pass through the body.
In designing biomonitoring studies, ATSDR must factor in a number of considerations. First, the cohort can be selected by several methods. A statistically representative cross-section of the population can be chosen by age, race, sex, diet or other factors that are relevant to the contaminant of concern. ATSDR typically does not take a community-wide screening approach. Instead, a strategy is implemented based on the worst-case scenario. The test population will consist of the highest exposed persons who reside at the site. If these individuals test negative for elevated levels of contaminants, the remainder of the population is unlikely to be exposed as well. The cohort often has a self-selection bias because persons who choose to participate in the study are most concerned about potential exposures. The test population may also be influenced by litigation. For example, residents at the Anniston, Alabama site were advised by attorneys not to participate in ATSDR's EI.
Second, obtaining appropriate biological specimens may not always be feasible. Since large volumes of blood must be collected to detect dioxin, samples cannot be taken from children or pregnant women. Gathering urine samples can also be difficult, particularly among infants, young children and working adults who cannot provide samples for a 24-hour period. Hair samples present problems as well due to the possibility of external contamination. Third, seasonal or temporal variation must be considered in designing EIs. For example, exposure from soil cannot be determined if snow is on the ground. Additionally, an accurate identification of time and activity patterns is critical in selecting sample locations because a child may be exposed from a source at the primary residence, day care facility, or the home of a care giver. Moreover, samples from biota can affect the contamination level. For example, fish will show higher levels of PCBs in the summer rather than winter.
Fourth, reference or comparison ranges must be available to interpret the results of the EI. ATSDR's gold standard for obtaining these data is NHANES because the surveys are based on a statistically selected cohort of the U.S. population. Only a small number of chemicals of interest to ATSDR have been examined under NHANES, but CDC is projecting that approximately 100 new contaminants will be added to the surveys over the next four years, including organochlorine pesticides. As a second option, ATSDR will use studies that have been published in the scientific or medical literature. Unfortunately, methodological differences exist due to great advancements that have been made in scientific approaches. Assurances must be made to obtain comparable results if data are compared with methodologies developed in 1970 and 2000. Additionally, published studies usually test exposed populations; therefore, ATSDR would be unable to use these ranges.
Data gaps for reference ranges are also a challenge due to decreasing body burdens and environmental levels for several contaminants, including PCBs and organochlorine pesticides. To address some of these problems, ATSDR will attempt to match certain factors between the test and reference populations, such as geography, gender, race, diet and age. However, ATSDR acknowledges that making these types of correlations is virtually impossible. If data from NHANES or published studies are not available, ATSDR will develop a reference range for the contaminant of concern. For example, reference ranges to examine dioxin levels in the Mossville, Louisiana community were developed in the 1980s and could not be applied to the current environment. Consequently, ATSDR used recent data collected by NCEH in five studies among five states to develop the reference range for dioxin. ATSDR documented that several Mossville residents had significant elevations of dioxin compared to the control population. The EI has ultimately led to several public health actions in the community.
Statistical issues are also a consideration in reference ranges because most studies only report a median, mean or other measure of central tendency. These data are insufficient because 50% of the population have levels that are above median reference ranges. A measure of the upper bound level of exposure is needed, such as a 95th percentile. However, more data points must be identified to obtain a meaningful or accurate 95th percentile. ATSDR's fifth consideration in designing biomonitoring studies lies in the ability to correlate exposure levels with health effects. Although studies have linked lead and mercury to adverse outcomes, data do not exist for a number of other chemicals.
Dr. Susan Metcalf of the Branch defined exposure as "contact over time between an individual and one or more biological, chemical or physical agents." Although the definition is simple, exposure is actually complex due to a variety of parameters and attributes. ATSDR makes strong efforts to identify an individual's dose and correlate potential health effects with an accurate amount of sensitivity and reliability. Exposure can be from one, multiple or mixed agents. The source of exposure can be from manmade or natural substances, focused in one point or area, or stationary or mobile. Exposure can be transported through air, water, food, dust, soil or other environmental media. The point of an individual's exposure may be from a residence, playground, job site, or other facility. The route of exposure may be through inhalation, ingestion or dermal contact. Overall, one of the most important aspects to consider is the concentration of the substance.
To determine the correlation between exposure and health effects, the duration, frequency, geographic scope, population, time frame, and environmental trends of the exposure must be considered as well. Dr. Metcalf noted that the update on EIs and biomarkers were presented for the purpose of ATSDR obtaining the Board's guidance in three areas.
Discussion. The deliberations on the EIs and biomarkers are as follows: For question 1, the BSC urged ATSDR to more actively involve communities in the initial development and implementation of EIs. The SCs emphasized that many residents do not participate in biomonitoring studies due to mistrust of the government and the untimely completion of activities. Efforts by agencies to broadly disseminate materials and make contacts within the community have been flawed as well. Guidance from the public is also imperative for EIs at federal facilities because residents can provide an accurate account of past activities or fill data gaps in the event of staff turnovers. The SCs requested that ATSDR examine more complex issues while conducting EIs at federal facilities, such as data from jet engine manufacturers on vapor contrails, unspent fuel and chemical mixtures in burned emissions. ATSDR was also asked to revisit sites where results of a previous EI showed no exposure because new activities may cause new exposures.
The BSC made several suggestions to address community concerns about EIs. ATSDR should examine exposures over time to collect more data and answer scientific questions about long-term health effects. This approach will provide additional opportunities to engage residents who previously were reluctant in participating or had no knowledge of the EI. The strategy also addresses some seasonal or temporal exposures that have been assumed by ATSDR. For example, exposure to soil cannot be determined if snow is on the ground, but samples can be collected in the area during warmer months. Overall, the approach will identify additional points of exposure for other individuals or groups. Examining exposures over time may also assist in resolving the high drop-out rate of community studies. A recommendation was made for ATSDR to consider incorporating incentive programs in the EIs and biomonitoring studies. The benefit of the studies to the population should be clearly delineated as well.
The BSC also encouraged ATSDR to pursue its proposal to adopt improved and innovative environmental sampling methods. This approach will provide better sensitivity to answer questions in the EI. In particular, data being generated for chemical mixtures should be applied in EIs. Additionally, biomarkers can be validated by exposing humans to low doses of chemicals in a purposeful and scientific investigation. The SCs suggested that ATSDR serve as the lead health agency at sites and coordinate previous sampling efforts by other agencies to ensure the inclusion of all data. This responsibility should not be placed at the community level. With respect to reference ranges, the SCs acknowledged that data gaps exist for many chemicals among the general population. However, ATSDR recently released the updated toxicological profile on DDT despite the fact that these data were collected some time ago.
The Board disagreed with ATSDR's statement that methods approved by NIOSH and OSHA are not adequate for its activities. Because workers have always served as positive controls for environmental experiments, ATSDR should be closely collaborating with these agencies. The enormous amount of overlap that exists in occupational health settings is not being fully utilized. In its proposal to utilize new biomarkers to assess populations, the BSC strongly urged ATSDR not to abandon previous or current approaches that have proven to be successful. For example, the new DNA adducts generated a fair amount of excitement, but the technology has not made many advances in epidemiology over the past fifteen years. Overall, the Board recommended that ATSDR explore new biomarkers in collaboration with NIEHS, but continue its efforts to improve existing methods.
For question 2, the BSC saw short-term benefits in ATSDR collecting comparison data as a routine component in some investigations. One approach to interpreting these data could be examining distance or other parameters to categorize individuals by level of exposure. Although internal comparison groups are not resource-intensive, the Board realized that this method has limitations. True reference ranges will not be generated and refined distinctions will not be made for larger populations. The BSC also acknowledged that if ATSDR does not have solid exposure data for internal comparison groups, health effects from an exposure cannot be evaluated. As a result, external comparison groups should be considered because previous investigations have shown exposures among populations that were assumed to be unexposed. For ATSDR's investigations of health effects, the comparison and exposed populations are equally important.
For question 3, the Board described the model used in industry. If the health significance of an exposure is unknown, then biological monitoring will not be undertaken. Tests or other activities that will not clearly define the level of exposure are not cost effective, which is particularly important when resources are limited. Funding should be spent in a more appropriate manner, such as a health evaluation of exposed persons. As another perspective, the BSC recommended that ATSDR train communities in interpreting data. An explanation of how exposures can be avoided in the future should be provided to residents as well. On the one hand, the SCs were pleased that the Agency has provided opportunities for communities to participate in EIs. On the other hand, residents are frustrated that polluters are funding ATSDR's research.
ATSDR made some follow-up comments based on the discussion. Before developing a plan for the EI, the Agency will first conduct a site visit to explain the purpose of the activity, discuss potential exposures, and obtain input in designing sampling efforts. Study participants are ypically selected by the community. In some instances, ATSDR trained community members in collecting samples, such as gathering soil from a child's play area. The Mossville site serves as a model of the partnership between ATSDR and the community because residents were even involved in creating an agenda for the EI. However, the Agency acknowledged that gaining the public's trust and identifying true community representatives are difficult actions which need constant improvement. ATSDR welcomes guidance from the BSC and CTS on this issue.
In terms of validating biomarkers, ATSDR explained that any activity involving humans must undergo examination by an Institutional Review Board to determine the benefits to science and the community. As a result, the activity would be defined as a study and could not be conducted as an EI. Since ATSDR does not intentionally expose humans to chemicals, biomarkers are validated by simultaneously collecting environmental and biological samples to identify any correlation between dose and effect. With respect to partnering with NIOSH and OSHA, ATSDR clarified that the agencies' methods are different, i.e., healthy workers versus children or eight-hour versus long-term exposures. Nevertheless, ATSDR uses these data whenever possible and also relies on EPA standards.
In terms of question 3, ATSDR clarified that it could not apply the industry model because communities may want an EI to be conducted regardless of whether scientific questions will be answered. Additionally, an EI that did not demonstrate exposure at one time may show exposure at another time. The overall goal of an EI is to gather enough information to make a public health judgment on a completed exposure pathway. Over the past six years, ATSDR has learned that communities must play an equal role in interpreting data. This partnership is enhanced by health education activities that build capacity at the local level.
Action Item: The BSC to revisit question 2 at a future meeting; the CTS to place question 3 on its agenda and report the findings at a future BSC meeting.
Pew Commission Report. Dr. Falk explained that the Pew Foundation has been engaged in strengthening environmental health for quite some time. Due to this interest, a commission was established which developed several reports. The initial Pew Commission reports specifically addressed environmental health problems, such as asthma and birth defects. The reports also highlighted inadequacies in current surveillance efforts for these types of diseases. The Pew Commission then produced America's Environmental Health Gap to point out the fact that most chronic diseases have an uncertain etiology and minimal efforts are expended to track these diseases. Another draft report by the Pew Commission is expected to be released shortly.
ATSDR has expertise in environmental disease surveillance, but the Pew Commission initially considered CDC, EPA and NIEHS as potential partners. As a result, Dr. Falk strongly advocated for the Agency's involvement in this activity. Additionally, ATSDR's mandate to conduct environmental disease surveillance should dictate its active participation in this area. The Pew Commission draft report will most likely focus on developing integrated public health systems to address environmental health issues and strengthen the role of health departments. The Pew Commission has been informed by state health departments about the usefulness of ATSDR's cooperative agreement program. The Pew Commission is now interested in broadly applying the Agency's model of assisting states in environmental health, including "Right To Know" issues.
Over the past year, the Pew Commission has focused more on chronic diseases rather than environmental diseases. The transition report that will be presented to Congress and the Administration will probably request a new environmental health and disease surveillance tracking network which is better funded and more strongly supported at national and federal levels. Since the Pew Commission has requested that Dr. Koplan submit plans for the national network, ATSDR and CDC will be involved in the initiative. Another Pew Commission report requested that activities among HHS agencies in the Atlanta area be consolidated. The Pew Commission also raised the need to strengthen the voice in Washington for environmental health because no individual currently advocates for this issue. Consideration is being given to the Surgeon General or another high-ranking official in HHS undertaking this role.
Another activity by the Pew Commission is the creation of Health Track to communicate environmental health issues to the public. The group is expected to undertake lobbying and educational initiatives in the future. Dr. Falk indicated that activities by the Pew Commission can be linked to ATSDR's research agenda, five-year strategic plan and other projects. The final language is expected to be finalized in an HHS appropriations bill. ATSDR will seek guidance from the BSC as activities are completed. The Pew Commission should disband later in December 2000, but follow-up mechanisms will be developed to implement proposals that are approved.
ATSDR's Cooperative Agreements for Site-Specific Activities. Mr. Richard Gillig, of the Division of Health Assessment and Consultation, conveyed that the primary goal of the program is to provide resources for state health departments to build capacity, develop a multi-disciplinary team of health professionals, and conduct site-specific health activities. The initiatives are designed to be integrated with ATSDR, communities, site managers and other agencies so that states can collaborate on developing and implementing effective intervention strategies. Approximately 20 Agency staff members from various divisions are involved with the cooperative agreement states on a daily basis. Additionally, the states regularly coordinate with other ATSDR programs and state organizations. Many of the partner states would have no environmental public health program without support from the Agency. To date, only 20% of states participating in two programs have state-funded positions that conduct site activities which are similar to those supported by ATSDR.
Cooperative agreement 607 targets states with the greatest number of sites on the National Priorities List (NPL). The program currently funds 23 state health departments that conduct PHAs, community involvement activities, health education and health studies. Individual cooperative agreements are awarded from $200,000-$800,000; staff positions range from 3-8 persons. Overall, the program is funded at $10 million per year. Cooperative agreement 98064 targets states with fewer NPL sites. The program currently funds 5 state health departments that conduct PHAs, community involvement activities, or public education activities. Individual cooperative agreements are awarded from $60,000-$200,000; staff positions range from 1-2 persons. Overall, the program is funded at $500,000 per year.
To support capacity and maintenance of the program, ATSDR provides state health departments with financial resources for staff salaries, expenses associated with site activities, technical guidance and training. This support allows states to assess and respond to public health issues related to human exposure to hazardous substances in the environment. Before ATSDR established programs 607 and 98064, separate cooperative agreements were specifically awarded for PHAs, health education or health studies. EIs, the preparation of PHAs and health consultations, and technical assistance to other agencies and communities are included under PHAs. Educational activities to communities and health professionals are included under health education. Epidemiologic studies and the evaluation of health outcome data are included under health studies.
Although states are given flexibility in implementing cooperative agreements, ATSDR's training and guidance materials ensure consistency among all grantees. The Agency also ensures the application of sound scientific principles by reviewing reports and products generated by states in each program area. ATSDR has identified four major benefits of the cooperative agreement program. First, linkages are made for site-related public health efforts at federal, state and local levels. Second, ATSDR's ability to provide timely public health services is enhanced. Third, ATSDR's resource base is expanded by approximately 30% because the program provides salaries for more than 120 state-based public health professionals, including toxicologists, environmental health scientists, health educators, community involvement specialists and epidemiologists. Fourth, environmental health capacity at state and local levels is strengthened.
As evidenced by recent trends, the cooperative agreement states are vital to ATSDR conducting site-related initiatives. State health departments have marketed the programs, documented activities and established contacts with other agencies to raise awareness of public health issues in the site management process. Consequently, involvement by states in site characterization, removal and remedial activities has dramatically increased. Over the past two years, participating states have compiled more than 60% of PHAs, prepared approximately 70% of health consultations, and conducted over 50% of EIs. For health education activities, states closely collaborate with communities and local health professionals to identify educational needs, gather data, and create and deliver health education programs that are effective, site-specific and chemical-specific. Participating states share materials developed under the cooperative agreements with other states and ATSDR staff for modification and utilization at other sites. Resource sharing reduces the cost of activities and allows educational efforts to be implemented in a more timely manner.
For health studies, epidemiologic expertise among states has been strengthened and expanded to other program areas. In FY'00, eight health studies were funded under the cooperative agreement. Both ATSDR and the partner states broaden the knowledge base of exposure outcome relationships for toxic substances, such as PCBs, lead, arsenic and VOCs. The scientific quality of PHAs and health education activities has improved to assist states in addressing community concerns related to potential excesses of cancer, birth defects, immune disorders, liver and kidney dysfunction, and lung, respiratory and neurotoxic disorders.
Prior to 1997, ATSDR's activities were primarily targeted to NPL sites. However, this focus has now shifted because fewer sites are added to the NPL. Additionally, states are identifying and addressing more health issues at non-NPL sites. State involvement at both NPL and non-NPL sites is encouraged, but the partner states have repeatedly requested that ATSDR broaden its legislative responsibilities and funding to cover more sites and issues. The programmatic changes of the cooperative agreements reflect modifications to the EPA Superfund program, i.e., the Superfund Accelerated Cleanup Model and the Construction Completion Program. Despite these changes, however, ATSDR will continue to provide public health guidance to site managers in a useful and timely manner. The states' goal of early involvement has resulted in activities being completed prior to sites being proposed to the NPL. This approach has strengthened state partnerships with communities as well as environmental health agencies at federal, state and local levels. The number of requests for state involvement in environmental public health activities has increased as well. However, the cooperative agreement states cannot respond to all requests due to resource limitations.
Several site-specific issues are currently of high interest to the partner states, including vermiculite ore in Minnesota; the indoor release of mercury in Illinois and Michigan; PCBs in Alabama and Massachusetts; elevated rates of childhood cancers from exposure to hazardous substances in New Jersey; exposure from airborne emissions of concentrated animal feed operations in Missouri; concerns of excess cancer and other diseases among students and residents near a former landfill in Texas; contaminated drinking water in California; and elevated lead levels among children in Utah.
At these sites, the cooperative agreement states are conducting PHAs, health studies and health education activities for impacted residents; providing technical support and guidance to federal, state and local agencies; conducting air monitoring; assessing public health implications; identifying and defining exposure pathways; addressing community concerns; advising site managers on site-related public health issues; developing a computer model of a local water distribution system; reviewing literature on toxicological properties for contaminants of concern; designing and implementing health education programs for teachers and health care providers; completing EIs; collecting historical data; providing alternative drinking water sources; and conducting lead testing on local residents.
In addition to the success of the cooperative agreement program, the participating states will face new challenges and opportunities in the future. Over the next ten months, the partner states will support ATSDR's efforts at more than 200 sites with potential asbestos releases from vermiculite ore mines in Libby, Montana. PCBs will be addressed at sites in Alabama, Georgia, Massachusetts and New York. Moreover, participating states will respond to a multitude of requests to become involved with health issues related to redevelopment and urbanization, drinking water contamination, air quality, landfills and animal residuals.
ATSDR's administrative challenges include the current development of a new program announcement. Assurances must be made that new grantees will adequately meet environmental public health needs for the respective states. Public health needs may be best met if ATSDR expands its responsibilities and obtain funding to address issues related to RCRA sites, redevelopment and urbanization, air and water quality, asbestos, and disease surveillance of exposure to hazardous contaminants. ATSDR is currently struggling to maintain the viability of its cooperative agreement program. Consideration has been given to funding fewer states, reducing the size of state programs, limiting activities to Superfund sites, or focusing resources on regional issues.
Growth of the Pediatric Environmental Health Speciality Unit (PEHSU) Program. Dr. Christine Rosheim, of the Office of Children's Health, explained that ATSDR is conducting the program under a cooperative agreement with the Association of Occupational and Environmental Clinics (AOEC). In October 2000, the second annual meeting of the program was held. In addition to representatives from the eight PEHSUs, staff from ATSDR and EPA attended the meeting as well. The purpose of the meeting was to discuss lessons learned, ongoing activities and future directions of the program. The attendees were pleased with the progress over the past year, particularly since only three EHSUs were in operation in 1999 and EPA was not a partner at that time. ATSDR hopes to add two more units to the program by the end of calendar year 2000 for a total of ten. EPA is a partner in six of the eight units. Another milestone is that public demand and interest in the program have increased.
The PEHSUs conduct three major activities. First, children are clinically evaluated by both a pediatric department and an occupational and environmental clinic. The number of children who were examined by PEHSUs increased from 123 in FY'98 to 929 in FY'00. Second, telephone consultations are made to local physicians on diagnosis, treatment and follow-up of patients. Telephone assistance is provided to the public as well. In FY'00, approximately 30,000 telephone calls were placed to PEHSUs. Third, educational outreach initiatives are being implemented, such as programs targeted to medical students, local physicians, EPA staff, local health officials and state health departments. The PEHSUs have also held public meetings.
Another significant accomplishment of the program is the clearinghouse of materials that has been developed, including published peer reviewed articles, medical school curricula, Congressional testimony, modules on CD-ROM, as well as newspaper and magazine articles. Due to the rapid growth of the program, discussions have been held about next steps and future directions. A solid marketing plan should be developed to inform physicians and the public about this resource. ATSDR, AOEC, EPA and the PEHSUs would undertake this effort at national meetings and conferences.
The program should be made available to developing countries. Both the individual PEHSUs and the overall program should be evaluated to determine if some units can be self-supporting. Collaborations should be strengthened with the CDC/EPA/NIEHS Centers of Children's Environmental Health and Disease Prevention Research initiative. Efforts should be continued to increase awareness about pediatric environmental medicine by publishing additional materials.
In addition to evaluating individual cases, the PEHSUs can also play a critical role in a public health emergency that involves a hazardous substance. The PEHSU in the Cook County, Chicago region took the following actions to respond to approximately 333,000 homes that were affected by mercury spills: (1) met with local officials to address health concerns; (2) made recommendations on how exposure histories, medical histories and urine specimens should be collected; (3) developed a screening tool to assist local hospitals and clinics in determining individual mercury exposure; (4) served as a consultant to community clinics and pediatricians; (5) informed the public about mercury through a telephone hotline, newspaper articles, radio interviews, and television appearances; (6) and provided information on treatment, mercury transmission through breast milk, chelation, and the accurate interpretation of laboratory results.
The Chicago PEHSU conducted these activities in collaboration with ATSDR, EPA, and the state health department. Current events on the Illinois mercury spill can be accessed at www.nicor.org. The Chicago model demonstrates the valuable contributions of PEHSUs in risk communication activities and the development of partnerships with local, state and federal agencies.
Dr. Falk added that the PEHSUs are beginning to train pediatricians because consideration has been given to establishing an environmental residency program. However, he emphasized that clinical training programs are outside the scope of ATSDR. He hoped that the American Academy of Pediatrics and other partners could undertake this activity with the PEHSUs in the future. Dr. Rosheim conveyed that another future initiative will allow the PEHSUs to develop specialties in certain areas, such as pesticide exposures, lead poisoning or birth defects. The Mount Sinai, New York PEHSU is currently examining a specialized area with its longitudinal study of toxic effects on the reproductive system. Dr. Rosheim distributed the November 30, 2000 version of the Child Health Workgroup Report. The Board was asked to provide comments on the document to the Office of Children's Health by December 31, 2000.
Public Comment Period. Ms. Judith Shojimade several observations based on ATSDR's presentations. One, strong efforts should be made to control chemicals to ensure that children who are exposed to toxic substances are not re-exposed. Two, ATSDR should not take the approach used by industry in conducting biomonitoring studies because communities should be informed about potential exposures. Three, ATSDR's research agenda has no concrete goals to assist impacted residents. Four, repeated requests by the CTS to receive an itemized breakdown of ATSDR's budget have been ignored. Shoji formally asked that this information be made available to the public. Citizens cannot understand ATSDR's constant emphasis on resource limitations when Board meetings are held at the Westin Peachtree Plaza Hotel. Five, the CTS and members of the public should be actively involved in all components of ATSDR's five-year strategic planning process. Six, the BSC should have an extensive discussion on the critically important issue of physician education at its next meeting. Seven, issues discussed at CTS meetings should be acknowledged and reinforced at BSC meetings, particularly since SCs reflect the general views of affected communities.
Ms. Doris Bradshaw of Memphis explained that two releases recently occurred at a local federal facility site. Workers became ill and residents were extremely concerned because no air monitors were placed at the site boundary to determine if hazardous substances traveled into the community. The site did not establish a telephone hotline, temporary clinic, surveillance system, monitoring program, or emergency mobile unit to address the community's concerns about the releases. At the last BSC meeting, Ms. Bradshaw asked ATSDR to inform high-ranking officials within the Department of Defense (DoD) that the Memphis site was not adhering to its mandate to respond to community concerns. The request was made to ATSDR because no mechanism has been established for citizens to register complaints about federal facilities.
Ms. Bradshaw distributed photographs to the Board to illustrate the close proximity of homes and a school to the site. She strongly reiterated that the Memphis community needs assistance, such as an air monitoring program and a registry of illnesses detected at Superfund sites. Although a nearby aquifer is contaminated by 289 different chemicals, no offsite testing has been conducted. ATSDR should identify the exposure pathway in the community. Ms. Bradshaw also repeated her request for ATSDR to urge DoD to address EJ concerns expressed by residents. The Memphis area wants to ensure that DoD does not implement these types of practices in other communities of color.
Ms. Cynthia Babich, Director of the Del Amo Action Committee, serves as a community advocate for two Superfund sites in California. The presence of DDT and benzene at the sites has placed a tremendous amount of stress on residents about decreases in property values and adverse health effects. The community is requesting that ATSDR revisit the sites because EPA is conducting risk assessments without considering all exposure pathways, particularly chicken eggs. EPA's sampling efforts of produce are flawed as well. Residents are also asking that Ms. Leslie Campbell of ATSDR be reassigned to the site to assist in reestablishing the community's voice. Assistance from ATSDR is also being solicited to develop and maintain capacity among local health professionals. Additionally, recent data on DDT endocrine disruptors should be incorporated into the community's risk assessments.
Ms. Babich asked to have a formal dialogue with ATSDR to determine next steps in the community investigation. The verbatim transcript of these remarks and a report of the Clinic Closure Public Meeting held in February 1998 were submitted into the record. The documents are collectively attached hereto and incorporated by reference as Exhibit 1*. She also presented a documentary that was filmed in the community to illustrate hazardous materials which were dumped in the area.
Ms. LeVonne Stone, Director of the Fort Ord Environmental Justice Network, explained that many problems in the community do not surface due to political issues. One housing area was built on a landfill, but hazardous substances that were present at the site were not identified for the community. Moreover, the largest impact area is heavily populated by minority residents and has been used as a dump. A number of injuries, serious accidents and deaths have occurred among children who play on the bases and find explosive materials or other hazardous substances. While attempting to gather data about these incidents, residents are intimidated and harassed.
There being no further discussion, Dr. Melius recessed the BSC meeting at 5:50 p.m. on November 30, 2000.
Report on the CTS Meeting. Dr. Melius reconvened the BSC meeting at 8:37 a.m. on December 1, 2000 and yielded the floor to the first presenter. Dr. William Au, the CTS Chair, first pointed out three issues related to membership. First, a new BSC member should be appointed to the CTS to replace Dr. LuAnn White whose term has expired. Second, the recruiting process should be started to replace SCs who will be rotating off the CTS. Third, consideration should be given to extending the terms of Ms. Doris Bradshaw and Mr. Gilbert Sanchez for one year to maintain institutional memory. Dr. Au then summarized the recommendations to ATSDR that were raised during the CTS meeting.
Based on ATSDR's presentations the previous day, the CTS added two more recommendations for the Board's consideration: allow the SCs to have a primary role in the strategic planning process, and formally incorporate the Alaska study and the OUA model into the research agenda.
Dr. Au presented a new organizational structure by which the CTS will operate. Task Forces will be formed to address specific issues using a concentrated strategy. The focus and productivity of the CTS will be enhanced by this approach as well. Two to three Task Forces will be established at one time; the membership will include one BSC member as chair, 3-6 SCs, and 1-3 ATSDR representatives with expertise in the particular area. The Task Forces will meet during CTS meetings and hold conference calls in between meetings. External experts will be involved with the initiative as the need arises. The Task Forces are expected to provide focused recommendations that will be presented to the full CTS and eventually forwarded to the BSC and ATSDR.
In general, the new structure was unanimously endorsed by the CTS. In particular, agreement was reached on the topics and membership as follows. Task Force 1 is "how to improve cultural sensitivity training of ATSDR staff." Dr. Millicent Collins will serve as chair; Ms. Doris Bradshaw, Mr. David Johnson and Mr. Gilbert Sanchez will serve as members. Task Force 2 is "how to improve and engage communities with disenfranchised groups." The new BSC member will serve as chair; Mr. Marvin Crafter, Ms. Anna Rondon-Manuelito and Ms. LeVonne Stone will serve as members. Task Force 3 is "how to communicate toxicology and public health information." Dr. Cynthia Harris will serve as chair; Ms. Cynthia Babich and Mr. Richard Matheny will serve as members.
Dr. Au distributed a handout that described objectives under each special topic. Based on the charge by Dr. Melius, ATSDR's third question on EIs will be addressed by Task Force 3. The first progress report of the Task Forces is expected to be made at the next BSC meeting. Dr. Au also informed the Board about the special issue of Environmental Epidemiology and Toxicology that will soon be released. The publication will focus on ATSDR's activities in evaluating health issues among communities and tribes that are exposed to environmental toxicants. In addition to manuscripts by scientists at ATSDR, EPA, NIEHS and other organizations, an article on environmental health problems at an agricultural landfill from a community perspective was published in the journal as well. The paper was written by Ms. Peggy Grandpre, who is a CTS SC. Dr. Falk was recognized for extensively supporting this initiative over the past eight months.
Discussion. The deliberations on the CTS report are as follows. In general, ATSDR committed to addressing all of the recommendations as quickly as possible. In particular, preliminary responses were provided for some of the items. First, the Agency confirmed that the CTS will be actively involved in the strategic planning process. Guidance from the CTS on ATSDR's ongoing activities and future directions will continue to be sought. Second, the Agency views the Alaska study as extremely important. Aggressive efforts to advance and expand the initiative will continue to be made.
Third, consideration will be given to changing the name of PHA, but "public health/site assessment" would be more appropriate since some PHAs extend beyond exposure pathway analyses. Additional suggestions for name changes should be submitted to the Agency. Fourth, ATSDR will have a follow-up discussion with the NEJAC Chair. Fifth, efforts will be made to build a partnership with the IHS to address health care issues. Sixth, the "community chair" model is a sound approach that will be explored. However, the CTS should realize that no single process can be broadly applied in all communities because sites have different methods, structures, and issues.
ATSDR was in favor of the Task Forces and made a commitment to provide support and personnel for the initiative. The Agency then proposed a new concept for the CTS to consider based on the public comment period the previous day. Most of the speakers requested assistance and information on site-specific issues. ATSDR is usually unable to provide an immediate response during the public comment period because time is needed to review ongoing activities at a site and determine gaps, deficiencies or the next course of action. As a result, ATSDR is proposing that one or two hours be set aside during CTS meetings for SCs to meet with Agency staff who have knowledge about the site in question. With this approach, site-specific issues can be addressed and pertinent documents can be provided to the SCs.
Another development of relevance to the CTS is ATSDR's appointment of a Tribal Coordinator for OTA. In addition to being a tribal member, Mr. Dean Seneca has a wealth of expertise in issues related to public health, minority health and environmental health. Mr. Seneca will begin his new position in January 2001. ATSDR recalled that a request was made during the public comment period for Ms. Leslie Campbell to be reassigned to the Del Amo community. Ms. Campbell is currently involved with the new Alaska project, but she will continue to be actively engaged with ATSDR's site activities. Both the Agency and the SCs recognized Ms. Campbell for her outstanding service as the Acting Tribal Coordinator for OTA.
For ATSDR's consideration of the cultural sensitivity recommendation, the BSC described an inexpensive process used by NIEHS. A Diversity Council holds monthly events in which employees or external presenters who have disabilities or are members of minority groups discuss issues that are unique to these and other special populations. The model has been well received by NIEHS. Dr. Melius entertained a motion to approve and forward the CTS recommendations to ATSDR. Dr. White so moved; Dr. Harris seconded the motion. There being no further discussion, the CTS recommendations were unanimously accepted by the BSC and will be forwarded to ATSDR.
Agenda Item: ATSDR to present a progress report of the Alaska project.
Developments in Washington, DC. Dr. Andrea Wargo, the ATSDR Associate Administrator, explained that well-established procedures currently exist for the transition to a new Administration. The White House recently requested that the 3,000 political appointees and U.S. Ambassadors tender official letters of resignation to be effective on January 20, 2001. Key Administration officials recently met to discuss personnel issues and prepare briefing packets for positions that will need to be filled. The officials also agreed to brief the new Administration on national security issues.
Transition documents that are prepared for agencies are eventually forwarded to departments. The HHS briefing book has already been completed, but the HHS bill has not yet been signed into law. The continuing resolution under which the HHS agencies have been operating will expire on December 5, 2000. A long-term continuing resolution of four months is expected to be developed. Either the FY'00 funding level or figures proposed in the unsigned HHS bill will be set, but the FY'00 budget will place some programs in jeopardy. Another problem is the extremely short time frame the new Administration will have to prepare and submit the President's budget to Congress. Programs may not be provided an opportunity to appeal earmarks. Most notably, time constraints may not allow ATSDR to weigh in on the fact that its base budget has remained steady at $64 million for several years.
In terms of Congress, 221 Republicans, 212 Democrats and 2 Independents are in the House. Under the Bush Administration, 50 Republicans and 50 Democrats will be in the Senate. Under the Gore Administration, 51 Republicans and 49 Democrats will be in the Senate. Due to the six-year term limit on Committee and Subcommittee Chairs, 14 out of 20 Committee Chairs will be under new leadership in the current Congress. Two Committees in the House have jurisdiction over Superfund. No action was taken by the 106th Congress on two Superfund bills due to extremely opposing views by the Administration and Congress on the need for comprehensive Superfund reform. Of the 13 House Appropriations Committee Chairs, 7 will change. The Chair of the Environment and Public Works Committee issued a press release that praised ATSDR's public health activities at a Nevada site. Medical testing was conducted on former mine workers who were exposed to asbestos in vermiculite. The Brownsfield bill is expected to be reintroduced, but the Administration's position is uncertain.
Medical Testing of Persons Exposed to Asbestos Contaminated Vermiculite in Libby, Montana. Dr. Jeffrey Lybarger, Director of the Division of Health Studies, provided an update on ATSDR's activities at the site. From July through November 2, 2000, the Agency conducted a clinical operation in Libby. The medical testing program included three views of chest radiographs, pulmonary spirometry, and an extensive interview to obtain exposure and medical histories. ATSDR divided the community into four exposure groups: occupational exposures to full-time and temporary workers; household contacts to family members of workers; recreational exposures to children; and air emissions to community residents. Medical testing criteria were defined by persons who lived or worked within a 2½-mile radius around the site or on the road that extended toward the mine.
Of the 6,787 persons who met the case definition and scheduled appointments, 6,147 individuals participated in the testing. In terms of the current status, data are being interpreted and analyzed. The local radiologist has evaluated all chest x-rays for clinical abnormalities that needed immediate attention. Examinations of chest x-rays by two B readers are expected to be completed in February 2001. If the two reviewers have different interpretations, the films are forwarded to a third reader for a final decision. All pulmonary function tests have been completed as well and entered into a database. ATSDR anticipates developing a preliminary data set within the next two months. Additionally, notification letters are being distributed to participants. However, the letter and chest x-ray films are sent to the designated primary care physician one week in advance in the event the patient has medical questions. The electronic database of chest x-rays will eventually be archived at the state health department.
As of October 19, 2000, questionnaires were completed for 5,497 participants. Of these persons, 49% are men; 51% are women; 9% are <17 years of age; 32% are 18-44 years of age; 42% are 45-64 years of age; 17% are >65 years of age; 300 reported work at WR Grace; 368 reported other vermiculite work; 1,085 reported household contacts; and 65% had a Libby zip code. Participants who were <17 years of age received a pulmonary function test and clinical interview, but did not receive chest x-rays due to the long latency period of the disease. Based on initial evaluations by the local radiologist, 323 participants were immediately referred for urgent care, i.e., 313 for abnormalities on chest x-rays and 10 for spirometry. The referrals were made due to 150-160 participants with heart-related conditions, several cases of densities in the lung, and 35 patients with plural thickening.
Of the 5,497 participants, 429 had completed chest radiograph interpretations. Reviewer 1 saw 2 lung and 38 plural abnormalities, while reviewer 2 saw 14 lung and 29 plural abnormalities. The percentages of asbestos-related abnormalities in this cohort as determined by the two reviewers were 9% and 10%, respectively. By mid-January 2001, ATSDR hopes to develop a preliminary data set of approximately 1,500 articipants. This information will be included in a program review and a written report for the community. In addition to medical testing, ATSDR is conducting other activities to evaluate the public health impact at the Libby site. Consultations and environmental reviews were conducted to support EPA's cleanup actions. A mortality analysis was recently completed to provide a better assessment of the burden of illness in the community as well as to make a case for additional resources.
A tremolite consultation was undertaken because the existing toxicological profile for asbestos did not specifically address vermiculite. The planning process to establish criteria for additional testing will begin later in the month. Consideration is being given to developing a registry of exposed persons with an initial focus being placed on former workers. Community involvement and health education activities were mplemented, including public availability sessions and physician education programs. In addition to these activities, two investigations are being conducted to evaluate the public health impact at the site.
First, a case series will characterize the clinical presentation and progression of illness to document the burden of disease in the community. These data will be used to educate physicians and provide the basis for longitudinal evaluations. The case series will initially include ten persons with no known occupational or recreational contacts. Clinical abstractions will eventually be conducted among 300 individuals. Second, the CT-scan study will measure the rate of abnormalities not identified by chest radiography to ensure that no clinical diseases were overlooked. The cohort for the CT-scans will include persons who did not meet the epidemiologic criteria for abnormalities in the medical testing component, including workers, family members of workers, and recreational contacts. The protocol for the test is currently under review. Data collected by the CT-scans will be used to make recommendations for future testing programs.
An activity that will extend beyond Libby is the national evaluation of more than 300 vermiculite sites. EPA will first identify and characterize the sites by conducting inspections and any necessary environmental testing. ATSDR will then assess the sites from an environmental perspective to identify those with risks of past and present exposure. To identify health impacts from past exposures, ATSDR will conduct a health statistics review at several sites as well. The Agency will continue to have a strong presence in the community by attending meetings and other events.
Discussion. The deliberations on ATSDR's activities at the Libby site are as follows. The SCs requested that consideration be given to implementing the Libby model in Los Alamos because several fires at the site emitted asbestos. An invitation was extended for ATSDR to visit the community and discuss potential asbestos exposure with residents. The SCs also requested details about the study from a community perspective: assurances made to provide impacted residents with accurate information; if the exposed population was treated; the number of exposed children; efforts to inform former workers and residents about the study; and efforts to engage surrounding neighborhoods. To assist in filling data gaps on tremolite, asbestos, mesothelioma risks and lung cancer risks, the BSC urged ATSDR to include data from the NIOSH study of Libby miners. Since workers had the highest exposure, data from this population will be extremely useful in subsequent studies of groups with lower exposure levels.
ATSDR responded to the community-related issues as follows. First, developing a cohort to examine asbestos in Los Alamos will be difficult because the site has no historical environmental data. Additionally, fire emissions do not usually cause asbestosis because the condition is dose-dependent and requires a fairly substantial longitudinal exposure. However, ATSDR will consider the possibility of conducting a statistics review to determine if other health outcomes were caused by the Los Alamos fires. Second, the data set for the number of exposed children is incomplete, but ATSDR expects to analyze information for this population by March 2001.
Third, data from five sources are clinically evaluated to ensure that impacted residents receive accurate information, i.e., the initial radiologist report; results from two or three physicians with expertise in diseases related to dust or asbestos; and findings from the pulmonary function test. Abnormalities seen by any of these providers are included in the notification letters to participants and their designated primary care physicians. Fourth, asbestos-related conditions are difficult to treat, but ATSDR ensures that physicians are informed about any serious complications to slow the progression of disease. ATSDR also facilitated a meeting in May 2000 for Libby physicians to learn about new therapies developed by the National Institutes of Health (NIH). Opportunities may be provided in the future for Libby residents to participate in NIH clinical trials.
Fifth, emphasis is being placed on national media efforts and word-of-mouth to inform former workers and residents about the study, but ATSDR realizes that these outreach activities are inadequate from a long-term perspective. The registry of miners will be a much better mechanism because company records will be used to identify former workers and include this population in future testing. Sixth, 91% of individuals who scheduled appointments were examined, which is an extremely solid participation rate for the area. The rate was also high among participants who were willing to share medical records with the local hospital and community asbestos clinic. Another measure of the community's strong interest was ATSDR's expectation that approximately 3,500 persons would enroll in the program. However, more than 6,000 individuals actually participated in the study.
In terms of the NIOSH study of Libby workers, ATSDR expressed a great interest in obtaining these data to include in a registry of miners. The findings could also assist the Agency in conducting another study to examine the progression of illness over time. However, NIOSH has not yet indicated its interest in this activity.
Minority Health Program. Dr. Reuben Warren, the OUA Director, explained that the office was established in 1997 to focus on minority health, Brownsfield and EJ issues. Although OUA has used the EJ Executive Order to integrate White low-income populations in its activities, the new focus has not detracted from the mandate to serve minority populations. This innovative public health approach allows ATSDR to actually enter communities and directly interact with residents. The Agency is also unique because its Minority Health Program was among the first to be developed in the U.S.
In 1985, the federal government first acknowledged that health disparities by race and ethnicity could be documented. HHS established an Office of Minority Health in 1986, but the realization was soon made that resources from one office could not address the huge issue of disparities. As a result, a minority health office was formed in each HHS agency, but ATSDR's Minority Health Program was already in operation prior to 1988. Additional details about the history of these events can be reviewed in the Minority Health and Environmental Justice program booklet. The document can be obtained from OUA.
Another event in which ATSDR served as the lead was the National Minority Health Conference. Communities throughout the country were invited to discuss minority health concerns with several PHS agencies. OUA will provide the conference proceedings upon request. ATSDR's current minority health activities are building upon programs that were established in 1987. For example, the Substance-Specific Applied Research Program allows Historically Black Colleges and Universities (HBCUs) to strengthen capacity and infrastructure in environmental health. The progress under this cooperative agreement has been remarkable. Additionally, ATSDR's support of the Mississippi Delta Project since 1994 has developed partnerships with 7 states, 219 counties and several local communities in the Mississippi Delta Region. ATSDR developed needs assessments of environmental and health concerns in the area and later implemented demonstration projects.
ATSDR's efforts in the Mississippi Delta Project were instrumental in funding four research projects in Memphis, Tennessee; New Orleans, Louisiana; Jackson, Mississippi; and Little Rock, Arkansas. Another ongoing initiative is ATSDR's cooperative agreement with Clark-Atlanta University and a local EJ consortium. While ATSDR will focus on the public health component of the activity, the institution's efforts will be targeted to EJ issues. ATSDR hopes to expand the initiative so that the EJ consortium will consider health from a public health perspective, particularly disease prevention and health promotion. Overall, ATSDR's public health practices have been consistent with recommendations published in a 1999 report by the Institutes of Medicine (IOM) and National Academy of Science (NAS). The document identified EJ initiatives, research activities and educational services that need to be implemented in the future. One of most significant recommendations in the report advised agencies to err on the side of the public's health even if a cause/effect relationship is doubtful.
OUA has used this concept to pursue its minority health agenda. On the one hand, partners and stakeholders are informed that ATSDR does not relocate residents, decide liability or provide care. On the other hand, the Agency's ethical responsibility to improve and coordinate access to primary care is highlighted. To assist in this effort, ATSDR identified federal, state and local agencies that provide care. In 1988, an MOU was signed by ATSDR and the Health Resources and Services Administration (HRSA). The purpose of the MOU was to allow ATSDR to build environmental health capacity among providers so long as this expertise was delivered in HRSA clinics. If the initiative proved to be successful, the knowledge and skills of providers would be strengthened in identifying, diagnosing and treating patients with environmental health concerns. HRSA welcomed the partnership due to the realization that environmental medicine is the least taught subject in medical school.
Memphis was specifically identified in the MOU as the first pilot site for the project. ATSDR has been conducting activities in the community for the past two years; the implementation phase is almost complete. The findings will eventually be evaluated and generalized to other communities. To date, ATSDR has held a continuing education session on environmental medicine for nurses. The curriculum developed under the program was reviewed and distributed to several nursing schools. Educational materials for physicians are currently being refined. ATSDR expects to hold a continuing education session for doctors in February 2001. Both the local health department and the Memphis Health Center have committed to implementing curricula developed for physicians and nurses.
Another activity under the MOU was ATSDR's application of the Memphis model in Mossville, Louisiana. The community was concerned that while partnerships were being developed among federal, state and local agencies, no actions would be taken to address 14 residents with elevated dioxin levels. As a result, ATSDR collaborated with the Lake Charles Neighborhood Health Center to facilitate a continuing education session to physicians and nurses on dioxin, including long-term and toxicological effects. The health center agreed to track the Mossville residents to monitor adverse effects from dioxin over time.
Other minority health activities include ATSDR's recent meeting with five HBCUs that have public health programs: Meharry Medical College, Morehouse School of Medicine, Florida A&M, Morgan State, and Jackson State. Of the five institutions, four have already included an environmental medicine component in the curriculum. ATSDR's goal is to enhance, complement or supplement the schools' environmental health programs to more fully integrate this component in minority communities. ATSDR has also established a relationship with the National Medical Association, which has a membership of 25,000 African American physicians. The group has formed an Environmental Health Task Force to more effectively serve low-income and minority populations. ATSDR hopes to develop a similar activity with the Inter-American College of Physicians and Surgeons, which is the largest association of Hispanic physicians in the U.S. Moreover, ATSDR's meeting with NEJAC on December 11, 2000 will reinforce commitments that have been made to improve access to medical care for environmental health concerns.
In addition to the accomplishments and positive future of the Minority Health Program, ATSDR will face two major challenges. First, current perceptions about Asian Americans and Pacific Islanders will need to be changed because these groups are believed to have no major health concerns. However, subgroups in these populations have similar environmental health problems as other disadvantaged communities. Efforts will be made to design projects that are specifically targeted to these subgroups. Second, ATSDR has a solid record of delivering environmental health products and services to Native Americans and Alaska Natives. However, 60% of these populations are disenfranchised or not serviced by IHS. Another barrier to fully integrating Native Americans and Alaska Natives in ATSDR's mission is that the groups can be viewed as either separate nations or a collective minority population.
Dr. Warren concluded by describing the major goals of ATSDR's Minority Health Program: (1) improve the assessment of minority populations; (2) fully integrate issues related to EJ and Brownsfield; and (3) eliminate disparities by ensuring that minority health concerns are the same as the reminder of the nation.
NCEH/ATSDR Shared Vision of Environmental Public Health. Ms. Georgi Jones of ATSDR and Mr. Mike Sage of NCEH lead the planning process of the initiative for the respective agencies. Dr. Koplan's initial charge was for CDC to define a comprehensive model of an environmental public health program and establish strategies to implement the activity. During the initial planning process, however, CDC realized that ATSDR's environmental health program should be included as well. As a result, the agencies agreed to develop a shared vision. A ten-member workgroup was established in August 2000 with five representatives from each agency. The workgroup's draft report will be submitted by December 15, 2000.
The first step in developing the shared vision was to identify challenges in the field of environmental public health. The three most recurring themes as determined by partners and stakeholders were fragmentation, the need for national leadership, and new emerging threats at local, national and international levels. The workgroup then defined four major goals of the shared vision. First, ATSDR and CDC should collectively serve as the national and global resource for environmental public health. Second, a seamless and complimentary approach should be developed to incorporate the expertise of both agencies. Third, environmental public health should be unified as a discipline. Fourth, health benefits should be provided to populations served by the agencies.
The next step in the process was to identify strengths and weaknesses of the agencies in accomplishing goals. Under technical capacity, NCEH already has a well-established laboratory component. Both agencies have strong skills in epidemiology and biostatistics, but neither ATSDR nor CDC has expertise in behavioral and social sciences. ATSDR's exposure registry and NCEH's exposure report card address the tracking and surveillance of exposures. Neither agency has a functional registry for the tracking and surveillance of diseases because actions have not been taken beyond an initial effort. No mechanism has been established in either agency for the tracking and surveillance of behaviors.
Under the gene/environment interaction, NCEH has conducted studies in this area. Under health and exposure assessments, ATSDR has expertise in toxicology, risk analysis, physiology, pathology, and environmental sciences, including air, food, soil and water. Geographic information systems and informatics were also identified as necessary tools. To address the problems, the agencies will need to take a more proactive role in providing guidance to regulators and decision-makers. ATSDR's advice has been primarily limited to EPA's Superfund program, but neither agency has made recommendations about air and water to regulators. Both ATSDR and NCEH realize the criticalimportance of developing solid health education and risk communication programs to accurately convey messages of the shared vision.
To treat the problems, guidance will need to be provided to health care professionals. Both agencies realize that skills to conduct behavioral change research will need to be strengthened. Health promotion activities, medical screening and initiatives to facilitate treatment will need to be implemented as well. To assess the shared vision, analytic capabilities will be required to evaluate the effectiveness of the program, conduct a cost-benefit analysis, and develop an economic analysis. To enhance environmental public health capacity at state, local and international levels, the agencies will need to transfer technology, provide training and technical assistance, assign staff members to the field, and provide financial support. After Dr. Koplan approves the first draft, the workgroup will begin obtaining input on the implementation plan from external partners and staff members at the two agencies.
Discussion. The deliberations on the environmental public health vision are as follow. The BSC was pleased that the draft plan includes the necessary components for a successful environmental public health program. However, the shared vision does not fully address the fragmentation issue, such as the tremendous gap between public health, environmental health and public health actions. For example, significant data gaps exist on compounds that cause no adverse effect in healthy populations, but may demonstrate an impact in persons with chronic diseases. During the implementation phase, the BSC suggested that successful models of interagency collaboration be applied. The Board also pointed out that the shared vision does not address issues related to bioethics, privacy, confidentiality and gene storage.
NCEH agreed that fragmentation is a major issue at local, state, federal, national and academic levels. To compliment the agencies' joint effort, the NCEH Directors' Advisory Committee has expressed an interest in meeting with the BSC. NCEH offered to present findings from the national exposure report card at a future Board meeting. As an initial step in solving the fragmentation problem, ATSDR realizes the need to partner more closely with NIH and other components of CDC, such as the National Center for Chronic Diseases. Both agencies were pleased that interest and support by Congress in environmental public health have increased.
ATSDR confirmed that existing models would be reviewed during the implementation phase. For example, the methyl parathion project was conducted under a solid partnership between ATSDR and NCEH. ATSDR has also sought guidance from the NCEH laboratory in several activities, while NCEH has used ATSDR's toxicological profiles in a number of studies. The Executive Secretary encouraged both agencies to include input from communities and tribes during the implementation phase. He also suggested that the agencies' research agendas and collaborative research efforts be coordinated under the shared vision. ATSDR and NCEH agreed with the Board's suggestion to include bioethical issues in the shared vision.
Public Comment Period. The Chair opened the floor for public comments; no attendees responded.
BSC Business. The recommendations, action items and agenda items raised during the meeting were reviewed by the Executive Secretary and are so noted in the minutes. Additional agenda items suggested by the Board are outlined below:
Closing Session. Dr. Falk thanked the Board for providing valuable input on the agenda items. The BSC's recommendations on ATSDR's future initiatives were particularly appreciated. The next BSC meeting will be held on May 3-4, 2000; the following meeting is tentatively scheduled for November 15-16, 2000.
There being no further discussion, Dr. McDiarmid adjourned the BSC meeting at 11:47 a.m. on December 1, 2000.
I hereby certify that to the best of my knowledge, the foregoing minutes of the proceedings are accurate and complete.
Dr. James Melius, Chair
Board of Scientific Counselors
-----------------------------------
*Exhibit 1 will be made available upon request.
This page last updated on August 14, 2001
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